amfAR, The Foundation for AIDS Research

An Interview with Randall L. Tobias—Spearheading the U.S. Response to Global AIDS


Randall L. Tobias
Randall L. Tobias 

October 2004—Randall L. Tobias was sworn in as President George W. Bush’s Global AIDS Coordinator on 6 October, 2003, and given the rank of ambassador. Reporting directly to Secretary of State Colin Powell, Ambassador Tobias is responsible for overseeing all U.S. international HIV/AIDS assistance and coordinating the efforts of the various agencies and departments of the U.S. government that deliver it. The appointment caps a successful business career, most recently at Eli Lilly and Company, where Ambassador Tobias was chairman, president, and CEO from 1993 until his retirement in January 1999.

TREAT Asia Report: How do you feel about the progress that you have made so far as the president’s Global AIDS Coordinator?

Ambassador Tobias: Well, in both absolute and relative terms, I feel very good about it. When I arrived in Washington about 14 months ago, there was nobody in the organization. There were concepts in a binder, there were lots of people with experience and capabilities scattered around the United States government who had been addressing AIDS for a long time, but there was really no coordinated effort. The people involved have really made quite extraordinary progress, including getting US$865 million committed to programs in the 15 focus countries. In total, we will have about $2.4 billion in fiscal year 2004 money disbursed by the end of this year.

By the same token, I think it’s very important for people to recognize that there are 8,000 people dying of AIDS every single day. Generally speaking, I don’t think that the American public has a concept of the magnitude of this problem and the devastation that it is bringing to many, many countries around the world. So we really have a job to do in telling this story.

TA Report: Could you give us a brief overview of PEPFAR—the President’s Emergency Plan for AIDS Relief?

Tobias: The idea of the plan was to commit $15 billion over five years to prevention, treatment, and care, with about $10 billion going to 15 countries that in total represent roughly 50 percent of HIV infections in the world. A billion dollars of the $15 billion is being distributed through the Global Fund to Fight AIDS, Tuberculosis and Malaria, and about $4 billion is going to programs in another 85 countries or so around the world where we have bilateral programs. The idea is that by focusing our resources and concentrating our efforts, we are much more likely to make an impact.

The first money became available in February 2004, and at this point we’re well on our way to getting treatment and prevention programs scaled up, and care programs, such as childhood and orphan care, are beginning to move ahead.

TA Report:  We were pleased to see Viet Nam added to the list of focus countries. Could you tell us what spurred this addition to the list?

Tobias: At the time they appropriated the money this year, the U.S. Congress directed me to add a fifteenth country to the program. I don’t anticipate that there will be other focus countries added going forward. We selected Viet Nam because of some unusual characteristics. At the end of 2003, there were an estimated 220,000 people infected with HIV in the country, but conventional wisdom says that, without intervention, there could be as many as a million people infected by 2010.

Until relatively recently, the epidemic in Viet Nam has been largely confined to commercial sex workers and even more particularly to intravenous drug users, but it’s now beginning to spread more broadly into the population. So we really have an opportunity, working with others, to try to prevent this spread. At the same time, the government has made a commitment to address the issue of HIV/AIDS. I’m happy to have a focus country in Asia because I think that in the longer term, what happens in Asia is going to be one of the determining factors in the outcome of the worldwide war on AIDS.

TA Report: How would you characterize the response to AIDS of other Asian governments?

Tobias: Thailand and Cambodia have both made a great deal of progress in containing their epidemics. Countries like India and China represent both huge opportunities and huge concerns, given the magnitude of their populations. India, for example, has an overall infection rate in the region of 0.8 percent, which is relatively low, yet the population of infected persons in India is second only to South Africa. There’s a great deal that India can do to help itself. There’s also evidence that the government in China is taking the issue much more seriously. Probably the single most important factor for any country addressing this issue is national leadership—leaders at all levels stepping up and talking about the issue and putting a strategy in place to address the things that need to be done.

TA Report: You might have seen the special report that TREAT Asia issued at the Bangkok meeting, which highlighted the lack of healthcare workers trained to deliver AIDS drugs safely and effectively. Is PEPFAR making any specific efforts to address healthcare training?

Tobias: Not only is it going to take investment in training and, in some cases, physical infrastructure, it’s going to take creativity in finding ways to use healthcare workers who can extend the reach of physicians. We have a program in at least one country—and we’ll be expanding this—where healthcare workers are monitoring patients who’ve been put on treatment by physicians in a clinic. The healthcare workers go out once a week and visit these patients in their homes, giving them their medication for the next week, monitoring them, answering their questions, and those kinds of things.

I think the number of companies that you identified in your report that are now making antiretroviral drugs points up another very important issue. The risk of the drugs not being safe and effective and of consistent quality is especially onerous because drug resistance can emerge. So it’s very important that, as more and more new companies begin to manufacture these drugs, we have processes in place to ensure that the medications we’re giving patients are actually medications that are going to do good. We’re trying to do that with our program, and to do it with a sense of urgency.

TA Report:  There’s been a little confusion about U.S. government policy towards purchasing generic drugs for HIV/AIDS. Could you clarify the U.S. position on this issue?

Tobias: There are people who, for whatever reasons, have spread a lot of misinformation about our policy or made assumptions about it. Our policy from the very beginning has been that we will approve the use of funding from our program for the acquisition of antiretroviral drugs without regard to whether they are generic or brand-name drugs, or whether they are copies of brand-name drugs that are still under patent protection in certain countries. We want to be satisfied that those drugs are safe and effective and of high quality.

So we put in place a process whereby the U.S. Food and Drug Administration does a very accelerated review of applications from drug companies from anywhere in the world to ensure that the drugs that are being proposed for funding through our program are, in fact, safe and effective. An important element of that is to ensure the bioequivalency of those drugs. In other words, are they going to act in exactly the same way as the brand-name drugs that originally gained approval through clinical trials?

I think the steps that the World Health Organization has taken recently to identify some drugs that were on their pre-qualification list but didn’t meet the standards points up the extreme importance of having a rigorous program in place.

TA Report:  So patents are not part of PEPFAR’s criteria for purchasing AIDS drugs?

Tobias: There have been agreements reached on the part of the United States Trade Representative Office and representatives of other governments concerned about patents and intellectual property issues. The bottom line is that, under certain well established procedures, developing countries that have an AIDS emergency and don’t have a drug industry can issue mandatory licenses and cause those drugs to be manufactured in the country or to be imported.

TA Report:  There’s been a lot of attention paid to individual countries’ contributions to the Global Fund. How do you evaluate the progress of the Fund?

Tobias: I think that the Fund and the people leading it have done an extraordinary job of bringing the world’s attention to HIV/AIDS. They’ve gotten something in the region of $6 billion in commitments so far, they have collected about $3 billion, and they’ve distributed about $450 million so far. It’s all in the early stages. As you know, the U.S. Congress appropriated a potential amount of $547 million this year for the U.S. contribution to the Global Fund, with the stipulation that the U.S. contribution not exceed 33 percent of total contributions from the rest of the world. I don’t think anybody has questioned that that was a very generous amount. Frankly, I’m disappointed that, to date, other donors in the world have not stepped up to the degree that’s going to be necessary for us to donate the full amount to the Global Fund. With the flexibility granted to me under the legislation, I created a 60-day extension, and we’re working closely with the Global Fund and hoping that the world will step up so that we can make that full contribution. I think the Global Fund and support for the Fund is one of the critical elements for the world’s success in addressing this issue.

TA Report: The AIDS field has always been heavily politicized. Have you been surprised in any way by the politics that surrounds this issue?

Tobias: I’ve been a little surprised at the willingness of some people to put the degree of energy that they do into debates and discussions and activities that don’t directly relate to all of us coming together and addressing treatment, prevention, and care needs. I think it’s very important for everybody who cares about this issue to recognize that the real enemies out there are denial and stigma, lack of adequate resources and medical infrastructure, and all those kind of things.

Other than that, I would say I’ve been reassured by the extraordinary number of people who are working on this issue who care very much about it, and I am optimistic that that we’re going to make progress. One of my roles is to help the American people understand how proud they need to be of what the United States is doing to contribute to this effort, because we need the ongoing support of the American people in order to provide the kind of resources that President Bush has committed.

TA Report:  Looking back, is there anything that you or your program or the United States government could have done differently, or could have done better, in responding to the global AIDS crisis?

Tobias: Sure. I think that, if I had it to do over again, I would put more energy early on into trying to communicate more clearly what we are doing. I found it necessary to spend a lot of time getting people to understand what our strategy really is, and what our policy really is about the acquisition of drugs, for example. My hope is that we’ll try enough things, we’ll take some risks, and we’ll correct the things that don’t work and put our energy into those that do work. If the only thing you’re doing is trying to be sure you don’t make any mistakes, you won’t accomplish much.

TA Report:  Any regrets about taking the job?

Tobias: None at all. No, I don’t see my grandchildren quite as often, but I think they’re very understanding and supportive, as my wife and children are, of what I’m doing here.

TA Report: Ambassador Tobias, thank you very much for your time and good luck to you.