Merck Pharmaceuticals Rofecoxib, or Vioxx,

Merck Pharmaceuticals

Rofecoxib, or Vioxx, is a non-steroid, anti-inflammatory drug developed by Merck Pharmaceuticals as a treatment for osteoarthritis, acute pain conditions and dysmenorrhoea. The drug received FDA approval in 1999 and began being marketed after that. However, in 2004, Merck voluntarily withdrew the drug from the market due to concerns that the taking of Vioxx actually increased the risk of having a heart attack and stroke.

The withdraw of Vioxx began following the Vioxx GI Outcomes Research study (VIGOR), a scientific study comparing the efficacy and adverse effect profiles of the drug. The results indicated a remarkable increase in risk for heart attack in individuals taking Vioxx. When made aware of the study, Merck argued that the results only showed that naproxen (the other drug used in the study) had a protective effect on preventing heart attacks. However, many scientist warned that this was an implausible argument since naproxen would have to be three times as effective as aspirin to account for the difference in the study. Further, Merck took no steps to research this claim. The results of the VIGOR test were given to the FDA, who thereafter ordered that all Vioxx come with warning labels regarding the "increased risk of cardiovascular events." preliminary version of the VIGOR results were later published by the New England Journal of Medicine (NEJM). However, after the article's preliminary publication, it was discovered by the publication's editors that some data reported to the FDA was not included in the NEJM article. It was later discovered that this information was clearly available to the article's authors. This data was in regarded to three additional heart attacks related to Vioxx use, which therefore would increase the relative risk of Vioxx from 4.25 fold to 5-fold. The articles authors were both independent and Merck hired writers.

A subsequent FDA study that Merck played no part in showed that Vioxx did indeed increase risk of hear attack. The FDA estimates that between 88,000 and 139,000 heart attacks, 30 to 40% of which were fatal, occurred as a result of Vioxx during its five-year market run.

All in all, Merck's handling of the research regarding Vioxx's overall safety is questionable, at best. An ethical question has to be raised as to Merk's direct role in both the research study and the resulting NEJM article. When the drug manufacturer is involved in a study regarding their leading products future, there is a blatant conflict of interest.

The actual marketing of Vioxx does not seem to pose any ethical questions. It was marketed as a drug that would assist with arthritis and other pain treatment. This is true and therefore was highly recommended by physicians. Further, when the initial concerns regarding the cardiovascular issues started to rise, Merck followed FDA regulations and used a warning label.

The evidence pertaining to the unknown emails and memos, however, are indicative of the fact that Merck's executives knew, yet failed to adequately disclose to doctors and patients, information on Vioxx's safety. This case for lack of full-disclosure is even more of an issue when coupled with the Merck authors failure to use all the available data of the study in authoring the NEMJ article.

Merck's marketing of its product directly to the consumer raises an ethical issue pertaining to the advertisement of all medications. According to the law, this form of advertisement is legal. However, whether it is ethical is a different questions altogether. Prescription drugs are not like other consumer products. Not everyone can take them. They are specifically made to treat specific conditions and are to be prescribed by doctors. However, by advertising the drug it is implied that they are available to the consumer, "just ask your doctor."