Regulatory Focus™ > News Articles > Judge Overrules FDA, Allows Trial for Terminally Ill Patient at Questionable Clinic to Resume

Judge Overrules FDA, Allows Trial for Terminally Ill Patient at Questionable Clinic to Resume

Posted 18 May 2016 | By Zachary Brennan 

Judge Overrules FDA, Allows Trial for Terminally Ill Patient at Questionable Clinic to Resume

A US District Court Judge late Tuesday overturned a US Food and Drug Administration (FDA) hold on a clinical trial for at least one patient with an incurable brain tumor, though the institute running the trial has been cited by FDA with numerous warning letters and criticized for offering false hopes to desperate patients for more than 30 years.

“The full clinical hold imposed by the Defendant [FDA] is lifted as to treatment for Eugene Neil Fachon for DIPG [Diffuse Intrinsic Pontine Glioma] at the Burzynski Research Institute, Inc. in Houston, TX,” Judge John J. McConnell, Jr. ruled on Tuesday. “The Defendants [FDA] are restrained and enjoined from interfering with this treatment for Mr. Fachon until a full hearing on a preliminary injunction takes place. The Court finds that there is a likelihood of success on the merits because Mr. Fachon has a liberty interest in continuing to receive a drug addressing his life-threatening disease that the FDA had previously allowed him to receive.”

The temporary restraining order was filed on Tuesday and immediately granted, which means FDA has not had a chance to respond. An FDA spokeswoman told Focus the agency cannot comment on pending litigation.

Neither the Burzynski institute, Neil Fachon, the patient involved in the trial and an engineering student at Northeastern University, nor his father responded to requests for comment.

Serious Questions

The ruling follows FDA’s decision in April to halt the clinical trial following a 2015 inspection of the institute’s manufacturing facility, during which FDA found a number of serious violations that raised concerns about the safety of those receiving products manufactured at the facility, including individuals enrolled in clinical investigations at the institute. 

FDA’s concerns follow a USA Today investigation from 2013 that found Stanislaw Burzynski “has been selling false hope to desperate families” for more than three decades, while an investigation from the Houston Press in 2008 revealed that FDA has been working to stop Burzynski since 1978.

Indeed, the National Cancer Institute (NCI) says there is no evidence that Burzynski, who is not board certified or formally trained in oncology, has cured a single patient or extended the lives of any patients.

FDA’s order from April also said the Burzynski Research Institute “is not permitted to enroll new subjects into clinical investigations, or to resume administration of antineoplastons to any individuals previously treated.”

That order followed a warning letter from 2013 to Burzynski for failing to protect the rights, safety and welfare of subjects under its care, among other issues. And back in 1995, a federal grand jury indicted Burzynski on felony charges, including for violations of the federal Food, Drug and Cosmetic Act. As a condition of his bail, a judge ordered him to stop prescribing what are called “antineoplastons." The NCI says in a 2006 report from Burzyniski summarizing the results from four Phase II trials of antineoplaston treatment for "high-grade, recurrent, and progressive brainstem glioma" in which complete responses were observed in two of the 18 patients, partial response in two cases, stable disease in seven cases and progressive disease in seven cases. Reversible anemia, the only reported adverse effect, occurred in three patients. 

“To date, no phase III randomized controlled trials of antineoplastons as a treatment for cancer have been conducted,” NCI says.

Antineoplastons are being used in the trial in which Judge McConnell ruled. 

Judge McConnell called FDA’s decision to halt the trial an “arbitrary and capricious claim given the extraordinarily long and unexplained delay between the March 19, 2015 conclusion of the inspection and the April 21, 2016 letter imposing a hold on the clinical trial … FDA has known the condition of this drug and the clinic for over a year, yet took no action until after Mr. Fachon had enrolled.”

A hearing on a preliminary injunction will be set within 14 days, Judge McConnell said.


Categories: Regulatory News

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