PI Perspective #14

June 1994     View PDF

The “AIDS Cure Act” - Science or Politics?

In May, H.R. 3310, “The AIDS Cure Act”, was introduced in Congress by Congressman Jerrold Nadler of New York. Also known as “The Barbara McClintock Project”, this bill calls for the creation of an expansive new program of AIDS research, something of a “Manhattan Project” on AIDS. Since many groups, including Project Inform, have been calling for a “Second Front” on AIDS—effective reforms and new AIDS research initiatives—it’s important to read the fine print. Not all proposals are alike and though well intended, not all are likely to speed the search for a cure. Many people have asked whether Project Inform supports this particular bill, and some wonder whether it is the same thing as the “Second Front” that we have called for and written about in previous publications. Project Inform supports the general concept of taking bold new initiatives in AIDS Research, and applaud Congressman Nadler for sticking his neck out on behalf of people with AIDS. Overall, however, Project Inform cannot support this bill in its present form, for the reasons described in this article.

First, there are several insightful suggestions in the “AIDS Cure Act” which are consistent with views expressed by several groups, including Project Inform. These areas of common interest include:

• Initiation of an intensified program of AIDS research. It is both scientifically and politically important in the current climate to make a “fresh start” on AIDS, to announce and implement a reinvigorated and more aggressive program.
• A focus on clarifying the pathogenesis of AIDS. While a great deal has been learned about HIV, less is known about how it causes damage. There are many competing theories of how the virus causes disease, but there does not appear to be a clear federal program for prioritizing and testing these theories. Until HIV pathogenesis is better understood, the element of chance will continue to play an unduly large role in the development of new therapies.
• A call for greater collaboration among scientists. AIDS research presently operates on an essentially competitive, rather than collaborative model. This model is mostly a reflection of 19th century traditions of science. It is not a model designed to produce the fastest or best results. The synergistic effects of teamwork, goal orientation, strategic planning, efficiency and quality assurance are the hallmarks of modern management practices in almost every other field of endeavor, but not in federally funded biomedical research.
• A call for scientists to work in a more scientifically focused environment. Today, it is all too common for AIDS researchers to serve many masters competing for their time and attention. Teaching duties, writing grants, university faculty responsibilities, consulting contracts and professional and political roles all impinge upon the time of many researchers, often to the detriment of their focus on AIDS.
• A call for a greater emphasis on project management. Much time and effort is lost in AIDS research because of the entangling web of bureaucratic and regulatory requirements. Giving a management team the authority to cut or streamline nonproductive government requirements would indeed be helpful.

While these areas of interest make sense to most people, several other aspects of the “AIDS Cure Act” are troubling and, we believe, run the risk of hindering rather than speeding progress. These areas of concern include:

• The call for a sweeping, new, all encompassing program which will run alongside, but not replace, existing programs. By definition, this implies a massive duplication of effort. The vast majority of work likely to occur under the proposed program is work that is already being done, perhaps in a different fashion, under existing programs. Since the majority of scientists interested in AIDS are already working in the existing system, it is difficult to understand where the personnel for the new project would come from. It is unclear how or why Congress could be motivated to fund a second massive program while maintaining support for duplicative parallel research. Similarly, it is unclear how such duplication of effort would demonstrate efficiency in facilitating research into new areas.
• An undue concentration on ideological issues. The “AIDS Cure Act” is excessively concerned with the exploration of “alternate” theories of the cause of AIDS. While better structures to support the development of complementary and alternative approaches to therapy are needed, alternative theories of AIDS are quite another matter. At this stage of the epidemic, all theories are not equally worthy of support or funding, nor should their study be politically mandated. There is sufficient opportunity within the existing scientific peer-review process for the testing of compelling new pathogenesis theories. Where such approaches have failed to achieve respected status, it has almost invariably been because they have failed to prove themselves in both human and laboratory experience.
• An insistence upon centralization of decision-making and a primary work location. When centralization was demanded in the original Manhattan Project, its primary purpose was driven by security needs of the top secret project. There may be benefits of working in close physical proximity, but they must be weighed against the enormous costs of uprooting hundreds of scientists, their families and their labs, as well as the time lost to relocation. While centralized information exchange, communications and management make sense, the principal effect of centralized labor would be a powerful disincentive for the best qualified scientists to participate.
• An insistence that participating scientists sever all other ties. Securing an increased amount of a scientists’ attention is a good thing, as is gaining assurance that conflict of interest will not bias their work. But forcing researchers to literally “marry” a project for its duration would be counterproductive. Scientists should not be forced to pay a large personal and professional price to participate and contribute to AIDS research. As conceived, the proposed project would expect scientists to abandon professional objectives, such as career-long university posts. Few are likely to be interested. Similarly, they would be asked to sever all industry consulting relationships. In the current system, such relationships are key to the flow of technology and thinking between government, academia and private industry. There are better and less destructive ways of handling concerns about conflict of interest.
• An insistence on majority control of the program by people with AIDS and their advocates. It is well-established that scientific programs benefit when the voices of people with AIDS and their advocates are heard. This is a long way from saying that majority control of programs should be left to the lay public, however well informed the public may be. Scientific programs should be primarily directed by properly trained scientists, with appropriate input from people living with HIV/AIDS and their advocates. Most importantly, the control issue should be discussed openly and not determined by language buried in the middle of complex legislation.
• An emphasis on force rather than incentives. The project talks of the use of eminent domain as means of seizing patents and products. An approach which favors incentives, rather than force, would be more likely to enhance cooperation, while avoiding the inevitable and crippling litigation that seizures would invite.
• A general misunderstanding of how drugs are developed. As proposed, the project model seems to place responsibility for drug development in the hands of government. Neither government nor academia has the capability or resources for doing major drug development work. The vast bulk of this work is done in private industry. The implied creation of new publicly owned resources and facilities for drug development purposes would be an enormous waste of taxpayer money, and any effort to seize existing resources would surely result in litigation. However, reforms which enable government to quickly fill gaps in drug development could well prove beneficial. Instead of creating an atmosphere which is hostile to industry, AIDS research would be best served if government learned to work more effectively with industry, letting each party do what they are best equipped to do. Rather than trying to subsume industry’s role, government should avoid creating obstacles to industry and encourage concentration on AIDS drug development.

Whatever Project Inform’s views, the “AIDS Cure Act” seems unlikely, in its present form, to receive the needed support of Congress or the scientific community. It seems likely that many individuals and organizations signed on to the bill as a statement, in general, in support of a reinvigorated new effort or “Second Front” in AIDS research. Project Inform also believes in the wisdom of a new approach, a “Second Front”, but not in all the specific aspects of the “AIDS Cure Act”. Any new initiative should be considered a pilot program, an effort to test new organizational and management approaches before any major step is taken to overturn current models. Even though such improved management models have worked well in other fields of scientific endeavor, they have not previously been employed in a federally funded biomedical research program. Any such new program should focus initially on a single aspect of AIDS research, ideally one where there is a crying need and opportunity for advances. The “Accelerated AIDS Research Initiative”, an outgrowth of last year’s Future Directions in AIDS Research meetings, is a draft model for such a project, one which provides most of the meaningful benefits, and none of the more controversial aspects, of the AIDS Cure Project. Copies of the proposal, a summary of which appeared in the most recent Project Inform Briefing Paper, are available from Project Inform upon request by calling the Project Inform treatment hotline at 800-822-7422, or in San Francisco 415-558-9051.

D4T: Accelerated Approval

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