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October / November 2010
From Mice Into Men
by Regan Hofmann with Tim Horn
Thankfully, the biotech and pharmaceutical industries stand to see a very healthy return on AIDS cure investments. In other words, finally, a cure may prove more profitable for them than a world of people on ARVs for the rest of their lives. And governments and insurance companies, which also bear the brunt of paying for HIV treatment, have a vested interest in heralding in a cure. One challenge is that the system itself is not set up to facilitate a cure for HIV. The same organizations (NIH) that fund basic biomedical research have no financial incentive to get a possible therapy to market. They are paid to discover the basic science, not develop it. And groups such as venture capital investment firms and pharmaceutical companies that could financially benefit from such development are shying away from investing in AIDS cure research, partly, because it has proved so expensive and challenging. One hope is that the epiphany that the global market for ARVs may not always prove lucrative may drive venture cap and pharmaceutical companies to get some skin in the cure game.
It is not sufficient to say, “Whoever finds the cure for AIDS will be rich.” Unless we spend enough money on the search, not enough people will look, and we will be less likely to find it. It takes a lot of money to look. And it takes a lot of money to get basic scientific discoveries translated into potential therapies that are ready to enter clinical trials and, if all goes well, get FDA approval. Consider this: The cost of researching and developing a single drug, from molecular discovery to pharmacy shelves, has been estimated as between $500 million and $2 billion—and that’s using the dollar value from a decade ago.
The AIDS Policy Project’s executive director Kate Krauss sums it up best: “We have a chance to dismantle this pandemic. What we do now as activists could determine whether the AIDS pandemic lasts another seven years—or 30—and who will outlive it. We need nine times more money than we have right now for scientists to pursue genuinely original ideas. We need to build a pipeline to test in people not just one or two treatments but a steady and growing list of potentially curative therapies. A workable cure may involve more than one approach, so collaboration—virologist-immunologist, Parisian-New Yorker—is critical. Researchers collaborate in real time in multiple sclerosis research, why not also with AIDS? New funding has to reward new ideas and real teamwork. Is the scientific world ready to promote and encourage another Gero Hütter? Not yet. But it should be. This [moment] is a rare opportunity for philanthropists to step up and do something pivotal in the history of the AIDS pandemic.”
In addition to awareness, advocacy, cash and scientific breakthroughs, we need to revolutionize the way we conduct AIDS research if we’re going to find the cure.
To create a bigger, bolder, more diverse pipeline, we need to put as many promising options for the cure into pilot studies within the next two years as possible. The days of five-year, three-country, 5,000-patient studies should be numbered. As long as we can establish legitimate baselines of safety, we should be able to forge ahead faster and more nimbly to get the answers millions desperately need. Let’s see some five-month, five-people trials. Researchers can no longer toil alone in their ivory towers, holding their ideas and discoveries close to their chests. We need to encourage openness and collaboration. We need to give people incentives to work together. And we need to share learning between groups along the way, not just when all is said and done—and published in medical journals. What about a centralized database of cure research projects, perhaps one that could allow researchers to share findings—and best practices—ideally mid-study?
We need to lure new talent from other areas of biomedical research (remember, the first man to perhaps technically cure AIDS was neither a virologist nor an immunologist). We need long-term, stable and flexible approaches to funding to allow scientists to focus on doing research, not applying for grants.
We need to better track AIDS research around the world, across our nation and within the NIH. The AIDS Policy Project identified that the NIH had trouble tracking AIDS cure research, in part, because it had no code to do so. It does now. It has been suggested that advocacy efforts include appealing to the Office of AIDS Research, led by Jack Whitescarver, PhD, at the NIH, to better follow the arc of AIDS cure research and that an annual report should be issued highlighting progress toward a cure.
We need the United States’ National HIV/AIDS Strategy to more clearly spell out a plan for AIDS cure research. And to encourage its stewards to ensure that that happens. We need to educate members of the U.S. House of Representatives and the Senate about AIDS cure research so they will fund it properly.
Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), a division of the NIH, recently announced a NIAID research grant named in honor of legendary treatment activist Martin Delaney. The grant allocates $8.5 million a year for five years to search for a functional cure. Sean Strub, POZ’s founder, said in response to the grant, “If Pharma [sic], the public health establishment and AIDS service organizations lobbied for funding for cure research the way they lobby (directly and indirectly) for ‘routinizing’ testing, PrEP, ‘Test and Treat,’ etc., this would be $8.5 billion rather than $8.5 million. “
Referencing the power of lobbyists for AIDS vaccine research, Françoise Barré-Sinoussi (who codiscovered HIV) said, “There is no equivalent for research into remission or [a] functional cure [for AIDS].” Barré-Sinoussi, who will head the International AIDS Society beginning in 2012, led a two-day workshop on the cure just before the IAC in Vienna.
Thanks to pressure from advocates like the folks at the AIDS Policy Project and others, the tide may be beginning to turn. On August 31, Carl Dieffenbach, PhD, director of AIDS at NIAID, announced in a conference call with activists that “AIDS cure research” would be one of the top four NIH priorities next year. It is up to us to keep the heat on that promise.
Accelerating the cure for AIDS will require more attention; more money; more, and new kinds of research; greater determination—and people living with HIV who are willing to enroll in pilot studies. Because while mice are nice, the fastest way to get to an actionable cure for AIDS is to test potential therapies, when proven safe, as quickly as possible in people living with the virus.
Of all the things we need to do to hasten the end of AIDS, we need to not be afraid to dream of the cure and to say it out loud. Because when it comes to the cure for AIDS, we’ve already seen that it doesn’t pay to be quiet as a mouse.
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