Drugmaker Johnson & Johnson said today that it would tap bioethicist Arthur Caplan of the NYU School of Medicine to lead an independent group overseeing requests from dying patients to use experimental medications.
The company says the panel will be the first of its kind, advising J&J subsidiary Janssen Pharmaceutical Cos. on whether to allow terminally ill patients who are not in clinical trials access to experimental drugs. The pilot program will initially cover requests for just one yet-to-be identified Janssen medication, but the company says it could expand.
J&J’s move comes amid growing support for the so-called “right to try” movement in the US. Last year, Colorado became the first state to allow terminal patients to request experimental drugs without approval from the federal Food and Drug Administration.
“The laws basically say, you know what? We’re tired of all these bureaucratic obstacles,” Caplan told the PBS NewsHour last year. “We’re going to pass a law in our state that says, if you’re terminally ill, once it’s passed phase one — that tiny safety testing on a small number of people — you can get anything you want.”
The FDA has long had a protocol for compassionate use — and says it approves nearly all requests, but often drug companies themselves are reluctant to allow expanded use. Sometimes the companies don’t have enough doses or the doses are prohibitively expensive. And other times the companies worry a complication could compromise the ability of a drug to get to market.
“Many new drugs can make you die faster,” said Caplan. “And I’ve personally given access through sitting on research ethics committees and working with the FDA to many new drugs. A number of them killed the person who got them more quickly than they would’ve died from their disease.”
The Division of Medical Ethics at the NYU School of Medicine will be compensated for committee members’ work but Caplan himself won’t be paid directly.