Via Instapundit, I learn that Dr. Sidney Wolfe of Public Citizen has been appointed (under the Bush Administration's watch) to a four-year term on the FDA's Drug Safety and Risk Management Committee, as the "consumer" representative. It's hard to imagine a worse choice.
Wolfe and Public Citizen have the unique distinction of being primary instigators of (at least--these are the ones I'm familiar with) two of the worst junk science episodes in American legal history, the Bendectin and silicone breast implant litigation.
Here are some choice excerpts regarding Wolfe from my article on the breast implant litigation:
On November 9 [1988], Public Citizen publicly called on the FDA to ban implants. Public Citizen released internal documents from Dow Corning and the FDA that showed the company's scientists had implanted a blob of the gel under the skin of 200 rats. Between one-fifth and one-quarter of the rats developed fibrosarcoma, a form of cancer. Public Citizen's president, Dr. Sidney Wolfe, told the media that implants were dangerous and should be banned. Wolfe's comments “sent many women into something of a panic." To calm the furor, the FDA agreed to consider the cancer issue at its November 22nd meeting.There was never any sound scientific evidence linking implants to either cancer or, as litigants (and Wolfe) later alleged, immune system disease. And now there is a substantial body of evidence to the contrary, as there has been for years. To my knowledge, Wolfe not only never apologized for his role in stirring up the litigation but, at least as of 1998, he was still arguing-against the great weight of scientific evidence-that breast implants may pose a significant risk of cancer and immune-system diseases. And Wolfe was a leading opponent of the reapproval of implants by the FDA a few years back, offering his "expert" opinion on other potential health risks from implants, without a trace of embarrassment about his prior advocacy of the cancer and immune system disease theories. (FWIW, I once asked current Public Citizen president Joan Claybrook at a public forum at Georgetown Law Center if the organization had any regrets about its role in the breast implant litigation. Not only did she disclaim any regrets, but she did so in the most arrogant and obnoxious manner of anyone to whom I've ever asked a question (and my question was polite)!)Although a few FDA employees expressed concern about the implications of the rat studies, Wolfe knew or should have known that fibrosarcoma occurs in rodents in response to the implantation of any large smooth object. No one has been able to demonstrate that this phenomenon, known as solid-state carcinogenesis, occurs in humans. After receiving advice from the National Center for Toxicological Research, the FDA concluded that "the types of tumors seen in the rats would be unlikely to occur in humans, and that, if a human cancer risk does exist, it would be small."....
Linking implants to cancer based on the rat studies was only the first of many unduly alarmist comments made by Wolfe in the course of the breast implant litigation. .... By the Spring of 1991, breast implant plaintiffs' attorneys, Sybil Goldrich and other leaders of anti-implant organizations, and Sidney Wolfe were actively coordinating their attack on implants. In a subsequent interview, Wolfe acknowledged that he intended to help provoke a deluge of lawsuits against implant manufacturers. By June, the "Silicone Clearinghouse," organized by Public Citizen, had thirty-nine member law firms....
In April 1992, the Journal of Plastic and Reconstructive Surgery published a study that showed no link between breast implants and cancer. Two months later, the New England Journal of Medicine published another study reaching the same conclusion. While Wolfe refused to concede that these studies had merit, plaintiffs' lawyers began to shift their resources from cancer claims to claims that implants cause systemic immune system diseases [a cause that Wolfe also joined].
* Also known as The One, the Infanticide President, Obambi McHopenchange, etc.
NOTHING is without risk. The point is that silicon implants do NOT cause cancer and do NOT cause Lupus or other autoimmune disease.
As it happens, perfectly natural nature-provided breasts are also not without risk. That's why at least some women end up needing/desiring silicon implants. The question is not what is without risk. The question is whether or not to acknowledge that the specific risks claimed against these implants by Wolfe's group were without ANY scientific merit.
While we're at it, how many people are dead because of the DDT scare?
But never fear, for Captain Hopenchange is here, promising to "restore science to its rightful place."
Could it be that this is a spite move on Bush's part? That Wolfe would never have been appointed by Obama, but that Bush calculated that Obama wouldn't dare replace a sitting Sidney Wolfe, given his propaganda machine? And that Bush would be very happy to make us all more miserable if he can make it appear to be the Democrats' fault?
Say it again, Dave, one of the commentors supra has his head infra.
Dr. Wolfe is one of the worst examples of the non-expert medical expert who parlays bullshit and fears into a career as a public "defender" of health. He's like the doctors who claim vaccines cause autism, that high power electrical lines cause leukemia, that cell phones cause brain cancer, or that part-per-trillion pesticide residues are toxic. Such physicians are non-scientific, unethical con artists.
Not sure I understand that simply being on an advisory committee is all that important, but I'm in favor of ending the kind of indistry-consumer group battles over regulatory agencies like the FDA by doing away with the FDA entirely.
Heck, yes. If the label says it's safe that's good enough for me!
He means it ironically of course, providing an oblique argument against abolishing the FDA, attempting a reductio. The irony is he really believes "if the label says it's safe that's good enough for him" must be true as long as some FDA bureaucrat confirms it first. Why he has such faith in nameless bureaucrats, when history shows government regulatory agencies are easily taken over by the regulated industry, is less clear.
Here are some other truths Grover should be aware of:
If the label saying its safe is NOT good enough for you, you don't have to take it.
If you want to pay for second opinions, you are entitled to do so.
If you think you have the option of suing a company for providing you with dangerous medicine, that option is lessened when the FDA has already gone on record that it's safe, and the FDA can make mistakes.
One thing that can never, in this country, be good enough for Grover is the medicine that could have saved his life but hasn't yet been approved for marketing by the FDA, a process that still takes several years.
Without an FDA, I would be able to resort to others with more expertise, consumer reports, and my rights if I am harmed. We would be better served if the FDA simply provided information but otherwise stepped out of the way. Its presence (and the laws it enforces) both restrict consumer choices and protect industry by erecting barriers to entry.
oppressiveimpressive.Fixed.
Fixed some more.
Breasts should be called MEDs: Male Enslavement Devices.
FDA approval is not accomplished by arbitrary bureaucratswith visors on their foreheads sitting throwing darts against a wall behind pulled shades .
It requires extensive, audited clinical testing using standard and up-to date experimental methods and statistical analysis. The data from these is reviewed by an ad hoc scientific committee composed of recognized experts without conflict of interest.
The FDA almost always follows the advice of its ad hoc committee. And it can reopen approval or disapproval if further material data come in. (Because the people using a newly approved drug in clinical practice are likely to have other diseases, take other med that the research subjects did not, it is not uncommon to see new complications when a drug is released for general use.)
As a physician, and as a member of the public who takes a number of drugs, I'm happy to have FDA protection, imperfect though it may be. I'm happpy to require that new drugs undergo stringent tests, and that the effectiveness and toxicity of the dbe quantified and publicized before patients can take them.
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