Dear Physicians & Scientists,
Before the era of COVID-19, the Right-to-Try Act had not compelled pharmaceutical companies to allow early access to their medication; however, in the current climate, urgency is paramount. In this crisis, policies and procedures are evolving to advance new therapies and allow them to be tested and implemented. The FDA has shown that when there are "no adequate, approved, or available alternative treatments," they will seek multiple pathways to help critical patients. Dr. Tony Fauci has stated they are "going to do everything we can to make things that have even a hint of efficacy more readily available."
Neurodegenerative disorders are in this same battle over disability and death, and yet amongst all these diseases, Don's case is unique. He participated in a Phase I clinical trial with Biogen's medication BIIB092, Gosuranemab. Don has received the drug for 12 months without any adverse effects, and it worked! We have data that it has remarkably reduced symptoms and may lead to a cure. His case is the one that should be studied, and we are willing to grant access to Don in the form of MRIs, cerebrospinal taps, blood work, and anything we can do to help.
Biogen has repeatedly denied him access to their medication, because it was investigator sponsored. We are asking that the same measure of urgency that is being applied in the COVID-19 crisis be applied to Don, and that Biogen would mercifully allow him access to their life-saving drug BIIB092, Gosuranemab.
Since the TauBasket clinical trial was terminated, Don has regressed 20-25% in a six month period.
Laurie Zoloth, from the University of Chicago, summarizes the responsibilities of a clinical trial with this statement:
Before the era of COVID-19, the Right-to-Try Act had not compelled pharmaceutical companies to allow early access to their medication; however, in the current climate, urgency is paramount. In this crisis, policies and procedures are evolving to advance new therapies and allow them to be tested and implemented. The FDA has shown that when there are "no adequate, approved, or available alternative treatments," they will seek multiple pathways to help critical patients. Dr. Tony Fauci has stated they are "going to do everything we can to make things that have even a hint of efficacy more readily available."
Neurodegenerative disorders are in this same battle over disability and death, and yet amongst all these diseases, Don's case is unique. He participated in a Phase I clinical trial with Biogen's medication BIIB092, Gosuranemab. Don has received the drug for 12 months without any adverse effects, and it worked! We have data that it has remarkably reduced symptoms and may lead to a cure. His case is the one that should be studied, and we are willing to grant access to Don in the form of MRIs, cerebrospinal taps, blood work, and anything we can do to help.
Biogen has repeatedly denied him access to their medication, because it was investigator sponsored. We are asking that the same measure of urgency that is being applied in the COVID-19 crisis be applied to Don, and that Biogen would mercifully allow him access to their life-saving drug BIIB092, Gosuranemab.
Since the TauBasket clinical trial was terminated, Don has regressed 20-25% in a six month period.
Laurie Zoloth, from the University of Chicago, summarizes the responsibilities of a clinical trial with this statement:
“Having a human being as a subject means you have different obligations than you would to an animal or a petri dish.” - Laurie Zoloth
Please join us in requesting access to Biogen’s medication for my husband, Don Sladek.
Respectfully,
Chavonne Sladek
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THANK YOU“I would like to thank all of you from the bottom of my heart that took the time to read this site and those that took action concerning my situation with CBS. The clinical trial has helped my quality of life. My goal has always been to help science to help others with this terrible disease. God bless and thank you all.”
- Don Sladek |
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