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A new model for AIDS treatment activism

If all these hurdles are cleared, exactly what might the database reveal? Figuring out whether drugs are effective--let alone which combinations have an edge on others--can be surprisingly difficult, even in a carefully constructed clinical trial. By their nature, "observational databases," as scientists call studies like TDP, aren't controlled or randomized.That makes it hard--some say impossible--to deduce why patients are doing well on any given drug regimen. Maybe their good fortune is due to the drugs, but maybe it's because of some other factor. "The danger of drawing incorrect conclusions is greater," says Sam Bozzette, a heavyweight researcher from the University of California at San Diego. If that happened, he says, spurious findings could be accepted as fact, and actually harm patients.

Yet Bozzette is a self-described "cheerleader" for the project: "It might be a very good way to pick up side effects, unusual occurrences, patterns in the data. That could be quite valuable." Indeed, it could push researchers to conduct more precise clinical trials. And a rigorous study design "doesn't inoculate you against the wrong inference," he says, citing a heart medication that, in a controlled clinical trial, was shown to allay abnormal heartbeats. It also caused cardiac arrest and death, a fact that was only discovered, he notes, through "an observational approach."

Indeed, clinical trials usually exclude people with messy treatment histories and complicating health problems. That's one reason drugs almost always work better in clinical trials than in the real world. Observational databases, on the other hand, describe what's happening on the ground. And if they amass enough participants, statisticians can provide evidence about what's working--and what's not--for various subgroups.

Bozzette insists that TDP's real use will be for the patient or doctor who doesn't have time to wait for pristine answers but is "sitting there saying, 'Shit, I've got to do something.'" Through TDP, he says, patients will "be able to ask 10,000 friends, and that would be powerful." If Bozzette were with a patient who had a complicated history of failing various regimens, "I might think of some combinations and pump them into this database just to see if anyone had any experience with them. Who knows? It might have been taken by seven people and in five cases their hair fell out."

Finally, if the project were to succeed, how would the database be used? Would managed-care companies look to it for reasons to limit treatment options? Not likely, says Empire Blue Cross's Stocker, since even the most expensive drug regimens are cheaper than hospital stays. McFarlane hopes to tap pharmaceutical funding; will these companies try to control access to the data, or determine the research agenda?

Kramer has a history of turning on groups he founded; he has excoriated GMHC and ACT UP. How long will it be before he attacks TDP? Kramer laughs. "I'm 63 years old now," he says. Then, getting serious, he vows he won't turn on the project "as long as it works well and no one tries to put anything over on anyone."

Ultimately, the whole enterprise depends on patients. "Patients will have to be extremely involved and very dedicated to putting their data in over a long period of time, in a way the pros would say is very unlikely--nutty, in fact," says Bozzette. "But nobody on my side of the fence is in a position to tell Rodger and Larry what the community can and can't do. I'd love this to work."

"My instinct is that patients will do a lot better job than we think they'll do," says Empire Blue Cross's Stocker. "That's based on my experience as a physician. Patients have a totally different motivation than doctors. There's usually a genuine desire on their part to help other patients. So I'm kind of hopeful."

"GMHC and ACT UP were both grounded in a notion of patient empowerment and this seems like the next step," says Kramer. While everyone else on the project tries to downplay expectations, Kramer wants to "revolutionize how medical data is collected." He hopes to enlist a quarter-million HIV patients. "Size does matter," says McFarlane, but he adds that the project could yield useful data with just 1 percent of Kramer's goal.

Does Kramer think TDP is going to work? "I never doubted from day one, when I helped start GMHC, that there wasn't a cure for AIDS. I never thought it would defeat us totally. I've always thought that if we fought long enough and hard enough, we could get to the top of the mountain."

Research assistance: Tyler Schnoebelen

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