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What is the FDA Thinking?
By Mark Schauss | February 24, 2008
The drug Avastin, has just been approved by the Federal Drug Administration for the treatment of breast cancer despite it having shown no benefits over exisiting drugs in prolonging life or improving the quality of life of women taking the drug. What is the point of taking a drug that doesn’t benefit the patient aside from making money for the pharmaceutical company (Genentech in this case)? I thought the criteria for the approval of cancer drugs is that it shows benefits for the users not ones that have greater side-effects like this one.
While the drug has shown to help in the shrinking of tumors, I cannot for the life of me understand how you approve a drug which fails at improving life quality and longevity and even has been shown to increase the risk of death. This is a horrible failure of the FDA to uphold its agenda. The independent outside advisor committee voted 5-4 AGAINST the approval for the drug yet the FDA in its puzzling wisdom rejected that advise. One has to wonder what their thinking was if you can call it thought.
Another bad day for the agency that needs a major overhaul.
Topics: Drugs, Health, Research | 1 Comment »
February 24th, 2008 at 11:44 am
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