… is well-known. But it’s a sort of background fact until forced resignations and conflict of interest scandals break through to the daily papers.
That’s what’s happening today, as its head of medical device regulation resigns (way industry-friendly, he approved all sorts of quackery) at the same time as its head of drug approval gets investigated for conflict of interest.
In the COI case, Janet Woodcock appears to have been been friends – and a collaborator on scientific papers and articles – with MIT Professor Ram Sasisekharan.
They wrote one of those thirty-author, ten-page thingies you see in the New England Journal of Medicine. Here’s the thing itself:
Kishimoto TK, Viswanathan K, Ganguly T, Elankumaran S, Smith S, Pelzer K, Lansing JC, Sriranganathan N, Zhao G, Galcheva-Gargova Z, Al-Hakim A, Bailey GS, Fraser B, Roy S, Rogers-Cotrone T, Buhse L, Whary M, Fox J, Nasr M, Dal Pan GJ, Shriver Z, Langer RS, Venkataraman G, Austen KF, Woodcock J, and Sasisekharan R. “Contaminaed Heparin Associated with Adverse Clinical Events and Activation of the Contact System.” N Engl J Med 2008 Jun 5;358(23):2457-67
And of course the MIT guy’s really an entrepreneur with his own company and that company appears to have been unfairly favored by the FDA in a recent competition for approval for a blood thinner; and the competing company filed an ethics complaint against Woodcock, which is now being investigated by the Inspector General.
In April 2008, after the tainted-heparin article was published, an investment report from Morgan Stanley cited Momenta’s FDA connection as a “game-changer,” and Momenta’s stock jumped 17% in a day.
Ten little pages, and look what happened! Talk about significant research results…
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Update: Roy Poses, at Health Care Renewal, provides crucial background and analysis on the heparin scandal.
August 13th, 2009 at 2:00PM
Unless we put medical freedom into the constitution the time will come when medicine will organize into an undercover dictatorship and force people who wish doctors and treatment of their own choice to submit to only what the dictating outfit offers.
This is the state of medicine today. It is a sad state of affairs. Our drug-based medicine heals little, poisons many, and still our people are clamoring for access to it.
Virtually every law restricting the practice of medicine in America has been enacted not on the crest of public demand, but due to intense pressure from the political representatives of physicians. [Goodman, John C, Musgrave, Gerald L., Patient Power: Solving America’s Health-Care Crisis, Cato Institute, 1992]
There is, however, an underlying reason why we have this terrible system; why Americans pay the highest health care costs on the planet yet receive an inferior system of health care in which our longevity rate is ranked 20th world wide and our infant mortality rate is ranked 20th.
The reason: our government has, since 1806, worked towards making “regular” medicine (conventional, drug based, allopathic) a powerful monopoly.
During much of the 19th century, licensing laws came and went and the public was free to choose its health care. Their options were wide open: nutritional medicine, hydrotherapy, eclectics, Indian Medicine, homeopathy, herbalism, a combination any of these, midwifery, or a regular physician. By the end of the 19th century, osteopathy, chiropractic, and naturopathy had come into the mainstream.
And then something happened that defines the ruling class in our society, or as J D Rockefeller once said: “Competition is a sin.”
It is a sad historical truism that you can always hire half the poor to kill the other half. This is why we have wars. There will always be someone poor enough to fight them. The poor will not unite, till the rich unite them, arm them, uniform them, and send them off to war.
1847: Regular physicians united and formed the American Medical Association.
The professed highfalutin reasons for the association were to establish standards of medical ethics and medical education; that all doctors should have a "suitable education" and that a "uniform elevated standard of requirements for the degree of M.D. should be adopted by all medical schools in the U.S."
The ulterior motives would soon come to light.
It was the Council on Medical Education that devised a plan to rank medical schools throughout the country, grading them on a scale from A to C. Working with state medical boards, by 1910 they succeeded in cutting the number of schools from 166 to 131.
But they ran out of money.
The Rockefellers had joined forces with the Carnegie foundation to create an education fund. They were approached by N P Colwell, the secretary of the AMA’s Council on Medical Education, to finish the job they had started, but could no longer fund.
Simon Flexnor, the director of the Rockefeller Institute for Medical Research, proposed that his brother, Abraham Flexnor, be hired to finish ranking medical schools. Abraham Flexnor owned a bankrupt prep school and knew nothing about medicine. He took his orders from the AMA and the two foundations.
Many historians feel that the Rockefellers were truly the bad guys in this alliance, but Colter (Divided Legacy) and Brown (Rockefeller’s Medicine Men) seem to feel that John D Rockefeller had been duped.
You see, John D Rockefeller was a friend of homeopathy. He referred to it as “a progressive and aggressive step in medicine.” Rockefeller lived to the ripe old age of 99 using only homeopathy in the latter part of his life.
John D Rockefeller had made major grants to homeopathic institutions over the years, and gave specific instructions to Fredrick Gates, his financial advisor, to continue to do so. However, Gates was no friend to homeopathy, and all subsequent grants went only to the orthodox medical institutions; some 300 to 400 million dollars. [Brown, Rockefeller’s Medicine Men, Berkeley: University of California, 1979]
Got that? Our Government has systematically maneuvered to make orthodox, regular medicine a powerful and profitable monopoly.
And you expect the government to fix a problem it has been creating for 200 years?
Better still, look at the FDA as the prime example of what an agency that purportedly looks after the public good really does and who it really serves.
In the words of one of their own:
"The FDA ‘protects’ the big drug companies and are subsequently rewarded, and using the government’s police powers they attack those who threaten the big drug companies. People think that the FDA is protecting them.
It isn’t.
What the FDA is doing and what the public thinks it is doing are as different as night and day."
Dr. Herbert Ley-
Former U.S. FDA Commissioner
Remember what I told you about Borchers? This system has 5 lobbyists for every member of Congress. It’s not going to change without removing the influence of pharmacuetical and insurance companies.
August 13th, 2009 at 2:29PM
I think I’ll leave it to Prof Soltan to reply to "truthgiver."
However, I do think this case is more complicated than the WSJ article suggests. Please see our discussion on Health Care Renewal:
http://hcrenewal.blogspot.com/2009/08/who-investigated-case-of-deadly.html
The issue is not only whether there was a conflict in the approval process for Amphastar’s product, but whether there was conflict in the scientific investigation of last year’s case of the deadly contaminated heparin (which was implicated in over 100 fatalities)?
August 13th, 2009 at 7:00PM
Thank you Dr. Poses for the link and background information on this issue. I realize my post might offend members of your profession but, I feel it’s important to understand the history of allopathic medicine before the system can be improved. My son suffered a traumatic brain injury in 2007 and, during his hospital stay, we were constantly pressured to authorize drugs for his "treatment", including medications that specifically said "not for use with brain injuries"! I spent many hours reading about these medications, often from the producers websites. At one point, after finding little information, I consulted a doctor who said "if my son had a brain injury, there is no way I would give him that medication". Until this system is driven by decisions made in the best interest of the patient, we will continue to see more examples of profits guiding hospitals and doctors.
August 18th, 2009 at 1:31PM
[…] tip to and see further comments by Prof Margaret Soltan in the University Diaries […]
August 18th, 2009 at 1:31PM
[…] tip to and see further comments by Prof Margaret Soltan in the University Diaries […]