The push to promote Plavix took on another dimension when it involved the strange case of “aspirin resistance.” This is a controversial condition, first described in 2002, which is being used to discredit aspirin, a drug first trademarked by Bayer in 1899. So-called aspirin resistance has fueled the rise of companies, such as Accumetrics and Dade Behring, recently acquired by Siemens Healthcare Diagnostics,which develop, manufacture, and market tests for aspirin/platelet resistance. This is but another success story for Plavix and its admirers and a subtle blow against aspirin.
Many doctors get kickbacks for recommending these tests or have them done in house. Insurance companies don’t pay for them, but some heart attack victims are persuaded by their physicians that it makes no sense to take aspirin for the rest of their lives if they are “resistant” and not getting optimal results. Plavix would seem to be the obvious alternative. Another example of Big Pharma abuse is that the Plavix patent was due to expire next month but they got a 3 year extension based on a study in China for another indication. Apotex had approval for a generic to be available the next month but they received $60 million to hold off until eight months before the new patent expiration date in 2011. This plan backfired when the cash payment became the subject of a Justice Department investigation.
Apotex immediately began marketing the drug while the patent was still in force. As a result, the cost of Plavix has already dropping by 50% and may drop another 30% or more. Bristol-Myers-Squibb is now being sued by health plans and other fiscal intermediaries since this deal may violate federal antitrust laws.
The latest news on Zetia and Vytorin came out the other day, and is being featured in the major media: Merck and Schering-Plough released the results of a study (the Enhance Trial) showing these drugs failed to benefit patients in a two-year trial ending in April 2006. The House Energy and Commerce committee is investigating why the companies sat on their findings of this negative study for over 19 months.