Fw: Response to attacks on me in Steve Milloy's Dec 20 article

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----- Original Message ----- From: Zuckerman

Sent: Monday, December 23, 2002 9:34 PM

Subject: Response to attacks on me in Steve Milloy's Dec 20 article

Dear Friends,

Several of you expressed concerns about Steve Milloy's pro-implant article on Fox News Views, which criticized me personally as well as criticizing the NCI study of implants.

In the spirit of the season, I turned the other cheek for a few days. But, I decided it was important to respond, so I just finished my letter (having finished my holiday shopping earlier today).

Here is the response I sent to Fox News. I hope to have the chance to publish an article on their website.

Happy Holidays to all of you.

Best wishes,

Zuckerman, Ph.D.PresidentNational Center for Policy Research (CPR) for Women & Families1901 Pennsylvania Avenue, NWSuite 901Washington, DC 20006202 223-4000www.center4policy.org

Remember CPR when you give to United Way or CFC, by designating #9884!

----- Original Message -----

From: Zuckerman

views@...

Sent: Tuesday, December 24, 2002 12:25 AM

Subject: Response to attacks on me in Steve Milloy's Dec 20 article

To the Editor:

I have appeared as an expert many times on Fox News but I don't think I have ever been mentioned on your website -- until now. Steve Milloy criticized and represented my views and I would appreciate the opportunity to respond, preferably in my own opinion article.

Steve Milloy has been writing about breast implants and junk science for years, but his latest column, published on your website on December 20 (reprinted below) shows that he either does not bother to read the scientific papers he talks about, or does not understand them.

Mr. Milloy correctly asserts that I am on the National Cancer Institute's (NCI) scientific advisory panel for their studies of breast implants. He does not mention that this committee, which consists primarily of well-respected faculty members from across the country, works to ensure that these studies are scientifically solid.

Mr. Milloy misrepresents my views when he claims that I have misinterpreted the data from the 2 NCI studies on breast implants. The quote he attributes to me was instead based on my summary of 3 federally-funded studies. Two of these were conducted by the NCI and one by the FDA. (I have pasted the excerpt from my Congressional testimony, below this letter, so that you can see my remarks for yourself).

Unlike Mr. Malloy, I was trained in epidemiology at Yale Medical School. I assure you and Mr. Malloy that I understand the data in the three studies and those data clearly show a statistically significant increased risk of certain cancers, fibromyalgia, and other potentially fatal diseases among breast implant patients. In the NCI studies, there was an increased risk of death for women with implants (silicone or saline) compared to other plastic surgery patients (this is an appropriate comparison sample because they are similar on important demographic characteristics). In the FDA study, the increased risk was among women whose implants were ruptured and leaking, compared to women whose implants were not leaking.

Mr. Malloy refers to me as a "key spokesperson for activists." I'm not sure what that means. Whenever I speak about any medical product, I speak as a trained scientist. It is true, however, that I agree with patients and consumers that believe they would have been better served if breast implants (and bladder slings, and gastric LAP bands, and other implants) had been carefully studied in long-term clinical trials before being implanted in women. If expressing one's opinion makes one an activist, then I would have to agree that Mr. Malloy and I are both activists for our respective points of view.

In addition to misrepresenting my views in his column, Mr. Milloy criticized the NCI's Dr. Louise Brinton for meeting with attorneys representing breast implant patients. He failed to mention that in conducting the study, she and her research colleagues worked closely with plastic surgeons who perform implant surgery and others whose very favorable opinions of implants clearly counter-balance the negative opinions of the patients' attorneys. In fact, the participation of implant patients in the study was entirely dependent on the cooperation of their plastic surgeons. If there is bias, it is coming from both directions, probably balancing each other.

I would appreciate the opportunity to publish an op-ed in Fox News Views, expressing my views. "Junk science" is a term that is most often used by scientists who work for and/or defend companies whose products (cigarettes, pesticides, and others) are being criticized as dangerous. In my opinion, the worst junk science is the checkbook science that journalists who are not trained in science so often embrace -- research that is bought and paid for by companies whose products are being studied -- and those companies then spend millions on PR firms that place news articles about those same studies.

Would you consider publishing an article I wrote entitled "Hype in Health Reporting" which was published in Extra! and is about to be published in an international health magazine? You can check it out at: http://www.cpr4womenandfamilies.org/newsflash.html

Sincerely,

Zuckerman, Ph.D.PresidentNational Center for Policy Research (CPR) for Women & Families1901 Pennsylvania Avenue, NWWashington, DC 20006202 223-4000www.center4policy.org

Remember us when you give to United Way or CFC, by designating #9884!

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Here is the excerpt from my Congressional testimony last year, taken directly from the Congressional website:

http://energycommerce.house.gov/107/hearings/11152001Hearing428/Zuckerman728.htm

"... just a few months ago, three major new studies reported that women who have breast implants are at significant risk for several debilitating and fatal diseases.

One study, conducted by researchers at the National Cancer Institute (NCI) reported that women with implants were more likely to die from brain cancer, lung cancer, other respiratory diseases, and suicide compared to other plastic surgery patients.

A second study, also by NCI, reported that women with breast implants are more likely to develop cancer compared to other women their age.

Both of these studies were of women who had either silicone or saline breast implants for at least 8 years. In contrast, the studies showing no increase in disease for women with implants included many women who had implants for short periods of time – even as short as one month. Obviously, cancer and autoimmune diseases do not develop that quickly.

A third study, conducted by scientists at the FDA, found that women with leaking silicone gel breast implants are more likely to have several painful and potentially fatal autoimmune diseases. Implants were found to be increasingly likely to break as they got older, and most implants were broken by the time they were 10-15 years old. This study may provide an important clue: it is possible that illnesses reported by women with implants are a result of leaking implants – which would explain why most women do not have systemic health problems until after they have had implants for several years. "

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The FDA study is available online:

http://www.fda.gov/cdrh/breastimplants/extracapstudy.html

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Friday, December 20, 2002By Milloy

Silicone breast implants are coming back. That's good news for breast cancer survivors and other women who want implants.

Blocking the way, though, are junk science-fueled, anti-implant activists and their personal injury lawyer-sponsors who may be poised to steer the outcome of an upcoming federal report on SBI safety.

A new federal law enacted in October requires the National Institutes of Health to report to Congress on the status of breast implant research. Activists had perennially lobbied for the provision until it was finally inserted into a broader bill updating medical device regulation.

SBIs are the poster child of 1990s' junk science. That decade saw personal lawyers generate about 170,000 plaintiffs, now in the final stages of extorting a $4.5 billion settlement from former SBI manufacturers.

Yet no scientific evidence supported claims that SBIs caused disease -- so concluded a comprehensive 1999 review of the relevant scientific data by multidisciplinary experts at the National Academy of Sciences' Institute of Medicine.

But the report came too late to prevent the damage done by Food and Drug Administration Commissioner Kessler's 1992 ban on SBIs. Kessler's shoot-first-ask-questions-later action was a bureaucratic blunder that opened the litigation floodgates. The ban forced implant manufacturers to buy peace from tort lawyers rather than risk unpredictable litigation that might last for decades.

With extensive study failing to provide evidence that SBIs cause disease, several manufacturers now are preparing to seek "pre-marketing approval" for SBIs from the FDA.

Unfortunately, the new law leaves the activists and lawyers well-positioned to pervert the process and recreate the junk science circus of the 1990s.

The NIH point person on SBIs is Louise Brinton, chief of the National Cancer Institute's environmental epidemiology branch. That description, though, doesn't do her justice.

Brinton has an extensive history of collaborating with anti-implant activists and tort lawyers, according to Meroney of the American Enterprise Institute.

A Freedom of Information Act request revealed that, while working as a government employee on a $4 million study of implants, Brinton was in contact with attorney LeRoy Hersh, a member of the Plaintiff's Steering Committee of top lawyers handling implant litigation. Hersh's firm won $1.7 million from Dow Corning in 1985 in one of the first major SBI cases.

Brinton eventually agreed in 1995 to serve as a consultant for Hersh.

Tort lawyer Sheller arranged a speaking engagement for Brinton before prominent SBI plaintiff attorneys in July 1995. She was a guest of trial lawyers at yet another meeting in Miami in November 1995.

Brinton allowed tort lawyers to help her develop a 28-page research questionnaire sent to study subjects. The lawyers shared the draft with anti-implant activists who apparently weren't happy with the draft. Brinton was advised to be more definite about her goal.

Appealing to the victimology, Brinton responded on government letterhead: "The study provides an opportunity for women who may be suffering as a result of implants to be heard. Now is your chance."

Ties to anti-implant activists also were uncovered. Brinton asked the head of American Silicone Implant Survivors for "any support [she] could provide" and advice on how to best recruit "implant survivors."

Brinton participated in an August 1995 conference call with activists where she described earlier SBI studies as "bad science" and said, "We need your help in telling women that this one is valid."

Though Brinton's own research so far has failed to link SBIs with health problems, she seems to have a problem communicating these results to the media.

"Study Links Breast Implants To Lung and Brain Cancers" headlined an April 2001 New York Times report about a Brinton study, despite the fact that the study made no such linkage and Brinton acknowledged as much.

Part of this communications breakdown may be due to Zuckerman, a scientific advisor on Brinton's studies and, incidentally, a key spokesperson for activists.

Despite Brinton's acknowledgement of no demonstrable cause-and-effect relationship between implants and disease, Zuckerman tells congressional and FDA staff, and the media that Brinton's studies report women with SBIs "are at significant risk for debilitating and fatal disease."

I don't know for sure that Brinton is biased against SBIs. But her background raises serious questions about her qualifications to lead the NIH study. In addition to her apparent conflict-of-interest, as a mere epidemiologist, Brinton lacks the necessary medical and scientific expertise to properly conduct the study.

Rather than risking a hijacking of the NIH study by anti-implant activists and lawyers, the NIH should immediately engage a panel of independent experts from a variety of relevant disciplines to produce an unbiased and unimpeachable report -- as the Institute of Medicine did in 1999.

Qualified and reputable clinicians and scientists -- rather than irrational activists and unscrupulous lawyers -- should determine whether women once again will be able to choose silicone breast implants.

Milloy is the publisher ofJunkScience.com , an adjunct scholar at the Cato Institute and the author of Junk Science Judo: Self-defense Against Health Scares and Scams (Cato Institute, 2001)