Raymond V. Gilmartin, Chairman, President & Chief Executive Officer, Merck & Co., Whitehouse Station, NJ testifies before the Senate Finance Committee hearing on FDA, Merck, and Vioxx on November 18, 2004 in Washington as Dr. David J. Graham of the Food and Drug Administration and Dr. Bruce M. Psaty look on. (UPI Photo/Michael Kleinfeld) | License Photo
The pharmaceutical company Merck has expanded access to the anti-PD-1 drug, which enables the human immune system to attack and kill tumor cells -- and which showed early promise in several clinical trials.
While the news is likely well-received by dozens of patients suffering advanced stages of melanoma, it will come as little consolation to the family of Nick Auden, a 41-year-old father of three who campaigned for access to the drug but was denied. Auden died last fall.
“It is absolutely devastating that it was only a matter of timing that Nick did not get the drug,” his wife Amy Auden told ABCNews.com. “Every minute of every day, I am reminded that Nick is not here, and I am widowed at 38 with three young kids.”
Because of health complications, Auden was disqualified from participating in a clinical trial for the drug, which also goes by the names PD1 or PD1 Blockers. When Auden pleaded for access to the drug, pharmaceutical companies said they needed to build up a larger supply and gather more evidence of the drug's safety.
Auden's family even started a Change.org petition, and earned more than 189,000 signatures, but the support didn't move drug companies to alter their position.
Drugs still in the experimental stage and unapproved by the FDA can sometimes be offered to patients outside of clinical trials via "compassionate use" or "expanded access" programs.
Now, Merck is ready to expand access to the drug.
"We have been accelerating all aspects of the development program to bring this investigational medicine to as many people who might benefit from it as quickly and fairly as possible," Ian McConnell, Merck spokesperson, told ABCNews.com. “Now that we have more safety and efficacy data in melanoma, and we have adequate supply we have started our planned [Expanded Access Program] in the U.S. for treatment of eligible patients with advanced melanoma.”
A young girl in Oregon is currently experiencing the same frustrating ordeal that Auden experienced several months ago.
16-year-old Nathalie Traller is hopeful that PD1 could help her fight off a rare form of cancer, but she's too young to participate in clinical trials -- patients must be 18.
Traller and her family have lobbied drug companies, like Genentech and Merck, for access to the drug, but so far the answer has been no.
"I really don’t know why we’re receiving this answer, but it doesn’t feel very compassionate," Traller's father, Nathan, told local news station KOIN.
It's not clear what the news from Merck means for someone like Traller, but the family is holding out hope.