|Dying Dad Pleads for Unapproved Cancer Drug|
|By SYDNEY LUPKIN (@slupkin)||Sep 13, 2013, 2:40 AM|
A Denver man has one last chance to beat terminal cancer: a so-called wonder drug that helps a patient's immune system shrink tumors for good.
The trouble is, hours after Nick Auden, 40, was admitted into a clinical trial on July 2, he suffered a complication and was immediately disqualified. What's more, the drug companies that make the "wonder drug" won't allow him to take it on his own.
"I could not sleep," his wife, Amy Auden, told ABCNews.com. "I was lying awake at night thinking, I can't just lie here and do nothing."
Without the drug, Auden's doctor told his wife that "this is the end of the road," and that her husband had between three and six months to live.
So she started sending emails at 3 a.m. and the "Save Locky's Dad" campaign was born. The Audens aren't looking for money -- just signatures on a petition addressed to drug companies Merck and Bristol-Myers Squibb, pleading for access to one of their immune-boosting anti-PD-1 cancer drugs.
Lachlan, nicknamed "Locky," is Auden's 7-year-old son, and he is included in a video on the "Save Locky's Dad" website asking for people to support his dad.
"I want my dad to get the PD-1 drug because then I can do the things I like to do with him all the time," Locky says in the video, flashing a smile that's missing two front teeth between shots of the two playing Frisbee.
The Audens Change.org petition has more than 189,000 signatures and counting.
Auden's story started in March 2010, when he had a cancerous mole removed. Although it put him at risk for more skin cancer, he continued to live an active life, running, biking and hiking.
But in September 2011, Auden said his doctors sat him down and told him the cancer had returned and had spread throughout his body. The official diagnosis was stage 4 melanoma.
"Some people survive, 90-odd percent don't," he said. "There's no doubt that was tough news. I had trouble not being emotional about it every time I thought of the concept of not being there to watch the kids grow up."
Auden's wife was pregnant with the couple's third child when doctors told her husband that his median life expectancy was between six and nine months.
Two years of radiation and other experimental treatments later, Auden's still alive, but time is running out, his doctors say.
Auden continues to stay fit despite the cancer. He took a long ride on his mountain bike this week regardless of a tumor on his left femur that doctors are treating with radiation.
"Every now and then, I have things like that that pop up," he said of the tumor.
When he learned about the anti-PD-1 drugs and their ability to treat melanoma, he got excited. Studies of Merck's version of the drug found that 38 percent of participants in a clinical trial for patients with melanoma saw tumors shrink. Of those who took the highest doses of the drug, 52 percent experienced tumor shrinkage.
Dr. Jedd Wolchok, an oncologist who has not met or treated Auden but has corresponded with him through email, told ABCNews.com that immune cells typically don't attack cancer in a meaningful way because of a kind of natural brake function called PD-1. But the new anti-PD-1 drugs cancel out that brake and allow the immune cells to attack the cancer.
Although there are currently no anti-PD-1 drugs in "compassionate use" trials -- trials for individuals who don't qualify for clinical trials but still want the drug -- Wolchok said there was chance the drug could offer Auden long-term benefits.
"This kind of medicine is not the kind of medicine that if it works, it works for a few weeks and stops working," said Wolchok, a melanoma specialist at Memorial Sloan-Kettering Cancer Center in New York. "If medications like this work, they tend to benefit people for months or years. Some people might even be 'cured.'"
Auden said he was told that in order to be accepted into a clinical trial for the anti-PD-1 drug, he would need to have either no brain tumors or brain tumors that were at least no longer growing.
Wolchok explained that the drug had the potential to cause brain swelling in people with existing brain disease.
Since Auden had brain tumors, he and his oncologist, who declined to be interviewed for this story, worked to stabilize the tumors using a combination of drugs and other therapies. After months of monitoring his brain scans, Auden got good news in July: His tumors had not grown, and he qualified for the Merck trial.
They high-fived in the doctor's office.
But hours later, Auden experienced abdominal pain and sent his doctor a message. The doctor said to go straight to an emergency room, because there was a possibility he had a perforated intestine.
"Sure enough, I did," Auden said. "That instantly disqualifies you for the trial."
Auden's wife, of course, had other plans, hatched during those sleepless nights at 3 a.m.
Maybe he could become an individual case study under compassionate use rules, which give people access to experimental drugs even if they don't fit into clinical trials, the Audens thought.
That's when the "Save Locky's Dad" campaign took hold, launching two weeks ago with the goal of reaching 150,000 signatures. Once it attained that goal, the Audens upped it to 200,000.
"It's really surpassed anything that we could have imagined," Amy Auden said.
Emails poured into the Audens' inbox from people wishing them luck and sharing stories of how their relatives used the drugs and had positive results.
Bristol-Myers Squibb told ABCNews.com it couldn't comment on Auden's case but couldn't yet allow the drug to be used outside clinical trials, citing safety considerations.
"When you've been given a terminal diagnosis, you're prepared to accept a drug that's 50 percent effective," Auden said. "Safety concerns don't really figure in the same way."
In a statement to ABCNews.com, Merck said it was working to make the drug available to patients outside clinical trials, but its supply was limited. All available supplies, it said, were being used in clinical trials.
"Merck cares deeply about helping patients who face significant treatment challenges, and we are dedicated to making our medicines available to all patients as soon as possible," a Merck spokesman said in the statement. "That is why we have moved our PD-1 program forward faster than any other research program in nearly 20 years, and we have accelerated production."