– A Statement by Gregg Gonsalves, Policy Director of the Treatment Action Group, on the Vaccines for the New Millennium Act of 2000 –

Everyone wants an AIDS vaccine. With the staggering numbers of HIV infections around the globe and the prohibitive cost and limited effectiveness of current antiretroviral therapy, the only way to stem the tide of the epidemic will be to develop a safe and effective vaccine to protect the uninfected from HIV transmission. As advocates for people with HIV infection and with many of us at the Treatment Action Group (TAG) living with the disease ourselves, we are acutely aware of the devastation that AIDS can bring to individuals and their families.

That being said, TAG believes that the major obstacles to AIDS vaccine development are scientific. Developing a vaccine that will provide sterilizing immunity, blocking HIV infection, is a long way off. Figuring out how to induce relevant strong, long-lasting, cross-reactive, neutralizing antibody, cytotoxic and helper lymphocyte responses is the primary hurdle in our search. We will only be able to surmount this obstacle by a vigorous investment in both basic and clinical research on AIDS vaccines and related areas (e.g. human immunology) at the National Institutes of Health (NIH) and by the pharmaceutical and biotechnology industries.

Because we believe that the rate limiting factor in AIDS vaccine development is scientific, it is not clear to us that a legislative initiative will bring us closer to our collective goal. However, because of the urgency of the epidemic, we are willing to support reasonable proposals that might spur research and development efforts on AIDS vaccines. To that end, TAG supports some provisions in the Vaccines for the New Millennium Act of 2000 and opposes others features of the bills recently introduced by Senators John Kerry (D-Mass.) and Bill Frist (R-Tenn.) and Rep. Nancy Pelosi (D-Ca.).

We fully support the establishment of a vaccine purchase fund and negotiations to initiate a multilateral vaccine purchase fund as well. The success of any effective immunization campaign for AIDS or any other infectious disease depends on the ability of a vaccine to be purchased and distributed in an expeditious fashion. Authorizing the appropriation of funds for this purpose once a vaccine is proven safe and efficacious is sound public policy. The vaccine purchase fund may also function as an incentive to the pharmaceutical and biotechnology companies that may have concerns about the potential market for their agents.

While we have reservations about the merits of a broad tax credit for research and development on vaccines and microbicides, the current tax credit proposal in the bill offers a credit only on new investments in research by companies or their investors and we can support it. Wisely, the framers of the legislation have included a mandate for a review of the success of this tax credit by the Secretary of the Treasury within four years of the enactment of the bill. If there is no evidence that the tax credit has spurred new research and development into vaccines and microbicides for serious diseases after this time, the credit should be repealed.

We do not support the establishment of yet another vaccine advisory commission as outlined in the bill. There are several national and international bodies that perform the deliberative functions that are described in the legislation. If there are specific needs to be addressed regarding vaccine research and development, we believe these institutions can craft processes to investigate these issues. We have had specific experience with a similar national commission, the National Task Force on AIDS Drug Development, in the 1990s. While the intentions behind the establishment of the task force were noble, the group did little to advance the development of antiretroviral drugs and was disbanded.

We are particularly opposed to the provisions in the bill which authorize a direct Congressional appropriation of 10-20 million dollars to the International AIDS Vaccine Initiative (IAVI). While we strongly support its work, we believe a direct appropriation for vaccine research to IAVI is unnecessary and potentially counter-productive. The budget for AIDS vaccine research at the NIH has risen substantially in the past few years. While we support continued increases in vaccine funding at the NIH, we do not support the establishment of a new federal funding stream for biomedical research outside of the NIH and other federal agencies charged with this task. We think it is duplicative and sets a bad precedent for funding for other areas of research whose advocates might seek similar authorizations which we believe could eventually undermine the work of the NIH. We also believe that funding for non-governmental organizations of any kind should be administered through a competitive, peer-reviewed process and not through a direct Congressional appropriation.

The road to a safe and effective AIDS vaccine is going to be a long one. As advocates, we should do our best to expedite the progress of research and development in this field. However, we should never use the urgency of our task as an excuse for bad public policy. The best provisions of the Vaccines for the New Millennium Act of 2000 are reasonable and practical solutions to the problems facing vaccine and microbicide development. They are initiatives we all can support.