Very political science

By Kenneth Smith Copyright 1999 Washington Times June 24, 1999

It has become fashionable in some quarters to argue that women ought to be able to make such decisions on their own. If members of our society were empowered to make their own decisions about the entire range of products for which the Food and Drug Administration has responsibility, however, then the whole rationale for the agency would cease to exist."

So wrote then-agency head David Kessler in the New England Journal of Medicine in 1992. He was defending his decision that year to ban silicone-gel-filled breast implants on grounds that the agency could not ensure they were safe. Not that the agency had proved they weren't safe. Implants had been around for several decades in as many as 2 million women, and despite grim anecdotes about ruptures of the device, the overwhelming majority of women were pretty happy with them. Hence the need for Mr. Kessler's warnings that women could not be trusted to make the decision of whether to have them.

In the ensuing panic Dow Corning Corp. went bankrupt after being inundated with claims from women, to say nothing of their lawyers, who accused the company of manufacturing breast implants that caused major illnesses in users. Dow has agreed to pay $3.2 billion to settle the claims. Other manufacturers, among them Baxter International, Bristol-Myers Squibb and Minnesota Mining and Manufacturing, have agreed to a settlement estimated at $3 billion combined.

Today, though, there is one less rationale for the FDA to exist and one more reason to avoid scaring women for political or other reasons. Yet another group of scientists, this one under the auspices of a group belonging to the National Academy of Sciences, has been unable to find any link between the implants and cancer, immunologic diseases, or neurological problems. Such diseases are the basis for much of the litigation the companies have had to endure.

Reported the scientists:

(1) There is no evidence to suggest that the silicones used in implants are toxic to humans. When individual studies have pointed to possible toxic, immunological, or neurological effects, more extensive analysis failed to uncover associations with specific diseases or conditions.

(2) There is no established link between implants and a unique disease syndrome. Syndromes of the type ascribed to implants generally involve symptoms that are nonspecific and common in the general population.

(3) There is no evidence that conclusively links silicone to harmful effects on the immune system. Early studies addressing the immunology of silicones are limited and have substantial technical problems. Follow-up analysis have failed to uncover associations with specific immunological diseases or other conditions. In addition, the committee also could find no evidence that mothers with implants pass silicone on to infants when breast-feeding. It turns out there are higher levels of silicon in cows' milk and commercially available infant formula than in the milk of nursing mothers with implants.(Brace yourself for suits against cows and infant formula.)

Not that there aren't any problems for women with implants. They do suffer from some of these diseases but at a rate no higher than the rest of the population. They also have to deal with a variety of potentially painful, local complications that can require additional surgery. Anyone who is contemplating getting breast implants better keep those complications in mind. Still even those injuries, which industry does not necessarily dispute, are hardly sufficient to bring down a major corporation.

Activists and trial lawyers who have made a good living off this long-running scare tried to knock the new report down, saying it showed industry bias. Well, then there must be a lot of bias around because almost any study on the subject that matters has been unable to find any major illness related to implants.

David Bernstein, a law professor and adviser for a tort reform group, told the New York Times the report might help end the ongoing litigation. "It is a very strong statement," he said. "It would have been nice to have had this $7 billion ago," Mr. Bernstein said.

Mr. Kessler's contempt for the choices of individual women wasn't the only problem here. The media had a big part in it too. In a famous, or rather infamous, episode of "Face to Face with Connie Chung," Ms. Chung began her program saying, "Coming up, some shocking information about breast implants." Anyone watching would have expected this worse, and Ms. Chung did not disappoint. She interviewed several women who claimed their breast implants had caused serious problems and left the audience wondering why FDA had not stepped in to ban the devices.

The impression that first-hand testimony like this has on listeners is hard to overestimate. The Academy of Sciences group heard much the same kind of stories from women both directly and indirectly. Many of the women, the scientists noted, are "seriously ill." The experts listening to them were "moved by their suffering." But they still couldn't find the link between implants and more serious diseases. A scientific panel can sort out life-threatening health problems from those that cause pain and discomfort. It can sort out fact from emotion. Not only are the media careless in distinguishing between them, they can disregard the differences recklessly. Consider one newspaper headline from 1992 that is not for the faint-hearted: "Under the knife: Woman Uses Razor to Remove Implants."

While scientists try to clean up the mess that Mr. Kessler and others have left behind, he has moved on to bigger, more politically correct wars against the tobacco industry. Apparently being a federal scaremonger means never having to say you're sorry for being arrogant. In the New England Journal he wrote that caveat emptor - let the buyer beware - would never be FDA's philosophy. Let Americans beware the David Kesslers of the world.

Kenneth Smith is deputy editor of The Washington Times editorial page.

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