Women's Implant Support Newsletter ~ January 7, 2000

Date: Fri, 7 Jan 2000 06:20:22 -0800

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Dow Chemical seeks to keep implant suits under one judge Thank you Kathy Nye for sending our way

Chemical Marketing Reporter

New York

Aug 5, 1996

Authors: Anonymous

Volume: 250

Issue: 6

Start Page: 4

ISSN: 00900907

Subject Terms: Products liability

Federal court decisions

Chemical industry

Breast implants

Classification Codes: 9190: US

9000: Short article

8640: Chemical industry, includes rubber & plastics

4330: Litigation

Geographic Names: US

Companies:

Company Name: Dow Chemical Co

Ticker: DOW

DUNS: 00-138-1581

Abstract:

Dow Chemical Co. is appealing a decision by Judge Denise Page Hood of the Federal District Court in Detroit, Michigan, to deny herself sole jurisdiction over thousands of silicone breast implant lawsuits. Copyright Schnell Publishing Company Aug 5, 1996

Full Text:

Dow Chemical Company is appealing a decision by Judge Denise Page Hood of the Federal District Court in Detroit to deny herself sole jurisdiction over thousands of silicone breast implant lawsuits. Dow wanted Judge Hood to combine the implant-related liability suits against it with the bankruptcy proceedings against Dow Corning, its jointly-owned subsidiary that manufactured the implants. Judge Hood, however, granted a plaintiffs' motion

that the lawsuits not be restricted to a single court. Implant manufacturers feel they will receive a fairer and more accurate hearing if the cases are consolidated, but plaintiffs want to bring cases in separate state and Federal courts.

Judge Hood previously transferred the Dow Chemical cases pending before her to Federal District Judge Sam Pointer, in Birmingham, Ala. The remainder of the cases pending in Federal court are also before Judge Pointer.

In April, the Court of Appeals for the Sixth Circuit ruled that the breast implant cases against Dow were related to Dow Corning's bankruptcy proceedings and therefore within Judge Hood's jurisdiction, should she decide to keep them in the Federal court system. But the Sixth Circuit court also asked that Judge Hood decide whether to abstain from such jurisdiction.

John Scriven, Dow's general counsel, says the company will fight the ruling. "The Sixth Circuit's decision in this case repeatedly emphasized the benefits of keeping all of the litigation concerning Dow Corning's breast implants together in one forum, rather than protracting the litigation by scattering the cases to virtually every jurisdiction in the land," he says.

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One woman's medical nightmare Thank you Kathy for sending this our way.

The following article has been sent by a user at READING AREA COMMUNITY COLLEGE via ProQuest, a Bell & Howell information service.

New Woman

New York

Dec 1996

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Authors: Lauretig, Lynette

Volume: 26

Issue: 12

Pagination: 99, 101+

ISSN: 00286974

Subject Terms: Breast implants

Defective products

Medical disorders

Abstract:

Lauretig has traced years of chronic illness to silicone breast implants she received 20 years ago. Her story is detailed. Copyright Rodale Press, Incorporated Dec 1996

Full Text:

Surviving when implants go wrong.

[IMAGE PHOTOGRAPH] Captioned as: Lynette Lauretig traced years of chronic illness to silicone breast implants she received 20 years ago.

In 1975, I was 26 years old, single, and working as an elementary school teacher in Beaufort, South Carolina. I had been reading in a number of women's magazines about the safety and ease of breast implants. The articles piqued my interest because I had never been entirely satisfied with my breasts. Not only were they rather small-which had been a cause of some embarrassment since high school-but they were also asymmetrical, and the left one had a small extra nipple at the bottom of the breast that was hardly noticeable but bothered me nonetheless. I didn't seriously think about surgery until I made a routine visit to my uncle, who was an osteopath in Orlando. He mentioned that he knew a local plastic surgeon who was well known for implant operations and was becoming fairly famous for the excellent work he did.

Because my uncle thought so highly of this surgeon, I made an appointment to see him. I spent about an hour with him, and he explained that it was an in-office procedure that required only local anesthesia with sedation and that the silicone implants should be good for life. He suggested larger implants than I had in mind and seemed surprised when I insisted I wasn't interested. Although I was somewhat ashamed of having the operation, I decided that if it ended my self-consciousness about my breasts, it would be worth it.

I was awake during the surgery and have no memory of any pain. There were no complications; I felt great afterward and went back to work within a week. I was happy with the size (having gone from about an A cup to a B cup), that they were even, and that the extra nipple was now hidden underneath the fold of my breast. But two things surprised me: First, I thought my breasts looked unnaturally lifted, and worse, I had no feeling at all in my breasts. I didn't recall having been warned about any loss of sensation and I was upset and worried about how it would affect my sex life. Still, I didn't regret the surgery.

About a year later I moved to Venezuela to teach at the American School in Caracas, for what turned out 101 research on implants, and Angell has written,, both in the Journal and in her book, Science on Trial: The Clash cf Medical Evideuce and the Law in the Breast Implant Case, that the major scientific studies have found no compelling link between silicone implants and autoimmune problems.

"The fact is that, by coincidence, ten thousand women who have breast implants will also have connective tissue disease," Angell says. In other words, the number of women with breast implants who have developed autoimmune problems has been statistically no higher than the number in the general population who develop these diseases.

There is also a definite undercurrent of belief that many of these women are using their implants as a catch-all explanation for all kinds of vague, and not particularly convincing, aches and pains. Dr. Fredricks believes a lot of them are actually experiencing a kind of mass hysteria. "I believe women have been unduly panicked.They feel dread and apprehension totally unrelated to the facts," he says. "The subject has taken on a life of its own. I have women coming in-they say `I'm forgetful, I've lost a little hair, my hands are paining me now.' But when they find out they're not ill, they're almost disappointed-as if they'd rather it was some terrible illness" Dr. Fredricks adds that sometimes these women are driven to sue by avaricious law/yers eager to make their fortunes from the misfortunes of their clients.

But on the other side of the debate are a number of reputable medical practitioners who insist that women do have some terrible illness, and that it's silicone, not fate, that is responsible for their agonizing symptoms. D. R. Shanklin, M.D., professor of pathology and obstetrics and gynecology at the University of Tennessee, is one of a group of doctors across the country who believe that, far from being "inert," as the manufacturers claim, silicone, once it has entered the bloodstream, can have disastrous effects on the organs. They add that silicone is also "unstable," meaning that once inside the body it can be transformed into substances like silica and silicate, which are both known to have carcinogenic properties. (The ED.A. has said that cancer risks from implants are tiny, but studies dating back to the 1950s, when silicone was still being introduced directly into the body, found increased tumors in rats that were injected with the substance.)

Still, autoimmune diseases remain the greatest fear: "I have seen it in my patients time and time again," Dr. Shanklin says. "There's no question-silicone causes some kind of an independent, immunopathic disease."

When women first began reporting their clusters of symptoms, doctors claimed never to have seen them in those particular constellations before and didn't know how to diagnose them. Even today, many doctors dismiss this clustering as too vague and all-encompassing: fatigue, muscle aches, sinusitis, and feelings of depression and despair can be attributed to a host of other causes, they say. Meanwhile, women tell stories of going from one health professional to another, having test after test, all to no avail. The reason, according to Andrew Campbell, M.D., medical director for the Center for Immune, Environmental, and Toxic Disorders in Houston, Texas, is that often they are being tested for the wrong disease.

"The tests look for typical diseases, but from my experience examining women, what they have is not a typical disease, it's atypical," Dr. Campbell says.

Today, as more and more women show up with broadly similar patterns of symptoms, and as doctors become more familiar with these patterns, there is a growing school of thought that holds that these women have developed a new form of autoimmune disease that is produced by silicone migrating into the body. This disease, believe some doctors, manifests atypical symptoms and evades detection by conventional autoimmune-disease tests. Doctors have coined the name "Siliconosis" or "Systemic Silicone Related Disorder" (S.S.R.D.) to describe the new disease.

"Anyone who has seen more than two dozen women has seen that their stories are too similar for us not to find something in common here," says Gary Solomon, M.D., associate director for rheumatology at the Hospital for Joint Diseases Orthopedic Institute in NewYork City.

Certainly, the women's stories are persuasive enough to convince jury after jury of their peers. Time and time again, the tales told by these women-who have sat in court often desperately ill, sometimes alienated from their families or fired from their jobs because of their debilities-have been eloquent enough to cut a swath through all the legal fences. Of more than 40 cases that have reached verdicts in the past five years, some two thirds have been decided in favor of the plaintiffs. Most of these women have left the courtroom with very large sums of money: (The biggest award to date is $25 million.)

Sifting Through the Science

And yet, despite the juries' verdicts, a number of highly publicized scientific studies continue to claim there is no clear connection between silicone-gel implants and disease.

The Studies Of the two studies most often touted as proof of this, one was produced by researchers at the Mayo Clinic in Rochester, Minnesota, and the other at Harvard University in conjunction with the Brigham and Women's Hospital in Boston. The Mayo Clinic study came first, in 1994, and compared the health records of 749 Minnesota women who had received implants between 1964 and 1991 with those of 1,498 women who had not. It found that women with implants were no more likely to develop autoimmune diseases than women without. This, according to Kessler, was the first "reasonable reassurance" that implants do not increase the risk of autoimmune disease.

Next, the Harvard study, released in June 1995, traced the medical histories of 87,501 nurses between 1976 and 1990; 1,183 of them had had implants. The researchers found that women with implants were actually slightly less likely to develop connective tissue diseases than those without. The investigation, heralded by the New York Times as "the most definitive study yet," added further support to the manufacturers' case that implants are safe.

The Critics But critics found many reasons to dispute the studies' findings. First, they criticized both research institutions for receiving money from implant manufacturers or for using the manufacturers' funds to pay individual researchers. While medical science tends to rely on grants from device makers and drug companies (which increasingly pick up the slack as government sources, like the National Institutes of Health, run out of money), many experts considered the implant makers' financial interest in the women's studies too close for comfort. And when it was discovered that two of Harvard's researchers, Peter Schur and Matthew Liang, M.D., had been paid consultants for law firms representing implant makers or the makers themselves, the university felt compelled to launch an internal investigation into what it termed "the perception of conflict of interest." The final recommendation: All future implant studies should be carried out by independent researchers.

The second critique of the studies involved their methodology. Critics complained that the researchers relied solely on questionnaires to reach their conclusions: Not a single woman in either study had actually been examined. And more seriously, they charged that the statistics had been skewed. Many women were included whose implants had not been in place long enough for autoimmune problems to have developed (some for as little as one month, even though serious symptoms don't usually become apparent before seven to ten years). The Mayo study, in particular, they said, included far too few women to draw conclusions.

Since only a small proportion of women with implants develop connective-tissue disorders in the first place, these critics found it hardly surprising that, with a sample of fewer than 1,000 women, the study found little cause for alarm. The Mayo researchers themselves admitted that they would have had to survey 62,000 women to get a statistically significant sample. "Our results cannot be considered definitive proof of the absence of an Association between breast implants and connective tissue disease," they wrote in their findings.

Dr. Solomon feels that the smallness of the sample sizes has been a problem with several of the recent studies. "Lupus and scleroderma are very rare diseases," he says. "Lupus only occurs in one in twelve hundred or so women. And scleroderma only occurs in one in fifteen thousand women. So to conclude that it's not there if you don't find it among the eight hundred or nine hundred women in the studies is quite dishonest." Many have suggested that even in a similarly sized study of smokers, researchers would not find a link between cigarettes and cancer.

But why, if these studies are flawed, are there no reliable ones? And where are the studies that support the theory that silicone is causing women's illnesses? Dr. Shanklin says they exist but are unpublicized. "I have a hundred-page bibliography of scientific literature on the cellular biology of silicone disease that confirms that something is indeed rotten in the state of Denmark," he says. Dr. Solomon adds that in the next year or two, at least two more large-scale studies are expected, one of which is from the National Cancer Institutes. Dr. Solomon is confident that the necessary evidence will show up.

A study produced earlier this year by researchers at Harvard Medical School is among the most persuasive of published reports finding links between implants and illness. The largest survey so far, it involved almost 400,000 women enrolled in the Women's Health Study; 10,830 of them had breast implants, and 231 of these reported illnesses like rheumatoid arthritis, scleroderma, and lupus.That rate of illness was 24 percent higher than in the women without implants. This ratio, the researchers concluded, represents a "small but statistically significant increased risk" of developing immunesystem problems. These results were enough for the American College of Rheumatology to reconsider its initial judgment that implants posed no significant risk-pending further evidence.

The Politics of Paranoia

Armed with a growing arsenal of studies, editors like Angell conclude that science is "progressing as it should," constructing in incremental steps a reassuring picture of the safety of silicone implants. A number of mainstream journalists share her opinion. New York Times science reporter Gina Kolata has repeatedly represented the Mayo and early Harvard studies as the definitive word, suggesting the controversy is closed. One Wall Street Journal editorial dismissed the plaintiffs' evidence about silicone dangers as "junk science," unacceptable for consideration in a courtroom. Newsweek declared that the women's cases were "fueled less by scientific evidence than the vague suspicion that big business is up to no good."

These same publications have also shown the implant makers in a sympathetic light. The Wall Street Journal published an outraged editorial when, in an implant case, Dow Chemical was found liable along with Dow Corning (of which Dow Chemical owns 50 percent). In the New York Times, Bernadine Healy, a former director of the National Institutes of Health, lamented Dow Corning's bankruptcy as "an outrage," criticizing the attitude " `So what if a big company bites the dust.' I find it hideous. What about our fundamental system of justice?"

Although a handful of reporters at mainstream publications have explored the issue in less biased ways, it has mostly been left to the alternative press-publications like Mother Jones and Ms.-to ask about a system of justice that fails to demand that corporations take some responsibility for marketing untested, if not dangerous, products, sold with false claims of safety. These publications are also the ones that reported the studies finding links between implants and disease, and that doctors exist who firmly believe in these links based on their having examined scores-sometimes hundreds--of women.

Paranoid-or Right?

Why are corporations, plastic surgeons, and even reporters (whose brief is to uncover the truth) so anxious to discredit the believers? It seems reporters are bending over backward to show they're not swayed by weeping women but instead are taking a hard-nosed, scientific approach.

The motivation of manufacturers and surgeons is easy to understand: money. Breast implantation has been one of the staples of plastic surgery, and the ban has meant severe income cuts for doctors. Many are angry with the manufacturers for having defaulted in their duty by not proving the safety of implants before they marketed them: Some, including Dr. Fredricks, have filed lawsuits against them for withholding vital information. Although implants have been available for almost 30 years, legitimate scientific studies were not performed until the ED.A. withdrew them. So it was only in 1995 that a University of California magnetic resonance imaging study of 775 women with implants established that ten to 12 years after surgery, as many as 91 percent of polyurethane-coated silicone implants had ruptured, as had 31 percent of conventional silicone devices.

"What is the sense in outlawing the injection of silicone directly, but allowing the implantation of a product that ruptures at a rate of approximately five percent a year-and dumps silicone in the very same place [the chest cavity]?" asks Dr. Shanklin. "There's no sense."

It seems the manufacturers may know this. Internal memos from Dow Corning executives dating from the mid-'70s show several safety concerns with their product that still haven't been put to rest: the effects of the implants' leakage and rupture rates, their long-term safety, and the speed with which they were rushing their new, still incompletely tested product to market. "Is there something in the implant that migrates out or off the mammary prosthesis? Yes or No!" one executive wrote impatiently. "Time is going to run out on us...," he added several months later. Another memo from the company's Mammary Task Force instructs salespeople in how to clean off the silicone sweat from an implant before showing it to potential buyers. This memo offers proof that concern over the implants' capacity to "sweat" or "bleed" their contents through their containers has existed since 1975.

Given the disturbing history of silicone, it is hardly surprising that women are worried. And given the distressing history of product-liability cases, it is also not surprising that they expect the worst. Back in the '50s, they fought bitterly with manufacturers over the disastrous repercussions of the drug Thalidomide, which caused terrible deformities in their babies. In the '70s, an antimiscarriage drug, DES (diethylstilbestrol), was found to raise the risk of cancer in women who took it, and caused malformed reproductive organs in their daughters. As late as the '80s, some intrauterine contraceptive devices were linked to sterility, pelvic disease, and even miscarriage-related death. Women have had to fight for years to get these flawed products off the market. More recently, a suit has been brought against the makers of another contraceptive device, Norplant, which is thought to cause various thrombotic and immune disorders and which has been found in many cases to be excessively difficult to remove.

With these past cases as the backdrop, and because the price of liability has risen precipitously in our modern litigious society, the stakes in the silicone breastimplant saga are dizzyingly high. Science may uphold the mainstream opinion that implants do not cause systemic disease. If it does, it will certainly come as happy news to the hundreds of thousands of women whose implants have now been in place for several years, and who, even though they are healthy now, fear they may be walking around with time bombs ticking in their chests.

But it is also possible that science will find more evidence linking silicone implants and the terrible diseases many women are enduring. And if that turns out to be the case, who will take the blame for discrediting and disbelieving the women's stories? And who will pay the enormous price owed to those whose lives have been ruined for the sake of profit?

And after he had been passed internal memos from Dow Corning employees voicing their fears about the safety of Dow Corning's products, F.D.A. commissioner David Kessler decided to call a moratorium on the use of silicone implants. He gave the manufacturers until 1999 to run safety studies, the results of which (see main article) have been coming in over the past few years. (The F.D.A. conducts no testing of its own, but rather reviews the studies that manufacturers organize.) In the meantime, the F.D.A. has ruled that silicone implants may only be used for reconstruction in patients enrolled in small, tightly controlled studies with strict eligibility requirements. However, saline implants (which provide less satisfactory cosmetic results) are available to anyone who wants them. As for the future, manufacturers are working on making implants with different, totally safe, fillers: An F.D.A.-approved pilot study of 50 patients is currently under way to test the most promising of these, a purified form of soybean oil.

Sue Woodman, a freelance writer who specializes in health and social issues, lives in New York City.

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Parting Interview with David Kessler

February 10, 1997

TRANSCRIPT

The FDA's authority to regulate tobacco was argued today in a federal court in North Carolina, and the issue may well end up in the Supreme Court.

Those regulations were adopted under the watch of Food & Drug Administration Commissioner David Kessler, who has announced he will leave the agency later this month. Here's a parting interview with him.

ELIZABETH FARNSWORTH: Now, the outgoing head of the Food & Drug Administration. As we reported, the FDA's authority to regulate tobacco was argued today in a federal court in North Carolina, and the issue may well end up in the Supreme Court. Those regulations were adopted under the watch of FDA Commissioner David Kessler, who has announced he will leave the agency later this month. Margaret Warner recently spoke to him.

MARGARET WARNER: David Kessler will soon step down from the job of FDA Commissioner after six stormy years in the post. We'll talk to Dr. Kessler about his tenure, but first this background from Kwame Holman.

KWAME HOLMAN: David Kessler was picked by President Bush in 1990 to head the Food & Drug Administration. At the time the regulatory agency was considered hopelessly bureaucratic by critics on Capitol hill and elsewhere and beset by cases of corruption that resulted in prosecution of agency employees. The Food & Drug Administration was established in 1906, after tainted food scandals involving meat packing. Today the agency certifies the safety of virtually all food products and tests new drugs and medical therapies before they're sold or used.

DR. DAVID KESSLER, Food & Drug Administration: (March 3, 1995) Our mission, as the nation's oldest consumer protection agency, is to provide basic public health protection for the foods we eat, for the drugs we take, and the medical devices we use.

KWAME HOLMAN: From the beginning of his tenure pediatrician and lawyerKessler said he'd be an activist and aggressively pursue strict health and safety standards. And it didn't take long for Kessler to make headlines. In 1991, he ordered the FDA to seize 40,000 gallons of Proctor & Gamble Orange Juice that was labeled "fresh" but had been made from concentrate. That began a series of Kessler initiatives his critics called "overzealous" and designed more to grab publicity than to address serious public health issues. That same year Kessler revolutionized food product labeling by requiring that uniform nutritional information be listed on all packaged food. Food makers not only had to be more specific and accurate in their labeling, the FDA also cracked down on what Kessler called widely misused terms such as "fresh" and "low fat." The agency set strict standards for use of all such terms.

In 1992, Kessler imposed a moratorium on the use of silicone implants for cosmetic breast surgery.

DR. DAVID KESSLER: (1992) One of the things that concerns me most is that breast implants may rupture, leak, or bleed more frequently than we had originally thought. We had been told that these are rare events. How often do these devices actually rupture? What happens to these devices ten or twenty or thirty or fifty years after implantation?

KWAME HOLMAN: But some in the medical community and in Congress said Kessler's silicone implant decision was premature and not justified by scientific findings. For years, the FDA had been criticized for taking too long to approve the sale of new drugs. In 1993, Kessler allowed drug manufacturers to pay a fee to get their products reviewed more quickly. One result was approval times were reduced by several months. Kessler also developed an even speedier fast-track approval process for therapies for life-threatening illnesses, such as cancer and AIDS. But for some in Congress the process still was too slow.

After Republicans became the majority in both Houses of Congress in 1995, Kessler's agency came under fresh scrutiny. At a Capitol Hill hearing that year, the FDA was accused of being hostile to the industries it regulates.

REP. JACK KINGSTON, (R) Georgia: (1995) The No. 1 criticism cutting through all this is that FDA is antagonistic, rather than conciliatory. Those people come to 'em.

You don't have a "can do" attitude; you have a "can't do" attitude towards the drug company or the medical device manufacturer, or something like that.

DR. DAVID KESSLER: You don't think, Congressman, that I want to get a device that is going to improve people's lives out there as soon as possible? I know it's not politically correct to say this these days, but I am and the agency is a regulatory agency.

KWAME HOLMAN: But the criticism from Republicans continued. Newt Gingrich once called Kessler "a thug and a bully," and presidential candidate Bob Dole said Kessler would have no place in a Dole administration. Kessler might be best known outside Washington for his high profile run-ins with the tobacco industry. Early in his tenure he suggested the FDA should consider regulating the nicotine and tobacco products as a drug. Then at a March 1994 congressional hearing Kessler accused tobacco companies of manipulating nicotine levels in cigarettes.

DR. DAVID KESSLER: Whose choice is actually driving demand for cigarettes in this country? Is it a choice by consumers to continue smoking, or is it a choice by cigarette companies to maintain addictive levels of nicotine in their cigarettes?

KWAME HOLMAN: Despite industry complaints, Kessler's anti-tobacco efforts culminated in a presidential initiative last summer. It established 18 as the minimum age to purchase tobacco products legally. Tobacco advertising and promotions targeted at teens were severely curtailed, and cigarette vending machines were banned from places frequented by young people.

MARGARET WARNER: And joining us now is David Kessler. Welcome.

DR. DAVID KESSLER, Food & Drug Administration: Thanks for having me.

MARGARET WARNER: Do you leave this job thinking you have made a real and lasting difference?

DR. DAVID KESSLER: We've tried. FDA is the most important consumer protection agency in the world. Just think about it. We have a responsibility for the safety of all foods, except meat and poultry, all drugs, cosmetics, medical devices. Our job is to protect and promote the public health. I think we've done a pretty good job.

MARGARET WARNER: Why do we need, in your view, such an activist government in protecting public health and safety? I mean, 50 years ago the FDA, while it existed, was certainly not half as aggressive as it is now. And yet people didn't die by the thousands from, from tainted meat and drugs. Why do you feel we need such an activist agency such as yours?

DR. DAVID KESSLER: First of all, I take exception to your statement that people didn't die, I mean, people today still, I mean, have ill effects from the foods that we eat, certainly not in numbers that we had at the beginning of the century, and the food industry has done a tremendous job, but even several months ago, remember the unpasteurized apple juice, and the deaths from that? I think that the American people expect us to be vigilant.

MARGARET WARNER: Do you think technology and science and medical advancement has also changed the nature of what's necessary?

DR. DAVID KESSLER: Oh, absolutely. Last year--this last year we approved 52 new molecular entities, new drugs whose chemical structure never existed before. We never had that many new drugs, and that's because in this nation's investment in biomedical science, we're reaping those rewards. I mean, there's real hope there, a hope that we've never seen before. The next 15 years we'll see discoveries that really will change medicine from an art into a science.

MARGARET WARNER: Now, your critics on Capitol Hill, Sen. Orrin Hatch, others, as we've just seen in the taped piece, say that the FDA under you demanded essentially zero risk and that, in fact, stood in the way of a lot of these wonderful advances and that people paid a price in being denied life saving drugs, or other, other treatments. What do you say to those critics that in a way your standards are too absolute?

DR. DAVID KESSLER: I ask them to name one drug, one therapy that's available somewhere else that works and is not available here in this country. Every single age drug--we have nine now available--were approved here first in this country. And it's not just AIDS. It'S drugs for Alzheimer's disease. It's drugs for ovarian cancer. This country is the world's leader. Yes, we have high standards. Yes, I stand and the agency stands and believes in those high standards, but we also can do it efficiently and get drugs to patients who need them rapidly.

MARGARET WARNER: All right. Let's turn to the tobacco issue, because that's one, of course, you've taken a lot of criticism on.

Tobacco--I mean, cigarette packs have a warning on them. I think every American knows that cigarettes are dangerous for their health. So have you--I know you don't think so--but where is the line between protecting health and safety and becoming essentially--as your critics would say--a national nanny for Americans who have to, after all, take some responsibility for their own health?

DR. DAVID KESSLER: The tobacco companies argue that smoking is a choice, that it's an adult choice. They're simply wrong. Ask a smoker when he or she began, and you'll hear the tale of a child. And it's not only that children are beginning to smoke at eleven, twelve, or thirteen, but they're becoming addicted by sixteen, seventeen, or eighteen. You're dealing with an addiction. You're not dealing with a choice. And it's not adults who are becoming addicted. It's children and adolescents who are becoming addicted.

MARGARET WARNER: All right. But if it's that dangerous, then why wouldn't the government ban them altogether?

DR. DAVID KESSLER: I think you've seen the president. You've seen this agency for the first time in 30 years stand up and put into place measures, reasonable measures, things that I think whether you're a smoker or a non-smoker, whether you're from Kentucky, or you're from Maine, make sense. They're aimed at reducing young people from starting. There are 50 million smokers in this country, 35 to 45 million of whom are addicted. Prohibition simply wouldn't work.

MARGARET WARNER: All right. Let's turn to another, earlier decision of yours on silicone breast implants. And at that time when you put the moratorium on their use for cosmetic purposes, the feeling was that the science was not completely conclusive.

DR. DAVID KESSLER: It wasn't there. The data was not there.

MARGARET WARNER: Now, you wouldn't approve a drug if the data weren't there that it was safe and effective. Why, essentially, unapprove something when the data was incomplete?

DR. DAVID KESSLER: Because the law requires it. The law gave the manufacturer a period of time. In fact, it had over a decade in which to collect that data, and they didn't do it.

MARGARET WARNER: So you mean the burden was on them?

DR. DAVID KESSLER: Exactly.

MARGARET WARNER: All right. Let's turn to another one. We didn't refer to it in the taped piece, but where Congress did clip your wings in a way, and that had to do with your attempt to bring nutritional and dietary supplements, the kind of things we see in health food stores and so on, under the same requirements to prove their own efficacy and safety as over-the-counter drugs and prescriptions. Now you lost that battle in '94. Congress essentially protected those drugs from that standard. Why--this is maybe a more political question--why did you lose that battle when you won so many others?

DR. DAVID KESSLER: It's a good question. I'm not sure I know the answer. There was a lot of political pressure by a lot of special interests brought on the Congress. What we said is that before you go make a claim, before you say this dietary supplement is useful in treating cancer or heart disease, or is good for you for certain health reasons, that you have the scientific data. That's what we stood for. There's a lot of miscommunication. People said we were going to make all dietary supplements by prescription. That was absolute nonsense. We weren't going to provide access to dietary supplements. It couldn't be farther from the truth. What we simply said was if you're going to make a claim that you be able to have the data, that you be able to support it. And Congress reduced the standards, lowered the standards somewhat, not entirely, made it more difficult for us to regulate those products. So when you walk in today to a store and you see those dietary supplements, you see many of them, you assume that we've done our job. You can't make that assumption.

MARGARET WARNER: This Congress, this Republican Congress and also even the Democratic Congress before, in fact, it was the Democratic Congress under which you lost that battle, I believe, in '94, has been filled with critics who said, yes, you've speeded up drug approval process but it's still too slow. I know you feel that you've done as much as you can, but why do you think that there is still that criticism there? I mean, surely these members of Congress don't want you to approve unsafe drugs?

DR. DAVID KESSLER: How long do you think it takes us to approve a

drug for AIDS, or a drug for cancer?

MARGARET WARNER: Tell us.

DR. DAVID KESSLER: Six months? Seven months? We approved the protease inhibitors in 40 days. What we cared about was making sure that we didn't stand in the way for even one day of getting those drugs to patients who needed them. People say they want to have access and they want to have access today to everything. It's true with dietary supplements, but then what happens when something goes wrong? What do we say? They say, where were you, FDA? You can almost call it the American way. We want it both ways.

MARGARET WARNER: What is your assessment, and have you tried to factor it in terms of what the public wants? Does the public have this kind of ambivalence?

DR. DAVID KESSLER: I think the public does expect from us a high degree of vigilance. The public expects us to be on their side. They expect us to make decisions in their interest, in their interest alone.

MARGARET WARNER: But yet there are times where they say, as you've said, we want the drugs now, government's too overbearing, it regulates too much?

DR. DAVID KESSLER: Yes. They say it, and when you ask your questions, do you want to get government off your backs, do you want to get government out of your lives, people always say, yes, we want that. But then if I ask you what's the role of government in the safety of your foods, what about the safety of the blood supply, what about in finding discoveries in pediatric AIDS? The same majority that will vote to get government off their backs will vote for government intervention in those cases.

MARGARET WARNER: Now how confident are you your legacy will endure? When your resignation was announced, tobacco stock prices soared, and there have been articles speculating that with your resignation the President may, in fact, negotiate some deals with this Republican Congress, either a legislative settlement on the tobacco business, or some sort of reforms of the FDA that would clip the agency's wings.

DR. DAVID KESSLER: I've spoken to the President. I've spoken to the Vice President. They care very deeply about what we have done in tobacco. They're not going to have those regulations watered down.

MARGARET WARNER: So you're absolutely confident of that?

DR. DAVID KESSLER: For the first time in our history an American president has stood up. In the last 30 years since we've known about the hazards of tobacco and literally said enough, we need to do something, and not only did he do it, but as it turned out, the public really did support, and it wasn't just people who don't smoke, the President did this--he won Kentucky.

MARGARET WARNER: What is the personal toll of a job like this and all of this controversy for someone like yourself? What's it been like?

DR. DAVID KESSLER: I wouldn't have traded this for anything. It was the most challenging, the most demanding time of--of my life. But look at the--what you can actually do. You go into the supermarket, you pull the can off the shelf, you look at that panel, that nutrition facts panel; you can know what's in the food. Where do you get opportunities to have that kind of impact on the public health?

MARGARET WARNER: What are your plans for the future?

DR. DAVID KESSLER: I'll probably go back to an academic environment.

MARGARET WARNER: All right. Well, I hope it gives you the same satisfaction.

DR. DAVID KESSLER: Thank you.

MARGARET WARNER: Thanks, David Kessler.

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OTHER SILICONE RELATED RESOURCES ARE AVAILABLE THROUGH

THE SILICONE WEBRING

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WHERE THERE'S SMOKE THERE'S FIRE ~ On The Net

The following websites have the "Where There's Smoke There's Fire" documents:

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FOR AOL MEMBERS OR OTHERS, WORKING WITH ON-LINE SERVICES NOT EASILY ACCOMMODATING THE FORMAT OF THESE NEWSLETTERS, YOU MAY ACCESS THEM FROM THE CANADIAN CONNECTION WEBSITE AT THE HYPERLINK BELOW. TONY & MICHELINE LAMBERT HAVE GRACIOUSLY ARCHIVED THEM FOR US.

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HUMOR

The Year is 2222

The year is 2222 and Mike and Maureen land on Mars after accumulating enough frequent flier miles. They meet a Martian couple and are talking about all sorts of things.

Mike asks if Mars has a stock market, if they have laptop computers, how they make money, etc.

Finally, Maureen brings up the subject of sex. "Just how do you guys do it?" asks Maureen.

The Martian responds, "Pretty much the way you do." A discussion ensues and finally the couples decide to swap partners for the night and experience one another. Maureen and the male Martian go off to a bedroom where the Martian strips. He's got only a teeny, weenie member-about half an inch long and just a quarter inch thick. "I don't think this is going to work," says Maureen.

"Why?" he asks, "What's the matter?"

"Well," she replies,

"It's just not long enough to reach me!" "No problem," he says, and proceeds to slap his forehead with his palm. With each slap of his forehead, his member grows until it's quite impressively long.

"Well," she says, "That's quite impressive, but it is still narrow." "No problem," he says, and starts pulling his ears. With each pull, his member grows wider and wider until the entire measurement is extremely exciting to the woman.

"Wow!" she exclaims, as they fell into bed and made mad, passionate love.

The next day the couples rejoin their normal partners and go theirseparate ways. As they walk along, Mike asks, "Well, was it any good?"

"I hate to say it," says Maureen, "but it was pretty wonderful."

"How about you?"

"It was horrible," he replies,"All I got was a headache. . .she kept slapping my forehead and pulling my ears."