August 24, 2005
A Texas jury’s recent $253 million verdict against Merck for the deadly side effects caused by its painkiller Vioxx underscores the dramatic need for passage of drug safety legislation this year in Congress. Bills pending in both the Senate and House would address many of the safety issues involved in the Vioxx case – most notably, requiring drug companies to make public studies that show harmful drug side effects, and ensuring drug makers conduct safety studies when problems first arise.
Consumers Union, the non-profit publisher of Consumer Reports, urges you to support legislation similar to S. 470 and S. 930 and HR 3196. These measures would not only give the Food and Drug Administration the tools to avoid future Vioxx-type incidents, but would dramatically restore consumer trust and confidence in our drug safety system.
None of these bills will slow or impede the flow of important life-saving therapies to patients. Rather, they will ensure that the attention and resources applied over the past decade to speeding treatments to patients will be matched with equal focus on ensuring the safety of those products once on the market.
S. 470 and HR 3196 would:
• Require almost all clinical drug trials be registered and their results made public. Having this trial data available would have enabled independent researchers to determine there were serious problems with Vioxx about five years before it was pulled from the market for safety reasons.
S. 930 would:
• Give the FDA the effective authority to require drug makers conduct follow-up studies on the long-term safety of drugs once they are on the market. Many drugs, including Vioxx, are approved for a small, targeted group of patients but are marketed by the drug maker to a broad population for which the risk may surpass the benefit. Also, the harmful side effects of some drugs for chronic illnesses (arthritis pain, heartburn, etc.) do not become apparent until they are used over a long period of time by a large population. Right now, the FDA has no authority to require further studies of drugs on the market even when safety problems arise.
• Ensure direct-to-consumer advertising accurately reflects risks as well as benefits, and that potentially unsafe drugs not be widely advertised. Such restrictions could have helped avoid many of the deaths and cardiovascular incidents linked to Vioxx, which was heavily marketed to the general population despite early safety concerns. Vioxx was used by more than 20 million people and had annual sales of $2.5 billion before being withdrawn from the market.
Making sure that adequate attention is given to drug safety — without slowing down the approval process — will save drug companies, patients and society tens of thousands of lives and billions of dollars in the years to come.
Please let us know if you would like additional information on these bills or documentation on why they are needed.
Senior Policy Analyst