When noncompliance is your best option

Last week Lungevity hosted the Scientific and Clinical Research Roundtable in DC and I was invited to be the keynote speaker. Really. I could be wrong but I have a sneaking suspicion that most of my invitations to speak will not be followed up with a second invitation. I have transitioned unequivocally from advocate to activist and I’m not sure everyone is ready to hear what I now feel the strong need to say. In a nutshell, I feel that clinical trial participants are the graduate students/sherpas/indentured servants of the cancer world. We do the heavy lifting–it’s all guts and no glory but we can’t say no because we’ve got nowhere else to turn.

I’ve shared the entire transcript of my talk here. It’s a long haul and for those of you familiar with my story, there will be some repetition in the first half. But then I get down to nuts and bolts (or screws and nails, the way I describe my neuropathy).

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Good afternoon. I am happy to be here today. In fact, I am happy to be here every day.

It’s not something I take for granted, ever. The first thing I do when I wake in the morning is to say ‘I’m alive.’

The wonder never lessens. And that is because a little over eight years ago, I heard the words ‘there is nothing else we can do.’ Never one to turn away from the truth I wanted to know more, I wanted to know how much time remained. The answer was three to five months.

And so I began to let go of my life—and to help my family do the same. Both I and my youngest, then eleven, started individual counseling. I travelled to Colorado, for a hastily organized and tearful family reunion. I said my goodbyes.

But then at my next oncology appointment something totally unexpected happened. A recent biopsy had been submitted for genetic testing and had come back positive for a newly identified target in non small cell lung cancer, an ALK translocation. A phase I clinical trial for an experimental agent targeting ALK mutations had begun recruiting at my hospital. So far there had been only one other participant and he had died within weeks of starting the trial, in part because of side effects of the experimental agent.

It was not a lot of information to go on but I liked the sound of targeted and my oncologist, though cautious, seemed enthusiastic as well. I hoped the drug wouldn’t hasten my death, but I knew that if I did nothing, my cancer would surely kill me. I was between a rock and a hard place but the way I saw it, this clinical trial offered at least a sliver of hope where now I had none. And I said yes.

On October 1st of 2008 I became the fourth person in the world with non small cell lung cancer to take crizotinib. Seven weeks later, as we went over my scans, my oncologist characterized my response as flipping amazing. And all those goodbyes became hello, I’m back.

I got lucky, really lucky. I was at the right place, in the right time, and with the right oncologist. And I’ve been lucky ever since, having now been an early participant in three phase I clinical trials. Innovative medical research has extended my life far beyond what I ever thought possible.

This has meant the world to me and my family. In June, almost eight years to the day after I was told I had three to five months left to live, I watched my youngest graduate cum laude from Phillips Exeter Academy. Four weeks ago he began his freshman year at MIT.

And me? I’m loving life, all of it. 45 when diagnosed, I will turn 57 in November. Between my three kids, art, writing, advocacy and my plethora of friends, I couldn’t be busier.

Of course, I do still have lung cancer. Although I have enjoyed two years of stability on my current therapy, my most recent scan showed progression. I have scans again in two days, and by next week, I should know if it is time to switch things up again.

I hope that medical research will stay one step ahead of me. I also hope my body will hold out.

It has been my privilege to participate in clinical research. But it has also been my burden. I have shared my joy, my gratitude. Now I would like to share my concerns and I feel I have rather a unique perspective for doing so.

There was an old paradigm for clinical trials, and that was that they were usually a one off.

When I enrolled in the trial for crizotinib in 2008, it was with the hope that it might extend my life for several months, nothing more than that. Because honestly, there was no precedence.

Even once it became clear that I’d in fact responded to the experimental therapy, my joy was tempered with the knowledge that I would eventually develop resistance to the drug and that when I did, I was once again out of options. Because that is where things stood in 2008.

I never imagined that I would go from trial to trial, and, at that time, I’m not sure anyone else could have imagined such a scenario either.

But I have and my participation has kept me alive. However, it has come at a price.

Enrollment in a clinical trial requires a greater commitment of time, resources, blood and tissue. And often, additional scans as well.

The clinical trial that I am now enrolled in initially had a protocol that required not only a Chest CT scan, but an abdominal scan, brain MRI, and echocardiogram every six weeks. I might point out that a schedule more akin to every three months is the standard of care when it comes to scans for a metastatic patient. I might also point out that my histology, invasive mucinous adenocarcinoma, almost always stays confined to the chest when it metastasizes, and that I have never had brain, bone or abdominal mets.

Initially my trial also required a bone scan, every three months. I had the first one, and afterward was handed the the same little card that you carry around for three days after every PET scan, just in case someone in law enforcement or at an airport picks up remaining background radiation. This struck me as ludicrous, and also an unacceptable risk with neither scientific justification nor personal gain. I told my oncologist that I wasn’t going to get any more bone scans even if it meant dropping out of the trial. Fortunately she is as invested in my future as I am and as a PI in the trial, was able to contact the sponsor and had the protocol changed.

Fast forward to July of 2015 when I happened to see a report in the Stanford Medicine newsletter regarding DNA damage seen in patients undergoing CT scanning. This line in particular jumped out at me ‘“We now know that even exposure to small amounts of radiation from computed tomagraphy scanning is associated with cellular damage.” I started to think about all the scans I’d had and would continue to get and wondered if anyone was keeping track. With access to my electronic medical records, I decided to tabulate the results myself and what I found shocked me. Now keep in mind that this only reflects care and clinical trial participation at my current hospital, and does not take into account previous imaging, such as the scans that led up to my diagnosis. Or workups for other health issues, or routine imaging such as mammograms or dental work.

When I sat down and counted I found that I’d had 19 chest x-rays but also close to 70 CT scans of my chest. For those of you who don’t know, each chest CT scan, even those that are low dose, has the equivalent radiation of 4-500 chest x-rays. Now multiply 400 times 70 and tell me if that is a number you are comfortable with. I was really surprised when I counted the number of abdominal scans I’d been given; 44. Given the complexity of the tissue in the abdomen, scans of that area of the body expose cells to an even greater amount of radiation. And keep in mind that I have no cancer in that part of my body. Yet. But I do have highly mutable cells.

The first CT scan of my chest saved my life. But is my scan schedule eventually going to lead to a secondary cancer?

I don’t know, but I can’t let that happen. And so I did what any reasonable person would do. I spoke not only to my oncologist, a PI in the trial, I contacted the sponsor personally. However, I really made no headway until I talked to the right person in a bar. That’s right. I have been a peer reviewer for the CDMRP for a number of years and after a session last fall I chatted up a fellow reviewer in the bar—told them my tale of woe. When I concluded he let me know that his wife worked for the sponsor and he was going to share my story with her.

Well sometimes the back door is the right one and this time the sponsor contacted me. I had a private phone conference where I spoke not only about my scans but about what I view as a rather prevalent disregard of the sacrifices clinical trial participants make. And I asked that they not only change the scan schedule, but that they pay for parking.

When I got my response it was from my scheduler. My scan schedule would not be changed. I told her to tell my oncologist that I now had no choice but to become noncompliant—that I would continue to get CT scans of my chest but there would be no more abdominal scans.

I am fortunate that my oncologist truly is as invested in my future as I am. She called me almost immediately and we discussed the situation. To my surprise, she was fully supportive, although she did explain what noncompliance put at risk for me personally as well as for the trial and my institution. I told her that if she asked me to go to Mars the next day I would do it, I trust her so implicitly, but that I simply could not keep getting scans every six weeks for the rest of my life.

The bottom line is this—currently clinical trials are monitored as discreet events, a residual of the old one-off paradigm. No one seems to be keeping track of patients such as myself, who are traveling from trial to trial. I am an outlier, an exceptional responder, and I am also a bit of an anomaly amongst the ALK positive population with my invasive mucinous adenocarcinoma histology.

But that is the point—I am first and foremost an individual, a human being. Participation in clinical trials does not cede my humanity, although it certainly does result in a certain loss of autonomy. And words like compliant and noncompliant only underscore that fact.

Per my scans—I really like to do things the right way. Also, as an advocate, this was never just about me but rather about everyone who participates in clinical trials. And so I would periodically contact the sponsor. What I didn’t realize is that my oncologist was also in continuing dialogue with them about the scanning schedule. Several months ago I got word that the protocol would be changed and that after a year on trial, participant’s scans would move out to every three months, the standard of care. When I spoke to my oncologist, I realized that it was her input, not mine, that made the real difference. But the important thing is, she respected my concerns which motivated her to request a change in protocol.

As for me, I moved to the every three month schedule as soon as I heard the news, even though it is not yet official. Jumping the gun a little, but then again, I remain noncompliant as to my abdominal scans, so what’s a skipped chest CT scan or two. And don’t think I am simply being cheeky—I donated my body to science a long time ago and I feel no guilt when it comes to a skipped scan or two.

I still wish I didn’t have to get brain MRI’s every six weeks—I’ve now had almost thirty and nothing causes me more anxiety than the loud clanking, claustrophobia of a brain MRI. Also, I am convinced that we don’t yet understand the risks—again, there is very little precedence for such a frequent MRI schedule in someone with healthy brain tissue. After reading that the contrast agent, gadolinium, is not readily cleared from the body I did request that we forgo contrast so that is one small victory.

The irony is, were this anything other than a clinical trial, say, a war or a sporting event, I and my fellow participants would not be fighting for our basic human rights. We would be decorated for our valor, celebrated, maybe even highly compensated. And we can’t even get our parking comped.

And yet, I am alive. It is a wondrous thing, and something most people take for granted.

I would do almost anything to stay alive. I already have. But I am also not willing to throw away this second chance at life by submitting to ridiculous requirements simply to satisfy the science and to speed drugs to market. As Richard Pazdur has said, ‘People are not for clinical trials. Clinical trials are for people.’ It’s imperative that we not lose sight of why trials exist in the first place. It is not to advance the careers of researchers. It is not to keep oncologists and hospitals in business. It is not to enrich sponsors and their shareholders.

Rather, it is to provide patients such as myself with an opportunity to hang onto our very dear lives.

*for a dose of happy/hopeful Linnea, check out this video interview about Clinical Trials from the Lungevity site.

44 responses to “When noncompliance is your best option

  1. Very interesting Linnea. I see Dr Shaw this week for scans and Lorlatinib.
    I will contact you if i’m feeling ok. going off criz has been NOT a joy.
    crummy feeling……..

  2. Linnea –
    So glad you spoke up, and so eloquently!!! Your voice needs to be heard — over and over again! We all thank you for your bravery!!!
    ❤ m

  3. Linnea – I fully agree. I often characterize my situation as being my attempt to survive the survival of NSCLC! I almost wonder if we should be issued one of those radiation exposure badges at our initial diagnosis? While we deal with excessive radiation, heavy metals toxicity, overuse of miracle drugs like prednisone, and are put continually at risk, the overriding attitude is often that we should be happy to be alive! But it’s never that simple. Love you dear. Stay loud! Jim

    • Jim, I am happy to be alive but that is something that others do get to take for granted and for which we have worked so very hard. I am grateful for the care I receive but I also know that this system needs some tweaking. I am not going to get quiet anytime soon 😉 xo

      Linnea

  4. What a story! I am in the same department so to speak, xalkori etc. IStage four. I lung cancer. Ihave been studying a lot, like Ty bollinger, Dr. tom O’Brian and many other since my diagnosis in January 2016. Last pet etc showed nothing in lymphs, lungs, spine. Small increase in brain ( migth be inflammation if you ask me). Developed my protocol based on the numbers around, amazing results.. love to share. Best regards Paul ( norwegian)

    • Paul, congrats on your latest PET. Xalkori is not so effective at crossing the blood/brain barrier but some of the newer ALK inhibitors (such as lorlatinib, the drug I am now taking) are. Did you develop your own protocol?

      Linnea

      • Hi Linnea, I certainly did. Detox, alkali diet, no grain etc. Also Moringa supermix, the stuff from Epigenetic labs, recently mret and LifeOne etc. Just incredible.

  5. So well said Linnea! I, too, keep hammering about the unnecessary radiation exposure from the abdominal and pelvis cat scans I’ve have over the last 8 and a half years. No one ever expected us stage IV survivors to be here as long as we have. It truly is negligent on the part of the researchers who develop the trials. Years ago, when I complained to my oncologist, he told me I wouldn’t live long enough to develop a secondary cancer from the radiation. I’m not so sure he would have the same response today. Thank you for being such an advocate AND activist!
    Sharon

    • Sharon, thank you and keep hammering away. I remind people sometimes that our lives matter more to each of us than they do to anyone else and we need to be our best advocates. I also had a doctor ask me why I wanted a colonoscopy when I turned 50. I mean, I had terminal lung cancer. I told him I guess I just thought I was going to live 🙂 Keep on keeping on!

      xo Linnea

  6. Thanks, as always, for sharing your story, Linnea; the good and the bad. It needs to be told and you are so courageous to do so.

  7. Hi Linnea, thank you for your thoughtful, clear, and passionately human words. As a fellow outlier you have given me much to mull over.

    Dave

  8. Cristina Thorson

    Jeez, you’re a good writer. Nothing wrong with your brain, Chica. What was the response to your speech??

    • Thanks Cristina. I think some people were a little taken aback but several thanked me personally and it opened the way for some constructive dialogue. Of course I had some more to say 😉 BTW, extra love to you right now.

      xo Linnea

  9. Bravo Linnea! I will be discussing a couple of scan schedules with my Oncologist. Thank you for helping to shape the future of clinical trials. Scientist don’t always get the human factor element. Your insights are invaluable!

    Peace, Love, Joy and Happiness
    Elizabeth

    • Elizabeth, I am glad you will be having this conversation. It’s important to steer our own course. Many of us may be in treatment for the rest of our lives so we can’t be complacent per these things.

      xo Linnea

  10. Thank you, Linnea. Your story is very articulate and persuasive. I’m going to spend some time rethinking my own clinical trial, which has scans every six weeks.

    • Dann, I think that’s a good idea. You’ve been at this a long time just as I have. And hopefully, we’ll be at it for a good deal longer.

      Linnea

  11. Wonderful! I too refused to get more abdominal scans and asked to go to CTs with longer intervals. It’s our life and our bodies. 10+ years stage 4 CRC. many doctors feel better sticking to a schedule and that makes them comfortable, but we know our bodies better. Way to go Linnea!

    • Jackie, good for you. And congrats on 10+ years with CRC–phenomenal. It’s a whole new concept—this surviving with advanced cancer thing. So we need to help rewrite the rules as we go along.

      Linnea

  12. Linnea,
    You were put on this earth to do many beautiful things. One is the gift to teach humanity. I love receiving your emails because they are so freakin honest, kind and beautifully written. With all this crap you have endured, you don’t lash out at others. Simply astonishing. To all the others who are fighting in clinical trials, I want to thank you for giving back knowledge to push for a better life for all.

    Linda

    • Linda, you made me cry (but I’m smiling through those tears). Thank you. I am a happy person (by choice and a lot of practice) and cancer can’t take that away. I just want us all to get the best shot possible.

      xo Linnea

  13. A ton of good wishes for your scan. Rock it!

  14. I just climbed in bed so dead tired. Then I remembered I had an email saying there was a new post on your blog so I reached over & grabbed my iPad from the night stand. Well said Linnea! The goodness in all of this cancer bull crap is, it has brought the best people in my life. This includes you Linnea. You are a wonderful writer, talented artist, loving mother, well loved by many friends & you offer us so much support by sharing your deepest thoughts & your kindness to open the door for us too peek in on your life.
    “And yet, I am alive. It is a wondrous thing”. It is, it is truly wonderful to be alive…… Good night, Katie

    • Katie, I agree about the best people part. I was joking with Lysa B. yesterday that being nice/smart/generous is obviously a risk factor for lung cancer. And that’s just the people with the disease–there are so many others that have come into our sphere as caretakers/friends/advocates/researchers/journalists… I never imagined my life would turn out like this but I also couldn’t have pictured it being so very full. I hope you slept well.

      Linnea

  15. Linnea, I’ve followed your story for five years now, since my Steve was first diagnosed and you’ve always been a hero to me. Once again you are Standing Strong for what you believe is best for you and other NSCLC patients. I know now you will never give up in your fight to live and live fully with cancer battling your every step. You weren’t made to be a compliant sheep, allowing researchers to make all the decisions regarding your body. You have earned the right to decide just how many times you are exposing your one body to all those toxins and damaging rays. My two granddaughters have serious health issues, many heart surgeries, a kidney transplant and a possible lung transplant and they have shown equally amazing strength as you. I pray each morning that my three heroes will have another day to live the good life and fight the good fight. Stand Strong Linnea, for yourself and all who follow. Sincerely, Hedy

  16. Hedy, I had no idea your granddaughters were dealing with such serious health challenges—you do a good job of keeping the happy on throughout all of this. I wish them the very best.

    xo Linnea

  17. Love this, Linnea. Such an eloquently written piece on such a vitally important topic. Inspired.

    • Hey Emily, I think it is vitally important for all of us but younger people in particular to pay attention to the side effects of not just treatment but monitoring for cancer. It is ironic that the necessary lifestyle of a cancer patient exposes one’s cells to constant insult. Stay vigilant!

      xo Linnea

  18. Linnea, You are a brave lion. I am a frightened little mouse. Your words always help me so much and I thank you. How can I “comp” you for your parking? Are you comfortable emailing your mailing address to me so I can send a check? Or could I send it to Dr. Shaw’s office so they can give it to you? Hoping I can cover several visits – I could be wrong though because parking in Houston is not the same as parking in Boston. In any case, let me know. You have no idea how much you help me. I have my scans/appointment in a week and a half and have been very gradually educating myself (too much info and I get really scared). Histology? I would never have known to even get that info. Guess I will ask about that at my appointment. Have been fortunate to avoid treatment since right bi-lobectomy in Jan. 2011. Think I’ll have to make Big Decisions in the near future so I’m trying to get informed. Again, thank you for your advocacy and activism. Good luck on your next scan. Joan.

    • Joan, what a sweet comment. I have found myself moved to tears a fair amount lately and your comment got me weepy (in a good way, as I always say). First of all, I think you are probably so much stronger than you think you are. Also, it is a process. When I was first diagnosed with cancer, I was afraid of so many things (with cancer being one of my worst fears). Simply living with my fears has decreased their power to frighten me. If you have decisions coming up, it is probably better to make them with as much information as possible, so that they will be informed choices. Also, I am so touched by your offer to pay for my parking but I’m going to keep wrangling with my hospital and the sponsors of my trial per that issue—I feel it is their responsibility. But thank you, thank you.

      xo Linnea

  19. I am alive & I am awesome! (add that to your morning!) Thank you!

  20. Linnea, Thank you for your info. I am going to ask my oncology to see if I can get my scan reduce. I already compliant to him not long ago but this time I can refer to your case and Dr. Shaw’s support.
    Joanna

    • Hi Joanna—good to hear from you and best of luck getting the schedule changed. There are so many of us now who are have been in treatment and often enrolled in clinical trials for extended periods and scan schedules need to be reconsidered.

      xo Linnea

  21. So well said Linnea! I, too, keep hammering about the unnecessary radiation exposure from the abdominal and pelvis cat scans I’ve have over the last 8 and a half years. No one ever expected us stage IV survivors to be here as long as we have. It truly is negligent on the part of the researchers who develop the trials. Years ago, when I complained to my oncologist, he told me I wouldn’t live long enough to develop a secondary cancer from the radiation. I’m not so sure he would have the same response today. Thank you for being such an advocate AND activist!

    • Summer, thank you. It is hard to get people to take the long view with this disease. When I turned 50 I went in for my colonoscopy and after that doctor heard I had advanced lung cancer his response was ‘Then why do you want a colonoscopy?’ I told him that I guess I thought I was going to live.

      Linnea

  22. Pingback: Good4Patients - Dear FDA: If We Listen, They Will Tell Us - Rx4Good

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