Much has been made of Health and Human Services Secretary Kathleen Sebelius’ decision last month to overrule Food and Drug Administration scientists and prohibit the over-the-counter sale of the morning after pill to minors. Many observers blasted the move as a blatant political move by the White House, which didn’t want to antagonize social conservatives ahead of this year’s election.
Now there is the possibility politicians on Capitol Hill are also influencing some choices being made at the FDA. It involves the agency’s decision last month to appoint at least three scientists to a high-profile drug safety advisory committee without disclosing they had conflicts of interest with the company – Bayer – whose product – birth control pills – was up for review.
The committee recommended that Bayer be allowed to keep its problematic birth control pills – sold as Yaz and Yasmin – on the market even though the agency’s adverse events reporting system had turned up dozens of deaths from blood clots. Thousands of lawsuits have been filed against the company alleging the pills damaged women’s health. Still, the committee said the benefits of having another birth control option on the market outweighed the risks.
The vote was close – 15-11 – and dogged by controversy. Before the meeting, the FDA ruled that the safety committee’s usual consumer representative, Dr. Sidney Wolfe from Public Citizen, a long-time thorn in industry’s side, couldn’t participate because his newsletter, “Worst Pills, Best Pills,” had already called for banning the drugs. In addition, the agency refused to distribute a long legal and scientific brief prepared for plaintiffs’ attorneys by Dr. David Kessler, who once headed the agency. He submitted it too late, the agency ruled.
The latest scandal was turned up by investigative reporters for the British Medical Journal, where many of the studies outlining the risks from birth control pills first appeared. Their report, which appeared earlier this week in the Washington Monthly, revealed that at least three obstetricians/gynecologists on the committee had financial ties to Bayer. Not only that, the FDA knew about the financial conflicts of interest and didn’t tell the public.
The Wall Street Journal on Wednesday followed up with some juicy details about the ties between some of the researchers and Bayer. For instance, Dr. Paula Hillard, an obstetrics professor at Stanford University School of Medicine, attended two meetings sponsored by the company in 2010 to help it deal with the blood clot controversy, and was paid “less than $10,000” for her efforts, the paper reported. She, like the others named in the Monthly article, voted to keep the pills on the market.
So where does Capitol Hill come in? Last October, Senators Michael Bennet (D-Co.), Richard Burr (R-N.C.), and Amy Klobuchar (D-Minn.) introduced legislation that would loosen the FDA’s conflict of interest policies. The ostensible goal? To speed up the review of medical products. That legislation followed statements by FDA Commission Margaret Hamburg that the agency was having difficulties finding people without conflicts of interest to serve on its 55 committees.
The FDA, like every federal agency, is forbidden from appointing scientists with conflicts of interest to its technical advisory committees. However, the law allows exceptions. If the agency needs that particular person’s expertise, it can grant a waiver as long as it is disclosed to the public. It can also waive the conflict if it is considered too minor to actually affect a person’s judgment. Unfortunately, the law does not specify what is considered “de minimus.” $50,000? $5,000? $500?
Time for some personal disclosure: I spent five years during the 2000s as a public interest advocate lobbying to ban the use of scientists with conflicts of interest on federal advisory committees. It never passed Congress, but in 2007 the reauthorization of the Prescription Drug User Fee Act included a section that limited the total number of waivers allowed by the FDA.
My reasoning, like the many consumer organizations which backed a total ban on using conflicted scientists, was that there are plenty of non-conflicted experts at American universities, research institutes or in private practice who are just as knowledgeable as people who sign consulting deals with industry. Moreover, eliminating the whiff of impropriety that appointing scientists with conflicts of interest brings would maintain the public’s faith in the integrity of the process, even if the appointee swears up and down that is or she isn't biased by the relationship.
The fact the FDA didn’t even disclose through the waiver process that those ties existed was deeply troubling to many observers. “Lack of disclosure undermines the credibility of the advisory committee process and undermines public trust in the fairness of the regulatory process,” Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, told the Journal. The process is further undermined if the agency skirts its own rules to placate critics on Capitol Hill.
