Speak Up: Reflections from a Nightmare Patient - Me!
The below article from the Oncology Times medical journal, was authored by Dr. Andrew D. Lawson, FRCA, FANZCA, MSC, a consultant in Intensive Care, Pain Management and Anesthesia in the UK and Australia and an Honorary Senior Lecturer in Medical Ethics at Imperial College in London. Dr. Lawson was diagnosed with malignant pleural mesothelioma in 2007 at the age of 47. Following his diagnosis, Dr. Lawson read every publication he could find about mesothelioma and discussed available treatments with colleagues from a variety of disciplines.
In the article, Dr. Lawson expresses concern and anger over the way many doctors view treatment for mesothelioma and other terminal illnesses. He laments the position shared by many doctors that: “It has been deemed that nothing works, so the best thing to do is to use us as subjects in clinical trials.” He states that this position “ignores, however, the individual patient and starts from the position that you must have an RCT [randomized clinical trial] in order to use a treatment.” He, instead, concludes that, especially in cases where the prognosis is less than one year, “therapy cannot wait for trials to be conducted” and that “the moral duty to treat may trump the notion of scientific rigour.”
Dr. Lawson describes how, on the very day he was diagnosed with pleural mesothelioma, his doctor recommended that he enroll in a randomized clinical trial involving the Extrapleural Pneumonectomy surgical procedure. Before agreeing to participate in the trial, Dr. Lawson’s own research led him to an article in theAnnals of Surgical Oncology authored by thoracic surgeon Dr. Robert Cameron. Dr. Lawson states that, after reading this article, “whatever reservations I had about EPP were confirmed” and that “not surprisingly, I chose not to go down that route.” He notes that others he knows in the field, including senior doctors, also advised him not to have an EPP.
Dr. Lawson goes on to compare participation in the EPP clinical trial to being “sacrificed on the altar of evidence-based medicine” and questions whether informed consent for EPP could exist without reading Dr. Cameron’s article along with one supporting the surgery.
We believe that Dr. Lawson’s article is a must-read for any patient who is contemplating EPP.
Speak Up: Reflections from a Nightmare Patient - Me!
http://journals.lww.com/oncology-times/Fulltext/2010/06250/Speak_Up__Reflections_from_a_Nightmare_Patient__.16.aspx
In BMJlast summer, Prof Kieran Sweeney published a moving piece about his journey as a patient with Mesothelioma. I agree with many of his thoughts and ground rules regarding how we as a profession should deal with patients with such an appalling prognosis. It is true that there seems to be little that can be done for patients with mesothelioma; many of whom feel left alone in what Professor Sweeney called the kingdom of the sick.
I, like he, also have been diagnosed with malignant pleural mesothelioma. Mine was diagnosed when I was 48 in 2007. Of the three doctors that I know of who trained at Guy's Hospital in London who have contracted the disease, I am the only one still alive. Prof Sweeney died on Christmas Eve 2009; he made some helpful comments on this piece prior to that, so I'd like to dedicate this to his memory.
I too have experienced some insensitivity along the way. Perhaps the radiologist who rang me up at home to tell me my CXR showed I had cancer and would I like to come in for a CT could have been a bit more subtle.
The most farcical incident, though, was when I was having a pleural biopsy. I have been there with piles of opened kit and nothing quite fitting, when putting in Hickman lines myself. We all know the scene; piles of paper wrapping, discarded syringes etc. It's no problem when you have an anesthetized or sedated patient. I, however, was fully conscious, with my wife (a forensic physician) looking on in horror. Call me old fashioned, but when a patient says, “Do you know that as a consultant anaesthetist of some years, I have always found it is helpful to wait for the local anaesthetic to work,” the response should not be to just push harder!
My wife and I agreed afterwards that a video of the whole procedure, particularly the bit with the three registrars (interns) with their backs to me staring at the ultrasound machine and fiddling with knobs, would make a great example of how not to do something, especially to a colleague
Diagnosis Established, Now on to Treatment
Diagnosis established, I moved on to treatment. I was treated with Alimta and cis-platinum, which suddenly midway 2007 became officially available on the NHS in England. It has always amazed me how drugs can suddenly become more cost effective after publicity or high-profile cases. One moment it's not worth a QALY, and then it is; it must be that level one evidence, politics!
Like Professor Sweeney, I have researched my illness. I see every paper published on Medline on mesothelioma. I have read all the abstracts from the international Mesothelioma Interest Group meetings, and I discussed my treatments with many colleagues from a variety of disciplines. I suppose I am the nightmare patient.
My concern and, to some extent anger, is focused on how some in my profession view treatment for this terrible disease, you have your chemo and or surgery and that is it. I accept that concepts of redistributive justice place constraints on treatments, but as will be seen, I merely augmented my treatments with relatively inexpensive drugs already on the market for other illnesses. Other patients who asked for these were refused
Bisphosphonates
My surgeon alerted me to the putative effect of bisphosphonates on mesothelioma. IV bisphosphonates have been shown to have an inhibitory effect on mesothelioma cells in a mouse model in vitro and in vivo. I corresponded with the researcher in Alabama and was interested in the model. I mentioned this to an oncologist whom I used to see. The reply was, “You can't do that; we won't know whether the chemo has worked.”
There is not much more to say. I changed oncologist, and, of course, I have had IV bisphosphonates. Why? Because there is a plausible biological rationale for their use, a known side-effect profile, they are available, and apparently I was going to die.
What possible, sustainable, cogent, and moral reason could a physician looking after me have for not agreeing to my request? Or indeed, not suggesting it in the first place? Is it because the prognosis is so poor that data-gathering has become the principal activity of some doctors treating not just patients with mesothelioma but anybody?
It has been deemed that nothing works, so the best thing to do is to use us as subjects in clinical trials. This is a perfectly respectable consequentialist argument. It ignores, however, the individual patient and starts from the position that you must have an RCT in order to use a treatment.
Indeed on the day of diagnosis it was suggested to me that I might enroll in the MARS (Mesothelioma and Radical Surgery) study—the surgery being extrapleural pneumonectomy (EPP).
Of course some patients might acquiesce, even accepting the very high morbidity rate and a not inconsequential mortality rate. The question is how many would accept surgery of this kind in a trial or otherwise if they were then handed this quotation from an internationally respected surgical oncological journal: “EPP should not become the [Sir Edmund] Hillary operation of thoracic surgery: being done simply because it is there and it can be done.”
Or this from the same article: “It is clear that if nothing else, one should learn from history and not make the same mistakes. The history of radical surgical procedures is littered with abandoned operations.”
Clearly the investigators were trying to tease out evidence from a very cluttered field, a laudable aim. I found the journal article quoted using a web search and whatever reservations I had about EPP were confirmed. Could informed consent for the procedure exist without having read this article as well as the one supporting surgery? I am not sure.
Not surprisingly I chose not to go down that route. What is worrying is that people I know in the field, and other senior doctors also privately advised me not to go down that route. This is a sad truism in medicine; we frequently will not have done to us what we do unto others.
In Prof Sweeney's article there is a physician's perspective in which an oncologist states that randomized trials “show little evidence of survival or quality of life benefits”—true. However what does this undoubted fact mean for patients like me? The implication being that, as the RCTs do not show much, then there really is nothing that can be done
How to Deal with Suffering & Illness in the Face of Uncertainty?
Here is a key question, though: How do doctors make a decision about how to deal with suffering and illness in the face of uncertainty? It seems to me that the profession has thrown up a defensive barrier of scientific orthodoxy, the RCT, behind which we can retreat when we seem to have nothing to offer.
Because RCTs have shown little if any benefit, then the oncologist states, “the role for active supportive care is paramount.” Should I accept just active supportive care (do they do inactive supportive care, a sort of supportive care lite?)? Should it be paramount?
Supportive care is thus more important than an attempt at treatment. Do I accept this? No. Should patients accept this? I would not advise it. I say this not as a criticism of the oncologist but of a system that seems at times to have lost view of our core raison d'être.
As the GMC (General Medical Council) puts it, “Make the care of your patient your first concern.” Nowhere in the GMC guidelines does it state that in the absence of an RCT you should not actively treat the disease to the best of your ability. I accept that concepts of redistributive justice place constraints on treatments but as will be seen I merely augmented my treatments with relatively inexpensive drugs already on the market for other illnesses. Other patients who asked for these were refused.
The problem lies with what we accept as evidence, as Sackett et al said: “Some questions about therapy do not require randomized trials (successful interventions for otherwise fatal conditions) or cannot wait for the trials to be conducted. And if no randomized trial has been carried out for our patients predicament, we must follow the trail to the next best external evidence and work from there.”
I figured that, having had the best available chemotherapy; it was not in my interests to hang around waiting for the next trial. Pain relief is part of “active supportive care.” One of my doctors pointed out that celecoxib (a COX-2 inhibitor) as well as being an analgesic might have some anti-mesothelioma properties.
Here is quote from a paper in the International Journal of Cancer in 2004: “In mice implanted with mesothelioma, celecoxib treatment significantly increased average survival from 45 days to 62 days, the researchers note, and there were three long-term (more than 120 days) survivors among the treated mice."
Which Is the Honest Answer?
I am not troubled with pain from my tumor, but I do have a chronic shoulder problem, so what analgesic do I use? Celecoxib, of course, and my question to other clinicians is this: If you have a mesothelioma patient in pain, then why not use celecoxib, other things being equal?
Or, to put it another way: If you do not offer it then why not? The Cochrane database supports it as a single-dose analgesic for postoperative pain (in comparison to ibuprofen), and the caveat for its long-term use in rheumatoid arthritis is cost.
So do you say to your patients, there is an analgesic available that might also affect your tumor progression, but we do not use it because it is too expensive, or do you say there is no evidence? Which is the more honest answer?
IP Gene Therapy
Since the bisphosphonates, I went on to have intrapleural gene therapy in Philadelphia (Hospital of the University of Pennsylvania—HUP ) in a Phase I study.
There is a tendency to bash US medicine in the UK; criticism of the lack of coverage is I think quite justifiable, but from a personal point of view I was very impressed, both by the efficiency as well as the sense of can-do (or at least try to do!), in contrast to the nihilism I encountered from some in the UK.
I had a mixed response to that treatment. Later when there was some progression on CT/PET, my oncologist was happy to try metronomic cyclophosphamide and gemcitabine to my regime on the basis of another basic science paper and the knowledge that a Phase I trial was in the offing.
This regime seems to have produced a significant response. I am lucky to be in the hands of a surgeon who supports my wish to try other things prior to surgery, but who will operate if I request or the disease progresses and an oncologist similarly concurs.
Moral Duty to Treat
In 2008 I gave a talk to a group from the Medical Research Council oncology clinical trials unit. I suggested that in diseases with a very poor prognosis such as mine, that the moral duty to treat may trump the notion of scientific rigour, that biological plausibility combined with patient consent was a sufficient mandate to treat.
One in the audience said that this would produce anarchy. Is this really what our profession is most concerned with? Keeping everything ordered and neat, our p values and powers just right? Looking for good and best evidence is an ethical duty, but we do have duties to our patients. There are ethical tensions between the quest for the gold standard of evidence and the moral duty to care for patients—how do we decide which is the more important?
If you have a prognosis of less than a year, then I would suggest that therapy cannot wait for trials to be conducted—call me just a tad cynical, but I guess an oncologist with mesothelioma might agree.
When HIV was running riot in the early ‘90s nobody waited for an RCT to treat. Why? The patients were dying, they had a voice, and the physicians looking after them were doing just that—looking after them.
I accept that my future is bleak, that in all probability I shall die sooner rather than later from this disease, but I believe that I have a right to have my doctors look after my best interests, and for the moment that consists of living as long and as well as possible.
It is of course possible that my survival of 36 months is a fluke and has nothing to do with my off-trial treatments. However I hear that EPP is losing favor, how would I be now if, like a frightened rabbit, I had agreed to be part of that trial and had been in the surgical arm?
I would not have been skiing in Switzerland last week or be able to cycle 90 km on dirt roads in Cambodia as I did at Christmas.
Evidence is crucial to medicine. However we need to be wary of using it as a drunk uses a lamppost, more for support than illumination, and I do not expect or wish to be sacrificed on the altar of evidence-based medicine.