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Never Enough: Steroids in Sports: Part Two
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Never Enough: Steroids in Sports: Part Two - 10-09-2005, 08:25 PM

http://www.post-gazette.com/pg/05276/581527.stm

Never Enough: Steroids in Sports / Part Two
Monday, October 03, 2005

By Robert Dvorchak, Pittsburgh Post-Gazette


Steve Mellon, Post-Gazette
Pittsburgh attorney Jerry McDevitt put the government on trial in his defense of In defense of Vincent K. McMahon Jr., the driving force behind the World Wrestling Federation, who was indicted in 1993 for conspiring to distribute $530 worth of steroids to his wrestlers. McDevitt spent two years compiling what is thought to be the only existing regulatory history of steroids.
Click photo for larger image.

About this series


This is the second story in a four-part series on the history of steroids and how they spread throughout athletics.

YESTERDAY: An experiment in York, Pa., plants the seed for the steroids epidemic. Read more ...

TODAY: A Pittsburgh attorney put the government on trial to get his client acquitted of steroids charges.

TOMORROW: Ran*** drug testing is part of life for today's NFL players.

WEDNESDAY: The ethics of steroids use will continue to perplex society as researchers explore its age-defying benefits.


Audio summary


A conversation with author Robert Dvorchak: Few people know how the steroids epidemic in sports really started. On Day One of the series, he introduces readers to the first U.S. athlete to use steroids to enhance his performance. On Day Two, he explores how steroid use outpaced government regulation.


Your Views


Join the series' author, Robert Dvorchak, for an online chat about the issues raised in his reports. The session is scheduled from noon to 1 p.m., Friday, Oct. 7. Click here to log-in as early as 11:30 a.m. that day to post your questions ahead of the session.



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In the waning months of 1993, Pittsburgh attorney Jerry McDevitt began a two-year quest to learn everything he could about anabolic steroids -- what they were, where they came from, how they spread -- to cobble together a history.

He tracked down Bill March, a participant in the original human experiment that had spun out of control at the York Barbell Co. He pored over the books by experts and dug up newspaper and magazine articles. And using requests under the Free*** of Information Act, he obtained government documents in the musty files of the Food and Drug Administration.

Those documents tell an untold chapter in the Age of Steroids and are the foundation of McDevitt's conclusions: The government that demonized steroids as a controlled substance is the same government that approved their use in the first place, allowed pharmaceutical behemoths to sell steroids for decades, tried to curb their use by warning that steroids didn't help athletes and bungled attempts to remove them from the market while the games went on.

"Nobody has told this story from the beginning," said McDevitt of Kirkpatrick & Lockhart LLP. "The principle side effect of steroids is lying."

Using those documents as a road map, McDevitt convinced a federal jury of the veracity of his claim and won an acquittal for his client in a 1995 federal trial without calling a single defense witness.

That client was Vincent K. McMahon Jr., the driving force behind the World Wrestling Federation, who was indicted in 1993 for conspiring to distribute $530 worth of steroids to his wrestlers.

To the government, McMahon was an admitted steroids user who was a prime candidate for a legal body-slamming under a 1988 law that made it a federal crime to possess steroids with intent to distribute.

McMahon's indictment followed on the heels of the conviction of Dr. George Zahorian, a urologist hired by the state of Pennsylvania as the ringside physician at wrestling shows and boxing matches in central Pennsylvania. Zahorian was found guilty of peddling steroids from his medicine bag and a couple of tackle boxes to Hulk Hogan, Roddy Piper and other wrestlers.

For his part, McDevitt didn't defend McMahon's actions, and he didn't defend steroids. He did put the government on trial by compiling what is thought to be the only existing regulatory history of steroids.

It was the government that inquired about history this spring during one of the congressional hearings on drug-free sports. U.S. Rep. Joe Barton, chairman of the House Commerce Committee, posed this rhetorical question at one of the sessions: "So how in the world did we ever get in a position where steroids were swallowed like M&Ms and adults winked at each other when baseball players started growing arms as big as tree trunks?"




The long, winding trail of steroids took McDevitt back to York, Pa., during the '50s and to Dr. John Ziegler, who pioneered the development of Dianabol in concert with Ciba Pharmaceutical Co.



Post-Gazette Archives
Vincent K. McMahon Jr. takes center stage at a World Wrestling Federation event in 1999.
Click photo for larger image.








There was a two-fold strategy from the start. Ziegler supplied test-tube testosterone to athletes competing for national honor against the Russians while Ciba peddled it on the U.S. drug market for medicinal purposes after it was approved for use by the FDA.

But Dianabol was only one of a number of anabolic steroids that appeared around 1960, all of them derivatives of a sex hormone. The tongue-twisting names sound futuristic, but they're commonplace in the medicine chest of today's athlete and familiar to any teenager with a working knowledge of the gym and the black market of the Internet.

Fluoxymesterone was made by Upjohn as Halotestin and by E.R. Squibb and Ciba under other names. Durabolin (nandrolone phenpropionate) originated in the labs of Organon Inc., the same pharmaceutical company that churned out the injectable Deca-Durabolin (nandrolone deconate) and Maxibolin (ethylestrenol). Oxymetholone was marketed as Anadrol by Syntrex Laboratories Inc. and as Adroyd by Parke-Davis & Co. Winstrol (stanozolol) was developed in Great Britain and marketed in America by Winthrop Laboratories in 1962 -- 26 years before it tripped up Canadian sprinter Ben Johnson in the Olympics and 43 years before Rafael Palmeiro became the highest-profile name in baseball to test positive for steroids. Anavar was produced by G.D. Searle & Co.

"When you ask where this stuff came from, this is a picture of corporate America. They made fortunes selling it," McDevitt said.

All of them enhanced muscle-building properties while limiting but not eliminating the masculinizing effects of testosterone. All of them made claims that, among other things, they could restore burned skin, strengthen frail bones, help patients recover from surgery, provide testosterone for those whose bodies failed to produce it naturally and help offset the effects of breast cancer, anemia and other conditions.

All were licensed for sale by the FDA, but none of them mentioned the performance-enhancing capabilities on their labels.

Under FDA safeguards in today's day and age, it would take perhaps as long as eight years for a drug company to bring a product to market. After being produced in the lab, a new drug would have to be fed experimentally to animals before it could be approved for tightly controlled, double-blind experiments with human volunteers to show that it is safe and works for its stated purpose. Only after all of those steps are taken could it be considered for approval.

Anabolic steroids, however, led a charmed life.



Tim Boyle, Getty Images
Former MLB player Jose Canseco poses with five-year-old Chicago Cubs fan Ben Slack in March while promoting his book "Juiced" at Borders Books in Chicago, Illinois. The book book alleges common use of anabolic steroids in Major League Baseball.
Click photo for larger image.








They appeared as prescription drugs when federal regulations were so lax that a drug could be approved for use if its maker showed that you wouldn't fall over if you swallowed it. Manufacturers were not required to show that it was effective for what it claimed to do.

That changed, however, in 1962 when Congress amended the Food, Drug and Cosmetic Act to require drug-makers to prove the effectiveness of products already on the market. It was called the Drug Efficacy Study Implementation program, or DESI. Drug companies were given a two-year window to comply.

But steroids benefitted from another loophole. Once a drug is on the market, it can be legally prescribed for off-label purposes. That meant athletes could openly and legally get anabolic steroids from their doctors to build muscle.

Take, for example, Dianabol.

At the request of the FDA, Ciba Pharmaceuticals claimed in 1965 that Dianabol had legitimate medical uses for helping patients in debilitated states and those with weakened bones, those convalescing from surgeries or those with arthritis.

The written filing neglected to say anything about the doses or durations Ziegler had prescribed for his secret experiment -- five, 10 and 15 milligrams per day depending on body size, to be used for six weeks and then stopped for five weeks, with periodic medical checkups and a liver test every four months. Those outside of Ziegler's control group experimented with their own doses.

But while steroids spread from sport to sport and gym to gym, the bureaucracy moved at a glacial pace. The FDA made its first findings about Dianabol in 1970, saying that it was "possibly effective" as adjunctive therapy in the treatment of senile and post-menopausal osteoporosis and for pituitary dwarfism. More time was given the manufacturer to prove of its other claims.

Years passed, but proof never came. So in 1980, the FDA triggered the mechanism to withdraw Dianabol and other anabolic steroids from the market because they were not shown to be effective for their labeled uses but were being consumed in mass quantities by weight-lifters and athletes.

However, it wasn't until three years later that the FDA revoked the temporary exemption that allowed Dianabol to stay on the market. In June 1983, the FDA formally announced it had withdrawn the license for Dianabol -- 23 years after it was first approved. Adroyd and Anadrol were also withdrawn because their makers had failed to show the drugs did what their labels said they did.

"In plain English, Dianabol was sold for decades in this country without ever proving it was effective for labeled uses and without ever being required to provide instructions for use for the specific purpose designed by Dr. Ziegler," McDevitt said.



One of the most baffling and inexplicable elements about steroids involves the FDA's first public finding about them.



Associated Press
Canadian sprinter Ben John son became the world's fastest human with a time of 9.79 seconds in the 100-meter dash at the Seoul Olympics. He had been taking Winstrol for eight years without failing a drug test.
Click photo for larger image.








In 1972, a dozen years after Ziegler gave Dianabol to athletes for the express purpose of keeping up with the Russians, the FDA required Ciba to add the following to its label: "WARNING: Anabolic steroids do not enhance athletic ability."

The warning was inserted into the Physician's Desk Reference for all anabolic steroids.

"This might be the biggest lie ever told by the government," McDevitt said. "This stuff does exactly what it was designed to do -- make you bigger, faster and stronger. It's remarkably effective."

The wording is a bit of government gobbledygook. It is true but false. Doses of artificial testosterone do not enhance an athlete's hand-eye coordination to, say, hit a sinking fastball thrown at 95 mph. But they do give a talented athlete a way to muscle up and hit it harder. They also allow more training by reducing the amount of time the body needs to recover from strenuous workouts.

One of the most widely circulated quotes about steroids was attributed to weight lifter Ken Patera before the FDA warning was issued. On the cusp of the 1972 Olympics in Munich, Patera told The Los Angeles Times that he was looking forward to his match-up with Soviet heavyweight Vasily Alexeyev: "Last year, the only difference between me and him was I couldn't afford his drug bill. Now I can. When I hit Munich, I'll weigh in at about 340, or maybe 350 [pounds]. Then we'll see which are better, his steroids or mine."

The overwhelmed FDA could not fathom why healthy athletes would take something that was touted as a medicine for the frail, and it didn't have much hard medical evidence about the ability of steroids to build size and strength.

Initial tests on steroids were done with patients who were not elite athletes motivated to work out to the point of fanaticism, and the doctors doing the studies were unfamiliar with locker room mind-sets or what the Russians were up to.

In 1964, a joint statement by the U.S. Olympic Committee and the American Medical Association listed the known risks of steroids to the liver but cited the apparent lack of real benefit to boost athletic performance.

The American College of Sports Medicine, the most prestigious organization of its kind in the world, looked at two dozen studies on steroids done over an 11-year period and was conflicted about the results. It issued an official position in 1977 that said: "There is no conclusive scientific evidence that extremely large doses of ... steroids either aid or hinder athletic performance."

Seven years later, that same body reversed itself, saying that steroids can increase strength in some individuals on high protein diets who work out vigorously.

One of those who sounded the earliest alarms about steroids is Dr. Charles Yesalis of Penn State University, who has spent a quarter century documenting their impact and potential dangers, especially among adolescents and women.

If there is ever going to be a serious national policy on steroids, people ought to confront why these substances have such an irresistible allure, Yesalis said.

"If I could put you on just one cycle of steroid use, you'd never ask these two questions again: Do steroids work? And why do athletes take them?" Yesalis said.

And to understand how powerful the artificial hormones are, Yesalis cited two queries he gets all the time.

"People ask if they can get big, strong and fast without using steroids. The answer is yes. When they ask if they can get as big, as strong and as fast if they don't use them, the answer is no," Yesalis said.

The inability of mainstream medicine to identify what it was up against contributed to the proliferation of steroids. When doctors began warning of the dangers steroids pose to the heart and liver and tendons, users shrugged them off.



Charles Dharapak, Associated Press
Former Steelers lineman Steve Courson testifies before the House Committee on Government Reform regarding the NFL's steroid policy in April. He said steroids are used on "pretty much every team."
Click photo for larger image.








"Athletes lost faith in the medical community long ago," said Steve Courson, a former Steelers lineman who has devoted his life to counseling youngsters about the consequences of steroid use and abuse. "Steroids will take you places you can't imagine. I had a love-hate relationship with them. I loved what they did for my body, but I hated myself for having to take them."

Even doctors who are doing breakthrough treatments in hormone replacement condemn the use of steroids by athletes as drug abuse. To them, that FDA warning clouded the issue.

"It's crazy. It's stupid. It's idiotic for the medical profession to have denied the performance-enhancing capabilities. Every athlete in the world knows you're going to get some performance enhancement from steroids, but the price is too high," said Dr. Alan Mintz, founder of the Cenegenics Medical Institute in Las Vegas.

Over time, the FDA did revisit its warning on steroids, according to documents uncovered by McDevitt.

In a memo for the files dated Aug. 31, 1983, a recommendation for more precise wording was proposed by Dr. Gloria Troendle, a pediatrician who was deputy director of the FDA's Division of Metabolism and Endocrine Drug Products.

"It is quite possible that anabolic steroids do enhance athletic ability. This has not been convincingly shown so far as I know, but the opposite has not been shown either," she wrote.

In 1984, Dr. Thomas Murray of The Hastings Center said that use of steroids was then epidemic among weight-lifters and Olympic throwers, according to the certified minutes of a meeting of FDA officials. He noted that athletes were using 20 times the medically recommended doses, and there was no research on the consequences of taking such large amounts.

"However, no institutional review board would approve such large doses for a scientific study," he said in his report. "While marginal athletes are willing to accept risks of drug use, top competitors attempt to obtain that last bit of edge that could mean placing among the medal winners."

Finally, on Feb. 22, 1988, a revision did make it onto the label of steroids. It now read in capital letters: ANABOLIC STEROIDS HAVE NOT BEEN SHOWN TO ENHANCE ATHLETIC ABILITY.

Later that year, at the Olympics in Seoul, Canadian sprinter Ben Johnson became the world's fastest human with a time of 9.79 seconds in the 100-meter dash. He had been taking Winstrol for eight years without ever having failed a drug test.

Also in 1988, Jose Canseco was the unanimous winner of the American League MVP award. He later wrote a book calling himself the godfather of steroids, which he said he began using in 1984.



Another case study of note involves Anavar, a staple for muscle-builders but a steroid that is particularly nasty in its effect upon the liver, according to documents compiled by McDevitt.

Officials from Searle, its manufacturer, were asked by the FDA's Division of Metabolic and Endocrine Drug Products to supply scientific evidence that Anavar did what its label proclaimed -- restore weight loss after surgery, relieve bone pain caused by osteoporosis and treat chronic infections and severe trauma.

A memo dated March 27, 1983, was prepared by the FDA's Peter Vaccari from that meeting. His findings were: "Searle has a poor record of cooperation with the Division and has used the exclusion of Anavar from the DESI review as a technicality to avoid proving efficacy ... The Division feels strongly that Anavar is misbranded and that it should be removed from the market."

In a separate memo for the FDA files written later that year, Dr. Troendle detailed a side effect of Anavar to create blood-filled cysts in the liver, and to lower good cholesterol with a concurrent raising of bad cholesterol.

But it wasn't until 1988 that warnings were posted on the Anavar labels concerning the toxic effects on the liver, heart and cholesterol levels.

Searle withdrew its application to market Anavar on May 5, 1988. It finally stopped distribution on May 31, 1989, and sold the license in 1990.

But even when drug companies stopped making steroids, they could still sell their existing inventories to drug warehouses, which continued to ship them to doctors.

"The drug companies didn't have to do what Congress asked them to do -- show that their products were effective for medical uses," McDevitt said.



After years of holding hearings, Congress made it a federal crime to possess steroids with intent to distribute without a valid medical prescription. The bill passed on Nov. 18, 1988, in the era of the war on drugs and just a month and a half after the Ben Johnson scandal.



Associated Press
Arnold Schwarzenegger shows off his steroid-enhanced body in 1977 while promoting the documentary film "Pumping Iron" at the Cannes Film Festival.
Click photo for larger image.








At the same time, Congress asked its investigative arm, the General Accounting Office, to report on the health risks of steroids. The GAO found: "Much media attention has been given to the health risks of anabolic steroids among athletes and bodybuilders. No systematic studies of the health risks to athletes have been conducted, however. Thus, the information on health risks is lacking."

To this day, no definitive study on the long-term health effects of steroids on athletes has been done.

Congress then passed a second steroids law. Effective on Feb. 28, 1991, steroids were classified as a controlled substance, and the possession and use of steroids were now a felony under federal law.

An amendment was proposed to provide criminal penalties for coaches, trainers and advisors who persuade athletes to take steroids. That section was not enacted.

A short time after President George H.W. Bush signed the steroids act into law, he named Arnold Schwarzenegger as the chairman of the President's Council on Physical Fitness. Schwarzenegger, now the Republican governor of California, has acknowledged that he used steroids in his body-building days.



Vince McMahon's trial opened in Uniondale, N.Y., in 1994. It was held at the same time the media's attention was focused on the O.J. Simpson murder trial in California.


Matt Sayles, Associated Press
Wrestler Hulk Hogan, who admitted he took steroids from 1976 to 1989, was inducted into the WWE Hall of Fame in April.
Click photo for larger image.



Among the 19 witnesses called by the government was wrestling champion Hulk Hogan, who was given immunity for his testimony. Under oath, Hogan admitted he took steroids from 1976 to 1989 and estimated that 80 percent of the WWF entertainers were juiced. He also said that he shared them with McMahon, but that McMahon did not push the steroids on his wrestlers.

Not a single defense witness was called, but McDevitt entered the FDA documents he obtained as defense exhibits that are part of the trial record.

During deliberations, the jury asked for one clarification from the court in the form of a question to the judge: Did the government know about Anavar and still allow it stay on the market?

"I knew right then and there the case was over," McDevitt said. "The jury understood the hypocrisy of it all, that the policy was not even to remove the dangerous drugs from the market."

On July 22, 1994, after 16 hours of deliberations, the jury voted to acquit.

"It was a slam-dunk case that demonstrated the government's ineptitude in regulating this drug," McDevitt said. "I hate witch hunts. The thing to fear most is the witch-hunters."

The steroids story didn't end there, however, for Congress or the FDA.

The same year as the McMahon acquittal, with the World Series cancelled because of a bitter labor dispute in Major League Baseball, Congress unanimously passed the Dietary Supplements Health and Education Act, known as DSHEA.

DSHEA was introduced by U.S. Sen. Orrin Hatch, a Republican from Utah, which is the center of the billion-dollar supplements industry. He heralded the law as a way to provide consumers with a greater choice of medicinal remedies. What it did was shift the burden of proof for a product's safety from the manufacturer to the FDA.


BSMG Marketing
Mark McGwire flaunts his physique in a 1998 Milk Moustache celebrity advertisement. He has denied steroid use throughout his career. Androstenedione, not banned by baseball at the time, was spotted by an AP reporter in McGwire's locker.
Click photo for larger image.



Among the products classified as a food supplement was Andro, or androstenedione, which entered the sports world courtesy of the East German doping machine in the 1970s. That state-sponsored program of feeding steroids to young athletes without their knowledge was headed by Manfred Ewald, a member of the Hitler Youth and later a full-fledged member of the Nazi Party.

Essentially, Andro is converted to a steroid by the body, and it stimulates hormone production in men and women. If someone happened to be taking test-tube testosterone, Andro would kick it into high gear.

Although it had been banned by the International Olympic Committee, the NFL and the NCAA, Andro was sold over the counter in stores like GNC. It entered the public lexicon in 1998, the year Mark McGwire hit 70 home runs to smash the single-season record during a heralded duel with Sammy Sosa.

A jar of Andro was spotted in McGwire's locker by a reporter for The Associated Press. At the time, Sosa attributed his mass and bulk to Flintstone vitamins.

More than five years later, Andro was reclassified as a steroid. Baseball quietly banned it on April 12, 2004, the same day it was banned for over-the-counter sales by the FDA.

There is no end to the steroids story, however.

Even though most of the steroids approved by the FDA have been removed from the market, many of their manufacturers sold the formulas to foreign pharmacies, many of which operate in Mexico, where the drugs are not outlawed.

Health officials warn that there is no quality control in foreign pharmacies, and there's no telling what ingredients are actually in the drugs.

Another favorite place for steroid users to get their supply is the race track, where veterinarians supply steroids for racehorses. In addition, unlicensed labs are believed to be making designer steroids that can't be detected yet on drug tests.

It's easy to purchase steroids on the Internet and have them mailed to a home address. There is also advice by bloggers on how to take them without the safety net of accountability.

"By driving them underground, the government has actually exposed users to more dangerous drugs," McDevitt said. "In a sense, we're back to where we started."

And that, in part, is how baseball players developed arms as big as tree trunks.



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(Robert Dvorchak can be reached at [email protected] or 412-263-1959.)
   
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