Provenge Activists Accuse FDA Of Violating FOIA
15 CommentsBy Ed Silverman // February 6th, 2008 // 11:13 am
As a congressional committee moves closer to deciding on whether to hold hearings into the controversy over the Dendreon’s Provenge prostate-cancer vaccine, a non-profit group and the FDA are locked in a battle over documents that may shed light on why approval was delayed. So far, though, the FDA has turned over only a few documents, and so the non-profit group, Care To Live, has filed a new complaint charging the agency with violating the Freedom of Information Act.
You may recall that an FDA advisory panel last spring recommended approval. But then two FDA panel members wrote the agency urging delay and the FDA shortly thereafter agreed. However, the group’s lawsuit claims the panel members held undisclosed financial conflicts of interest - one panel member serves on the advisory board of a venture capital firm that invested in a company developing a rival cancer med - and alleged a Byzantine power play involving a key FDA official who sought to sway the approval. Care To Live wants the entire paper trail leading to the delay.
The group’s latest move comes after a recent FDA response to its FOIA request contained a curious reply - FDA commish Andy von Eschenbach’s office has not located any responsive records concerning the controversial medication, despite a ‘diligent search.’ 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 can read more about that right here).
In response to the complaint, the FDA continues to argue that there are no ‘responsive documents,’ a reference to paperwork that isn’t in the Andy’s possession. (Of course, he may well have read those documents at one time.) The agency goes on to say that it faces “exceptional circumstances” in this case, although doesn’t specify what that may be. (This is the FDA reply). The attorney for Care To Live suggests the FDA is reacting, in part, to the threat of a congressional hearing.
“The Center for Drug Evaluation and Research division, as well as the Commissioner’s office has not been forthcoming with easily accessible documents and appear to be stonewalling for reasons that may include the fact that three members of Congress have called for a Congressional hearing of the underlying matter, for which the FOIA request, if properly responded to, might provide evidence helpful to that investigation of the underlying wrongful actions of the FDA,” according to the Care To Live complaint.
MyPharmalotID
The DOJ’s defense of the FDA in the matter of CareToLive’s (CTL’s) FOIA request makes the characters in Alice in Wonderland look like they belonged to a rationale society!
If anything, the DOJ should be joining forces with HHS’ Office of the Inspector General (OIG) to investigate the egregious conflicts of interest (COIs) cited in the call for a Congressional inquiry by the House Committee on Energy and Commerce (Hon. John Dingell, Chairman) by Messrs. Michaud, Burton, and Ryan.
Quoting from that letter: “Prostate cancer activists have raised questions about two of the negative voters, academic medical oncologists, Maha Hussain and Howard Scher. Dr. Howard Scher is lead investigator for a competing cancer drug made by Novacea and is listed as an adviser to a large venture capital firm that is also a major investor in Novacea. We believe the FDA should not be appointing scientists leading the testing of a rival drug for another firm onto an advisory committee evaluating Provenge nor should the FDA appoint an adviser to a large investor in such a competitive firm as a panel member. It is important that Congress examines possible ethical violations of these panel Members considering the viability of potentially important life-saving drugs.” (Letter to Hon. John Dingell, December 13, 2007)
It should be apparent to all, by now, that a group of FDA and NCI government and special government employees colluded on the development of Dr. Scher’s infamous letter disparaging a drug (Provenge) that was up for approval within the FDA, and that they used SKMCC’s stationery as the vehicle by which to convey their message to the FDA.
Further, there is anecdotal evidence that Dr. Scher had been “invited” by someone within the FDA to write his letter to the agency. (Dr. Scher was overheard mentioning this to colleagues at a cancer meeting last summer.) The person who invited Dr. Scher to write his letter obviously had a private agenda focused on derailing Provenge approval, and it involved using Dr. Scher (who was and still is a consultant to CDER) to push his agenda forward.
Frankly, many believe that the person behind this entire debacle really didn’t care whether or not the letter, allegedly from Dr. Scher (he did sign it, after all), reached its intended addressees within the FDA. Rather, they believe that the letter’s real purpose (as was the case for similar letters written by Drs. Hussain and Fleming) was to be “leaked” to The Cancer Letter immediately upon “delivery” (if not before), where it would become the stalking horse* in a major challenge to the forces within the FDA promoting Provenge approval?
This is what the DOJ should be spending its time and out tax dollars on…not defending the very people who have colluded in this travesty that to date has resulted in the deaths of more than 22,000 men with prostate cancer, many of whom could have been helped by Provenge.
Shame on the DOJ! Shame on the FDA! Shame on this Administration, the most corrupt in the history of this nation.
*A stalking horse is someone or something whose role is to become the focal point for, or the initiator of, a debate or challenge. In reality, however, their leadership role may be an illusion, and the stalking horse is really working to promote a challenge or debate that will benefit a third party whose identity remains a secret. In the case of Provenge, the Scher, Hussain, and Fleming letters were stalking horses, created for the benefit of…ah, that is the big question.
http://en.wikipedia.org/wiki/Stalking_horse
Arnold Mass
Recs: 4 Re: Pharmalot’s all over the pathetic DOJ response to CTL in the FOIA matter…
The agency goes on to say that it faces “exceptional circumstances” in this case, although doesn’t specify what that may be. (This is the FDA reply). The attorney for Care To Live suggests the FDA is reacting, in part, to the threat of a congressional hearing.<<
Is it possible that the FDA is saying that demands from the Administration is what is keeping it from delivering the information requested.And what would prompt the Administration to react so negatively? Who is it trying to protect?THE SHORTS,Big Pharma?The answer is to be found in the Congressional Hearings,imho.
Dick and Jane
See Dick and Jane
See Andy and Dick
See Andy snub CTL
Hear Col. Klink say…
“I saw nothing!!”
Is Andy Col. Klink??
See Dick hiding in the shadows
Why is Dick in the shadows?
Is Andy protecting Dick?
Does Dick worry about Erbitux?
Why is Dick being a dick?
See the FDA.
See the FDA snubbing CTL.
What does Freedom of Information mean?
Why does the FDA squelch Freedom of Information?
Why does the FDA bite the taxpayer’s hand that feeds them?
Run Dick run.
Run Andy run.
See Dingell and his posse kick some serious ass!!!
Lawrence
Have we Lost the WAR on Terror? By the way the U.S. Government is run it appears that Al-Queda has Won the War and are in control of the U.S. Government as we Speak. It’s time for the FDA, SEC & DOJ to be placed under Homeland Security. Is there ZERO Accountability in ALL of Government? Do we elect Officials to Steal & Cheat the American People? We need to bring our Boys HOME and turn them loose on Washington.
kolson
“Shame on this Administration, the most corrupt in the history of this nation.”
This is the most absurd statement in the history of this nation. You, Mr.MyPharmalotID, have in this one statement rendered your entire rant nothing more than hogwash. You want to talk about corruption? Take a look at the “stalking” donkey in the Clinton Administration.
berlinda waldenfels
I’m just so glad to be reading more articles on this Provenge debacle. My husband’s prostrate count has been on the rise and we always thought, if god forbid he ever did get the big PC, that he would at least have a choice in his treatment. Why wouldn’t someone want flu like symptoms vs. poisoning your whole body. I just think the decision is a no brainer. With the technology we have today I just don’t understand why we are so far behind. Again, great writing. Please keep this fight alive. Approve Provenge Now.
Berlinda Waldenfels
kolson
“Do we elect Officials to Steal & Cheat the American People?” Obviously some Americans do just that…they elected Bill Clinton, didn’t they?
Kerry Donahue
Note that the response from the FOIA folks at CDER (which includes OOD and Pazdur) in November, were that they were working on the response and it should be completed shortly. Two follow up calls by CTL later the FOIA representative changed to their tone to: we would not be receiving a response any time soon. Something or someone intervened.
The CDER division of the FDA has yet to provide any official response to the request.
Clearly the letters went to Richard Pazdur (or came from him) yet he refuses to provide the documents as requested in the CTL FOIA request.
I would also surmize that there exists the possibility that the “exceptional circumstances” could be a pending criminal investigation, although that is just speculation on my part.
The alternative may be as guessed, that they do not want to deliver the smoking gun in the face of a possible Congressional Investigation.
A congressional subpoena would be certain to result in production of the documents forthwith.
Paul
C-Change was founded by Dr. Andrew von Eschenbach. President George H. Bush is Co-Chair to C-Change. Dr. Donald Coffey is a central figure to C-Change and Board Member as well and an advisor to Michael Milken. In fact, the Prostate Cancer Foundation has an award named after him and one which Dr. Howard Scher is an award recipient in 2004. Dr. Coffey and Michael Milken even collaborated on a book together. Dr. Coffey was also a member of the DOD CDMRP PCRP.
When Dr. von Eschenbach was appointed FDA Commissioner by President W. Bush, John Niederhuber was selected to replace him as Director of NCI. Prior to being named Director of NCI, John Niederhuber was the Vice Chairman of C-Change. Niederhuber continues as a Board Member to C-Change today.
Prior to President George W. Bush’s appointment of Dr. von Eschenbach to Commissioner of the FDA, Dr. von Eschenbach was Vice Chairman of C-Change. 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 C-Change. The waiver was granted October, 2003 by the Secretary of HHS and fellow Bush Cabinet Member, Tommy Thompson. The waiver allowed Dr. von Eschenbach—with conflicted interests—to serve both posts (NCI and C-Change, and no reason was provided why HHS needed to waive the conflict of interest.
When President George Bush nominated Andrew von Eschenbach to acting FDA Commissioner in 2005, he allowed Dr. von Eschenbach to continue as NCI Director. Serving a dual role with NCI and the FDA.
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
At the President’s Cancer Panel held in Atlanta, GA September 10, 2007 the participants represented included:
1) NCI Director John Neiderhuber
2) Vice Chairman of C-Change
3) Greg Simon, President of FasterCures. FasterCures is part of the Milken Institute.
Do you remember the Editorial in Nature Clinincal Practice Oncology by Vincent DeVita Jr. defending the Provenge decision by the FDA? Well, Vincent DeVita is an honorary member of Dr. von Eschenbach’s C-Change.
I have demonstrated that the conflicts of interest rise to the Commissioner of the FDA himself. It appears to me that President George Bush was unconcerned about the startling array conflicts of interest attributed to Dr. von Eschenbach when he selected him to be the Commisioner of the FDA.
As the Commissioner of the FDA, who himself has serious conflicts of interest, how is a reasonable person expected to believe that the agency, under his leadership, is serious about addressing the matter of conflicts within the agency? Add to that the long and personal relationship that Dr. von Eschenbach has to George Bush, Dr. von Eschenbach must feel confident in his position as FDA Commisioner. With such powerful friends as both Michael Milken and President George Bush, Dr. von Eschenbach must feel he can operate with impunity. A Congressional investigation into this matter is warranted.
MyPharmalotID
Kolson,
The last time I checked, which was in May of last year, corruption at the Cabinet level in the Bush administration was in the stratosphere.
Correct me if I’m wrong, please, but were not the departments of Defense, Education, Justice, Interior, Homeland Security, Veterans Affairs, Health and Human Services and Housing and Urban Development being investigated for corruption, contracting scandals, and other major infractions?
And how about the deputy secretary in the State Department who resigned in a prostitution scandal? Or the GSA, which was being investigated for steering federal favors to Republican congressional candidates in 2006? Of the OMB, whose chief procurement officer was sentenced to prison in the Abramoff fallout?
Oh, yes, If I recall, too, four inspectors general also were under investigation…all at the same time. Now, THAT is a new record.
I stopped keeping records at that point. But I’m sure others can add to my list. At the top of almost everybody’s would be the move within the FDA by party or parties unknown to stop the approval of Provenge, which includes the actions of two individuals with significant unreported conflicts of interest (COIs), disparaging letters authored by government and special government employees from the FDA and NCI, leaks to The Cancer Letter, and so forth. The beat goes on!
The Dude Abides
kolson, no matter how much and how often you fluff, Rush will remain limp. All federal departments have suffered under this administration, which couldn’t be said for his father’s. The differences between the last three administrations are astonishing. In 2000, the younger Bush was the least qualified person to ever become president. He obviously did not grow into the job after the promising first few weeks of the Afghanistan War.
kolson
MyMyPharmId,
You appear to be well-versed in political matters…able to rattle off a dozen of “investigations” led by a pack of corrupt Democrats. You fail to cite corruption on Bush’s part…because there hasn’t been any. Too bad you aren’t well-versed in the science of Provenge. Provenge wasn’t approved because the FDA needed additional data. Pure and simple. Save your breath telling me about conflicts of interest. Provenge will be approved when the interim results of the fully enrolled study show efficacy.
I have no time nor desire to enlighten you concerning all Clinton’s dirty deeds. By the time I cease naming them his wife will have provided you and the rest of the illiterate Americans who vote for her with even more corruption than even Bill could pull off. But I will give you one example…one concrete example of Bill’s pathetic “cashing in.” Remember when good old Bill decided to federalize 2 million acres of land in Utah, making it a national monument? He did so without a word to anybody in Utah, by the way. The scumbag had to sign the order in Arizona because he couldn’t face the school children he had robbed. This land contains over $1.2 trillion worth of minable clean low-sulfer coal. A trust fund had been set aside years ago to generate over $1 billion for Utah schools. Aside from stealing from the children, Bill never gave a thought to the idea that mining this $1.2 trillion exceptionally clean coal would help our country be less dependent on foreign sources. He was too busy “making a deal” to ensure illegal campaign contributions from a family in Indonesia who owned the second-largest coal producing deposit in the world. Thanks to our second most corrupt President (Carter was worse), we Americans were robbed of the LARGEST deposit of clean coal…right in Utah. Robbed Americans so that his campaign contributors could become number one. So don’t talk about big pharma ties to the Bush Administration and how he “profits” from keeping Provenge approved…unless you can provide proof. Obviously, you can’t.
MyPharmalotID
Kolson, there must be a pony in there somewhere, but right now, I’ll leave the field to you.
Gaucho
Kolson Has got a Clinton Persecution Complex
I suppose that Clinton was responsible for the lies that got us into IRAQ. Watch “Uncovered: The war in IRAQ” it is at video stores and Netflix (downloadable to) and shorter version are on You Tube and Yahoo Video. There is nothing “NOTHING” That Clinton was even accused of that comes close to this corrupt Bush administration. Ohh I forgot lets beat the dead horse (pun intended) about sex with an attractive 22 year old. Other than that there has been innuendo and endless character assignation by some bought and paid for media hacks.
How can you compare and estimated 600K dead Iraqis and thousands of dead American soldiers duped into fighting a war to protect us from WMDs that didn’t exist or connections to terrorists that didn’t exist at that time. Basically we raped that country for the 200billion barrels of cheap old for Bush and other oil baron buddies.
How about the nearly 5 trillion additional in debt for this country?
How about the mismanagement of the Iraq war?
How about mismanagement of the Afghanistan war?
How about Halliburton no bid contracts which Chaney still owns stock?
How about the denial of global warming?
How about torture of foreign nationals?
How about illegal wire tapping Americans ?
How about lifting oversight of our financial industry?
How about possible treason? Watch Loose Change II and final version (google free)
I could go on and on but I am sure you won’t get the point. Just keep watching Hannity, and Limbaugh and those letters from the heritage foundation, they will keep you fat and stupid.
Ed Silverman
Hi Folks,
I enjoy and appreciate the passion you’re all displaying, but if it’s not asking too much, it’d be swell if we could find our way back to the topic, or at least something more closely related.
Many thanks
ed at Pharmalot