The FDA's latest campaign to protect the profits of a drug company over the safety of Americans is unprecedented, and the organizers include a gang of current and former FDA officials largely credited with turning the nation's regulatory beagle into a lapdog for Big Pharma under the Bush Administration.
FDA spokesman Douglas Arbesfeld, apparently the industry's new inside guy, kicked off the campaign by sending an e-mail to journalists which was intended to discredit Dr Steven Nissen and the Cleveland Clinic. Dr Nissen's study appeared online on May 21, 2007, in the New England Journal of Medicine and warned that GlaxoSmithKline's diabetes drug Avandia increased the risk of heart attacks by 43% and death from cardiovascular events by possibly 64%.
The talking points for the media appear to have been formulated and agreed upon ahead of time between Arbesfeld and others (see below) because more than one story from ostensibly different sources later appeared in the media and on the internet referring to Dr Nissen with such names as "St Steven", "Patron Saint of Drug Safety" and "Saint Steven the Pure."
In his email to journalists, Mr Arbesfeld pasted portions of an article which appeared on the Heartwire website, containing umpteen critical comments about Dr Nissen and the Avandia study, as well as comments made by an anonymous blogger on the internet who said that business at the Cleveland Clinic is run similar to a Mafia TV series. The full bog states:
"Wake up pharmaceutical companies, this is a call from Dr. Nissen, if you don't hire the Cleveland Clinic for your big trials then you face the firing squad from Nissen and Company."
"The Cleveland Clinic was one of the most respected names in medicine, now they are positioning themselves as candidates to take over for a new series on HBO to replace the Soprano's - the Clinico's 'next week who should we wack ......' - Bata bing bata boon. Comment by Brian A - May 22, 2007."
However, it could just as easily be inferred that Mr Arbesfeld authored the slanderous blog and supplied it to Heartwire with the intention of quoting it later from a "reputable" web site. For its part, Heartwire has since removed what it says are "unsubstantiated remarks about Dr Nissen and the Cleveland Clinic," and states: "In retrospect we regret that we published those sentences, as they do not meet the highest standards of journalistic or scientific integrity or credibility."
The smear campaign has federal lawmakers up in arms. At a June 6, 2007 hearing before the House Oversight and Government Reform Committee, in response to questions about Mr Arbesfeld sending the e-mail under his official title of FDA spokesman, FDA Commissioner Andrew von Eschenbach told the lawmakers, "It was an inappropriate and unfortunate act on the part of an individual which has been addressed through disciplinary procedures."
Dr Nissen is none too happy about the stunt either. "I'm a pretty tough guy," he told ABC News on May 30, 2007, "but I'll tell you, having this kind of an e-mail that questions my motives, broadcast to the major journalists with whom I work and have established a reputation, is -- it's an outrage."
As for his part, Mr Arbesfeld told the Boston Globe that the email reflected his own personal views and not the FDA's. Any assertion that the email reflected his own personal views is not quite credible considering that his previous employment was always promoting the views of the industry.
A few articles in the media mentioned that Mr Arbesfeld worked for Johnson & Johnson, but his employment with public relations firm Manning Selvage & Lee was not noted. On December 16, 1999, the Healthcare Marketing & Communications Council reported that Mr Arbesfeld had joined Manning as Senior Vice President in New York.
On January 5, 2001, the firm issued a press release to announce the promotion of Mr Arbesfeld and others and referred to Manning as "one of the largest healthcare practices worldwide and has a broad array of clients including Allergan, Amgen, Eli Lilly and Company, Genentech, Hoffmann La-Roche, Kaiser Permanente, Novartis, Pharmacia and Procter & Gamble."
In reading the press release, Mr Arbesfeld's expertise with using the Internet is apparently a bi-product of his work for Manning. "In this role," it said, "Arbesfeld will help healthcare clients maximize internet-relations in the marketing and communications mix, and will expand the Practice's strategic e-product offerings."
On August 5, 2002, Arbesfeld identified himself in a Reuters article as representing none other than Glaxo, along with six other drug giants including Bristol-Myers, Aventis, J&J, AstraZeneca, Abbott Labs and Novartis, in a campaign to promote the "Together Rx" prescription drug card program for senior citizens. In 2005, the Reporters Handbook listed him as the contact person for J&J subsidiaries, Janssen Pharmaceutica, Ortho-McNeil Pharmaceutical and Ortho Biotech Products.
Less than a week after Mr Arbesfeld's hatchet job on Dr Nissen, ex-FDA Deputy Commissioner Dr Scott Gottlieb planted an editorial in the May 29, 2007, Wall Street Journal entitled, "Journalist Malpractice," accusing the New England Medical Journal of intentionally publishing the Nissen study to make the FDA look impotent. "The publication was timed," he wrote, "to get ahead of the Food and Drug Administration's more careful evaluation of the same issues."
"The journal seemed bent on beating the FDA to the punch," Dr Gottlieb claimed.
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
