Best wishes to one and all,

Carl

The more you dig into the FDA’s handling of Provenge, the more you realize that “good science” had little to do with the FDA’s final decision to issue a Complete Response Letter. Politics and the ability to act with impunity allowed a corrupted FDA process to conduct “real meetings” in secret and AC panel meetings in public.

Kerry M Donahue, the attorney who filed the CareToLive lawsuit clearly saw this impunity when he wisely noted that the FDA took the ‘due’ out of ‘due process’ in the Provenge hearings. The following excerpt from the lawsuit speaks for itself:

“Its not meaningful if the public AC hearing is merely a sham and the “real meeting” occurs behind closed doors in ignorance that this is The United States of America where operating in secrecy in a non- democratic manner is frowned upon. The decision to take the “due” out of due process was a deliberate wrongdoing and more than just run of the mill negligent conduct…”

In the case of Provenge, the FDA’s move to overrule its panel was, as you know, unprecedented because the agency had never before ruled against a positive panel finding in a terminal illness. Why did they do it with Provenge? And that question begs a larger question:

Who stands to benefit in this country or within the FDA by giving the FDA absolute sovereignty over matters of Life & Death without due process? And what of the potential absolute corruption that that power can engender? And is this really the way Congress wants the FDA to conduct its business?

When ruling against a panel in a terminal illness finding, shouldn’t the FDA—especially being a “science-based agency,” be mandated to give us at the minimum what the Supreme Court provides –a list of who voted; how they voted and a summary of their arguments? As Kerry wisely noted, considering this is the United States of America, do Americans—especially the Fourth Estate and Congress, really have to beg our FDA to tell us that life and death decisions are not being made with “winks & nods” but with serious discussion and debate? And here’s a frightening thought for RPM readers and all Americans:
Since no one outside of the FDA is privy to the internal discussions that took place in the Provenge decision (or any other) what if we discovered that, in fact, no internal discussions take place? What then?

Does our FDA really make decisions based on ‘good science’ but is afraid to publish their arguments? Or do they make decisions based on emotions?

Does Andy vE or Dr Richard Pazdur just pick up a phone and tell someone to kill the application?

Given what is being discussed here I think it is clear the time has come for Americans and particularly the Fourth Estate to ask for complete access to FDA records for these meetings or non-meetings –specifically (i) who calls for the “real meetings” (ii) who attends the “real” meetings and (iii) transcripts of all arguments, notes and votes of those who attended.

Taking the “due” out of “due process” is not just a ‘deliberate wrongdoing’ by the FDA –it shreds the entire fabric of this Republic.

Dr. Pazdur, who recruited Dr. Scher, were poised to see Provenge approval denied before the AC. They conspired and successfully sabotaged Provenge making a non science based decision (it was denied approval despite a 17-0 and 14-3 vote even after Pazdur tried to modify the question to obtain “no” votes.

Any insiders at the FDA please provide us with any knowlede you have about the power play of CDER vs. CBER that went on regarding Provenge.

This information could help 83 men a day who are dying. About once a weeek or so CTL is contact by the family member (usually a wife) who wants to know about gaining acess to Provenge which she had been unable to obtain through any so called passssionate use program.

Provenge should have recived conditional approval and it could be helping these men now. These people are dying, desperate and need hope!

We believe responses to the CareToLive Freedom of Information Request to be prepared and sitting in a room not being delivered since the Court gave them until December 9th. If the Court knew that the docuemnts had already been compiled and reviewed by the FDA and available to be sent the Court would be very angry and order them produceds. They would then shed light on Dr. Padur and his conspiracy to see Provenge denied.

Any information regarding responsive documents to our FOIA request or or about Pazdurs threat to hold a demonstration if CBER did not do as he wanted please sent to me at my private e-mail DonahueDublin@aol.com.

Any info on why the language of the question got changed and why they made a non science based decision that is costing lives. Dendreon is not big pharma they are a small biotech..which maybe the biggest hurdle at the fda.

Please help the patients!

Dr. Pazdur, who recruited Dr. Scher, were poised to see Provenge approval denied before the AC. They conspired and successfully sabotaged Provenge making a non science based decision (it was denied approval despite a 17-0 and 14-3 vote even after Pazdur tried to modify the question to obtain “no” votes.

Any insiders at the FDA please provide us with any knowlede you have about the power play of CDER vs. CBER that went on regarding Provenge.

This information could help 83 men a day who are dying. About once a weeek or so CTL is contact by the family member (usually a wife) who wants to know about gaining acess to Provenge which she had been unable to obtain through any so called passssionate use program.

Provenge should have recived conditional approval and it could be helping these men now. These people are dying, desperate and need hope!

We believe responses to the CareToLive Freedom of Information Request to be prepared and sitting in a room not being delivered since the Court gave them until December 9th. If the Court knew that the docuemnts had already been compiled and reviewed by the FDA and available to be sent the Court would be very angry and order them produceds. They would then shed light on Dr. Padur and his conspiracy to see Provenge denied.

Any information regarding responsive documents to our FOIA request or or about Pazdurs threast to hold a demonstration if CBER did not do as he wanted please sent to me at my private e-mail DonahueDublin@aol.com.

Any info on why the language of the question got changed and why they made a non science based decision that is costing lives. Dendreon is not big pharma they are a small biotech..which maybe the biggest hurdle at the fda.

Please help the patients!

Ed: Thanks for the updates and the additional work in clearing this up. Much appreciated.

Dr. Kavanagh: Thank you for your intelligent post and your willingness to discuss the agency you work for. I commend your public service and admire your dedication.

Jaynesday: Well said; I agree wholeheartedly.

Justice in MI: Again, well said.

Mr. Dickinson: Thanks for replying to Ed. Perhaps “critic” was the wrong choice of words. Please feel free to substitute “watchdog” or “follower” if those are more accurate. I also agree with your more positive assessment of the agency as the current administration loses its power. We can all hope for the best – and sites such as yours (and maybe Thoreau-FDA) – will contribute to a much-needed public dialogue about the agency’s issues. I will stand behind the use of the phrase “long-time,” however, as 28 years is, well, a long time. (Indeed, I was in grade school.)

Dr. Kavanagh: I’m pleased to hear that Thoreau-FDA will provide a forum for your ideas and thoughts, and please do use it to publish writings from your unique and informed perspective. I’ll be reading.

Thanks to all.

FDA reviewers have every possible financial, career, and personal reason NOT to post comments on this site, and the very fact that people are willing to speak out publicly, even if anonymously, speaks volumes and follows in a great American tradition.

This is in contrast to the some in the financial, public relations, and media, as well as many people in academia.

As a new site I will support it and intend to send in pieces for publication. Thank you Gretchen for identifying how to do it for me.

Let’s remember what Silence Dogood said on September 18, 1787 to Mrs. Powel’s question, “Well Doctor, what have got a republic or a monarchy?” “A republic, if you can keep it.”

For further comments please watch Thoreau-FDA.com.

Ron Kavanagh, B.S.Pharm., Pharm.D., Ph.D.

OUCH! “A long time FDA critic”?? Actually, I have been a long time defender (since 1974) of my favorite agency. Only since the abusive politicization of FDA took real flight with the advent of the Bush Administration (for which I voted in 1980 but not again) have I become a critic.

If that’s a long-time posture in your eyes, I envy you your wonderful youth!

On a more positive note, I see several signs of the agency getting its moxie back as the Bush Administration visibly wanes, and as the consequences of Bushism leave FDA with no other sane alternative.

As preemption and similar initiatives become part of the landscape, there is a great deal of mythology disguised as fact about how things work at the agency. If we are to have anything approaching rational policy, we need to hear from those who are there.

I personally thank anyone who is able and willing to do come forward, and whether their view supports my own perspective or not.