Merc & Vioxx Case
The Causes The first sign of trouble really came when according to the reading, an unpublished 1998 Merck clinical trial called “study 090,” which involved 978 patients, showed that serious cardiovascular events, including heart attack and stroke, occurred about six times more often in patients taking Vioxx than in patient taking another arthritis drug or a placebo.
But Merck dismissed these findings saying the study was too small for any significant conclusions to be drawn.
Then came the big study hinting at real trouble, VIGOR, in which over 8000 patients were enrolled in Merck’s post-approval study of upper gastrointestinal (UGI) toxicity of Vioxx. It was a double blind, randomized trial comparing the occurrence of gastrointestinal toxicity of Vioxx and naproxen (Aleve, another non-steroidal anti-inflammatory) in arthritis patients. The trial showed that the risk of “important” UGI adverse events was significantly lower in the Vioxx group compared to the naproxen group.
Further analysis, however, showed that the risk of heart attack was four times higher than that of the naproxen group. According to the reading, these results were not a complete surprise to Merck.
It was something the company had known would show up one day. In some of the e-mails exchanged, Merck’s chief of research, Ed Scolnick was quoted saying that the cardiovascular events “are clearly there. It is a shame but it is a low incidence and it is mechanism based as we worried it was,” (Sulkowski).
I can understand that this is a business, and these pharmaceutical firms are in to make money, but at the same time it is human life that these companies are really toying around with, basically. I was very disturbed by Scolnick’s lack of immediate action upon discovering this huge flaw in the drug, and instead of taking responsibility and trying to come up with solutions to solve the problem, he went on the offensive saying that all drugs have hazards, and Vioxx therefore was no exception. Another very disturbing factor was the company’s “Dodge Ball Vioxx” training document.
According to the case, the results of the Vioxx-naproxen study alerted doctors and patients, and in order to help sales personnel deal with questions that both doctors and patients raised, the company developed a sales aid called “Dodge Ball Vioxx,” basically a document intended to help sales representatives get away with questions regarding concerns that customers and doctors had about the drug. Who does that? I was seriously shocked that the company would go to such extremes to avoid taking responsibility, especially when thousands of people’s lives depended on it.
Clearly Merck was determined to fight anyone who was skeptical about Vioxx’s safety. This was shown through its actions to shut down academic researchers who tried questioning the drug’s safety by withdrawing its funding to these institutions or lectures that it sponsored at the various schools. Merck even ignored the Kaiser Permanente study, which was sponsored by the FDA.
The results of the study showed that patients taking the highest recommended dosage of Vioxx had nearly 2. times the risk of heart attack and sudden cardiac death as patients taking Celebrex. Again Merck dismissed these FDA conclusions about Vioxx. All this fighting back was beginning to be suspicious to many people, and outside research and articles started being written and published about Vioxx and other Cox-2 inhibitor drugs. It wasn’t until September 23, 2004, almost four and half years later that Merck’s second trial study testing Vioxx’s safety (APPROVe), showed some really troubling results that the company finally pulled the drug off the market.
I definitely agree with the medical experts in the reading that Merck should have done more studies when doubts about Vioxx first merged. The company’s strategies to dodge the problem and take offense whenever researchers and medical experts questioned the drug’s safety were a really bad move that indeed cost the company not only millions of dollars, but its reputation too. Being a pharmaceutical company the public needs to have faith and trust in it. People need to be assured that the drugs being given to them are going to improve their health, not cause more problems or kill them.
The public indeed lost trust in Merck because it didn’t act responsibly and waited several years to pull the drug, despite warning signs of multiple studies showing potential risks of Vioxx since its approval. It wasn’t only the direct consumers, but investors in the company were also disappointed.
The stock price decreased 27% in value the day of the recall and continued to drop in the following weeks. The company has lost over $150 billion in market capitalization since 2000. I’m trying to put myself in Ray Gilmartin’s shoes, Merck’s CEO at the time, and see what I might have done differently.