When Karen Ruiz read about a popular herbal dietary supplement that claimed to be a natural way to lose weight and gain energy, the busy homemaker and mother of two eagerly snapped it up.
"By day five or six, it was like I had gone from first to fourth gear," Ruiz said on ABCNEWS' Good Morning America.
After a few days of taking the supplements and marveling at her own efficiency, Ruiz was literally running through the house, getting her cleaning and other tasks done faster than ever. But then, things took a strange turn.
Ruiz started hearing voices, and came to believe that she was being called away from her family to warn people that the end of the world was approaching. Her husband worried about leaving her alone with the children because she believed her son was the reincarnation of Jesus Christ.
Ruiz ended up in a psychiatric ward for 10 days, where a doctor told her that the combination of ephedra and guarana herbs in her dietary supplement produced an amphetamine effect that could lead to psychosis.
Now, Ruiz is speaking out against the herbal dietary supplement that she says caused the episodes. Senators will hear from Ruiz on the issue today in a Senate Governmental Affairs subcommittee hearing on consumer safety and weight loss supplements.
Ephedra, like all herbal dietary supplements, is not regulated by the Food and Drug Administration. The FDA has commissioned the National Academy of Sciences to come up with a framework to evaluate the safety of dietary supplements, now estimated to be a $17 to $20 billion industry.
Sen. Dick Durban, D-Ill., who is chairing today's hearing, says the regulation of herbal supplements is long overdue. "The Food and Drug Administration has little, if any, authority to police these products," Durban said. "We have to come up with a standard that's reasonable when it comes to dietary supplements."
A ‘Backwards’ Approach
Ephedrine, the active ingredient in ephedra, (which is also called Ma Huang) is classified as a stimulant. It is often combined with ingredients such as guarana (herbal caffeine) to create dietary supplements. Ephedrine can cause blood pressure and heart rate to rise, and is also linked to anxiety and insomnia.
Pharmaceutical experts applauded the move toward government regulation of herbal dietary supplements.
"With prescription drugs and over-the-counter medications, we show the evidence first, before they go on the shelves," said Candy Tsourounis, a clinical pharmacist and associate professor at UCLA San Francisco. "With these dietary supplements, it's backward. Ten people die, and then we find out why."
In November 2000, the Food and Drug Administration issued a strong warning, urging Americans to stop using drugs containing phenylpropanolamine (PPA), an ingredient found in dozens of over-the-counter cold remedies and diet pills. Products containing PPA were removed from drug store shelves amid government warnings that the ingredient had been linked to hemorrhagic strokes, particularly in young women.
But herbal weight loss supplements containing ephedrine and guarana have quickly filled the vacuum left by PPA, which was the only FDA-approved weight loss drug sold over the counter, Tsourounis said.
The new weight loss supplements, other herbal remedies, and even vitamins fall under something called the Dietary Supplement Health Education Act, approved by Congress in 1994. Dietary supplement makers are not obligated to test their products before selling them, nor do they need to report health problems that result from their use.
While defenders of the herbal supplement business say supplements are safe for most of the public, some admit there's no way of knowing who will have a bad reaction. "It is well tolerated by many people who take it." Michael McGuffin of the American Herbal Products said. "Ephedra must be taken cautiously, it's not for everyone."
Scrutiny Long Overdue
Dr. Don Catlin, director of the UCLA Olympic Analytical Lab, and an associate professor of molecular and medical pharmacology says the lack of regulation is dangerous.
"It should have been done a long time ago," Catlin said. "They're over-the-counter drugs, and it's assumed by the public that they're safe when they may not be." Adverse reactions to stimulants such as ephedra include racing heart, high blood pressure and heart arrhythmia, and combining it with other stimulants just boosts those reactions, he said.
"It's like taking amphetamines," Catlin said.
Other factors, such as taking the drugs and being overly exposed to heat, can make these fairly common reactions more severe. Scientists found that the supplements may have helped to fuel the rate of death from heatstroke among professional football players, researchers reported in a new study in the August issue of Neurosurgery.
Ephedra, which is sold as an energy enhancer, as well as a weight-loss supplement, and creatine, promoted to build muscles, can both increase the risk of dehydration, particularly during the hot summer season.
Dietary supplements are often inaccurately labeled, making it difficult for doctors to tell what, precisely, patients took if they do have a problem, Catlin said.
"There's a lot of things that lead people to seek these type of products, which are right there next to our over-the-counter medications, but it's the wrong way for people to lose weight," Tsourounis said. "We don't know enough about them."