An alert reader noted this timely piece that suggests that Merck tried to obtain a patent in 2001 for another drug that was intended to provide "the cardiovascular protective effect of aspirin . . . for patients who are taking COX-2 selective inhibitors."
Trial lawyers cited in the piece claim this is a "smoking gun" that proves Merck "knew" that Vioxx created an increased risk of heart disease. Not surprisingly, Merck representatives disagree.
The reader, noting my recent post on Vioxx litigation in Michigan, suggests that this article "demonstrates Wilson's faith in Merck is not well founded."
The article is interesting and the question of Merck's knowledge at various points in time will undoubtably be explored in the Vioxx litigation. But a few items require mentioning:
1. My prior post was not intended to demonstrate my "faith" in Merck. As I said before, I have no special knowledge about the Vioxx litigation and do not know, one way or the other, whether Vioxx is a safe drug.
My only point on the safety of Vioxx is that the public does not know today whether or not it is safe. Merck's own studies suggested there may have been a correlation between an increased risk of heart disease and use of Vioxx. Not all studies demonstrated this same correlation. As a result there is no final answer today.
2. Correlation is not causation. Merck voluntarily recalled the drug--even though the FDA subsequently cleared Vioxx for use on the market--because it found a correllation. Scientists do not yet know whether the heart disease noted in the studies were caused by Vioxx or were merely a correlation with some other factor.
3. While the 2001 patent application may turn out to be a "smoking gun", it doesn't necessarily prove anything. Further discovery will be required to connect the dots between this patent application and Merck's knowledge.
There is nothing necessarily inconsistent with believing (a) Vioxx poses no increased risk of heart disease and (b) for patients taking Vioxx who wish to have "the cardiovascular protective effect of aspirin" there is this additional drug, etc.
Consumers who buy cars with airbags do not necessarily do so because they expect to have head-on collisions. Boaters who wear life-preservers do not do so because they expect their boats to capsive. You get the idea.
4. The real issue is whether a drug manufacturer ought to have any liability for selling a drug that has been tested and approved by the FDA (setting aside situations of intentional falsehood or misrepresentation on the part of the manufacturer).
Michigan's legislature answered this question in the negative more than a decade ago and trial lawyer activists are trying to reverse that decision through the legislative process in order to open up the state to Vioxx lawsuits. Through the wonders of the U.S. federal system we can observe how that decision works (or doesn't) and the other 49 states are free to learn whatever lessons they wish.