Cardiologists Concerned Over Unexplained Two-Year Delay in Drug Study Results
Cardiologists are growing increasingly suspicious over the hesitation of drug makers to release the results of clinical trials for the cholesterol-lowering drugs Vytorin and Zetia, according to a recent New York Times article. The two drugs are prescribed for an estimated 800,000 Americans every week, generating sales of $4 billion in 2007 alone. Clinical trials of the drugs ended two years ago, but manufacturers Merck and Schering-Plough have yet to release those research results.
Recently, the two drug companies announced a sudden change in the "primary endpoint" of their joint clinical trial. A primary endpoint is the primary medical result being studied. Such a change runs contrary to generally accepted scientific methodology for clinical trials, and seems to parallel, in some ways, a manipulation of research data by drug maker Pfizer in 2001. Pfizer's clinical trial data was manipulated at that time to demonstrate that the drug Celebrex did not cause ulcers after 6 months of use. The study had initially been designed to demonstrate that Celebrex did not cause ulcers after 1 year of use, but clinical trials suggested that it did, in fact, cause ulcers after 1 year, and so the length of the trial was adjusted to achieve a favorable outcome.
Zetia is the brand name of cholesterol-lowering drug ezetimibe. Vytorin is a combination of both Zetia and simvastatin (the active ingredient in Zocor).
Merck and Schering-Plough attempted to pacify critics most recently by committing to release a portion of the data from their joint clinical trial next March. The full set of research data will still not be released at that time. The drug manufacturers maintain that the clinical trial endpoint was changed only to facilitate a more timely analysis of the data they were able to gather.
Previously on the DC Metro Area Medical Malpractice Law Blog, we have posted articles related to:
- An FDA advisement that Tamiflu and Relenza should carry additional pediatric warnings
- A marketing suspension of cardiac drug, Trasylol, over increased risks of death
- An FDA advisory regarding Fentora, a pain medication, over safety concerns
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