Dear Politicians and Policy Makers,
The National Institutes of Health and The Federal Drug Administration have been tasked with providing medication in a responsible scientific manner, a decision that we applaud. We want you to research medication and make sure that it is safe. We believe in the scientific method. My husband, Don Sladek, is a Vietnam Era Veteran who was stationed in Southeast Asia. We proudly stand by the United States of America. He worked at Edwards Air Force Base's Rocket Propulsion Laboratory in the area of research and development. We understand and respect the benefits of well-coordinated research.
We are also aware that when dealing with terminal illnesses, there is not always the time that is needed to be as thorough as the scientific community would like. It is our understanding that was the purpose of having Compassionate Use or Early Access available. Alas, that was found to be inefficient, and the Right-to-Try Act was touted as the answer. This has also been a dismal failure for patients.
And yet, here is another conundrum. Don was healthy enough to participate in a Phase I, TauBasket clinical trial. There were 22 patients in that trial from four different cohorts with tau related diseases. He received an infusion of Biogen's BIIB092, Gosuranemab, every 28 days. The medication was found to be safe and has entered into a Phase II trial for Alzheimer's called the TANGO trial. The drug was found to be ineffective in a separate trial for Progressive Supranuclear Palsy (PSP) called the PASSPORT trial, and it was halted. Biogen did not sponsor the TauBasket trial, but provided the medication and capriciously terminated access to it when the PASSPORT trial was halted. What should be done when a trial medication is shown to be efficacious in a patient? In my opinion, if the drug is still being manufactured for another trial, it should be allowed for those that it has shown to work.
Don has requested access through the Right-To-Try Act to Biogen. He has been denied four times. We appealed to the FDA and were told, "We are currently reviewing the Right to Try Act and working to implement it in a manner consistent with Congressional intent and with FDA's public health mission."
In the world of COVID-19, the political and scientific community have shown they have the coalition and strength to work towards a solution utilizing clinical trials, experimental drugs, and medication used for other diseases. We ask that same courtesy be given to Don and that you intercede with Biogen and allow Don access to their potential life-saving medication.
We respect the liberty of pharmaceutical companies to operate without onerous backbreaking FDA restrictions, but there must be an industry self-regulated code of ethics. We need to amend the "Right-to-Try" Act to include access to success for volunteers in post clinical trials.
Respectfully,
Chavonne Sladek
The National Institutes of Health and The Federal Drug Administration have been tasked with providing medication in a responsible scientific manner, a decision that we applaud. We want you to research medication and make sure that it is safe. We believe in the scientific method. My husband, Don Sladek, is a Vietnam Era Veteran who was stationed in Southeast Asia. We proudly stand by the United States of America. He worked at Edwards Air Force Base's Rocket Propulsion Laboratory in the area of research and development. We understand and respect the benefits of well-coordinated research.
We are also aware that when dealing with terminal illnesses, there is not always the time that is needed to be as thorough as the scientific community would like. It is our understanding that was the purpose of having Compassionate Use or Early Access available. Alas, that was found to be inefficient, and the Right-to-Try Act was touted as the answer. This has also been a dismal failure for patients.
And yet, here is another conundrum. Don was healthy enough to participate in a Phase I, TauBasket clinical trial. There were 22 patients in that trial from four different cohorts with tau related diseases. He received an infusion of Biogen's BIIB092, Gosuranemab, every 28 days. The medication was found to be safe and has entered into a Phase II trial for Alzheimer's called the TANGO trial. The drug was found to be ineffective in a separate trial for Progressive Supranuclear Palsy (PSP) called the PASSPORT trial, and it was halted. Biogen did not sponsor the TauBasket trial, but provided the medication and capriciously terminated access to it when the PASSPORT trial was halted. What should be done when a trial medication is shown to be efficacious in a patient? In my opinion, if the drug is still being manufactured for another trial, it should be allowed for those that it has shown to work.
Don has requested access through the Right-To-Try Act to Biogen. He has been denied four times. We appealed to the FDA and were told, "We are currently reviewing the Right to Try Act and working to implement it in a manner consistent with Congressional intent and with FDA's public health mission."
In the world of COVID-19, the political and scientific community have shown they have the coalition and strength to work towards a solution utilizing clinical trials, experimental drugs, and medication used for other diseases. We ask that same courtesy be given to Don and that you intercede with Biogen and allow Don access to their potential life-saving medication.
We respect the liberty of pharmaceutical companies to operate without onerous backbreaking FDA restrictions, but there must be an industry self-regulated code of ethics. We need to amend the "Right-to-Try" Act to include access to success for volunteers in post clinical trials.
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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