Blog | Thursday, March 5, 2015

FDA and herbal medicine--caveat emptor!

Many of my patients are taking herbal supplements, or so they think. This herbal and health supplements industry likely is envied by traditional pharmaceutical companies. The latter has to spend zillions of dollars proving safety and efficacy to the Food and Drug Administration (FDA). Many of these drugs are cast aside during the approval process or afterwards when serious side effects become known or a new medicine is proved safer and superior. While it's not quite a crapshoot, there is a strong element of chance at play here.

Herbs and the supplements that are saturating our airwaves escape FDA scrutiny. They will only draw governmental fire if they are deemed to be dangerous. They are required to use certain language in their promotional materials that differs from traditional FDA approved prescription medicines. Take a look at this example:

Fosamax: The FDA has approved this for the treatment and prevention of osteoporosis

Glucosamine chondroitin: Promotes bone health

Somehow the vague but promising phrase, “promotes bone health” is supposed to insulate the company from a claim that it is approved to treat an actual disease. However, for most of us, promoting bone health sounds like it's designed to prevent osteoporosis, which is exactly the intent of the company's marketing folks. The language may be legally distinct from the Fosomax verbiage, but it sure sounds the same to me.

The FDA has a very light regulatory hand over dietary supplements, making sure that there are no overtly misleading claims and that the product contains what the label states it is. There is no FDA approval of efficacy as is required for prescription pharmaceuticals.

With a market worth billions of dollars, would you prefer to invest in a pharmaceutical company that might need 7 years to bring a drug to market or in a supplement manufacturer that only needs to cross over a few speed bumps before marketing potions that combat fatigue, joint pain, depression and memory lapses?

It amazes me that the public swallows millions of these pills in the absence of medical evidence of efficacy. Who says that Americans are not a people of faith?

Recently, a New York State investigation discovered that 4 out of 5 herbal products tested contained none of the herbs listed. The investigation examined herbal products at some little known “mom & pop” pill shops including Walmart, GNC, Target and Walgreens.

If a company is peddling a placebo, can't it at least accurately label the herb? If I'm buying a jar of snake oil to ease my rheumatism, or should I say to promote good joint health, then I expect that the useless elixir won't be lizard oil, olive oil, or motor oil.

This post by Michael Kirsch, MD, FACP, appeared at MD Whistleblower. Dr. Kirsch is a full time practicing physician and writer who addresses the joys and challenges of medical practice, including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When he's not writing, he's performing colonoscopies.