Science & Pseudoscience Review in Mental Health

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Health Concerns Grow Over Herbal Aids

From: Washington Post Sunday, March 19, 2000
By Guy Gugliotta, Staff Writer

Mounting evidence suggests that increasing numbers of Americans are falling seriously ill or even dying after taking dietary supplements that promise everything from extra energy to sounder sleep.

The victims include men and women of all ages as well as children whose parents are feeding them snacks, drinks and nostrums made with herbal supplements that are neither regulated by the federal government nor tested for their effects on the young.

While the Food and Drug Administration issues periodic warnings about the dangers of individual supplements, no organization or agency has ever made a comprehensive analysis of the sickness and death associated with them.

But in attempting the first national survey, The Washington Post collected statistical snapshots from health officials, researchers and advocates reaching almost every state in the country. Among the findings:

Exempt From Regulation

While health care providers concede that diet supplements are not as dangerous as automobiles, which killed 41,826 people nationally in 1998, or diseases such as kidney disease, which killed 26,295, most experts consulted by The Post suspect their data vastly understate the incidents that actually occur.

This is because a 1994 federal law, fiercely pushed by the industry through an acquiescent Congress, exempts supplement companies from almost all federal regulation, including any requirement that they file reports when the use of one of their products goes wrong. Unlike pharmaceuticals or food additives, supplements do not have to be pre-screened by the FDA, nor do they have to demonstrate through peer-reviewed science that they are safe before they can be sold. And once on sale, the burden of proof is on the FDA to show that a supplement is dangerous before it can be taken off the market. The only tool federal officials have are the sketchy, patchwork reports voluntarily called in to them.

And the industry is expanding rapidly, with hundreds of herbal products and product blends. Since 1994, supplement sales have grown by nearly 80 percent, from $8.8 billion to a projected $15.7 billion for 2000, according to the Nutrition Business Journal. Ephedra, for example, is sold as a "natural" way to increase human metabolism. St. John's wort is fast becoming a Prozac competitor. Melatonin is touted as an elite cure for jet lag. Ginseng is a purported key to sexual stamina and eternal youth. Ginkgo biloba allegedly sharpens the mind and wards off Alzheimer's disease. Senna is a natural purgative to aid in weight-loss and exercise regimes.

Faced with the federal government's inability to regulate supplements, many states have passed their own restrictive laws. They also are collecting data on an industry that experts such as Lee C. Vermeulen, director of the University of Wisconsin Poison Control Center, expect will keep growing, along with its attendant problems, until "the economy goes south."

In this environment, the experts say they are catching only glimpses of supplements' potential dangers: "Ninety percent of the time we get called [only] when people are using these things from abuse," said Greene Shepherd, director of the North Texas Poison Control Center in Dallas, voicing a frequently heard complaint. "There's a huge portion that we're missing." Also, added Prosy Abarquez-Delacruz, regional administrator for the California Health Services Department's Food and Drug Branch, companies have hastened to take advantage of the dearth of regulation.

"It's the John Wayne industry, like the wild, wild West, and the practices of the few have tainted the many," said Abarquez-Delacruz. In the past year her office temporarily halted sales of $1.5 million in exotic teas and beverages because of misleading label claims.

Many health professionals, including strong critics of supplements, acknowledge that they can be both useful and safe, if taken in reasonable doses.

But many consumers become victims because they "believe that if a product wasn't safe, the government wouldn't allow it to be sold," said consumer advocate Bruce Silverglade, legal affairs director of the Center for Science in the Public Interest. "In this case that's just a false assumption."

In fact, cautioned New York City Poison Center Director Robert Hoffman, many supplements "are drugs. There's no doubt about it."

And in essence, added pediatrician Howard Mofenson, director of the Long Island Poison Center in Mineola, N.Y., public consumption of supplements has become the clinical trial: "Nothing will be done unless a tremendous outbreak occurs," Mofenson said. "This law is the greatest uncontrolled experiment that the United States has ever undergone."

A Deep Divide

"Dietary supplements," as defined in the 1994 Dietary Supplement Health and Education Act, include vitamins, minerals, herbals, amino acids and derivatives of these substances.

Health food advocates and supplement companies concede that new products need more rigorous testing but say that many substances they sell are time-tested natural remedies whose efficiency and safety have been established for hundreds, even thousands of years.

R. William Soller of the Consumer Healthcare Products Association, representing supplements manufacturers and distributors, predicted that testing will increase "as you see the field evolve," especially when companies start competing head-to-head with each other, and with over-the-counter drugs.

And when it comes to adverse events, Soller drew a distinction between mainstream herbs and fringe products, which he said included a variety of rare Asian herbals and substances such as GHB, which he described as illicit drugs masquerading as supplements.

For most of the consumer groups and health care providers consulted by The Post, however, a different picture emerged of the risks associated with supplements, including mainstream products.

The 1994 act, Abarquez-Delacruz said, "started it all" by giving the supplements industry license to do almost anything it wants with almost no accountability: "It's the Food Fraud Facilitation Act--at least in the minds of health professionals," she said.

The sources consulted by The Post collected information in different ways, making it impossible to compare individual studies. Still, the data showed that the number of serious incidents occurring in individual states far exceeds the number of reports received by the FDA's Special Nutritionals Adverse Events Monitoring System, the source most frequently cited as a national benchmark.

The disparity is stark. The FDA's monitoring system implicated dietary supplements in 2,621 adverse events between 1993 and Oct. 10, 1998, with 184 of them resulting in death.

The American Association of Poison Control Centers, by contrast, received 6,914 reports on supplements in 1998 alone, including 1,369 cases involving treatment in a health care facility. The association's figures did not include ephedra and its derivatives, which account for the biggest chunk of the FDA's cases.

Sixty-four percent of the association's reports involved children under age 6, a trend also noted among many member poison centers. Of 599 supplement reports documented by University of California pharmacologist Candy Tsourounis at five California centers between January 1997 and June 1998, more than half were pediatric.

"Children see it as 'What's Mommy taking?' " said Tsourounis, and supplement bottles tend not to have child-proof caps. Also, Tsourounis added, supplement companies are providing entire product lines aimed at children--products that, like their adult equivalents, have not been tested for possible side effects or effects on the young.

Herbs, or Drugs?

Perhaps nowhere has the danger of unregulated supplements been more apparent than in the case of GHB, used among athletes as a muscle builder and relaxant, and by partygoers as a way to lose inhibitions. Over the past decade considerable evidence showed that GHB, and "precursors" that convert to GHB inside the human body, can cause a variety of severe side effects, including coma and death.

The FDA's 1993-98 adverse-events system, however, lists only 14 GHB and precursor episodes, and one death, while states contacted by The Post routinely reported dozens of cases annually, with Florida's 549 incidents topping the list.

In January 1999, the FDA proclaimed GHB precursors "unapproved new drugs," said it had documented 55 adverse reactions, warned manufacturers to take the products off the market and threatened lawsuits and seizure if they refused to comply.

A year later, with GHB abuse reports higher than ever, Congress trumped the 1994 law by outlawing GHB and its precursors as dangerous drugs. At that point the Drug Enforcement Administration had blamed 60 deaths on GHB-type supplements nationwide.

Congress has been much slower to act on ephedra, challenging the accuracy of FDA data that documented 685 possible adverse reactions to the supplement or its derivatives, and 39 deaths.

"A sufficient body of evidence . . . has yet to be presented" to "challenge the safety of ephedra," the Consumer Healthcare Products Association's Soller said. "It still remains as a dietary supplement that can be considered safe" as long as recommended dosages are followed.

Last month the FDA called off a three-year attempt to impose dosage regulations on ephedra products, but has assembled new data on 134 ephedra cases in preparation for a new round of rulemaking.

Others, including states and private individuals, are gathering information. By the end of 1999, California-based activist Barbara Michal had gathered 215 Web site complaints about ephedra in a little more than a year. Thirty percent of her contacts acknowledged addiction to the supplement.

And the Texas Department of Health collected 418 adverse-event reports from 1993 to 1995 from two companies whose telephone complaint line records were subpoenaed. In 1999, San Francisco trial lawyer Christopher E. Grell took a deposition from a company executive who said the firm had received "roughly 3,500 complaints" about its ephedrine product, none of which had been reported to the FDA.

"On a 'good week,' we may encounter it [ephedra] daily," said pharmacist Carl Hornfeldt, director of the Hennepin Regional Poison Center in Minneapolis. "It's kind of a dirty drug. Some people say they have done 20 tablets a day without problems, but then an adolescent took seven or eight and died."

Another area of controversy is sports nutrients such as the steroid hormone androstenedione, sales of which skyrocketed in 1998 after St. Louis Cardinals slugger Mark McGwire reported using it in his race to break the single-season home run record.

"Andro" is banned by the National Football League, the Olympics and the National Collegiate Athletic Association, and a Major League Baseball-funded study last month found that the supplement raised testosterone levels and could be hazardous.

Also controversial is creatine, a naturally occurring substance used by athletes for explosive bursts of power. Although studies have shown no evidence of adverse reactions, there continues to be concern about the supplement's long-term effects, especially in adolescents.

This was one reason that Texas State Rep. Glen Maxey (D) easily won passage of legislation last year forbidding employees of the Texas public school system to sell or promote "performance-enhancing products" on school time.

"We found it happening across the state," Maxey said. "We found high school budgets were buying dietary supplements for students. You get a football helmet, shoulder pads, a jockstrap and creatine."

Staff researchers Lynn Davis and Nicholas Johnston contributed to this report.

2000 The Washington Post Company