J&J’s Janssen Wants Ethicists’ Input on Compassionate Use

Johnson & Johnson’s Janssen subsidiary has enlisted a leading bioethicist to help the company determine who should qualify for compassionate use of its experimental drugs, in what J&J is billing as a first-of-its-kind partnership.

Dr. Arthur Caplan, director of New York University’s Division of Bioethics, will head a new compassionate use advisory panel with nine other internationally known medical experts, bioethicists and patient representatives. They will advise the drugmaker on how best to allocate investigational medicines outside of clinical trials or expanded access programs.

The partnership will kick off in a couple of weeks with a pilot program involving one of Janssen’s investigational medicines, the company said Thursday. If successful, the pilot would be expanded to other drugs.

Company spokesman Larry Thompson declined to name the initial drug candidate, saying the company hasn’t made a final decision.

Janssen generally opens expanded access programs for patients with life-threatening conditions who have exhausted all available therapeutic options only after the company’s clinical trials are completed and the therapy is awaiting regulatory approval.

Most of the patients who apply for compassionate use tend to have diseases closely related to those covered by clinical trials or expanded access programs, Thompson said. While there’s no official record, he estimates the company has received hundreds of requests over the past few years.

This worries Craig Klugman, chairman of the Department of Health Sciences at DePaul University, who says providing drugs for compassionate use can end up delaying clinical trials if there are limited doses available. That’s what happened with the experimental Ebola virus treatment ZMapp, when several

American aid workers were given the drug months before it was tested in any kind of human trials.

Caplan ultimately hopes to establish a system akin to the United Network for Organ Sharing’s allocation process, which places patients on transplant lists according to their hometowns and the severity of their illnesses. — Lena Freund