Tag Archives: clinical trials

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.

Clinical Trials Transformation Initiative

Every once in a blue moon I have the opportunity to participate in a project that feels truly substantive. Transformational, even. Last week I was in Silver Springs, Maryland serving on a panel at a workshop that was a collaboration between CTTI (Clinical Trials Transformation Initiative) and the FDA (Food and Drug Administration).

The last supper? Hopefully one of many.

It was a full day of intelligent dialogue about the actual patient experience per clinical trials. Barriers, burdens, successes, failures. With a clear focus on ways of doing better.

Cary Medosch, Bray Patrick-Lake, Linnea Olson ๐Ÿ™‚

I am grateful to Duke, CTTI and the FDA for the opportunity to have this conversation. I left feeling very hopeful. For those of you who are curious as to what transpired, the workshop was recorded and you can view the video by following this link. My session was the third; but all of them well worth watching.

Don’t call me partner

Warning: this may be the most contentious blog I’ve ever written.

That is because I am about to desecrate a sacred cow–the idea of patient as a partnerย in medical research. Lovely in notion, the reality is something quite different and nowhere has that been more clear to me than sitting in the audience at DPharm 2018.

Let’s start with the straightforward definition of partner:

And then let’s parse that definition, piece by piece. A person who takes part in an undertaking with another or others.ย I have no quibble with this. As a participant (I refuse to call myself a volunteer—I did not ‘volunteer’ for this shit) in a clinical trial, I am a member of a ‘team’ composed of researchers, other participants, clinicians, schedulers, nurses, sponsor, phlebotomists, techs, lead investigator, regulators; even payers.

Every member of this team has an important role to play and, as the term stakeholders implies, to a certain degree the outcome of our endeavor will impact each of us personally.

However, this is where the concept of partner starts to fall apart; shared risks and profits.

No one has more on the line than the participant. The skin in the game is not figurative for us, it’s our actual tissue. Best case scenario: we get to continue living. Worst case scenario: we die. Those are some pretty bloody high stakes and not in the same category as fourth quarter losses.

And now we get to the word profit. Don’t even get me started. I payย for the privilege of participation. Clinical trials are not gratis. The experimental agent/therapy is provided to me free of charge and sometimes certain labs or procedures; in the trial I am currently enrolled in echocardiograms are covered by the sponsor. However, everything elseย is billed to insurance, and I am responsible for deductibles and copays. Gas, parking, lunch—all paid for by me.

And then there is the physical toll. One hundred and one chest CT scans, 60 abdominal CT scans, 42 brain MRI’s.

So, let’s just get really real here and stop the pretense. I am not your partner and if I am, this is one heck of an abusive relationship. One in which I am bound to you by desperation, you call all the shots, and my only true power is to withhold. Where words like compliant and noncompliant are used to describe me. One in which your need for data is greater than my need for autonomy/personal safety. Sure, you keep me alive but you can also kick me to the curb if my cancer gets out of line again. And when and if you do, there will be nowhere else for me to turn.

We are codependent, you and I. That much is true. But we are not equals and certainly not partners. And we won’t be until you recognize that I am a human being. That I have hopes and dreams and family too. It is my bad luck that I also have cancer. I want to live and I will do almost anything to stay alive. You know that. But don’t exploit it. Do not continually ask me for more blood, more sweat, more tears, more money.

Instead, provide me with genuine support. Understand what I have sacrificed and compensate me for my time, just as you compensate healthy ‘volunteers’ in clinical trials. Being a subject in a trial does not mean that I am also subhuman so treat me with the respect that I deserve. Let’s ditch the condescension and start with transparency. Stop pretending that I am your partner. I know what a true partnership looks/feels like, and baby, we’re not there yet.

For the record: my contribution to medical research

First, a proposal. All you clinical trial sponsors, listen up. I really feel that upon enrollment in a clinical trial, each participant should be assigned a case manager as a perk of participation.

In reality, it is a necessity.

Take my case as an example. Thirteen going on fourteen years of surviving. A complicated treatment profile that involves surgery, four different chemotherapy regimens, as well as a TKI unrelated to ALK. Participation in three phase I clinical trials added into the mix.

When a protocol for a trial is established, it is viewed as a discrete event. IRB (internal review board) notwithstanding, there is currently no way to take into account individual circumstance. Say, how many clinical trials you’ve been in previously.

Or, do you have a cancer that is histologically different than the other clinical trial participants. Again, myself as an example. My cancer is invasive adenocarcinoma, mucinous, once referred to as mucinous BAC. Although every bit as lethal, it does have a distinct advantage in that it generally stays confined to the lungs–no distant metastases to deal with.

This histology makes me an odd peg when it comes to a one size fits all clinical trial. And it means that I have been subjected to excessive scans that were not clinically indicatedย and yet were mandated by protocol.

It is already well established that I have mutable cells. When I finally took a tally of all my scans, I became concerned and made a formal request that my scanning schedule be amended. I should add that at this point the schedule bore no resemblance to standard of care, with scans every six weeks. Part of what I was asking for was that scans be moved out to every three months once a participant had been in trial for more than a year. My request was denied.

And that is when I became officially noncompliant–refusing to get anymore abdominal CT scans. Per my insistence, my chest CT scans were also moved to every three months. Eventually, protocol was changed to my original request, with the scanning schedule changing to every three months once a participant had been enrolled for one year and I like to think my noncompliance made a difference.

However, for myself, the collateral damage has been tremendous. I have had a mind boggling number of scans, most of them medically unnecessary. It is infuriating, frightening and sad. Had I a case manager, I like to think this sort of thing would not have happened. At the moment, I am down to a chest CT every three months and brain MRI’s once a year. When you see how many scans I have had, imagine how many moreย there would be if I had not become noncompliant several years ago.

We’ll start with the small stuff. Keep in mind that this is only tests I’ve had done at MGH. It does not included x-rays (including those at a community hospital where I was diagnosed with lung cancer), scans, MRI’s prior to my time at MGH nor does it take into account dental imaging, colonoscopy or mammograms.

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The thirty-seven blue diamondsย ๐Ÿ”นrepresent chest x-rays.

Brain MRI’s are represented by a division sign:ย โž—ย andย I have had forty-two brain MRI’s. In case you didn’t catch that, 42. And I have no brain metastases.ย 

The black multiplication signย โœ–๏ธย represents abdominal CT scans. I have had 54ย CT scans of my abdomen. Plus six more, represented by the red circleย โญ•ย that were combination PET/CT scans (unbeknownst to me—the PET/CT combination). So, a total of 60ย abdominal CT scans and no abdominal metastases.ย Yet. Abdominal CT scans have a formidable amount of background radiation and it pains me to know that I have had so many unnecessary scans due to my participation in clinical trials.

And now the really, truly impressive number. Represented by a plus signย โž•ย .ย I have had 91ย chest CT’s—plus an additional 10ย PET/CT’s of my chest, again represented by the red circleย โญ•ย . One hundred and oneย chest CT scans. At least there is some clinical justification here, as I do have cancer in my lungs. However, even given that, had I not spent so much time in clinical trials, there is no way I would have had so many scans.

Oh and this symbol, the radioactive emoji:ย โ˜ข๏ธย . That’s a stand in for the full body PET scans and Bone Scans I have received. I should add that when I began this trial there was a requirement that a bone scan be given every three months. I told my oncologist that I would drop out of the trial before I’d get a bone scan that often and she contacted the sponsor and in that case the protocol was changed.

My calculated cumulative radiation exposure

For those who are curious, here is a graphic on the amount of radiation received by survivors of Hiroshima compared to other sources of radiation.

On the balance, there are patients who are underscanned. All of us would rather err on the side of caution. However, I would argue that in my own case, caution was thrown to the wind. As I moved from patient to participant, I lost my autonomy/individuality, as the need for data superseded my own clinical necessity.

There is no justifiable excuse for the fact that I endured 60 abdominal CT scans and 42 brain MRI’s and that as a result of this excessive scanning, I now have a gadolinium deposit in my brain–a finding with unknown clinical significance.

What is known is that no human being should receive as much radiation as I have unless it is absolutely medically necessary. And it is not hard to argue that given my lack of distant mets, those 60 abdominal CT scans and 42 brain MRI’s were not for my benefit.

Nope. I have, in so very many ways, already donated my body to science. And that’s why my gratitude is tempered.

My participation in clinical trials has been a privilege. But also a burden. In forthcoming blogs I shall reiterate my stance that clinical trial participants should be not only recognized for their tremendous contributions to medical research, they should also be offered support in multiple ways. A case worker. And compensation.

The down, the dirty, the skinny, the scat.

Gadolinium: heavy on my mind

You have no idea what’s going on in my head. Really. And, nor do they–the authorities.

That’s an MRI of my brain, demonstrating gadolinium deposition secondary to injected contrast. It is the rather faint, white, symmetrical ‘stain’ (it is actually referred to as a brain stain). Rorschach like. It’s been there since at least December of 2016, when it first showed up in my radiology report:ย There is nonspecific intrinsic T1 hyperintensity involving the globus pallidusย and dentate nuclei bilaterally likely secondary to gadolinium deposition ofย uncertain clinical significance.

I had been aware of the possibility of gadolinium retention for at least a year prior to this finding and because of my concerns, had once again become non-compliant—in this case, refusing contrast.

To be clear, I have more latitude here than someone with either active or a history of brain mets. I’ve never had mets to my brain, which is part of the reason I have pushed back on scans that were mandated by protocol but not clinically indicated. Part of the rub when one is a clinical trial participant rather than a patient.

The day I found out about the gadolinium I was pissed. Really, really pissed.

As a requirement of the trial we took a cognitive test at each visit and part of that test was to write a simple sentence. I had a monkey in the cage/rage moment; threw a little scat at the keeper, if you will. My sentence that day read ‘Fuck you (sponsor of the trial), I have heavy metal on my brain.’

The jury is still out as to whether or not there already have been or will be side effects associated with gadolinium retention. Although everyone can certainly agree that it’s probably better notย to have gadolinium in one’s brain.

And before anyone panics, know that it is still extraordinarily uncommon (and no, I did not want to be the poster child for this one). I believe I am Dr. Shaw’s only patient to date with this finding. And in discussion with her about this issue, she is adamant that a CT scan of the brain without contrast is basically useless.

My frustration was with the fact that I didn’t need the bloody MRI’s in the first place and I have had–at MGH alone–42 of them. That, my friends, is why I no longer hesitate to be noncompliant.

Filthy lucre

Screen Shot 2018-07-10 at 11.28.22 AMOk, let’s get real. I don’t expect to get paid $5000 a month to participate in a clinical trial and I deleted that rash comment from my last post. Fantasy, folks, that’s all. However, any sort of financial assistance in the form of compensation would be welcomed. When I met with the head of the cancer center, I also suggested that greater supportive services would go a long way. Free parking and a comped lunch, but also someone to help me navigate the financial morass while I’m on a drug with known cognitive side effects. Visits to a nutritionist, as just like everyone else on my therapy, my cholesterol is through the roof. How about some free massages—to make my life better/more relaxed? And I mean gratis—not billable to insurance.

In other words, there are ways to make the whole clinical trial experience more welcoming and sustainable. These are relatively new concepts as not so very long ago, most clinical trial participants were a one and done—in the most literal sense.

That was the expectation when I enrolled in my first trial ten years ago. That, best case scenario, my life would be extended for a few months. I am incredibly blessed that I have had the opportunity to go on to subsequent treatments and trials, extending my life far beyond what I ever thought possible. I am sensitive to the fact that my grousing about money is potentially ย unseemly for those who would give anything to be in my position–alive.

Gratitude is far more palatable and it makes my disease/continuing survival easier for all to digest. However, the problems I face are faced by others as well and as an advocate/activist, I feel it is vitally important to discuss them—in a public forum.

Being alive is a good problem to have. But having to worry all the timeย about the expense associated with your medical care is not. I now have way more anxiety about my money than my cancer. How crazy is that?

And the thing is, I am not poor. However, with health costs exceeding a third of my income, it’s not doable.

What if (and I don’t feel this is unreasonable) trial sponsors covered all medical costs for participants, just as so many people already assume is true? If that was taken off my plate than I could pay my other bills. My financial situation would still be tight but it would be tenable. And that is all I’m asking for; (I’m talking to the medical establishment now) don’t make this already tough situation–living with a terminal illness–more difficult than it needs to be. Show some appreciation for the very real contribution I and other clinical trial participants make. Without us and our mutations (that’s right, we actually represent a rare commodity, not just an opportunity) these drugs would never make it to market. That would be a real loss, both in terms of lives and dollars.

So let’s keep this conversation going. My experience might be fairly unusual in terms of years spent in trial, personal finances and marital status, but it’s not unique. Clinical trials are the lynch pin when it comes to cancer therapeutics. Things have been done a certain way in large part because few have questioned the status quo. We, as consumers, have greater value than we sometimes realize and it is time we demand a better experience. As a society, let’s stop asking clinical trial participants for more blood, more sweat, more tears and instead find a way to support them as they lead the way. It’s the right thing to do from both a humanitarian and a business perspective—in a word, profitable.

Losing it

Earlier this week I made my morning cup of coffee immediately upon rising, just as I always do. But then I couldn’t find it. Anywhere. And I live in a one room loft. I also left my eyeglasses at a local restaurant over the weekend and as their staff’s search turned up nothing, I’m going to have to buy a new pair. Yesterday I misplaced the bra I was planning on wearing. I later found it in a bowl of oranges. Don’t ask, as I couldn’t answer, because I simply do not know.

Sometimes it’s funny, other times it’s frustrating as hell.

All these years of clinical trials and continuous treatment are catching up to me. Add in menopause and advancing age as well as the fact that I live alone, in itself a rather extraordinary thing for a person dealing with a terminal illness.

Yet there is an upside. I am now convinced that children have incredibly short attention spans by design (so to speak). That if they were able to mull, ponder and plan the way adults do, they might well waste the precious time allotted to childhood. There is a magnificent advantage to a wandering perspective–so incredibly well suited to experiencing the world with eyes wide open and without bias.

With my limited ability to recall, I am rather like a child. Everything feels fresh and seemingly brand new. My focus is short, but also incredibly intense. At times it as if I am tripping, my senses tickled by any stimulus at all. As an artist, this is a boon. Emotionally, it can also be of enormous benefit, as I am no longer prone to extensive rumination; once upon a time, losing my (beautiful and expensive) blue eyeglasses would have undone me, at least for a time. I regret their loss, but in the same way a child mourns a broken toy–briefly.

It is only when I need to function as an adult; someone with responsibilities and hard deadlines, that this lack of linear concentration becomes a true liability. I would in fact consider it almost a disability, although one that is neither obvious nor fully understood by those around me. I believe that might be because my cognitive challenges don’t reflect diminished intellect but rather the increasing inability to retain, recollect and organize information.

I could use some help–some sort of cheery task master. Someone who would commit to a couple of hours each week to assist me with those chores I now find so daunting (paying bills, taxes, getting my vintage clothing business up and running, managing my finances).

I already devote well over a third of my income to health care and I think a personal assistant is likely a luxury above my means. However, I would like to propose that there should be some sort of federal agency (yes, I’m dreaming) akin to the U.S. Department of Veterans Affairs for clinical trial participants. That there be recognition (on the federal level) that in the war on cancer, clinical trial participants are serving on the front line. And that we,ย like veterans of other wars, deserve some sort of special consideration of both what has been given but also taken. Financially, emotionally, physically.

I’m committed to continuing to fight the good fight–and I do so gladly. With or without assistance. However, if anybody out there with mad organizational skills and a little spare time wants to come hang out, coffee’s included.

*if I can find it ๐Ÿ™‚