GLAXO'S BLOCKBUSTER DRUG PAXIL HAS BEEN LINKED TO BIRTH DEFECTS AND INCREASED RATES OF SUICIDE
NEW INFORMATION SUGGESTS THAT THE COMPANY MANIPULATED A PIVOTAL TRIAL TO SHOW GREATER EFFICACY IN REDUCING SUICIDE.
When the proper analysis was performed, not only was the drug less effective at reducing suicide, but more participants committed suicide on the drug than on a sugar pill. This is yet another example that may shed additional light on the FDA's inability to adequately regulate Big Pharma.
Additional information on the Paxil links to persistent pulmonary hypertension (PPH).
New questions have emerged whether Glaxo intentionally misrepresented data on suicide risk when it applied to the FDA for approval. The company has denied this charge.
A study underwritten by Harvard and consumer advocates determined that Glaxo's study used for approval showed that the real risk for suicidality was 8 times the risk for un-medicated patients. Glaxo interpreted the data in a misleading fashion, and the FDA relied on the company's conclusions. Had the appropriate conclusion and risk been provided to the FDA when it was originally approved, the FDA would likely have added additional warnings. In 2004, the FDA did add warnings. And in 2006, the company issued a Dear Doctor letter advising the physicians that the drug posed a risk of 6.7 times that of placebo (sugar pill).
Although the true risk is now being disclosed, the delay has allowed for more profits and likely caused the un-necessary loss of lives. In light of the evidence, the studies should also be scrutinized to look for any evidence of birth defects as well.
New questions have emerged whether Glaxo intentionally misrepresented data on suicide risk when it applied to the FDA for approval. The company has denied this charge.
A study underwritten by Harvard and consumer advocates determined that Glaxo's study used for approval showed that the real risk for suicidality was 8 times the risk for un-medicated patients. Glaxo interpreted the data in a misleading fashion, and the FDA relied on the company's conclusions. Had the appropriate conclusion and risk been provided to the FDA when it was originally approved, the FDA would likely have added additional warnings. In 2004, the FDA did add warnings. And in 2006, the company issued a Dear Doctor letter advising the physicians that the drug posed a risk of 6.7 times that of placebo (sugar pill).
Although the true risk is now being disclosed, the delay has allowed for more profits and likely caused the un-necessary loss of lives. In light of the evidence, the studies should also be scrutinized to look for any evidence of birth defects as well.
