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NYT: Bayer Misleading Consumers over Risks Associated with Popular Contraceptives

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From The New York Times:

The oral contraceptives Yaz and Yasmin are the top-selling pharmaceutical line for Bayer HealthCare, largely as a result of marketing that presents them as much more than mere pregnancy prevention.

Yaz, in particular, the top-selling birth control pill in the United States, owes much of its popularity to multimillion-dollar ad campaigns that have promoted the drug as a quality-of-life treatment to combat acne and severe premenstrual depression.

Yaz, a newer sister drug to Yasmin, contains less estrogen. The franchise had worldwide sales of about $1.8 billion last year, based on Bayer’s successful positioning of Yasmin and Yaz as the go-to drug brands for women under 35.

But recently, the Yaz line’s image has been clouded by concerns from some researchers, health advocates and plaintiffs’ lawyers. They say that the drugs put women at higher risk for blood clots, strokes and other health problems than some other birth control pills do.

Those critics, though, are up against a large European health study, sponsored by Bayer, the German pharmaceutical giant, that reported the opposite conclusion. The Bayer-financed study said that cardiovascular risks in women taking Bayer products were comparable to those taking an older formula of birth control pills.

But regulators are finding other faults with the Yaz franchise. The Food and Drug Administration early this year asked Bayer to correct misleading television commercials. Last month, the agency cited the company for not following proper quality control procedures at a plant that makes hormone ingredients.

In e-mail responses to a reporter’s queries, the American unit of the company said that its birth-control drugs had been and continued to be extensively studied and that the company stood behind their safety. The company also said it had responded to the F.D.A.’s questions about manufacturing practices, which it said it took very seriously.

But even if Bayer can adequately respond to the safety and other concerns, some industry analysts say that the avalanche of criticism could tarnish the Yaz line’s image. Other products by Bayer, like the erectile dysfunction drug Levitra and the intrauterine birth-control system Mirena, generate far less income than the Yaz product family.

“For Bayer, it is by far the highest margin and the fastest-growing brand,” Martin Brunninger, an analyst with the European investment bank Bryan, Garnier & Company, said in a phone interview from London on Wednesday. “Whether this turns out to be a serious issue or not, when a drug is stigmatized in public, people just withdraw from taking it.”

Bayer said that the company had been served with 74 lawsuits brought by women who charge that they developed health problems after taking Yaz or Yasmin. The company says it intends to defend itself vigorously against the suits.

The health questions and the lawsuits may rattle consumer confidence, but the warnings from federal health authorities about advertising and quality control raise larger questions about Bayer’s approach to complying with government rules, said Michael A. Santoro, an associate professor at the Rutgers Business School who has studied ethics in the pharmaceutical industry.

Birth control pills work by altering a woman’s hormone levels. Researchers have long known that taking a combination hormone birth control pill — which contains estrogen and a progestin hormone — can increase the risk of stroke and blood clots in the legs and lungs. That is because estrogen can play a role in blood coagulation. Indeed, since the introduction of oral contraceptives in the 1960s, drug companies have greatly reduced estrogen doses to decrease the risk of thrombosis, the medical term for blood clots.

With lower-dose estrogen pills now available, the safety debate, continuing for the last decade, has focused on whether the type of progestin in a formula may also play a role in the risk of cardiovascular problems.

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*Also, anyone who has been adversely affected due to taking these prescription drugs should get in touch with Helen Zukin. Ms. Zukin recently retained a client, a young woman, who unfortunately suffered from a stroke, after only taking Ocella (generic version of Yaz) for a month.