New Study Finds Likely Bias Among FDA Advisors With Industry Ties

A new report suggests that independent advisors to the U.S. Food and Drug Administration (FDA) are likely to be biased if they also receive money from manufacturers or pharmaceutical companies.

In an original investigation published in the latest issue of the Milbank Quarterly (PDF), researchers found that conflicts of interest among FDA advisory committee members have real-world effects on how that committee votes.

The report raises questions about the influence of the drug industry on the FDA’s decision-making process, which heavily relies on recommendations from what are supposed to be independent medical experts.

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“FDA Center for Drug Evaluation and Research advisory committee members who have financial ties solely to the firms sponsoring the drug under review are more likely to vote in ways favorable to the sponsor,” the report determined. “Committee members who serve on advisory boards for sponsoring firms show particularly strong pro-sponsor bias.”

Drug Industry Ties Influence Votes

The researchers looked at voting behavior and reported financial interests of 1,379 FDA advisory committee members on the Center for Drug Evaluation and Research (CDER) advisory committee from 1997 to 2011. The data included information on 1,168 questions, 15,739 question-votes, and 379 meetings.

The study found that individuals with financial ties to a drug company were almost 50% more likely to vote in favor of that company than those with no financial ties. The researchers also found that the bias disappeared if the individual had financial ties to a number of different firms at once.

When a drug comes up for review by the CDER advisory committee, the study indicates that an average of 13% of the committee’s members have a financial tie to the drug manufacturer. At the actual meetings, about half have at least one member at the meeting with a financial interest in the company sponsoring the drug.

Overall, CDER committee members slightly favor sponsoring drug companies, with a 52% chance of voting in favor of the drug up for review. However, members with financial ties to that particular company have a 63% chance of voting in favor for the drug.

Advisors Influence FDA Regulations

The FDA advisory boards are designed to be independent panels whose meetings, agendas and the questions raised are directed by the FDA. However, the advisory boards members are comprised of a number of experts from various disciplines.

The committees make recommendations to the FDA that are non-binding, meaning the agency can choose to ignore their advice. However, the advisory committees often have a strong influence on the agency’s decisions.

Concerns over conflicts of interest on the committees, particularly the CDER have simmered for some time over the years, flaring up when particularly controversial drug issues come before the advisors.

“Having a vastly expanded data set of FDA CDER advisory committee member votes and financial interests has allowed us to detect relationships that had previously been missed,” the researchers concluded. “In contrast to earlier research, this study finds that individuals with financial interests solely in the sponsoring firm are more likely to vote in favor of the sponsor than are members who have no financial ties; moreover, this pro-sponsor bias appears to be larger when we look at non-unanimous votes — cases in which the scientific evidence may be more ambiguous.”

In December 2011, the FDA convened an advisory committee panel to discuss the risks of Bayer’s Yaz and Yasmin birth control pills that brought protests from consumer watchdog groups and women’s health organizations after it was revealed that four members of the committee had conflicts of interest, having worked as consultants or researched for Bayer.

The committee voted 15 to 11 to decide that the drugs, linked to high rates of blood clot-related illnesses, had benefits that out-weighed the risks; a margin of four votes.

Tags: Yasmin, Yaz

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