Felled by ‘Herbal’ Diet Drug

Rosie Talbert, a working mother of four, relied on energy and enthusiasm to hold her own on the volleyball court. “Spiking was way out of my league since I’m short,” she said, “but I could really get under the ball.”

During one game at a state park campground in the summer of 1995, she felt sick, staggered to the sidelines and collapsed. Talbert was diagnosed as suffering from heat exhaustion. As they sent her home, emergency room doctors gave her husband, Dan, this advice: “Get her some Gatorade.”

Three days later, Talbert’s condition had not improved. A brain scan showed that she had suffered a massive stroke. A weeklong battery of tests failed to determine why.

“They said they couldn’t guarantee I wouldn’t have another,” she recalled recently. “I was terrified.”

For nearly two years, Talbert had been putting diet drops in her coffee three times a day. The drops were made by a Utah company called E’Ola International, and they contained ephedrine, a popular but controversial herbal stimulant.

Ephedrine is the key ingredient in dozens of dietary supplements sold at supermarkets, drugstores, even health clubs. It gives athletes an energy surge and helps dieters control their appetites. But a growing body of evidence has linked ephedrine to heart attacks, strokes and other side effects.

In 1995, awareness of these risks was not widespread, even in the medical community. Talbert’s doctors were at a loss to explain why this physically active, 34-year-old woman had been stricken.

In time, they and she came to believe that the diet drops were to blame. The more Talbert thought about it, the angrier she got. She hired a lawyer and set out to hold E’Ola International accountable. She wanted money, but not only that. She wanted publicity too. The more the better.

She knew it would not happen quickly. Finally, in an Anchorage courtroom last year, Talbert’s lawyer subjected E’Ola to the kind of public scrutiny the supplement industry had long sought to avoid.

What the testimony revealed about E’Ola was described by the judge and jury as “outrageous.”

The dietary supplement industry has grown rapidly in recent years and offers hundreds of herbal products touted as promoting everything from muscle mass to sexual potency.

Sales have nearly doubled, to $16 billion a year, since 1994. In that year, Congress exempted supplements from nearly all federal regulation. Supplement makers are major donors to congressional and presidential campaigns, and they lobbied hard for the legislation.

Its effects were sweeping. Unlike pharmaceuticals or food additives, herbal supplements do not have to be screened by the Food and Drug Administration before going on the market, or proved safe through research.

And unlike drug companies, supplement makers are not required to notify the FDA of adverse reactions to their products. The agency has relied on voluntary reporting by physicians and consumers in piecing together a picture of ephedrine’s dangers.

The industry’s most important Washington ally is Sen. Orrin G. Hatch (R-Utah). A supplement user himself, Hatch says he is acting to preserve freedom of choice for consumers and to protect companies that are major employers and taxpayers in his state. He says herbal products such as ephedrine are not foods or drugs and should not be subject to “arbitrary” actions by federal bureaucrats.

Herb Used in China

Ephedrine is derived from a plant called ephedra, or ma huang, a medicinal herb used in teas in China. It is a chemical cousin of amphetamine and a stimulant to the heart and nervous system.

Ephedrine energy supplements with names such as Ripped Fuel and Andro Heat are popular with athletes and bodybuilders. Such products are suspected of contributing to the deaths of several college and professional football players over the last year.

But FDA data show that most of those who suffer serious side effects from ephedrine are women--typically, women in their 30s and 40s who were taking supplements to lose weight.

Especially risky, according to the FDA, are products containing both caffeine and ephedrine.

E’Ola’s AMP II Pro drops were such a product. Rosie Talbert began taking them in 1993. She often struggled to control her weight, especially during the long Alaskan winters. She learned about the diet drops from her mother, who had learned about them from a deli manager, who said they had helped her shed 80 pounds.

The drops cost $15 to $20 for a 1-ounce squeeze bottle. Talbert’s mother became an E’Ola distributor so she could get a nearly 30% discount. Talbert helped out, delivering the drops to her co-workers at Chugach Electric, a southern Alaska utility.

E’Ola literature touted the drops as “all herbal” and safe. Talbert took them without incident for nearly two years, losing 20 to 30 pounds.

Then, on June 3, 1995, she suffered her stroke. It left two lumps of dead tissue in her cerebellum, each the size of a golf ball.

The next several months, she said, were filled with fear and uncertainty.

“I couldn’t walk straight. My left hand would shake uncontrollably. And I couldn’t control my right hand,” she said.

Although her condition improved slightly, Talbert continued to be plagued by nausea, a loss of muscle control, vision problems and short-term memory lapses. Once, after a trip to a supermarket, she circled the parking lot, unable to remember what her car looked like.

She tried to return to her job in the utility’s credit department but lasted only a day: She couldn’t focus on her computer screen.

The Talberts had to sell their home and move into a trailer with their four children, whose ages ranged from 8 to 16. Talbert fearedthat her marriage was failing. She lost all interest in sex and offered to release Dan from their wedding vows. He refused and instead arranged a ceremony to renew them.

Her doctors, meanwhile, were still trying to figure out what caused her collapse. Talbert had told them about the diet drops, but the information did not raise a flag. In 1994, the FDA had issued a medical bulletin warning that supplements combining caffeine and ephedrine could cause heart attacks, strokes and other side effects. But the bulletin got little attention. There had been no published medical studies linking ephedrine to strokes.

Then, Talbert read a newspaper article about ephedrine. “It urged you to contact the FDA if you had any questions,” she said. Talbert did just that and within days had an FDA computer disk describing ephedrine’s danger signs. Many of them matched her symptoms.

“I was just shocked,” she said.

She brought the information to her neurologist, who concluded that ephedrine had probably caused her stroke. In mid-1996, Talbert hired Anchorage attorney Richard E. Vollertsen to sue E’Ola.

At first, Vollertsen was wary. Supplement companies were regarded as particularly tough courtroom adversaries.

“The food supplement industry is well-heeled and throws lots at you,” said Mark I. Hefter, a Texas lawyer who has won out-of-court settlements in three ephedrine cases.

In one of them, Next Nutrition of Carlsbad, maker of an ephedrine energy drink called Ultimate Orange, paid $4 million to Todd Weger, a Gulf War veteran who suffered a stroke after drinking Ultimate Orange and jogging on a treadmill. He was 31 at the time.

After doing some research on Talbert’s case, Vollertsen came to believe she had a decent chance of winning. Texas, he learned, had banned a product almost identical to the AMP II drops, and the FDA had begun disclosing reports of heart attacks, strokes and other “adverse events” associated with ephedrine supplements.

As Talbert’s trial date approached, the two sides held settlement discussions. Talbert rejected E’Ola’s offer. Vollertsen said it barely would have covered the $500,000 in medical and legal expenses she was facing.

That was not all. The company wanted any settlement to be confidential. Talbert wouldn’t hear of it. She says she wanted other women to know about the dangers of ephedrine. She wanted to make some noise.

First Case to Trial

The trial began Nov. 12, 1998, in the Anchorage courthouse, a modern, pink-granite building whose entryway is adorned with totem poles carved with eagles and ravens. A light snow was falling. Talbert’s four children wanted to attend, but she insisted they go to school.

The case marked a first: There had been previous lawsuits over ephedrine, but none had gone to trial. Over the next three weeks, Vollertsen exposed E’Ola’s inner workings to public view. A sobering picture emerged.

E’Ola was founded in 1991 by a former Honolulu car salesman, Don Rivers. Rivers had retired to Utah, the heartland of the supplement industry, and was looking for a way to increase his retirement income.

He went into business with Barry Naef, an entrepreneur from Fullerton who had been drawn to Utah by his dream of making a liquid diet potion. A mutual acquaintance introduced them to Blaine Rudd, a Salt Lake City hairdresser who was looking to get into the supplement business. Wayne Reis, one of Rivers’ colleagues from the Honolulu car lot, became president of E’Ola.

Rudd developed the formula for the AMP II diet drops. His only previous work experience, he testified, was cutting, perming and dyeing hair. Rivers’ son Ray mixed and bottled the drops by hand in plastic buckets. His previous job: digging swimming pools.

Later, E’Ola contracted with a private laboratory to produce AMP II. Even then, the drops were not tested for safety, company officials testified, and there was no quality control.

Tests conducted for the plaintiffs by an independent laboratory showed that the amount of ephedrine in the drops could differ by as much as 100% from one batch to the next.

For a time, E’Ola officials tried to make the diet drops purely with herbal ephedra. But the herbal concoction was too weak, they testified, and sales plummeted. E’Ola then added synthetic ephedrine hydrochloride to boost the supplement’s potency, testimony showed.

Ephedrine hydrochloride is the prime ingredient in the street drug methamphetamine and is a controlled substance under the nation’s drug laws. Inside the body, it breaks down into the same chemical constituents as herbal ephedrine, but its effect is even more powerful.

It is illegal to put ephedrine hydrochloride in a product marketed as an herbal supplement. The substance was not listed as an ingredient on AMP II bottles.

The drops that Talbert took contained ephedrine hydrochloride, but Vollertsen did not try to prove that it, in particular, caused her stroke. Rather, he introduced the evidence of spiking in an effort to paint E’Ola as a rogue company unconcerned with customer safety.

However slapdash its methods, E’Ola was a success. The AMP II drops, the company’s main product, brought in as much as $50 million annually, testimony showed. Don Rivers was paid as much as $10 million a year.

Defense Insists on Proof

Vollertsen’s star witness was Dr. George A. Ricaurte, a Johns Hopkins University neurology professor who had served on a special FDA panel on ephedrine.

Ricaurte testified about incidents reported to the FDA that linked ephedrine to serious side effects. Defense lawyers objected, arguing that the reports had not been scientifically verified.

When the judge overruled the objection, the defense challenged Ricaurte to cite a single medical study proving that ephedrine supplements caused strokes.

“If you’re asking me has anyone ever taken a group of patients and given them increasing doses of ephedrine to see if we can produce strokes, no. That would be unethical,” Ricaurte replied. But, he added, “there is a vast literature that makes a compelling case that these ephedrine alkaloids have the potential to produce stroke in living human beings that had no risk factors.”

The defense countered with Dr. Lorne S. Label, a neurologist from Thousand Oaks. In a written report, Label cited two possible causes for Talbert’s stroke: high blood pressure and lupus, an autoimmune disorder that attacks blood vessels and the brain.

Once on the stand, Label voiced a different opinion: that Talbert was felled by “a showering” of microscopic clots that blocked the blood flow in her brain.

He went on to cite “risk factors” that he said made Talbert particularly susceptible, including her occasional use of alcohol and her weight--130 pounds on a 5-foot-1 frame, which he described as obese.

Rivers, the company founder, also took the stand. He defended his product, saying he had no knowledge that AMP II drops had ever been linked to heart attacks or strokes.

E’Ola’s attorney, Phillip J. Eide, hammered away at the lack of scientific studies proving that the level of ephedrine in recommended doses of AMP II was dangerous.

“It’s not dangerous,” Eide told the jury. “It doesn’t cause heart attacks, doesn’t cause strokes, doesn’t cause any kind of dangerous reaction.”

As the trial wore on, Superior Court Judge John Reese grew indignant at the testimony of E’Ola officials. In a conference with the lawyers in his chambers, he likened the company’s position to keeping one’s “head in the sand: ‘I don’t care how many people have died from it, there’s no scientific method that proved it.’

“This is the sort of case that could have been brought as a criminal case,” Reese said in one closed-door conference. “. . . It’s just outrageous conduct by these people.”

Jurors did not see it that way. After deliberating 5 1/2 hours, they voted, 10 to 2, against Talbert. She would get nothing.

Talbert was stunned. “I spent many a night awake thinking about it and crying,” she said. “I felt numb for quite a while afterward.”

Vollertsen bolstered her spirit, insisting that they had merely lost the first round. In early 1999, he filed a motion for a new trial. Soon, new evidence would surface--evidence that would blast a hole in E’Ola’s trial defense.

FDA Papers Revealing

A year earlier, Vollertsen had requested FDA documents on E’Ola under the Freedom of Information Act. Now, two months after the end of the trial, the agency had finally produced the records.

They showed, as Judge Reese later wrote, that “E’Ola officials perjured themselves. . . . E’Ola was made aware by the FDA of incidents or injuries and strokes caused by their product.” Nevertheless, the judge wrote, “E’Ola falsely testified that they were unaware of injuries.”

The judge found that E’Ola had misled jurors on another crucial point. Eide told the jury that the FDA had never taken enforcement action against E’Ola. The newly released documents showed otherwise.

The FDA’s authority over supplements was narrow, but it had used that authority against E’Ola. In 1992, the agency cited the company for claiming that the AMP II drops had medicinal value as an asthma treatment, and for spiking them with ephedrine hydrochloride.

The judge ordered a new trial.

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.”

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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.

* June 2, 1997: The FDA proposes limiting the amount of ephedrine in recommended doses of dietary supplements and requiring labels that warn consumers that exceeding those doses could cause seizures, heart attacks and strokes. The FDA later withdraws the proposal in the face of strong industry and congressional opposition.

* Feb. 7, 2001: An Anchorage jury awards Rosie Talbert $13.3 million after concluding that ephedrine diet drops made by E’Ola International of St. George, Utah, caused her stroke.

* Aug. 3, 2001: Rashidi Wheeler, a Northwestern University football player, collapses and dies during a workout. An autopsy identifies asthma as the cause of death, but university officials say ephedrine may also have played a role. Before the workout, Wheeler took two energy supplements containing the substance. Wheeler’s death was one of three football fatalities that year in which ephedrine was suspected.

* Sept. 8, 2001: The National Football League adds ephedrine to its list of banned substances, following the lead of the National Collegiate Athletic Assn. and the International Olympic Committee.

* Jan. 10, 2002: Canadian health authorities call on manufacturers to stop selling ephedrine supplements containing more than a certain dosage level, or those that contain caffeine.