Regulations Crush Hopes of Cancer Patient
Right-to-try laws challenge FDA's bottleneck on a promising treatment.


Jillian Kay Melchior

‘I met my wife in sixth grade,” says Keith Knapp, age 24. “She transferred to this small little school I was going to, and I liked her right away. I stopped playing basketball at recess and instead started swinging with her.” Life moved fast for Keith and his beloved Mikaela ever since — the two started dating in 2005, at age 15. In 2011, they got married in Hawaii. This year, he’s fighting to save Mikaela’s life.

Last year, Mikaela noticed a painful lump on her ribs. At first, her doctor diagnosed it as a fluid buildup and sent her home with painkillers and steroids, which seemed to help. But by fall, the bump was back and bigger. A CT scan revealed numerous tumors, which were at first diagnosed as lymphoma.

But after a pathology test, “the oncologist came in looking very grim and told us it was kidney cancer,” Keith says, recalling how he immediately began researching the illness on his computer. “It went to way over 90 percent chance of not living over a year. And over the course of the next couple days, we found out it had spread to her bones, her brain, and to her lungs. . . . It was a nasty type. It wasn’t even just generic kidney cancer. It was a rare subtype. There have only been a couple hundred cases in the medical literature. So every day, we’d get woken up at like six in the morning [at the hospital], and they’d just be dumping new bad news on us.”

In the six months since 25-year-old Mikaela’s diagnosis, she and her doctors have exhausted all treatment options — save one. An experimental cancer drug called anti-PD-L1 immunotherapy is currently in clinical trials and has shown great promise in treating cancer, even in advanced stages like Mikaela’s.

There is no guarantee that the experimental drug would save Mikaela’s life, but “just that little chance of a miracle happening — it’s so much more to latch on to than what we’ve had up to this point,” Keith says. “So if there’s some little, tiny chance that it may cure her cancer — an infinitesimally small number that’s larger than zero — that’s still greater than zero.”

The problem is, red tape has prevented Mikaela from even trying this treatment.

Clinical trials accept only “typical” patients — Mikaela’s rare form of kidney cancer has ruled her out, but for others in her situation, complications as common as diabetes or high blood pressure could also be reason for ineligibility.

And the Food and Drug Administration’s approval process for “compassionate use” of an experimental drug outside of clinical trials is extremely arduous.