National Panel Urges Testing, Standards For Diet Supplements

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National panel urges testing, standards for diet supplements
Institute of Medicine study suggests steps to ensure alternative remedy safety
By Jonathan Bor - Sun Staff
Originally published January 13, 2005

Alternative therapies ranging from Chinese herbs to high-dose vitamins and dietary supplements should be more rigorously tested to ensure that they're safe and actually work, a national panel of experts said yesterday.
With more than a third of Americans reporting that they try alternative treatments, a panel convened by the Institute of Medicine said the remedies should be held to the same standards as conventional therapies. The group, however, did not report that many people are being harmed by the products.

"Complementary and alternative medicine is widespread and here to stay," Dr. Stuart Bondurant, executive dean of Georgetown University Medical Center and the panel's chairman, said in a media briefing. "The same rules should apply ... regardless of [a treatment's] origin and whether it is conventional or alternative medicine."

The panel called for changes to a 1994 law that classified dietary supplements as foods, thereby exempting marketers from proving their products are safe and effective, as pharmaceutical companies must do.

Left unsaid was how the law should be changed. The panel, for example, did not specifically recommend that dietary supplements be classified as drugs, which would require manufacturers to spend tens of millions of dollars on studies. Instead, the group called upon Congress and federal agencies to find a solution after consulting with consumers, research scientists and manufacturers.

The Washington-based Institute of Medicine is an independent organization chartered by Congress to advise the nation on important health issues. For this study, the institute picked a 17-member panel that included a massage therapist, an anthropologist and several doctors who head medical school programs that integrate conventional and alternative medicine.

The panel also called for stricter manufacturing standards for dietary supplements, saying that consumers have no way of knowing whether they contain the ingredients on the label and in the specified amounts.

"Product reliability is low," the committee said in its 330-page report.

Dr. Brian Berman, a panel member who heads the integrative medicine department at the University of Maryland Medical Center, said poor quality control has also hampered research into alternative medicine.

"It's difficult unless we know that the product is consistent from batch to batch," said Berman. "And it's very difficult for health care providers to give informed guidance when often we don't have safety and efficacy data."

More than a third of Americans use an alternative treatment, and visit alternative-medicine providers such as herbalists, acupuncturists and massage therapists more often than primary care doctors, the report said. Americans spend more than $27 billion annually on visits to practitioners offering complementary and alternative medicine, commonly referred to as CAM.

A separate study released yesterday by the Harvard Medical School said that the number of people using CAM therapy remained stable at 72 million between 1997 and 2002.

But the use of herbal supplements rose by 50 percent, and the practice of yoga increased by 40 percent over the same period. The popularity of acupuncture, biofeedback, energy healing and hypnosis remained unchanged, while the use of homeopathy, high-dose vitamins, chiropractic and massage therapy declined.

The Institute of Medicine report, among the most sweeping reviews of alternative medicine by a mainstream medical organization, drew sharp rebukes yesterday from alternative medicine practitioners.

Some said that incidences of adverse reactions to supplements such as ephedra pale in comparison to recent problems with Vioxx and other Cox-2 inhibitors, a class of painkillers under scrutiny because of their possible harmful effects on the heart.

"Show me evidence that points to the fact that there are any more people taken advantage of or harmed by alternative practices than there are harmed or taken advantage of by conventional medicine," said Brian Sanderoff, a pharmacist whose Owings Mills store specializes in alternative products. "That evidence doesn't exist as far as I know."

"Virtually nobody is dying at the hand of complementary physicians," said Dr. Jacob Teitelbaum, an Annapolis internist who incorporates alternative therapies into his practice. "Therefore, to require the same level, the same burden I think is absurd."

A 1999 report by the Institute of Medicine estimated that up to 100,000 people die annually in hospitals because of errors involving conventional treatments.

The expert panel acknowledged that manufacturers of alternative medicines have no incentive to invest in testing because their products - containing botanical and other natural materials - cannot be patented.

Accordingly, the group suggested that the federal government encourage private funding of studies. Many products, it said, can be tested with methods that are cheaper and quicker than placebo-controlled studies, which are widely considered the gold standard for drug research.

The panel did note that testing of alternative therapies, though of varying quality, is on the rise.

It discovered 7,000 randomly controlled trials of such remedies since 1982. There have also been 23 "systematic reviews" by the Cochrane Collaboration, a respected group that compiles results of similarly designed studies to reach conclusions about a drug or treatment. The group's alternative medicine section is based at the University of Maryland Medical Center in Baltimore.

In half the cases, such reviews have failed to find evidence that alternative therapies actually worked, compared with about a fifth of conventional treatments studied.

On the other hand, the studies found evidence of harm in less than 1 percent of the alternative treatments - compared with 8 percent of conventional therapies.

The Institute of Medicine's report is available online at www.iom.edu.