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In today's New York Times:
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.
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.
, doesn't generally happen around here (disregard that Toolbox fella 
