Leaked documents show Merck knew of Vioxx dangers, yet hid them for years

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"What are the long-term benefits of your being able to bring value to the relationship with our customers?” Merck asked sales trainees in a PowerPoint slide captioned “The Payoff.” “Bonus,” appeared on the next slide, showing a sales representative holding a glowing bag of money. This is from a company that is “really putting patient safety first,” according to Merck Chief Executive Raymond Gilmartin’s statement in September 2004, upon finally pulling Vioxx of the market.

As the thousands of wrongful death and injury lawsuits against Merck go to trial one by one, internal company documents like this training slide show are beginning to reach the public eye.

These leaked documents began with previously undisclosed emails discussing safety risk, but the clamor has now reached crescendo with the most potentially damaging document yet: A leaked communication between Merck researchers and the company’s patent department.

An application for a patent seems harmless enough, except when the product in question is a correcting reformulation of the now-withdrawn prescription drug Vioxx. In this leaked document, the authors specifically stated that Vioxx increases the risk of potentially fatal cardiovascular disease by reducing the body’s production of a substance called prostacyclin, which prevents platelet coagulation. This reduction may alter the ratio of prostacyclin to thromboxane, a substance which can constrict blood vessels, resulting in excessive blood clotting, and, consequently, Heart Attacks and Strokes—the very disorders that Merck denies Vioxx promotes.

In other words, based on this evidence, Merck has apparently been feigning ignorance of Vioxx’s disastrous complications for the last five years. Their knowledge of the risk wasn’t cursory, either. In fact, as early as March 30, 2000, Edward Scolnick, the former head of Merck’s research labs, realized the risk was high enough to suggest that Vioxx be combined with an anti-clotting agent. Then, in 2001, Merck filed an application with the U.S. Patent Office for a new-and-improved Vioxx that was to be combined with a thromboxane inhibitor, but Merck eventually dropped the project and the patent. In response to the leaked document concerning the proposed patent, Merck’s law firm released a statement saying that the application had nothing to do with Merck’s firm belief that Vioxx was safe; however, the statement seems illogical: Why would Merck wish to fix what wasn’t broken?

How to bury scientific truth
On Nov. 1, 2004, the eastern edition of The Wall Street Journal broke the story: “Warning Signs: Emails Suggest Merck Knew Vioxx’s Dangers at Early Stage,” discrediting Merck’s feigned ignorance of Vioxx’s cardiovascular risks. According to a memo dated Nov. 21, 1996, Merck officials first “wrestled” with the issue of Vioxx’s dangerous effects in 1996 when they considered running a trial to demonstrate that Vioxx is gentler on the digestive system than other painkillers, like aspirin. Officials feared that the study would also reveal Vioxx’s cardiovascular risk because the subjects of course would not be able to avoid the risk by taking aspirin. The controversy continued into 1997, when Merck official Briggs Morrison sent an email dated Feb. 25, 1997, arguing that, unless test subjects received aspirin, the revealed cardiovascular risks would “kill drug.”

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