The Times also noted that a half-dozen current and former FDA officials said they did not know of anyone else from Wall Street ever moving directly into such a high-level job at the agency.
A couple months later, the November 12, 2005, Boston Globe reported that Dr Gottlieb could not participate in formulating the nation's defense plan against the avian flu due to conflicts of interest. He "was recused from key parts of the planning effort because his past consulting work for Manning Selvage & Lee involved companies whose products would be used to combat a flu pandemic," it said. Yes, the very same Manning Selvage & Lee at which Arbesfeld held the Senior Vice President position. Does anyone smell a rat (or several)?
The article pointed out that Dr Gottlieb's former clients included Roche, the manufacturer of Tamiflu, and Sanofi-Aventis, the parent company of the nation's sole flu vaccine maker.
According to the Globe, Manning paid Gottlieb a $12,500 monthly retainer for nine months for projects that included eight companies, and he was also paid $9,000 for private consulting work for VanGen Inc, a firm that won a $878-million contract to supply the US government with 75 million doses of anthrax vaccine.
Dr Nissen and Dr Gottlieb's disputes are not new. In fact, on August 2, 2006, they participated in a debate on the topic: "Government Science Panels: Fair and Balanced?" sponsored by the Center for Science in the Public Interest, and reported on by Russell Mokhiber and Robert Weissman in Common Dreams.
Likewise, lawmakers have mentioned in their communications with the FDA that they found it "troubling" that Mr Arbesfeld might be trying to settle old scores with Dr Nissen because they were on opposite sides regarding the approval of the heart failure drug Natrecor.
Much to his credit, Dr Nissen openly communicated his objections to the industry's infiltration of the FDA. While sitting right next to Dr Gottlieb, he candidly described the conflicts of interest, which he stated were "evident at the highest levels of the FDA."
"For years," he said of FDA leadership, "we had an interim FDA Commissioner, Lester Crawford, who shortly after confirmation, abruptly resigns, apparently because he and his wife owned stock in regulated companies."
"Then the administration appointed Andrew von Eschenbach as interim commissioner creating another conflict," he said. "In his role as director of the National Cancer Institute, von Eschenbach must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict," he noted.
"But even worse," Dr Nissen stated, "the administration appointed Scott Gottlieb as deputy commissioner."
"He came to this job with no regulatory experience, directly from Wall Street, where he served as a biotech analyst and stock promoter," Dr Nissen told the audience.
Dr Gottlieb's response to Dr Nissen's comments was, in essence, that he would not dignify the comments with a response.
Firms with which Dr Gottlieb was involved prior to his gig at the FDA, according to the Globe, also include the Inamed Corp, one of two companies that were seeking to return silicone gel implants to the market and on November 17, 2006, the FDA announced that it would lift restrictions on the sale of the implants.
When Dr Gottlieb left the FDA, he headed right back to greener pastures with the drug giant Novartis. The press release to announce his hiring read: "Bench International Places Eminent Regulatory Advisor Scott Gottlieb, M.D., as Senior Counsel to Novartis."
"Under an exclusive consulting agreement," the release stated, "Scott Gottlieb, M.D., will provide advisory services to Novartis on matters of global regulatory policy and strategy." Two more members of FDA's alumni, Peter Pitts and Robert Goldberg took another swipe at Dr. Nissen in a June 6, 2007 commentary in the Washington Times, using the same talking points as the anonymous blogger, likewise referring to Dr. Nissen as a "self-appointed and media-anointed Patron Saint of Drug Safety" and "Saint Steven the Pure."
For much of the childish commentary, they poke fun at Dr Nissen because he acknowledged in the NEJM that he consults for many drug companies but said he "requires them to donate all honoraria or consulting fees directly to charity so that he receives neither income nor a tax deduction."
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
