In September the IWF, under the direction of our Science Advisor and Senior Fellow Sally L. Satel, M.D., held the latest in a series of important press briefings to examine unfounded health scares. The IWF maintains that while caution and skepticism are necessary, a potent combination of unfounded fear plus overheated emotion ultimately inhibits medical progress and innovation.

The panel included medical experts who separated hype and hysteria from sound scientific evidence on recent health scares including: breast implants, tampons and dioxin, prozac and other related antidepressants, and genetically modified food.

The panel included medical experts who separated hype and hysteria from sound scientific evidence on recent health scares including: breast implants, tampons and dioxin, prozac and other related antidepressants, and genetically modified food.

The panel included medical experts who separated hype and hysteria from sound scientific evidence on recent health scares including: breast implants, tampons and dioxin, prozac and other related antidepressants, and genetically modified food.

The panel included medical experts who separated hype and hysteria from sound scientific evidence on recent health scares including: breast implants, tampons and dioxin, prozac and other related antidepressants, and genetically modified food.

What Science Says About Breast Implants
By Roger C. Herdman

Beginning in the late 1980s women expressed concerns about the safety of silicone breast implants. The allegations were that silicone was toxic and that it caused auto-immune disease, cancer, neurological diseases, and disease in children born to women with implants.

The issue is not whether some women with implants are ill, because many of them are ill. We do have an obligation, however, to ask if the woman’s illness is truly causally related to the breast implant.

Let?s consider four things. First, there are certain symptoms that are common in women. For example, we know that 10 percent of women will have breast cancer and so we would expect that 10 percent of women with implants would also have breast cancer. And there are a number of other common, less well-defined conditions — many people have dry eyes, dry mouth, morning stiffness, or trouble sleeping. We would expect to see those things in women who have implants as well as women who don’t.

Secondly, many of the scientific reports on associations of various conditions with implants are flawed.

Thirdly, a silicone gel implant is a large foreign body and you would expect to see some reaction and local complications. And you do.

Finally, many of these questions have been tried in the courts where the standard of evidence involves an adversarial process, which is much different than the standard of scientific evidence.

Silicone is enormously prevalent in our environment. It is normally present in our body. This is not some unusual and foreign substance.

The studies of the systemic problems associated with implants, with stunning consistency, are definitive: There is no association of immune problems with silicone breast implants. These studies have been carried out over the last decade and are conclusive.

When the new disease which many women believed they were suffering from — systemic silicone-related disease — was studied, the evidence was substantial that there was no such disease. The symptoms described were just as common in women without implants.

With research on cancer, it appeared that the breast implants were actually mildly protective against both breast cancer and recurrences of breast cancer.  

Lastly, studies of silicone levels in breast milk of women with implants did not detect elevated levels com-pared to women without implants. In fact, the levels were identical.

So what is the problem? The implants are a foreign body and cause scarring; they break, cause pain, and are sometimes misplaced, which has to be corrected. They can get infections around them. For women choosing augmentation, those complications are fairly frequent for an elective device. About 20 or 30 percent of those women over the ensuing five years will need another procedure to address one of those problems.

When saline breast implants break, the salt water leaks out into the tissue, which is harmless, but then the implant must be removed or replaced. With silicone implants, when the gel gets out into the tissues, it may migrate. That is quite rare, but it can occur. So, there are complications that women should know about.

It has always been a question of how many gel implants actually rupture. I understand that recently the FDA, in cooperation with the National Cancer Institute, attempted to study the incidence of rupture by performing magnetic resonance imaging on a group of women who had received implants some 10 or 15 years ago. Unfortunately, the majority of the implants in that study probably don?t represent the implants that are being placed today. So one would want to ask, how meaningful is a study of a few types of implants that were on the market 10 or 15 years ago in terms of what women are facing today? And what does that actually tell you about the universe of literally hundreds of types and models of implants that were in use decades ago?

The major safety concern with silicone breast implants is not systemic effects but the local complications. This emphasizes the need for the scientific community to try and make the implants better, and the need for women to have informed consent when they undergo implantation.

Roger C. Herdman, M.D., is Director of the National Cancer Policy Board and Study Director of the National Academy of Sciences’ 1999 report, ?The Safety of Silicone Breast Implants.

What’s in That Tampon? Don’t Look for Answers on the Internet
By Mary Jane Minkin

Tampons have been around a lot longer than the Internet, but the Internet seems to make it easy to spread pseudo-science and misinformation about tampons. Now the rumor is that tampons are loaded with dioxins.

Dioxins, to be sure, are bad for your health, but they are not found in tampons. The Food and Drug Administration has reviewed all the data and concluded that old tampon manufacturing processes might have produced dioxin levels of less than one part per trillion — essentially un-detectable. This is far surpassed by the amount of dioxin people consume in their diets, from dioxins present in the environment. In any event, modern manufacturing processes for tampons produce no dioxins at all.

So where did these rumors originate, that tampons are loaded with dioxin? Well, there is a lady in Canada, a back-to-nature type person, who makes her own tampons and she sells her homemade tampons on the Internet. She claims that her tampons are unbleached and therefore they contain no dioxins. But the commercially available tampons in the U.S. and Canada don’t have any dioxins either, so hers are not extra special just because they are not bleached.

The next leap of faith is that not only are tampons loaded with dioxins but that dioxins produce endometriosis. So, how did this rumor get started? Well, there is a woman whose name is Ruth. Now, Ruth doesn’t use her last name so I don’t what Ruth’s last name is. But, she has gotten on the Internet and then some TV stations picked this up from the Internet, and Ruth goes on and tells the dramatic story of her sufferings from endometriosis and she blames tampons. That is where this big rumor got its scientific basis.

Well, endometriosis is a terrible disease that occurs in as many as 10 percent of the women in this country, and nobody knows the cause of endometriosis. If I knew, I would be very famous.

Anyway, Ruth will tell you it is from tampons and it is from the dioxins in tampons that have given her endometriosis. There is no association between endometriosis and tampon use, period, let alone the dioxins in the tampons. But again, you get it on the Internet — this stuff gets publicized without any significant truth behind it whatsoever.

Now, there have been a few studies in monkeys showing that high dioxin exposure may promote the growth of a type of endometriotic tissue, which is experimentally induced in these monkeys. This is a highly artificial situation. Unfortunately, these studies have lots of methodological flaws, including the fact that dioxin actually seems to inhibit the action of estrogen, which traditionally is thought to be the thing that helps promote the growth of endometriosis — a very interesting paradox, if this association is true.

Unfortunately we do have data from one incident that occurred in a town in Italy where about 24 years ago a chemical factory exploded, exposing about 37,000 townspeople to extremely high levels of dioxin. This population has been studied now for many years, and there does not seem to be any increase in endometriosis or in cancers either.

But anybody can say anything on the Internet. It is our job as good physicians, scientists, and journalists to try to search out the facts and to provide our patients and our readers with the truth.

Tampons are medical devices and as such are regulated by the FDA. They don’t have to be regulated by Ruth and the lady in her cabin in Canada. Unfortunately a bill has been proposed in Congress by Rep. Carolyn Maloney (D-NY) to require further studies of tampons, toxic shock syndrome, and dioxin. To look at tampons for dioxin is really silly because they don’t have dioxin in them; and to study toxic shock syndrome now is, I think, pretty much of an academic exercise because there are vanishingly few cases currently reported despite the literally billions of tampons that are marketed and used every year.

I think we should instead be out there trying to find what is causing endometriosis or what is causing breast cancer, and let’s try to figure out how to protect women from heart disease. That is where good science will be productive. But to waste our time studying empty rumors doesn’t seem to make much sense.

Mary Jane Minkin, M.D., is a Clinical Professor of Obstetrics and Gynecology at Yale School of Medicine, co-author of two books on menopause, and a syndicated columnist specializing in reproduction and women’s health.

The Truth About Anti-Depressants Will Cheer You Up
By Sally L. Satel

In 1988 the anti-depressant Prozac arrived and made a huge impact on both the pharmaceutical market and the culture. We have heard virtually everything about the drug: that it makes some people “better-than-well,” and that it is to blame for the murders committed by one of the Columbine killers.

Of course the truth lies somewhere in between, but considerably closer to the benign end of the spectrum.

Are Prozac and its relatives, Paxil, Zoloft, Effexor, and Luvox, free of side effects? Of course not. But lawsuits have been charging that these medications have caused people to kill themselves, to kill others, and even to rob banks.

As a psychiatrist, I have prescribed these anti-depressants to hundreds of people. Formally, they are classified as SRIs (serotonin reuptake inhibitors) and, yes, there can be serious side effects, but those are very rare.

Over the years, a number of anti-Prozac books have appeared. Last spring, Prozac Backlash written by a psychiatrist, Joseph Glenmullen, was published and renewed the controversy over SRIs? safety. The claims made in that book fostered needless alarm. When there is needless alarm, of course, patients suffer. The book’s claims of induced suicide, homicide, and crippling neurological disorders are vastly oversold. If I were a patient taking Prozac, I would flush my pills down the toilet after reading Glenmullen’s book. I do agree that Prozac has been embraced perhaps too enthusiastically as a panacea for the human condition, but it has also extended the treatment of depression in positive ways. No longer are anti-depressants reserved for the most profoundly depressed.

Why have Prozac and similar drugs been used more liberally than their predecessors? First, they have fewer side effects. Blurry vision, low blood pressure, and sedation were common problems with earlier anti-depressants like the tricyclics and monamine oxidase inhibitors. In the case of monamine oxidase inhibitors, patients had to adhere to a special diet to avoid risk of stroke.

Also, they are much less dangerous in overdose, something one worries about with people who may be suicidal.

Many depressed people who probably couldn’t tolerate the side effects of those earlier anti-depressants have benefited. I do suspect, however, that the threshold has been lowered too far in some cases — such that individuals who didn’t need anti-depressants, whose mood would have resolved on its own, or who would have responded well to psychotherapy alone — were put on medication.

Most people who ask for SRIs are depressed. But Peter Kramer’s book, Listening to Prozac, talks about the phenomenon of “cosmetic psychopharmacology” in which personality traits like shyness, perfectionism, lack of confidence, fear of intimacy, over-or-under-competitiveness, even jealousy are “cured” by Prozac. Psychiatrists’ prescribing of Prozac for these purposes has, not surprisingly, come under scrutiny by the profession and the pundits alike, but the most dramatic controversy has been spurred by allegations of the violent urges that Prozac and other SRIs may produce — suicide as well as assault and murder.

There have been cases of people who kill themselves on Prozac. This is tragic, but it is far from a shock. After all, who are the recipients of these drugs? The risk of suicide in the general population is 1 percent; in the depressed population it is 15 percent.

One of the very first things that medical students learn is that patients are at a higher risk for suicide right after anti-depressants of any kind are initiated. Why? Because the various symptoms of depression don’t resolve all at once and frequently what’s first to improve are the energy level and sleep. And if a patient’s energy returns but he is still utterly depressed he can mobilize himself sufficiently to attempt and complete suicide.

Also, it is not unusual for patients to look a lot brighter once they have made the decision that they are going to kill themselves. They have a paradoxical mood lift, because they feel they have resolved their problem. Psychiatrists are trained to watch for this.

There have been some reports of people committing suicide on anti-depressants who hadn?t previously entertained suicidal thoughts. One of the most compelling theories behind this is a side effect called akathisia, which is a profound kind of restlessness. Patients will describe feeling like their organs are writhing in their body and they just have to move. Akathisia can be so distressing as to drive a patient to suicide.

No one had reason to believe that the Prozac-type drugs would cause this side effect. It was heretofore associated with anti-psychotic drugs. But within the last decade some patients on anti-depressants did develop akathisia.

This is so rare: At least three million people a year take these medications. Over a 10-year period one study found 92 case reports of these side effects. It?s a tiny percentage. But, of course, when it happens it’s spectacular.

The very important point is that these phenomena don’t start overnight. The intense agitation develops over a course of days or weeks. And that is why it is so important for the psychiatrist to follow the patients carefully.

That is the key: These medications are not so risky that they shouldn’t be prescribed, but they should be prescribed by people who are knowledgeable and have the capacity to hospitalize a patient if the situation turns dire.

Finally, you’re probably familiar with the more common side effects of SRIs: insomnia, nausea, decreased appetite, and impaired sexual functioning. These are often trade-offs that patients are willing to endure until their mood improves. And it is a good trade-off for them.

These medications help millions and millions of people. Are there some side effects? Yes. But the more dramatic incidents are enormously rare, and it is clear from the literature, and from my experience in the clinical world, that the benefits far outweigh the risks.

IWF Science Advisor Sally L. Satel, M.D., is a Lecturer in Psychiatry at Yale School of Medicine and W.H. Brady Fellow at the American Enterprise Institute. Her book PC M.D.: How Political Correctness Is Corrupting Medicine will be published by Basic Books in January.

Eat Your Vegetables: Why Biotechnology is Good for Food
By Henry I. Miller

The topic today has a number of different names: biotechnology, genetic modification, gene-splicing. All these terms involve taking living organisms, or parts of them, and using some sort of genetic improvement to create useful and important products. Whatever it is called, bio-tech has in recent years generated a great deal of controversy, most of it gratuitous.

Biotech is an area that has been largely distorted and misrepresented. I often have conversations with TV or radio producers who want to provide “both sides” of the issue. Well, that is rather like trying to discuss both sides of whether blood transfusion is a good thing, or whether the use of antibiotics for somebody who has pneumonia is a good thing.

There really are no two sides to the issue. Biotech is an improvement over previous technologies used for similar purposes; stands on its own safety record; and has produced important consumer benefits of all kinds. When we talk about the opposition to biotechnology, it is really an issue of faith or mythology rather than an issue of science and of learning from the data, and from our experience.

We need to keep in mind three essential points: First, that the genetic modification of plants and micro-organisms for food, agricultural purposes, and environmental uses is not new. It is just an extension or refinement of breeding and hybridization practices’ thousands of years old. What is new is that through modern techniques we can engineer genetic improvements much more precisely, predictably, and faster than ever before.

Second, the use of gene-spliced plants for food and fiber and other purposes has an amazing record of both environmental and human health safety.

Third, in spite of this point that gene-splicing is really an extension or refinement of what we have seen before and that it is demonstrably safe and has given rise to a number of useful products, it is massively over-regulated. United States Department of Agriculture (USDA), (EPA), and now the Food and Drug Administration (FDA) all have regulatory policies that discriminate against these products, that single out the use of these gene-splicing techniques per se as the trigger for excessive regulatory regimes.

Although many of us would not have predicted this (we would have predicted that the data would stand on their own), in fact this has become worse in recent years, not better. As recently as April, the FDA changed its long-standing policy of regulating on the basis of genuine risk, of treating gene-spliced foods no differently from others. Now FDA is introducing a mandatory pre-market evaluation, which exists only for gene-spliced foods and for nothing else.

USDA has long had a discriminatory policy, and EPA is about to introduce a rule that will regulate plants that have been genetically improved for pest or disease resistance and improved with gene-splicing techniques as pesticides. EPA will regulate gene-spliced marigolds, strawberries, wheat, corn, essentially as stringently as they would regulate malathion or parathion or substances similar to DDT. It is quite extraordinary. This is a proposal that came out in 1984 and has been roundly and consistently condemned by the scientific community, but EPA is just determined to get this rule out in the waning days of the Clinton Administration.

Over-regulation has been supported by activists and regulators and, surprisingly, even by big agribusiness. Why is that? This coalition of regulatory interests is an example of what economist Bruce Yandle at Clemson has called the “bootleggers and Baptists” parable of regulation.

According to Yandle, in the South, there continue to be Sunday closing laws that make it illegal to sell alcohol on Sundays. These laws are maintained by an inadvertent coalition of what he calls the “Baptists and bootleggers.” The Baptists provide the public outcry against consuming alcoholic beverages on Sunday, while the bootleggers, who actually sell these products illegally and benefit handsomely from them, use political contributions and other means of lobbying to quietly persuade legislators to maintain these laws.

Much of environmental regulation follows a similar path. In this case, the “Baptists” are the coalition of government regulators and radical environmental groups that want unnecessary regulation for their own reasons: It expands their influence, it heightens their profiles, and in the case of the environmental groups, it provides them a very potent fundraising tool because of the publicity that this subject offers.

The “bootleggers,” in this case are the big agribusiness companies that profit when competition can be kept down by high levels of regulation. Big companies don’t mind a great deal of expense; they can build it into the cost of research and development. Their object is to prevent seed companies and entrepreneurial biotech companies from being able to do this research cost effectively, and in fact, they have accomplished that very effectively.

Gene-splicing is now excessively and unscientifically regulated by U.S. agencies, by the European Union and, perhaps most ominously, by United Nations agencies and programs which are really not accountable to anyone. As these controversies (or pseudo-controversies) unfold, I hope you will be skeptical about them and ask about the scientific principles and existing data. Most of all I hope that you will think of where the self-interest lies when you hear “both sides” of these issues explored.

Henry I. Miller, M.D., Ph.D., is a Senior Research Fellow at the Hoover Institution at Stanford University. He was the founding Director of the FDA’s Office of Biotechnology and is the author of Policy Controversy in Biotechnology: An Insider’s View Landes/Academic Press, 1997) and To America’s Health: A Proposal to Reform the Food and Drug Administration (Hoover Institution Press, 2000).