Key questions related to Vioxx recall

U.S. Senator Max Baucus has developed a list of key questions raised by recall of Vioxx by Merck. These relate not only to what Merck and FDA should have done to prevent over 25,000 American deaths but also to the basic structure of how the United States approves drugs and monitors their performance over time

• When did Merck know about the potential dangers of Vioxx?
• And should the company have acted sooner to withdraw the drug?
• Why didn’t the FDA detect the risks associated with Vioxx during the initial approval process, or even in the 5 years since approval?
• Does the FDA have sufficient resources, authority and independence to ensure that the drugs it approves are safe?
• And should we be doing more to monitor drug safety after a drug has been approved?

Experts believe that while faster drug approval may be in the interest of American people but it should not allow a company to play with American lives. That is where the role of FDA is crucial. Baucus adds, "I am concerned that what happened with Vioxx may have been due, in part, to insufficient emphasis on complete, rigorous, and expansive clinical trials. Clinical trials focused on drug safety should not stop when the FDA approves a drug. We need to continue testing drugs to thoroughly evaluate the potential risks, not just the benefits."

He also raises questions about the broad implications of the medical malpractice reform bill currently being considered by the Congress. As it is American people are totally helpless when it comes to being used by drug companies. With denial of a legal remedy to Americans, the Congress will give a boost to the efforts of drug companies to abuse the system. He expressed his concern by saying, "Liability restrictions in this bill apply not just to doctors and hospitals. They also include pharmaceutical and medical product manufacturers, such as Merck. And the legislation creates new protections for products approved by the FDA, like Vioxx."

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