MinTankesmie

Kan vi stole på legemiddelindustrien?

Kan vi stole på legemiddelindustrien?
LEDER
Tidsskr Nor Legeforen 2010; 130:1013 (20.5.2010)
Det er objektivt klanderverdig å konstruere studier ut fra hva man ønsker å vise og å unnlate å publisere viktige data. Legemiddelindustrien gjør begge deler

Min allmennpraktiserende kollega Ingard Løge i Trondheim sa en gang at «Hvem som helst kan skrive resept. Det er alt det andre som er legekunst». Løge mente ikke å si at farmakoterapi alltid er enkelt, men at vi har et for sterkt fokus på legemidler – og for lite fokus på «alt det andre». Løges kloke ord reflekteres i Robin Holtedahls oversiktsartikkel om pregabalin ved fibromyalgi i dette nummer av Tidsskriftet (1). (...)

(Anm: Uredelighet og fusk i medisinsk forskning. (mintankesmie.no/).)

- Tror du legemidlene din lege forskriver er trygge? Vel, ikke vær for sikker

Think the drugs your GP gives you are safe? Well, don't be so sure (Tror du legemidlene din lege forskriver er trygge? Vel, ikke vær for sikker)
By Professor David Healy
dailymail.co.uk 24.4.2012
We are all swallowing an increasing number of pills, not just to treat disease but to cut the risk of getting a disease in the first place. Even in a time of austerity the NHS is spending nearly £12 billion on drugs and the total keeps rising.

People believe the drugs are effective and safe because they have all been properly tested in clinical trials. But this is a dangerous delusion.

Failures in our system for testing drugs mean not only are drugs often no better than a placebo, but, at worst, they end up damaging the health of tens of thousands of Britons every year. Pharmaceutical companies spend billions conducting trials to come up with evidence for the benefits of drugs, but they have a number of ways of making small benefits look impressive. (...)

As a psychiatrist who has spent nearly 15 years uncovering concealed evidence of how SSRIs can cause patients to commit suicide, I’m very aware of the ability of drug companies and drug regulators to keep asserting there is no problem in the face of the most damning evidence.

In a system committed to patient safety, reports of side-effects would be carefully investigated. But when I uncovered evidence that the companies making the SSRI drugs for depression were hiding studies that showed a raised suicide risk, no one wanted to know. The UK drug watchdog — the MHRA — did nothing. Another technique to play down unfavourable results is ‘ghost writing’. In theory, the scientist heading a clinical trial analyses the findings and the results are published with his or her name on it. Not so in the distorted version of evidence-based medicine created by drug companies.

Payouts: Pharmaceutical companies have had to pay millions in compensation to patients who have had adverse reactions to drugs

We are talking here about the controlled trials, which doctors and regulators rely on to tell if a drug is more likely to work for you or to cause you harm. Worryingly, many that appear in top journals such as the New England Journal of Medicine have actually been written up by ‘ghosts’ employed by the pharmaceutical company that has a patent on the drug, and so are far more likely to provide the results they want.

However, the name that appears on the paper is often that of a senior consultant who is well paid for lending his name and authority to the work.
Sometimes, there can be a shocking gap between what the trial had found and how it was written up. (...)

Also, the side-effects are often the same as the ones caused by the disease. Depression raises the risk of suicide but so do SSRI anti-depressants. Cardiovascular conditions cause memory loss and diabetes — as do statins. The way to isolate the side-effects of the drugs is to test them on healthy volunteers, which companies have to do, but the results are rarely released to the public.

Just how much the system allows drug companies to accentuate the positive and eliminate the negative was shown in the way a tranquiliser called Zyprexa (olanzapine in the UK) was promoted. It was licensed on the basis of four clinical trials involving just over 2,000 patients.

Yet the company was able to carve up the results into separate articles that appeared in 234 medical publications all saying how effective this drug was. The evidence for its benefits appeared overwhelming when it was just the same data being repeated.

Sales soared. There was no mention of the potentially deadly side-effects, even though it was known to increase the risk of diabetes and heart disease — as well as being linked with suicide. The companies cut the risk up into small bits so that overall it looks safe.

But until trial data is freely available for independent researchers to examine, these abuses are likely to continue. (...)

(Anm: Statlig legemiddelkontroll (Statens legemiddelverk etc.) (mintankesmie.no).)

(Anm: The European Medicines Agency (EMA) (tidligere EMEA) (den europeiske legemiddelkontrollen) (mintankesmie.no).)

- Mottrekk mot legemiddelindustriens markedsføringsmaskin

Countering the drug industry's marketing machine (Mottrekk mot legemiddelindustriens markedsføringsmaskin)
newscientist.com 30.4.2012
Patients, not drug companies, should give feedback on medicines for a true picture of their effectiveness

Your new book is called Pharmageddon. What does the title mean?

"Pharmageddon" refers to a change in healthcare that's rather like climate change. When we hop in our cars to go to work, this seems to be a good thing. But we don't connect it to the fact that we may be pushing the climate towards the brink. In the same way, the climate of healthcare is being pushed towards the brink by doctors giving patients expensive and risky drugs - and failing to notice when things go wrong. Medicine as we had it will cease to exist. It will become Healthcare Inc.

Why has this happened?

Worldwide product patents give companies such extraordinary returns that they have got a tremendous incentive to hype the benefits of drugs and hide any possible risks. Then we made these drugs prescription-only, so the true consumers of a drug are not you and me. The consumer, from the industry's point of view, is the doctor who prescribes the drug. Companies offer free gifts for doctors, trips to the Caribbean to meetings, and so on. But most doctors, while they probably are influenced by these things, are even more influenced by the evidence.

So hasn't evidence-based medicine helped?

I'm an advocate of controlled trials but we have an overblown estimate of how useful they can be. Clinical trials are done mostly by the industry. Only half of the trials are published and of those that are, ghostwriters for the industry polish a negative trial so that it's glowingly positive.

Couldn't these problems with clinical trials be fixed?

If we had the capability to do 100 times more trials than we're doing, if the trials were independent and we had access to all the data, then we would be much further forward. But you have to wonder how realistic that is. Controlled trials are hugely useful but they shouldn't be the only club that you take to the golf course. We need to restore people's ability to make judgement calls based on the evidence in front of their own eyes.

How will your new website, RxISK.org, help?

The idea is to encourage people to produce the best possible descriptions of things that happened to them on treatment and to take the descriptions to their doctor, with a view to engaging him or her in the process. If we get a bunch of people who have the same issue, we'll be able to tease things apart. We'll be giving people feedback in real time, saying: "We've got 200 people who have reported the same problem." It's going to make lots of patients and doctors much happier to speak up. (...)

- Enorm korrupsjon innen legemiddelindustrien

Documentary reveals the unhealthy profits of the pharmaceutical industry (Dokumentar avslører skadelig profitt innen legemiddelindustrien)
thebureauinvestigates.com 11.8.2010
USAs helseindustri er verdens største – med 300 milliarder dollar hvert år brukt bare på legemiddelforskrivninger, og omsetningen er økende. Men i løpet av de siste månedene er det dukket opp helseskandaler på helseskandaler, hvor noen av verdens største legemiddelfirmaer er idømt bøter for milliarder av dollar. (The United States healthcare industry is the world’s biggest – with $300 billion a year spent on prescription drugs alone, and rising. But recent months have seen health scandal after health scandal, with some of the world’s biggest pharmaceutical companies fined billions of dollars.)

Disse sakene avslører enorm korrupsjon innen legemiddelindustrien, med avsløringer av svindel, underslag av dødelige sideeffekter og store penger under bordet til leger. Vår granskning avslører historien om hvordan helseomsorg ble skadelig profitt. (…) (These cases are beginning to reveal vast corruption in the drug industry, with revelations of fraud, of cover-ups of fatal side effects and huge kickbacks paid to doctors. Our investigation reveals the story of how healthcare became unhealthy profit.)

US health department recovers $4bn through antifraud action (Amerikanske helsedepartementer er tilkjent erstatninger på 4 milliarder dollar gjennom antisvindeltiltak)
BMJ 2011; 2011; 342:d615 (28 January)
The US Department of Health and Human Services and the Department of Justice announced on Monday 24 January that the government’s healthcare fraud prevention and enforcement efforts had recovered more than $4bn (€2.5bn; $2.9bn) in the 2010 fiscal year.

Pengene kom fra legemiddelfirmaer, sykehus, legekontorer, sykehjem, og andre helse- og sosialtjenester som hadde svindlet staten. Det var "det høyeste årlige beløp som hittil er tilkjent fra mennesker som forsøkte å svindle seniorer og skattebetalerne,” uttalte departementene i et felles meddelelse. (The money came from drug companies, hospitals, doctors’ offices, nursing homes, and other healthcare providers that had cheated the government. It was “the highest annual amount ever recovered from people who tried to defraud seniors and taxpayers,” the departments said in a joint statement.)

The $4bn had been stolen from federal healthcare programmes and was returned to Medicare, which provides health insurance for elderly people, the Treasury, and other programmes. (...)

Bitter pills for drug companies (Bitre piller for legemiddelfirmaer)
BMJ 2010; 341:c5095 (17 September)
Etter kritikk om at kraftige bøter ikke får legemiddelfirmaer til å avstå fra å involvere seg i ulovlig forretningspraksis, er amerikanske myndigheter i ferd med å ty til mer radikale tvangsmiddel. (After criticism that massive fines are failing to dissuade drug companies from engaging in fraudulent business practices, the US government is turning to more radical enforcement measures. Melanie Newman reports)

It was the biggest fine ever imposed in America, the largest healthcare fraud settlement in Department of Justice history, and the largest civil fraud settlement ever paid by a drug company. It was, said Kevin Perkins, assistant director of the Federal Bureau of Investigation’s criminal investigative division “a clear message” to drug companies that they would not be allowed to “peddle their prescriptions or products for uses beyond their intended—and federal government-approved—purpose.”

Pfizer had just agreed to be fined a record $2.3bn (£1.5bn; €1.8bn) for illegally promoting four drugs—valdecoxib, ziprasidone, linezolid, and pregabalin—for uses that the US Food and Drug Administration had not approved.1 The company was also accused of paying incentives or “kickbacks” to doctors to prescribe the drugs, a charge that was also resolved under the terms of the settlement. Both practices are considered fraudulent in the US, because they mean government healthcare programmes are paying for drugs that may not work effectively or are unnecessary.

On the day after the fine was announced, the New York Times pointed out that $2.3bn amounted to less than three weeks of Pfizer’s sales.2 And US authorities admitted that Pfizer was illegally marketing its drugs at the same time as it was negotiating settlement terms for a similar, previous offence. (...)

Glaxo Hit by $3.5 Billion Charge
online.wsj.com 17.1.2011
LONDON—U.K. drug giant GlaxoSmithKline PLC said it will record a £2.2 billion ($3.49 billion) charge in the fourth quarter to cover costs relating to a U.S. government investigation of Glaxo's marketing practices, as well as additional costs tied to consumer lawsuits regarding the diabetes drug Avandia.

The sum is the latest in a series of large charges Glaxo has taken in recent quarters as it tries to settle a number of investigations and other liabilities hanging over it. In the second quarter of 2010 the company took a charge of £1.57 billion to settle lawsuits involving Avandia and the antidepressant Paxil, and to settle a U.S. government investigation of a Glaxo factory in Puerto Rico.

The latest £2.2 billion charge—which will likely eclipse Glaxo's profit for the quarter—is a sign that Glaxo is drawing nearer to settling a seven-year-old U.S. government investigation of its marketing practices, which has examined Glaxo's promotion of several drugs between 1997 and 2004. That investigation began at the U.S. Attorney's Office in Colorado, but is now being led by the U.S. Attorney's Office in Massachusetts. (...)

(Anm: Seroxat (Paxil) (paroxetine; paroksetin) (SSRI) (mintankesmie.no).)

- Legemiddelfirmaer tatt på fersken igjen: store gap mellom fremlagte data, og firmaenes tall

Pharma caught off-guard again: big gaps between state payment data, company numbers (Legemiddelfirmaer tatt på fersken igjen: store gap mellom fremlagte data, og firmaenes tall)
postscript.communitycatalyst.org (16.12.2010)
An investigative outfit’s consolidation and analysis of payments that drug companies made to doctors has refocused attention on state efforts to shine light on the financial ties between doctors and drugmakers.

Currently three states—Minnesota, Massachusetts, and Vermont—require drug companies to disclose payments to prescribers and make some of that data public. While each of these states takes a different approach to collecting and making the payment data available to the public (more on that here), information from all three have been extremely valuable in demonstrating the dimensions and scope of these marketing relationships. And now a new value to the state data has emerged: demonstrating that pharma isn’t keeping very good track of who it’s been paying what.

The ProPublica report in Monday’s Minnesota Star Tribune and here online found a series of big discrepancies between what a company said it paid a doctor on its website and what it told the state of Minnesota it paid the same person. Right now, ProPublica can only crosscheck the seven companies that have posted payments on their own websites. (...)

Drug companies' reports aren't always accurate (Legemiddelfirmaenes rapporter ikke alltid riktige)
startribune.com 12.12.2010
A new federal plan will require drug and medical device companies to report all payments to U.S. physicians in 2013. The danger? As Minnesota found, some information may be incorrect.

Long before the rest of the country cared, Minnesota took aim at the pharmaceutical industry.

In 1993 it passed a novel law: If drug companies paid any of the state's health providers to push their pills, the money had to be publicly reported.

Two decades later, the federal government is poised to follow suit, promising a new era of openness.

But a ProPublica analysis of drug company disclosures in Minnesota provides a cautionary lesson: The information submitted may not be accurate.

To vet Minnesota's reports, ProPublica compared them to its Dollars for Docs database, a compilation of speaking fees and consulting payments reported by seven drug companies since 2009. (...)

- Legemiddelindustrien er nå den som svindler staten for mest penger

New image for the drug industry
Drug industry is now biggest defrauder of US government (Legemiddelindustrien er nå den som svindler staten for mest penger)
BMJ 2012;344:d8219 (10 January)
Stephen Whitehead, the new head of the Association of the British Pharmaceutical Industry, thinks that the bad press given to the drug industry is largely undeserved.¹ A paragraph heading calls for collaboration. Facts are clear and this call is frightening because in the US laws exist and are implemented.
Public Citizen has made the diagnosis: “While the defense industry used to be the biggest defrauder of the federal government under the False Claims Act, a law enacted in 1863 to prevent military contractor fraud, the pharmaceutical industry has greatly overtaken the defense industry.” Settlements for criminal and civil monetary penalties reached a total of $20bn (£12.9bn; €15.4bn) during 1991-2010, with three quarters of the settlements and penalties occurring between 2006 and 2010.²

Merck agreed with the US Department of Justice on 22 November 2011 to pay $950m to resolve criminal and civil charges over the promotion and marketing of rofecoxib (Vioxx).³ A few weeks before, GlaxoSmithKline agreed on $3bn to settle civil and criminal investigations into its sales practices for numerous drugs—its fourth case since April 2008. This payment surpassed the previous record of $2.3bn by Pfizer in 2009.⁴

The Foreign Corrupt Practices Act (FCPA; US Bribery Act) is enforced by the Securities and Exchange Commission and the US Justice Department. Recently they have been looking into drug companies’ foreign sales practices. Johnson & Johnson was the first company to pay to resolve FCPA allegations in April 2011 ($70m). Pfizer has just reached agreement in principle to resolve “improper payment” matters outside the US.5 Eli Lilly is close to a settlement. AstraZeneca is working to reach an agreement. Many others are being questioned. (...)

- Leger krever uhildet viten om legemidler

Læger kræver uvildig viden om medicin (Leger krever uhildet viten om legemidler)
b.dk 28.11.2011
Lægemiddelindustrien driver og finansierer lægernes vigtigste opslagsværk om medicin. Det vil lægerne stoppe.

Læger skal have nem adgang til uvildig information om lægemidler, som ikke kan mistænkes for at være styret af lægemiddelindustrien.

Lægeforeningen opfordrer nu sundhedsminister Astrid Krag (SF) til at etablere et nationalt videncenter, som sikrer sundhedspersonale adgang til de nødvendige oplysninger.

I dag er lægers primære kilde til viden om medicin opslagsværket promedicin.dk, som ejes og drives af medicinalindustrien.

- Det er fagligt stærkt og brugervenligt, men signalet er simpelthen forkert. Det er uholdbart, at medicinalindustrien ejer det mest benyttede opslagsværk om lægemidler, siger Lægeforeningens formand, Mads Koch Hansen, og fortsætter:

- Det er afgørende, at patienter og læger har tillid til, at de får uvildig rådgivning. Det sikres bedst, hvis en offentlig myndighed er garant for informationen.

Lægeforeningen opfordrer derfor sundhedsministeren til at etablere et videncenter, der samler ekspertisen fra flere myndigheder og råd, som i dag vurderer lægemidler.

Mads Koch Hansen peger på, at finansloven afsætter midler til at lave faglige retningslinjer for bedste behandling af de enkelte sygdomme. Det betyder også, at eksperter skal fordybe sig i brugen af lægemidler.

- Derfor håber vi på sundhedsministerens forståelse for, at retningslinjerne kan kobles sammen med en uvildig medicininformation, siger Mads Koch Hansen.
I en undersøgelse for nylig blandt praktiserende læger sagde 9 ud af 10 nej til industribetalte oplysninger om medicin og bivirkninger. 85 procent ønskede, at det offentlige overtager driften af promedicin.dk.

Undersøgelsen kom i kølvandet på afsløring af, at promedicin.dk var et år om at opdatere opslagsværket med vigtige oplysninger om, at gravides ufødte børn risikerede alvorlige bivirkninger ved en række lykkepiller. (...)

- "Invers nytte-lov forklarer hvordan markedsføring av legemidler undergraver pasientsikkerhet

“Inverse benefit law” explains how drug marketing undermines patient safety ("Invers nytte-lov forklarer hvordan markedsføring av legemidler undergraver pasientsikkerhet)
BMJ 2011; 2011; 342:d598 (28 January)
Drug companies show a clear, repeated pattern in which “drugs discovered with good science for a specific set of patients are marketed to a larger population” for whom they are less appropriate and less safe, says Howard Brody, professor and director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston.

The “inverse benefit law” was published online in the American Journal of Public Health (doi:10.2105/AJPH.2010.199844).

Dr Brody told the BMJ, “You have to be really sceptical and careful not be seduced by research findings that are apparently very valid scientifically, but if you drill down they are really industry marketing disguised as research rather than scientifically valid research . . . Scientists in [industry] laboratories never make a move without somebody from marketing being there while they’re planning their research.”

The inverse benefit law echoes Julian Tudor Hart’s “inverse care law,” which says that availability of good medical care varies inversely with the need for it in the population (Lancet 1971;i:405-12).

The inverse benefit law says that patients with the most severe symptoms or the highest level of risk will receive the greatest benefit from treatment with a drug. The risk of an adverse event, however, is spread among all people receiving the drug.

Because only a few people would receive the drug on the basis of evidence based treatment, marketing from drug companies seeks to increase the number of people who should be treated, using six mechanisms:

• Reducing the threshold for diagnosing disease, such as lowering the level for diagnosing type 2 diabetes and hypertension
• Relying on surrogate end points, such as glucose concentrations and blood pressure levels, rather than patient outcomes such as myocardial infarction, stroke, and death
• Exaggerating safety claims (so that doctors prescribed newer antipsychotics more often, for example)
• exaggerating effectiveness claims—as with cyclo-oxygenase-2 inhibitors, which were no better as analgesics than older non-steroidal anti-inflammatory drugs, had only a modestly lower risk of gastrointestinal bleeding, and were later found to raise cardiovascular risks
• creating new diseases, such as social phobia, pre-diabetes, and pre-hypertension; and
• encouraging unapproved uses—such as through continuing education campaigns, talks by physicians, and ghostwritten articles. (...)

- Legemiddelfirmaer setter folkehelsen i fare

US drug companies paid $15bn in fines for fraudulent marketing in past five years (Amerikanske legemiddelfirmaer har betalt 15 milliarder dollar i bøter for straffbar markedsføring de siste fem år)
BMJ 2010; 341:c7360 (21 December)
Legemiddelfirmaers ulovlige markedsføring har økt i løpet av de siste fem år, hvilket ifølge Public Citizen, en uavhengig amerikansk vaktbikkjeorganisasjon, fører til store bøter når firmaer blir saksøkt. De har kalt legemiddelindustrien “den største bedrager av staten.” (Illegal marketing activities by drug companies have risen over the past five years, leading to major penalties when companies are prosecuted, says Public Citizen, an independent US watchdog organisation. It has called the drug industry “the biggest defrauder of the federal government.”)

Selv om rapporter om legemiddelfirmaers misgjerninger er rapportert tidligere, oppsummerer Public Citizens nye rapport situasjonen. (Although reports of drug companies’ misdeeds have been reported before, Public Citizen’s new report summarises the situation.)

Industritalsmenn sa at problemene lå bak dem og at industrien har fått strengere retningslinjer på plass. (Industry spokespeople said that the problems were behind them and that the industry had put stricter guidelines in place.)

Sidney Wolfe, direktør for Public Citizens helseforskningsgruppe, fortalte BMJ at legemiddelindustrien i løpet av de siste fem årene har gått forbi forsvarsindustrien og alle andre industrier i antall sivile og kriminelle forlik av handlinger mot den føderale regjeringen og statlige regjeringer. I rapporten fremgår at 165 legemiddelfirmaers forlik utgjør 19,8 milliarder dollar (£12.8bn; €15bn) i bøter i løpet av de siste 20 årene, 73 % av forlik og 75 % av bøtene skjedde i løpet av de siste fem årrene. (Sidney Wolfe, director of Public Citizen’s health research group, told the BMJ that in the past five years the drug industry moved ahead of the defence industry and all other industry sectors in the number of civil and criminal settlements of actions against the federal government and state governments. The report said that of 165 drug company settlements comprising $19.8bn (£12.8bn; €15bn) in penalties over the past 20 years, 73% of settlements and 75% of penalties occurred in the past five years.)

Dr. Wolfe sa at økningen i antallet av saker skyldes i hovedsak legemiddelfirmaenes sterke bruk av ulovlig markedsføringspraksis, slik som promotering av forskrivning av legemidler utenfor preparatomtale, og myndighetenes økte håndhevelse, som fikk mer innsideinformasjon fra varslere, som kan motta betydelige belønninger. (Dr Wolfe said that the rise in the number of cases was largely because of drug companies’ greater use of illegal marketing practices, such as the promotion of off-label uses of drugs, and increased enforcement by authorities, which were getting more insider information from whistleblowers, who can receive substantial rewards.)

Han uttalte, “Det eneste som kan stoppe dette er . . . dersom noen puttes i fengsel, fordi dette er kriminelle lovbrudd og de setter folkehelsen i fare.” (...) (He said, “The only way it will stop is . . . if someone goes to jail, because these are criminal violations and they endanger the public health.” )

Rapidly Increasing Criminal and Civil Monetary Penalties against the Pharmaceutical Industry: 1991 to 2010 is available at www.citizen.org/hrg1924. (...)

(Anm: Pharmaceutical Industry Is Biggest Defrauder of the Federal Government Under the False Claims Act, New Public Citizen Study Finds - Civil, Criminal Settlements Have Increased Dramatically; Off-Label Promotion Largely Responsible. (citizen.org 15.12.2010).)

(Anm: Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry: 1991 to 2010. (citizen.org 15.12.2010).)

Läkemedelsindustrin i fokus för utredningar om bedrägeri
lakemedelsvarlden.se 20.12.2010
Den amerikanska försvarsindustrin är inte längre den bransch som fälls för flest bedrägeri- och mutbrott. Enligt en ny rapport är det läkemedelsindustrin.

SKUMT Läkemedelsindustrin har gått om försvarsindustrin som det främsta målet för federala bedrägeriutredningar i USA. Det konstateras i en rapport från organisationen Public Citizen.

De senaste fem åren har branschen betalat närmare 15 miljarder dollar i böter och i uppgörelser med staten.

Studien omfattar brott mot marknadsföring samt bedrägeri mot Medicaid, det vill säga saltade räkningar till den statliga sjukvårdsförsäkringen.

De som betalat mest är GlaxoSmithKline, Pfizer, Eli Lilly och Schering-Plough som enligt rapporten stått för 10, 5 miljarder av de utbetalade böterna och uppgörelserna.

I några fall har företagen samtidigt som man tillbakavisat påståendena om bedrägeri och mutor, betalat ut stora summor i uppgörelser med regeringen i stället för att driva ärendena vidare.

Pfizer är det enskilda företag som hittills betalat ut mest. (...)

(Anm: Uredelighet og fusk i medisinsk forskning. (mintankesmie.no/).)

- WikiLeaks-telegrammer: Pfizer "brukte skitne triks for å unngå utbetalinger for kliniske forsøk"

WikiLeaks cables: Pfizer 'used dirty tricks to avoid clinical trial payout' (WikiLeaks-telegrammer: Pfizer "brukte skitne triks for å unngå utbetalinger for kliniske forsøk")
guardian.co.uk 9.12.2010
Cables say drug giant hired investigators to find evidence of corruption on Nigerian attorney general to persuade him to drop legal action

The world's biggest pharmaceutical company hired investigators to unearth evidence of corruption against the Nigerian attorney general in order to persuade him to drop legal action over a controversial drug trial involving children with meningitis, according to a leaked US embassy cable.

Pfizer was sued by the Nigerian state and federal authorities, who claimed that children were harmed by a new antibiotic, Trovan, during the trial, which took place in the middle of a meningitis epidemic of unprecedented scale in Kano in the north of Nigeria in 1996.

Last year, the company came to a tentative settlement with the Kano state government which was to cost it $75m.

But the cable suggests that the US drug giant did not want to pay out to settle the two cases – one civil and one criminal – brought by the Nigerian federal government. (...)

Medicinalgigant bagvaskede justitsminister efter nigerianske børneforsøg
politiken.dk 10.12.2010
Detektiver skulle grave snavs frem for at stoppe retssag mod Pfizer, viser WikiLeaks-dokument.

Medicinalgiganten Pfizer, som blandt andet producerer potenspillen Viagra, brugte beskidte tricks for at stoppe en millionretssag i Nigeria efter kontroversielle medicinforsøg på børn.

Det viser et dokument fra den amerikanske ambassade i Nigerias hovedstad Abuja til Washington, som er blevet offentliggjort i forbindelse med den verserende WikiLeaks lækage i diplomatiske indberetninger.

Sagen drejer sig om kliniske medicinforsøg på 200 børn under en meningitis-epidemi i Kano i det nordlige Nigeria i 1996.

DOKUMENTATION Se Pfizer-dokumentet her (engelsk)

Efterfølgende lagde Nigeria sag an mod medicinalgiganten, fordi Pfizer ikke havde fået tilladelse til eksperimentialbehandling fra forældrene med medicinen, som i dag kun bruges i nødstilfælde i USA og er helt ulovlig i Europa.

Det var for at lægge pres på den nigerianske justitsminister Michael Aondoakaa og få ham til at droppe retssagen, at Pfizer greb til hårdhændede metoder. (...)

Pfizer sought corruption links to end Trovan case; WikiLeaks
in-pharmatechnologist.com13.12.2010
Pfizer hired investigators to expose corrupt behaviour of the former Nigerian attorney general to ‘pressure’ him to drop legal action against the contentious Trovan drug trial, according to a leaked US embassy cable.

The cable, released by whistle-blowing website WikiLeaks, outlines details of the Nigerian state and federal authorities’ lawsuit against the world’s largest drug company over the trial of the oral antibiotic, trovafloxacin, during the 1996 meningitis epidemic in Kano, north of Nigeria.

The trial involved 100 children with meningitis, and allegedly led to the deaths of 11 children and rendered dozens more disabled, however Pfizer denies these charges.

Last year, Pfizer reached a $75m (€57m) settlement with Nigeria’s Kano government, including a $10m payout for legal fees, $30m to the Kano state government, and $35m for the affected trial participants and families.

Yet the cable suggests the drug major was reluctant to hand out the money agreed to settle the two cases – one criminal and one civil – brought by the Nigerian federal government.

The cable reports a meeting on 9 April 2009 between Pfizer's country manager, Enrico Liggeri, and US officials at the Abuja embassy, during which Liggeri claimed “Pfizer had hired investigators to uncover corruption links to federal attorney general, Michael Aondoakaa to expose him and put pressure on him to drop the federal case.”

Liggeri said Pfizer’s investigators handed over evidence of alleged corruption, but had “much more damaging information” on Aondoakaa that they refrained from passing on to the local media. The information was intended to be used to raise fears that additional negative articles being published. (...)

- Legemiddelfirmaer anklaget for å bruke uegnede leger til å promotere sine produkter

Drug companies are accused of using unsuitable doctors to promote their products (Legemiddelfirmaer anklaget for å bruke uegnede leger til å promotere sine produkter)
BMJ 2010; 341:c6026 (26 October)
Hundreds of doctors who have been disciplined for ethical breaches or had their medical licences revoked are on drug companies’ payrolls as speakers and consultants, an investigative report released on 18 October says.

The wide ranging investigation took months and was the product of a collaboration between the investigative news organisation ProPublica, a non-profit group based in New York, and five other news outlets: National Public Radio, the Chicago Tribune, the Boston Globe, Consumer Reports, and the US Public Broadcasting Service’s Nightly Business Report.

Doctors cited in the report include a pain physician who had performed “unnecessary” nerve tests on 20 patients and an anaesthetist who had admitted giving young female patients rectal and vaginal exams without documenting why.

The reporters created a searchable database of payments to doctors since 2009. The database includes $258m (£163m; €185m) in payments to 17 700 individuals by seven drug companies: Pfizer, GlaxoSmithKline, Merck & Co, Johnson & Johnson, Eli Lilly, AstraZeneca, and Cephalon. The seven companies collectively comprise a 36% share of the $300bn drug market in the United States. (...)

- Big Pharma ønsker å bli venn med deg

Big Pharma would like to befriend you (Big Pharma ønsker å bli venn med deg)
BMJ 2011; 342:d4075 (28 June)
Online social media such as Facebook, Twitter, and YouTube are a “gold mine” where the “sky is the limit” for drug companies, a marketing expert has said.

During a recent “webinar” on how drug companies can expand their presence in social media, Adam Kleger, vice president of business development at ListenLogic Health, a social intelligence company serving the pharmaceutical and healthcare industries, told the audience that the industry can use social media to create “personal relationships” with patients and healthcare providers—relationships he likened to “going to a cocktail party or a wedding reception” where information is exchanged.
The benefits of “social CRM” (customer relationship management), said Mr Kleger, include the ability to direct patients to branded drug sites, recruit patients into clinical trials, and to collect business intelligence on patients and healthcare providers. It also allows the industry to identify “KOOLs” (key online opinion leaders).

The webinar was sponsored by PharmaLive, a project of UBM Canon, which is based in Newton, Pennsylvania, and which provides the “$500bn pharmaceutical industry with need-to-know business information.”

Mr Kleger said that obtaining intelligence on doctors and other healthcare providers can be difficult, as most avoid conversations on public websites. However, some “innovative companies” have managed to monitor private sites, such as those of Medscape, where doctors do carry on conversations, he said.

Social media intelligence is so prized, said Mr Kleger, that individuals who gain expertise in the field “skyrocket to become . . . the leader, the rock star . . . within their organisation.”

Jennifer Fenoglio Barnard, director of global consumer and digital marketing at Acclarent, a medical device company in Menlo Park, California, recently told another online audience that social media have a “huge allure and sexiness.” (...)

– Lager ikke medisiner for fattige

Legemiddelindustrien vil ha mindre kritikk og mer samarbeid
nrk.no 13.10.2011
Leger uten grenser bør bruke mer tid på samarbeid og mindre tid på skyldfordeling, mener Karita Bekkemellem, direktør i Legemiddelindustrien.

Legemiddelindustrien mener Leger uten grenser retter kritikken mot feil aktør. Direktør Karita Bekkemellem mener politikerne må ta mer ansvar for at det blir utviklet nye medisiner for glemte sykdommer i utviklingsland. (...)

– Gjort mye for utviklingsland
Direktør i Legemiddelindustrien, Karita Bekkemellem mener det er urimelig å antyde at legemiddelindustrien har skylden for at det årlig dør 100 000 mennesker på grunn av glemte sykdommer.

Hun sier det er direkte feil av Leger uten grenser å hevde at legemiddelindustrien ikke bidrar til medisinutvikling i utviklingsland. (...)

– Du ser ikke Statoil gi bort oljen gratis
Ifølge direktøren er det naturlig at legemiddelindustrien har et større engasjement i forskning på sykdommer som rammer rike land, ettersom det er overskuddet fra dette markedet, som gir firmaene mulighet til å utvikle medisiner til bruk i fattige land.

«Å utvikle et nytt legemiddel koster i gjennomsnitt mer enn 800 millioner amerikanske dollar og tar gjennomsnittlig 13 år av patenttiden på 20 år. Bare 10 av 1000 legemidler under utvikling kommer på markedet,» skriver Roche, et av verdens ledende firmaer innen legemidler på sine nettsider.

– Vi er kommersielle aktører, så vi kan ikke drive selskapene som veldedighetsorganisasjoner. Du ser ikke Statoil gi bort oljen gratis til fattige land fordi de trenger det, sier Bekkemellem. (...)

– Lager ikke medisiner for fattige
nrk.no 8.10.2011
Glemte sykdommer i verden

Hvert år dør over 100 000 mennesker i fattige land av sykdommer som kan behandles med de rette medisinene, men legemiddelindustrien vil ikke bruke penger på «fattigfolksykdommer», mener Leger uten grenser.

Mer enn ti millioner mennesker er smittet av parasittsykdommer som «sovesyke», «Kala Azar» og «Chargas».

Flertallet av pasientene bor i fattige land som Bolivia, Kongo, Bangladesh, Guatemala og Sør-Sudan.

Mange av dem har ikke penger å bruke på mat, med mindre medisiner.

– Medisinselskapene tjener ikke penger på å lage medisiner for fattige, så da bruker de heller ikke ressurser på å utvikle bedre medisiner, sier lege Morten Rostrup fra Leger uten grenser.

• Les: – Pressen svikter sin oppgave

– Forferdelig å behandle folk med giftige medisiner

Den erfarne legen har blant annet jobbet med diverse prosjekter knyttet til sovesyke i Kongo.
Sovesyken er en parasittsykdom som smitter gjennom Tsetse-fluen. Lenge fantes det kun én medisin mot sovesyke, «Melarsoprol».

– Det var en gammel og giftig medisin som inneholdt arsenikk. Mellom tre og ti prosent av pasientene døde av behandlingen, forteller Rostrup. (...)

Navlebeskuende presse
Rostrup mener norske medier er for opptatt av nærhet som et nyhetskriterium.

– Kan man knytte en krise opp mot Norge, nordmenn eller norske interesser er det alltid lettere å få oppmerksomhet, sier Rostrup.

Han mener det ikke er relevant, sett fra et humanitært perspektiv.

– Dette er enkeltmennesker som lider. Man bør gjøre noe, uansett om de har noen tilknytning til Norge eller ei, sier Rostrup. (...)

- Opplyser ikke om bivirkninger

Industry-paid studies likely to favor company drug (Studier betalt av industrien favoriserer høyst sannsynlig firmaets legemiddel)
reuters.com 2.8.2010
(Reuters Health) - Når legemiddelfirmaene finansierer studier på sine egne produkter er det mye mer sannsynlig at resultatene er positive enn når staten tar regningen, uttalte amerikanske forskere mandag. (- When drugmakers fund studies of their own products, the results are much more likely to be positive than when the government picks up the bill, US researchers said Monday.)

De fant at omtrent 85 prosent av industristøttede studier rapporterte positive resultater, sammenliknet med bare halvparten av de med statlig finansiering. Blant de nesten 550 studier av vanlige legemidler som forskerne undersøkte, var trefjerdedeler av de som hadde blitt publisert i medisinske tidsskrifter støttet av industrien. (...) (They found that about 85 percent of industry-backed studies reported positive outcomes, compared to only half of those with federal funding. Among the nearly 550 studies of common drugs the researchers examined, three-quarters of those that had been published in medical journals had industry backing)

(Anm: Uredelighet og fusk i medisinsk forskning. (mintankesmie.no/).)

(Anm: Outcome Reporting Among Drug Trials Registered in ClinicalTrials.gov. Ann Intern Med 2010;153:158-166 (August 3).)

- Feilinformasjon gir økt pillebruk
p4.no 24.7.2010
P4 (Lillehammer): - Feilinformasjon fra legemiddelselskapene og reklame for medisiner gir økt pillebruk.

Hør lyd: - Må øke kontrollen

Det mener både Legemiddelverket og Norsk psykiatrisk forening, som nå krever at man bruker 1 prosent av omsetningen i legemiddelindustrien til å opprette et offentlig fond som kan sørge for nøytral informasjon.

Problemet er ifølge fagfolkene at helsepersonell i stor grad må stole på informasjon fra legemiddelprodusentene. (...)

«Feilinformasjon gir økt pillebruk»
aftenposten.no 24.7.2010
Legemiddelverket mener gal informasjon om nye legemidler fører til overforbruk av medikamenter. Nå vil norske psykiatere ha strengere krav til legemiddelindustrien. (...)

Steinar Madsen, overlege i Legemiddelverket, mener legemiddelindustriens markedsføring påvirker legene. Han viser til USA hvor det i en dom er slått fast at uriktig markedsføring har ført til kunstig høye salgstall av enkelte medikamenter.

- Feilinformasjon fra legemiddelindustrien gir økt medikamentbruk, sier han, og mener det er to grunner til bekymring:

- Hvis legen anbefaler et medikament til pasienter med høy risiko for bivirkning, nettopp fordi han har inntrykk av at risikoen er liten, vil det kunne få farlige konsekvenser for pasienten. For det andre koster økt bruk mye.

I 2007 ble selskapet AstraZeneca nektet å markedsføre sine produkter etter at de hadde brutt bestemmelsene om markedsføring. (...)

Salget av antidepressiva har eksplodert
vg.no 24.7.2010
Salget av antidepressiva er nesten femdoblet på 20 år, og Legemiddelverket mener feilinformasjon fra produsentene bidrar til overforbruk. (...)

En rapport fra Folkehelseinstituttet viser at salget av antidepressiva har økt med 379 prosent de siste 20 årene.

Legemiddelindustriens markedsføring er en sterkt medvirkende årsak til økningen, tror overlege Steinar Madsen i Legemiddelverket. (...)

Knasker lykkepiller som aldri før
dn.no 24.7.2010
Salget av antidepressiva er nesten femdoblet på 20 år. (...)

Norsk psykiatrisk forening (NPF) etterlyser strengere regelverk for reklame for legemidler og tar til orde for at 1 prosent av legemiddel-omsetningen skal gå til et fond for nøytral informasjon og forskning.

– Vi mener det er uansvarlig av myndighetene å overlate dette til industrien, sier NPFs nestleder Ann Færden.

Færden frykter psykiatere skriver ut medikamenter hvor den kliniske effekten er mindre enn den testede, slik at folk ikke får den hjelpen de behøver og i verste fall unødvendige bivirkninger og plager.

– Det bør bli helt slutt på lunsjmøter og at industrien betaler kursavgifter, reise og opphold på kongresser. Helseforetakene bør pålegges større ansvar i å samle informasjon og ha en bred faglig drøfting om hvilke medisiner som brukes. Industrien kan inviteres til å ta del i diskusjonen, men ikke lede den, sier hun. (©NTB)

Opplyser ikke om bivirkninger
aftenposten.no 6.7.2010
Legemiddelverket har dukket uanmeldt opp på 28 møter mellom leger og Legemiddelindustrien de siste årene. På 24 av møtene ga selgerne gal eller skjev informasjon. (...)

Fastlege Odd Bøyesen ved Markveien legesenter i Oslo, kjenner godt til hvordan legemiddelindustrien kommuniserer med leger som skal holde seg oppdatert om ny medisin på markedet. Regelmessig møter han selgere på kontoret og på konferanser.

– Informasjonen er pakket inn på en måte som skal selge. Men det blir feil når selgerne underrapporterer bivirkninger, overvurderer effekten av preparatet og ikke tar hensyn til samfunnsøkonomisk nytte. Hvis vi blir villedet, er det klart det kan gå ut over pasientene, sier Bøyesen.

Nå viser nemlig 28 uanmeldte tilsyn Legemiddelverket har foretatt, at Legemiddelindustrien svært ofte feilinformerer legene. (...)

(Anm: Legemiddelkonsulenter. (mintankesmie.no).)

– Vi har en utfordring når det gjelder å få frem budskapet om virkeligheten, sier direktør Karita Bekkemellem i Legemiddelindustriforeningen

Driver ikke ulovlige kontroller
JOHNNY JAKOBSEN - avdelingsdirektør, avdeling for legemiddelinformasjon, Statens legemiddelverk
aftenposten.no 25.7.2010
Legemiddelindustrien, ved administrerende direktør i Legemiddelindustriforeningen Karita Bekkemellem, påstår 19. juli at det er ulovlig og unødvendig for
myndighetene å ha tilsyn med den muntlige legemiddelreklamen industrien retter mot leger. Dette er vi uenig i.

Legemiddelverket har hjemmel til å føre tilsyn med all skriftlig og muntlig reklame industrien driver med. Det er ikke geografisk plassering av møtet som avgjør dette. Vi kan ikke gå inn på legekontoret mot legens ønske. Dette er ikke noe problem. Vi blir tatt godt imot der vi kommer. Legemiddelverket driver ikke tilsyn med leger, men med informasjonen legemiddelindustrien formidler til legene.

Vi avdekker feil, og tilstedeværelse på møter er den eneste muligheten myndighetene har til å vurdere muntlig reklame. Bekkemellem skriver: «De færreste er av den oppfatning at ulovlige kontroller er greit fordi det potensielt vil kunne avdekke regelbrudd ». Legemiddelverket driver ikke ulovlige kontroller. Vi bidrar til at pasientene får trygge og sikre legemidler. Vi kan ikke ha lukkede romder legemiddelindustrien påvirker legene uten
innsyn fra myndighetene. Her er alle tjent med åpenhet! (...)

Legemiddelindustrien kontrollerer
KARITA BEKKEMELLEM- administrerende direktør, Legemiddelindustriforeningen
aftenposten.no 19.7.2010
Legemidler godkjennes av myndighetene etter omfattende dokumentasjon av kvalitet, sikkerhet og effekt, skriver Karita Bekkemellem.

Kritikk. Ved en artikkel og en leder i forrige uke gir Aftenposten inntrykk av at industrien regelmessig gir uriktig informasjon om legemidler.

Legemidler godkjennes av myndighetene etter omfattende dokumentasjon av kvalitet, sikkerhet og effekt.

All informasjon om legemiddelets nytte og risiko er offentlig tilgjengelig i form av preparatomtale og pakningsvedlegg, og skal danne grunnlag for all kommunikasjon om legemidlet fra industrien. Dette overvåkes av bransjens eget selvjustisorgan og av Statens legemiddelverk. (...)

Studentene er industriskeptiske
dagensmedisin.no 23.3.2010
Norske medisinstudenter er skeptiske til legemiddelindustrien, ifølge en ny studie. – Vi har en utfordring når det gjelder å få frem budskapet om virkeligheten, sier direktør Karita Bekkemellem i Legemiddelindustriforeningen.

Bare hver femte til sjette medisinstudent (17,5 prosent) er positive til legemiddelindustrien, mens resten er negative (40,7 prosent) eller stiller seg nøytrale (41,8 prosent).

Dette viser en nasjonal studie blant femte- og sjetteårsstudenter som sisteårstudent Dordi Lea på medisinerutdanningen ved NTNU har gjennomført som ledd i sin hovedoppgave sammen med professorene Olav Spigset og Lars Slørdal. (...)

- Bør holde seg til fakta

Bør holde seg til fakta
ODDBJØRN TYSNES - samfunnsdirektør, Apotekforeningen
aftenposten.no 16.10.2010
Stortingsrepresentant Kjersti Toppe og Legemiddelindustriens direktør Karita Bekkemellem gir ulike beskrivelser av hvordan salget av smertestillende legemidler har utviklet seg, senest i Aftenposten 11. oktober. Fakta er følgende: Siden 2003 har det totale salget av smertestillende legemidler i Norge økt med 53,6 prosent. Økningen har vært sterkest for reseptpliktige legemidler, som har økt salget med 67,1prosent. Men salget av reseptfrie smertestillende legemidler har også økt sterkt, med 42,4 prosent. Statistikken viser dermed at forbruket har økt markant etter at det ble tillatt å selge reseptfrie smertestillende legemidler i butikker, kiosker og bensinstasjoner. (...)

Kortene blandes
KARITA BEKKEMELLEM - administrerende direktør, Legemiddelindustrien
aftenposten.no 11.10.2010
Kjersti Toppe (Sp) kommenterer i Aftenposten mitt innlegg om salg av legemidler utenfor apotek. Jeg påpekte at det har vært nedgang i salget av reseptfrie smertestillende legemidler. Toppe viser til at det har vært økning i reseptbelagt bruk av de samme medisinene. Det bruker hun som argument for å få reseptfrie legemidler bort fra butikkene. (...)

(Anm: Paracetamol (acetaminophen) og diverse andre smertetillende midler (mintankesmie.no.).)

Spin avslørt i mer enn halvparten av konklusjoner i rapportering fra negative forsøk

Spin found in more than half of abstract conclusions in reports of negative trials (Spin avslørt i mer enn halvparten av konklusjoner i rapportering fra negative forsøk)
BMJ 2010;340:c2873 (2 June) (British Medical Journal)
Short Cuts - All you need to read in the other general journals
JAMA 2010;303:2058-64[Abstract/Full Text]
Hvor ofte fremstilles negative forsøk som positive, og hvordan gjøres det? En studie forsøkte å besvare disse spørsmålene ved å granske alle rapporter av parallelle gruppeforsøk med ikke-signifikante resultater for opprinnelige sluttresultater, som ble publisert i desember 2006 og indeksert i PubMed. I de 72 identifiserte arbeider, 49 (68 %) abstrakter og 44 (61 %) hovedtekster, fant man minst én fordreid presentasjon eller "spin," som ble definert som spesifikke rapporteringsstrategier, uten hensyn til motivet, med det formål å presentere den eksperimentelle behandlingen som nyttig til tross for en ikke-statistisk forskjell i det opprinnelige sluttresultatet, eller målsetning om å lede leseren bort fra ikke-signifikante resultater. (How often are negative trials made to look positive, and how is this done? A study tried to answer these questions by examining all reports of parallel group trials with non-significant results on primary outcomes, which were published in December of 2006 and indexed in PubMed. In the 72 identified papers, 49 (68%) abstracts and 44 (61%) main texts were found to have at least one distorted presentation or "spin," which was defined as the use of specific reporting strategies, regardless of the motive, with the aim of presenting the experimental treatment as beneficial despite a statistically non-significant difference for the primary outcome, or the aim of distracting the reader from statistically non-significant results.)

In 13 articles a spin was found in the title. In abstracts, 27 (38%) results sections and 42 (58%) conclusion sections had at least one spin. In the main texts, this was 21 (29%), 31 (43%), and 36 (50%) for the results, discussion, and conclusions sections, respectively. (...)

Spin kan være tilsiktede forsøk på å villede leseren eller det kan være et resultat av manglende kunnskap eller ikke bevisst bias. (...) (Spins may be a deliberate attempt to mislead the reader or they may be the result of poor knowledge or an unconscious bias.)

(Anm: Reporting and Interpretation of Randomized Controlled Trials With Statistically Nonsignificant Results for Primary Outcomes. JAMA. 2010;303(20):2058-2064. (May 26).)

(Anm: Medisinske tidsskrifter og uavhengighet etc. (mintankesmie.no).)

(Anm: bias; (...) valg og vurderinger som på systematisk måte avviker fra det som er faktisk korrekt. Kilde: Store norske leksikon.)

(Anm: bias [baies] -en, - skjevhet i vitenskapelig undersøkelse el. resultat pga. mangelfull systematikk i innsamlingen av data. Etym.: eng., fr. biais helning, tendens. Kilde: ordnett.no.)

Stephen Foley: The best prescription for pharma firms (Stephen Foley: Den beste forskrivning for legemiddelfirmaer)
independent.co.uk 12.6.2010
US Outlook: It was a legal battering in the US over the depression medicine Paxil that bounced GlaxoSmithKline into setting up an online register of all its clinical trial data, regardless of whether it had pushed to have the results of a study published in a medical journal. The company had been accused of burying studies which showed the medicine was less effective or more dangerous. (...)

(Anm: Seroxat (Paxil) (paroxetine; paroksetin) (SSRI) (mintankesmie.no).)

– Blir forført av legemiddelindustrien
aftenposten.no 17.6.2010
• Les også: –Det sløses mest på friske pasienter

– Bak mange medisinske fagmiljøer står det en legemiddelindustri som arbeider målbevisst for å få både leger og befolkning til å utvide sin opplevelse av hva som er sykdom, sier Steinar Westin, professor i samfunnsmedisin ved NTNU. Han mener båndene fortsatt er for tette mellom legemiddelindustrien og de som utformer retningslinjer for leger. –Det kan se ut som også de beste medisinske eksperter lar seg forføre av mangeårig forskning på industriens oppdrag.

Forskere finner link mellom Avandia-forsvarere og legemiddelfirmaer

Researchers Find Link between Avandia Defenders and Drug Companies (Forskere finner link mellom Avandia-forsvarere og legemiddelfirmaer)
lawyersandsettlements.com 21.3.2010
Rochester, MN: Forskergruppes resultater viser at eksperter som forsvarte Avandia mot negativ publisitet hadde økonomiske forbindelser til legemiddelfirmaet GlaxoSmithKline. Resultatene reiser spørsmål om etikken til studieforfattere med forbindelser til legemiddelindustrien. (...) (Rochester, MN: A team of researchers has found that many of the experts who defended Avandia against negative publicity actually have financial ties to drugmaker GlaxoSmithKline. The findings raise questions over the ethics of study authors who have ties to the pharmaceutical industry.)

The study, published in the British Medical Journal on 3/18/10, concludes, "Disclosure rates for financial conflicts of interest were unexpectedly low, and there was a clear and strong link between the orientation of authors' expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies." (...)

(Anm: Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review. BMJ 2010;340:c1344 (18 March).)

(Anm: Avandia (rosiglitazone) - informasjon versus kunnskap og visdom - hvem visste hva? (mintankesmie.no).)

Interessekonflikter

Is Your Doctor Getting Cash from Big Pharma? Find Out (Mottar din lege penger fra Big Pharma? Finn ut av det)
lawyersandsettlements.com 20.10.2010
It’s been a good year for Dr. Firhaad Ismail. Indeed! Financially speaking, that is. See, according to the info over at ProPublica, in their Dollars for Docs report, Dr. Ismail took in no less than $303,558 from big pharmaceutical companies GlaxoSmithKline (GSK…the folks who brought you Avandia and Paxil), Eli LIlly, and Merck.

Now, Dr. Ismail is just one of 384 doctors nationwide who’ve received payment from big pharma. Ismail is based in Vegas (clearly, if ProPublica’s involved, what goes on in Vegas is not staying in Vegas) and his specialty is Endocrinology and Metabolism. And he appears to do a fair amount of consulting on the topic. On big pharma’s dime.

Dr. Ismail may be the best damn doctor there is in his specialty. I don’t know. But what I do know is that the ProPublica report indicates that Dr. Ismail received a total of $209,400 from GSK alone. Recall what area of practice Dr. Ismail is in…Endocrinology. What does Endocrinology deal with? Well, diabetes for one. And last I checked, Avandia is a type 2 diabetes drug made by GSK. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Antibiotics don't cure colds, so why do patients think they do? (Antibiotika kurerer ikke forkjølelse, så hvorfor tror pasienter at de gjør det?)
guardian.co.uk 20.3.2010
Leger som nører opp under pasientpress skaper etterspørsel (Doctors who cave into patient pressure create demand)

Sist måned forslo regjeringen å tillate farmasøyter å erstatte forskrivninger av originallegemidler med generiske alternativer. Et protestbrev ble publisert i The Times, signert av en rekke pasientgrupper og eksperter, med positiv dekning i flyveblader. The Times rapporterte at "eksperter sier at plan om å bytte til billigere legemidler vil skade pasienter". De viste til og med til en case studie: "Pasienter som fikk Seroxat-kopier i stedet for originalen følte seg uvel innen to dager." (Last month the government proposed allowing pharmacists to substitute prescriptions for branded medicines with generic alternatives. A letter of protest appeared in the Times, signed by various patient groups and experts, with positive coverage in the broadsheets. "Plan to switch to cheaper medicines will harm patients, say experts," reported the Times. They even had a case study: "Patient given Seroxat substitute felt unwell within two days.")

Men lege Margaret McCartney, som har gjort en gravejobb, skriver i British Medical Journal: i virkeligheten er brevet koordinert og skrevet av PR-firmaet Burson-Marsteller, betalt av legemiddelfirmaet Norgine. Til tross for at det var Norgines virksomhetsleder Peter Martin, som hadde størst innflytelse på kampanjen, signerte han ikke brevet selv. På spørsmål om hvorfor, svarte han: "Der var ingen konspirasjon. Den oppriktige sannhet, den redelige sannhet, er at jeg tenkte at det å blande inn et legemiddelfirma på en måte ville gjøre budskapet litt mindre troverdig. (...) (But Margaret McCartney GP, writing in the British Medical Journal, has been digging: in fact the letter was coordinated and written by the PR company Burson-Marsteller, paid by the drug company Norgine. Norgine's chief operating officer, Peter Martin, , despite being the major influence behind the campaign, did not sign the letter himself. Asked why not, he said: "There was no conspiracy. The frank truth, the honest truth, is that I thought that having a pharmaceutical company in there would sully the message somewhat.")

(Anm: Generic drugs: protest group was not quite what it seemed. BMJ 2010;340:c1514 (17 March).)

Many Avandia defenders have drug co. ties: study (Mange forsvarere av Avandia hadde forbindelser til legemiddelfirmaer)
reuters.com 18.3.2010
(Reuters) - Praktisk talt alle eksperter som skrev fordelaktig om GlaxoSmithKline Plcs kriseramte diabeteslegemiddel Avandia hadde økonomiske forbindelser til legemiddelfirmaer, et resultat som viser behovet for å reformere slike forbindelser, uttalte amerikanske forskere torsdag. (Virtually all of the experts who wrote favorably about GlaxoSmithKline Plc's troubled diabetes drug Avandia had financial ties to drug makers, a finding that shows the need for reform of such relationships, U.S. researchers said on Thursday.)

A team at the Mayo Clinic in Rochester, Minnesota, pored through more than 200 scientific studies and commentaries that offered positive opinions about the drug after a May 2007 study suggested Avandia significantly increased the risk of heart attacks.

De fant at 94 prosent av forfattere som forsvarte legemidlet, kjent under det generiske navnet rosiglitazone, hadde forbindelser til legemiddelfirmaer, og nesten halvparten hadde økonomiske forbindelser som representerte interessekonflikter. (...) (They found that 94 percent of the authors who defended the drug, known generically as rosiglitazone, had ties to drug companies, and nearly half had financial ties that presented a conflict of interest.)

(Anm: Avandia (rosiglitazone) - informasjon versus kunnskap og visdom - hvem visste hva? (mintankesmie.no).)

The Missing Voice of Patients in Drug-Safety Reporting (Pasientenes manglende stemme ved rapportering av legemiddelsikkerhet)
healthcarereform.nejm.org 10.3.2010 (New England Journal of Medicine)
En pasient ønsker å bli informert om hvilke symptomer hun kan få av et legemiddel som inntas. Ved å lese avsnittet “Uheldige reaksjoner” i pakningsvedlegget finner hun et vell av data, men hun er ikke oppmerksom på at denne informasjonen, som i hovedsak er samlet inn i løpet av kliniske forsøk, nesten utelukkende er basert på klinikernes inntrykk av pasienters symptomer — ikke på pasienters rapporteringer av egne erfaringer med legemidlet. (A patient wants to know about symptoms she may have from a prescription drug she is taking. Consulting the label’s “Adverse Reactions” section, she finds a wealth of data. Little does she realize that this information, largely collected during clinical trials, is based almost entirely on clinicians’ impressions of patients’ symptoms — not on patients’ own firsthand reports of their experiences with the drug.)

Den nåværende praksis med pakningsvedlegg for uheldige hendelser er stilltiende basert på den forutsetning at en nøyaktig fremstilling av pasientens subjektive erfaringer alene kan fremskaffes gjennom klinkernes dokumentasjon. Selv om det er en betydelig bevismengde som ikke støtter denne antakelsen, viser det seg at klinikere systematisk undervurderer alvorligheten av pasienters symptomer, at pasienters selvrapporteringer ofte påviser sideeffekter som klinikere overser, og at klinikerne svikter når det gjelder å notere denne type symptomer hvilket resulterer i uheldige hendelser som kunne forebygges.^{1, 2} (...) (The current drug-labeling practice for adverse events is based on the implicit assumption that an accurate portrait of patients’ subjective experiences can be provided by clinicians’ documentation alone. Yet a substantial body of evidence contradicts this assumption, showing that clinicians systematically downgrade the severity of patients’ symptoms, that patients’ self-reports frequently capture side effects that clinicians miss, and that clinicians’ failure to note these symptoms results in the occurrence of preventable adverse events.^{1, 2})

(Anm: Legemiddelstudier, åpenhet, uredelighet og kvalitet. (mintankesmie.no).)

(Anm: Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists. BMJ 2011; 342:c7153 (6 January).)

Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists (Hyppighet og årsaker til rapportering-bias av resultater i kliniske forsøk: intervju med de som utfører forsøk)
BMJ 2011; 342:c7153 (6 January)
Objectives To provide information on the frequency and reasons for outcome reporting bias in clinical trials. (...)

Conclusion The prevalence of incomplete outcome reporting is high. Trialists seemed generally unaware of the implications for the evidence base of not reporting all outcomes and protocol changes. A general lack of consensus regarding the choice of outcomes in particular clinical settings was evident and affects trial design, conduct, analysis, and reporting. (...)

(Anm: bias [baies] -en, - skjevhet i vitenskapelig undersøkelse el. resultat pga. mangelfull systematikk i innsamlingen av data. Etym.: eng., fr. biais helning, tendens. Kilde: ordnett.no.)

(Anm: bias; (...) valg og vurderinger som på systematisk måte avviker fra det som er faktisk korrekt. Kilde: Store norske leksikon.)

FDA urged to probe digital marketing by drugmakers
pharmatimes.com 3.3.2010
The US Food and Drug Administration has been urged to conduct a thorough investigation into the use by pharmaceutical companies of digital marketing techniques.

The health and safety of US consumers must be protected from “inappropriate and potentially harmful use of digital marketing applications that have been embraced by pharmaceutical and health marketers,” and which have given the industry “unprecedented abilities to take advantage of consumers,” claims the non-profit Center for Digital Democracy (CDD). (...)

Industriens angrep på folkehelsen i USA
Tidsskr Nor Legeforen 2010; 130:415 (25.2.2010)
How industry’s assault on science threatens your health. 372 s. Oxford: Oxford University Press, 2008. (...)

Dette er en bemerkelsesverdig bok. Den handler om hvordan storindustrien i USA har manipulert vitenskapelige data, produsert egne data og publisert dem i vennligsinnede, til dels egenkontrollerte tidsskrifter med fagfellevurdering (1), og gjennom dette arbeidet til dels oppnådd å lamme deler av tilsynsetatene i USA. (...)

På vaskeseddelen er det gjengitt et utsagn fra Donald Kennedy, sjefredaktør i Science som sier at boken «gir en livlig og overbevisende framstilling av hvordan den ene folkehelseetaten etter den andre er blitt blokkert. (...)

Glaxo Knew Avandia Caused Heart Risk, Report Says (Update1) (Glaxo visste ifølge rapport at Avandia medførte hjerterisiko)
bloomberg.com 20.2.2010
Feb. 20 (Bloomberg) -- Safety reviewers at the U.S. Food and Drug Administration urged the agency to take GlaxoSmithKline Plc’s diabetes drug Avandia off the market in 2008 because they said it was causing 500 additional heart attacks per month. Two U.S. senators say they want to know why the medicine remains on pharmacy shelves.

A report released today by Senators Max Baucus and Charles Grassley said Glaxo knew Avandia may cause heart damage several years before a study documented the risk and the company pressed doctors to retract warnings about side effects. Baucus, chair of the Senate Finance Committee, and Grassley, the committee’s ranking Republican, are pressing the FDA for answers. (...)

(Anm: Avandia (rosiglitazone) - informasjon versus kunnskap og visdom - hvem visste hva? (mintankesmie.no).)

Sen Grassley Probes Relationship Between WebMD, Pharma Indus (Senator Grassley gransker forbindelser mellom WebMD, legemiddelindustrien)
online.wsj.com 19.2.2010
WASHINGTON (Dow Jones)--Sen. Charles Grassley (R., Iowa) is investigating ties between the pharmaceutical industry and WebMD Health Corp. (WBMD) after learning WedMD is running an advertisement on television that encourages people to take a depression-screening test sponsored by Eli Lilly & Co. (LLY).

Grassley wants WedMD, a popular resource for medical information online, to provide detailed information about its relationship with the pharmaceutical industry. In a letter to the chief executive of WebMD dated Thursday, Grassley said WebMD is seen as an independent, objective medical resource and the sponsorship from Eli Lilly raises questions about WebMD’s "independence." (...)

Grassley has been probing the relationship between the pharmaceutical industry and academia, nonprofits and other groups. He wants WebMD to respond by March 4. (...)

(Anm: Legenettsteder (legemiddelfirmasponset helseinformasjon). (mintankesmie.no).)

(Anm: Interessekonflikter, bestikkelser og korrupsjon (mintankesmie.no).)

Big Pharma’s long tentacles (Big Pharmas lange tentakler)
Industry influence
BMJ 2010;340:c941 (16 February)
The BMJ gives two more examples of penetration by the pharmaceutical industry into what, in a better world, would be protected places: Harvard Medical School¹ and the World Health Organization.²

In this atmosphere of hidden payments and conflict of interest, medical professionals still go with some confidence to journals such as the BMJ, and the general public to trusted media such as the New York Times. It is distressing therefore to come across an article in the New York Times calling into question the safety and effectiveness of generic medicines.³ It has already met with warm approval on the internet, especially on pharmaceutical industry sponsored websites.

But before suspicion of generic drugs becomes received wisdom under the imprimatur of the New York Times, the subject deserves a closer look. (...)

(Anm: Generiske legemidler (generika) (mintankesmie.no).)

– Bruker 85 milliarder på falske medisiner
nrk.no 16.2.2010
Europeere bruker milliarder av kroner på å kjøpe falske medisiner på internett eller i utlandet, hevder legemiddelprodusenter. (...)

– Forstår ikke hva de vil
tk.no 10.2.2010
Oslo (ANB): Karita Bekkemellem forstår ikke hva Senterpartiet tenker på når de vil fjerne Ibux og Paracet fra butikkhyllene. (...)

GSK shifts away from antidepressants
ft.com 4.2.2010
GlaxoSmithKline is to stop researching antidepressant medicines as part of a shake up in research and development designed to strengthen productivity.

Andrew Witty, chief executive, said the pharmaceutical company would cease discovery work in depression, a pivotal part of its historical neuroscience activity, in an effort to save £500m a year in costs by 2012.

The move came as he unveiled an 18 per cent rise in full-year pre-tax profits to £7.9bn on sales up 16 per cent to £28.4bn in the 12 months to December 31.

It marks a symbolic shift for GSK, which as recently as 2006 generated more than £2bn from sales of its antidepressants Wellbutrin and Seroxat or Paxil, a drug that has sparked criticism from regulators and a series of litigations against the company.

Other large pharmaceutical groups including AstraZeneca and Pfizer have also unveiled significant cost- cutting and a shift towards more licensing of drugs at the expense of in-house drug development. (...)

Vermont Attorney General Wants Drug Makers to Disclose Free Samples
pharmpro.com (5.2.2010)
MONTPELIER, Vt. (AP) — The state of Vermont, which last year enacted a law banning drug companies from providing free lunches to doctors, now may go a step further by requiring the companies to disclose the free drug samples they give to physicians.

If the state enacts the requirement, it would be the first to do so.

Attorney General William Sorrell, who recommended in a recent report that the drug companies be required to disclose what it gives to doctors and other providers, is to testify before lawmakers at a hearing Friday in the Statehouse. (...)

Vaccinmakare försvarar sig mot kritik
lakemedelsvarlden.se 27.1.2010
Representanter för de stora vaccintillverkarna försvarade sig i går under en offentlig utfrågning. De menar att de inte varit med och skapat en falsk bild av hotet med svininfluensan.

Vid en så kallad publik hearing i Europarådets parlamentariska församling, PACE, på tisdagen nekade läkemedelsindustrin till anklagelser om att de skulle ha spritt en falsk bild av hotet från influensan. Heringen hölls efter att den tyska politikern och epidemiologen Wolfgang Wodarg presenterat misstankar om att industrin påverkat Europas myndigheter. (...)

Legemiddelindustriens makt i WHO og i Norge - spørsmål nr 216 til skriftlig besvarelse
regjeringen.no 30.11.2009
Det vises til ekspedisjon av 19. november 2009 fra Stortingets president med følgende spørsmål til skriftlig besvarelse fra representanten Geir-Ketil Hansen:
På hvilken måte blir dette tatt opp av regjeringa i WHO, og på hvilken måte jobber regjeringen for å stramme inn overfor legemiddelindustriens makt, i WHO og i Norge? (...)

EU-regler tvinger industrien til medicinforsøg på børn
business.dk 30.9.2009
Industriens hastigt voksende interesse for at teste medicin på børn skyldes nye EU-krav om test med børn, som blev indført i 2007. Foto: Linda Henriksen
Antallet af medicinske forsøg på børn ventes at stige voldsomt i de næste par år herhjemme og i resten af Europa. Nye EU-krav tvinger industrien til at teste, hvordan medicin virker på børn. (...)

Ghosts in the medical machine (Spøkelser i det medisinske maskineri)
philly.com 20.9.2009
Redaktør Christine Laine i Annals of Internal Medicine uttaler at hun ønsker at medisinske forskningssentre forbyr spøkelsesskriving. (Annals of Internal Medicine editor Christine Laine said she wanted medical-research centers to forbid ghostwriting.)

Var legemiddelforskning infisert av spøkelsesforfattere? I Seroxat-søksmål, sier et Chadds Ford-firma at det var etisk. (Was drug research infected by ghostwriters? With Paxil suit in court, a Chadds Ford firm says it was ethical.)

Da markedsførere i GlaxoSmithKline P.L.C. søkte etter leger til å reklamere for sitt antidepressiva Seroxat, kalte de prosjektet CASPPER. (When GlaxoSmithKline P.L.C. marketers looked for doctors to promote the antidepressant Paxil, they called the project CASPPER.)

Navnet var mer enn bare en underlig anerkjennelse av det vennlige spøkelse i tegnefilmserien. Det var et blunk og et nikk til "spøkelsesskriving," en tvilsom praksis hvor forskere setter sitt navn på forskning skrevet av en annen, vanligvis betalt av et legemiddelfirma. (The name was more than just an offbeat tribute to the friendly cartoon ghost. It was a wink and a nod to "ghostwriting," a questionable practice in which scientists put their names on research written by someone else, usually a writer paid by a drugmaker.)

Kritikere av spøkelsesskriving uttaler at det maskerer markedsføringsmateriale som vitenskapelig forskning. (Ghostwriting critics say it disguises marketing material as scientific research.)

Ghostwriting harms patients, said Adriane Fugh-Berman, a doctor and associate professor at Georgetown University and a paid witness in litigation involving complaints over Wyeth's hormone drugs, Premarin and Prempro.

Documents released in connection with 8,000 lawsuits filed against Wyeth over Premarin and Prempro show that the company, which employs several thousand people in Collegeville, paid a medical-writing firm to produce articles from 1998 to 2005 that allegedly downplayed the risks of hormone treatment and emphasized benefits. (...)

(Anm: Spøkelsesforfattere (ghostwriters) (mintankesmie.no).)

LEGEMIDDELINDUSTRIEN:
Fokus på verdiskaping
norskindustri.no 31.8.2009
Karita Bekkemellem er godt i gang i sin nye jobb som adm. direktør for Legemiddelindustrien (LMI). Bransjeforeningen er tilknyttet Norsk Industri. Bekkemellem er opptatt av at bedriftene i legemiddelindustrien i enda større grad skal få bidra til verdiskaping i Norge.

- Bedriftene skaper med sin forskning og produksjon av legemidler allerede store verdier, men det er rom for mer produksjon her i Norge, mener Karita Bekkemellem. - Vi må alle få øyene opp for hvilke muligheter som ligger i denne industrien. Lar vi teknologien få blomstre i enda større grad, og kan mer ny teknologi få slippe til på sykehusene rundt om i landet, vil mange mennesker bli spart for lidelser og flere liv kan reddes. (...)

Riktig legemiddelbruk er viktig
PER OLAV KORMESET- fungerende adm. direktør i Legemiddelindustriforeningen
aftenposten.no 11.5.2009
Reseptmedisin. Aftenposten gjengir søndag 3. mai ferske tall fra Reseptregisteret/Legemiddelverket som viser at 915000 nordmenn bruker minst tre reseptbelagte medisiner daglig, og 415000 får minst fem medisiner daglig. Legemiddelverket uttrykker at de er overrasket over hvor mange mennesker som bruker så kolossalt mange forskjellige legemidler. (...)

Medical experts want crackdown on drugmaker money (Medisinske eksperter ønsker å slå ned på legemiddelprodusentpenger)
forbes.com 28.4.2009 (Associated Press)
Millions of dollars in gifts, travel and consulting fees from the pharmaceutical industry should be eliminated to stop companies from influencing how doctors practice medicine, a report by the government's top medical advisers says.

The sweeping recommendations from the Institute of Medicine call on medical professionals - from university professors to family doctors - to shun financial arrangements with companies that have flourished over the past three decades.

Taking free lunches from company salespeople, giving paid lectures on their behalf and other practices "erode public trust while providing no meaningful benefits to patients or society," institute panel chair Dr. Bernard Lo said in a statement.

The report calls on medical schools, hospitals and physician groups to:

• publicly report funding they receive from companies.
• not accept free meals, gifts or other items from companies.
• prohibit doctors who have a financial conflicts of interest from testing new therapies on people.

The 353-page document arrives as state and federal lawmakers bolster efforts to require companies to publicly report the money they spend courting physicians. The report could give them more leverage in their push to untangle the knotty relationships between industry and physicians, which some say drive up the cost of medicine. (...)

Amerikanska läkare vill minska industrins inflytande
lakemedelsvarlden.se 1.4.2009
Nu höjs fler röster i USA som vill minska industrins möjligheter att finansiera medicinska föreningar och läkare. I en artikel i JAMA manar elva forskare och läkare till hårdare regler.

Denna gång är det de många medicinska föreningarna, professional medical associations eller PMA som står i fokus. Dessa finansieras i hög utsträckning av industrin och är med och utformar riktlinjer för behandlingar inom sina respektive område. Författarna till artikeln i JAMA föreslår att alla PMA med omedelbar verkan ska låta 25 procent av sin finansiering komma från industrin. På sikt vill de ha ett totalförbud. (...)

Professional Medical Associations and Their Relationships With Industry
JAMA. 2009;301(13):1367-1372. (April 1)
Proposal for Controlling Conflict of Interest (...)

(Anm: Interessekonflikter, bestikkelser og korrupsjon (mintankesmie.no).)

Patients and the public deserve big changes in evaluation of drugs
BMJ 2009;338:b1025 (31 March)
Silvio Garattini and Iain Chalmers argue that ending the secrecy surrounding drug trials would benefit all parties (...)

Fattige er prøvekaninar for medisin
nrk.no 22.3.2009
Praksisen byt med menneskerettane, seier president Sven Mollekleiv i Noregs Røde Kors.

Norske ekspertar tordnar mot legemiddelindustrien som utnyttar folk i u-land.

Legemiddelindustrien flyttar testinga av medisinar til land i den tredje verda og til Aust-Europa for å spare pengar. Det er billigare og mindre byråkrati i fattige land enn i Vesten.

- Har alt å tape
Menneske i fattige land blir dermed prøvekaninar for medisinar som skal brukast i rike land, viser ein ny forskingsrapport frå Duke University i North Carolina, USA.

- Menneska forsøka blir utførte på har alt å tape. Dei blir utsette for all risiko og ingen vinning, seier professorar ved Duke University.

Professor Eric Peterson er redd forskinga i fattige land ikkje fylgjer den same etiske standarden som i Vesten. Han meiner norske styresmakter må sørgje for snu utviklinga. (...)

Drug Companies & Doctors: A Story of Corruption (Legemiddelfirmaer & leger: En historie om korrupsjon)
By Marcia Angell
The New York Review of Books 2009;56(1) (JANUARY 15) (About the Review)
Recently Senator Charles Grassley, ranking Republican on the Senate Finance Committee, has been looking into financial ties between the pharmaceutical industry and the academic physicians who largely determine the market value of prescription drugs. He hasn't had to look very hard.

Take the case of Dr. Joseph L. Biederman, professor of psychiatry at Harvard Medical School and chief of pediatric psychopharmacology at Harvard's Massachusetts General Hospital. Thanks largely to him, children as young as two years old are now being diagnosed with bipolar disorder and treated with a cocktail of powerful drugs, many of which were not approved by the Food and Drug Administration (FDA) for that purpose and none of which were approved for children below ten years of age. (...)

EU accuses pharma companies of adopting anti-competitive practices (EU anklager legemiddelfirmaer for innføring av antikonkurransepraksis)
pharmaceutical-business-review.com 2.12.2008
The European Union has blamed the drug makers for their role in the escalating healthcare costs. It has accused the pharma companies of indulging in anti-competitive practices that blocked the sales of low-cost generic medicines, reported The New York times. (...)

Legal tactics to delay launch of generic drugs cost Europe €3bn, report says (Rettslig taktikk for å forsinke generiske legemidler koster Europe 3 milliarder euro, ifølge rapport)
BMJ 2008;337:a2817 (1 December 2008)
Drug companies are bracing themselves for the launch of a series of antitrust investigations in Europe after the European Commission published a highly critical report on industry practices.

The 426 page preliminary report by the commission’s Competition Directorate, which is to be followed by a final version next spring, highlights widespread legal tactics by drug companies to defend their patents. The commission says that such tactics have delayed the entry of cheaper generic drugs, at a cost of 3bn (£2.5bn; $3.8bn) since the start of the decade. (...)

Pharmaceutical Sector Inquiry: Preliminary Report is at http://ec.europa.eu/. (...)

Krass kritikk av legemiddelbransjen
dn.no 28.11.2008
EU-kommisjonen anklager legemiddelbransjen for bevisst å blokkere billige medisiner.

Dermed bidrar bransjen til unødvendig høye priser for forbrukerne i Europa, mener EU . (...)

– Betaler konkurrenter
Blant papirene som Kommisjonen fikk se, fant man blant annet bevis for at de store selskapene i enkelte tilfeller har betalt kopiselskapene for ikke å lansere billige kopipreparater. Over 200 millioner euro, om lag 1,8 milliarder kroner, skal ha blitt brukt på slike avtaler.

I et annet tilfelle hadde et storselskap lagt inn ikke mindre enn 1.300 patentsøknader for ett enkelt preparat, for å hindre kopier å komme på markedet. (...)

EU-kommissionen till attack mot läkemedelsföretag
lakemedelsvarlden.se 28.11.2008
Originalföretagens strategier för att försena försäljningen av generika har kostat konsumenterna i Europa runt 30 miljarder kronor. Det hävdas i en rapport från EU idag.

Anklagelserna bygger på bevis som EU-kommissionen samlade in under oannonserade inspektioner under januari månad. Då fick Astrazeneca, Glaxosmitkline och åtminstone sju bolag till oväntade besök från kommissionens kontrollanter. (...)

”Jag förmodar att vi alla haft diskussioner om hur vi ska kunna hindra generikaföretagen”, är ett citat från dokumentation som kommissionens kontrollanter fann vid sin raid. ”Vänta inte för länge med att patentera nya salter, generikaföretagen startar allt tidigare” ett annat citat. (...)

Pharmaceuticals
Sector Inquiry
ec.europa.eu 28.11.2008
"Individuals and governments want a strong pharmaceuticals sector that delivers better products and value for money. But if innovative products are not being produced, and cheaper generic alternatives to existing products are being delayed, then we need to find out why and, if necessary, take action."

Neelie Kroes, European Commissioner for competition

Public presentation of preliminary findings on 28 November 2008
The Commission is presenting the preliminary findings at a conference on 28th November 2008 in Brussels. (...)

(Anm: Preliminary Report (28 November 2008) Executive Summary en - Preliminary Report.)

Drugmaker Delay on Generics Cost EU 3 Billion, EU Says (Update2) (Legemiddelprodusenters forsinkelse av generika koster EU 3 milliarder, ifølge EU)
bloomberg.com 28.11.2008
Nov. 28 (Bloomberg) -- European Union regulators accused drugmakers of costing consumers in 17 countries as much as 3 billion euros ($3.9 billion) by using patent lawsuits and other tactics to keep cheaper generic medicines off the market.

The claim, part of an interim report by the European Commission today, was based on evidence collected during January raids at GlaxoSmithKline Plc, AstraZeneca Plc and at least seven other competitors. EU Competition Commissioner Neelie Kroes in Brussels said she “would not hesitate” to open antitrust cases when there’s evidence of restrictive business practices. (...)

Europe Accuses Drug Makers of Padding Health Care Costs
nytimes.com 28.11.2008
BRUSSELS — The European Union accused drug companies on Friday of adding billions of dollars to health care costs by delaying or blocking the sale of less expensive generic medicines. (...)

Big Pharma Faces a Crackdown in Europe
time.com 28.11.2008
The pharmaceutical industry is one of the few sectors around that appears to be weathering these difficult times with relative ease. On Friday the European Commission suggested why that might be: it claims Big Pharma systematically rigged the market to squeeze out copycat medicines.

By using patent lawsuits and other delaying tactics to prevent cheaper generic medicines from entering the market, the drug majors cost European consumers up to $4 billion over an eight-year period until 2007, E.U. competition commissioner Neelie Kroes contends. "Market entry of generic companies and the development of new and more affordable medicines is sometimes blocked or delayed, at significant cost to health-care systems, consumers and taxpayers," she said in Brussels. (...)

Editorial Says Big Pharma's Support for Democrats Could End Up Hurting Them in the Long Run
kaisernetwork.org 29.10.2008
"With a liberal supermajority in Washington increasingly possible," the pharmaceutical industry is "trying to buy up protection in the hopes that Democrats will go easier on them," a Wall Street Journal editorial states, adding, "Money follows power, and obviously the drugmakers believe they need to reposition themselves politically with the prospect of a Democratic Congress and [Democratic presidential nominee Sen. Barack Obama (Ill.)] in the White House." (...)

Witty needs to be wise - and lucky
guardian.co.uk 8.2.2008
When Jean-Pierre Garnier became chief executive of GlaxoSmithKline at the start of 2001, the talk was of a new era in medical science. The biggest research budgets in history would be lavished on the most efficient drug-discovery units. The future was bright and so was the share price, jogging along above £20.

Yesterday Garnier, presenting his last set of full-year results, bowed out with a profits warning, a grumble about how the outside world doesn't understand the nature of risk in pharmaceutical products, and a hint that Glaxo is re-jigging its approach to drug development. The share price is £10.78. How on earth did it get so bad? (...)

Los Angeles Times Examines Problems With Pharmaceutical Industry Focus on 'Blockbuster' Medications
kaisernetwork.org 28.1.2008
The Los Angeles Times on Sunday examined how the business "strategy that has made the pharmaceutical industry one of the wealthiest and most powerful on Earth" might have begun to "betray it."

Pharmaceutical companies for 25 years have "imitated the basic business model of Hollywood" and have "focused on creating blockbusters," which they "hope will appeal to masses" and "promote like mad," according to the Times. Pharmaceutical companies must spend as much as $1 billion to promote new medications in their first two years on the market to make the products into a "mega-brand" with at least $1 billion in annual sales. (...)

A bitter pill for Big Pharma
latimes.com 27.1.2008
Overdependence on 'blockbuster' drugs is taking a toll on the industry.

The strategy that has made the pharmaceutical industry one of the wealthiest and most powerful on Earth is finally starting to betray it. (...)

Don't blame it all on the bogey (Ikke legg all skyld på busemannen)
BMJ 2007;334:1250-1251 (16 June)
Medicine and the media
UK and European policymakers and journalists could learn a lot from the way in which their US counterparts are ready to turn the heat on drug regulators, not just on big pharma, writes Michael Day (...)

The British press has been quick to report concerns about "disease mongering" by the drugs industry as well as safety fears over Vioxx (rofecoxib), Seroxat (paroxetine), Avandia (rosiglitazone), and others. But it has largely been left to campaigners such as Charles Medawar in Social Audit to tackle the failings of the Medicines and Healthcare products Regulatory Agency—and to call for the heat to be turned up on the people who regulate drug companies, rather than simply demonising these profit-making organisations for cutting corners and doing what they do best . . . making profits.

No so in the United States, where thorough newspaper reporting of the Food and Drug Administration's inadequacies has prompted members of the US Congress to now push for proper post-marketing surveillance of new medicines, and even for the FDA to be split into two separate bodies—one that awards drugs licences, and another that continues to monitor safety and has the power to rescind them.

The real impetus behind these calls for change has been the Vioxx disaster. The agency's failure to act more quickly on Vioxx, and the behaviour of key figures within the organisation are probably the most alarming aspects of a new investigative documentary on the dark side of the pharmaceutical industry, We'll Take Care of You by Lattanzio Firmian and Alberto Baudo. (...)

(Anm: Statlig legemiddelkontroll (Statens legemiddelverk etc.) (mintankesmie.no).)

(Anm: Varslere (medisinske varslere) (whistleblowers) etc. (mintankesmie.no).)

Vil skjulte pengeavtaler til livs

Brustad vil granske Gardasil-skandalen
helserevyen.no 2.1.2007
Helse- og omsorgsminister Sylvia Brustad vil se nærmere på habiliteten til norske helseeksperter som har fått penger for sine bidrag til utviklingen av kreftvaksinen Gardasil. (...)

Vil skjulte pengeavtaler til livs
dn.no 30.12.2006
Helseminister Sylvia Brustad vil skjerpe regelverket for kontakt mellom helsepersonell og legemiddelindustrien. (...)

Utspillet kommer etter avsløringene om Kreftregisterets og forskeres skjulte pengeavtaler med legemiddelindustrien.

– Jeg vil forsikre meg om at det blir gjort grundig vurdering av habilitet og uavhengighet til dem som er involvert i utredningsprosessen. Det viser behov for å innskjerpe regelverket for kontakt mellom helsepersonell og legemiddelindustri og sørge for at det blir etterlevd. Dette vil vi umiddelbart gripe fatt i, sier ministeren til VG. (...)

Legemiddelfirmaer betaler leger for møtevirksomhet

Betaler legar for møteverksemd
nrk.no 15.2.2006
Anerkjente legar får pengar av legemiddelindustrien for å være med på møter. Slik omgår industrien reglane om sponsing, meiner kritiske legar.

Industrien samlar legane i rådgjevningsgrupper, men er i realiteten lite interessert i råda dei får frå legane. Det seier Sture Rognstad, spesialist i allmennmedisin i Lillestrøm og lektor ved Universitetet i Oslo.

Han sat tidlegare i eit såkalla 'advisory board', men opplevde at legemiddelfirmaet ikkje var interessert nokon av dei råda han og dei andre legane kom med.

- Vi vart overkøyrde og dei prøvde å overbevise oss om at det var deira behandlingsstrategi som var best. Det vart raskt openbart at mi rolle der ikkje var å gje råd, men å ta i mot bodskapen frå firmaet, seier Rognstad. Han anbefalar legar å halde seg vekke frå slike rådgjevingsgrupper. (...)

-Uproblematisk
For Legemiddelindustriforeningen er rådgjevingsgruppene uproblematiske.

- Vi har eksempel på at det har blitt gjennomført møter som ikkje tilfredstiller krava vi stiller til rådgjevingsgrupper. Men i hovudsak trur eg industrien held seg til reglane, seier administrerende direktør i LMI, Pål Christian Roland. Han meiner samarbeidet er naudsynt og positivt. (...)

Legemiddelfirma drifter medisinske nettsider

Legemiddelfirma drifter medisinske nettsider
helserevyen.no 29.11.2006
Legemiddelindustrien kjøper opp domener og drifter en rekke nettsider der de har full kontroll over hvilke medisiner som profileres.

Flere hundre internettsider er de siste årene registrert på norske legemiddelselskap, som angst.no, demens.no, kols.no, potens.no, lykkepille.no, pollenvarsel.no og enzym.no, melder NRK.

Legemiddelselskapet AstraZeneca leder for eksempel brukere som taster inn adresser som www.kols.no og www.astma.no til sin egen informasjonsside www.astmainfo.no. Det innebærer en stor grad av kontroll over hvor nettbrukerne havner når de søker opp informasjon om sykdommer og lidelser de er rammet av.

Samtidig oppstår det et habilitetsproblem fordi disse nettstedene eies av de samme som produserer legemidlene. (...)

Uproblematisk
Administrerende direktør Pål Christian Roland i Legemiddelindustriforeningen mener de medisinske nettsidene er uproblematiske.

- Legemiddelindustrien er naturligvis oppatt av å få ut informasjonen sin, og vi mener at industrien spiller en viktig rolle i å få presentert helseinformasjon, seier Roland til NRK. (...)

Drug tales and other stories
Ike Iheanacho, editor, Drug and Therapeutics Bulletin
BMJ 2007;334:904 (28 April)
Myths and realities

Big pharma has quite a record in the creation and dissemination of myths. However, the industry would probably rather be seen as a debunker. For instance, the Association of the British Pharmaceutical Industry, which represents major UK companies, recently reissued a "media briefing" entitled "Information about medicines: myths and realities." Focusing on the restrictions that limit companies' direct provision of information to patients, the document attacks supposedly prevalent views relating to this area.
For example, according to the briefing, it's a myth that "the industry can't be trusted to provide honest information." Tell that to those who regularly find half truths and worse in drug companies' promotional material, despite the various legal and other safeguards against such deception. Odder still are some of the other "myths." For example, where is the hard evidence of widespread belief and active propagation of the notions that "consumers do not want information," that "being ‘more informed' does not benefit the patient" and that "patients are not in a position to understand or interpret information about medicines"?

The rest of the "myths" are similarly unimpressive, also coming across as crude devices for making the briefing's central point: companies would like the right "to provide more high-quality, non-promotional information to benefit patients and carers." The suggestion that this is the industry's main motivation is a pretty big myth in itself.

Of course, businesses are entitled to highlight genuine views, concerns, and misapprehensions of clients, customers, or the wider public. But in the court of public opinion the drug industry can be a terrible witness and a lousy advocate. (...)

- Misbruk av vaksinepenger

- Misbruk av vaksinepenger
aftenposten.no 3.3.2008
Flere milliarder kroner som skulle gå til utvikling av nye vaksiner til verdens fattigste barn, går rett i lommen til legemiddelindustrien. Det hevder flere internasjonale eksperter på vaksineforskning og ulandsmedisin. (...)

Statsminister Jens Stoltenbergs prestisjeprosjekt, Den globale vaksinealliansen (GAVI), får beinhard kritikk fra tung vitenskapelig ekspertise innen vaksineforskning og epidemier. Kritikerne mener GAVIs forsøk på å få industrien til å utvikle nye vaksiner, eller justere eksisterende vaksinene slik at de kan brukes til å vaksinere barn i u-land, er feilslått. (...)

- Dette er misbruk av penger. Bare 25 prosent av pengene går til å dekke vaksinekostnader, mens 75 prosent går til store farmasøytiske selskaper som betaling for vaksiner de allerede tjener godt på, sier professor Donald W. Light ved Center for Bioetichs ved Princeton-universitetet i USA. (...)

Stoltenberg har gjort GAVI til en viktig del av norsk utenrikspolitikk. Norge gir en halv milliard kroner i året til GAVI. Frem til 2015 skal Norge gi 6 milliarder kroner for å nå FNs tusenårsmål om å redusere barnedødeligheten med to tredjedeler. (...)

9 milliarder kroner har donorlandene lagt på bordet til AMC for en tiårsperiode. Norge bidrag på 350 millioner kroner går av den ordinære potten fra Norge til GAVI på 500 millioner kroner årlig frem 2015. (...)

Stor fortjeneste.
Light mener den første "AMC-vaksinen" er en vaksine som allerede er oppdaget, og som selskapene som fikk oppdraget - Wyeth og GlaxoSmithKline - allerede har hatt stor fortjeneste på.

- Industriens kliniske prøver og utvikling er allerede finansiert og har gjort selskapene rike. Denne AMC-piloten er derfor egentlig et gigantisk pengeoverføring fra donorlandene til industrien, penger som heller burde ha gått til å vaksinere enda flere barn enn man til nå har greid.

Light har beregnet at den nye vaksinen vil kunne kjøpes for 1,25 dollar pr. dose (inkludert kapitalkostnader). (...)

– Stoltenbergs vaksinepenger er misbruk
ukeavisenledelse.no 3.3.2008
Internasjonale eksperter på vaksineforskning og u-landsmedisin hevder at penger til statsminister Jens Stoltenbergs vaksineprosjekt går rett i lomma til legeindustrien. (...)

- I korrupsjonens tegn?

Pharma needs to restore its reputation with public and fast
pharmatimes.com 24.1.2007
Pharmaceutical firms need to make some drastic changes to the way they do business if they are to regain the public's trust and must be seen to be more interested in medicines than market share to avoid even more damage to their image, a leading industry observer has told PharmaTimes World News. (…)

I korrupsjonens tegn?
Pål Christian Roland, administrerende direktør Legemiddelindustriforeningen (LMI)
nationen.no 9.1.2007
Faktum er likevel at det i Norge aldri har vært korrupsjonssaker knyttet til legemiddelindustrien. (...)

Legemiddelindustriforeningen (LMI) er opptatt av at all samhandling mellom industrien og helsetjenesten skal være egnet til å tåle dagens lys. Det er derfor etablert et detaljert regelverk og omfattende samarbeidsavtaler med både profesjonsforeninger og de regionale helseforetakene for å sikre at all samhandling er tuftet på prinsipper blant annet om åpenhet, etterprøvbarhet og ledelsesforankring. Reglene følges også opp av et omfattende arbeid for å sikre etterlevelse.

At vi innen legemiddelindustrien, i likhet med øvrige bransjer i Norge, kan ha utfordringer på området skal ikke underslås. Faktum er likevel at det i Norge aldri har vært korrupsjonssaker knyttet til legemiddelindustrien. Det er derfor særdeles underlig at Nationen velger å bruke det meste av lederen under tittelen «Norge i korrupsjonens tegn» på legemiddelindustrien. Dette er uverdig, lettvint og useriøs journalistikk. (...)

Norge i korrupsjonens tegn
Leder
nationen.no 2.1.2007
Selv den minste lille smøring og grådighet undergraver tilliten

Året vi nettopp har lagt bak oss, var et år i korrupsjonens tegn. Den ene saken etter den andre ble avdekket, fra ren svindel og direkte bestikkelser, til samrøre, smøring og kokkelimonke i gråsoner mellom lovverk, anstendighet og etikk. (...)

De har ikke forstått at dette handler om tillit. Den farmasøytiske industrien har et frynsete rykte, etter flere store skandaler, hvor midler med alvorlige bivirkninger er sendt ut på markedet. Undersøkelser blir skreddersydd for å få de svar man vil ha, og leger kjøpes for å gi nye medikamenter troverdighet. Det er ikke uten grunn at legemiddelindustriens kynisme er blitt et stort internasjonalt tema. (...)

Regelendringene har ingen effekt

Leger fortsatt på smøreturer
nrk.no 16.6.2006
Norske leger reiser fortsatt på faglige samlinger betalt av legemiddelindustrien, selv om reglene er skjerpet de siste to årene.

Regelendringene innebærer blant annet at kurs som er helt eller delvis betalt av industrien ikke teller som etterutdanning.

De fem første månedene i år sendte legemiddelindustrien i Norge ut kurs- og kongressinvitasjoner til over 1400 ulike arrangementer, viser en gjennomgang NRK har gjort.

De fleste arrangementene er helt gratis for legene og inkluderer reise, hotellovernatting og middager.

Ventelister
Noen av utenlandskongressene er så populære at leger setter seg på venteliste for å få komme med.

Administrerende direktør Pål Christian Roland i Legemiddelindustriforeningen mener samarbeidet er greit og nødvendig.

Han viser til at møter mellom industrien og legene både gir tilbakemelding til industrien fra legene og kunnskap fra industrien til legene.

Har sluttet
En av dem som har sluttet å reise på slike turer, er allmenpraktiker og universitetslektor Sture Rognstad ved Universitetet i Oslo. Han misliker de tette båndene som da kan oppstå.

- På en sånn tur kommer man tett inn på representantene som er både koselige og spandable underveis, og man vil få etablert sterke relasjoner og assosiasjoner mellom det som skal være vår uhildede jobb og de som leverer legemidler, sier Rognstad. (...)

U.S. Medical Schools, Drug Makers Share Strong Ties

U.S. Medical Schools, Drug Makers Share Strong Ties
healthfinder.gov 16.10.2007
Majority of department chairs have connections with industry, study finds.

(SOURCES: Eric G. Campbell, Ph.D., associate professor, Institute for Health Policy at Massachusetts General Hospital and Harvard Medical School, Boston; David Korn, M.D., senior vice president, division of biomedical and health sciences research, Association of American Medical Colleges, Washington, D.C.; Oct. 17, 2007, Journal of the American Medical Association)

TUESDAY, Oct. 16 (HealthDay News) -- More than half of department chairs at U.S. medical schools and teaching hospitals have financial ties with the drug industry, a new study finds.

These institutional relationships seemed to be just as widespread as those of individual physicians or scientists with industry.

"There is not a single aspect of medicine in which the drug companies do not have substantial and deep relationships, affecting not only doctors-in-training, resident physicians, researchers, physicians-in-practice, the people who review drugs for the federal government and the people who review studies," said lead researcher Eric Campbell, associate professor at the Institute for Health Policy at Massachusetts General Hospital and Harvard Medical School in Boston.

"Drug companies have relationships with everyone," he continued. "They're involved in every aspect of medicine. Someone has to decide which of these is OK."

The study, the first to examine the extent of these institutional relationships, is published in the Oct. 17 issue of the Journal of the American Medical Association. (...)

Lederartikkel i det medisinske tidsskriftet Lancet

Editorial (Lederartikkel)
The tightening grip of big pharma (Big pharmas knugende grep)
The Lancet 2001;357:1141 (14.4.2001)
Legemiddelfirmaenes streben etter å skjule, spinne, og formørke de funn som ikke passer deres kommersielle formål ble først til det fulle, dødbringende omfang, avslørt under thalidomidtragedien. Selv om myndighetenes planer for legemiddelreguleringer nå er på plass over hele verden, er big pharmas lumske taktikk ikke i nevneverdig grad endret. (Efforts by drug companies to suppress, spin, and obfuscate findings that do not suit their commercial purposes were first revealed to their full, lethal extent during the thalidomide tragedy. Although government drug regulation schemes around the world are now in place, the insidious tactics of big pharma have changed little.)

Ingen vil nekte et farmasøytisk firma retten til å utnytte vitenskapelig forskning forretningsmessig. Men det spørsmålet er et helt annet enn ”rett” til å blokkere publikasjon. (...) (Nobody would deny a pharmaceutical company its right to commercialise results of scientific research. But that issue is completely different from its ”right” to block publication.)

(Anm: Statlig legemiddelkontroll (Statens legemiddelverk). (mintankesmie.no).)

Administrerende direktør Pål Christian Roland i Legemiddelindustriforeningen stiller seg undrende til kritikken

- Stiller meg undrende til kritikken
Aftenposten 9.1.2006
- Jeg opplever at man i industrien har høy integritet og stiller høye krav til de studiene som blir publisert. Han stiller seg undrende til Drazens påstander om at det er en negativ utvikling. Min erfaring er det motsatte, også i internasjonal sammenheng, sier administrerende direktør Pål Christian Roland i Legemiddelindustriforeningen. Han erkjenner at sakene om Vioxx og Celebra har skadet industriens omdømme, men sier likevel: - Generelt kan både leger

Troverdighet

Høyest tillit til apotek
apotek.no 13.12.2010
Folks tillit til apotekene er fremdeles svært høy, og høyere enn tilliten til både leger og sykehus. Det viser tall fra TNS Gallups Apotekbarometer for desember 2010.

- Dette er et meget godt resultat for apotekene. Jeg tror tilfredsheten henger sammen med det høye servicenivået i apotekene, og ikke minst den svært høye legemiddelfaglige kompetansen hos de ansatte. Man får gode råd i apoteket, og man vet at de er til å stole på, sier konstituert adm. dir. i Apotekforeningen, Oddbjørn Tysnes.

I undersøkelsen får apotekene en tillitsscore på 78 poeng av 100. Legene får en score på 70 poeng, og sykehusene like under med 66 poeng. Nederst ligger legemiddelindustrien med 44 poeng og helsekostbransjen med 39 poeng. (...)

Industrins image i USA rekorddålig
Läkemedelsvärlden (Oktober 2005)
Enligt en rapport från det amerikanska undersökningsföretaget Datamonitor är amerikanernas tilltro till läkemedelsindustrin lägre än någonsin.

LÄKEMEDELSINDUSTRI Amerikanarna har mycket lågt förtroende för läkemedelsindustrin.

Färre än 13 procent tror att information från industrin är mer trovärdig än den som kommer från andra organisationer. Enligt det amerikanska undersökningsföretaget Datamonitor är det sämre än någonsin.

Enligt den analys som företaget gjort ifrågasätter konsumenterna om det är patienternas bästa som företagen har som målsättning när man marknadsför en produkt. Undersökningen visar också att medborgarnas kritiska inställning påverkar industrin mer negativt än ökade statliga regleringar.

De skarpare varningarna för läkemedel som Roches Accutane, GSK:s Paxil, liksom indragningen av MSD:s Vioxx har underminerat konsumenternas tilltro till både industrin och dess produkter, är undersökningsföretagets analys. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Legemiddelfirmaer anklages for å sette pasienters liv i fare

Drug companies accused of putting patients' lives at risk (Legemiddelfirmaer anklages for å sette pasienters liv i fare)
independent.co.uk 15.10.2004
Patients' lives are being put at risk by the practices used by some drug companies to promote their products, medical experts warned MPs yesterday.

Many papers on new drugs published in respected journals such as the British Medical Journal and The Lancet were ghost written by drug company advisers, MPs on the Commons Health Select Committee were told. Drug companies also bombarded doctors with gifts. The pharmaceutical industry's code of practice on free gifts was broken "on a daily basis" but neither doctors nor drug companies admitted it.

One doctor revealed he had been offered a bribe of two years' salary not to publish research on the side effects of a new heart drug which ran "counter to the interests" of the company producing it.

The MPs were told that some senior medical consultants received consultancy fees from drug companies of more than £20,000 for a few hours' work. Experts could also earn more than £4,000 an hour for extolling the virtues of new drugs to other doctors.

Members of the select committee, which is investigating the way the pharmaceutical industry operates, said later they were horrified by some of the evidence they took from two panels of experts.

Some of the most disturbing evidence centred on the efforts by the drug companies to persuade family doctors to use their products by persuading some of the leading medical experts in the country to put their names to technical reports about trials of new drugs.

Drug companies used euphemisms to describe the side effects, it was alleged. (...)

Too Much Research
The Independent 17.7.2005
TO GRASP the central crisis in the health system, consider the history of cancer drugs. In 1992 a new breast cancer medicine called Taxol was marketed at $4,000 for a year's prescription, a sum considered exorbitant at the time. Six years later, as the New York Times reported on Tuesday, another breast cancer drug called Herceptin hit the market at $20,000. Then in 2002 a colon cancer drug called Erbitux weighed in at $100,000 -- a twenty-five-fold increase in the space of 10 years. Drug companies charge this much mostly because our broken non-market system allows them to get away with it.

The standard justification for high drug prices is that they finance medical research. Yet huge research budgets are justified only if they achieve something useful. Usefulness means not just producing drugs but extending and improving the quality of life at a reasonable price. Because decisions about treatment are made by patients and doctors who don't pay for medicines, drugs that fail the usefulness test nonetheless get purchased. Cancer doctors are willing to prescribe medicines costing more than $300,000 for an extra year of life, according to a study by Dr. Eric Nadler of Harvard Medical School. But by analyzing how much people are willing to pay for various life-extending safety precautions, health economists have concluded that society values an extra year of life at about $75,000. The physicians' indifference to cost explains why drug firms charge outrageous prices.

Paying too much has painful consequences, even if they aren't immediately visible. The rising cost of health care helps to explain why airlines are going bankrupt and why Detroit has trouble competing against foreign automakers. To the extent that corporations cushion themselves by holding down wages, rising health costs contribute to the stagnation of incomes in the bottom half of the workforce. Medical inflation also obliges some people to do without insurance: Between 2000 and 2003, the percentage of Americans covered by employment-based health benefits fell from 63.6 percent to 60.4 percent. Finally, medical inflation drives up the cost of Medicare and Medicaid, which will ultimately force taxes up. (...)

Is Glaxo's Pipeline Half Full or Half Empty? Views Differ
New York times 12.8.2005
- Has GlaxoSmithKline turned the corner? It depends on whom you ask.

Glaxo has been showing signs of a revival after a series of problems in the last year, including a run-in with Eliot Spitzer, the New York attorney general, over the company's handling of clinical trials data; shrinking profits from some big-name drugs; and the Food and Drug Administration's temporary closure of a plant for quality control problems.

The company, which is Europe's largest drug maker and second only to Pfizer worldwide, recently reported higher sales and a better-than-expected profit for the second quarter and first half of the year - in contrast to four consecutive quarters of falling profits in 2003 and 2004. Its American depository receipts, while off a peak reached in May, are up nearly 24 percent from last August.

And to hear the chief executive, Jean-Pierre Garnier, tell it, things are about to get better for GlaxoSmithKline, which was created five years ago by the merger of Glaxo Wellcome and SmithKline Beecham. Mr. Garnier, a former SmithKline executive who has run the company since the merger, promises that a pipeline of new drugs will soon set Glaxo apart from other struggling pharmaceutical companies.

"We are coming out of a difficult period and things are clicking very nicely," Mr. Garnier said in a recent interview. Glaxo is facing the "moment of truth for half a dozen really exciting drugs," he said.

Some analysts, though, are starting to take a hard look at Glaxo's new drug pipeline and are wondering whether Mr. Garnier is realistic about the state of research and development at his company. (...)

Drug companies monitor web chat for adverse reaction reports
BMJ 2005;330:1347 (11 June)
Drug companies are harvesting comments posted on the internet about drug side effects using new computer technology. NetRank, a UK based internet consultancy, said this week that at least one "well known drug company" is using a product called i-reputation, which monitors the internet for postings about specific products.

Critics of the pharmaceutical industry expressed concern about the way the information might be used. (...)

Among internet enthusiasts, such programs are widely known as "spyware." John Straw, NetRank's chief executive, said that the system posed no threat to privacy, however. (...)

Despite Vow, Drug Makers Still Withhold Clinical Information
TheNew York Times 31.5.2005
When the drug industry came under fire last summer for failing to disclose poor results from studies of antidepressants, major drug makers promised to provide more information about their research on new medicines. But nearly a year later, crucial facts about many clinical trials remain hidden, scientists independent of the companies say. (...)

In August, GlaxoSmithKline agreed to pay $2.5 million to settle a suit by Eliot Spitzer, the New York attorney general, alleging that Glaxo had hidden results from trials showing that its antidepressant Paxil might increase suicidal thoughts in children and teenagers. At a House hearing in September, Republican and Democratic lawmakers excoriated executives from several top companies, including Pfizer and Wyeth, for hiding study results. In response, many companies promised to do better. (...)

IFPMA

New IFPMA Code of Pharmaceutical Marketing Practices (Nye IPFMA-retningslinjerfor farmasøytisk markedsføring)
ifpma.org 3.1.2007
Geneva, 1/3/2007 - An updated version of the IFPMA Code of Pharmaceutical Marketing Practices entered into force on 1 January 2007. The new Code, whose applicability extends to every country and is required of all IFPMA members, imposes even stricter and clearer requirements on pharmaceutical companies, to ensure the ethical promotion of their products to health care professionals. (...)

De nye IPFMA-retningslinjer for farmasøytisk markedsføring på engelsk er tilgjengelig på www.ifpma.org/pdf/IFPMA-TheCode-FinalVersion-30May2006-EN.pdf. (The new IFPMA Code of Pharmaceutical Marketing Practices can be found: in English at www.ifpma.org/pdf/IFPMA-TheCode-FinalVersion-30May2006-EN.pdf.)

(Anm: Sitat fra de nye retningslinjer (jf. pkt. 7.5.3): "As a general rule, the
hospitality provided should not exceed what healthcare professional recipients would normally be prepared to pay for themselves." (Som en generell regel, bør ikke gjestmildheten overfor helsepersonell som mottar ytelsen, overskride hva de normalt ville være forberedt på å betale selv.)

Pål Christian Roland inn i styret i IFPMA
lmi.no 13.10.2006
Ny ledelse valgt i Geneve i går.
Pål Christian Roland, adm. direktør i LMI, er valgt inn i styret til den internasjonale legemiddelindustriforeningen, IFPMA.

Foreningen er en paraplyorganisasjon for den forskningsbaserte legemiddelindustrien, holder til i Geneve og har medlemmer fra 60 land. De siste årene har organisasjonen bla arbeidet med utvikling av en søkeportal for kliniske studier, regler for industriens markedsføring og utviklet samarbeid mellom legemiddelfirmaer, myndigheter og organisasjoner om helseprosjekter i den tredje verden. (...)

Les mer om IFPMA: www.ifpma.org (...)

Legemiddelfirmaers oppfølging av sikkerhet

LMI ber Legemiddelverket vurdere å fjerne krav om papirkopi ved innsendelse av periodiske sikkerhetsoppdateringer
lmi.no 30.10.2007 (Legemiddelindustriforeningen (LMI))
LMI ønsker med dette å be Legemiddelverket vurdere om kravet om papirkopi av periodiske sikkerhetsoppdateringer (PSUR) for legemidler kan fjernes.

PSUR’ene medfører innsendelse av store mengder dokumentasjon til Legemiddelverket. LMIs registreringsutvalg anslår at en gjennomsnittlig PSUR for et legemiddel er på ca. 5000 sider. Denne rapporten skal, ihht. ny legemiddellovgivning, sendes inn to ganger i året for nye legemidler, deretter årlig, deretter hvert tredje år for eldre legemidler. (...)

Hvordan bruger vi sikkerhedsdata i et lægemiddelfirma?
Ebbe Englev, læge, medicinsk direktør, Abbott Laboratories A/S

Ebbe Englev indledte med en orientering om lægemidlernes udviklingsproces, der kan vare fra 10-15 år fra idé til færdigt produkt. Udfordringen er at skabe overensstemmelse mellem udviklingsfasens lukkede, velkontrollerede og veldefinerede lille patientpopulation til den langt mere inhomogene population, der rent faktisk ender med at bruge lægemidlet i fasen efter markedsføringsdatoen. Rapporteringer af uønskede hændelser i kliniske forsøg vurderes af Lægemiddelstyrelsen og videnskabsetisk komite (VEK), og de uønskede hændelser registreres i patientskema (CRF). Alvorlige eller uventede hændelser med mulig årsagssammenhæng skal meldes til Lægemiddelstyrelsen, og firmaet skal mindst 1 x årligt indsende en rapport (PSUR) til lægemiddelstyrelsen og VEK. Firmaet skal derudover føre optegnelser over og indberette alle formodede bivirkninger, indsende sikkerhedsopdateringer og andre relevante oplysninger. Endelig skal firmaet overvåge sikkerhedsprofilen, opdatere produktresumeet og sikre en Risk Management Plan for produktet. Ved behov for yderligere aktiviteter iværksættes en handlingsplan for "safety issues".

På spørgsmål fra salen om, hvor ofte disse bivirkningsrapporter fører til ændringer i produktresumeet, svarede Ebbe Englev, at det gør det i ca. 95 % af tilfældene, men at det er en langvarig proces. (...)

Ebbe Englevs præsentation (207 KB) (...)

Patient Compliance Europe

Patient Compliance Europe
keywordpharma.com 19.8.2006
In-depth report from the eyeforpharma conference, Amsterdam, 1-2 June 2006.

Doctors have probably been telling people to ‘keep taking the tablets’ since the earliest shamans and folk healers were first frustrated by the non-compliance of their prehistoric patients.

Today, the pharmaceutical industry is leaving an estimated US$25 billion on the shelf every year through lack of patient compliance. Events like eyeforpharma’s conference, Patient Compliance Europe, now in its third year, reflect a growing recognition of the importance of patient compliance and its impact on revenues.

Current estimates put non-compliance possibly as high as 50-70%. This is despite the well-known fact that poor compliance is associated with a lower quality of life, poor clinical outcomes, increased hospitalisations and higher overall healthcare costs. Clearly, compliance is actually synonymous with patient well-being. (...)

Lundbeck

EU opens antitrust proceedings against Lundbeck
pharmatimes.com 8.1.2010
The European Commission announced yesterday that it has opened a formal antitrust investigation into Danish drugmaker H Lundbeck.

The Commission says it will investigate, “as a matter of priority,” potential breaches by the company of European Union (EU) rules on restrictive business practices and abuse of a dominant market position. In particular, it intends to probe “unilateral behaviour and agreements” by Lundbeck related to delays in entry of generic versions of its antidepressant Celexa/Cipramil (citalopram) into European Economic Area (EEA) markets. Lundbeck’s patent on the drug, a selective serotonin reuptake inhibitor (SSRI), expired in 2003. (...)

Ny mega-skuffelse fra Lundbeck
business.dk 30.6.2008
Blot ganske få uger efter køb af muligt alzheimer-middel afskriver Lundbeck knap halv milliard efter katastrofale fase 3-data. Elendig start for ny Lundbeck-chef.

Lundbeck er kastet ud i en en regulær krise, efter at data fra et fase III-forsøg med det nyindkøbte Alzheimermiddel Flurizan ikke viste den ønskede effekt. Dermed ser midlet ikke ud til at blive den storsællert, som selskabet havde forventet og håbet på.

"De kliniske fase III-data svarer ikke til de data, der blev observeret i klinisk fase II i patienter med mild Alzheimers sygdom. Lundbeck og Myriad vil nu undersøge resultaterne yderligere for at opnå forståelse af forsøgsresultaterne, hvor stoffet ikke opfyldte de to primære effekt mål".

Lundbeck betalte for nylig 100 mio. dollar i initialbetaling for Flurizan. Men da det nu er mindre sandsynligt, at lægemidlet overhovedet bliver til noget, afskriver Lundbeck hele beløbet som engangsomkostninger i 2. kvartal af regnskabsåret. (...)

Tilbageslag for ny Lundbeck-medicin
business.dk 29.2.2008
Den amerikanske medicinalgigant Wyeth har netop droppet stoffet bifeprunox i USA på grund af svigtende salgspotentiale, hvilket er et hårdt slag for danske Lundbeck, der netop nu arbejder på at lancere stoffet i Europa. (...)

”Lundbeck har rettighederne i Europa og kan selvfølgelig se det her som en mulighed for at lancere stoffet i USA. Men jeg tror ikke, det er aktuelt for Lundbeck, da de ikke ønsker at satse på en amerikansk lancering af et middelmådigt og risikofyldt produkt,” siger han.

Analytiker Torben Vest fra Standard & Poor’s mener ligesom Martin Parkhøi, at Wyeths afvisning af lægemidlet ikke er gode nyheder for Lundbeck. Men han mener stadig Lundbeck kan fortsætte med at udvikle lægemidlet til de europæiske skizofreni-patienter. (...)

Lundbeck i historisk svag position
berlingske.dk 15.3.2006
Lundbeck er omringet af problemer efter et af de mest problematiske år i selskabets historie. Salget svigtede i USA, en retssag truer, forberedelsen af nye produkter går trægt. Og 2006 bliver værre end 2005.

Grunden ryster under Lundbeck, Danmarks næststørste medicinalselskab, efter et 2005, der mildt sagt har været noget af en skuffelse for selskabets topchef Claus Bræstrup.

Omsætningen faldt i 2005 med syv procent til 9,070 mia. kr., og overskudet af den primære drift droppede 15 procent til 2,1 mia. kr. Og i 2006 bliver tallene ikke bedre: Her regner Lundbeck med et resultat af den primære drift på 1,6 mia. kr., en halv mia. mindre end i 2005. (...)

8. februar lammetævede aktiemarkedet Lundbeck, da selskabet nedjusterede på grund af en ilde salgsvækst i USA. Derfor var aktiemarkedets reaktion i går på det dårlige regnskab beskeden og endte med en stigning på 0.57 procent.
Men flere analytikere påpeger nu, at selskabet er i store problemer på tre punkter:

Det amerikanske marked er gået i stå - salget af hovedproduktet Lexapro svigter.

En retssag, der starter mandag, udfordrer patentet på Lexapro. Et nederlag vil udløse retssager i Europa, som kan være decideret livstruende for selskabet, der i 2005 solgte Lexapro og Cipralex for 6,3 mia. kr., 69 procent af omsætningen.

Udviklingen af nye produkter, der kan overtage salget, når de nuværende og næste hovedprodukter mister patent, går for langsomt. (...)

Patent udløber
Mistanke om en forhøjet selvmordsrate blandt børn, der er i behandling med Lexapro, har været med til at sænke de amerikanske lægers udskrivning af lundbeckproduktet.

»Spørgsmålet er, om vi taler om en blivende effekt (på salget, red.). Det ved vi ikke,« siger Claus Bræstrup.

Til efteråret udløber patentet på den storsælgende konkurrent til Lexapro, Pfizers Zooft. Herefter vil billige Zoloft-kopier strømme ind i USA, og Lundbeck ved ikke, hvordan det vil påvirke salget af Lexapro.

Lundbeck kan dog glæde sig over et eksplossivt salg af Cipralex på 58 procent i Europa. (...)

Legemiddelindustriforeningen (LMI)

Myter om legemiddelomsetning
Av Pål Christian Roland, adm. direktør i Legemiddelindustriforeningen aftenposten.no 17.5.2007
I løpet av våren har Aftenposten satt søkelyset på legemidler og legemiddelpriser. Når legemidler debatteres, fremkommer både myter og sannheter. (...)

Dokumenterer underforbruk av medisiner
helserevyen.no 20.3.2006
- Økt bruk av legemidler innenfor seks terapiområder kan gi positive effekter for pasientene og spare samfunnet for millionbeløp i følgeskader av for lavt medisinbruk.

Det mener Legemiddelindustriforeningen (LMI), som med rapporten «Riktig bruk av legemidler» kaster en brannfakkel inn i debatten om forbruket av legemidler i Norge. (...)

(Anm: Riktig bruk av legemidler. Omtale av LMIs presentasjon av rapporten på Apotekforeningens Legemiddeldag. (08.09.2006).

Lav tillit til helsepolitikerne og legemiddelindustrien

Lav tillit til helsepolitikerne og legemiddelindustrien
helserevyen.no 13.2.2006
Helsepolitikere og legemiddelfirmaer kommer dårligst ut i en stor nasjonal undersøkelse gjennomført av Norstat på vegne av legemiddelselskapet Pfizer. (...)

4001 personer deltok i undersøkelsen gjennom telefonintervjuer utført av Norstat. Spørsmålene er utviklet og testet i samarbeid med Statistisk sentralbyrå, etter de metodene SSB anbefaler for sine egne spørreskjemaer.
Resultatene

• 67 prosent har nemlig tillit til fastlegen sin
• 49 prosent har tillit til offentlige sykehus
• 39 prosent har tillit til sykepleiere
• 37 prosent har tillit til pasientorganisasjoner
• private sykehus og apoteker får henholdsvis 36 og 32 prosent
• 10 prosent har tillit til alternativ medisin
• 7 prosent har tillit til legemiddelindustrien
• helsepolitikerne har tillit hos 4 prosent av de spurte
• 22 prosent av de som har fått legebehandling de siste fem årene ikke er trygge på at de har fått tilfredsstillende behandling.

- Bortsett fra fastlegen er det ingen som kan si seg fornøyd med denne målingen, som er et varsko om at folk flest ikke stoler på helsevesenet vårt.

Selv om offentlige aktører har høyere tillit enn private, er det et klart svakhetstegn at de offentlige sykehusene vi er så avhengige av ikke har et flertall av befolkningens tillit, sier Grethe Aasved, direktør for samfunnskontakt i Pfizer.

- Målingen er heller ikke hyggelig for legemiddelbransjen, som jeg selv representerer. Vi må bli bedre til å forklare folk hvordan vår innsats for å forske frem og utvikle nye og bedre medisiner er avgjørende for utviklingen av folkehelsa, legger hun til.

Politikerne på bunnen
Aller lavest tillit har helsepolitikerne, med kun 4 prosent oppslutning. Det understrekes av at 50 prosent av befolkningen mener politikerne ikke tar landets helseutfordringer på alvor. Her er de med lavest inntekt og utdanning også mest kritiske til politikerne. I tillegg er det stor forskjell mellom kjønnene. 58 prosent av kvinnene, mot 43 prosent av mennene, mener politikerne ikke tar helseutfordringene på alvor.

Eldreomsorg
Undersøkelsen viser videre at den norske befolkningen er svært skeptisk til om landets eldreomsorg er god nok. 66 prosent er ikke trygge på at det offentlige helsevesen vil gi dem god pleie i alderdommen, og 51 prosent er ikke trygge på at de vil få tilfredsstillende medisinsk behandling.

- Resultatene knyttet til eldreomsorgen er alarmerende. Selv om eldreomsorg har vært et sentralt politisk tema i mange år, er det tydelig at folk ikke tror man har klart et godt tilbud. Her har politikerne fortsatt en enorm utfordring foran seg. Dersom det ikke gjøres noen svært gode grep, vil problemene bare bli større etter hvert som vi går inn i eldrebølgen, sier Aasved.

Administrerende direktør i Pfizer Norge, Håvard Ebbestad, sier legemiddelselskapet ønsker å være en partner for bedre helse, og planlegger å gjennomføre en slik undersøkelse årlig for å kunne måle utviklingen over tid, og ta opp aktuelle problemstillinger. (...)

Bare én av fire har tillit til de politiske partiene
vg.no 15.11.2005 Bare én av fire nordmenn har tillit til de politiske partiene, viser den europeiske undersøkelsen European Social Survey.

Undersøkelsen kartlegger holdninger og samfunnsforhold i 17 europeiske land. Den viser at 26,7 prosent av de spurte i Norge har tillit til de politiske partiene.

Resultatet er omtrent gjennomsnittlig blant landene i undersøkelsen, skriver Dagbladet.

Nordmenn har likevel langt lavere tillit til politiske partier enn dansker og finner. I Danmark svarer 52 prosent at de stoler på politikerne, i Finland har 42 prosent tillit og i Sverige er tilliten til politikerne bare litt høyere enn i Norge; 28,4 prosent.

Professor i statsvitenskap, Ola Listhaug ved NTNU i Trondheim, tror nordmenn mister troen på de folkevalgte når folk ser uløste oppgaver samtidig som pengebingen bare vokser.

- Folk føler de er med på å bake en kake de ikke får smake, sier han. (...)

Konkurranse

Surt marked presser medicinalfirmaer
berlingske.dk 22.11.2005
En bitter cocktail af patentudløb, øget konkurrence fra kopiproducenter samt nye tilskudsregler fører nu til fyringer i medicinalbranchen. Industrien har været for godt vant, mener ekspert. (...)

Kostnader for å finne såkalte nye legemidler

Pfizer Tries to Sell Research Spending
wsj.com 25.11.2006
Next week, Pfizer Inc. makes its most aggressive pitch ever to convince investors that the billions of dollars it spends each year on research are paying off. But it could be a tough sell.

The pharmaceutical giant consistently spends the most of any company to find new drugs -- more than $7 billion a year since 2003. Some optimists assert the company's market valuation doesn't adequately reflect the promise of gems hidden inside its labs. But the company's research track record is poor. Pfizer's most recent big hits have been Viagra, launched in 1998, and the painkiller Celebrex, which hit (...)

Ny skarp kritik mot den globala läkemedelsindustrin

Drug Industry Is on Defensive as Power Shifts
nytimes.com 23.11.2006
WASHINGTON, Nov. 23 — Alarmed at the prospect of Democratic control of Congress, top executives from two dozen drug companies met here last week to assess what appears to them to be a harsh new political climate, and to draft a battle plan. (...)

”Läkemedelsindustrins vinstjakt kostar dem livet”
Läkemedelsvärlden 2006(11) (November)
Ny skarp kritik mot den globala läkemedelsindustrin

Varje år dör 14-15 miljoner människor av smittsamma sjukdomar trots att det i många fall finns effektiva läkemedel. Men dagens handels- och forskningspolitik begränsar tillgången till livsnödvändig medicin.

KRITIK Det framgår av en studie som publiceras idag: Öppna sår i den globala politiken – Forskning, handelsavtal och tillgången till medicin.
- Vi vill ge en aktuell summering av de konsekvenser som internationella handelsregler och forskningspolitik har när det gäller tillgången till mediciner för sjukdomar som främst drabbar människor i utvecklingsländer, och samtidigt lägga fram rekommendationer för vad svenska politiker kan göra för att förbättra situationen, säger Göran Eklöf som gjort studien på uppdrag av Afrikagrupperna, Diakonia, Forum Syd och Läkare Utan Gränser.

Skälen till att människor saknar tillgång till mediciner som kan rädda liv är många. Ett av dem är att läkemedelsbolagen tar ut priser som varken vården eller den enskilde patienten i fattiga länder har råd att betala. Rådande patentregler bidrar till de höga priserna.

För vissa sjukdomar finns emellertid inga effektiva och säkra läkemedel. Eftersom dessa nästan uteslutande drabbar fattiga människor i fattiga länder, som inte har råd att betala vad det kostar ens när det handlar om att rädda liv, så investerar den marknadsbaserade läkemedelsindustrin inte i forskning och utveckling av mediciner mot dessa sjukdomar. (...)

Manglende tilsyn og oppfølging av legemiddelstudier

Report: FDA struggles to track foreign drug trials (Rapport: FDA sliter med å holde oversikten over utenlandske legemiddelforsøk)
pharmpro.com 22.6.2010
The Food and Drug Administration is reviewing only a fraction of foreign drug trials, as companies increasingly move drug testing overseas to reduce costs, a report by agency overseers said Tuesday.

The FDA inspected about one percent of foreign drug testing sites in fiscal year 2008, according to a report issued Tuesday by the Inspector General for the Department of Health and Human Services. The FDA is responsible for looking out for the safety of patients enrolled in studies of all drugs destined for the U.S. market.

However, the inspector found that the FDA was often unaware of early-stage trials conducted in developing countries in South and Central America. (...)

FDA's Foreign Inspection Budget Lean (FDAs budsjett for utenlandsk inspeksjon er magert)
washingtonpost.com 1.11.2007
Although the volume of prescription drugs and drug ingredients coming into the country from foreign manufacturers in developing nations such as India and China has exploded in recent years, the Food and Drug Administration's budget for foreign inspections has not kept pace and will be lower in 2008 than it was in 2002, according to congressional investigators.

As a result, foreign drug and drug ingredient makers are inspected on average once every eight to 12 years, while American-based manufacturers must be inspected at least once every two years. (...)

In addition, the investigators reported, FDA officials generally do not bring their own translators, and so in countries such as China they rely on company-supplied translators to conduct inspections. They also have to tell foreign manufacturers in advance that they are coming, while FDA inspectors can go into American plants at any time unannounced. (...)

"China alone has more than 700 firms making drug products for the U.S., yet the FDA has resources to conduct only about 20 inspections a year in China," he said. "This is dangerously inadequate." (...)

A bipartisan group of inspectors from the committee's oversight and investigations subcommittee accompanied FDA inspectors on an August trip to India and China -- two nations that have become major players in supplying the U.S. drug market. Neither country has a strong drug regulatory agency, and the committee inspectors concluded that setting up permanent FDA offices could solve many inspection problems. They reported that Indian officials supported the idea, while the Chinese officials' position was unclear. (...)

GSK to strip down through outsourcing and offshoring

US Senator seeks probe into pharma outsourcing (Amerikansk senator ber om granskning av legemidelfirmaers outsourcing)
in-pharmatechnologist.com 16.6.2008
- A US senator has asked the Food and Drug Administration (FDA) for a probe into outsourcing of production for pharmaceuticals, as well as ways to make drugmakers accountable for products which fail to meet quality standards.
Senator Sherrod Brown (Democrat -Ohio) is particularly concerned about cases where elements of production have been outsourced to overseas companies, noting: "In recent testimony to the Senate Committee on Health, Education, Labor, and Pensions (HELP), an FDA official acknowledged that American drug companies outsource operations to take advantage of weak drug safety standards abroad." (...)

Draft legislation has also been proposed - the FDA Globalisation Act of 2008 - which would require the FDA to inspect foreign manufacturing plants every four years. (...)

GSK to strip down through outsourcing and offshoring (GSK skjærer ned gjennom outsourcing og offshoring)
in-pharmatechnologist.com 26.10.2007
- GlaxoSmithKline (GSK) is planning to strip itself down closer to the bare bones of the business through further outsourcing and offshoring, with hopes of making itself into a lean, mean, pharma machine.

The pharma heavyweight announced a sweeping restructuring plan in the form of an 'Operational Excellence' programme, designed to achieve savings of up to £700m (€1bn) by 2010 - 40 per cent of which will come from cutting down on manufacturing sites and simplifying production processes and activities to reduce over capacity.

The cornerstones of this new programme are "persistent focus across all functions; a reduction in complexity, to be achieved by standardisation, consolidation, outsourcing and offshoring; and the exploitation of global opportunities, in regard to procurement, skills, labour cost and arbitrage," indicated GSK's CEO Dr J.P. Garnier.

As with most pharm firms in today's tough business climate, GSK has already been embracing outsourcing and offshoring to a certain extent in order to tighten its purse strings, however, as more parts of the business are seeing the fruits of this strategy, the firm is stepping up its resolve in this regard. (...)

- Alle de gale tallene

All The Wrong Numbers (Alle de gale tallene)
forbes.com 14.3.2008
Thursday, Amgen shares surged 5% as advisers told the Food and Drug Administration to warn patients not to use the company's top-selling anemia drug for head and neck cancer, breast cancer or in any case where patients might be cured of their cancer by chemotherapy. (...)

"Drugs aren't simple. Drugs are complicated," says Steven Nissen, of the Cleveland Clinic, speaking about the ACCORD diabetes trial. "They do many things, and we don't understand all the things they do." (...)

- Leverandører for LFH en viktig alliansepartner for Legemiddelindustrien

Leverandører for LFH en viktig alliansepartner for Legemiddelindustrien
lfh.no (9.11.2010)
Karita Bekkemellem holdt innlegg på LFHs ekstraordinære generalforsamling 26.oktober.

LFH er en viktig samarbeidspartner og vi kan lage en felles møteplass med myndighetene, sa Karita Bekkemellem på møtet. LFH har i høst underskrevet samarbeidsavtaler med de regionale helseforetakene, og LMI har hatt gleden av å være med på disse møtene. Det er viktig at vi nå står sammen om å påse at lederne i helseforetakene informerer og følger avtalene, sa Bekkemellem. Vi har nå samarbeidsavtaler som regulerer samhandlingen, og vi må nå sørge for at det blir samhandling og samarbeid som kommer pasientene tilgode, og som også fremmer forskning og næringsutvikling i Norge, sa Bekkemellem.

Bekkemellem slo fast at innsatsen fra kommersielle leverandører er for lite verdsatt i helsepolitikken, og at det må være et mål for oss å sitte ved myndighetenes bord der avgjørelsene blir tatt. Våre produkter står til sammen bare for 8 prosent av utgiftene ved helseforetakene, men vi kan effektivisere helsetjenesten dersom våre produkter raskt blir tatt i bruk, sa Bekkemellem. (...)

(Anm: Medisinsk utstyr (mintankesmie.no).)

- Rollen til "Offentlig-sektor forskning" ved oppdagelsen av legemidler og vaksiner

The Role of Public-Sector Research in the Discovery of Drugs and Vaccines (pdf) (Rollen til "Offentlig-sektor forskning" ved oppdagelsen av legemidler og vaksiner)
NEJM 2011 (February 9)
Historically, there has been a clear distinction between the roles of public-sector research and corporate research in the discovery of new drugs and vaccines to solve unmet medical needs. Public-sector research institutions (PSRIs) have performed the upstream, basic research to elucidate the underlying mechanisms and pathways of disease and identify promising points of intervention, whereas corporate researchers have performed the downstream, applied research to discover drugs that can be used to treat diseases and have then carried out the development activities to bring the drugs to market. The intellectual property that protects the investment in developing these drugs is created in the applied-research phase. (...)

There is little dispute about the importance to drug discovery of basic research at PSRIs under the traditional approach. Studies by Cockburn and Henderson¹ showed the complex relationships between public and private research in the pharmaceutical industry. Zycher et al.² found that at least 80% of 35 major drugs that they studied were based on scientific discoveries made by PSRIs, whereas Toole³ found a quantifiable correlation between investment in publicly funded basic research and corporately funded applied research: an increase of 1% in the funding of public basic research led to an increase of 1.8% in the number of successful applications for new molecular entities (compounds that have not been approved for marketing in the United States)⁴ after a lag of about 17 years. He found that a $1 investment in public-sector basic research yielded $0.43 in annual benefits in the development of new molecular entities in perpetuity. (...)

Drugs developed by Uncle Sam, PhD, play an outsized role in medicine
latimes.com 10.2.2011
If you take prescription medications, thank a taxpayer.

That’s the take-away from an article being published in Thursday’s edition of the New England Journal of Medicine that examined the role of “public-sector research institutions” – think universities, hospitals, nonprofits and federal labs like the National Institutes of Health – in drug development. (...)

But public-sector research institutions (or PSRIs, for short) became more active players in drug development following the biotech revolution of the mid-1970s. Government-funded researchers used recombinant DNA technology and monoclonal antibodies to discover and invent biologic and small-molecule drugs. Patents proliferated, but few of these candidate drugs were licensed to the private sector. Then, in 1980, the Bayh-Dole Act and other federal legislation changed the rules on technology licensing, making it more appealing for drug companies. (...)

Offentlig-sektor forskning har hatt en umiddelbar effekt på å forbedre folkehelsen: Study
news-medical.net 14.2.2011
AUTM President Ashley Stevens, D. Phil. (Oxon), er CLP hovedforfatter av The Role of Public Sector Research i Funn av narkotika og vaksiner, en artikkel publisert i det 10 februar utgaven av The New England Journal of Medicine.

Studien av Stevens, forskere fra Boston University Schools of Medicine, jus og ledelse, Radiumhospitalet, Oslo, sammen med samarbeidspartnere fra National Institutes of Health ledet av senior forfatter, Mark L. Rohrbaugh, Ph.D., JD, som finner offentlig forskning har hatt en mer umiddelbar effekt på å bedre folkehelsen enn tidligere realisert. Forskerne fant at i løpet av de siste 30 årene, var 153 nye FDA-godkjente legemidler, vaksiner, eller nye indikasjoner for eksisterende legemidler oppdaget gjennom forskning utført i offentlig sektor forskningsinstitusjoner (PSRIs). Disse stoffene inkluderte 93 små-molekyl narkotika, 36 biologiske, 15 vaksiner, åtte in-vivo diagnostikk materialer, og en over-the-counter narkotika.

"Vi mener at vår studie støtter konseptet om at fremveksten av bioteknologi i midten av 1970-tallet, kombinert med passering av Bayh-Dole Act, tillot disse institusjonene til å spille en viktig rolle i nedstrøms, anvendt fase av medisiner," sa Stevens. (...)

- Legemiddelutvikling (forskning og utvikling) koster mindre enn estimert - så hvorfor er prisene så høye?

Drug R&D costs are less than estimated – so why the high prices? (Legemiddelutvikling (forskning og utvikling) koster mindre enn estimert - så hvorfor er prisene så høye?)
theglobeandmail.com 22.2.2011
It costs, on average, $1.3-billion (U.S.) in research and development to bring a new drug to market. That level of investment in R&D by Big Pharma justifies the high cost of prescription drugs.

Those statements are repeated so often that they have come to be accepted as fact.

But are they fact or fiction?

An article in the current edition of the journal BioSocieties, a publication of the London School of Economics, argues that the real cost of R&D is, in fact, a fraction of the commonly cited estimate and we are having the wool pulled over our eyes.

The authors – Donald Light, professor of comparative health care at the University of Medicine and Dentistry of New Jersey in Newark, N.J., and Rebecca Warburton, a health economist at the University of Victoria – have returned to the source of the original estimate and deconstructed it.

Here is the Coles Notes version of their detailed analysis.

In 2003, Joseph DiMasi and a team of researchers from the Center for the Study of Drug Development at Tufts University in Boston published an article in the journal Health Economics titled The Price of Innovation: New Estimates of Drug Development Costs.

It concluded that the mean R&D cost for a new drug was $802-million in the year 2000. (The Pharmaceutical Research and Manufacturers of America, or PhRMA, later “updated” this figure to $1.32-billion in 2006 dollars.) Let’s look at how they arrived at the final figure. (...)

So, what do you get when you crunch all those numbers?

According to Dr. Light and Dr. Warburton, the net median R&D cost of developing a prescription drugs varies from $13-million to $204-million, depending on the kind of drug.

Over all, they estimate R&D costs $59.4-million for each new drug.

That is a far cry from $802-million or $1.3-billion.

Consumers who use prescription drugs, and the drug plans that are the principal purchasers, need to start questioning the “facts” and asking some tough questions.

If R&D costs are only a fraction of what is asserted, then what is the justification for high prescription drug prices?

Somebody got some ’splainin’ to do. (...)

- Legemiddelindustriens globale utgifter til forskning og utvikling var 7,9 % av salget i 2010

Pharmaceutical global R&D was 7.9 percent of sales in 2010 (Legemiddelindustriens globale utgifter til forskning og utvikling var 7,9 % av salget i 2010)
keionline.org 9.6.2011
Using industry assertions of R&D spending, pharmaceutical related R&D spending by the private sector was less than 8 percent of global sales in 2010.

These are the data:
2010 Global R&D by all private companies: - $67.4 billion
Source: Page 2 of the 2011 PhRMA industry profile
http://www.phrma.org/sites/default/files/159/phrma_profile_2011_final.pdf
2010 Global sales - $856
Source: IMS Health Market Prognosis, March 2011
http://www.imshealth.com/deployedfiles/imshealth/Global/Content/StaticFi...
R&D / Sales = 0.078738318
How much of the 7.9 percent invested in R&D is invested in the development of new products that are medically important? Given the small number of FDA priority NCE approvals, that number is significantly lower. (...)

Diverse artikler

Google-stifter finansierer medicinalfirmaers forskning
medwatch.dk 11.5.2012
Sergey Brin, der har opbygget en enorm formue gennem Google, kaster af personlige årsager betydelige summer ind i GSK og Pfizers forskning i Parkinsonslægemidler.

Den ene af de to Google-stiftere, Sergey Brin, opdagede i 2008, at han har et gen, der prædisponerer ham for Parkinsons. Et gen, som han deler med sin mor, der allerede har udvklet sygdommen.

Dette fik ifølge Bloomberg den hovedrige IT-entreprenør (han har en anslået formue på 19 mia. dollar) til øge donationerne til forskningen på området.
Indtil videre har han doneret 132 mio. dollar, hovedsageligt til Michael J. Fox Foundation for Parkinson’s Research. Og en del af pengene er gået direkte til GSK og Pfizers udvikling af lægemidler.

I 2009 donerede Brin 15 millioner dollar, der er møntet på udviklingen af såkaldt LRRK2-medicin, og han har været hovedsponsor på Fox Fondens LRRK2-indsats siden. (...)

Alastair Reith, der er GSK's forskningsleder på projektet, mener ikke, at arbejdet med lægemidlerne havde været muligt uden donationen, for hjernesygdomme er ifølge lederen ikke højt på prioritetslisten hos medicinalfirmaerne. (...)

GSK goes hostile with $2.60 billion HGS bid
pharmatimes.com 10.5.2012
GlaxoSmithKline is taking the hostile route in its $2.60 billion bid to buy Human Genome Sciences, going straight to shareholders with its previously-rejected offer instead of participating in the latter's "strategic alternatives review".

Last month, the board at HGS, which developed the lupus drug Benlysta (belimumab) with GSK, turned down the $13.00 per share offer, which represented an 81% premium to its stock price on April 18, the day before the bid was disclosed. The rejection followed consultation with financial and legal advisors and the board set it believed the bid "does not reflect the value inherent in HGS".

HGS hired Goldman Sachs and Credit Suisse to explore "strategic alternatives…including, but not limited to, a potential sale of the company" and GSK was invited to participate in this process. However, the UK major is not interested in that option. (...)

U.S. to partner with Big Pharma for drug discovery
reuters.com 3.5.2012
(Reuters) - The U.S. government will help drug companies find treatments for a host of diseases through a new collaboration in which researchers will test experimental drugs provided by manufacturers.

The National Institutes of Health said on Thursday that Pfizer Inc, AstraZeneca Plc and Eli Lilly and Co have agreed to make 24 compounds available for a pilot phase of the project, the biggest of its kind ever launched in the United States.

All of the compounds have been tried in people and found to be safe, but the drugmakers have abandoned them because they did not work for the disease they were intended to treat. The NIH will provide $20 million in grants each year to researchers trying to find new uses for the compounds.

"The goal is simple: to see whether we can teach an old drug new tricks," said Health and Human Services Secretary Kathleen Sebelius during a press conference.

Big advances in genetics have allowed researchers to identify causes of more than 4,500 diseases. But turning those discoveries into treatments has been difficult, and there are drugs to treat only about 250 of these conditions.

NIH Director Dr. Francis Collins said "diseases of the brain" represent an especially urgent unmet need. (...)

GSK insists it best owner for Human Genome
reuters.com 25.4.2012
(Reuters) - Drugmaker GlaxoSmithKline said on Wednesday its $2.6 billion bid for long-time partner Human Genome Sciences was "full and fair" and it was the only obvious owner for the U.S. biotechnology firm.

After releasing disappointing first-quarter results, Britain's biggest drugmaker insisted its $13 a share offer was generous and Chief Executive Andrew Witty played down the possibility of increasing the price.

"We absolutely believe that we are the compelling owner for this business," he told reporters in a conference call.

"We have the rights and the operational control for the three main assets and we believe this is the right time to maximize value for both sets of shareholders."

Buying Human Genome would give GSK full ownership of lupus drug Benlysta, as well as an experimental diabetes drug and heart medicine called darapladib that some analysts think could rake in annual sales of $10 billion - if it works. (...)

Merck ordered to pay $321 million in criminal Vioxx probe
reuters.com 19.4.2012
(Reuters) - A Boston federal judge on Thursday sentenced Merck & Co to pay a $321 million criminal fine for improperly marketing its Vioxx painkiller a decade ago.

The U.S. drugmaker pleaded guilty in recent months to having illegally promoted Vioxx for treatment of rheumatoid arthritis before it was approved for that use in 2002. The pill, approved in 1999 as a painkiller, was withdrawn from the market in 2004 after it was linked to risk of heart attack and stroke.

Federal prosecutors in Boston said Merck illegally promoted Vioxx for rheumatoid arthritis for three years, continuing to do so after being reprimanded in September 2001 by the U.S. Food and Drug Administration. (...)

How Big Pharma gets rich at our expense
theglobeandmail.com 13.4.2012
The bond between healer and patient is born of common purpose with a strong dose of faith. Buttressed by modern medical science, both share the belief that medicine does more good than harm.

That faith, plus savvy marketing, has turned the pharmaceutical industry into a recession-proof juggernaut earning more than $900-billion (U.S.) annually worldwide. However, what we get for an increasingly expensive pallet of pills are dubious benefits plus side effects that may be worse than the diseases they were developed to fight. (...)

Insight: Antidepressants give drugmakers the blues (Innsikt: Antidepressiva gir legemiddelfirmaer dårlig humør)
reuters.com 23.3.2012
Hungarian scientist Tamas Freund holds a human brain at the Institute of Experimental Medicine of Hungarian Academy of Science in Budapest in this March 16, 2011 file photo. Data from Thomson Reuters Pharma shows returns for pharmaceutical companies in the antidepressant market are collapsing - despite widespread use of pills like Prozac - as patents expire and new drugs fail to make it to market.

(Reuters) - The development of a novel antidepressant ground to a halt this week when researchers found it did not make patients feel any better than the pills they were already taking.

The drug firms took the hit, with shares tumbling in Targacept, while AstraZeneca wrote off a total of $146.5 million for the drug's failure.

It was bad news for investors and bad news for patients - and a depressingly familiar tale for drugmakers seeking to develop new treatments for brain illnesses.

Data from Thomson Reuters Pharma shows returns for pharmaceutical companies in the antidepressant market are collapsing - despite widespread use of pills like Prozac - as patents expire and new drugs fail to make it to market.

Some Big Pharma firms are quitting the field altogether. Others are hacking back investment and shedding jobs.

These might seem like prudent decisions in an increasingly expensive and frustrating field. Other diseases such as cancer and diabetes are reckoned to be better areas to be in these days. Yet some scientists say the timing could hardly be worse.

Researchers who study the brain believe they are finally figuring out the basic mechanics of depression and other mental disorders, discoveries that should open the door to far more effective ways to tackle illnesses that can cripple society.

"It's a great time for brain science, but at the same time a poor time for drug discovery for brain disorders," says David Nutt, professor of neuropsychopharmacology at Imperial College London. "That's an amazing paradox which we need to do something about." (...)

Drug firms may be spending as much as €91m a year on lobbying in Europe
BMJ2012;344:e2465 (30 March)
The drug industry’s lobbying power in Europe dwarfs that of opposing campaign groups and is largely hidden thanks to lax rules that allow drug companies to conceal how much they spend on attempts to influence European Union policy, a new report claims.

The report, produced by the charities Corporate Europe Observatory and Health Action International Europe, says that the industry is known to spend more than €40m (£33m; $53m) a year in attempts to influence decision making in the EU. It says that nearly half of this sum is spent by drug manufacturers on their own in-house lobbyists.

By contrast, campaign groups active on issues concerning medicines in the EU spend just €3.4m between them a year. “With the immense disparity between the affluence of public interest groups and the industrial lobby, it becomes even more difficult to level the policy playing field,” said Katrina Perehudoff, Europe project officer for Health Action International.

But the study indicates that, with many drug firms failing to declare their EU lobbying activities on the official register, adherence to which is voluntary, the real amount spent by the industry might be as high as €91m a year.

This sum, the researchers note, would be similar to the industry’s spending in the United States, where lobbying costs must be declared. In the US the pharmaceutical manufacturing sector last year spent about €86m on lobbying. (...)

Big pharma spends 40 million euros per year lobbying in EU (Big pharma bruker 40 millioner euro per år på lobbying)
pharmatimes.com 28.3.2012
The pharmaceutical industry lobby is spending more than 40 million euros annually to influence decision-making in the European Union, of which nearly half is spent on in-house lobbyists.

This is one of the key findings of a report produced by Corporate Europe Observatory (CEO) and Health Action International (HAI) Europe, which surveyed the entries made by pharmaceutical companies and their representatives in the EU’s lobby transparency register. The analysis also notes that the sum dwarves the combined 3.4 million euros per year spent by public health non-governmental organisations.

Many drugmakers do not declare activities
With the "immense disparity between the affluence of public interest groups and the industrial lobby, it becomes even more difficult to level the policy playing field", the report notes. Furthermore, it adds that many pharmaceutical companies lobbying the European Commission on legislation fail to declare their activities.

HAI Europe and CEO note that as registration to the transparency register is voluntary, many pharmaceutical companies choose not to declare their spend. If recorded properly, they claim that "expenditure on lobbying activities by the industry could be shown to be as high as 91 million euros annually, which would be more comparable with the lobby spending declared in the USA; the report estimates that 220 lobbyists are active in the EU on behalf of the sector.

HAI Europe project officer Katrina Perehudoff said the pharmaceuticals industry "has a significant presence in Brussels, and is clearly spending considerable sums of money on lobbying. This information should be available so that decision makers have a clear idea of the level of industry activity – but at the moment we only have a partial picture.”

Olivier Hoedeman from CEO added that “there is an urgent need to strengthen the EU's lobby transparency register and make it mandatory for lobbies to sign up and ensure that the information disclosed is reliable". (...)

- USA (2011 Lobbying Disclosure)

2011 Lobbying Disclosure
Observations on Lobbyists' Compliance with Disclosure Requirements (PDF)
(GAO-12-492, Mar 30, 2012)
What GAO Found

Most lobbyists were able to provide documentation to demonstrate compliance with disclosure requirements. This finding is similar to GAO’s results from prior reviews. There are no specific requirements for lobbyists to create or maintain documentation related to disclosure reports they file under the Lobbying Disclosure Act of 1995 as amended (LDA). Nonetheless, and similar to last year’s results, for two key elements of the reports (income and expenses), GAO estimates that lobbyists could provide documentation to support approximately 93 percent of the disclosure reports for the third and fourth quarters of 2010 and the first and second quarters of 2011. According to documentation lobbyists provided for income and expenses, GAO estimates that the amounts disclosed were properly reported and supported for 63 percent of the quarterly lobbying disclosure (LD-2) reports. For lobbyists and lobbying firms listed on the LD-2 report, an estimated 86 percent filed year-end 2010 or midyear 2011 reports of federal political campaign contributions (LD-203) reports as required. For LD-203 political contributions reports, GAO estimates that a minimum of 4 percent of all LD-203 reports omitted one or more reportable political contributions that were documented in the Federal Election Commission database. Fewer lobbyists—17 this year versus 21 in the prior year—stated that they planned to amend their LD-2 report following GAO’s reviews to make correction on one or more data elements. As of March 2012, 9 of 17 amended their disclosure reports.
Lobbyists are required to file LD-2 reports for the quarter in which they first register. The majority of lobbyists who newly registered with the Secretary of the Senate and Clerk of the House of Representatives in the third and fourth quarters of 2010 and first and second quarters of 2011 filed required disclosure reports for that period. GAO could identify corresponding reports on file for lobbying activity for 88 percent of registrants.

The majority of lobbyists felt that the terms associated with disclosure reporting were clear and understandable and the requirements were easy to meet. However, a few lobbyists reported challenges in complying with the LDA. (...)

(Anm: Report. 2011 Lobbying Disclosure. Observations on Lobbyists' Compliance with Disclosure Requirements. GAO-12-492, Mar 30, 2012.)

U.S. Medical Schools make great strides in quest for professionalism of tomorrow’s doctors
postscript.communitycatalyst.org 10.3.2012
Yesterday, the American Medical Student Association (AMSA) released their 2011-2012 PharmFree Scorecard, now in its fifth iteration. The Scorecard evaluates conflict-of-interest policies at the 152 medical schools in the U.S. and Puerto Rico, as well as a number of affiliated academic medical centers. With growing consumer and government scrutiny of the relationships between doctors and pharmaceutical companies (see, e.g., ProPublica’s series Dollars for Docs and the Physician Payment Sunshine Act), the Scorecard takes a unique look at how well professional standards are being introduced to the next generation of doctors. We don’t doubt the importance of education about pharmaceutical interventions and treatments, but it is also important to learn to question the veracity of information presented at industry-funded events, and understand the pharmaceutical marketing machine before a doctor begins her practice.

The Scorecard assesses policies that seek to reduce drug industry influence on the educational and clinical environment in which physicians do their training—including bans or limits on industry provision of gifts, meals speaker’s bureaus and samples; on industry influence on medical education and drug purchases by hospitals; on drug reps’ access to clinical areas; and, disclosure of industry relationships. This year’s grades demonstrate that medical schools are taking important measures to control the interaction between students or faculty and the pharmaceutical industry. Twenty-eight schools received an A (28 percent), 74 schools received a B (49 percent), 15 schools received a C (10 percent), and 13 schools received a D (9 percent). That leaves 9 schools with an F, and 15 “In Progress” schools. Despite progress overall, challenges remain, especially with policies on disclosure of financial ties with industry, samples, and access by sales representatives. (...)

Nordmenn bruker færrest medisiner
aftenposten.no 3.3.2012
Administrerende direktør Karita Bekkemellem i Legemiddelindustrien påpeker at nordmenns lave medisinbruk ikke nødvendigvis henger sammen med bedre generell helse.

Vi bruker færrest medisiner av alle de nordiske landene. - Ikke nødvendigvis fordi vi er friskere, sier Karita Bekkemellem i Legemiddelindustrien. (...)

Greklands läkemedelsnota högst i industrivärlden
di.se 20.2.2012
Grekland spenderar mer pengar på läkemedel än någon annan industrination. Den grekiska läkemedelssektorn är hårt skadad av slösaktiga traditioner och mutsystemet ”fakelaki”. Det skriver Financial Times.

”Förut fanns ingen kontroll över utgifterna, hela systemet gynnade konsumtion”, säger Antonis Karokis, den grekiska chefen för den amerikanska läkemedelskoncernen Merck till Financial Times.

Under 2011 spenderade den grekiska offentliga och privata hälso- och sjukvården 4 miljarder euro, cirka 35 miljarder kronor, bara på medicin. Det motsvarar 2,4 procent av BNP - den högsta andelen av alla industriländer, skriver tidningen vidare.

Det har inte funnits några riktlinjer för vilka läkemedel som ska användas, eller system för att bedöma deras kostnadseffektivitet, skriver tidningen vidare.

Systemet med mutor och seden att lämna över ett kuvert, "fakelaki", när man ber om tjänster, är också vida utbrett. Bland annat förekommer det på Atens stora sjukhus, skriver Financial Times.

Det finns enligt tidningen heller inga krav på grekiska läkare att skriva ut billigare kopior, så kallad generika, när patentet har gått ut. (...)

Medicinalvirksomheder indser at sjældne sygdomme kan være bedste investering
medwatch.dk 15.2.2012
MEDWATCH ANBEFALER: (www.mesotheliomahelp.net) - Mesotholiom, en asbest-relateret kræfttype, er en af næsten 7.000 sygdomstilstande der identificeres som en såkaldt ’orphan disease’ i USA. En del af disse sjældne sygdomme rammer så få mennesker at forskere og medicinal firmaer ikke finder det indbringende nok at bruge tid, kræfter og penge på at finde og udarbejde en behandling eller kur mod dem.

Men ifølge www.Pharmaceutical-Technology.com, en net-baseret nyhedskilde for den globale medicinalindustri, er medicinal virksomheder ved at opdage at ”sjældne sygdomme er særdeles små, men ift. afkast på investeringer er de særdeles store.”
I et interview med www.Pharmaceutical-Technology.com var Alastair Kent fra Genetic Alliance UK, Tim Cote fra National Organization for Rare Disorders og Dr. Steve Groft fra Office of Rare Diseases Research enige om, at selv om de fleste medicinal virksomheder skærer i deres R&D budgetter, så burde udviklingen af medicin til sjældne sygdomme ikke blive påvirket af det.

Læs hele historien her. (...)

Dansk firma kan spænde ben for Gingrich i republikansk valgdrama
politiken.dk 27.1.2012
LOBBYIST? Mitt Romney, der konkurrerer mod Newt Gingrich (billedet) om at blive republikanernes præsidentkandidat, beskylder sin stærkeste modstander for lobbyisme.

Gingrich afviser lobbyisme, efter Novo Nordisk har betalt hans firma millioner. (...)

Romney: Det er ikke i orden
Det har fået rivalen Mitt Romney til at beskylde Newt Gingrich for at have arbejdet som lobbyist:

»Hvis man bliver betalt af medicinalfirmaer, som kan tjene på en bestemt lov, og du så mødes med republikanske medlemmer af Kongressen og opfordrer dem til at støtte den lov – ja, du kan kalde det, hvad du vil. Jeg kalder det at falbyde indflydelse. Det er ikke i orden«, sagde Mitt Romney under en tv-debat i denne uge. (...)

James Murdoch quits GlaxoSmithKline board
telegraph.co.uk 27.1.2012
James Murdoch, the News Corporation executive embroiled in the News of the World phone-hacking scandal, is quitting the board of drug-maker GlaxoSmithKline.

James Murdoch is cutting back on his non-executive commitments, in the wake of the phone hacking scandal, to focus on News Corp and chairing BSkyB. (...)

Markant flere læger søger om lov til industri-samarbejde
dagenspharma.dk 26.1.2012
Læger ansøger i stigende grad myndighederne om lov til at lave samarbejde med medicinalindustrien. Det viser tal, som Lægemiddelstyrelsen har trukket ud for Dagens Pharma.

Mens Lægemiddelstyrelsen i årene 2002-2006 samlet modtog blot 32 ansøgninger, steg det tal til ca. 2.400 ansøgninger i rekordåret 2010. Tallet faldt en smule i 2011 til 2.250 ansøgninger, men tendensen er klar, siger Henrik G. Jensen, kontorchef for forbrugersikkerhed i Lægemiddelstyrelsen.

»Der er tale om en markant ændring, og det skyldes bl.a., at der har været og stadig er stor fokus fra især medierne på forholdet mellem læger og industri og der derfor er et ønske fra lægerne om at have papirerne i orden,« siger Henrik G. Jensen. Desuden understreger han, at udviklingen skyldes en lovændring i 2009, der betød, at også medicinalvirksomhederne blev pålagt at indberette til Lægemiddelstyrelsen, hvem de samarbejder med. Tidligere var det kun lægerne, der havde ansvar for at oplyse og søge om tilladelse om samarbejdet. (...)

India’s drug trials fuel consent controversy
washingtonpost.com 2.1.2012
KHANDWA, India — Two months after he lost his wife to Alzheimer’s disease, 80-year-old Sharad Geete made a shocking discovery. The free drugs his wife, Sheela, had been receiving for two years before she died were part of a clinical trial.

“The doctor told us that the medicines will be given free and that they were going to be launched soon by a foreign company. Not once did he say it was an experiment or a trial. If I knew, would I have taken the risk?” asked Geete, sitting in his home in Khandwa, a small town in the central Indian state of Madhya Pradesh.

Since India eased guidelines for conducting drug trials in 2005, the number of Indians participating has shot up to 150,000 from close to zero, as international drug companies take advantage of lower costs here. But questions about the consent process have fueled fears that many Indians are entering the trials without knowing the risks.

A Madhya Pradesh state government probe found that six doctors had violated ethical standards in gaining patients’ consent for participation in drug trials and did not compensate those who suffered adverse side effects in 76 drug trials on 3,300 patients since 2006, according to results released last June.

In the wake of the recent controversies, the Indian Council for Medical Research invited public feedback on draft guidelines about compensation for injuries that occur during clinical research. (...)

'Me-too' pharma firms will 'disappear' - Roche's Schwan
pharmatimes.com 7.12.2011
Drugmakers whose offerings do not offer any genuine value are going to "literally disappear" over the next decade, according to Roche's chief executive.
Speaking at the FT Pharmaceutical and Biotechnology conference in London, Severin Schwan (pictured) described a three-segment model with highly-innovative companies on one side and generics firm on the other. The number of players in the latter will be reduced through consolidation but the companies in the (middle) third segment, those that offer me-too treatments of "limited differentiation" will be squeezed out of business.

Their disappearance is inevitable, Dr Schwan said, given an environment where payers "will only reward true innovation". In terms of me-toos, he argued "who will pay for that? No money".

He began by saying that "pharma is in a perfect storm", with "the regulators' wind blowing in our face [and] investors breathing down our neck". He noted that payers are under enormous funding constraints while the sector is barely recouping the cost of its R&D spend.

Dr Schwan went on to say that in terms of pricing, there needs to be more differentiation and it has to be linked with actual benefit and real-world data needs to be combined with clinical data. However, on this topic, he asked "who is going to take the lead".

He also spoke of the importance of collaboration but acknowledged that "there is still distrust and both perceived and real conflicts of interest' that can make partnerships among the various stakeholders in healthcare "a real minefield". When asked about Roche's merger-and-acquisition strategy, Dr Schwan said that the firm is only interested in bolt-on deals and stressed the ever-increasing importance of its diagnostics division. (...)

BigPharma and unethical marketing of medicinal products
Southern Med Review ( 2011) 4;2:1-1 (December)
In today’s environment, the main focus of the critical mass towards the multinational companies is on access to new patented and more expensive products. Many of them essential medicines, but many more non-essential ‘me-too’ medicines developed to get a piece of the blockbuster cake or to go from one patent to the next (evergreening). However, there are also other issues that BigPharma could be confronted with and help us solve. One of them is unethical marketing of products with no medical value or which are potentially dangerous. (...)

There are of course numerous examples of potentially toxic or irrational products out there and many companies besides the multinationals that market such products. As I write this editorial, I have been told that Roche is continuing to manufacture Halfan for both children and adults. Halfan contains halofantrine, an
antimalarial that has serious side effects but worryingly still seems to be on the French, Portuguese and South African markets3 as well as in many low- and middle-income countries. By pointing finger at the multinationals, I want to highlight the paradoxes in the research-based companies that on the one side claim to do so much good for public health but continue to produce products detrimental to people’s health. Of particular concern is of course medicines for children.

How can large research-based companies defend marketing useless products for malnourished children who need proper nutrition? (...)

How clinical and research failures lead to suboptimal prescribing: the example of chronic gout
BMJ 2011;343 (1 December)
Despite the existence of several effective drugs for chronic tophaceous gout, management is often neither rational nor effective. Wendy Lipworth and colleagues examine the possible reasons

An evidence based or “rational” approach to prescribing is thought to maximise the benefit and minimise the harm from prescription drugs. Unfortunately, prescribing often does not meet this ideal despite clinicians’ best intentions. We use treatment of chronic tophaceous gout to show how apparently irrational prescribing arises from several interacting “failures” in both clinical practice and drug development. (...)

Failure of drug development?
But suboptimal treatment of chronic gout is not only the result of failure in clinical practice. Given that prescribing is only as rational as the evidence on which it based, we also need to consider the role of the drug development process.

The development of new drugs, although providing benefits for a small subset of patients, might not contribute much to the overall disease burden of chronic tophaceous gout and might carry considerable cost. One such example is febuxostat, a non-purine xanthine oxidase inhibitor approved by the European Medicines Agency in 2008 and by the FDA in 2009. On the face of it, there is nothing wrong with developing additional drugs for people who cannot use existing treatments. But new drugs like febuxostat (which is considerably more expensive than allopurinol) can easily become preferentially prescribed without a robust rationale or sufficient knowledge of long term safety—a concern with febuxostat, for which further data are needed on cardiovascular safety and hypersensitivity. (...)

System for disclosing hospitality should be transparent
BMJ 2011;343 (15 November)
I have in front of me an invitation to a “Changing Faces conference—examining advances in diagnosis and treatment of bipolar 1 disorder.” This conference is sponsored by Lundbeck, is certified for continuous professional development, but is a symposium to promote asenapine (Syncrest). I would suggest this much is transparent.

I support the pharmaceutical industry, research, innovation, and development. But I do not support the mixing of marketing with education. I never will.

Forth Valley NHS has a voluntary system for disclosing “hospitality.” This register has not so far been accessible. Surely here we have opacity rather than transparency?¹ (...)

Slutt på legenes sponsorturer fra nyttår
vg.no 2.11.2011
** Sykehusene har ikke fått ekstra penger til å betale for kurs og turer selv
** Overlegeforeningen frykter det går ut over kvaliteten i sykehusene

(VG Nett) Fra nyttår må sykehusene selv betale for legenes etter - og videreutdanning. Det har de ikke fått ekstra penger til å dekke.

Selv om legene støtter vedtaket, er flere redde for at sykehusene ikke skal ta regningen eller ta penger fra andre budsjettposter.

Overlegeforeningen frykter det kan føre til dårligere sykehus for både pasienter og ansatte.

- Jeg er bekymret, sier Jon Helle, leder i Overlegeforeningen, til VG Nett.

I flere år har leger fått sponset reiser og kongresser av legemiddelindustrien. Ordningen har fått mye kritikk fordi den kan skape uheldige bindinger mellom leger og industrien, som i fjor sommer varslet at de ikke lenger vil punge ut. (...)

Professor skjelt ut av lege fra Algeta
dn.no 3.11.2011
Strid om medisinresultatene til børsfavoritten Algeta.

Etter svært oppløftende rapporter om resultatene av kreftmedisinen Alpharadin, har Algeta-aksjen steget 36,7 prosent hittil i år og nesten 1.100 prosent de siste tre årene, til en markedsverdi på 7,68 milliarder kroner.

Det har gjort Algeta-ledelsen meget velstående.

Det er imidlertid flere tvilere i familjøet, skriver Finansavisen.

Professor i onkologi (kreft) Inger D. Fosså ved Oslo universitetssykehus Radiumhospitalet, deltok med 30 pasienter i en blindtest med Alpharadin, og fant ingen effekt hos disse. I ettertid viste det seg at 17 av pasientene fikk Alpharadin.

Første gang hun gikk offentlig ut og fortalte at hun ikke hadde funnet noen effekt av medisinen, ble hun ifølge Finansavisen ringt opp av en lege fra Algeta som skal ha skjelt henne ut.

- Jeg nektet
Igår ble hun kontaktet av et tysk firma som ba henne revurdere bivirkningenes relasjon til behandlingen på oppdrag fra Bayer.

-Jeg nektet å gjøre dette. Jeg har aldri før opplevd at et legemiddelfirma opptrer slik, sier Fosså til avisen.

Dr. med Erlend Hem mener det er umulig å si om Algetas medisin fungerer.

Han sier man ikke har sett Algetas resultater, bare det Algeta sier at er deres resultater. Han mener Algeta burde lagt frem resultatene på en konferanse, samtidig som resultatene ble publisert i et vitenskapelig tidsskrift slik at fageksperter ville kunnet kommet med innvendinger.

Algeta mener det ikke finnes noen tvil om at deres medisin Alpharadin fungerer.

Les også: Kreftmedisin fra Algeta bedre enn ventet (...)

Legemiddelgigant betaler 3 milliarder dollar
aftenposten.no 3.11.2011
Historisk utbetaling etter Avandia-skandalen.

• Svineinfluensavaksiner kostet 650 millioner kroner
• Selgere av medisiner tier om bivirkningene

Medisinen Avandia skulle hjelpe folk med diabetes type 2 til lavere blodsukker og dermed redusere risikoen for hjerteinfarkt. Den britiske legemiddelgiganten GlaxoSmithKline drev pågående markedsføring. I Norge begynte Staten å betale for medisinen over blå resept i 2004.

Salget skjøt i været i mange land, og Avandia ble én av selskapets største seddelpresser.

Hjerteinfarkt
For fire år siden ble medisinen brukt av 5000 nordmenn. Så viste en studie i tidsskriftet New England Journal of Medicine at Avandia i stedet kunne øke risikoen for hjerteinfarkt.

I dag setter GlaxoSmithKline et kostbart punktum for en etterforskning som har pågått i flere år. Selskapet går med på å betale rekordhøye 3 milliarder dollar i Avandia-saken. Det tilsvarer 16.587.300.000 norske kroner.

3 milliarder dollar tilsvarer dessuten Glaxos inntekt av Avandia-salget i 2006, ifølge Euroinvestor.

Gigantutbetalingen innebærer at det også blir satt punktum for en granskning av Glaxos prissetting vis-à-vis det amerikanske Medicaid-programmet, der legemiddelprodusentene er pålagt å senke prisene.

GlaxoSmithKline er for nordmenn kjent som selskapet som produserer Pandemrix - vaksinen som blir brukt mot svineinfluensa. (...)

Legemiddelindustrien og dobbeltmoralen
G Gradek
Tidsskr Nor Legeforen 2011; 131:2111 (1.11.2011)
I Tidsskriftet nr. 15/2011 forklarer Karita Bekkemellem pent hvorfor legemiddelindustrien sluttet å sponse reise på kongresser for norske leger (1). En av årsakene til dette var at de mente sponsing av deltakelse på kongresser kunne gjøre at leger ikke forskrev beste medisin for sine pasienter, men i stedet skrev ut medisin fra det firmaet som hadde sponset dem.

Jeg har praktisert i Norge i 30 år og jeg har vært på mange kongresser som ble betalt av firmaer. Men jeg har aldri utskrevet en eneste medisin som jeg ikke var overbevist om var den beste for pasienten, uansett med hvilket firma jeg har reist og hvor god middag og vin jeg har fått. At den farmasøytiske industri sluttet å invitere leger på viktige faglige kongresser, tror jeg kan ha negativ betydning for mange legers evne til å oppdatere sin kunnskap. Det er nemlig mange som ikke blir sponset av sin arbeidsgiver og som ikke selv har råd til å delta på medisinske kongresser. Legemiddelindustrien har de siste årene vært opptatt av at legene som reiser på kongresser ikke skal ha bra hotell og rimelig bra mat, og de har gitt dem billigste vin, men samtidig har den medisinske industri drevet meget aggressiv markedsføring av sine medisinske produkter. Hvorfor har ikke Legemiddelindustrien noe imot at medisinske firmaer inviterer leger på sine egne symposier og at firmarepresentanter kommer til legekontoret? På slike møter blir legene mest hjernevasket av medisinske firmaer, som prøver å forklare hvor godt produkt de har og ofte at deres produkt er mye bedre enn de andres. Jeg har opplevd flere ganger at små studier plutselig ble store studier, og negative studier ble omgjort til positive av medisinske firmaer.

Hvis Legemiddelindustrien virkelig vil være helt sikre på at de ikke påvirker leger til å skrive ut medisiner, bør de slutte med besøk av legemiddelrepresentanter på legekontorer, slutte å invitere på sine egne symposier som veldig ofte har lavt medisinsk nivå, slutte å sende brosjyrer til legene og kun annonsere sine egne produkter i Tidsskiftet. (...)

Legemiddelindustriens politiske korrekthet
Tidsskr Nor Legeforen 2011; 131:1986 (18.10.2011)
Administrerende direktør i Legemiddelindustrien (LMI) Karita Bekkemellem kommer i Tidsskriftet nr. 15/2011 med sin begrunnelse for at leger ikke lenger skal sponses av industrien (1). Foreningens medlemmer skal ikke ha anledning til å betale helsepersonells reiser til fagkongresser i utlandet. Argumentet er at det er blitt stilt kritiske spørsmål til om det er industriens oppgave å «sponse» etterutdanning for leger og at dette kan skape uheldige bindinger mellom firmaer og leger.

Det er selvfølgelig helt i orden å stille spørsmål ved dette, men samtidig undrer man seg over tidspunktet dette blir tatt opp til diskusjon og avgjort i Legemiddelindustrien. Direktøren forklarer at det er sterk konkurranse innen medisinsk forskning og økte kostnader, slik at legemiddelforskningen går ned. Dette tolker jeg til at en del av inntjeningsgrunnlaget faller bort slik at overskuddet minsker. Hvorfor sier da ikke direktøren direkte at et viktig argument fra Legemiddelindustrien for innføringen av dette «forbudet mot sponsing» er økonomisk innsparing for foreningens medlemmer? Kan det tenkes at medlemmene har kommet frem til at det å invitere helsepersonell til internasjonale kongresser ikke er lønnsomt? Kan det være at det ikke er samarbeidet som er problematisk, men at trange økonomiske kår er hovedgrunnen? (...)

Bill Daley's Big Pharma History: Drugs, Profits And Trade Deals
huffingtonpost.com 28.9.2011
This piece is a continuation of The Huffington Post's collaboration on trade issues with The Dylan Ratigan Show, called Trading Our Future.

WASHINGTON -- As commerce secretary under Bill Clinton, William Daley worked with U.S. pharmaceutical giants to curb the use of cheaper generic drugs abroad. As a board member for Abbott Laboratories, he had a front-row seat on a brutal clash between a major drug company and a developing nation over access to life-saving medication. And as White House chief of staff today, Daley has President Barack Obama’s ear.

Add up Daley’s power and experience, and experts who follow public health policy suspect his influence in the U.S. stance in negotiations over a major international trade deal -- a stance with hugely profitable implications for giant American drugmakers.

The United States is in talks with eight other Pacific nations to establish the Trans-Pacific Partnership, which the administration hopes will serve as a template for other trade pacts. According to leaked documents from the negotiations, the Obama administration is using the deal to push hard-line intellectual property standards that could drive up medicine prices overseas, boosting the bottom line for U.S. drugmakers like Abbott Labs at the expense of public health. (...)

Drug deaths now outnumber traffic fatalities in U.S., data show (Data viser at dør flere av legemidler enn i trafikken i USA)
latimes.com 17.9.2011
Fueling the surge are prescription pain and anxiety drugs that are potent, highly addictive and especially dangerous when combined with one another or with other drugs or alcohol. (...)

Drugs exceeded motor vehicle accidents as a cause of death in 2009, killing at least 37,485 people nationwide, according to preliminary data from the U.S. Centers for Disease Control and Prevention.

While most major causes of preventable death are declining, drugs are an exception. The death toll has doubled in the last decade, now claiming a life every 14 minutes. By contrast, traffic accidents have been dropping for decades because of huge investments in auto safety. (...)

Preventable deaths from drugs, motor vehicles and firearms (Dødsfall som kan forhindres fra legemidler, trafikkulykker og våpen)
graphics.latimes.com 18.9.2011
Drug-induced deaths, pushed by increasing prescription narcotic overdoses, outnumbered motor vehicle deaths in 2009, according to preliminary government data for that year. (...)

Novo Nordisk anklaget for bestikkelse
bt.dk 25.9.2011
Læge står frem: Fik hotelophold, restaurantbesøg og penge

Militærlæge Ian Black fortæller om bestikkelse fra Novo Nordisk.

Novo Nordisk er anklaget for at have bestukket læger i det amerikanske militær til at bruge et medicin mod blødninger. Men medicinen har ikke en dokumenteret virkning.

Nu står en af lægerne frem i 21 Søndag på DR 1. Den amerikanske militærlæge Ian Black brugte medicinen til sårede amerikanske soldater, men han fandt ud af, at det ikke virkede. Militærlægen oplevede alvorlige bivirkninger, når han brugte det på amerikanske soldater.

- Jeg oplevede hjerteanfald, slagtilfælde og mærkelige blodpropper i indvoldene, fortæller Ian Black i 21 Søndag på DR 1.

Ifølge DR’s indslag i aftes viste en undersøgelse i 2005, at næsten 10 pct. af de, der blev behandlet med NovoSeven, fik blodpropper. Dermed blev Ian Blacks observationer bekræftet.

Alvorlige bivirkninger
Den påstand bakkes op af Steffen Thirstrup, som er leder af Lægemiddelstyrelsen i Danmark. Ifølge Lægemiddelstyrelsen er der ingen dokumentation for virkningen af medicinen.

- Lægemidlet bliver brugt til patienter, der ikke har gavn af det. De har på bundlinjen kun risiko for blodpropper, siger han til 21 Søndag. Lægemiddelstyrelsen kritiserer Novo Nordisk for at have tjent millioner kroner på medicinen, uden at der er blevet lavet kliniske studier, der viser, om den virker.

- Der er tale om medicin med de alvorligste bivirkninger, nemlig at man kan få blodpropper og dø af det, siger Steffen Thirstrup.

Efter indslaget fortalte Kim Bildsøe Lassen, at Novo Nordisk havde solgt for 1,2 mia. kr off-label, altså til formål, der ikke er godkendt.

Sag mod Novo Nordisk
Da Ian Black opdagede bivirkningerne gik han til myndighederne, og det amerikanske justitsministerium lagde sag an mod Novo Nordisk.

Militærlægen var kronvidne og whistleblower i sagen. Det var altså ham, der fortalte ministeriet om de alvorlige følger af NovoSeven, og om at Novo Nordisk havde bestukket ham og andre læger.

- Jeg blev tilbudt ubegrænsede penge til uddannelse, gode middage på dyre restauranter og firestjernede hotelophold, siger Ian Black.

Men sagen kom aldrig i retten, og i stedet invilligede Novo Nordisk i at betale 25 mio. dollars - ca. 130 mio. kr - i et forlig. Ian Black mener, at det forlig har været en god forretning for Novo Nordisk.

- 25 mio. dollars er mange penge, men sammenlignet med de mange mio., de har tjent, så er det ikke ret meget, siger han til 21 Søndag. (...)

Medisiner virker
BJARNE JOHNSON - daglig leder, AstraZeneca Norge
aftenposten.no 5.9.2011
I forbindelse med Paulsrudutvalgets utredning om bruk av tvang innen psykisk helsevern har en rekke debattinnlegg blitt skrevet. Flere ganger er det antydet at legemidler brukt i psykiatrisk behandling ikke virker, og at legemiddelselskapene nærmest er ansvarlige for at de brukes under tvang. Det stemmer ikke.

AstraZeneca forsker frem og markedsfører medisiner som gjennom kliniske studier har dokumentert et positivt nytte/risiko-forhold for syke mennesker. Alle legemidler
som finnes på markedet er godkjent av offentlige legemiddelmyndigheter og har dokumentert kvalitet, sikkerhet og effekt. I Norge har vi strenge lover som regulerer hvordan vi kan markedsføre medisiner.

Dessverre er det ikke slik at medisiner virker likt på alle. Vi er forskjellige, og det påvirker hvordan medisinene tas opp i kroppen, brytes ned og skilles ut. Både effekt og bivirkninger kan variere fra pasient til pasient. Vi har ingen medisin innen psykiatri som er tilpasset den enkelte pasients genetiske profil. AstraZeneca prøver å forske frem «skreddersydde » medisiner, men vi har en lang vei å gå. (...)

Novo Nordisk anklages for at smøre militærlæger
business.dk 23.8.2011
Den amerikanske hær begyndte i 2004 at bruge NovoSeven som standardbehandling til sårede amerikanske soldater i Irak.

Millionforlig i sag, hvor Novo Nordisk mistænkes for at give limousinetransport og dyre middage til militærlæger, hvidvaskning af bestikkelse til lægerne og ulovlig betaling for forsøg med sårede soldater i Irak og Afghanistan.

Det er ikke småting, Novo Nordisk beskyldes for at stå bag, når man læser søgsmålet om ulovlig markedsføring af blødermedicinen NovoSeven, som det amerikanske justitsministerium sammen med 24 delstater og to såkaldte whistleblowers afleverede for snart to år siden.

Søgsmålet, som først nu er kommet til offentlighedens kendskab, resulterede i juni i år i, at Novo Nordisk indgik et 130 millioner kroner stort forlig, uden at den danske medicinalkoncern erkender skyld. Novo Nordisks ledelse fastholder, at selskabet ikke har gjort noget forkert.

Søgsmålet tegner billedet af en virksomhed, hvis sælgere har været villige til at gå langt for at leve op til de store krav, som blev stillet til dem fra virksomhedens side. I anklageskriftet konstateres det, at Novo Nordisk på systematisk vis forsøgte at få udbredt brugen af NovoSeven til behandling af traumepatienter, selv om midlet ikke var godkendt til formålet. (...)

The 50 Largest Pharmaceutical Companies by Sales
seekingalpha.com 15.8.2011
The pharmaceutical industry used be a highly profitable industry and pharma stocks were long considered as conservative investments that offered slow, steady growth with attractive yields. However that has changed in the past couple of decades. Though profit margins for blockbuster drugs are high, drug companies’ earnings are under enormous pressure due to many factors including regulatory issues, high R&D expenses, length of time for FDA approvals, legal costs, etc.

Despite these issues, stocks of some pharma companies are good long-term investment opportunities. For example, companies that have high exposure to emerging markets offer potential for growth as the demand for drugs grows in those countries. For example the Danish drug maker Novo Nordisk (NVO) is a world leader in diabetes care. With diabetes becoming more prevalent in emerging countries such as China, Novo Nordisk can tap this huge growing market. According to one estimate, the number of Chinese having Type 2 diabetes may reach 80 million over the next 15 years. As of this year, China is the third biggest market for Novo Nordisk and the second largest insulin market. (...)

A Dearth of New Meds (En knapphet på nye legemidler)
sciencedaily.com 9.8.2011
Drugs to treat neuropsychiatric disorders have become too risky for Big Pharma

Schizophrenia, depression, addiction and other mental disorders cause suffering and cost billions of dollars every year in lost productivity. Neurological and psychiatric conditions account for 13 percent of the global burden of disease, a measure of years of life lost because of premature mortality and living in a state of less than full health, according to the World Health Organization.

Despite the critical need for newer and better medications to treat a range of psychiatric and neurodegenerative diseases, including Alzheimer’s and Parkinson’s, drugs to treat these diseases are just too complex and costly for big pharmaceutical companies to develop. The risk of spending millions on new drugs only to have them fail in the pipeline is too great. That’s why many big drug companies are pulling the plug on R&D for neuropsychiatric and other central nervous system (CNS) medicines.

Our team at the Tufts Center for the Study of Drug Development has arrived at this conclusion after conducting surveys of pharmaceutical and biotechnology companies about the drug development process. These surveys allow us to generate reliable estimates of the time, cost and risk of designing new drugs. Our analyses show that central nervous system agents are far more difficult to develop than most other types. (...)

Åpenhet om samarbeid og deling av kunnskap
K Bekkemellem
Tidsskr Nor Legeforen 2011; 131:1528 (9.8.2011)
Forholdet mellom leger og legemiddelindustri har vært i søkelyset i mange år. Vi har samme mål: Å fremme god helse og behandle sykdom.

Legemiddelindustrien er forskningsintensiv. Selve motoren er ønsket om forbedre dagens legemiddelbehandling, redusere bivirkninger og utvikle helt nye legemidler der det er medisinsk behov. Dette arbeidet skjer i tett samarbeid med leger i og utenfor industrien - gjennom forskningsprosjekter, kliniske studier, tilbakemeldinger om bruk og bivirkninger og gjennom formidling av ny forskning.

For å få til dette må vi ha møteplasser der viktig informasjonsutveksling kan finne sted. Samtidig er ingen av oss tjent med at det settes spørsmålstegn ved samarbeidet vårt. En pasient må ha full tillit til at legen velger den beste og mest effektive medisinen. Når det offentlige betaler en så stor del av regningen, må de også ha full tillit til at legen forholder seg til de retningslinjer myndighetene har satt opp om valg av kostnadseffektive medisiner.

Legemiddelindustrien i Norge har i mange år dekket reiseutgifter for leger til internasjonale fagkongresser. Det har bidratt til at medisinske miljøer i Norge har fått oppdatert kunnskap om ny forskning og kan ha bidratt til bedre pasientbehandling. Men vi har også sett at det er blitt stilt kritiske spørsmål til om industrien skal «sponse» slik etterutdanning. Kan det skape uheldige bindinger mellom firmaer og leger? Er det ikke myndighetene og arbeidsgiverne som bør sørge for å gi denne etterutdanningen selv? (...)

Drug Prices to Plummet in Wave of Expiring Patents
healthland.time.com 25.7.2011 (Time)
The cost of prescription medicines used by millions of people every day is about to plummet.

The next 14 months will bring generic versions of seven of the world's 20 best-selling drugs, including the top two: cholesterol fighter Lipitor and blood thinner Plavix.

The magnitude of this wave of expiring drugs patents is unprecedented. Between now and 2016, blockbusters with about $255 billion in global annual sales will go off patent, notes EvaluatePharma Ltd., a London research firm. Generic competition will decimate sales of the brand-name drugs and slash the cost to patients and companies that provide health benefits.

Top drugs getting generic competition by September 2012 are taken by millions every day: Lipitor alone is taken by about 4.3 million Americans and Plavix by 1.4 million. Generic versions of big-selling drugs for blood pressure, asthma, diabetes, depression, high triglycerides, HIV and bipolar disorder also are coming by then.

The flood of generics will continue for the next decade or so, as about 120 brand-name prescription drugs lose market exclusivity, according to prescription benefits manager Medco Health Solutions Inc. (...)

Drugmakers under fire over high HIV prices in less poor countries
pharmatimes.com 19.7.2011
As the International AIDS Society Conference gets underway in Rome, several pharmaceutical companies stand accused of abandoning HIV drug discount programmes in middle-income countries.

The claim is made by Medicins Sans Frontieres (MSF – Doctors Without Borders) which has analysed the prices of 23 antiretrovirals with information provided by 19 manufacturers. It notes that Johnson & Johnson's Tibotec unit exclude all countries classified as middle-income from their price reductions, while Abbott Laboratories gives no discounts to low-income and lower middle-income countries for one of its drugs.

MSF's report goes on to state that ViiV, the joint venture between Pfizer and GlaxoSmithKline, no longer offers reduced prices to middle-income countries, "even when programmes are fully funded by the Global Fund to fight AIDS, TB and malaria or the US government’s PEPFAR programme". It also claims that Merck & Co has reversed a previous policy and will no longer issue price discounts for 49 middle-income countries for Isentress (raltegravir). (...)

What is James Murdoch doing on the GlaxoSmithKline board?
Richard Northedge takes on corporate finance
dofonline.co.uk 18.7.2011 (text)
Nevermind whether James Murdoch should remain chairman of British Sky Broadcasting, how long before someone asks why he is on the board of GlaxoSmithKlein Plc (LON:GSK)?

Unnoticed amid all the headlines about Rupert Murdoch’s media empire is that his favourite son is a non-executive director of Britain’s biggest pharmaceutical company.

And if television is a business regulated by governments, so much more so are drug companies – not just in Britain, but globally. Including America. Pharm companies cannot afford to court controversy in their governance.

James Murdoch has been a Glaxo main-board director since May 2009. Yes, FTSE 100 companies tend to recruit their non-execs from the execs of other Footsie firms and James was chief executive of BSkyB before he became chairman. But shareholders might belatedly start asking what experience he brings: his whole working life has been inside his father’s empire. (...)

James Murdoch to remain on GSK's board
reuters.com 15.7.2011
* Drugmaker says Murdoch has made strong contribution
* Investigations need to run their course
* News Corp executive also sits on Sotheby's board

LONDON, July 15 (Reuters) - GlaxoSmithKline , Britain's biggest drugmaker, said James Murdoch continued to serve as a non-executive director, and it would watch investigations into the phone-hacking scandal engulfing his family's newspaper business.

The 38-year-old heir apparent to his father Rupert Mordoch's News Corp joined GSK's board in 2009, since when he has made "a strong contribution", a GSK spokesman said on Friday.

In recent days, James Murdoch's reputation has taken a pummelling, with critics saying he was too slow to realise the enormity of the scandal at News International, the British newspaper unit he chairs.

GSK -- a group with plenty of experience of corporate controversy, ranging from rows over executive pay to safety alarms about some of its medicines -- will watch developments closely and is not rushing to any judgments.

"With regard to the activities that are alleged to have taken place at News International, we believe that the full facts must be established and the ongoing investigations be allowed to take place and come to a considered conclusion," the spokesman said.

James Murdoch was paid 98,000 pounds ($158,000) in shares for serving on GSK's board in 2010. He is member of both the drugmaker's corporate responsibility and remuneration committees. (...)

Flacking for Big Pharma (Promotering for Big Pharma)
theamericanscholar.org (1.7.2011)
Drugmakers don’t just compromise doctors; they also undermine top medical journals and skew medical research

“Drug Makers Cut Out Goodies for Doctors” and “Drugmakers Pulling Plug on Free Pens, Mugs & Pads” read headlines in The New York Times and The Wall Street Journal Health Blog at the end of 2008 after, in a very public act of contrition, 38 members of the pharmaceutical industry vowed to cease bestowing on prescribing physicians goodies such as pens, mugs, and other tchotchkes branded with their names. Some physicians and ethicists had long expressed concern about the “relationship of reciprocity” that even a pizza or cheap mug can establish between doctors and drugmakers, and branded trinkets also send a message to the patient, who might reason that Gardasil must be a good drug if her doctor wields a reflex hammer inscribed with its name. But while the popular press celebrated this sudden attack of nanoconscience and while we still gravely debate whether physicians’ loyalties can really be bought for a disposable pen or a free lunch, the $310 billion pharmaceutical industry quietly buys something far more influential: the contents of medical journals and, all too often, the trajectory of medical research itself.

How can this be? Flimsy plastic pens that scream the virtues of Vioxx and articles published in the pages of The New England Journal of Medicine would seem to mark the two poles of medical influence. Scarcely any doctor admits to being influenced by the former; every doctor boasts of being guided by the latter. In fact, medical-journal articles are widely embraced as irreproachable bastions of disinterested scientific evaluation and as antidotes to the long fiscal arm of pharmaceutical-industry influence.

And yet, “All journals are bought—or at least cleverly used—by the pharmaceutical industry,” says Richard Smith, former editor of the British Medical Journal, who now sits on the board of Public Library of Science (PLoS), a nonprofit open-access group publishing scientific journals that eschew corporate financing and are freely available online to the public.

Big Pharma, as the top tier of the industry is known, starts modestly, inserting the thin edge of its wedge by advertising copiously—and often inaccurately—in medical journals. In 1981, concerned officials at the Food and Drug Administration recognized the educational nature of pharmaceutical advertising by establishing explicit standards for medical-journal ads that mandate “true statements relating to side effects, contraindications, and effectiveness,” and a “fair balance” of statements about medication risks and benefits. (...)

Bad Side-Effects Ahead For Pharma?
blogs.forbes.com 30.6.2011
In 2006, according to The New York Review of Books, four-year-old Rebecca Riley died of the effects of two prescription drugs—Clonidine and Depakote.

These medications, along with Seroquel, were prescribed for Rebecca after she was diagnosed, at the age of two, with attention deficit hyperactivity disorder (ADHD) and bipolar disorder. The three drugs are not approved by the Food and Drug Administration (FDA) for treatment of ADHD or long-term treatment of bipolar disorder, nor are they approved for children as young as Rebecca.

The New York Review of Books’ recent two-part article (1) by Marcia Angell on the treatment of mental illness with psychoactive drugs (those that affect the mental state) addresses an issue that may one day prove very important to investors in pharmaceutical stocks. (All statistics and quotations herein are drawn from Dr. Angell’s article.)

It is not illegal for a doctor to prescribe a drug off-label, that is, for a non-FDA-approved use, but a drug marketer cannot lawfully encourage a doctor to do so. The profits in psychoactive drugs, however, make it tempting to flout the law. In the past four years, AstraZeneca (AZN), Pfizer (PFE), Eli Lilly (LLY), Bristol-Myers Squibb (BMY) and Forest Labs (FRX) have all settled federal charges of marketing psychoactive drugs off-label, at a cost running into hundreds of millions.

Seeing that pharmaceutical marketing executives are evidently undeterred by the law, Dr. Angell, a senior lecturer in social medicine at Harvard Medical School and former editor in chief of The New England Journal of Medicine, advocates a prohibition on prescribing psychoactive drugs off-label.

A ban would cut into a major growth area for pharmaceutical companies. (...)

The Best Drug Companies Of 2020
blogs.forbes.com 30.6.2011
Usually sales projections ten years out for a very volatile industry are an exercise in proving that Neils Bohr and Yogi Berra were both geniuses: it’s very hard to predict anything. Especially the future. But a report from Timothy Anderson at Sanford C. Bernstein doing just that has gotten some significant play already — Jim Edwards at BNET, Derek Lowe at In The Pipeline and Duff Wilson at the New York Times have beat me to this particular ground. And rightly so — what Anderson did is very smart.

Everybody knows that large drug companies such as Pfizer, Eli Lilly, and Merck are facing the expiry of patents on their best sellers. At the same time they are having trouble inventing new medicines, and this means that the drug industry’s sales may at best tread water — and could face some steep drops. The point of Anderson’s exercise is to see what happens after the immediate patent expirations, like the loss of Lipitor from Pfizer and Zyprexa from Eli Lilly, to see what happens next. And it is truly informative.

In all of Anderson’s analyses, Novartis and GlaxoSmithKline fared very well, growing more than their competitors. By contrast, Eli Lilly and AstraZeneca emerged as the worst-in-class companies, losing a third of their revenue. Bristol-Myers Squibb emerges as a bit of a wild card: if it’s pipeline of experimental drugs comes through, it could be one companies that grow sales. (...)

Study: Drug Dropout in Clinical Trials Is at Unsustainable Levels (Studie: Nivået på dropout i kliniske legemiddelforsøk er uholdbart)
pharmpro.com 28.6.2011
The pharmaceutical industry spent less on drug R&D last year than at any time in the last three years, according to data released today from the 2011Pharmaceutical R&D Factbook complied by CMR International, a Thomson Reuters business.

Key highlights from the 2011 R&D Factbook include:

-- 21 new molecular entities (NMEs) were launched on the global market in 2010, a decrease from 26 in the previous year.

-- 2010 saw the lowest number of NMEs launched by Major Pharma in the past 10 years -- The number of drugs entering Phase I and Phase II trials fell 47% and 53% respectively -- Self-originated molecules have a 20% greater chance of reaching the market from Phase III and Submission versus in-licensed or acquired compounds -- Patient recruitment for clinical trials has shifted towards SE Asia -- The proportion of total sales from drugs reached an all time high of $856 billion* The 2011 edition of the Pharmaceutical R&D Factbook shows that R&D expenditure continued to drop in 2010 to an estimated three year low of $68 billion, which is in stark contrast to the growth rate leading up to 2008. The report also highlights that drug success rates continue to show the declining trends of the past decade. There were 55 phase III drug terminations during 2008-2010, more than double the number of terminations during 2005-2007; in addition the number of drugs entering phase III clinical trials fell by 55 percent in 2010.

Faced with more than 110 drugs losing patent exclusivity in the US, including 14 "blockbusters", the world's leading pharmaceutical companies face considerable risk to their revenue streams in next three years. The strategy of in-licensing or acquiring compounds is also facing difficulty, as self-originated drugs currently have a 20% higher chance of making it to market.

Phil Miller, product director at Thomson Reuters, said: "High failure rates continue to be of great concern to the industry and this is compounded by the decrease in NMEs. The strategy of big pharma to in-license more drugs for development does not appear to be paying off at present. An earlier focus on clearing out weak drug candidates will be instrumental to successfully progressing drugs to market." In addition, despite the overall decrease in the number of new drugs entering each stage of clinical trials, Anti-Cancer is one of only two therapeutic areas to see positive growth in the number of drugs being developed for launch.

The information published in the Factbook is based on primary sources covering major pharmaceutical companies which account for approximately 80 percent of the industry's global R&D expenditure. (...)

Crossing the Line: The Trial of GlaxoSmithKline Lawyer Lauren Stevens
law.com 23.6.2011
When the U.S. Department of Justice charged former in-house lawyer Lauren Stevens with six felonies, it aimed to send a clear message that no one should lie to federal investigators—including lawyers. But the short and bitter trial that followed backfired. In the end it conveyed a message to both in-house counsel and prosecutors about the dangers of overzealousness.

On May 10, in a move that was as sudden as it was dramatic, a federal district court judge in midtrial acquitted the former in-house counsel at GlaxoSmithKline of all six counts. While Stevens and her lawyers celebrated with champagne, sources say the stunned prosecutors privately complained that the jury would have found Stevens guilty had the judge let the trial continue. (...)

Kutter sponsing og reklameeffekter
dagensmedisin.no 16.6.2011
Legemiddelfirmaet AstraZeneca har avsluttet all sponsing av kongresser og turer for helsepersonell. Reklameeffekter som kulepenner og blokker er det også slutt på.

Den nye policyen til AstraZeneca gjelder all virksomhet til det globale legemiddelfirmaet.

- Bakgrunnen er et ønske om å bedre vårt renommé overfor omverdenen; helsevesenet, pasienter og myndigheter. Vårt mål er å utvikle innovative legemidler som kan bedre livet til befolkningen verden over samt å markedsføre disse ovenfor helsepersonell slik at de blir brukt på rett måte. Da ønsker vi å rette fokus mot dette - ikke betale for reiser, kongresser eller reklameeffekter. Ved å etterleve vårt globale regelverk, håper vi å bedre tilliten til oss som selskap og industri, sier country manager Bjarne Johnson i AstraZeneca til Dagens Medisin.

Globalt regelverk
Han lister opp ting som selskapet nå kutter ut å betale for;

- flyreiser
- hotellovernattinger
- kongressavgifter
- reklameeffekter som penner, blokker og andre «gimmiker». (...)

Bekkemellem reagerer på utspill fra Legemiddelverket
dagensmedisin.no 23.5.2011
Administrerende direktør Karita Bekkemellem i Legemiddelindustrien reagerer på Legemiddelverkets uttalelser om at den eksperimentelle behandlingen av makuladegenerasjon er akseptabel.

I en tidligere artikkel fortalte Dagens Medisin at mange nordmenn behandles med medikamentet Aventis mot makuladegenerasjon (skarpsynsvekkelse).

Brukes uten godkjennelse
Aventis er ikke et godkjent legemiddel i behandlingen mot øyelidelsen. Det er derimot den betydelig dyrere medisinen Lucentis.

– Slik bruk er ikke ulovlig i Norge. Det er tvert imot en helt nødvendig sikkerhetsventil. Det settes imidlertid krav til lege eller sykehus om å sette seg godt inn i effektene av det aktuelle medikamentet, sa Steinar Madsen i Statens legemiddelverk i en kommentar til saken.

– Undergraver seg selv
Dette får Karita Bekkemellem til å reagere. – Statens legemiddelverks rolle blir totalt undergravet ved Madsens utspill, sier Bekkemellem på vegne av bransjeforeningen for legemiddelindustrien i Norge.

Hun minner om hvilken oppgave Statens legemiddelverk skal ha.

– Legemiddelverkets primære jobb er å sørge for at legemidler oppfyller de krav til dokumentasjon og sikkerhet som ivaretar pasientenes interesser med tanke på effekt og bivirkninger. Steinar Madsen vet utmerket godt hvilke krav som stilles for å få godkjent et legemiddel i Norge, fastslår hun. (...)

Generics seen slashing global drug sales growth
reuters.com 18.5.2011
(Reuters) - Global sales growth of prescription drugs could be cut in half over the next five years as lucrative brands lose patent protection and cheaper generics and emerging markets become the only significant growth drivers, according to IMS Health

"Past patterns of spending offer few clues about the level of expected growth through 2015," said Murray Aitken, an IMS Health executive whose division conducted the study.

"There are unprecedented dynamics at play, which are driving rapid shifts in the mix of spending by patients and payers between branded products and generics," said Aitken, whose company tracks prescription drug sales and trends.

Average annual sales are expected to grow 3 to 6 percent during the period, reaching nearly $1.1 trillion by 2015. But the trend reflects a slowdown from annual growth of 6.2 percent seen during the past five years, the report said.

U.S. sales will grow only 0 to 3 percent a year over the period, while sales in Europe will rise 1 to 4 percent. Spending on branded drugs is expected to be little changed in such developed markets in 2015, with growth coming instead from higher demand for cheaper generics. (...)

US pharma: “851 drugs now in R&D for diseases mainly affecting women"
pharmatimes.com 17.5.2011
US drugmakers currently have 851 medicines in development for diseases which disproportionately affect women, says a new industry report.

The products, which are all now in human clinical trials or awaiting Food and Drug Administration (FDA) review, include 139 potential treatments for cancers affecting women - 91 for breast cancer, 49 for ovarian cancer and nine for cervical cancer, says the report, from the Pharmaceutical Research and Manufacturers of America (PhRMA).

There are also 114 potential new treatments for arthritis and musculoskeletal disorders, says the group, noting that 60% of US patients with some type of arthritis or related conditions are female. 83 new treatments are in R&D for Alzheimer's disease - two-thirds of the 5.4 million Americans living with the disease are women - and 72 for depression and anxiety, which affect almost twice as many women as men.

110 treatments are now in R&D for autoimmune diseases such as multiple sclerosis (MS) and rheumatoid arthritis (RA), which strike women three times more than men, and 64 are being developed for obstetric and gynaecological conditions, says the industry group. Researchers are also working on 299 medicines for heart disease and stroke, which kill nearly 500,000 women in the US every year, and 98 medicines for lung cancer, the leading cancer killer of women, it adds.

"As recently as a couple of decades ago, there was a basic assumption that what was good medically for men was good for women in almost every case," said PhRMA chief executive John Castellani. "Today, our increasing knowledge of the less-obvious differences between man and women is providing great promise for new and better treatments that will benefit both sexes," he added.

The study shows that women account for around 90% of US patients suffering from lupus, migraines and fibromyalgia. Moreover, for many diseases, they may present with symptoms which are different from those seen in men. For example, men having heart attacks typically report chest pain that radiates down the arm, while women may instead feel indigestion, extreme fatigue and nausea. (...)

Inadequate reporting of research ethics review and informed consent in cluster randomised trials: review of random sample of published trials
BMJ 2011; 342:d2496 (11 May)
Objectives To investigate the extent to which authors of cluster randomised trials adhered to two basic requirements of the World Medical Association’s Declaration of Helsinki and the International Committee of Medical Journal Editors’ uniform requirements for manuscripts (namely, reporting of research ethics review and informed consent), to determine whether the adequacy of reporting has improved over time, and to identify characteristics of cluster randomised trials associated with reporting of ethics practices. (...)

Conclusions Reporting of research ethics protections in cluster randomised trials is inadequate. In addition to research ethics approval, authors should report whether informed consent was sought, from whom consent was sought, and what consent was for. (...)

Head to head comparisons are missing from half of new drug approvals
BMJ 2011; 342:d2841 (11 May)
All you need to read in the other general journals

JAMA2011;305:1786-9 [Abstract/Full text]
Doctors prescribing a new drug need to know how it compares with established alternatives. Regulators approving new drugs for market don’t always insist on head to head trials, however, so comparative effectiveness data can be hard to find in the crucial few years after the launch of a new drug. Preapproval documentation submitted to regulators is a potential source of information, although it was patchy in one recent study from the US.

Researchers analysed packages of documents submitted to the Food and Drug Administration for new drug approvals between 2000 and 2010. Just over half the packages (100/197) contained one or more studies that compared the new drug with an active alternative. The regulator’s decision was based on comparative efficacy data for just 59 out of 197 drugs.

So some data are available, some of the time. The researchers weren’t able to say whether the head to head studies found on the FDA’s website were good enough to be useful to doctors, other prescribers, or decision makers in charge of formularies. But they do think the source has potential and should be more accessible and easier to use. They would also like to see more comparative studies before drugs are approved. The findings of this US analysis are broadly in line with a study of approval decisions made by the European regulator between 1999 and 2005. (...)

Special report: Big Pharma's global guinea pigs
reuters.com 6.5.2011
(Reuters) - The Polish port city of Gdansk is famous for its shipyards. Hungary's fifth largest city, Pecs, is known for its ancient architecture and brewery. Neither is particularly renowned for medicine. Yet when AstraZeneca Plc tested its big new drug hope Brilinta on heart attack patients in a major clinical study, it was hospitals in these places that enrolled some of the highest number of patients anywhere in the world. (...)

"The motivation to involve lots of patients is very high in Eastern European countries and also in Asia," says Dr. Ivan Horvath, head of interventional cardiology at the University of Pecs. "There are three factors driving this. Our patients get access to a new drug, which is free during the trial. It is also very important for scientific reasons. And we get paid." (...)

In the United States, the widespread "off-shoring" of research was highlighted in a report last year by the inspector general of the Department of Health and Human Services, which revealed just how reliant the country has become on foreign testing. In 2008, a total of 78 percent of all subjects participating in trials to support drug applications submitted to the Food and Drug Administration (FDA) were enrolled at foreign sites -- and as more experimental medicines move through the pipeline the numbers are set to increase further. (...)

Making raw data more widely available (Å gjøre rådata mer alminnelig tilgjengelig)
BMJ 2011; 342:d2323 (4 May)
New initiative by the Wellcome Trust sets out some guiding principles

Medical investigators routinely refuse to share data from medical studies, seeming to regard such data as private property rather than a public resource for the benefit of medical science and future generations of patients. One survey found that 75% of pharmaceutical researchers were opposed in principle to making raw data available.¹ Two studies have found that only a minority of researchers (10% and 25%) share data when publishing in journals with explicit policies that raw data must be made available.^{2 3} Even in genomics research, where the principle that microarray data should be deposited in a publicly accessible database is widely accepted, many published studies do not have an associated data set publicly available.^{4 5}

The benefits of sharing raw data from medical studies have been widely discussed.^{6 7 8 9} Data sharing ensures reproducibility, allows testing of secondary hypotheses, facilitates development of new statistical methods, provides a resource for teaching, aids design of new studies, simplifies data acquisition for meta-analysis, and helps prevent fraud and selective reporting. (...)

Ex-Glaxo Lawyer `Went Too Far,’ U.S Says at Opening of Obstruction Trial
bloomberg.com 27.4.2011
An ex-GlaxoSmithKline Plc (GSK) attorney accused of covering up the company’s improper marketing of its antidepressant drug Wellbutrin SR is a “lawyer who went too far,” a federal prosecutor said as her trial began.

Lauren Stevens, former vice president and associate general counsel for London-based Glaxo, is charged with impeding an inquiry in 2002 and 2003 by the U.S. Food and Drug Administration into the marketing of the drug for uses not approved by the FDA.

“This is a case about a lawyer who put loyalty to her company above fidelity to the truth and to the law,” said Patrick Jasperse, a Justice Department lawyer, during opening statements today in Greenbelt, Maryland, federal court. “This is a case about a lawyer who went too far, from aggressively representing her company to breaking the law.” (...)

Push to spur more drugs for deadly rare diseases
forbes.com 26.4.2011 (Associated Press)
Every other week, 7-year-old twins Addison and Cassidy Hempel have an experimental medicine injected into their spines in hopes of battling a rare, fatal disease. (...)

But it's a huge challenge to generate drug company interest in the expensive testing of medicines for diseases so rare - like her girls' Niemann-Pick Type C - that the market is only a few hundred or few thousand people a year.

There are treatments for just 200 of the roughly 7,000 rare diseases, illnesses that affect fewer than 200,000 people, often far, far fewer. Yet add those diseases together, and more than 20 million Americans have one.

Now a movement is beginning to spur more rare-disease treatments: The National Institutes of Health this fall will open a center to speed genetic discoveries into usable therapies, doing some of the riskiest early-stage research in hopes companies then will step in.

A new International Rare Diseases Research Consortium is pushing for at least 200 more treatments by 2020, in part by pooling the work of far-flung scientists and families.

Rather than starting from scratch, the Food and Drug Administration is pointing the way for manufacturers to "repurpose" old drugs for new use against rare diseases, publishing a list of those deemed particularly promising. (...)

Links between non-profit foundations and companies pose potential conflicts of interest (Linker mellom ikke-profitt organisasjoner og firmaer utgjør mulige interessekonflikter)
BMJ 2011; 342:d2490 (15 April) (pdf)
Big philanthropic foundations are transforming public health around the world, but their links to food and drug companies pose potential conflicts of interest, says a study.
The research says that some of the corporations benefit directly from grants from foundations, and foundations in turn have investments in the corporations to which they award the grants.

Foundation board members and decision makers also sit on the boards of some for-profit corporations benefiting from their grants.

Three experts on public health examined the activities, financial investments, and institutional relations of five of the biggest private global health foundations, including the world’s largest, the Bill and Melinda Gates Foundation (PLoS Medicine 2011;8(4):e1001020, doi:10.1371/journal.pmed.1001020).

At the end of 2008 the Gates Foundation had $29.6bn (£18bn; €20.5bn) of assets under its management, “financing greater than the budget of the entire World Health Organisation,” says the report. The foundation funds medical research and drug and vaccines programmes in developing countries.

The study says that the Gates Foundation’s corporate stock endowment is “heavily” invested in food and drug companies, both directly and indirectly, and that it holds “significant” shares in McDonald’s and Coca-Cola.

The foundation also participates in grants that encourage farmers in developing countries to become business affiliates of Coca-Cola.

The study also looked at the Ford, Rockefeller, W K Kellogg, and Robert Wood Johnson foundations. (...)

(Anm: Global Health Philanthropy and Institutional Relationships: How Should Conflicts of Interest Be Addressed? PLoS Med 8(4): e1001020 (April 12).)

The Death Of The Blockbuster Drug: A Cheat Sheet
By MATTHEW HERPER
blogs.forbes.com 13.4.2011
Earlier today I wrote a quick post on a stunning tally from Challenger, Gray & Christmas: 297,650 pharmaceutical jobs have been cut since the beginning of 2000. Rich Meyer, a former Lilly employee, wrote a really touching post about what that number really means on his blog.

There really is an upheaval happening now in the way medicines are invented and also in how they are sold. In November, when the first generic versions of Pfizer’s Lipitor are set to arrive, there will not be a single drug in the top 15 most-prescribed medicines that is still sold only in it’s branded version. The last drug to become a blockbuster by being widely prescribed was Januvia, the diabetes pill from Merck. These days, drugs become big sellers because they justify extremely high prices for narrow uses. I count nine medicines with annual per patient costs about $200,000.

In the latest issue of Forbes, I published a bit of a cheat sheet on the decline of the the pharmaceutical industry. I’m including it below. (...)

Novo sendte millioner til skattely
business.dk 17.3.2011
Novo indrømmer at sende store summer til hemmelige konti op gennem 00'erne.

Novo Nordisk har sendt millioner af kroner til hemmelige konti i skattely, når der blev indgået store salgsaftaler om insulin til det russiske marked, skriver Morgenavisen Jyllands-Posten torsdag.

Det indrømmer medicinalfirmaet konfronteret med nye oplysninger om medicinalkoncernens forretninger i Rusland. Flere kilder har oplyst om, hvordan Novo Nordisk op gennem 00'erne opretholdt tårnhøje kommissioner på op til 40 pct. til sine distributører, så der var økonomisk rum til smørelse af embedsmænd i det russiske sundhedssystem.

Novo afviste påstanden, men skred alligevel i 2006 til fyring af to medarbejdere efter vedholdende korruptionsrygter.

Ifølge kilderne blev distributørernes kommission reguleret ved hjælp af store kreditnotaer. Når Novo solgte et parti medicin og havde fået betaling, gav man efterfølgende rabat i form af en kreditnota.

Men i stedet for at modregne rabatten i det næste salg eller tilbageføre pengene til distributørens konto, accepterede Novo at sende pengene til ukendte konti i skattely som eksempelvis Cypern, Schweiz og Cayman Islands. (...)

How Eli Lilly Will Face Patent Expirations
seekingalpha.com 14.3.2011
Eli Lilly (LLY) appears perilously perched on the precipice of a patent cliff. A plummet could result in revenue falling for at least the next two years, and loss of more than 75% of sales within the next 7 years. Worse yet, there’s no parachute of freshly approved drugs to replace this revenue. Lilly’s perch is perhaps the best example of the crisis faced by much of the pharmaceutical industry faces. However, it’s not the end of the world. Even acrophobic investors should take a closer look at patent expiration dates before abandoning hope of possible replacements for this revenue. (...)

GlaxoSmithKline risks promoting Student fee inflation
dofonline.co.uk 8.3.2011
GlaxoSmithKline Plc’s (LON:GSK) decision to pay the university fees of up to 100 students looks generous – even politically controversial – but it risks being inflationary. The more easily colleges can recover their charges from future employers rather than future employees, the more readily they will raise rates.

The UK’s top pharmaceutical company is offering to pay fees of upto £27,000 over three years, bettering an earlier scheme from the accountants KPMG.

At present the maximum any university can charge is £9,000 a term, but while it was assumed only the elite teaching institutions could charge that, Glaxo’s move makes it more likely that the £9,000 will become a norm as well as a ceiling. Exeter – not a member of the top Russell Group of universities – has already said it will join Oxford, Cambridge and Imperial College in charging the full sum.

Once lower-tier universities are charging £9,000 a year, how long before the top degree-giving centres lobby to have the maximum increased to re-establish their premium? (...)

Senate bill aims to combat pharmaceutical theft
forbes.com 10.3.2011
WASHINGTON -- Law enforcement officials would have more leeway to pursue and punish criminals who steal prescription pharmaceuticals under a proposal introduced Tuesday by Senate lawmakers.

A bill supported by six Democrats would increase the penalties for stealing stolen medical products and give police extra tools, including wiretaps, to track thieves. The bill accomplishes this by bringing medical theft under the Racketeer Influenced and Corrupt Organizations law, which was originally developed to prosecute organized crime.

The measure comes amid a rise in the value of pharmaceutical heists, which has increased 350 percent since 2007. Last March, the theft of $75 million worth of Eli Lilly drugs from a Connecticut warehouse drew new attention to the problem. It was the largest crime of its kind on record.
Along with stiffer penalties, the bill would formally criminalize the acts of storing, transporting or changing labels on stolen medical products. Those activities are currently not covered by criminal statutes. (...)

Lilly sees hope in emerging markets outside U.S.
ibj.com 19.2.2011
In a kind of alternate drug universe, sales of Eli Lilly and Co.’s ghosts of blockbusters past are soaring in China—prompting the drugmaker to pour money into emerging markets in an attempt to prop up revenue.

Sales of Prozac, which lost its U.S. patent a decade ago, grew 22 percent in China last year. Vancocin, an antibiotic Lilly introduced in the 1950s, grew more than 40 percent last year. And Zyprexa, Lilly’s $5 billion-a-year drug that will lose patent protection in the United States and Europe this year, is already off-patent in China and battling against a dozen copycat competitors. Yet its sales last year surged 22 percent among brand-conscious Chinese consumers. (...)

Fattige pasienter som "forsøkskaniner"
etikkom.no 16.2.2011
Over 26 % av befolkningen i India lever under fattigdomsgrensen ifølge Verdens helseorganisasjon. Illustrasjonsfoto: Shutterstock

En helseordning for fattige i India har gjort det mulig for internasjonale legemiddelfirma å rekruttere mange fattige som forsøkspersoner. Prosjekter blir gjennomført på mye kortere tid enn i USA. En indisk lege og forsker ser på dette med stor bekymring.

En helseordning, Arogyasri community health insurance scheme for fattige ble satt i gang som et prøveprosjekt i India i april 2007. Da ble tre distrikt innlemmet i ordningen: Mahboonnagar, Anantapur og Srikakulam. Dette var et pilotprosjekt som i dag er utvidet til en fast ordning for 70 millioner mennesker.

Målet med ordningen, i tillegg til å gi gratis helsetilbud, er å identifisere sykdommer og hvordan medisiner for disse sykdommene blir brukt. Både offentlige og private sykehus bruker kunnskapen som blir generert i ordningen. (...)

Apotek är amerikanska statens visselblåsare
lakemedelsvarlden.se 26.1.2011
Ett apotek i Florida tjänar sina mesta pengar på att anmäla läkemedelsföretag som lurar staten på pengar.

WHISTLEBLOWER Ven-A-Care är apoteket som tjänar sina mesta pengar, enligt Los Angeles Times tiotals miljoner dollar, på att anmäla läkemedelsföretag som lurar det statliga Medicare och Medicaid på pengar. Apoteket jämför fakturor till apotek och vårdgivare med de priser som rapporteras till staten. Skillnaden kan ibland vara gigantisk. Enligt artikeln var till exempel priset som ett apotek betalade för blodtrycksmedlet atenolol drygt tre dollar medan uppgiften till Medicare var 70 dollar.

I Kalifornien har drygt 2000 stämningar mot 39 läkemedelsföretag, baserat på apotekets anklagelser dragit in 95 miljoner dollar till statskassan.
Medan en del beskriver apoteket som att ”de städar upp i en kloak” menar andra att ersättningen för visselblåsandet är allt för höga och att staten spenderar för mycket pengar på informationen. (...)

Glaxo Takes $3.4 Billion Charge on Legal Problems
nytimes.com 17.1.2011
The British drug maker, GlaxoSmithKline, announced Monday that it was setting aside $3.4 billion to pay for United States government investigations and for product liability cases over its marketing of the diabetes drug Avandia in the face of heart attack risks.

The one-time charge is expected to wipe out its fourth-quarter profit, by consensus analyst estimates. GlaxoSmithKline’s European shares fell about 2 percent on the news.

Avandia, once the world’s top-selling diabetes medicine, was severely restricted in September by the Food and Drug Administration and banned by the European Medicines Agency after safety reviews. (...)

Glaxo Takes $3.4 Billion Charge on Legal Problems
nytimes.com 17.1.2011
The British drug maker, GlaxoSmithKline, announced Monday that it was setting aside $3.4 billion to pay for United States government investigations and for product liability cases over its marketing of the diabetes drug Avandia in the face of heart attack risks.

The one-time charge is expected to wipe out its fourth-quarter profit, by consensus analyst estimates. GlaxoSmithKline’s European shares fell about 2 percent on the news.

Avandia, once the world’s top-selling diabetes medicine, was severely restricted in September by the Food and Drug Administration and banned by the European Medicines Agency after safety reviews. (...)

AstraZeneca Feels Big Pharma's Pain
online.wsj.com 18.12.2010
AstraZeneca looks vulnerable. A delay in U.S. regulatory approval for one of its most promising new treatments caught the market by surprise Friday. The subsequent drop in the share price of the U.K. pharmaceuticals group reflects a worst-case scenario for the drug.

But the news comes a day after regulators said they plan to revoke approval of rival Roche Holding's best seller Avastin for treatment of advanced breast cancer. Fears about rising regulatory hurdles will (...)

GSK lawyer is indicted on charges of obstructing FDA proceeding (GSK-advokat er siktet etter anklager om å forhindre FDA-prosedyre)
BMJ 2010; 341:c6570 (17 November)
The US Department of Justice has charged Lauren Stevens, a retired GlaxoSmithKline (GSK) lawyer, in relation to alleged off-label marketing of a drug. She faces one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency, and four counts of making false statements to the Food and Drug Administration.

Although drug companies have in the past been charged with off-label marketing of drugs, and several have paid large fines, it is thought that this is the first time an individual has been charged. GSK has not been charged and is not identified in the indictment.

The charges relate to the alleged off-label marketing of the antidepressant bupropion (marketed by GSK as Wellbutrin) for weight loss, and each carries a possible penalty of five to 20 years in prison. (...)

US drug company executives could face criminal charges for off-label promotion
BMJ 2010; 341:c5808 (19 October)
Executives of drug companies may face charges in a criminal court if their companies promote the off-label use of drugs, an attorney for the US Food and Drug Administration has said.

The agency’s deputy chief for litigation, Eric Blumberg, speaking at a conference in Washington, DC, said, “It’s clear we’re not getting the job done with large, monetary settlements. Unless the government shows more resolve to criminally charge individuals at all levels in the company, we cannot expect to make progress in deterring off-label promotion.”

Blumberg cited Pfizer, the world’s largest drug manufacturer, for violating regulations forbidding the promotion of drugs for conditions other than those approved by the FDA. (...)

Bolag får betala miljarder
dagensmedicin.se 29.10.2010
Läkemedelsbolaget Glaxo Smithkline måste betala motsvarande 6 miljarder kronor efter att föroreningsproblem och fusk med mängden aktiv substans i läkemedel har avslöjats i företagets fabrik.

I veckan avgjordes en åtta år lång rättsprocess i USA. Glaxo Smithkline ska nu betala den amerikanska staten 750 miljoner dollar.

Dessutom får Cheryl Eckard, en före detta anställd, 96 miljoner dollar som belöning för att hon avslöjade missförhållandena i företagets läkemedelsproduktion. Det skriver tidningen Guardian på nätet. (...)

Glaxo lawsuit shows hypocrisy of drug industry
By Editorial Board
sunjournal.com 29.10.2010
(...) The settlement shows two things:

First, that the drug makers themselves manufacture overseas and, at least in the GSK case, have lax standards.

Second, that the U.S. government needs an independent way to monitor the quality and efficacy of drugs made either here or abroad. We shouldn't have to rely on whistleblowers for our safety.

Having an independent agency would also open the door to re-importing brand-name drugs from overseas.

As we have long argued, it is simply nuts that Americans pay to educate scientists who develop drugs, we fund much of the research that leads to drug innovations, and then we pay the highest drug prices in the world. (...)

When we wonder why our medical costs are the highest on earth, this is one of the major reasons — this legalized gouging of American consumers.

If we don't allow price controls like other countries, at least allow the federal government to negotiate for better rates and allow the re-importation of medicines from low-cost countries.

If we are serious about controlling out-of-control medical expenses, this is the place to start. (...)

Drug companies are accused of using unsuitable doctors to promote their products (Legemiddelfirmaer anklaget for å bruke uegnede leger til å promotere sine produkter)
BMJ 2010; 341:c6026 (26 October)
Hundreds of doctors who have been disciplined for ethical breaches or had their medical licences revoked are on drug companies’ payrolls as speakers and consultants, an investigative report released on 18 October says.

The wide ranging investigation took months and was the product of a collaboration between the investigative news organisation ProPublica, a non-profit group based in New York, and five other news outlets: National Public Radio, the Chicago Tribune, the Boston Globe, Consumer Reports, and the US Public Broadcasting Service’s Nightly Business Report.

Doctors cited in the report include a pain physician who had performed “unnecessary” nerve tests on 20 patients and an anaesthetist who had admitted giving young female patients rectal and vaginal exams without documenting why.

The reporters created a searchable database of payments to doctors since 2009. The database includes $258m (£163m; €185m) in payments to 17 700 individuals by seven drug companies: Pfizer, GlaxoSmithKline, Merck & Co, Johnson & Johnson, Eli Lilly, AstraZeneca, and Cephalon. The seven companies collectively comprise a 36% share of the $300bn drug market in the United States. (...)

Glaxo to Pay $750 Million in Pact; Whistleblower Due Big Payment
online.wsj.com 27.10.2010
GlaxoSmithKline PLC agreed to pay $750 million and plead guilty to a criminal charge to settle a U.S. government investigation of manufacturing deficiencies at its former plant in Puerto Rico.

The probe was sparked by a suit filed by a former employee who is now entitled to $96 million from the settlement under a federal whistleblower law, according to the Justice Department.

Glaxo previously disclosed in July it had reached an agreement in principle to settle the probe, which stemmed from the manufacture of defective pills including the Paxil antidepressant at Glaxo's plant in Cidra, Puerto Rico, between 2001 and (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Big Pharma Begins Outsourcing Research and Development
seekingalpha.com 14.10.2010
Big pharmaceutical companies seem to be taking tips from an unlikely source these days.

A decade ago, big mining companies had a big problem on their hands in the form of declining prices. With less incoming funds to spend on finding new deposits, they started thinking creatively… They let small entrepreneurial companies handle early-stage exploration, a difficult task in remote parts of the world. Then, if those operations struck it rich, the big miners swooped in to buy them out.

Drug development might not seem like it has much in common with such ventures. But it involves the same high-risk, high reward discovery efforts.

So the pharmaceuticals are going for the gold as well with this new approach. Cutting back on in-house research and development (R&D), they’re hiring contract research organizations (CROs) like Covance (NYSE: CVD) instead. (...)

'Industry-Occupied Medicine . . . Somewhat Like a Communist State' ("Industri-okkupert medisin... Ganske likt en kommunisstat)
medpagetoday.com 13.10.2010
That's the way Dr. Peter Mansfield of the Healthy Skepticism organization -- run out of his home in Australia -- describes the status quo.

Mansfield, just one of the planners for last week's international "Selling Sickness" conference in Amsterdam, is a soft-spoken man who has carried a big stick at times in his 25+ years of railing against drug industry practices. His main aim for Healthy Skepticism: "to improve health by reducing harm from misleading health information." His first encounter: as a medical student in the '80s complaining to Bayer about a "tonic for stress" marketed in Pakistan "which was essentially a light beer with arsenic and strychnine. We actually got a dozen products withdrawn in the '80s." All on a budget of about $100-200 US.

In a portion of an interview I conducted with him in Amsterdam, Mansfield discussed troublesome drug advertising and promotion and "industry-occupied medicine" somewhat akin to a Communist state with people afraid to speak out.

The "Selling Sickness" conference was hosted by the Dutch Institute for Rational Use of Medicine, whose own "healthy skepticism" initiative is called "Gezonde scepsis." Congratulations to Sandra van Nuland, project manager, for her work on the event.

In the days (I hope it doesn't take weeks) to come, I will be posting other video interviews from the "Selling Sickness" conference. Stay tuned. (...)

Drug Firms Face Bribery Probe (Legemiddelfirmaer granskes for bestikkelser)
online.wsj.com 5.10.2010
Federal investigators are looking at ways that drug makers could be paying bribes overseas to boost sales and speed approvals, according to letters sent to the companies and people close to the matter.

Big companies—including Merck & Co., AstraZeneca PLC, Bristol-Myers Squibb Co. and GlaxoSmithKline PLC—in recent months have disclosed they are being investigated for possible violations of a 1977 law that makes it illegal for companies whose stock is traded in the U.S. to bribe government officials in other countries to get business.

The companies said they are cooperating with the government, with several adding that the investigation is industry-wide and broader than their companies specifically. Many said they have policies meant to ensure compliance with the Foreign Corrupt Practices Act.

So far, none of the companies has been accused of wrongdoing, and the investigation ultimately may not result in charges. (...)

Bloomberg Analysis Finds 'Doughnut Hole' Deal To Cost Drugmakers Less Than 1% Of Profits
kaiserhealthnews.org 1.10.2010
News outlets report how closing the Medicare 'Doughnut Hole' affects drugmakers and seniors.

Bloomberg: "Drugmakers led by Pfizer Inc., AstraZeneca and Bristol-Myers Squibb Co. may provide more than $2 billion in drug discounts to senior citizens next year under a deal pharmaceutical companies made with the White House, according to data compiled by Bloomberg." The data came from a recent report released by Medicare. "Pfizer, the world's largest drug company, will cede less than half of 1 percent of its $50 billion in annual revenue under the arrangement." Les Funteyder, a health care analyst in New York, calls it "a good deal for pharma." (...)

Finnes det noen vaksine mot legemiddelindustriens grådighet?
Francis Lundh - Helsejournalist i VG Nett
francislundh.vgb.no 16.9.2010
Dette var temaet for en debatt jeg ledet på Protestfestivalen i Kristiansand i går (navnet på debatten var ikke bestemt av meg). I panelet var Steinar Madsen fra Statens Legemiddelverk og direktør Åge Nærdal fra firmaet som laget svineinfluensavaksinen. Innleder: Den relativt innbitte vaksinemotstander Kjetil Dreyer fra Vaksineaksjonen. De som ventet avsløring av konspirasjoner ble antakelig skuffet, ellers har de svært god fantasi. Likevel ble det en debatt som slo fast et par viktige ting, og noe av det kanskje mest overraskende var at Madsen var såpass klar på at WHOs erklæring av svineinfluensaen som en global pandemi kunne være overdrevet. Ikke en oppsiktsvekkende uttalelse i seg selv, men mer oppsiktsvekkende fordi den kommer så direkte fra det holdet. Også referert i egen sak på fvn.no. Pandemirutinene bør dermed undersøkes, i etterpåklokskapens lys, noe også vaksineprodusenten ei heller fant nødvendig å protestere. (...)

Scientists slam EU/industry pharma initiative
pharmatimes.com 8.9.2010
A group of leading European researchers has strongly criticised the European Union/European Federation of Pharmaceutical Industries and Associations (EU/EFPIA) Innovative Medicines Initiative (IMI), saying it “shows how a private-public partnership (PPP) should not be set up.”

Launched in 2007, the IMI is the largest public-private partnership in life sciences R&D worldwide, with funding totalings 2 billion euros to 2017, contributed equally by the EU and the industry. But researchers have repeatedly criticised its intellectual property (IP) rights policy and funding model, and a letter sent to the IMI board this month by the League of European Research Universities (LERU) says the problems in these areas “represents a double negative” to participation by academia or small and medium-sized enterprises (SMEs). (...)

Drug industry accused of complicity (Legemiddelindustrien anklaget for delaktighet)
pharmacyeurope.net 18.8.2010
The global pharmaceutical industry is little more than a "market for lemons" that dupes doctors and patients about the effectiveness of its products, a report has said.

Professor Donald Light made a series of controversial allegations against so-called "Big Pharma" in his report, "Pharmaceuticals: A Two-Tier Market for Producing 'Lemons' and Serious Harm", in which he accused pharmaceutical companies of downplaying the side effects of drugs while over-promoting their benefits.

The industry enjoys the safety of the specialist knowledge that goes into producing drugs and exploits it to its advantage, making it simply a "market for lemons", he said.

Prof Light, a professor of comparative health policy at the University of Medicine and Dentistry in New Jersey, said: "Sometimes drug companies hide or downplay information about serious side effects of new drugs and overstate the drugs' benefits.

"Then, they spend two to three times more on marketing than on research to persuade doctors to prescribe these new drugs. Doctors may get misleading information and then misinform patients about the risks of a new drug. It's really a two-tier market for lemons."

The author made the accusations at the American Sociological Association's annual meeting in Atlanta, Georgia, during which he also accused "Big Pharma" of owning independent drug testing companies and hiding behind legal "firewalls" that protect them from questions over the effectiveness of their products.

He said 85% of new drugs pose more harm than good to patients, adding that the "relatively low bar" for effectiveness means that drug companies can push through drugs for approval too easily. (...)

Forbes Investigation: Why Big Pharma Ignores Suicide
blogs.forbes.com 26.8.2010
Nearly 35,000 people die a year from suicide, while another million people try to kill themselves. The vast majority have some sort of mental health problem.

Yet top drug companies such as Pfizer, GlaxoSmithkline and Eli Lilly routinely exclude high-risk suicidal patients from studies. Academic psychiatrists don’t study treatments for suicidal patients thanks to lack of funding and interest. University review boards are skittish about performing studies on high-risk patients thanks to fear of lawsuits. As a result, doctors have little idea how to treat those psychiatric patients most at risk of serious harm.

A six month Forbes investigation reveals a multi-billion dollar mental health industry that ignores sick suicidal patients that need help the most thanks to fear of lawsuits, social stigma, and lack of a profit motive. It profiles a handful of daring researchers who are trying to change this. The full story is HERE. (...)

The Forgotten Patients
forbes.com 26.8.2010
The mental health industry ignores the 35,000 people a year who commit suicide. A few researchers are trying to change that.

Alexsandra Wixom started experiencing uncontrollable bouts of sadness when she was 15. "I was emotionally off. I cried all the time," recalls the Seattle-area resident, who is now 25. Her mood swings eventually became so wild the former honors student had to quit going to high school. Over the next eight years she saw a psychiatrist every other week. Her doctors tried everything from Zoloft to mood stabilizers to heavy-duty antipsychotics, but none of them helped for long. (...)

Astra Zeneca i mututredning
dagensmedicin.se 13.8.2010
Fler stora läkemedelsbolag har blivit kontaktade av justitiedepartementet i USA i samband med en granskning av mutor i läkemedelsbranschen.

Bland bolagen finns Astra Zeneca, Glaxo Smithkline, Pfizer och Merck, uppger TT.

Granskningen ska omfatta bland annat bolagens rekrytering av läkare för kliniska prövningar av läkemedel samt betalningar av konsulter, licensavtal och donationer till välgörande ändamål. (...)

Kynisme og profittjag
L Slørdal
Tidsskr Nor Legeforen 2010; 130:1447 (12.8.2010)
Yngve Mikkelsen, Trond Methi og Monica Kjeken forsvarer legemiddelindustrien i Tidsskriftet nr. 13–14/2010 (1–3). De tre innleggene gjelder Robin Holtedahls artikkel om pregabalin ved fibromyalgi (4) og min leder om det samme tema (5). I motsetning til Holtedahl fikk jeg – til tross for at jeg innstendig ba redaksjonen i Tidsskriftet om det – ikke besvare innleggene i samme nummer. Det liker jeg dårlig.

Sist jeg diskuterte publiseringsetikk med Pfizer et al, var tema en legemiddelgruppe som for ettertiden vil være knyttet til den kanskje største sikkerhetsskandalen noensinne – de selektive COX-2-hemmerne (6). Det ser dessverre ut til at industrien har lært lite av den tildragelsen, der i gården er det tydeligvis «business as usual». (...)

Is Pfizer the BP of drug companies? (Er Pfizer BP blant legemiddelfirmaer?)
By Martha Rosenberg
onlinejournal.com 26.7.2010
Pfizer is best known for Lipitor, a drug that brings cholesterol down and Viagra, a drug that brings other things up. (...)

In fact, to say Pfizer’s been accused of wrongdoing is like saying BP had an oil spill. Other drug companies have a portfolio of products, Pfizer has a portfolio of scandals including, but not limited to, Chantix, Lipitor, Viagra, Geodon, Trovan, Bextra, Celebrex, Lyrica, Zoloft, Halcion and drugs for osteoarthritis, Parkinson’s disease, kidney transplants and leukemia.

During one week in June Pfizer: 1) Agreed to pull its 10-year-old leukemia drug Mylotarg from the market because it caused more not less patient deaths 2) Suspended pediatric trials of Geodon two months after the FDA said children were being overdosed 3) Suspended trials of Tanezumab, an osteoarthritis pain drug, because patients got worse not better, some needing joint replacements (pattern, anyone?) 4) Was investigated by the House for off-label marketing of kidney transplant drug Rapamune and targeting African-Americans 5) Saw a researcher who helped established its Bextra, Celebrex and Lyrica as effective pain meds, Scott S Reuben, MD, trotted off to prison for research fraud 6) was sued by Blue Cross Blue Shield to recoup money it overpaid for Bextra and other drugs 7) received a letter from Sen. Charles Grassley (R-Iowa) requesting its whistleblower policy and 8) had its appeal to end lawsuits by Nigerian families who accuse it of illegal trials of the antibiotic Trovan in which 11 children died, rejected by the Supreme Court. And how was your week?

Nor does Pfizer back down when faced with legal troubles. (...)

Legal charges drag GSK into the red for Q2 (Rettslige krav gir GSK røde tall i annet kvartel)
pharmatimes.com 21.7.2010
GlaxoSmithKline took a massive hit from one-time legal and restructuring charges during the second quarter of 2010, leaving its books well in the red compared to the healthy profit booked a year ago.

The world’s second-largest drugmaker warned last week that legal settlements, primarily relating to the antidepressant Paxil (paroxetine) and the diabetes drug Avandia (rosiglitazone), would alone swipe £1.57 billion off its second-quarter results. And this, coupled with a £590 million restructuring charge, secured a loss of £304 million for the period, a far cry from the profit of £1.43 billion GSK booked for Q2 2009.

The group’s swing into the red masked an OK growth in sales for the period given the current tough economic conditions, with revenue up 4% at £7 billion, though down 2% if pandemic products are taken out of the equation. (...)

Data shows declining productivity in drug R&D
reuters.com 27.6.2010
(Reuters) - Drugmakers still rely heavily on sales from an aging portfolio of products and the proportion of sales from newer medicines actually fell last year, after a decade of record research spending yielded few new winners. (...)

Many companies -- including Pfizer Inc, GlaxoSmithKline Plc and AstraZeneca Plc -- have been taking a knife to research operations in a bid to improve returns, a trend which analysts expect to gather momentum this year and next.

As a result total research and development (R&D) expenditure dropped by 0.3 percent in 2009, after a 6.6 percent rise in 2008 and rapid growth seen in earlier years. (...)

Competing interests
The odium of industry engagement (Motviljen mot industriengasjementer)
BMJ 2010;341:c3575 (7 July)
The risks of odium associated with declaring competing interests have become such that many researchers are now intimidated into refusing industry engagement. I have refused for a decade as I value my independence. But this is not a healthy development. Widespread disengagement with vaccine producers would be like dietitians refusing to have anything to do with the food industry which supplies almost all of the very items that dietitians urge be consumed more. (...)

Industries wanting independent expertise should contribute to a central pool, governed entirely by research bodies.³ All payments would be via the pool, not directly through a company or industry body. Such an arrangement would seem likely to reduce the extent to which researchers might be tempted into the sorts of lack of judgment that can arise from being too close to a company, while at the same time acknowledging the importance of industry engagement. (...)

India Expands Role as Drug Producer
nytimes.com 6.7.2010
HALOL, India — Below an ancient hilltop temple to Kali, the Hindu goddess associated with destruction and change, Sun Pharmaceutical Industries churns out generic versions of cancer drugs and epilepsy medications bound for the United States.

Business is so brisk that Sun, with revenue of 41 billion rupees ($880 million) last year, predicts sales will grow 20 percent this year and is expanding its Halol factory.

“This site specializes in making difficult things,” Sampad Bhattacharya, Sun’s vice president in charge of operations, said during a recent factory tour. The blue and gray concrete building, which will be nearly 800,000 square feet after the expansion, would not look out of place in the pharmaceutical manufacturing centers of New Jersey, except for the herds of cattle and buffalo wandering nearby. (...)

Bråstopp for sponsorreisene til norske leger
vg.no 19.6.2010
(VG Nett) Det blir i fremtiden full stopp for norske leger som reiser på kongresser i utlandet sponset av legemiddelindustrien. Det har industrien selv bestemt.

Flere hundre norske leger får årlig invitasjon til sponsede kongressreiser i utlandet der de får informasjon om nye medisiner, forskning og behandlingsmetoder.

Nå har derimot styret i Legemiddelindustriforeningen (LMI) fattet et vedtak om at norske leger i fremtiden må få andre til å betale kongressreisene sine.

- Fra 1. januar 2012 det blir helt slutt på at legemiddelindustrien betaler for kongressreiser i utlandet til leger. Etter det jeg har sjekket ut er Norge det første landet som gjør disse tingene, sier administrerende direktør Karita Bekkemellem til VG Nett. (...)

The Truth About The New-Drug Drought
blogs.forbes.com 4.6.2010
It's no secret that the pharmaceutical industry's problem is that it can't invent enough drugs. There was a flood of big selling medicines launched by pharmaceutical companies, and since then, despite a collective research budget that eclipses the annual spend of the National Institutes of Health, new medicines are approved at comparative trickle.

That's all pretty much true, but it's put into a very different context by this graph, which plots the number of new drugs approved each year going back to 1940 (data courtesy of the Food and Drug Administration.) (...)

Dansk medisingigant trekker seg fra Hellas
dn.no 29.5.2010
Verdens største insulinprodusent, danske Novo Nordisk, trekker sine nyeste produkter fra apotekene i Hellas i protest mot den greske regjeringen.

Regjeringen i Aten har diktert at prisen på legemidler i Hellas skal reduseres med 25 prosent. Det vil ikke det danske selskapet gå med på.

– Vi beklager situasjonen overfor våre greske kunder, men både de og vi er tatt som gisler av den greske regjeringens feilslåtte økonomiske politikk, sier Lars Rebien Sørensen, konsernsjef i Novo Nordisk, til DR Nyheder.

Ifølge Sørensen vil selskapet gå med tap dersom det skulle fulgt beskjeden fra de greske politikerne.

Beslutningen vil ramme rundt 55.000 greske diabetikere som bruker Novo Nordisks medisin i dag, melder DR. (©NTB)

Glaxo is testing info sharing
online.wsj.com 26.5.2010
Drug maker uses open-source principles on long-guarded formulas to develop malaria drug

A decade ago, the Linux operating system helped spark a revolution in how software is developed. A move by GlaxoSmithKline PLC could test how well similar open-source principles work for developing new drugs.

The pharmaceutical giant last week opened to the public the designs behind 13,500 chemical compounds that it said may be capable of inhibiting the parasite that causes malaria.

Glaxo and others hope that sharing information and working together will lead scientists to come up with a drug for treating the mosquito-borne disease faster than the company could on its own. Other researchers "may look at these structures in quite a different way and see something that we don't," said Nick Cammack, head of Glaxo's Medicines Development Campus in Spain. (...)

Glaxo says that it won't seek patents on any malaria drug that the compounds yield, and hopes other researchers will also donate their intellectual property to a patent pool for so-called neglected diseases like malaria. If the Glaxo compounds are used to develop a drug for other types of diseases, then the company "would consider" the intellectual property issues, a Glaxo spokeswoman said. (...)

Grænser for hvor meget medicinalindustrien kan presses
business.dk 24.3.2010
Medicinalindustrien fylder så meget herhjemme, at der er grænser for, hvor meget politikerne vil presse industrien for at spare den sidste femøre, siger en af landets førende sundhedsøkonomer. (...)

I Danmark er medicinalindustrien forholdsvis stor og har stor samfundsmæssig betydning. Derfor er der en øvre grænse for, hvor meget vi vil genere industrien. Der er grænser for, hvor meget man vil gøre for at hente den sidste femøre,” siger Jakob Kjellberg.

Og når politikerne alligevel forsøger at gribe ind, så står industrien klar med en massiv lobbyindsats. Det er sidste års forsøg fra regionernes side på at få indført referencepriser efter netop norsk model et eksempel på. (...)

Han mener også, at det er forkert, når industrien fremstiller det som om, at priserne på de dyre kræft- og gigtlægemidler ligger fast og ikke kan forhandles.
”Selvfølgelig kan man forhandle en pris, også på medicin,” siger Jakob Kjellberg. (...)

US drug manufacturers will have to disclose payments to doctors (Amerikanske produsenter må offentliggjøre betalinger til leger)
BMJ 2010;340:c1648 (23 March)
Nye regler som tvinger legemiddel- og utstyrsprodusenter til å offentliggjøre utbetalinger til leger blir lov i USA etter en historisk reform av helsevesenet som passerte Representantenes hus denne helgen (BMJ 2010;340:c1635, 22 Mar, doi:10.1136/bmj.c1635). (New rules forcing drug and device manufacturers to disclose all payments to doctors look set to become law in the United States, after the historic healthcare reform bill was passed by the House of Representatives this weekend (BMJ 2010;340:c1635, 22 Mar, doi:10.1136/bmj.c1635.)

"Sunshine Act" ble først foreslått som et separat lovinngrep for tre år siden, men dets vilkår ble innlemmet i et mer omfattende lovforslag, som nå er nær ved å bli vedtatt, i den nye loven må alle produsenter av legemidler, utstyr og biologiske produkter gi staten detaljerte opplysninger om alle utbetalinger til leger og utdannelsessykehus, som så vil bli offentliggjort. (The "Sunshine Act" was first proposed as standalone legislation three years ago, but its provisions were incorporated into the wider reform bill now close to being signed into law. Under the new law all manufacturers of drugs, devices, and biologicals will have to provide details to the government of all payments they make to doctors and teaching hospitals, which will then be made publicly available.)

Navnene på leger som mottar og hvor mye de mottar må gjøres tilgjengelig på et søkbart nettsted i et "klart og forståelig" format som lett kan lastes ned. (The names of receiving doctors and how much they received will have to be made accessible on a searchable website in a "clear and understandable" format that can be easily downloaded.)

Under de nye reglene må firmaer offentliggjøre konsulentvederlag, honorarer, gaver, underholdning, mat, reiser, utdannelse, forskning, honorarer for foredrag, og stipender. Utbetalinger på mindre enn 10 dollar (£7; €7.4) vil være fritatt, men straks en lege samlet fra et firma mottar mer enn 100 dollar i et gitt år må alle utbetalinger offentliggjøres. I tillegg må detaljer for alle direkte investeringer i firmaet, inklusive aksjeposter, som gjelder leger eller deres familier, offentliggjøres. (Under the new rules companies will have to disclose consulting fees, honorariums, gifts, entertainment, food, travel, education, research, speaking fees, and grants. Payments of less than $10 (£7; 7.4) will be exempted, but once a doctor receives more than $100 in total in any given year from one company, all payments will have to be disclosed. In addition, the details of any direct investments in the company, including shareholdings, by doctors or their families will have to be made public.)

Dersom et firma kjenner til utbetalinger eller investeringer og forsettlig lar være å rapportere dette kan de straffes med bøter på opptil én million dollar. (...) (If a company is aware of any payments or investments and knowingly fails to report them it will liable for penalties up to $1m.)

Medicinalfirmaer kaster sig over sociale medier
business.dk 22.3.2010
Står det til verdens største medicinalkoncern, amerikanske Pfizer, er en fremtid, hvor en stor del af markedsføringen foregår via sociale medier, lige om hjørnet. Vi skal være der, hvor patienterne og lægerne er, siger koncernens øverste medicinske direktør. Herhjemme har Lundbeck drevet debatforum på nettet i ni år, mens Novo Nordisk stadig er forbeholden.

Har du overvejet at være Facebook-ven med et medicinalselskab, deltage i en indsamling til behandling af sjældne sygdomme arrangeret af den danske medicinalkoncern Lundbeck på Twitter, eller se en video om hvor godt den nyeste astmamedicin virker på YouTube?

Eller hvad med at deltage i et socialt netværk på nettet, som skal bringe patienter og de læger, der lave medicinforsøg, tættere sammen, sponsoreret af verdens største medicinalkoncern Pfizer. (...)

Senator asks drugmakers to explain prices
reuters.com 17.3.2010
(Reuters) - A Senate Democrat asked top drugmakers on Wednesday to explain why Americans pay higher prices for prescription drugs than patients do in other developed nations. (...)

Prescription-drug heists on the rise
forbes.com 17.3.2010
WASHINGTON -- The $75 million heist at a pharmaceutical warehouse in Connecticut this week was just the most audacious example of a growing phenomenon: Thieves are stealing large quantities of prescription drugs for resale on the black market.

Pharmaceutical heists in the U.S. have quadrupled since 2006, a coalition of industry and law enforcement estimates. And experts say the reasons include spotty security and high drug prices that can make such thefts extremely lucrative. (...)

Drug Giants Lag Where Sales Boom, Study Says
nytimes.com 17.3.2010
The leading drug makers need to move quickly to adapt to a new world order in which some emerging markets are set to overtake some established national markets in pharmaceutical sales, according to a report issued Tuesday. (...)

Will GlaxoSmithKline's Blood Money Go Unpunished?
seekingalpha.com 22.2.2010
In the 1970s, economist Milton Friedman penned an opinion piece in The New York Times Magazine that discussed his view on corporations' social responsibilities. Friedman's take on corporate social responsibility was summed up in his famous quote - "There is one and only one social responsibility of business - to use its resources and engage in activities designed to increase its profits so long as it stays within the rules of the game, which is to say, engages in open and free competition without deception or fraud." If the recent years have demonstrated anything, it's that without strong regulations, empowered enforcers, and lawmakers providing legitimate public service as opposed to lining their own pockets and shilling for large companies, corporations will freely and enthusiastically engage in competition utilizing deception and fraud in order to drive profits. (...)

Glaxo leads FTSE fallers after US Senate's warning
forbes.com 22.2.2010 (Associated Press)
LONDON -- Shares in GlaxoSmithKline PLC topped the list of fallers on Britain's FTSE 100 index of leading shares Monday after a U.S. Senate report said the drug maker knew of possible heart attack risks tied to Avandia, its blockbuster diabetes medication, years before such evidence became public. (...)

Läkemedelsindustrin slår sig ihop med mobilutvecklare
lakemedelsvarlden.se 11.2.2010
För att få patienter att bli mer följsamma håller flera läkemedelsföretag nu på att utveckla olika mobillösningar tillsammans med spel- och dataföretag. De företag som lyckas har mycket att vinna på den framtida läkemedelsmarknaden konstaterar Ernst & Young i en rapport.

Exemplen på att läkemedelsföretagen satsar på nya tekniklösningar för att öka följsamheten är många, rapporterar Reuters. Till exempel håller Bayer på att koppla ihop sin glukosmätare för barn med diabetes till Nintendos spelkonsoler för att få dem att mäta sitt blodsocker oftare. Johnson & Johnson’s har tagit fram en iPhone-applikation med liknande syfte. Novartis har tagit det hela ytterligare ett steg och tecknade förra månaden ett avtal med företaget Proteus Biomedical för att ta fram ett ”smart piller”. Tanken är att det smarta pillret ska kunna rapportera data från insidan av kroppen för att övervaka att patienterna tagit sina läkemedel enligt plan. (...)

Killing research no certain cure for Big Pharma
reuters.com 6.2.2010
LONDON (Reuters) - The axe is swinging in research labs once hailed as the life blood of the drug industry, as companies conclude they are not getting enough bang for their buck.

AstraZeneca, GlaxoSmithKline and Pfizer, have all taken a knife to research and development in the past week, ditching drug discovery work that does not pay its way.

France's Sanofi-Aventis, which wraps up the pharmaceutical reporting season on February 10, is another strong candidate for new research cutbacks, analysts believe. (...)

Drug companies should target drug plans, rather than physicians, consultant says
CMAJ 2010;182 (1) (January 12)
Pharmaceutical companies should increasingly focus their attention on payers, such as public and private drug plans, rather than physicians, says Paul Crotty, general manager of IMS Health Canada Ltd.

"What amazes me is the lack of connection between Big Pharma and the payers," Crotty told the seventh annual Canadian meeting of the Drug Information Association in Ottawa, Ontario on Nov. 3.

"Over time, the role of the doctor in deciding what prescriptions get written has eroded," said Crotty, head of the Canadian branch of a global consulting company that provides market research and intelligence to the pharmaceutical and health care industries. (...)

Misstanke om prishöjning inför amerikansk sjukvårdsreform
lakemedelsvarlden.se 19.11.2009
Demokratiska representanter från det amerikanska representanthuset vill utreda om läkemedelsföretagen är i färd med att smyghöja priserna inför en eventuell sjukvårdsreform. De kräver att höjningarna jämförs med konsumentprisindex. (...)

The US Pharmaceutical Market Outlook To 2014: Market trends, leading players and forecasts
globalmarketsdirect.com (Published: Jun-2009)
(...) The US pharmaceutical market recorded sales of $279bn in 2007, a 3.9% increase over 2006. The top 10 brands of the US market represented 14.4% of total market value in 2007. (...)

Politisk reality
aftenposten.no 4.11.2009
(...) Innholdet i Karita Bekkemellems selvbiografi Mitt røde hjerte tør være kjent for de fleste etter store nyhetsoppslag i forrige uke. (...)

«Sakene er alltid det viktigste,» skriver hun. Samtidig ønsker hun «å gi et innblikk i politiske prosesser.» Egentlig fremstår dette som en falsk motsetning i boken. Man får inntrykk at spillet er selve saken, og at det viktigste, også i rikspolitikken, etter hvert er Karita Bekkemellem selv. Når hun blir kvotert ut av Regjeringen til fordel for en innvandrer, beskriver hun det som et overgrep, trass i at hun selv er tilhenger av kvotering. (...)

Tilsvarende flytende er grensen mellom politikk og næringsliv. Direktørstillingen i legemiddelindustriforeningen beskriver hun som et slags humanitært oppdrag, uten å nevne kontroversielle aspekter ved industrien. Bekkemellems enestående evner til å selge budskap på TV, henger kanskje sammen med at hun ser seg selv som de svakes beskytter også i sammenhenger der hun representerer ganske andre interesser. (...)

Vaksineprodusent med knalltall
e24.no 28.10.2009
Det britiske legemiddelkonsernet GlaxoSmithKline kan vise til sterke resultater i tredje kvartal.

Selskapet lager både vaksine og medisin mot svineinfluensa.

Konsernets overskudd er på over 19 milliarder kroner før skatt i tredje kvartal.
Verden hamstrer H1N1-vaksiner og influensamedisin, noe som har gitt enorme inntekter for legemiddelbransjen. GlaxoSmithKline lager vaksinen Pandemrix og influensamedisinen Relenza.

GSK ser for seg videre forbedring av resultatet og bra salg også i fjerde kvartal på grunn av etterspørselen etter influensamedisin og – vaksine.

– Resultatet vårt i tredje kvartal styrker forventningen vår om et bedret resultat i GSK i andre halvdel av 2009, sier GSK-sjef Andrew Witty. (...)

The Pharmaceutical Industrial Complex: A Deadly Fairy Tale
globalresearch.ca 21.10.2009
It has been a particularly bad month for the pharmaceutical industrial complex in its ongoing litigations in American courts. Among the main pharmaceutical headlines, Merck’s Gardasil vaccine for HPV, now being widely administered to pre-teens, was found to be linked to amyltrophic lateral sclerosis, commonly known as Lou Gehrig’s disease; following a $1.4 billion fine in promoting one of its blockbuster drugs Zyprexa off-label, deceptive correspondence was uncovered by Eli Lilly gaming the system again by promoting another one of its drugs, Cymbalta, off-label for fibromyalgia; AstraZeneca was fined $160 million for scamming the Medicaid system in Kentucky after being fined $215 million for ripping off Alabama; Glaxo lost a Pennsylvania trial for failing to warn doctors and pregnant women of the dangers of its antidepressant drug Paxil related to birth defects; and Pfizer scored a record-breaking fine of $2.3 billion for illegally marketing several drugs over the years: Bextra, Zyvox, Geodon and Lyrica. These kinds of charges, among the many others, have become a habit for drug makers for the past dozen years. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Little Turnaround For Big Pharma?
forbes.com 14.10.2009
Drug stocks have sat out the rally so far, but with bargain basement valuations, that may be about to change.

The $773 billion pharmaceutical industry is about to lose some of its best-known brands to patent expirations, lay off thousands of people and is spending more research money to invent fewer drugs than ever before. (...)

The Big Government-Big Pharma Complex: Disease Mongering for Fear and Profit (Big Government-Big Pharma komplekset: Sykdomssalg for frykt og profitt)
by Karen De Coster
lewrockwell.com 10.10.2009
Ronit Ridberg has given the world a marvelous look into the fraudulent, Big Government-Big Pharma complex with his documentary film, Big Bucks, Big Pharma: Marketing Disease and Pushing Drugs. It's a bit dated, from 2006, but certainly, that is no hindrance to the message of the film. It's an hour long, but worth every minute of your time. Below, I have compiled a list of some interesting points from the film. I have also included a lot of my own thoughts from my research on issues brought up in the film, so not all of the material I have presented is contained within the documentary.

Big Pharma is a monster that’s long been out of control, and that is due to its chief enabler, big government, whose bureaucrats profit immensely from promoting Big Pharma’s agenda to grow and protect its profits. In spite of what Michael Moore would say, this arrangement is not capitalism, or as he means it, the free market. It is state capitalism, or, as some may call it, socialist corporatism. (...)

Leger uten grenser: - Karita kan forandre verden
vg.no 2.10.2009
(VG Nett) - Få legemiddelselskapene med på et frivillig patentsamarbeid som sikrer at færre dør, oppfordrer Leger uten grenser i en e-postkampanje rettet mot Karita Bekkemellem. (...)

- Av de viktigste medisinene, er 95 prosent gått av patent. Det forskes stadig på å finne medisiner mot HIV/Aids, og jeg regner med at Leger uten grenser vet hvor lang tid det tar å forske fram nye legemidler, sier Karita Bekkemellem og understreker at legemiddelindustrien er nødt til å tjene penger på å forske fram bedre medisiner.

- Hvis Leger uten grenser mener patenter er hovedproblemet, er det helt feil. De som står for utviklingen av viktige legemidler er en komersiell bransje som er nødt til å tjene penger, sier Bekkemellem til VG Nett. (...)

Hun frykter en nedtrapping av forskningen om ikke bransjen får ha visse rammebetingelser. (...)

Per Olav Kormeset og Margrethe Lied slutter i LMI
lmi.no 24.9.2009
Legemiddelbransjen er inne i en utfordrende tid, der vi ser kostnadskutt, omstrukturering og nedbemanninger i en rekke av LMIs medlemsfirmaer. Det er naturlig at dette også får konsekvenser for LMI. Styret og administrerende direktør har derfor kommet frem til at det skal foretas en nedbemanning i LMIs administrasjon. På den bakgrunn er det inngått avtale om avslutning av arbeidsforholdet for Per Olav Kormeset og Margrethe Lied. (...)

Federal Court Grants Public Access to Evidence that Drug Company
'Ghostwrote' Medical Articles About Deadly Hormone Therapy Drug
publicjustice.net 24.9.2009 (News release)
(...) The evidence has been under seal in an ongoing federal lawsuit filed on behalf of victims of Prempro. Public Justice, a national public interest law firm headquartered in Washington D.C., sought access to the evidence on behalf of PLoS Medicine, a medical journal published by the nonprofit Public Library of Science (PLOS). Along with the New York Times, PLOS had moved to
interevene in the case to unseal the ghostwriting documents because the public has powerful interest in knowing the truth about the drug companies' conduct and the safety of their drugs.

"We are thrilled by the Court’s decision to stop Wyeth’s attempt to hide evidence of its ghostwriting,” said Amy Radon, Public Justice's lead attorney for PLoS Medicine. "Public health and safety is put at serious risk when a drug company fails to reveal its role in authoring a medical journal article touting its own product." (...)

Drug industry must be regulated more tightly in recession, says think tank (Legemiddelindustri må reguleres strammere i nedgangstider, ifølge tenketank)
BMJ 2009;339:b3597 (3 September)
Tighter curbs are needed on the influence of the UK drug industry on doctors and patient groups, particularly during a recession, says a report from the left wing think tank Compass.

With fewer opportunities to make profits from existing bestselling drugs, many of which come off patent between now and 2011, companies are likely to "squeeze more from less" through increasingly dubious methods, say the authors.

Drug companies exert too much influence over prescribing practice, which can unnecessarily raise costs for the NHS and raise risks for patients, they say, pointing out that the drug industry spends £1.65bn (€ 1.88bn; $2.68bn) on postgraduate education for doctors—more than 300 times as much as the Department of Health, which invests nearly £4.95m in postgraduate medical education. (...)

A Bitter Pill to Swallow is at www.compassonline.org.uk. (...)

NEJM & BMJ editors to challenge pharma conducting its own clinical trials
pharmatimes.com 27.8.2009
The pharmaceutical industry faces an ethical dilemma when it conducts trials on its own drugs, Dr Jeffrey Drazen Editor in Chief of the New England Journal of Medicine and Dr Fiona Godlee, Editor in Chief of British Medical Journal, will argue in the world famous debating chamber at Oxford Union this month alongside Guardian Bad Science columnist Ben Goldacre.

Clinical trials are central to the success of the industry, providing the bedrock of evidence for a medicine’s use. Typically, these studies are conducted and paid for by pharma: in other words, the medicines developed by industry are tested by the industry.

But is this a conflict of interest? Is it acceptable for industry to pay for and run clinical trials of its own medicines – either for the purposes of registration or subsequent use?

Arguing in industry’s favour at the PharmaTimes’ Great Oxford Debate will be Robert Ruffolo, former R&D President of Research at Wyeth, Scott Gottlieb, former FDA senior official and a frequentWall Street Journal columnist, and Vincent Lawton, ex-Managing Director of MSD and President of the Association of the British Pharmaceutical Industry. (...)

Årsaker til globalisering av klinisk forskning
O Flaten
Tidsskr Nor Legeforen 2009; 129:1660-1 (27.8.2009)
Det er viktig å diskutere etiske problemer ved globaliseringen av klinisk forskning, slik det ble gjort i en kommentar i Tidsskriftet nr. 9/2009 (1) som hovedsakelig refererte en artikkel i New England Journal of Medicine (2). Det er et faktum at en større og større del av den kliniske legemiddelforskningen utføres i Russland (og andre tidligere sovjetstater), India, Kina, Latin-Amerika og Det fjerne østen, de såkalte nye markedene («emerging markets»). (...)

European Commission takes on Big Pharma
The Lancet 2009;374(9690):599-600 (22 August)
For more than a year, European Commissioner Neelie Kroes (taking action against business practices that restrict competition in the European Union) has awaited the conclusion of an investigation of the antitrust behaviour of large multinational drug companies. ¹ This thorough investigation paints an alarming picture of how the large multinationals bar generic producers from entering the market.

The investigation presents a dilemma for the European Commission: how can it create an ideal business env (...)

Why Pharma Wants ObamaCare
forbes.com 20.8.2009
There are reasons it could be good for drug companies--and they're not what you think. (...)

Obama endangering developing countries' access to affordable drugs, activists charge
latimes.com 19.8.2009
The administration may be reluctant to confront pharmaceutical firms during the healthcare debate, critics say. 'We had high hopes for change' after Bush, an Oxfam official says. (...)

Stephen Foley: ObamaCare is bad news for Big Pharma
independent.co.uk/ 15.8.2009
(...) I still can't quite get my head around the idea we have to weigh our health against our wallets in this country, but this is the system that opponents of change say is the best in the world, despite all statistical evidence to the contrary. (...)

It is certainly the best system in the world for the healthcare companies, whose margins in the US are fatter than they are anywhere else. Two of the UK's biggest firms, the pharmaceuticals companies GlaxoSmithKline and AstraZeneca, get around 40 per cent of their revenues from the US, making them critical players in the debate here – and meaning that the outcome of Barack Obama's fight for reform has some significant financial implications for UK shareholders. (...)

New, but Not Improved? Incorporating Comparative-Effectiveness Information into FDA Labeling
healthcarereform.nejm.org August 12th
New technologies, including prescription drugs and medical devices, are a major driver of increases in U.S. health care expenditures, which have grown by an estimated 71% since 2000.1 The U.S. market for drugs and devices is regulated by the Food and Drug Administration (FDA), which scrutinizes clinical trial data for evidence of safety and efficacy. Although the FDA has been criticized for missteps and inefficiencies in its approval process, these are not the causes of increasing health care expenditures. More relevant is FDA oversight of the labeling and promotion of medical products. (...)

Influensan bingo för vaccinjättar
svd.se 21.7.2009
Svininfluensan skapar rädsla men för vaccinindustrin ger den miljardintäkter. Tre europeiska läkemedelsjättar dominerar vaccinmarknaden som förra året omsatte 185 miljarder kronor.

Svininfluensan betyder mångmiljardintäkter för den internationella vaccinindustrin. Medan världen oroas över sjukdomens spridning kan vaccinjättarna räkna med kraftiga försäljningsökningar. I Sverige kom nyligen priset för vaccinet från brittiska Glaxo Smithkline som en chock för landstingen. (...)

För de tre bolagen – brittiska Glaxo Smithkline, schweiziska Novartis och franska Sanofi-Aventis – innebär spridningen av svininfluensan enorma affärsmöjligheter. Även amerikanska Baxter är en viktig aktör. (...)

Men när notan kom blev det en chock, enligt Göran Stiernstedt som är chef för vård och omsorg på Sveriges Kommuner och Landsting.

–Ett vanligt influensavaccin kostar 35 kronor per dos. Den här gången tar de 65 kronor per dos. Den prisökningen kom som en kalldusch för oss. Totalt blir det 1,3 miljarder kronor, säger Göran Stiernstedt och medger att landstingen borde ha varit mer uppmärksamma på priset vid ordertillfället. (...)

Drug Firms See Poorer Nations as Sales Cure (Legemiddelfirmaer ser fattige land som en mulighet for å opprettholde salget)
online.wsj.com 7.7.2009
(...) It was business as usual for Mr. Rodriguez. As a representative in Venezuela for U.S. pharmaceutical giant Pfizer Inc., his sales route takes him through one of Latin America's most dangerous neighborhoods. To avoid attracting attention, he wears a polo shirt with a red logo, the color worn by supporters of President Hugo Chávez.

Mr. Rodriguez is part of a strategic shift in the $770 billion pharmaceutical industry to target the working poor in the developing world.

For the first time in a half-century, sales of prescription drugs are forecast to decline this year in the U.S., historically the industry's biggest and most profitable market. The Obama administration and Congress's attempt to pass legislation overhauling the health-care system, including provisions that could lower the cost of medicine, could put drug makers' U.S. businesses under further pressure.

As a result, developing countries like Venezuela have begun to look more attractive to the industry. Sales of prescription drugs in emerging markets reached $152.7 billion in 2008, up from $67.2 billion in 2003, according to IMS Health, which tracks the industry. IMS forecasts sales will climb to $265 billion by 2013. (...)

Congress’ $1.2 Million a Day Drug Habit - and Pharma’s Phony ‘Gift’ to Health Care Reform
ampedstatus.com 1.7.2009
Big Pharma’s PR Ploy: Is the industry’s contribution to health care reform just a scheme to keep us overspending on prescription meds?

Big Pharma pulled off a first-class PR coup last week with its widely celebrated pledge to support health care reform by offering up a package of discounts they claim will run to $80 billion over the next ten years. The highlight of the package, said to be worth about $30 billion, is a 50 percent discount offered to old and disabled people who fall into the “donut hole,” the notorious coverage gap in the Medicare Part D prescription drug benefit, which leaves some of us paying as much as $3,000 out of pocket for our meds. (...)

The Real Reason Big Pharma Mergers Are Wise
Leadership
forbes.com 26.6.2009
The giants of the pharmaceutical industry may have found their salvation in the wave of consolidation that's changing the face of the industry. But not for the reasons that have been used to justify Pfizer's acquisition of Wyeth, Merck's purchase of Schering-Plough and Genentech's deal with Roche.

The acquirers have hoped those big-ticket transactions will fill gaps in their research-and-development pipelines and buy them time to develop new products. That's important because of the looming "patent cliff," as blockbuster drugs lose their patent protection faster than new ones can emerge. But none of those deals cure the companies' basic innovation problem. (...)

Vetenskaplig rådgivning tillsammans med TLV
lakemedelsverket.se 4.6.2009
Nu erbjuds läkemedelsindustrin gemensam vetenskaplig rådgivning från Läkemedelsverket och Tandvårds- och Läkemedelsförmånsverket. Detta är ett pilotprojekt som löper året ut. Läkemedelsverket (LV) och Tandvårds- och Läkemedelsförmånsverket (TLV) har fått förfrågningar från läkemedelsindustrin angående möjligheten att anordna gemensamma vetenskapliga rådgivningsmöten. Mot den bakgrunden påbörjas nu ett pilotprojekt som löper under perioden 1 september 2009 – 31 december 2009, innefattande rådgivningsmöten där båda myndigheterna kommer att vara representerade. (...)

Pillepusher rømmer landet
na24.no 14.5.2009
Legegigant legger ned i Norge. Kun selgerne beholder jobben.

Det er store endringer på gang i legemiddelselskapet AstraZeneca. Det svensk-britiske selskapet kutter alle «kontorstillinger» i Norge, og beholder kun kundebehandlerne og salgsfunksjonen. (...)

Globalisering av klinisk forskning – etiske spørsmål
O Riska
Tidsskr Nor Legeforen 2009; 129:902 (30.4.2009)
Mer og mer klinisk forskning foregår i global skala. Mye amerikansk forskning utføres i andre land, ofte utviklingsland. En grunn til dette er de sterkt reduserte kostnadene ved å utføre fase 2- og 3-studier i f.eks. India eller Sør-Amerika – det kan koste mindre enn en tiendedel sammenliknet med USA. En artikkel i New England Journal of Medicine reiser spørsmål ved de etiske og vitenskapelige konsekvensene av denne trenden, når resultatene brukes til å godkjenne medikamenter for bruk i USA (1). (...)

Mere og bedre information om lægemidler
lifdk.dk 20.3.2009 (Lægemiddelindustriforeningen (Lif))
Hvis det går, som EU-Kommissionen med et nyt forslag lægger op til, får lægemiddelvirksomheder lov til i større omfang at informere borgere og patienter om receptpligtige lægemidler. Det har hidtil været muligt i nogle EU-lande, men ikke i Danmark. Lif bakker op om forslaget og glæder sig over, at der ikke er udsigt til amerikanske tilstande, hvor tv, radio og aviser må bruges til reklamefremstød for lægemidler.

»Alle patienter har krav på let adgang til saglig, nøgtern og velkvalificeret information om deres sygdom og behandlingsmuligheder.« Det mener viceadm. direktør i Lif Henrik Vestergaard, der derfor bakker op om et nyt forslag fra EU-Kommissionen, der skal sikre, at alle EU-borgere får adgang til det samme niveau af information om sundhed og receptpligtig medicin. Hidtil har manglende EU-harmonisering af patientinformation medført forskellige nationale regler og ulige adgang til information blandt EU-borgerne. (...)

Seroxat and the suppression of clinical trial data: regulatory failure and the uses of legal ambiguity
J. Med. Ethics 2009;35;107-112 (14 February)
ABSTRACT
This article critically evaluates the Medicines and Healthcare products Regulatory Agency’s announcement, in March 2008, that GlaxoSmithKline would not face prosecution for deliberately withholding trial data, which revealed not only that Seroxat was ineffective at treating childhood depression but also that it increased the risk of suicidal behaviour in this patient group. The decision not
to prosecute followed a four and a half year investigation and was taken on the grounds that the law at the relevant time was insufficiently clear. This article assesses the existence of significant gaps in the duty of candour which had been assumed to exist between drugs companies and the regulator, and reflects upon what this episode tells us about the robustness, or otherwise, of the UK’s regulation of medicines. (...)

Pfizer pulls plug on two Ph III drugs
in-pharmatechnologist.com 25.2.2009
Pfizer’s primary care business unit has dropped two Phase III candidates, further reducing the drug giant’s product pipeline and raising more questions about its R&D decisions.

The firm said that that the compounds in question, esreboxetine for fibromyalgia and PD332334 for generalised anxiety disorder (GAD), had been abandoned after a review of existing clinical data.

Company spokeswoman Kristen Neese told in-PharmaTechnologist that the latest decision reflects both current market dynamics and the expectation that the dropped candidates would not have offered significant medical benefits over available products.

Neese went on to say that drugs currently in development for other indications would provide a better return for Pfizer’s clinical investment and added that the firm is “still on track to have between 24 and 29 candidates in Phase III development by the end of 2009.” (...)

(Anm: reboxetine (Edronax) (felleskatalogen.no).)

GSK promises to cap price of its drugs in poorest countries
BMJ 2009;338:b686 (18 February)
GlaxoSmithKline, the United Kingdom based pharmaceutical group, has unveiled a series of policies to boost access to its drugs in poorer and richer countries alike (www.gsk.com/media/Witty-Harvard-Speech-Summary.pdf).

In a speech at Harvard Medical School last week, Andrew Witty laid out his approach for the first time since taking over as the company’s chief executive last spring, saying: "Society expects us to do more . . . To be frank, I agree. We have the capacity to do more and we can do more." (...)

Billigere medicin er politik
business.dk 17.2.2009
Den britiske medicinalkoncern Glaxo Smith Kline har vakt opsigt med et løfte om at skære medicinpriserne ned med 75 pct. i de fattigste lande i verden. Men det er mere end en politisk udmelding end en reel hjælp til de fattigste, lyder kritikken. (...)

»Der er positive signaler i udmeldingerne fra Glaxo Smith Kline, men langt hen ad vejen er der tale om politik. Skal adgangen til medicin i de fattige lande virkelig udvides, må medicinalindustrien tage et meget større skridt,« siger Michelle Childs, leder for Læger Uden Grænsers internationale kampagne for øget adgang til medicin, til Berlingske Business.

Samme holdning har Mikkel Wakefield, der er salgsdirektør i danske MissionPharma, som specialiserer sig i at sælge kopimedicin til de fattigste lande.

»Det lyder flot, men er ren politik. For dem handler det om deres offentlige image. De store medicinalkoncerner er ikke særlig velsete i de fattige lande på grund af patenter og høje priser,« siger Mikkel Wakefield. (...)

Billig fornøjelse
Prisnedsættelserne og investeringerne i infrastruktur kommer da heller ikke til at koste Glaxo Smith Kline de store beløb. Det erkender Andrew Witty selv ifølge Wall Street Journal. I dag omsætter Glaxo Smith Kline for i cirka 250 millioner kr. i de 50 fattigste lande i verden. 20 pct. af overskuddet på salget i disse lande vil udgøre et sted mellem otte og 16 millioner kr. (...)

Some drug companies are facing heat
chron.com 15.2.2009
At one time, used-car salesmen were down near the bottom of the ladder of respect and reputation. But now that automobile sales are scraping bottom, people are actually feeling sorry for the poor guys.

Bankers and Wall Street power brokers have taken their place on the scum scale. But despite all the abuses — the bad judgment and the big bonuses — there has been relatively little illegal activity revealed.

Pharmaceutical-industry bigwigs, on the other hand, have not gotten much public scrutiny. These executives have largely escaped criticism despite decisions that have been unethical at best and in many cases downright illegal. What’s worse, despite stiff fines, many drug companies are repeat offenders. (...)

People's Pharmacy: Medicines pay for medical breakthroughs
chron.com 18.1.2009
(...) When you look at last year’s crop of Food and Drug Administration drug approvals, there are few breakthroughs. A new antidepressant was approved called Pristiq. The generic name for this medicine is desvenlafaxine. If that sounds familiar, there’s a good reason. The generic name for the antidepressant Effexor, introduced in 1993, is venlafaxine. In other words, these drugs are chemically related.

The same company makes both Effexor and Pristiq. Why would Wyeth spend countless millions to develop a similar antidepressant? Effexor went off patent in 2006, and a long-acting version, Effexor XR, will lose its patent protection next year. (...)

Er blockbuster lægemidlernes tidsalder ved at være slut?
Af Jan Trøst Jørgensen, farmaceut, ph.d.
lifdk.dk 4.12.2008 (Lægemiddelindustriforeningen)
Fremtidens lægemiddelbehandling bliver mere individuel.

Et større antal blockbuster lægemidler vil miste deres patentetbeskyttelse i løbet af ganske få år, og da mange af de store pharmavirksomheder ikke har erstatninger i deres pipeline for disse storsælgende lægemidler, vil det få konsekvenser for indtjeningen blandt virksomhederne. Årsagen, til at mange pharmavirksomheder vil havne i den situation, er, at de ikke i tide har indset, at ”blockbuster tidsalderen” er ved at være et overstået kapitel. Deres forsatte fokusering på lægemidler med et salgspotentiale i multimilliard klassen har hæmmet deres kreativt inden for forskning og udvikling og dermed på sigt også deres indtjening. Der er ingen tvivl om, at fremtidens lægemiddelbehandling vil blive langt mere individualiseret end dem, vi i dag kender, og det er en udvikling, der vil sætte sig spor i hele kæden fra forskning og udvikling over markedsføring og frem til brugen af lægemidlerne i sundhedsvæsnet. (...)

Bekkemellem blir ny LMI-sjef
dagensmedisin.no 13.11.2008
Legemiddelindustriforeningen (LMI) ansetter Karita Bekkemellem som ny administrerende direktør.

– I Karita Bekkemellem får LMI en sterk leder med bred erfaring fra norsk samfunnsliv, sier styreleder Håvard Selby Ebbestad i Legemiddelindustriforeningen.

Den tidligere barne- og likestillingsministeren vil fullføre sin femte periode på Stortinget, og hun tiltrer i LMI i løpet av høsten 2009. (...)

Bekkemellem etterfølger Pål Christian Roland, som fratrådte som administrerende direktør tidligere i år.

LMI er en bransjeforening tilknyttet Norsk Industri og NHO. De 44 medlemsbedriftene i LMI sysselsetter nærmere 4300 ansatte i Norge, og representerte over 80 prosent av legemiddelomsetningen i 2007. (...)

Pharmaceutical Industry Spends More Than $13M on Ads 'Thanking' Lawmakers Who Supported SCHIP Legislation (Legemiddelindustrien bruker mer enn 13 millioner dollar på reklame som "takker" lovgiverne som støttet SCHIP-lovgivning)
kaisernetwork.org 24.10.2008
The pharmaceutical industry has paid $13.2 million for television advertisements that "thank" 28 federal lawmakers -- 25 of whom are Democrats -- who supported the 2007 SCHIP expansion legislation, the Wall Street Journal reports. The ad campaign is "an example of how interest groups are already adjusting to the prospect of stronger Democratic control of Congress in 2009," and of how "after years of donating overwhelmingly to Republicans, the pharmaceutical industry is now splitting campaign contributions between the political parties," according to the Journal. (...)

PhRMA Contributes $11.3M To SCHIP Advertising Campaign
kaisernetwork.org 22.9.2008
The Pharmaceutical Research and Manufacturers of America has contributed $11.3 million to the advocacy group America's Agenda: Health Care for Kids for advertisements supporting SCHIP expansion, CQ HealthBeat reports. The ads will appear in at least 25 lawmakers' states and congressional districts. The ads do not name SCHIP specifically but commend lawmakers who supported a bill (HR 3963) that would have expanded SCHIP. President Bush vetoed the bill, citing cost concerns (Jansen, CQ HealthBeat, 9/19). (...)

New Developments in Managing Physician-Industry Relationships
JAMA. 2008;300(9):1067-1069 (September 3)
Over the past 2 years, policies governing the relationship between physicians and pharmaceutical and device companies have undergone remarkable changes. A 2004 task force appointed by the American Board of Internal Medicine Foundation (ABIM) and the Institute on Medicine as a Profession (IMAP) found existing guidelines to be lax.¹ (...)

Holger Moe Tørisen går av som direktør i Felleskatalogen
lmi.no 27.8.2008
Ble tildelt Kongens fortjenestemedalje på avslutningsmarkeringen.

Tirsdag 26. august ble det holdt en avslutningsmarkering for Holger Moe Tørisen som etter 36 år som redaktør og direktør i Felleskatalogen nå går av med pensjon. Nestleder i LMIs styre, Unni Hjelmaas overrakte Kongens fortjenestemedalje i sølv som ble tildelt for hans store innsats innenfor legemiddelindustrien og farmasimiljøet i Norge. Foruten ansvaret for utviklingen av Felleskatalogen har Moe Tørisen også arbeidet med utvikling av bransjens selvjustisordninger og bygget opp utdanningsordningen for legemiddelkonsulenter. Han har også lagt ned et betydelig arbeid i dokumentering av farmasiens historie i Norge. (...)

Triple therapy
Face value
economist.com 14.8.2008 (From The Economist print edition)
Andrew Witty of GlaxoSmithKline has a three-part prescription for the pharmaceuticals giant (...)

His plan has three components. First, he wants to end the obsession with blockbusters, which he likens to “finding a needle in a haystack right when you need it”. The industry’s reliance on risky blockbusters, he reckons, makes it vulnerable to “sudden torpedoes” in the form of lawsuits from generics firms, or regulatory crackdowns like the one that recently hit Avandia, GSK’s big diabetes drug. Instead he wants researchers to look for many more potential drugs, both small and large, that can make up a more reliable pipeline. This, he reckons, will make GSK’s drug-discovery efforts more akin to a nimble fleet of destroyers, rather than two or three vulnerable battleships. (...)

Legemiddelindustrien forsker mindre
lmi.no 18.7.2008
Legemiddelindustrien investerer mindre i forskning på pasienter ved norske sykehus, skriver Dagens Næringsliv.

Legemiddelfirmaer i Norge investerte totalt 940 millioner kroner i forskning og utvikling i fjor. Dette er en nedgang på 12 prosent fra året førs, skriver Dagens Næringsliv (DN) i papirutgaven i dag. DN omtaler Legemiddelindustriforeningens (LMI’s) årlige FoU-undersøkelse, og har intervjuet både LMIs styreleder og adm. direktør i Pfizer, Håvard S. Ebbestad og lederen i LMIs FoU-utvalg og medisinsk direktør i Glaxo SmithKline, Olav Flaten. (...)

Olav Flaten påpeker at de norske helseforetakene mangler infrastruktur til å sette i gang kliniske forskningsprosjekter i regi av legemiddelindustrien. – Helseforetakene har ikke apparatet tilgjengelig. Dessverre hender det at det tar så lang tid å sette i gang en studie at toget har gått, sier Flaten til Dagens Næringsliv.

Statssekretær i Helse- og Omsorgsdepartementet, Svein Sundsbø, avviser kritikken fra LMI. – Det har aldri vært brukt så mye ressurser på klinisk forskning i sykehusene som i dag, sier han. Nasjonale målinger viser at dette gir resultater i form av økning i vitenskapelige publikasjoner og avlagte doktorgrader. (...)

The next Viagra
investorschronicle.co.uk 11.7.2008
Pharmaceutical companies are under siege from generic providers of drugs. They're also under the thumb of drug regulators and under pressure to develop best-selling wonder drugs. (...)

Most recently GlaxoSmithKline's anti-depressant treatment Seroxat has come under close scrutiny following complaints that it triggers suicidal feelings in some patients. The company is under fire from the Medicines and Healthcare products Regulatory Agency (MHRA) for failing to raise the public's awareness of these side-effects, of which it had evidence. (...)

Europe’s drug companies are better than those in US in making drugs accessible to poor countries
BMJ 2008;336:1396 (21 June)
Drug companies in Europe do more to make drugs available and affordable to the world’s poor countries than their counterparts in the United States or Japan, concludes a new type of assessment of company policies.
The Access to Medicines Index (www.atmindex.org), a Dutch foundation established by Wim Leereveld, a former marketing consultant to the drug industry, tries to strip away the public relations rhetoric to quantify and compare meaningful corporate contributions. (...)

Fixing Pharma
forbes.com 6.6.2008
Drug discovery is a cruel business. A hundred thousand people die every year because of adverse drug side effects. Millions die too young because drugs just aren't good enough. (...)

"The system is failing," says Gabriela Cezar, who left Pfizer to study stem cells at the University of Wisconsin-Madison.

It's a testament to the ingenuity of pharmaceutical researchers that the system works at all. Nine out of ten drugs studied in humans turn out not to work or to be too toxic. Sanofi-Aventis (nyse: SNY - news - people), Pfizer and AstraZeneca have all had promising compounds go up in flames because of dangerous side effects. One solution may be to use embryonic stem cells to test drugs for safety and efficacy. "You should be able to get rid of some of the nasty drugs before they even hit clinical trials," says uw-Madison stem cell pioneer James Thomson. "And we're able to do that today." (...)

Who Are The Most Influential People In Pharma?
pharmalot.com 22.5.2008
Depends who you ask, of course. But everyone seems to love a list and so the latest ranking from a trade magazine offers an interesting - some may say curious - mix of ceo’s, politicians, regulators, scientists, academics and trade group types. (...)

Who else scored? Carl Icahn shows up as 26th. Cass Wheeler of the American Heart Association finished at No. 36. Merck’s Dick Clark squeaked in at No. 38. Oh, we almost forgot - Pfizer’s Jeff Kindler is No. 11, no doubt because he influences so many unhappy investors. Here is the complete list and accompanying article. (...)

A painful prognosis for crisis-hit big drugmakers
thefinancialexpress-bd.com 11.5.2008
London: Some of the world's biggest pharmaceuticals companies, including GlaxoSmithKline and AstraZeneca, face their worst crisis in decades, as their future revenues come are under threat from shrinking drug pipelines, increased competition from generics and a slew of patent expires.

"For the first time in history, the industry will have negative growth in 2011," says Alexis de Rosnay, global co-head of healthcare at Lehman Brothers. This is a time-bomb the sector has known about for some time. (...)

Industry support for university research waning, ABPI warns
pharmatimes.com 30.4.2008
The Association of the British Pharmaceutical Industry (ABPI) has issued another warning about the threat to the UK’s research base in an uncertain regulatory climate and amid the growing challenge from Asian markets.

Last month a survey conducted by the ABPI with the Confederation of British Industry (CBI) revealed that 35% of the companies polled expected to cut their investment in research and development (R&D) over the next 12 months, while 46% said they would be conducting fewer clinical trials.

This time the focus is on the industry’s collaborative research links with UK universities. An ABPI survey of 11 UK-based member companies showed that in 2007 there were 606 collaborations between industry and UK universities involving PhD studentships, 9.1% fewer than the 667 collaborations seen in 2005 and 13.7% fewer than in 2003 (702). (...)

Big pharma to persist with external reliance
in-pharmatechnologist.com 3.3.2008
- Big pharma's thirst for external innovation is set to persist amidst the blockbuster drought.

Mergers, collaborative risk-sharing, joint ventures and other co-promotion arrangements between big pharmaceutical and life sciences companies are increasingly common and the trend is set to continue, according to a report from PricewaterhouseCoopers (PWC). (...)

Fas noll kan öka farten
lakemedelsvarlden.se 3.3.2008
En smärre revolution är på gång inom läkemedelsforskningen. En ny teknik som populärt kallas ”fas 0” har utvecklats för att snabbare kunna gå från djurförsök till test på människor. Nyckeln är att ge substanserna i mikrodoser som saknar farmakologisk effekt. (...)

Pharmaceutical outsourcing: people on the move
in-pharmatechnologist.com 19.2.2008
19-Feb-2008 - Shasun Chemicals, Patheon, Tepnel Research, ClinPhone and PharmEng have all had people on the move in the world of pharmaceutical outsourcing. (...)

Amerikanske pharma-selskaber på desperat opkøbsjagt
business.dk 14.1.2008
Antallet af nye lægemidler, der blev godkendt sidste år i USA, er det laveste siden 1983. En række af de store amerikanske medicinalselskaber er derfor på intens jagt efter nye produkter, og flere af dem har danske virksomheder i kikkerten.

De amerikanske myndigheder blåstemplede i 2007 kun 19 nye lægemidler, hvilket er det laveste antal i siden 1983. (...)

Rekordlavt antal nye lægemidler godkendt i USA
pharmadanmark.dk 9.1.2008
Medicinalvirksomhederne bruger pengene på udvikling af eksisterende lægemidler frem for udvikling af nye. Kun 19 nye lægemidler blev i 2007 godkendt i USA. (...)

Den amerikanske lægemiddelstyrelse, FDA, godkendte i 2007 19 nye lægemidler, hvilket er det laveste antal i 24 år. Årsagen er, at medicinalfirmaerne har koncentreret om at udvikle nye anvendelser af eksisterende produkter. Ifølge Kenneth I. Kaitin, der leder det farmaceutiske fakultet ved Tufts University Center i Boston, kan medicinalvirksomhedernes nye strategi gå ud over udviklingen af nye lægemidler, hvis pengene bruges til at forlænge eksisterende præparaters levetid.

Medicinalfirmaer som GlaxoSmithKline hævder, at FDA har hævet sine krav til godkendelser, men den påstand afviser FDA. (...)

Pfizer, Glaxo Drug Research Success Fails to Impress Investors
bloomberg.com 11.1.2008
Jan. 11 (Bloomberg) -- Pfizer Inc., GlaxoSmithKline Plc and Sanofi-Aventis SA are testing a record number of experimental drugs, and so far shareholders are unimpressed.

There are about 1,425 potential therapies in the drug industry's research pipeline, 50 percent more than a decade ago, according to Cowen & Co., the New York securities firm. The treatments, for diabetes, cancer and brain disorders, may help offset an industrywide revenue decline commencing in 2011, when drugs generating $150 billion annually face generic competition. (...)

Drug Companies Look to Niche Treatments
forbes.com 30.12.2007
There is no quick remedy for what ails the pharmaceutical industry: a tougher environment for drug approvals and a dwindling pipeline of new medications.
But these twin challenges - evidence that the heyday of blockbuster drug-development is over - are forcing the industry to ponder big changes in the laboratory. The biggest, analysts say, is likely to be a shift toward finding treatments for patients with rare diseases, or unusual strains of common afflictions. (...)

UK Demands Documents From Drug Companies
forbes.com 30.12.2007
Britain's Serious Fraud Office has demanded documents from three major drug makers in connection with allegations the companies paid bribes to secure lucrative contracts in Iraq while Saddam Hussein was in power, the companies said.
GlaxoSmithKline (nyse: GSK - news - people) PLC, AstraZeneca PLC (nyse: AZN - news - people) and Eli Lilly and Co. (nyse: LLY - news - people) Ltd. - the British affiliate of Indianapolis, Indiana-based Eli Lilly and Co. - are all accused of violating the U.N.'s oil-for-food program, established in the mid-1990s to ease the impact on Iraqis of sanctions imposed on Saddam's regime after his 1990 invasion of Kuwait.

Under the program, money from Iraqi oil sales was to have been used for food and medicine.

All three companies have denied wrongdoing and said they were cooperating with the investigation. (...)

Klasseskille i medisinmarkedet
aftenposten.no 15.11.2007
Stadig flere medisiner blir bare tilgjengelige for de rike og velutdannede. Årsaken er at stadig flere medisiner fjernes fra blåreseptordningen og over på såkalt individuell refusjon. (...)

Klasseskille i medisinmarkedet
vg.no 15.11.2007
Stadig flere medisiner blir bare tilgjengelige for de rike og velutdannede. Årsaken er at stadig flere medisiner fjernes fra blåreseptordningen og over på såkalt individuell refusjon. (...)

Dårlig medisin
nrk.no 15.11.2007
Regjeringens politikk fører til større sosial ulikhet, viser ny forskning.

De fattige får de dårligste medisinene, og de med høy utdanning får de beste medisinene på markedet, viser ny forskning. (...)

- Regjeringen lurer seg selv
Stortinget har bestemt at det er et mål at folk får lettere tilgang til legemidler på blåresept.

Store pasientgrupper opplever at de blir tvunget over på dårligere og billigere medisin.

Individuell refusjon er innført for de som har astma og allergi, diabetes, høyt kolesterol og KOLS.

- Regjeringen lurer seg selv hvis den tror at den sparer penger på denne måten, sier Pål Christian Roland i Legemiddelindustriforeningen.

Han sier at regjeringens politikk ikke samsvarer med målsettingen om å reduserer sosial ulikhet og tilgang til helsetjenester. (...)

Medicinalgigant taber milliarder på fejlsatsning
politiken.dk 18.10.2007
Pfizers dropper sin storsatsning, inhalerbar insulin, der er et af de dyreste lægemidler på markedet. Firmaet mister 15 milliarder kroner.

Et af de dyreste lægemidler nogensinde bliver trukket tilbage fra markedet. (...)

Should we loosen the grip on drug companies?
BMJ 2007;335:454 (1 September)
It costs $40bn a year to produce just a handful of new drugs. Richard Smith reviews a highly publicised new book that claims over-regulation is holding the drug industry back. (...)

. The differences between him and Angell are probably driven by their different perspectives, and most doctors unsurprisingly will find themselves on the side of Angell. The biggest difference may be that Epstein seems to believe that almost all drugs, including me toos, have something important to offer, whereas doctors are unimpressed with many new drugs. (...)

The first problem that Epstein sees in the United States is that "overreactive conflict of interest regulations" have driven researchers in academia and the private sector apart, so reducing chances of cross-fertilisation. (...)

Such a system would, however, depend on a reliable flow of uncorrupted evidence, which may not be easy to achieve. (...)

Lighter regulation won't solve the problems of the drug industry, but anybody who wants to enter seriously into the debate around regulation of the drug industry should read this book. It will infuriate some, but I like to believe that rationality, paying close attention to argument and evidence rather than polemic and emotion, will best take us forward—and many others believe so as well. Unfortunately we're probably all wrong. (...)

Wyeth's Worries
forbes.com 13.8.2007
A pair of decisions from the Food and Drug Administration and a stopped clinical trial have left drug giant Wyeth without three of the biggest hopes for future growth. (...)

Drug Industry Sees Big Job Cuts
forbes.com 3.8.2007
When the traditional safe bet among the big pharmaceutical companies, giant Johnson & Johnson, starts the biggest restructuring in its 121-year history, it's clear things aren't rosy for the industry. (...)

Drugs, tales, and other stories
BMJ 2007;335:160 (21 July)
Ike Iheanacho, editor, Drug and Therapeutics Bulletin
Having produced a new treatment, drug companies take great care to avoid testing it too exhaustively in patients. (...)

In response, companies can say, correctly, they only do as they're told by medicines regulators, the real villains of the piece. The framework that governs licensing of new drugs is ultimately responsible for the lamentably low standards that allow companies to conduct studies that duck away from answering key clinical questions. (...)

Beyond the blockbuster
economist.com 28.6.2007
From The Economist print edition
Drugs firms are rethinking their business model (...)

Calls mount for rethink of "Big Pharma" model
By Ben Hirschler, European Pharmaceuticals Correspondent
reuters.co.uk 20.6.2007
LONDON (Reuters) - Is the "Big Pharma" model broken? An increasing number of people seem to think so.

Institutional investors with more than $1 trillion (500 billion pounds) of assets under management were the latest to call on drugmakers to offer better value to both customers and shareholders in a report on Tuesday. (...)

Big Pharma Disappoints Big Money
blogs.wsj.com 19.6.2007
Some of Big Pharma’s biggest honchos and some of the sector’s biggest investors had a sit-down recently to hash out the industry’s most pressing problems: unproductive research, penny-pinching payers and increasing demands to supply cheap drugs to poor patients.

Today the group publishes a report on the conversation called Pharma Futures: Prescription for Long-Term Value. The opinions of pension funds mangers, with $1.2 trillion of assets, were stark. The drug industry’s perceived value has dropped sharply from the late 1990s, when the market awarded drug companies a 40% premium over the net present value of their products. These days investors are giving the sector no premium above that same benchmark. (...)

GSK opens doors to 'world-leading' imaging centre in London
pharmatimes.com 14.6.2007
GlaxoSmithKline has joined forces with its former chairman Sir Richard Sykes and unveiled what will be a world-leading medical research imaging centre in west London. (...)

Drugs industry economics not sustainable' – report (Legemiddelindustriøkonomi ikke "bærekraftig" ifølge rapport)
business.guardian.co.uk 13.6.2007
The pharmaceutical industry business model is "economically unsustainable", according to a report by accountants PricewaterhouseCoopers. The study suggested drug companies' reliance on heavy marketing of a few drugs in the hope of huge sales meant they were "operationally incapable" of acting quickly enough to produce innovative treatments demanded by global markets.

According to Steve Arlington, the main author, drug companies spend twice as much on research and development than 10 years ago, yet produce half as many drugs: 40 to 45% of medicines in phase 3 clinical trials, the last stage, now failed.

Shares in pharmaceutical companies have not performed well, sales and marketing costs have increased, as have legal and regulatory constraints and the reputation of the industry has been tarnished by high-profile cases such as Vioxx, Merck's painkiller that has provoked thousands of lawsuits. (...)

GlaxoSmithKline Brings New Management To Chinese R&D Center
chinacsr.com 28.5.2007
GlaxoSmithKline has announced the appointment of Jingwu Zang to head a new GSK research and development center in Shanghai. (...)

Dr. Slaoui commented: "We are entering an exciting period of expansion for our R&D organization as it builds on the strength of the superb science now being conducted in China. We intend to be part of a future in which the phrase 'discovered in China' is heard as often as 'made in China' is heard today.

"Our initiative in China reflects our commitment to ally GSK with talented researchers wherever we can find them and to further encourage within R&D the contest of ideas needed to create new medicines. (...)

Syklet opp på Nordkapp-platået
dagbladet.no 26.5.2007
(Dagbladet.no): Åge Nærdal, administrerende direktør i GlaxoSmithKline Norge, fronter med glede Sykle til Jobben 2007; han hadde et lidenskapelig forhold til sin første sykkel og syklet for to år siden opp på Nordkapp-platået. (...)

Editorials Address Pharmaceutical Industry
kaisernetwork.org 14.5.2007
Daily Health Policy Report
Two newspapers recently published editorials related to prescription drugs. Summaries appear below. (...)

Pharmaceutical sector has big image problem, says survey
pharmatimes.com 13.4.2007
Pharma needs to restore its reputation with public and fast (...)

(...) If companies could raise awareness of their philanthropic actions, "they would undoubtedly make gains in countering negative feelings toward the sector," the report concludes. (...)

Drug makers set lobbying record
latimes.com 3.4.2007
A public interest group report distorts their role in Washington, pharmaceutical officials say, which is primarily educational and scientific.

WASHINGTON — Drug makers spent $155 million lobbying the federal government from 2005 to mid-2006, setting a record that they could top this year as Congress considers high stakes legislation for the industry and consumers, a public interest group said in a report Monday. (...)

Critic of big-drug industry speaks
commercialappeal.com 23.2.2007
Dr. Marcia Angell of Harvard Medical School was in Memphis on Thursday to continue her public criticism of big drug companies.

Angell, a former editor of the New England Journal of Medicine and author of the 2004 book, "The Truth About the Drug Companies: How They Deceive Us and What to Do About It," has accused drug firms of abuses including price-gouging and running biased clinical trials. (...)

Inside big pharma's box of tricks
BMJ 2007;334:209 (27 January)
The list of examples of big pharma's trickery seems endless (even though many of those employed in it are of the highest calibre and of unquestionable integrity). Indeed, it is as though, in the marketing arm of some drug companies, mischief is institutionalised. But much of this is recognised, and the adverse effects of drug companies could be countered by alert regulators, scientists, prescribers, and the medical press. All too often, however, these checks fail. There is even evidence that, in some cases, these counter-forces collude with industry and so compound its indiscretions. It is this area, the interplay between industry and some of the would-be counter-forces, that Panorama's "The Secrets of Seroxat" seeks to tackle. (...)

Billion dollar pills
economist.com 25.1.2007
Special report - Pharmaceuticals
An overhaul at Pfizer, the biggest and most conservative of drugs firms, shows what ails the industry (...)

Pfizer expected to announce more cuts
marketwatch.com 16.1.2007
BOSTON (MarketWatch) -- As part of its ongoing effort to contain costs, Pfizer is expected to announce deeper cuts to its workforce next Monday when it is scheduled to release its 2006 earnings and meet with industry analysts, according to Pfizer watchers. (...)

Pfizer's Strategy Takes Shape
wsj.com (15.1.2007)
Europe Sales Team May Be Cut Deeply;
Reorganizing R&D
As new Pfizer Inc. chief Jeffrey B. Kindler prepares to give the first details on his strategic vision for the company, his plan is likely to involve shedding more jobs and rethinking the way the drug giant develops, makes and markets medicines. (...)

Drug stocks? Take a pill and call me in the morning
usatoday.com 10.1.2007
(...) Even if you got in early, a rash of bad news has whacked drugmakers' stocks out of all proportion. The stocks first hit the wall over the Merck's Vioxx recall. More recently, there are serious concerns about the viability of new products in the companies' pipelines. (...)

New Year’s Resolutions for Big Pharma
by Martha Rosenberg
opednews.com 30.12.2006
It was another year of fighting black boxes, sweet talking juries and burying incriminating clinical data for Big Pharma.

But before its reputation is completely gone--How many pharmaceutical salesmen does it take to change a light bulb? It doesn't need to be changed; it just needs a new name and formulation before the patent runs out--Big Pharma could make the following New Year's resolutions. (...)

Congress v. Big Pharma
James Ridgeway is the Washington correspondent for Mother Jones . Additional research by Caroline Dobuzinskis
tompaine.com 15.12.2006
With its stranglehold on the nation's health care bills and its record-high profits, including billions from public coffers, no industry may be an easier target for reform than Big Pharma. But don't hold your breath for any meaningful reforms from the next Congress, given that even the most obvious ideas—such as expanding the Medicare drug benefit and opening the door to drug imports from Canada and elsewhere—will face unrelenting pushback from the massive drug lobby. In the end, Congressional Democrats may not accomplish much to help patients, but they will likely launch the first serious investigations of the industry in decades. (The only pharma oversight effort in the past six years, led by Charles Grassley, R-Iowa, in 2004, focused on poor FDA oversight of drugs such as Vioxx). (...)

Lilly Delivers Promising Update to Wall Street on Strategic Priorities, Pipeline Progress and Earnings Guidance
drugnewswire.com 8.12.2006
Company Sets Clear Focus on Accelerating Sales Growth, Increasing Productivity, Bringing New Drugs to Market and Replenishing the Late-Stage Pipeline. (...)

When the drugs don't work
economist.com 5.12.2006
Pfizer gives a lesson in risk and reward (...)

End of Drug Trial Is a Big Loss for Pfizer
nytimes.com 4.12.2006
Pfizer chief Jeffrey B. Kindler said he was surprised and disappointed by the results of the drug trial. (...)

When Big Pharma gets too big
money.cnn.com 4.12.2006
Analysis from FORTUNE: Plugged In
The meltdown at Pfizer demonstrates that too many pharmaceutical giants have too much riding on a handful of potential drugs, argues Fortune's John Simons.

-- For as long as anyone on Wall Street can remember, Pfizer (Charts) executives have promised to follow up Lipitor, the company's blockbuster cholesterol pill, with something even bigger and better.

It's not an assurance that's easily kept. Lipitor, after all, generates $12 billion in annual revenue and is the biggest-selling medicine produced by any Big Pharma - ever. (...)

og pasienter ha tillit til legemiddelindustrien. (...)

Industry group suspends drug company for breaching code
BMJ 2006;333:717 (7 October)
Merck Sharp & Dohme UK (MSD) has been suspended from the Association of the British Pharmaceutical Industry for offering a blood pressure testing service only to doctors who prescribed the company's hypertension drug losartan (Cozaar). (...)

GlaxoSmithKline Sees 25 Pct. Profit Rise
forbes.com 27.4.2006
GlaxoSmithKline PLC said Thursday its first-quarter profit rose 25 percent compared to a year ago, and forecast a 10 percent boost in earnings per share this year.

GlaxoSmithKline, the world's second-largest pharmaceutical company, said net profit in the three months to March 31 was 1.5 billion pounds ($2.7 billion), compared to 1.2 billion pounds in the first quarter of 2005.

Sales of 5.81 billion pounds ($10.4 billion) were up 15 percent compared to the year-ago quarter thanks to strong revenues from asthma drug Advair/Seretide, diabetes treatment Avandia/Avandamet and the vaccines unit, the company said.

"This has been a quarter of strong financial performance, driven by top-line pharma sales growth of 10 percent," Chief Executive Officer Jean-Pierre Garnier said in a statement.

Shares in Glaxo rose 3.6 percent to 15.39 pounds ($27.50) on the London Stock Exchange. (...)

Drugmakers Increasingly Targeting Rare Diseases
washingtonpost.com 25.4.2006
People often criticize the brand-name drug industry for its focus on blockbuster drugs that can be sold to millions of people with common problems. What people may not have noticed is that drug companies have become increasingly successful in discovering and winning approval for medications that treat rare, or "orphan," diseases.

A new report from the Pharmaceutical Research and Manufacturers of America, in conjunction with two groups that represent people who suffer from these diseases, finds that 160 drugs were approved in the past decade for ailments that each affect 200,000 or fewer people. That compares with 108 in the previous decade and only 10 during the 1970s. (...)

The National Institutes of Health estimates there are 6,000 to 7,000 rare diseases that together afflict some 25 million Americans. Many of the diseases are serious or life-threatening.

Two of the greatest successes involve diseases that compromise the body's ability to break down food and to fight chronic inflammation in the intestines -- Fabry's disease and Crohn's disease. Others include treatments for leprosy, low blood pressure, unusual types of cancer, tuberculosis, hemophilia B and acromegaly, a condition that leads to abnormally large hands, feet and facial features. (...)

GlaxoSmithKline earnings rise 45%
marketwatch.com 8.2.2006
LONDON (MarketWatch) -- British drug giant GlaxoSmithKline reported a 45% rise in quarterly profit, helped by the popularity of its asthma and diabetes drugs as well as cost cutting. (...)

Tysk pillekrig
aftenposten.no 14.3.2006
Tyske Merck forsøker å skape en europeisk legemiddelgigant med et fiendtlig oppkjøp av tyske Schering for 121 milliarder. (...)

Glaxo Predicted To Report 7% Sales Gain for 2005
forbes.com 7.2.2006
Standard & Poor’s Equity Research analyst Sho Matsubara upgraded the price target on GlaxoSmithKline (nyse: GSK - news - people) to $56 from $55 ahead of the company’s announcement of 2005 earnings results scheduled for Wednesday.

In a report issued Monday, the analyst predicted a sales gain of 7% for full-year 2005. He cited the drugs Seretide, Avandia, Lamictal, Valtrex, Coreg and vaccines, as key drivers for sales.

He added that the company is well-positioned in the Medicare, Medicaid and managed-care markets.

Matsubara also said he believes the company’s research and development pipeline “exceeds its peers both in quality and quantity.”

The analyst reiterated a “buy” opinion on GlaxoSmithKline. (...)

Drug makers face looming obstacles
reuters.com 7.11.2005
Safety concerns and generic competition are dogging blockbuster products, but innovation for new medicines has been slow and investors have grown impatient. (...)

Politicians are clamoring for increased vaccine production -- which drug makers cast aside in favor of more lucrative therapeutic areas such as cholesterol reduction and erectile dysfunction -- to help match demand as the world copes with the threat of a potential flu pandemic.

And the U.S. Food and Drug Administration is leaderless once again, leaving health-care companies, patients and investors uncertain if the world's most powerful health regulator will slow the approval of new medicines.

"There are some glimmers of hope with the vaccines coming out from Merck (MRK.N: Quote, Profile, Research) and GlaxoSmithKline (GSK.L: Quote, Profile, Research) and with new drugs coming out for Type 2 diabetes and the potential for inhaled insulin, but there's a long way to go," Hazlett said.

These topics and more will take center stage at the 2005 Reuters Health Summit being held in New York this week, where some of the world's top names in health care will sit down with Reuters reporters in an exclusive three-day event. (...)

Drug business prescribes a novel cure for its ills
New York Daily News 17.10.2005
Who knew that the multibillion-dollar U.S. pharmaceutical industry was so keen on publishing pulp fiction?

In a tale worthy of a zany Washington satire - except for the lamentable fact that it's true - the rich and powerful pharmaceutical lobby secretly commissioned a thriller novel whose aim was to scare the living daylights out of folks who might want to buy cheap drugs from Canada.

When the project fell through in July, I'm told the drug lobby offered $100,000 to the co-authors and publisher in a vain effort to sweep it under the rug. (...)