Vioxx Recall Incites Concerns with FDA

It is estimated that 2.5 million persons in the United States are affected by rheumatoid arthritis. Given the extensive breadth of this problem, it is no wonder why drugs targeted to relieve the pain associated with arthritis are so popular in this country and around the world. The incredible dependence on this type of medication also explains why Americans are expressing such outrage surrounding the late September recall of Vioxx, an FDA-approved drug since 1999 which was recently blamed for an increased risk of heart attack and stroke.

The FDA and some medical experts advise that the public should remain reasonably comfortable taking government-approved prescription drugs, despite the recent controversy. Vioxx is the first prescription drug to be recalled for safety reasons since 2001. The withdrawal was announced in late September, after Merck raked in $2.5 billion in worldwide sales in 2003 alone. Prior to the recall, the FDA had approved Vioxx to be prescribed for adults and for children as young as 2 years old.

The recall of Vioxx raises questions about the review process used by the FDA to approve new drugs as well as its oversight methods employed to pull defective drugs from the market. In response to reports of thousands of injuries related to Vioxx, FDA spokeswoman, Crystal Rice, advised that "No drug is fully safe," and stated that the FDA acted appropriately "based on the risk-benefit profile for a drug and the societal need and desire for new drugs".

The FDA has been accused of succumbing to the intense industry pressures to expedite the approval of drugs, despite clinical trials with limited sample sizes and abbreviated trial periods. Medical scholars have noted that problems with drugs can lie hidden due to inherent limitations in clinical trials until drugs go into wider use. Critics of the FDA complain that the agency has failed to act aggressively to avoid these shortcomings.

In turn, the FDA placed blame with the pharmaceuticals companies themselves, stating that many firms failed to meet their end of research agreements. The FDA claimed to enter into nearly 2,500 agreements to conduct post-marketing studies on drugs. Less than half of those studies were ever completed, according to the most recent FDA data available.

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