Statement of NRC Senior Fellow Sonia Nagda, MD, MPH at the Pediatrics FDA Advisory Committee Meeting on Beyaz and Similar Oral Contraceptives, September 11, 2012

Statement to an FDA Advisory Committee Concerning Beyaz

September 11, 2012

Thank you for the opportunity to speak today. I am from the National Research Center for Women & Families, a nonprofit research center that does not accept funding from pharmaceutical companies. I am Dr. Sonia Nagda, and my statement is on behalf of myself and the Center’s president, Dr. Diana Zuckerman.

I am a physician with a public health degree from Harvard. Dr. Zuckerman trained in epidemiology at Yale and was on the faculty at Vassar and Yale. Our statement today reflects our expertise in women’s health and public health.

There are so few studies on Beyaz that we need to make assumptions about the risks based on data from other DRSP oral contraceptives.  There are more than 80 oral contraceptives on the market, many with lower VTE risks than Beyaz and other DRSP oral contraceptives. Beyaz is safer than pregnancy but less safe than dozens of other pills. Beyaz’s risks cannot be justified for treating irregular or unpleasant menstrual periods.

The FDA documents provided to this committee include several written BEFORE the most recent research showing the increased risks of DRSP. For that reason, those documents should be excluded from your considerations regarding Beyaz.

Although all birth control pills can cause blood clots, a review of nine recent studies found higher risks from drospirenone in seven of them. Two studies published in 2009 reported drospirenone contraceptives increase the risk of blood clots by 1.5-to-2 times compared to pills containing levonorgestrel.1,2 Two articles published in 2011 in BMJ reported an increased risk of blood clots that was 2 to 3 times higher than other birth control pills.3,4

In addition, FDA funded its own study, which reviewed the medical records of more than 800,000 women taking birth control. This study found that the risk of blood clots increases from six in 10,000 teens and women on levonorgestrel to 10 per 10,000 teens and women on DRSP.5 When they focused on new users, drospirenone increased the risk of blood clots and heart attacks, especially for females under 35.

Only two published studies — one led by Seeger and one by Dinger – reported no elevated risk with DRSP contraceptives.6,7 Those authors had financial ties to DRSP pills, and they did not separately analyze women younger or older than 35, which could have influenced the results.

Because of the overwhelming evidence in well-designed studies indicating an increased VTE risk of DRSP compared to safer, less expensive contraceptives, we urge the FDA to take these pills off the market. Meanwhile, we urge you to express your concerns to the FDA about their widespread off-label use for regulating periods or reducing other menstrual symptoms. The risks are too great for those indications.

Last year, an FDA Advisory Committee voted for stronger warnings about VTE risks of DRSP, and FDA complied. But many on that Advisory Committee wanted to do more to save lives. Unfortunately, they were outnumbered due to the members with financial ties to Beyaz’s manufacturer. An Advisory Committee member who had previously expressed concern about the safety of DRSP was NOT allowed to vote. If the members who had financial ties to Yaz had ALSO been excluded from voting, the vote would have been different.

Based on what Advisory Committee members stated at that public FDA meeting last year, most Committee members believe that the risks of DRSP outweighed the benefits compared to other oral contraceptives. That’s true even if you include members with conflicts of interest.

You have seen the AERS data, but under-reporting makes those reports almost useless. VTE risks may be rare, but with more than 250,000 teenagers under 18 taking these drugs, as well as millions of older teens and young women, too many girls are dying or being permanently harmed unnecessarily. You have heard about some of those tragedies today.

Former FDA Commissioner Dr. David Kesssler has reported that Bayer intentionally withheld key safety data from the FDA which showed as much as a 10-fold increase in serious adverse reports with their OCs. According to Dr. Kessler, Bayer “did not adequately inform FDA, doctors or consumers of the thromboembolic risks, from pre-marketing to the present.” Kessler also stated that, “Bayer presented a selective view of the data, and that presentation obscured the potential risks” of DRSP.

There are VTE warnings on the label of Beyaz. Teenagers are not going to read that label. Unfortunately, their parents probably won’t either and if they did, most would not know what a VTE is. Moreover, patients trust their doctors, and assume that doctors know best. However, most doctors are not going to read the studies and determine which ones to believe and which ones might be tainted by financial conflicts of interest. They are going to assume that this Advisory Committee will safeguard their loved ones.

There is no evidence that birth control pills containing drospirenone have significant advantages that would outweigh the risks of VTEs compared to other oral contraceptives. If parents understood the latest research, why would anyone choose to have their daughters take those risks?

What can you do to help doctors and parents understand these risks? You can urge the FDA to take Beyaz off the market for all women, or at least for all young women.

Meanwhile, you can make sure that the label clearly explains that these pills are NOT safe to use for any purpose other than contraception because the risks outweigh the benefits.