15 July 2005

Rep. Joe Barton, Chairman
Rep. John D. Dingell, Ranking Member
Committee on Energy & Commerce
2125 Rayburn House Office Building
Washington, DC 20515

Dear Chairman Barton and Representative Dingell:

We write to comment on the draft House legislation to amend title IV of the Public Health Service Act to revise and extend the authorities of the National Institutes of Health.

As the nation's only organization exclusively dedicated to advocating for accelerated, expanded, and better-focused research to end the HIV/AIDS pandemic, the Treatment Action Group (TAG) played a key role in developing and supporting enactment of the AIDS-related provisions of the NIH Revitalization Act of 1993, which strengthened the NIH Office of AIDS Research (OAR) and its legislative authority to plan, coordinate, evaluate, and determine the budget for AIDS research across the NIH and its many institutes and centers.

We welcome this opportunity to comment on the draft NIH reauthorization legislation and look forward to working with you and the members of your Committee to craft language which helps to streamline and coordinate research without weakening the essential authorities of the Office of AIDS Research (OAR).

As NIH Director Zerhouni noted in his testimony to your committee on 17 March 2005, OAR's cross-institute authorities are in fact a paradigm for better coordination of NIH research programs:

Currently, many priorities are set by the planning programs at each of the Institutes and Centers at NIH that support research grants. In recent years, NIH has facilitated collaborations and co-funded innovative trans-Agency research. In the case of HIV/AIDS research, we are shifting resources to fund vaccine research to respond to urgency as well as opportunity…
What are these offices doing? They are responding to a need that I think all of us see, and that is the need of coordination, a strategic coordination, a strategic optimization. So what happened in the '90s [was the] creation of the Office of AIDS Research, which has special authorities to look across institutes and across silos to maximize the investment in AIDS research, and you've seen the results in AIDS Research… We can be proud of the fact that, in less than 15 years, we have developed over 80 drugs that are effective in HIV [and related conditions], and, today, we have five candidate vaccines ready to enter trials. Whether they will work or not, I can't tell…
So, for example, last year, I asked all of the institutes to give me their five-year forecast in terms of both budgets, but also scientific challenge[s], and the NIAID told me about the four or five new vaccines that are becoming ready to be tested. It's a very expensive proposition to test vaccines in the global population, so that we could see there would be a shortfall of about $200 million in '06 in, I mean, a tight budget year. So what we did within the AIDS [program], Dr. Whitescarver, who runs the Office of AIDS Research, reallocated across the entire portfolio over $100 million for vaccine trials away from other areas.

TAG recognizes the need for greater coordination of cross-institute research planning and program prioritization at the NIH, especially in this era of intensified interdisciplinary science. At the same time it is essential to preserve the free spirit of scientific inquiry unencumbered by politics and ideology, and to maintain the strong base of peer-reviewed scientific priority setting and review. Therefore we would like to provide some constructive input on the draft legislation regarding NIH reauthorization.

HIV/AIDS will continue to be a global pandemic emergency for the foreseeable future.

First, the HIV/AIDS pandemic is a continuing worldwide emergency with up to 40 million people infected with HIV, 25 million deaths to date, three million deaths per year, and five million new infections per year. In the United States, over one million people are now living with HIV, according to the CDC's latest figures, and over 40,000 new infections occur annually.

Only new research will give us tools to end the pandemic emergency.

Second, the current Administration has recognized the emergency nature of the AIDS pandemic with the President's Emergency Plan for AIDS Relief (PEPFAR), which will spend $15 billion over five years – or about one half the NIH's annual budget – delivering AIDS services and treatment to affected communities worldwide. Ultimately, however, only expanded research to improve treatments and prevention and develop a vaccine will lead to a world where PEPFAR and other emergency programs are no longer needed.

NIH will continue to be the world's lead HIV/AIDS research agency.

Third, the NIH AIDS research program is by far the largest, most broad-based, and most well-focused part of the global HIV/AIDS research effort. (The French ANRS, the world's second-largest public funder of AIDS research, has an annual budget of $60 million, or just 2% of the current NIH AIDS research budget of $2.92 billion). Under the leadership of the OAR and with strategic direction from the NIH AIDS coordinating committees, the OAR Advisory Council, and extramural scientists across the United States, approximately ten percent of the NIH budget is spent on AIDS research. About half of the AIDS research program is designed and carried out by the lead institute – the National Institute of Allergy and Infectious Diseases (NIAID). The other half is spread across the NIH's other institutes and centers (ICs) which apply their scientific expertise and experience to this cross-cutting research area, because AIDS affects nearly every organ, every stage of life, and requires every scientific tool.

OAR provides NIH with the structure it needs to coordinate its AIDS programs.

As both Dr. Zerhouni and NIAID Director Anthony S. Fauci has stated on many recent occasions, the oversight and assistance of the OAR have been essential in helping to focus and prioritize newly increased support for HIV vaccine development in a time of constrained budgetary increases at NIH and in many other areas.

The Office of AIDS Research (OAR) was created by act of Congress in 1988 and strengthened in 1993 as a response to this growing emergency. As Dr. Zerhouni noted in his testimony to your Committee, the OAR has been a very successful model of trans-NIH planning, budgeting and evaluation. The HIV/AIDS crisis continues to be a worldwide emergency and will remain so for the foreseeable future – not least, until a safe and effective preventive vaccine is tested, proved effective, approved, distributed, and disseminated to people at risk for HIV infection around the world. Most experts, including NIAID Director Anthony S. Fauci, do not expect such a vaccine to be discovered, developed, and deployed for another decade at least. Therefore it is a matter of considerable urgency to preserve the existing authorities and powers of the Office of AIDS Research (OAR) within a strengthened NIH Office of the Director (OD).

After the 1993 Act, the OAR, under its first two directors, Dr. William E. Paul, and Dr. Neal Nathanson – one a renowned immunologist, the second a highly-regarded virologist – convened external groups of scientists to review the budget and provide input into priorities. The OAR Advisory Council (OARAC) commissioned the pivotal 1996 report of the AIDS Research Program Evaluation Working Group (the Levine Committee), whose recommendations led to the prioritization of vaccine science, the formation of the Vaccine Research Center (VRC), and whose review of the NIH-wide program led to the elimination of duplicative programs and new resources where more science was needed. In the first decade of OAR's enhanced powers, because of basic and clinical research sponsored by NIH, perinatally-acquired HIV virtually ceased to exist in the United States, and the AIDS death rate nationwide dropped by two-thirds due to the introduction of new, potent, triple combination therapies, used together with new viral load and resistance testing technologies. NIH also sponsored pivotal research which led to reductions in perinatal HIV in developing countries.

However, these gains were achieved in a period of healthy budget growth at NIH. A rising tide lifts all boats. Difficult decisions could sometimes be postponed because all programs were growing. Now, facing flat budgets, the need for a strong OAR to coordinate AIDS research across the NIH is even greater. Researchers face the unyielding stubbornness of the virus which refuses to give up clues to making an effective vaccine or a cure. Treatment complications of life-long combination therapy must be studied and therapies developed. Children once likely to die of perinatally-acquired HIV are now growing up, and must be followed for life to determine the effects of early antiretroviral therapy on their growth and health. And prevention and treatment science must move massively to developed world, where scale-up of HIV/AIDS prevention and treatment is taking place at unprecedented levels, through PEPFAR and other programs. Research will be critical here to define better interventions for use in resource-poor settings.

AIDS demands, and OAR draws in, expertise and experience, from across the biomedical and behavioral sciences, from child health to aging, genome science to mental health and drug abuse, bioinformatics to epidemiology, virology to immunology, infectious diseases to cancer. The framers of the 1993 bill recognized that creating a single AIDS 'institute', or housing the AIDS program entirely within an existing one such as NIAID, would be detrimental to the quest for better treatments, better preventive interventions – many of which hinge upon human behavior, which is difficult to study, let alone to change – a cure and a vaccine. The need for cross-cutting oversight and coordination of the now vast NIH AIDS research portfolio is even greater in the new century.

A strong OAR with a direct reporting line to the NIH Director is essential.

In brief, we recommend that the legislation clarify that the OAR will continue to report directly to the NIH Director, and explicitly state that the OAR will maintain its existing authorities to plan, coordinate, budget, and evaluate the NIH AIDS research program across all institutes and centers (ICs). Vital to the OAR's effectiveness are its budget authorities, including the annual strategic plan linked with the trans-NIH AIDS research budget, the ability to reallocate funds across ICs, and the emergency discretionary fund. Also essential is the OAR's Congressionally mandated Advisory Council and the trans-NIH AIDS coordinating committees. These authorities were established in Title XVIII of the NIH Revitalization Act of 1993. We believe they should be explicitly preserved in the 2005 Reauthorization legislation.

Our more detailed comments on the draft legislation are below.

Sec. 2. Organization of NIH - (d) Division of Program Coordination, Planning, and Strategic Initiatives [p.4]

We firmly believe that the direct reporting line of the OAR to the NIH Director must be preserved. Therefore, we suggest that the DPCPSI be created as a strategic planning office within the NIH Office of the Director (OD), parallel to the existing Offices rather than with the Offices reporting to them. This would give the NIH Director a strategic planning staff without interposing an extra layer of bureaucracy between OAR (and other necessary Offices) and the Director.

(2) Reorganization of Institutes and Centers.- [p.5]

We recognize that previous and current NIH Directors Varmus and Zerhouni have raised valid issues about the proliferation of NIH institutes and centers without a co-ordinated strategic plan or structure. Indeed, the very existence of successful Offices such as the Office of AIDS Research (OAR) within the Office of the Director (OD) represent an effort to address the need for planning, coordination, and evaluation of trans-NIH activities. At the same time, too-hasty or too-drastic reorganization could impose costly delays in life-saving research programs. Too much centralization can hinder scientific creativity, flexibility, and freedom.

The draft legislation, in our view, overcompensates for the current somewhat balkanized and fragmented NIH structure with an excessively centralized one. We support vesting the NIH Director with new authorities to streamline and coordinate cross-cutting NIH research programs across existing institutional lines, within defined parameters and through an open, transparent, and public process after full participation of all affected stakeholders in publicly funded research.

However, we are very concerned that the current draft legislation leaves far too much to the arbitrary discretion of a single political appointee of the President. The current NIH Director has been a strong defender of the autonomy of peer-reviewed science. We cannot be sure, however, that providing all future Directors with such sweeping authority to add, remove, and transfer institute responsibilities without a more public process might not lead to much more dangerous levels of politicization of science.

We would suggest modifying the current legislative language to require the NIH Director to submit a reorganization plan to Congress in time for the next reauthorization, after public input, including testimony from professional societies, researchers, clinicians, health care providers, patient advocacy groups, and other interested parties.

(e) Organization-(3) Reorganization of Office of Director. [p.7]

Because of the continuing emergency nature of the AIDS pandemic, as noted above, and the continuing key leadership role NIH plays in coordinating a comprehensive research response which is the lead agency and driving force in global AIDS research, also noted above, we oppose giving the NIH Director the authority to abolish the Office of AIDS Research or to weaken its powers. Therefore, the legislation should specify that the OAR may not be abolished, nor its authorities diminished, without Congressional authorization.

Sec. 3. Authority of Director of NIH. (a) In general - (7) (A)
[regarding research involving responsibilities of more than one IC]; (7) (B) [regarding allocating funds to IC's for such research] [p.12]

Currently the OAR has these cross-cutting responsibilities for AIDS and AIDS-related research across the NIH. Because the OAR needs to keep these responsibilities for the foreseeable future, we oppose transferring them either laterally or upwardly (depending on where the Division of Program Coordination, Planning, and Strategic Initiatives is housed) to the DPCPSI.

We do support vesting such authorities for non-AIDS-related research in the NIH Office of the Director, but not, however, in a way which would weaken the OAR, which has demonstrated its success in the past 12 years, as Dr. Zerhouni himself testified, nor by centralizing arbitrary, excessive, unaccountable power in the Office of the Director.

Sec. 402A. Authorization of Appropriations.

a. In General.-(1) for the OD, NIH; (2) for the DPCPSI; (3) for the mission-specific IC's; (4) for the science-enabling IC's. [p. 15]

Since the structure and authority of the DPCPSI and its relation to current offices are not fully defined in the draft legislation, and since we support the preservation of the Office of AIDS Research's current authorities, including budget authorities, we are uncomfortable with reducing the NIH budget to four line items, with so much of the program- and disease- or research area-specific detail left to the discretion of the NIH Director and the DPCPSI; however

b. Transfer of Funds. [p.16]

We support granting the NIH Director the authority to transfer not more than 5% of the NIH budget across IC lines in accordance with sound, scientifically-driven trans-NIH strategic priorities. This power of the Director with respect to AIDS research should continue to be delegated to and exercised by the Director of the Office of AIDS Research in accordance with title XVIII in the 1993 NIH Revitalization Act.

Sec. 5 Reports.

Sec. 402B. Electronic coding of grants and activities. [p.21]

We strongly support an improved NIH-wide grants and projects management database with uniform coding and full public access. In this area, again, the OAR has set a good paradigm with its AIDS Research Information System (ARIS) database, which tracks all AIDS-related grants across the NIH. We support this provision of the legislation.

Sec. 403. Biennial reports of Director of NIH. [p.23]

We are concerned that the list of research activities in the Director's Biennial report to Congress in (5) is arbitrary and does not include, for example:

• Infectious diseases, including HIV/AIDS, tuberculosis, malaria, hepatitis viruses, emerging pathogens, biodefense research. Research on most of these diseases is carried out across many institutes;
• Behavioral, social sciences, and prevention research, which are also cross-cutting NIH research areas with broad and vital implications for public health.

The final legislation should specify that both of these categories must be included in the Director's biennial report to Congress.

Strong, independent, scientifically-expert peer review remains essential.

We do not see a house for the Center for Scientific Review (CSR) in the Committee's draft legislation. We want to ensure that the legislation preserves the role of strong, independent, expert scientific peer review as the basis for NIH funding decisions, and hope that subsequent drafts will clarify the role of the CSR.

We hope that you will consider these concerns as you move forward to create legislation preparing NIH to retain its vital role as the driving engine of U.S. biomedical and behavioral research and strengthening it to meet the new challenges and opportunities of science for public health in the twenty-first century, and look forward to working with you and the members of your Committee to craft language which helps to streamline and coordinate research without weakening the essential authorities of the Office of AIDS Research (OAR).

Yours truly,

Mark Harrington
Executive Director
Treatment Action Group

cc: Committee on Energy and Commerce, U.S. House of Representatives
Committee on Health, Education, Labor & Pensions, U.S. Senate
Mike Leavitt, Secretary, Department of Health & Human Services
Christopher H. Bates, Acting Director, Office of HIV/AIDS Policy, DHHS
Dr. Elias A. Zerhouni, Director, National Institutes of Health (NIH)
Dr. Jack Whitescarver, Director, Office of AIDS Research (OAR)
Dr. Anthony S. Fauci, Director, National Institute of Allergy & Infectious Diseases (NIAID), NIH
Federal AIDS Policy Partnership
Research Working Group