Merck and Vioxx -- Research Data How

Merck and Vioxx -- Research Data How did Merck misuse research data to support their decision for marketing the COX-2 Drug Vioxx? In November of 1998 the pharmaceutical company Merck submitted Vioxx's application to the Food and Drug Administration seeking approval for the COX-2 inhibitor drug, as a treatment for osteoarthritis, on the basis of clinical trials involving 5,400 patients. Merck said the rates of cardiovascular risk were "similar" among patients taking Vioxx, placebo or other pain relievers. This, however, was not the case.

In fact, Vioxx had a higher risk of cardiovascular problems among patients taking Vioxx vs. patients taking the pain reliever naproxen. (Steyer, 2004) Merck excused this by stating that the pain killers Vioxx was being compared to such as naproxen, the generic form of Advil or Motrin, had additional heart protective effects, although they were less effective in preventing pain.

But according to CNN Money, the Wall Street Journal reported later on that internal company e-mails indicate that Merck executives were worried as early as the mid-to-late 1990's that Vioxx would show greater heart risk than cheaper painkillers that were harsh on the stomach but were believed to reduce the risk of heart attacks.

Thus, Merck deliberately ignored fears that Vioxx was harmful to the hearts of current and potential users of the painkillers, and misused the data that indicated that the risks were compensated by the heart protective effects of naproxen. What were the results? The results were that Vioxx takers showed a higher level of heart problems than those using the other comparative painkillers in the study, used as placebos.

At the time of the study's release, Merck stated that the resulting difference was merely caused by the heart-protective effect of naproxen rather than the heart-risk effect of Vioxx, not by any additional risk. (Steyer, 2004) But in later data showed that the heart-risk effects of Vioxx exceeded any potential screening capabilities from attacks on the part of naproxen. What are the limitations and significance of the research data? This highlights the dangers of using two drugs during a clinical research study.

Naproxen may indeed have a heart-protective capacity -- but that does not mean that Vioxx cannot compromise many patients' heart health. Nor is the heart-protective capability of naporoxen entirely proven. Regardless, "preliminary data from an FDA-financed study, using patient data compiled by the Kaiser Permanente health maintenance organization, says.