Taking the Good with the Bad, with Beyaz

Pisa, ItalyBeyaz is a third-generation oral contraceptive manufactured by Bayer that contains drospirenone and thus is affected by label changes recently urged by an FDA expert panel that affects all oral contraceptives containing the synthetic hormone. Of concern are Beyaz side effects inherent with an increased risk for blood clot, according to some studies—even though Bayer argues its new-age contraceptives are at no greater risk for deep vein thrombosis than older-generation birth control pills.

Indeed, it appears as if Bayer is most concerned with protecting Beyaz sales and market share than the ultimate welfare of women who use Beyaz. To that end, Bayer HealthCare Pharmaceuticals Inc., Bayer Pharma AG, and Merck & Co. filed a Beyaz lawsuit against a competitor in February of this year. According to PR Newswire (2/10/12), the action is intended to prevent Watson Pharmaceuticals from commercializing a Beyaz generic prior to the expiration of the patent that the various stakeholders have with Beyaz.

The introduction of less-expensive generics usually serves to decimate sales of the original product, which can continue to be sold even after the patent protection expires. The end result is that Bayer et al will no longer have a lock on the market for its hybrid contraceptive, as it does now.

The stakes are high. According to IMS Health, Bayer raked in about $97 million in Beyaz sales for the 12 months ending December 21, 2011.

As the "first applicant" for the generic Beyaz, Watson would have 180 days of generic market exclusivity before other generic applicants are allowed onto the market.

The business side of Beyaz is a side the average consumer cannot appreciate, let alone comprehend. Consumers use medical products such as Beyaz drospirenone in order to avoid pregnancy. And despite warning labels, there remains a widespread belief that a product approved for sale and dispensation suggests that product is inherently safe.

However, Beyaz birth control is part of a group of products that narrowly escaped an FDA panel vote for market removal, due in part to the fear over the potential of Beyaz blood clots.

At the other end of the spectrum, are studies that appear to promote the value of Beyaz. Women's Health Weekly (2/23/12) reports that researchers from Pisa, Italy, addressed the inclusion of levomefolate calcium in Beyaz, which serves to boost red blood cell and plasma folate levels and thereby reduces the risk for neural tube defects in newborns.

The researchers concluded: "Because of this, the folate-containing pill may aid in reducing the risk of neural tube defects in a pregnancy conceived during use or shortly after the discontinuation of the product."

The study, published in a recent edition of Women's Health, did not appear to address the side effects of Beyaz. Instead, women have to rely on their doctors to demystify the often-cumbersome warning labels, and articulate risks in a language the average patient can understand. Beyond that, a Beyaz client must hope to be spared the potential for Beyaz blood clots…and the Beyaz lawsuit that may ensue.