Melanoma patient Darcy Doherty fought to get an experimental drug to prolong his life and became the face of the terminally ill who need compassionate access to last-chance therapies.
On Tuesday, his battle ended. The 48-year-old father of three died at his Toronto home surrounded by family.
Mr. Doherty requested the experimental trial drug BMS-936558 after scans showed that tumours had spread to his brain. He believed the monoclonal antibody was his last, best chance, and early testing showed some promising results. His oncologist was in favour.
But the request was turned down in April. Bristol-Myers Squibb, the drug company, said that the tests were still in the early stages, and side-effects were not fully known.
The family waged a public battle to persuade the company to relent that included a petition with more than 190,000 signatures, an e-mail campaign and several videos.
Mr. Doherty was diagnosed with cancer in 2003. He received the devastating news that it had metastasized to his lungs and brain in 2007.
A drug provided as part of a clinical trial gave him another four years. It became less effective, and Mr. Doherty was hoping the new experimental medication would prolong his life.
"We always remained hopeful that BMS would change its mind and Darcy would have another miracle," his wife, Rebecca Cumming, said in a statement. "Sadly, that did not happen."
Mr. Doherty's public campaign sparked an ethical debate. Should patients, especially those with little hope, have compassionate access to drugs outside of clinical trials when other options have been exhausted? Or is it too risky to give unfettered access to drugs not yet approved by Health Canada that could cause adverse events, including death?
Drug companies do provide some compassionate access, but only on a case-by-case basis and when the drug is farther along in the testing process.
Udo Schüklenk, Ontario research chair in bioethics at Queen's University, said countries such as the United States provide drugs on compassionate grounds in similar circumstances.
"We need a societal debate about the rights of dying patients to make informed decisions to access such experimental drugs and to see their decisions respected," Dr. Schüklenk said.
Fewer than 100 melanoma patients, most in the United States, have been treated with the monoclonal antibody. While some of them have shown positive results, the side-effects remain unclear.
Bristol-Myers declined to comment on Wednesday, saying it can't speak about specific patients. In a statement, it said patient safety comes first and cancer medications are best developed through "carefully controlled clinical trials in order to establish the benefit and risk of investigational compounds."
Mr. Doherty's family asked for privacy on Wednesday. But Douglas Boyce, a family friend, said his case illustrates that the system is not working properly.
"Darcy is not a unique individual. There are many people who have come to the end of the road as far as treatments go," he said, "and they need some hope and some options."