Tag Archives: clinical trials

And here I go, reacting

Can’t help it, y’all. As I scramble to come up with the money to pay last years taxes, it hurts, actually hurts, to know that those who participate in clinical trials for a COVID-19 vaccine are being compensated.

Read this article from the NCBI and weep. Tell me, again, why it is that those of us who are both unfortunate enough to have contracted terminal cancer and also desperate enough to stay alive that we will do almost anything, are somehow a different story. Are we too not deserving of assistance and recognition “for the fair value of…time and effort expended in research participation?

And how about this paragraph rationalizing compensation for vaccine ‘volunteers’: “Compensation also should be viewed as the ethical default because it helps to minimize the chance participants will be exploited by receiving benefits that are disproportionately low compared to the burdens they undertake and the value they contribute to research. While the prospect of direct benefit is relevant to avoiding exploitation, research benefits are not always present and are never certain. Thus, it often makes sense to compensate participants for their work via a wage-payment model, using a fair local wage for similarly burdensome nonresearch endeavors as a benchmark. This is not intended to make participants better off as compared to their financial baseline or even to fully compensate for participants’ opportunity costs but rather to acknowledge the value of their time and effort. Compensation can also help distinguish research activities, with their distinct goals and risks, from clinical care, signaling that participants are contributing to science and that individual benefit may not result from their research participation.

Um, yeah. I can hope like hell that when I participate in a clinical trial I shall attain some personal benefit, but–particularly in phase I where safety versus efficacy is being assessed–it’s a crapshoot.

So why why why why why why why are cancer patients treated differently? This is a human rights issue. I am/we are more than our tissue. Those of us dealing with advanced cancer are desperately ill individuals who are taking on tremendous risk and burden in order to A. hopefully live longer and B. advance medical research—A being the far dicier of the two propositions.

And then there is this curious sentence: “We argue that reimbursement and compensation should be offered in COVID-19 trials as a matter of fairness, as is true for other types of clinical research.” I’m all for the fairness part but clearly they are talking about medical research with ‘healthy volunteers’, not those of us with cancer.

Thanks to COVID-19, clinical trials are having a big ass moment right now. Let’s not waste this opportunity to have some constructive dialogue per ongoing issues related to medical research such as disparity, accrual and compensation. And while we’re at it, let’s stop hiding the dirty little secret that exploiting cancer patients didn’t stop with Henrietta Lacks.

We can, and should, do better.

Hitting that glass ceiling

I had to be in Boston bright and early yesterday morning for an echocardiogram. The technician noted that this was my 36th echo, and that she thought that was probably a record.

Honey, don’t get me started. I’m in the triple digits for chest CT scans. Forty some brain MRI’s and over sixty abdominal CT scans.

This is why I am once again noncompliant as I partake in my fourth first in human trial: after the first two CT’s, I have refused additional abdominal scans.

Trials are a necessary way of life for many of us with advanced cancer. But never forget that this is a codependent relationship; trials also require people like me. Emphasis on person.

I am, first and foremost, a human being. One who shall continue fighting not only for my life, but for my personal rights. And for yours as well.

Medical research cannot move forward without the consented participation of so called ‘volunteers’ such as myself. As I am in this for the long haul, I will not agree to onerous demands that put my already compromised health at greater risk.

I urge you to do the same. Question the necessity of tests that are not clinically indicated. Remind sponsors that you are more than your tissue. Stand up for yourself in a trial just as you would if you were a patient rather than a participant. Challenge the medical research establishment to make good on the aspirational ‘patients as partners.’

It is up to us to initiate change because we have the most at stake (literal skin in the game). We cannot afford to be complacent. And if you think about it, there is nothing to fear but cancer itself. Seriously. Question the unequal power dynamic and the status quo.

To do so does not indicate that you are anti research. In fact, I would posit that it means quite the opposite. You wish to be in this relationship but you also desire that it be healthy and productive for all involved. Demand respect. And always remember, assent is not your only option. It’s ok to say no, and better yet, to suggest an alternative.

Less passive participation is not only good for the individual, it will ultimately benefit research as a whole. So don’t hesitate to speak up. Speak out. Advocate for yourself but also for a truer alliance. An actual partnership.

Let’s move this needle forward together.

TEDX: Patient, Parent, Person, Research Subject

It now seems that immediately after giving my TEDX talk, the world became a heck of a lot more complicated. First, for me personally, as I added chemotherapy to lorlatinib and then transitioned to yet another clinical trial. In the midst of all this I was moving my household, vintage clothing business and studio for the SECOND time in one year. All in all it felt impossible, and that was before the pandemic hit.

So anyway, I never got around to sharing the edited view of my TEDX talk on clinical trials.

If you have fifteen minutes to spare, I believe this information is more pertinent than ever. My friend Janet Freeman Daly just spoke about clinical trials at the IASLC virtual Presidential Forum–I believe that with the current focus on old paradigms and social justice, the world is ready to listen up. In a nutshell, they need us (trials) and we need them but it is a relationship that has historically been both unbalanced and codependent. Let’s challenge and change that.

My talk: TEDX Beacon Hill Linnea Olson

In every crisis there is opportunity

Without a doubt part of what gets me through is a solid belief that nothing is wasted. Even the shittiest of circumstances can be the basis for good compost and thence a thriving garden.

After a four week break I had yet another infusion last Wednesday. Happily, it took a week for the mucositis to rear its ugly head and thus far it is manageable.

The day after infusion I felt a distinct lack of motivation. However it would take another several days for depression to kick in.

To return to the metaphor of agriculture, this is no garden variety depression. Rather, it is something I can only describe as despair.

So very unfamiliar to me, who has cycled quickly in and out of depression my entire life. This is something different–something heavy that sits upon the center of my chest and refuses to budge. Without raising red flags (I’ve got this) it is the sort of boundless sadness that includes suicidal ideation.

Yes, that bad. And yet—I understand implicitly that this is chemical. Previously I wondered how much had to do with being uncomfortable–the mouth sores–but this time it is clearly independent.

For whatever reason this drug fucks with my head–big time. It is difficult to collaborate when you are the only person reporting such a side effect and unlike lorlatinib, this is not a small molecule designed to cross the blood brain barrier.

No matter. My empirical evidence rests on my own account–the very reason humans are used in phase I trials. Although this molecule may be having some modest benefit against my cancer, the cost to my psyche is untenable.

Surviving is a tricky business. The first requirement is consent–another way of saying a strong desire to live. This drug diminishes that instinct in me–to a notable degree. Had I not so much self control and the ability to step back and be unemotional, I would say to a dangerous degree.

As someone who has (and continues to) dally with recreational drugs I understand that this is chemical and therefore not without end. When I take an edible (THC) and get too high, I know that within perhaps a five hour window, I will come back down. This is going to take longer—possibly weeks. However, I am reassured that although it is me feeling this way (despair) it is not without provocation. There is a light at the end of the tunnel–my will to survive and its attendant joie de vivre will return. I just have to hang on.

I have the ability to remove myself from certain situations–not take it so personally. This sucks but it is also the fodder for great learning. As a cup half full individual I don’t believe I have ever fully appreciated the challenges of mental illness and depression. I now understand that mental health is even more fundamental than physical health. I am currently not suffering physically but my mental state is precarious. That is instructional and humbling both.

In two weeks I will have to decide if it is worth having yet another infusion. Today I would say no. Adamantly. As important as my lungs are, it is my brain and my mental state that actually commands this ship. And these high seas are not to my liking.

The anxiety

It’s Tuesday. Although my mucositis is much improved I still have sores in my mouth and esophagus–almost five weeks after my last infusion.

I am scheduled for my fifth infusion on Thursday. However Dr. Lin called me this morning and it pushing it back another week–fortunately the trial allows for up to a four week delay.

Do I go for one more? Maybe even two? Wait until my next scan to decide?

Damn this is difficult.

My mood is so very improved and I suspect there is a direct relationship between positivity/motivation and feeling better. I am decidedly anxious that if I get another infusion, it will not only be my mouth that starts hurting again.

So I don’t know. My higher morale has also been correlative with a greater desire to survive. And the difficulty with clinical trials as they currently exist is that as a participant I am given very little latitude. Should I drop out there is no returning.

Chances are I’m going with infusion, simply because it places me in a position of greater options. But psychologically, this is a tough one.

I’m so very relieved that I have another week to think and hopefully heal.

And some piece of mind

I have scans again one week from today. Two days later I am to review them and to have another infusion. I already know that my new oncologist will not be able to meet with me that day—I believe she shall be in the ICU. Younger doctors are being asked to fill all sorts of roles now—previously she was on the COVID19 unit. I am sure they are receiving a phenomenal education but the stress must be extraordinary. And of course, it is hard for their cancer patients as well.

Given the gravity of my decision (yes) I decided that it was best to get in touch with Alice. Yesterday I sent her this message:

“Good morning. Scans a week from Tuesday and I won’t actually be seeing Jess so thought I’d discuss with you. I have been pretty flipping miserable for weeks now—physically and emotionally. Last night my mouth/throat/tongue were the worst yet. Unless those scans show some very compelling reason as to why to stay on this I am done. Done to the point that even if there is not a good next choice done. If I have six months to live I’d rather not be miserable. If there is a good chance the MEK inhibitor will have similar side effects than it is not the drug for me. Honestly I have been so depressed that at times I have been ready to call it quits all together. However, given the possibility of improvement while retaining quality of life, I could rally. So let’s discuss what that might or might not look like.

She responded immediately and then called me later. This next scan shall be telling but my mind is made up per suffering—if it is for naught, I am not on board.

Today was better—the discomfort remains great but knowing that I have drawn a line in the sand I feel safer somehow. Just as it is powerful to know one’s strengths it is also imperative to appreciate one’s limits.

I love life. So very much. But pain is incredibly demoralizing and I have made the choice that for me, not how I wish to spend the rest of my time here.

Fingers crossed that there is an easier option.

And so it begins

Milk thistle and dandelion tea plus a hella lot of water and I got those enzymes down more than forty points. So my biopsy was a go yesterday.

Happy to report that it all went smoothly and to my delight (the perks of a progressing cancer) the surgeon was able to go in from the side of my chest rather than straight through my left boob (no fun). This meant that A. I could watch the biopsy on a screen–not everyone’s cup of tea but I thought it was wicked cool–and B. my time in recovery was spent on my side rather than flat on my stomach; so much more comfortable.

It was a long, long day and big credit to my friend Diane who ferried me to and from. I am so very grateful for my incredible cadre of friends.

This morning a friend of Diane’s kindly picked me up at 5:30 am for the first day of the DS-1062a trial (‘DS1062a is a trophoblast cell-surface antigen 2 (TROP2)-targeting antibody drug conjugate’).

Room without a view

I have now been at the Termeer Center for Targeted Therapies for almost five hours. In that time I have been weighed, had two vials of blood drawn, and the first of three EKG’s taken. I have also peed twice, napped, and met with Dr. Lin, my new oncologist now that I am on trial. Drug was finally released an hour ago but it is frozen and takes three hours to defrost, so infusion will not begin until one. Lots of hurry up and wait.

Last night I was pre-dosed with five 4 mg tabs of dexamethasone as well 360 mg of fexofenadine, both of which will be repeated just prior to infusion. There have been lots of reactions to this experimental therapeutic but fortunately I am entering trial after MTD has been established and they are getting a better handle on how to handle side effects. Also anticipated are some pretty gnarly sounding mouth sores (dime size, painful plaques) which could put a crimp in my dating schedule 😉 I am to prophylactically swish with a steroid mouthwash and have a paste for when they emerge. I have been advised that I shall likely lose weight (those sores) and may lose my hair as well. And there have been some eye issues, so I have been using lubricating drops. Aside from that, fatigue and mild nausea. There is always a price to pay.

On a positive note, some of the side effects of lorlatinib have noticeably receded. My skin—a mess of crusty sores as of late, has begun to clear up and heal (hallelujah). I had to go off of statins because of my elevated liver enzymes and my cholesterol was through the roof last time (high 300’s) but hopefully that shall start to come down as well. The cadence of my speech is speeding up (‘So you’re not going to sound like John Wayne anymore?’ asked one of my friends) and I am already feeling more like me: Linnea pre lorlatinib. Less rage-y, more clearheaded. I like it.

So consider this installment one. More to come post infusion.

xo

It was

Me giving me encouragement: the Wall of Hope on floor eight of the Yawkey building at MGH. When I first started getting treatment, a secret goal was to one day appear on the Wall of Hope. 🙂

A long, long day. But in the parlance of my kind (the terminally ill), a long day beats a short day all to heck.

First, my life is blessed with a plethora of goddesses. Childhood friends, my daughter, sisters, my many new friends, nurses, phlebotomists, counselors, medical doctors. Men are great and I love a heap of them as well but this group of women has been my consistent go to for the tough stuff.

One goddess was in tow yesterday, my friend Sally: pals since the fifth grade. I am beginning to realize how beneficial it is to have company at these visits, after years and years of going it alone.

I had an appointment with the goddess who takes care of me from the neck up (as I like to say), Mary Susan Convery, my thoracic social worker. She keeps my head on straight.

A quick trip down Charles St for a hug from my daughter (Sally is her actual godmother) and a delicious lamb sandwich at Tatte. And then a long wait in those spaces appropriately called waiting rooms.

Oh, the irony. Those of us to whom time is so precious spend far too much of it waiting.

Anyway, the action got started around four with a visit from the head goddess, Alice. Chit chat about how I am feeling (great for the moment, on that artificial steroid high, my dyspnea temporarily under control.) But I was eager to cut to the chase—how about those scans? She had read them herself and her assessment was that they were mildly worse than the ones in December. Now remember this is while getting chemo so bummer. Of concern is the lymphangitic spread as well as the fact that the slight amount of fluid in the bottom of my left upper lobe is also increasing.

Alice puts more store in symptoms though and mine are not encouraging. Definite downward trend. So we agreed that I’d go ahead and get chemo one more time (and possibly two, depending on timing and tolerance) in the hope that it is at least slowing down progression.

There was a bright spot though and that was in the form of options. I figured we were down to one–lorlatinib plus a mek inhibitor. But Alice described yet another possibility. That after all these years on TKI-s it might be good to take a break. Maybe let my cancer forget some of what it has learned. To try a novel therapeutic, one my cancer is completely naive to.

While getting infused I signed the consent forms for a phase I clinical trial for a drug called DS-1062a; an antibody drug conjugate which targets a protein called trophoblast cell-surface antigen2 (TROP2), which is found in copious quantities on the surface of cancer cells.

This sounds exciting to me–a fresh possibility. But it is going to be intense. First there are the necessary hoops to jump through in order to qualify, including a lung biopsy, heart scan, ECHO, and eye exam. And all that blood, blood, blood (30 teaspoons for the first three cycles).

Every three week infusions but the first week, at least two additional visits. And then for the subsequent nine weeks, I return to the hospital once a week, with a second lung biopsy at week two. It is going to be consuming–that is, assuming I qualify.

But it also has given me fresh hope (I love the luxury of choices).

Good thing. Chemo may not be kicking cancer’s ass, but it is kicking mine. My liver is a tad inflamed–Alice asked me if alcohol might be involved. Truth? Yes. Goodbye to that for the time being. Sally filled me with healthy fluids last night and this morning she made me oatmeal, hot lemon water, and a vegetable chicken soup. I am in good and loving hands.

So yes. Stability or response would have been the preferred report but this feels if not a door, at least a window. And that’s what I need. Fresh air and a bit of a vista to contemplate.

xo

Working it

Last week I spent two days at pharmaceutical companies in Cambridge MA (a mecca for pharma) describing my personal experience with cancer and clinical trials.

As an advocate/activist for lung cancer, I continue to represent the viewpoint that those of us in clinical trials should be treated with deference and respect. That words such as compliant and noncompliant should just go away. That we be compensated for our time just as healthy volunteers are. Perhaps most importantly, that no one lose track of the fact that we are human beings, who are enrolling in medical research not because we want an advanced degree in community service, but rather because we are hoping that these experimental therapies will extend our lives. As people, it is our right to assume that we will not be subjected to a plethora of non clinically indicated testing–we are more than our tissue. That we are pleased that our contribution will help others but that it is not and should not be our primary onus. We, like everyone else, wish to live. And we want to do so with dignity and respect. The current model of more blood, more sweat, more tears, more money has got to be realigned. If it is, recalcitrant issues like accrual and disparity will be addressed as well. Win win.

Blue in the face I am, repeating this message for so long now. However, and this is important, I am beginning to feel heard. The emphasis on partnering with patients—more an aspiration than a reality—means there is far greater interest in learning from patient experiences. ‘We are sentient beings’, I remind my audience. Unlike the white mice who are our direct mammalian predecessors when research moves from in vitro to in vivo, we can communicate. ‘Talk to us’, I say. Listen. Learn. Stop making it so damn complicated. Make us true members of the team and treat us like the astronauts we are.

In September I will have the opportunity to travel to Barcelona as faculty for the annual meeting of the IASLC. I will once again be discussing my experience in clinical trials. Patient as partner; and faculty. It has taken a long time and we have far to travel yet, but progress is being made.

Keep talking.

Patients talk about Clinical Trials

Couple of my friends/fellow panelists shared this video on facebook and I felt I probably ought to do the same. This is from last spring–thank you Bonnie Addario for inviting us to participate and share our experiences and viewpoints. Together we are moving that needle.