MinTankesmie

- Forståelse av interessekonflikter

Understanding financial conflicts of interest. (Forståelse av økonomiske interessekonflikter.)
New England Journal of Medicin (NEJM) 1993;329:573-6
Problemet med interessekonflikter begynte å få seriøs oppmerksomhet i medisinsk litteratur på 1980-tallet.^1,2 (...) (The problem of conflicts of interest began to receive serious attention in the medical literature in the 1980s.^1,2)

Likevel er begrepet interessekonflikter i seg selv ikke blitt tilstrekkelig analysert, og følgelig er dets bestanddeler, formålet med regulering, og standarder for bedømmelse fremdeles ofte misforstått. (...) (Yet the concept of conflict of interest itself has been inadequately analyzed, and consequently its elements, the purposes of regulation, and standards for assessment are still often misunderstood.)

Interessekonflikters bestanddeler. (Elements of Conflicts of Interest.)

En interessekonflikt er et sett av omstendigheter hvor profesjonell dømmekraft angående en primær interesse (slik som en pasients velferd eller troverdigheten til forskning) er tilbøyelig til å bli urimelig influert av en sekundær interesse (slik som økonomisk vinning). Regler for interessekonflikter, uformelle og formelle, regulerer åpen redegjørelse og unngåelse av disse forholdene. (...) (A conflict of interest is a set of conditions in which professional judgment concerning a primary interest (such as a patient's welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain). Conflict-of-interest rules, informal and formal, regulate the disclosure and avoidance of these conditions.)

Selv om det iblant er omstridt hva disse plikter er (og pliktene selv kan være i konflikt med hverandre), er der vanligvis enighet om hva de enn er, bør de primært behandles med omtanke i enhver profesjonell beslutningsprosess, som en lege, vitenskapsmann, eller lærer, foretar. I sin mest vanlige form, er de primære interesser pasienters helse, forskningens integritet, og utdannelsen til studenter. (Although what these duties are may sometimes be controversial (and the duties themselves may conflict), there is normally agreement that whatever they are, they should be the primary consideration in any professional decision that a physician, scholar, or teacher makes. In their most general form, the primary interests are the health of patients, the integrity of research, and the education of students.)

Den sekundære interesse er i seg selv vanligvis ikke ulovlig, og kan i virkeligheten kanskje enda til være en nødvendig og ønskelig del av profesjonell praksis. Kun dens relative innflytelse på profesjonelle beslutningsprosesser er problematisk. Siktemålet er ikke å eliminere eller nødvendigvis å redusere økonomisk vinning eller andre sekundære interesser (slik som begunstigelse av familie eller venner eller et begjær etter prestisje og makt). Det er snarere å forhindre at disse sekundære faktorer dominerer den relevante primære interesse i det å fatte profesjonelle beslutninger. (The secondary interest is usually not illegitimate in itself, and indeed it may even be a necessary and desirable part of professional practice. Only its relative weight in professional decisions is problematic. The aim is not to eliminate or necessarily to reduce financial gain or other secondary interests (such as preference for family and friends or the desire for prestige and power). It is rather to prevent these secondary factors from dominating or appearing to dominate the relevant primary interest in the making of professional decisions.)

Vedtekter for interessekonflikter legger vanligvis hovedvekten på økonomisk vinning, ikke fordi de er mer skadelige enn andre sekundære interesser, men fordi de er mer objektive og ombyttelige. Penger er lettere å regulere ved upartiske regler, og er vanligvis også anvendelige for flere formål. Det er derfor en misforståelse å protestere mot restriksjonene på økonomisk vinning ved å klage på at der er andre typer av påvirkning (for eksempel ”en interesse i å innhente kontrollerende resultater” eller press for å favorisere ”tidligere publiserte funn av kollegaer, venner, eller forskere i samarbeidende grupper”^13,14) som kan ha like dårlig eller verre effekt på profesjonell dømmekraft. Nettopp fordi vi ikke kan gjøre mye angående de andre sekundære interesser, er det ikke dermed sagt at vi skal gjøre lite med økonomisk vinning. (Dette poeng gjelder også for ulike typer av økonomiske interesser; vi skulle kanskje velge å forby en type, men ikke en annen.¹⁵) (Conflict-of-interest rules usually focus on financial gain, not because it is more pernicious than other secondary interests but because it is more objective and more fungible. Money is easier to regulate by impartial rules, and it is also generally useful for more purposes. It is therefore a mistake to object to the constraints on financial gain by complaining that there are other kinds of influence (e.g., ”an interest in obtaining provocative results” or pressure to favor previously published findings of colleagues, friends, or researchers in collaborating groups”^13,14) that can have equally bad or worse effects on professional judgment. Just because we cannot do much about the other secondary interests, it does not follow that we should do little about financial gain. (This point also applies to types of financial interests; we might choose to proscribe one type, but not another.¹⁵)

Det er også en misforståelse å behandle interessekonflikter som bare nok et slags valg mellom konkurrerende verdier, som opptrer ved etiske dilemmaer som involverer avslutning av behandling, taushetsplikt, eller bruken av mennesker i forskning. I så fall vil utvannes begrepet interessekonflikter og oppmuntrer til holdninger om at konflikter er så utbredt at de ikke kan unngås. I etiske dilemmaer har begge de konkurrerende interesser formodentlig et krav på prioritet, og problemet er å foreta et valg. I tilfellet økonomiske interessekonflikter har bare en av interessene et krav på prioritet, og problemet er å sikre at den andre interessen ikke dominerer. Denne manglende symmetri mellom interesser er et karakteristisk trekk ved interessekonflikter. (...) (It is also a mistake to treat conflicts of interest as just another kind of choice between competing values, as occurs with ethical dilemmas involving termination of care, confidentiality, or the use of human subjects in research. To do so dilutes the concept of a conflict of interest and encourages the attitude that conflicts are so pervasive that they cannot be avoided. In ethical dilemmas, both of the competing interests have a presumptive claim to priority, and the problem is in deciding which to choose. In the case of financial conflicts of interest, only one of the interests has a claim to priority, and the problem is to ensure that the other interest does not dominate. This asymmetry between interests is a distinctive characteristic of conflicts of interest.)

(Anm: Forskning og ressurser (mintankesmie.no).)

- En solskinnshistorie

En solskinnshistorie
Leder
Tidsskr Nor Legeforen 2010; 130:919 (6.5.2010)
Ny amerikansk lovgivning krever at produsenter av legemidler og medisinsk utstyr må rapportere absolutt alle bidrag til leger og sykehus i en offentlig tilgjengelig database

President Barack Obama signerte 23.3.2010 lovene som vil reformere helsevesenet i USA. Dypt begravet i den omfattende lovgivningen finnes en lov som foreløpig ikke har fått så mye oppmerksomhet, men som vil få stor betydning for leger og legemiddel- og utstyrsindustrien: the Physician Payments Sunshine Act (1). Loven krever at alle amerikanske bedrifter som produserer legemidler, utstyr, reagenser m.m. som brukes i helsevesenet, må rapportere absolutt alle bidrag til leger og sykehus til en offentlig tilgjengelig database. Vi snakker da om alt som overstiger 10 amerikanske dollar i verdi. Alle slags bidrag er omfattet: gaver (inkludert penner og post it-blokker), honorarer, ulike former for utgiftskompensasjon, reisebidrag, måltider, forskningsstøtte og stipender, støtte til kurs og møter – og selvsagt slikt som aksjer, medeierskap og patentrettigheter. Kort sagt alt som på amerikansk benevnes som «transfer of value». Det vil kreves detaljert rapportering av både legen(e)s navn og adresse samt overføringens verdi, dato og hvordan den ble gitt eller kompensert. Og dersom betalingen er knyttet til markedsføring, foredrag, kurs eller forskning knyttet til et bestemt produkt, må produktets navn rapporteres. Alt – smått og stort – skal nå offentliggjøres.

Den nye amerikanske lovgivningen er presset frem av en stadig økende tverrpolitisk skepsis til konsekvensene av de store økonomiske overføringene mellom kommersielle aktører og leger og forskere. Anslagsvis 30 millarder dollar per år brukes til ren markedsføring av legemidler bare i USA. Utgiftene til reseptbelagte legemidler ble femdoblet i perioden 2000–05. Men detaljeringsgraden i the Physician Payments Sunshine Act og at det som tidligere har vært regnet som ubetydelige små gaver skal rapporteres, vil nok komme som en overraskelse på mange amerikanske leger. Det gir også grunn til ettertanke for oss. (...)

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

(Anm: Where’s the Sunshine? (postscript.communitycatalyst.org 7.11.2011).)

JAMA-redaktøren lei av å bli forsøkt lurt
Tidsskr Nor Legeforen 2009; 129: (17.3.2009)
- Vi må finne en måte å jobbe sammen med legemiddelindustrien på – en ærlig måte. Det sier sjefredaktøren i JAMA, Catherine DeAngelis, som besøker Tidsskriftets møte for faglige medarbeidere.

DeAngelis holder foredrag under Tidsskriftets årlige møte for faglige medarbeidere, som pågår tirsdag og onsdag denne uken. 120 av de faglige medarbeiderne er samlet for å diskutere, lære og utveksle erfaringer om fagvurdering, om forfatterskap og om Tidsskriftet. Ett av temaene på møtet er interessekonflikter. Hvordan bør de håndteres? Og hva er egentlig en interessekonflikt? (...)

Verste sort
- Legemiddelindustrien i USA betaler for forskningen, de kontrollerer den. Jeg er ikke i mot legemiddelindustrien, de er enormt viktige med tanke på utvikle nye og bedre medisiner til beste for pasientene. Men når de opererer under falske premisser, når de fremmer legemidler med tanke på å tjene mest mulig penger fremfor med tanke på pasientenes beste, da går det galt. Leger som blir med på dette løpet har interessekonflikter av verste sort, sier hun. (...)

- En solskinns-forordning for Europa

A sunshine act for Europe (En solskinns-forordning for Europa)
Leder
BMJ 2011; 343:d6593 (13 October)
As the days grow shorter in this northern outpost of Europe, we can dream about sunshine, real and metaphorical. Barack Obama’s Sunshine Act comes into force in 2013, requiring drug companies to declare all payments and hospitality they give to doctors. As Andrew Jack explains, the aggressive marketing of drugs in the United States is now being met with an equally aggressive response from government, fuelled by exposés, law suits, and public pressure (doi:10.1136/bmj.d6459).

Jennifer Neuman and colleagues give the bandwagon another shove (doi:10.1136/bmj.d5621). Their review of clinical guidelines in the US and Canada finds that half the panel members had conflicts of interest. These were substantially more common on non-government sponsored guidelines and were especially prevalent on guidelines produced by specialty societies, a fact not lost on Edwin Gale in his linked editorial (doi:10.1136/bmj.d5728). (...)

- USA tvinger legemiddelfirmaer til å rapportere pengebeløp betalt til leger

Who Else Is Paying Your Doctor? (Hvilke andre betaler din lege?)
EDITORIAL
nytimes.com 23.1.2012
It took longer than expected, but the Obama administration is finally poised to enact badly needed regulations requiring that the manufacturers of drugs, medical devices and medical supplies disclose all payments they make to doctors or teaching hospitals. The information, which would be posted on a government Web site, will allow patients to decide whether they need to worry about any possible conflicts of interest.

Such payments can be for legitimate research and consulting. But there is also a lot of cash being spread around to pay for doctors’ travel and entertainment or for gifts or modest meals for a prescribing doctor’s staff.

As Robert Pear reported in The Times this week, some prominent doctors and researchers receive hundreds of thousands or even millions of dollars a year in exchange for providing advice to a company or giving lectures on its behalf. About a quarter of all doctors take some cash payments from drug or device makers and nearly two-thirds accept meals or food gifts. Analysts contend that even seemingly trivial gifts can influence doctors to prescribe expensive drugs that may not be best for a patient’s health or pocketbook.

The new rules were championed by Senator Charles Grassley, a Republican, and Senator Herb Kohl, a Democrat, and incorporated into the health care reforms enacted in 2010. The reform law required the Department of Health and Human Services to establish reporting procedures by Oct. 1, 2011, and required manufacturers to start collecting the relevant data by Jan. 1, 2012. The proposed rules were finally issued on Dec. 14 and are subject to comment until Feb. 17, after which they will be revised and issued in final form. (...)

Related News - U.S. to Force Drug Firms to Report Money Paid to Doctors(January 17, 2012) (...)

Betalinger til læger i USA skal indberettes til offentligt register
dagenspharma.dk 17.1.2012
Obama-regeringen vil kræve, at lægemiddelvirksomheder i USA offentliggør, hvor meget de betaler læger for forskning, rådgivning, tale, rejser og underholdning. Det skriver New York Times.

Kravene er en del af en ny sundhedslov, og regeringen forventer, at reglerne vil øge sandsynligheden for, at læger træffer beslutninger til gavn for patienterne uden hensyntagen til lægens økonomiske interesser.

Den nye lov vil betyde, at virksomheder, som har blot et lægemiddel dækket af de offentlige forsikringsordninger Medicare og Medicaid, skal offentliggøre alle betalinger til læger, der ikke er blandt virksomhedens ansatte. Oplysningerne skal indberettes uanset, om der er tale om betaling for at udvikle, bedømme, eller promovere et lægemiddel. Betaling for royalties for opfindelser eller opdagelser samt betalinger for forskning og undervising vil også være indberetningspligtig, ligesom det skal indberettes, hvis lægemiddelkonsulent medbringer kaffe og donuts til et møde på lægens kontor.

Obama-regeringen lover, at oplysningerne vil blive gjort offentligt tilgængeligt på internettet. I alt forventer regeringen, at flere end 1.100 lægemiddel- og medicovirksomheder skal indsende rapporter, og at det vil være nødvendigt med et tilsyn, som overvåger, om indberetningerne er fyldestgørende og nøjagtige.

Virksomheder, som ikke indberetter korrekt, vil ifølge lovforslaget kunne straffes med bøde på op til 58.000 kr., og firmaer, der bevidst undlader at indberette betalingerne, vil risikerer bøder på op til 580.000 kr. op til maksimalt 5,8 mio. kr. om året. (...)

(Anm: ProPublica (Journalism in the Public Interest). (mintankesmie.no).)

U.S. to Force Drug Firms to Report Money Paid to Doctors (USA tvinger legemiddelfirmaer til å rapportere pengebeløp betalt til leger)
nytimes.com 16.1.2012
WASHINGTON — To head off medical conflicts of interest, the Obama administration is poised to require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment.

Many researchers have found evidence that such payments can influence doctors’ treatment decisions and contribute to higher costs by encouraging the use of more expensive drugs and medical devices.

Consumer advocates and members of Congress say patients may benefit from the new standards, being issued by the government under the new health care law. Officials said the disclosures increased the likelihood that doctors would make decisions in the best interests of patients, without regard to the doctors’ financial interests.

Large numbers of doctors receive payments from drug and device companies every year — sometimes into the hundreds of thousands or millions of dollars — in exchange for providing advice and giving lectures. Analyses by The New York Times and others have found that about a quarter of doctors take cash payments from drug or device makers and that nearly two-thirds accept routine gifts of food, including lunch for staff members and dinner for themselves. (...)

- Flodbølgen av interessekonflikter

Lobby groups call for closure of “revolving door” between drug regulators and industry (Lobbygrupper ber om at "svingdøren" mellom legemiddelkontroller og industrien lukkes)
BMJ 2011;343 (30 December)
The European Commission has been urged to review procedures at the European Medicines Agency (EMA) and the staff regulations that govern the conduct of EU officials, after claims that a former executive director of EMA arranged to become a consultant to the drug industry while still employed by the agency.

Thomas Lönngren, who ran Europe’s drug regulatory agency for 10 years before stepping down at the end of 2010, has already been told by the EMA that he should not provide product related advice to drug companies nor take managerial, executive, or consultative positions in the industry for a period of two years.

But three European activist groups say the agency has done too little to close the “revolving door” through which former regulators become industry advisers paid for their expertise. The Alliance for Lobbying Transparency and Ethics Regulation, Formindep, and Health Action International wrote an open letter last month to John Dalli, the European Commissioner for Health and Consumer Policy, saying that the evidence about Mr Lönngren’s activities demands revisions and tightening of the regulations. (...)

In a letter to the committee from his lawyers, Mr Lönngren said that he would be advising NDA on heath technology assessment and would not be involved in regulatory issues. (...)

Anne Chailleu from Revolving doors, where the regulated become confused with the regulators, are at the core of NDA’s business model.Formindep, a French group that campaigns for independent information and education in healthcare, said: “

“Six out of the ten members of NDA’s advisory board are former regulators at EMA and other regulatory agencies. Industry is exploiting its links to the European regulatory framework. This is damaging the trust that European citizens should place in officials appointed to protect public health.”

The EMA told the BMJ that it was preparing a response to the open letter. (...)

(Anm: NDA (NDA.com).)

(Anm: ALTER-EU The Alliance for Lobbying Transparency and Ethics Regulation. (alter-eu.org).)

(Anm: Formindep (formindep.com).)

Who watches the watchmen? (Hvem vokter vokteren?)
Nature 2011; 476: 125 (11 August)
Late last month, the US government proposed an overhaul of regulations covering research on human volunteers. It includes a move to allow single institutional review boards (IRBs) to oversee US multi-site clinical trials. Such boards underpin the ethics and safety of a trial, reviewing all research protocols and consent forms before it is launched. Currently, dozens or scores of IRBs — one for each trial site — can separately review and approve a clinical trial and its necessary paperwork, leading to massive duplication of effort and delays. (...)

Turning the tide on conflicts of interest (Å snu flodbølgen av interessekonflikter)
Editor's Choice
BMJ 2011; 343:d5147 (10 August)
The US Food and Drug Administration says it may loosen its conflict of interest policies (doi:10.1136/bmj.d5070). A shortage of independent experts means that its current rule—no more than 13% of advisers with industry ties—is delaying the introduction of new drugs, says its commissioner. (...)

Back tracking now on conflicts of interest would send the wrong message, especially to the EMA, which has some catching up to do. It still has a reputation for being more on the industry’s side than the public’s, not helped by its outgoing executive director Thomas Lönngren’s revolving door appointment as an adviser to industry (www.pharmatimes.com/Article/11-01-18/Ex-EMA_chief_joins_new_market_access_business.aspx).

WHO too is vulnerable to criticism on this score. A recent report on its handling of the A/H1N1 influenza pandemic concluded that it had not followed its own rules on conflict of interest and that these needed strengthening (BMJ 2011;342:d3378). Now it is under fire for proposals that would increase industry’s influence on how it sets its priorities (doi:10.1136/bmj.d5012). A word of warning to its director general: back in the 1990s, among those telling WHO to stick to its knitting and focus on infectious diseases in the third world were experts covertly funded by the tobacco industry (BMJ 2000;321:314, doi:10.1136/bmj.321.7257.314).

The FDA should stand firm. Not only is the tide turning in its favour, but strong policies are helping to turn the tide. So here’s a question: should the BMJ repeat the NEJM’s experiment and ban editorials and clinical reviews from authors with ties to industry? I’d welcome your views in rapid responses. (...)

FDA is criticised for hinting it may loosen conflict of interest rules (FDA kritisert for å antyde slakkere krav til interessekonflikter)
BMJ 2011; 343:d5070 (8 August)
The US Food and Drug Administration has come under fire for suggesting that it may loosen conflict of interest rules for its advisers, because of a shortage of experts without ties to the drug and medical devices industry.

The FDA’s commissioner, Margaret Hamburg, said that strict rules on conflict of interest implemented in 2008, which limit the proportion of advisory panellists with industry ties to 13%, may be slowing down approvals of products and hindering innovation.

Dr Hamburg told journalists at a meeting held by the non-profit watchdog Public Citizen in Washington, DC, on 25 July that the agency had to be sure it had “subject-matter experts” “for our important decision making,” reported the online news service Bloomberg News (http://bloom.bg/r2QbrF). (...)

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

Conflict-of-Interest Rules May Be Relaxed in 2012, Hamburg Says (Kan bli slakkere regler for interessekonflikter i 2012, ifølge Hamburg)
bloomberg.com 25.7.2011
Conflict-of-interest rules restricting scientists with financial ties to drug and device-makers from advising U.S. regulators may loosen next year, said Food and Drug Administration Commissioner Margaret Hamburg.

A 2008 policy limiting researchers who were paid by manufacturers from serving on advisory panels may be curtailing feedback the FDA receives, Hamburg told the advocacy group Public Citizen in Washington today. Changes may come through a renewal of the law letting the agency receive fees from companies such as Pfizer Inc. (PFE) for product reviews.

“We have to be sure that FDA has subject-matter experts that we need for our important decision making,” Hamburg said, adding that the agency also must “prevent inappropriate influence or distortion of information” that may compromise reviews. Patient-advocacy groups and academic researchers have expressed “valid concerns” about the conflict-of-interest policy, prompting an agency rules review, she said.

Republicans in Congress and manufacturers have criticized the pace of FDA reviews as too slow, blaming unanticipated requests for safety information from FDA staff and advisers. (...)

- Separer leger fra industri

Separate doctors from industry (Separer leger fra industri)
boston.com 16.8.2010
SIST MÅNED kunngjorde Harvard Medical School nye restriksjoner på forbindelsene mellom fakultet (universitet) og legemiddel- og medisinske utstyrsprodusenter. Disse bestemmelsene forbyr fakultetet å akseptere gaver og måltider, hvilket begrenser deres inntekter på konsulteringer, og krever offentliggjøring av enhver betaling som mottas. Målsettingen er å eliminere en oppfattelse av en utilbørlig påvirkning av medisinsk utdanning. Dette er en riktig beslutning av Harvard. Tiden er inne for at alle andre medisinske skoler og undervisningssykehus å følge opp. (LAST MONTH, Harvard Medical School announced new restrictions on the relationships between its faculty and the pharmaceutical and medical device industries. The policy prohibits faculty from accepting gifts and meals, limits their consulting income, and requires public reporting of any payments received. The stated goal is to eliminate a perception of undue commercial influence in medical education. This is the right decision by Harvard. It is now time that all other medical schools and teaching hospitals follow suit.)

The medical/pharmaceutical industry influence on academic medicine is ubiquitous. In 2007, a survey of academic department chairs published in the Journal of the American Medical Association revealed that 60 percent reported some form of personal relationship with industry, including as a consultant, paid speaker, officer, founder, or member of a board. (...)

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

- Dollar til leger - Hva legemiddelfirmaer betaler din lege

Dollars for Docs
What Drug Companies are Paying Your Doctor (Dollar til leger - Hva legemiddelfirmaer betaler din lege)
propublica.org (14.5.2011)
Drug companies have long kept secret details of the payments they make to doctors for promoting their drugs. But eight companies have begun posting names and compensation on the Web, some as the result of legal settlements. ProPublica compiled these disclosures, totaling $320 million, into a single database that allows patients to search for their doctor. Receiving payments isn’t necessarily wrong, but it does raise ethical issues.

Financial Ties Bind Medical Societies to Drug and Device Makers

Concerns about the influence of industry money have prompted universities to ban drug sales representatives from the halls of their hospitals and bar doctors from paid promotional speaking. One area of medicine still welcomes the largesse: societies that represent specialists. Read more... (...)

- Leger som eier eget utstyr for skanning er mer sannsynlig å rekvirere skannininger, ifølge studie

Doctors who own scanning equipment are more likely to order scans, study shows (Leger som eier eget utstyr for skanning er mer sannsynlig å rekvirere skannininger, ifølge studie)
BMJ 2011; 342:d2760 (3 May)
US doctors with a financial interest in magnetic resonance imaging (MRI) equipment, either owning or leasing it, are more likely to order scans for lower back pain than doctors who have no such stake. And those who are orthopaedic specialists are more likely to go on to order surgery, finds a new study published in Health Services Research (doi:10.1111/j.1475-6773.2011.01265.x).

The study was based on regression modelling of data from Medicare, the national health insurance programme for people 65 or older, for the period 1998 to 2005. Around 2.8 million visits to doctors over that period were for non-specific lower back pain, and the study sampled about a quarter of those files.

The condition was chosen because there is a wide variety of treatment options and no consensus on how to evaluate or treat it, said Jacqueline Baras Shreibati, lead author of the study and a professor at Stanford University School of Medicine. An estimated $80bn (£48bn; €54bn) a year is spent in the United States on spine related conditions. (...)

- Legemiddelfirmaer betaler leger?

Se om din læge er i lommen på medicinalindustrien
ekstrabladet.dkm 24.6.2010
Som patient i det danske sundhedsvæsen kan du langtfra være sikker på, at der ikke ligger økonomiske interesser bag den behandling, du får af din læge.

De danske læger bijobber nemlig på livet løs for de medicinalvirksomheder, der producerer den medicin, lægerne udskriver til deres patienter.

Ifølge nye tal fra Lægemiddelstyrelsen er hele 1694 danske læger på lønningslisten hos en lang række medicinalvirksomheder. Og for mange af lægerne er det slet ikke nok at være tilknyttet en enkelt virksomhed.

Nogle modtager honorarer fra helt op til 13 forskellige arbejdsgivere i medicinalindustrien. Det fremgår af Lægemiddelstyrelsens liste over læger med tilknytning til lægemiddelvirksomheder – en liste du kan se i uddrag på side otte og i dens fulde udstrækning på ekstrabladet.dk.

Må være svært
Mickael Bech, der er professor i sundhedsøkonomi på Syddansk Universitet, vurderer, at dobbeltrollen giver interessekonflikter:

– Problemet er, at valg af behandling kan være betinget af tilknytning til medicinalindustrien, så lægen eksempelvis ordinerer et præparat fra en bestemt virksomhed, som er dyrere, men ikke bedre end de præparater, man ellers kunne have valgt.

Bent Hansen, formand for Danske Regioner, er bekymret for, at bijobberiet skal gå ud over patienterne.

– I det her omfang – når man har så mange arbejdsgivere – så må det være svært at passe sit normale arbejde.

– Det er vigtigt, at man tager det her alvorligt og sørger for, at lægerne kun tjener én herre, og at samarbejdet ikke påvirker lægens daglige arbejde eller holdningen til, hvilken behandling og medicin man giver patienterne, siger Bent Hansen. (...)

Drug Companies Paying Doctors? (Legemiddelfirmaer betaler leger?)
cbsnews.com 2.7.2008 (CBS News Online)
Paying Doctors? (Betaling av leger?)
En studie anslår at legemiddelfirmaer årlig betaler leger 57 milliarder dollar i honorarer og ytelser, hvilket medfører at noen bekymrer seg for at beslutninger om forskrivning er urimelig påvirket. Rapporterer Wyatt Andrews. (...) (A study estimates drug companies pay doctors $57 billion a year in fees and services, causing some to worry that decisions on prescription are being unduly influenced. Wyatt Andrews reports.)

Lawmakers Push To Tighten Conflict-Of-Interest By Drugmakers (Lovgivere presser på for å begrense legemiddelprodusenters interessekonflikter)
injuryboard.com 30.6.2008
Når du går til din lege, antas at han eller hun forskriver et legemiddel som er den beste behandling for din sykdom, ikke det legemidlet som legen er betalt for å promotere. (When you go to your doctor, you presume that he or she is prescribing you a drug that will be the best cure for your ailment, not the drug that your doctor is being paid to promote.)

Men i dag er det sannsynlig at din lege aksepterer ytelser fra legemiddelfirmaer. (...) (But today, the chances are that your doctor does accept benefits from drug companies.)

Diagnosis: Conflict of Interest (Diagnose: Interessekonflikter)
nytimes.com 13.6.2007
THE revelation that the diabetes drug Avandia can potentially cause heart disease is the latest in a string of pharmaceutical disappointments. Vioxx was pulled from the market in 2004 because it doubled the risks for heart attacks and strokes. Eli Lilly recently paid $750 million to settle lawsuits alleging that Zyprexa causes diabetes. Many have criticized the Food and Drug Administration as being too lax about monitoring drug safety.

While those criticisms have merit, there is another culprit: the transformation of continuing medical education into an enterprise for drug marketing. The chore of teaching doctors how to practice medicine has been handed to the pharmaceutical industry. As a result, dangerous side effects are rarely on the curriculum. (...)

Because pharmaceutical companies now set much of the agenda for what doctors learn about drugs, crucial information about potential drug dangers is played down, to the detriment of patient care.

For example, GlaxoSmithKline footed the bill for dozens of educational courses intended to emphasize the benefits of Avandia over other drugs. An influential Internet-based educational program paid for by the company focused on specific studies that highlighted Avandia’s advantages without discussing one of the drug’s most worrisome side effects, increased levels of the lipids implicated in heart disease. (...)

Drug companies should never have been allowed to become the primary educator for America’s doctors. (...)

These companies receive millions of dollars from drug companies to create course work and to pay doctors to deliver the content. Sometimes, they pay doctors to give lectures to other doctors. Other times, prominent doctors are paid to be listed as the authors of journal articles that are written by ghost writers, a practice that was extensively documented in court records from a lawsuit against Pfizer. (...)

Doctors, in turn, would be encouraged to seek medical education from sources that are not financed by drug companies. (...)

- Lovgivere ber om register over legemiddelfirmaers utbetalinger til leger

Doctors and Drug Companies — Scrutinizing Influential Relationships (Leger og legemiddelfirmaer - Granskning av innflytelsesrike forbindelser)
NEJM 2007; 357:1796-1797 (November 1)
On September 6, 2007, Senators Charles Grassley (R-IA), the ranking member of the Committee on Finance, and Herb Kohl (D-WI), chairman of the Special Committee on Aging, introduced the Physician Payments Sunshine Act — so named because it aims to "shine a much needed ray of sunlight on a situation that contributes to the exorbitant cost of health care," according to cosponsor Senator Charles Schumer (D-NY). The bill would require manufacturers of pharmaceuticals and medical devices with annual revenues of more than $100 million to disclose the amount of money they give to physicians — whether in the form of a free dinner or vacation or a consulting fee. "This bill is about letting the sun shine in so that the public can know," says Grassley. (...)

Indeed, the nature, extent, and consequences of physicians' relationships with industry have become one of the most fiercely debated issues in health care today. At the simplest level, such a relationship exists whenever a physician accepts anything from a company whose products or services are related to the practice of medicine. And such interactions are ubiquitous: according to a recent survey, although the frequency and intensity of the ties vary according to physicians' personal and professional characteristics, virtually all physicians (94%) have some type of relationship with industry.¹ Most commonly, physicians report receiving food and beverages in the workplace (83%) or being given drug samples by a manufacturer's representative (78%). More than one third of physicians (35%) receive reimbursement for costs associated with professional meetings or continuing medical education, and more than one quarter (28%) receive payments for consulting, speaking, or enrolling patients in trials (see graph).¹ (...)

Individual physicians can take some steps to maximize the benefits for patients and minimize the risks associated with their own industry relationships. They can start by recognizing that such relationships are designed to influence prescribing behavior and by carefully considering the potential effects that their own associations may have on their patients. They can familiarize themselves with and adhere to the guidelines established by the institutions in which they practice and the professional associations to which they belong. And they can bear in mind that the costs of industry dinners, trips, and other incentives are passed along to their patients in the form of higher drug prices. (...)

Senators Seek Public Listing of Payments to Doctors (Senatorer søker offentlig opplisting av betalinger til leger)
nytimes.com 7.9.2007
WASHINGTON, Sept. 6 — I et forslag introdusert på torsdag lovpålegges legemiddel- og medisinske utstyrsprodusenter, offentlig å redegjøre for nesten alle utbetaling og gaver til leger. (Makers of drugs and medical devices would be required to report publicly nearly all payments and gifts to doctors under legislation introduced Thursday in the Senate.)

“Ifølge senator Charles E. Grassley, fremstående republikaner fra Iowa, som sitter i Senate Finance Committee, og er en av forfatterne av lovforslaget, kan ikke publikum vite hvorvidt en lege mottar penger som kan påvirke forskrivningsvaner. (...) (“Right now, the public has no way to know whether a doctor’s been given money that might affect prescribing habits,” said Senator Charles E. Grassley of Iowa, the ranking Republican on the Senate Finance Committee and one of the bill’s authors.)

Lawmaker Calls for Registry of Drug Firms Paying Doctors (Lovgivere ber om register over legemiddelfirmaers utbetalinger til leger)
nytimes.com 4.8.2007
WASHINGTON, Aug. 3 — An influential Republican senator says he will propose legislation requiring drug makers to disclose the payments they make to doctors for services like consulting, lectures and attendance at seminars. (...)

- Legemiddelfirmaenes "konflikter" får hard kritikk i helserapport om svindel

Pharma “conflicts” slammed in health fraud report (Legemiddelfirmaenes "konflikter" får hard kritikk i helserapport om svindel)
pharmatimes.com 7.10.2010
Health care fraud costs the European Union an estimated 56 billion euros each year, but conflicts of interest within in the pharmaceutical sector mean the full extent of the problem is difficult to measure, say experts.

A recent study by the European Healthcare Fraud and Corruption Network (EHFCN) conducted across seven EU member states discovered 4,188 cases of suspected fraud, with the highest rates found in Belgium and the Netherlands. Overall, losses due to fraud and corruption are estimated to account for nearly 6% of EU governments’ health care budgets, says the Network.

Related Links
US govt probes overseas bribes by pharma - WSJ

The study shows that health care fraud and corruption can take many different shapes, from dentists claiming fillings they have not performed in Ireland, doctors getting a fee from hospitals when they refer a patient to them in Germany or people creating fake companies with fake employees who claim sick leave in France, said the EHFCN, presenting the findings of its investigation at its annual conference in Brussels. (...)

- Lovforslag krever at FDA setter en stopper for interessekonflikter

Bill calls for FDA to end all conflicts of interest (Lovforslag krever at FDA setter en stopper for interessekonflikter)
boston.com 7.8.2007
Agency faces pressure on advisers who have financial ties to firms

WASHINGTON -- The Food and Drug Administration could face a tough new assignment from Congress: Eliminate all conflicts of interest on outside advisory panels whose votes heavily guide the agency's decision-making.

US Representative Maurice Hinchey, Democrat of New York, attached such language to an agriculture appropriations bill passed by the House last week. The funding measure next moves to the Senate, where the FDA conflicts section faces a tough fight; opponents include Senator Edward M. Kennedy, Democrat of Massachusetts. (...)

Gifts to Physicians Questioned
JAMA. 2007;298:618.
The drug industry's practice of providing gifts and payments to physicians came under scrutiny at a June 27 hearing before the Senate Special Committee on Aging.

Committee Chairman Herb Kohl (D, Wis) convened the hearing to hear testimony about the kinds of influence that may be wielded by pharmaceutical manufacturers as they spend about $19 billion annually on lecture honoraria, conference registration fees, research grants, trips, meals, drug samples, and other items for physicians.

"The financial ties between doctors and drug companies are only deepening," Kohl said. "These gifts and payments can compromise physicians' medical judgment by putting their financial interest ahead of the welfare of their patients." Kohl is expected to push for a national registry in which drug companies and medical device manufacturers would have to report their gifts and payments to physicians. (...)

- Lovgivning krever at FDA gradvis avvikler interessekonflikter

FDA considers reforming use, selection of advisory panels (FDA vurderer å reformere utvelgelsen til rådgivende paneler)
boston.com 22.9.2007
(...) The Food and Drug Administration is considering a top-to-bottom reshaping of how it picks and uses the outside scientists who serve on the agency's advisory panels. (...)

The FDA's move toward internal reform comes even as Congress this week passed sweeping drug safety reform legislation. The bill, which awaits President Bush's signature, includes a compromise that would place new conflict-of-interest restrictions on advisory panel participants. It would require the FDA to decrease the number of participants with conflicts by 5 percent a year. (...)

"When members of the advisory committee have conflicts of interest, it not only hurts the public, but it also destroys the credibility of the committee's recommendations," said US Representative Edward Markey, Democrat of Malden. "The FDA should not allow individuals with conflicts of interest to vote on decisions and the FDA should significantly limit conflicted individuals' participation, in order to preserve the integrity of the process." (...)

"Even if you concede some very large proportion of the qualified scientists and physicians out there do have financial conflicts of interests, all FDA needs is less than 500 people," she said.

"It may take outreach. It may take a more active and engaged FDA," Wood said. "There truly are people out there who are unconflicted - if we just look."

Wood and others who share her view say limiting the number of advisers with conflicts could boost public confidence in FDA decision-making. (...)

But Dr. Steve Nissen, a prominent cardiologist at the Cleveland Clinic, said the FDA can skew advisory recommendations by selecting certain scientists to serve on panels, and through the way it compiles background documents used to brief panels. (...)

- Denne farsen har pågått lenge nok

Glukosamin - den store sukkerpillebløffen
Tidsskr Nor Lægeforen 2007; 127: 2121-2
(...) Glukosamin burde aldri ha vært godkjent som legemiddel, og nå må man i det minste ta til fornuft og reversere denne feilaktige avgjørelsen. Snuoperasjonen bør omfatte kvalitetssikring av anbefalings- og godkjenningsprosedyrene i Statens legemiddelverk, og arbeid med retningslinjer bør ekskludere aktører med interessekonflikter, anvende anerkjente metoder og graderes med hensyn til evidensstyrke. Denne farsen har pågått lenge nok. (...)

Lancet om interessekonflikter og korrupsjon i helsevesenet

Corruption in health care costs lives (Korrupsjon i helsevesenet koster liv)
Lederartikkel
Lancet 2006; 367:447
I de senere år, har nyhetsaviser vært fulle av eksempler på korrupsjon og kriminell forretningsmessig praksis som fører til berikelse av et fåtall griske individer. (...) (In recent years, newspaper business pages have been full of examples of corruption and criminal business practices that led to the enrichment of a few greedy individuals.)

Men helsevesenet er likevel en enorm forretningsvirksomhet som påvirker alles liv, som hovedsakelig er finansiert med skattebetalernes penger og omsetter for anslagsvis 3 billioner dollar per år på verdensbasis, og er merkelig nok fritatt fra inngående gransking. Svært lite er kjent om hvor mye korrupsjon påvirker helsevesenet og leverandører av produkter og tjenester. Ordet korrupsjon — misbruk av betrodd makt for å oppnå personlig vinning — opptas sjelden i helsepersonells vokabular og tones ofte ned til uetisk eller uprofesjonell atferd. (Yet, one enormous business affecting everyone's life, the health-care sector, which is worth an estimated US$3 trillion per year worldwide and which is mostly funded by taxpayers' money, is strangely exempt from close scrutiny. Very little is known about the extent to which corruption affects health-care systems and providers. The word corruption—abuse of entrusted power for private gain—rarely enters health professionals' vocabulary and is frequently softened to unethical or unprofessional behaviour.)

I sin globale korrupsjonsrapport for 2006, publisert 1. februar, retter den ikke-statlige Transparency International søkelyset mot helsevesenet og konkluderer at korrupsjon gjennomsyrer formidlingen av helseomsorg på alle nivåer og i alle land. Helsesektoren er spesielt utsatt for korrupsjon, hevder rapporten, idet den utgjør en labyrint av komplekse og ugjennomsiktige systemer som gir god grobunn for ulovligheter. (...) (In its annual Global Corruption Report 2006, released on Feb 1, the non-governmental organisation Transparency International shines a spotlight on the health-care sector and concludes that corruption permeates the provision of health care at all levels and in all countries. The health sector is particularly prone to corruption, argues the report, as it constitutes a maze of complex and opaque systems that provide a fertile ground for malfeasance.)

Korrupsjon, argumenterer rapportens forfattere, er en av de viktigste grunner til at det globale samfunn etter planen ikke oppnår tusenårsskiftets helserelaterte utviklingsmål. (Corruption, argue the report's authors, is one of the main reasons why the global community is off target to achieve the health-related Millennium Development Goals.)

Hva er omfanget av problemet? Når det gjelder finansielle kostnader, er det umulig å legge frem et eksakt tall, men anslag går på titalls milliarder dollar hvert år. Spekteret av korrupsjon strekker seg fra leger med interessekonflikter som er talsmann for en spesiell behandling på uriktig grunnlag till aggressive markedsføringsstrategier fra farmasøytiske firmaer; til underbetalt helsepersonell som aksepterer små bestikkelser fra pasienter til forsyninger av virkningsløse etterligninger av legemidler; til storstilet underslag av offentlig innsamlede helsemidler til massiv skjevhet i helsepolitikken og finansiering av korrupte statstjenestemenn. (What is the scale of the problem? In terms of financial costs, it is impossible to state an exact figure, but the estimate goes into tens of billions of dollars per year. The spectrum of corruption ranges from physicians with conflicts of interest advocating a particular treatment for the wrong reasons to aggressive marketing strategies by pharmaceutical companies; from underpaid health workers accepting small bribes from patients to the provision of ineffective counterfeit drugs; from large-scale embezzlement of public-health funds to massive distortions of health policy and funding by corrupt government officials.)

Imidlertid, er der mye å gjøre og rapporten kommer avslutnigsvis med fornuftige, og tildels slagkraftige anbefalinger. Enhver behandling bør starte med maksimal transparens. Givere og statlige mottakere må gi mulighet for lett tilgang til informasjon om helserelaterte prosjekter, og strategier som tillater uavhengige offentlige høringer. (...) (However, there is much to do and the report ends with sensible, and in part hard-hitting, recommendations. Any cure should start with maximum transparency. Donor and recipient governments need to grant easy access to information on health-related projects, budgets, and policies to allow independent and public audits.)

Det er nødvendig å innføre atferdsregler for ansatte i helsevesenet og private virksomheter. I denne sammenheng, går anbefalingene så langt som å forby leger fra gjøre seg til talsmenn for legemidler eller utstyr som de har økonomiske interesser i og fra å ta del i "speakers' bureaus" finansiert av farmasøytiske firmaer. Offentlig helsepolitikk bør uavhengig overvåkes på nasjonalt og and internasjonalt nivå og disse rapporter bør vær offentlig tilgjengelige. Innkjøpsprosesser bør være konkurransedyktige og transparente. Eventuelle overtredelser må rettslig strengt følges opp med tiltale. Varslere (whistleblowers) fra alle sektorer bør beskyttes. (Codes of conduct need to be adopted by health workers and private sector companies. In this context, the recommendation goes as far as prohibiting physicians from advocating drugs or devices they have a financial interest in and from taking part in speakers' bureaus funded by pharmaceutical companies. Public-health policies should be independently monitored at national and international level and these reports need to be publicly available. Procurement processes should be competitive and transparent. Any transgressions have to be rigorously prosecuted. Whistleblowers from all sectors should be protected.)

Disse velkomne anbefalinger bør tas alvorlig av alle involverte og mekanismer bør etableres for å tilstrebe å oppnå dem. Ved å gjøre så kunne ikke bare enorme pengebeløp men også liv kan spares. (...) (These welcome recommendations should be taken seriously by all involved and mechanisms should be established to strive towards achieving them. By doing so not only enormous amounts of money but also many lives could be saved.)

Who om interessekonflikter og korrupsjon i helsevesenet

New report on corruption in health (Ny rapport om helsekorrupsjon)
Bulletin of the World Health Organization (BLT) 2006;84(2): 81-160 (2, February)
Verdens helsesystemer er sårbare for korrupsjon i alle land og på ethvert nivå fra sentraladministrasjon til pasienter dem selv, ifølge en omfattende rapport på korrupsjon publisert av Transparency International. (...) (Bulletin of the World Health Organization (BLT) 2006;84(2): 81-160 (2, February)
The world’s health systems are vulnerable to corruption in every country and at every level from central government to patients themselves, according to an encyclopaedic report into corruption released by Transparency International.)

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

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

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

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

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

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

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

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

- Omdømme til salgs?

Reputations for sale? (Omdømme til salgs?)
bbc.co.uk 29.1.2007
Fiona Godlee is the editor in chief of the British Medical Journal and has written this article about Secrets of the Drugs Trials.

Panorama's account of GlaxoSmithKline's successful attempts to market Seroxat for use in children, despite the fact that its own published trial found evidence of serious adverse effects and failed to show benefit, is fascinating but depressingly familiar.

What is even more depressing is that such behaviour is still so widely tolerated within medicine.

There has been no shortage of outcry or official condemnation - including clear statements from the World Association of Medical Editors, the International Committee of Medical Journal Editors, and industry itself through its Good Publication Practice guidelines - that undeclared conflicts of interest and ghost writing are unacceptable.

But, you might reasonably ask, what use are such huffings and puffings in the face of the individual rewards on offer from drug companies.

Let's be clear what is and is not acceptable. There is nothing wrong with getting help from medical writers, provided they and their source of funding are clearly acknowledged.

Nor is there anything wrong with academics or clinicians working with industry, provided they remain personally accountable for everything they say.
What is clearly wrong is writers, academics, or clinicians concealing under their coat tails an army of company spin doctors intent on distorting the scientific record.

Legislation is not going to happen soon - the powerful industry lobby will make sure of that. Regulation is still inadequate.

So what can we do to change the blind-eye culture of medicine? In the interests of patients and professional integrity I suggest intolerance and exposure. (...)

And if journals discover authors who are guests on their own papers, they should report them to their institution, admonish them in the journal and probably retract the paper.

Reputations for sale are reputations at risk. We need to make that risk so high it's not worth taking." (...)

Legemiddelfirmaer betaler leger for møtevirksomhet

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

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

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

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

Omfanget uvisst
I rådgjevingsgrupper inviterer legemiddelfirma eit knippe fagleg tunge legar til å komme med råd om nye medisinar. Dei hentar inn dei største namna innen legestanden, fordi dei veit at desse folka er såkalla opionsdannarar, seier Rognstad. Anerkjente legar påverkar i stor andre kollegaer som også sit med reseptblokka, meiner han.

For kvart møte får legen opptil 4 000 kroner, i følge fleire legemiddelfirma NRK har vore i kontakt med. Kor mange slike grupper som er etablert er usikkert, og legemiddelprodusentane vil ikkje ut med namnet på legar som deltek.

Hard konkurranse
Legemiddelprodusentane konkurrerer om å få legane til å skrive ut deira medisinar. Men i fjor starta ein etisk ryddesjau i bransjen, og regelverket for sponsing av legar har blitt stramma inn på fleire frontar. Blant anna har Legemiddelindustriforeningenm, LMI, og Legeforeningen inngått ei avtale som avgrensar legane sine tilbod om å reise på dyre kurs og kongressar på pillefirma si rekning.

Også dei regionale helseføretaka har skjerpa inn regelverket. Resultatet er at medisinprodusentane misser verdifulle kontaktar i legestanden og må gå nye vegar.

Faren er at legemiddelfirma no prøver å etablere band til legane på måtar som er vanskelege å få innsyn i. Det seier professor i medisinsk etikk, Jan Helge Solbakk. Han fryktar at sjølv om reglane er blitt skjerpa, så er sjansane for å følge med i kontakten mellom legane og industrien blitt vanskelegare.

-Uproblematisk
For Legemiddelindustriforeningen er rådgjevingsgruppene uproblematiske.

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

- Ny fokus på granskning av bestikkelser: Leger

New Focus of Inquiry Into Bribes: Doctors (Ny fokus på granskning av bestikkelser: Leger)
nytimes.com 22.3.2008
A long-running federal investigation into the orthopedic device industry’s suspected kickback payments to hip and knee surgeons now has the doctors in the spotlight.

Having reached settlements with the five leading makers of artificial joints last year over the payments, the government has been focusing on the many doctors who receive money as the companies’ paid consultants.

“We are going to be looking at those soliciting kickbacks,” Lewis Morris, the chief counsel in the federal office that pursues civil complaints of Medicare fraud, told an audience of hundreds of doctors, company representatives and investors this month in San Francisco at the annual meeting of the American Academy of Orthopedic Surgeons. (...)

Dr. Coon declined to say how much he was owed after Zimmer halted payments in October. Zimmer’s disclosure said it paid him $158,420 last year — in addition to $1,944 for air travel, $2,498 for lodging, $1,034 for meals, $440 for ground transportation and $10 for a gift. (...)

- Psykiatere topper listen over gaver fra legemiddelprodusenter

Psychiatrists Top List in Drug Maker Gifts (Psykiatere topper listen over gaver fra legemiddelprodusenter)
nytimes.com 26.6.2007
WASHINGTON, June 26 — As states begin to require that drug companies disclose their payments to doctors for lectures and other services, a pattern has emerged: psychiatrists earn more money from drug makers than doctors in any other specialty. (...)

And today, the Senate Special Committee on Aging, which is led by Senator Herb Kohl, Democrat of Wisconsin, will hold the first of a series of hearings on the issue, which could lead to legislative proposals to restrict and require disclosure of payments and gifts to doctors from drug companies nationwide. (...)

Lee Greenfield, a former state representative in Minnesota and one of the law’s authors, said it passed with little fanfare or debate after legislators heard stories about doctors accepting gifts of great value from drug makers.

“Why do we want them bribing doctors to use what may not be the best or most cost-effective drug for the patient purely to get some hand-held TV, we all asked,” Mr. Greenfield said.

Still, compliance with the law has been spotty. Some companies never responded to the board’s requests for disclosures. Others did so fitfully. A few sent letters saying they did not collect that information and thus could not provide it. (...)

States Note Higher Drug Payments to Psychiatrists (Stater opplyser at psykiatere mottar høyere betalinger fra legemiddelfiraer)
healthdecisions.org 27.7.2007
Idet stater har begynt å kreve at legemiddelfirmaer opplyser om sine utbetalinger til leger for foredrag og andre ytelser, fremstår et mønster: Psykiatere mottar mer penger fra legemiddelprodusenter enn noen annen profesjon. (...) (As states begin to require that drug companies disclose their payments to doctors for lectures and other services, a pattern has emerged: Psychiatrists earn more money from drugmakers than doctors in any other specialty.)

- Senator stiller psykiatrisk forening spørsmål om økonomisk firmastøtte

Feelings About Pharma (Følelser omkring legemiddelindustrien)
Psychiatr News 2008;43(19):3 (October 3) (American Psychiatric Association)
From the President - Nada Stotland, M.D., M.P.H.
In the September 5 Psychiatric News, I described APA's response to Sen. Charles Grassley's request for information about every kind of revenue that APA has received from the pharmaceutical industry, and I asked for your opinions. (Unfortunately, the APA members-only Web site link to the cover letter that accompanied the 50-page report to Sen. Grassley, which outlines the issues and the contents, was not functional at the time of that column; you can read that letter now at <http://psych.org/ (...)>.

Thanks to everyone who wrote. I am proud, but not surprised, that every message focused on the welfare of our patients. I am heartened that many of you think APA is heading in the right direction. Our healthy self-examination preceded any inquiry from outside. As one member proclaimed:

• "Let's be bold. Let's make the rules. Let's not wait for the drug companies or the Congress to tell us what to do." (...)

Senator asks psychiatrists’ association about drug company funding (Senator stiller psykiatrisk forening spørsmål om økonomisk firmastøtte)
BMJ 2008;337:a929 (21 July)
(...) Senator Grassley said in a letter to the association, "It is alleged that pharmaceutical companies give money to non-profits in an attempt to garner favor in ways that increase sales of their products." (...)

He asked the association, which represents 38 000 psychiatrists, to provide him with "an accounting of industry funding that pharmaceutical companies and/or the foundations established by these companies have provided" to the association. Funding, Senator Grassley said, included grants, donations, and sponsorship of meetings and programmes. (...)

Nada Stotland, president of the association, said that the association was assembling the requested material "in a timely manner." She said that her organisation was a leader in regard to disclosure and "supports full transparency and disclosure of relationships between medicine and industry." (...)

- GlaxoSmithKline betaler omtrent titalls milliarder kroner for å forlike svindelanklager

GlaxoSmithKline settles U.S. drug rows for $3 billion (GlaxoSmithKline forliker amerikansk legemiddelstrid for tre milliarder dollar)
reuters.com 3.11.2011
A GlaxoSmithKline logo is seen outside one of its buildings in west London, February 6, 2008.

(Reuters) - GlaxoSmithKline Plc has agreed in principle to settle its most significant disputes with the U.S. government over the way it marketed and developed its drugs, at a cost of $3 billion, which is covered by existing provisions.

The settlement, over both civil and criminal claims, is expected to be finalized in 2012. It includes a Department of Justice investigation into the company's controversial diabetes drug Avandia, which has been linked to heart risks.

Britain's biggest drugmaker already took massive charges last year related to liability claims from patients who had been taking Avandia.
The company's current legal provisions are 2.9 billion pounds ($4.6 billion).

The deal to resolve the latest disputes follows a clampdown in the United States on unfair pharmaceutical industry practices that has forced major drugmakers to rethink the way they do business in the world's biggest market.

Since the late 1990s the number of industry settlements with U.S. states and the federal government has soared as authorities have taken an increasingly tough line on practices that may have put commercial goals above the interests of payers and patients, such as marketing drugs for unapproved uses. (...)

In mid-2010, GSK took a $2.4 billion charge after settling most patient liability claims relating to Avandia, as well as an investigation into its former factory at Cidra in Puerto Rico, and anti-trust and product liability litigation over antidepressant Paxil. (...)

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

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

Glaxo Pays $3 Billion To Settle U.S. Investigations (Glaxo betaler tre milliarder dollar for å forlike amerikanske granskninger)
kaiserhealthnews.org 3.11.2011
The settlement will also cover a Department of Justice probe into Glaxo's development and marketing of the diabetes drug Avandia.

The Wall Street Journal: Glaxo Settles With U.S. For $3 Billion
GlaxoSmithKline PLC said it will pay the U.S. government $3 billion to settle several long-running criminal and civil investigations into the company, including allegations that Glaxo marketed some drugs illegally and defrauded the Medicaid program. The settlement will also cover a Department of Justice probe into Glaxo's development and marketing of the diabetes drug Avandia, which has been linked to heart attack risks (Whalen, 11/3).

Bloomberg: Glaxo To Pay $3B To Settle U.S. Sales, Avandia Cases

GlaxoSmithKline Plc (GSK) agreed to pay $3 billion to resolve U.S. criminal and civil investigations into whether the U.K. company marketed drugs for unapproved uses and other matters, its biggest legal settlement. Negotiations over the terms are ongoing and will be completed next year, the London-based company said in a statement today. The cost is covered by existing legal provisions and will be paid from the company's cash resources, Glaxo said (Serafino and Kitamura, 11/3).

Fox Business: GlaxoSmithKline To Pay $3B To Settle U.S. Probes
GlaxoSmithKline PLC, the London health care major, said Thursday that it would pay $3 billion to settle multiple U.S. government investigations. The inquiries were focused on GSK's sales and marketing practices; issues tied to the Medicaid Rebate Program, and the development and marketing of the diabetes drug Avandia, GlaxoSmithKline said. The company said it has set aside provisions for the settlement and hopes to complete the agreement with the U.S. in 2012 (Daniel, 11/3). (...)

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

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

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

Drug Giant GlaxoSmithKline P.L.C. to Pay $3.4 Billion in Biggest Tax Settlement in U.S. History
pharmalive.com 6.10.2006
(...) GlaxoSmithKline admitted no wrongdoing in the settlement, and insisted it allocated its revenues and expenses fairly among its U.S. and British subsidiaries. Glaxo said the settlement, while large, saved it from a possible tax bill as high as $15 billion if it had lost the dispute, which was scheduled for trial in February 2007. (...)

Glaxo må slippe 20 mia. i forlig
berlingske.dk 12.9.2006
Medicinalgiganten betaler næsten 20 mia. kr. for at undgå retssag om skattesnyd ved hjælp af interne afregninger i selskabet.

Den britiske medicinalgigant GlaxoSmithKline har accepteret et historisk dyrt forlig med det amerikanske skattevæsen. Selskabet gør nu klar til at overføre 19,7 mia. kr. til de amerikanske skatteborgere.

Få måneder før selskabet skulle i skatteretten i USA om sine forhold for årene 1989-2005 blev parterne enige om i stedet at indgå et forlig, som Glaxo næppe er helt utilfreds med. Selskabet havde i sine regnskaber afsat hele 26 mia. kr. for det tilfælde, at man skulle tabe den nu aflyste retssag.

Slagsmålet handler om såkaldt »price transfering«, den interne afregningspris i koncernen mellem hovedkvarteret i Storbritanien og det amerikanske selskab.

Skattevæsenet mener, at Glaxos amerikanske afdeling betalte overpris for Glaxos produkter, bl.a. selskabets absolut største produkt i de år, mavesårsmedicinen Zantac, så man slap billigere over for det amerikanske skattevæsen.

Det amerikanske skattevæsen er meget tilfreds med forliget, for det kan bane vejen for afgørelse af stribevis af andre sager om price transfering, som står i kø i systemet. (...)

GlaxoSmithKline pays in Medicaid fraud case
philadelphia.bizjournals.com 1.9.2006
The Missouri Department of Social Services received a check Thursday for $235,757 from a Medicaid fraud settlement with pharmaceutical giant GlaxoSmithKline, according to Missouri Attorney General Jay Nixon.
The check reimburses the Missouri Medicaid program for overpayments made by Medicaid as a result of inaccurate drug prices reported by GlaxoSmithKline (NYSE: GSK).

The agreement, made in conjunction with an earlier settlement with the federal government, resolved concerns that the company improperly inflated the prices it reported that drug purchasers paid for the injectable drugs Kytril and Zofran, which are used to treat nausea related to chemotherapy. The overpayment from the Medicaid program acted as an incentive for physicians and other drug purchasers reimbursed. (...)

Glaxo Pays $150M Price Fraud Fine (Glaxo betaler 150 millioner dollar i bot for prissvindel)
CBS 20.9.2005
GlaxoSmithKline PLC har samtykket å betale mer enn 150 millioner dollar for å forlike svindelanklager om prisingen og markedsføringen av to legemidler mot kvalme, sa Justisdepartementet tirsdag. (...) (GlaxoSmithKline PLC has agreed to pay more than $150 million to settle fraud allegations over the pricing and marketing of two anti-nausea drugs, the Justice Department said Tuesday.)

GlaxoSmithKline innrømmet ingen ugjerning som del av forliket. Det er det siste i en serie av svindelforlik med store legemiddelprodusenter som høster millioner av dollar fra store statlige programmer. (...) (GlaxoSmithKline admitted no wrongdoing as part of the settlement. It is the latest in a series of fraud settlements with major drug manufacturers that reap millions of dollars from the mammoth federal programs.)

Legenes selvregulering fungerer ikke

Health Industry Practices That Create Conflicts of Interest (Praksis innen helseindustrien skaper interessekonflikter)
Journal of the American Medical Association (JAMA) 2006;295:429-433 (January 25)
Et strategiforslag for akademiske medisinske sentre (A Policy Proposal for Academic Medical Centers)

Interessekonflikter mellom legers forpliktelser til pasienter og ønskene til farmasøytiske firmaer og deres representanters om å selge sine produkter skaper utfordringer til prinsippene om medisinsk profesjonalisme. Disse konflikter opptrer når leger har motiver eller er i situasjoner som fornuftige iakttakere kunne konkludere at de moralske krav til legens rolle er brakt i vanry. (...) (Conflicts of interest between physicians' commitment to patient care and the desire of pharmaceutical companies and their representatives to sell their products pose challenges to the principles of medical professionalism. These conflicts occur when physicians have motives or are in situations for which reasonable observers could conclude that the moral requirements of the physician's roles are or will be compromised.)

Selv om legegrupper, produsenter, og statlige myndigheter har innført selvregulering av markedsføring, indikerer psykologisk og samfunnsvitenskaplig forskning at nåværende kontroller av gaver og bidrag ikke på tilfredsstillende måte beskytter pasientenes interesser. (...) (Although physician groups, the manufacturers, and the federal government have instituted self-regulation of marketing, research in the psychology and social science of gift receipt and giving indicates that current controls will not satisfactorily protect the interests of patients.)

Økonomiske bånd mellom medisinske firmaer og leverandører av helseomsorg

Drugs, Devices and Doctors (Legemidler, utstyr og leger)
The New York Times 16.12.2005
I vårt medisinske system, er ikke interessekonflikter unntaket - de er normen. (...) (In our medical system, conflicts of interest aren't the exception - they're the norm.)

Opinion | Conflicts of Interest Between Providers, Drug, Device Makers the 'Norm,' Columnist Writes (Mening | Det er "norm" for interessekonflikter mellom leverandører, legemidler, utstyrsprodusenter, skriver spaltist)
Kaisernetwork.org 16.12.2005
"Avgjørende vitenskapelig forskning og kritiske medisinske beslutninger må betraktes som tvilsomme på grunn av finansielle bånd mellom medisinske firmaer, medisinske forskere og leverandører av helseomsorg," sa han. Ifølge Krugman, eksisterer der et "helt system av insitamenter" som oppmuntrer leverandører og forskere til "å tjene interessene til medisinsk industri." I dette system, konstaterer Krugman, bruker "et umåtelig medisinsk-industrielt kompleks" "dype finansielle forbindelser" til å knytte bånd mellom de som leverer helseomsorg, forskningsinstitusjoner, legemiddelfirmaer og utstyrsprodusenter. Han fortsetter, "Økonomiske trender gav vekst til det medisinsk-industrielle kompleks, men bare fordi disse trender gjensidig påvirker dårlige strategier, som kan være avtalt." Krugman sier at han i fremtidige spalter vil adressere "hvordan seriøs helseomsorg kan redusere interessekonfliktene som besudler vårt nåværende system" (...) ("[C]rucial scientific research and crucial medical decisions have to be considered suspect because of financial ties among medical companies, medical researchers and health care providers," he says. According to Krugman, there exists a "whole system of incentives" encouraging providers and researchers "to serve the interests of the medical industry." Under this system, Krugman states, "a vast medical-industrial complex" uses "deep financial links" to tie health care providers and research institutions to drug companies and device makers. He continues, "Economic trends gave rise to the medical-industrial complex, but only because those trends interacted with bad policies, which can be fixed." Krugman says that in future columns he will address "how serious health care can reduce the conflicts of interest that are tainting our current system")

Interessekonflikter påvirker profesjonell ansvarlighet

Our Approach to Addressing Potential Conflicts of Interest (Vår tilnærming til å addressere mulige interessekonflikter)
Arch Otolaryngol Head Neck Surg. 2005;131:943-944.
Overskriftene er altfor kjent. Politikere, FN-personale, administrerende direktører, bankforbindelser, børsmeglere, ledere i farmasøytiske firmaer, geistlige, footballtrenere, og leger har alle blitt fanget i spindelvevet "interessekonflikter." (The headlines are all too familiar. Politicians, United Nations officials, CEOs, bankers, brokers, pharmaceutical company executives, clergy, football coaches, and physicians have all been caught in the web of "conflict of interest.")

Interessekonflikter, som definert av Michael McDonald¹ ved W. Maurice Young Centre for Applied Ethics (University of British Columbia, Vancouver), er "en situasjon hvor en person, slik som en offentlig tjenestemann, en ansatt, eller en fagmann, har en tilstrekkelig privat eller personlig interesse som synes å påvirke den objektive utøvelse av hans eller hennes plikter som tjenestemann." Den private eller personlige interesse er ofte økonomisk, men den kan omfatte det å gi en fordel til en venn eller familiemedlem. Dersom disse interesser kommer i konflikt med en av tjenestemannens plikter, da må forpliktelser overfor klienter, arbeidsgivere, eller andre fortrenges. Interessekonflikter forstyrrer profesjonell ansvarlighet på en alminnelig måte, nemlig, ved å hindre objektiv bedømmelse og . . . [Full Text of this Article] (...) (Conflict of interest, as defined by Michael McDonald¹ of the W. Maurice Young Centre for Applied Ethics (University of British Columbia, Vancouver), is "a situation in which a person, such as a public official, an employee, or a professional, has a private or personal interest sufficient to appear to influence the objective exercise of his or her official duties." The private or personal interest is often financial, but it can involve providing an advantage to a friend or family member. If this interest were to conflict with one’s official duties, then obligations to clients, employers, or others must supersede. Conflicts of interest interfere with professional responsibilities through a common pathway, namely, by interfering with objective judgment and . . . [Full Text of this Article])

Din leges integritet og uavhengighet er kompromittert av disse forbindelser

Doctors, industry — a conflict? (Leger, industri - en konflikt?)
jsonline.com 12.2.2006
Økonomiske forbindelser går ofte under radaren (Financial ties often go under the radar)

Du kan aldri vite om din lege har økonomiske bånd til farmasøytiske firmaer eller utstyrsleverandør - og kanskje heller ikke sykehuset hvor legen praktiserer. (...) (You may never know if your doctor has financial ties to a pharmaceutical or medical device company - and neither may the hospital where the doctor practices.)

"Din leges integritet og uavhengighet er kompromittert av disse forbindelser," sa Katie Watson, advokat og etiker ved Northwestern University's Feinberg School of Medicine. ("Your physician's integrity and independence will be compromised by these relationships," said Katie Watson, a lawyer and ethicist at Northwestern University's Feinberg School of Medicine.)

Helseomsorg bruker nå en sjettedel av amerikansk økonomi. I 2004, var det samlede beløp 1,9 billioner - eller 6 280 dollar for hver enkelt, mann, kvinne og barn i USA. (...) (Health care spending now accounts for one-sixth of the U.S. economy. In 2004, it totaled $1.9 trillion - or $6,280 for every man, woman and child in the United States.)

"Vi er avhengige av vurderingsevnen til legene," sa Anne Ballentine, en talsmann for Covenant. (...) ("We rely on the judgment of physicians," said Anne Ballentine, a Covenant spokeswoman.)

Akademiske sentre med mulige interessekonflikter

Ties to Industry Cloud a Clinics Mission (Bånd til industri kaster en skygge over klinikks oppgave)
The New York Times 17.12.2005
Dr. Eric J. Topol, en hjertespesialist, er kanskje blitt prestisjetunge Cleveland Clinic Foundationdet mest offentlig kjente fjes, et fremstående medisinsk senter som er ansett som et av landets beste. (...) (Dr. Eric J. Topol, a cardiologist, has been perhaps the most public face of the prestigious Cleveland Clinic Foundation, a prominent medical center regarded as one of the nation's best.)

"Det er ikke bare Cleveland Clinic," sa Les Funtleyder, en strateg hos investeringsselskapet Miller Tabak & Company i New York. Han sier andre prominente akademiske sentre også har tallrike finansielle bånd som øker potensialet for interessekonflikter. ("It's not just the Cleveland Clinic," said Les Funtleyder, a health care strategist at the investment company Miller Tabak & Company in New York. He says other high-profile academic medical centers also have numerous financial ties that raise the potential for conflicts of interest.)

Dr. Jerome P. Kassirer, tidligere redaktør hovedsakelig for New England Journal of Medicine, beskriver mulige interessekonflikter ved klinikken "som særdeles alvorlige," men bemerker at Cleveland Clinic "ikke på noen måte er enestående." (Dr. Jerome P. Kassirer, a former editor in chief for The New England Journal of Medicine, describes the potential conflicts at the clinic "as extremely serious ones" but notes that the Cleveland Clinic is "not unique at all.")

Det var dr. Topols kritikk av Merck som indirekte brakte klinikkens konflikter frem i lyset. Etter at legemidlet ble trukket fra markedet av Merck i september 2004, kritiserte dr. Topol, som i tidsskriftartikler hadde stilt spørsmål om legemidlets kardiovaskulære sikkerhet, firmaets opptreden. (...) (It was Dr. Topol's criticism of Merck that indirectly brought the clinic's conflicts to the fore. After the drug was withdrawn in September 2004 by Merck, Dr. Topol, who in journal articles had questioned the drug's cardiovascular safety, criticized the company's conduct.)

- Amerikanske medisinske skoler har sterke bånd til legemiddel- og utstyrsprodusenter

US medical school faculty still break conflict of interest rules, report says (Amerikanske medisinske skoler bryter fremdeles regler for interessekonflikter, ifølge rapport)
BMJ 2010; 341:c7435 (30 December)
ProPublica, an independent, non-profit investigative journalism project, reported that although medical schools have strengthened their rules about faculty members’ interactions with drug companies, some doctors still break their institutions’ conflict of interest rules.

The report is part of ProPublica’s Dollars for Docs project, which it launched in October 2010 (BMJ 2010;341:c6026; doi:10.1136/bmj.c6026).

The recent report said that some medical schools with tough conflict of interest policies were not checking to make sure faculty members followed the rules. It pointed to Stanford University, among others, saying that faculty members had not disclosed ties to drug and device companies. (...)

Harvard puts tighter limits on medical faculty (Harvard strammer inn reglene på medisinsk fakultet)
boston.com 21.7.2010
Harvard Medical School will prohibit its 11,000 faculty from giving promotional talks for drug and medical device makers and accepting personal gifts, travel, or meals, under a new policy intended partly to guard against companies’ use of Harvard’s prestige to market their products.

The conflict-of-interest rules also place stricter limits on the income faculty can earn from companies for consulting, joining boards, and other work; require public reporting of payments of at least $5,000 on a medical school website; and promise more robust internal reporting and monitoring of these relationships. (...)

Most leading US medical schools lack rules on ghostwriting (De fleste amerikanske medisinske skoler mangler regler for spøkelsesskriving)
BMJ 2010;340:c799 (8 February)
A survey of the top 50 US medical schools found that only 13 have policies prohibiting ghostwriting of scientific articles, a new report has found.

Last year the US Institute of Medicine recommended that US academic medical centres prohibit ghostwriting by their teaching staff.

One of the paper’s coauthors, Jeffrey Lacasse, from Arizona State University in Phoenix, told the BMJ, "This is one of the most pressing problems in evidence based medicine . . . Nobody has ever been sanctioned [for cooperating in ghostwriting]." (...)

The Agenda for Continuing Medical Education — Limiting Industry's Influence
NEJM 2009; 361(25):2478-2482 (December 17)
Most physicians must complete accredited continuing medical education (CME) programs to maintain their medical licenses, hospital privileges, and specialty board certifications. (...)

CME is increasingly underwritten by commercial sponsors — primarily manufacturers of drugs, biologic therapies, or medical devices — that spend more than $1 billion per year in educational grants and other funding to cover more than half the costs for CME activities.1 Industry funding of accredited CME increased by more than 300% between 1998 and 2007.1 Since the marketing goals of pharmaceutical and device companies can influence CME funding, preservation of the academic integrity of CME requires clear boundaries separating education and marketing. (...)

The government has an interest in protecting the integrity of CME to ensure that physicians have the knowledge and skills necessary to render high-quality care. Industry-sponsored CME can also implicate several federal statutes. For example, the criminal anti-kickback statute prohibits the knowing and willful offer or payment of anything of value to induce referrals to the federal health care programs. (...)

Medical Schools Quizzed on Ghostwriting
nytimes.com 17.11.2009
Senator Charles E. Grassley wrote to 10 top medical schools Tuesday to ask what they are doing about professors who put their names on ghostwritten articles in medical journals — and why that practice was any different from plagiarism by students. (...)

At Top Schools, More Than Half the Profs Have Industry Ties
By Jacob Goldstein
blogs.wsj.com 4.11.2009
Sometimes it seems like everybody has financial ties to the drug or device industry. As it turns out, it’s only a little more than half of everybody.
A survey conducted in 2006-07 and published this week in the journal Health Affairs found that 53% of academic research faculty in the life sciences at top schools reported financial ties to industry. (...)

Med School Grades Mixed on Conflict-of-Interest Rules
Psychiatr News 2009;44(15):7 (August 7) (American Psychiatric Association)
Medical institutions that have received high scores from a national organization can serve as models for other schools to implement more stringent policies to minimize conflict-of-interest problems.

The trend by U.S. medical schools to establish or strengthen policies to regulate and restrict conflict-of-interest problems in relationships with the pharmaceutical industry has picked up steam since 2008, a survey by the American Medical Student Association (AMSA) has found. However, 1 in 4 schools still received a failing grade. (...)

US senator seeks information about medical faculty links to drug industry
BMJ 2009;339:b2725 (6 July)
Senator Chuck Grassley has asked 23 US medical schools for information about their policies on conflicts of interest and requirements for disclosure of financial ties between staff members and drug firms.

Senator Grassley, an Iowa Republican who is the leading minority member on the Senate Committee on Finance, wrote to 23 medical schools that had not completed a survey by the American Medical Student Association.

The senator is active in investigating ties between medical schools, leading doctors, and drug and device manufacturers. He is particularly interested in doctors who receive grants from the National Institutes of Health who may also have relationships with drug, device, or biotechnology companies.

Academic institutions that receive funding from the National Institutes of Health (NIH) are required to track and report such financial relationships, but the senator says he has found enforcement of these regulations to be "either lax or in violation." The NIH awards $24bn (£15bn; 17bn) in grants each year.

The student association surveyed all 146 US allopathic (regular) and osteopathic medical schools, of which 126 provided information about their policies. The association posted the results on its "PharmFree Scorecard" website (www.amsascorecard.org) and graded the schools’ policies from A to F (failing).
However, 23 schools did not respond or did not submit their policies. (...)

US medical schools should say no to pharma support
BMJ 2008;336:1035 (10 May)
A report from the Association of American Medical Colleges suggests that all 129 member medical schools should prohibit pharmaceutical and devices manufacturers from providing gifts, food, and travel to doctors, faculty members, and students. The report will be considered at the association’s meeting in June.

The association set up a task force to examine industry funding and to guide the association, medical schools, and teaching hospitals in developing policies and procedures about gifts and funding from industry. The report, based on their two year study, is available at www.amc.org.

Most medical schools follow the association’s recommendations, although they are not required to. (...)

Ban Urged on Gifts at Medical Schools (Ber om forbud mot gaver ved medisinske skoler)
nytimes.com 28.4.2008
Drug and medical device companies should be banned from offering free food, gifts, travel and ghost-writing services to doctors, staff and students in all 129 of the nation’s medical colleges, an influential college association has concluded. (...)

US medical schools far too reliant on support of big pharma (Amerikanske skoler altfor avhengig av støtte fra big parma)
pharmatimes.com 29.4.2008
Medical schools in the USA should reject offers of free gifts and food, travel and ghostwriting services from drugmakers in order to avoid conflicts of interest, according to a major new report. (...)

U.S. Medical Schools, Drug Makers Share Strong Ties (Amerikanske medisinske skoler har sterke bånd til legemiddelprodusenter)
healthfinder.gov 16.10.2007
Majority of department chairs have connections with industry, study finds.

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

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

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

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

"Legemiddelfirmaer har forbindelser til alle," fortsatte han. "De er involvert i alle aspekter innen medisin. Noen må avgjøre om dette er OK." ("Drug companies have relationships with everyone," he continued. "They're involved in every aspect of medicine. Someone has to decide which of these is OK.")

Den første studien, som gransker omfanget av disse institusjonelle forbindelser, er publisert i oktoberutgaven av Journal of the American Medical Association. (...) (The study, the first to examine the extent of these institutional relationships, is published in the Oct. 17 issue of the Journal of the American Medical Association.)

(Anm: Institutional Academic–Industry Relationships. JAMA. 2007;298:1779-1786.)

About 60% of Medical School Department Heads Have Ties With Pharmaceutical Companies, According to Study
kaisernetwork.org 17.10.2007
About 60% of department heads at medical schools and teaching hospitals in the U.S. have personal financial relationships with pharmaceutical or medical device companies, according to a study published on Wednesday in the Journal of the American Medical Association, the AP/Philadelphia Inquirer reports. For the study -- led by Eric Campbell, a researcher at Massachusetts General Hospital and Harvard Medical School -- researchers sent a survey to department heads at all 125 accredited medical schools and the 15 largest teaching hospitals in the U.S. About two-thirds of department heads responded to the survey.

According to the study, 27% of respondents said that they recently had served as paid consultants, and the same percentage said that they had served on a company scientific advisory board. In addition, about 21% of respondents who headed departments of medical specialties with close relationships to patient care said that they had served on an industry speaker bureau, the study found. (...)

Senator Grassley krever informasjon om fortsatte tilskudd til medisinsk utdannelse fra farmasøytiske firmaer

Stanford to Limit Drug Maker Financing
nytimes.com 25.8.2008
Stanford University, concerned about the influence drug companies may have on medical education, is expected to announce Tuesday that it will severely restrict industry financing of doctors’ continuing education at its medical school. (...)

A Historical Perspective of Pharmaceutical Promotion and Physician Education
JAMA. 2008;300(7):831-833 (August 20)
The medical profession has recently awakened to a crisis over industrial influence in medical education. In recent years, the problem of industrial funding of continuing medical education (CME) has been the subject of stern warnings from academic medicine, prominent congressional hearings, and strict revisions of the Accreditation Council for Continuing Medical Education's Standards for Commercial Support. Commercial support for CME continues to increase and now comprises more than half of all CME income. (...)

Is the relationship between pharma and medical education on the rocks?
BMJ 2008;337:a925 (14 August 2008)
Sponsorship of Medical Education

In the heart of Manhattan Island one misty morning a few years back, I watched as hundreds of psychiatrists streamed into their flagship educational event, the annual congress. ¹ Even before arriving they were welcomed by giant advertising billboards on the streets outside, plastered with the name of a major sponsor, Pfizer, the biggest drug company in the world and the maker of Zoloft, the world’s top selling antidepressant. (...)

Sen. Grassley Requests Information on Continuing Medical Educational Grants From Pharmaceutical Companies (Senator Grassley krever informasjon om fortsatte tilskudd til medisinsk utdannelse fra farmasøytiske firmaer)
kaisernetwork.org 26.2.2008
Senate Finance Committee ranking member Chuck Grassley (R-Iowa) on Tuesday sent letters to Pfizer and 14 other pharmaceutical companies to request information on continuing medical education grants that they award to physicians amid concerns of potential abuse, USA Today reports. Under federal law, pharmaceutical companies cannot use CME grants to promote their medications. (...)

Medical schools still not declaring financial conflicts (Medisinske skoler deklarer fortsatt ikke interessekonflikter)
Nature 2008;451:879 (20 February)
Many US medical schools do not have policies to address potential conflicts of interest, according to a study published last week (S. H. Ehringhaus et al. J. Am. Med. Assoc. 299, 665–671; 2008). (...)

Interaksjoner mellom legemiddelfirmaer og den amerikanske psykiatriske forening (American Psychiatric Association (APA))

Psychiatric Group Faces Scrutiny Over Drug Industry Ties (Psykiatrisk forenings forbindelser til legemiddelindustri granskes)
nytimes.com 12.7.2008
It seemed an ideal marriage, a scientific partnership that would attack mental illness from all sides. Psychiatrists would bring to the union their expertise and clinical experience, drug makers would provide their products and the money to run rigorous studies, and patients would get better medications, faster. (...)

But now the profession itself is under attack in Congress, accused of allowing this relationship to become too cozy. After a series of stinging investigations of individual doctors’ arrangements with drug makers, Senator Charles E. Grassley, Republican of Iowa, is demanding that the American Psychiatric Association, the field’s premier professional organization, give an accounting of its financing.

The association is the voice of establishment psychiatry, publishing the field’s major journals and its standard diagnostic manual.

“Jeg har forstått at penger fra framasøytisk industri kan sette dagsorden for ideelle foreninger som gir seg ut for å være uavhengige i sine synspunkter og handlinger,” sa Grassley aid torsdag i et brev til foreningen. (“I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions,” Mr. Grassley said Thursday in a letter to the association.)

I 2006, det siste år som tall er tilgjengelige, stod legemiddelindustrien for omtrent 30 prosent av foreningens finansiering på 62,5 millioner dollar. Omtrent halvparten av pengene gikk til legemiddelannonser i psykiatriske tidsskrifter og utstillinger på det årlige møte, og den andre halvparten til sponsing av foreninger, konferanser og industrisymposier på det årlige møte. (...) (In 2006, the latest year for which numbers are available, the drug industry accounted for about 30 percent of the association’s $62.5 million in financing. About half of that money went to drug advertisements in psychiatric journals and exhibits at the annual meeting, and the other half to sponsor fellowships, conferences and industry symposiums at the annual meeting.)

An analysis of Minnesota data by The New York Times last year found that on average, psychiatrists who received at least $5,000 from makers of newer-generation antipsychotic drugs appear to have written three times as many prescriptions to children for the drugs as psychiatrists who received less money or none. The drugs are not approved for most uses in children, who appear to be especially susceptible to the side effects, including rapid weight gain.

Senator Grassley’s investigations have not only detailed how lucrative those arrangements can be but have also shown that some top psychiatrists failed to report all their earnings as required. (...)

Big Pharma and American Psychiatry: The Good, the Bad, and the Ugly (Big Pharma og amerikansk psykiatri: Den gode, den dårlige, og den stygge)
From the President (Fra presidenten)
Steven S. Sharfstein, M.D.
Psychiatric News August 19, 2005 Volume 40 Number 16 © 2005 American Psychiatric Association

APAs årlige møte er en av de største medisinske sammenkomster i USA og det største psykiatriske møte i verden. Der er noe for enhver på vårt vidunderlige møte, men mange har overfor meg kommentert den ekstraordinære tilstedeværelse av farmasøytisk industri igjennom de vitenskapelige programmer og utstillingene. (APA's annual meeting is one of the largest medical meetings in the United States and the largest psychiatric meeting in the world. There is something for everyone at our wonderful meeting, but many have commented to me on the extraordinary presence of the pharmaceutical industry throughout the scientific programs and on the exhibit floor.)

Den amerikanske farmasøytiske industri er en av de mest lønnsomme industrier i verdenshistorien, med et gjennomsnitt på 17 prosent av inntekten det siste kvart århundre. Legemiddelkostnader er blitt det hurtigst voksende element når det gjelder forbruket innen helsomsorg de senere år. Antidepressive legemidler rangerer alene som nummer tre for farmasøytisk salg på verdensbasis, med 13,4 milliarder dollar i årlig salg. Dette representerer 4,2 prosent av alt globalt farmasøytisk salg. Antipsykotiske legemidler innbrakte 6,5 milliarder dollar i inntekter. (...) (The U.S. pharmaceutical industry is one of the most profitable industries in the history of the world, averaging a return of 17 percent on revenue over the last quarter century. Drug costs have been the most rapidly rising element in health care spending in recent years. Antidepressant medications rank third in pharmaceutical sales worldwide, with $13.4 billion in sales last year alone. This represents 4.2 percent of all pharmaceutical sales globally. Antipsychotic medications generated $6.5 billion in revenue.)

(Anm: Det fremgår av American Psychiatric Associations (APAs) etiske retningelinjer (Internet Archive) at foreningen i stor grad tilsynelatende aksepterer interessekonflikter mellom leger og legemiddelfirmaer.)

Omfattende overtredelser av markedsføringsregler på konferansen til den amerikanske psykiatriske forening (American Psychiatric Association (APA))

Widespread Drug Marketing Violations Occurred at American Psychiatric Association Convention, Public Citizen Writes in Journal of Public Health Policy (Omfattende overtredelser for markedsføring på konferansen til den amerikanske psykiatriske forening (American Psychiatric Association), skriver Public Citizen i Journal of Public Health Policy.)
Public Citizen 15.12.2005
Mer enn halvparten av legemiddelprodusenter overtrådte konferansens regler (More Than Half Of Drug Makers at Convention Violated Rules)

WASHINGTON, D.C. – mer en halvparten av legemiddelprodusentene som deltok på konferansen til American Psychiatric Association (APA) i 2002 brøt reglene som var satt opp av foreningen eller den amerikanske legemiddelkontrollen Food and Drug Administration (FDA), skriver Public Citizen i study i den nyeste utgave av Journal of Public Health Policy. (– More than half the drug makers that participated in the 2002 American Psychiatric Association (APA) convention violated drug marketing rules set up by the association or the Food and Drug Administration (FDA), Public Citizen writes in a study in the current issue of The Journal of Public Health Policy.)

Studien finansiert av Greenwall Foundation og Medicine as a Profession Program til Open Society Institute, undersøkte 24 legemiddelfirmaer salgsstander på APAs konferanse i 2002 ved å dokumentere interaksjoner med farmasøytiske firmarepresentanter og innhenting av gaver fra firmaer til leger. Syv forskningsassistenter samlet også informasjon ved å fylle ut et spørreskjema med en sjekkliste av mulige overtredelser av APA konferansens retningslinjer umiddelbart etter å ha beøkt salgstander. (The study, funded by the Greenwall Foundation and the Medicine as a Profession Program of the Open Society Institute, examined 24 drug company booths at the 2002 APA convention by documenting interactions with pharmaceutical company representatives and collecting the gifts provided by the companies to physicians. Seven research assistants also gathered information by filling out a questionnaire with a checklist of potential promotional violations of the APA convention guidelines immediately after visiting the booths.)

Forskerne fant 16 overtredelser av APAs regler for utstilling: Åtte firmaer hadde et brudd og to firmaer (Eli Lilly og Pfizer) hadde fire overtredelser hver. De mest vanlige APA-overtredelser var å gi gaver verdt mer enn 10 dollar, salgstander med “grelt lys,” salgsfremmende aktiviteter utenfor salgsstander og å gi bort småting eller lekedyr. Firmaene delte ut et spekter av artikler som inkluderte CD-er, bagasjemerker med ens navn på, palm pilot tilbehør, vesker, turistguider, krus i vesker i fløyel og telefonkort. Andre gratis vareprøver var invitasjoner til selskapeligheter, underholdning og kunstrelaterte begivenheter. (The researchers found 16 violations of the APA’s exhibit rules: Eight companies had one violation and two companies (Eli Lilly and Pfizer) had four violations eac