Darcy Doherty is dying of melanoma. The only chance to prolong his life rests with an experimental drug he has been refused. He has become a living example of why the terminally ill need compassionate access to last-chance therapies.
The 48-year-old father of three in Toronto is seeking what anyone in his situation would: to obtain the drug, a monoclonal antibody, outside a clinical trial from which he was excluded because of tumours in his brain. His oncologist recommends that he be given the drug, BMS-936558, saying it may help. But Bristol-Myers Squibb has denied the request, saying it has a responsibility to protect patient safety in the research and development of its medicines.
Interim results show BMS-936558 has been tested on 94 melanoma patients, 26 of whom have responded to it, as well as some sufferers from kidney and lung cancer. Common side effects are fatigue, rashes and diarrhea; a few patients died of uncontrolled lung inflammation. Mr. Doherty is willing to accept all those risks, because he feels he has nothing to lose.
The ethical issue affecting Mr. Doherty comes down to this question: How much medical evidence is enough to justify use of the drug outside a clinical trial?
Tania Stafinski, director of the health technology and policy unity at the University of Alberta’s school of public health, says there appears to be enough safety data to justify its use in Mr. Doherty’s situation.
Udo Schüklenk, Ontario research chair in bioethics at Queen’s University, is more pointed. “In such cases of catastrophic disease, if you have competent patients, if they want to roll the dice one last time, how dare society say, ‘We don’t care, we have our procedures in place,’” he says.
Canada needs a public debate about the need for compassionate access legislation, so that carefully selected patients with no other alternative can access drugs, under a doctor’s supervision. While it is important to maintain rigorous scientific methods when running clinical trials, in cases of catastrophic illness, the system should be more nimble in allowing terminally ill people to obtain prompt access.