The Archives of Internal Medicine reports higher than expected cancer rates in Effient, Eli Lily’s blood thinner that competes with Plavix. Doctors, patients, and, frankly, plaintiffs’ lawyers, do not quite know what this means.
First, a quick background. The FDA approved Effient last July for the reduction of thrombotic cardiovascular events (including stent thrombosis) in heart patients with acute coronary syndromes (ACS) who get an artery-opening procedure called a percutaneous coronary intervention. In other words, Effient is a serious drug with a lifesaving purpose.
Effient has also apparently shown efficacy and has given doctors another treatment option in treating high-risk patients. Effient was still getting killed by Plavix in terms of market share, but it was considered to be a good option for doctors. Everything seemed to be working as it should.
But then came this cancer risk data. Interestingly, in another arrow to the chest for the logic of preemption, because of FDA approval, researchers did not rely on new data for the study. Instead, they just analyzed unpublished data from a study that was key to FDA approval in the first place. The study found that the risk of new or worsened solid tumors was 60 percent higher with Effient than with Plavix.
Should plaintiffs’ lawyers get ready for class action Effient lawsuits? No. There is still a lot more to find out and we could still find out that this study is wrong and Effient is as safe and effective as hoped. But is this new cause for potential concern that patients and doctors should keep their eye on closely? Of course.