NEWS

Government-Industry Collaborations Explored for Alternative Medicine

Phyllis McIntosh

As more and more Americans turn to complementary and alternative medicine, cooperation between the National Institutes of Health and the companies and organizations that produce, market, and help ensure the quality of CAM therapies is essential if the public is to get reliable information on their safety and efficacy.

That was the conclusion of those attending the first-ever colloquium to explore opportunities for cooperation between NIH’s National Center for Complementary and Alternative Medicine and the CAM therapeutics industry. The colloquium brought together more than 200 representatives of industry, research communities, third-party payers, consumers, government agencies, and CAM and conventional practitioners.

According to NCCAM, more than 40% of Americans use alternative remedies such as herbs, traditional oriental medicines, megavitamins, acupuncture, therapeutic massage, and energy healing to prevent or treat disease. A recent study published in the Journal of Clinical Oncology found that 83% of 453 cancer patients had used at least one CAM therapy as part of their treatment.

Several studies are under way to test CAM therapies in cancer patients. They include testing a special dietary regimen for treatment of inoperable pancreatic cancer, shark cartilage as an antiangiogenic agent to combat lung cancer, a mixture of Chinese herbal medications in men with prostate cancer, and hyperbaric oxygen therapy for treatment of head and neck tumors.

Most biological-based products, such as herbs and botanicals, are classified as dietary supplements and can be marketed without U.S. Food and Drug Administration approval or the rigorous demonstration of safety and efficacy required of new drugs.

A host of organizations, including the U.S. Pharmacopeia, the European Pharmacopeia, and the American Herbal Pharmacopeia, have established standards of identity and quality for many botanicals, spelling out such details as the amount of an active ingredient that should be in a particular product. However, these are purely voluntary and may or may not be followed by manufacturers.

As a result, various speakers said, there is a lack of uniformity in quality and consistency, which can hinder CAM research and make it more difficult to compare results of various studies.

Among the problems cited: Plants may be grown, harvested, and processed under varying conditions; some may even be adulterated with heavy metals or pesticides; and labels may misidentify the species or call the plant by different names depending on country of origin.

The difficulty in ensuring uniformity is exacerbated by the fact that the industry itself is so diverse, ranging from large corporations importing tons of material to Mom and Pop operations dealing directly with a few herbalists, noted Joseph M. Betz, Ph.D., director of scientific affairs for the American Herbal Products Association.

Because there is no financial incentive for industry to spend millions to test the safety and efficacy of many remedies that are already widely available, NCCAM has taken on the role of designing and funding CAM studies. In most cases, companies cannot patent these products and enjoy years of market exclusivity as they do with a new chemical entity developed and approved as a drug.

The issue is complicated by the fact that with many CAM products, the line between food and drug becomes quite blurred, said Freddie Ann Hoffman, M.D., formerly with NIH and FDA and now with private industry. "Pharmaceutical companies are in the business of developing products to treat disease, and they don’t know what to do with some of these CAM remedies that looked like foods in the past but are now being asked to do druglike things," she said.

There are several opportunities for cooperation between NCCAM and industry to help get reliable information and products to the public. "What industry brings to the table is expertise about CAM therapies," said Betz. "We know what the products are, what they’re used for, how they’re made, and what quality assurance tools need to be brought to bear."

What NCCAM contributes, the conferees agreed, is rigorous scientific review, the credibility that accompanies NIH-sponsored research, and all-important funding for studies large and small —from in vitro and animal studies to determine what deserves further investigation to definitive clinical trials that evaluate safety, efficacy, and potential interactions with conventional medications.

NCCAM and industry also need to work together to ensure a steady supply of quality materials for study and to encourage standard-setting organizations to establish uniform specifications for the quality and composition of materials to be tested and sold. NCCAM can further use its expertise "to help small CAM developers and inventors who may not know how or be able to afford to proceed on their own to move their products through the regulatory process," said Hoffman.

There already are mechanisms, such as Cooperative Research and Development Agreements (CRADAs), in place to encourage collaboration between NIH and industry by protecting confidentiality and proprietary rights of both private and government investigators.

In collaborating with NIH on CAM research, industry could benefit by learning of products currently available only in niche markets in the United States that it could develop and bring to a broader public through the established drug approval process or perhaps as a new class of food-drug hybrid.

A number of conferees called for legislation to revamp the current FDA classifications. "We need a new definition of drug to permit herbal medications to be properly manufactured and labeled and to allow for functional foods that enable people to stay well or deal with chronic disease through their daily food supply," said Scott Bass, J.D., a Washington, D.C. attorney who specializes in food and drug law.

"NIH-funded research should provide the underpinning of the CAM industry just as it has for the pharmaceutical and biotech industries," said Peter Reinecke, legislative director for U.S. Sen. Tom Harkin, who spearheaded legislation that created NCCAM. "We all have the common viewpoint that we want quality products and effective therapies. We need to build from that common ground."



             
Copyright © 2001 Oxford University Press (unless otherwise stated)
Oxford University Press Privacy Policy and Legal Statement