In a world first, Johnson & Johnson has set up a unique alliance that will see an external party make ethical decisions on requests for access to its experimental therapies under the compassionate use programme.
The firm has established a partnership with the Division of Medical Ethics at the NYU School of Medicine in order to obtain independent advice and ensure that such requests “are treated in the most fair and ethical manner”.
The School will establish a Compassionate-Use Advisory Committee (CompAC) - an external group of 10 medical experts, bioethicists and patient representatives - to pilot the new approach, which will initially focus on a single Janssen investigational medicine, as yet undisclosed.
"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,” said J&J chief medical officer Amrit Ray.
However, the CompAC will operate as an advisory body only, leaving the final decision with J&J, and its recommendations will reportedly be kept out of the public domain.
"I'd like to think this is a well-meaning way to make compassionate-use decisions as objective as possible. But my cynical side says it gives the company another way to say no,” ethicist Craig Klugman of DePaul University told Reuters.