Mattes faced the challenge head-on. "I decided that it would be very, very important for me to do an awful lot of listening,"
he says. He took J&J and Tibotec managers to hospitals, public clinics, and AIDS service organizations in and around Newark.
The trip was just half an hour's drive from the company's Bridgewater office, but it took them to another planet, populated
as it was by the nation's highest proportion of women with HIV, most of them poor, black, and dependent on public funds for
treatment and care. "We were staggered by the demographics and the breadth of the disease," Mattes recalls. "It was a quiet
ride back to the office."
If Mattes was new to AIDS, two of his big hires were veterans. Alan Tennenberg, MD, Tibotec's vice president of clinical affairs,
had started his own public clinic for 1,400 AIDS patients in Jacksonville, FA, where his first order of business was to broker
a cease-fire between the department of health and the HIV community. "During my time at the clinic," he recalls, "we brought
the two together, and they went from being antagonistic to a nice partnership." Lew Silbert, Tibotec's global vice president
of professional affairs, boasted similar stripes. He was at Burroughs-Wellcome when activists campaigned to lower the $8,000
price of AZT. "We realized after four people from ACT UP came in and made themselves comfortable with handcuffs that there
was a better way of communicating," he recalls. "I took my cue from that and said, 'Well, why should this be any different
than any other human interaction?'"
In fact, over two decades, the pharmaceutical industry and AIDS activists have alternately fought, exploited, and befriended
each other. And when they join forces, as on such issues as streamlining FDA drug approval and targeting public funds for
AIDS programs, they make an unbeatable team. "We both want to get the drugs out as fast as possible," says Rob Camp, cochair
of ATAC's drug development committee. "Once they realize that, they see that all of our other concerns about patient needs
might be worth serious consideration."
Doing Well and Doing Good
This realization was crucial when ATAC and Tibotec sat down to discuss the design of Phase III trials of Prezista and etravarine.
The activists proposed that the company step up and conduct the first-ever two-experimental-agent study, a huge boon to salvage
patients because it would deliver a double-barreled shot at HIV, while substandard single-drug therapy can be outwitted by
the virus with as little as a single genetic mutation.
ATAC had been pushing drugmakers for years to collaborate with each other on such a study, but even pressure from FDA failed
to get anyone to bite. Adding a second experimental drug would only double the unknowns and risks; patients would be less
safe, trials would take longer, each compound's effects would be harder to clarify—and who needed the headache of sharing
proprietary information and other resources with a competitor?
"Here was Tibotec, a company that had two agents of their own that could be tested together," says Heidi Nass, who heads ATAC's
drug-development projects with Rob Camp and, like Camp, is HIV-positive. "We thought, If not them, then who?"
Tibotec signed on to the idea not only to serve salvage patients but also to test its two drugs' viability as a marketable
combo. Dubbed DUET-1 (Prezista with etravarine) and DUET-2 (etravarine alone), the studies were up and running with 1,200
patients in record time. The typical DUETer had burned through 12 HIV drugs, had extreme resistance, severe immune damage,
and was too sick to qualify for most other industry-sponsored trials.