A letter to Joe Biden

Two questions for the Vice-President

Alison McCarthy

A boy walks across the beach, throwing starfish back into the sea.

Old man: What are you doing?
Boy: (flings a starfish into the sea) Saving starfish from drying up on the beach.
Old man: (laughing) What’s the point? There are millions of starfish dying on beaches. Throwing one back won’t matter.
Boy: (picks up another starfish)

————-

Dear Mr. Vice President;

My wife and I were deeply touched and saddened when we heard of your son’s passing, because we often remarked how unfair your life had already been. How you’ve managed your grief so well, I cannot fathom.

I write to ask that you help spare my family the grief and anguish that your family had to bear both those times.

My wife, Alison, and I have struggled for years to have a family. We suffered several losses in the past few years. That alone would be enough to break someone but my wife persevered. You would like her because, like you, she does not quit.

We were finally blessed with our son Nathan on November 3rd, 2015. But on November 8th, just five days later, she had a seizure and was rushed to the hospital. After a biopsy, we found out she had an incurable, aggressive brain cancer. I believe it was the same brain cancer that took Beau from you: A glioblastoma (GBM).

Since that day, I’ve done nothing but research the disease and help my wife. And in that time, in less than a month and a half, she’s had a total of three brain surgeries.

As you know, glioblastoma has an almost 100% death rate with a near 100% recurrence rate. Yet after over 50 years of research, little has changed: median survival is only an abysmal 14.6 months – in the past 15 years, there’s been almost no progress in survival rate.

Brain tumors are the leading cause of cancer-related deaths in children under 14, and the second leading cause of cancer-related deaths in children under 20.

14,000 Americans are stricken with it each year, each with names and families. Names like Brittany Maynard, Lauren Hill, Theodore Kennedy, Beau Biden, and Alison McCarthy. Families like yours and mine.

We learned we had this insidious disease the same month you attended the GBM AGILE Reception. There, Dr. Anna Barker said the problem is clear – outdated FDA rules that were never meant to deal with aggressive terminal illnesses:

“Randomized clinical trials [the current standard clinical trials] are 70 years old…what other technology doesn’t change in 70 years? … Meanwhile, cancer biology is moving at light speed and potential treatments have to wait in the queue.”1

Thousands are dying each year while these outdated rules stand in the way of potentially life-saving research and everyone knows it, because we treat brain cancer like an infectious disease. We think that there should be one cure (eg, penicillin) for one disease (eg, strep throat).

But GBM is not strep throat. It is closest to AIDS, when it first arrived, in that it is terminal and terminal very quickly. And time is a luxury GBM patients do not have.

Here’s what an FDA trial requires, of which every step is an excruciating hurdle for a GBM patient:

Phase 1 – Examines the safety of a product in a very small group of healthy volunteers or patients to determine appropriate dose ranges. (20-80 patients)

But: A patient with a GBM is, by definition, not healthy. My wife is not eligible for any clinical trial right now because she is not healthy enough for one.

Phase 2 – Evaluates the safety and efficacy of the product at a pre-determined dose in comparison to the standard care treatment (100-300 patients)

But: This means half the patients don’t have access to a drug that might help them and, for someone with a one-year life span, if that dose is wrong, there is no second chance to get it right – because that’s not the purpose of a clinical trials.

Phase 3 – Tests the product in double-blind comparison to the standard care treatment with a large and diverse population to determine efficacy and usage guidelines (1000-3000 patients)

But: Because GBM is rare, these patients are not to be found. Moreover, double-blind means that half the patients, again, are on placebos.

This is why in the past 15 years, there have only been four advancements in GBM therapy: Optune (2015), Avastin (2009), Temodar (2005), and Gliadel wafers (2002).

The outcome is so consistently dire, we cannot afford to deal with each treatment option via FDA rules, which have a real-world cost of over 2.5 billion US dollars per trial.

The cost, coupled with the requirements, make it easy to see why only four advancements happened in the past 14 years.

People think – in fact our doctor thinks – that the Hippocratic Oath says, “First do no harm.” This is false.

In fact, the Hippocratic Oath does not say that. It does, however, say “I will apply, for the benefit of the sick, all measures which are required.”

Similarly, researchers are held the standard of the Declaration of Helsinki which expressly states that “concern for the interests of the subject must always prevail over the interests of science and society.”

Here is my first question: Can we honestly say that the FDA regulations in place now for GBM aren’t in violation of those oaths?

The rules are not there to save patients, but to aid science. A laudable goal, but one directly in conflict to these sworn oaths.

This is precisely why Larry Kramer wrote in the NY Times about AIDS decades ago, stating that “Double-blind (placebo) studies were not designed for terminal illnesses in mind. … It’s genocide by neglect.

My second question is equally simple: If there is credible evidence that a treatment may improve both progression free survival and/or overall survival, and GBM has an almost 100% death rate with a near 100% recurrence rate, why would we not afford a patient every bit of chance possible?

For example, Valcyte is a medication for HIV use but has been shown to have some effect on GBM. However, “it is not standard practice to prescribe medications that have not been vetted through appropriately designed phase II trials.” This, despite the fact that the drug is well-tolerated and has minimal risk.2

Similar to HIV treatment, gonorrhea, combination therapies are the only hope for a cancer as deadly and insidious as glioblastomas.

Yet FDA rules are designed for monotherapies – again, treating this terminal illness like a mere infectious disease.

Dr. Emil Freireich, one of the three doctors that promulgated combination therapy to cure leukemia, is on record saying, “Would the things we did in 1960 be possible today? The answer is unequivocally capital N, capital O, no. … Reforming regulation is the most important thing we can do.”

– https://vimeo.com/119006145 at 1:04:13

ACT-UP transformed AIDS from a death sentence to a chronic condition through by-passing the FDA and creating a drug cocktail, a combination therapy of current drugs to deal with a terminal disease.

To this date, there has never been an FDA randomized Phase 3 trial for the AIDS cocktail. This is totally due to political will.

“If AIDS patients demanded direct access to drugs and treatments, should cancer patients with terminal illnesses not also make similar demands?”

The Emperor of All Maladies: A Biography of Cancer, pg 310

Everything we knew and read of Beau Biden confirms your statement that he was the finest man you have ever known.

My wife has been heartbroken, not because she has to go through this, but because my son and I have to go through it. For this and countless other reasons, she’s the finest human being I have ever known.

Your grandchildren deserved every chance – however minute – to grow old with their father, to remain on top of the mountain. My son is only some 70 days old as of this writing. He deserves to know his mother, just like every child deserves to know his or her parent.

We must hold doctors and clinicians to their oaths and put patients first, not science and rules. Instead of these onerous rules, doctors and their patients should, together, be allowed to simply weigh the benefits against the risks.

I ask for GBM patients what the AIDS activists demanded for their loved ones, when faced with a terminal illness, as delineated more thoroughly here:

  1. Shorten the drug approval process.
  2. Eliminate double-blind placebo trials – this is the height of cruelty.
  3. Include people from all affected populations at all stages of GBM in clinical trials – currently there is a clear distinction between “new” and “recurrent” patients.
    • Why on earth is that? Beau and Alison should have had access to everything the moment they found out they had a GBM.
  4. Medicaid and private health insurance must be made to pay for experimental therapies. This is critical with the passage of the ACA.
  5. Doctors must inform patients of any and all clinical trials that a patient may be eligible for.
    • Currently, patients must learn that clinical trials even exist on their own. Then they must research to see if they are eligible for them, also independently.
  6. The FDA must support a goal of keeping patients – that is keeping people – alive, rather than furthering science.

Curing cancer – especially this cancer – is not a moonshot because we’re lacking the knowledge, sir, it’s a moonshot because we’re lacking the political will to change regulation.

Please help me save my wife, Mr. Vice-President, and all those waiting for a cure for this horrible cancer. We don’t have much time.

Please #SaveAlison.

Logan Lo

 

————-

Boy: (shrugging and flinging the starfish into the sea) It matters to this one.

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Location: home with my family
Mood: determined
Music: Together we could break this trap
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37 thoughts on “A letter to Joe Biden”

  1. Great letter – well written. Do we know that Mr. Biden has seen this? How will we know if he does see/respond?
    Thanks, Ellen Hale (GBM x 14 months and fighting)

    1. Ellen, I’m so sorry to hear that you have this terrifying disease. May I ask what you’ve done so far to keep it at bay?

      I hope that I’ll hear from MR. Biden, or one of his people, and be able to relate it to all of you.

  2. I shared on Facebook and asked my friends to do the same. I have GBM in my spinal cord. I was diagnosed May 2014 when I was 28 and the only treatment I was offered is the same for in the brain. However, I have been excluded from every clinical trial I’ve looked into because it’s not in my brain. I understand controls, but if the trial will lead to the same kind of treatment why is it not studied on all otherwise healthy GBM patients? I hope your letter reaches the right people.

    1. Matt, that is just terrible to read. I’m so very sorry. I hope that this letter, or something, causes the status quo to change.

      May I ask how you’re doing and what you’ve done to fight this?

      1. I did all of the standard treatments: surgery, avastin, radiation, and a little bit of chemo but the extra time generally gained didn’t seem worth it compared to the illness I felt. I did CBD oil until my source couldn’t get it anymore and I was stable for months afterward. It’s legal now in New Hampshire, but I can’t get a card because my hospice isn’t yet set up for how to deal with it. So I need to really push them to get this resolved soon. I dropped my NO because she was no longer being helpful and refused to let me try Keytruda. Have you asked your wife’s doctor about that drug? It shows a lot of promise for fighting all kinds of cancers and the fact that it is approved for at least one type means you can go “off label” with it for GBM. I’m in a tough position because Mass General dominates brain cancer in the entire region and if they won’t let me do something I have nowhere to go. I’ve lost so much independence since the tumor began to grow again so traveling is out of the question. I shared your blog post on Facebook and begged my friends to do the same. So far quite a few have so hopefully we get people to read it and understand how messed up the current process is.

        1. Matt, you’ve got too much to deal with on your own to do all that. Do you have someone with whom you trust that you can give (1) power of attorney to for the purposes of helping you get things done and (b) a healthcare proxy, for when you’re sicker (if you get sicker)?

          With those two docs, someone else can try and get you a marijuana card and do things like try to get you off-label meds.

  3. People are surviving this beast by the use of Cannabis oil. I just read about a lady who is now cancer free and she had a GBM. I’m well aware of this because my daughter died on 2/2/12 of a GBM at the age of 20. It’s too bad I didn’t know about cannabis oil back then.

    1. Carol, I’m so sorry to hear this and all the other stories of people that have had the unfortunate luck to meet this horrifying disease. Many I ask what you did for her when she was first diagnosed?

      Yes, I’ve been looking at cannabis oil, but it’s not legal nor easy to get in NYS. I hope that changes somehow. Can you send me that information about the lady you mentioned?

  4. I hope Alison is having a good day.
    She will survive this. She will.

    Various contacts and information about trial vaccines can be found at Braincancer.org I was told.

    1. I hope you are right. I’ve been to braincancer.org and there isn’t any trial that she’s eligible for. I’m fervently hoping that will change and soon.

  5. Wonderful letter–eloquent, articulate, passionate. Hoping and praying for positive results. So glad my cousin has a husband who is so loving and caring–and a great writer. Keep fighting and keep writing.

    1. Thanks, Mary. She and I want her to get back to her old life as quickly as possible, if at all possible.

  6. Hi Logan, what an amazingly accurate, compelling, and passionate letter. I hope the VP Biden responds. Your story is just heartbreaking, as are far too many stories out there. We hear how rare GBM is but once you start looking there so so many lives devastated by this insidious disease. My 39 yo husband has it as well. The research is overwhelming and exhausting isn’t it? I’d be happy to connect offline to discuss more specifically about his care if you’d like to email me directly. My thoughts are with your family. Laura

    1. It is exhausting. We’re wrapping up chemo and radiation soon so our waiting game begins soon.

      When was your husband diagnosed, if I may ask? And what have you done differently?

      1. Hi Logan, We haven’t done anything out of the ordinary. My husbands tumor progressed after radiation while on Temodar. He’s been unresponsive to 2 other chemotherapies and a clinical trial since then. We did add Cannabis oil and frankincense after reoccurrence. Even here in CA the NO’s aren’t very progressive about cannabis, but we figured it can’t hurt. I rub frankincense on his scar and neck/spine. The boswellia is supposed to have an anti-inflammatory effect but mostly I just like to feel like I can do something for him. There are no words to describe how difficult this is, and I feel for you both so deeply having to deal with it amidst the joy of welcoming a precious newborn. We have 2 children and can’t begin to imagine a life without their amazing Dad. Did you submit your letter to: https://www.whitehouse.gov/webform/cancer-touches-all-us-share-your-story-here? I would love your permission to copy and paste your letter while adding my own story. I would give you authors credit of course. I just know I can’t do better than you did 🙂

        1. I’m so sorry to hear that. I keep hoping that our stories – all of our stories – will be different, somehow. Hope is a blessing and a curse.

          Yes, please copy and past my letter, but could you put a link to the original if at all possible? I’m hoping someone reads it that can make a real difference for all of us.

          1. I will absolutely include a link. We just got home from the NO and they are suggesting my husband go to the ER for emergency surgery to take out new tumor, as he’s starting to lose some vision :/ Things really do change fast. I realize I didn’t answer your question about diagnosis…he was diagnosed with a grade 2 diffuse astrocytoma 11/14 and it became GBM June 2015.

  7. Logan, have you consulted Dr Raymond Chang in Manhattan? Have you seen survivingterminalcancer.com? How about Dr Ben Williams’s thorough research available at virtualtrials.org? There is also a listserv for brain tumor patients and caregivers who share treatment experiences. Some of the participants are long-term survivors (braintrust.org). I feel for you, Alison, and your precious son. GBM reared its ugly head in our family also. But survival is possible!!! Even in this terrible regulatory environment!!

    1. Logan, you mention waiting. I hope in the meantime you are getting complementary treatments in place. It is imperative that you get out in front of the cancer — not just react to it. Your wife is young. She has a better chance of long-term survival. It’s a big fight, and the patients who win have usually done a ton of research and advocacy on their own behalf. It is patient-directed, doctor-assisted treatment that is the formula for success. Check out Jessica Oldwyn’s tumor blog. She is about the same age as your wife, and she is a role model. She is also a patient of Dr Raymond Chang in Manhattan. There is no time to waste! I wish you success.

  8. One more quick tip: consider the ketogenic diet. Brain cancer loves sugar. Going keto can slow down the growth. Cancer is clever though and can find other ways to get sugar (gluconeogenesis) so some doctors prescribe things like chloroquine and metformin to block other pathways to sugar. Google ketogenic diet for cancer. The learning curve is steep but once you get the hang of it it’s not hard. There is a nutritionist at the Charlie Foundation who helps GBM patients get onto the ketogenic diet. Good luck to you.

  9. Hi Logan,
    Thank you for sending this article. Praying for your family. My husband has GBM, 34 years old, diagnosed in November 2015, resection on 11/4, and just completed chemo and radiation. First MRI on Tuesday 2/23. Positive attitude- strong faith!

  10. Logan and family;
    Thanks for writing this incredibly touching description of what a glioblastoma brain tumour does to families at all levels…
    I hope and pray for a cure fast for all
    Of is and our lives ones suffering from this no stripes disease!!! Why can’t we get the cannabis oil if it helps our patients ??? This is truly ridiculous ….
    Only big PHARMA and their lobbyists ca. Have what they want …. Not the dying patient ! No wonder th world is angry !! It has reasons to be angry !!!suzanne and Joe florida

  11. Logan,

    I’m so sorry you have to go through this, it is not fair that people become inflicted with such aggressive illnesses.
    I have worked in clinical cancer research for over 6 years and I can tell you that there are many things that are being done to treat these diseases.

    First, I want to share a link to ClinicalTrials.gov in the hopes you might find a clinical trial for your wife (if that’s an avenue you’d like to pursue): https://clinicaltrials.gov/ct2/results?term=glioblastoma&Search=Search

    EVERY FDA approved clinical research trial is REQUIRED to register on clinicaltrials.gov. That is the best place for anyone to go to find a research trial for their specific disease.

    Secondly, I do want to give some clarification on some of the points you made. I struggled with whether to reply to this blog post, because I do truly believe that you are fighting for a noble cause. I want to stress that I think that the fact that you’re fighting for your wife is admirable, and making legislative changes is definitely an option for furthering research. However, some of the facts that you’re using are not applicable to cancer research. This is actually because cancer research is special due to the aggressive and chronic nature of the diseases.

    I agree that double-blind placebo studies would be inhumane and cruel for cancer or AIDs patients. However, those are some of the diseases that are exempt from double-blind phase 2/3 studies. (Per Phases of Research (21 CFR 312.12 and 312.23 and ICH GCP
    Guideline E6 3.1.3) “Exception: For some investigational products, like antibiotics and cancer agents, proof of greater efficacy in comparison to a placebo is not required. This is justifiable, because it would be unethical to not treat these disease states. For these products, the comparative control is always an approved investigational product or historical data.”
    For example, I am in charge of a phase 2 cancer study that currently enrolls all patients in the active treatment (we are not even using standard of care as a comparison because we are using historical data from treatments that have been used for the past 15 years).

    There are also what we call “Compassionate-Use Studies” which allow investigational product to be available to patients who have no therapeutic alternatives even if they do not meet eligibility criteria for clinical trials conducted
    under an IND (21 CFR 312.34).

    Finally, and I know it’s hard to hear, some patients really don’t qualify for certain research studies. This is because there’s a high possibility that treating them on that study would cause side effects that would be fatal. I know that many people want to be as aggressive as they can with a disease, but there’s that unfortunate saying “the cure is worse than the illness” and this is a very accurate statement when it comes to cancer treatment.

    I hate the idea that some patients are not receiving the best care for such aggressive illnesses. And of course, my point of view is skewed because I work in clinical research and only see the patients who are actively on trials. However, I hope that what I’ve shared can actually make you feel more hopeful about how we conduct our trials and research. I know that the doctors, nurses, and research staff I work with care greatly about the patients. We care about each and every person afflicted with these diseases and we want to cure and treat the people (not the diseases).

    1. Katherine – thanks for writing. Yes, I’m aware of ClinicalTrials.gov and the mandate for all trials to be listed there. Alison does not qualify for any of them as you noted and why.

      Also, the double-blind placebo exception is just that, and exception. The rule is for double-blind placebo. I know of one person that was on the failed Celldex ACT IV for two years, and only found out this month that he was on the placebo. If that’s not the height of cruelty, I’m not sure what is.

      Note that I have no doubt that you and many of your colleagues want to save patients, but clearly that’s not the goal of a clinical trial, as you noted. I’m afraid one’s inner feelings and the ones actions in the scope of work are two wholly different matters that have little, or nothing, to do with each other.

      Finally, surely you know that I appreciate that side effects might be fatal with any treatment? But isn’t that something that the patient can decide on as well? If a patient is apprised of all the risks and still wants to proceed, why would you, or anyone, prohibit them from doing so?

      Thanks again for the comment.

  12. https://www.crowdrise.com/judicial-integrityonhold/fundraiser/stephanshowstark
    My wife and partner of 21 years underwent 3 brain cancer GBM surgeries and behavioral changes over 12 months.She was taken out of the hospital unbeknownst to me after her third surgery and then divorced from me 31 days later in another county .The divorce hearing had no medical testimony, and i was not present, an act that failed to demonstrate judicial integrity to its fullest. I never saw her again after she was secreted away. My wife was placed in a care facility then hospice and passed away. This is not the only case of judicial imprudence suffered by the citizens of Florida. There should be a LAW in place that if someone comes before a judge with this type of severe malady that there Must Be Medical Testimony and the Spouse and or significant other Be Present

    1. That is one of the saddest things I’ve ever read. I’m so sorry. Did you ever pursue a case against the judge or bring it up with the local bar?

      1. I have been in court for two-and-a-half years trying to right this wrong I am amazed at the lack of judicial integrity . lies that have bee Overlooked By the powers that should be in control here …the judge up here where the case was sent to divide the property has no interest in hearing the truth. I have started a GoFundMe site

  13. An amazing post. I’m quite sure that Mr. Biden would be approving everything that had been highlighted in this letter. I am glad you spent so much time on researching and actually providing significant information. My friend’s cousin passed away from this disease last year after years of battle so I did learn about the issues associated with medication and treatments for terminal diseases.
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