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COLUMN ONE

Felled by 'Herbal' Diet Drug

AMP II drops, a potent mix of stimulants including ephedrine, caused a woman's stroke, she alleges. Her case shines a light on a largely unregulated industry.

April 04, 2002|RAY F. HERNDON | TIMES STAFF WRITER

It began Jan. 2, 2001, 5 1/2 years after Talbert had collapsed at the state park campground. By then, her case had been strengthened considerably by two new medical studies.

In the first, published in the New England Journal of Medicine, UC San Francisco researchers linked dietary supplements such as E'Ola's to as many as 10 deaths and 20 heart attacks and strokes reported to the FDA over a two-year period.

In some cases, researchers found, the victims had received much lower doses of ephedrine than users of the E'Ola drops were getting.

The same issue of the medical journal reported the results of a Yale University study of stroke victims that led to a nationwide recall of diet drugs and cold remedies containing phenylpropanolamine, or PPA--a compound closely related to ephedrine.

The researchers found that using appetite suppressants with PPA (since banned in the U.S.) increased the risk of stroke in young women 17-fold.

Both studies were introduced as evidence in the second trial.

The defense had a new lineup of experts and a new theory to explain Talbert's stroke. Dr. Wade Smith, director of stroke services at UC San Francisco and a defense expert, said the likely cause was a tear in an artery in Talbert's neck.

In his closing argument, Vollertsen appealed to jurors to send a message.

"The question is how loudly you're going to speak with your verdict," he said. "We are asking you to speak loudly enough to be heard. The louder you speak, the farther away you will be heard."

'Outrageous' Conduct

On Feb. 7, 2001, the jury found for Talbert, deciding by an 11-1 vote that the AMP II drops had caused her stroke and that E'Ola had misrepresented a defective product as safe.

On the issue of damages, the jurors spoke loudly. They awarded Talbert $13.3 million--$1.3 million to cover her medical bills, lost earnings and other expenses, and $12 million in punitive damages to penalize E'Ola for "outrageous" conduct.

Rivers, who had earned more than $25 million from E'Ola, was personally ordered to pay more than half the judgment. The rest was to come from the company itself and Reis, the president.

Last month, the trial judge reduced the total damages to about $13.1 million, but otherwise upheld the jury's decision.

E'Ola is contesting the verdict in Alaska's appellate courts, and Talbert will not receive any money until the appeals are exhausted.

Last fall, the FDA again took action against E'Ola for putting ephedrine hydrochloride in its diet drops. At the FDA's request, U.S. marshals raided E'Ola's headquarters and seized its entire stock of AMP II, as well as its supplies of ephedrine hydrochloride.

Under threat of further FDA seizures, the company has stopped selling AMP II.

But there was nothing to prevent E'Ola from launching new ephedrine products: ThermoAMP drops and foil-wrapped, chocolate-flavored ThermoAMP Herbal Chews. Both contain caffeine and ephedrine--the combination that prompted the 1994 FDA warning about possible heart attacks and strokes.

E'Ola insists its products are safe. Eileen Harding, a company vice president, said in a statement: "We are proud of our entire product line. E'Ola has served the dietary and health needs of millions of satisfied customers, and we will continue to do so."

Talbert is back at her job at Chugach Electric. She is still unsteady on her feet, has difficulty speaking and has not regained full use of her left hand. Her doctors have barred her from volleyball.

She expressed disappointment that new E'Ola products have replaced the AMP II drops but said she feels vindicated.

"We just hope we got their attention and that the next time the company makes decisions affecting consumer health, they'll act responsibly and put health before profit."

(BEGIN TEXT OF INFOBOX / INFOGRAPHIC)

Ancient Treatment Came West in 1920s Ephedrine is derived from ephedra, a shrub that thrives in semi-arid regions of Asia. Often called by its Chinese name, ma huang, ephedra is a stimulant to the heart and nervous system. It has been used in China for more than 4,000 years to treat asthma and upper respiratory infections. It was introduced into Western medicine in the 1920s.

In recent years, ephedrine has become a popular, and controversial, ingredient in dietary supplements. The Food and Drug Administration says it has received reports of hundreds of strokes, heart attacks and other "adverse events" associated with ephedrine. Supplement makers say there is no scientific evidence that ephedrine products are unsafe if taken at recommended doses.

Key dates in the controversy:

* Oct. 25, 1994: President Clinton signs the Dietary Supplement Health and Education Act, which permits supplement makers to market herbal products without proving them safe and effective. The act is sponsored by Sen. Orrin G. Hatch (R-Utah), whose state is home to many supplement companies.

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