Vioxx Case Study

Outline

Thesis: There were unethical decisions made by executives of Merck. Clinical studies showed an increase in cardiovascular events and yet they chose to ignore that information so that they could continue to market the very profitable drug. The decisions of Merck executives were based on money and greed, and they were not taking the health and lives of the Vioxx users into account.

1. The clinical trials.

a. New Drug Application

b. VIGOR submitted for review.

2. Merck Instructed Sales Representative to Give Misleading Information.

a. The "New Obstacle Response"

3. Merck's internal clinical trial

a. APPROVe Study

4. Recall of Vioxx.

Conclusion: Despite numerous study results, Merck continued to market Vioxx. The only concern was profit.

Ethics

Merck's Unethical Decisions Concerning Vioxx

Vioxx was marketed as a miracle painkiller for those suffering from migraines, arthritis, etc. The decision to continue to market Vioxx even after studies showed an increase in cardiovascular events was unethical. Records suggest Merck executives were aware of increased cardiovascular events and yet they continued to market the dangerous drug.

The Clinical Studies

The New Drug Application

As with any new drug, Vioxx was subject to clinical trials prior to its release in May 1999. Merck submitted a New Drug Application (NDA) for Vioxx on November 23, 1998. In the original application, there were no significant cardiovascular events.

The VIGOR Submitted For Review

In the month following the release of Vioxx, the VIGOR (Vioxx Gastrointestinal Outcome studies) was submitted for review. The VIGOR began their research in January of 1999 and continued into the spring of 2000. The studies showed an increase in cardiovascular events . As with most clinical trials throughout the United States, the VIGOR was monitored by a Data and Safety Monitoring Board (DSMB). The reason for a DSMB was "to ensure the safety of the trial participants" . Although patient safety is the top priority for the DSMB, they do not have the authority to alter or stop a clinical trial. Those abilities lie in the hands of a Steering Committee, which is made of outside consultants, and employees of Merck. The DSMB notified the Steering Committee of "excess deaths and cardiovascular adverse experiences" in November of 1999