The Rise and Fall of VioxA Case Analysis
... Journal reported that an e-mail dated March 9, 2000, suggested Merck recognized that ‘something’ in Vioxx was linked to increased heart risk. Edward Scolnick, Merck research chief at the time, wrote in the e-mail that cardiovascular events "are clearly there" and called it a "shame." (3) Although Scolnick compared Vioxx with other drugs with known side effects and wrote, "there is always a hazard," the company's public statements continued to reject the link between Vioxx and increased intrinsic risk. Additionally, a memorandum dated Nov. 21, 1996, by a Merck official illustrated that the company wrestled with Vioxx's potential to induce a cardiac event, the report said. Another e-mail highlighted the possibility that patients could suffer blood clots unless they were also given aspirin. (3) Even after these documents were identified, Merck issued a statement saying that it acted "responsibly and appropriately" in developing and marketing Vioxx. (3) Despite prior information that Vioxx was linked to increased cardiovascular complications, Merck did not take appropriate action until undisputable external adverse findings, increased pressure from the FDA, and impending lawsuits forced them to do so. Many critics, including Dr. Eric Topol, Chief of Cardiovascular Medicine at the Cleveland Clinic, have publicly voiced their outrage at Merck and the FDA for not taking action sooner given the numerous early warning signs. Dr. Topol criticized Merck for not conducting additional clinical trials before releasing the drug, despite strong recommendations from the FDA Advisory Committee to do so, and particularly after they had identified concerns in their own internal pre-market trials. According to Dr. Topel, "The FDA didn't do anything"…"They were passive here." (4) International concerns related to the timely withdraw of Vioxx have also been voiced. The British medical weekly, ‘The Lancet’ reported that the arthritis drug Vioxx should have been pulled from the market four years earlier. Additionally, Swiss scientists claim that scientific evidence of increased heart attack risk associated with popular arthritis drug Vioxx was available as early as 2000 although the drug was only withdrawn in September 2004. (6) Furthermore, in a statement made the day Merck announced the recall, Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said, “This is not a total surprise."…"We have been concerned and aware of the potential for cardiovascular effects for the last few years”. In fact, as early as April 2000, the FDA required Merck to add labeling information about a possible link to such problems. (4) The rise and fall of Vioxx is described as “a cautionary tale of masterful public relations, aggressive marketing. and ineffective regulation”. (4) Apparently, Merck’s commercial interest in Vioxx sales exceeded its concern about the drug’s potential cardiovascular toxicity. (5) ANALYSIS: Case summary: This case involves a leading pharmaceutical manufacturing and research company who made history and headlines after recalling their drug, Vioxx, from US and worldwide markets. The recall came after many years of continued study results had indicated that drug was linked to serious cardiovascular complications. The recall also came after millions of patients had already used the drug and more than 27,000 related cardiac arrests and sudden cardiac deaths had occurred. Both Merck and Co, Inc. and the FDA had knowledge of the dangers of this drug, but neither took steps to remove it from the market for several years. Apparently, the executives at Merck made a decision to protect sales and profits rather than to protect their patients’ safety. In the end, however, the decision backfired and will ultimately become extremely costly in terms of looming lawsuits, angry investors, declining profits, and a marred reputation. Key Stakeholders: Merck and Co, Inc., Executives of Merck, Stockholders of Merck, The FDA, patients taking Vioxx, the families of patients affected by Vioxx, doctors, pharmacists, healthcare organizations, lawyers, and the public in general. Key Ethical Issues: *This leading drug and research company, who has extensive resources and who had knowledge of potential risks related to Vioxx, did not invest in additional clinical trials, further research, aggressive warning labels, or in educating patients and/or doctors regarding the dangers of Vioxx. *Merck delayed withdrawing the drug from the market because they did not want to jeopardize profits by releasing information that could potentially damage sales. Merck obviously placed a greater value on profits, sales, and revenues than on the value of patient safety and human life. *Merck suppressed information that Vioxx increased cardiovascular risks. Rather than airing on the side of caution, Merck continued to justify negative study results and minimize unfavorable indications of any risks. *Merck continued to actively market and promote Vioxx for several years, denying any potential danger or risk, and did little to advise doctors and/or patients of serious risks associated with Vioxx. *The FDA also had knowledge of problems and did not act in a timely manner to require additional research, monitoring, or removal of the drug from the market. *Both Merck and the FDA acted passively and did little to monitor drug safety or to protect the health, safety, and well-being of patients taking Vioxx. Opposing Argument: It can be argued that study results may not be as significant as they have been made to appear. Merck claimed that according to the FDA study at Kaiser Permanente, only 1.3 patients out of every 1000 who use Vioxx for more than 18 months are affected. The majority of patients on Vioxx do not take the highest dose and are not on the drug for more than several weeks. Therefore the percent of complications relative to the total patients using the drug would be relatively low. Merck further argued that Vioxx falsely looked risky compared to Naproxen because Naproxen thins the blood much like aspirin does and thus protects against heart attacks. (2) Closing Argument: Despite the opposing argument that findings may not be significant, in my opinion, 27,000 people is very significant, especially if these complications c...