HUDSON — A Hudson cancer patient has been granted permission to begin treatment with a drug that has not been approved by the Food and Drug Administration.
But before 12-year-old McKenzie Lowe can begin antineoplaston treatment (ANP), an alternative medicine piloted by controversial Texas doctor Stanislaw Burzynski, her family must find a local doctor who is willing to help.
McKenzie, the daughter of Ron and Dianne Lowe, was diagnosed with a DIPG, a rare, inoperable brain tumor in November 2012. After conventional treatments failed, the Lowe family began lobbying the FDA to grant McKenzie a compassion exemption.
FDA officials will occasionally allow use of an experimental drug in cases where a patient's diagnosis is terminal and traditional treatments, such as radiation and chemotherapy, aren't working.
This week, family friend Kim Frenette said finding a doctor willing to treat McKenzie with ANP is easier said than done.
"In order to help us, that doctor would have to be willing to work with the FDA," Frenette said. "And the FDA would have to be willing to work with that doctor."
To complicate matters further, a potential doctor would need to fill out a 200-page FDA application as part of the compassion exemption process.
Burzynski has agreed to work with the family and any local doctor they choose, and has also agreed to provide the ANP infusions at no charge.
The drugs are administered intravenously, with patients wearing a portable backpack.
Frank LaFountain, McKenzie's grandfather, said the family's insurance policy would hopefully cover any doctor's fees, though that too is unclear at this time. LaFountain had previously moved to Florida for his retirement, but returned to the area following McKenzie's diagnosis.
"A big problem is, no doctor wants to be associated with Burzynski," Frenette said. "He's controversial, and for many it would be career suicide."
For that reason, Frenette said, the family believes an ideal situation would be to work with a doctor who is not only experienced in pediatrics and oncology, but is also nearing retirement. They're hoping they'll be able to begin treatment while McKenzie is still relatively healthy and active.
As they wait to see what tomorrow may bring, the family is staying positive.
"We're pushing forward and making some progress anyways," Frenette said. "Things are starting to happen."
Burzynski began treating certain brain tumors with ANP nearly four decades ago, though his most recent clinical trials were put on hold by the FDA last year after a six-year-old New Jersey patient died while being treated with the experimental drug.
Proponents of ANP treatment noted the little boy's diagnosis was already terminal, and he had already received extensive chemotherapy and radiation by the time he began receiving treatment for his inoperable brain tumor at Burzynski's clinic
Last Friday, the FDA agreed to allow McKenzie and seven other patients around the country to be treated with ANP, on the FDA's terms.
"Even in our family there is discussion and disagreement with trying this," LaFountain said this week. "But what really matters is that McKenzie wants to do this and her parents want to do this. What else is there?"
Ric Schiff, founder of the California-based ANP Coalition, said the FDA recently granted Burzynski permission to enter the second phase of the drug's clinical trial — an early step in the approval process.
Schiff said the clinical trial process is a slow one and tumors like McKenzie's are relatively rare, making it difficult to find enough patients to participate.
Meanwhile, McKenzie and other families hoping to work with other doctors in their respective compassion exemption cases are in a race against time.
Schiff said he knows of at least one doctor in Texas who has agreed to work with Burzynski and the FDA to help another brain tumor patient.
"He's in the application process right now," Schiff said on Monday.
He added that it's "very, very difficult to find a doctor willing to work with an investigational new drug."
"You're signing up to work with a patient that's not expected to live," Schiff said. "That doctor, in turn, is agreeing to very little compensation, a huge amount of paperwork and the potential for liability."