By Byron J. Richards, CCN
June 14, 2007
Under the false pretense of improved food and drug safety the FDA is re-inventing itself as a kingpin drug company. This charade has so far hoodwinked virtually all members of Congress. The Senate has already approved this FDA transformation. The House will bring similar legislation out of committee next week, with a vote in the full House likely in July. The measure will then go to a conference committee to work out the differences. The final chapter in this transformation occurs when the Reagan-Udall Foundation for the FDA becomes law, which is scheduled to happen some time before September 30, 2007.
Even well-intended FDA employees are actively seeking new employment in more meaningful work. Such is the case with Rosemary Johann-Liang, former FDA deputy director of the Division of Drug Risk Evaluation. Last year she was reprimanded for trying to put a black box warning on Avandia, a move the FDA itself made last week in a damage-control effort to cover its complicity with GlaxoSmithKline. After 6 ½ years Johann-Liang is leaving the FDA. As the USA Today reports:
She begins working Monday as chief medical officer in the vaccine injury compensation program at the federal Health Resources and Services Administration. Still, she says, she might have tried to figure out how to stay at the FDA “if the agency had a vision of promoting and protecting public health.”
The 10,000 or so laid off Pfizer employees should cheer up, gainful employment for a legion of drug reps will soon be available through spin-off companies of the FDA’s Regan-Udall Foundation. Yes indeed, times are a changing.
How Did this Happen?
The Bush administration figured out that the fastest way to get the FDA out of the way of Big Pharma’s profits was to appoint FDA critics to key positions, thereby changing the FDA from within. This began in August of 2001 when Bush appointed Daniel Troy as chief counsel of the FDA, a man best known for defending tobacco companies. Mr. Troy invited Big Pharma to submit cases to him so that the FDA could help Big Pharma defeat citizens who were complaining that drugs and medical devices injured them. This has resulted in legal case precedent that ties up damage claim cases indefinitely and creates “trade secret laws” wherein the FDA claims it is legally obligated to withhold drug risks from the public to protect Big Pharma’s proprietary knowledge.
Another active critic of the FDA, Scott Gottlieb, M.D., a Wall Street biotech sales rep and member of the American Enterprise Institute was invited into the FDA to rewrite its medical policy. Shortly after that Bush appointed him to the number two position at the FDA, even though he was a young and inexperienced physician with no expertise in drug safety – just a major agenda to bring unproven drugs to the market with far less safety or effectiveness testing for the benefits of Wall Street.
These appointments were just warm-ups for Bush. His appointment that floored the drug-safety world and sent well-intentioned FDA employees running for cover was the appointment of Andrew von Eschenbach to head the FDA, an appointment that the Senate made permanent in last year’s Lame Duck session. The FDA is now headed by a representative of the pharmaceutical and biotech industries. It is informative to understand the chain of events enabling von Eschenbach to attempt his transformation of the FDA into a drug company.
Andrew von Eschenbach is a founding member of C-Change, short for Cancer Change (originally called The National Dialogue on Cancer) – a group that was created and funded in 1998 by the American Cancer Society. This group has become a conglomeration of the most powerful players in the cancer treatment industry, as can readily be judged by looking at their member list. Their unstated goal is taking the national cancer agenda away from the public sector and placing it into private for-profit hands. The group is headed by former President Bush and his wife, Barbara. Until recently von Eschenbach was the vice chairman of the board. Since becoming permanent head of the FDA he relinquished his board position and is now only a member.
Von Eschenbach is an oncologist by trade, a cancer survivor himself, and had a long career running the MD Anderson Cancer Center in Texas. He parlayed his close relationship with the Bushes and cancer-industry players into an appointment to head the National Cancer Institute (January 2002). And thus began the final stages in the transfer of power from public health interests to Big Pharma and Big Biotech. The initial and extensive C-Change conflicts of interest are fully explained in a revealing article on the Cancer Prevention Coalition website, including the assistance of tobacco companies and their PR firms in setting up this arrangement.
On February 22, 2002, Diane Feinstein (D-CA), the only Senator that is a member of C-Change, introduced The National Cancer Act of 2002 (S.1976). While this legislation never became law, it was quite telling as regards the C-Change plan – to shift the national cancer agenda and funding away from the public interest and into the hands of the American Cancer Society, C-Change, and related pharmaceutical companies.
Astonishingly, then director of Health and Human Services Tommy Thompson approved a waiver allowing von Eschenbach to remain vice chairman of C-Change while heading NCI, a dramatic conflict of interest. Tommy Thompson, like von Eschenbach, is a founding member of C-Change. During the von Eschenbach rein at NCI hundreds of millions of dollars in research grants were channeled to his C-Change friends and away from basic cancer research and public health measures relating to easily preventable cancers.
As head of NCI, von Eschenbach reorganized its administration bringing in a new layer of management spearheaded by the chairperson of the C-Change cancer research team and former biotech CEO, Anna Barker, Ph.D. Part of this new team included C-Change member Mark Clanton, M.D., as deputy director for cancer care and delivery. This C-Change management team met behind closed doors, setting NCI priorities independent of NCI’s traditional scientific advisors.
Von Eschenbach then funneled NCI money into Big Biotech projects relating to genomic-based cancer research, nanotechnology, proteomics, and the establishment of biomarkers relating to disease and cancer identification. While such innovative projects are on the one hand admirable, they are quite detached from the real-world issues that cause cancer in many Americans and are in many ways a diversion from what should be done now to realistically help many people not get cancer. Furthermore, there is no near-term tangible result. The problem for all of this type of research is how to get potential products to the market when the cost for drug development is so high and the FDA has no guidelines as to how these drugs even work or can be monitored for safety.
The Critical Path Initiative
The FDA “solution” to this problem, announced in March of 2004, was to set up a collaboration with industry to design the next generation of drugs. This plan is called the Critical Path Initiative and it refers to streamlining the path for approval to get new drugs on the market faster with less expense and less testing for safety or effectiveness. I would like to point out that the entire Critical Path Initiative, admirable as it may seem to some, is going to produce an increase in public health disasters like Vioxx. This is because the FDA (or more specifically von Eschenbach and friends) think the pharmaceutical industry’s problems are all based on a failure to get approval of new drugs fast enough.
In reality, the pharmaceutical industry’s real problem is a failure to get results in the marketplace. When a new drug is approved very little is actually known about how it will perform in the real world. This problem is complicated by direct to consumer promotion that typically misrepresents the drug, massive off label promotion and use of the drug, and no system that monitors what is really happening with the drug as it is used. By rushing more drugs onto the market faster, the failure to get results issue will be magnified – and the safeguards proposed in S.1082 are inadequate. Any savings in the cost of bringing a drug to market will be offset by the costs of lawsuits related to damages. The FDA is trying to “solve” that problem by preventing citizens from suing drug companies when an FDA-approved drug injures or kills. Von Eschenbach and the FDA have pushed forward with this very misguided marketing strategy.
In June of 2004 von Eschenbach’s NCI awarded SRI International a long term grant to evaluate the safety and pharmacology of these new biological drug cancer treatments. More related grants have followed. SRI specializes in cancer biology and toxicology research, as well as helping to patent, license, and spin off inventions into commercial applications. SRI also does extensive work for the Department of Defense and Homeland Security. Some of SRI’s largest clients besides government are the Rockefeller Foundation, the Ford Foundation, and the Bill and Melinda Gates Foundation.
In March of 2005 the FDA announced its first Critical Path collaboration known as the C-Path Institute in Tucson, Arizona. This is a collaboration between the University of Arizona, the FDA, and SRI International. One of its first projects is the establishment of cardiovascular biomarkers, working in conjunction with the University of Utah. Following this announcement the governors of the States of Arizona and Utah joined C-Change.
Conflict of interest reached a new level in October of 2005 when President Bush appointed von Eschenbach as temporary head of the FDA, a position he took while maintaining his roles as head of NCI and as vice chairman of the board of C-Change.
The Reagan-Udall Foundation for the FDA
Once von Eschenbach took over at the FDA, and eventually gave up his role at NCI, his main priority became promoting the Critical Path Initiative (not food or drug safety). He worked diligently with Senators Mike Enzi (R-WY) and Edward Kennedy (D-MA) to create a vehicle within the FDA to develop the next generation of biotech drugs. In last year’s version of this legislation (which never came out of committee), this project was called The Reagan-Udall Institute for Applied Biomedical Research.
This legislation would have set up the Institute within the FDA.
This year, Kennedy and Enzi tacked this piece of legislation onto required FDA funding, lumping numerous FDA issues into one huge bill (S.1082) and telling everyone it is a safety bill. Within this new legislation is the creation of the Reagan-Udall Foundation for the FDA, set up as an independent non-profit Foundation that will be under the control of the FDA. The Senate fought bitterly over various drug-safety issues unrelated to the Reagan-Udall Foundation, as if these issues acted as a smoke screen to slip past members of the Senate the creation of the Reagan-Udall Foundation for the FDA, the von Eschenbach dream come true.
Not a single Senator raised one concern about the significant safety issues inherent in the Critical Path Initiative/Reagan-Udall Foundation or conflicts of interest when Big Pharma and the FDA work side by side to develop, patent, and license drugs. The entire history of von Eschenbach’s relationship with Big Pharma, Big Biotech, and C-Change has been conveniently ignored. This issue now moves to the House, where it will be interesting to see if Representatives are as poorly informed as Senators as to what is actually going on. For part 2 click below.
Click here for part -----> 2,