Tag Archives: clinical trials

Self survival

How did I do it. Emerge intact.

2020 was a beast. 2019 the hellish hors’doeuvre.

Two awful landlords, two impossible moves. Three clinical trials. One full year of infusion and all its attendant side effects with a few unexpected ones thrown in just for fun. A global pandemic. Business partners who (ahem) took financial liberties.

Becoming increasingly breathless, dealing with alopecia as well as mucositis and skin issues, I somehow continued to online date. That was, in retrospect, insanity.

That I have emerged, not only alive, but on the road to some sort of recovery, self esteem alive and well, boy howdy. Implausible. Unlikely as fuck. But, for the record, true. This, I can vouch for.


Henrietta Lacks and her legacy

The Senate has passed a Henrietta Lacks Bill.

Henrietta Lack’s story is a cautionary tale and this bill is an attempt to right an eternal wrong (the cell line derived from Henrietta’s tumor is immortal).

However, I can’t help but feel that this is not only too little too late, it is disingenuous as well. Take line seven and eight from the bill:

(8) For more than 20 years, the advances made possible by Henrietta Lacks’ cells were without her or her family’s consent, and the revenues they generated were not known to or shared with her family.

(9) Henrietta Lacks and her family’s experience is fundamental to modern and future bioethics policies and informed consent laws that benefit patients nationwide by building patient trust; promoting ethical research that benefits all individuals, including traditionally underrepresented populations; and protecting research participants.

So what has changed in the 70 years since tissue was taken from the tumor of Henrietta Lack’s without her knowledge? This. Now we must give informed consent. However, how informed is that consent? As I quoted an article from ASCO in a previous post:  ‘Informed consent forms may not adequately describe the risks and the nonbeneficial nature of research biopsies in language that facilitates comprehension.

There have been efforts to make reparations to the Lacks family–in October a six figure donation was made to The Henrietta Lacks Foundation by the Howard Hughes Medical Institute. But I can assure you that those of us participating in medical research now do not share in any of the profit and to suggest otherwise is erroneous. Should we be injured as a result of a clinical trial, there are no reparations–our insurance will be billed. If we are lucky, then some of our additional expenses are repaid. In my own case, I have yet to be compensated for anything. Certainly not co-pays. Not even my parking.

I am not in the position, as a white woman, to even begin to address the part of Henrietta’s story that has to do with race. All I can do is to acknowledge it. Henrietta’s story, like the Tuskegee Syphilis Study, took place such a very short time ago. And faith takes a very long time to rebuild. The Henrietta Lacks Bill will oversee a study into barriers to participation in medical research. Some of those barriers–mistrust and misunderstanding, are both understandable and difficult to address. However, transparency is an excellent place to start.

This is where I am qualified to comment. As someone who has now spent more than a decade in clinical trials, I have had to learn as I have gone along. The difference between a research biopsy and a clinical biopsy? I figured that out a very short time ago, and only because I asked a specific question regarding return of results.

So. It’s good that medical research is having such a moment. But let’s not pretend that something like informed consent is all about the patient. No, it is essentially legal jargon, designed to protect the physician from litigation. The tip off? That word consent, which connotes permission. Because how can you say yes with certainty when you don’t truly understand what it is that you are agreeing to?

Staying in the game

I am watching the Queen’s Gambit on Netflix. Although not a fan of board games (Scrabble aside), I love me a scrappy protagonist. Female, better yet.

This might be the time to mention that I possess confidence. Extraordinary confidence. Not that I shall win, but rather that I have the ability to lose and lose again. And still want to keep playing.

To me, that is by far the most accurate definition of self assuredness. Whatever comes, I can and will handle it.

When I was first diagnosed with lung cancer, I looked at those five year statistics for any stage (14% in 2005) and I said to myself, this is going to be hard, but I can do this.

I based my self assessment on a realistic understanding of my strong points. I had never been the fastest, the strongest, or the smartest. Certainly not the luckiest. But I had a wicked strong streak of stamina. Knock me down and I’ll come right back for more.

Damned if it isn’t one handy quality to be in possession of. As of late my perspective has often been from the ground up. My labs today showed an elevation of Creatine Kinase, and my thighs were hurting—something I attributed to yesterday’s hike on the beach. However, it can also be an indicator of Rhabdomyolysis, which can happen both as a side effect of statin use (high cholesterol is secondary to lorlatinib) and binimetinib. My trend is yet mild (400) but they take this shit seriously, so for the moment I am holding both binimetinib and atorvastin. Tomorrow I have a crown replaced where I have developed a cavity, secondary to mucositis due to my previous therapy. And on Wednesday, I get to spend several hours with an ophthalmologist as I have also developed a mild case of retinopathy, a possible side effect of binimetinib.

In addition, I shall get labs again on Wednesday and if my CK levels are within normal, I am back on binimetinib with a long day of pharmacokinetics at MGH on Thursday and then back again for bloodwork on Friday.

What with all this time devoted to cancer, I hardly have time to be an artist.

I am only sort of joking. Again, this is why I feel participants in clinical trials should be compensated. Enrolling in a trial is often akin to a full time job.

Let’s just hope all this effort achieves its goal—keeping me around so that I can devote time to higher pursuits. Like art. And life.


Role reversal

Just another evening in paradise. Baking a cake, because tomorrow is my daughter Jemesii’s thirty sixth birthday.

Also memorizing my lines (Evalynn Linnea Olson, 11/26/1959) for my debut in yet another trial. Crack o dawn and I’ll be on the road to Boston and my lead in dose.

I’m preparing mentally for the rigors of this new role. A host of side effects with the most common being:

increase in cholesterol and triglycerides which can increase your chance of heart disease and stroke

damage to nerves in arms, legs, feet or hands causing tingling or numbness

slowing of speech

vision changes


rash, acne, or skin irritation including redness, raised bumps, dryness or itching

swell or fluid retention in the abdomen, arms, legs, hands, feet, face, or eyes

muscles spasms, muscle pain, or inflammation



Some of this is old news to me, as I spent more than five years on lorlatinib. The zits are something I’ve not experienced since my brief tenure on tarceva in 2008. I am relieved that my hair is growing back. Better not to be bald and broken out. Whoopee!–In a deal with the devil sort of way. Signing on for whatever may come because I love life so fucking much.

There is no poetic justice here. Just a strong stomach for discomfort and an even stronger will to live.

Bring it.

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.