April 16, 2008 - Merck Manipulated Data in Vioxx Studies

Two reports published in the “Journal of the American Medical Association” (JAMA) claim that Merck, Inc., maker of Vioxx, concealed mortality risks in two key studies, and hired “ghostwriters” to author research that they said had been conducted by independent scientists. These reports highlight the extent to which drug companies are able to manipulate and conceal clinical trial data. Such practices are used throughout the drug industry, though they are hard to document, the authors of the JAMA reports said. The only reason that the deception surrounding the Vioxx studies is coming to light is because lawsuits filed on behalf of people injured by the defective drug forced Merck to release documents that reveal their unethical 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 that the drug's maker, Johnson & Johnson, concealed information about Ortho Evra’s blood clot risks. Tthe recent scandal surrounding tainted heparin has shown that the FDA is ill-equipped to police the safety of even the most routine medications.

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 that deceptive and potentially harmful practices 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 similar case involving the drug maker Wyeth. Many legal experts expect the court to rule in favor of drug companies, much as it did in February, when it sided with device maker Medtronic. That ruling bars litigation in state courts over faulty devices that have received the approval of the FDA.

The conduct of both Merck, Inc. and the FDA hasalready been called into question as a result of the safety issues surrounding Vioxx. After the drug was pulled from the market in 2004, it was revealed that the FDA had tried to silence the drug expert who headed a study estimatiang Vioxx contributed to 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003. 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.

It now appears 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 fraudulent studies. 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 possessed data indicating that in two separate Alzheimer’s studies, the patients on Vioxx had a higher death rate than those on placebo. Merck failed to publish that data in a timely fashion, and provided information to the FDA that downplayed the deaths, the report says.

Lawsuits such as those involving Vioxx are extremely important because they reveal the lengths to which drug makers will go to conceal or manipulate research data, and the routine deception in which they engage in order to protect sales. Litigation is the primary means for creating public awareness of this unethical behavior and placing pressure on the FDA to begin regulating the drug makers, instead of accomodating them. When the Supreme Court hears the Wyeth case later this year, their decision could have a profound effect on drug safety litigation and the future monitoring of pharmaceutical companies. << back

The above is not legal advice. That can only come from a qualified attorney who is familiar with all the facts and circumstances of a particular, specific case and the relevant law. See Terms of Use.

For questions about personal injury laws, fill out the form below or contact us by phone.
Law Offices of
Rosenberg, Kirby,
Cahill & Stankowitz
29 Main Street
Toms River, NJ 08753

(732) 341-3337
Toms River/Central Ocean

(609) 971-7300
Southern Ocean

(732) 785-9145
Northern Ocean/Monmouth

| | | | |