*EPF308 12/15/2004
Excerpt: Safety of AIDS Drug Nevirapine Raised At White House Briefing
(McClellan responds to reporters' charges) (1220)

The U.S. Public Health Service continues to recommend short-term therapy with the anti-AIDS drug nevirapine "as an option for women who enter care late in pregnancy,"
White House Press Secretary Scott McClellan said December 14.

Responding to charges presented by reporters that the U.S. National Institutes of Health (NIH) did not fully disclose possible risks of nevirapine, which is used to prevent mother-to-child transmission of the AIDS virus, such as possibly lethal effects including liver damage, McClellan noted that nevirapine has been approved for use in the United States since the 1990s.

The drug, he said, "has been proven to be effective in stopping mother-to-child transmissions of the AIDS virus" and "can have very important, positive effects when it is used in the proper dosage.

"The NIH has stood behind its effectiveness," he reiterated. "But because some questions had been raised, they have also asked that the Institute of Medicine do a further analysis of the drug. And so we look forward to seeing what that analysis is."

President Bush "remains committed to doing all that we can to stop the spread of AIDS" and to implementing preventive measures to help those in the most afflicted areas, McClellan said, adding, "But we will always work to improve medicines and treatments on all diseases, and that includes HIV/AIDS."

Following is an excerpt from the briefing:

(begin excerpt)

THE WHITE HOUSE
Office of the Press Secretary
December 14, 2004

PRESS BRIEFING BY SCOTT McCLELLAN

Q: There's a report that NIH did not fully disclose the risk associated with the AIDS drug Nevirapine, that would be used for pregnant women who are infected with the disease, to protect their unborn children, particularly at the time two years ago, when the White House was considering using this drug for its AIDS prevention program in Africa. First, is the White House satisfied with the way NIH has handled the matter, in terms of the information, whether or not it was given in a timely fashion? And, second, will it have any impact on the administration's program to use the drug in Africa?

MR. McCLELLAN: A couple things. One, the President's emergency plan for AIDS relief is about saving lives. The United States does more than any nation in the world to combat AIDS. The President made an unprecedented commitment to addressing the pandemic and helping those who are suffering in our most afflicted areas of the world. That was the $15 billion commitment over a five-year period.

In terms of the specific drug, Nevirapine, it's been approved in the United States since the 1990s, and it's been a proven -- a drug that's been proven to be effective in stopping mother-to-child transmissions of the AIDS virus. And the NIH has stood behind its effectiveness. But because some questions had been raised, they've also asked that the Institute of Medicine do a further analysis of the drug. And so we look forward to seeing what that analysis is. But the President remains committed to doing all that we can to stop the spread of AIDS and prevent -- and implement preventive measures to help those in the most afflicted areas.

Q: And is he satisfied with the way NIH handled disclosing the information about the risk?

MR. McCLELLAN: Well, I don't -- in what term -- in what ways? The NIH referred the matter to the Institute of Medicine for further analysis. It's a drug that is approved for use here in the United States. It is a drug that can help save lives. And the U.S. Public Health Service guidelines continue to recommend short-term therapy with Nevirapine as an option for women who enter care late in pregnancy.

Q: If I could follow up to that --

MR. McCLELLAN: Go ahead.

Q: You're talking about -- the President is talking about saving lives, but this drug has lethal effects to include liver damage. How are you saving lives one way, and then letting somebody die from a lethal effect another way?

MR. McCLELLAN: I take exception to the way you characterize that, April. The President's plan is about saving lives. And we want to make sure that people who are afflicted have lifesaving drugs available to them, or people in those afflicted areas have lifesaving drugs available to them. I just pointed out that the NIH, because of the questions that have been raised, has referred to the Institutes of Medicine for further analysis. We want to see what that analysis is. But we will always work to improve medicines and treatments on all diseases, and that includes HIV/AIDS. In the meantime, though, we're pursuing the available treatments that have shown to be effective, and it is something that is approved for use here in the United States of America. And it can have very important, positive effects when it is used in the proper dosage.

Q: Two things real quick. Isn't there a concern at the White House that the President was not made aware of these lethal effects of this drug when he signed off on sending the drug there? And two, what does the White House say to some African Americans saying this looks like, if you turn your head one way and close your eye another way, it looks like --

MR. McCLELLAN: In what sense? I don't know what you're referring to.

Q: -- it looks like it could be syphilis all over again in another country [a reference to a now infamous study of the effects of untreated syphilis, conducted for 40 years by U.S. public health officials on a group of unsuspecting black men in Tuskegee, Alabama].

MR. McCLELLAN: In what sense? It's approved for use here in the United States. But there have been questions raised, and the NIH is taking an appropriate step to ask for further analysis of the drug. That's what their role is in this. In terms of the review and testing of medications, the White House is not involved in that. That's something that the FDA is involved in.

Q: Shouldn't the White House have known about this effect before the President signed off on it?

MR. McCLELLAN: I just pointed out that it's a drug that's approved for use in the United States.

Q: But does it make it right? Does that make it right? Just because it's approved --

MR. McCLELLAN: Well, there's some questions -- let me reiterate again, and then I'm going to move on. It has been approved here for use in the U.S., but there have been some questions raised, and the National Institutes of Health is asking for further analysis by the Institute of Medicine. And so that's where it stands.

We look forward to that analysis. But the President is going to continue moving forward on his AIDS relief initiative to help those in the most afflicted areas of the world and to save lives. That's what that initiative is about. And it's used here in the United States and we want to make sure that lifesaving drugs that are available here in the United States are also available to people in other parts of the world who are in the afflicted areas.

(end excerpt)

(Distributed by the Bureau of International Information Programs, U.S. Department of State. Web site: http://usinfo.state.gov)

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