NuvaRing: Will Merck Allow Independent Review Of Blood Clot Clinical Trial Safety Data?

More than 700 women had filed lawsuits alleging they developed blood clots or strokes while using NuvaRing, and the first bellwhether trials are schedule to take place early next year in New Jersey. Just last month, the Court entered an order precluding several of Merck’s research scientists from giving opinion testimony at the trials unless they provide the plaintiff’s lawyers, before the trial, with expert reports explaining the basis of those opinions.

In the meantime, the scientific evidence demonstrating that NuvaRing itself has a higher risk of blood clots, pulmonary embolism, DVT, stroke and death than oral birth control pills continues to mount. Back in 2011, the Food and Drug Administration’s own internal researchers found an increased risk. In May 2012, the British Medical Journal published a study showing an incidence rate of venous thrombosis of 7.8 per 10,000 years of exposure among women, or 8 patients a year with a serious blood clot for every 10,000 patients using NuvaRing – double the risk of oral contraceptives like Plan B.

Merck has responded by going on the offensive. Since 2007, Merck has sponsored a clinical trial, called the “Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing,” that is supposed to look for the following:

The primary objective of this study is to characterize and compare the risks of short- and long-term use of NuvaRing® with marketed combined OCs. The main clinical outcomes of interest for the short and long-term follow-up are:

• Deep Venous Thrombosis (DVT)
• Pulmonary Embolism (PE)
• Acute Myocardial Infarction (AMI)
• Cerebrovascular Accidents (CVA)

In response to the British Medical Journal study, Merck has started referencing the data in that trial at health care professional conferences, and has sent letters complaining (Microsoft Word file) about the BMJ article,but they have not opened up the results to peer review by independent scientists.

We think that silence speaks for itself. If they had favorable data, they wouldn’t just talk about it, they would show everyone. We’re confident that NuvaRing is more likely to cause blood clots, and that the patients injured and their NuvaRing lawyers will be able to prove in Court that Merck failed to properly warn patients that NuvaRing wasn’t just more convenient than the birth control pill – it was also more dangerous, just like Ortho Evra, the other major non-pill contraceptive, turned out to be.