Rutgers researcher discusses ethics of placebos in HIV clinical trials

A recent paper discussed the ethics and scientific purposes behind including a control group in HIV clinical trials.

Monica Magalhaes, the associate director of the Center for Population–Level Bioethics and a lead author of the paper, said many HIV-positive individuals rely on antiretroviral drugs to remain healthy.

During clinical trials for potential HIV cures, participants may have to pause their antiretroviral therapy so researchers can independently analyze the effects of the experimental treatment, she said.

During these trials, Magalhaes said that control group participants must stop taking antiretroviral drugs and not receive the experimental treatment — an arrangement that can be perceived as individuals accumulating risk without any benefits.

“Since we were working on ethical questions related to HIV cure trials, we decided to look at these worries carefully,” she said. “And our view, that we defend in the paper, is that participants in these trials who get placebo face a similar or better risk-benefit balance than the participants who get the experimental treatment.”

To come to this conclusion, Magalhaes said the team considered the low success rates of past HIV cure trials and how none of them have led to a conclusive cure for HIV. Additionally, she said the trial’s experimental treatment is riskier than a placebo due to its potential side effects and the low likelihood of its success.

She said the paper’s authors reasoned that the control group participants receiving a placebo is in a relatively safe position, considering that they will only receive the experimental treatment if it proved to be successful during the trial.

For the paper, Magalhaes worked alongside Nir Eyal, a Henry Rutgers professor in the Department of Health Behavior, Society and Policy and director of the Center for Population–Level Bioethics, and Daniel Kuritzkes, chief of the Division of Infectious Diseases at Brigham and Women’s Hospital and a researcher at Harvard University.

“We have been working together for years on a project about the ethics of research on HIV trials, the risks involved and how patients living with HIV feel about trials of potential cures and about the idea of participating in these trials,” she said.

The project originated at Harvard, where Eyal and Kuritzkes met each other, started a dialogue about ethics and began doing collaborative research with researchers at various institutions, Magalhaes said. She said she eventually joined the project after finishing her doctorate degree.

Magalhaes said she wanted the paper to reach scientists involved in HIV cure research but was unsure if scientific journals would be willing to publish it, considering that most of their literature revolves around clinical studies. 

Though, she said the publication process was easier than she thought it would be, and her top journal choice the Journal of Virus Eradication was interested in publishing the paper.

Magalhaes said she hopes the argument of this paper will aid scientists and clinicians who work on HIV cure trials and encourage them to use placebo control groups for their research.

She said that not only is using placebos for these trials ethical but they also make result analysis easier for researchers.

 “It is important to think carefully about risks and benefits of research, not only in HIV but in any area where risky trials can have major benefits to science and to society,” Magalhaes said.

Editor's Note: This article has been updated to further clarify information.