FDA to Review Safety Issues Surrounding Leading Birth Control Pill Yaz

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Made by Bayer HealthCare Pharmaceuticals, Yaz sales rocketed to nearly $2 billion a year after its release in 2006, making it at one time the leading birth control pill on the market and Bayer's top-selling drug.

And there was a lot of buzz surrounding Yaz, from popular women's magazines touting it as "the pill for PMS" and "super pill" to TV news segments, like one in Dallas that called Yaz, "a miracle pill that gets rid of most of the uncomfortable symptoms of PMS."

Some company executives apparently encouraged these exaggerated claims, ABC News has learned. Internal documents obtained by ABC News show their reactions: "[T]his is outstanding!!! can we get good morning america to do the same segment!!!???!! (tee hee)," one executive wrote about the Dallas segment that called Yaz a miracle pill for PMS.

But the Food and Drug Administration wasn't amused. In 2008, the FDA said Yaz was not shown to be effective for common PMS, just a rare and serious form of menstrual symptoms, and that Yaz's success with acne was "misleadingly overstate(d)."

State authorities also accused Bayer of deceptive advertising.

Bayer denied any wrongdoing, but in an unusual legal settlement agreed to spend $20 million on corrective TV ads, which said, "Yaz is for the treatment of premenstrual dysphonic disorder, or PMDD, and moderate acne, not for the treatment of PMS or mild acne."

But by then, millions of women had already opted for Yaz.

Some experts say there is cause for concern about recent medical findings. Jick found it noteworthy that the studies funded by Bayer found no difference in risk, while all four of the most recent independent studies found increased risk.

Jick added that when she sent her study to Bayer, she was surprised that they never responded or asked to work with her.

"The studies that have found increased risks are not in the best interest of the company," Jick said.

Columbia University medical ethicist David Rothman added that, in general, "We have got to look at drug studies published by the company producing the products with a lot of suspicion. They have too much skin in the game."

Internal Bayer documents obtained by ABC News raise questions about some of the company's research. According to one report, Bayer apparently kept the name of one of two employees off a company-sponsored study because, according to an internal email, "there is a negative value to having a corporate author on the paper."

"It's really nefarious, a basic violation of scientific integrity, when the person who did the research doesn't even appear on the paper," Rothman said.

Thousands of women are now suing Bayer, including Carissa Ubersox, but the company continues to deny any wrongdoing. Citing those lawsuits, Bayer refused to be interviewed for this story and instead sent ABC News a statement saying Yaz is as safe as any other birth control pill when used correctly.

There are no answers yet for Ubersox, whose life has changed forever. She is no longer a pediatric nurse, no longer engaged and, she said, "everything that I thought I worked so hard for has disappeared."

Yaz, she said, is to blame.

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