The Agenda Ahead
TAG Policy Director and Recent McArthur Fellow Warns Against Premature Declarations of Victory
Mark Harrington, propelled further into the limelight by his recent selection as a recipient of a McArthur ‘genius’ award, has been out on the lecture circuit of late. And as he tours the country he bears the burden of negotiating that ever so delicate balance between celebration and caution. Celebration over the treatment advances of the past two years; caution about the pitfalls that lie ahead and of the danger in claiming victory prematurely. Following are excerpts from his remarks.
As we enter 1998, it is timely to consider the unfinished business of AIDS activism. We have much to celebrate. Just 18 months ago, quite suddenly, HIV became a treatable disease. This treatment revolution has bought us a precious window of opportunity. But it would be a grave mistake to believe -- as some in the media would have us believe -- that the AIDS epidemic is anywhere near over.
Around the country -- and elsewhere in the world -- where people have access to the latest combination therapies, laboratory monitoring and treatment information, we have seen dramatic and continuing declines in AIDS-related opportunistic infections and deaths. But it would be a mistake to conclude -- as some have -- that the AIDS epidemic is over.
The Challenges of Antiretroviral Therapy: Resistance, Adherence, Access
We cannot afford to succumb to the premature belief that AIDS is under control. It it not. Our most difficult work lies ahead. We must begin planning immediately for the likelihood that the new treatment advances will be only temporary. Already, a full one quarter of the patients in David Ho's triple combo therapy study have had their virus rebound -- at least temporarily -- from "undetectable" levels. Protease combination therapy is not a panacea -- and becoming "undetectable" is no guarantee of staying that way.
It is becoming clear that once resistance develops to any single protease inhibitor, the chances of having an optimal response to any subsequent protease inhibitor are seriously diminished. The same problem appears likely to apply to the non-nucleoside reverse transcriptase inhibitors (NNRTIs): nevirapine, delavirdine and efavirenz (formerly known as DMP-266). The problem of cross-resistance is also turning out to greatly limit the efficacy of the new nucleoside analogue agent abacavir (formerly known as 1592U89). Thus, for the large and growing population of individuals failing on triple combination antiretroviral therapy, therapeutic options appear limited despite the likely approval -- or, at least, much broader availability -- of such new drugs in 1998 as abacavir, adefovir, efavirenz and amprenavir.
There is a very real danger that many people who don't need it yet or aren't ready for it will be put on treatment prematurely. While the dogma of "Hit hard" has clearly been proved, the "Hit early" part still begs the question: How early? The recent HHS treatment guidelines only evade the question by recommending that "treatment be offered" and that "the strength of the recommendation depends on the likelihood of progression as assessed by viral load and CD4 count." Furthermore, no clinical trials are yet planned to address this critical public health question. So we may never know the right time to start antiretroviral therapy in healthy asymptomatics.
Linked to this uncertainty is the increasing importance of strategies to enhance adherence to complex medical regimens by individuals on combination antiretroviral therapy. Since it still appears that HIV infection is likely to be lifelong, so will be treatment -- once it is irrevocably begun. Yet past experience with adherence even over short periods of time -- such as in combination treatment for TB or for organ transplant rejection -- is mixed at best.
If people aren't given the information and support they need to use the drugs properly, and if the drugs fail, the patients might be blamed. The only solution to this dilemma is more research, more treatment education programs for patients and physicians, and more money for health care. Yet treatment education programs remain tiny and inadequate within most AIDS service organizations, which were founded and grew in a very difference environment -- when AIDS programs focused either on primary prevention or on end-stage services and care.
We are also beginning to experience a crisis of solidarity within the AIDS community. For those with access to health care, treatment and information, AIDS can sometimes be managed. For many others, these interventions are not accessible. Our country is going through one of its periodic reactionary fits where life-saving services are denied to poor people (and recent immigrants), who are blamed for their plight. If we really care about ending AIDS, we must tackle the national health care crisis.
The Plight of AIDS Prevention
A safe and effective AIDS vaccine is still years -- or decades -- away. In the meantime, we must continue to relay on two cheap, low-tech approaches which have already saved more lives than antiviral therapy: the latex condom and the clean needle. Our government still refuses to fund these programs, and as a result, thousands of citizens become infected unnecessarily each year.
A dangerous idea which began circulating last year is the fantasy that triple drug therapy is a valid "morning after pill" for potential HIV exposure. This is a dangerous high-tech pipe dream for which no supporting data exist. It's a lot easier to use a 50 cent condom every time you have sex than to get infected and start taking a $20,000 a year "morning after" regimen for the rest of your life. The drug companies would love it, and we should fight it! Condoms may not be fun, but they are a lot more fun than triple combo therapy! And cheaper too.
Streamlining AIDS Research
Research advocates will have their hands full this year keeping the 1.5 billion dollar AIDS research effort sponsored by the National Institutes of Health (NIH) on track. After four valiant years at the helm, former Office of AIDS Research (OAR) director William E. Paul has returned to the laboratory to dedicate himself to the quest for an AIDS vaccine. While Dr. Paul built a strong foundation and helped restructure and streamline the previously fragmented NIH AIDS research effort, much work remains to be done. NIH still runs twelve inefficient, overlapping clinical trials networks to study new drugs for AIDS. The vaccine discovery effort needs the continuing supervision of Nobel Prize laureate David Baltimore and the AIDS Vaccine Research Committee -- and the promised opening of the new AIDS Vaccine Laboratory in 2000. The search for a new OAR director will take up the first half of the year, and it is critical that NIH not lose momentum in implementing the sweeping reforms recommended by the Levine Committee in 1996.
The NIH is also due for Congressional reauthorization in 1998, and the provisions empowering the OAR to oversee the AIDS research effort must be renewed if OAR is to continue as a strong central coordinating point for the 24 byzantine NIH institutes which conduct AIDS research. Moreover, the AIDS research budget remains under attack by some disease constituencies who feel it is more productive to attack the successes of AIDS research advocates rather than struggle alongside them -- and other disease groups -- to increase the entire NIH budget. Luckily, it appears that in 1998 there is bipartisan support in Congress for increasing the NIH budget by as much as 15% per year, which would double the overall bio-medical research budget by the year 2003!
AIDS As a Global Problem
Finally, we must remember that AIDS is a global problem. Last year, 1.5 million people died of AIDS. By the 2000 it will surpass malaria and tuberculosis as the leading infectious cause of death worldwide. The U.S. funds 85% of the world's AIDS research. It is up to us to ensure that the fruits of that research are not limited to only those who dwell within the fifty states.