Get your original unscrubbed FDA prasugrel review document right here

The FDA has rescrubbed the prasugrel review document on its site. You can see the original document, as it was posted last Friday, right here. You can find the hidden text by using the text tool in Adobe Reader and selecting the blank sections on pages 77 and 80 of the PDF document.

Comments

  1. Theodore J. Cohen says

    If you really want to see “incompetence” (you did mean “corruption”, I assume), take a look at the Advisory Committee meeting held on March 29, 2007, for Dendreon’s Provenge for end stage prostate cancer. This immunotherapy was voted safe (17-0) as well as having demonstrated substantial efficacy (13-0). Yet, because of actions both by federal and special government employees (two of whom sat on the AC and who had substantial unreported conflicts of interest), the FDA was pursuaded to call for more data. The actions taken by these two special government employees include not only questionable actions at the AC, but also the preparation of letters to Dr. von Eschenbach (FDA Commissioner) denigrating Provenge, both of which (together with third letter by another consultant to the FDA) that were leaked to The Cancer Letter either prior to or immediately after their receipt at the agency. A draft of one of the letters was found on the computer of a federal employee at the National Cancer Institute (NCI), and another NCI scientist has admitted to attending a meeting at the FDA that was called to discuss the development of the same letter. Sadly, since the FDA called for more data on May 8, 2007, more than 53,000 men have died of PCa, many of whom could have been helped by Provenge. Unlike its chemotherapeudic competition, Provenge’s only side effects are flu-like symptoms lasting 2-3 days. Let’s see…Chemo, Provenge? Chemo…Provenge? Give me a break! The “incompetence” at the FDA is staggering!

  2. Theodore J. Cohen says

    Correction: The vote for evidencing substantial efficacy was 13-4. I regret the earlier error.

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  1. […] that there has been little public discussion about the FDA briefing document, which contained apparently redacted content that was easily recovered in the PDF document originally posted on the FDA website. One important point here: some of the redacted content in the […]

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