Posted on June 3, 2015 at 10:06 PM
May 7, 2015, The New York Times reported that Johnson & Johnson (New Brunswick,
New Jersey) had asked
Arthur Caplan, PhD, Professor of Bioethics at New York University School of
Medicine to create a new panel “that will make decisions about patients’ requests for
potentially 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 [by the FDA].”
use” experimental drugs have been available for some time. In the recent Ebola crisis, last year the FDA “allowed the makers of ZMapp, an
experimental treatment, to be used on a handful of patients, but the company
quickly exhausted its limited supply.” Of late, several states have enacted
“Right to Try” statutes in an attempt to craft a legally-recognized right to
early access to drugs still in clinical trials.
A drug company, like Johnson &
Johnson, establishing a bioethics panel to review individual patient requests
is a new strategy. However, in looking a the other complex issues involved, a
skeptic may view this novel development as a public relations ploy to deflect
social media pressure rather than as a serious solution to the associated
Might some diversion of an already limited
supply of experimental drugs for individual “compassionate use” further delay
the clinical trials – and FDA approval – for a larger group of patients with
the same disease?
Who will bear the cost for making the
“compassionate use” experimental drug available to eligible patients? “Expanded
access programs” (EAPs) – as drug companies and regulators label “compassionate
use” availability programs – are very expensive to establish and maintain. Will
the poor and uninsured – or those enrolled in Medicare and Medicaid – have as
equal an access as the privately insured?
Who should establish and maintain eligibility
criteria for availability of “compassionate use” experimental drugs?
Who should be responsible for reporting drug
safety profile data and adverse effects of an experimental drug and sorting out
whether or not the drug was the cause of any misadventure?
As part of the informed consent process, will
the patient be deemed to have assumed the risk of any ill effects that might be
attributed to the drug? Almost all of these issues are far outside the scope of any one entity having
the Johnson & Johnson panel may help in educating patients and the public
about drug trials and the fairness and ethical challenges in drug research. And
in situations like this – when patients are dying because no good therapies
exist – education may be the lasting legacy for such panels.
The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI’s online graduate programs, please visit our website.