U.S. Moves to Improve Access to Generic AIDS Drugs Overseas
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GWEN IFILL: Now, to President Bush’s point man on AIDS. Last weekend, the administration announced it is shifting direction to make AIDS drugs available more cheaply and more quickly in Africa and the Caribbean. The plan, which would allow two or three anti-retroviral drugs to be combined into a single pill, was applauded by drug companies but received a more mixed reaction elsewhere. Will this plan perform as promised? For that, we turn to Ambassador Randall Tobias, the administration’s global AIDS coordinator.
AMB. RANDALL TOBIAS: Thank you.
GWEN IFILL: So how does this plan that has been laid out by and by Secretary Tommy Thompson differ from previous administration policy?
AMB. RANDALL TOBIAS: Well, it’s really not a change in policy, it’s really just a new tool to implement the policy we’ve had. From the time President Bush announced this extraordinary $15 billion commitment to fighting global AIDS, our policy has been to acquire drugs at the lowest possible cost we could, from whatever sources, whether they’re domestic or anywhere around the world, brand name drugs, copy drugs, generic drugs as long as they are safe and effective. There’s just been no mechanism on the copy drugs to determine whether they’re safe and effective. And so this is a new tool that will permit every drug company in the world to submit their drugs to the FDA for a very accelerated review process. And I, in turn, can then make decisions knowing that if they’ve passed FDA scrutiny, they are in fact safe.
GWEN IFILL: Let’s talk about the approval process in a moment. First I want to talk about the impact. How much are we talking about do these drugs cost for people in these impoverished nations and who will be benefiting from this?
AMB. RANDALL TOBIAS: Well, there are about 40 million people infected in the world today, not all of those people need anti-retroviral treatment, but eventually they will. So we’re talking about very, very large numbers. And in the developing world where we are focusing our attention, our intent is to get two million people under treatment, under the president’s plan, in the next five years. The drugs range in quoted prices anywhere from in the $150-a-year range to maybe $300, $350, although it’s very hard to compare because sometimes those prices include transportation and warehousing and sometimes they don’t. But the prices have come down very dramatically in the last few years, really in the last few months on the part of all of the suppliers.
GWEN IFILL: Now, three drug companies said, right as this was announced that they were going to band together to produce this pill for this program. How quickly then will this be able to get into the hands of some of these people who are suffering?
AMB. RANDALL TOBIAS: Well, right now we’re treating people and adding more people to the program all of the time using the branded drugs that are available. The issue here really is one of combining these drugs into a single pill and the FDA indicates that depending on the status of the data that’s available and submitted by the companies who apply, that they’ll be able to process these applications in as little as two weeks and maybe six weeks or something in that timeframe.
GWEN IFILL: Once it has already passed muster by the FDA’s own standards about what’s safe?
AMB. RANDALL TOBIAS: Yeah.
GWEN IFILL: So that might take a little longer than two to six weeks?
AMB. RANDALL TOBIAS: No, no, no, the FDA process, if people for example were putting their applications in today or tomorrow, we’re really talking about the FDA being geared up to get the approval in a matter of a very few weeks.
GWEN IFILL: Would generic drug manufacturers from other countries, say India, be qualified to provide drugs under this program?
AMB. RANDALL TOBIAS: It’s important to define the terms here. If you and I go to the corner pharmacy with a prescription from our doctor and get it filled with either a brand name drug from a research company or with a generic that means that the patent is– no longer applies, what we know is that those drugs are essentially identical because they have both gone through the FDA’s process in a very identical way. The companies in India, for example, that are making the drugs that have been in question are really making copies of drugs that are still under patent protection in the United States. And those drugs have never been reviewed by any stringent regulatory authority.
GWEN IFILL: But doesn’t the World Health Organization already make some of those drugs available?
AMB. RANDALL TOBIAS: Well, the World Health Organization, with whom we have worked very closely on all of this, has a process that they call their prequalification process. And it’s based on some principles that enable countries that don’t have something like the FDA to have a starting point for making informed decisions when they purchase drugs. But it’s not the same as having something like the FDA, and I think it is for that reason that Dr. Lee Jong-wook, the director general of the World Health Organization, announced today that he was applauding what we were doing and thaw it was a very positive move.
GWEN IFILL: But still defends his own prequalification process?
AMB. RANDALL TOBIAS: The World Health Organization does not represent their process to be a regulatory review process that’s comparable to what the FDA does.
GWEN IFILL: Now, you realize I’m certain that some critics, Doctors Without Borders, the Africa Action Group, Trans-Africa Forum, they have all said that they feel that the administration’s laying on extra burdens, they’re creating a parallel process which is actually going to slow the distribution of these drugs rather than expedite it. What’s your response to that?
AMB. RANDALL TOBIAS: Well, I’d say we’re providing a new door that will speed up the process, because we now have a very clear, transparent and very quick process that any company in the world can take advantage of, and submit their drugs to very quick approval. So I think this is really going to accelerate our ability to implement the president’s program.
GWEN IFILL: How about children, will they be treated under this program, will they, will these drugs be made available to children, have they been tested on children?
AMB. RANDALL TOBIAS: The president’s program really has three areas of focus, treatment, prevention and care. And children are a very important part of the entire program. I would have to leave it to the medical authorities in terms of the specific regimens that we will use, but treating children with AIDS is certainly a big and growing problem.
GWEN IFILL: I was traveling in Africa a few weeks ago looking at just this issue and one of the things that came up was this idea of the ABC program, the three ABC’s of AIDS prevention or AIDS cure, AIDS curbing, which is abstinence, being faithful, and condom use. What is the emphasis in your mind– in the U.S. government’s mind of those three things?
AMB. RANDALL TOBIAS: The emphasis is A and B and C. All three components of that program have a very important role in this. This is a program that was really launched back in the late 80s in Uganda by President Museveni who has done a wonderful job of stepping up and providing leadership and essentially what he said to the people of Uganda and is still saying today that A and B and C is not a cafeteria list of choices, but it’s rather starting out with young people, and I know it’s hard to imagine here in the United States when you haven’t been to the places that you’re describing, but these are young people whose mothers are dying, their fathers are dying, their teachers are dying and what they’re being given is hope about how to take control of their own lives.
GWEN IFILL: Some of them said to me that they feel like they don’t have access to some of the U.S. funding because they want to emphasize condom use, and that the U.S. discourages that?
AMB. RANDALL TOBIAS: Well, the U.S. doesn’t discourage that; we’re buying as many condoms now as has ever been the case. But the fact of the matter is that the evidence suggests that– doesn’t suggest, the evidence really shows that condoms have never been effective anywhere in the world in curtailing broad based general epidemics in the broad population.
The United Nations AIDS organization has just released a new study that makes that point, and there’s a growing body of evidence. So condoms are not the end all, but in very targeted ways for people who are either going to engage in risky behavior or who have no choice about engaging in risky behavior, it is a very important tool and that’s why the president’s program is A and B and C. But changing behavior is what is really making the difference in Uganda and other places, and that means getting people to do two things: To delay the age at which they become sexually active, and then reducing the number of partners they have when they are sexually active.
GWEN IFILL: Let’s talk about resources in the little time we have left. The president announced just a little over a year ago a $15 billion AIDS pool of money for AIDS research for AIDS spending in these countries. And I think so far only $350 million has been dispersed. Does it seem that it’s going kind of slowly?
AMB. RANDALL TOBIAS: No, quite the contrary. There’s $350 million that’s been put into the 14 focus countries so far this year, in the next month we will have that number will be up to about $850 million. And by the end of the year with that and the other aspects of this program, we will spend the entire $2.4 billion that Congress has appropriated for this year. The request for next year is $2.8 billion, and I’m sure we will put that in place. But we’re ramping this up because, as you probably know, the biggest roadblock in virtually all of these countries is the lack of an adequate health care system: Not enough infrastructure, not enough medical personnel, and so the first thing we’re doing is getting that kind of resource in place as we gear up this program.
GWEN IFILL: Ambassador Randall Tobias, thank you very much for joining us.
AMB. RANDALL TOBIAS: Thank you.