Ruling could boost cost of supplements

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http://www.azstarnet.com/allheadlines/144833 Ruling could boost cost of supplements By Linda Fantin SALT LAKE TRIBUNE If the benefits of dietary supplements — enough to outweigh any health risks — were backed by scientific proof, how much would you be willing to pay for them? It's a question some Americans may soon ponder. The 1994 Dietary Supplements Health and Education Act exempts supplement companies from testing products before putting them on the market. As a result, there is little incentive to conduct clinical research. But a recent court ruling in Denver might change that. The Aug. 17 decision not only upheld the federal ban on the diet aid ephedra, it also sanctioned a new

standard for evaluating the safety of supplements — a risk-benefit analysis. Sen. Orrin Hatch, R-Utah, who authored the 1994 bill, insists Congress never contemplated that. The dietary supplements act was meant to force the U.S. Food and Drug Administration to acknowledge the benefits of supplements, not question them, Hatch says. If the ephedra decision is allowed to stand, manufacturers will have little choice but to fund expensive studies — and pass those costs on to consumers — in hopes of persuading the FDA their products are worth the risk. And that, he says, is why the ruling is wrong and must be appealed to U.S. Supreme Court if necessary. "I can live with ephedra being off the market," Hatch says. "But if you give bureaucrats the right to determine the risks and benefits of supplements, the same standard used to evaluate drugs, (supplements) will be priced out of the marketplace just like drugs are now." Some scientists say

small companies unable to fund experiments will simply fold, lessening competition and further driving up prices. But they also say any decision that encourages additional and better research is a good thing. "This ruling could have a huge impact on industry," says Mary Ann Lila, professor of biological sciences at the University of Illinois at Champaign-Urbana, one of six institutions that make up the National Institutes on Health Botanical Center for Age Related Diseases. "It will increase costs, yes. But it also could change things for the better." NIH funds most studies Most studies on supplements are funded by NIH grants and conducted at academic research centers, such as the one Lila directs. The NIH Office of Dietary Supplements, for example, supports six dedicated Dietary Supplement Research Centers with five-year grants. Current studies include the use of black cohosh and red clover in menopausal

therapies, treatment of bronchial asthma with borage seed oil, the role of echinacea and turmeric in cancer treatment and the use of antioxidants to promote eye health. Stephen Coates, head of the dietary supplements office, says funding for his office has increased from $1 million in 1995 to $27 million this year. For every dollar his office spends on research, other NIH centers, led by the National Center for Complementary and Alternative Medicine, spend $10, he says. Still, that's half of what pharmaceutical companies spent to develop a single drug — seven years ago. The lack of dietary supplement research was a major factor in the ephedra debate. "There wasn't much to work with," Coates says. "FDA had a tough job to figure out what to do." Coates should know. His department helped fund the FDA's analysis of the research, and was preparing preclinical animal studies on potential harm and benefit when the

FDA came calling. That research was suspended when the FDA banned ephedra-based supplements in February 2004, Coates said. By the time the ban took effect, the FDA had received 19,000 reports of harmful side effects, such as heart attacks, strokes and seizures, and even death, in people taking ephedrine alkaloids for weight loss and athletic performance enhancement. After reviewing the research, the FDA deemed the products unsafe at any dose. Nutraceutical Corp. of Park City, Utah, challenged the ban, arguing that most of the serious side effects were caused by high doses of ephedra combined with caffeine or other stimulants, and that the FDA lacked proof that lower doses of 10 mg or less were harmful. Most manufacturers, scared off by product-liability suits and the difficulty of obtaining insurance, had already stopped selling ephedra. "The last thing we needed was to get more lawyers and judges involved," said Hatch. "It just

wasn't worth it." "So much damage" Loren Israelsen, executive director of the Utah Natural Products Alliance, also saw the Nutraceutical suit as problematic. If the ban were overturned, opponents could argue the supplement act should be rewritten to give the FDA more authority over supplements. If the ban were upheld, the FDA would be empowered to go after products even if the science is sketchy. "We were not happy with how FDA reasoned its decision, but ephedra had done so much damage to the industry it was time to move on," Israelsen said. In April 2005, Utah District Judge Tena Campbell sided with Nutraceutical. The FDA appealed, and on Aug. 17 a three-judge panel from the 10th Circuit Court of Appeals in Denver issued its rebuke. The panel rejected Campbell's rationale that the FDA's risk-benefit analysis put the burden on manufacturers to show the products have a benefit. And it

sanctioned the FDA's dangerous-at-any dose conclusion, though the ban doesn't apply to traditional remedies, ephedra teas, over-the-counter asthma medications or nasal sprays. Under the dietary supplement act, the FDA is directed to "take swift action" against supplements that are unsafe or present "a significant or unreasonable risk of illness or injury." Noting that a risk can be significant yet reasonable, the court said Congress clearly intended that determining "unreasonable risk" involves a comparison of the risks and benefits. The court, however, didn't say the FDA is liable for conducting independent research, only for "gathering data, soliciting comments, and conducting a risk-benefit analysis." Israelsen says the ruling goes against the dietary supplement act's main principle — that supplements be treated like foods. And no one at the FDA is suggesting a risk-benefit analysis for Pepsi and Cool Whip. "I may

think it's dumb to eat Twinkies, but I don't think it's the government's job to tell other people to put them down," Israelsen says. "Get off your ass and take your government back." ~Rocky Ward

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