Merck Telling Trial Patients If They Got HIV Vaccine

The idea is to tell the 3,000 volunteers so they know whether to pursue HIV testing. You may recall that, shortly after Merck halted its HIV vaccine, the drugmaker acknowledged the experimental med may have compromised patient immune systems, making those who were vaccinated more vulnerable to the risk of infection. The move was made after a conference last week with its partners, the NIH and the HIV Vaccine Trials Network.

However, the move raises a potentially different set of problems. As Merck's statement this afternoon makes clear, the researchers still intend to continue following the trial participants to gauge infection rates. But the behavior of the trial participants may very well change after knowing whether they were vaccinated or given a placebo. This, obviously, could make it more difficult to interpret the data, which is already posing challenging questions.

The decision wasn't easily reached. “Clearly, the overarching and most important consideration is the well being of the volunteers,” Mark Feinberg, vp for medical affairs and health policy in Merck’s vaccine division, tells the WSJ Health Blog. Arguing against the unblinding was George Counts, a retired infectious-disease doc formerly with HVTN, who on a panel that debated the issue last week. “It will be difficult to answer any of the critical questions about this vaccine or the immune response,” he tells the blog. “It just seems to me that we have an obligation to (participants) to get the most precise information out of this research study for which they have so courageously offered their willingness to participate.”

This raises an ethical quandary. What do you think?

Is this the right thing to do?

• Yes (85%, 22 Votes)
• No (15%, 4 Votes)

Total Voters: 26

Hat tip to the WSJ Health Blog