Wednesday, June 21, 2006

British Medical Journal Highlights Conflicts of Interest

The latest issue of the British Medical Journal featured several articles on conflicts of interest and the integrity of the evidence base for health care.

WHO Obesity Task Force Linked to Pharmaceutical Companies

The main points of this article [ Moynihan R. Obesity task force linked to WHO takes "millions from drug firms. Br Med J 2006; 332: 1412.] were:


The International Obesity Task Force has relied heavily on funding from the drug industry for a decade, despite being widely seen as an independent think tank and having ties to the World Health Organization.

Set up in the mid-1990s with help from grants from three drug companies, the task force aims to portray obesity as a 'serious medical condition' and to promote better prevention and management strategies.

It has a high media profile and is highly influential. A senior US member and a well respected authority on obesity, William Dietz, is currently one of the driving forces behind a controversial change in definitions of childhood overweight and obesity, which some researchers believe may exaggerate the problem and unnecessarily label children as diseased.

Although the task force has at times disclosed the names of drug company sponsors, the exact amount of that sponsorship remains secret.

In 2002 the International Obesity Task Force officially merged with another group called the International Association for the Study of Obesity. The most recent annual report of the newly merged group highlights close ties with WHO but also shows that two drug companies, Roche and Abbott, are primary sponsors, supplying around two thirds of its total funding. Roche makes the antiobesity drug orlistat (Xenical), and Abbott makes sibutramine hydrocholoride (Reductil).

A senior member of the merged group who has seen funding documents but did not want to be identified told the BMJ that over recent years sponsorship from drug companies is likely to have amounted to 'millions.'

Tim Gill, a representative of the task force and executive officer of the Australasian Society for the Study of Obesity, said that although the task force focused mainly on prevention rather than treatment, drug companies benefited anyway from raised public awareness....
My comment is that ideally, organizations that claim to speak with the authority of the WHO ideally should be free from conflicts of interest, but practically, at a minimum should fully disclose all potential and actual conflicts of interest. Thus, the International Obesity Task Force (IOTF) ideally should operate without financial ties to organizations and firms that might financially or ideologically benefit from promotion of certain anti-obesity measures. If it must continue such ties, they should be clearly revealed, so those reading the IOTF pronouncements may know where they come from.

CONSTRUCTIVE SUGGESTION

Any readers who know someone on the WHO Executive Board should consider contacting them suggesting a more rigorous policy to govern conflicts of interest that may affect WHO affiliate organizations.

Conflicts of Interest and Journal Editors and Publishers

A commentary discussed how editors and owners of medical journals may be affected by conflicts of interest [Lexchin J, Light DW. Commercial influence and the content of medical journals. Br Med J 2006; 332: 1444-7.] Its main points were:
  • Although government and organizations may influence medical journals, "we think the greatest potential for biases comes from commercial influences."
  • A minority of major journals have stated policies on editors' conflicts of interest.
  • Income that could constitute institutional conflicts of interest for journals may come from publishing supplements, which are often heavily supported by pharmaceutical companies; selling reprints, which journals may heavily market to pharmaceutical companies; and from advertising.
  • Journals rarely report their sources of revenue.
  • There is anecdotal evidence that journals' publishing decisions may be affected by concerns about effects on advertising.
  • Recommendations for change included disclosure of all sources of funding; adherence to international guidelines on conflicts of interest; editorial disclosure of personal conflicts of interest; banning editors from having any financial ties to companies that advertise in the journal; development of a classification of all possible financial ties among authors and commercial firms, which should then be fully disclosed using this system; publishing manuscript drafts and reviewers' comments on the internet; and a thorough external independent investigation of the issues.
Holding Out Against Conflicts of Interests

A personal essay by Joe Collier [Collier J. The price of independence. Br Med J 2006; 332: 1447-9.] focussed on independence, a positive term for the absence of conflicts of interest and external influence. Collier made a strong plea for the importance of independence for journal editors.
What has emerged over the years is that my views have needed to be much more than independent. To be of real value, they have needed to be delivered in a way that the message was clear, pertinent, honest, and unambiguous. Advice that can be misinterpreted or leaves room for misunderstanding is often unusable and may be dangerous. In my experience, people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult.

Independence in itself does not make the advice right, and, conversely, partisan advice is not necessarily wrong. Similarly, an adviser's bias will not necessarily colour all of their judgments adversely. A chief executive of a large drug company could give unbiased and invaluable guidance on how to increase business success. But the same executive's advice on the best drug for headache is unlikely to be helpful. What independence does is to improve clarity.

I attempt to live in a way that is consistent with the Nolan principles, which were developed as a set of standards of behaviour for ministers, members of parliament, civil servants, and other senior public servants. But even these are incomplete and would benefit from strengthening by the addition of sections of the recently introduced Duties of an Expert Witness:

Selflessness—No advice should be influenced by the possibility that it might result in financial gain or other material benefits for the advisers, their families, their friends, or other interested third parties.
Integrity—Independent advisers should not place themselves under any financial or other obligation to outside persons or organisations that might influence them inappropriately.
Objectivity and openness—Independent advisers must be able to explain why they have reached their conclusion and what reasoning led to their opinion.
Accountability—Independent advisers must be fully accountable for the advice they give and be prepared for their advice and their methods to be scrutinised.
Honesty—Independent advisers must declare each and every one of their competing interests that might have a bearing on the advice. It is for the recipient of the advice, not the adviser, to decide what that bearing might be.

But even these principles and the notion of proportionality are not enough. There are two additional requirements: advisers should respond if their position is challenged—silence is not a real option—and if an error has been made, the adviser is duty bound to point it out (preferably being the first to do so) and offer an apology and a correction.
Collier's statement about the personal cost of being independent was striking:
For me, independence has meant saying what I mean and often being seen as rude and uncaring; holding no favours; deciding on each issue on the basis of the evidence rather than blindly following the majority; risking being seen as inconsistent (a loose cannon); not necessarily being able to support friends and colleagues; giving advice that runs counter to my personal interest; and criticising employers or senior members of the establishment. Perhaps predictably, the positions I have taken have often caused me difficulties. I have lost friends, been ostracised by the establishment, and had my career advancement undermined.
Much of this must seem familiar to those who have blown the whistle about health care mismanagement, conflicts of interest, and corruption.

But there is an up-side:
But the freedoms and intellectual satisfaction gained by being allowed to be an independent thinker giving unfettered advice have far outweighed these burdens. Moreover, for each of the friends I have lost, I believe I have gained professional colleagues who value and trust my judgments. My career progression is not necessarily what one would advise for someone starting out in medicine, but for those who put independence of thought high in their hierarchy of values, the stance is worthwhile and rewarding.
Summary

Finally, there was a nice editorial summary [Godlee F. What price integrity? Br Med J 2006; 332: ], which included an assertion that the BMJ is currently following most of the reccomendations set forth by Lexchin and Light, and may consider full disclosure of all sources of revenue.

It's nice to report some positive news now and then. The increasing emphasis by major medical journals on the problems causes by conflicts of interest has to be a positive development.

3 comments:

T Young, Ph.D. said...

Thanks for the heads up on the new issue of BMJ. I kind of took it and ran with it (http://community.livejournal.com/poundofcure/27595.html).

xenical said...

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