Awards of Courage
Honoring with Pride 2001 Honoree
The Founding Director of Project Inform, Martin Delaney is an internationally recognized leader of the movement to accelerate approval of promising HIV/AIDS drugs. He also played a key role in developing accelerated approval regulations and the parallel track system, which facilitate access to experimental drugs prior to formal FDA approval. He helped found the community-based research movement and paved the way for the unprecedented level of HIV treatment information that is available to today's physicians and patients.
Mr. Delaney was presented with amfAR’s “Award of Courage” at the Foundation's Honoring with Pride 2001 benefit in New York and was interviewed following the event. Portions of that interview are excerpted below.
You have been involved in the fight against AIDS right from the beginning. Can you talk about how you first got involved and how Project Inform came about?
In the late 1970s I was disabled with chronic hepatitis B, which eventually caused me to move from Chicago out to the West Coast. I was deteriorating rapidly, and I decided if I couldn't work, that I might as well move out to the beach area—you know, the wonders of California. So I did, and while there, I stumbled into a research program at Stanford University where they were attempting multi-drug combination therapy for hepatitis B. I was one of the lucky ones. It was a double-blind placebo trial, and I got all of the drugs and responded well. In the fifth month of a six-month therapy program, I came out of it and my health started to return. But I then suffered a side effect of the drugs, which left me partially disabled.
During this time period, I was involved in support groups for hepatitis, which gradually evolved into first support groups for AIDS because there was such an overlap of the people—between one infection and the other—which is still a major issue today. And within this group, people began dying of the new disease, as well as from hepatitis. Because they’d seen me recover from hepatitis, there was sort of a pressure from within these support groups that essentially said, "You've been saved to do something." And then I began seeing friends get sick and die of the new disease, and I learned that some of them were going down to Mexico.
As soon as the government announced the cause of the disease and identified candidate drugs for research, two of the three things they were researching were already available over the counter in Mexico. And the third one was compound S, which became AZT, and you couldn't get that anywhere. So I got involved in going down to Mexico and bringing drugs back for friends. And eventually I began to wonder whether this was really helping people, or was it a just a scam, or a waste of money? Or could these drugs actually be hurting people? You have to remember that nobody really knew in those days. So Project Inform was first created to be a community research project into the drugs that people were bringing back from Mexico, and whether they were helping, hurting, or just wasting money.
Unfortunately, this was in 1985, and the community research movement didn't really get off its feet in a formal way for a number of years yet. We quickly found that the medical community wasn't ready to have lay people involved in research, and there wasn't financial support available for it. So while we continued to pursue that objective, we focused on doing what we could in the meantime—and that was initially to provide information. You know, we could at least tell people what was being learned, what was being said, and report on the research. And this was unusual at the time; there were really no other groups focusing on treatment. Most AIDS groups in that era were involved with helping patients die. More than anything else they were supporting them during the process, helping them with their basic needs and helping get their things in order, with meals programs and things. And amfAR was just coming into being to support research, so we sort of took it on ourselves to take on education for people who were HIV-positive, and that very quickly led to advocacy around research and treatment issues, because you couldn't talk about one without bumping into the other. And that's where the mission of Project Inform got hammered out, namely education about treatment of the disease and advocacy around research.
So Project Inform evolved out of a lot of us just trying to do things for our friends and seeing a broader need. At the time, I thought of it as something that was only going to last a short time. You know we called it a "project." We didn't call it an "institution." We never expected to create a nonprofit foundation that would continue for 15 or 20 years. We thought what we were doing would start, stop, and be over with. Obviously that wasn't the case. Each year brought us into bigger and bigger battles, serving larger and larger numbers of people. And what led to the next step in Project Inform’s evolution was in early 1987, when the first reform in FDA procedures was underway—what were called the treatment IND, or investigational new drug, rules. Larry Kramer had heard about what we were doing on the West Coast to help accelerate the drug approval process, and he was appearing on the “Phil Donahue Show”—he and Tom Stoddard of the Lambda Legal Defense Fund—to talk about the work they were doing on HIV/AIDS. And Larry invited me to come do the Donahue show with him, to add another angle to the issue. So I did, and that got him very interested in treatment. And ACT UP was actually born later that same week.
Until this time, Project Inform had been kind of a part-time thing for me. But after being on the Donahue show, I got contacted by “Nightline” to talk about the same issues. And I did, and that really changed my life forever in a lot of ways. The “Nightline” appearance put me up there, debating the commissioner of the Food and Drug Administration, and while that was good for the AIDS movement, it destroyed my business as a consultant, because I worked with companies that often dealt with the government—financial services and high-tech electronic companies. So in that one week my life changed, the direction of activism changed, and my business was pretty much shot. From that point on, Project Inform became my full-time occupation.
What did you and other treatment advocates learn from working alongside FDA and NIH officials to help accelerate the drug approval process, expand access to experimental drugs, and shape the AIDS research agenda?
Well, I think we've certainly learned that there are good reasons for what these agencies do. I mean there's sort of the libertarian view, which says caveat emptor—let the buyer beware. And there's the business view, the Republican view, which might be described as, “Let the marketplace figure this stuff out.” And we don't really agree with either of these positions. We think there is a need for government to play a role in evaluating the effectiveness of therapies and demanding that companies who sell this stuff prove that it works and that it's safe. So I think we learned that there really was an important function for regulation. But at the same time, I think the innovation we brought to the process was to say, "That's fine, but the rules have to be different for a life-threatening illness like AIDS than for medicine in general." I think in many ways that was the key argument that eventually brought the FDA to change and to develop a different set of rules for illnesses that were truly life threatening than would apply to, say, a new pain pill or a drug to prevent hair loss or something like that. So we learned the necessity of regulation, and also how to fix it. We learned that we could really make a difference in government and could change things.
And I think we also learned that government wasn't our enemy. Prior to that time, our view of government's role in AIDS had been dealing with the Reagan Administration, which didn't want to hear about it, didn't want to talk about it. And we tended to brand scientists as part of that, because they were part of the government. But as we began to meet the scientists, we realized that there were a lot of caring, decent people among them who wanted to end the epidemic as much as we did (and who were burying their own friends, too). Frankly a lot of the scientists working on AIDS were gay and lesbian themselves. Certainly not all, but plenty of them were. So we learned that scientists were not automatically bad people and that we had to learn to work with them. We learned a lot from them. Obviously I didn't have scientific training on medical issues, and frankly physicians didn't have any training in dealing with a disease like AIDS either. Nobody did. So we all kind of learned together. We were tutored by the scientists about the scientific issues and the scientific process, and how to think like a scientist. And that made it possible for us to suggest ways to improve that process.
As the demographics of HIV/AIDS in this country have changed, how has Project Inform adapted and transformed itself to suit the needs of different communities?
I think the biggest change for us has been the creation of new departments whose function is outreach into communities that we haven't reached previously. On the one hand, that’s meant bringing in new staff who are more connected to the affected communities. At the same time, there’s been a soul-searching process of trying to figure out where Project Inform fits. And that's been a long process for a lot of people and a lot of agencies. Your first instinct is to say, “Okay, this is what we do. We do education about treatment—now we need to take it to Harlem, or we need to take it to wherever else.” But even though that's the instinctive response, I think we've learned that that's really not what's asked of us, as gay organizations. And I say gay as independent of race, because demographically there have always been a lot of people of color in the gay community affected by HIV.
But we have to remember what worked for the gay community, whether we were white men or black men, and that’s the notion of empowerment— of getting people to take responsibility for their own health, to get educated and get informed. And the reason we were successful at that was because we were seen as members of that community. People listened to us because we came from that community, and with that came the realization that if you're going to repeat that success in primarily African American or Latino communities, it's got to be African American or Latino people that are at the forefront. These populations don't necessarily want to hear from gay white men. They want to hear from people that look like and think like them, or at least have that quality known as “cultural competence.”
So where does an organization like Project Inform fit into that? One way is in hiring members of these communities to become part of Project Inform. And a second is in realizing that we're not always going to be able to be the direct service provider. But what we can do is provide expertise and training to the grassroots organizations. We think it’s critical that grassroots organizations form within those communities—that's how we got empowered. So we think money's got to be there. We shouldn't be competing for grants against grassroots groups in communities of color; we should be supporting them and asking, "How can we assist you, and how can we make sure we don't compete with you for funding?" So a large part of what we do right now is running training programs in communities of color for treatment advocates. We try to train people to replace ourselves, so that they can take the message directly to the communities they represent.
How does Project Inform translate medical and scientific research into practical treatment information that people living with HIV/AIDS can use?
That's a huge challenge, and it's one area where we sometimes disagree with other groups. Obviously, you need to translate material into understandable English that people can comprehend. But it's so critical that in doing so you don't sacrifice accuracy or meaning. And I think that's more difficult than people realize. It's not that difficult to make something understandable, but it's very difficult to make it understandable and exclude the possibility of its being misleading. Simplicity is one thing, but simplicity plus accuracy is a much more difficult challenge. So how do we do that?
We started with addressing a fairly well-educated part of the community, fairly high-level material. But over the years, we've looked at ways to simplify the language. But it always goes through a pretty intensive internal review process that looks at the question, "In the process of simplifying this, are we creating the possibility that it will be misunderstood for cultural reasons, for differences in the way people use language, or the way they hear things?" For example, when we first started developing materials that were going to be widely used in African American communities, we used to use the word “trial” when we were talking about clinical research studies. Finally someone pointed out to us, "When you say 'trial,' we think courtroom. We don't think clinical research center." And it was a kick in the head to us, a reminder that different words have different meanings to different communities, depending on their cultural experience. So obviously it became critical to include people from the communities we were trying to reach as part of the reviewing process. Or else you run the risk of putting out a misleading message without even knowing you're doing it.
Is AIDS activism gaining momentum again now that there are signs of a resurgence of the disease in the U.S., especially among gay men and ethnic minorities?
I think where there's a resurgence of activism is around international issues. But coupled with that is a diminishment of interest on national issues. People don't get it that there still are an awful lot of folks in poorer communities here for whom the problems are very similar to the problems in the developing world, where access to treatment is not a reality and access to care is not a reality. So I think it's a dual response. International activism is growing as public awareness of the pandemic rises. And international work is very sexy right now. It's such a huge problem, you feel good to be working on it.
But I think there's a real danger if you let go of the work here, because for one, we haven't taken care of Harlem yet, we haven't taken care of East Palo Alto or Oakland. There are a lot of places in the U.S. where there's still a huge AIDS problem. And secondly, if we don't continue treatment activism and research activism, we're going to be doing a disservice in the long run to the developing world because the drugs we're sending over there now have the potential for doing harm as well as good. In the short term, they will do more good than harm, but in the long term, if we don't continually improve them, we will have delivered this whole range of side effects and drug problems to places that don't have the infrastructure or medical capacity to deal with them.
People in the U.S. don’t understand that while we've had this great drop in the AIDS death rate, it hasn't been eliminated. And the actual number of times people are going to doctors is up, not down, compared to prior years, largely because of the complex side effects of the drugs being used. So when you translate that to places that don't really have much of a health care structure to begin with, essentially what you're saying is that people are going to be on their own, coping with those side effects. And I think that's a disaster waiting to happen. So we have got to continue to fight for much better treatment here—treatment that will simplify or eliminate side effects—or find other ways of dealing with the disease that don't involve these kinds of problems.
What are the most significant changes you've seen over the past 20 years?
Well, one of the most fundamental changes is in the doctor-patient relationship. This disease has crystallized our understanding that the patient is really in charge of the process—that healing is a partnership between the doctor and the patient, as opposed to something that's dictated by the doctor. You have an empowered patient community that's well informed and wants to, and will be, part of the decision-making process. And that's very different from most diseases. I think the doctors who have gone through that change found it difficult at first, but in the long term, I think they like it. I think most of them feel like they have much better informed patients now, and patients who are therefore more likely to report problems, side effects, and symptoms. And they are more likely to speak up in ways that help both the patient and the doctor.
What do you see as some of the challenges that lie ahead in the fight against AIDS?
Well, obviously the challenge of creating an international front—a unified, well-thought-out plan—is enormously complex. I mean right now what you've got is a lot of dueling factions. Some believe the answer is just to get the pills out there. Others argue that we need to get an infrastructure in place before distributing medication. And still others believe that we’ve got to overcome poverty before any of this can happen. Some people don’t think we’re going to solve anything with drugs, that prevention should be the primary emphasis. All of these people are sincere, and they're each right in their own ways. But they're not going to be able to come up with a real solution until they can all get together and jointly come up with a comprehensive plan.
And that’s going to take leadership from the top levels of government. It's not something that activists alone are going to fix. We can provoke it, demand it, and identify it. But until the leadership of the G7 and the leaders of the African, Asian, and other countries involved come to the table together and plot out truly comprehensive solutions, I think we're just going to be throwing money at a problem without solving it. I think history shows we’ve been doing exactly that with malaria and tuberculosis. We've had cures for those diseases for decades, and they've been available cheaply in developing countries. Yet six million people a year are dying from malaria across Africa. That's just unconscionable. So that to me is the biggest challenge—to get everybody to check their egos at the door and recognize they're all working to try and solve the same problem. Hopefully we will begin this process of building a truly comprehensive approach, so that we can overcome the health care issue once and for all in developing nations.