Report Reveals Some FDA Advisors Have Undisclosed Financial Ties

An investigative report by the Wall Street Journal suggests that the FDA may have failed to disclose a number of cases where members of its advisory panels were also working for drug companies and medical device manufacturers whose products were being reviewed, raising questions about the independence of the recommendations issued by these panel of outside experts.

FDA advisory panels are often convened by the agency to review the safety and efficacy of medications, devices and medical procedures. The outside experts are supposed to be independent and make recommendations about which products should be approved by the agency, when new warnings should be placed on specific products and when manufacturers need to do additional research to establish that their products are safe.

While recommendations made by the panels are not binding, they often have a significant influence on the FDA’s final regulator decisions.

A report by the Wall Street Journal (subscription required) this week suggests that the FDA has not disclosed potential conflicts of interest among members of its advisory boards on a number of occasions, even though it appears those allegiances might have had an effect on the board’s recommendations.

The investigation found that from 2012 through 2014, one-third of the 122 members that served on FDA advisory panels had received compensation from medical device companies. In nearly 10% of those cases, board members had at some point been compensated by company’s whose devices they were reviewing. However, the FDA only reported about 1% of those financial ties.

As recently as July, an advisory panel member stepped down when it was revealed that he had received payments from a medical device manufacturer involved in the production of power morcellators. The panel was convened evaluate the risk of spreading cancer from uterine fibroid morcellation, evaluating whether the devices should be recalled or allowed to remain on the market with stronger warnings.

Ultimately, the panel concluded that power morcellators can not be used during laparoscopic hysterectomy or myomectomy procedures without posing a risk of disseminating uterine cancers that are not diagnosed before the surgery, such as leiomyosarcoma or endometrial stromal sarcoma. However, the panel could not reach a conclusion about whether to recommend a recall or black box warning.

In a controversial decision, the FDA subsequently announced last month that power morcellators will receive the strongest warning possible, but will remain on the market.

After the Wall Street Journal revealed that a panel member was connected to manufacturers of the controversial devices, which the FDA failed to disclosed, the gynecologist stepped down from the board.

History of Industry Influence Concerns

FDA advisory panels have been the subject of much debate, and repeated issues have come up regarding conflicts of interest and potential undue influence by companies that have large financial stakes in the recommendations made to the FDA.

In 2010, the U.S. Department of Health and Human Services’ Office of the Inspector General (OIG) lauinched an investigation into an FDA advisory committee that recommended against a recall of the diabetes drug Avandia, which was linked to an increased risk of heart attacks.

That investigation involved endocrinologist and board member David Capuzzi, who was one of only three members on the panel who voted that no action at all needed to be taken to warn the public about Avandia heart attack risks.

The investigation announcement came after GlaxoSmithKline, the manufacturer of Avandia, revealed that Capuzzi had been paid to serve on an Avandia advisory board, contradicting earlier statements by Capuzzi, who said he had only spoken about other drugs for GlaxoSmithKline. FDA officials said they were unaware at the time of the vote that Capuzzi had spoken for GlaxoSmithKline in any capacity.

In 2012, similar concerns rose following an advisory board meeting on the potential side effects of Yaz and Yasmin birth control pills after information came to light that four FDA advisory committee members who voted to keep Yaz and Yasmin on the market had worked as consultants for, or received funding from, Bayer, the manufacturer.

The committee voted 15 to 11 that the benefits of Yaz, Yasmin and other drospirenone-based birth control pills outweigh the health risks, allowing Bayer to avoid a Yaz and Yasmin recall.

The deciding margin was the same as the number of board members with ties to Bayer.

Some groups say the influence does not end with panel members currently serving on the boards. In September, the consumer watchdog group Public Citizen sent a letter to the FDA urging it to take action on what appeared to be “influence peddling,” pointing out that the committees appear to have a “revolving door” policy that allows advisors to leave the panel to work with the industry and then quickly return to speak with their former colleagues and friends to win votes in favor of products sold by their new employer.