Merck Inc. concealed mortality risks in two key Vioxx studies, and hired “ghostwriters” to author research that was supposedly conducted by independent scientists. These revelations – detailed in two reports published in the “Journal of the American Medical Association” (JAMA) – show the extent to which drug companies are able to manipulate clinical trial data. Such practices are used throughout the drug industry, though they are hard to document, the authors of the JAMA reports said. In fact, the only reason the manipulations surrounding the Vioxx studies are coming to light is because lawsuits filed on behalf of people injured by the defective drug forced Merck to release documents detailing the practices
This is not the first time drug makers have been accused of withholding vital safety information about their medications. Recent litigation involving the Ortho Evra birth control patch has revealed documents that indicate Johnson & Johnson hid information on Ortho Evra’s blood clot risk from the Food & Drug Administration (FDA). And the recent scandal surrounding tainted heparin has proven that the FDA is ill-equipped to police the safety of even the most routine medicines.
Such drug safety scandals, taken together with today’s Vioxx revelations, raise serious questions about attempts by the pharmaceutical and medical industries to convince courts that FDA approval of drugs preempts drug injury lawsuits in state courts. With pharmaceutical and medical device makers going to great lengths to manipulate and withhold results of clinical trials, and the FDA seemingly unable to adequately oversee safety, litigation is often the only way abuses such as Merck’s are ever made known. Unfortunately, the US Supreme Court has already extended a lawsuit shield to device makers, and this fall it will hear a second pre-emption case involving the drug maker Wyeth. Many legal experts expect the court to rule in favor of drug companies.
Patient advocates, including Jerry Parker, Managing Partner at Parker Waichman Alonso LLP, a law firm that has represented thousands of people injured by defective drugs, says such a development would be a blow to patients. “Vioxx is just more reason – if we needed it after Ortho Evra – that the civil justice system plays an important role in policing the pharmaceutical and medical device companies,” Parker said. “It is the role that the FDA was supposed to play but is unable to.”
The conduct of Merck and the FDA had already come under a great deal of scrutiny because of the Vioxx debacle. In 2004, an FDA study estimated that Vioxx could have contributed to 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003. After Vioxx was pulled from the market in 2004, it was revealed that the FDA had tried to silence the drug expert who headed that study. Dr. David Graham, associate director for science in the FDA Drug Center’s Office of Drug Safety, told Senate investigators that he had been subjected to veiled threats and intimidation when he informed the FDA of his findings.
Now, it seems that Merck was less than forthcoming about two studies involving Vioxx and Alzheimer’s Disease patients. According to an analysis of court documents uncovered in the course of Vioxx injury lawsuits, Merck employees worked alone or with publishing companies to write study manuscripts and later recruited academic medical experts to put their names as first authors on the studies. In many cases, Merck’s involvement in producing the data wasn’t disclosed.
Merck also used its control over Vioxx studies to manipulate the data so that it favored the now-recalled drug. One of the JAMA articles says that in 2001, Merck had data that Vioxx patients in two Alzheimer’s studies had a higher death rate than patients on dummy pills. Merck didn’t publicize that “in a timely fashion” and provided information to the FDA that downplayed the deaths, the report said.
Senator Charles Grassley (R-Iowa), a long-time critic of both the drug industry and the FDA, said in an emailed statement to Bloomberg.com that the revelations about the ghostwritten Vioxx articles reveal the lengths to which a drug maker might to bury information that might hurt sales. “Revealing this kind of activity is very important in building pressure on the FDA to regulate, not accommodate drug makers,” Grassley said.
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