U.S. health chief: Evidence strong for ephedra ban
U.S. Health and Human Services Secretary Tommy Thompson
U.S. Health and Human Services Secretary Tommy Thompson says sales of ephedra will be banned.
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(CNN) -- Federal officials announced Tuesday a move to ban products containing ephedra, a controversial dietary supplement found in various substances claiming to help weight loss, increase energy or enhance athletic performance.
U.S. Health and Human Services Secretary Tommy Thompson explained the government's decision and took questions from the public during an interview Tuesday with CNN anchor Carol Lin.
LIN: First, I'd like to just get some background in case folks missed the news conference. ... What is the reasoning behind this ban?
THOMPSON: Well, there's several reasons.
No. 1 is that ephedra, based upon the scientific conclusions that we've been able to come up with, really causes high blood pressure and shortness of breath, and may, in some cases, lead to death.
There have been a couple of deaths as everybody knows. Steve Bechler, the Baltimore Orioles pitcher, was one of the ones that come clearly in mind. Ephedra consists of about 5 [percent] to 7 percent of supplements' sales as far as dietary supplements, but it has about 45 [percent] to 47 percent of the adverse incident reports [coming] in against it.
So there's a real strong bevy of evidence showing that this is not very healthy.
LIN: Mr. Secretary, this debate has been raging for years. I mean, more than 100 deaths -- even your own studies have shown some 16,000 cases of people who were severely affected by ephedra. Why now, and why not sooner?
THOMPSON: ... First off, this started back in 1995 under the Clinton administration, and nothing was done. This is the first time that the FDA and the Department of Health and Human Services have taken a food supplement off the market based upon public health considerations.
The law requires us to go through very much of a scientific finding. And when a pharmaceutical company wants to put a drug on the market, they have to prove its efficacy and safety. But nutrition and food supplement drugs don't have to go through that process. The FDA has to prove that it's unsafe publicly and that it has an adverse impact on the public health.
So it takes a long effort, a long period of evaluations, which we did. We crossed every "T," dotted every "I." We had a Rand study [outside research by a nonprofit organization]. We had over 16,000 adverse incident reports. We've done some scientific analysis, and we came to the conclusion that this product was publicly unsafe to be used by the public. ...
LIN: ... Let me continue with the line of questioning that I had with you. The industry has [had] its own panel of experts in the past ... including doctors from Harvard Medical School, who had examined ephedra and concluded -- the industry concluded that ephedra was safe, that the number of people affected are a tiny minority compared to the millions of people consuming billions of pills over time.
How do the medical experts by the government match up with those conclusions, and how do people really know what to believe?
THOMPSON: Well, even if there's only a couple of deaths, doesn't that indicate that the product is not safe?
And we have had many incidents, adverse incidents come in, over 16,000 that were submitted by the companies that sell ephedra, indicating that there are some problems with it.
Ephedra has sales of about 7 percent of the food supplements but over 45 percent of the adverse incident reports, which indicates that there's a lot of public out there that have had something wrong with them after taking the medicine or the pill, and therefore, decided that they should write in or make a report.
I had scientists review it. We found out that if you use it, there's really no empirical evidence whatsoever, no scientific evidence, that says that it enhances your athletic performance, which was one of the considerations early on.
The second one is it was supposed to [help] lose weight. Well, we found that it does lose weight in the short term, but then the weight starts coming back. But also with the loss of weight, you have an increase of high blood pressure, which you're supposed to have a reduction of high blood pressure when you lose weight. So just the opposite is happening when you use ephedra. [We've] drawn the conclusion that this is unsafe for the consuming public.
LIN: All right. Mr. Secretary, we've got Sally on the telephone from California. Sally, what's your question?
CALLER: My question is, what are you going to do about all of the people that have asthma that are taking ephedra now? And the ephedra is the only drug that works on my asthma.
THOMPSON: We haven't got any scientific basis whatsoever that ephedra helps asthma patients. And we have looked at all of the conditions, all of the pronouncements, and we haven't found anything. The only thing we have found -- and that was that for a short period of time -- you do have short-term weight loss. But at the same time, you have an increase of palpitations of the heart and high blood pressure, which to me is a bad trade-off for the public health.
So we don't think that ephedra helps you in your asthma. I'm sorry to disagree with you. And we feel it's unsafe to the consuming public.
LIN: Mr. Secretary, what happens to all of the ephedra that's on store shelves right now?
THOMPSON: Well, we're hoping that the companies will act as good corporate citizens and withdraw it and make the necessary reimbursements to the stores that are selling it. We do not believe they should continue to sell it, even though the rule does not go into effect for a couple of months yet.
First, we have to post the rule, and then it takes 60 days thereafter before it goes into effect. So during this period of time, we'll be sending out letters to the companies. We'll be sending out letters and public announcements to the public.
And we're hoping that the store owners will not sell it, and we're hoping the companies will take the ephedra back and make reimbursements to the companies that have currently purchased it.
LIN: All right. We've got Kathleen on the telephone from Louisiana -- Kathleen.
CALLER: Yes, I think you pretty much answered my question. My question dealt with the small convenience stores that are selling this all over the place. ... And I was concerned as to how they would be able to get it off the shelf.
THOMPSON: Well, we're hoping that, you know, the fact that we announced it today, prior to the new year, that companies will act in a good, corporate spirit and will make the reimbursements to the small companies and grocery stores that are selling it and take it off the shelves.
We also want to make sure that the consuming public realizes that this is the holiday season, and of course, it's time that we may put on a few extra pounds. And we don't want the consuming public to go out there and feel that they're going to get short-term weight loss by taking ephedra. So we want to give people notice immediately, and that's why we're announcing it before the new year.
LIN: Mr. Secretary, what does this ban on ephedra [say] about the regulation of other herbal supplements now, the role of the federal government?
THOMPSON: Well, it's the first time that we have gone through the process and actually removed a dietary supplement product. This is the first time since the law was passed in '94. It's a very long process that you have to go through, and as I've indicated, when pharmaceutical companies put a pharmacy drug -- a drug out there for the consuming public, they have to prove its efficacy and its safety.
But food supplements and dietary supplements don't have to do go through that laborious process. They can put it out there, and then FDA has the burden to prove that it's unsafe.
And so we went through this process for the first time. It's taken a long time, several months, in order to get to the point we are right now. And more than likely we'll end up probably being sued by some of the companies that sell ephedra. But hopefully they will not, but we have to assume that they will. That's why we went through every particular process, and we dotted every "I" and crossed every "T," to make sure there would not be any reason for the courts to reverse this.