TOPICS > Health

Newsmaker: Mark McClellan

December 30, 2003 at 12:00 AM EDT

GWEN IFILL: Banning ephedra. We’ll talk with FDA Commissioner Mark McClellan about today’s decision after this background report from health correspondent Susan Dentzer.

SUSAN DENTZER: In announcing today’s move to ban dietary supplements containing ephedra, Health and Human Services Secretary Tommy Thompson signaled the action was overdue.

TOMMY THOMPSON: For too long, dietary supplements containing ephedrine alkaloids have been heavily promoted and widely used. They are simply too risky to be used, whether by people who want to lose weight, or by elite athletes seeking to enhance their performance, or by youngsters who want to be like these athletes.

SUSAN DENTZER: One such athlete was Baltimore Orioles pitcher Steve Bechler, whose death earlier this year was linked to use of an ephedra supplement. Bechler’s mother blamed supplement manufacturers when she testified at a congressional hearing last summer.

BECHLER’S MOTHER: They took our pride and joy from us, and his wife and his baby. And they took our baby from our lives. Steve was our life and his daughter will never know him.

SUSAN DENTZER: Bechler’s was just one of an estimated 155 U.S. deaths believed to be linked to ephedra. In addition, there have been more than 16,000 reports of such adverse events as heart attacks, strokes and seizures.

TOMMY THOMPSON: I don’t know why anyone would take ephedra. I wouldn’t, and I wouldn’t want anyone in my family to take it, either.

SUSAN DENTZER: But today one leading manufacturer of ephedra products, Metabolife International, said it “strongly believes in the science supporting the safety and efficacy of dietary supplements that contain ephedra when used as directed.”

Ephedra products are usually made from a Chinese herb extract called Ma Huang. They were used as far back as the 1920s as a treatment for colds or asthma. For the past decade they’ve been widely used to boost energy or aid in weight loss. But as evidence of the risks have mounted in recent years, three states — California, New York and Illinois — have already banned the supplements.

In the meantime, many large supplement manufacturers or retailers, like GNC, have also stopped making or distributing the products. The trade publication Nutrition Business Journal estimates that sales of ephedra products will slump to as low as $510 million this year. That’s down 61 percent from peak ephedra sales of about $1.3 billion in 2001. Although the government has long known about ephedra’s risks, Thompson said today that the controversial 1994 federal law governing dietary supplements had slowed its ability to respond.

TOMMY THOMPSON: Under the current law, pharmaceutical companies, when they bring drugs to the market, have got to prove their safety and efficacy before they get approved by FDA. As far as supplements, the other side of the coin comes into play. We have to … the FDA, the government, the department, has got to prove that they are unsafe. And so it’s a completely different burden of responsibility, but that’s the law.

SUSAN DENTZER: Thompson vowed again today to work with Congress to seek changes in the dietary supplements law. But those are likely to be resisted by the $19 billion dietary supplements industry.

TERENCE SMITH: I’m joined by FDA Commissioner McClellan. Dr. McClellan, thank you for being here. How widespread a problem is this?

DR. MARK McCLELLAN: Ephedra is a popular dietary supplement. It accounts for perhaps 5 percent of dietary supplement sales in recent years. It accounts for a much larger share of the adverse events, the serious health problems that are reported by people who are taking dietary supplements, close to half of all those adverse events.

TERENCE SMITH: So millions of people?

DR. MARK McCLELLAN: Millions of people in past years, as you reported in your segment, the number of users has gone down, as we’ve tried to take steps to help educate the public about the risks, and as many responsible manufacturers have gotten out of the business.

TERENCE SMITH: In that segment, Secretary Thompson himself noted that this has been a long time coming, so I guess the question is: Why so long?

DR. MARK McCLELLAN: It has been a long time coming. The FDA originally proposed some regulations restricting ephedra use in 1997. But at that time, the General Accounting Office and many other commenters felt we didn’t have the evidence we needed in order to take action.

And the reason for that goes back to the way the law is set up. For dietary supplements in this country, the presumption is that they’re safe, and there are many safe dietary supplements, including many that have important health benefits. But the burden is on the FDA to prove that a dietary supplement is unsafe, and we have no authority at all to compel studies of safety or studies of effectiveness, we can’t even compel companies to give us the safety information that they have.

So we took an awful lot of effort this past year to both have a public comment period and to review, collect and then review all of the possible scientific evidence available that had a bearing on the risks and benefits of ephedra use to try to meet that very difficult statutory standard. And the result of all of that work is what our action that we’ve announced today.

TERENCE SMITH: So this is a very big step and a real departure?

DR. MARK McCLELLAN: It is a big step. This is the first time that the dietary supplement law, which has been on the books for ten years, has actually been used to restrict or in effect ban the use of a dietary supplement on safety grounds. We’re laying out a new framework here for how we think the law should be interpreted and we have done all the work necessary to prove that case.

TERENCE SMITH: Does this suggest that there are other dietary supplements that you’re concerned about or will be looking at in the future?

DR. MARK McCLELLAN: We’re going to remain vigilant using all the tools we have, and in the area of dietary supplement they are more limited than for drugs. We’re going to use all the tools that we have to keep an eye out for important safety risks. And the advantage of the approach that we’ve taken here is that we will now have a framework in place that can potentially be used to bring legal action, enforcement action against other supplements that may pose a risk.

TERENCE SMITH: What’s your response to the industry comment that we had in the piece there saying that these things are safe when used as directed?

DR. MARK McCLELLAN: Terry, we have comprehensively looked at all of the evidence out there, not just the adverse event reports, including serious adverse events like the unfortunate incident that happened with Mr. Bechler that you heard about in the segment as well, but also studies that have been done of ephedra, the limited studies that have been done, other studies of the way the drug works in the body, the so-called pharmacology, and we’ve put all that together in a comprehensive evaluation that is the basis for regulatory action. So we’re quite confident in taking the action that we announced today that the evidence is there that the risks of evidence ephedra outweigh its benefits regardless of what warnings might be on the label.

TERENCE SMITH: So your advice is to stop taking it now, not to wait for the 60-day period that you’re required by law?

DR. MARK McCLELLAN: Not to wait for the regulation to come out and not to way for the 60 days for to it go into effect. We wanted the public to know as soon as we had reached a conclusion about what our conclusion involved. And this is the time of year when many people are thinking about resolutions for the next year, you know, dropping a few pounds, getting in better shape, living a healthier life.

It’s important to keep in mind that ephedra is not a good fix; it’s a quick fix that will have risks that outweigh the benefits in the long term. Even if it does help you drop a few pounds in the short term, it increases your blood pressure, it stresses your heart, it therefore leads to important health risks that are exactly what weight loss is supposed to prevent.

TERENCE SMITH: What sort of response are you expecting from the industry which as Susan Dentzer pointed out in her piece is a large and powerful and politically well connected industry?

DR. MARK McCLELLAN: Well, Terry, we’re focused on what is best for the public health and how we can use the available scientific evidence to best protect and advance the health of Americans. So I really don’t care what industry has to say about our particular conclusions. My focus is on making sure that we have reached on conclusions that are scientifically valid and doing all the work, dotting all the I’s, crossing all the T’s necessary for our scientific conclusions to stands up in court and is that our main focus.

TERENCE SMITH: Stand up in court, you expect this will go into court, that the industry will sue?

DR. MARK McCLELLAN: I hope not. I think that responsible manufacturers will continue to do what some have already been doing, and that’s getting out of this industry, and we think they should take their products off the shelves as soon as possible.

But we are prepared to battle this one out if necessary, and this is a new legal approach. This is the first time this law has been used to restrict access to a dietary supplement in order to protect Americans. And that’s why we went to all the lengths that we did to make sure we’ve got a fully complete scientific case that can stand up in court.

TERENCE SMITH: Are you also going to try, or is the administration going to try to get the law modified, to change some of that burden of proof that you and the secretary were talking about?

DR. MARK McCLELLAN: Well, Secretary Thompson talked about that today and I have to tell you that from where I sit, I focus mostly in my day-to-day work on how I can use the authority that we’ve been given by Congress as effectively as possible to protect the health of the public. We’ve got an awfully broad set of responsibilities at FDA, and I know you’re going to be talking about mad cow disease and protecting the food supply later, but we face a lot of challenges.

So we think every day about how we can use our resources and authority as effectively as possible. And we have gone the whole nine yards on this one to review, to obtain and then review all scientific evidence and we’ve reached a conclusion that ephedra presents an unreasonable risk.

And so even though I think there are a lot of different views about whether the law should be reopened, I think there should be a consensus that we’ve done all we can to make this law work, and if we at the end of the day have reached a conclusion that this product is unsafe and yet the law cannot, the law does not allow us to hold up that conclusion in court, then it’s definitely time to revisit the law.

TERENCE SMITH: It is also a curiosity that the industry today was divided in its response. Some, as Susan pointed out, have already pulled their ephedra-based products.

DR. MARK McCLELLAN: That’s right. I think the responsible manufacturers are getting out of this line of business. There are plenty of other dietary supplements on the market that do not pose these kinds of health risks, there are plenty of other approaches that people can take, and it does take a little motivation, and there’s not going to be a quick fix, but there are plenty of approaches that people can take that will help them lose weight and get in better shape safely. We hope the companies in this country will help us move the public in that direction.

TERENCE SMITH: Even if you do succeed in getting — pulling these off the market, will people still be able to obtain ephedra online or overseas?

DR. MARK McCLELLAN: There are a lot of problems today with Internet operations out to make a fast buck, opening up shop, somewhere outside of the United States, and using the Internet to get their products just a click away from the public.

And we are going to be taking a lot of steps in the coming year, not just FDA, but working with our partner, law enforcement and consumer protection agencies, the Bureau of Customs and Border Protection, the Federal Trade Commission, the Drug Enforcement Administration, to help make sure that the products people get online are safe and effective and are approved in the United States.

TERENCE SMITH: Does existing law make it illegal if you go ahead and ban these things to import them?

DR. MARK McCLELLAN: The unapproved products that are subject to safety concerns in the United States would be illegal under our law. Our finding is that technically is that dietary supplements containing ephedra are adulterated under the Food, Drug and Cosmetic Act because they do present this unreasonable risk of a health problem to the public. So any imported products would be subject to that same regulation.

TERENCE SMITH: And so regulated.

DR. MARK McCLELLAN: And so regulated.

TERENCE SMITH: Dr. McClellan, thank so you much.

DR. MARK McCLELLAN: Terry, have a good new year and a safe one.