The Treating Corticobasal Syndrome (CBS) website was created after Don Sladek courageously and successfully participated in a Phase I trial with Biogen’s medication: BIIB092, Gosuranemab; and then denied access to the drug. We, as well as Don’s neurologist, Dr. Yvette Borderlon from the University of California, Los Angeles, have applied to Biogen under the Right-to-Try Act, and Compassionate Use and denied four times. We are pleading for help to have Biogen revisit their policy.
My husband, Don, has Corticobasal Syndrome (CBS), and he participated in the TauBasket Trial at the University of California, San Francisco (UCSF), with Dr. Boxer as the primary investigator. Biogen provided the drug BIIB092, Gosuranemab, but was not the sponsor. Don has had miraculous improvement, although no one is quite sure why.
The drug was also studied in a trial for Progressive Supranuclear Palsy (PSP) called the PASSPORT trial. Unfortunately, this trial did not meet its endpoint goals. As devastating as this is for the PSP patients and families; personally, I’m in favor of stopping a trial that is not working. It’s not fair to the investors, and most important, it’s not fair to the patients. They need to be able to go on to the next potential cure, and for goodness sake, let’s not sell snake oil to desperate people.
But here is our problem, when Biogen stopped the PSP trial, they capriciously terminated access to the medication for anyone that participated in the TauBasket trial. Furthermore, they refuse to acknowledge the TauBasket trial because UCSF was the sponsor.
I am advocating for him to continue the drug. It is my understanding that the TauBasket had a total of 22 patients; 8 were CBS patients, and two of the eight saw significant improvement, including Don, who saw miraculous changes. We want to continue the drug.
Biogen is currently manufacturing the same drug for 645 patients in its Alzheimer’s TANGO, phase 2 trial; making a few more doses for those that have a PROVEN and DOCUMENTED improvement should be allowed, and encouraged. Biogen should be grateful that an independent investigator sponsored trial has shown such efficacy with their medication.
Don does not have any other options available to him. There has never been a medication available that may slow the progression or cure Corticobasal Syndrome. CBS is an orphan disease. We are not confused; his life, as one individual, has no value. We have been told that IF another clinical trial becomes available, Don would have to go through the 6-month washout period, and still, he may NOT be allowed access. The likelihood of another drug company accepting Don is slim because any positive effect could be linked back to Biogen and not that company’s drug.
Biogen has had no problem asking volunteers to be human lab rats and check the tolerance of their drug.
Isn’t there an ethical component to offer the drug when it works?
Doesn’t the scientific community want to know what has happened with these two volunteers?
Isn’t the goal of a clinical trial to find treatment that works?
The Treating Corticobasal Syndrome (CBS) website was created after Don Sladek courageously and successfully participated in a Phase I trial with Biogen’s medication: BIIB092, Gosuranemab; and then denied access to the drug. We, as well as Don’s neurologist, Dr. Yvette Borderlon from the University of California, Los Angeles, have applied to Biogen under the Right-to-Try Act, and Compassionate Use and denied four times. We are pleading for help to have Biogen revisit their policy.
My husband, Don, has Corticobasal Syndrome (CBS), and he participated in the TauBasket Trial at the University of California, San Francisco (UCSF), with Dr. Boxer as the primary investigator. Biogen provided the drug BIIB092, Gosuranemab, but was not the sponsor. Don has had miraculous improvement, although no one is quite sure why.
The drug was also studied in a trial for Progressive Supranuclear Palsy (PSP) called the PASSPORT trial. Unfortunately, this trial did not meet its endpoint goals. As devastating as this is for the PSP patients and families; personally, I’m in favor of stopping a trial that is not working. It’s not fair to the investors, and most important, it’s not fair to the patients. They need to be able to go on to the next potential cure, and for goodness sake, let’s not sell snake oil to desperate people.
But here is our problem, when Biogen stopped the PSP trial, they capriciously terminated access to the medication for anyone that participated in the TauBasket trial. Furthermore, they refuse to acknowledge the TauBasket trial because UCSF was the sponsor.
I am advocating for him to continue the drug. It is my understanding that the TauBasket had a total of 22 patients; 8 were CBS patients, and two of the eight saw significant improvement, including Don, who saw miraculous changes. We want to continue the drug.
Biogen is currently manufacturing the same drug for 645 patients in its Alzheimer’s TANGO, phase 2 trial; making a few more doses for those that have a PROVEN and DOCUMENTED improvement should be allowed, and encouraged. Biogen should be grateful that an independent investigator sponsored trial has shown such efficacy with their medication.
Don does not have any other options available to him. There has never been a medication available that may slow the progression or cure Corticobasal Syndrome. CBS is an orphan disease. We are not confused; his life, as one individual, has no value. We have been told that IF another clinical trial becomes available, Don would have to go through the 6-month washout period, and still, he may NOT be allowed access. The likelihood of another drug company accepting Don is slim because any positive effect could be linked back to Biogen and not that company’s drug.
Biogen has had no problem asking volunteers to be human lab rats and check the tolerance of their drug.
Isn’t there an ethical component to offer the drug when it works?
Doesn’t the scientific community want to know what has happened with these two volunteers?
Isn’t the goal of a clinical trial to find treatment that works?
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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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