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Urge: Naked World
The rise and fall of erotica
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Asian eyes
Some turn to glue or surgery for a new "look."
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[02/16/00]

Urge: Naked World
The sex-switching saga of "Bruce-to-Brenda"
A failed attempt to "reassign" the gender of a Canadian boy after a clumsy circumcision has become a focal point in the debate over gender identity.
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Urge
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Europeans have such a flair for flirting that it must be transmitted via breast milk. Why don't Americans get it?
By Christine Schoefer
[02/15/00]

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"It's resource-intensive to look at herb/drug interactions but in the U.S. with the amount of resources (we have), we are capable of doing that," says Richard Ko, a food and drug scientist responsible for regulating ethnic drugs, like Chinese herbs, for the California Department of Health Services. "Right now, the companies are under no obligation and have no incentive to do the research, especially the herbal manufacturers. That's why most of the research on herbal products is mainly being done in Japan and European countries."

And that brings up the larger issue of how dietary supplements are regulated in the United States. Many countries consider them drugs, and manufacturers fund the studies required before a new remedy can be sold. In the United States, the Food and Drug Administration regulates dietary supplements less stringently than it does drugs and food. As a result, the makers of these products are not required to report adverse reactions even when they learn about them. So there isn't an agency thoroughly tracking these kinds of interactions. A spokesman for the American Association of Poison Control Centers says they have noticed an increase in calls but, at best, the evidence is anecdotal.

Although some companies do voluntarily provide information, this regulatory fact greatly reduces the number of adverse reactions and side effects reported to the FDA; most of the information it receives comes from consumers and doctors and is reported to the FDA's MedWatch program. An official at the FDA says that if the Center for Drug Evaluation and Research had to rely only on the MedWatch program -- which accounts for only 6 to 10 percent of all the drug-to-drug interactions being reported -- it would be receiving only a trickle of the information it receives now.

Indeed, what the FDA receives on dietary supplements is a trickle. Since 1993, when the Center for Food Safety and Applied Nutrition started looking at adverse reactions to dietary supplements, it has recorded 2,621, and 101 people have died as a result. But these numbers don't tell us whether the reactions are to a dietary supplement, or to an herb/drug interaction. Also, these statistics are from 1998 -- the last time the center made the numbers public. (The FDA asked Congress for an additional $2.5 million to monitor supplements but the money was denied.)

"They get fewer reports than we do," says Dr. Peter Honig, deputy director of the FDA's office of post-marketing drug risk assessment. "It's just the nature of voluntary reporting; the consumers are not necessarily tuned in to the reporting of dietary supplements, nor are physicians." Honig says in order to receive more reports on dietary supplements, either a law would have to be written to require reporting from its manufacturers, or consumers and physicians would have to overcome the barriers that prevent them from reporting interactions.

Pharmacists say one of the main reasons why reporting is scarce is that many doctors don't recognize herb/drug interactions when they see them. A patient may report an interaction but the doctor might think it's just the prescription medicine that's causing the adverse effects.

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