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Health and Human Services Secretary Tommy Thompson Gives Press Conference on Dietary Supplements Containing Ephedra

Aired February 28, 2003 - 15:36   ET


ARTHEL NEVILLE, CNN ANCHOR: We're going to go to Washington now. That press conference with the FDA, as well as the Health and Human Services secretary is just about to get under way. We're going to dip in now.
OK. Apparently, they are not quite ready to start that discussion. So we are going to go ahead and talk back to -- I'm told that the news conference is beginning. We will go ahead and dip in now.

TOMMY THOMPSON, HHS SECRETARY: I want to introduce Dr. Mark McClellan, who is with me this afternoon. Of course is the head of the FDA. And will be making comments later on this very important subject.

Tim Morris from the Federal Trade Commission is the chair. And very happy that you're here, Tim. And Steve Strauss, from the National Institutes of Health, who is in charge of research and alternative therapies and drugs. And I'm very happy that he's here as well to answer any questions you might have.

Is Steve here? Back of the room.

First, let me welcome you to the Humphrey Building, and thank you very much for coming. And I thank you very much for coming on a Friday afternoon. I understand from Kevin Keen (ph) that some of you were critical that we were waiting till 3:30 this afternoon to have this press conference. Let me tell you why we're doing that.

It's because we have just received the Rand Report. I want to get the Rand Report out, because I've been waiting for that for a long time in order to make some decisions dealing with ephedra. And I've just come back from the White House. I couldn't get here any sooner, and that's why it's at 3:30 this afternoon, because we have the Rand Report that will be distributed so the press will have an opportunity to evaluate it and look at it.

Throughout America, there continues to be tragic incidents that link dietary supplements containing ephedra to serious health problems and consumers that use these products. There continue to be adverse event reports -- too many, from my perspective -- regarding ephedra supplements. And there continue to be serious questions about the risks surrounding this particular dietary supplement. The law has created a very tough burden on the Food and Drug Administration and on me, as secretary of Health and Human Services. Section 402 F-1A (ph) of the Federal Food and Drug Cosmetic Act states that a dietary supplement can be taken off the market if it presents a significant or unreasonable risk of illness or injury. Further, the law states the United States shall bear the burden of proof on each element to show that a dietary supplement adulterated.

And even further, the law takes the extraordinary step of requiring a court to review all of my conclusions and decisions on a de novo (ph) basis, which gives my decisions no deference. For you who are not attorneys, de novo (ph) means that anything that is appealed from my decision goes to court with no deference whatsoever, no basis for granting a decision based upon what we have decided. And so the burden is very, very high in this area of the law.

And it's surprising to me, drugs have to prove their safety in order to get proved. Dietary supplements, on the other hand, we have to prove that they are unreasonably unsafe for us to take them off the market. So the burden is strictly shifted from pharmaceutical drugs that are licensed to dietary supplements that are not.

So it puts the burden on FDA to show, through science, that a dietary supplement such as ephedra should not be on the market. And, as I've indicated, this is contrary to the pharmaceuticals that we take, where the burden is on the manufacturer to prove that these drugs are safe for human consumption. This department, through the National Institutes of Health, commissioned and asked the Rand Corporation of California to conduct a very comprehensive review of the existing science on dietary supplements that contain ephedra.

And so today, as I mentioned, when I started, we are releasing the Rand Report. I have been promised the Rand Report from November, December, January and February. It came in, and we are releasing it today, and that's why we're holding the press release. Federal trade -- the FDA commissioner and the Federal Trade Commissioner Chairman, Tim, and Mark McClellan will speak more about the science shortly. But let me, for everybody's edification, tell you that the efficacy of the Rand Report, the results of the ephedra trials, show that no studies of improved use for athletic performance.

And two, there's been some modest weight lost of two pounds per month seen in four small studies. But no evidence of sustainability of that weight loss. And achieving that weight loss would require taking more milligrams than what FDA would recommend.

So the Rand Report pointed this out. And so today, we're releasing that Rand Report, and the Rand Report also says that it requires further science. But based upon this new suggestive evidence in medical literature and the Rand Report, as well as the adverse events report, there are many reasons for me for heightened concern that dietary supplements containing ephedra may present a significant and an unreasonable risk of illness and injury.

Therefore, the department, through FDA, is going to take the following steps towards building the case -- building the case for further regulatory action under the law. We're going to seek, in a short period of time, 31 days, public comment on the new evidence on health risks associated with ephedra in order to establish an up-to- date record to support the new restrictions on ephedra contain containing products.

Two, we're seeking public comments on whether the available evidence in medical literature on ephedra presents a significant and unreasonable risk of illness or injury. We're asking all scientists and medical professionals who have scientific evidence to submit that during this short period of comment.

Propose and seek public comment on a brand new strong new warning label on any ephedra products that will continue to be marketed. This label will include a warning about possible death. This allows us to strengthen consumer information now.

NEVILLE: OK. We've been listening to Health and Human Services Secretary Tommy Thompson.


Press Conference on Dietary Supplements Containing Ephedra>

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