For all but one of the past seven years I have served as a peer reviewer for the CDMRP. It is perhaps the toughest form of advocacy that I have undertaken but also one of the most rewarding. I never got around to mentioning it (oh, I am so behind!) but last summer I was featured as a consumer reviewer on the CDMRP site. I was honored as I am to simply serve as a peer reviewer and I encourage any of you who are interested to apply.
My featured story gives a shout-out to medical research and segues nicely into the next part of my post, which offers a slightly more critical view of clinical trials.
The thing is, I ❤ clinical trials 100%: I absolutely would not be alive today had I not had the opportunity to enroll in a clinical trial back in 2008. Because of how far down the treatment pike I have come, clinical trials are my next best hope and I am keeping my fingers crossed that when the time comes, there will be yet another in which I can enroll.
Unfortunately, clinical trials have a bit of an image problem, as many people consider them risky and a choice only for desperate people—something I can’t really argue with. When I enrolled in my first clinical trial it was a different time; one with absolutely zero expectation of success (and yet a wild fleeting hope, which was the motivation behind my decision to enroll). However, with the advent of targeted therapies as well as a sudden wealth of experimental therapies to treat NSCLC, more and more people are enrolling in not just one, but several clinical trials.
The previous paradigm was one which assumed that participants in trials were likely on their last leg. Issues relating to quality of life were simply not considered. I’ve now spent almost a tenth of my life enrolled in a clinical trial and last summer, after Stanford came out with a report about the cellular damage exacted from each CT scan, I sat down and counted how many scans I’d had. And I was shocked.
Since then I’ve been trying to find a sympathetic ear. At the end of our first day of CDMRP peer reviews this year, I chatted up the right person in the lounge. They connected me with someone from the pharmaceutical company who is the sponsor of my trial and I sent them this email. I’m sharing it with you now because a member of my blogging community recently asked the question online as to whether or not it was better to stay in a trial or to switch to prescription once a therapy has gained FDA approval. It was my viewpoint that if it meant a decrease in scans, I would switch to prescription.
So back to the image problem. Only 3-5% of cancer patients enroll in clinical trials and I believe there is the potential to increase those numbers. And I think it might well start with really recognizing the contribution trial participants make. How about just saying thank you—at the end of every peer review I receive a nice note from the Department of Defense thanking me for my service–that gratitude and recognition never grows old.
Please know that I don’t feel that this is under poor circumstance—I would just like to start some dialogue. When someone is feeling disenfranchised, the first thing they want is to feel heard.
I would love to speak to you on the phone and would also welcome an opportunity to share my perspective with a larger audience. There is a lot of buzz about patients as partners but we can only be a partner if we have an equal voice. I am grateful for and a champion of clinical research (my eighteen year old son had an internship at the Koch Institute this summer, and was engaged in pancreatic cancer research). I am also only too aware that I would not be alive today without clinical trials. However, as this is my third phase I clinical trial, I am in a unique position to offer some observations about how that process can be made better for patients.
A couple of talking points that I would like to discuss:
1. The loss of autonomy. As a patient becomes a participant they lose some control. Per my issue with the number of CT scans I’ve had—even my oncologist was surprised when I told her that I had added them up and that I’d had more than one hundred. Obviously, no one is keeping track of this sort of thing and with patients now going from trial to trial, I feel there should be some guidelines established and I don’t feel those should be guidelines of exclusion (because most of us will do anything to stay alive). Rather, I think that there should be a way to view participants as individuals and not just data. In my case the scans to my abdomen and head are totally uncalled for and expose my already mutable cells to additional radiation. Ideally there would be a way to follow me in a trial but to also take into consideration that I have a lung cancer that has and almost certainly will remain contained to my lungs.
2. Parking. That’s just sort of my bottom line. I was at my PCP’s yesterday (also at MGH—where I get my cancer care) and saw a bulletin board with notices for participation in clinical trials for things other than cancer. The participants would be compensated ($) and given parking vouchers. This always burns me up. Everyone makes money off of my disease but me, and I’m the one who has to have the stupid disease in the first place and I’m supposed to always be in grateful mode. As I tweeted a week ago–‘I ❤ being alive but I want free parking too’. I just don’t buy this inducement stuff. I also tweeted (I’m going all radical on you) in a conversation about patients as stakeholders—‘I don’t just want to be a stakeholder I want to be a stockholder too’. I’m really not kidding—I think it is time to talk about the major contribution early participants in clinical trials make. Another analogy—there would be no horse and pony show without the horses and ponies.
3. The story about my having to pay for Xalkori the second time around. Obviously there was no way for anyone to know I was the 4th person in the world (with NSCLC) to take this drug. But even if they had known, it would not have made a difference. I was able to afford Xalkori by prescription only because I qualified for financial assistance (not an easy process to go through when you are stressed, alone (I had recently separated from my husband) and, to be frank, once again heading down a path where if things don’t change, you will soon be dead. The whole experience kind of dashed any feeling I might have had that as an early participant I was somehow special. In truth, I feel early participants should be accorded the same sort of respect that veterans of the service are. We put our lives on the line, taking risks that many, many people never would. And our sacrifices benefit all.
4. I think it would behoove pharmaceutical companies to develop a patient advisory council. I have served on such a council at MGH for three years now and we have provided feedback on any number of healthcare initiatives.
5. Compliance. According to my nurse, compliance is only 60% in the trial I am currently in. Prescribing oral chemotherapies in a pill bottle just seems crazy to me. A blister pack (with a way to have a calendar printed on it) would be such a simple way to help patients with dosing. As one of those (often) non-compliant patients, I have such a difficult time recalling whether or not I’ve taken my pills and so skip a dose rather than risking double-dosing.
It is my understanding that only 5% of cancer patients enroll in clinical trials. I know little about the regulatory process but I do believe that if participants were treated better (induce us!) those numbers could rise. And I would love to be part of the conversation about how to make some improvements.