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Scientifically, implant ban was a bust

So Marcia Angell was right.

In 1992, the then-executive editor of the New England Journal of Medicine wrote an editorial challenging the Food and Drug Administration's decision to ban the manufacture of silicone breast implants. "There hadn't been any medical studies," Dr. Angell explains. "How were women supposed to react to the ban? What were they supposed to do with this information?"

Four years later, with the FDA ban still in effect and an estimated 20,000 American women pursuing tort claims against implant manufacturers -- Dow Corning declared bankruptcy as a result of the litigation -- Angell published the book "Science on Trial." It was polemical, well written, smart, and advanced a boldly counterintuitive thesis: With the tort lawyers closing in on a record $4.25 billion settlement against the implant manufacturers, Angell wrote that there was no evidence that the implants harmed women's health. Rather, clinical studies published in the NEJM and elsewhere proved the opposite.

Now an FDA advisory panel has voted to lift the 12-year-old ban on silicone implants, validating Angell's claim that junk science triumphed in the courtroom, at the FDA, and in the theater of public opinion. "The breast implant controversy shows the proclivity of the public -- unable to tolerate uncertainty, unwilling to make minimal efforts to evaluate scientific stories, and reinforced by the media -- to embrace uncritically the medical scare of the day," she wrote.

Needless to say, Angell's message was not universally well received. Many feminists felt that a cherished cause -- breast implants, after all, gratified the male perception of female anatomical correctness -- had been sold out by a woman. FDA boss David Kessler didn't like being shown up, and of course the trial lawyers -- including John O'Quinn, the notorious "King of Torts" -- didn't appreciate having their shady business put on the street, as it were.

"I had a lot of positive feedback from people I didn't necessarily want to be associated with," says Angell, who now teaches at Harvard Medical School. "Feminists accused me of betraying the sisterhood. The manufacturers said I was terrific."

"The whole sequence was upside-down," Angell says. "First we had the lawsuits, then the FDA ban, and then the announcement of the largest class-action settlement in history. Only two months later did we get the first scientific study of the issue in question. What causes this is the use of expert witnesses. The expert gives an opinion, and that becomes the evidence. Since they are hired by the adversaries, they get the most extreme people they can find. In science it's the opposite. It doesn't matter who you are; what matters are what your data say."

Down from the ivory tower

Boston College professor Paul Lewis is an able writer and possessed of sharp wit; for instance, he coined the term "Frankenfood." His academic field of expertise is humor, but when Lewis wrote a caustic op-ed piece for the Toronto Globe and Mail last month, not everyone got the joke.

Titled "Can We Democrats Be Your Next Province?" Lewis playfully suggested that the states that voted Democratic in the 2000 election might secede and join Canada. But his tone was bitter and corrosive -- e.g., "We new Canadians will (shortly) acquire a national leader capable of producing coherent sentences in at least two languages. We will leave behind a US composed of increasingly polluted semi-tropical and desert states inhabited by citizens hell-bent on posting the Ten Commandments in public washrooms, installing a Star Wars defence system around fast-food restaurants, and generally doing what they can to bring on the Apocalypse."

Surprisingly (to him, not to me), Lewis was instantly vilified by dozens of right-wing Internet wackos, most of them apparently perusers of the website He received at least one death threat, and an ad hominem attack in Hilton Kramer's Frankenzine, The New Criterion. "It's a take no prisoners attitude that is not democratic in its instinct," says Lewis. "There is this disturbing quality of intimidation on the right now."

Alex Beam is a Globe columnist. Hise-dress is

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