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Biotech / Medical : CEPH - CEPHALON

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To: Icebrg who wrote (70)10/23/2003 4:18:51 AM
From: Icebrg  Read Replies (1) of 109
 
Steroid flap overshadows another drug
MANY ATHLETES TEST POSITIVE FOR MILD STIMULANT MODAFINIL
By Mark Emmons and Pete Carey
Mercury News

When sprinter Kelli White tested positive for a mild stimulant called modafinil at the World Championships in Paris in August, she had an explanation. She told officials that she suffers from narcolepsy and that her doctor prescribed the drug to combat her excessive fatigue.

But now that extensive laboratory sleuthing by the U.S. Anti-Doping Agency has found several other American track athletes, so far unnamed, who tested positive for modafinil this summer, one of two conclusions can be drawn:

• There is an epidemic of sleep disorders among the U.S. track elite.

• At least some athletes believe the drug enhances performance.

Thursday, the anti-doping agency said it was ``fairly certain'' that Balco Laboratories of Burlingame was the source of a sample of a previously unknown ``designer'' steroid, tetrahydrogestrinone, for which several athletes at the national championships at Stanford University tested positive. Balco and its president, Victor Conte Jr., also are targets of a federal grand jury that has subpoenaed dozens of athletes to testify.

Another drug

But almost lost in the steroid controversy is the anti-doping agency's announcement Thursday that track athletes may be using another banned drug to aid them on the track: modafinil.

Asked Thursday if modafinil improves performance, the agency's chief executive, Terry Madden, said bluntly: ``Absolutely.''

Yet sleep experts who prescribe the drug to patients sharply disagree.

``If I was an athlete, I sure wouldn't pick modafinil,'' said Dr. Thomas Scammell of Beth Israel Deaconess Medical Center in Boston.

White, of Union City, is facing the loss of two gold medals and $120,000 that she won in Paris. She denies that she took modafinil, sold under the brand name Provigil, to give her an extra boost.

Last week European newspapers reported that a second U.S. athlete, hurdler Chris White, also tested positive for modafinil. He finished sixth in the 110-meter hurdles in Paris.

Sprinter's defense

White says she didn't know the International Association of Athletics Federations considered modafinil a ``related substance'' to other stimulants on the official banned list. But she also didn't disclose, on a form that all athletes must complete listing the medications they are ingesting, that she was taking Provigil.

Dr. Brian Goldman, an East Bay physician who at one time was Balco's medical director, said he prescribed the drug for White when she showed symptoms of narcolepsy, including fatigue and depression, before the World Championships. Goldman said White's mother and maternal aunt also have the ailment.

Sleep experts respond

Goldman said that he had ``no idea'' athletes were using the drug when he gave White some samples of Provigil. He believes White, at least, had a legitimate reason to take it. He also remains convinced that the drug doesn't do anything to improve athletic performance.

But he does note that because athletes may have been convinced that it would help them, a ``placebo effect'' could have helped their performance.

``Athletes are very prone to a placebo effect,'' Goldman said. ``So maybe they believe it works, so it does.''

But several sleep disorder experts say they don't understand how international sports organizations can consider modafinil a substance that would make track athletes faster. They say it does not act like a traditional stimulant, a main reason prescriptions for it have grown sharply in recent years.

``I don't know what their issue is,'' said Joyce A. Walsleben, director at the New York University School of Medicine's Sleep Disorders Center. ``It's not a stimulant as we know the word stimulant.

``It is a wake promoter, working in the area of the brain that wakes people up. It does not stimulate the cardiovascular system or muscle system as amphetamines do.''

Dr. James Wyatt of Chicago's Rush University Medical Center said, ``It is actually one of the less potent medications available. That's one of the reasons why it is preferred by sleep disorder specialists.''

A representative for Cephalon, the West Chester, Pa., company that makes Provigil, said reports of athletes using the drug are mystifying.

``We heard Kelli White had narcolepsy, so it wasn't surprising that she was taking Provigil, because that's the standard of care for excessive sleep,'' Sheryl Williams said. ``The whole situation with the IAAF is something that we weren't expecting and prepared for because we make a pharmaceutical product for sick people.''

Other uses

Although the Food and Drug Administration approved Provigil in 1998 for narcolepsy treatment, Williams said only about 20 percent of prescriptions concern sleep disorders. She said it also is used to treat fatigue associated with multiple sclerosis, depression, Parkinson's disease and chronic fatigue syndrome, among other conditions.

In fact, physicians have found plenty of ``off-label'' uses for Provigil. People who need to stay awake for long periods of time, such as truck drivers, use it. The U.S. military is testing Provigil on pilots.

Dr. Frank Baldino, Cephalon's chief executive, recently told Fortune magazine that some of the off-label uses of Provigil make him slightly uncomfortable. ``In some sense, physicians are way ahead of us,'' he said.

The question is whether athletes think they're way ahead, too.

When the anti-doping agency began its steroid investigation, it re-examined 350 urine samples taken at the USA Outdoor Track & Field Championships at Stanford University and took 200 additional out-of-competition samples from athletes in track and other Olympic sports.

`Really frustrating'

While the stunning news was the discovery of the designer steroid in some samples, the agency said ``several'' positive tests for modafinil also were found.

Those who test positive for steroids risk a minimum two-year ban from competition. The penalty for using modafinil is disqualification from the meet where an athlete tested positive.

Goldman said that whether other athletes were taking it to gain an advantage, White was taking it legitimately.

Contacted last week at her East Bay home, White sounded weary. She has been subpoenaed to testify before a grand jury in the federal investigation of Balco. She adamantly denied being one of the athletes who tested positive for THG.

``I've already got enough stuff to deal with,'' White said, referring to the modafinil case.

Then, after a deep sigh, she added: ``This is really frustrating and it's probably going to get even more frustrating over the next few weeks.''

bayarea.com
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