Merck under Fire over Ghostwritten Studies on Vioxx
In the corporate world, the end game of maximizing profits has led many companies into questionable territory, both socially and ethically speaking. On Total Injury, we've written extensively about the practices of insurance companies—whose profits are dependent on denying coverage—and drug companies—whose profits max out only when they can discourage and even hide unfavorable side effects and adverse reactions.
We've also detailed the sordid history of drug giant Merck, who not only actively withheld information about the known dangers of its drug Vioxx, but chose to fight each defective drug lawsuit against it before it recently decided to settle the lawsuits together for $4.85 billion.
Now, it seems, Merck has been taking fire over a study published by the American Medical Association showing that the company conducted its own research, then hired third-party companies to ghostwrite reports that it submitted for approval to the FDA and other organizations. In this way, they were able to tout the names of industry-leading researchers on their reports, while doing the bulk of the research themselves. Needless to say, many are skeptical of the objectivity of such practices.
While many industry experts claim that the practice is not uncommon, Merck's extensive litigation has exposed many of their documents to a greater level of scrutiny than is typically the case with drug companies. The report, drafted by medical researchers from Harvard, Brown and Yale Universities, and the Mt. Sinai School of Medicine in New York, examined 250 documents completed between 1996 and 2004.
They found that despite the fact that much of what Merck did in their research practices is common methodology in the drug industry, the extent to which Merck's research was their own and not the work of the prestigious researchers makes their claims of innocence dubious. With the reports mostly drafted and the researchers often just checking conclusions and numbers, the company was able to put their own spins on much of the work in the writing without stretching the truth in terms of actual conclusions.
Merck's Vioxx, an arthritis drug, hit the market in 1999 and was marketed until 2004, when the company recalled the drug due to studies linking it to higher risk of heart attack and stroke. Since that time, more than 10,000 lawsuits have been filed over Vioxx-related cardiac episodes.
Of course, it's not a problem for drug companies to complete extensive research studies on their products; as researchers and developers of new drugs, their job is to discover new drugs for potential consumer use and test the effects of these drugs thoroughly before making them commercially available. However, the problem comes when their studies are the only source of research, when third-party work is nonexistent or cursory, as revealed in this particular instance with Vioxx.
What becomes even more problematic is the path toward preemption of tort laws along which government agencies are currently moving. A recent Supreme Court decision upheld the FDA's right to preempt state laws against suing medical device manufacturers, which means that if the FDA approves a medical device, anyone injured as a result of using the device cannot sue the manufacturer.
In the fall, the Supreme Court will consider a similar case involving prescription drugs approved by the FDA. Considering their previous decision, it's not farfetched to think that they will side the FDA once again in this matter. And that spells T-R-O-U-B-L-E for injured consumers trying to get compensation. As Merck proved, if companies provide their own studies—and spin—to the FDA for their approval, how can they ever be held responsible for a defective product passed through with shoddy, incomplete or just plain deceptive research?