Executive Summary
The Food and Drug Administration (FDA) advisory committee meetings have, on average, 13% of members with financial conflicts of interest, according to a recent study.
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Some argue the FDA should require panel members with financial ties to recuse themselves from decisions.
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It is difficult for regulators to detect financial conflicts of interest.
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Some doctors may seek out more financial ties as a means to hide biases.
Food & Drug Administration (FDA) advisory committee meetings have, on average, 13% of members with financial conflicts of interest, according to a recent study. Researchers analyzed financial conflicts of 1,400 advisory committee members over a 15-year period.1
One set of findings in particular surprised the researcher. “We typically think that, if one financial tie is bad, then more financial ties must be worse,” says Genevieve Pham-Kanter, PhD, assistant professor in the Department of Health Management and Policy at Drexel University School of Public Health in Philadelphia.
What she found instead was that those FDA advisors with multiple financial ties were less likely to vote in favor of firms with whom they have ties than advisors with single ties. In fact, the scientists with multiple financial relationships didn’t vote any differently from those with no financial ties.
“This could be because they were less dependent on any single firm, or because these people with multiple ties are different than those who have exclusive ties,” says Pham-Kanter. It is possible they had more expertise, or were more skeptical than those with exclusive financial ties to firms.
Regarding specific types of financial ties and how they were associated with voting behaviors, the findings were fairly predictable, she says. The types of financial ties that were most strongly associated with voting bias were being on an advisory board for a firm and holding some ownership or equity stake in the firm — “in other words, ties where people who had greatest potential for financial gain,” says Pham-Kanter.
L. Lewis Wall, MD, DPhil, MBioeth, professor of obstetrics and gynecology at Washington University School of Medicine in St. Louis, would have expected the number of conflicted FDA advisors to be substantially higher.
“This was somewhat surprising, given how the pharmaceutical industry targets ‘thought leaders’ in the medical world,” he says. “This is actually a huge problem.”
Physicians generally are in denial that financial relationships with pharmaceutical companies influence their decisions, adds Wall. Evidence suggests that even small gifts to doctors influence prescribing habits.2,3,4
It is not so much that a doctor can be “bought” for a packet of candy, he explains. Rather, gifting and other financial relationships sets up a mental predisposition to favor the one who has previously favored you.
“And it works — or the pharmaceutical industry would not spend so much money doing it,” says Wall.
Pham-Kanter says the study’s findings raise the following ethical concerns:
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It is difficult for policymakers and regulators to detect financial conflicts of interest that may be detrimental to the public interest.
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It is possible that some doctors will now seek out more financial ties as a means to hide their own biases.
If a doctor with an exclusive tie is worried about scrutiny or perhaps even knows that he or she has some bias, says Pham-Kanter, “he or she might attempt to limit scrutiny and/or cloak the bias by seeking out ties from other firms in an attempt to look like the unbiased and high-expertise scientists with multiple ties.”
Institutions that employ doctors who serve in research advisory capacities should be vigilant about this, says Pham-Kanter. “For starters, they could do more than a cursory review of their advisors’ financial ties,” she says. “A simple numeric count won’t be sufficient to distinguish potentially problematic ties from those that are not.”
Institutions could also focus on the nature of the tie, she says. For example, ownership and advisory board ties should be bigger red flags than other kinds of financial ties.
The FDA should require panel members with financial ties to recuse themselves from decisions where financial relationships exist with industry, says Wall. “The public expects no less,” says Wall. “There will be increasing pressure to eliminate such conflicts of interest in FDA decisions — and that is the right thing to do.”
Pham-Kanter hopes that the research will encourage a more sophisticated approach toward the regulation of physician-industry relationships. “Not all ties are alike,” she says. “We will lose some good along with the bad, if we just do a simple tally of financial ties as a measure of badness.”
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Pham-Kanter G. Revisiting financial conflicts of interest in FDA advisory committees. Milbank Quarterly 2014, 92: 446–470.
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Lieb K, Scheurich A. Contact between doctors and the pharmaceutical industry, their perceptions, and the effects on prescribing habits. PLoS ONE 9(10): e110130.
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Wall LL, Brown D. The high cost of free lunch. Obstet Gynecol 2007; 110:169-173.
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Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA 2000; 283(3):373-380.
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Genevieve Pham-Kanter, PhD, Assistant Professor, Department of Health Management and Policy, Drexel University School of Public Health, Philadelphia, PA. Phone: (267) 359-6163. Fax: (267) 359-6001. E-mail [email protected].
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L. Lewis Wall, MD, DPhil, MBioeth, Professor of Obstetrics and Gynecology, Washington University School of Medicine, St. Louis, MO. Phone: (314) 362-4511. Fax: (314) 362-3328 Email: [email protected]
