How Conflicted Experts Can Sway FDA Drug Approval Decisions: A Case Study on Yaz

April 13, 2012 | 3:00 pm
Francesca Grifo
Former contributor

Experts on FDA advisory panels with financial conflicts of interest can influence the approval of a drug in multiple ways, not only by voting to approve a drug but also by dominating the discussion and pressuring other panelists. In the case of the popular contraceptive drug Yaz, four scientists with financial conflicts of interest were enough to push the vote in favor of the drug, with significant consequences for some women.

On December 9, 2011, a panel convened by the FDA to evaluate the risks and benefits of Yaz voted to keep it on the market after deciding that the drug’s benefits outweighed its risks. Yaz had come under scrutiny after multiple independent studies found that the cardiovascular risk for women on the drug was significantly higher than other oral contraceptives (such as levonorgestrel, commonly known as Plan B).

Yaz birth control pills in packet

The birth control pill Yaz increases the risk of developing a blood clot, which can be fatal. Several scientists on an FDA advisory committee who had undisclosed financial conflicts of interest voted in December to keep the drug on the market. Photo: Flickr user Stacy Lynn Baum

Washington Monthly and the British Medical Journal (BMJ) reported that at least four scientists on the panel had direct financial ties to Bayer, the drug’s manufacturer, or its affiliates. A fifth scientist had been paid by a law firm representing the company.

The committee voted 15-11 in favor of the drug; had the conflicted scientists not voted, the panel would not have recommended that the drug stay on the market. The FDA is required by law to tell the public when it allows scientists with financial conflicts of interest to serve and vote on committees by granting them waivers. But while the scientists had reported their financial ties to the FDA, the agency failed to disqualify them or publicly release any waivers.

The new wonder drug?

In 2006, Yaz was approved and was advertised as a miracle drug for women suffering from severe PMS and acne. An ad by Bayer stated, “Yaz is the only birth control proven to treat the physical and emotional premenstrual symptoms that are severe enough to impact your life.” Within two years, it was the most popular birth control pill in the United States, reaching sales of $781 million in 2009.

This is part of a series of posts on drug safety reform at FDA.

Women like Carissa Ubersox were attracted to the claims that it reduces acne and bloating. In 2007, Carissa, a young professional working as a pediatric nurse, started taking Yaz. Less than three months later, she felt aching in her legs, and the next day was hospitalized.

The aches were caused by blood clots that subsequently traveled to her lungs, resulting in a pulmonary embolism. She slipped into a coma and stayed there for two weeks. When Carissa regained consciousness, she was blind, and remains so to this day. She has since given up her job as a pediatric nurse. “Everything that I thought I worked so hard for has disappeared,” she told ABC news.

Yaz is riskier than other birth control pills

All birth control pills carry some risk. According to the FDA, the risk of developing a blood clot when using traditional birth control pills is six in 10,000. However, five independent studies found that drospirenone, the active ingredient in Yaz, significantly increased that risk. One FDA-commissioned study found that drospirenone increased risk by nearly 75% compared to women on other birth control pills. Another study of more than 1 million women in Denmark found the risk to be ten in 10,000.

These independent studies ran counter to a Bayer-sponsored study finding no greater risk for Yaz compared to other oral contraceptives.

We owe it to Clarissa and other women that have been harmed by Yaz to do better. Scientific advisory committees should be fully independent and able to consider the best available scientific information when making recommendations regarding a drug’s safety and effectiveness compared to its alternatives. Financial pressures should never be a factor.