Tuesday, March 23, 2010

Does conflict of interest jeopardize public health

Generally, a conflict of interest can be characterized as any situation in which an individual could exploit his/her official position in some way for personal gain. Conflicts of interest do not not necessarily have to be monetary. They can be personal, political, academic, religious, or any combination of these factors.

The mere existence of a conflict of interest is not considered evidence of wrong doing or unethical behaviour. Rather, it is the way in which an individual or organization deals with the conflict that usually creates the problem.

For example, the board of directors of a housing co-op meets to discuss the awarding of a contract for remedial work on the boiler system. One of the quotes is from a company owned by the brother-in-law of one of the directors. That director has a definite and definitive conflict of interest. He has a fiduciary responsibility as a director of the co-op. But, he also has a vested interest in the financial well-being of his brother-in-law, and his decision may be biased to the detriment of the co-op.

If the brother-in-law's company is awarded the contract, there is justifiable cause for his competitors to claim bias.

Even if the board is satisfied that the director could make an objective, unbiased decision, it may not be enough to simply disclose the conflict. There would still be a perceived conflict. A reasonably prudent individual could justifiably argue that the board was unduly influenced by the conflicted director should he be permitted to debate or vote on the issue.

In such a situation, the board may deem it advisable to have the director refrain from participating in the discussion or voting on the issue, or perhaps even absent himself from the boardroom during debate on the issue.

So, at a minimum, there should be full disclosure of any conflict of interest as part of the public record to avoid any appearance of impropriety. And, in some cases , additional action may be necessary to alleviate concerns regarding bias in the decision making process.

The potential for conflict of interest exists in many, if not most, professions. However, in some lines of work, it is much more complicated than in typical business situations. And, the implications can be more far reaching.

One such field is medical research, especially studies dealing with smoking. Research requires funding. And, over the past two decades, more and more research funding has been coming from the pharmaceutical industry.

Not surprisingly, this has introduced an element of bias into the medical research. A 2009 article by Dr. Ben Goldacre (published in the BMJ) notes that: “A systematic review found 30 studies investigating whether [drug] industry funding is associated with outcomes that favour the funder: studies sponsored by drug companies were more than four times as likely to have outcomes favouring the funder, compared with studies with other sponsors.”

And, unfortunately, it has also raised serious questions regarding conflict of interest.

In May, 2008, an NIH (National Institute of Health) expert panel released an update of the Clinical Practice Guideline regarding the treatment of tobacco use and dependence. The project was funded by RWJF (Robert Wood Johnson Foundation), the philanthropic arm of drug manufacturer Johnson and Johnson.

The expert panel recommended use of buproprion (Zyban); nicotine gum; nicotine patch; nicotine nasal spray; nicotine lozenge; nicotine inhaler; and Chantix (or a combination of those drugs) to treat tobacco dependence. But, the efficacy of NRT is questionable. And, both Chantix and Zyban have been associated with serious side effects, including suicidal ideation (including actual suicides).

Since these clinical guidelines are referred to by the vast majority of doctors across the US, it is extremely important that they represent as unbiased an opinion as possible and that they be free from the taint of conflict of interest.

But, in a May, 2008 post on his blog, anti-smoking activist Dr. Michael Siegel notes that: “the guideline is a heavily biased analysis that is plagued by the presence of severe financial conflicts of interest among the panel's chair (Dr. Michael Fiore), and at least 8 of its other members.”

Siegel was referring to the fact that some members of the expert panel had been financially compensated as consultants or lecturers by one or more drug companies, including those who manufactured or distributed smoking cessation products.

This does not make those panel members guilty of any crime. But, it does raise questions about their objectivity. Were their recommendations based on an honest evaluation of the evidence? Or, were they concerned that a recommendation not supportive of drug treatment might jeopardize future research funding, or income from consultant and lecture fees?

The pharmaceutical industry is in direct competition with the tobacco industry. They both sell nicotine delivery systems; the tobacco companies in the form of cigarettes and other tobacco products and the drug companies in the form of nicotine replacement therapy.

Recently, the US FDA (Food and Drug Administration) announced four new members to their Tobacco Products Scientific Advisory Committee. The committee will advise the FDA on tobacco related issues. But, all four of these new appointees have received money from the pharmaceutical industry.

Siegel notes in a March 2, 2010 blog entry: “There is no way this panel can objectively consider tobacco product regulation and policy - based purely on the science - in the midst of such a potpourri of pharmaceutical financial interests and conflicts of interest.”

Anti-smoker activists have been critical of all research funded by the tobacco industry. Studies conducted with research grants from the tobacco companies are dismissed out of hand as prone to bias simply because of the source of funding. Highly qualified, objective researchers accepting tobacco funding have been vilified as stooges of the industry when their research does not reinforce anti-smoker theory.

But, are studies funded by the pharmaceutical industry any more reliable? Are the researchers any less prone to bias in favour of those providing the funding?

Should such examples of blatant conflict of interest and the resulting bias be ignored by the scientific community or the government

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