HUDSON — Back from his whirlwind trip to Washington, D.C., last week, Frank LaFountain is feeling hopeful for granddaughter McKenzie Lowe’s future.
LaFountain spent Tuesday through Friday knocking on doors in the nation’s capital, hoping to make a personal plea to legislators and the FDA to reconsider its decision to prohibit Lowe from obtaining an alternative treatment for her brain tumor.
The Hudson 12-year-old, who is the daughter of Pinehurst Drive residents Ron and Dianne Lowe, was diagnosed with an inoperable brain tumor known as Diffuse Intrinsic Pontine Glioma (DIPG) in November 2012.
Following unsuccessful conventional treatments, Lowe’s family has been trying to have her treated with antineoplaston therapy at Dr. Stanislaw Burzynski’s controversial clinic, the Burzynski Research Institute in Houston.
In such therapy, used in clinical trials or under a compassion exemption, a patient carries a backpack containing a portable device that administers antineoplastons into the bloodstream intravenously.
According to Burzynski, antineoplastons are naturally occurring peptides found in blood and urine. Burzynski says antineoplastons have the ability to reprogram cancer cells without destroying normal cells.
Antineoplastons, or ANP, were developed in the late 1960s and are now produced synthetically.
Until last year, the cancer therapy had been offered as part of clinical trials in the United States since the early 1980s, but the FDA has yet to approve it for general use.
New clinical trials of ANP were stopped at Burzynski’s clinic after the U.S. Food and Drug Administration (FDA) released documents from an inspection there that accused the doctor of “admitting patients who failed to meet inclusion criteria and failing to stop treatment in patients who had reactions to the antineoplastons.”
The FDA placed a partial clinical hold on Burzynski’s practice — meaning patients already involved in the trials could continue but new patients would not be allowed — and over the past few months, Lowe’s family has been trying to obtain a “compassion exemption,” the term used when FDA officials allow an experimental drug to be used in cases where a patient’s diagnosis is terminal.
An online petition on the Change.org website for McKenzie Lowe had 64,204 signatures on Tuesday. Family friend Kim Frenette said she’s hoping to see that number reach 100,000 to help influence the folks in Washington.
LaFountain, a native of Billerica, Mass., who moved to Florida but is staying in Hudson for now, said he is fully aware of the sanctions against Burzynski.
“It’s a chance you have to take when it’s the only chance that you have,” he said.
LaFountain met individually with some legislators or their staffs last week, including U.S. Sens. Kelly Ayotte, R-N.H., and Jeanne Shaheen, D-N.H., as well as Elizabeth Warren, D-Mass., Ted Cruz, R-Texas, Rand Paul, R-Ky., Ed Markey, D-Mass., Dianne Feinstein, D-Calif., and Tom Harkin, D-Iowa.
He also attended a meeting with seven FDA officials, though FDA Commissioner Margaret Hamburg was traveling and wasn’t present at the meeting.
“Basically, we told (the FDA) that it would be nice if we could get everyone sitting down at one table with them — doctors, patients and legislators,” LaFountain said. “Because there hasn’t been enough communication here. To date, no one has told the Burzynski clinic exactly what needs to be corrected.”
The Lowe family is also working with lobbyists to further extend their influence on the FDA.
One issue that arose in last week’s discussions, LaFountain said, was the fact that traditionally parents had treated their children with Burzynski’s intravenous therapy at home, which may have led to problems in the past.
Local legislators have stood by the Lowe family, maintaining the family’s right to have their child treated as they see fit.
Ayotte and Shaheen contacted Hamburg last month, urging the FDA to work directly with the Lowe family.
“Given the complexity of her medical issues, we feel the FDA could be helpful by speaking directly with McKenzie’s family,” the two senators wrote in a Jan. 17 letter. “A discussion would allow both the family and agency to provide updated information on all the relevant issues surrounding this difficult case.”
As is stands now, the Lowe family is awaiting further word from Washington.
During a partial clinical hold, the Burzynski clinic can treat only current patients and isn’t permitted to accrue any new patients until the hold is lifted.
Dr. Greg Burzynski, son of Stanislaw Burzynski, is the founder of the Burzynski Research Institute and vowed to assist the Lowe family in every way possible.
The younger Burzynski, who serves as the clinic’s vice president, said the FDA’s partial clinical hold has affected several other patients, and officials were trying to comply with the FDA in order to get back into practice.
Once that happens, Lowe’s family won’t have to pay for the antineoplaston, as the Burzynski clinic offers its ANP formulations free of charge to patients participating in clinical trials or under compassion exemption. The family is hoping their insurance plan will cover associated medical costs — including local doctor visits — which can average thousands of dollars each month.
“Right now, it’s a waiting game,” he said. “But the bottom line is we’re committed to doing everything we can to ensure McKenzie gets her treatments as planned.”
California resident Ric Schiff, founder of the nonprofit ANP Coalition group, said the clinic’s ongoing battle with the FDA is misleading the public.
“The simple fact is, these clinical studies wouldn’t have gone on as long as they had if (the FDA) didn’t believe they worked,” Schiff said.
Still, there are some members of the medical community who support the sanctions against Burzynski.
In 2012, the FDA investigated the death of Josia Cotto, 6, who died of complications from his brain tumor. Doctors said the boy’s sodium levels were elevated while he was being treated with ANP.
Schiff noted the child’s condition was declared terminal prior to his treatment at Burzynski’s clinic and he’d already received extensive chemotherapy and radiation by that time, both of which can also have devastating side effects.
“Let’s keep in mind that just about everybody that goes to Burzynski’s clinic already had terminal cancer by definition,” he said. “Most of them have already tried chemo and radiation and it’s failed them. So this is their last shot.”
Of the Burzynski therapy, the American Cancer Society said last week: “Relying on this type of treatment alone avoiding or delaying conventional medical care for cancer may have serious health consequences.’’
Science blogger Robert Blaskiewicz of the Skeptics for the Protection of Cancer Patients group, said he’s been researching Burzynski for the past two years and is genuinely concerned for Lowe’s well-being, should she ultimately be able to obtain ANP treatment.
“I’m all for patient choice,” Blaskiewicz said. “But I’m also for informed consent. Is the Lowe family aware of the stories, of the 20-year pattern of patients believing that unambiguous signs of progression are signs of success?”
Dr. David Gorski, an oncologist and the administrator of the sciencebasedmedicine.org website, has likewise devoted much of site to speaking out against Burzynski as well as the anti-vaccine movement and various forms of alternative medicine.
Contacted this week, Gorski said he believed previous trials of ANP “were designed to let Burzynski treat patients, not find answers.”
“There is no convincing evidence that antineoplastons are better than the current standard of care or even that they have any significant activity against (brain tumors) at all,” Gorski said.
But despite the naysayers, many patients and their families still consider the Houston physician nothing less than a miracle worker.
Manchester mother Cindy Smith said if it wasn’t for ANP, her son wouldn’t be alive today.
“We were one of the fortunate families that were allowed to go to Dr. Burzynski and without trying traditional chemo or radiation first,” Smith said.
Smith’s son, Ryan, was 10 when doctors diagnosed incurable brain cancer. She said she was told to “bring her son home and take him fishing, because even with chemotherapy he will only survive 18 months.”
Instead, the Smith family traveled to Houston, where he started ANP treatment,
“I’m happy to report he’ll be 27 this summer thanks to the antineoplastons,” Smith said.