First, please understand that the call for hearings is not over. There are still numerous Congressman that do not agree with the Dingell response. Hearings could still happen they just won’t happen soon and they won’t likely be championed by E & C. Please keep lobbying your representatives and keep the health staffers informed. The Petition has got lots of signatures but it can do so much better if those reading this, yes you, sent it to 25 people each and asked them to send it to 25 of their friends. If you do not have 25 friends then you might be named Scher or Pazdur. There should be 5,000 signatures by now.

Second, the legal action is pending on two fronts. There is an appeal pending in the 6th circuit court of appeals that should be fully briefed by all parties by the first of March. We also have the pending FOIA claim against CDER. In my opinion Richard Pazdur has the smoking gun but he is not giving it up. Richard Pazdur has still not responded to the August CTL FOIA request. It is my belief that the FDA intentionally withheld these documents (consequences be damned) because of the scrutiny. They are damaging and would have assured consequences in the face of hearings. I am 100% certain that if we saw Dr. Pazdur’s hard drive the conspiracy against Provenge would be fully uncovered.

Third, the CareToLive Citizens Petition is pending. In fact I talked to the FDA (counsel for CBER) tonight. While some on this board have indicated they believe Congress acted as they did because they were told that conditional approval was forthcoming that is not the case. However, my contact assured me that they are “very actively” reviewing the matter including all the material that has been provided by way of comments and attachments. Do not send them more documents at this point. They have it all and additional comments might slow down the process. I do believe after talking to her that they really are taking what we have sent them very seriously and that Jesse Goodman is committed to getting treatments to the patients as soon as is possible. I have said this again and will say it again I think Goodman is the right person to have reviewing this matter. I believe success, while not assured, is very possible. There are still politics inside the FDA at work but Goodman has a chance to overcome the obstacles (like Pazdur). While we lacked a champion on E & C we may have one in Goodman

One other thing I would like to express my opinion on. The Dingell response stated:

“An initial examination of the panel in question here indicates that each individual’s financial interests were disclosed and that appropriate waivers were granted in writing,”

In my opinion this statement was not arrived at because anyone in Congress, such as Dingell, cross examined Scher and Hussain under oath. It is my belief that there is an internal investigative report (that we will never see) that was generated by internal FDA investigation and that this report in part was provided to E & C (Paul Jung). This report says that as part of the internal investigation that Scher and Hussain were questioned and that they indicated that they reported all conflicts….end of story. They were not put under oath, not cross examined, not ordered to produce any financial documents, not sent subpoenas………….. and that the entire “examination” was a few pre posed questions and answers by FDA insiders and that’s it. I stand by my previous opinion that if Scher was ever put under oath and questioned he would plead the fifth to avoid prosecution.

Amazingly someone we all know and respect told me even before that statement was issued by the FDA to Congress that this FDA would never admit to anything wrong happening by anyone at FDA…they do not admit mistakes. The FDA acted as predicted, Congress bought it. The FDA sold the E & C a bill of goods.

The fight is far from over.

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Tags: Care To Live, CareToLive, FDA, Prostate Cancer

This entry was posted on Thursday, February 21st, 2008 at 12:16 pm and is filed under The Cause, The Dysfunctional FDA, The Lawsuit. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.