Summary
Dr. David Graham, a top FDA scientist, released information today that stated the FDA forced him to blow the whistle on Vioxx by neglecting to protect consumers. Dr. Graham felt that his hand had been forced after numerous studies showed that patients taking Vioxx were twice as likely to suffer a heart attack. Dr. Graham feels that the FDA waited too long and should have banned the drug in 2000, when the studies were first released. Consumers would most likely agree with Dr. Graham, especially since more than 20 million people were prescribed Vioxx, not knowing the horrific consequences that could occur while taking the medication.
Original source:
http://www.medicalnewstoday.com/medicalnews.php?newsid=16846
Details
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Dr David Graham says circumstances at the FDA became such that he felt forced blow the whistle - he said he had to protect consumers from dangerous drugs.
- Dr Graham reckons Vioxx harmed at least 88,000 people, of which at least one third died.
- He claimed during a TV program called Nightline (ABC TV) that he felt the situation had forced him to speak.
- Dr Graham said during the Nightline program, "We have a system that is biased toward approving drugs almost regardless of the safety risks.
- Any reason will be looked for to approve a drug, unless there's an overwhelming safety reason not to approve a drug."
- Dr Graham is one of the top FDA scientists.
- During his 20 years at the FDA he has overseen the recalling of 10 drugs.
- The recall of Vioxx is the biggest selling drug ever to be recalled.
- It had been consumed by 20 million people in the USA alone.
- According to Merck's studies, patients taking Vioxx had double the heart attack risk when compared to a placebo - Vioxx gave patients a 15 per thousand risk compared to a placebo's 7.5 per thousand risk.
- Graham reckons the FDA dragged its feet and should have told people about the risks earlier on.
- He said that if things had been different the drug would have been banned in 2000 (as soon as study results were known).
- The FDA is holding a meeting on Vioxx next year.
- Many Americans wonder why the import ban on prescription drugs should carry on.
- President Bush had told the public that drugs approved in the USA gave US citizens a guarantee of quality and safety.
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