The Food and Drug Administration (FDA) assembles expert panels that vote to recommend whether that federal agency should approve or deny approval for new drugs and devices.
But after harsh criticism about conflicts of interest in the media and from the prestigious Institute of Medicine, the agency is now rethinking its guidelines for membership on these expert panels.
A report last year in the Journal of the American Medical Association (JAMA) brought to light the extent to which panel members were receiving support from the very companies whose drugs they were voting on — a clear conflict of interest.
The report found that in meetings held by 16 advisory panels between 2001 and 2004, at least one panel member had a conflict in 73 percent of meetings. And here's an even more shocking indictment: In 22 percent of the meetings examined in the JAMA study, more than half of the individual panel members at those meetings had a conflict of interest.
These conflicts are important to consumers because usually, but not always, the final FDA decision follows the recommendation made by the advisory panel. And we all want the FDA to approve a medication because the scientific evidence shows the drug to be safe and effective, not because one or more panel members have a special interest — even a financial one — in seeing that a particular company's drug is approved.
From my own three-year experience as a member of an FDA advisory panel, I can say that some decisions were quite difficult enough, even without the overlay of special interest. In one case, I voted with the majority to approve a drug, despite worrisome findings in laboratory animals.
Fortunately, the drug has proven effective and safe over the years. But that was before the days when academic researchers were wined and dined or offered generous consulting fees by pharmaceutical companies. Today, I can see how a highly respected and influential panel member, one who is also getting industry support, could sway a panel's vote simply by giving strong support for a particular drug.
To avoid such conflicts, the FDA proposes barring advisory committee membership to, or limiting voting privileges for, scientists or clinicians who receive significant remuneration from industry. Except in rare circumstances, individuals would not be allowed to serve on an advisory panel if they received more than $50,000 from the manufacturer of a product under review — and those who received less than $50,000 in the preceding 12 months could only become non-voting members of a panel.
Only those who received no money at all from the drug manufacturer in question or from a company with a competing drug could be voting members.
Among the types of support covered by the proposed guidelines are stocks, consulting arrangements, and other financial ties. It's not clear whether money given to a university by a pharmaceutical company to support the research of a faculty member would fall under "other financial ties." I believe it should.
The guidelines don't cover other, subtler ways companies use to increase sales of their products, such as trips, dinners, and honoraria for talks.But their impact is less than direct financial rewards, and I can't imagine how these inducements could possibly be quantified.
I strongly support these proposed changes but they must be considered as only the first steps in the FDA's attempt to clean up its act. Some who are concerned about the changes have argued that industry ties to researchers at American universities are so pervasive that the FDA may not always be able to find the best-informed and brightest scientists to serve on its advisory panels. In my opinion, however, many able researchers and clinicians have no conflict of interest. The FDA just needs to dig a little deeper to find them.


