Ten years ago, TAG was one of the only voices calling for the nation to double its investment in biomedical research at the National Institutes of Health (NIH). We felt that if NIH grew as a whole, the AIDS research enterprise would benefit from research in other areas. In addition, we advocated dramatic increases in the AIDS research budget itself, and better planning, coordination, and evaluation of the NIH AIDS research program through the NIH Office of AIDS Research. These recommendations — but not the doubling of NIH as a whole — became law through the NIH Revitalization Act of 1993. In the mid-1990s, the NIH budget was jeopardized after the Republican takeover of Congress by the “Contract on America” and efforts to balance the budget. Luckily, however, a bipartisan consensus emerged that a healthy and growing NIH was in the nation’s interest, and in 1997 both parties agreed to double the NIH budget by the year 2003. Thus, healthy increases in AIDS research in the mid-1990s were supplemented by healthy increases in the NIH budget as a whole.

Many questioned whether the new Administration would keep the NIH on track for doubling its budget by 2003. The President’s Budget, issued on 4 February 2002, looks like it will result in a doubling of the budget. However, the lion’s share of the new expenditures are in response to the emergency posed by the threat of bioterrorism. The President proposes a budget increase of 16.7% for a total budget of “$27,335 million for NIH, an increase of $3.902 million, or 16.7%, over the FY [fiscal year] 2002 estimate.” [NIH Press Release for the FY 2003 President’s Budget, 4 February 2002]

Highlights of the new budget include a 600% increase for bioterrorism research, a 13% increase for cancer, and a 10% increase for AIDS research. Most of the other NIH institutes will have to make do with an eight percent increase.

Some have speculated that the author of last fall’s anthrax attacks was a research insider who may have been trying to awake the nation to the threat of bioterror. If so she or he was astonishingly successful. The NIH will allocate $1.473B in new funds to fight bioterrorism. Some of this research will likely benefit biomedical research and infectious disease research in general, but spending the money wisely will be a challenge. Items in the bioterror research budget include:

• $376 million for basic R&D, including extramural research centers, pathogen genomics and proteomics;
• $533 million for drug screening, diagnostics, and animal models;
• $134 million for clinical trials, including smallpox vaccine trials; and
• $430 million for biosafety level 3 and 4 facilities at NIH and extramurally, and increased security at NIH. [Jocelyn Kaiser, “Bioterrorism Drives Record NIH Request,” Science 295, 1 February 2002, p. 785]

Ninety-five percent of the new bioterror funds will go to the National Institute of Allergy & Infectious Diseases (NIAID). Overall, NIAID will enjoy a budget of $3.959 billion, an almost $1.6 billion increase over FY 2002.

Highlights of the 10% increase for AIDS research at NIH include $82 million in funding for AIDS vaccine research (much of it likely destined for a controversial phase III trial of the ALVAC canarypox/gp120 prime-boost approach). However, NIH is also being asked to absorb the Department of Defense (DOD) AIDS research program, which currently costs over $25 million per year. It is unclear whether this unfunded merger will make it more likely that the two planned ALVAC studies (one by DOD, one by the NIH-funded HIV Vaccine Trials Network, HVTN) will be coordinated or even merged (see Richard Jefferys’ “A Tale of Two Trials: Vaccine Researcher Questions the Need for Two Massive ALVAC Studies,” in TAGline). Overall the AIDS program areas will grow to $771 million for basic science, $750 million for therapeutics, $422 million for vaccines, $375 million for behavioral research, $294 million for epidemiology, $118 million for training and infrastructure, and $37 million for information dissemination.

Meanwhile the Federal biomedical research enterprise is leaderless and adrift. After over a year, the Administration has yet to nominate a Commissioner for the Food & Drug Administration (FDA) or a Director for the NIH. Both NIH and its Office of AIDS Research have lacked full directors since 1999. In addition, six NIH institutes are leaderless.

The leadership vacuum can be attributed at least in part to political maneuvers by right-wing supporters of the Administration. In the case of FDA, supporters of the drug and biotechnology industries are pushing for someone who will back a deregulationist agenda, while others — and in particular Senator Edward Kennedy of Massachusetts, who chairs the Senate Health, Education, Labor & Pensions Committee, which confirms both FDA and NIH leaders — advocate someone who will be more consumer oriented.

In the case of NIH, the stumbling block appears to be research related to stem cell research. For awhile it appeared likely that the Administration might nominate NIAID’s Anthony Fauci to the NIH Director’s job. However, a group of right-wing social conservatives apparently helped to block Fauci’s nomination, citing remarks he made about the potentially broad benefits of stem cell research. It’s unclear whether this was the reason the White House recently announced it would not nominate Fauci, despite the strong support of HHS Secretary Tommy Thompson and of many in the biomedical research and advocacy communities. Another reason given, at least publicly, was that Fauci did not want to give up his research as director of the Laboratory of Immunoregulation, and wanted to stay as Director of NIAID, whose responsibilities have increased with the advent of the bioterror threat.

What may have been bad news for NIH was probably good news for AIDS research, since Fauci’s scientific credibility, his bureaucratic experience, his political expertise, his links with the AIDS research community, the advocacy communities, and the Administration mean that someone who understands the AIDS pandemic will at least sometimes have the President’s ear in a time of distraction, recession, war, and political uncertainty.

The outlook for the AIDS budget aside from NIH is much more bleak. The President flat-funded CDC prevention programs and the Ryan White CARE Act. Unless reversed by Congress, this will result in program cuts for AIDS Drug Assistance Programs (ADAPs) and for many community-based organizations around the country. The Administration also intends to spend more of its limited HIV prevention dollars on ineffective abstinence programs. While resources are being cut at home, the battle to provide massively increased international AIDS assistance is continuing. The President’s budget doubles U.S. funding for the Global Fund for AIDS, Tuberculosis & Malaria (GFATM) to $200 million in FY 2003, which is still less than the $2.5 billion which many agree the U.S. should be providing. It remains to be seen whether divide and conquer tactics (prevention vs. treatment, domestic vs. international, etc.) will result in an AIDS funding stalemate, or whether Congress will, in an election year, despite war and recession, impose enlightened and targeted increases to help stem the AIDS pandemic at home and abroad.