Merck - Ethical Decisions

Merck is a multinational pharmaceutical company established in 1891. Merck researches, discovers, develops, manufactures and markets numerous vaccines and medicines through far-reaching programs that help deliver them to the people who need them.

Although Merck publishes unbiased, not necessarily the same biases used when preparing research (Bazerman, 2006), health information as a not-for-profit service, it appears that Merck misused data to delay the decision to withdrawal Vioxx.

It goes without question that Merck indeed successfully conducted research that gathered information related to the possible ill effects Vioxx may introduce. The controversy lays with their data analysis preparation techniques during the VIGOR (VIOXX Gastrointestinal Outcomes Research) & APPROVe (Adenomatous Polyp Prevention on VIOXX) studies (Sekaran, 2006).

The VIGOR study was primarily designed to examine the effects of Vioxx on side effects such as stomach ulcers and bleeding. The study did quantifiably show that patients prescribed Vioxx had fewer stomach ulcers and bleeding than patients on another drug but also revealed that there was a statistical increase in the number of cardiovascular events and stokes occurring in Vioxx patients (Kweder, 2004). But this was no great revelation. In 2001 an FDA advisory committee had to pass a vote to ensure that physicians were being informed of the VIGOR study findings (Kaiser, 2005).

APPROVe was a 156 week, 2600 person Vioxx vs. multi-centre, randomized, placebo-controlled double-blind quantitative study that investigated the side effects of Vioxx (Merck, 2004). APPROVe found that after 18 months of treatment, patients taking Vioxx had twice the risk of a myocardial infraction compared to those receiving a placebo. This study is believed to have tipped the risk benefit equation leading to the September 30th, 2004 global withdrawal (Emerson, 2004).

Merck policies maybe legal but are they ethical? Merck used outdated and misleading data to indicate that Vioxx was safer than alternatives. This prevented the release of educational data to physicians related to Vioxx’s potential health risks so restructured sales campaigns based upon the information would meet sales goals. (Kaiser, 2005).

Did Merck hide behind the FDA labeling guidelines with intent to misuse and restrict data? According to the FDA, Merck only had to release information related to approved labeling guidelines. Coincidently, new content and formatting requirements quickly followed the withdrawal of Vioxx. The Drug Information Association in conjunction with the Office of Medical Policy, the Canter for Drug Evaluation and Research, and the FDA briefed the newly revised safety requirements and the adverse reaction definition to demonstrate the necessary adaptations needed to ensure that there is a need for