[Paleopsych] NYT: Beyond Balco: How One Pill Escaped a Place on List of Controlled Steroids

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Beyond Balco: How One Pill Escaped a Place on List of Controlled Steroids
http://www.nytimes.com/2005/04/17/national/17steroid.html
April 17, 2005

    By ANNE E. KORNBLUT and [1]DUFF WILSON

    WASHINGTON, April 16 - On the shelves of health stores across the
    country sits a dietary supplement that advertisements boast can
    "significantly alter body composition" - by converting to steroids in
    the bloodstream and, for some, helping pump up muscles like
    traditional steroids do.

    But unlike every other substance in the steroid family, the
    supplement, DHEA, is not classified as a controlled substance. In
    fact, the chalky white pills and capsules enjoy a special exemption
    under federal law, thanks to a bill quietly passed by Congress late
    last year.

    How DHEA, or dehydroepiandrosterone, came to enjoy special legal
    protections granted by Congress - at the very moment that steroid
    abuse was grabbing national headlines, and just months before Congress
    itself held hearings on body-building drug use in professional
    baseball - is a study in skillful political maneuvering, according to
    participants in the deal.

    Sports officials had favored an overall ban on steroids and related
    pills, like DHEA, which is banned by the Olympics, the World
    Anti-Doping Agency, the National Collegiate Athletics Association, the
    National Football League, the National Basketball Association and
    baseball minor leagues.

    Major League Baseball is the exception on banning DHEA, and at last
    month's congressional hearings, the top medical adviser to the league
    turned the tables on lawmakers, accusing them of failing to write
    zero-tolerance toward steroids into federal law. Baseball officials
    complain that the legal loophole has made it harder for them to ban
    DHEA in their own drug policy, which is already under fire.

    "It is difficult, from a collective bargaining perspective, to explain
    to people why they should ban a substance that the federal government
    says you can buy at a nutrition center," said Rob Manfred, executive
    vice president for labor relations at Major League Baseball.

    Nevertheless, Senator Orrin G. Hatch of Utah, a Republican who
    represents a state where many dietary supplements are produced and a
    longtime champion of herbal remedies, felt strongly last year that
    DHEA must be kept legal and available as an "anti-aging" pill. Other
    lawmakers and staff members said he threatened to kill a far-reaching
    piece of legislation restricting the sale of other steroids, educating
    children about the dangers of steroids and increasing penalties for
    illegal use if his colleagues did not agree to include an exemption
    for it.

    His son, Scott Hatch, is a lobbyist for the National Nutritional Foods
    Association, a trade association for the dietary supplement industry,
    and has represented supplement companies themselves, including Twin
    Laboratories, which sells DHEA. The elder Mr. Hatch said he did not
    think he had been lobbied by his son, and cited the legitimate uses
    for DHEA as his reason for fighting for it.

    "There is a big argument that DHEA is very beneficial for health and
    well-being," Mr. Hatch said, noting that he did not believe there was
    significant opposition to leaving DHEA on the market. "I didn't see
    much resistance," Mr. Hatch said. "There are always those who are
    against any dietary supplement or anything not subject to total FDA
    approval." He was joined in fighting for the exemption by Senator Tom
    Harkin, Democrat of Iowa, a leading supporter of dietary supplements.

    Most DHEA is manufactured in China from the dried roots of wild yam.
    About $47 million worth was sold in the United States in 2003, the
    most recent year for which sales figures have been compiled, according
    to Patrick D. Rea, research director for The Nutrition Business
    Journal. In humans, where DHEA is produced naturally in the adrenal
    glands, levels of the hormone usually peak by the time a person is age
    25. The synthetic version is primarily marketed as an anti-aging drug.

    The F.D.A. banned over-the-counter sales of DHEA in 1985. It
    reappeared after Congress passed the Dietary Supplement Health and
    Education Act of 1994, releasing a flood of supplements classified as
    foods rather than drugs, and not requiring the F.D.A.'s approval.
    Senators Hatch and Harkin also led the push for that bill.

    Although DHEA advocates say the supplement has a good safety record,
    there have been only limited studies of its performance and side
    effects. Its promised benefits, including enhanced mental acuity and
    slowed aging, have not been proven conclusively, and some scientists
    say there is still concern it could accelerate cancers.

    "There isn't any logical reason it should be exempt," said Sidney
    Wolfe, director of the Health Research Group at Public Citizen.

    Utah, the home state of Senator Hatch and his son, is a nexus for
    vitamin and supplement production and distribution and the
    father-and-son Hatch team have a history of fighting for herbal
    remedies. The elder Hatch has played a leading role on two Senate
    committees that have oversight over the Food and Drug Administration
    and the Drug Enforcement Agency.

    Senator Hatch has also in the past defended the herbal supplement
    ephedra, which has been linked with more than 100 deaths. He supported
    a federal ban of ephedra in April 2004 after the deaths were reported.
    A federal judge in Salt Lake City overturned the ban last week.

    Lawmakers in both parties said the unusual exemption for DHEA was
    created only in order to secure passage of a broader bill, the
    Anabolic Steroid Control Act of 2004.

    The law, which took effect on Jan. 20, expanded the definition of
    anabolic steroids to include substances like andro, or
    androstenedione, which turns into testosterone after it is ingested.
    Andro was made famous by the former St. Louis Cardinals player Mark
    McGwire, who admitted taking it around the time of his record-breaking
    home run season in 1998. Andro and other steroids can enhance muscle
    growth; if abused, they can cause longterm physical and psychological
    harm.

    As the abuse of steroid-like supplements became more widely
    discovered, athletic and medical groups pressed for stricter
    legislation, arguing that any substance that turns into a steroid
    hormone once it is digested should be regulated by the Drug
    Enforcement Administration.

    But faced with opposition from Mr. Hatch, lawmakers ultimately decided
    it was not worth sinking the entire bill to ban DHEA, several said.
    The law, which was passed without objection, gave the Drug Enforcement
    Administration more power to ban new steroids, with one named
    exemption, DHEA.

    "We had to make a practical decision to get it passed," said
    Representative John Sweeney, Republican of New York.

    Representative Henry Waxman, Democrat of California, said DHEA was
    protected "because of the economic pressures from the dietary
    supplement people that stand to make a lot more money by selling it."

    Besides the supplement industry and its select advocates in Congress,
    Mr. Waxman said: "No one else argued it should be given an exemption.
    The only opposition came from the supplements industry, and they're
    making millions off the sale of DHEA supplements."

    According to one congressional aide who worked on writing the
    legislation, in one particularly intense negotiation with Senator
    Hatch, the Utah senator's staff members "were adamant that they were
    not going to take out the exemption."

    Other current and former congressional staff members - all speaking on
    condition of anonymity because they were not authorized to talk about
    back-room negotiations - gave similar accounts. One senior
    congressional aide who helped broker the agreement said: "We had to do
    an exemption for DHEA not because it was the right thing to do, to be
    perfectly honest, but because it was the politically necessary thing
    to do."

    Congressional aides said they had not dealt directly with Scott Hatch,
    the senator's son, but had worked with Jack Martin, a partner in his
    firm, on this and other supplement issues. Mr. Martin is a former
    longtime aide to Senator Hatch. They did not return calls for comment.

    Senator Hatch, in an interview, defended the DHEA exemption, calling
    it "basically a good dietary supplement." "Andro is an anabolic
    steroid precursor, and DHEA is far removed from that, from everything
    I've read and everything I've studied," he said. In fact, DHEA is a
    first cousin of andro: in the body, DHEA metabolizes into andro and
    then into testosterone.

    Asked whether his son had lobbied on the exemption, Mr. Hatch replied,
    "Not that I know of."

    "In fact, he won't even talk to me. He is that touchy," Mr. Hatch
    said. "He works the House and does it very honorably. He's very prissy
    about it, in fact. He doesn't have to be that prissy about it." He
    added: "His business is his business, not mine."

    With andro now illegal, athletes who want to try to get a steroid
    effect from a legal pill are now more likely to turn to DHEA,
    according to Dr. Gary Green of the Olympic Analytical Laboratory at
    the University of California, Los Angeles. Speaking to high school
    coaches in Texas about steroids in February, Dr.

    Green, an adviser to baseball, said coaches should ask why DHEA
    received a special exemption, which member of Congress was responsible
    for that, what state he was from and what state DHEA is sold from.

    But there is no evidence yet, other than chatter on Web sites, that
    athletes or young people are turning to DHEA as a replacement for
    traditional steroids and precursors, despite the fears of some medical
    experts that the trend will begin now that the law banning other
    substances has taken effect.

    Susan Trimbo, a scientist with General Nutrition Centers, one of the
    nation's largest sellers of DHEA, said the drug has a good safety
    record, with side effects including acne and some facial hair issues
    in women. The drug affects women more than men because women naturally
    produce less testosterone.

    "It's a rather weak steroid, so I don't see it as a good substance for
    abuse, from my perspective," Ms. Trimbo said.

    But some advertisements do take aim at athletes, including promotions
    on the Web sites [2]www.teenbodybuilding.com, [3]www.bodybuilding.com
    and [4]www.musclesurf.com.

    One ad says: "DHEA is HOT, and you will see why. As a pre-cursor
    hormone, as it leads to the production of other hormones. When this
    compound is supplemented, it has been shown to have awesome effects."

    Another ad, from AST Sports Sciences, says: "What Can DHEA Do For Me?
    If you're a bodybuilder, and want to increase in lean body mass at the
    expense of body fat, studies show this supplement may significantly
    alter body composition, favoring lean mass accrual."

    There have been few randomized, double-blind studies of the effects of
    large doses of DHEA. One, in 1988, found that DHEA decreased body fat
    and increased muscle mass in five young men given 1600 milligrams a
    day for 28 days, compared with five men given placebos.

    "Fortunately, reports of serious side effects to date have been
    minimal," Patricia D. Kroboth, dean at the University of Pittsburgh
    School of Pharmacy, wrote in a review article in 1999. But she noted
    there have been no large-scale clinical trials gathering information
    on side effects, concluding, "Until we understand the risks and
    benefits of DHEA administration, its use in other than an experimental
    setting is not warranted."

References

    1. http://query.nytimes.com/search/query?ppds=bylL&v1=DUFF%20WILSON&fdq=19960101&td=sysdate&sort=newest&ac=DUFF%20WILSON&inline=nyt-per
    2. http://www.teenbodybuilding.com/
    3. http://www.bodybuilding.com/
    4. http://www.musclesurf.com/