Supplement Questions

March 10, 2004 3:31 PM

Why do health-food supplements like ginseng and glucosamine go for years without the necessary study to prove or disprove, once and for all, their value? Perhaps these examples are not perfect ones, but it does seem as if there's a world of "nutriceuticals" out there are no one really understands well enough. Why?

example:

"As with many nutraceuticals that currently are widely touted as beneficial for common but difficult-to-treat disorders, the promotional enthusiasm often far surpasses the scientific evidence supporting clinical use. Until high-quality studies, such as the National Institutes of Health study, are completed, work such as [the meta-analysis] is the best hope for providing physicians with information necessary to advise their patients about the risks and benefits of these therapies [2]."

posted by scarabic to health & fitness (10 comments total)

Clinical studies are incredibly expensive. There's no incentive to test public domain ingredients because nobody can patent them and recoup the cost of the studies. And recent laws have allowed the use of vague claims like "improves immune function", "cleanses toxins", etc., as long as there's a disclaimer that they're unproven and they do no obvious harm (e.g. ephedra).
posted by TimeFactor at 3:50 PM on March 10, 2004

Yeah, I gather that anything classified as a "nutritional supplement" can be sold without rigorous FDA approval. The packaging can't make promises, but that doesn't stop a wide body of literature from doing so. Clinical trials are expensive, but there's a ton of money in health food supplements, too. I guess I just see that classification system as screwy. For one thing, if the benefits are real, people ought to be able to get the supplements through their insurance. So the core of my question seems to be how they decide what's a supplement and what's a pharmaceutical? How does "public domain" play out, TimeFactor?
posted by scarabic at 4:11 PM on March 10, 2004

I've been wondering if I'm just completely wasting my money on the additives at Smoothie King.
posted by crunchland at 4:37 PM on March 10, 2004

An overview from the FDA. The difference between supplements and drugs (as the FDA refers to them) seems to be only related to whether or not the FDA approved the substance as safe for use in humans.

The problem is not whether the the FDA agrees that ginseng is beneficial, it's whether some company has undertaken the expensive proposition of proving they are safe to the FDA. As TimeFactor points out, it's difficult to justify the expense without expecting some payback. If your 'drug' is in the public domain (as in, my back yard), it's hard to understand what the payback will be.

Also, consider that drugs are not approved because they are "good". Drugs are approved because of specific benefits vs. actual risk in studies. Smoothie King's claims are probably not specific enough to actually test.

Having said that, I am infact talking entirely out of my butt on this. it's my all speculation, no real expertise.
posted by daver at 4:53 PM on March 10, 2004

If the ingredients are already being used for something - e.g. glucosamine for arthritis - then there's prior art and that ingredient can't be patented for that use. That's what I meant by "public domain". If some natural occuring substance is discovered to have some novel pharmaceutical application then it can be patented. And drug companies spend lots of money scanning all sorts of organisms for drug activity. I think the anti-cancer drug taxol, derived from yew tree bark, is an example (although the patent is in dispute).
Some countries do cover over-the-counter natural compunds as part of their natural health care. I know that Germany has been at the forefront of testing and approving herbal remedies and that approved ones are covered.
posted by TimeFactor at 4:54 PM on March 10, 2004

While the arguments why drug companies don't do these studies are on target, why don't we see universities and orgs like the National Institute of Health doing them?
posted by billsaysthis at 5:45 PM on March 10, 2004

why don't we see universities and orgs like the National Institute of Health doing them

Increasingly, publicly funded institutions are encouraged to meet the needs of industry, rather than...you guessed it... the public.
posted by stonerose at 6:40 PM on March 10, 2004

why don't we see universities and orgs like the National Institute of Health doing them?

We do. To the tune of over $100M/year. If you google for ' NIH herbal grant", you'll find thousands of hits about different grants from NIH to study herbal medicine, acupuncture, and other alternative stuff.

"Universities and orgs like NIH" is misleading, though. What you tend to see is universities doing the research with money from NIH.

My understanding is also that NIH and the like tend to focus more on early-stage basic research than on the final-stage research of "Does this drug help fix this problem with acceptable side effects?"

Increasingly, publicly funded institutions are encouraged to meet the needs of industry, rather than...you guessed it... the public.

Actually, funding in this area has increased about tenfold in the past 5 or so years.
posted by ROU_Xenophobe at 7:30 PM on March 10, 2004

Very interesting, y'all. Keep it rolling if there's more.
posted by scarabic at 8:00 PM on March 10, 2004

here's a whole Frontline 'bout the "alternative healthcare" (hah!) industry, with a special emphasis on, um, "supplements."
posted by LimePi at 5:31 PM on March 11, 2004