He’s 20. Has brain cancer. And is caught in the crossfire between the FDA and a renegade doctor
The dizziness didn’t much worry Neil Fachon. Neither did the double vision. He was recovering from concussions he had sustained while playing sports, and the symptoms weren’t enough to keep him from his engineering classes at Northeastern University in Boston.
Then came some inexplicable struggles with handwriting and swallowing.
Doctors scheduled an MRI. On March 4, his life came unhinged.
Oncologists at Massachusetts General Hospital told Neil, 20, that he had a rare and incurable form of cancer known as DIPG, or diffuse intrinsic pontine glioma, which attacks the brain stem and
usually kills its victims in a year or less.
The diagnosis dropped the college sophomore into a maelstrom. Doctors laid out one course that seemed of little use. Herbalists recommended dietary changes. Neil and his family grew excited about an experimental therapy offered by a renegade Texas physician, Dr. Stanislaw Burzynski, and he flew to Houston to get infusions — but got them for just for a single day before federal regulators abruptly ordered the treatments to stop.
Soon, Neil’s family was suing the Food and Drug Administration for the right to keep trying the new therapy. Late last week, the Fachons won, and Neil resumed the treatments.
The family drama comes amid growing tension — in Congress and across the US — about how far terminally ill patients can, and should, go in search of a miracle.
The family had known about Stanislaw Burzynski, who promotes an experimental treatment made from amino acids and peptides that he says cancer patients lack. Burzynski has tangled for decades with federal and state regulators; they have accused him of unethical conduct, of sloppy record keeping — and of repeatedly jeopardizing his patients with risky treatments and drug overdoses.
Despite his record, the Food and Drug Administration authorized Burzynski to run a clinical trial of his treatment on a brain stem tumor. The clinical trial meant the family would not have to pay for the treatment, which can run in the tens of thousands of dollars and is not covered by insurance.
In mid-April, Neil became
the one and only patient enrolled.
In the 1980s, the Texas Medical Board reviewed Burzynski’s use of antineoplaston therapy on about 60 patients to see if it was safe. The results were inconclusive. In 1988, the board accused him of violating the Medical Practice Act, in part because he had given patients the therapy after the FDA had put a hold on clinical trials. A Texas trial court later threw the case out. The board has called for suspending his license for violating medical standards.
The FDA has come down on Burzynski, too. Of particular interest to the agency: the clinic’s Institutional Review Board, which is charged with approving the protocols of research trials and protecting patient safety. The FDA concluded in 2008 that the board didn’t do enough to minimize risk to trial participants, failed to ensure patients gave informed consent, and otherwise neglected its responsibilities.
Strikingly, the FDA also said that when a member of the review board had a conflict of interest, non-IRB members were allowed to step in as substitutes. FDA regulations prohibit that practice. The FDA sent several warning letters but did not shut down the clinic.
In 2012, a young boy died in one of Burzynki’s trials, and both the Texas Medical Board and the FDA again investigated. The results were troubling for Burzynski.
In a harsh warning letter to Burzynski, dated Dec. 3, 2013, the FDA said the doctor had “failed to protect the rights, safety and welfare of subjects under your care.”
The agency also noted that Burzynski had
failed to report adverse reactions that patients suffered in the clinical trial, as required by law, and neglected to obtain informed consent, especially regarding additional fees for the treatment. He was also cited for
failing to maintain accurate case histories — which are crucial to figuring out whether a treatment actually works.
And that wasn’t all.
“Overdoses have been reported to you on a weekly basis during your Monday, Wednesday and Friday staff meetings. There is no documentation to show that you have implemented corrective actions during this time period to ensure the safety and welfare of subjects,” reads one federal inspection report from 2013.
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Originally Posted by donnay
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