Fw: The Case of Silicone Breast Implants

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From: Ilena Rose <ilena@...>

Sent: Tuesday, January 30, 2001 10:44 PM

Subject: The Case of Silicone Breast Implants

> http://www.fplc.edu/risk/vol5/summer/nelkin.htm

>

>

>

> Reporting Risk:

> The Case of Silicone Breast Implants

> Dorothy Nelkin1*

>

> The media coverage of the 1992 dispute over regulation of silicone breast

> implants, devices suspected of causing autoimmune disorders and

> neurological diseases, became in itself a part of this bitter controversy.

> Many physicians were angry at the coverage, accusing journalists of

> projecting their personal opinion, of irresponsible sensationalism, of

> jumping to conclusions without listening to experts. They blamed the media

> for creating unnecessary fear. A review of this case suggests some of the

> dilemmas involved in risk communication.

>

> Media reports on the breast implant controversy were influenced by several

> factors that more broadly characterize risk events. First, despite Food

> and Drug Administration (FDA) mandates requiring that the device be

> systematically tested, no adequate data were available. The Advisory

> Panel, meeting in 1992 to assess the risk had to make decisions about

> regulating the implants mainly on the basis of anecdotal evidence and

> individual testimony. The media also had to rely on these anecdotes.

>

> Second, many dimensions of the risk from implants were complex,

> controversial, and poorly understood. Scientists themselves did not fully

> agree about the nature and extent of risk. Were the cases of leaking

> silicone aberrant or inevitable? Were the damaged implants defective or

> would all implants eventually fail? What was the effect of silicone on the

> body? Were the reported cases simply anecdotes from women seeking money

> from malpractice suits, or were there significant patterns? In light of

> the debates over these questions, who were reporters to believe?

>

> Third, like so many questions of risk, this issue was socially and

> politically controversial. In the deregulatory climate of the Bush

> Administration, Kessler as an activist FDA commissioner, was an

> anomaly, and, in an election year, a publicized risk controversy was

> threatening. Moreover, the issue became a media event at a time when the

> American medical profession was under attack for its neglect of the

> diseases of women. A National Institutes of Health initiative to remedy

> the situation had called public attention to the history of this neglect,

> creating awareness of the problems of using a device on women that had

> never been adequately tested. The case also followed the much publicized

> dispute over the Dalkon Shield. The risk of silicone breast implants,

> then, became one more issue in a parade of uncomfortable incidents.

>

> Finally, the reporting of the risk of silicone breast implants, was bound

> to have a direct and immediate effect on the behavior of women. Some use

> implants for breast augmentation -- that is, for cosmetic surgery that

> some regard as frivolous, but others as essential. Implants are also used

> as reconstruction after mastectomy, and are considered essential for the

> psychological and even physical recovery of cancer patients.

>

> Like so many risk disputes, the reporting of the silicone breast implant

> controversy took place in a context of technical uncertainty and political

> controversy about social and clinical implications. The complaints of

> physicians about overblown media reports resembled those of a chemist some

> years ago who accused the press of reporting that modern technology is

> poisoning America. " If there is any poisoning of America going on, it is

> not chemicals that are the culprit, it is the media which seem intent on

> burying us in purple prose -- a sort of verbal poison. Journalists have

> helped to create crises where none exist (the cancer epidemic), have blown

> out of proportion legitimate stories (Three Mile Island) and avidly hunted

> for crises to come (acid rain). "

>

> The physicians' irritation with the media reports reflected the

> controversial implications of risk reporting. By their selection of news,

> journalists set the agenda for public policy. They can point the finger of

> blame -- in the implant case towards the product manufacturer -- and imply

> responsibility for remedial action. They can define an issue as an urgent

> problem or reduce it to an aberration. By creating public issues out of

> particular events, the media can force regulatory agencies to action

> simply out of concern for public image. The media interest in the drama of

> the silicone breast implant controversy was important in encouraging the

> appointment of a commission to decide on regulation.

>

> Through their disclosure of new discoveries the press can also affect

> consumer behavior. We know this from many cases. After extensive media

> reports on the dietary studies relating cholesterol-producing foods with

> heart disease, consumption of beef, eggs and fatty milk products declined.

> Similarly, the media attention to the risks of the silicone implants have

> greatly increased the use of saline implants though this is a far more

> complex and costly procedure.

>

> Given the impact of reporting, control over the information and images,

> the values and views, the signs and symbols conveyed to the public are

> understandably a sensitive issue. Industries, political institutions,

> professional groups and aspiring individuals all want to manage the

> messages that enter the cultural arena. Public relations efforts are a

> growing aspect of every field of science, technology and medicine, but

> they are most elaborate in the promotion of dramatic medical

> interventions, promising new discoveries or therapeutic techniques. Recall

> the extraordinary publicity over the artificial heart, promoted as a

> " revolutionary development, " a miraculously effective solution for heart

> patients, a medical milestone.

>

> Sometimes firms try to market products by defining them as newsworthy

> discoveries. Silicone breast implants had been widely promoted by the

> company and by some private physicians as a panacea for women who, for

> reasons of vanity, or for post operative reconstruction, were extremely

> vulnerable to such sell. This, however, was hardly the first instance of

> such promotion. In the 1970's physicians and drug firms promoted estrogen

> replacement therapy by claiming it would reduce the biological effect of

> aging. Promotional materials on estrogen were designed to attract the

> press, which was, of course, attracted in any case to stories on a therapy

> that promised eternal youth. Thus news articles on estrogen replacement

> therapy were headlined: " Science Paints Bright Picture for Older Women. "

> Eager for copy, journalists uncritically accepted the claims of interested

> experts who debunked the growing set of studies that suggested a

> relationship between estrogen and endometrial cancer, well after the FDA

> issued warnings to that effect. The press uncritically cited estrogen

> proponents who dismissed the concern about risk: " When we drive down the

> freeways, we take a risk. "

>

> Drug companies use " science-based press agentry " to market their products,

> in effect pushing products as newsworthy discoveries. Lilly's arthritis

> drug, Oraflex, was initially marketed this way as the firm's public

> relations office sent out press kits promoting the drug as a

> scientifically proven way to relieve arthritis. When the media covered the

> product as science news, in prescriptions increased from 2,000 to 55,000 a

> week. Twelve weeks later, a report showed its harmful side effects and it

> was withdrawn from the market. Similarly, silicone breast implants had

> been marketed for many years without significant testing despite

> uncertainty about long term risks. In the course of investigation,

> Dow-Corning admitted misleading the FDA and the public about its data on

> the possible problems of implants, and other companies had not collected

> data at all. Meanwhile, the media encouraged the use of implants by

> playing up to women's concerns about image and capitalizing on the belief

> that large breasts mean sex appeal.

>

> Just as the media have been used as a tool to market new products by

> defining them as scientific discoveries, so there are efforts to manage

> the media's reporting of risk from technologies. Efforts to control the

> communication of risk was evident in the nuclear industry's use of the

> media to project positive images of nuclear power to allay public fear.

> The chemical industry employs similar strategies, using scientific

> expertise in their public relations as a means of damage control in risk

> disputes. So too in the silicone implant controversy, both the industry

> and the women who suffered disorders from the implants engaged both

> scientific experts and public relations practitioners to support their

> conflicting claims.

>

> Journalists are vulnerable to such public relations strategies, for they

> are constrained by intense competition, tight deadlines, limited budgets

> and the need to cover complex and often technical material within limited

> space and time. Pressed for time, they are inclined to rely uncritically

> on material that is conveniently packaged by public relations staffs. This

> gives an unusual degree of power to those sources best organized to

> provide facts in a manageable and efficient form. Thus institutions

> skilled in organizing timely and lucid material have considerable

> influence on the media. Though ambivalent about public relations and aware

> of efforts to subordinate journalism to private interests, journalists are

> still influenced by it -- a fact which prompted Upton Sinclair to define

> journalism as " a business in the practice of presenting the news of the

> day in the interest of economic privilege. "

>

> By now, with 20 years of experience in risk reporting, reporters approach

> the subject with greater independence and, indeed, a certain cynicism

> about corporate behavior. The silicone implant fiasco followed on the

> heels of a series of cases in which companies have been found to obfuscate

> known risks -- for example, the risks of asbestos, of dioxin and of

> cigarette smoking. Investigations, sometimes by journalists, had uncovered

> many cases of products that were marketed even when known to be harmful.

>

> Reporters are especially skeptical of the increasing pressures from

> science-based institutions: " I get calls from Dr. Knowledge, the world's

> leading authority on X disease or Y technology, who is also president of Z

> society. " They refer to " pesky PR types, " or " the flacks. " Irritation is

> not limited to corporate public relations. " They're all grinding the same

> axe, from breakthrough university to wonder pharmaceuticals to the

> National Institute of Nearly Cured Diseases. "

>

> The physicians' anger at the media coverage of the risks of silicone

> breast implants reflect less the actual content of the media coverage than

> the broader tensions between the medical and journalist communities. These

> groups hold fundamentally different views on the appropriate behavior and

> role of journalism. First, there are differences in judgments about what

> is news. In the medical community, research results become reliable and

> therefore newsworthy through the endorsement of professional colleagues.

> Research findings are provisional -- and therefore not newsworthy -- until

> certified by peers to fit into the existing framework of knowledge. The

> physicians could not see this issue as newsworthy because there were no

> adequate data, and without such data they felt that no public judgments

> should be made about risks and howthey should be balanced against the

> benefits to their patients. They did not regard the testimony of

> individual women who had been harmed by the devices as news. As one critic

> put it starkly: " Distraught women are not news. "

>

> A related source of tensions concerns when to release information to the

> public. In the case of suspected risk, how much evidence is necessary

> before informing the public? How certain must the evidence be? How much

> scientific consensus must there be before problems or potential problems

> are widely disclosed? Are there situations when reporting risk may cause

> unnecessary panic or counterproductive behavior when nondisclosure of

> risks would be desirable? Most journalists believe that risk data should

> be promptly available to the public. But the doctors, facing patients who

> were even reluctant to have mammograms if they thought they might be

> disfigured, believed that releasing information before risks were well

> understood was irresponsible. While their desire for definitive knowledge

> is understandable, if certainty was a condition for disclosure there would

> be no public information at all.

>

> A further set of conflicts follows from different assumptions about how to

> communicate risk. Journalistic conventions may violate the norms of the

> scientific and medical community. To create a human interest angle,

> journalists will focus on conflict and create polarities; technologies are

> either risky or they are safe. Their quest for simplicity, drama, and

> brevity preclude the nuanced and complex positions that scientists prefer.

> Moreover, journalists follow the principle that verity in reporting

> disputes can be established by balancing conflicting claims. This clearly

> contradicts the scientists' view that claims can be verified only by

> empirical evidence.

>

> A related source of tension lies in the conflict between the professional

> practices of journalism and scientific expectations about appropriate

> styles of communication. Constrained by the interests of their readers,

> journalists must select and simplify technical information. This often

> precludes the precautionary qualifications that scientists feel are

> necessary to accurately present their work. Readability in the eyes of the

> journalist may be oversimplification to the scientist. Indeed, many

> accusations of inaccuracy follow less from actual errors than from efforts

> to present complex material about risk in a readable and appealing style.

>

> Differences in the use of language contribute to strain. The language of

> science is precise and instrumental. Information is communicated for a

> purpose -- to indicate regularities and aggregate patterns, and to provide

> technical data. In contrast, journalistic language is often chosen for

> richness of reference and suggestiveness. Scientists or, in this case,

> physicians are used to directing their professional communication to an

> audience trained in their discipline. They often forget that some words

> with special meanings in a scientific context may be interpreted quite

> differently by the lay reader. Take, for example, the word " evidence. "

> Biostatisticians use the word " evidence " as a statistical concept. For

> biomedical researchers, the critical experiment is also defined as

> evidence. Most laypersons accept as evidence anecdotal information or

> individual cases. Thus the media considered the experience of the

> individual women as news. While physicians wanted aggregate data,

> reporters wrote of the immediate concerns of their readers.

>

> Finally, an important source of strain between scientists and journalists

> lies in the ambiguity about the appropriate role for the press. Many

> professionals talk about the press as a conduit or pipeline, responsible

> for converting technical information into a form where it may be easily

> transported to the public. Regarding the press as a technique to further

> technical or medical goals, they expect to control the flow of information

> to the public just as they do within their own domain, and feel betrayed

> when their views are challenged. Physicians are especially aggrieved when

> the issue has immediate policy or clinical relevance.

>

> The silicone breast implant controversy was marked by such strains. The

> tensions over the coverage of this dispute illustrate the important role

> of the media in risk disputes and the difficulties that are intrinsic to

> this role.

>

> * Dorothy Nelkin is University Professor at New York University, teaching

> in the Department of Sociology and the School of Law.

>

>

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