May 7, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Johnson & Johnson has become the world’s first pharmaceutical company to institute a consulting process with non-company-affiliated medical ethicists about “compassionate use” requests from patients desperate to try new therapies in hopes of regaining quality of life or lengthened survival.
The company said Thursday that it will do so via a partnership with the Division of Medical Ethics at the NYU School of Medicine, as a way obtain independent advice and institute a process so that all such requests “are treated in the most fair and ethical manner.”
The FDA describes compassionate use as “a pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases or conditions. Such investigational drugs have not yet been approved by the FDA, and they have not been proven to be safe and effective.”
Johnson & Johnson said in a statement it had already established protocol for receiving and reviewing these requests through an outside, independent committee.
“As part of this collaboration, the NYU School of Medicine will establish the Compassionate-Use Advisory Committee (CompAC), an external group of 10 internationally recognized medical experts, bioethicists and patient representatives to pilot the new approach,” it said.
The new process means that CompAC will make recommendations regarding individual patient requests from anywhere in the world.
“Investigational medicines are still in development and usually limited in supply, and the committee’s careful consideration and recommendations based on its independent review will inform Janssen clinicians, who will make the final decision,” said the company.
Still, despite J&J’s attempt to appear magnanimous and ethical, some ethicists questioned the company’s motives Thursday, saying it may just be a smoke screen to protect the companies legally in case they want to find a way to deny a request.
“I’d like to think this is a well-meaning way to make compassionate-use decisions as objective as possible,” said Craig Klugman of DePaul University told Reuters. “But my cynical side says it gives the company another way to say no.”
There’s no question that denying patients crucial, lifesaving medications has been a hot button issue for other companies as well. Chimerix, Inc. underwent a barrage of public criticism after the parents of a 7-year-old boy denied its anti-viral brincidofovir took their struggle public, which resulted in the company backtracking and administering the drug—and firing Chimerix’s CEO at the time. The child recovered fully.
The process of who gets lifesaving medication and who doesn’t is often a gut-wrenching one, said an executive at Johnson & Johnson, who added he hoped this new process would make the company’s ethical obligations crystal clear.
“We have a responsibility to patients and their families to ensure their well-being in everything we do,” said Amrit Ray, chief medical officer for Janssen Pharmaceutical Companies of Johnson & Johnson. “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.”
Will Hungry Pfizer Make a Play for Struggling GlaxoSmithKline?
Almost a year after its $119 billion offer for AstraZeneca PLC fell apart in the face of massive opposition from regulators and internal dissent, global drugmaker Pfizer Inc. is once again being floated as a potential buyer of another marquee-name British pharmaceutical company: GlaxoSmithKline . We at BioSpace want to know your thoughts: With cash to burn, will Pfizer go hunting for Glaxo?
