Science Under Pressure

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This article was first published as "Science Under Pressure: Dow-Funded Studies Say "No Problem", PR Watch, volume 3, number 1, First Quarter 1996. The original article was authored by John Stauber and Sheldon Rampton and is used here with permission. As with all SourceWatch articles, feel free to edit and revise.

Breast implant makers and plastic surgeons have spent vastly more money on PR, attorneys, and lobbying than the women who are suing them for damages. Thanks to PR, the industry has achieved a remarkable reversal, persuading large sectors of the news media that it is the victim of politics, greed and "junk science."

New York Times reporter Gina Kolata has typified the trend, penning stories such as "Implant Lawsuits Create a Medical Rush to Cash In," which portrays the 400,000 women who have joined a class-action lawsuit against the industry as greedy opportunists goaded on by slick attorneys. [1] Similar stories have appeared on 60 Minutes and PBS-TV's Frontline.

At the heart of this line of defense is a strategy outlined by Burson-Marsteller in 1991 as Dow was preparing to withdraw from the breast implant market. "Research continues regardless of the disposition of the business," advised one memo. In order to achieve the long-term goal of rehabilitating Dow's reputation, B-M argued, the company would have to produce scientific data from seemingly independent, "third party" sources, which it could point to as proof that silicone was safe.

B-M warns Dow its "credibility is still low"

In 1992, B-M warned that the company's "credibility is still low. Of course, company and its employees will play a key role in disseminating message. But . . . core of message must be scientific, third-party support. Research studies already announced will be helpful when done. . . . We must begin by identifying supportive science, scientists, across the spectrum of uses for silicone; training and supporting them to get our message out; . . . using them proactively to brief the trade, general and business media; . . . using them reactively as a 'truth squad' to refute antagonists."

Frontline's February 1996 program on the silicone controversy provided a textbook example of this strategy in action. It built its case around the opinions of Dr. Marcia Angell, editor of the New England Journal of Medicine, which Frontline described as "the most prestigious medical journal in the world." Angell has overseen the publication of the two best-known epidemiological studies to date on breast implants--one by the Mayo Clinic, the other by Harvard researchers and Brigham & Women's Hospital--both of which found "no evidence" that implants cause serious long-term illness.

"What was so startling to me," Angell told Frontline, "was the disconnect between the science . . . and what was happening in the courts and what was happening at the FDA and what was happening in public opinion. The disconnect was amazing."

Over 90,000 women have provided evidence to the FDA of health problems that they attribute to their implants. Angell dismissed these complaints as "coincidental" and argued that "Passion, anecdotes, claims, testimonials will not settle this issue. It can only be settled by science."

Based largely on Angell's characterizations, Frontline portrayed FDA Commissioner David Kessler as somone who was "horrified" by the results of his 1992 decision to ban cosmetic use of silicone breast implants, and who now believes that science has proven them safe.

In fact, however, Kessler has continued to repeat his concerns. In April 1996, a month after the Frontline piece aired, Kessler joined several other physicians in authoring an article for the Annals of Internal Medicine which found methodological flaws in all 13 of the epidemiological studies which have been performed to date on systemic health problems related to implants.

According to the article, "Some of the problems common to these different studies include (1) sample sizes inadequate to rule out rare outcomes, (2) study methods inappropriate for detecting atypical syndromes, (3) poor choice of comparison group, and (4) inadequate duration of follow-up or information-gathering techniques that may have biased the detection of implants or clinical outcomes."

What Angell and Frontline never mentioned, moreover, were the numerous scientific studies that have found evidence of silicone-related illnesses, and which have been published in medical journals including the Annals of Plastic Surgery, The Journal of Aesthetic Plastic Surgery, The American Journal of Clinical Pathology, The British Journal of Plastic Surgery, Plastic and Reconstructive Surgery, The Journal of the American Medical Association, Arthritis & Rheumatism, and The Archives of Pathology and Laboratory Medicine.

Pure Science or Pure Hoopla?

Despite its prestige, moreover, the New England Journal of Medicine is not as pristine and infallible as Frontline would have the public believe. In fact, the journal has lent itself to junk science in the service of PR on several prior occasions.

In 1982, for example, a federation of French artificial-insemination centers used the NEJM to promote a misleading study that raised female fears of infertility by claiming that women who pass the age of 30 stand a nearly 40 percent chance of being infertile. Actually, the true rate of infertility at that age is only 13.6 percent, according to authoritative research by the U.S. National Center for Health Statistics. Not only did the NEJM publish the French study--whose conclusions were eventually abandoned even by its own authors--it added an accompanying editorial, moralizing that women should "reevaluate their goals" and have babies before starting careers.

In another case in 1986, the NEJM published one study and rejected another which reached opposite conclusions about the antibiotic amoxicillin, even though both studies were based on the same data. Scientists involved with the first study had received $1.6 million in grants from the drug manufacturer, while the critic had refused corporate funding. NEJM proclaimed the pro-amoxicillin study the "authorized" version. Five years later, the critical study finally found publication in the Journal of the American Medical Association, and large-scale testing of children showed that those who took amoxicillin actually experienced lower recovery rates than people who took no medicine at all.

Like the French fertility survey and the amoxicillin study, both of the breast implant studies published by NEJM were heavily funded by partisan sources. Dow Corning and other manufacturers funneled funding into the Mayo Clinic Study through the Plastic Surgery Educational Foundation (PSEF) of the American Society of Plastic and Reconstructive Surgeons.

The Harvard-Brigham study claims it did not receive direct funding from Dow, but according to plaintiff's attorney Stephen Sheller, the company did provide corporate grants to the hospital totalling at least $7 million during the period that the study was underway. Sheller bases that figure on depositions taken from Peter Schur, a professor at Brigham who supervised one of the major authors of the study.

Schur also admitted in December 1994 that during the course of the Harvard-Brigham study, he was also working for $300 an hour as a consultant and expert witness for law firms defending implant makers. Simultaneously, he was editor of Arthritis & Rheumatism, a medical journal in which he had published an article defending implant safety while rejecting submitted studies that found links between implants and health problems. Schur's associate editor at Arthritis & Rheumatism was Dr. Matthew Liang, also a Brigham & Women's professor who moonlighted as a consultant for the manufacturers' law firms and who worked on the Harvard-Brigham study.

After their multiple roles were disclosed, Liang and Schur resigned from a second Harvard implant study, also funded by Dow Corning, to avoid "the appearance of conflict of interest." Liang has also admitted giving information about the first Harvard study to Dow while the study was in progress, but has refused to provide information that would clarify whether Dow actually had a hand in shaping the study's methodology.

The Madness in the Method

In fact, critics of implants, such as Ben Lilliston of the Cancer Prevention Coalition in Chicago, have found numerous flaws in the method of both studies. "Perhaps the most significant problem with the studies is their time frame," Lilliston says. "Most researchers who have studied women with implants say that it usually takes 10 years or more for symptoms to develop. In the Mayo Clinic study, women had the implants in for a mean of 7.8 years. In the Harvard study the mean was 9.9 years." Since the real boom in implant popularity occurred in the late 1980s, two-thirds of all women with implants have not had them long enough to start showing symptoms yet.

"It's easy to get a negative study; you just look too soon," agrees Shanna Swan, an epidemiologist from the University of California at Berkeley. "This is not unlike R.J. Reynolds funding a study that examines people in their thirties, and finding no increased risk of lung cancer."

In addition, breast implant plaintiffs point out that the Mayo and Harvard-Brigham studies did not look for the "atypical" cluster symptoms that most women report. Instead, they looked for traditional connective-tissue diseases, such as rheumatoid arthritis and lupus. Most researchers studying "silicone associated disease" believe that it is a nontraditional disorder with its own set of unique characteristics.

"We're dealing with atypical disorders. Anyone who read the literature going back to the 1970s would have known that you need to look beyond classical diseases," says Dr. Gary Solomon, the associate director of rheumatology at the Hospital for Joint Diseases Orthopaedic Institute in New York City. "It is frankly disturbing that these medical studies did not consider this."

Critics also say that the studies do not look at enough women to produce meaningful statistical results. "To detect even a doubling in the baseline rate of scleroderma, you would need to have at least 30,000 women in your study," says Dr. Solomon.

Finally, women who have suffered illnesses fault the studies for relying on questionnaires and old medical charts--where atypical symptoms are less likely to have been noted than firm disease diagnoses--while failing to examine the women themselves. Neither study involved physical examinations or even interviews with any of the women under study.

"Every study we see seems to focus on the attorneys and the epidemiology studies," says implant recipient and activist Janice Ferriell. "Why don't they look at us, and figure out what's going on?"

"I have breast implants. I know," says Mary Feller, another implant litigant from San Rafael, California. "I've suffered all of those undefinable, diffuse symptoms--severe fatigue, night sweats, terrible headaches, stiff shoulders, neck and jaw."

Feller says the medical studies remind her of "the old joke about the drunk looking for his money under the lamppost because that's 'where the light is.' The same thing is happening with implants. The disease is out there in the dark, but the medical community insists on looking under the lamppost, probably because the light is provided by Dow."

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