NEW: Sen. Reed Speaks with FDA on Behalf of Dying East Greenwich 20-Year-Old
Monday, May 16, 2016
GoLocal has learned that United States Senator Jack Reed (D-RI) spoke Saturday with the head of the Food and Drug Administration, Dr. Robert M. Califf, MD, on behalf of the terminally ill Eugene “Neil” Fashon.
According to Reed’s office and the Fashon family, the Senator asked Dr. Califf to review why the Phase II Clinical Trial consisting of Fashon, which had been approved by the FDA, was canceled after 10 days of treatment.
The FDA approved Eugene “Neil” Fachon’s last hope to live, and now they have halted the very clinical trial they had approved.
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As GoLocal reported on Saturday, Fachon is facing a death sentence. The 20-year-old from East Greenwich has an incurable form of pediatric cancer — Diffuse Intrinsic Pontine Glioma (DIPG).
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.
Fachon was diagnosed on March 4 of this year at Mass General Hospital and was told that he had approximately three months to live, according to Dean Fachon, the father of Neil.
The Fashon family has been frustrated by the FDA’s decision to stop the trial. In April, Fachon was selected for an approved clinical trial by a Houston-based physician, Stanislaw Burzynski, who is the founder of the Burzynski Research Institute. Burzynski is highly controversial and now under review from the Texas Medical Board.
According to the federal government, the clinical trial, titled “A Study of Atengenal and Astugenal in Diffuse Intrinsic Pontine Glioma (DIPG),” which was first green-lighted in April of this year and is termed “experimental” is now marked on the website as “this study is ongoing, but not recruiting participants."
Now, the family anxiously awaits an FDA approval. The Fashon’s attorney Kathleen Hagerty told GoLocal on Friday that they will pursue every option.
"It is our sincerest hope that the people within the FDA will reconsider and reverse the decision to suspend the clinical trial Neil had been participating in. Neil is out of options, conventional treatments are ineffective and time is of the essence,” said Hagerty. “We are prepared to petition the court if need be but would much prefer to come to a resolution with the agency that would permit Neil to resume and sustain his treatment, without which there is every reason to believe Neil will succumb to this cancer, possibly within weeks per his original diagnosis."
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