The study was intended to expand the drug’s approved indications by showing that it would have fewer gastrointestinal side effects than naproxen for the treatment of rheumatoid arthritis. Research later published in the medical journal Lancet estimates that 88, Americans had heart attacks from taking Vioxx, and 38, of them died. H M Krumholz ude. Even before the drug was approved, some evidence cast doubt on the safety of Vioxx. This article has been cited by other articles in PMC. COX-1, it was found, performed several beneficial functions, including protecting the stomach lining.

Five years after Vioxx’s launch, Merck withdrew the drug from the market. Nearly million prescriptions for rofecoxib were dispensed in the US between and September , 21 when the drug was withdrawn from the market, and none of the people picking up those prescriptions had the opportunity to consider the true balance of its risks and benefits. Events reported later won’t be included in the initial analysis. Researchers had found, the scientists told him, that after 18 months of continuous use, individuals taking Vioxx were more than twice as likely to have a heart attack or stroke than those taking a placebo. A renewed commitment by all those involved and the institution of these systems are the only way to extract something positive from this unfortunate affair.

DSE has studied and reported corporate corruption of science. Our orders are delivered strictly on time without delay.

merck the fda and the vioxx recall case study questions

Be assured that Merck will continue to do everything we can to maintain the safety of our medicines. Our mercck depends on putting patients’ interests first. The better we have remembered that, the larger they have been.

What have we learnt from Vioxx?

The following day, Gilmartin notified the board, and the company contacted the FDA. Events reported later won’t be included in the initial analysis.


With more than 8, participants, it is the largest study ever done of the drug. In assets and market value, it ranked 5th.

merck the fda and the vioxx recall case study questions

Cardiovascular outcomes with etoricoxib questionx diclofenac in patients with osteoarthritis and rheumatoid xase in the multinational etoricoxib and diclofenac arthritis long-term MEDAL programme: A study code-named VIGOR, completed in after the drug was already on the market, compared rheumatoid arthritis patients taking Vioxx with another group taking naproxen.

United States Securities and Exchange Commission. The study showed that rofecoxib was not more effective in relieving symptoms of rheumatoid arthritis but did halve the risk of gastrointestinal events. Journalists have questioned the ethics of industry and academic researchers.

Timeline: The Rise and Fall of Vioxx

If short term use was not associated with increased cardiovascular risk, Merck’s liability would potentially be drastically reduced. Therefore companies had an incentive to continue to study approved drugs to provide data that they were safe and effective for the treatment of other conditions.

The minutes of the panel’s November meeting note that “while the trends are disconcerting, the numbers of events are small. The journals published the studies, and the academic community accepted the findings without expressing much concern.

Merck had long enjoyed a reputation as one of the most ethical and socially responsible of the major drug companies. Half take Vioxx and the other half take naproxen.

In testimony before Congress, Dr David Graham, a staff scientist at the FDA estimated that as many aspeople in the USA had had heart attacks or strokes as a result of taking Vioxx, and about 55, of these had died. This highly irregular procedure was not described in casw publication and had the effect of favouring the drug’s effect on gastrointestinal events while understating the risk of cardiovascular events.


What have we learnt from Vioxx?

In response to your questions: Publicly, Merck hypothesized that these fea were due to the heart-protective effects of naproxen, rather than any defect inherent in Vioxx. References w1-w37 are on bmj. Medical affairs procedures and policies.

Articles should be accompanied by editorials by people without financial conflicts of interest.

merck the fda and the vioxx recall case study questions

It is not for the profits. A number of drug companies, including Merck, were intrigued by the possibility of developing a medicine that would block just the COX-2, leaving the stomach-protecting COX-1 intact.

At that time, the company considered reformulating Vioxx by adding an agent to prevent blood clots questioons reduce CV riskbut then dropped the project. Merck had influence over all aspects, including data analysis, safety monitoring, and reporting.

How should the present system be changed, if at all, to better protect patients? Support Center Support Center. Industry should not be allowed to select who serves on these boards or allowed to compensate members after their service.

Kim, president of Merck Research Labs, received merci phone call from scientists monitoring the colon polyp study. This story offers important lessons about how best to promote constructive collaboration between academic medicine and industry.

In October UK patients who had cardiovascular events while taking rofecoxib lost the right to fight Merck in the US for compensation.