Time is running out for a dying Denver father who is pleading with drug companies for access to a breakthrough cancer drug that could save him.
Nick Auden's family started an online petition to get the cancer drug last month because within hours of qualifying for a clinical trial to get the drug, he suffered a medical complication that disqualified him. They have gathered more than 500,000 signatures for the "Save Locky's Dad" petition – named for Auden's son, Locky -- but Auden, 40, is no closer to getting the drug than he was a month ago.
"His oncologist says he must have the drug now to survive," his wife, Amy Auden, told ABCNews.com in an email this week. "The tumors do not stop growing throughout this process."
He will undergo surgery on Monday to remove the melanoma tumors that have spread to his brain since he started the petition last month, she said.
Two drug companies – Merck and Bristol-Myers Squibb – make versions of the so-called anti-PD-1 drug, which teaches the immune system to attack cancer, but they've both declined to provide it to Auden outside of a clinical trial. Bristol-Myers Squibb cited safety concerns, and Merck said it just doesn't have enough of the drug to give to him.
The FDA gave Merck's drug "breakthrough therapy" status in April, allowing the pharmaceutical company to speed up clinical trials in the hopes of approving it, and making it more widely available, sooner, according to company filings.
But that meant it would need to increase its supply of the drug for the ramped-up clinical trials, which Merck spokesman Steven Cragle said is no easy feat. Because the drug is made from mammalian cells, it takes time to literally grow the supply in a lab. As such, Merck only has enough for the clinical trials.
"Nature is working against us," Cragle said. "It's hard to conceptualize why we can't just 'bake a bigger loaf of bread,' so to speak."
He added that Merck is working to make enough of the drug to develop an expanded access program -- which would benefit patients like Auden, who don't fit into clinical trials – but there's no timeline for it yet.
"Not everyone has as short a window as I," Auden said. "Why can't they supply me now rather than me missing by a couple of months? Imagine Amy explaining that to the kids..."
Although Auden is the highest profile patient seeking the anti-PD-1 drug outside of clinical trials, he's not the only one, Cragle said.
Dr. Yoram Unguru, a pediatric oncologist who also works at the Johns Hopkins Berman Institute of Bioethics, said cases like Auden's are complicated because the drugs aren't yet approved, limiting supply and causing safety and efficacy concerns. However, they may be the last chance for terminal patients to survive.
But drug companies are by no means required to help these patients, which is why Unguru thinks perhaps the clinical trial system as a whole needs to be amended to better help patients with terminal diseases who have exhausted all other therapies.
"It's at their whim," Unguru said. "It's through the kindness of their heart, as it were -- or not."
Although drug companies tend to get positive press from helping patients like Nick, there's also a risk the patient will have a serious complication and generate bad press, he said.
"I have been given a zero chance of survival past the next few months without this drug," Auden said in an email on Friday. "It looks pretty good to me!"