I heard an ad on the radio today for some herbal supplement for men that's supposed to increase libido. One of the sales pitch lines went something like this:

"And it's all natural, so it doesn't have any side effects!"

Where the hell did that come from? All natural products have no side effects? Wormwood, psychedelic mushrooms, and poison oak are all natural, and they all have some pretty harsh side effects. Even aspirin, which is derived from willow bark, can cause ulcers and even death in kids under 18 years of age. Another of my favorite lines from this particular ad:

"No chemicals!"

What is that supposed to mean? Everything is a chemical. Even water is a chemical. And finally, the real doozy:

"Studies suggest that the active ingredient in SuperLibido (or whatever the product was) helps release pent-up testosterone!"

First of all, "studies suggest" is not sufficient evidence. The FDA may allow such claims, but any intelligent person won't be convinced by them. Second, if this product truly does release "pent-up testosterone" (which I highly doubt), then it will almost surely have some incredible side effects -- basically the same as taking steroids. Finally, anyone who's having problems with their libido needs to see a doctor before taking anything. Diminished libido can be the result of a myriad of physical and mental conditions, some of which can be harmful or even deadly. Bottom line: Herbal supplements can be very helpful. In some cases, they can even prevent or treat disease. But everyone needs to be wary of the claims that any company makes about its product -- be it herbal supplements, pharmaceutical drugs, or even that "home drycleaning system".

Part of the problem with herbal medicines in the U.S. is that the FDA has a separate category for them. Congress passed the "Dietary Supplement" bill in 1994, which classifies herbs as dietary supplements, not drugs. As such, they cannot be regulated by the FDA (or any other government agency), as long as they are marketed without specific health claims.

So why not make the claims anyway? Why hasn't e.g. Glaxo or Pfizer done some research and marketed (insert favorite herbal supplement here) as a drug with real health claims? The answer is in the economics of the process: it is profoundly expensive and labor intensive to bring a drug to market under FDA rules. There is the R&D cost, plus three phases of clinical trials (these literally take years and the execution cost is phenomenally high), then you have to file an NDA ("new drug application") and wait for approval, which the FDA may or may not give. Depending on the drug and who you believe, estimates range from around $50-$100 million to well north of $250 million in some cases for the cost of the entire process.

This is, in a sense, what patent protection is for: it allows companies to recoup some of the enormous costs they have racked up by being given a temporary monopoly to sell the drug. (It is also one reason why prescription drugs, which cost nothing to produce on the margin, cost so much.) No "big pharma" company is going to pony up all that money if the drug can be sold as an herbal supplement by other companies that didn't incur those costs.

The irony here is that while most herbal supplements are completely ineffective (or even harmful), there are almost certainly several that have genuine pharmaceutical effects that could be isolated, refined, and brought into real medical use. We will never know which ones, though, until the economic incentives are changed, or government subsidizes the drug discovery process.

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