3/4/03 NYT piece on usnic acid (over-the-counter diet stuff, sold by a T-shirt salesman, that can kill you).
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March 4, 2003
Seeking to Shed Fat, She Lost Her Liver
By DENISE GRADY
The capsules, recommended by a friend, sounded wonderful:
they were supposed to increase metabolism to help the body
burn off fat.
"It was like you're doing aerobic exercise while you're
just sitting there," said Jennifer Rosenthal, 28, a truck
dispatcher and the mother of a 4-year-old in Long Beach,
Calif.
The capsules, sold over the Internet at $39.95 for a bottle
of 90, had just one ingredient, usnic acid, a chemical
found in certain species of lichen plants. The chemical is
not approved for any medical use, but the label on the
bottle said it would make the body burn calories "at an
accelerated rate."
In early October, Ms. Rosenthal began swallowing four
125-milligram capsules a day, half the maximum dose
recommended on the label. She took them for two weeks,
skipped two weeks as the label directed, and then started
again. She was not overweight; she just wanted to stay in
shape. She took the capsules for a total of 17 days.
By Nov. 8, Ms. Rosenthal was in a coma, connected to a
respirator and a web of tubes, her skin a dusky yellow.
Her liver had failed, and her swift decline put her at the
top of the waiting list for a transplant at the University
of California at Los Angeles. On Nov. 12, a liver became
available from a cadaver.
Without it, Ms. Rosenthal's surgeon said, she would
probably not have lasted another day. Her liver was so
badly damaged that it had shriveled to about a third of
what it should have weighed.
Ms. Rosenthal's doctors said they thought usnic acid was
almost certainly to blame. Before taking it, she had been
perfectly healthy, and they could find no other explanation
for her illness. But the doctors said they did not know how
the chemical could have killed so many liver cells so
quickly.
"This is a young woman who almost lost her life," said Dr.
Ronald W. Busuttil, her surgeon. "Although she's got her
life back now, she has to be under life-long medical care.
Her life has been altered forever. The fact that you can
get these things over the Internet is mind-boggling."
Usnic acid is one of hundreds of substances sold either
alone or with other ingredients as "dietary supplements," a
loosely regulated category of products that includes
vitamins, minerals, herbs, amino acids, enzymes and other
chemicals found in plants and foods. Though many are
harmless and some may be beneficial, others have been
linked to serious health problems.
Among the most notorious is another substance promoted for
weight loss, ephedra, which is suspected of playing a part
in the death of Steve Bechler, a 23-year-old pitcher for
the Baltimore Orioles who collapsed during a workout on
Feb. 16 and and died the next day in a Fort Lauderdale
hospital.
The Food and Drug Administration has received more than 100
reports of deaths among ephedra users, as well as 16,000
reports of other problems, including strokes, seizures,
heatstroke, heart disorders and psychotic episodes.
On Friday, the government called for new labels for ephedra
to warn consumers of the risk of heart attack, stroke and
death. Tommy G. Thompson, the secretary of health and human
services, said he was considering banning ephedra outright.
But by law, the government must prove an unreasonable risk
of harm to ban a dietary supplement.
The true extent of illness caused by supplements is not
known, because while the worst cases attract attention,
less serious ones may go undiagnosed or unreported. The
F.D.A. itself estimates that it gets reports on fewer than
1 percent of the severe adverse effects linked to dietary
supplements.
A study published in January based on 489 reports to
American poison control centers in 1998 found that various
supplements were also implicated in heart attacks,
bleeding, seizures and deaths.
The supplement industry, with sales of more than $17
billion a year, is so loosely regulated that products can
be marketed without the proof of safety and efficacy
required for drugs by the food and drug agency, which
cannot take a supplement off the market unless there is
proof that consumers have been harmed. As long as
manufacturers do not claim that their products can be used
to treat or cure disease, they are not regarded as drugs.
"With supplements, the burden of proof is on the agency to
show a product is unsafe," said Monica Revelle, a
spokeswoman for the F.D.A. "We have to prove a causal
link."
F.D.A. officials declined to discuss usnic acid, Ms.
Revelle said, except to say that they were "monitoring it
very closely."
Though usnic acid supplements have been blamed in other
cases of liver failure, Ms. Rosenthal's doctors said they
did not know of other cases of liver failure from the
product she took. It was sold by a company called AAA
Services in Frazier Park, Calif., but the company's owner,
Jerry Parker, said in an interview that he stopped selling
it as soon as a doctor at U.C.L.A. called to tell him about
Ms. Rosenthal.
Mr. Parker said he had used his own product with no ill
effects. He added that he had sold 500 to 600 bottles of it
and that as far as he knew Ms. Rosenthal was the only
person to develop liver failure.
But another weight-loss product, Lipokinetix, which
contained a form of usnic acid called sodium usniate, and
other ingredients, has been blamed for a death from liver
failure, two liver transplants and seven cases of liver
failure from which patients recovered.
Doctors suspect that usnic acid played a role. Lipokinetix
is no longer on the market, but other products containing
usnic acid are still available.
The supplement industry has grown rapidly in the past
decade, and so have doctors' worries about side effects
from poorly understood ingredients. Recently, liver damage
has been a particular concern. In the past year, several
medical journals and government publications have described
liver problems, including hepatitis, cirrhosis and acute
liver failure requiring a transplant, from dozens of
supplements.
Kava, a root extract widely promoted to help people relax,
has been blamed for several deaths from liver failure in
the United States and Europe since 1999, about a dozen
cases of liver failure that led to transplants and dozens
of other reports of liver damage.
Even though such reactions are thought to be rare, kava has
been taken off the market in the European Union and Canada.
It is still available in the United States, though in March
2002 the F.D.A. issued warnings to doctors and consumers
about potential liver problems linked to kava.
The supplement industry has questioned the reports on kava,
noting that it has been used safely for centuries in the
South Pacific. Nonetheless, a trade group has recommended
that kava labels be changed to warn consumers to stop
taking it if they develop signs of liver problems like
jaundice, vomiting, abdominal pain or dark urine.
What some doctors find particularly troubling is that
supplements are popular among people who may be especially
vulnerable to harm from them, for example, patients who
already have liver disease.
Dr. Bill McGhee, a clinical pharmacy specialist at
Children's Hospital in Pittsburgh, said that 25 to 30
percent of people with liver disease take supplements to
treat themselves. He tries to talk them out of it, he said.
In November 2001, the F.D.A. warned doctors and consumers
that Lipokinetix had been linked to liver problems in about
half a dozen people. The agency wrote to the manufacturer,
Syntrax Innovations, in Chaffee, Mo., to "strongly
recommend" that the product be taken off the market. It is
no longer available.
The president of Syntrax, Derek Cornelius, who is being
sued by former customers with liver failure, refused to be
interviewed.
Syntrax also ran afoul of the F.D.A. earlier in 2001, for
marketing a weight-loss product that contained a powerful
thyroid hormone. The drug agency said the product was a
drug and not a supplement, seized it and obtained a court
order to stop its distribution.
According to its Web site, Syntrax continues to market a
variety of pills and powders that it promotes as muscle
builders and fat burners.
Dr. Joya Favreau, an internist at Cedars Sinai Medical
Center in Los Angeles who treated five patients who had
severe liver problems after taking Lipokinetix, said she
thought usnic acid was to blame, but could not be certain.
The other ingredients in Lipokinetix, Dr. Favreau said, had
been used in the past without being linked to liver
failure.
"With usnic acid, we don't have a lot of data in humans,"
she said. "We don't necessarily know how it harms the
liver."
Dr. Neil Kaplowitz, a researcher at the University of
Southern California who tested usnic acid in cultures of
mouse liver cells at the request of the F.D.A., said it was
"fairly potent" and could kill all the cells in less than a
day. But that does not mean the chemical would act the same
way in people, Dr. Kaplowitz said, adding, "There may be
individuals who are more susceptible for reasons we're not
certain about, but that all remains to be seen."
When Jennifer Rosenthal took usnic acid, she said, it never
occurred to her to wonder whether or not the product had
been tested, studied or approved by the F.D.A.
"I didn't think about that kind of stuff," she said. "Not
very smart."
In fact, the product she took was not regulated by anybody.
Mr. Parker, who produced the capsules, does not have a
college degree or any training in pharmacology. He sells
promotional T-shirts for a living. He said usnic acid was
"just a little sideline."
Mr. Parker said that bodybuilding was a hobby of his, and
that taking usnic acid for weight loss had been "a buzz in
the health and fitness community for years."
About a year ago, he said, he found a supplier in China via
the Internet, ordered the usnic acid in 11-pound lots, had
it tested for purity and then sent it to a local company to
have it put in capsules and bottled.
He wrote the dosage instructions himself, he said, based on
Internet research and feedback from people who used the
compound. He then sold it, mostly via the Internet but also
through a few health food stores.
Mr. Parker said he was so alarmed by what happened to Ms.
Rosenthal that he stopped selling usnic acid as soon as he
heard about her case.
"I obviously feel horrible about it," he said.
Ms.
Rosenthal has recuperated from her operation, and last
month she returned to work. But like all recent transplant
recipients, she needs many medications to prevent rejection
and other problems: for now, that means 47 pills a day. She
has hired a lawyer and said she plans to sue Mr. Parker.
Copyright 2003 The New York Times Company. |
