UPDATED: Judge Rules for Dying RI Student to Resume Clinical Trial, Over FDA Objection
Wednesday, May 18, 2016
Kathleen Hagerty and Thomas Dickinson, the attorneys for dying 20-year-old East Greenwich college student Eugene "Neil" Fachon, today filed a suit against the U.S. Food and Drug Administration (FDA) in federal court. The suit seeks a temporary restraining order (TRO) against the FDA which will allow the previously approved Phase II Clinical Trial to resume.
The suit, EUGENE "NEIL" FACHON v UNlTED STATES FOOD AND DRUG ADMINISTRATION, and ROBERT M. CALIFF, IN HIS CAPACITY AS COMMISSIONER OF FOOD AND DRUGS, "seeks declaratory judgment that application of the Defendant FDA's clinical hold to him is arbitrary and capricious and deprives him of liberty without due process of law in violation of the Fifth Amendment. In addition, the suit asks the court to issue "an immediate Temporary Restraining Order permitting him to continue to receive treatment as provided in the approved clinical trial and prohibiting the Defendant FDA from interfering in any manner with that treatment."
The court ruled in favor of Fachon late today. Judge John McConnell granted the motions for the TRO against the FDA. Fachon's treatment will begin again starting tomorrow according to the family's attorney Hagerty.
GET THE LATEST BREAKING NEWS HERE -- SIGN UP FOR GOLOCAL FREE DAILY EBLASTNeil's father Dean Fachon tells GoLocal, "While it's a shame we had to seek legal assistance just for common sense to be heard, we are very thankful to Kathleen (Hagerty) for kicking into overdrive to work this as swiftly and professionally as we could have possibly hoped. Our battle is still just beginning, but at least we have a reprieve. Now we need to build a groundswell of support for the next hurdle, and ultimately to take the FDA to task for the pain and suffering they have caused."
Latest Step
As GoLocal first reported on Saturday, Eugene “Neil” Fachon has an incurable form of pediatric cancer — Diffuse Intrinsic Pontine Glioma (DIPG). Fachon entered into an approved FDA Clinical Trial in April and ten days into treatment, the FDA pulled the plug on the treatment.
“All we are asking for is the FDA to allow what they have already approved to go forward — it is literally our son’s last best hope,” said Neil’s father - Dean Fachon.
According to the FDA in response to questions submitted by GoLocal last Friday, the agency said it stopped the trial because "during a 2015 inspection of the S.R. Burzynski Manufacturing Facility, FDA found a number of serious violations of applicable law and FDA regulations that raised concerns about the safety of human subjects who received products manufactured at that facility, including individuals who are or may be enrolled in clinical investigations at the Burzynski Research Institute. In light of these concerns, at this time 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."
It is unclear why if there was a deficiency in 2015, the trial was able to begin in 2016 and then shut down within weeks. The agency refused to eloborate on the inconsistency, "Right now, the original answer below to the question of why allow the trial is the agency’s current response. If that changes, I will definitely let you know," said a spokesperson for the FDA in an email to GoLocal.
Last Chance?
Each year there are approximately 300 to 350 new cases of DIPG diagnosed in the U.S. — usually in children under ten. There is a zero survival rate for those diagnosed with DIPG, according to experts at the Weill Cornell Brain and Spine Center, who spoke with GoLocal on Friday.
The complaint filed in court today reaffirms that Fachon's future is bleak. "In or about March of this year Plaintiff was diagnosed by physicians at Massachusetts General Hospital with Diffuse Intrinsic Pontine Glioma (DIPG). The diagnosis was confirmed by Dr. Mark Kiernan of the Dana Farber Institute, a leading DIPG expert. This is a form of cancer for which there is no known cure, and which is expected to cause Plaintiff's death within approximately three months from his diagnosis. The standard care for DIPG patients is radiation therapy which is believed to prolong survival by no more than approximately three months.
Plaintiff has, after consultation with his family and multiple physicians, declined to pursue radiation therapy."
On Saturday, U.S. States Senator Jack Reed called the Commissioner of the FDA on behalf of Fachon asking Dr. Robert Califf to review the case.
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