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Investigation of a Fatal Remedy

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TIMES MEDICAL WRITER

Liang Qing Ye was about one month pregnant the April day she walked into the South-North China Herb Co. store in San Francisco’s Chinatown, where she lived. A 23-year-old seamstress who earned $4.25 an hour, she was looking for something to help her sustain the pregnancy because she previously had a miscarriage.

She left with two small packets of brown paper, each supposedly containing a blend of a dozen dried herbs.

That evening, she emptied a packet into a ceramic pot, steeped the contents as instructed and drank the hot tea.

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Two and a half hours later, she died of a heart attack.

An autopsy the next morning turned up little. But an elaborate monthlong investigation by the California Department of Health Services eventually pinpointed the cause, which the San Francisco County coroner then recorded as “acute cardiac glycoside poisoning due to ingestion of Chinese herbal medication.”

Liang’s death in 1993, described (without naming her) in the Western Journal of Medicine last year, dramatizes the often unacknowledged risks of the booming herbal medicine trade. Americans spent $1.5 billion on herbal remedies in 1995, and sales are growing by 15% annually as magazines and best-selling books tout “herbal wellness” and herb-induced “spontaneous healing.”

The allure of herbal remedies is easy to understand, what with their hint of ancient, “natural” ways of caring that are presumed to be gentler than today’s high-tech medical assault. And scientific studies have found that a handful of botanical folk therapies appear to be effective as well as safe.

But researchers and regulators are increasingly concerned about the possible side effects of some preparations. The best-known recent example of herbal toxicity involves ephedra, used in a traditional Chinese medicine called ma huang. The Food and Drug Administration has received more than 800 reports of adverse reactions, including strokes and deaths, blamed on ephedra products. The plant extract, which contains a natural version of the stimulant ephedrine, was marketed as Herbal Ecstasy and Cloud 9, among other names.

Although the FDA is considering classifying ephedra as a drug, the agency generally regards herbal preparations as dietary supplements, which do not have to be proven safe and effective before marketing. Also, dietary supplements are not subjected to the same stringent federal manufacturing standards that dictate the composition and purity of drugs.

Robert Moore, a senior regulatory scientist in the FDA’s office of special nutritionals, said that consumers seldom realize that herbal medicines have undergone no official safety review.

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“There’s a lot of concern in the medical community and by state and federal regulators that Americans are [unknowingly] conducting an experiment on themselves to identify the level of safety on these products,” he said.

In a sense, that laxity helps explain how Ye died.

“Anybody can sell herbs without any quality control of the product,” said Richard Ko, a California health department chemist and pharmacist who led the investigation into Ye’s death.

The herb tea was such an obvious suspect from the start that state investigators visited the herb store the day after Ye died. But they would not learn what to look for until the lab tests were completed weeks later.

After analyzing the leftover brewed tea and the packet of unused herbs, Ko, who specializes in ethnic medicines, found that they contained bufotoxins, powerful drugs extracted from the glands of venomous toads, such as Bufo melanosticus.

Toad venom is the main ingredient in a Chinese folk remedy called ch’an su, which is traditionally given in extremely small doses to stimulate the heart, among other organs. Dried ch’an su, which is so rare and so potent that Ko says it costs thousands of dollars an ounce, contains compounds that also trigger hallucinations. California prohibits the import or sale of purified toad venom compounds and ch’an su.

Ko concluded that the “most likely scenario” for Ye’s poisoning was that a South-North herbalist put ch’an su in the herb blend by accident, perhaps mistaking the brownish pellets for the dried asshide powder listed in the tea recipe. That scenario received support after the state health lab failed to find asshide powder in Ye’s packet of unused tea.

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It is illegal in California even to possess ch’an su--just as it is illegal to practice medicine without a license--but the store was not charged with a crime.

“We felt unless we could show that the pharmacist knew or should have known that this would occur that we wouldn’t have a good case,” said Robert H. Perez, a San Francisco assistant district attorney, who was then in charge of consumer and environmental protection. “A search of the premises was done . . . and we couldn’t show that the owner had this [toad’s venom] as part of his inventory.”

Lawyers for South-North’s proprietor, Alan Wong, say that Ye must have obtained ch’an su somewhere else: “At absolutely no time prior to Ye coming into South, or thereafter, has Wong ever purchased, sold, or prescribed ch’an su, and no such ingredient was ever placed in any of the mixture which was selected by Ye.”

Ye’s husband, Min Chen, sued South-North for wrongful death; the case was settled out of court for an undisclosed amount, with South-North admitting no wrongdoing.

Still, Ko and his colleagues argue that Ye’s death illustrates a dangerous lack of oversight of herbal medicine. “Without uniform standards of practice and licensing of herbal practitioners and dispensers,” Ko and his colleagues wrote, “consumers of herbal remedies have no assurance that products they receive are safe.”

After Ye died, the investigators reviewed 3,000 San Francisco County death certificates and found no other bufotoxin fatalities.

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“We feel pretty comfortable that it was a stand-alone case,” Ko said. “But it was sad because she was so young.”

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