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FDA: Flawed Drug Approvals?

FDA logo.gifAs Europe approves the blood thinning drug prasugrel, a nasty smell is emerging from America about the drug’s potential approval there.

The much criticised Food and Drug Administration, which will have to approve or reject the product, has admitted making a mistake by booting one researcher off a panel considering the drug.

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, says researcher Sanjay Kaul was removed from the panel after prasugrel’s manufacturer Eli Lilly complained about research papers in which he questioned the drug’s safety (Bloomberg).

The drug ended up being approved by the panel by nine votes for versus none against.

“Basically, this was a mistake,” Woodcock told HeartWire. “And like many other errors, there were a series of small errors that led up to this happening.”

In a letter to the FDA, James Floyd and Sidney Wolfe of the consumer group non-profit Public Citizen, write:

Now, more than ever, the FDA needs to clarify and disclose to the public how it defines “intellectual bias” and the policy and procedures by which it decides to exclude members of Advisory Committees based on such perceived bias. The case of Dr. Kaul creates the appearance of a lack of such a policy, or the flawed execution of one if it exists.

Tamara Hull, a Lilly spokeswoman, told Bloomberg, “Panel membership is at the sole discretion of the FDA. We made the FDA aware that Dr. Kaul had previously published abstracts and made many public statements regarding prasugrel.”


  1. Report this comment

    J Wiley said:

    this is very common, check out the works of Dr. Peter Breggin and his battle over anti-depressants with Eli Lilly, refer specifically to his books TOXIC PSYCHIATRY and TALKING BACK TO PROZAC.

  2. Report this comment

    mag said:

    Do you sometimes get the feeling that the FDA approves poison on purpose? I know it’s a bit out there, but it seems to me that anymore, the stuff they approve turns out to be quite dangerous when discovered YEARS down the road when it’s too late for the people it’s already harmed.

    We would probably be better off and healthier without the FDA.

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