FDA Commish On Provenge: What Letters?
35 CommentsBy Ed Silverman // January 30th, 2008 // 10:43 am
As part of its ongoing effort to get the FDA to approve Dendreon’s Provenge prostate-cancer vaccine, the non-profit Care To Live group has submitted several Freedom of Information Act requests to obtain documents for use in its lawsuit. A new FDA response, however, contains something curious - FDA commish Andy von Eschenbach’s office has no trace that he received any records concerning the controversial medication, despite a ‘diligent search.’ (This is the reply). Yet, there is evidence that key letters and memos were either addressed to him directly or he was among those listed to receive copies.
You may recall that an FDA advisory panel last spring recommended full agency approval. But then two FDA panel members wrote the agency - including von Eschenbach - urging a go-slow approach, and the FDA shortly thereafter decided to delay approval. One panel member was Howard Scher, an oncologist at Memorial Sloan-Kettering Cancer who serves on the advisory board of a venture capital firm that invested in Novacea, which is developing a rival cancer med. The other was Maha Hussain, a University of Michigan oncologist.
The behind-the-scenes machinations caused a firestorm - the two cancer docs say they received threats; the chain of events fueled debate about the use and approval of experimental meds, and some cancer patients and Dendreon investors filed a lawsuit against the FDA. The Care To Live suit claims the two panel members held undisclosed financial conflicts of interest and alleged a Byzantine power play involving a key FDA official who sought to sway the outcome. A federal judge recently dismissed most of the suit, but three congressman are urging an investigation.
How much does Andy know about all this? The FDA has studiously declined comment, citing the pending litigation. But as you can tell from looking at the letters - one from Hussain is addressed to Andy and other FDA officials, and Scher wrote one directly to “Andrew” - there was clearly an effort to bring him into the loop. (To see more correspondence, including Hussain’s e-mail to Andy, go here). So one has to wonder whether Andy doesn’t open his own mail, he has a terrible memory, his elves tossed the letters before he got a chance to see them, or the FDA legal staff is trying to keep him from getting sucked into the litigation any further.
Whatever the reason, it is puzzling, at the very least, that Andy’s office comes up blank.
Sam Henderson
Sounds like someone is caught in the net of deception and fabrication that was created buy their actions,(or lack of).
MyPharmalotID
This is government fraud at its most blatant. And the American Public, and Congress as well, are being play for fools.
One only can hope that Mr. Dingell and his House Committee on Energy and Commerce will finally put an end to these games and install some adult supervision at the FDA at the earliest possible time.
grr
Thank you for keeping this issue on the front burner where it belongs.
Please send this info to Rep. Dingell who is considering holding hearings on this matter.
Thanks
didier malagies
it is time to save lives and get provenge fully approved, how can the government allow this to happen to our citizens
clean it up, approve it and work on not having this happen again for personal gain.
Phil Vardena
>> So one has to wonder whether Andy doesn’t open his own mail, he has a terrible memory, his elves tossed the letters before he got a chance to see them, or the FDA legal staff is trying to keep him from getting sucked up into the litigation any further.
Whatever the reason, it is puzzling, at the very least, that Andy’s office comes up blank. <<
If he is “clean”, so to speak; if Commissioner Andrew von Eschenbach has nothing to hide… why all this mess?
This is a red flag like no other. I hope Congress will hear about the Provenge debacle!
Regards,
phil
Tom
Fascinating stuff that begs a question: Will those calling for Andy’s head because of the approval delay do exactly the same once news of the first unexpected side effect is smeared across the front page of the NY Times?
Phil Vardena
@ Tom:
Which side effects are talking about? The flu-like symptoms that last a couple of days?
Don’t forget Provenge is going to be administered to AIPC prostate cancer patients: they don’t have treatments available except Taxotere (which, in turn, has side effects so serious many patients refuse to take it).
The AC panel voted 17-0 Provenge is safe - Hussain and Scher included!
Regards,
phil
MyPharmalotID
Tom, if I had end stage PCa, I’d risk any side effect - bar none - for a chance a few more months…possibly years…of life. I’m going to die anyway, probably sooner than later, so what’s your point?
Nathan
As someone who works in the pharma industry, it is very refreshing to hear uproar against the FDA about a drug NOT being approved!
Lately the uproar has been in exactly the opposite direction…
Dr Clayton
Ed: Excellent piece on this travesty inflicted on tens of thousands of men with no other viable treatment alternatives by extremely conflicted elements both within and outside the FDA, including likely criminal activity.
Tom: You are exceptionally uninformed. Provenge has now been administered to many hundreds of patients in various trials for many years now: there are NO consequential side effects.
Bob Freeman
“You’re doing a heckuva job, Andy”
Lisa Van S
Nathan,
Shhhh!! not a good time to brag about being in Industry.
And before you bite back,.. I’ve supported the approval of Provenge!!!!
Kyoto27
We got what we deserved in our FDA, and in von E.
And the CTL lawsuit nailed the real issue that should have outraged all Americans:
“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…”
No,Ed,the time has come now for this insanity to stop:
What is needed is complete access by the public to FDA records:
Who calls for the “real meetings”; who attends the “real” meetings; transcripts of all arguments, notes and votes of those who attended the real meetings.
Instead, here we sit, with doltish reverence –in the United States of America, begging our FDA to tell us that life and death decisions are not being made with “winks & nods” but with serious discussion and debate?
Who in Hell benefits in this country from giving the FDA absolute sovereignty over matters of Life & Death without due process? And the absolute corruption it has engendered?
Taking the “due” out of “due process” was not just a ‘deliberate wrongdoing’ –it shreds the entire fabric of this Republic.
And what is truly puzzling in all of this Ed is why you are standing virtually alone in this vigil to protect this deliberate wrongdoing? Where is the outrage from your colleagues in the Fourth Estate over the trampling of ‘due process’ –and the abandonment of those who need our help the most.
No wonder mainstream media is losing its circulation and ad dollars –-in tandem with losing the relevance it once enjoyed.
AIPC in the family
Like a bad parody of Stalag 13 the FDA holds Provenge prisoner until an armistice with Big Pharma is signed. Commissioner Von Eschenbach doesn’t come of very well in the role of “I know nothing” Sgt. Schulz who actually saw everything. He may be obliged under questioning to take on the role of Colonel Klink who suspected everything but was too incompetent to do anything about it. The big question is whether the truth of the matter is that Von Eschenbach was playing himself and was up to his eyeballs in a plot to delay Provenge at the expense of countless lives in order to favor his historical ties with competing prostate cancer research.
Phil Vardena (Pharm. D.)
@ Nathan
Let’s not muddy the waters:
1 - Provenge is NOT a “ME TOO” drug. If the FDA approves me-too drugs with a corrupt process, of course it is to blame!
2 - Provenge is a therapy directed to people with no choice and a short span to live. If the FDA denied approval due to a corrupt process, of course it is to blame!
Do you see the light?
Regards,
phil
MyPharmalotID
“And what is truly puzzling in all of this Ed is why you are standing virtually alone in this vigil to protect this deliberate wrongdoing? Where is the outrage from your colleagues in the Fourth Estate over the trampling of ‘due process’ –and the abandonment of those who need our help the most.
“No wonder mainstream media is losing its circulation and ad dollars –-in tandem with losing the relevance it once enjoyed.”
I agree that the mainstream media is asleep at the switch. Even the articles that have appeared in The Washington Post, the Boston Globe, and the Philadelphia Inquirer were sophomoric. The article in the Inquirer came closest to the truth, but even so, the reporter didn’t “get” the COIs, and abandoned the hunt before writing the story of her life…the one thar probably would have won her the Pulitzer Prize. Meanwhile, the Wall Street Journal and The New York Times are nowhere to be found.
Besides Ed, though, Evelyn Pringle has done a masterfull job of unearthing this scandal. If you really want to see what Scher, Hussain, Fleming, Padzur, Martin, Streicher, and others have been up to while the print media slept, take at look at these URLs:
http://www.lawyersandsettlements.com/articles/01422/fda-sued.html
http://www.lawyersandsettlements.com/articles/01430/fda-lawsuit.html
http://www.lawyersandsettlements.com/articles/01635/provenge.html
http://www.lawyersandsettlements.com/articles/01644/provenge-appeal.html
http://www.opednews.com/articles/1/genera_evelyn_p_080108_bush_s_fda___perpetu.htm
Lucy
Ed,
Total grants to Howard Scher’s Memorial Sloan Kettering and Dr. von Eschenbach’s University of Texas, M.D. Anderson Cancer Center from PCF since inception through 2005 have totaled approximately $33 million. Far surpassing grants from PCF to any other individual or research center. M. D. Anderson President, Dr. John Mendelsohn, appointed Dr. von Eschenbach as executive vice president and chief academic officer to M. D. Anderson. Dr. Scher and Dr. von Eschenbach have been key to PCF since its inception in 1993. Dr. von Eschenbach was a board member and scientific advisor to the Prostate Cancer Foundation.
Dr. von Eschenbach is credited with lobbying for the establishment of Department of Defense Congressionally Directed Medical Research Programs PCRP (DOD CDMRP PCRP. Dr. von Eschenbach’s own FDA biography lists him as a as founding director of the Prostate Cancer Research Program http://www.fda.gov/oc/voneschenbach/bio.html
The majority of PCRP consortium doctors who sit in review of PCRP grant applications are consortium doctors to PCF too. Notably, Dr. Howard Scher and Dr. Maha Hussain… and many of these same doctors sit on the scientific advisory board of Proquest Investments. NPCC, which was established and chaired by Michael Milken, lobbies for PCRP appropriations.
NPCC also helped to establish new National Cancer Institute sponsored Specialized Programs of Research Excellence (SPOREs) for prostate cancer. NCI’s SPORE program is the largest source of prostate cancer research funding. Second is DOD CDMRP PCRP and third is the Prostate Cancer Foundation.
C-Change, which was founded by Dr. von Eschenbach, is in partnership with the Prostate Cancer Foundation. Dr. von Eschenbach, the Commisioner of the FDA, is credited with bringing the Bush family into “C-Change”, a non-profit group headed by George and Barbara Bush (also known as National Dialogue on Cancer). Dr. von Eschenbach remains Vice Chairman of the Board to C-Change despite his appointment to the FDA.
When Dr. von Eschenbach was named NCI Director, HHS officials granted Dr. von Eschenbach a waiver to continue to function as a C-Change fiduciary and Vice Chairman of the Board. When President George Bush nominated Andrew von Eschenbach to acting FDA Commissioner, he allowed Dr. von Eschenbach to continue as NCI director. Serving a dual role with NCI and the FDA was particularly shocking to many.
Dr. von Eschenbach faced a triple sets of conflicts:
1) His duties at NCI vs. his duties at FDA
2) His duties at NCI vs. his duties at C-Change, and
3) His duties at FDA vs. his duties at C-Change
Dr. von Eschenbach waiver for his own conflicts of interest by (which was granted by HHS) allowed Dr. von Eschenbach—with conflicted interests—to serve both posts as NCI Director and Commisioner of the FDA without reason.
Knowing of Dr. von Eschenbach’s own personal history and conflicts of interest, how is the public to believe that Dr. von Eschenbach is serious about enforcing FDA policy regarding disclosure of conflicts of interest for Special Government Employees participating in FDA Advisory Commitees?
Recall also in September when activists rallied outside the FDA headquarters in support of access to developmental drugs (like Provenge) for terminal patients, Dr. von Eschenbach would only agree to talk to the domonstrators IF THE DEMONSTRATORS CALLED OFF THE RALLY!
It appears to me that the entire drug research and review process for prostate cancer therapies is being systematically manipulated. I am alarmed by the amount of control and influence that Michael Milken possesses over the prostate cancer community, Dr. Howard Scher’s and Dr. Andrew von Eschenbach’s long and close professional relationship to Michael Milken and Dr. Scher’s and Dr. von Eschenbach’s authority and position within the FDA.
There appears to be a related party factor that calls into question Dr. Scher’s and Dr. von Eschenbach’s true independence as a FDA panel doctor and FDA Commissioner. With such high powered contacts, Dr. Scher’s unmatched power and influence, Dr. von Eschenbach position and authority as FDA commissioner, is there really a level playing field for anyone in which Dr. Scher, ProQuest Investments (or its principals) does not have a financial interest in? This is an assault on the trustworthiness of the FDA and our government in general.
Knowing of Dr. Scher’s and Dr. von Eschenbach’s close professional relationship to PCF and Michael Milken, how is the public to believe that the FDA made the correct decision regarding Provenge? Dr. Scher’s participation in the Provenge advisory panel is akin to a defendant’s own sibling participating on a jury resulting in a hung jury decision. I fear the Commissioner himself was complicit in the Provenge decision. Such conflicts of public and personal interest jeopardize the legitimacy of one proclaiming to act on behalf of the public’s best interests or under the auspices of science. The FDA subjected the terminally ill AIPC patients to more suffering whereby a few would benefit financially. To date, over 20,000 men have died from prostate cancer since Black Wednesday. How many more will die before congress investigates this matter?
Lawrence
Who needs to worry about Al-Queda when we have the FDA?
Just who is responsible for more Deaths?
And just where are ALL the Government Official’s who are responsible for letting something like this to happen in the 1st PLACE?
Hard Ball
AMEN.
KEN
17-0 and 14-3. these 3 should be held for murder as many more are suffering, get it passed now
Rick Wilson
This is a perfect example of why Americans no longer trust their government. Mr Dingell, please investigate this mess and press charges against those responsible.
Sharon Romero
Thank you so much for your dedication to this travesty of justice forced on American citizens by an arm of the government elected to protect them from such injustice. Are government officals so apthetic that that they tune out blantant miscarriages of justice such as this one unless it interferes with their own personal agendas. WAKE UP. One day it might be you that becomes the victim of such disgraceful and criminal activities prepetrated by our own government.
Laurie
“As someone who works in the pharma industry, it is very refreshing to hear uproar against the FDA about a drug NOT being approved!
Lately the uproar has been in exactly the opposite direction…”
Corruption at the FDA effects everyone, yes even pharma.
David
‘Lucy’ post has no attribution! Taken from IV-DNDN #178315.
MyPharmalotID
Letter, letter, who’s got the letters? Von E does!
If you go to the CareToLive site and take a look at the letters received via FOIA here’s what you will find (From CareToLive…http://caretolive.com/wp-content/uploads/2007/11/leakedletters.pdf)
At the bottom of page 5, it shows Dr. Scher’s letter to Janet Woodcock was cc’d to Von E
Page 16 shows Dr.Hussain’s e-mail was sent, and first on the list is Von E
Page 17 is hard copy of Dr. Hussain’s letter, and it is addressed to 5 doctors, the first of which is Von E
Page 23 is hard copy of Dr. Scher’s letter to Celia Witten, and it was CC’d to Von E
Page 24 is hard copy of Dr. Scher’s letter, and it is addressed to, and only to, Dr. Von E - this is
the one that someone wrote “Andrew!” across the salutation.
CTL still is waiting for a response to the FOIA request for information from Dr. Pazdur’s office.
So when Von E’s office states there were no letters, it is difficult to believe them because the document received from another source via FOIA shows there were several attempts to get the letters to him via e-mail and/or regular mail.
I guess von E, have succeeded in selling everyone a bridge that didn’t exist, now thinks he can convince everyone he didn’t receive the letters he has hidden in the lower left-hand drawer of his desk.
Tom Smith
Avon,Scher, Hussain,Pazdur are all responsible for ~20,000 plus men that have died since May 9th 2007. IMHO this was a big conspiracy! Power, MONEY Big Chemo, and Hedge Funds that increased their short positions by over 10 million shares after the AC committee voted 13-4 and 17-0. The only way anyone of right mind would increase their short position by this magnitude would be if they knew a CR letter was going to be issued! That’s why the SEC and DOJ need to look into who this short/s were and find out who at the FDA relayed this info to them! As it has been said many times follow the money!!! Lets hope that Dingell and the House Energy and Commerce Committee pursue hearings and get to the bottom of this great injustice to PC patients and family members! Where the hell is the DOJ,SEC??? A sleep at the wheel or turning a blind eye???
Tom Smith
Avon’s nose is getting longer and longer(Pinocchio)! How do these people at the FDA sleep at night!
Kerry Donahue
Excellent comments.
Soon the world will know what the FDA did to Provenge.
CaretoLive will continue to fight for the right of dying cancer patients to have access to Provenge.
Congress needs to find a way to make sure life saving treatments for the terminally ill get to them sooner.
We hope to avenge the memory of John Fish who fought with CareToLive to undo the injustice at the FDA.
CareToLive has still received no response to the FOIA directed at Richard Pazdur. He refuses to respond even though his answer was due in September/October.
While 80 men a day die without hope the FDA has asked for more time (beyond the 6 months recently expired)to respond to the CareToLive Citizens Petition to undo this injustice. Many do not have time so PLEASE fix this and get Provenge to the patients now.
Hey hey FDA, how about a little overtime for those that have so little time left.
qetzal
Ed, you wrote:
But that’s not quite what the letter said. It said:
(emphasis added)
“Responsive records” sounds like code for “records that we have to give you.” Maybe those letters (assuming von Eschenbach’s office has them) aren’t subject to FOI? Anybody know enough about FOI to comment?
Ed Silverman
Hi Qetzal,
I’m not an attorney, but I believe the phrase refers to conducting a complete search for any and all records described in a request. Those would be the responsive records. If there’s a lawyer in the house who can clarify this, please join in.
Hope this helps,
ed
Chris
If he did not keep the mail or documents received or forwarded them elsewhere, then he would not have any responsive records. That is not necessarily the same as saying that he never saw these documents.
Bob Freeman
A political comment, if I may: as long as we continue to elect politicians who distrust, if not hate, government, we are going to continue to have incompetent agency heads. In particular, those who hold the government in low regard are put in charge of running its agencies. If I’m not mistaken the FDA has been “directed” by acting or interim heads during much of this administration.
You want public health advocates in charge of HHS divisions, not corporate types or persons beholden to them.
In addition to being independent from corporate influences, you also want independence from patient advocacy groups that pursue their own agendas.
Kerry Donahue
There are certain documents that are exempted under the Freedom of Information Act (FOIA). The FDA could have responded that the information requested was exempt under one of the many listed categories of exemption. However to do that they would have to claim that exemption and reference it explicitly. That is not what they did so there is no reason to think that they are asserting a privilege that would excuse their performance under FOIA.
Hard Ball
Easy answer.
This little band of self-helping mauraders merely pass back sealed envelopes with PRIVATE/PERSONAL “To Andy from Dick” scratched on the face of it.
Nor is it not like they can’t all have lunch together and plot through the night via cellphones.
Nobody upstairs cares how these guys go on in conspiring to enrich themselves.
They only ever got that high as payback to start with.
The people who put them therein the first place are too deep into their own spider web of con games, only on an even larger scale.
This is what our once inspiring democracy has been reduced to. All to the advantage of those who willing take what they can. We are a sad America.
Advanced Prostate Cancer » Public Petition About Conflicts of Interest At The FDA
[...] Act had already produced documents that show relevant letters had been addressed to him. http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/ Undisclosed Conflicts of Interest: Howard Scher, Provenge Advisory Committee Member. [...]