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Herbal
products take a human toll
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NBC's
Dan Lothian reports on the first attempt to gather national comprehensive
data on sicknesses and deaths caused by dietary supplements.
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Alternative medicines
promise
health, but often don’t deliver
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By Guy Gugliotta
WASHINGTON POST
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 WASHINGTON,
March 19 — Mounting evidence
suggests that increasing numbers of Americans are falling seriously ill
or even dying after taking dietary supplements that promise everything
from extra energy to sounder sleep.
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THE VICTIMS INCLUDE men and
women of all ages as well as children whose parents are feeding them
snacks, drinks and nostrums made with herbal supplements that are neither
regulated by the federal government nor tested for their effects on the
young.
While the Food and Drug Administration issues
periodic warnings about the dangers of individual supplements, no
organization or agency has ever made a comprehensive analysis of the
sickness and death associated with them.
But in attempting the first national survey, The
Washington Post collected statistical snapshots from health officials,
researchers and advocates reaching almost every state in the country. Among
the findings:
 Abuse of the
bodybuilding supplement gamma-hydroxybutyrate (GHB) and similar substances
has skyrocketed in recent years. In 1997-98, Texas recorded 86 hospital
visits involving GHB. In 1999, three Florida poison centers logged 549 GHB
incidents and two deaths. Last December, Phoenix Suns forward Tom
Gugliotta, no relation to this reporter, took a GHB-related supplement,
collapsed on the team bus and nearly died at a Portland, Ore., hospital.
 Tests continue
to reveal dangerous contaminants and poor quality control in supplement
ingredients. California investigators in 1998 found that nearly one-third
of 260 imported Asian herbals were either spiked with drugs not listed on
the label or contained lead, arsenic or mercury. Last month, state
officials discovered five Chinese herbals that contained powerful diabetes
drugs. Health professionals across the country complain they cannot be sure
how powerful a supplement is because the actual potency of the pill often
doesn’t match the legend on the label.
 The weight-loss
and energy supplement ephedra, also known as ma huang, and its derivatives
are producing a stream of complaints from many states, including Georgia,
Kentucky, Minnesota, Nebraska, Ohio, Pennsylvania and Texas. New,
previously unreleased FDA data implicate about two dozen different ephedra
products in 134 cases involving everything from jitteriness, chest pains and
insomnia to addiction, stroke and death.
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Poison control centers in various states are reporting
adverse reactions to a broad range of supplements. Pittsburgh documented
198 incidents involving herbal supplements in the 15 months ending last
March, with ginseng and St. John’s wort, an antidepressant, the most
frequently mentioned substances. In Georgia, ephedra and melatonin, a sleep
aid, led the list in 1999. In New Mexico, St. John’s wort ranked first in
1998, followed by a compound that eases teething pain in infants.
 Children are
increasingly becoming the victims of supplement abuse. Last year
pediatrician Hillary Perr reported on children from wealthy California
families who were malnourished from eating snack food spiked with
supplements. In Long Island, a mother gave her 18-month-old baby a teaspoon
of eucalyptus oil last year because a store clerk told her it was good for
a fever. The child suffered permanent neurological damage and almost died.
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UNCONTROLLED EXPERIMENTATION
While health care providers concede that diet
supplements are not as dangerous as automobiles, which killed 41,826 people
nationally in 1998, or diseases such as kidney disease, which killed
26,295, most experts consulted by The Post suspect their data vastly
understate the incidents that actually occur.
This is because a 1994 federal law, fiercely
pushed by the industry through an acquiescent Congress, exempts supplement
companies from almost all federal regulation, including any requirement
that they file reports when the use of one of their products goes wrong.
Unlike pharmaceuticals or food additives, supplements do not have to be
pre-screened by the FDA, nor do they have to demonstrate through
peer-reviewed science that they are safe before they can be sold. And once
on sale, the burden of proof is on the FDA to show that a supplement is
dangerous before it can be taken off the market. The only tool federal
officials have are the sketchy, patchwork reports voluntarily called in to
them.
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economy goes south.”
In this environment, the experts say they are
catching only glimpses of supplements’ potential dangers: “Ninety percent
of the time we get called [only] when people are using these things from
abuse,” said Greene Shepherd, director of the North Texas Poison Control
Center in Dallas, voicing a frequently heard complaint. “There’s a huge
portion that we’re missing.”
Also, added Prosy Abarquez-Delacruz, regional
administrator for the California Health Services Department’s Food and Drug
Branch, companies have hastened to take advantage of the dearth of
regulation.
“It’s the John Wayne industry, like the wild,
wild West, and the practices of the few have tainted the many,” said
Abarquez-Delacruz. In the past year her office temporarily halted sales of
$1.5 million in exotic teas and beverages because of misleading label
claims.
Many health professionals, including strong
critics of supplements, acknowledge that they can be both useful and safe,
if taken in reasonable doses. But many consumers
become victims because they “believe that if a product wasn’t safe, the
government wouldn’t allow it to be sold,” said consumer advocate Bruce
Silverglade, legal affairs director of the Center for Science in the Public
Interest. “In this case that’s just a false assumption.”
In fact, cautioned New York City Poison Center
Director Robert Hoffman, many supplements “are drugs. There’s no doubt
about it.”
And in essence, added pediatrician Howard
Mofenson, director of the Long Island Poison Center in Mineola, N.Y., public
consumption of supplements has become the clinical trial: “Nothing will be
done unless a tremendous outbreak occurs,” Mofenson said. “This law is the
greatest uncontrolled experiment that the United States has ever
undergone.”
NO ACCOUNTABILITY
“Dietary supplements” as defined in the 1994
Dietary Supplement Health and Education Act, include vitamins, minerals,
herbals, amino acids and derivatives of these substances.
Health food advocates and supplement companies
concede that new products need more rigorous testing but say that many
substances they sell are time-tested natural remedies whose  efficiency and safety have
been established for hundreds, even thousands of years.
R. William Soller of the Consumer Healthcare
Products Association, representing supplements manufacturers and
distributors, predicted that testing will increase “as you see the field
evolve,” especially when companies start competing head-to-head with each
other, and with over-the-counter drugs.
And when it comes to adverse events, Soller drew
a distinction between mainstream herbs and fringe products, which he said
included a variety of rare Asian herbals and substances such as GHB, which
he described as illicit drugs masquerading as supplements.
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For most of the consumer
groups and health care providers consulted by The Post, however, a
different picture emerged of the risks associated with supplements,
including mainstream products.
The 1994 act, Abarquez-Delacruz said, “started
it all” by giving the supplements industry license to do almost anything it
wants with almost no accountability: “It’s the Food Fraud Facilitation Act
– at least in the minds of health professionals,” she said.
The sources consulted by The Post collected
information in different ways, making it impossible to compare individual
studies. Still, the data showed that the number of serious incidents
occurring in individual states far exceeds the number of reports received
by the FDA’s Special Nutritionals Adverse Events Monitoring System, the
source most frequently cited as a national benchmark.
The disparity is stark. The FDA’s monitoring
system implicated dietary supplements in 2,621 adverse events between 1993
and Oct. 10, 1998, with 184 of them resulting in death.
The American Association of Poison Control
Centers, by contrast, received 6,914 reports on supplements in 1998 alone,
including 1,369 cases involving treatment in a health care facility. The
association’s figures did not include ephedra and its derivatives, which
account for the biggest chunk of the FDA’s cases.
Sixty-four percent of the.
association’s reports involved children under age 6, a
trend also noted among many member poison centers. Of 599 supplement
reports documented by University of California pharmacologist Candy
Tsourounis at five California centers between January 1997 and June 1998,
more than half were pediatric.
“Children see it as ‘What’s Mommy taking?’” said
Tsourounis, and supplement bottles tend not to have child-proof caps. Also,
Tsourounis added, supplement companies are providing entire product lines
aimed at children – products that, like their adult equivalents, have not
been tested for possible side effects or effects on the young.
PROLIFIC USE
Perhaps nowhere has the danger of unregulated
supplements been more apparent than in the case of GHB, used among athletes
as a muscle builder and relaxant, and by partygoers as a way to lose
inhibitions. Over the past decade considerable evidence showed that GHB,
and “precursors” that convert to GHB inside the human body, can cause a
variety of severe side effects, including coma and death.
‘We found
high school budgets were buying dietary supplements for students. You get a
football helmet, shoulder pads, a jockstrap and creatine.’
— TEXAS STATE REP. GLEN
MAXEY
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Ephedra is
‘kind of a dirty drug. Some people say they have done 20 tablets a day
without problems, but then an adolescent took seven or eight and died.’
— CARL HORNFELDT
Hennepin Regional Poison
Center in Minneapolis The FDA’s 1993-98 adverse-events system,
however, lists only 14 GHB and precursor episodes, and one death, while
states contacted by The Post routinely reported dozens of cases annually,
with Florida’s 549 incidents topping the list.
In January 1999, the FDA proclaimed GHB
precursors “unapproved new drugs,” said it had documented 55 adverse
reactions, warned manufacturers to take the products off the market and
threatened lawsuits and seizure if they refused to comply.
A year later, with GHB abuse reports higher than
ever, Congress trumped the 1994 law by outlawing GHB and its precursors as
dangerous drugs. At that point the Drug Enforcement Administration had
blamed 60 deaths on GHB-type supplements nationwide.
Congress has been much slower to act on ephedra,
challenging the accuracy of FDA data that documented 685 possibletions to
the supplement or its derivatives, and 39 deaths.
“A sufficient body of evidence ... has yet to be
presented” to “challenge the safety of ephedra,” the Consumer Healthcare
Products Association’s Soller said. “It still remains as a dietary
supplement that can be considered safe” as long as recommended dosages are
followed.
Last month the FDA called off a three-year
attempt to impose dosage regulations on ephedra products, but has assembled
new data on 134 ephedra cases in preparation for a new round of rulemaking.
Others, including states and private
individuals, are gathering information. By the end of 1999,
California-based activist Barbara Michal had gathered 215 Web site
complaints about ephedra in a little more than a year. Thirty percent of
her contacts acknowledged addiction to the supplement.
And the Texas Department of Health collected 418
adverse-event reports from 1993 to 1995 from two companies whose telephone
complaint line records were subpoenaed. In 1999, San Francisco trial lawyer
Christopher E. Grell took a deposition from a company executive who said
the firm had received “roughly 3,500 complaints” about its ephedrine
product, none of which had been reported to the FDA.
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“On a ‘good week,’ we may
encounter it [ephedra] daily,” said pharmacist Carl Hornfeldt, director of
the Hennepin Regional Poison Center in Minneapolis. “It’s kind of a dirty
drug. Some people say they have done 20 tablets a day without problems, but
then an adolescent took seven or eight and died.”
Another area of controversy is sports nutrients
such as the steroid hormone androstenedione, sales of which skyrocketed in
1998 after St. Louis Cardinals slugger Mark McGwire reported using it in
his race to break the single-season home run record.
“Andro” is banned by the National Football
League, the Olympics and the National Collegiate Athletic Association, and
a Major League Baseball-funded study last month found that the supplement
raised testosterone levels and could be hazardous.
Also controversial is creatine, a naturally
occurring substance used by athletes for explosive bursts of power.
Although studies have shown no evidence of adverse reactions, there
continues to be concern about the supplement’s long-term effects,
especially in adolescents.
This was one reason that Texas state Rep. Glen
Maxey (D) easily won passage of legislation last year forbidding employees
of the Texas public school system to sell or promote “performance-enhancing
products” on school time.
“We found it happening across the state,” Maxey
said. “We found high school budgets were buying dietary supplements for
students. You get a football helmet, shoulder pads, a jockstrap and
creatine.”
Staff researchers Lynn Davis and Nicholas
Johnston contributed to this report.
© 2000 The Washington Post Company
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