Conflicts of Financial Interest Have Arguably Captured Medicine’s Clinical Practice Guidelines Panels — According to a New Study
© 2011 Peter Free
12 October 2011
Why should the medical-industrial complex do good science, when it can just buy guidelines recommenders?
In regard to financial conflicts of interest in medicine, the British Medical Journal published an American study that casts doubt on the objectivity of medical practice guidelines that are issued in the United States and Canada:
For diabetes and hyperlipidaemia, we found that conflicts of interest (COI) were present for the vast majority of guideline panels reviewed.
We also found that among panels that had chairs, half of these had COI.
In addition, among panellists with an opportunity to publicly report COI, one out of nine reported no COI but were found to have undeclared COI.
Our data illustrate the pervasiveness of COI among members of guideline panels and may raise questions about the independence and objectivity of the guideline development process in the United States and Canada.
© 2011 Jennifer Neuman, Deborah Korenstein, Joseph S Ross, and Salomeh Keyhani, Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study, British Medical Journal 343:d5621, doi: 10.1136/bmj.d5621 (11 October 2011) (paragraph split)
“Why should we care?”
The study’s authors put medical financial conflicts of interest problem in perspective:
[T]he latest revelations about frequent and large “consultancy” payments to physicians, the practice of “ghost writing” by drug company employees, and the prevalence of industry funded “key opinion leaders” in medicine raise concern that physicians’ financial relations with industry may undermine the practice and promotion of high quality evidence based care.
One area in which the presence of COI may be particularly concerning is the development of clinical practice guidelines.
Guidelines serve to standardise care, to inform evidence based practice, and ultimately to protect patients, so their freedom from bias is particularly important.
© 2011 Jennifer Neuman, Deborah Korenstein, Joseph S Ross, and Salomeh Keyhani, Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study, British Medical Journal 343:d5621, doi: 10.1136/bmj.d5621 (11 October 2011) (paragraph split)
Smart policy would exclude people with conflicts of interest from medical recommendation panels
The United Kingdom’s “National Institute for Health and Clinical Excellence” excludes panel members who have conflicts of interest.
The United States’ Institute of Medicine also recommends that conflicts of interest have no place on guidelines panels:
These recommendations call for the exclusion of panel members with financial COI, the appointment of a chair without COI, and an end to direct funding of guidelines by industry.
They also recommend full disclosure of the COI policy of each guideline panel, along with the potential COI of all panel members.
Lastly, they recommend that if appointing panellists with COI is unavoidable, their presence should be limited to a minority and they should be prohibited from voting.
© 2011 Jennifer Neuman, Deborah Korenstein, Joseph S Ross, and Salomeh Keyhani, Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study, British Medical Journal 343:d5621, doi: 10.1136/bmj.d5621 (11 October 2011) (paragraph split)
For those who are unfamiliar with the Institute of Medicine, it is generally perceived as unbiased. It’s one of the United States’ National Academy of Sciences.
Citation — to the Institute of Medicine’s recommendations about conflicts of interest
Institute of Medicine (US) Committee on Conflict of Interest in Medical Research, Conflict of interest in medical research, education, and practice, National Academies Press (2009)
American control of conflicts of interest is lax
American guidelines are issued by a variety of panels, each with their own policies, most of which only pretend to deal with the conflicts of interest problem.
What the research team did
To find out whether our cavalier attitude regarding conflicts of interest posed potential problems for science-based medicine, the study’s authors probed for conflicts among the authors of 14 clinical practice guidelines (11 American and 3 Canadian).
They focused on guidelines for diabetes and hyperlipidemia. The recommendations they examined had been issued between 2000 and 2010, and the authors included 7 for each illness.
Why pick these two illnesses?
The team reasoned that diabetes and hyperlipidemia are highly prevalent and account for the biggest share of American Medicare drug spending. Worldwide, the associated drugs also account for enormous outlays.
How did the team define a conflict of interest?
In common sense terms:
We defined financial COI as the direct compensation of a guideline panellist by a manufacturer of a drug used to treat the disease of interest in the guideline, in the form of grants (including research), speakers’ fees, honorariums, consultant/adviser/employee relationships, and stock ownership.
We classified COI into three categories: declared in the guideline; undeclared in the guideline but identified through our search strategy; and no opportunity to declare COI in the guideline but identified COI by our search strategy.
© 2011 Jennifer Neuman, Deborah Korenstein, Joseph S Ross, and Salomeh Keyhani, Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study, British Medical Journal 343:d5621, doi: 10.1136/bmj.d5621 (11 October 2011) (paragraph split)
The study casts doubt on the way we do things
At least, if getting bias out of medicine is the goal:
In summary, among 288 members of guideline panels, 52% (n=150) had COI, of which 138 were declared and 12 undeclared. Four undeclared conflicts were among panel members of guidelines without an opportunity to declare COI.
© 2011 Jennifer Neuman, Deborah Korenstein, Joseph S Ross, and Salomeh Keyhani, Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study, British Medical Journal 343:d5621, doi: 10.1136/bmj.d5621 (11 October 2011)
More startling was the high proportion of conflicted “specialty” panels
This finding is revealing:
In contrast to government sponsored panels, we found that COI were very common among panel members for guidelines produced by specialty societies.
Guidelines produced by non-government sponsored organisations have been shown to be of poor methodological quality; however, they contribute substantially to the guideline pool in the United States and Canada, with specialty societies alone accounting for almost 40% of guidelines in the National Guideline Clearinghouse.
Furthermore, several of the specialty societies included in our review have international prominence outside of North America, and their guidelines may have broad international influence.
© 2011 Jennifer Neuman, Deborah Korenstein, Joseph S Ross, and Salomeh Keyhani, Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study, British Medical Journal 343:d5621, doi: 10.1136/bmj.d5621 (11 October 2011) (paragraph split)
The moral? — Greed is everywhere, and it is not your medical friend
The study’s authors recommended that disclosure is not enough to control biased clinical practice recommendations.
They think the fact that government is able to recruit conflict-free panel members suggests that the same is possible outside government.
But that observation partially misses the point.
It is not (at least yet) the impossibility of recruiting the untainted that is the problem. Human nature and the ethical decline of all our institutions and professions is the problem.
Corporate money, dangling Avarice’s carrot, has insidiously corrupted much of medicine. This rot exactly parallels the way plutocrats have bought our democratic institutions out from under us.
Until we get money’s unbridled clout out of governance and medical ethics, we’re in for an increasingly nasty ride.