Unit #1 – Ethics 1) Introduction of Vioxx a) Introduction in 1999 b) Withdrawal of the drug in 2004 due to heart attacks c) Merck’s knowledge of the effects of Vioxx and unethical decision to continue to sell the drug 2) Vigor Study d) Vioxx lessened stomach bleeding e) Results also showed higher risk of heart attacks f) Merck blamed naproxen for skewing the results against Vioxx 3) New England Journal of Medicine Omission g) Merck omits three heart attacks from article submission h) Inclusion of omitted data caused a significantly greater result 4) FDA Reaction i) Letter regarding downplay of risks j) Addition of warning label to Vioxx k) Additional study results 5) Approve Study l) Results with placebo group cause Merck to recall drug 6) Trials m) Challenge of showing causation n) 18 month defense 7) Settlement o) $4.85 Billion Settlement p) Admission of guilt 8) Merck’s Choices q) Merck made choices that showed clear wrongdoing
Introduction of Vioxx
In May of 1999, the FDA approved the use of rofecoxib. Marketed under the name of Vioxx, rofecoxib was manufactured and distributed by Merck, a large pharmaceutical company. Doctors prescribed the drug as a non-steroidal anti-inflammatory and prescription painkiller. Five years after its release, rofecoxib was withdrawn because of a study that showed the drug more than doubled the risk of heart attack or stroke. Because of Merck’s ongoing and increasing knowledge of the dangerous effects of the drug while continuing to distribute rofecoxib, Merck should be held accountable for acting unethically.
Less than a year after the drug’s release, a study named Vigor was completed. The study’s intent was to compare Vioxx and naproxen and the drugs’ effects on the gastrointestinal system. Results from the study showed Vioxx lessened internal bleeding but the