conflicts of interest
by Alex Boersma
“MONEY FROM DRUG COMPANIES IS THE OXYGEN ON WHICH THE ACADEMIC MEDICAL WORLD DEPENDS (Dr. Edwin Gale, Heartwire)
I have spoken before about the ethical abyss which distinguishes the production and implementation of medical guidelines. Along comes a new piece of research published in the British Medical Journal which should become required reading for anybody who takes advice from a doctor. I am not going to add much commentary here, because I believe the paper speaks for itself. I also believe you owe it to yourself to follow the link above and read the whole thing.
The researchers set out to determine the prevalence of financial conflicts of interest among members of panels producing clinical practice guidelines (i.e. the guidelines doctors use in their practices) for hyperlipidaemia (high cholesterol) and diabetes. At the end of their research, this is what they concluded:
”The prevalence of financial conflicts of interest and their under-reporting by members of panels producing clinical practice guidelines on hyperlipidaemia or diabetes was high, and a relatively high proportion of guidelines did not have public disclosure of conflicts of interest. Organisations that produce guidelines should minimise conflicts of interest among panel members to ensure the credibility and evidence based nature of the guidelines’ content.”
Here are the juicy bits. For guidelines which reported conflicts of interest, 66% of panelists involved in telling you that LDL causes heart disease(and you should probably take a statin even if your LDL is pretty low)were getting money from the people making statins. In the same category, 70% of the panelists telling diabetics not to worry about carbohydrate intake(as long as they keep taking their metformin and insulin) also got money from the people making metformin and insulin.
A Heartwire (sign-up free but required) story which delved more deeply into the dilemma found that this was not the first time such conflicts of interest had been reported. The author quotes Dr. James Kirkpatrick, who studied the same issue for the American Heart Association:
“There are plenty of people who participated in the guidelines process who reported no disclosures. The implications are that it would not be too difficult to construct a guidelines panel without COI (conflict of interest), or at least—as we suggested, and the authors also seem to suggest—with only COI related to research grant funding, exclusive of direct financial payments to members”
The quote above refers to the often suggested hypothesis that “all the experts already work for the pharmaceutical companies, therefore it is impossible to find a panel of experts who don’t have conflicts of interest.” That is exactly the excuse the U.S. Heart and Lung Foundation used to rationalize 8 of 9 panelists on the statin promoting cholesterol guidelines committee being paid by the statin makers. Dr. Kirkpatrick is suggesting that it is quite possible to form a panel of conflict-of-interest-free experts, especially if we disqualify only those who receive “honoraria” for such things as speaking engagements and lobbying. Personally, I still think it would be difficult for a panelist to remain neutral if he or she knows that the future of their research depends on renewed funding from a pharmaceutical company. Still, I think that eliminating the “salesman” experts from guideline panels would be a step in the right direction.
The Heartwire story goes on to shine a profound light into the heart of this dilemma. The author quotes an accompanying editorial by a Dr. Edwin Gale. This is what Dr. Gale has to say about the situation:
“The common suggestion that guideline committees should include only experts with no conflicts of interest has “a charming sense of unreality,” Gale argues. “Money from drug companies is the oxygen on which the academic medical world depends. The income of the professional societies that publish guidelines largely derives from their annual conferences, which depend on the rents charged to exhibitors and the registration of company-sponsored delegates,” he observes. “Let us therefore forget the hand-wringing and confront the reality of the world in which we live.”
Dr. Gale seems to believe that the only way to solve the problem is to eliminate paid experts entirely. Quote:
“Legislation will not change the situation, for the smart money is always one step ahead. What is needed is a change of culture in which serving two masters becomes as socially unacceptable as smoking a cigarette. Until then, the drug industry will continue to model its behavior on that of its consumers, and we will continue to get the drug industry we deserve.”
Here’s the thing. Consumers of medical advice (that’s you and me) exist within a bewildering domain of conflicting information. We hang on to our “charming sense of unreality” because without it we wouldn’t know who to listen to. We like to think that our doctors give us unbiased advice, but the truth is that much of that advice is paid for by pharmaceutical companies. Paid for by massive marketing campaigns, by lavish golf tournaments and ”educational” conferences, by free samples, free journals and free lunches. That conflicts of interest in the medical/pharmaceutical realm exist is not debated. Nor, as this Financial Times article explains, is it debated that pharmaceutical companies are guilty of breaking conflict of interest laws on an overwhelming scale. The only question left to be answered is what to do about it. With over 1,200 whistle-blower drug cases under investigation in the U.S. and the potential of billions of dollars in fines being awarded, the pharmaceutical companies are beginning to pay attention. But if Dr. Gale’s predictions ring even remotely true, I suspect there will always be ways to buy the support of researchers and medical professionals…smart money is always one step ahead.
If anyone still believes that pharmaceutical companies are motivated by ethics rather than profits, they should probably think about taking up smoking or buying swamp land in Florida. That is as it should be, since these are, indeed, multi-national corporations beholden to their stock holders. But when our health-care institutions construct their guidelines around advice provided by vested researchers, the public trust is betrayed. The people telling us if and when to take a statin should not be the same people who stand to make money if more of us take statins. This is fundamentally wrong but it is, as Dr. Gale says, “the reality of the world in which we live”
I leave you, then, with a little insight into the reality of the world in which we live. Below is the financial disclosure list for the 9 panelists who formulated the 2004 U.S. guidelines on cholesterol levels and heart disease. If these guidelines are strictly followed by our doctors, 10s of millions of new “patients” will begin taking statins and pharmaceutical companies will stand to make billions more in profits each year.
I have highlighted any conflict of interest items which fall under the “getting paid by the pharmaceutical company for something other than research” category.
Dr. Grundy has received honorariafrom Merck, Pfizer, Sankyo, Bayer, Merck/Schering-Plough, Kos, Abbott, Bristol-Myers Squibb, and AstraZeneca; he has received research grants from Merck, Abbott, and Glaxo Smith Kline.
Dr. Cleeman has no financial relationships to disclose.
Dr. Bairey Merz has received lecturehonorariafrom Pfizer, Merck, and Kos; she has served as a consultant for Pfizer, Bayer, and EHC (Merck); she has received unrestricted institutional grants for Continuing Medical Education from Pfizer, Procter & Gamble, Novartis, Wyeth, AstraZeneca, and Bristol-Myers Squibb Medical Imaging; she has received a research grant from Merck; she has stockin Boston Scientific, IVAX, Eli Lilly, Medtronic, Johnson & Johnson, SCIPIE Insurance, ATS Medical, and Biosite.
Dr. Brewer has received honorariafrom AstraZeneca, Pfizer, Lipid Sciences, Merck, Merck/Schering-Plough, Fournier, Tularik, Esperion, and Novartis; he has served as a consultantfor AstraZeneca, Pfizer, Lipid Sciences, Merck, Merck/Schering-Plough, Fournier, Tularik, Sankyo, and Novartis.
Dr. Clark has received honorariafor educational presentations from Abbott, AstraZeneca, Bristol-Myers Squibb, Merck, and Pfizer; he has received grant/research support from Abbott, AstraZeneca, Bristol-Myers Squibb, Merck, and Pfizer.
Dr. Hunninghake has received honorariafor consulting and speakers bureau from AstraZeneca, Merck, Merck/Schering-Plough, and Pfizer, and for consulting from Kos; he has received research grants from AstraZeneca, Bristol-Myers Squibb, Kos, Merck, Merck/Schering-Plough, Novartis, and Pfizer.
Dr. Pasternak has served as a speakerfor Pfizer, Merck, Merck/Schering-Plough, Takeda, Kos, BMS-Sanofi, and Novartis; he has served as a consultant for Merck, Merck/Schering-Plough, Sanofi, Pfizer Health Solutions, Johnson & Johnson-Merck, and AstraZeneca.
Dr. Smith has received institutional research support from Merck; he has stockin Medtronic and Johnson & Johnson.
Dr. Stone has received honorariafor educational lectures from Abbott, AstraZeneca, Bristol-Myers Squibb, Kos, Merck, Merck/Schering-Plough, Novartis, Pfizer, Reliant, and Sankyo; he has served as a consultantfor Abbott, Merck, Merck/Schering-Plough, Pfizer, and Reliant.
Remember, both the BMJ paper above and the findings of Dr. Kirkpatrick for the American Heart Association suggest that it is entirely possible to formulate a panel out of members who are not “getting paid by the pharmaceutical companies for something other than research”.
Right after the guidelines were published, a group of 35 prominent physicians and researchers demanded an independent review of the evidence, claiming foremost that the evidence did not fit the recommendations and secondarily that the credibility of the panelists was compromised by their financial ties to pharmaceutical companies. You can read the letter here. It was largely ignored.
In case you feel secure, like I did, that Canadian guidelines were free of such conflicts of interest, think again. Below are the financial disclosures for the four authors of the Canadian Cardiovascular Society 2009 Position Statement regarding cholesterol and heart disease.
Canadian Cardiovascular Society position statement – Recommendations for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease
CONFLICT OF INTEREST:
Dr Ruth McPherson has received honorariafrom AstraZeneca (Crestor), GlaxoSmithKline (Mevacor), Merck Frosst (Ezetrol), Pfizer (Lipitor) and Schering (Zetia and Vytorin) for conferences or advisory boards, with no ownership of stock or options.
Dr Jiri Frohlich has receivedhonorariafrom AstraZeneca, Merck Frosst, Pfizer and Schering for conferences or advisory boards, with no ownership of stock or options.
Dr George Fodor has received honorariafrom AstraZeneca, Merck Frosst, Pfizer and Schering for conferences or advisory boards, with no ownership of stock or options.
Dr Jacques Genest has received honorariafrom Merck Frosst Canada, Schering-Plough, Pfizer, Novartis (Flustatin) and AstraZeneca for conferences, advisory boards and consultant work, with no ownership of stock or options.
Are these really the people you want telling your doctor whether or not you need to take one of the drugs made by any of these companies? You tell me.