Ephedra discussed in US House Committee

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23 July 2003 - the US House Energy and Commerce oversight subcommittee is hearing evidence on ephedra-containing supplements. The hearings will last two days and might result in a ban or restriction on ephedra sales by Congress, according to the committee chairman Billy Tauzin.

''These supplements ... can be bought at any 7-Eleven convenience store or gas station by anyone, including those under 18,'' Tauzin said, questioning ''whether continuation of such a policy for ephedra makes sense, given what we have learned about the dangers of ephedra.''

Ephedra is a Chinese herb, also known as Ma Huang, which has medicinal properties. Asthma sufferers might be prescribed ephedra by their traditional Chinese herbal practitioner. However in the US, the herb and a synthetic version of the active substance - ephedrine - has been promoted for other uses such as slimming and boosting energy. There have been reports of side effects in such widespread use, where sometimes consumers do not read or follow the instructions on the package.

Some charge that ephedra is being used in a bid to institute general restrictions on the availability of supplements in the US, circumventing a 1994 law that put supplements squarely in the food area, ending decades of FDA persecution of supplement manufacturers.

As reported in the Washinton Post today, the US Health and Human Services Secretary Tommy G. Thompson made the point that the Food and Drug Administration is "somewhat hampered" by a lack of good data from the supplements industry. See the article "Thompson Urges More Data on Diet Supplements" at the end of this post.

We may well be seeing a similar pattern in the US as what already transpired in Australia, Canada and Europe. Supplements headed for a hard time? Can't find them any more in your health food store? Certainly yes, if pharmaceutical interests have their way.

Article found on WROCTV

House Begins Two Days Of Hearings On Ephedra

7/23/2003 4:00 PM (Washington-AP)

Many people who followed guidelines for using the herbal stimulant ephedra still reported health problems, congressional investigators found.

In addition, many complaints came from users under 30, the General Accounting Office said in testimony prepared for Wednesday's hearing on dietary supplements before the House Energy and Commerce oversight subcommittee.

Marcia Crosse, the GAO's acting director of health care-public health and science issues, said the reports of health problems made to drug-maker Metabolife International included heart attacks, strokes and seizures. Five deaths also were reported.

Crosse also noted the Food and Drug Administration has received more reports of problems from taking supplements with ephedra than any other ingredient.

Crosse said the problems reported to Metabolife ''are consistent with the types of adverse events reported to FDA and with the documented physiological effects of ephedra.'' In addition, she said, the records of calls to Metabolife ''contain reports of serious adverse effects in consumers who were young and among those who used the product within the recommended guidelines.''

She said the average age of those who included an age when they called was 38, and ranged from 17 to 65. More than one-third were under 30.

In a statement submitted to the subcommittee, Metabolife said the company ''strongly believes in the science supporting the safety and efficacy of dietary supplements that contain ephedra when used as directed.''

The House subcommittee is holding two days of hearings on ephedra, which was thrust into the spotlight in February following the death of Baltimore Orioles minor league pitcher Steve Bechler, who had taken a dietary
supplement containing ephedra.

Testifying before the subcommittee was Kevin Riggins, whose 16-year-old son, Sean, died of a heart attack blamed on ephedra.

''The little packages, which promote weight loss, performance and energy enhancement, were being sold right next to the Twinkies and candy bars,'' Riggins said in his prepared testimony. ''The use of these products was so casual, none of the kids believed they were taking a drug.''

Congress in 1994 severely limited federal oversight of dietary supplements, but some lawmakers said they should reconsider the law. ''Some say that the law has allowed 'buyer beware' to replace 'safe and effective when used as directed,' '' said Rep. Diana DeGette, D-Colo.

House Energy and Commerce Committee chairman Billy Tauzin, R-La., raised the possibility that could Congress could ban or restrict ephedra sales.

''These supplements ... can be bought at any 7-Eleven convenience store or gas station by anyone, including those under 18,'' Tauzin said, questioning ''whether continuation of such a policy for ephedra makes sense, given what we have learned about the dangers of ephedra.''

The FDA is sifting through 16,000 comments responding to its March proposal to order warning labels on bottles of ephedra. The FDA has not tried to ban the product, despite reports of more than 100 deaths being linked to the
herb, citing the 1994 law.

In May, Illinois Gov. Rod Blagojevich signed the nation's first statewide ban on ephedra.

Kiley Bechler, the pitcher's widow, filed suit in federal court last week against the manufacturer and distributor of the supplement containing ephedra that was found in her husband's locker.

Medical Examiner Joshua Perper in Fort Lauderdale, Fla., where Bechler died, said ephedra in the weight-loss supplement Xenadrine RFA-1 contributed to the heatstroke that killed the pitcher.

Officials of Cytodyne, which makes Xenadrine, released a letter to the House committee from forensic pathologist Dr. Michael Baden, former New York City chief medical examiner, who said ephedra didn't cause Bechler's death.

Ephedra is banned by the NCAA, the NFL and the International Olympic Committee, but not major league baseball.

Thompson Urges More Data on Diet Supplements

Thursday, July 24, 2003

The dietary supplement industry should supply the government with more complete, timely and accurate data about the safety and effectiveness of its products, Health and Human Services Secretary Tommy G. Thompson said yesterday.

Responding to questions from reporters, he said the Food and Drug Administration is "somewhat hampered" by a lack of good data from the industry, the Associated Press reported.

"We are unable to really do as effective a job as possible," Thompson said at a news conference about food safety. Unlike the manufacturers of prescription drugs and over-the-counter medications, dietary supplement makers do not have to prove that their products are safe and effective or report adverse reactions to the federal government.

Critics have charged that leaves consumers vulnerable to unsafe products. The dietary supplement ephedra, which is sold as an energy booster and weight-loss aid, has come under the most criticism amid reports of serious side effects.

Thompson's comments came as the House Energy and Commerce oversight subcommittee opened two days of hearings on dietary supplements.

-- Rob Stein

Related article

The War Against Supplements

Bill S 722

Recent (March 2004):The Ephedra Battle Moves To The Courts

Here is a discussion of the level of risk in ephedra supplements which I believe may add to our understanding of what is really going on:

From: Ron Law
Sent: Saturday, July 26, 2003
To: len@******

Surprised you'd sacrifice ephedra -- there will always be a product/ingredient in the firing line. We need scientifically sound risk analyses around marginal or controversial products to provide benchmarks ... it's stunningly simple -- 3x30 mg per day upper limit and deal with fraud hard ....

Response on 28 July 2003

I agree there always will b a product, but think its too late for ephedra and industry has to take a visible step back in order to protect the existing regulatory environment , otherwise it'll all come tumbling down.

I agree the risk analysis is required, and it will ultimately come from pre-market mechanisms. This is one aspect of S.722 with any product containing stimulants. Unfortunately, that bill has been lumped with a section that is pretty onerous on adverse experiences, more significant in fact than drugs. And if that bill passes, then it unravels DSHEA.

I have believed for some time that industry has an opportunity to make a stand based on responsibility and that ephedra could be that stand. They could then position it as a model in the new environment and reintroduce it. Now it's a dead subject and this eventual battle will come over a future product, and I think, from what I've seen industry losing this and successive battles. The momentum is building against the industry.

Further response on 28 July 2003:

When one looks at the evidence against ephedra -- it is seriously flawed. Given the volume of use the risks associated with ephedra use under 3x30 mg per day is at de minimis levels. Industry can never regulate industry on its own as any voluntary regulation can only deal with the majority -- ie those who want to buy in -- people even break government rules -- it requires the applied force of law to be effective.

Have you seen the Cantox risk analysis? What about the GAO reports?

When you say, "I agree the risk analysis is required, and it will ultimately come from pre-market mechanisms. " are you suggesting that all products should have pre-market approval? RCT are sensitive to n/3. ie, if the size of the clinical study is 1,500 t