"The goal?" he said, "Painting the FDA as impotent, in order to argue for legislation winding through Congress that would increase regulatory hurdles for drug approvals."
The only problem with the Nissen-NEJM conspiracy theory is that the issue under investigation in Congress right now is why the FDA did not warn the public about Avandia heart risks six months before the Nissen study was ever published.
In the end, when it comes to "Journalistic Malpractice," the larger question would seem to be how was it that so many industry shills were able to get the major media outlets and medical journals to immediately publish commentaries and editorials attacking the NEJM and the Nissen research with headlines splashing all over the internet.
In his editorial, Dr Gottlieb notes that there are "questions" whether Avandia is associated with heart risks, but says they are "so far unsupported by more rigorous, randomized studies and extensive review by the FDA and other authorities around the world."
"When it comes to the issue du jour, drug safety," he wrote, "no description of medical research in a medical journal comes close to the detail level or scrutiny imposed by the FDA on study results before approval."
Assuming this is true, the problem is that the industry insiders running the FDA refuse to act on the advice of the agency's top scientists with first hand access to the underlying data. In a July 26, 2007 speech on the Senate floor, Senator Charles Grassley (R-Iowa), of the Senate Finance Committee, said that, in the case of Avandia, "Not only did the FDA disregard the concerns and recommendations from the office responsible for post-marketing surveillance, but I have found that it also attempted to suppress scientific dissent."
In the past two months, he told his fellow senators, "I've had to write to the FDA regarding the suppression of dissent from not one but two FDA officials involved in the review of Avandia."
The Heartwire website conveniently echoed Dr Gottlieb's sentiments by featuring portions of a May 23, 2007, unsigned editorial from the medical journal The Lancet, which claimed that the verdict on Avandia should await the results of a Glaxo sponsored trial called RECORD, not due out until 2009.
"Taken together," the editorial said of Dr Nissen's findings, "these results, although based on very small numbers of events, certainly raise a signal of concern and indicate the need for more reliable information about rosiglitazone's safety."
"But the FDA, physicians, and patients can reasonably await the results of RECORD, a phase 3 trial designed specifically to study cardiovascular outcomes," it said.
"Until the results of RECORD are in," the Lancet noted, "it would be premature to overinterpret a meta-analysis that the authors and NEJM editorialists all acknowledge contains important weaknesses."
The problem with waiting two years for the results of the RECORD trial is that FDA scientist Dr David Graham reviewed the results of this study thus far and told an FDA advisory panel that the study design is so flawed that the results should not be considered in any risk benefit analysis of Avandia now, or in 2009.
In fact, Dr Graham says the RECORD study is so useless that it is probably unethical to allow it to continue because no possible benefit can be achieved by allowing it to go on and that Avandia should be pulled off the market now because thousands of patients are being injured each month by using the drug.
At the end of his editorial, Dr Gottlieb lists himself as a physician and a resident fellow at the American Enterprise Institute, as well as former Deputy Commissioner of the FDA from 2005 to 2007. However, back on August 24, 2005, the Seattle Times provided a much better picture of his background and highlighted the oddity of the FDA hiring him in the first place in light of his solid alliance with the industry. "Only a month ago," the article states, "Dr Scott Gottlieb was a Wall Street insider, promoting hot biotech stocks to investors."
At the time, the Times noted, "Now Gottlieb holds the No. 2 job at the federal agency that approves new drugs, oversees their safety and affects the fortunes of companies he once touted."
"Now, as one of three deputy commissioners," the article said, "Gottlieb will help oversee such major policies as the FDA's fast-track approval process for drug and biotech products, a priority for many Wall Street funds and the pharmaceutical industry."
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
