07/31/06By IN-SUNG YOO
The News Journal
06/20/2006
With as many health problems as he's had over the years, Tom Domingue looks to stay a step ahead however he can.
The 69-year-old from Midway fought through polio as a child and now suffers from the fatigue and muscle weakness of post-polio syndrome. He's also had surgery to treat colon cancer and takes medication for high blood pressure.
In 1990, after a bout with cancer, Domingue became fascinated with the precepts of natural healing. He now supplements his diet with fish oil, saw palmetto and other herbs, and acidophilus tablets. But before he starting taking these natural products, he checked with his doctor.
"I always mention whenever I introduce anything to my body," he said.
It's a smart approach that not everyone takes, doctors say. None of the supplements Domingue takes is known to carry a risk of dangerous interactions with his blood pressure medication. But some popular natural remedies have been found to have a negative effect on prescription and over-the-counter drugs. For instance, the natural mood-enhancer St. John's wort may reduce the effectiveness of as many as half of all prescription drugs, including antidepressants, blood-thinners and birth control pills.
Such findings underline a growing concern among the public and the medical community, first sparked by the U.S. Food and Drug Administration's ban on the weight-loss supplement ephedra in 2004. The agency's action turned a harsh light on herbal cures, which are finally starting to be recognized as the powerful substances they are, experts say.
But the real concern is not what we know, it's what we don't know, said Dr. Brian Strom, chairman and professor of biostatistics and epidemiology at the University of Pennsylvania. There's almost no good scientific research to support the effectiveness of any herbal supplement, despite a $20 billion market for such products. And when it comes to interactions, we're flying blind, he said.
"At least [with prescription drugs] we know what the side effects are," Strom said. "Knowing those, we can make a deliberate trade-off. With herbs, if we're lucky they're placebos, but unfortunately some of them are not."
'Do your own research'
The claims on labels of herbal products can range from the fairly mundane -- "boosts your immune system" -- to the more cryptic --"supports Yin energy," as the Native Woman supplement from MycoMedicinals touts.
A registered nurse, Emily Whiteman, 37, knows not to take them at face value. She consults regularly with the Physicians' Desk Reference, a trusted index of drug information, and her doctor. Whiteman is on an organic diet and takes probiotic supplements for some gastrointestinal problems, but doesn't subscribe to the idea that a product is safe just because it comes from nature.
"You absolutely have to do your own research," she said.
Despite the fallout from the federal ban on ephedra, many people still prefer herbal cures to their chemically tailored pharmaceutical brethren. But the truth is that for most herbal products, we don't even know what the active ingredient is, Strom said. That's not to say natural supplements are a waste of time, but the lack of federal oversight makes for a troubling situation, he said.
"No one has studied them, yet there's a sense of, they've been used for thousands of years so they're safe, which is nonsense. It's a public health disaster waiting to happen," Strom said.
Increasing our knowledge of herb-drug interactions will be difficult, said David Kroll, senior research pharmacologist at RTI International, an independent research group. Manufacturers have little incentive to fund research because their products don't need to be FDA-approved. And while there's plenty of interest among researchers for this sort of study, only a small amount of the National Institutes of Health budget is allocated for this topic.
More alarming, Kroll said, is the lack of standardization among herbal products. A recent report by the independent testing organization Consumer Lab.com found that six of 19 ginseng supplements failed quality tests due to lead contamination, lack of ingredients or inadequate labeling. One product had less than 10 percent of the claimed amount of ginsenosides, the compound suspected of being the primary active ingredient in ginseng.
"The lot-to-lot variability and variability between manufacturers is quite great," he said. "The quality control is still not what it is for comparative over-the-counter drugs."
Ask a medical professional
When customers come in to Harvest Market Natural Foods in Hockessin to shop for supplements, they inevitably have plenty of questions, said store owner Bob Kleszics.
That's where Donna Merrill comes in. The registered nurse and medical herbalist visits the store three days a week to help customers make choices that won't put them at risk.
"We have literally had people come in with boxes filled with their medications," Kleszics said.
Domingue, of Midway, goes to Dr. Elisa Montross-Lopez's office every six months to get his blood pressure checked. Whenever he does, he also lets her know about any new herbal supplements he's interested in taking.
"She usually says it's fine," he said.
Montross-Lopez said she typically supports the use of herbal supplements by her patients, as long as they confer with her.
"It shows me that they're paying attention to what they're putting in their bodies," she said. "They enable patients to take more responsibility for their care and it empowers them. I've seen a lot of benefits."
Still, it's easy to get caught up in the hype of a glitzy commercial for a product that promises the world. Montross-Lopez favors supplements that stick to one ingredient, rather than those that mix a slew of herbs into a single product.
"There's the kind of supplements that you get from an herbalist and then there's the kind you buy over the Internet," she said. "You have no idea what's in them and they're extremely expensive. I tell my patients to be very wary."
Cheyenne Luzader, coordinator of integrative health at Beebe Medical Center in Lewes, said some people worry that their doctors will be offended at the notion of using non-Western medicine. But it is in the patient's best interest to engage -- and, to an extent, educate -- their doctors, she said. Such knowledge is especially crucial in the event that surgery is needed, as some herbal supplements can lead to complications such as increased bleeding and decreased effectiveness of anesthesia.
"I think people are becoming much more aware of the idea that these are powerful drugs," she said. "In the earlier years, there wasn't much information, period, so the people who used these were doing so without much thought."
As with any medication, it's important to realize more isn't better, Luzader said. One practice she recommends -- and follows -- is to take only small amounts of any supplement you've recently added to your routine. That way, you can test for potential allergic reactions such as upset stomach or headaches. People with seasonal allergies also should know that a number of herbal products are related to ragweed.
"These may be natural, but they're more concentrated in a tablet," she said. "People don't realize that."
More regulation needed?
Stuart Beattie, 65, of Avondale, Pa., tries to keep up on the latest news about the herbal supplements he takes.
Beattie says he's a big fan of natural remedies but is never surprised when he learns a natural cure has side effects. After all, "a large number of prescription drugs originally come from plant sources," said Beattie, who was shopping for supplements at Harvest Market last week.
Yet, when it comes to pharmaceuticals, manufacturers must prove the product's safety before the FDA will allow it to go to market. Dietary supplements, on the other hand, can go to market without such evaluation. Harmful effects must be proven before the federal government can restrict sales of the product.
That laissez-faire approach is based on the fact that many of these products have a long history of human use and that they are not permitted to make medicinal claims anyway, said Strom. But the lessons learned from ephedra -- which was linked to the deaths of 81 people and more than 1,000 adverse effects -- have shown that approach is no longer acceptable, said Strom.
"When it comes to herbals, we're in kind of a pre-FDA era," he said. "I'm not saying they should be taken off the market, but these are drugs and they should be regulated as drugs."
Kroll would like to see a regulatory approach similar to that taken by federal authorities in Canada, where herbal manufacturers must provide more documentation attesting to their products' history of safety, but still don't have to undergo clinical trials with humans. All natural supplements also must be licensed, and companies must adhere to specific manufacturing standards, report adverse reactions and follow labeling guidelines.
"It's a system that's very similar to what we had in the '60s when the law was passed that gave us our framework for clinical and pre-clinical trials," he said. "Before 1962, there were a bunch of drugs out there, including aspirin and acetaminophin, that are known to be effective but had never been tested in a clinical trial."
In 2003, the FDA proposed a rule to establish manufacturing standards that would ensure the strength and purity of dietary supplements. But that rule hasn't been implemented and the agency hasn't made any other moves to change the way it regulates such products, said spokesman Michael Herndon.
Domingue, of Midway, would rather not see government regulation of herbal products. He thinks consumers should take it upon themselves to research products and consult with trained herbalists and doctors to make informed choices.
After living with post-polio syndrome for decades, Domingue also knows better than to expect a miracle herb. But then again, Western medicine hasn't seemed to do the trick either, so he said he'll continue to proceed with cautious optimism.
"I think all of the supplements I take, they're helping me," said Domingue. "To the extent that they can."