honoluluadvertiser.com

Sponsored by:

Comment, blog & share photos

Log in | Become a member
The Honolulu Advertiser
Posted on: Sunday, May 20, 2007

FDA should embrace alternative medicine

StoryChat: Comment on this story

There's a clear disconnect between government regulators and the growing field of complementary and alternative medicine (CAM), which is growing in stature. It also has attracted a burgeoning industry of companies manufacturing botanicals and other supplemental treatments aimed at improving health.

The latest uproar between that industry and the Food and Drug Administration has to do with the publication of a draft "guidance" on CAM products and their regulation.

The guidance is not a new regulation itself, but a statement of how the FDA reads its own responsibility laid down by the 1994 Dietary Supplements Health and Education Act. This is the law that spelled out what kind of claims could be made of products, depending on the research available, and how otherwise the product label should reflect its contents.

The 17-page document cites a rise in imports of CAM products and increasing "confusion" about which products are subject to which regulation.

For starters, the FDA is considering extending the comment period on this document, which officially lapsed April 30.

That would be a wise idea. Given how much the alternative medicine sector distrusts the FDA, the federal agency should do everything it can to try to address the concerns.

About those concerns: The general conclusion by health practitioners of alternative medicine is that the FDA is driven by its close ties with the pharmaceutical industry.

Those misgivings have a rational basis. For example, a bill giving the FDA needed powers to regulate drugs already on the market recently passed the Senate.

The downside, however, is that the "new" FDA would rely even more heavily on user fees paid by pharmaceutical companies to pay for the increased oversight.

The complementary and alternative medicine professionals, who already feel iced out from the FDA, now see the love affair between the feds and the drug companies deepening even further.

The bottom line is that CAM products need regulating, just like anything else.

But holding the chemically complex herbal products to the same standards of efficacy as the more concentrated, isolated drug compounds is unrealistic.

Other countries, such as Australia, offer a more nuanced approach toward regulating these products, separately from pharmaceuticals. Unlike the black-and-white, it's-a-drug-or-it's-not regimen at the FDA, the Australian government allows more claims to be made as more clinical evidence comes in.

This model may be worth emulating here. The academic community is embracing CAM as departments within medical schools — including Hawai'i's John A. Burns School of Medicine. The National Institutes of Health now include a National Center for Complementary and Alternative Medicine.

The FDA needs to join this inclusive trend, ideally by establishing a subordinate office that deals strictly with alternative treatments, but at least by increasing the influence of these health professionals within the agency.

Taking more time to hear their complaints would be a start.