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HOW DANGEROUS IS EPHEDRA?



Published: Fri, August 30, 2002 @ 12:00 a.m.



HOW DANGEROUS IS EPHEDRA?

Chicago Tribune: Need to lose some weight? Boost your energy? Improve your athletic performance? Millions of people looking for a quick fix to those kinds of health problems have turned to dietary supplements containing ephedra.

Such supplements have been widely linked to heart attacks, strokes, seizures, psychosis and death -- and that's a partial list.

The manufacturers claim (and the government, for now, agrees) there is no proof their products caused the unwanted side effects; it's always possible the victims were taking something else simultaneously, or had some undetected illness. But the hundreds of "adverse event reports" voluntarily filed with the U.S. Food and Drug Administration should give anyone pause.

The American Medical Association has urged the FDA to ban ephedra products. Canada has advised its citizens not to take them, and the National Football League has banned them.

Under a 1994 law effectively deregulating dietary supplements, the manufacturer is solely responsible for determining that a product is safe and that any claims made about it are not false or misleading.

Red flag

Dietary supplements do not need pre-market approval. That should be a red flag. The only authority left to the FDA is to remove a product from the market or restrict its use -- but only after it proves that the product is unsafe.

So buyers had better beware.

Here are some things you can do to protect yourself:

Ask your doctor if ephedra or any other dietary supplement is safe, considering your personal health profile and other prescription and over-the-counter drugs you may be taking.

Consult the FDA's Web site, which contains some tips for consumers.

Be skeptical. If a product sounds too good to be true, it probably is.

And here is an idea for Congress:

Require that dietary supplement manufacturers add an additional bit of information to their packaging -- the quality of the evidence on which their safety and effectiveness claims are based. The FDA could devise a scheme that, for example, assigns an "A" to placebo-controlled clinical trials and an "E" to anecdotal evidence.

Practitioners of evidence-based medicine, such as the U.S. Preventive Services Task Force, already note the level of evidence on which their public-health recommendations are based. When the task force recommended earlier this year that women start getting regular mammograms in their 40s, it also downgraded the evidence from "good" to "fair," reflecting recent criticism of the clinical trials that established that screening mammography reduces deaths from breast cancer.

Like mammograms, dietary supplements were thought, until recently, to be risk-free. If they don't help, most people assumed, at least they can't hurt. We now know, though, that there is pretty good anecdotal evidence that ephedra is risky. The FDA may eventually ban it. In the meantime, people don't have to wait for a government order to start using good judgment.

FBI PROBE OF SENATORS GOING TOO FAR

Dallas Morning News: Americans had every right to expect the executive and legislative branches to work together in the war on terrorism. But this can't be what they had in mind. The executive branch is investigating the legislative.

The Federal Bureau of Investigation -- the top investigative agency in the Justice Department -- is probing whether members of the Senate Intelligence Committee have forgotten the old wartime adage "Loose lips sink ships." The FBI wants to know if it was a lawmaker who spilled the beans about how the National Security Agency intercepted messages alluding vaguely to an impending attack on the United States on Sept. 10 -- but didn't translate them until Sept. 12. The bureau has asked Intelligence Committee members for everything from office telephone records to members' personal Palm Pilots.

Polygraph tests

Most senators are cooperating, and some have even offered to take polygraph tests to prove they can too keep secrets. Also, while both chambers got briefed, apparently only the Senate has been hit with requests for information. Rep. Nancy Pelosi of California, the ranking Democrat on the House Intelligence Committee, seemed to suggest on Sunday that, if that changed, she would still back the investigation out of concern that the leaks advanced the "distorted view" that the attacks could have been prevented.

If Congress isn't up in arms, then what's the fuss? Well, the issue is larger than one agency and one committee. Some scholars have expressed concerns that having one branch of government poke around in the affairs of another -- rather than uphold the idea of checks and balances -- violates it by giving the FBI a tool to intimidate or harass members of the very committee responsible for supervising the FBI.

The FBI seems to be going too far.




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