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David Graham, the associate director for science and medicine at the FDA's Office of Drug Safety, told the Senate Finance Committee that his agency's earlier projection that Vioxx may have caused roughly 28,000 heart attacks or sudden cardiac deaths was "an extremely conservative estimate." Graham said Thursday that the number of deaths alone may have been as many as 55,000.
Analgesics called Cox-2 inhibitors can not only damage the heart and blood vessels but may also suppress the immune system. A study published this week in the Journal of Immunology shows the drugs, used by arthritis sufferers, might affect the antibodies that attack invading germs. This is not necessarily a bad thing; there are situations where one may want to reduce antibody production -- for example in people with autoimmune diseases such as rheumatoid arthritis and lupus.
Vioxx was released on the United States public in 1999 and has been marketed and distributed in more than 80 countries. (In some countries, the same drug is marketed under the trademark CEOXX). Worldwide sales of Vioxx in 2003 were $2.5 billion. Over Ninety One Million people in the United States have been exposed to Vioxx since it's release, and it is estimated that approximately 100,000 people have suffered a sever reaction to the drug, up to and including death.
FDA safety officer David Graham and others estimate that Merck's signature arthritis drug, Vioxx, has caused as many as 140,000 heart attacks and strokes and killed as many as 55,000 people since being approved by the FDA in 1999. Documents made public on May 5, 2005 by the House Government Reform Committee constitute the strongest evidence yet that Merck executives were aware of the dangers of the drug and took aggressive steps to conceal them, endangering countless lives.
The director for Science and Medicine at the Office of Drug Safety, David Graham, delivered a scathing assessment of FDA drug approval policy. He blamed the 55,000 or more Vioxx deaths on the FDA's decision in 1999 to approve Merck & Co.'s sale of the drug, despite data that suggested the arthritis medication was linked to increased risks of heart attack and stroke. "Unless the FDA establishes an independent division to monitor the safety of drugs once they're on the market, Graham said, more Vioxx-like disasters are likely."
Evidence of cardiovascular problems linked to Vioxx first appeared in 2001, when the so-called VIGOR study found that certain Vioxx users suffered twice as many heart attacks and other cardiovascular problems as users of the older painkiller naproxen. The following year, the FDA added warnings to Vioxx's label. At first, scientists thought it may be because Vioxx users weren't getting a blood-thinning benefit that comes with many older painkillers. But by 2002, top specialists were worried that Vioxx might be the direct culprit, and Merck's own follow-up research prompted it to pull the drug.