I just donated $20 to the go fund me set up for Jake just because I was in awe of your writing and of the daunting struggles you describe. I am part of the chronic pain community and we are faced with our own struggle to live life with dignity, while so many of us are being denied adequate pain control. I see our stories parallel as you describe the denial of effective medications to those in dire need. Wishing you more good days than bad in the time you have together.
Thank you for writing this and sharing your story. My husband was diagnosed with GBM in 2017 and we spent the following couple of years navigating all of this, concerned about clinical trial doors closing as he started his second and then third chemo, then Avastin, etc. I remember feeling trapped trying to make decisions between treatment and accessing clinical trials with promising drugs. We are in need of a change for sure.
I am so sorry you and Jake have been there too, and I’m sorry to hear of the latest update. I wish you both strength and peace and precious time together. ❤️
Bess, I just read Jake's most recent post and wanted to send you some love from an internet stranger and a mother of an Athena. You and he are both remarkable. So many of us are thinking of you. I wish I had more to offer than distant support and the grief of a stranger, but it's what I have so there it is. You and Jake have made such an impact with your work and writing
Many years ago, my friend's husband developed a terminal cancer. (don't ask what kind because this was in late 70's, early 80's. M.D. Anderson entered him into a trial drug. My friend and her husband both said something like: "they know Randy is dying, but this drug may help." He volunteered to try it for the sake of others. Does this make sense to you, or is it just lay people trying to grasp life and death? Or, U of A oncologist offered my husband a trial---which turned out to be a placebo---and I thought that was cruel to prolong his bladder cancer metz to liver any longer. Our daughter is a psychologist PhD in the U of New South Wales Aus Med school. We used her contacts and databases to do some research on the drug John was offered. Perhapds, we should have left UA care and resolved to travel to PHX and back to be under the care of Donald L. Lamm MD, researcher now in private practice. Lamm did the research and gained FDA approval for BCG use for bladder cancer. He treated John from 2005 til 2013. John died in 2017. I didn't have the connections that you have, but enough healthcare experience to know just enought to be dangerous. Blessings on you and Jake. Say hi to your parents---those wonderful people.
I just read the latest update on Jake, and you, I’m so sorry you are going through this hell, and then the “should be avoidable hell” of trying to access available treatments that might help him!
Thinking of you, sending strength and peace to you both. 💞
Maybe a Constitutional law expert can answer this question: now that the Chevron doctrine is gone, would it be possible for a citizen to sue the FDA for the unjustifiable foot-dragging they've been doing on the so-called "fast-tracked" Covid medicine Xocova?
I imagine any sensible judge could read this year-old Atlantic article, see the absence of any progress - "fast" or otherwise, and quickly rule that the FDA's reflexive Tuskegee-style denial of lifesaving medicines really isn't what Congress had in mind.
Suing over Xocova wouldn't help Jake (unless he happens to catch Covid, in which case a giant mountain of clinical trial data tell us it would definitely help Jake), but the Xocova case could still be useful for highlighting the basic fact that the FDA has been slowly drifting into functioning as un-checked power-mad authoritarian autocracy. And I am really pulling my adjectival punches there. Inventing new words for the acronym FDA is one of my minor hobbies these days.
Awhile back, one of Jake's posts tipped me off to some draft legislation called the Promising Pathway Act. I'm finally getting around to writing my Congressional delegation. I stopped short of requesting that it be renamed the Seliger-Stillman Act, but others could feel free to do so.
Dear Senator XX,
I’m a constituent and an avid supporter residing in XX. I have a happy pandemic memory of the time my husband and I randomly met you and your dog in XX Park while we were on our way to XX Brewing.
I’m a research scientist specializing in vaccine development. During the pandemic, I’ve become increasingly interested in the topic of FDA policy reform - which is why I’m writing you to express my support for the bipartisan Promising Pathway Act (PPA) sponsored by Senators Mike Braun (R-IN), and Kristen Gillibrand (D-NY). My hope is that you can help to move the bill out of the Senate Committee on Aging for a floor vote.
My interest in the reforms proposed in the PPA is partly driven by a family tragedy. In late 2022, my cousin Marika was diagnosed with glioblastoma. She traveled to XX for treatment and her initial test results showed a mutation in a gene called FGFR2. Pemigatinib, a drug that specifically targets FGFR2, has been approved for treatment for a different type of cancer called cholangiocarcinoma. Marika’s requests to try Pemigatinib were denied. She died in the Spring of 2023.
Hi Bess! There is a program called “compassionate use” where a doctor can petition a drug company to provide a patient with a drug which is a part of a clinical trial without the patient partaking in the trial. The drug is provided for free to waive the drug company of any liability. However, the insurance company still needs to pay for the services associated with administering the drug.
In your previous blog posts you mentioned searching for trials which would be best for your husband according to his disease biology. Two recent tools have become available to streamline this process:
I just donated $20 to the go fund me set up for Jake just because I was in awe of your writing and of the daunting struggles you describe. I am part of the chronic pain community and we are faced with our own struggle to live life with dignity, while so many of us are being denied adequate pain control. I see our stories parallel as you describe the denial of effective medications to those in dire need. Wishing you more good days than bad in the time you have together.
Thank you for writing this and sharing your story. My husband was diagnosed with GBM in 2017 and we spent the following couple of years navigating all of this, concerned about clinical trial doors closing as he started his second and then third chemo, then Avastin, etc. I remember feeling trapped trying to make decisions between treatment and accessing clinical trials with promising drugs. We are in need of a change for sure.
I am so sorry you and Jake have been there too, and I’m sorry to hear of the latest update. I wish you both strength and peace and precious time together. ❤️
Bess, I just read Jake's most recent post and wanted to send you some love from an internet stranger and a mother of an Athena. You and he are both remarkable. So many of us are thinking of you. I wish I had more to offer than distant support and the grief of a stranger, but it's what I have so there it is. You and Jake have made such an impact with your work and writing
Many years ago, my friend's husband developed a terminal cancer. (don't ask what kind because this was in late 70's, early 80's. M.D. Anderson entered him into a trial drug. My friend and her husband both said something like: "they know Randy is dying, but this drug may help." He volunteered to try it for the sake of others. Does this make sense to you, or is it just lay people trying to grasp life and death? Or, U of A oncologist offered my husband a trial---which turned out to be a placebo---and I thought that was cruel to prolong his bladder cancer metz to liver any longer. Our daughter is a psychologist PhD in the U of New South Wales Aus Med school. We used her contacts and databases to do some research on the drug John was offered. Perhapds, we should have left UA care and resolved to travel to PHX and back to be under the care of Donald L. Lamm MD, researcher now in private practice. Lamm did the research and gained FDA approval for BCG use for bladder cancer. He treated John from 2005 til 2013. John died in 2017. I didn't have the connections that you have, but enough healthcare experience to know just enought to be dangerous. Blessings on you and Jake. Say hi to your parents---those wonderful people.
I just read the latest update on Jake, and you, I’m so sorry you are going through this hell, and then the “should be avoidable hell” of trying to access available treatments that might help him!
Thinking of you, sending strength and peace to you both. 💞
O wow, I can see a whole new service vision here, to consult patients and help them find what you found. Blessings to you both 🙏
Maybe a Constitutional law expert can answer this question: now that the Chevron doctrine is gone, would it be possible for a citizen to sue the FDA for the unjustifiable foot-dragging they've been doing on the so-called "fast-tracked" Covid medicine Xocova?
https://www.theatlantic.com/health/archive/2023/10/xocova-ensitrelvir-covid-antiviral/675768/
I imagine any sensible judge could read this year-old Atlantic article, see the absence of any progress - "fast" or otherwise, and quickly rule that the FDA's reflexive Tuskegee-style denial of lifesaving medicines really isn't what Congress had in mind.
Suing over Xocova wouldn't help Jake (unless he happens to catch Covid, in which case a giant mountain of clinical trial data tell us it would definitely help Jake), but the Xocova case could still be useful for highlighting the basic fact that the FDA has been slowly drifting into functioning as un-checked power-mad authoritarian autocracy. And I am really pulling my adjectival punches there. Inventing new words for the acronym FDA is one of my minor hobbies these days.
Eloquently written.. a “terminal trial track” sounds like a no brainer to me! Thank you for sharing your story
Awhile back, one of Jake's posts tipped me off to some draft legislation called the Promising Pathway Act. I'm finally getting around to writing my Congressional delegation. I stopped short of requesting that it be renamed the Seliger-Stillman Act, but others could feel free to do so.
Dear Senator XX,
I’m a constituent and an avid supporter residing in XX. I have a happy pandemic memory of the time my husband and I randomly met you and your dog in XX Park while we were on our way to XX Brewing.
I’m a research scientist specializing in vaccine development. During the pandemic, I’ve become increasingly interested in the topic of FDA policy reform - which is why I’m writing you to express my support for the bipartisan Promising Pathway Act (PPA) sponsored by Senators Mike Braun (R-IN), and Kristen Gillibrand (D-NY). My hope is that you can help to move the bill out of the Senate Committee on Aging for a floor vote.
My interest in the reforms proposed in the PPA is partly driven by a family tragedy. In late 2022, my cousin Marika was diagnosed with glioblastoma. She traveled to XX for treatment and her initial test results showed a mutation in a gene called FGFR2. Pemigatinib, a drug that specifically targets FGFR2, has been approved for treatment for a different type of cancer called cholangiocarcinoma. Marika’s requests to try Pemigatinib were denied. She died in the Spring of 2023.
I’ve written a blog post detailing my support for the types of reforms embodied in the PPA: https://cbuck.substack.com/p/life-liberty-and-the-pursuit-of-health
Sincerely, Dr. Christopher Buck, PhD
cc: Senator YY, Representative ZZ
Hi Bess! There is a program called “compassionate use” where a doctor can petition a drug company to provide a patient with a drug which is a part of a clinical trial without the patient partaking in the trial. The drug is provided for free to waive the drug company of any liability. However, the insurance company still needs to pay for the services associated with administering the drug.
In your previous blog posts you mentioned searching for trials which would be best for your husband according to his disease biology. Two recent tools have become available to streamline this process:
Ckb.Jax.org
Oncokb.org
I hope this helps in your future endeavors! There’s still hope to get him a drug while not a part of a clinical trial.
This article touched briefly on the difficulties of invoking compassionate use.
Thank you for the stunning insight into drug approval, and sending hope ( is that a thing to send?) to you and your husband 🙏
Helen x