Subject:   Regarding the Failure of the Public Safety System For Drug Testing in the Case of Vioxx
Date:   2004-10-16

The voluntary withdrawal by Merck of its anti-arthritis drug Vioxx®, due to adverse cardiovascular events, has led to questions regarding the protective system in place that provides for our public safety. The study that led to the withdrawal was conducted by the drug company and the finding of adverse cardiovascular events was an incidental result, as Merck was examining another adverse event issue.

1. In follow-up studies of 18 months the drug was found to double the risk of heart attacks and strokes, possibly by increasing the chance of clotting. It turns out that studies involving 2,500 people over an 18 month period revealed the adverse event pattern as being significantly high.
2. A study over four years old had already indicated a high risk in these categories, but the problem was handled by labeling, not by further studies to determine the full level of risk. The 2001 special communication in JAMA, 286:954-959, was entitled Risk of cardiovascular events associated with selective COX-2 inhibitors. The authors warned that available data raised a cautionary flag and suggested further trial evaluations. A later 2002 news item from the British Journal of Medicine, on September 1, 2001 was titled COX 2 inhibitors may increase risk of heart attack. *
3. Over 80 million people were given prescriptions since its approval in 1999, and two million people were taking the drug world-wide at the time of withdrawal —  meaning that the use of the drug constituted a public safety epidemic. Relying on the drug company to conduct a study and to withdraw the drug after four years of exposure points to the failure of our current system, including the FDA, to protect the public safety.

In sum we find:

1. A failure in the adverse event reporting system generally.
2. The absence of any requirement to perform follow-up studies once real cautionary flags were raised.

It may be that the general class of drugs of COX inhibitors present the same risk and studies need to be conducted here as well. There may be yet other classes of drugs which are presenting a similar high risk, and as of yet are unknown because of insufficient follow up testing and a voluntary reporting system.

The larger question of whether interventions on the molecular level, as emphasized in contemporary medicine, will of necessity (in many cases) incur many adverse events due to the body's homeostasis mechanism remains largely unexplored or unaddressed by the research community.

We at CIRCARE propose that an on-going phase four study be conducted once a given drug hits the market, for a long term period from 1–5 years to monitor significant adverse events: deaths and hospitalizations. Only with adequate follow-up research can we grant true informed consent to the public, so that they may truly know the risk of  any drug they may take.

Michael A. Susko MS, CIRCARE President
(410) 499-4895

Adil Shamoo Ph.D., CIRCARE Co-Founder
(410) 706-3327

* Complete citations: Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA. 2001;286:954-959; Gottlieb S. COX 2 inhibitors may increase risk of heart attack. BMJ. 2001;323:471.

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Last Updated: 2006-04-25

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