PERSPECTIVE ON AIDS RESEARCH : Without Incentives, We’ll See No Cure : Unlocking this virus’ secret requires massive biotech investment, which the new Clinton proposal discourages.
In establishing an AIDS drug task force last week, the White House stressed the importance of getting drug companies, the National Institutes of Health, activist groups and others to cooperate in developing an effective AIDS drug. Cooperation is cheap and laudable. But the research needed to develop a breakthrough AIDS drug is risky and expensive--just the qualities that a White House plan to control the price of new drugs will discourage.
The White House insists that the only thing lacking is coordination. But substantial cooperation already exists among government, academic scientists, pharmaceutical firms and biotechnology companies. The NIH and private companies fund academic research. There are 19 antiviral drugs in clinical trials, with many others in development. Several of these involve joint ventures by drug companies, universities and biotech firms.
So lack of cooperation is hardly a barrier to a cure. The real problem is that we simply do not know enough about how the human immunodeficiency virus behaves to tame it or kill it. It is lack of certainty, not lack of purpose, that is absent in AIDS research. Every new compound or discovery is rushed into trials. While these discoveries work in the lab, they fail in the field.
The recent Berlin conference on AIDS research was a watershed for researchers and activists alike because so many of these failures were reported at the same time. The Treatment Action Group, an AIDS organization, issued a report at the Berlin meeting stating, “Even our best attempts to grease the wheels of clinical (AIDS) research . . . will draw us no closer to a cure unless we make significant advances in our basic knowledge of its pathogenesis.”
Similarly, Dr. Anthony Fauci, head of the U.S. National Institutes of Allergy and Infectious Disease, noted that “the mechanisms underlying HIV infection are not unidimensional but, rather, extremely complex.” He urged the research community to examine a number of different therapeutic approaches, including treatments that combine antiviral drugs with vaccines that stimulate an immune response.
Instead of promising faster action on antiviral drugs, the task force should encourage more basic research and the sort of multidimensional therapeutic intervention envisioned by Fauci and AIDS activists. Government labs can’t do it alone. Biotechnology and pharmaceutical firms will have to continue to invest in AIDS research over the next decade. The cost of such research will run into the billions, and most of the clinical trials will fail.
Investors must be encouraged with more than rhetoric to risk capital on the quest for an AIDS drug to meet the task-force goal.
The problem is, President Clinton’s proposal to control new-drug prices has caused a decline in biotech investment. Recently, a White House official said he doubted that the proposal was affecting research. “I just can’t imagine that people are relying on this provision to decide whether to invest money,” he said. But as Groucho Marx once said, “Who do you believe, me or your eyes?” Fear of price controls has contributed to the 60% decline in capital raised for biotechnology firms since 1992.
Investment in biotechnology has been likened to playing the lottery; the whole industry will be set back by the Clinton proposals. But AIDS research is one of the biggest gambles of them all. Even now, only a handful of biotech firms invest in AIDS treatment research. Price controls on new drugs would limit returns on investment at a time when such research has never been riskier. The effects are already being felt.
A survey of biotechnology firms doing AIDS research found that 19 out of 30 companies responding were planning to curtail or delay the development of AIDS drugs due to funding constraints. Sixteen of the companies blamed their cash shortage on the fact that the Clinton plan would impose limits on new-drug prices and reduce return on investment.
Research that can expand the understanding of the HIV disease is already being derailed. Isis Pharmaceuticals has stopped development of AIDS drugs that inhibit production of the HIV proteins in favor of less risky products. Viagene, a leader in research on HIV vaccines, has curtailed clinical trials for lack of funding. Tanox Biosystems has stopped trials of antibodies designed to halt HIV infection in infants.
The Clinton Administration is faced with a profound contradiction: It is pledging to increase the number of AIDS drugs in development while advocating policies that discourage investment in AIDS research. Maybe the first order of business for the task force should be to clarify this contradiction for the President.