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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.
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.
* 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.
Exempt From Regulation
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.
And the industry is expanding rapidly, with hundreds of herbal
products and product blends. Since 1994, supplement sales have
grown by nearly 80 percent, from $8.8 billion to a projected
$15.7 billion for 2000, according to the Nutrition Business
Journal. Ephedra, for example, is sold as a "natural"
way to increase human metabolism. St. John's wort is fast
becoming a Prozac competitor. Melatonin is touted as an elite
cure for jet lag. Ginseng is a purported key to sexual stamina
and eternal youth. Ginkgo biloba allegedly sharpens the mind and
wards off Alzheimer's disease. Senna is a natural purgative to
aid in weight-loss and exercise regimes.
Faced with the federal government's inability to regulate
supplements, many states have passed their own restrictive laws.
They also are collecting data on an industry that experts such as
Lee C. Vermeulen, director of the University of Wisconsin Poison
Control Center, expect will keep growing, along with its
attendant problems, until "the 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."
A Deep Divide
"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.
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.
Herbs, or Drugs?
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.
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 possible adverse
reactions 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.
"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.
SOME COMMON SUPPLEMENTS:
* St. John's wort
Description: The leaves and yellow flowers of the shrub are
ingested.
Use: Treatment of anxiety and depression.
* Senna
Description: The leaves and seed pods of this herb are
ingested.
Use: Laxative and in sore throat remedies.
* GHB
Description: A fatty acid found in the human body.
Use: Outlawed. Bodybuilding supplement and party drug.
* Androstenedione
Description: A naturally occurring steroid hormone.
Use: Increase strength and stamina.
* Ginkgo biloba
Description: Spatula-shaped leaves from tree are ingested.
Use: Improve circulation and alertness.
* Ephedra
Description: Alkaloid is extracted from ma huang plant or made
synthetically.
Use: Boost energy, aid in weight loss, relieve chest conditions.
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