WASHINGTON – The Institute of Medicine called on lawmakers Wednesday to amend an 11-year-old law regulating the safety of alternative medicines such as herbal remedies and dietary supplements.
The institute released the results of a two-year study that examined the rapid growth of alternative therapies in the United States. According to the report,dietary supplements such as herbal products and vitamin pills are among the most widely used alternative medicines. The use of herbal products jumped 380 percent from 1990 to 1997.
Members of the Committee on the Use of Complementary and Alternative Medicine by the American Public determined that more than one-third of adults in the United States have used some form of alternative treatment,including herbal remedies,acupuncture and dietary supplements,spending $30 billion every year,Dr. Stuart Bondurant said.
Bondurant,executive vice president at Georgetown University Medical Center, chaired the 17-member committee.
“Americans' use of complementary and alternative medicine is widespread,yet much remains unknown about these therapies,” Bondurant said at a public briefing on the report.
Less than 40 percent of people who regularly use these treatments have told their physicians,according to the report.
Bondurant said the committee found the Dietary Supplement Health and Education Act (DSHEA),adopted in 1994,to be insufficient in ensuring consumers have adequate information about risks associated with some alternative medicines.
Under DSHEA vitamins,minerals and dietary supplements are regulated as foods rather than drugs,and manufacturers are not required by the Food and Drug Administration to conduct safety tests or clinical trials on these products.
“What we really determined is that Congress should work with stakeholders to amend DSHEA,” said Dr. Florence Comite,a committee member and associate clinical professor at the Yale University School of Medicine.
Bondurant said the committee concluded that alternative medicines should be held to the same quality and control standards used by the FDA to regulate pharmaceutical drugs,including clinical trials and extensive labeling.
During a question and answer session after the briefing,Karen Robin,director of communications for the American Herbal Products Association,said many of the DSHEA provisions have not been carried out. She asked the committee how the law could be amended when it has not been given a chance to go into effect.
“I would say the panel was aware,like most laws,DSHEA has not been fully implemented,” Bondurant replied. “But DSHEA,even if implemented,would not be enough.”
In an interview after the hearing,Robins said amendments to DSHEA should be delayed until the law is given a chance to prove itself effective.
“DSHEA is not a sacred cow,” Robin said. “But there are provisions the FDA is just getting into.”
FDA spokeswoman Kimberly Rawlings said the agency announced in November it is adopting initiatives to carry out all DSHEA provisions,including gathering more information about supplements,better labeling of ingredients and ensuring product quality.
“The initiatives will help the FDA improve the consistency of its regulatory actions to protect consumers against unsafe dietary supplements,” Rawlings said.
The committee also suggested that health profession schools incorporate information about alternative medicines into their curriculums.
Bondurant said the committee's recommendations would require both private and public funding.
“The report stops short of putting a dollar amount on any of these,” Bondurant said.
“What happens next will depend on the responses from several entities.”
Christine Stencel,media relations officer for the Institute of Medicine of the National Academies,confirmed the White House had requested a copy of the report.