California couple begs Big Pharma for potentially lifesaving treatment

They were high school sweethearts, meeting in sixth grade. She wore a pink dress as his prom date and he wore a pink tie as her bridegroom when they married in Maui after college graduation. They've traveled around the world, lived in San Francisco and New York City, and been through an ordeal no couple should face in their mid 20s: two years after their wedding, Mikaela was diagnosed with Stage IV kidney cancer.

Sometimes cancer patients are eligible for clinical trials, where they are given medication that isn't yet approved by the FDA. Mikaela is not elegible for a clinical trial for three reasons: the cancer has spread to her brain, she has a history of pneumonia, and her cancer is a rare subtype of renal cell carcinoma. After being rejected from several trials and having exhausted all other FDA-approved treatments, the couple's Hail Mary strategy is to petition Merck, Bristol Myers-Squibb and Genentech for a compassionate use trial. All three companies are developing new forms of treatment that prevent cancer cells from "hiding" from the body's immune system.

Compassionate use is exactly what it sounds like: it provides the patient with an as-yet unapproved drug on a case-by-case basis, depending on two factors. One, there must be an oncologist willing to oversee the treatment, and two, a pharmaceutical company must be willing to provide the drug. As Mikaela's husband, Keith Knapp, explains, "Compassionate use is a clinical trial (with a sample size) of one. They have something to gain because they haven't found whether these drugs have any impact on brain metastases (spreading of cancer to the brain). I don't see why it would be an issue when we're willing to completely sign away any right to sue if she dies. "

Mikaela has intense pain in her lower back on the right side, where her kidney tumor resides. She's on an extreme pain regimen (methadone, gabapentin, oxycodone, fentanyl, dilaudid) and the pain still breaks through. She also has been fighting pneumonia, and her breathing gets labored. She is on oxygen all the time because her lungs can't effectively process oxygen to her blood. She lost her hair because of brain radiation. The couple has found that marijuana is the best antidote to the nausea that Mikaela feels.

But through it all, Mikaela has kept a positive attitude. Photos show her gamely eating popsicles and smiling up from hospital bed after hospital bed as she fights for additional years of happiness.

Speaking of their meeting in sixth grade at a small school near Sacramento, Keith says, "I eschewed sports at recess that year to swing on the swings with Mikaela... I liked her right away." The couple is encouraged by recent communications from Merck, which expressed interest in talking with their oncologist. A representative from Merck did not immediately return inquiries for comment. Meanwhile Mikaela's petition has garnered more than 150,000 signatures.

The couple may also take hope from another "compassionate use" plea that took social media by storm earlier this month. Supporters of 7-year-old Josh Hardy, a cancer patient battling a life-threatening infection, were able to convince N.C.-based drug maker Chimerix to offer a new pilot study with Josh as the first patient.

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