Case Analysis #1
Tuesday, January 22, 2013
Merck & Company, Inc: The Recall of Vioxx
Geroge W. Merck stated once stated, “We try never to forget that medicine is for the people. It is not for the profits. The profits follow. Initially, Vioxx was the blockbuster drug that Merck needed due to the upcoming Zocor patent cliff in 2006. With an estimated 27,785 heart attacks and sudden cardiac deaths that could have been avoided if Celebrex had been used instead of Vioxx, Merck faces the possibility of not only having to pay enormous civil and criminal penalties, but also losing the trust of patients. Many parties are partially culpable, but Merck faces the ...view middle of the document...
Instead, Merck spent a record amount on advertising the gastrointestinal benefit of the drug in a period of uncertainty. The advertising in the time of uncertainty is really unparalleled, and opens the door to questioning (Appendix).
Merck wanted to discover a drug in the Cox-2 inhibitor class that would compete with another class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDS). Cox-2 inhibitors were developed to eliminate the most common side effects of other NSAIDs, ulcers and gastrointestinal bleeding, as an estimated 15,000 people die from GI bleeding annually; Vioxx was designed to treat those high-risk candidates. Vioxx was the only Cox-2 inhibitor proven to have a benefit for ulcers and GI bleeding. Thus, the blockbuster status was created: a stronger drug with a proven benefit for ulcers and gastrointestinal bleeding. As the events unfold in the case, the crucial errors occur prior to the decision to recall the drug on September 30, 2004. After Merck learned that patients had double the risk of heart attack or stroke than if they took placebo and two new competing Cox-2 inhibitors were introduced, Merck decided to pull the drug, but it was already far too late.
Dr. Eric Topol, a highly regarded cardiologist conducting research at the Cleveland Clinic, was the first researcher to raise questions about Vioxx. While he concluded that Vioxx produces a risk of heart attack five times greater than naproxen sodium, some believed that Merck’s scientists interpreted the data opportunistically; by saying the difference was due to the protective effect of naproxen, this downplayed the important possibility that Vioxx was contributing to cardiovascular problems. Some scientists say that the protective effect of naproxen argument is implausible, and noted that naproxen would have to be three times as effective as aspirin to account for the difference. While the FDA didn’t buy this argument and issued a warning on all Vioxx labels, many began to wonder if this was the first sign of an unethical deception, cover-up, and manipulation by Merck.
Additionally, as the label was added, Merck would later ironically cite the VIGOR study in defense of Vioxx: it increased the risk only in those patients believe to be a high risk. However, Dr. Gregory D. Curfman, editor of the prominent New England Journal of Medicine noted that it had “solid evidence that important data on cardiac events was deleted or withheld.” Dr. Curfman argued that the three deleted heart attacks occurred in people who were otherwise at low risk for heart problems, which would ultimately discredit Merck’s claim that is only increased the risk for high-risk patients.
The FDA’s mild warning hardly curbed the widespread use of the drug, yet Merck continued to advertise its big benefit to consumers more than any other company in 2000 (Appendx): it causes fewer cases of stomach bleeding. However, this is only a problem for a very small...