Apr 23 2008
The cornerstone of science-based medicine is, of course, scientific research. The integrity and quality of biomedical research is therefore of critical importance and to be thoughtfully and jealously guarded, if we care about maintaining an optimal standard of care. There are many threats and hazards to the institutions of medical research – mostly ideological. One that has not been discussed much on this blog but has been in the news recently is that of conflict of interest. Upon close examination this is a more complex issue than it may at first appear.
The most recent controversy over conflicts of interest were sparked by an article published in JAMA in which the authors allege that published studies that downplayed the risks of Vioxx (A Cox-2 inhibitor marketed as a pain killer that was removed from the market for increased cardiac risk) were in fact ghost-written by employees of Merck, the manufacturer of Vioxx. The names of two academic researchers were then attached to the studies to give them legitimacy. If true this is a damning episode, and no one would reasonably disagree with the contention that companies writing research on their own products represents an unacceptable conflict of interest. For the record, both Merk and the one surviving academic deny the accusations completely.
Many other forms of potential conflict of interest have also been raised in the discussion of medical research. Journals now require that authors disclose any financial ties to the subject of their research. Some of these conflicts are clear, for example – owning stock in the company who manufactures or sells the object of research, or holding a patent in the drug or technology. In any situation in which the outcome of research will affect the value of a researcher’s stock or patent there is a clear and unambiguous conflict.
Other conflicts that are fairly clear include researchers or academics who receive large sums of money for consulting fees or similar from a company that they then conduct research for. If a substantial portion of one’s income could be threatened by an unfavorable outcome of one’s research, a conflict is clear. Regarding regulatory agencies, it is clear that regulators should not be rendering decisions regarding companies from whom they are accepting consulting fees or for whom they expect to work.
Then there are more subtle or questionable forms of conflict, and this is where there is great controversy. Minor ties to companies are common for academics. For example, small speaking fees are often given to experts with reputations in their field. Recognized experts are also frequently consulted for their expertise. Experts, for example, are often consulted to help decide fruitful avenues of future research, or to design clinical trials.
In response to the recent attention given to cases of conflict of interest or the appearance of such conflict, many institutions now require full disclosure on the part of their faculty. Typically a threshold of significance – - $5,000-$10,000 for example – is often used. This is in addition to the requirements of most journals from their authors. Research consortia may also have their own disclosure requirements.
In response to worry over the appearance of conflict, many academics are simply not supplementing their earnings with the occasional lecture or consultation. It is simply easier to avoid future conflict and accusations.
Not everyone agrees that this trend toward avoiding any appearance of conflict is an unalloyed boon to medical research. Elizabeth Whelan, writing in the Washington Times, points out that frivolous accusations of conflict has a “chilling” effect on the conduct of industry research. We all benefit from a productive a collaborative relationship between industry and the best minds in medical academia. Scaring off these experts from the most minor relationship with industry could hurt the quality of research.
There is also a growing trend to use the accusation of conflict, even when it is slight and questionable, to dismiss the findings of research inconvenient to ones own interests or ideology. For example, those who claim, falsely, that there is an association between vaccines and autism have used the slightest appearance of conflict to dismiss the evidence against any role of vaccines in autism.
There also seems to be an unfair asymmetry. While mainstream medicine is wrangling with this thorny issue, those on the fringe may ignore their own conflicts. For example, Andrew Wakefield is accused of receiving consulting fees from attorneys who were suing for vaccine injuries while he was conducting research supporting such a connection.
The issue of conflict of interest in medical research is a serious one. The medical profession needs to resist the urge to “circle the wagons” while taking a serious and open look at this issue. I think they have largely done so, but more work is to be done.
However, we should not go so far as to stigmatize even minor connections to industry or allow the weeding out of genuine conflicts turn into a thoughtless witch hunt. We should further be critical of those who use the accusation of conflict where one does not genuinely exist as a weapon against research the results of which they dislike.
As in many things, a proper balance is optimal. I think we are evolving toward a reasonable balance. Academics and experts should be able to provide their experience and expertise to industry and be appropriately compensated for their time and efforts. But industry should be prevented from putting their thumb on the scale of medical research, to gain the outcomes they desire by the application of funding and fees.
This should not be an intractable problem as long as we are thoughtful, consider all sides of the equation, and don’t allow bias and ideology to rule over reason.
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