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 partner 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. 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 pay 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 else 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.
life and breath: outliving lung cancer 
Clearly we are not full partners. Maybe more like a silent partner. If my trial really listened to me as a full partner they’d let me move my experimental drug up to a larger dose that might fully control my cancer for years instead of not-quite-enough.
Absolutely Craig. Don’t stop pushing that because not quite enough is not good enough.
xo Linnea
Love it! You are right on!
🙂
xo Linnea
You have a wonderful way of breaking down the barriers of truth and fiction when it comes to clinical trials. My wife Suzanne, God bless her, was willing to subject herself to all that big pharma asked of her in order to prolong her life, multiple flights from Baltimore to Boston, tests and scans done locally at Johns Hopkins as required by Dr. Shaw’s sponsors, and then back to Boston for more drugs and more tests and eventually death.
Cancer makes the living desperate, and drug companies and researchers prey on that desperation, not necessarily in a bad way, framing it as a hopeful way, if not for you than hopefully for others in the future.
It is a sad and painful journey that lasts longer for some than others, with no real sense of opportunity to relax and enjoy that extra time because you are always haunted by the reality that death lurks, perhaps, around the next corner.
You are one helluva of a spokeswoman for all those similarly afflicted. Bless you for your courage and clarity. May you never, as you continue to live, stop being you.
Ray, I am so sorry about Suzanne. It absolutely is a sad and painful journey and the outcome is never certain. It is a shame that society does not understand that those of us who are stricken need assistance, just like someone who has had the bad fortune to experience a natural disaster. Instead, we are asked to take on more risk and financial burden and to be gracious and benevolent as we do so. It is an impossible situation. Thank you for writing.
xo Linnea
YES YES YES. Can I share this?
Always 🙂
Omg whoever you are I love you!
Thank you thank you thank you for putting into words the words I could not find!
Patients are not stupid. Ditch the condescension and start with transparency.
Meliz, whoever you are I love you back 😉 And yes, without honesty we will never repair this relationship.
xo Linnea
Preach!
To the choir but done!
xo Linnea
Linnea,
You are 100% correct. You have taught me so much about what happens to a lung cancer clinical trial participant. As you SHARE with great wisdom and intelligence everything you endure, some of us not having to endure what you do are learning so much, and sad you must lead the way just so you can
live your life. Where are those individuals who do not have lung cancer, who
benefit from studying people like you in all of this? Is there not ONE leader
who has committment to start a change? Why do so few have to suffer, for
thousands to benefit in the end? Peace of mind comes in many forms. Having money to know you can pay your Cobra premium and other bills is
the least these mega-billion dollar pharmaceutical companies SHOULD COVER. You have given back enough. I will write to ANY AND ALL of your specific connections to implore them to respond to this huge issue!! Please
let those of us that are ready to write our letters have this information. We must express what is right. If I had money, I would cover your bills so you
could get a break from this insanity. Thank you so much for forging this long
lung cancer path for us to learn from. Now, it’s your turn to find some peace.
Linda
I love you Linda. I really do.
xo Linnea
I love you too Linnea. If you do feel like sharing your contact information as far as those that I can write to, please do. I will help!!! I promise!!
I think you need to start with the definition of “Trial “ as in “ do you want to participate in a controlled clinical trial?” If the trial is not strictly structured, the effectiveness it is invalid. If the patient is able to dictate how little, how much, how short, how long and all other conditions they feel like doing on any given day or week depending on their mood at the time, then it no longer is a controlled trial.
What pharma company would invest in uncontrolled trials? What drug would be worth approving without a controlled test group. The trial isn’t meant to support you, although it may, it is meant to help thousands in the future. I feel sorry for you. But the trial is not about you.
Kevin, I understand your logic. But keep in mind that we are talking about human beings. We are not just people performing high intensity community service. In my own case I exhausted traditional therapies years ago and clinical trials are my only option when it comes to treatment. I am thrilled that my contribution will help others (that is a privilege) but I think there are ways to make clinical trials more supportive, sustainable and humane. And unless you yourself are or have been a clinical trial participant, I’m not sure you are really qualified to weigh in on this. Just as I can’t speak to what it is like to be a person of color in America.
xo Linnea
ps: keep in mind that what I am addressing here is the disingenuousness of ‘patients as partners’–not whether clinical trials exist for me or not. I understand their function.
I’m sorry, but it has to be more about NEEDS of the patient. I understand what you are saying, however, these are human beings, not mice. Would it be so wrong to give back some financial support for “the givers?”
Actually, they do more for the mice — they breed them into existence, provide food and shelter (they bring their own clothing), free transportation to medical research appointments, and free medical care . . . . just not the kind they ever would have wanted. Maybe being treated like mice could be an improvement?
(Yes, I’m just kidding, . . . . . . . . . . . . . .or am I?)
Thank you, mice, all of you, for having suffered the indignity and pains of all the testing that led to the experimental treatment keeping people and some of you alive longer.
Best hopes,
Craig in PA
Kevin, I understand your point and it is valid, but some people might misinterpret your use of the term “controlled”. In the context of the word “trial” it does not mean tightly-managed, but rather refers to there being an experimental group (getting the experimental treatment) and a “control” group (not getting the experimental treatment, just the “standard of care” normal treatment, or a placebo, or nothing). Early trials (phase 1 and 2) of experimental drugs like lorlatinib (in Linnea’s case) and repotrectinib (in my case) are not usually “controlled” — they do not usually have a control group because they aren’t trying to prove one is better than the other, just that the experimental treatment isn’t harmful, seems to to do something beneficial at the dose they figured out during the experiment.
Yes, trials have to be approved by many experts and everyone at every location has to follow the trial “protocol” to the last letter. However, what Linnea was referring to was not the trial protocol rules that are necessary for consistency and evaluation, but those that are pointless.
An example in my current trial is the stupid pills-taken log forms. Columns are not set out in any logical way and as a result invites errors. (Time of food after dose is to the left the dose taken time, so that column needs to be skipped until hours later.) And dates are an odd format (DD-MMM-YY with a three letter abbreviation rather than MM/DD/YY or DD/MM/YY). And so much space is wasted on form structure that only 4 days fit on a page so about 8 pages are needed even though all the data could easily fit on one well-designed page. It’s in the protocol this way because nobody asked a patient.
A more significant example is that both Linnea and I have a subtype of cancer that is not expected to leave the lungs and has not for 7 years so far in my case. So if the cancer won’t jump to groin or brain, it is pointless to require those patients be subjected to dozens of scans that are known to cause harm (including possibly further cancerous mutations which would contaminate the trial’s experiment)? Linnea’s only option is to become “non-compliant” and they’ll probably allow it given how many years she’s already been in the trial (they don’t want to end that data,and if they do get a whole body scan when she dies of old age they’ll have proof she never showed any evidence of progression outside what they scanned every couple of months).
Best hopes,
Craig in PA
I am on the website to learn in order to help my wife. Perhaps the trials should use “participant “ in place of partner. However, a partner has an interest in the outcome and success. There are many many partners in a trial of which you are one but only one. I don’t believe that it is reasonable to negate a trial if one partner or participant feels that they personally may benefit more regardless of the detriment to any or all others. I assume you joined this because you have no other hope. I sincerely pray that you are helped. The trial is not about curing you now. It’s about curing many later. Best wishes and prayers
Kevin, best of luck to your wife. And understand that when I join a trial it is in fact about me. Yes, I hope that my contribution will benefit others but I am, with no shame, trying to save my own ass. Logical, good for my family, and so far, beneficial to many others as well. The saving of my ass.
xo Linnea
Three cheers for Linnea’s ass! Yooray! Yooray! Yooray!
Three more for the rest of us! Yooray! Yooray! Yooray!
I’m one of those who followed behind you and really appreciated your ass being there right in front of my face!
LOL. ROFL.
Best hopes,
Craig in PA
Linnea, it is about you, because this is your life. Kevin, it is also about all those that will benefit from Linnea and all the people who participate in clinical trials. What I feel…. is that it’s time for you and all the others to get
a new kind of support. Some financial support. Is this really asking too much? I don’t think so.
Dear Linnea ~ I want your ass saved!!! Yes, I do! And I’d like mine saved… and his… and hers… I’ve been reading your blog for awhile now and I knew I’d write you when the time was right. The time is here! So, I have lung cancer, stage 4 and have the ALK gene too. There is so much I could say about my story but for now, I’ll cut to a few specifics. I started my treatment 3 years ago with Xalkori but switched to Alecensa when a change was needed. As an aside, in sort of a desperation mode, I tried an experimental treatment of massive doses of medical marijuana on my own for 5 months in CA. It was supervised by a medical establishment and was intended to kill lung tumors as it has done for some children with gliobastoma brain cancer. It did not work the same for me. The Alecensa has been successful now for 13 months though. I had no idea about the trials and tribulations of being a participant in clinical trials. I’m sure most people don’t. Thank you for speaking out about the nitty-gritty reality of them. To repeat ~ I certainly hope, no I FERVENTLY hope that this trial saves your ass JUST FOR YOU, not because you’re in a codependent relationship with the drug company and it’s good for the world. JUST FOR YOU!!! Just wanted you to know that.
Leila Jane, bless you. Firstly, may Alecensa continue to be effective for some time. Rest easier knowing that there are options—always a good feeling to have something in the bank. And thank you for understanding. I refuse to feel guilty for placing staying alive as my primary goal (not so selfish, really). As a passenger on a plane you are instructed to place your own oxygen mask on first, even if your child is sitting next to you. My three children are damn happy I’m still around, and so am I. And you, just keep on keeping on. GUILT FREE.
xoxo Linnea
Good morning Linnea,
I only met you once 7 or 8 years ago
In Colorado. We were lung cancer patient guests at a four day seminar
With one of the large lung cancer organizations. A key focus in discussions was to educate people in regards to why we needed to stop asking people with lung cancer if they smoked. It was all about the stigma.
This was one reason research funding is so low for lung cancer. At the end of our intense Discussions, you stood up and said
Something close to this…. “I don’t smoke and I don’t like cigarettes.”
You were willing to acknowledge a bigger issue that mattered. You never
Placed blame on people, just felt
Strongly to speak your truth. Since that time, a lot of great work has been done to help bring lung cancer into focus. YOU ARE ONE OF OUR LEADERS!!!
(Please ignore caps in wrong places. My phone is messing up.)
Hi Linda. I do hate cigarettes, I always have. But I don’t hate smokers and that’s the big difference 😉 I think in the beginning I was still so stunned to have this disease that I too had strongly associated with smoking. But along the way I have learned how stigma gets in the way of compassion. Two things I know for certain. Life is not fair and no one deserves something as awful as lung cancer.
xoxo Linnea
Craig, my own silly blog format won’t allow me to leave my reply right after your comment (formatting!). But thank you for your longer, spot on explanation/response and yeah, three cheers for all our asses!
xo Linnea
Pingback: Sigh. | life and breath: outliving lung cancer
Pingback: Here we go again | life and breath: outliving lung cancer