On June 29, 2016, Michael Mosier Defeat DIPG Foundation Executive Director Jenny Mosier gave a statement at a U.S. Food and Drug Administration public hearing on DIPG, before the the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee. She was grateful to attend as a National Brain Tumor Society volunteer and on behalf of Michael Mosier Defeat DIPG Foundation.
“I respectfully urge the FDA to adopt the view that pre-treatment biopsy is an ethical, and potentially essential, surgical intervention that could benefit children facing this disease that is presently considered terminal on diagnosis,” Mrs. Mosier stated, “We were choosing a treatment that would be our six-year-old son’s only chance of surviving. We would have wanted any additional information we coul gather to guide us towards the most promising therapy . . . the existing options are simply insufficient and unacceptable.”
The Pediatric Subcommittee of the Oncologic Drugs Advisory Committee concluded that given the prospect of benefit for the population of DIPG patients, coupled with the evidence that biopsies can be conducted on tumors in the brainstem without significant adverse incidence, there is a favorable risk/benefit calculation that led the group to conclude they were supportive of the use of biopsies when done within a clinical trial or systematic investigation. This conclusion followed strong presentations from outside guest speakers Dr. Mark Kieran, Dr. Jeffrey Leonard, and Dr. Nalin Gupta pertaining to DIPG treatment opportunities and details on surgical experiences with DIPG biopsies. Five parents, including Mrs. Mosier, spoke at the hearing to share their children’s treatment experiences and provide the parent perspective on the question of pre-treatment biopsies.
The subcommittee considered DIPG biopsy and treatment options in the context of the devastation that this disease inflicts: that 90% of kids will not survive 2 years and that overall survival is near 0%. There was a general consensus that we have to look at new, creative, and novel approaches. The FDA’s conclusions were positive steps towards advancement in the search for treatments and a cure to DIPG. Michael Mosier Defeat DIPG Foundation expresses its appreciation to the FDA, and in particular the Pediatric Subcommittee, for its time and careful attention to these important issues.
The full text of Jenny Mosier’s statement can be found HERE.