Thank you Leon Peek for sharing this story. This fight with the FDA over their approval process is not new and we must honor Kyle and so many others by picking up the battle where they left off.
by Terry Frank – November 23, 1999
The painfully disturbing picture “The Scream” painted by Edvard Munch is one of those images that once seen, is forever burned into memory.
I always thought of that painting as a silent scream, but never had I thought in a million years, I would have to witness just that, a silent scream. More haunting then Munch’s masterpiece, is the true life image that is now indelibly etched on my brain. Kyle was told yesterday that his Myotrophin injections were about to come to a screeching halt. What we both truly believe is responsible for his still being with us today, is now to be removed from his repertoire of hope.
Nearly 200 other PALS received the news today from NORD (National Organization of Rare Disorders) of Cephalon’s discontinuance of the MYOTROPHIN expanded access program. Due to the lengthy delay in achieving marketing approval status from the Food & Drug Administration, and no clear sign that an approval will be in the near future, Cephalon felt they could no longer afford to provide no cost access to Myotrophin, as it has for the past 3 years. NORD has been the organization handling the random selection process for the expanded access program of Myotrophin.
The ALS March of Faces Banner had begun, because Kyle and so many other PALS had the courage to speak out to the FDA on just this matter. To give us the hope, the 26% slowing of progression hope, the additional few years of quality life hope, the chance to see a cure found hope.
It is unfathomable to us how this could happen, when just 2 years ago, we talked with so many officials from the FDA. Back then, I specifically asked Dr. Robert Temple, Director of Medical Policy, what if Myotrophin doesn’t get approved, what do you tell the patients like Kyle, who are on the drug and feel there is benefit?
Dr. Temple replied, that generally the pharmaceutical company will continue to supply the drug as long as the patient wishes to continue.
Well, perhaps Dr. Temple was thinking of a much larger pharmaceutical company, or perhaps Dr. Temple didn’t think Kyle or nearly 200 other patients would still be around in 3 years for it to matter. It DOES matter, Dr. Temple, and personally I believe you should have been the one to tell Kyle and face that silent scream.
Aug. 7 1958 – Aug. 9 2003