Product News and Recalls

Writer says Yaz maker has dicey definition of ‘risk’

In an article on problems with the Yaz line of contraceptives for BNET online magazine, Jim Edwards writes that Yaz manufacturer Bayer seems to have a troubling perspective on the very concept of risk.

As Edwards writes, Yaz is the focus of concerns that it causes more blood clots in users than older safer pills.

A number of studies show that pills containing the compound drospirenone – which include Yaz, Yasmin, Beyaz and Ocella – carry up to three times the risk of potentially fatal blood clots compared to other types of birth control pills on the market.

Edwards mentions a New York Times piece on the issue and spotlights three quotes from the story.

Dr. David A. Grimes, a professor of obstetrics and gynecology at the University of North Carolina medical school and a paid consultant to Bayer, says: “My dictum is that a multiple of a rare event is still a rare event.”

Dr. Frits R. Rosendaal, a professor of clinical epidemiology at Leiden University Medical Center and an author of a study that noted increased risk with Yaz, says: “Even if the risk of thrombosis is low, why not choose the lowest risk, just in case?”

And Michael A. Santoro, an associate professor at the Rutgers Business School, says: “It tells me … that it [Bayer] is not understanding the business that it is in, that it is not understanding the health risks that it is posing to the public or the financial risk that it is creating for its shareholders.”

Edwards points out that the views on risk expressed by Grimes and Rosendaal are inherently contradictory. He also observes that Grimes’ assertion is essentially meaningless, in that a “multiple of a rare event” may indeed be rare until it occurs so many times that it’s no longer rare.

Edwards ties that perspective in to an incident in which the U.S. Food and Drug Association cited Bayer for a factory that did not meet FDA standards. The FDA found that Bayer was averaging the results of multiple tests to measure standards, rather than treating each individual failure as a problem to be addressed.

“It looks complicated, but the takeaway here is that the FDA is literally accusing Bayer of manipulating its statistics in order to hide problems at its factory,” Edwards writes. “This is why Bayer’s history on Yaz is so worrying.”

Patients should consult their doctors before making any changes in their medication. A consultation with a Beyaz lawyer is also important if there are significant injuries.

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