May 5, 2010
by Tim Horn
Is it possible that enrollment in START, with its deferred treatment arm, will be considered unethical in light of the DHHS guidelines revisions and specific groups pushing for immediate treatment? Collins doesn’t think so, despite the fact that the potential for an ethics conundrum was raised in the START CAB sign-on letter. “After speaking with a wide range of advocates and researchers in the U.S., it’s clear that many take what they want from the guidelines and do what they want otherwise,” he says. “It would be nice if this were publicly known, however.”
Milano agrees and says the language employed by the guidelines panel and other groups is tricky and should be clarified, so that people living with HIV and their care providers know that they do in fact have options. “The DHHS guidelines say over and over again that they are just that—guidelines,” he says. “If doctors would stop using them as rules, it would not affect enrollment of START. If the panel members felt that cohort studies argue for earlier treatment, it would be unethical to withhold their ‘recommendation’ just to help START enroll. But they need to emphasize that the new guidelines are—as they have usually been—a best guess, and that START should move forward.”
Huff doesn’t doubt the merits of START. “I agree that a large clinical trial of this question is essential, but I don’t think communities should be restricted from doing what they think is best at this point based on available data.”
He also argues that the push for early treatment by some cities and local organizations shouldn’t be viewed as a direct threat to the study, but rather an opportunity for supplemental learning. “I don’t think a nationwide recommendation by the CDC or the guidelines committee is warranted by the evidence at this point, and neither does the committee, apparently,” he says.
“The experience [in San Francisco] will feed into the forming and shifting ‘cloud of consensus’ on this question over the next several years,” he says. “I expect researchers in the city health department and elsewhere will report on the impact of the campaign. I hope Project Inform also reports on its experiences with communicating its position in the community and what it learns about the range of individual experiences with quality of care, protection of rights and respect for people with HIV as this program goes forward. If universal testing and treating become the standard of care in the future, other cities and organizations will look to the experiences in San Francisco and other pioneer cities to learn what worked and what didn’t.”
Project Inform stresses that it supports the need for, and completion of, START. “The study’s main endpoints and data from its many planned sub-studies can only help to define the best time to start therapy.” When asked why it didn’t include a reference to START—and the controversies it hopes to settle—in its position paper, Van Gorder says that it didn’t mention the study “because START, among other study data, will be more carefully discussed [elsewhere on Project Inform’s website].
“Given recent changes in earlier treatment advocacy, concern for fully enrolling START is understandable,” he adds. “Project Inform wants to see START fully enrolled and completed, and will work with its CAB to support successful implementation of the study.”
Collins says he hopes the sign-on letter will lead to an even larger national dialog about the DHHS recommendations and emerging public policy favoring immediate treatment. “This is almost creating a panic to get on treatment, when we already know that at high CD4 counts there is rarely any urgency for treatment. We are saying that we want to see the evidence of both the risks and the benefits.”
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