At the end of the commentary, Mr Pitts says he is a former FDA associate commissioner, and both men list their affiliation with the Center for Medicine in the Public Interest; but as usual, that listing really does not give credit where credit is due.
On its web site, the Center describes itself as "a non-partisan, non-profit educational charity," and Mr Pitts is indeed listed as President, but his bio also says he is the Senior Vice President for Global Health Affairs at none other than Manning, Selvege & Lee.
The Manning firm apparently fills two important roles. It's a breeding ground for industry moles preparing to enter "public service" and serves as an employment hub for industry shills once they finish their on average 2- to 3-year stint inside the Bush Administration.
In his CMPI bio, Mr Pitts describes his duties as the FDA's Associate Commissioner from 2002 to 2004 as serving as the agency's "Chief Messaging Officer."
On June 7, 2007, Mr Pitts had this to say in defense of fellow hit-man Mr Arbesfeld on the Pharmalot web site: "I know Doug Arbesfeld and he is a guy devoted to advancing the public health."
According to Mr Pitts, in sending the derogatory e-mail about Dr Nissen to journalists, Mr Arbesfeld was just standing up for the FDA and that people should know about the sacrifice he made by accepting a job in government.
"He is also a guy," Mr Pitts says, "who took a pretty significant pay cut to put in some time in public service."
Some would no doubt argue that it's difficult to imagine that Mr Arbesfeld will end up in the poor house as a result of serving as the top industry mole inside the FDA.
Mr Pitts' sidekick, Mr Goldberg, is indeed listed as the vice president of CMPI, but Mr Goldberg's bio also says he used to be Director of the Manhattan Institute's Center for Medical Progress and Chairman of its 21st Century FDA Task Force.
In fact, a review of the CMPI web site turned up a whole nest of ex-moles who served the industry in one capacity or another in the Bush Administration's FDA. For instance, Daniel Troy, the former FDA Chief Counsel, also known as the "Godfather of Preemption," sits on this "charity's" Advisory Board.
Troy's bio points out that he "played a principal role in FDA's generally successful assertion of preemption in selected product liability cases."
This "assertion of preemption" says that, as long as the FDA has approved a drug and its label, private citizens in state courts cannot sue the drug company for failing to warn about a product's serious health risks, even in cases where it can be shown that the company concealed studies that revealed the risk from the public and the FDA.
Now that he's switched back to private practice, Mr Troy's CMPI bio says he currently specializes in constitutional and appellate litigation, as well as strategic counseling with "particular focus" on what else - clients regulated by the FDA.
The Advisory Board also includes, Tomas Philipson, whose bio says he served as the Senior Economic Advisor to the commissioner of FDA during 2003 and 2004 and as the Senior Economic Advisor to the administrator of the Centers for Medicare and Medicaid Services in 2004 and 2005.
That would mean that Mr Philipson served Mark McClellan, and they are now apparently joined at the hip because, as part of a program called "Patient-Centric and Prospective Medicine," CMPI says it has created the Patient-Centric Health Forum and that Mr McClellan, "former Medicare administrator and FDA commissioner, will chair the group."
So, it would appear that anyone looking for the retirement home for industry hit men who served in the Bush Administration's FDA can find it right in the middle of cyberspace on the CMPI web site.
Avandia isn't alone... Look at Dendreon's PROVENGE!
Avandia isn't the only company being screwed by the FDA.
Dendreon's Provenge had an FDA Advisory Committee (AC) on March 29th. The Oncologists, Immunotherapists, statiticians and others on the AC voted 17 to 0 positive that Provenge was safe; they voted 13-4 that it showed substantial efficacy (that it worked).
Two oncologists/chemotheraphy reseachers on the panel who voted NO weren't satisfied to be in the minority; they mounted a campaign to overturn the positive recommendation and to get the FDA to deny Provenge to TERMINAL prostate cancer patients. They are Maha Hussian of Michigan and Howard Isador Scher of Sloan-Kettering.
The most egregious actions appear to come from Scher, although both wrote CONFIDENTIAL letters to the FDA which, miraculously, were leaked to "The Cancer Letter" who published both.
Provenge treats TERMINAL prostate cancer victims (having about 18 months of life left) and who have but 1 other treatment available--the horrible chemo, Taxetore, which actually kills 1 to 2% of the patients taking this treatment. Ironic the "cure" is worse than the disease for those men taking Taxetore!
Prostate cancer kills 82 men each and every day; far more by multiples than the loss of our young men and women in the Iraq and Afghanistan Wars. If the Nightly News media put up these statistics, we'd get something done about this tragedy... "Tonight, 8 U.S. military were lost in the Middle East; on the home front, 82 men died in the U.S. today from prostate cancer".
Despite the overwhelmingly positive recommendation of this Advisory Committee--a vote which the FDA has traditionally followed--the FDA postponed for perhaps up to 2 or 3 years allowing Provenge to Market last May 9th.
Provenge is an immunotherapy revving up the body's own defenses to fight the cancer; Taxetore is a deadly poinson--a chemotherapy--which kills both the cancer cells and "good" body cells.
In order to sit on the FDA's Advisory Committee judging Provenge, members were required to tell the FDA of any/all Conflict of Interests (COI). Scher reported only 3 COI's to the FDA which appears to be composed of ownership of 1 stock and 2 competing industry interest.
Internet research shows the following for Scher thus far--PLEASE note items #1 and #16 in particular!!!!
1. NOVACEA: grants & research support; STUDY CHAIR of DN-101; Direct competitor to Provenge
2. GPB BIOTECH: financial conflict of interest per Scher in MedPage
3. PHARMION: financial conflict of interest per Scher in MedPage
4. SANOFI-AVENTIS: grants & research support
5. BRISTOL MYERS SQUIBB: consultant, grants & research
6. MILLENNIUM PHARMCEUTICALS: grant of research support
7. COUGAR BIOTECHNOLOGY: principal investigator; advisory board;
8. INNOVIVE PHARMACEUTICALS: principal investigator
9. INFINITY PHARMACEUTICALS: principal investigator
10. BIOGEN-IDEC: jointly held stock with spouse
11. PFIZER: jointly held stock with spouse
12. GENTA: scientific advisory board (as of March 6, 2007; since removed from web, but cached)
13. DEPARTMENT of DEFENSE: Principal Investigator PC Clinical Trials-P1 and P2
14. AMBRILIA BIOPHARMA INC: Principal Investigator PCK3145, Phase I/II
15. MEDIVATION, INC: principal investigator MDV3100
There appears to be a significant and disturbing difference between his 3 disclosures to the FDA and the alleged 16 COI's found so far on the internet. For Scher to "forget" so many apparent COIs… that is simply beyond all reasonableness and suggests intentional dishonesty or deceit.
Even more disturbing is the FDA's Office of Inspector General and others at the FDA to whom this information has been supplied and their apparent failure to investigate these charges that Scher has more COI's than he disclosed to them. When such information is provided and such allegations of potential federal law violation is involved, any ordinary citizen has the right to expect our government to investigate such allegations timely and thoroughly.
As a "temporary government employee" at the FDA, he is obligated, under Federal law, to provide full and complete disclosure. If he didn't, he may have the potential for liability for law violation(s) as well as for providing false data to the FDA under which he secured a waiver in order to participate on the Provenge AC meeting March 29th.
Cancer advocates, patients, physicians and others are gathering at the Washington FDA offices Sept 18th - 10 a.m. - to Rally in support of cancer patients. Info is at www.caretolive.com and at www.arighttolive.com Come join in supporting cancer victims or help cancer patients in your local area however you can!
Thanks, again, for a wonderful article exposing questionable actions by the FDA!!!
by
Tony F (0 articles, 0 quicklinks, 0 diaries, 1 comments)
on Thursday, August 16, 2007 at 10:56:43 AM
1 comments
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