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Re: It's bigger than a menopause questionFrom: art fougner, md (evsono@pipeline.com)Tue May 15 08:11:20 2001
It sure is, Jay in today's ReutersHealth NIH looks to industry input on assessing alternative medicine safety Last Updated: 2001-05-14 17:05:21 EDT (Reuters Health) By Chris Gearon WASHINGTON (Reuters Health) - The US government Monday launched an initiative to solicit the ideas of producers and manufacturers of complementary and alternative medicine (CAM) therapeutics and other industrial stakeholders in order to create a process to evaluate such products for composition and patient safety. The effort by the National Center for Complementary and Alternative Medicine (NCCAM), which is also focused on providing consumers and clinicians with safety information on a host of popular non-conventional therapies, comes as American consumers increasingly look to complementary or non-conventional measures to treat illness. About 40% of Americans are using one or more CAM modalities, while 60% of those individuals don't even tell their doctors they do so, Dr. Stephen Straus, NCCAM's director, told participants attending a colloquium here. Meanwhile, the research to support whether dietary supplements and a host of other alternative modalities are safe is lacking. "There's a lack of product and practice standards," Straus said. NCCAM is the National Institutes of Health entity charged with developing and supporting research on alternative medicine treatments. However, that task is a daunting one for a host of reasons. These include the fact that there are few competent CAM investigators, "market disincentives," a regulatory framework suited to approving conventional medications, lack of uniformity in product content of nutritional supplements and differing interests among various industry stakeholders. While industry stakeholders--ranging from companies that produce, distribute and label CAM therapeutics to quality assessment organizations--all welcome NCCAM's role in helping to create standards for conducting research on alternative therapies, different industry stakeholders had different or even competing views on NCCAM's role in working with industry participants. The dietary supplement industry, for example, would like the government to recognize and even approve alternative therapies on a different standard that is currently used by the FDA in approving conventional drugs, said Jim Lassiter, principal of the dietary supplement industry regulatory consulting firm The Lassiter Group. In the US, regulatory bodies approve compounds for specific purposes and fail to evaluate "complex" products, such as botanicals, that could be used for multiple purposes, he added. Government regulatory bodies should factor in anecdotal evidence, research done in other countries, research undertaken by unlicensed practitioners and other research that doesn't live up to the "Gold Standard" of randomized, controlled trials regarding the regulation of dietary supplements, he said. "Is there not room for an alternative model?," Lassiter asked. "And I think NCCAM needs to participate in this in fully." However, drug and food companies want assurances that such products work in humans, Dr. Freddie Ann Hoffman, senior director of Pfizer Inc.'s medical and clinical consumer healthcare unit, told Reuters Health. "Mainstream industry are indeed mainstream," and view CAM as "quackery" and without scientific rationale, Hoffman said. "Companies are very concerned about putting out things that don't work." She added that NCCAM can help define and confirm the safety and efficacy of alternative products and the process in which they are approved. Meanwhile, Marilyn Barrett, president of Pharmacognosy Consulting Services, said that she would like NCCAM to play a role that supports companies with quality CAM therapeutics through the FDA approval process. "The tendency is to distill products into boxes we know, and that is drugs," said Dr. Steven Dentali, scientific director for Botanical Sciences, Nutricia/Rexall Sundown. "NCCAM can play a key role in expanding that box." -Westport Newsroom 203 319 2700 art
At Tue, 15 May 2001, jkulkin wrote:
>
-- art fougner, md
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