| Quote of the Day |
| One of the first duties of the physician is to educate the masses not to take medicine. |
| - Sir William Osler |
NEJM CRITICIZES MERCK VIOXX STUDIES
Neither of the two major forces in this five-and-a-half-year affair — neither Merck nor the FDA — fulfilled its responsibilities to the public. The pivotal trial for rofecoxib involved 8076 patients with rheumatoid arthritis and demonstrated that this coxib had lower gastrointestinal toxicity than naproxen. Even though the drug was approved in 1999 on the basis of data submitted to the FDA, the data were not submitted to a peer-reviewed journal until the following year and did not appear in print until November 23, 2000, one and a half years after commercial approval had been granted. The cardiovascular data reported in that article were incomplete, in part because of incomplete ascertainment: the design and execution of the trial had not anticipated that untoward cardiovascular events might occur.
This will pour gasoline on the flames of pending litigation in the latest pharmaceutical mass tort litigation. Expert testimony is critical in the Vioxx litigation and the score is 1 to 1, with many thousands of cases to go, as Merck has announced its intent to litigate each one.
Plaintiffs must first show that Vioxx increases the risk of heart attack, and for each plaintiff must also show; (1) the plaintiff died of hart problems; and (2) those hear problems are associated with Vioxx. Since heart disease is the leading cause of death plaintiffs have a particularly difficult time proving number 2.
Additionally, if the doctor and the patient are aware of the rises associated with a particular drug, then the patient and doctor can make an informed decision. Informed consent can be a defense in any later litigation.
Rezulin is a good example of such disclosure. Rezulin was known to cause liver damage, but was an effective treatment for serious diabetes. Armed with this knowledge, the doctor and patient could make an informed decision to use Rezulin making the determination that the benefits outweighed the risks and also performing frequent liver studies to monitor any damage. When other drugs became as effective as Rezulin without the adverse liver effects, Rezulin was withdrawn.
With the publication of the New England Journal of medicine article, plaintiffs will have an easier time showing that Vioxx does cause heart problems and that the faulty studies precluded any ability to make any informed decision. Merck can't be happy with this announcement from a disinterested source.
Posted by
Joseph R. McFaul
on Friday, December 09, 2005 at 10:43
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