Subject: Regarding the Failure of the Public Safety System For Drug Testing in the Case of Vioxx
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.
Risk of cardiovascular events associated with selective COX-2 inhibitors.The authors warned that available data raised
a cautionary flagand 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.*
In sum we find:
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
Adil Shamoo Ph.D., CIRCARE Co-Founder
* 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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<a href="http://www.circare.org/im/im16Oct2004.htm">Regarding the Failure of the Public Safety System For Drug Testing in the Case of Vioxx</a>. CIRCARE InfoMail (2004-10-16)
Last Updated: 2006-04-25
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