The Volokh Conspiracy - A Wolf in Wolfe's Clothing:

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.

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].

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)!)

	[David Bernstein, January 20, 2009 at 6:20pm] Trackbacks A Wolf in Wolfe's Clothing: 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. 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]. 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)!)