Ephedra Ma Huang, What are we going to do?

[Guest guest]

This was in today's New York Times.

 

 

 

March 1, 2003

 

 

 

U.S. Sounds Health Warning on Ephedra Supplements

 

By REUTERS

 

 

 

 

 

 

 

 

Filed at 6:30 a.m. ET

 

 

 

WASHINGTON (Reuters) - U.S. health officials on Friday warned Americans against

taking dietary supplements containing ephedra and said they could ban the

stimulant that was recently cited in the death of a professional baseball

player.

 

 

 

Health and Human Services Secretary Tommy Thompson unveiled plans for a tough

new warning label that mentions death among the possible side effects of

ephedra, marketed as a weight-loss aid, energy booster and sports performance

enhancer.

 

 

 

``I would not take this, not give it to my family. And I don't know why anyone

would take these products,'' Thompson told a news conference.

 

 

 

The federal government is also seeking public comment of whether ephedra poses a

``significant or unreasonable risk of illness or injury'' -- the standard of

proof required under law before the Food and Drug Administration can ban a

dietary supplement.

 

 

 

Asked whether an outright ban of ephedra was an option, Thompson simply said:

``yes.''

 

 

 

Actions short of a ban, such as restricting ephedra doses, also will be

considered, said FDA Commissioner Mark McClellan.

 

 

 

Ephedra, derived from the Chinese herb Ma Huang, is an adrenaline-like stimulant

affecting the heart and nervous system.

 

 

 

Manufacturers of the supplement have insisted their product is safe when taken

as directed, but some consumer groups are lobbying to have ephedra products

banned completely.

 

 

 

A RAND Corp. study, released on Friday by the government, reviewed 16,000

adverse event reports found two deaths, four heart attacks, and nine strokes

involving ephedra where no other contributing factors were identified.

 

 

 

SIDE EFFECTS

 

 

 

Ephedra, the RAND study said, is associated with higher risks of mild to

moderate side effects such as heart palpitations, tremor and insomnia,

especially when taken with other stimulants.

 

 

 

Earlier this month, researchers in San Francisco said they had found that

ephedra is responsible for 64 percent of all adverse reactions reported from

herb use, although ephedra accounts for less than 1 percent of such supplements

sold.

 

 

 

The National Football League, the International Olympic Committee and the

National Collegiate Athletics Association have banned ephedra use among players.

 

 

 

Canada recalled ephedra products last year. Denmark allows ephedrine alkaloids

to treat obesity but only with a prescription.

 

 

 

Consumer group Public Citizen issued a statement criticizing McClellan's failure

to ban ephedra as ``cowardly.''

 

 

 

The Ephedra Education Council said the risks had been overstated by the

government but it believed ephedra makers would accept the proposed warning

label.

 

 

 

``The important thing ... is they are not banning ephedra and people who need it

for weight loss are still going to have access to it,'' said Wes Siegner, legal

counsel for the industry group.

 

 

 

Unlike pharmaceuticals, where the manufacturer must prove a drug's safety, the

legal burden is on the FDA to show a dietary supplement is unsafe.

 

 

 

The subject of debate for years, ephedra was thrust back into the spotlight last

week with the Feb. 17 death of Baltimore Orioles pitching prospect Steve

Bechler, who collapsing during spring training.

 

 

 

Bechler, 23, was slightly overweight and ephedra supplements were found in his

locker.

 

 

 

Broward County, Florida, Medical Examiner Dr. Joshua Perper said he believed the

supplement had something to do with Bechler's death from heatstroke.

 

 

 

McClellan told reporters it was ``within the realm of possibility'' that the

government could order black-box warning labels on ephedra products before the

end of the year.

 

 

 

McClellan said new evidence about the drug's side effects has emerged since

1997, when the FDA first proposed placing a warning label on ephedra products.

 

 

 

``We want to caution all Americans, particularly athletes and those who engage

in strenuous activity, about using dietary supplements that contain ephedra,''

Thompson said.

 

 

 

 

 

 

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