Thursday, May 7, 2015

NYTimes: Company Creates Bioethics Panel on Trial Drugs

Johnson & Johnson has appointed a nationally known bioethicist to create a panel that will make decisions about patients' requests for lifesaving medicine, responding to an emotional debate over whether companies should allow desperately ill people to have access to the drugs before they are approved.

The move, to be announced by the company on Thursday, is believed to be the first of its kind in the industry and, given the size and influence of the drug maker, could inspire other companies to follow suit. It comes as a small but growing number of patients with terminal illnesses have sought the right to obtain drugs still in the testing phase that show promise for treating their diseases.

Some of the requests have become highly publicized cases on social media, where family members and advocates have lobbied the companies on patients' behalf — often to no avail because drug makers fear that doing so would interfere with clinical trials, or, in the case of the Ebola outbreak, that they have too little available. The issue, which involves fundamental questions of fairness and equal access to care, has become so intense that more than a dozen states have taken up legislation to speed the process.

Johnson & Johnson said the bioethicist, Arthur L. Caplan of New York University, who has written extensively about the issue of experimental drug availability — known as "compassionate use" — would oversee an independent panel of doctors, ethicists and patient advocates that will review requests for access to a limited array of experimental medicines and decide how Johnson & Johnson should respond.

The pilot program will be funded by the company but will have no influence on the panel's decisions, Johnson & Johnson said, adding that payments will go directly to the university. Dr. Caplan will not be paid in his work in the program.

Dr. Caplan, who has argued that the industry needs a fairer, more consistent system for deciding whose requests should be granted, said he was intrigued when company executives approached him about the idea. "If we could structure this right, this would be a chance to not just complain about what's wrong, but maybe to suggest a way forward," he said in an interview.

Drug companies have been granting emergency access to their unapproved drugs since the AIDS epidemic of the 1980s, when the Food and Drug Administration set up a process to help desperate patients get experimental treatments. The F.D.A. typically signs off on use of unapproved drugs, but not until the company agrees.

But saying yes is not so simple: Manufacturers often have a limited supply of such treatments, leading to anguished decisions over who should be given the products. The unproved drugs also might not work, or could even cause harm. And the time and resources involved in granting access to such drugs could delay efforts to get them approved for a much wider population of needy patients, especially at smaller companies. In the case of the Ebola epidemic, last year the F.D.A. allowed the makers of ZMapp, an experimental treatment, to be used on a handful of patients, but the company quickly exhausted its limited supply.

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Johnson & Johnson named the bioethicist Arthur L. Caplan to create a panel to decide on patients' requests for lifesaving medicines before they are approved.