Om Vioxx, fortjeneste og søksmål

Risiko vedvarer etter avsluttet behandling (pharmatimes.com 14.10.2008)

Vioxx-studier var marknads-föring (lakemedelsvarlden.se 19.8.2008)

Stat saksøker Merck for villedende (bedragersk) markedsføring (bizjournals.com 1.10.2008)

Totalfortjenesten på dette medikamentet i fem år er beregnet til ca. 5 milliarder dollar, noe av dette er år 2000-penger. Så i år 2006-penger vil nettofortjenesten sannsynligvis være 7 milliarder dollar. Hvis de må betale 2 millarder dollar i erstatning, har de tjent 5 milliarder dollar! Og det er nettopp den kalkylen som teller. (Tidsskr Nor Lægeforen 2006; 126: 52-5)

The company and the Food and Drug Administration have defended their actions in numerous lawsuits brought since the drug introduced in 1999 was withdrawn from the market in late 2004. (news-journalonline.com 4.12.2006)


Om objektiv informasjon

Vi mener at vi i Norge mangler et fagorgan som forvalter «objektiv» medisinsk informasjon til norske leger. (Tidsskr Nor Lægeforen 2006; 126: 49-51)

Canadian Panel Votes to Bring Back Vioxx (newsmax.com 7.7.2005)

Merck slipper billig (forbes.com 9.11.2007)

Norges Bank mot pillegigant
(dn.no 2.1.2009)

- Krever svar om skandalemedisin

Krever svar om skandalemedisin
vg.no 17.10.2013
STOPPET: Vioxx ble trukket tilbake da det ble kjent at medisinen hadde langt høyere risiko for hjerte- og karbivirkninger enn først antatt.

400 nordmenn kan ha mistet livet etter å ha brukt skandalemedisinen Vioxx på begynnelsen av 2000-tallet. Ni år etter skandalen krever Helse- og omsorgsdepartementet svar.

I et brev til Statens Legemiddelverk stiller de flere spørsmål om Vioxx, og ber blant annet om å få vite under hvilken prosedyre medisinen ble godkjent.

Bakgrunnen for brevet er en rekke bekymringsmeldinger fra en enkeltperson.

I flere brev til departementet slås det alarm om Statens Legemmiddelverks håndtering av skandalemedisinen Vioxx.

Medisinen skulle lindre smerter ved slitasjegikt og leddgikt, og ble solgt inn som en revolusjon for pasientene. Brukt riktig skulle den ha mindre risiko for mage- og tarmbivirkninger enn flere andre medisiner i samme gruppe.

Men i 2004 ble det kjent at Vioxx ga langt høyere risiko for hjertesykdom enn først antatt, og det ble trukket fra markedet.

- Etter vår oppfatning så har vi håndtert saken riktig. Dette er et preparat som var godkjent i EU, og vi har ikke håndtert den på noen annen måte enn andre EU-land har gjort, sier Ivar Vollset, assisterende direktør i Statens Legemiddelverk til VG. (...)

(Anm: Pasientsikkerhet (rettssikkerhet) (mintankesmie.no).)

(Anm: Fri tilgang til forskningsresultater? (forskningsdata) (mintankesmie.no).)

(Anm: The hidden side of clinical trials | Sile Lane | TEDxMadrid (youtube.com).)

(Anm: Forvaltningsmakt og kunnskapspolitikk. Sammendrag. Helse- og omsorgsdepartementet benekter at de ønsker å styre forskninga i underliggende etater, og ser ingen problemer med at forskninga ligger under forvaltninga. Rus & Samfunn 05 / 2016 (Volum 9) Side: 33-35.)

(Anm: Frie forskere eller maktens lakeier? Abstrakt. Det går et skisma gjennom den samfunnsvitenskapelige rusforskningen. Ved første øyekast er det vanskelig å forstå hvorfor. Rus & Samfunn 05 / 2016 (Volum 9) Side: 36-40.)

(Anm: Nesten halvparten av alle studier som er gjennomført av store sponsorer i det siste tiåret er upublisert (Nearly half of all trials run by major sponsors in past decade are unpublished.) BMJ 2016;355:i5955 (Published 04 November 2016).)

(Anm: Who's not sharing their trial results? (trialstracker.ebmdatalab.net).)

(Anm: Transparency for patients: How much is too much? (pharmafile.com 11.10.2016).)

(Anm: Parlamentsmedlemmer hører at kliniske forsøk er byråkratiske, uklare, og forvirrende for forskere og pasienter. (…) "Det har vært en rekke kjente tilfeller hvor godkjente legemidler er basert på ufullstendig informasjon — og hvor den informasjonen som senere er stilt til rådighet har vist at legemidlet er ineffektivt eller faktisk skadelig.  (Clinical trials are bureaucratic, opaque, and offputting to researchers and patients, MPs hear.) BMJ 2013;346:f1711 (14 March 2013).)

(Anm: Lett for unge å kjøpe paracetamol. Til tross for 18 års aldersgrense, selger mange legemidler med paracetamol til mindreårige. Det viser en stikkprøve NRK har gjort. (…) Heller ikke hos apotekene var det vanskelig å kjøpe Paracet, uten samtidig å få den påbudte veiledningen. Tablettene ble solgt uten spørsmål hos alle de 15 apotekene som ble oppsøkt. (nrk.no 17.2.2016).)

(Anm: Cheflæge advarer mod »totalt forkert« kultur i topfodbold, og landsholdsspillere bekræfter den. Tidligere Fifa-boss påpeger systematisk brug af smertestillende medicin i topfodbold. Landstræneren tager ikke afstand fra det. MÜNCHEN — Halvdelen af topspillerne i alle turneringer arrangeret af Det Internationale Fodboldforbund (Fifa) i årene 1998-2014, inklusive VM-slutrunder, tager jævnligt smertestillende medicin for at kunne spille. Medicinen dækker over alt fra brugen af gigtmedicin til smertestillende indsprøjtninger; såkaldte blokader. (politiken.dk 25.3.2017).)

(Anm: 50 % av kvinnelige metadonpasienter startet med reseptbelagte smertestillende. (50% of female methadone patients started with prescription painkillers.) (medicalnewstoday.com 10.11.2015).)

(Anm: Rusproblem blant eldre. Bruk og misbruk av alkohol og reseptbelagte legemidler er et økende problem blant eldre. Bruk, misbruk eller feilbruk av alkohol og psykofarmaka blant eldre vil komme til å utgjøre en stor folkehelseutfordring, skriver artikkelforfatteren. (dn.no 2.8.2016).)

(Anm: Reseptbelagt misbruk av legemidler i Europa er et større problem enn tidligere antatt. (Prescription drug abuse in Europe is a bigger problem than previously thought.) (medicalnewstoday.com 4.8.2016).)

(Anm: Opioider linket til dødsfall annet enn overdoser, ifølge studie. CHICAGO (AP) — Utilsiktede overdoser er ikke den eneste dødelig risiko ved bruk av kraftige reseptbelagte smertestillende — legemidlene kan også bidra til hjerterelaterte dødsfall og andre dødsfall, antyder ny forskning. (Opioids Linked with Deaths Other than Overdoses, Study Says. CHICAGO (AP) — Accidental overdoses aren't the only deadly risk from using powerful prescription painkillers — the drugs may also contribute to heart-related deaths and other fatalities, new research suggests. (pharmapro.com 15.6.2016).)

(Anm: Chronic opioid use risks increase with knee surgery, cesarean. The study, published in JAMA Internal Medicine, was led by Dr. Eric Sun and co-authored by Prof. Beth Darnall, from the Stanford University School of Medicine in California. According to the Centers for Disease Control and Prevention (CDC), prescription painkillers became more affordable and available in the mid-1990s. Since then, drug overdose rates in the U.S. have more than tripled. Every day, 78 Americans die from an opioid overdose. (medicalnewstoday.com 11.7.2016).)

(Anm: - 75 % av heroinbrukerne sier de startet med reseptbelagte opioider (- Opioid, heroindødsfall fortsetter å øke) (medpagetoday.com 1.7.2014).)

(Anm: -  NYU-studie finner at 75 prosent (3/4) av elever på videregående skole (high school) som er heroinbrukere startet med reseptbelagte opioider. (medpagetoday.com 4.12.2015).)

(Anm: Most teens who misuse prescription stimulants say they use other people's medication. Using someone else's medication is the most common form of prescription stimulant misuse among adolescents, according to a University of Florida Health study, which found that 88 percent of teens who used the drugs non-medically in the past 30 days said they had obtained the medications from someone else. (medicalnewstoday.com 4.3.2016).)

- Vioxx skadelig selv etter at pasienter har sluttet å ta det

Vioxx harmful even after patients stopped taking it (Vioxx skadelig selv etter at pasienter har sluttet å ta det)
reuters.com 13.12.2010
(Reuters Health) - Merck's withdrawn painkiller Vioxx may have continued to cause blood clots and perhaps deaths even after patients dropped it, U.S. researchers said Monday.

The drug was recalled by Merck in 2004 after a colon-polyp prevention study showed it increased the risk of heart disease and death in users. But over the five years it was on the market, researchers estimate it caused nearly 40,000 deaths.

The new findings, published in the Archives of Internal Medicine, are based on data made available by Merck during multibillion-dollar litigation against the company.

They show patients taking Vioxx (also called rofecoxib) doubled their chances of having blood clots or dying in the first half-year after discontinuing treatment, confirming earlier results that hinted the effects might last up to one year.

What happens after that is still an open question, said Dr. Joseph Ross of the Yale School of Medicine in New Haven, who worked on the study. (...)

(Anm: Persistence of Cardiovascular Risk After Rofecoxib Discontinuation. Arch Intern Med. 2010;170(22):2035-2036 (Dec 13/27).)

Australsk retts kjennelse angående Vioxx kan få globale følger

Australian court findings on Vioxx may have global ramifications (Australsk retts kjennelse angående Vioxx kan få globale følger)
BMJ 2010;340:c1485 (16 March)
A court in Melbourne has ruled that the anti-arthritis drug rofecoxib (Vioxx) increased the risk of heart attack, while finding that the Australian subsidiary of its manufacturer engaged in negligent and misleading behaviour.

In a class action judgment delivered earlier this month, the federal court judge Christopher Jessup found that rofecoxib contributed to the heart attack of plaintiff Graeme Peterson.

The judge ruled that Merck Sharp & Dohme "fell short" of what was required in the reasonable discharge of its "duty of care" by failing to warn Mr Peterson’s doctor of the drug’s potential cardiac risk and because sales representatives overemphasised its safety. (...)

- Klinisk forsøk var maskert markedsføring (a so-called "seeding" project)

News: Merck published fake journal (Nyheter: Merck publiserte falskt tidsskrift)
the-scientist.com 30.4.2009
Merck paid an undisclosed sum to Elsevier to produce several volumes of a publication that had the look of a peer-reviewed medical journal, but contained only reprinted or summarized articles--most of which presented data favorable to Merck products--that appeared to act solely as marketing tools with no disclosure of company sponsorship.

"I've seen no shortage of creativity emanating from the marketing departments of drug companies," Peter Lurie, deputy director of the public health research group at the consumer advocacy nonprofit Public Citizen, said, after reviewing two issues of the publication obtained by The Scientist. "But even for someone as jaded as me, this is a new wrinkle."

The Australasian Journal of Bone and Joint Medicine, which was published by Exerpta Medica, a division of scientific publishing juggernaut Elsevier, is not indexed in the MEDLINE database, and has no website (not even a defunct one). The Scientist obtained two issues of the journal: Volume 2, Issues 1 and 2, both dated 2003. The issues contained little in the way of advertisements apart from ads for Fosamax, a Merck drug for osteoporosis, and Vioxx. (Click here and here to view PDFs of the two issues.)

The claim that Merck had created a journal out of whole cloth to serve as a marketing tool was first reported by The Australian about three weeks ago. It came to light in the context of a civil suit filed by Graeme Peterson, who suffered a heart attack in 2003 while on Vioxx, against Merck and its Australian subsidiary, Merck, Sharp & Dohme Australia (MSDA). (...)

Vioxx-studier var marknadsföring
lakemedelsvarlden.se 19.8.2008
En studie som Merck gjorde av biverkningar på Vioxx var i själva verket en del av företagets marknadsföring. Studiens syfte var att öka försäljningen av preparatet. (...)

Merck Vioxx study was for marketing: researchers (Forskere: Merck Vioxx-studie var markedsføring)
reuters.com 19.8.2008
NEW YORK (Reuters) - The primary purpose of a 1999 clinical study that Merck & Co Inc said was done to test side effects of Vioxx was actually to support a marketing campaign before the now-withdrawn painkiller's launch, according to U.S. researchers.

The real aim of the study, called Advantage, was to promote prescription of the new medicine when it became available -- a so-called "seeding" project -- the researchers said on Tuesday. (...)

Merck Vioxx Trial Done to Boost Sales, Study Finds (Update1) (Merck Vioxx-forsøk utført for å øke salget, ifølge studie)
bloomberg.com 18.8.2008
Aug. 18 (Bloomberg) -- Merck & Co.'s marketing department devised a study on the painkiller Vioxx to persuade 600 doctors involved in the trial to prescribe the drug and recommend it to their peers, researchers say.

Their conclusions are based on 100 internal company memos and reports about the study known as Advantage obtained from lawsuits against Whitehouse Station, New Jersey-based Merck over heart risks tied to Vioxx, now withdrawn. The trial of 5,557 patients started in 1999, just as Vioxx was cleared for sale, according to the Annals of Internal Medicine report.

The study, which tested the drug's safety in the stomach, was primarily crafted by Merck's marketing department to get doctors to prescribe Vioxx, the researchers wrote. The report provides some of the first evidence of what is thought to be a widespread practice: recruiting doctors for a study to boost their confidence in a new drug and get them to promote it to colleagues, they said. (...)

'Patients at Risk'
"By publishing this article, we hope to shine a light on a practice that appears to be widespread, that really involves an element of deception because patients aren't told the true purpose of the trial,'' Sox said. "This is one practice that appears to put patients at risk when there may be little or no scientific benefit to the research. Indeed, some patients were injured by the drug.'' (...)

Clinical Trial Said to Have Been Marketing in Disguise (Klinisk forsøk sies å være maskert markedsføring)
medpagetoday.com 18.8.2008
BELMONT, Mass., Aug. 18 -- The ADVANTAGE trial comparing Merck's rofecoxib (Vioxx) with naproxen (Aleve) was designed and executed primarily for marketing purposes, said researchers here, but the company has denied the allegation.

Internal documents made public as part of Vioxx-related litigation show that Merck's marketing department conceived the trial as a way to introduce the drug to primary care physicians and turn them into advocates for the product, reported Kevin P. Hill, M.D., M.H.S., of McLean Hospital, and colleagues in the August 19 issue of Annals of Internal Medicine.

The researchers said it was the first clearly documented example of a "seeding trial," where marketing a drug to physicians is the main goal, rather than responding to regulatory requirements or answering a scientific question. (...)

(Anm: The ADVANTAGE seeding trial: a review of internal documents. Annals of Internal Medicine 2008;149:251-58.

(Anm: Seeding Trials: Just Say "No". Annals of Internal Medicine 2008; 149:279-80.)

Researchers: Merck Vioxx study was for marketing (Forskere: Merck Vioxx-studie var markedsføring)
money.cnn.com 18.8.2008
Researchers: Merck Vioxx study was designed to market the painkiller; company disputes that (...)

NEW YORK (Associated Press) - A 1999 Merck & Co. study of its since-withdrawn painkiller Vioxx, touted to participating doctors and patients as meant to show whether Vioxx caused fewer stomach problems than another drug, was primarily a stealth marketing strategy, researchers report.

The true purpose was to get lots of doctors and patients in the habit of using Vioxx just in time for its launch, according to doctors who uncovered internal Merck memos discussing the strategy behind the study, called ADVANTAGE. They did so while reviewing roughly a million Merck documents for plaintiffs' lawyers preparing for trials in Vioxx lawsuits. (...)

Using funding from the Robert Wood Johnson Foundation's clinical scholars program, they searched further, uncovering items such as a memo from two top Merck executives nominating the study for an internal marketing award.

"The objectives were to provide product trial among a key physician group to accelerate uptake of Vioxx as the second entrant in a highly competitive new class," the memo states. (...)

- Legemiddelsøksmål - villedende (bedragersk) markedsføring

Medicingigant ville miskreditere læger
politiken.dk 7.4.2009
Retssag afslører, at giganten Merck tilsyneladende ville påvirke læger til at se mere positivt på farlig gigtmedicin.

Et af verdens største medicinalfirmaer, Merck, gjorde sig i 1999 tilsyneladende store anstrengelser for at beskytte sin gigtmedidin Vioxx mod kritik.

Så store, at man udarbejdede interne lister over læger og forskere, som man enten ønskede at 'neutralisere' eller at 'miskreditere'.

De oplysninger er kommet frem under en retssag, der netop nu finder sted i Byron Bay i Australien, skriver British Medical Journal.

Her har en 58-årig mand, Graeme Peterson, og flere hundrede andre australiere, stævnet Merck. (...)

Norges Bank mot pillegigant
dn.no 2.1.2009
Mener legemiddelgiganten Merck holdt skjult dødelige bivirkninger av medikament. (...)

Vioxx ble godkjent av amerikanske myndigheter i 1999. I løpet av få år ble legemiddelet et av de mest solgte i verden. Også i Norge ble Vioxx hyppig skrevet ut på resept.

30. september 2004 ble legemiddelet brått trukket fra markedet av Merck. (...)

Noen dager senere kunne The Wall Street Journal avsløre at sentrale personer i ledelsen i Merck hadde kjent til bivirkningene helt tilbake til 2000. Dette dokumenterte avisen gjennom å trykke interne e-poster.

Informasjonssjef i Merck, Ronald Rogers, skriver i en epost til DN at de motsetter seg søksmålet. (...)

Dyr pillesmell for Gjedrem
na24.no 2.1.2009
Norges Bank krever 340 millioner i erstatning fra legemiddelgigant.

- Slike søksmål er en del av businessen, sier kommunikasjonsdirektør Siv Meisingset i Norges Bank.

Det er Oljefondet, som forvaltes av Norges Bank, som skal ha tapt 340 millioner på aksjene sine i legemiddelselskapet Merck. Svein Gjedrem & Co. hevder Merck-ledelsen i en årrekke skjulte at det smertestillende medikamentet Vioxx hadde dødelige bivirkninger, skriver Dagens Næringsliv. (...)

(Anm: Vioxx - informasjon vs kunnskap og visdom - hvem visste hva? (mintankesmie.no).)

(Anm: Ondskapens filosofi (“rule by nobody”) (mintankesmie.no).)

State sues Merck for deceptive marketing of Vioxx (Stat saksøker Merck for villedende (bedragersk) markedsføring)
bizjournals.com 1.10.2008 (South Florida Business Journal)
Florida Attorney General Bill McCollum has filed suit again Merck & Co. for alleged deceptive marketing and promotion of the prescription drug Vioxx.

The lawsuit claims that Merck repeatedly failed to disclose the drug’s adverse effects while offering it to the state’s Medicaid program as a safe painkiller, in direct violation of Florida’s Deceptive and Unfair Trade Practices Act.

Vioxx was used to treat joint pain until it was removed from the market in 2004 after studies suggested those taking it had an increased risk of heart attack and stroke associated with long-term use.

The lawsuit follows a three-year investigation of Merck’s promotional practices and alleges that, due to the company’s marketing practices, numerous state agencies approved the inclusion of Vioxx as a covered or approved drug, and agreed to pay for the prescription or reimburse its expense.

In a prepared statement, Merck said it acted responsibly and intends to defend the complaint, which is similar to those filed by eight other states and pending in federal and state courts. (...)

Vioxx-gransking?

Krever Vioxx-gransking
nrk.no 30.11.2006
Vioxx-skandalen må granskes, mener flertallet i Stortingets sosialkomité. Rundt 200 personer kan ha pådratt seg alvorlige bivirkninger etter å ha brukt legemiddelet.

Statens Legemiddelverk regner med at bruken av det smertestillende middelet kan ha påført rundt 200 personer alvorlige bivirkninger som hjerteinfarkt og hjerneslag.

TRUKKET: Legemiddelet Vioxx ble trukket fra markedet for to måneder siden. Nå krever politikere granskning.

- Må undersøkes
Sosialkomiteen på Stortinget mener omfanget av skadene og bruken av Vioxx må undersøkes nøye.

- Det er all grunn til å finne ut hva som har skjedd i dette tilfellet. Og det er nødvendig også for å forhindre at noe lignende skal skje i forhold til bruk av andre legemidler, sier Asmund Kristoffersen i Arbeiderpartiet.

Vioxx, som ble brukt for å lindre smerter på grunn av leddgikt og revmatisme, ble trukket fra markedet for to måneder siden.

27.000 i USA
Undersøkelser i USA viser at så mange som 27.000 personer kan ha blitt rammet av hjerteinfarkt eller hjerneslag etter å ha brukt legemiddelet. Nøyaktige tall er vanskelig å finne, men også i Norge har trolig mange blitt rammet av de alvorlige bivirkningene.

- En granskning som kan fortelle oss oss hvor mange pasienter som er rammet, eller hvilke enkeltpasienter som har vært skadelidende er veldig vanskelig å få til, sier Steinar Madsen i Statens Legemiddelverk.

Flere politikere mener imidlertid man likevel må kartlegge hvilke pasienter og hvor mange som har blitt rammet av bivirkningene til Vioxx.

- Jeg forventer at man setter i gang med en kartlegging for å finne ut av hvor mange som er skadet og i hvilket omfang, sier Harald Nesvik i Fremskrittspartiet. (...)

(Anm: Bare én av ti nordmenn som rammes av hjerneslag får behandling i tide (tv2.no 16.2.2014).)

(Anm: – Får du hjerneslag har du dårlig tid. Dersom du rammes av hjerneslag risikerer du å miste to millioner hjerneceller hvert minutt. Får du ikke behandling innen 4,5 timer, er risikoen for invaliditet og uførhet stor. (…) Slagambulanse med CT. (nrk.no 8.2.2016).)

(Anm: Ja til ny akuttmetode: Flere slagpasienter kan få tilbud om å «fiske ut» blodpropp av hjernen. To år etter mange andre land gis det nå klarsignal til å videreføre ny og effektiv behandlingsmetode for slagpasienter. I fjor fikk bare 150 pasienter inngrepet - som opptil tusen kan ha nytte av hvert år. (aftenposten.no 2.5.2017).)

(Anm: - Plutselig oppstått dobbeltsyn (- Visuelle komplikasjoner er vanlig etter hjerneslag) Sudden onset double vision BMJ 2014;348:g3286 (19 May 2014).)

(Anm: En av tre blev dement efter återkommande stroke. (…) Den nya analysen, som publiceras i dag, torsdag, på tidskriften Lancet Neurologys hemsida, baseras på 22 sjukhusstudier och åtta populationsstudier. Undersökningarna är utförda mellan 1950 och 2009. (dagensmedicin.se 24.9.2009).)

- Vioxx-slagrisiko kan vare i årevis

Vioxx risks persist after ending treatment (Risiko vedvarer etter avsluttet behandling)
pharmatimes.com 14.10.2008
Merck’s pain-killing arthritis drug Vioxx (rofecoxib) can still increase the risk of heart attack, stroke and death a year after patients have stopped taking the medicine, a study has found.

Published online by The Lancet, the study, funded by Merck, shows “the risk was increased close to twofold, and the risk persisted for approximately a year”, co-author Dr Robert Bresalier said.

The new study followed about 2000 people who had been involved with the three-year APPROVe trial that had been intended to show that Vioxx, a COX-2 inhibitor, could prevent the recurrence of colon cancer. (...)

(Anm: Bare én av ti nordmenn som rammes av hjerneslag får behandling i tide (tv2.no 16.2.2014).)

(Anm: – Får du hjerneslag har du dårlig tid. Dersom du rammes av hjerneslag risikerer du å miste to millioner hjerneceller hvert minutt. Får du ikke behandling innen 4,5 timer, er risikoen for invaliditet og uførhet stor. (…) Slagambulanse med CT. (nrk.no 8.2.2016).)

(Anm: Ja til ny akuttmetode: Flere slagpasienter kan få tilbud om å «fiske ut» blodpropp av hjernen. To år etter mange andre land gis det nå klarsignal til å videreføre ny og effektiv behandlingsmetode for slagpasienter. I fjor fikk bare 150 pasienter inngrepet - som opptil tusen kan ha nytte av hvert år. (aftenposten.no 2.5.2017).)

Vioxx Stroke Risk could last for Years (Vioxx-slagrisiko kan vare i årevis)
lawyersandsettlements.com 16.5.2007
New York, NY: Tidligere brukere av Vioxx kan være utsatt for risiko for å utvikle slag i årevis etter at de avsluttet bruken av legemidlet, opplyste en fremstående samfunnsmedisinsk ekspert. (Former users of Vioxx could be at risk for developing strokes for years after they have discontinued using the medication, a prominent public health expert has reported.)

Vioxx, som er brukt av millioner av amerikanere, ble trukket fra verdensmarkedet i september 2004 etter at det ble vist at det doblet risiko for hjerteanfall hos pasienter som tar det i 18 måneder eller lenger. (Vioxx, which was used by millions of Americans, was recalled worldwide in September, 2004 after it was shown to double heart attack risk among patients taking it 18 months or longer.)

"Permanent damage" (Permanent skade)
"Det kan være at Vioxx forårsaker varig skade på det kardiovaskulære system, i form av akselererende aterosklerose eller vedvarende økning i blodtrykket," sa dr. Curt Furberg ved den amerikanske Food and Drug Administrations Drug Safety and Risk Management Advisory Committee. ("It may be that Vioxx is causing permanent damage to the cardiovascular system, accelerating atherosclerosis or a sustained increase in blood pressure," said Dr. Curt Furberg of the U.S. Food and Drug Administration's Drug Safety and Risk Management Advisory Committee.)

De nye bekymringer har økt etter en 107 siders studie på pasienter som ble fulgt i et år etter at de avsluttet bruken av Vioxx. Rapporten slår fast at 28 mennesker i studien hadde hjerteanfall og slag innen et år etter at de sluttet med Vioxx. Dette sammenliknet med 16 pasienter fra forsøket som hadde tatt placebo. (...) (The new concerns have arisen from a 107-page study on patients who were followed for one year after they discontinued taking Vioxx. The report states that 28 people from the study had heart attacks and strokes within one year after they stopped taking Vioxx. This is compared with 16 patients from the trial that had taken placebos.)

- Shadow jury

When lawyers want to know what the Vioxx jurors are thinking ... the shadow jury knows
nj.com 13.2.2007
Legal battles involve a lot of strategy -- and sometimes a little intrigue.
After a dozen Vioxx trials, a case now being heard in Atlantic City has not attracted the kind of attention the media and Wall Street paid to earlier cases. Yet for past three weeks, a mysterious group of spectators has shown up every day for the often-tedious legal wrangling inside Superior Court Judge Carol Higbee's courtroom.

Their number has fluctuated between 10 and 13, and their casual clothing -- sneakers, sweats, leather jackets, pullover sweaters -- sharply contrasts with the dark suits and overcoats worn by the at torneys who fill up much of the courtroom.

The group has followed the proceedings closely, listening intently as the witnesses drone on, laughing at quips tossed out by the charismatic lead plaintiff attorney, Mark Lanier. Some have kept notes. They have largely kept to themselves, refusing to discuss why they are attending the trial.

In many ways, they resemble a jury. That's because they're being paid to. In the world of high-priced trial attorneys and big-time legal cases, the group is known as a shadow jury.

Court TV buffs, take note.

In high-stakes cases like the Vioxx litigation -- Merck faces about 27,000 product liability lawsuits -- trial attorneys routinely hire consultants, mock juries and focus groups to help them prepare and finesse their cases. (...)

"At the end of the day, the lawyers are saying, 'What are you feeling? Did you get this? Was that point made effectively?'" said Edward Ohlbaum, a profes sor at Temple University Law School. "It can be tremendously useful, like having a plant in the jury room."

"There is nothing wrong with it," Ohlbaum said. "It makes all the sense in the world." (...)

HIRED FOR A REASON
According to one person familiar with the shadow jurors' work in Atlantic City, the group is provided with a generous lunch. Each has received two checks, paying them roughly $125 a day, or $625 a week.

For that, they spend the day listening and watching. When court is recessed, they are led to a nearby office building. In a sparsely furnished first-floor office, the men and women take turns answering questions from an unidentified woman on the telephone. (...)

- Sakkyndige firmaleger

Merck's witness stands by opinion under cross examination
stclairrecord.com 21.3.2007
Merck's defense witness Jerome Cohen, M.D., a St. Louis cardiologist, said his ties to pharmaceutical companies did not influence his opinion that Vioxx did not cause Patricia Schwaller's death. (...)

Birchfield took issue with Cohen's previous testimony regarding a study that compared cardiovascular events at various intervals between patients in a trial taking Vioxx and a placebo, referred to as the "18 month issue."

"You're a good listener," Cohen told Birchfield.

"I've had a few days," Birchfield said.

"To sharpen your knives," Cohen said. Jurors and the audience laughed.

Birchfield projected for jurors a graphic listing the names of 32 doctors who advised the Food and Drug Administration that they agreed in 2005 that "Vioxx significantly increases the risk of cardiovascular events," as well as a committee of the American Heart Association. In an adjacent column with a header, "Consensus of Scientific Community," it listed only the name of Jerome Cohen.

Cohen said he stood by his report. (...)

"Based on the opinion you've given on Vioxx, Merck would know in advance your opinion on this case," Birchfield asked.

"Not true," Cohen answered. "Every case including Mrs. Schwaller's is unique." (...)

Canadian Panel Votes to Bring Back Vioxx

Now Bring Back Vioxx (Bring Vioxx tilbake nå)
wsj.com 9.6.2006
Multiple sclerosis victims got some great news Monday when the Food and Drug Administration allowed a drug called Tysabri to return to market. Tysabri was pulled in February 2005 after two patients died from a rare neurological infection.

There was a possible link, since Tysabri works by modulating the immune system. But we argued from the start that withdrawal was an overreaction. And spurred by growing evidence of Tysabri's effectiveness and the pleas of many desperate MS patients, (...)

(Anm: Tysabri (natalizumab)
fda.gov 27.2.2008
[Posted 02/27/2008] Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury. (...)

Canadian Panel Votes to Bring Back Vioxx
newsmax.com 7.7.2005
OTTAWA -- An expert panel is recommending that Health Canada allow the controversial painkiller Vioxx back onto the market.

By a 12-1 vote, panel members concluded the benefits of Vioxx in providing pain relief outweigh the increased risk of heart attack and stroke. Merck & Co. withdrew the drug from the worldwide market last September after a study showed it doubled patients risk of heart attacks and strokes. (...)

Legemiddelkonsulenter

Merck vilseledde läkare om hjärtriskerna med Vioxx
Läkemedelsvärlden 2005(1-2) (Mars)
Genom att låta sina konsulenter föra fram vetenskapligt undermåliga och irrelevanta data lyckades det amerikanska läkemedelsföretaget Merck under två års tid vilseleda läkare om hjärtriskerna med Vioxx.

VIOXX Läkemedelsföretag argumenterar ofta för att deras marknadsförare ute på fältet – läkemedelskonsulenterna – fyller en viktig funktion genom att föra ut ny kunskap om deras läkemedel och utbilda läkarna.

I kölvattnet av indragningen av det smärtstillande läkemedlet Vioxx kommer information som visar en annan verklighet. Efter att Merck självmant drog in Vioxx den 30 september 2004 begärde en amerikansk statlig kommitté in samtliga interna dokument rörande marknadsföringen av Vioxx liksom all kommunikation till hälso- och sjukvårdspersonal rörande säkerhet och effekt av läkemedlet.

Resultatet – över 20 000 sidor interna och externa dokument – visar att Merck systematiskt använde sin konsulentstyrka för att mörka och tysta ner hjärt-kärlriskerna och för att föra ut vetenskapligt felaktig information för att få det att se ut som om Vioxx faktiskt var säkrare än andra NSAID:s. (...)

(Anm: NSAID Use Is Associated with Elevated Risk for Bleeding in Patients with Atrial Fibrillation Receiving Antithrombotic Therapy Ann Intern Med 2014 Nov 18; 161:690.)

(Anm: Värktabletter kopplas till hjärtproblem. Det finns ett samband mellan en högre risk för hjärtsvikt och medicinering med värktabletter som Voltaren, Ipren och Magnecyl, enligt en ny stor studie. Studien som publicerats i British Medical Journal visar att personer, som inom de senaste 14 dagarna tagit så kallade NSAID-läkemedel, har en 19 procent högre risk för att tas in på sjukhus för hjärtsvikt, jämfört med personer som tagit tabletterna längre tillbaka i tiden. (dagensmedicin.se 30.9.2016).)

(Anm: Mange NSAID knyttet til hjertefeil. Many NSAIDs Associated With HF. 'A clear risk to some... and tighter regulation is justified'. (…) For the individual drugs, odds ratios ranged from 1.16 (95% CI 1.07-1.27) for naproxen to 1.83 (95% CI 1.66-2.02) for ketorolac, and were significant for the following: Diclofenac – Ibuprofen – Indomethacin – Ketorolac – Naproxen – Nimesulide – Piroxicam – Etoricoxib - Rofecoxib (medpagetoday.com 29.9.2016).)

(Anm: NSAID; non-steroidal anti-inflammatory drugs; Ikkesteroide antiinflammatoriske midler (no.wikipedia.org).)

(Anm: «Ufarlige» smertestillende knyttet til økt risiko for hjertestans. 'Harmless' Painkillers Associated With Increased Risk of Cardiac Arrest. Painkillers considered harmless by the general public are associated with increased risk of cardiac arrest, according to research published in the March issue of European Heart Journal - Cardiovascular Pharmacotherapy.1 Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most commonly used drugs worldwide and some, including ibuprofen, are available over the counter. (pharmpro.com 16.3.2017).)

(Anm: Combination of NSAIDs and gastric protection can lead to inflammation in small intestine. Patients with inflammatory diseases are often prescribed non-steroidal anti-inflammatory drugs. They are also often recommended to use a proton pump inhibitor to protect their stomach. (news-medical.net 11 .4.2017).)

(Anm: Reseptfrie NSAID-er linkes til økt risiko for hjertestans, ifølge studie. Smertestillende legemidler som anses ufarlige for publikum er assosiert med økt risiko for hjertestans, ifølge forskning publisert i dagens utgave av European Heart Journal - Cardiovascular Pharmacotherapy. (…) Disse inkluderte de ikke-selektive NSAID-er (diclofenac, naproxen, ibuprofen) og COX-2-hemmere (rofecoxib celekoksib). Over-the-counter NSAIDs linked to elevated risk of cardiac arrest, study finds. Painkillers considered harmless by the general public are associated with increased risk of cardiac arrest, according to research published today in the March issue of European Heart Journal - Cardiovascular Pharmacotherapy. (…) These included the non-selective NSAIDs (diclofenac, naproxen, ibuprofen), and COX-2 selective inhibitors (rofecoxib, celecoxib). (news-medical.net 15.3.2017).

(Anm: Ibuprofen er knyttet til 31 % økning i risiko for hjertestans. Ibuprofen linked to 31% increase in risk of cardiac arrest. A study emerging from Denmark has found that the use of over-the-counter pain killer, Ibuprofen, is associated with an increased risk of cardiac arrest. In particular, the research warned against the view of nonsteroidal anti-inflammatory drugs (NSAID) as without risk and advised against people using the pain killers who had pre-existing cardiovascular problems. (…) Of those who were taking NSAIDs, the use of ibuprofen was associated with a 31% increase in the risk of cardiac arrest. As well as this, patients taking diclofenac, another NSAID – only available by prescription in the USA and the UK, were found to have a 50% increase in the risk of cardiac arrest. (pharmatimes.com 16.3.2017).)

(Anm: Kardiovaskulære risici ved behandling med nonsteroide antiinflammatoriske lægemidler (NSAID). KONKLUSION NSAID-behandling er associeret med en lang række kardiale komplikationer i form af destabilisering af blodtryksbehandling, hjertesvigt, myokardieinfarkt, atrieflimren, venøs tromboemboli, blødning ved kombinationsbehandling med antitrombotika og pludselig hjertedød. Selv korttidsbehandling synes at være associeret med en øget risiko, og særligt diclofenac har en uheldig risikoprofil. Dertil kommer, at der er en dosisrelateret øgning i de kardiovaskulære risici forbundet med NSAID-behandling, hvorimod den terapeutiske og smertestillende effekt ikke øges tilsvarende. NSAID-behandling frarådes derfor til patienter med hjerte-kar-sygdom, og anvendelse af diclofenac frarådes generelt. Ugeskr Læger 2016;178:V08160612.)

(Anm: Using NSAIDs during a cold may increase heart attack risk. Taking ibuprofen or other nonsteroidal anti-inflammatory drugs to help relieve cold or flu symptoms may seem harmless, but new research suggests otherwise. It could increase the risk of heart attack. Study co-author Dr. Cheng-Chung Fang, of the National Taiwan University Hospital, and colleagues recently reported their findings in The Journal of Infectious Diseases. (medicalnewstoday.com 6.2.2017).)

(Anm: NSAIDs offer little benefit for spinal pain, review finds. Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen offer little more clinical benefit to patients with spinal pain than a placebo, a systematic review and meta-analysis has found. The review of 35 randomised placebo controlled trials involving 6065 people, published in the Annals of the Rheumatic Diseases,1 found that NSAIDs did provide some relief from pain and disability but found little evidence that they were more effective than placebo. Researchers found that, in every six patients treated with an NSAID, only one would benefit. BMJ 2017;356:j605 (Published 06 February 2017).)

(Anm: Demente rammes i højere grad af hjerte-kar-sygdom. Hjerteforeningen følger ministerens arbejde med handlingsplan om demens, der er essentiel for hjertepatienter også. Demens og hjerte-kar-sygdomme har fælles risikofaktorer, siger forskningschef. (hjerteforeningen.dk 3.10.2016).)

(Anm: NSAID-preparat farligt efter hjärtinfarkt. Antiinflammatoriska läkemedel av NSAID-typen är farligt ihop med blodförtunnare efter hjärtinfarkt. (lakemedelsvarlden.se 25.2.2015).)

(Anm: Vanlige smertestillende «øker risiko for hjertesvikt". (Common painkillers 'increase heart failure risk' (…) The British Medical Journal study looked at 10 million people, aged 77 on average, who took the drugs. (…) 'Use with caution' The British Heart Foundation (BHF) said patients should be on the lowest dose possible of NSAIDs for the shortest possible time.) (bbc.com 29.9.2016).)

(Anm: Vanlige smertestillende knyttet til svak økning i risiko for hjerteinfarkt. Common Painkillers Tied to Slight Rise in Heart Attack Risk. TUESDAY, May 9, 2017 (HealthDay News) -- Commonly used painkillers such as Motrin, Advil and Aleve might increase your risk for heart attack, even in the first week of use, a new study suggests. Overall, these drugs and others known as nonsteroidal anti-inflammatory drugs (NSAIDs) increase the risk of a heart attack by 20 to 50 percent, compared with not using them, researchers found. (medicinenet.com 9.5.2017).)

(Anm: Non-steroidal anti-inflammatory drugs and risk of heart failure in four European countries: nested case-control study. (…) Conclusions The risk of hospital admission for heart failure associated with current use of NSAIDs appears to vary between individual NSAIDs, and this effect is dose dependent. This risk is associated with the use of a large number of individual NSAIDs reported by this study, which could help to inform both clinicians and health regulators. BMJ 2016;354:i4857 (Published 28 September 2016).)

(Anm: Gigtmedicin skal bruges med omtanke til hjertepatienter. (…) Læger, der udskriver gigtmedicin af typen NSAID (non-steroide anti-inflammatoriske lægemidler), bør være særligt opmærksomme på, at denne type medicin giver en øget risiko for hjertesygdomme hos patienter. Det drejer sig specifikt om produkterne Diclofenac, Ibuprofen og Naproxen. I produktresumeerne for de nævnte produkter, står det udførligt beskrevet, at disse midler er kontraindicerede ved svær hjerteinsufficiens. (laegemiddelstyrelsen.dk 17.3.2016).)

(Anm: Potential Hazards of Adding Nonsteroidal Anti-inflammatory Drugs to Antithrombotic Therapy After Myocardial Infarction. Time for More Than a Gut Check. JAMA. 2015;313(8):801-802. (February 24).)

Legemiddelindustriens markedsføringstiltak ("best practice")

Marketing Drugs in an Era of Pharmacovigilance - Best practice after drug safety scares and the implications for the future
datamonitor.com 21.1.2006

Report Published: 21 December 2005

Buy this research

$11400

 

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Introduction

There have been several drug safety scares over the last five years, most notably the withdrawal of Vioxx and the problems with the SSRI antidepressants. With growing public and physician awareness of safety issues, and new PhRMA guidelines for direct-to-consumer advertising drawn up in response to the withdrawal of Vioxx, companies face new challenges when planning future promotional campaigns

Scope of this report

  • Detailed case studies of five different drug safety scares, using analysis of sales data, financial performance and promotional data
  • Use of different marketing channels, including physician detailing and direct-to-consumer advertising, is examined in detail
  • Comment and insight from five key opinion leaders whose practices have been affected by drug safety scares in the past
  • An assessment of the future direction of drug marketing and the impact of the greater emphasis on safety on marketing activity

Research and analysis highlights

Although not a new phenomenon, drug safety has become an issue of paramount importance, with the withdrawal of Vioxx shaking the pharmaceutical industry, the public and the physician community and resulting in significant changes to the regulatory and promotional pharmaceutical practices.

The impact of a safety scare is dependent on a number of factors, including perception of risk, size of the patient population, severity of the adverse drug reaction and the chronicity of treatment. The unmet need also exerts a significant effect, with some drugs being used despite serious adverse effects where no alternative treatment exists.

Promotional effort undertaken following a drug safety scare is crucial, as public confidence tends to be negatively affected and both patients and physicians require reassurance as to the safety of other, competitor products. However, targeted physician marketing may sometimes be more appropriate than aggressive direct-to-consumer campaigns.

Key reasons to read this report

  • Define the variables that will result in a drug safety scare having a permanent, sizable impact
  • Identify the most suitable promotional channels for re-establishing patient confidence after drug safety scares
  • Appreciate the need for open communication of pharmacovigilance activities and use these to best advantage in marketing campaigns

Reference Code: DMHC2149 (...)

Legemiddelovervåkning

Pharmacovigilance: A New Era of Drug Safety
datamonitor.com 19.12.2006
Report Published: 19 December 2005

Buy this research

$7600

 

 Buy Now


Introduction

A series of high profile safety concerns, such as the withdrawal of Vioxx (rofecoxib) and the link between antidepressants and suicidal thoughts in children over the last two years has made drug safety a major issue for governments, regulatory authorities and the pharma industry. This has triggered a period of change across the board, and the industry is now entering a new era of drug safety.

Scope of this report

  • Evaluation of the US and EU pharmacovigilance systems, including major regulatory changes implemented since the beginning of 2004
  • Examination of the future of pharmacovigilance in the US and EU, including analysis of major technological advances and proposed legislation
  • Recommendations on how companies can optimize their pharmacovigilance activities
  • Discussion of the changing pharmacovigilance environment with key stakeholders, including pharmaceutical company executives and physicians

Research and analysis highlights

Although the US has been considered to have a stronger pharmacovigilance system than the EU, new legislation implemented in the EU over the last two years has transformed pharmacovigilance regulations, with the EU finally catching up with the US system and even taking the lead in a number of ways.
It is necessary to take a more proactive approach to pharmacovigilance in the future. Over the last few years there has been a noticeable shift towards this driven by regulatory authorities, such as through their policy on risk management plans, and pharma companies, such as through the incorporation of pharmacogenomics in development programs.
It has become a essential for companies to increase the transparency of their activities and the communication of information about drugs, which was triggered by the lawsuit that Spitzer filed against GlaxoSmithKline in 2004, alleging that it withheld negative information about the use of Paxil (paroxetine) in children.

Key reasons to read this report

  • Get up to speed with recent developments in the pharmacovigilance systems in the EU and US
  • Assess the implications of regulatory and environmental changes that will shape the future of pharmacovigilance on your business
  • Understand the key steps necessary to optimize your pharmacovigilance activities

Reference Code: DMHC2150 (...)

Hvordan opplevde pasientene tilbaketrekkingen av Vioxx?

Hvordan opplevde pasientene tilbaketrekkingen av Vioxx?
Tidsskr Nor Lægeforen 2006; 126: 1326-7
Sammendrag
Bakgrunn. Tilbaketrekkingen av Vioxx (rofecoxib) fra verdensmarkedet på grunn av kardiovaskulære bivirkninger berørte mange pasienter og utløste store oppslag i mediene. (...)

Fortolkning. Medieoppslagene skapte angst og bekymringer blant pasientene, som mener de burde fått mer aktiv informasjon fra egen fastlege da Vioxx ble trukket. Med bedre rutiner og tilpasset dataverktøy kunne fastlegene møtt pasientenes ønske om tidlig informasjon. Forskrivning av rofecoxib på blåresept uten at formelle refusjonskriterier var godtgjort, kan ha vært utbredt. (...)

Få Vioxx-pasienter får erstatning

Få Vioxx-patienter får ersättning
lakemedelsvarlden.se 11.10.2007
Endast nio personer har hittills fått ersättning från Läkemedelsförsäkringen på grund av smärtläkemedlet Vioxx. För 108 personer anser försäkringen inte att sambandet mellan läkemedlet och sjukdom är klarlagt. (...)

I USA pågår flera rättegångar mot det amerikanska företaget Merck som sålde Vioxx. Enligt en artikel i New York Times från augusti i år har 45 000 personer stämt företaget i USA, men hittills har ingen person fått några pengar av företaget. (...)

Merck har brukt mer enn 1 milliard dollar på saksomkostninger for å bekjempe krav fra skadede pasienter

Plaintiffs Find Payday Elusive in Vioxx Cases
nytimes.com 21.8.2007
KEENE, Tex. — In Carol Ernst’s eyes, two years ago she won a measure of justice. (...)

But her comfort was premature. Merck, the third-largest American drug maker, appealed the verdict — which Texas laws on punitive damages automatically reduced to $26.1 million. Until higher courts rule on the appeal, Merck is not obligated to pay. So Mrs. Ernst, 62, has yet to receive any money.

In fact, none of the 45,000 people who have sued Merck, contending that they or their loved ones suffered heart attacks or strokes after taking Vioxx, have received payments from the company. The lawsuits continue, for now in a state of legal limbo, with little prospect of resolution.

In combating the litigation, Merck has made an aggressive, and so far successful, bet that forcing plaintiffs to trial will reduce the number of Vioxx lawsuits and, ultimately, its liability.

Promising to contest every case, Merck has spent more than $1 billion over the last three years in legal fees. It has refused, at least publicly, to consider even the possibility of an overall settlement to resolve all the lawsuits at once. (...)

Merck slipper billig

Merck Gets Off Cheap (Merck slipper billig)
forbes.com 9.11.2007
A few years ago it looked as if product liability battles might endanger the very existence of drug giants like Merck and Wyeth. Apparently not. (...)

If the deal really is ironclad, it represents a huge win for drug companies in general as they face potential liability on medicines that turn out to have side effects. The deal is estimated to cover perhaps 50,000 heart attacks, and those affected will get, on average, $125,000 each. Treating heart attacks costs far more than that. (...)

(Anm: Sakkyndige legers integritet, partiskhet og habilitet versus løgn.)

Merck Rises on Vioxx Deal
forbes.com 9.11.2007
(...) The widespread use of Vioxx meant the possibility of even greater legal costs. Merck faced lawsuits from 47,000 plaintiffs. Analysts earlier said that the legal liability could reach $50 billion.

Merck, however, was able to improve its bargaining position with strong showings in the courtroom. Of the seventeen cases that have gone to trial and reached a verdict, Merck has won 12. (...)

Minister dropper Vioxx-protest etter lobbying fra amerikansk legemiddelfirma

Merck defends Vioxx in court, as publisher apologises for fake journal (Merck forsvarer Vioxx i domstol, idet utgiver ber om unnskyldning for falskt tidsskrift)
BMJ 2009;338:b1914 (11 May)
Merck has begun the defence of its anti-arthritis drug rofecoxib (Vioxx) in the Federal Court of Australia, amid revelations that it lobbied to quash similar legal action in Britain, and as a publisher apologised for a journal sponsored by the company.

The United States based company is fighting a class action from more than 1000 Australians, led by Graeme Peterson, who had a heart attack in 2003 after taking rofecoxib for several years. (...)

On the eve of the company launching its defence in the Australian class action, in the United Kingdom the Guardian reported that Merck had run a campaign to "head off government support" for similar legal action there (www.guardian.co.uk/business/2009/may/04/merck-vioxx-campaign-parliament). It said that documents released under freedom of information legislation show that government ministers retreated from supporting people affected by rofecoxib, after a Merck campaign that involved a lobbying firm.
Asked about the alleged lobbying, Merck told the BMJ that the company had simply responded "properly" to comments made by a member of parliament. (...)

Ministers dropped Vioxx protest after lobbying from US drug firm (Minister dropper Vioxx-protest etter lobbying fra amerikansk legemiddelfirma)
guardian.co.uk 4.5.2009
Private lobbying by an American pharmaceutical company saw government ministers back down from supporting British people who claim one of its failed drugs caused them heart attacks and strokes.

A minister promised in parliament that the government would back their campaign against Merck, one of the world's largest drugs firms. But Whitehall documents obtained by the Guardian reveal Merck immediately put pressure on the minister and helped persuade the government to withdraw its support.
Merck is refusing to compensate hundreds of Britons who say their health was damaged even though the multinational has paid out more than £2bn to 44,000 people in America. (...)

- The Vioxx story really highlights the difference between marketing and informing

Vioxx Problems Known Years Before Recall
healthday.com 23.11.2009
Study points up weaknesses of drug approval process in United States, researcher says (...)

In a statement released Tuesday, Merck officials said this: "Merck believes the article published in The Archives of Internal Medicine in today's issue related to Vioxx used unreliable methods and reached incorrect conclusions."

"The first time Merck observed a difference in a placebo-controlled study was when it learned the results of the APPROVe study in September 2004. We voluntarily withdrew Vioxx from the market within a week of those results," the statement continued.

"Merck acted responsibly -- from researching Vioxx prior to approval in studies with approximately 10,000 patients to monitoring the medicine while it was on the market -- to voluntarily withdrawing the medicine when it did," the statement said. "Our decisions were based on the data from well-controlled clinical trials."
But the authors of the new study believe the Vioxx saga points to a larger problem, one that involves the drug approval process in the United States.

"One of the challenges in health care is to recognize these safety risks early," said lead researcher Dr. Joseph S. Ross, an assistant professor of geriatrics and palliative medicine at Mount Sinai School of Medicine in New York City. (...)

Bringing the FDA's Information to Market (Formidling av FDAs informasjon til markedet)
Arch Intern Med. 2009;169(21):1985-1987 (November 23)
Here is a challenge: Imagine you are asked to turn a new prescription drug into a blockbuster. The drug is approved by the US Food and Drug Administration (FDA) to treat arthritis pain. That is good news because the arthritis market is huge. But you face some big challenges. First, there are several over-the-counter drugs available that treat pain equally well and at one-fiftieth of the cost. Your only comparative advantage is that your drug causes less gastrointestinal tract (GI) bleeding than other arthritis pain medicines. But this reduction is not very big and only applies to a very small slice (probably <5%) of the market—people at high risk for GI bleeding. And, oh yes, your drug may triple the chance of myocardial infarction.

Do you think you could get physicians to prescribe your drug to over 20 million Americans? Could you achieve over $2 billion in annual sales? Well, the makers of Vioxx (Merck & Co Inc, Whitehouse Station, New Jersey) did just that—until the drug was pulled from the market.

Ross et al show how a cumulative meta-analysis might have led the FDA to halt sales of Vioxx in 2001, 3 years before Merck voluntarily stopped selling it. Doing so might have prevented thousands of myocardial infarctions. We applaud this study and hope that independent investigators will apply the same methods to other drugs to help answer important safety questions. But the article left us wondering, just how did Vioxx get so big and stay so big for so long?

-Vioxx-historien fremhever virkelig forskjellen mellom markedsføring og informasjon. Dersom leger og pasienter hadde hatt fakta hadde de hatt behov for en alkymist for å gjøre denne gråstein til gull, ikke en markedsføringsavdeling. (The Vioxx story really highlights the difference between marketing and informing. If physicians and patients had had the facts, it would have taken an alchemist, not a marketing department, to turn this lemon into gold.)

The problem is that when it comes to prescription drugs, a lot more effort goes into marketing than informing. It has been estimated that drug companies spend $30 billion to $50 billion a year on drug promotion (advertising, detailing visits, free samples, and other promotion techniques).1 That means that the industry can really get its message out. (...)

Diverse artikler

15 patienter får erstatning for behandling med gigtmedicin
dagenspharma.dk 22.10.2013
Patientforsikringen har udbetalt 7,4 mio. kr. i erstatninger i forbindelse med behandling med Cox-2-hæmmere. (...)

Australian court: Vioxx doubled heart attack risk
pharmpro.com 5.3.2010
The once-popular painkiller Vioxx doubled the risk of heart attack and was unfit for consumption, an Australian court ruled Friday, awarding a man leading a class action suit against the drug's maker 287,000 Australian dollars ($259,000) in compensation.

Melbourne Federal Court Judge Christopher Jessup's decision opens the door for claims from 600 other litigants in a lawsuit against U.S. pharmaceutical firm Merck & Co. over its since-recalled drug Vioxx. The painkiller was taken off the global market in 2004 after research showed it raised the risk of heart attacks and strokes. (...)

Merck: Last Vioxx Patient Payouts to be Made Soon
pharmpro.com 2.3.2010
TRENTON, N.J. (AP) — Drugmaker Merck & Co. has made its final, $4.1 billion payment into a fund to settle tens of thousands of U.S. claims that withdrawn painkiller Vioxx caused heart attacks or strokes, the company said in a regulatory filing Monday.

The final payouts to those patients or their survivors, from the $4.85 billion settlement fund, should be made by the end of June, according to the filing with the Securities and Exchange Commission.

About $4 billion of that was reserved for heart attack patients. Their claims have already been processed and either paid or denied. (...)

Risker med Vioxx kända tidigt
lakemedelsvarlden.se 24.11.2009
Redan fyra år innan det antiinflammatoriska Vioxx togs av marknaden fanns data som visade på risker med läkemedlet. Efter en analys av 30 studier av preparatet menar forskare att tydliga tecken visade att risken för hjärt-kärlrelaterade problem ökade med behandlingen.

Det är amerikanska forskare som har gått igenom 30 randomiserade placebokontrollerade studier av rofecoxib, den aktiva substansen i läkemedlet Vioxx. Preparatet kom ut på marknaden 1999 och marknadsfördes då av Merck som en nytt och säkrare alternativ till traditionella icke-steroida antiinflammatoriska medel. Men efter en tid blev det tydligt att personer som behandlades med rofecoxib löpte högre risk än andra att drabbas av hjärt-kärlsjukdomar och 2004 drogs det på grund av detta bort från marknaden.

Menforskarna bakom den nya analysen, som publicerats i Archives of Internal Medicine, en av JAMA-publikationerna, menar att riskerna med läkemedlet var kända redan flera år tidigare. Analysen innefattar totalt 20 152 patienter och studierna har varat från fyra veckor till fyra år. De doser som getts har varit mellan 12,5 till 50 mg. (...)

(Anm: Bringing the FDA's Information to Market. Arch Intern Med. 2009;169(21):1985-1987 (November 23).)

(Anm: Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data
Arch Intern Med. 2009;169(21):1976-1985 (November 23)
.)

US high court to decide if Vioxx lawsuits allowed (Amerikansk høyesterett avgjør om Vioxx-søksmål tillates)
businessweek.com 30.5.2009
The U.S. Supreme Court will decide whether shareholders can sue international pharmaceutical maker Merck & Co. because of the failure of its former blockbuster painkiller Vioxx.

The high court agreed Tuesday to review Merck's challenge to a federal appeals court's reinstatement of a class-action securities lawsuit. (...)

Ny chans för läkemedelsskadade
lakemedelsvarlden.se 14.5.2009
Ett nittiotal svenskar som anmält att de skadats av läkemedlet Vioxx får sina fall omprövade.

BIVERKAN De väntar nu på besked om ersättning för sina skador. Vioxx-skandalen kulminerade 2004 med att tillverkaren Merck drog tillbaka läkemedlet från världsmarknaden efter larmen om att den orsakade hjärtinfarkt och slaganfall. (...)

Vioxx ökar risk för hjärtinfarkt också på längre sikt
lakemedelsvarlden.se 14.10.2008
Efter den så kallade Approve-studien drogs cox 2-hämmaren Vioxx in från marknaden 2004 då det visade sig att läkemedlet ökade risken för hjärt-kärlsjukdomar. Nu kommer resultat från en uppföljningsstudie som stärker bevisen. (...)

Merck to start paying out on Vioxx settlement next month
pharmatimes.com 17.7.2008
Merck & Co says it is now ready to start issuing payments to claimants who joined in the $4.85 billion deal the firm set out last November to settle litigation relating to the withdrawn COX-2 inhibitor Vioxx.

The New Jersey-based firm stated “it is satisfied that the thresholds necessary to trigger funding of the programme” to resolve state and federal myocardial infarction and ischemic stroke claims concerning Vioxx (rofecoxib) will be met. More than 97% of eligible claimants now have initiated enrollment in the programme, which corresponds to more than 48,500 of the roughly 50,000 people who registered eligible injuries. (...)

Court overturns $32M Vioxx win against Merck
pharmatimes.com 15.5.2008
A Texan court has overturned a $32 million verdict issued in 2006 against Merck & Co in the latest news to come out of the ongoing Vioxx (rofecoxib) lawsuit.

Deeming the evidence to be “legally insufficient”, the jury unanimously agreed to dismiss the $7 million in compensation and $25 million in punitive damages first awarded against Merck to the wife of Leonel Garza. He suffered a fatal heart attack in 2001 alleged to have been caused by the COX-2 inhibitor Vioxx, which was withdrawn from the global market in 2004 after a study showed a doubling in the risk of heart attack and stroke after 18 months’ treatment. (...)

GPs have got Britain 'hooked on painkillers' (Allmennpraktiserende leger har gjort Storbritannia "hektet"på smertestillende preparater)
guardian.co.uk 10.2.2008
• Inquiry slams mis-prescribing of drugs
• Doctors 'ignoring official guidelines'

Doctors are unwittingly fuelling the growing number of Britons hooked on prescription drugs by giving patients dangerously high doses of medicines that can prove highly addictive, a parliamentary inquiry has concluded.

MPs say that 'mis-prescribing' of drugs such as painkillers, sleeping tablets and anti-anxiety pills by some doctors is 'leading to addiction and dependence'. (...)

No End in Sight for Vioxx Suits
chron.com 28.9.2007
TRENTON, N.J. — Three years after Merck & Co. pulled its blockbuster painkiller Vioxx from the market due to increased heart attack and stroke risk, there's no end in sight for the massive litigation it ignited.

Shortly after Vioxx was withdrawn on Sept. 30, 2004, stock analysts said Merck's liability could reach $50 billion, and doomsayers predicted Merck's demise.

Neither look possible now, as Merck has won nine of the 14 of product liability trials resolved so far and had other key victories, including beating back two multibillion-dollar class-action lawsuits, on behalf of shareholders and private insurers seeking to recoup what they paid for Vioxx prescriptions.

Still, legal experts say it will be a few years before it is clear how the Vioxx saga will end. (...)

Merck Wins N.J. Court Ruling on National Vioxx Case (Update4)
bloomberg.com 6.9.2007
Sept. 6 (Bloomberg) -- Merck & Co. doesn't have to defend a national class-action lawsuit seeking as much as $9 billion over claims it misled health insurers about the safety of its painkiller Vioxx, the New Jersey Supreme Court ruled. (...)

Merck Vioxx heart risks began sooner: WSJ
today.reuters.com 3.7.2007
NEW YORK (Reuters) - Heart risks associated with Merck & Co.'s painkiller Vioxx began much sooner than the company has claimed, The Wall Street Journal Online reported on Tuesday, citing a new study. (...)

New Vioxx Study May Cast Doubt On Merck Claims
online.wsj.com (3.7.2007)
In a new blow to Merck & Co.'s defense in the Vioxx litigation, results from a yet-to-be-published study suggest that increased heart risks associated with the painkiller began immediately after patients started taking the drug. (...)

Judge orders Merck to pay $4M in fees
euro2day 18.6.2007
ATLANTIC CITY, N.J. (AP) - Lawyers who helped a heart attack victim win a $13.5 million jury verdict in a Vioxx liability case should be paid about $4 million in legal fees by Merck & Co., a state judge has ruled. (...)

FDA Colludes With Merck To Avoid Vioxx Liability - Part I
By Evelyn Pringle
lawyersandsettlements.com 12.6.2007
Washington, DC: The FDA is still helping Merck escape liability for the Vioxx disaster. Texas Judge Randy Wilson, who is overseeing the Texas state court proceedings, recently granted Merck's motion to dismiss possibly thousands of lawsuits, essentially because the FDA refuses to acknowledge that Merck concealed information about the safety risks of Vioxx. (...)

Rulings in Barnett and Plunkett Vioxx cases
pointoflaw.com 7.6.2007
Judge Fallon issued two rulings in the MDL Vioxx docket in the last week.
In Barnett, he accepted the plaintiffs' request for remittitur as an alternative to a new trial on damages, and held that compensatory damages be limited to $600,000. As we noted when the original $50 million award was tossed:
Judge Fallon threw out the $51 million damages award in Barnett v. Merck, correctly noting that it was "excessive under any conceivable substantive standard of excessiveness." In one of the mysteries of American law, because the $50 million "compensatory" damages award was based on "passion or prejudice," the punitive damages award of $1 million was also thrown out—but Fallon refused to presume that the jury's factual findings are not similarly afflicted with "passion or prejudice," even though they were made at the same time, so the liability verdict stands.

Except, at least for now, even the $1 million punitive award stands. Plaintiffs have signalled that they will accept the new award, and Merck will appeal to the Fifth Circuit. (...)

Vioxx Damage Award
nytimes.com 6.6.2007
A judge who threw out a $51 million damage award against Merck last year over its Vioxx painkiller reversed himself and awarded $1.6 million to the plaintiff, a former F.B.I. agent who blamed the drug for his heart attack. (...)

Federal judge orders 3rd trial in case against Vioxx maker Merck
chron.com 30.5.2007
NEW ORLEANS — A federal judge has ordered a third trial in a lawsuit by a woman who blamed Merck & Co.'s painkiller Vioxx for the heart attack that killed her husband. (...)

Jurors in that trial ruled in favor of Merck and against Evelyn Irvin Plunkett, whose first husband, Richard "Dickie" Irvin, died of a heart attack after taking Vioxx for less than a month.

Lawyers learned about the ruling Wednesday. It had been signed Tuesday, but was made available on the Internet a day later. (...)

Merck Has No Plan To Pay Vioxx Victims
lawyersandsettlements.com 30.4.2007
Newark, NJ: In 2006, Merck spent $500 million, including $175 million in the fourth quarter, in legal defense costs worldwide related to Vioxx litigation, according to SEC filings.

In addition, after reviewing actual costs and estimating future costs, the company says it has recorded a charge of $75 million to increase the reserve for future defense costs related to Vioxx to $858 million as of December 31, 2006.

However, although the legal team obviously plans to get paid well, there is no indication that Merck plans to pay any money to people injured by Vioxx because, according to the filing, Merck has not established any reserves for potential liability related to Vioxx.

Judging by the win-lose scorecard for Vioxx, it appears that juries are ignoring Merck's culpability in placing a lethal drug on the market with full knowledge that people would be injured and killed and that 100s of thousands of Americans were in fact injured and killed. (...)

Judge's ruling could hamper lawsuits against drug companies
khou.com 16.4.2007
A jury awarded more than $250 million in damages to Carol Ernst, a woman who blamed Vioxx for the heart attack and death of her husband.
Joseph Halcomb is one of thousands of others who filed suit. (...)

“It’s about every pharmaceutical case in the state of Texas. It’s unfortunate because the legislature did not intend to take away from the Texas citizens the right to sue for failure to warn when the FDA has been lied to and misled,” Fibich said. (...)

Analysts puzzle over plan to sell a Vioxx-like drug
boston.com 30.3.2007
Furor over the Merck product spurred push to tighten FDA rules

WASHINGTON -- Some analysts are scratching their heads at the move Merck & Co. is planning : The drug maker wants to sell a new painkiller that is just like Vioxx, the blockbuster drug it pulled from the market in 2004 because the treatment doubled heart risks. (...)

British plaintiffs in Vioxx suit argue to move case back to the U.S. courts
nj.com 29.3.2007
Thursday, March 29, 2007
Merck's court battle over Vioxx is spawning more cases all the time. (...)

10th win for Merck on Vioxx
chicagotribune.com 27.3.2007
Madison County jury gives drug giant 1st Midwest victory

The maker of Vioxx, the pain medication pulled from the marketplace after being linked to heart attacks and strokes, chalked up its 10th victory Tuesday in Madison County, Ill., whose courts are known nationally for being friendly to people suing companies. (...)

Merck has set aside $858 million for future legal defense costs related to Vioxx. (...)

The Schwallers' family lawyer, Mikal Watts, said he has no plans to alter course as a result of the setback. He said he is involved in more than 2,000 other Vioxx cases.

"No one case is going to speed up or retard the litigation," said Watts, who added that Merck still faces the potential for massive financial losses.

Watts said the company has lost big with judgments of more than $20 million. "If they want to try 30,000 cases … there are consequences for failure," Watts said. "The Vioxx litigation is a marathon." (...)

Vioxx case puts spotlight on FDA drug approval process
stltoday.com 23.3.2007
EDWARDSVILLE — Drugmaker Merck studied its blockbuster painkiller Vioxx well beyond the minimum federal requirements. At all times, the pharmaceutical giant says, it was in contact with the Food and Drug Administration. (...)

'Bastards,' he said
Merck had the results in the spring of 2000, and they were detailed in an article in the New England Journal of Medicine later that year. Two years later, Vioxx's label was updated to include the information.

The label changes were negotiated between the FDA and Merck. At one point, highlighted in court trials, outspoken senior Merck scientist Edward Scolnick called a proposed warning "ugly cubed" and denounced FDA regulators as "bastards." When notice of the updated label was sent to doctors, it included the new study data as a precaution, but no concrete warning was given implying risk. (...)

Witness claims Vioxx did not cause heart attack
zwire.com 19.3.2007
EDWARDSVILLE - A prominent heart specialist testified Monday that Vioxx did not cause the death of a Granite City woman and does not appear to cause heart attacks in any patients. (...)

Merck executive testifies on Vioxx
stltoday.com/ 16.3.2007
EDWARDSVILLE — An executive for drugmaker Merck told a jury Thursday in Madison County that the data available on the painkiller Vioxx even a year after its release still didn't indicate any increased heart risks. (...)

Weitz & Luxenberg Hails $47.5 Million Vioxx Verdict against Merck - Class Action Lawsuits
lawfuel.com 14.3.2007
NEW YORK--LAWFUEL - Class Actions --On March 12, 2007, an Atlantic City, NJ jury unanimously awarded a $47.5 million verdict against Merck & Co. in its most recent Vioxx trial. Weitz & Luxenberg, P.C. congratulates the plaintiffs, Frederick Humeston, and his wife, Mary, as well as all of the attorneys responsible for this great success.

The jury awarded $18 million in compensatory damages to Humeston for his heart attack, $2 million to his wife for loss of consortium and $27.5 million in punitive damages, finding that Merck acted recklessly in promoting its dangerous pain-reliever Vioxx. Humeston proved that Merck knew of Vioxx's dangerous side effects, yet failed to warn prescribing physicians of those dangers. The jury also found that Merck committed consumer fraud by misrepresenting and omitting critical safety information about Vioxx. (...)

N.J. Jury Awards $20M to Vioxx User Who Suffered Heart Attack
law.com 13.3.2007
An Atlantic City, N.J., jury on Monday awarded $18 million in compensatory damages to a former user of the painkiller Vioxx, and $2 million to his wife, finding Merck & Co.'s failure to warn of the drug's cardiovascular risks substantially contributed to his heart attack. (...)

Merck & Co to appeal after defeat in latest Vioxx case
pharmatimes.com 13.3.2007
Merck & Co has suffered a setback in its ongoing legal battles over the painkiller Vioxx after a jury in New Jersey ordered the firm to pay $47.5 million in damages after finding that the drug was responsible for a plaintiff's heart attack. (...)

Medical experts take the stand for Vioxx plaintiff
stclairrecord.com 7.3.2007
A plaintiff's expert witness in Madison County's Vioxx trial testified that he has billed nearly $140,000 for his services on Vioxx cases.

In the trial's second week, Dr. Mark Furman of the University of Massachusetts Medical School told jurors he bills $400 per hour for reading medical records; $500 per hour when being deposed and $750 per hour when testifying in court. (...)

Lanier asked Anstice if Merck rushed Vioxx to the market so that executives like himself could still be paid millions of dollars and so the power bill could be paid.

Anstice responded by telling Lanier Vioxx was highly invested in because of the benefits it could provide to patients.

Lanier also accused Merck of giving doctors free dinners so they would write prescriptions. He also said that Merck employed the largest sales force in their history to promote Vioxx and gave more free samples to doctors than at any other time.

When Dr. Kopjas testified, he said that it was normal for "all" drug companies to take doctors to dinner and to give them free samples.

Merck executives are expected to testify on Thursday. (...)

Trial Attorney Says Merck is 'Step Closer to Accountability' as VIOXX Trial Continues
prnewswire.com 7.3.2007
Attorney Mark Lanier: 'Merck Can't Turn a Loss Into a Win Just By Saying
It's So' (...)

-- A jury on Friday in New Jersey Superior Court imposed a serious and strong verdict against Merck & Co., finding that the manufacturer of VIOXX(R) withheld information and made misrepresentations to doctors and to the public about the heart attack risks associated with the drug.

The jury unanimously confirmed four counts of fraud in the marketing of
VIOXX(R) making Merck liable for millions of dollars in damages, attorney
fees and expenses. Also, the jury unanimously found that Merck failed to
adequately warn patient Mike Humeston about the dangers posed by Vioxx. (...)

Mixed verdict in latest Vioxx battle
pharmatimes.com 5.3.2007
It was good news and bad news for Merck & Co on Friday, after a jury in New Jersey issued split verdicts in two cases regarding the US drugmaker's embattled COX-2 inhibitor Vioxx (rofecoxib), which was taken off the market in 2004 because of heart risks. (...)

Drugmaker was cautious in marketing Vioxx, lawyer tells jury
stltoday.com 2.3.2007
EDWARDSVILLE — Merck intensely studied blockbuster painkiller Vioxx before its release, rapidly warned doctors as safety concerns arose and eventually pulled the drug from the market entirely on its own, a defense lawyer told jurors Thursday in Madison County's high-profile Vioxx case. (...)

Lawyer Andy Birchfield said because of potential complications, Vioxx was the last thing an at-risk woman like Schwaller should have been taking. He also attacked the corporation's marketing of the drug and accused it of spinning news coverage and quashing criticism. (...)

High cholesterol raises stroke risk healthy women
reuters.com 19.2.2007
- Among women with no history of major illness, those with high cholesterol levels are significantly more likely to suffer a stroke, investigators in Boston report. (...)

Vioxx ska granskas igjen
dn.se 18.2.2007
Fler svenska patienter som fått biverkningar av läkemedlet Vioxx kan komma att få ersättning från Läkemedelsförsäkringen. Läkemedelsskadenämnden har tillsatt en arbetsgrupp som ska över de senaste forskningsrönen kring Vioxx biverkningar. (...)

New pain relievers boost blood pressure more
paktribune.com 17.2.2007
ISLAMABAD: Arthritis drugs known as COX-2 inhibitors raise blood pressure more than older pain relievers, which may explain why the newer medicines have been linked to heart attacks, Australian researchers reported. (...)

Painkillers, cholesterol linked (Smertestillende linket til kolesterol)
newsday.com 13.2.2007
Vioxx, Bextra forårsaker oppbygning av fettstooofer, med mulig hjerterisiko (Vioxx, Bextra found to cause lipid buildup, possible risk to heart)

Certain pain-relieving drugs that belong to a group of medications called COX inhibitors may impair the ability of human blood cells to rid themselves of cholesterol, according to research published Jan. 23 in the journal Arthritis Research & Therapy. (...)

Vioxx trial puts Louisiana in top 10 jury awards list
neworleanscitybusiness.com 12.2.2007
(...) In the second-largest Vioxx verdict to date, a federal jury in New Orleans awarded $51 million to a 62-year-old retired FBI agent who suffered a heart attack after taking the pain-killer Vioxx for 2 1/2 years. The damages portion of the case will be retired.

Lawyers USA reports the average 2006 damage verdict was one-third the average of the previous year. The average verdict in 2005 was half the 2004 average. (...)

The FDA and Congress Must Heed the Voices of Patients and Doctors
wsj.com (10.2.2007)
In regard to your Feb. 3 editorial "Orthopedists for Vioxx" concerning access to prescription drugs, I am writing on behalf of the 46 million Americans, including 300,000 children, who suffer from arthritis. They, perhaps more than any other group, have been adversely affected by the withdrawal of Vioxx, and their future is at stake in the current debate about reform at FDA and access to medication.

Your editorial called upon members of Congress to listen to what doctors have to... (...)

Judge changes mind over penalty for Merck lawyer
app.com 8.2.2007
— Merck & Co.'s lead attorney at a trial over its painkiller Vioxx was fined $1,000 yesterday and cited for contempt of court by a judge who changed her mind today and withdrew the punishment.

Superior Court Judge Carol Higbee sanctioned attorney Diane Sullivan in an Atlantic City trial on whether Vioxx caused two men's heart attacks. Higbee reversed herself in a written order today. Sullivan asked a plaintiff's expert about a government study the judge told her not to discuss. (...)

Business books: Ego Check; From New Recruit to High-Flyer
dallasnews.com 5.2.2007
Kidding themselves about their situation. Merck managers knew the cardiovascular warning signs of Vioxx as early as 1997. Merck took the low road, investing more than $500 million in marketing Vioxx. Five years and countless lawsuits later, the drug was withdrawn from the market. (...)

Orthopedists for Vioxx
wsj.com (3.2.2007)
The withdrawal of Merck's Vioxx from the market in 2004 led to Congressional demands for tougher FDA regulation and an explosion of litigation against the pharmaceutical industry. So it might interest readers to know that 80% of orthopedic surgeons surveyed in a new poll released by the Competitive Enterprise Institute think the painkiller should be back on the market.
That finding isn't all that surprising. These physicians work regularly with people suffering ... (...)

Merck net drops 58 percent in Q4
localnewsleader.com 30.1.2007
TRENTON, N.J. - Merck & Co. reported Tuesday that fourth-quarter profit plunged 58 percent despite higher revenues as the drugmaker took a slew of charges for restructuring costs, an acquisition and increased legal reserves, mainly for its withdrawn painkiller Vioxx . (...)

Earnings Preview: Merck & Co
businessweek.com 29.1.2007
Merck & Co. reports earnings for its fourth quarter on Tuesday. The following is a summary of key developments and analyst opinion related to the period.
OVERVIEW: Merck ended the year with about 27,200 personal injury lawsuits for the discontinued arthritis drug Vioxx, with reserves of nearly $1.6 billion for legal defense costs. (...)

COX-2 drugs may raise risk of repeat heart attack
reuters.co.uk 29.1.2007
NEW YORK (Reuters Health) - A large study confirms that Vioxx (rofecoxib), but not Celebrex (celecoxib), is associated with increased risk of a first heart attack. However, people with a prior heart attack may be at increased risk for experiencing another if they use either selective COX-2 inhibitor, the research indicates. (...)

Merck Lawyer Admonished for Arguments in Vioxx Trial (Update2)
bloomberg.com 23.1.2007
Jan. 23 (Bloomberg) -- Merck & Co.'s lead attorney at a New Jersey trial over its Vioxx painkiller acted unethically and unprofessionally in court yesterday during her opening statements, the judge said. (...)

What have we learnt from Vioxx?
BMJ 2007;334:120-123 (20 January),
In October UK patients who had cardiovascular events while taking rofecoxib lost the right to fight Merck in the US for compensation. But researchers and journals can still benefit from this case if they learn from the mistakes, write Harlan Krumholz and colleagues (...)

Judge cuts cases for next Vioxx trial
iht.com 15.1.2007
NEWARK, New Jersey: The drug maker Merck has persuaded a New Jersey judge to reduce to two from four the number of cases a jury will hear at the next trial over claims that its Vioxx painkiller caused heart attacks. (...)

Merck Judge Reduces Next Vioxx Trial From Four Cases to Two
bloomberg.com 13.1.2007
-- Merck & Co. persuaded a New Jersey judge to reduce from four to two the number of cases a jury will hear at the next trial over claims the company's Vioxx painkiller caused heart attacks. (...)

Texas judge cuts Vioxx award to $7.75M
businessweek.com 21.12.2006
A judge in a Texas widow's lawsuit regarding the Merck & Co. drug Vioxx on Thursday reduced a $32 million jury verdict to about $7.75 million, citing Texas' recently enacted caps on punitive damages. (...)

Latest Vioxx trial nears end
businessweek.com 13.12.2006
(...) Lawyers for Merck & Co. on Wednesday attacked the credibility of a man who blames his 2003 heart attack on the withdrawn painkiller Vioxx. (...)

Merck said it faces about 27,200 personal injury lawsuits over Vioxx, representing about 45,900 plaintiff groups, plus 265 potential class-action lawsuits. (...)

Merck's Battle-all-the-way Legal Strategy In Vioxx Cases Seems To Be Paying Off
theday.com 6.12.2006
(...) “A very bad day for Merck,” said one industry analyst.

In the months since, however, the great Vioxx turkey shoot has not materialized. Merck's strategy of taking every case to trial has resulted in more victories than losses. A Nov. 15 jury verdict absolving the company of blame for the heart attack of a 61-year-old Utah man was its seventh win overall and third in four federal trials. Another 10 cases set for trial have been dismissed.

Merck views those as wins, too, because the suits either cannot be refiled or aren't likely to be.

“You can never predict what one individual jury will do — there are some ups and downs — but we like our chances before a jury,” said New York attorney Ted Mayer, who is overseeing Merck's nationwide Vioxx litigation. “We do believe strongly in our message. We're encouraged that some of the juries are responding.”

Mark Lanier, a Houston plaintiff lawyer who represented Ernst and notched another big Vioxx win in New Jersey in April, said it is too early to sense a trend in the litigation, and added that he is not discouraged by Merck's recent triumphs.

“Any time you've got a mass tort action, historically the plaintiffs lose a lot of the first 10 to 12 cases,” Lanier said. “It takes you awhile to read through 8 million documents, learn the science and the scientists who invented the drug, and get the company's story all lined up.” (...)

Suit: Vioxx maker liable for mom' death
news-journalonline.com 4.12.2006
"Despite the risks, Merck continued to conceal or minimize the cardiovascular risks associated with Vioxx," said Bill Ogle, an attorney in Daytona Beach for the Golin family.

The company and the Food and Drug Administration have defended their actions in numerous lawsuits brought since the drug introduced in 1999 was withdrawn from the market in late 2004. Merck has won four of the seven cases to reach verdicts, including one for $50 million this summer, but still faces more than 21,000 Vioxx lawsuits like Golin's, up sharply from the 14,200 lawsuits reported in June. (...)

Merck Wins Latest Vioxx Suit
chron.com 15.11.2006
NEW ORLEANS — Evidence brought out the trial in 11th case alleging that Merck & Co. covered up dangers of its painkiller Vioxx shows just why the company wants to try each of the thousands of lawsuits on its own, company attorneys say. (...)

Merck CEO says any Vioxx settlements years away (Merck uttalte at forlik er mange år unna)
reuters.com 8.11.2006
NEW YORK (Reuters) - Merck & Co. (MRK.N: Quote, Profile, Research) Administrerende direktør Richard Clark sa på onsdag at det kunne gå flere år før de vurderte å forlike tusener av søksmål fra mennesker som hevder de er skadet av det tilbaketrukne atrititt-llegemidlet Vioxx. (Merck & Co. (MRK.N: Quote, Profile, Research) Chief Executive Richard Clark said on Wednesday it could be several years before it considers settling thousands of lawsuits brought by people who claim to have been harmed by its withdrawn arthritis drug Vioxx.)

I tillegg opplyste Clark på Reuters Healths toppmøte i New York at Merck undersøker om de skal bringe Vioxx tilbake på markedet. (In addition, Clark told the Reuters Health Summit in New York that Merck was still looking into bringing Vioxx back to the market.)

"Vi evaluerer dette, og førsøker å komme frem til en endelig konklusjon," sa Clark, som tilla at han hele tiden får brev fra pasienter som sier at Vioxx var det eneste som hjalp mot smerten. ("We're still evaluating that, and trying to make a final decision," Clark said, adding that he gets letters all the time from patients saying that Vioxx was the only thing that helped their pain.)

"Deres livsstil er forandret" uten Vioxx, sa han. (...) ("Their lifestyles have changed" without Vioxx, he said.)

Judge Orders Merck to Reveal Trial Cost,
chron.com 17.10.2006
NEW YORK — A N.J. judge ordered Merck & Co. on Tuesday to release records on how much it spent on a trial involving its Vioxx painkiller.

The information would provide a window into how much Merck spends on its trials, and what its legal defense costs could be in the future. More than 21,000 suits have been filed against Merck, which has vowed to try each case over Vioxx.

So far, Merck has reserved $970 million for legal costs and spent $285 million of that last year. (...)

Vioxx-Like Risks Linked to Another Pain Pill
latimes.com 13.9.2006
A report says diclofenac increases the chance of a heart attack. The FDA calls for further review. (...)

(Anm: Diklofenak og hjerteinfarkt (legemiddelverket.no 13.9.2006).)

(Anm: Diclofenac; fornorsket: diklofenak; markedsføres under handelsnavn som bl.a. Voltaren, Voltarol, Diclon, Diclodan, Dicloflex, Difen og Cataflam (pdr.net).)

(Anm: Vanlige smertestillende legemidler linket til en høyere risiko for hjerteproblemer. Common Pain Meds Are Linked to a Higher Risk of Heart Problems. Ibuprofen and other common painkillers are linked to an increased risk of cardiac arrest, according to a new Danish study published in the European Heart Journal—Cardiovascular Pharmacotherapy. The authors say these drugs should be used with caution and that people with heart problems may want to avoid them. (time.com 15.3.2017).)

(Anm: Diklofenak og ibuprofen er assosiert med øket risiko for hjertestans. Diclofenac and ibuprofen are associated with increased risk of cardiac arrest. Use of the non-steroidal anti-inflammatory drugs (NSAIDs) diclofenac and ibuprofen are associated with a significantly increased risk of cardiac arrest, a large Danish study has found. The authors of the study, which was reported in the European Heart Journal: Cardiovascular Pharmacotherapy,1 said that the findings were a stark reminder that NSAIDs were not harmless and should only be used after consulting a healthcare professional. BMJ 2017;356:j1358 (Published 16 March 2017).)

(Anm: Medisiner hjelper lite mot ryggsmerter. En ny studie viser at medisiner som Ibux og Voltaren ikke hjelper noe særlig mot akutte ryggsmerter. Eksperter mener det bør forskes mer på andre behandlingsmetoder. (nrk.no 4.2.2017).)

(Anm: Forskningschef: Gigtmidlet diclofenac bør ikke bruges. Hjerteforeningens forskningschef Gunnar Gislason mener, at der for hjertepatienter er høj risiko ved brugen af gigtmidlet diclofenac, og den modsvarer ikke effekten. (hjerteforeningen.dk 17.3.2016).)

(Anm: Diclofenac tablets now only available as a prescription medicine (medicalnewstoday.com 14.1.2015).)

Merck workers told not to dicuss Vioxx
courierpostonline.com 12.9.2006
Merck & Co. has agreed to tell its U.S. employees to immediately stop leaving messages about the painkiller Vioxx on the drug company's voice-mail system, according to an order from a New Jersey judge. (...)

Lawyer Says Merck Lost Sight of Truth
chron.com 11.9.2006
NEW ORLEANS — Drug maker Merck & Co. lost sight of the truth and patient safety in its zeal to promote blockbuster painkiller Vioxx, a lawyer for a man who blames his 2003 heart attack on the drug told a jury Monday. (...)

Merck Not Losing Sleep Over Vioxx Disaster
Evelyn Pringle
sierratimes.com 20.6.2006
Merck's top management team reportedly remains unphazed by Vioxx litigation woes. In fact, Prudential Equity Group analyst, Timothy Anderson, says Merck's Chief Executive, Richard Clark, specifically told him that “Vioxx does not keep him up at night.”

According to Mr Anderson, "the company believes that lower court cases will be overturned on appeal, and it is even considering trying to reintroduce Vioxx."

“A reintroduction might help Merck's legal case,” Mr Anderson states, “as long as the FDA or its advisers do not decide that Merck's risks really do outweigh its benefits,” he said in a June 21, 2006, article in Forbes.com,”

Critics say, that's not even a remote possibility because the FDA is still under fire for its own part in the Vioxx disaster and it wouldn’t dare pull a stunt like that. (...)

Witness says studies showed Vioxx users at risk of heart ailments
mercurynews.com 6.7.2006
LOS ANGELES - Patients who took the painkiller Vioxx were at risk of heart attacks and stroke - something shown by studies conducted before the product went on the market, a doctor testified Wednesday.

Dr. Lemuel Moye, a physician and professor of biostatistics at the University of Texas, took the witness stand as the first Vioxx liability trial in California entered its second week.

Moye concluded the painkiller carried more risk than benefits to patients after he reviewed clinical trials conducted by Vioxx maker Merck & Co. dating back to 1996.

"Vioxx is a hazard for a stroke and for heart attack," Moye testified. (...)

Forget Vioxx?
forbes.com 21.6.2006
What if the albatross around Merck's neck is an illusion? (...)

Lawyer: Merck Scrapped Study on Vioxx
forbes.com 16.6.2006
Merck & Co. scrapped a planned study of the cardiac safety of Vioxx once it knew U.S. regulators were going to tone down their warning about heart risks for patients taking the painkiller, a plaintiff's lawyer argued Friday in a product liability trial. (...)

Flere kan få Vioxx-erstatning
aftenposten.no 29.5.2006
Nye data tyder på at medisinen Vioxx gir risiko for slag og hjerteinfarkt raskere enn produsenten Merck hittil har hevdet. (...)

Ulogisk grense.
Merck har benektet at de nye opplysningene tyder på tidligere bivirkninger, men har møtt motbør.

- Hvorfor skulle en medisin ikke gi bivirkninger i 18 måneder, og så plutselig gi bivirkninger, spør kardiolog Steven Nissen ved Cleveland Clinic til National Public Radio.

Dette synet støtter både Steinar Madsen i Legemiddelverket og professor i kardiologi ved Aker universitetssykehus, Dan Atar.

- Jeg tror det var tilfeldig at den økte risikoen viste seg først etter 18 måneder. Det er ingen logikk i at det først skal skje så sent, sier Atar. (...)

The Vioxx Maelstrom
forbes.com 22.6.2006
NEW YORK - With all the sturm und drang surrounding the release of new data from the study that caused Vioxx to be pulled from the market, you'd think that there would be some answers about the drug's real public health risks. (...)

Fler Vioxx-patienter kan få ersättning
dn.se 20.5.2006
Fler svenska patienter som drabbats av biverkningar av smärtmedlet Vioxx kan komma att få ersättning. Nya uppgifter visar nämligen att risken att drabbas av hjärtinfarkt eller stroke ökade redan efter två veckors användning.

FORSKARE I KANADA har undersökt ett behandlings- och sjukvårdsregister omfattande över 110.000 slumpvis utvalda personer över 66 år som fått smärtlindrande läkemedel. Det visar sig att risken att drabbas av hjärtinfarkt eller stroke var högre hos dem som använde Vioxx och att en fjärdedel av dem som drabbades gjorde det redan inom två veckor efter att behandlingen påbörjats. Resultatet är förvånande eftersom tidigare studier visat en ökad risk först efter arton månaders användning.

- Undersökningen är välgjord och visar att det finns en undergrupp i befolkningen som verkar vara extra känslig för behandling med Vioxx, säger Dag Thelle, professor i hjärt-kärlepidemiologi och överläkare vid Östra sjukhuset i Göteborg. (...)

Vioxx stroke risk could last years: health expert
reutershealth.com 19.5.2006
NEW YORK (Reuters) - Former users of Merck & Co.'s Vioxx arthritis drug could be at risk of developing strokes for years, a prominent public health expert said on Thursday after examining new data from the drug maker.

"It may be that Vioxx is causing permanent damage to the cardiovascular system, accelerating atherosclerosis or a sustained increase in blood pressure," said Dr. Curt Furberg, a member of the U.S. Food and Drug Administration's Drug Safety and Risk Management Advisory Committee.

Furberg, a professor of public health at Wake Forest University, said his stroke concerns stem from a new 107-page report on patients who were followed for a year after they stopped taking Vioxx. Furberg made his comments in response to questions from Reuters.

The drug, used by 20 million Americans, was recalled in late 2004 after it was shown to double heart attack risk among patients taking it 18 months or longer in Merck's so-called APPROVe trial of the drug.

Merck issued a news release last week that briefly described the lengthy report, and made the report available to Reuters on Thursday. (...)

Vioxx farlig i åratal
sydsvenskan.se 19.5.2006
Smärtläkemedlet Vioxx kan vålla slaganfall flera år efter det att patienterna lagt av med det.
New York. De nya rönen redovisades i går av en ledande expert inom hälsovård, Curt Furberg, som arbetar med medicinska säkerhetsfrågor hos USA:s läkemedelsverk FDA. Furberg har gått igenom material som han fått ut från tillverkaren Merck.

- Kanske orsakar Vioxx permanenta skador i hjärt-kärlsystemet, påskyndad åderförkalkning (ateroskleros) eller förhöjt blodtryck.

Bakom uppgifterna ligger en uppföljande studie av patienter som slutat med läkemedlet. Enligt studien har 28 patienter dött av hjärtinfarkt eller slaganfall ett år efter det att de slutat ta Vioxx. På samma tid avled 16 patienter från en kontrollgrupp som fått något verkningslöst preparat.

Vioxx hörde till den nya generationen av smärtlindrare, avsedda främst för reumatiker som inte tålde eller inte fick tillräckligt lindring av äldre preparat. Enbart i USA tog 20 miljoner människor Vioxx tills Merck drog tillbaka det 2004 på grund av de allvarliga riskerna. Då blev det känt att risken för hjärtattack fördubblades när man ätit av medicinen i 1,5 år. (...)

Merck data suggests earlier onset of Vioxx risks
money.cnn.com 18.5.2006
Data suggest the cardiovascular risks associated with Vioxx begin after only four months, says a report. (...)

Report: Vioxx risk seen with short-term use
msnbc.msn.com 18.5.2006
Data showed all patients who took painkiller faced increased heart risk

- Merck & Co. Inc. has provided new data to U.S. regulators showing that all patients who took the arthritis medicine Vioxx were at increased risk of heart attacks, strokes and other complications, National Public Radio reported Wednesday.

Merck, which disputed the report, withdrew Vioxx from the market in September 2004 after a study showed the drug doubled the chances of heart attacks and strokes in patients who took it for at least 18 months.

A 107-page report provided to the Food and Drug Administration by Merck last week included data from a four-year study suggesting the risk started much earlier, NPR said.

“Experts who have reviewed (the data) for NPR say it shows that patients were at higher risk of heart problems and strokes almost as soon as they started taking Vioxx,” NPR said.

Merck, which is facing thousands of lawsuits alleging harm from Vioxx, disagreed with NPR’s description of the report. (...)

Vioxx lawsuits dismissed
theglobeandmail.com 16.5.2006
— A federal judge has dismissed a group of shareholder lawsuits that charged Merck & Co. officers and directors with violating their duties by concealing the health risks of the company's Vioxx painkiller. (...)

Follow-Up Study on Vioxx Safety Is Disputed
nytimes.com 13.5.2006
Two prominent medical researchers are taking issue with Merck's conclusion that a follow-up study of patients who took the painkiller Vioxx shows that the drug posed no "statistically significant" risk to the heart once people stopped taking it.

Merck announced its conclusion on Thursday in reporting on the health of patients in a Vioxx study a year after that study was suspended in September 2004.

The company ended that study because a disproportionate number of people taking the drug were having strokes or heart attacks. At the same time, Merck took Vioxx off the market. Since then, lawyers have filed thousands of lawsuits on behalf of former Vioxx patients or their families.

The two independent medical researchers said in interviews yesterday that Merck might have been premature in reaching the conclusion announced Thursday, in part because the patients in the study needed to be monitored for longer than one year. (...)

More Murk For Merck
forbes.com 11.5.2006
Pharmaceuticals Merck released new data about its now-withdrawn drug Vioxx, leaving open the possibility that the drug continued to increase patients' risk of heart attack and stroke for some time after they stopped taking it.

Merck says the data show that the heart risk from Vioxx does not persist, because the difference in outcomes between patients who stopped taking the drug and patients who stopped taking a placebo is not statistically significant. But responses from scientists and a Wall Street analyst were all over the map.

"I don't think these results help," says Timothy Anderson, an analyst at Prudential Equity Group. The fact that the study wasn't designed to deliver statistically significant results during the last year "undermines" Merck's point, and numerically, the trends went against Vioxx. The data are a wash, according to Anderson. "The outcome could have been worse."

Steven Nissen, interim chairman of cardiology at the Cleveland Clinic and an early Vioxx critic, describes the data as "troubling," adding that "they show that the relative risk persists during the year following discontinuation of Vioxx."
Particularly troubling for Merck investors is the company's failure to suggest a clear cut-off date of when a heart attack could be linked to Vioxx. (...)

Rofecoxib may cause heart attacks in first weeks of use
BMJ 2006;332:1114 (13 May)
A small but significant number of elderly people who began taking rofecoxib (Vioxx) had heart attacks in the first two weeks, a study has found. Previously the risk was thought to occur only after 18 months of treatment.

The study was posted online ahead of publication on 2 May by the CMAJ, the journal of the Canadian Medical Association (www.cmaj.ca, doi: 10.1503/cmaj.051 679). (...)

Vioxx Heart Risk Found to Be Early and Persistent
medpagetoday.com 3.5.2006
MONTREAL, May 3 — Vioxx (rofecoxib) attacks hearts early, not late, and its hazardous effect is sustained for seven days after treatment is stopped, according to researchers here.

The drug is now the centerpiece of hundreds of liability suits against Merck, which voluntarily pulled the Cox-2 inhibitor from the market almost two years ago.

First-time Vioxx users had a 67% increase in the risk of a myocardial infarction during the first six to 13 days of use Linda Levéque, a doctoral fellow at the Department of Epidemiology and Biostatistics at McGill University, and colleagues, reported in an early online release for the May 23 issue of the Journal of the Canadian Medical Association.

Vioxx users had a 23% increase in risk of MI for seven days after stopping treatment, but on day eight the risk returned to baseline values, the investigators found.

Levéque and colleagues identified 113,927 people, mean age 75.2, who had received at least one prescription for a non-steroidal anti-inflammatory drug from January 1999 to December 2002. At baseline this cohort included 30,274 people taking Vioxx and 44,885 who had prescriptions for Celebrex (celecoxib). The entire cohort was followed for average of 2.4 years, but the analysis was based on data collection at one year.

At that point, there were 783 MIs among non-users, 239 MIs among Vioxx users, and 287 MIs among Celebrex users. Sixty-five MIs occurred in first-time Vioxx users and 57 in first-time Celebrex users. (...)

(Anm: Time variations in the risk of myocardial infarction among elderly users of COX-2 inhibitors. CMAJ 2006; 174 (II) Online 1-8.)

Vioxx-patient får 35 miljoner
n24.se 7.4.2006
Fälld i ett fall, friad i ett annat. Det blev juryns utslag i det senaste skadeståndsmålet mot amerikanska läkemedelsjätten Merck. En 77-årig patient som fått hjärtproblem sedan han tagit den indragna smärtstillaren Vioxx till
dömdes 4,5 miljoner dollar, omkring 35 miljoner kronor, för sveda och värk.
Merck lanserade Vioxx 1999 med en massiv reklamkampanj. Och det blev snabbt en storsäljare som skrevs ut till patienter med bland annat reumatiska problem i mer än 80 länder – varav 20 miljoner i USA. Preparatet omsatte som mest 2,5 miljarder dollar om året.

I september 2004 publicerade dock det amerikanska läkemedelsverket FDA en studie som visade att patienter som tagit Vioxx i mer är 18 månader löpte dubbelt så hög risk som andra att drabbas av hjärtproblem eller stroke. (...)

Judge OKs subpoena of Vioxx critic at FDA
usatoday.com 15.3.2006
NEW YORK (AP) — A government whistle-blower who criticized the Food and Drug Administration's handling of Vioxx will be deposed, giving evidence that could aid thousands of lawsuits over the withdrawn painkiller.

A federal judge Monday refused to grant a government motion to quash plaintiffs' lawyers subpoena of drug reviewer David Graham, who testified at a 2004 congressional hearing that the Merck drug caused as many as 160,000 heart attacks and strokes. (...)

Scientists Again Defend Study on Vioxx
nytimes.com 23.2.2006
With a crucial personal-injury trial over Vioxx set to begin in New Jersey next week, the debate heated up again yesterday about whether Merck understated the drug's risks in a journal article in November 2000. (...)

But in an "expression of concern" also published on the Web site yesterday, the journal's editors reaffirmed their earlier complaint, saying the article "did not accurately reflect the potential for serious cardiovascular toxicity with Vioxx." (...)

FDA official: Merck had time to warn about Vioxx effects
philly.com 11.2.2006 (Associated Press)
NEW ORLEANS - Merck & Co. could have warned that its popular painkiller Vioxx might increase the risk of heart attacks as soon as the first evidence showed up, rather than waiting two years for federal approval, a former Food and Drug Administration official testified Friday. (...)

Article Wildcard In Vioxx Retrial
cbsnews.com 5.2.2006
(AP) A top medical journal's criticism of a study cited in Vioxx lawsuits is expected to play a part in the retrial of the first federal Vioxx lawsuit — but it's not clear if it will be a legal hand grenade or a nuclear warhead.

The disclosure that some negative data was omitted from the study could make manufacturer Merck & Co. look as if it's hiding something, legal experts say. That is what attorneys for Evelyn Irvin Plunkett, whose husband died after taking the drug for a month, say they can prove in the trial starting Monday.

The first federal trial — held in Houston in the wake of Hurricane Katrina — ended with a deadlock. Two jurors said the split was 8-1 in favor of Merck's contention that taking Vioxx had nothing to do with the death of Richard "Dickie" Irvin. (...)

Møte med Jeffrey Drazen:
Gi legemiddelindustrien kompasset tilbake!

Charlotte Haug
Tidsskr Nor Lægeforen 2006; 126: 52-5
Når Jeffrey Drazen, redaktør i New England Journal of Medicine, skal slappe ordentlig av, bygger han store klokker. Hvis mulig hører han på en baseballkamp på radioen samtidig. - Så får jeg brukt både hodet og hendene. Baseball er et utrolig spennende og intellektuelt utfordrende spill, skjønner du. Det skjønner jeg ikke. Men jeg skjønner at han kan ha flere tanker i hodet på én gang. Det er bl.a. derfor jeg ønsket en samtale med ham - om Vioxx-saken. (...)

Det hele endte med at MSDs medikament Vioxx måtte trekkes fra markedet høsten 2004. Hvordan kunne det gå slik med det som var drømmemedisinen fire år tidligere? Hva gikk galt? (...)

- Skal man forstå denne saken, må man gå tilbake til tidlig i 1980-årene, da mye av grunnarbeidet med arakidonsyremetabolittene ble gjort. (...)

Historien om COX-2-hemmerne, medikamentene som skulle ha bedre smertestillende effekt enn acetylsalisylsyre, men uten de gastrointestinale bivirkningene, har vært en av de mest dramatiske i medisinen de siste fem årene. Det har vært skyhøye forventninger, skuffende resultater i kliniske studier, aggressiv markedsføring og eventyrlige økonomiske gevinster. (...)

Det hele endte med at MSDs medikament Vioxx måtte trekkes fra markedet høsten 2004. Hvordan kunne det gå slik med det som var drømmemedisinen fire år tidligere? Hva gikk galt? (...)

Det var et intenst kappløp mellom firmaene for å oppnå resultater. Titusener av pasienter var inkludert i studiene, ved hundrevis av sentre verden rundt. Men Merck gjorde også merkelige ting i design av VIGOR-studien. De visste at de hadde hastverk og ønsket å markedsføre sitt legemiddel som gastroprotektivt raskest mulig. Husk disse legemidlene solgte for 1 milliard dollar per år - 30 millioner dollar per dag! Så hver eneste dag betydde massevis av penger. Det de gjorde, var å stenge databasen for informasjon om bivirkninger seks uker før den ble stengt for opplysninger om primære endepunkter. Argumentet for å gjøre dette var - korrekt nok - at for de fleste legemidler kommer bivirkningene i løpet av de første ukene etter behandlingsstart. Ved å stenge bivirkningsdatabasen seks uker for tidlig kunne de fremskynde resultatoppsummeringen. De mente det var usannsynlig at det ville være mange alvorlige bivirkninger i denne siste perioden - det var iallfall det de sa. Og det er ikke urimelig, gitt det man visste på den tiden disse studiene ble designet.

Hjerteinfarktene som ble «glemt»
- Mercks medikament var effektivt, det var færre gastrointestinale blødninger i Vioxx-gruppen enn i kontrollgruppen. Det som derimot overrasket forskerne omtrent halvveis i studien, var at det virket som om det var flere hjerteinfarkter i behandlingsgruppen enn i kontrollgruppen. Det var ikke mange - kanskje et dusin til sammen. Og det kunne være mange forklaringer. For eksempel: Du tar Vioxx - mot artritt - og den virker. Så du går ut for å løpe - og får et hjerteinfarkt! Derfor tok de ikke dette høytidelig til å begynne med og stengte altså bivirkningsdatabasen tidlig for å fremskynde publiseringen. Senere viste det seg at det var flere hjerteinfarkter i Vioxx-gruppen i denne siste perioden. Da de sendte artikkelen inn til oss i New England Journal of Medicine i slutten av mai 2000, hadde de ikke oversikt over de siste bivirkningsdataene ennå. De fortalte oss aldri at bivirkningsdatabasen var stengt for tidlig, og vi spurte naturligvis heller ikke - vi ante jo ingenting om det. Det er klart hvorfor de gjorde det - for å tjene penger - og hver dag telte. Da artikkelen ble innsendt, var ikke dataene om hjerteinfarkt tydelige. Og det var ikke underlig, for studien var ikke lagt opp til å monitorere kardiovaskulære hendelser. Dermed fikk Merck både indikasjonen (færre gastrointestinale bivirkninger) og artikkelen godkjent i løpet av sommeren 2000, siste versjon ble akseptert for publisering i august. De sendte forfatterkorrekturen tilbake 14. oktober 2000 - og de forandret ingenting. (...)

Nye avsløringer
I slutten av november 2005 ble det klart at forfatterne ikke hadde «glemt» eller oversett ekstra tilfeller av hjerteinfarkt i gruppen som ble behandlet med Vioxx i VIGOR-studien (se teksten). Tvert imot kan det se ut som om dataene er bevisst slettet fra manuskriptet som ble sendt inn til publisering i New England Journal of Medicine. Dette fikk redaktørene til å publisere en lederartikkel på nettet 8. desember 2005 der de ber forfatterne korrigere originalartikkelen. (...)

Én selger for hver sjette lege
I stedet for å prøve å finne farlige bivirkninger, ble medikamentene markedsført det remmer og tøy kunne holde. I USA brukte de alle midler - olympiske gullmedaljevinnere stod frem på TV og sa at de ikke kunne klart seg uten Vioxx.

- Det var én selger for hver sjette amerikanske lege! De skulle selge, og de tok 2 dollar per pille - for et medikament som har samme virkning som acetylsalisylsyre, kanskje noe mindre risiko for gastrointestinal blødning, men så var det dette med hjerteinfarkt, da… Det Merck sa, var at det var naproksen som var beskyttende mot hjerteinfarkt i kontrollgruppen i VIGOR-studien. Mange hevder at det var utenkelig. Men jeg må si at for fem år siden var det ikke så utenkelig. Samtidig kalte NIH sammen en komité for å se på sin studie med celekoksib. For de hadde jo ikke gjort kardiovaskulær monitorering i det hele tatt i den! De gikk derfor tilbake og så på alle data. Og det viste seg at det også kunne være en risiko ved celekoksib (Celebra).

Vi trenger legemiddelfirmaer, sier Drazen, - til å lage legemidler. Og jeg tror - i det store og hele - at forskere ønsker å lage gode legemidler. Konkurransefortrinnet burde være at «mitt legemiddel er mye bedre enn ditt» eller «mye bedre enn noe vi har fra før». Hvis man er åpen om bivirkninger, burde pasientene kunne gjøre seg opp sin egen mening om hvorvidt de ønsker å bruke medikamentet eller ikke.

Mulig milliardfortjeneste
- Det legemiddelfirmaene oppdaget, fortsetter Drazen, - var at for hver dollar de brukte på markedsføring, kunne de tjene 5 dollar. Det de kunne ha gjort, f.eks. med Vioxx, var ærlig å argumentere for at det var en liten forskjell, ikke stor. De kunne gått til legene og sagt at her ser det ut til å være en forbyggende effekt på mageblødning og en litt økt risiko for hjerteinfarkt. Pluss - ikke uvesentlig - pillen koster 2 dollar per stykk, mens alt annet koster 2 cent! Så kunne lege og pasient sammen bestemme hva som var ønsket behandling. Jeg tror det ville vært et marked. Kanskje et marked på 100 millioner dollar per år, men ikke et på en milliard dollar per år. På et 100-milliondollarmarked tar det ti år før man har tjent en milliard. Hvis de kalkulerte med at de kunne markedsføre preparatene for alt de var verdt (og mer til) og tjene en milliard i tre år, da ville de være milevis foran hva de kunne oppnå hvis de var konservative. Personlig tror jeg det er det som har gjort folk rasende: At firmaene bare tenkte på hvordan de kunne tjene penger! Og det på et medikament som ikke var så fordelaktig, sier Drazen.

- Selvsagt må legemiddelselskaper ha profitt, men forestillingen om at de må selge et preparat for minst en millard dollar i året, er usunn. Noe av årsaken er at det er dyrt å kjøre kliniske forsøk for å vise at medikamentene virker. Og patenttiden er begrenset. Når medikamentet er godkjent, er det vanligvis bare 5 - 7 år igjen. Jeg skulle gjerne sett at patenttiden begynte å løpe i det øyeblikk det var bevist at et medikament er klinisk effektivt - og trygt. Da kunne firmaene være mer forsiktige i markedsføring og salg. Og så kunne de bruke de to-tre første årene et medikament er på markedet til å undersøke og oppdage sjeldne bivirkninger - for disse viser seg aldri i kliniske studier. De ville ikke selge like mye, men de ville heller ikke være presset til å selge like mye, fordi de ville hatt bedre tid.

Kompasset tilbake
- Det jeg ville like å se, er at legemiddelfirmaene fikk kompasset sitt tilbake, utbryter Drazen.

- Ser du tegn til at det skjer?

- Nei, det er bare business akkurat nå. (...)

Profitt etter rettssaker
- Hva vil skje i kjølvannet av de rettssakene som pågår?

- Firmaene designer studier for å få medikamentene til å se bra ut. Hvis man ser på hva Merck gjorde, så er alt absolutt akseptabelt, det er bare det at det er litt rart. Når rettssakene er over, vil firmaets jurister gå gjennom saken og undersøke hvor det eventuelt gikk galt for dem. Hvis de taper. For her er poenget: Totalfortjenesten på dette medikamentet i fem år er beregnet til ca. 5 milliarder dollar, noe av dette er år 2000-penger. Så i år 2006-penger vil nettofortjenesten sannsynligvis være 7 milliarder dollar. Hvis de må betale 2 millarder dollar i erstatning, har de tjent 5 milliarder dollar! Og det er nettopp den kalkylen som teller.

- Hva mener du er den vanlige praktiserende leges rolle og ansvar her? Gjør legene til enhver tid bare det legemiddelfirmaene forteller dem?

- Nei, men de vil ha gode medikamenter til pasientene sine. Og - jeg vet ikke hvordan det er i Norge - men i USA vil pasientene gjerne ha det siste nye. Særlig hvis de har hatt mye smerte og ubehag. Og hvis det kommer noe nytt som kanskje kan hjelpe, så vil de gjerne forsøke det.

Lavere lønnsomhet er sunnere
- Hvor vil de store legemiddelfirmaene være om fem år?

- Veldig mye av innovasjonen nå kommer fra små firmaer. Men firmaer som Merck og Pfizer har så mye penger at når det dukker opp et innovativt selskap med en god idé, så bare kjøper de det! Og produktet blir et Merck-medikament, selv om det er andre som har forsket det frem. Hovedproblemet er finansfolkene, som gjerne vil at selskaper skal gi 20 % profitt - for hver 100 dollar i salg skal det gå 20 dollar til aksjonærene. På de fleste andre forretningsområder er en profittmargin på 5 - 6 % bra, legemiddelselskapene har vært blant de aller mest lønnsomme. Utfordringen er å få lønnsomheten ned på nivå med den i f.eks. IT- og telecomselskapene.

- Hvordan skal det skje?
- Jeg tror at et par katastrofer til av Vioxx-typen vil ha effekt. De vil bli nødt til å ta problemene alvorlig så snart de får mistanke om noe ugunstig. (...)

Pfizer drar lärdom av coxiblarm
Läkemedelsvärlden 2005(1-2) (Mars)
Coxiblarmet och indragningen av Vioxx fick flera konsekvenser. Förutom för de patienter som skadats av läkemedlet, försämrades tilltron till industrin. Pfizer diskuterar i en ”vitbok” vilka slutsatser man kan dra av det turbulenta året.

COXIBER Kommunikationen till patienter och förskrivare borde ha varit försiktigare och bättre koordinerad. Det är en generell slutsats som Pfizer dragit av händelseutvecklingen efter att MSD drog in coxiben Vioxx hösten 2004.
Indragningen kom också att leda till farhågor vad gällde de andra coxiberna, varav Pfizer är ansvariga för Celebra, Bextra och Dynastat. Bextra är för övrigt tillfälligt indraget i väntan på säkerhetsstudier.

Länge ovisst
Ovissheten om deras framtid var stor fram till att EMEA i somras presenterade sin slutliga översyn.

När Vioxx drogs in stod cirka 175 000 svenskar patienter på en coxib. Sedan dess har förskrivningen minskat med 75 procent. Självkritiskt är företaget främst vad gäller den annonsering för Celebra som följde direkt efter indragningen av Vioxx. Den blev väl aggressiv konstaterar bolaget i efterhand.

I vitboken diskuterar man också bland annat hur företaget ska bli bättre på att informera om hur man värderar nytta och risker med läkemedel. (...)

Legemidler til velsignelse og markedsføring til forbannelse
Andreas Moan Atle Skattebøl
Tidsskr Nor Lægeforen 2006; 126: 49-51
Vi tror at det i de kommende år vil finne sted to vesentlige forandringer på legemiddelfeltet. For det første vil det bli en betydelig omlegging av legemiddelforvaltningen i Norge, med et styrket medisinsk fagmiljø hos Statens legemiddelverk. For det andre vil økt forståelse av farmakogenetikk og molekylærbiologi gjøre skreddersydd medikamentell behandling til virkelighet. (...)

Celebrex's Toughest Trial
time.com 14.1.2005
With the risks of the painkilling drug still being debated, Pfizer tries to settle the safety question once and for all (...)

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