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verbatimreturned · #1 07-21-2006, 07:50 AM

I'd like you to read this buddy.....Interview with Norm Fost, M.D. A graduate of Princeton (A.B.), Yale (M.D.) and Harvard (M.P.H.), he’s not only a practicing pediatrician, but also an expert in medical ethics. Anther Article from SteroidLaw.com and just for your information last time I checked Rick Collin's was an Attorney and not a dealer of anabolics.

Quote:

STEROIDS AND SPORTS:
A PROVOCATIVE INTERVIEW WITH NORM FOST, M.D.

By Rick Collins, J.D.

By the time the torch was extinguished and the dust of Athens had settled at the end of the summer Olympics, a total of 24 athletes had been thrown out of the Games for cheating by the use of performance-enhancing drugs, double the previous record of 12 from the Los Angeles Games in 1984. And the testing process on other samples still isn’t finished.

As the commanding general leading the war against performance-enhancing drugs in sports, World Anti-Doping Agency president Dick Pound snared more headlines than most of the athletes. Sometimes it seemed like the war waged on cheating athletes overshadowed the events themselves. Perhaps more than by any other measure, a competitor’s strength of character is now defined by the purity of his or her urine.

Under IOC rules, anabolic steroid use is cheating. That steroid use in sports is dangerous, immoral and unethical is the principle that underlies its prohibition. This principle is so entrenched that it would seem unthinkable to hear someone seriously challenge it.

That’s where Norman Fost, M.D., comes in. This man has big cujones, which might seem to be an atypical descriptive term to stumble across when you’re reading an article concerning steroids, but it’s apt here. In this age of stifling political correctness and “same thinking”, it takes big, brass ones to reject the popular military drumbeat and march in the opposite direction.

Dr. Fost isn’t short on gray matter, either. A graduate of Princeton (A.B.), Yale (M.D.) and Harvard (M.P.H.), he’s not only a practicing pediatrician, but also an expert in medical ethics. In fact, he’s been the Professor of Pediatrics and Director of the Program in Medical Ethics at the University of Wisconsin since 1973. He’s Chairman of the Hospital Ethics Committee, heads the Child Protection Team, and is also a past-Chairman of the American Academy of Pediatrics Committee on Bioethics. Last year he received the William G. Bartholome Award for Excellence in Ethics from the American Academy of Pediatrics. His views are generating increasing mainstream media attention, and he has recently appeared on television and radio broadcasts including ESPN, CBS Evening News, NPR Morning Edition, and C-SPAN.

My personal views on the subject of steroids in competitive sports are fully spelled out in my book, Legal Muscle, and won’t be the focus here. Dr. Fost has his own take on the topic, and, right or wrong, what he has to say must seem like high treason to anti-steroid soldiers like Dick Pound. I had the opportunity to speak with Dr. Fost in a remarkable, no-holds-barred interview recently, and here are the highlights.

RC: The outcry over steroids in sports has always had two components. One is the potential health danger and the other is the “unfair advantage” issue. Let’s start with the health risks.

NF: First, I think we need to separate children and adults. I think absolutely they should be banned for children. Steroids can have permanent effects on growth and other metabolic effects, and children are in no position to be making choices about risks. Of course, there are also risks to competent adults. Many of them are reversible or cosmetic such as hair growth, hair loss, or voice changes. Infertility is an extremely common phenomenon in men and women, usually reversible. Certain oral steroids were associated with liver cancer, but to the best of my knowledge that has not been shown with contemporary injectable steroids. Steroid use does change blood lipids undesirably, and if sustained over many years or decades could increase one’s risk for heart disease, but I’m not aware of any studies showing an increase in heart disease among athletes who use them.

RC: So, there isn’t any scientific proof that the short-term changes that are common with intermittent steroid cycles are connected to heart disease?

NF: Correct, and the cardiologists that I have talked with think that it’s unlikely that it would be. Many steroid risks have been wildly exaggerated or misstated in the press. Take the famous interview with Lyle Alzado, the NFL player who developed a brain tumor and claimed, “See? This is what happens when you use anabolic steroids for too long.” Nowhere in the article was there a single reference or scientific source for any connection between steroids and brain tumors, because there is none. These stories appear in the leading journalistic media, creating the false impression that the claims are somehow supported by scientific studies.

RC: Have the media fairly put the risks in perspective of other risks that athletes voluntarily assume?

NF: No, not at all. For example, playing in the NFL for three years or more risks an extremely high rate – 80 to 90% in one study – of permanent disability. That’s unfortunate, but it goes with the territory and nobody says this is a reason to ban professional football. It’s something that competent adults decide to do in exchange for the money, glory and pleasure that they get out of it. We don’t think, in America, that people’s liberty to take risks like that should be interfered with, just so long as they are not harming anyone else. Whatever the risks of steroids, even the most extravagant view of the risks isn’t remotely in that category in terms of potential for permanent disability or even death. There have been dozens of deaths attributed to playing football. I’m not aware of any football players who have died because of steroid use.

RC: Steroid use for athletic performance is banned as “doping” in many sports, so somebody who breaks the rule should be punished, right?

NF: First, this whole idea of calling it “doping” bothers me. The noun “dope” typically refers to illicit narcotics. There’s a pejorative tone that is too widely accepted by constantly using the word “anti-doping.” It pre-judges the issue, and I think it ought not to be used. Regardless, sports have rules and you have to play by them. If you don’t, there are penalties and you suffer the consequences.

RC: Canadian sprinter Ben Johnson seems like the original poster child for that.

NF: To me, the moral issue that is most troubling about the Ben Johnson affair is the way that the press and the public treated this, not just as a breaking of the rule, but as a fundamental moral problem of enormous proportions. We don’t make moral judgments about people who commit fouls on the basketball court. It’s the claim that Ben Johnson was doing something immoral just because he broke the rule that astonishes me. On the same day that he was discovered to be steroid positive and had his medal taken away from him, American swimmer Janet Evans was holding a press conference about her greasy swimsuit which American technology had developed and kept secret from the East Germans, and which had unequivocally, in her view, shaved seconds off her time and contributed to her victory. Here you have a very clear case of unfair competition and yet this is hailed as a great triumph of American ingenuity. And on the other side you have Ben Johnson – who used something that while banned is universally accessible – being condemned as some sort of moral moron. It’s the disconnect between those two events that first got me interested in this and struck me as the most incoherent.

RC: If in a particular sport the rules are silent, you don’t see anything inherently unethical in using steroids? You don’t see it as an unfair advantage?

NF: It would strike me as one of a thousand things that athletes do to try to gain an advantage over competitors. It is not considered immoral to try to gain a competitive advantage. I would put steroids in the long list of things that athletes do to try to win. Better shoes, better equipment, better training, better coaching than the opponent has. If such advantages were not available to all competitors, then the advantage would be unfair. The usual solution to that is to equalize access. It is remarkable how people brag about manifestly unfair advantages, such as better training facilities, greasy swimsuits, or even superior coaches, and then express outrage about a drug that is generally available to anyone who wants it.

RC: But, doesn’t there have to be a line drawn somewhere, however subjective and arbitrary?

NF: Yes, but I don’t think steroids are anywhere near it.

RC: What about the claim that steroid use in sports coerces other athletes to use?

NF: “Coercion” is another one of those inflammatory scare words. Coercion in the dictionary means “the use or threat of force.” There is no claim that anyone in the United States is being forced into using steroids. You don’t have to use them to be successful in the NFL or Track and Field. There are users and non-users. But even if it were true that you couldn’t win at the elite level without them, that’s part of the cost of playing at that level. There are many risks and deprivations you have to undergo to be a football player – most of them involving far more risk than steroids – or a track star or a gymnast. And if you don’t want to do it because it’s just too risky, then don’t do it. No one is forcing you to do anything, at least not in this country. If they were, that would be wrong.

RC: You’re a pediatrician. What about the argument that condoning athletic steroid use among adults sends the “wrong message” to the children?

NF: Again, children should not be using these drugs. I am in favor of whatever it takes, including education and involuntary testing, to make sure children don’t use them. There’s very disturbing data about middle school children, boys mainly, using anabolic steroids as part of weight lifting programs. According to one study, it’s not football players for the most part, but boys who are doing it to make themselves more attractive to girls. The role models aren’t athletes. I am more worried about other role modeling in athletics, which I know occurs on a widespread basis and causes much more harm.

RC: What role modeling are you referring to?

NF: The role modeling of hurting people; causing injury; getting the quarterback out of the game; injuring the wide receiver. Look at hockey, where mayhem is mimicked at a very young age. There are articles about the development of youth hockey programs in Canada, in which it’s an explicit part of the youth league to teach violence – intimidating and hurting people – because it’s viewed that this sort of pit bull training is what it takes to succeed.

RC: If that sort of thing occurs here in the United States, President Bush isn’t taking time out of the State of the Union address to talk about it, and Government officials aren’t conducting any grand jury investigations into it, as they are into steroid use.

NF: Nor is it even criticized. Or generally reported in the sports pages the way steroids are. Yet I see it all around me. Even the coaches talk about it, “You got to take that guy out of the game.” It is widespread and pernicious. As far as I can tell, the use of steroids as role modeling in sports is miniscule compared to that.

RC: What are your thoughts about non-competing adult bodybuilders who elect to use steroids purely for cosmetic reasons?

NF: Whatever ethical issues there are in the use of steroids in competitive sports, which, as I’ve said, I don’t think are worth the attention they receive, they disappear with non-competing personal use. We are not talking about unfair competition, we’re not talking about coercion, and we’re not talking about undermining the integrity of sport. This is pure personal choice, right up there with smoking, drinking, bungee jumping – that is, choices people make in life which they should be free to make.

RC: Anabolic steroids were placed under the Controlled Substances Act in 1990, limiting the scope of physician prescribing with the threat of criminal penalties. Do steroids belong there?

NF: Whatever the arguments about our regulatory system for narcotics and marijuana and so on, they simply don’t apply to steroids. This is not a source of violent criminal activity, school dropouts and all the social problems of illicit drugs. So putting this in that category strikes me as bizarre. If the government is really concerned about safety, if that is really the issue, the steroid situation screams for regulating the drugs through the FDA, and facilitating supervision by doctors. By driving this behavior underground, we have increased whatever risks exist by ensuring that safety studies are not performed, either short or long term. We have also lost control of manufacturing processes, so the user has no way of knowing what, in fact, he is using. The policy of a ban, coupled with criminal penalties, is even more incoherent if safety is the argument.

RC: You’ve hit on a key theme explored in Legal Muscle. But do you think that steroid administration for the purpose of building muscle in healthy adults could be safely accomplished under the supervision of physicians?

NF: There’s no drug in the world that has zero risks. The issues are whether the risks are manageable, whether they are in the same ballpark as other drugs that are widely prescribed – and I think they are – and whether the risks can be reduced to an acceptable level. I think the risks are most reduced under a knowledgeable doctor’s supervision. No question, there will always be adverse effects, but the life-threatening or irreversible and disabling adverse effects are likely to be low, and risks a competent adult may choose to take on even if properly informed. If the risks are greater than present evidence shows, the most efficient way to learn about that is through well-designed studies, as we do for other regulated drugs.

RC: Critics would argue that if physicians could prescribe steroids for non-medical reasons, some might begin catering to overly ambitious bodybuilders, pushing the envelope further into more dangerous territory.

NF: Generally most doctors practice medicine in a rational, sensible way and we do have corrective measures for people who practice medicine irresponsibly. We have lawsuits and licensing boards to limit, though not prevent, the possibility of that. Besides, slippery slope arguments are not a reason for prohibiting a technology. All technologies have unanticipated harmful effects, but the possibility of that or even the certainty of that has never before been thought to be a reason for prohibition.

RC: What about critics who argue that the adverse effects of steroids won’t be seen or known for years, decades, or even generations?

NF: That’s an argument that can be made about any drug, any food, or any device that uses a new technology. It’s a reason why we have regulations; why we have an FDA that requires careful testing, and NIH funding for long-term studies. It’s a reason to do continuous monitoring of drugs’ effects, for having an adverse event reporting system, and for having people using these drugs under medical supervision. Everything has unknown risks. Steroids are no different. The mere fact that there are unknown risks is not a reason to prohibit something.

RC: Thanks, Doctor. Provocative stuff, to say the least.

Obviously, the existing rules against performance-enhancing drugs in sports must be enforced, and cheaters must be identified and punished for as long as the rules remain in effect. Personally, I have no sympathy for cheaters. But Dr. Fost might ask, looking ahead, “Are we winning the war against drugs in sports?” As drug-enhanced athletes become increasingly sophisticated and the specter of gene doping looms on the horizon (if it isn’t here already), do victory cries from Dick Pound and International Olympic Committee president Jacques Rogge seem to ring hollow?

Whatever our personal views on the ethics of steroids in competitive sports, the civilian casualties of this war are piling up outside the stadiums. The war intended to level the playing field in sports spawned criminal laws to facilitate it, yet those ensnared by these laws have been almost exclusively non-participants in the Olympics or any other professional or elite athletics. The arrest and prosecution of these non-participating civilians – mostly recreational bodybuilders, and my clients – will continue to be this war’s collateral damage.

verbatimreturned · #2 07-21-2006, 07:55 AM

Why doesn't the FDA regulate supplements....well I think you should have looked into this one too before you spoke. From THEIR OWN WEBSITE (legit if you ask me) http://www.cfsan.fda.gov/~dms/supplmnt.html

Quote:

FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.* Manufacturers must make sure that product label information is truthful and not misleading.

FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.

*Domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register their facility with the FDA. For more information, see Registration of Food Facilities.

EricT · #3 07-21-2006, 09:10 AM

Here's some further info as to the FDA's role in supplements:

Overview of Dietary Supplements
What is FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them?

In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements.

Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.

Also, manufacturers do not need to register themselves nor their dietary supplement products with FDA before producing or selling them. Currently, there are no FDA regulations that are specific to dietary supplements that establish a minimum standard of practice for manufacturing dietary supplements. However, FDA intends to issue regulations on good manufacturing practices that will focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements. At present, the manufacturer is responsible for establishing its own manufacturing practice guidelines to ensure that the dietary supplements it produces are safe and contain the ingredients listed on the label.

When must a manufacturer or distributor notify FDA about a dietary supplement it intends to market in the U.S.?

The Dietary Supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor notify FDA if it intends to market a dietary supplement in the U.S. that contains a "new dietary ingredient." The manufacturer (and distributor) must demonstrate to FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply.

There is no authoritative list of dietary ingredients that were marketed before October 15, 1994. Therefore, manufacturers and distributors are responsible for determining if a dietary ingredient is "new", and if it is not, for documenting that the dietary supplements its sells, containing the dietary ingredient, were marketed before October 15, 1994. For more detailed information on new dietary ingredients, go to: http://www.cfsan.fda.gov/~dms/ds-ingrd.html.
What information must the manufacturer disclose on the label of a dietary supplement?

FDA regulations require that certain information appear on dietary supplement labels. Information that must be on a dietary supplement label includes: a descriptive name of the product stating that it is a "supplement;" the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and the net contents of the product.

In addition, each dietary supplement (except for some small volume products or those produced by eligible small businesses) must have nutrition labeling in the form of a

"Supplement Facts" panel. This label must identify each dietary ingredient contained in the product.

Overview of Dietary Supplements
Must all ingredients be declared on the label of a dietary supplement?

Yes, ingredients not listed on the "Supplement Facts" panel must be listed in the "other ingredient" statement beneath the panel. The types of ingredients listed there could include the source of dietary ingredients, if not identified in the "Supplement Facts" panel (e.g., rose hips as the source of vitamin C), other food ingredients (e.g., water and sugar), and technical additives or processing aids (e.g., gelatin, starch, colors, stabilizers, preservatives, and flavors). For more details, see: http://www.cfsan.fda.gov/~lrd/fr97923a.html.

What is FDA's oversight responsibility for dietary supplements?

Because dietary supplements are under the "umbrella" of foods, FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency's oversight of these products. FDA's efforts to monitor the marketplace for potential illegal products (that is, products that may be unsafe or make false or misleading claims) include obtaining information from inspections of dietary supplement manufacturers and distributors, the Internet, consumer and trade complaints, occaisional laboratory analyses of selected products, and adverse events associated with the use of supplements that are reported to the agency.

Does FDA routinely analyze the content of dietary supplements?

In that FDA has limited resources

to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness. Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law. The remaining funds are used for routine monitoring of products pulled from store shelves or collected during inspections of manufacturing firms. The agency does not analyze dietary supplements before they are sold to consumers. The manufacturer is responsible for ensuring that the "Supplement Facts" label and ingredient list are accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the label. FDA does not have resources to analyze dietary supplements sent to the agency by consumers who want to know their content. Instead, consumers may contact the manufacturer or a commercial laboratory for an analysis of the content.

Quote:

Originally Posted by Peanut

the FDA Don't monitor all meat that comes in,but most of it.they Don't monitor bodybuilding supplements for a reason,they don't monitor crap.

Hmmm. To recap:

"Because dietary supplements are under the "umbrella" of foods, FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency's oversight of these products."

"In that FDA has limited resources to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness. "

It seems that many people have this notion that the government is standing by and watching over the shoulder company manufacturing food in the U.S. It doesn't work that way. One of the central reasons for this is that it would simply be to monumental and undertaking given the limited resources. It would stand to reason that a primary reason why the FDA would like to ban certain supplements is that it would simply be easier to ban things then to investigate legitimate claims of unsafe substances or to deal with the reports of side effects of those who stupidly abuse otherwise safe ones.

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