NEWSWEEK: Do you think the U.S. has provided enough support for the Global Fund [the international agency created in 2002 to coordinate international efforts to fight AIDS, tuberculosis and malaria]?
Paul Zeitz: There is a clear consensus among public-health experts that pooling technical and financial resources is the secret to creating an effective global response. That was the whole rationale for the Global Fund. But instead of supporting the Global Fund, this administration has taken deliberate, concerted action to undermine it.
The Bush administration’s 2004 budget [submitted to Congress in 2003] included only $200 million for the Global Fund. A bipartisan congressional majority came up with $550 million, despite the administration’s resistance. This year, the Global Fund is asking the United States to double its commitment to $1.2 billion. That’s America’s share of the $3.6 [billion] needed to sustain the Global Fund’s commitments through 2005. But instead of scaling up the commitment in 2005, the Bush administration wants to slash the commitment by 64 percent. The president has again requested only $200 million for the Global Fund–less than half the current U.S. spending level, and just one sixth of what is needed.
The big question right now is whether the Global Fund will maintain its momentum against diseases of mass destruction or be put out of business by the United States. There is no evidence that the administration’s bilateral programs will be more effective than multilateral programs. All we know for sure is that they’re more expensive, less efficient and harder for target countries to absorb.
Randall Tobias: When people say we’re not embracing a global strategy, I don’t know where they’re coming from factually. What country is playing the biggest role in making the Global Fund successful? The United States made the first contribution to the Global Fund, and we remain the biggest contributor. U.S. funds account for 35 percent of the Global Fund’s resources. We’re contributing nearly twice as much as all other donors combined.
An effective response has three parts: raising money, spending money and implementing programs. The Global Fund has done a wonderful job of raising awareness and money. It has collected $2.6 billion in pledges. But do you know what the Global Fund has actually dispensed? The amount is $400 million. PEPFAR will have dispensed $2.4 billion by end of this fiscal year, and $865 million will have gone into programs we’re funding in focus countries. If we put the same amount into Global Fund, it would have to sit in the World Bank.
When people say the Global Fund needs more money, they’re describing the magnitude of need in the world. They’re not describing funds required to implement approved programs. The Global Fund is only a few years old. It has done a wonderful job, but it’s still working to put mechanisms in place and get the money out. PEPFAR is building on almost 20 years of U.S. Government presence and experience in developing countries. We’re using the backbone of the USAID, CDC [Centers for Disease Control] and other agencies that have already been in the field.
Under a mandate from Congress, a third of PEPFAR’s prevention funds are earmarked for programs that focus exclusively on sexual abstinence. Is there a good rationale for that restriction?
Zeitz: There is no good scientific evidence that preaching abstinence protects people from HIV infection. And this administration’s ideological obsession with marriage could actually put young girls at even greater risk. Marriage is not protective for young women in Africa. Young women who get married are at higher risk than young women who stay single.
Tobias: I don’t disagree about the need for prevention efforts that go beyond abstinence and fidelity. If people choose to engage in risky behavior, or they lack choices, they should know about the correct use of condoms and should have access to them. We’re also committed to women’s education and empowerment, and we’re committed to microbicide development and vaccine development. But in terms of what we can do today, it’s obvious that condom-only programs have not gotten the job done. We need a balanced approach that includes abstinence and fidelity as well as condoms. When young people delay sexual activity and people reduce the number of sexual partners, those two factors can make significant contributions. We may have different programs that emphasize different elements of the “ABC” strategy [Abstain, Be faithful, use a Condom], but the president has stressed the need for all three.
The U.S. government has also been criticized for refusing to pay for generic AIDS drugs that the World Health Organization declares medically equivalent to costlier brand-name pharmaceuticals. Is this a fair criticism?
Zeitz: The global community asked the WHO to streamline procurement and create coherence by rigorously prequalifying antiretroviral medicines. The WHO responded. The rest of the world–including the Global Fund, the World Bank, the Nobel-Prize-winning relief group Medecins sans Frontieres–has enthusiastically embraced both the process and the products. The Bush administration stands alone in demanding a separate, U.S.-based certification process for fixed-dose combinations [pills that simplify treatment by combining drugs that would otherwise be administered separately]. The administration says it will accelerate the FDA [Food and Drug Administration] approval process, but there is no need to review the same drugs twice. We could be getting them out today through existing programs.
One reason for using fixed-dose combinations is to standardize treatment. By introducing separate, branded drugs into health districts where FDCs [fixed-dose combinations] are the norm, the U.S. program could cause confusion and chaos. Health-are providers in poor countries aren’t equipped to juggle different drugs, protocols and administrative requirements for different donor programs. When you create those burdens, you open the door to poorer adherence and increased drug resistance.
I also know from experience that people in southern Africa do things communally. There’s a communal approach to everything from food to medicine. If I’m on treatment, I’ll turn to my neighbor for advice and support–maybe even drugs when I can’t get to the clinic. If my neighbor and I are on different regimens, sharing becomes dangerous.
Tobias: The policy has always been that we will buy the least expensive drugs available, no matter where they’re made, as long as U.S. taxpayers can be sure the drugs are safe, effective and of high quality. We’re not placing onerous demands on manufacturers [by demanding that they apply separately for approval from the FDA]. I can’t imagine why the companies making copy drugs wouldn’t want to beat a path to the FDA’s door with their data. They have to know their drugs are bio-equivalent before bringing them to market. It’s just a matter of going through an accelerated review process. Once they do that, we’ll be comfortable because we will have seen the data ourselves.
Right now, we don’t know what the WHO does [to certify that generic drugs are equivalent to branded ones], and we don’t know what the manufacturers’ data look like. Many countries are getting ready to produce their own copy drugs. If we’re going to purchase and distribute those drugs, we need some firsthand knowledge of their safety and efficacy. It’s not unusual for governments to verify quality when spending their own money. I wouldn’t criticize another bilateral donor for setting rules to govern its own expenditures. The people attacking us on this have lots of motives.