J&J creates ethics panel to allow access to experimental drugs
Drugs maker says it gets hundreds of requests every year from critically ill patients
U.S. drugs maker Johnson & Johnson has created a new ethics panel that could soon allow seriously ill patients access to its experimental drugs, even if they aren't participating in a drug trial.
The New Brunswick, N.J.-based company announced today it has struck an independent panel, which includes doctors and bioethicists, to review requests from patients who believe a drug can help them.
J&J says it gets hundreds of such "compassionate care" requests every year and until recently, the decisions have been left in the hands of individual physicians who are working on the drugs.
"By ensuring compassionate use requests for our investigational medicines are evaluated by a well-informed, external committee, we can better weigh what we know about these therapies against the patient's condition and risk factors to make the most responsible decision for each patient," Dr. Amrit Ray, chief medical officer for Janssen Pharmaceutical Cos, a unit of Johnson & Johnson, said in a news release.
Pilot with single drug
The new approach will begin as a pilot program focused on a single Janssen investigational medicine and could be extended to other J&J drugs if it seems to work.
Doctors representing ill patients can apply through a single toll-free number or website.
J&J's 10-person ethics panel, affiliated with the division of medical ethics at the New York University School of Medicine and including patient representatives, represents a new approach to a difficult ethical dilemma.
Under U.S. law, companies generally can't give out unapproved drugs. However, the Food and Drug Administration has an application process that allows companies to give medicines for "compassionate use" to patients with serious and life-threatening illnesses.
The FDA has approved 99 per cent of such requests in recent years.
Ethical dilemma
Patient advocates say access to these drugs can be a matter of life and death for some people.
But companies worry about the legal implications if patients have adverse reactions or do not respond well to drugs still at the testing stage.
They also say they typically only make enough of experimental drugs to supply clinical trials and risk missing testing deadlines if they give the drug to numerous individuals.
Johnson & Johnson warns that drugs at experimental stages are not proven effective. Part of the panel's job is to weigh the risks to the patient against potential benefits.
However, the company said it is "committed to expanding access to its investigational medicines."
"Compassionate use decisions are incredibly challenging, and we readily acknowledge that the current allocation system remains a work in progress. This new initiative hopes to create a more robust model to help guide these decisions," said Art Caplan, director of NYU's division of medical ethics.
Meanwhile, some groups are pushing for wider access to unproven drugs for the critically ill.
The Goldwater Institute, a conservative think tank based in Phoenix, is fostering a national "right-to-try" movement, saying every patient has "the fundamental right to try to save their own lives."
Several states have passed "right-to-try" legislation, which encourages wider access to experimental drugs.