Remembering Martin Delaney

The world lost one of the giants of AIDS treatment activism on Friday, 23 January 2009, when Martin Delaney died of liver cancer in San Rafael, California.

Activists around the country and around the world paid tribute to Martin's work in a flood of on-line emails, blogs, and reminiscences.

For me, Martin Delaney embodied some of the things I most value in AIDS activists:

•    A willingness to challenge authority;
•    A belief that science is for people, not for scientists alone;
•    A belief that ordinary citizens have a right to scientific information, to participate in research (or not), and to access experimental treatments when there are no approved treatment options or when approved treatments are failing;
•    A willingness to listen to opposing views, and sometimes to change one's mind in light of changing circumstances or emerging new data;
•    A willingness to compromise where possible without compromising the essential rights mentioned above;
•    A fierce, dogged, and relentless tenacity that would not rest until the goal was achieved.

I first worked with Martin in the spring of 1989. It was the period when ACT UP/New York's Treatment and Data Committee (T+D) was sending delegations down monthly to the hearings of the Lasagna Committee, a panel appointed by President G.H.W. Bush to look at ways to speed up approval of AIDS and cancer drugs. At the same time, Martin Delaney and his ally, attorney Jay Lipner from the Lambda Legal Defense and Education Fund, were trying to negotiate with the Food and Drug Administration not only on how to speed up drug approvals, but also on how to provide broader access to experimental treatments when they were still in clinical trials.

Jim Eigo from ACT UP's T+D Committee began writing down the precepts of what would become Parallel Track, a proposal originally made by Delaney after long conversations with Lipner and with Anthony S. Fauci, the Director of the National Institute of Allergy & Infectious Diseases (NIAID), who was also seeking ways to reduce the pressure on the NIAID-funded AIDS Clinical Trials Group (ACTG), which could not possibly enroll all the nation's people with AIDS in its small, slow, and almost paralyzed clinical trials network (as documented by T+D in its report from November 1989, The AIDS Clinical Trials Group: A Critical Review, and later in an article I wrote for the Village Voice, "AIDS Research at a Standstill", in Spring 1990 just before ACT UP's "Storm the NIH" demonstration).

Delaney, Lipner, and Eigo were the key community activists in leading the negotiations with the FDA, with NIAID, and later with the drug company Bristol-Myers, which led to the Parallel Track program for didanosine (ddI), the second AZT-like drug to make its way through clinical trials. The ACTG was unable to enroll more than a couple thousand people with AIDS into its studies of ddI, while around the country, tens of thousands of people with AIDS (PWAs) were failing on or intolerant to AZT, the only approved drug.

With coordinated pressure from Project Inform, ACT UP, other activists organizations, as well as from Fauci at NIAID and Sam Broder, Director of the National Cancer Institute, the FDA allowed ddI to be released on a Parallel Track program in the fall of 1989. Eventually over 35,000 people with AIDS received ddI through Parallel Track before the drug was approved by the FDA in late 1991. Since the drug eventually proved to be effective, in retrospect the Parallel Track program is likely to have saved or extended thousands of lives.

Early in the period when Treatment Action Group split off from T+D and became an independent organization, we collaborated closely with Martin and with Jesse Dobson from Project Inform on what became the Immune Restoration Think Tank (IRTT) series of workshops to expedite research on restoring the immune system damaged by HIV.  Jesse Dobson died of AIDS in 1993 but Martin Delaney and Brenda Lein kept the IRTT workshops alive until the advent of HAART put a temporary eclipse on immune research.

Martin Delaney and Project Inform were also key players in supporting what became the FDA's accelerated approval program to expedite drug approvals based on changes in surrogate markers such as CD4 counts and later, HIV RNA (viral load), thus shortening the duration of pivotal clinical trials and hastening FDA approval. Once HIV RNA tests were developed that could monitor drug-induced changes in viral load in real time, the FDA began to approve drugs based on viral load changes (accelerated approval after 24 weeks, full approval after 48) rather than CD4 changes or clinical progression. This radically shortened drug approval time, and probably brought many more drug companies into the field.

Once these key steps were in place and after the development of viral load tests and the simultaneous discovery of highly active antiretroviral therapy (HAART) combinations in 1995-1996, the treatment landscape changed radically in the U.S. and other developed countries. AIDS death rates plummeted by over two-thirds, and with astonishing speed, a new standard of care for HIV was implemented across the wealthy world.

New challenges emerged--how to deal with the emerging side effects of HAART, how to prolong HAART efficacy, how to treat people who were already resistant to most drugs because of pre-existing monotherapy with AZT or dual therapy with suboptimal combinations such as AZT/ddI and AZT/ddC.

In the late 1990s TAG worked closely with Martin Delaney and his colleagues on several of these emerging challenges. Together we succeeded in getting the FDA to hold hearings to emphasize to industry the importance of studying new drugs in salvage (e.g., multi-drug experienced) populations. As a result, most of the new anti-HIV drugs approved in the past decade--tenofovir, FTC, T-20, tipranavir, darunavir, raltegravir, and maraviroc among them--were first studied and first approved in salvage therapy populations. The result was, again, the prolongation or saving of thousands of lives.

TAG also worked closely with Martin, with Project Inform, and with Linda Grinberg and her Foundation for AIDS and Immune Research (FAIR) on a series of workshops on structured treatment interruptions (STIs) in HIV therapy. Out of these workshops, held between 1999 and 2002, a series of clinical trials emerged. Unfortunately it turned out that treatment interruptions were neither safe nor effective under most conditions, but some of the trials, such as the SMART study, ended up providing compelling data on the importance of HAART in preventing some of the complications of HIV disease--such as cardiovascular, liver, and kidney disease--which some had previously thought were caused not by HIV but rather by HAART itself.

Marty also provided frequent and vital input on-line to assist South African AIDS activists such as Nathan Geffen from the Treatment Action Campaign (TAC) in their struggle against the AIDS denialism of South African President Thabo Mbeki and others in the South African government who were determined to block the roll-out of antiretroviral therapy for as long as possible in the country with the world's highest HIV case load (over 5.5 million and growing).

The last time I saw Marty in person was at last year's Retrovirus conference in Boston, where we met with Rowena Johnson from amfAR, Paul Dalton (then of Project Inform), and with Richard Jefferys and Bob Huff from TAG to plan what became the first workshop on eliminating HIV persistence and eradicating HIV infection, which TAG cosponsored with amfAR, FAIR, and Project Inform in November 2008.

By then, Martin was too sick to travel. After beating hepatitis B infection in the 1980s and surviving a quadruple bypass earlier in this decade, his two previous conditions had conspired to produce a virtually untreatable hepatocellular carcinoma which was only finally diagnosed in Fall 2008. The location of the tumor, its spread, and the prior cardiovascular disease made getting a new liver difficult if not impossible. Martin called me in early December and reported on his condition. He said, "I've survived two life-threatening diseases already, but I'm not sure I'll be able to make it this time."

As always, he faced the situation with courage and honesty. This time, there were not a lot of treatment options. He was surrounded by long time colleagues and friends such as Brenda Lein, Anne Donnelly, David Evans, and by his family in his last weeks. Over Christmas he even made it to Hawaii for a vacation. Upon his return to California he entered the hospital then returned home last week. Brenda called to let me know he wanted me to come out to see him. I booked a flight for last Friday, January 23. It was too late. By the time I landed, Martin was gone. I spent that evening with his friends and colleagues at the memorial wall at 18th and Castro Street where people left flowers, lit candles, hung Buddhist prayer flags, and posted tributes to Marty.

It's too soon for me to fully comprehend the loss of Marty. Today on the IRMA blog I read a summary of Martin's philosophy of AIDS activism which is a great way to remember his spirit, his work, his legacy, and what he has left us.

The Delaney Declaration