Ephedra discussed in US House Committee
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 SupplementsThursday, 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
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 2003I 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 test subjects (the average number of humans tested before approval) then the studies can detect an incidence of 1:500 adverse reactions with 95% certainty. Ephedra use has been around 3 billion 'servings' per annum at its peak. Assume the average intake was 3 per day, that's just on 3 million users per year at its peak.
The FDA's Rand risk analysis found there were no reports of serious adverse events in the controlled trials of ephedrine or ephedra, but these studies are insufficient to assess adverse events that occurred at a rate of less than 1.0 per 1000.
Rand concluded that whilst a large number of adverse event reports regarding herbal ephedra-containing dietary supplements have been filed with FDA the majority of FDA case reports are insufficiently documented to make an informed judgment about the relationship between the use of ephedra-containing dietary supplements and the adverse event in question.
Rand's extensive risk analysis identified two deaths, three myocardial infarctions, nine cerebrovascular accidents, three seizures, and five psychiatric cases as sentinel events with prior ephedra consumption; and three deaths, two myocardial infarctions, two cerebrovascular accidents, one seizure, and three psychiatric cases as sentinel events with prior ephedrine consumption. Classification as a sentinel event does not imply a proven cause and effect relationship. About half of the sentinel events occurred in persons aged 30 years or younger.
Let's assume all of these were genuine and let's assume these are all life threatening.
Now, let's analyse these stats.
2 deaths per 3 million users of Ephedra.
That's 0.67 deaths per million users.
If we look at 15-35 year olds, in 2000, the CDC says the following.
10 Leading Causes of Death, 2000, All Races, Both Sexes
Age Group
15-35
Sub Population
80,102,431Rank Deaths Cause of Death
1 27,213 Unintentional Injury
2 9,433 Homicide
3 9,347 Suicide
4 6,448 Malignant Neoplasms
5 4,582 Heart Disease
6 3,141 HIV
7 971 Congenital Anomalies
8 945 Cerebrovascular
9 885 Diabetes Mellitus
10 615 Influenza & PneumoniaFor 15-35 year olds, that's over 60,000 deaths per 80 million citizens or a death rate of 750 per million.
Please think about that for a minute. The death rate attributed to normal life hazards is 750/0.67 times that of consuming Ephedra, which equals some 1,125 times.
Even if one included all of the 22 serious events per 3 million users of Ephedra, that makes the risks associated with Ephedra use some 100 times less than that of normal life events.
Can I ask why you are prepared to sacrifice such a low risk product? There is a world of difference between reality and perception -- exceedingly few people look at reality and undertake critical analysis of data.
Why are you not supporting the industry groups that have advocated a responsible risk management strategy, groups such as CRN, AHPA, and the EEC?
Even in pharmaceutical medicines, risk analysis never comes from pre-market mechanisms as far as low rates of incidence of harm are concerned. No clinical trial has ever been undertaken, nor could it be economically sustained, to detect a 0.67 per million death rate with any degree of certainty.
I'm really disappointed that you see Ephedra as a dead subject. It's not -- and it shouldn't be -- and it is irresponsible of you to say it is. This is a product that should be used to draw the battle lines. There is no evidence on the planet to rationally justify banning or restricting ephedra at levels less that 90 mg spread over three doses. Banning Ephedra would be grossly unfair and scientifically indefensible. A responsible industry wouldn't allow itself to cave in to such suggestions.
Your final statement requires an investigative journalist response. You say, "The momentum is building against the industry." A good journalist would ask the questions -- "why?" "What is the agenda here?" "Why are such safe products being touted as unsafe when they are not?" "Why are some within industry prepared to forsake safe and effective products in the name of 'harmony'?"
Regards
Ron Law
Here a further discussion on the number of adverse event reports associated with ephedra and ephedrine containing supplementsin response to:
At 20:16 1/08/2003, Christine Doyle wrote:"... but we know these products are not safe since around 100 deaths and many thousands of adverse events have been reported."
Dear NutritionNewsFocusCan you please provide a reference to back up this verify ludicrous 'around 100 deaths' statement?
You seem to have fallen in to a trap that equates an alleged 104 deaths on the FDA adverse reaction reporting system tagged to supplement per se ... ie ALL deaths ASSOCIATED with supplement use.
I've tried to trace the source of the myth -- it seems some folk reinterpreted these references via an intriguing incidence of chinese whispers perhaps? ...
http://www.foodtechsource.com/emag/016/numbers.htm
I love this quote... "The story takes off talking about a trip to the emergency room by a 34-year-old woman using
the very controversial herb, ephedra, a natural form of caffeine..."http://www.thezephyr.com/health/healthit.htm
betterhealth-online.com/Hazards.html (no longer active)
Love this White Paper on Herbal Products scientific review in Pharmacotherapy 20(7):877-891, 2000....
It says, "Between January 1993 and October 1998, the Food and Drug Administration (FDA) received 2621 reports of serious problems involving these products, including 184 deaths. [10]"
Reference 10 is ... non other than the Washingto Post!!! Now that is high science indeed.
Gugliotta G. Health concerns grow over herbal ads. Washington Post. March 19, 2000:A01. 10.Even the EC has got caught up in this propaganda war...
How sad...
Have you seen the Cantox and Rand risk assessments of Ephedra? Maybe you should read these before joining the witch-hunt on Ephedra.
The Rand study identified 84 deaths ASSOCIATED with ephedra AND ephedrine use, but only classified 5 [2 ephedra, 3 ephedrine] as 'sentinel' [ie likely causality] and a further 12 as possible.... In other words, most of the adverse reaction reports simply did not stack up scientifically....
The Rand report concluded that a large number of adverse event reports regarding herbal ephedra-containing dietary supplements have been filed with FDA. The majority of FDA case reports are insufficiently documented to make an informed judgment about the relationship between the use of ephedra-containing dietary supplements and the adverse event in question.
A very large number of adverse events were reported to one manufacturer of ephedra-containing dietary supplements. Nearly all of the case reports were too poorly documented to permit us to make any judgments about the potential relationship between ephedra use and the event.
We identified two deaths, three myocardial infarctions, nine cerebrovascular accidents, three seizures, and five psychiatric cases as sentinel events with prior ephedra consumption; and three deaths, two myocardial infarctions, two cerebrovascular accidents, one seizure, and three psychiatric cases as sentinel events with prior ephedrine consumption. Classification as a sentinel event does not imply a proven cause and effect relationship.
We identified two deaths, three myocardial infarctions, nine cerebrovascular accidents, three seizures, and five psychiatric cases as sentinel events with prior ephedra consumption; and three deaths, two myocardial infarctions, two cerebrovascular accidents, one seizure, and three psychiatric cases as sentinel events with prior ephedrine consumption. Classification as a sentinel event does not imply a proven cause and effect relationship.
- We identified 43 additional cases as possible sentinel events with prior ephedra consumption and seven additional cases as possible sentinel events with prior ephedrine consumption."
In other words, only 65 reports out of more than 18,000 could be classified as sentinel or possible sentinel events which themselves do not imply a proven cause and effect relationship.
That means that 0.36% of all the reports contained sufficient information to label as a concern.
Your quote of around 100 deaths is woefully inadequate for a posting suggesting that a product is unsafe.
FDA Docket -- chap 5You say "but we know these products are not safe since around 100 deaths and many thousands of adverse events have been reported. Even if only a portion of adverse reactions reported were truly a result of using the supplement, this is not a safe product."
Let's examine the four components of this statement.
1. but we know these products are not safe
Who is 'we?' And how do you 'know?'
2. since around 100 deaths
This is factually incorrect -- at most 84 deaths have been reported for both ephedra and ephedrine products.
3. and many thousands of adverse events have been reported.
The Cantox and Rand reports prove that the many thousands of reports are no more credible than the thousands of reports of sightings of Elvis...
4. Even if only a portion of adverse reactions reported were truly a result of using the supplement, this is not a safe product.
Given the fact that several billion doses of ephedra are consumed each year, and given the fact that of the at least 3 million users there are around 30,000 deaths from all causes, 2 of these 30,000 being tagged to ephedra hardly registers on any public health Richter Scale I'm aware of.
Please read the attached.
Regards
posted by Sepp Hasslberger on Thursday July 24 2003
updated on Thursday December 2 2010URL of this article:
http://www.newmediaexplorer.org/sepp/2003/07/24/ephedra_discussed_in_us_house_committee.htm
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April 09, 2004 - Sepp Hasslberger
