October 18, 2012
BETHESDA, Md.The National Institutes of Health's new database of substances associated with liver damage misses the mark on many botanicals, according to Steven Dentali, Ph.d., chief science officer, the American Herbal Products Association (AHPA). This database appears to lack the herbal expertise necessary for such a document, Dentali said.
"It's a good idea to have a database of substances that have been shown to cause liver problems," Dentali said. "But appropriate, well-qualified information is also needed for botanicals and dietary supplements in general."
The LiverTox database is designed as a free source for health care professionals and researchers studying liver injury associated with prescription and over-the-counter (OCT) drugs, herbs and supplements.
LiverTox, which was created at NIHs National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), has a searchable database of about 700 medications available in the United States by prescription or OTC. Over the next few years, NIH expects another 300 substances will be added.
A few of the problems Dentali noticed with the database included:
The database says saw palmetto berries and leaves are used to make supplements. "No one uses saw palmetto leaves, and technically I suppose that palms don't even have leaves," Dentali said.
Latin binominal nomenclature isn't italicized, and some are spelled wrong. Dentali also found a novel misspelling of the word "flavanoid."
With Aloe vera, the database talks about products made by the gelatinous center of the leaf, and some products are made this way, Dentali said. "But the laxative products discussed are made from the leaf latex, and that's where adverse events are coming from. This is important information to differentiate." He noted AHPA has a code of ethics guidance on stimulant laxatives that explains how to appropriately label them. Find out more on the differences in Aloe vera manufacturing in the INSIDER article, "Mature Aloe Vera Market Needs Fresh Standards."
Under the chaparral section, the database said the herb has been restricted in the United States and other countries. "I'm not aware of any restrictions on U.S. sales, but AHPA does have labeling recommendations for this herb because of associated rare reports of serious liver disease."
Dentali also pointed out where improvements are needed in the germander, skullcap, pennyroyal oil, kava and black cohosh sections. He said issues of adulteration and plant part use need to be addressed in these sections.
Steven Phillips, M.D., co-sponsor of LiverTox and director of the National Library of Medicine's (NLM) Division of Specialized Information Services, said the database was a collaboration between the national and international clinical and research communities, NIDDK and NLM.
NIH said the developers of LiverTox worked with outside experts in drug-induced liver disease as well as specialists in arthritis, cancer, diabetes, infectious diseases and other conditions. The agency added that the content of each section of the database was reviewed by an outside expert. The finished website was also reviewed by FDA and pharmaceutical industry experts, according to NIH.
However, Dentali said, "It doesnt look like appropriate experts from industry, the Office of Dietary Supplements (ODS), the National Center for Complementary and Alternative Medicine (NCCAM) or even the US Pharmacopeia were involved in the review of the herbs and dietary supplement section and entries. There are pharmacognosists (experts in disciplines regarding botanical and other natural products) at all of those organizations. I don't think NIH had the ethnobotanist at FDA take a look at it either."
Dentali said APHA is willing to work with the appropriate federal officials to help improve the database. "There continues to be a larger world that doesn't recognize the botanical expertise that's available today. It's incumbent upon us to help them find it so that health care professionals, researchers and consumers benefit alike."
Here more from Dentali at his SupplySide West education session, "Understanding Botanical Materials: A Three-Times-Three Approach" on Tues. Nov. 6 from 3 to 3:50 p.m.
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