(An earlier version of this blog appeared on Phoenix Rising)
‘Let the Patient Revolution Begin’
A militant cry from those difficult ME/CFS patients unwilling to listen to doctors, researchers and government departments who only have patients’ best interests at heart? No, this dramatic call comes from that pillar of the medical establishment, the British Medical Journal (BMJ). It’s recent editorial argues that the healthcare system as a whole is actually badly broken and can only be fixed by an active partnership with patients:
[Most patients face] tests and treatments whose merits are hyped and harms underplayed…
Practice is informed by an incomplete research base bedevilled with selection and reporting bias, and at worst fraud. The preservation of institutional bureaucracies, as well as professional and commercial vested interests, have consistently trumped the interests of patients. The healthcare industrial complex stands accused of losing its moral purpose…
How better to [fix this] than to enlist the help of those whom the system is supposed to serve—patients?
BMJ Editorial: Let the patient revolution begin, May 2013
The BMJ may not have had ME/CFS in mind specifically, but their comment “Far more than clinicians, patients understand the realities of their condition, the impact of disease and its treatment on their lives, and how services could be better designed to help them” sums up the ME/CFS predicament perfectly.
Some patients have good constructive relationships with their physicians. Dan Peterson’s patients, for instance, are practically queuing up to praise him. Yet many have had a terrible time with doctors who dictate to patients without really listening to them, and who sometimes think this illness isn’t much more than an attitude problem. It varies a lot – I’ve experienced both sides of the coin myself – but there are too many examples of patients having horrific experiences at the hands of the health service. And for the severely-affected there is often nothing on offer at all.
‘Healthcare won’t get better until patients play a leading role in fixing it’
That quote comes from the BMJ editorial again, but, of course, patients from many disorders have been calling for change for years. One of the leading advocates for putting patients centre-stage is e-Patient Dave, (Dave deBronkart) who says “The most underutilized resource in all of healthcare is the patient“.
The BMJ said “Patient engagement is seen as a way to help health systems become sustainable”. Some have argued it is the “blockbuster drug of the century” and will deliver equivalent dividends.”
Patients Rising: TED talk from e-Patient Dave
The E-patient (and How the Web Changed Everything)
Tom Ferguson, the medical editor of the hippy Whole Earth Catalogue, played a key role in Dave’s understanding of patient empowerment. Tom pointed out in the 1970’s that most healthcare consisted of healthy people looking after themselves, but somehow when people become ill, their healthcare became the provence of the health care system. So he coined the word e-patient, to describe a person who was Equipped, Enabled, Empowered and Engaged (to which others have added Equals and Expert), in actively treating their disease.
Then the web changed everything. Dave emphasized that the Internet lets patients find information and connect with one another. In his case, it allowed him to find local doctors using a new and aggressive treatment for his terminal-diagnosed cancer that ended up saving his life. The patients who lead him to the treatment said it probably wouldn’t work, but it might – and in his case it did (see his BMJ article: “How the e-patient community helped save my life”).
This isn’t to suggest a miracle cure for ME/CFS can be found online, but it does show how online patients can access well-informed, highly relevant information that wouldn’t otherwise be available. The BMJ too emphasizes the value of patient communities:
Online patient communities where patients meet, talk, support, inform, and coach each other are empowering patients… They also provide a rich and as yet largely untapped learning resource for health professionals. ] There are salutary lessons in the gulf between conversations in the clinic and the concerns patients share with their peers. [BMJ editorial]
Unfortunately, not all doctors see patient forums so positively.
Clinics That Give Patients What They Want?
The BMJ said, “Far more than clinicians, patients understand the realities of their condition and how services could be better designed to help them” and this is probably nowhere more true than for ME/CFS.
Things should be changing in the UK, at least in theory. The UK Government’s new Health and Social Care Act aims for there to be “no decision about me, without me” for patients and their own care. This sounds good, but how well these ideals translate into better patient care remains to be seen.
Putting Patients at the Heart of Research
Medical research needs to change so that it serves the interests of patients as well. The United States government has set up a new agency, Patient-Centred Outcomes Research Institute (PCORI), to focus on outcomes that matter most to patients.
This is serious work: their budget was $150m and they plan to spend $3.5 billion by 2019.
This year both the CFIDS Association of America and the Open Medicine Institute (OMI) applied for a share of $12 million to establish patient networks of individuals willing to provide clinical and self-reported data for research studies that promise to improve outcomes for patients. (Health Rising is supporting both applications. More about the OMI initiative below.)
In the UK, groups of patients, carers, and clinicians are focusing on questions about treatment outcomes – good and bad – that researchers need to answer. The results is DUETS, a database of uncertainties about the effects of treatment. Unfortunately, such an enlightened approach has yet to reach ME/CFS, as was shown by the world’s largest CFS clinical trial, the £5 million PACE study, which defined success and failure without consulting patients.
Not Everyone Wants to Collaborate With Patients…
The PACE Trial’s recent paper claimed that 22% of patients ‘recovered’ with CBT or Graded Exercise (compared with 7% without). However, the authors abandoned their original protocol definition of recovery and created a new version with much looser criteria. To give an idea of how far-fetched some of the new ‘recovery’ criteria are, 13% of the patients in the trial met the fatigue or function ‘recovery’ criteria at the start of the trial, while simultaneously meeting criteria for ‘severe and disabling fatigue’.
Plus a quarter of the new patients seen in clinical practice had physical function scores that met PACE criteria for ‘recovery’. Surely the prime arbiters of what counts as recovery should be patients, who live the real-world consequences of the illness, not researchers who might be more concerned with making their study look good?
When it came to measuring treatment ‘Harms’, the PACE trial went further in collecting data than any previous CBT/GET study, but they revised the original protocol definition of ‘Harms’, making it harder to for problems to count as ‘harm’, and made it technically impossible for anyone to deteriorate seriously in the second 6 months of the trial.
It’s worth noting that ME/CFS patient surveys based on patients receiving normal clinical services rather than the highly controlled therapies of research trials consistently find high levels of adverse reactions with CBT and graded exercise. This information hasn’t always been taken very seriously by researchers and clinicians. Patient advocate and researcher Tom Kindlon has highlighted the problems of poor Harms reporting in ME/CFS research in a peer-reviewed paper.
Elsewhere, The Cochrane Collaboration has raised standards by producing systematic reviews of evidence on a topic, so that doctors can see the whole picture rather than relying on cherry-picked studies. Every Cochrane Review has a plain language summary aimed at patients, and they’ve gone further with the creation of the Cochrane Consumer Network, ccnet, that involves patients and patient advocates in preparing reviews – to make sure that Reviews address the issues that matter most to patients. Sadly, there is no patient involvement in the forthcoming review on exercise therapy for CFS – though an undertaking has been made that patients will be involved in future Reviews.
Other organisations show new signs of being willing to listen too. The recent FDA workshop gave over much of the first day to patients talking about their experiences. It quickly became clear that many at the FDA had no idea of the level of suffering of ME/CFS patients and the often-moving testimony from sufferers seemed to make a difference.
Patients Doing it for Themselves
Patients are increasingly becoming a driving force in research, rather than simply being consumers or particpants:
Crowd-sourcing to Speed Up Research
The Open Medicine Institute’s OpenMedNet will give patients the opportunity to share as little or as much of their clinical data, biological samples or both with researchers. Including devices such as Fitbit that monitor activity levels and sleep, will give researchers an unparalleled opportunity to study patients ‘in the wild’ rather than just in the lab. OpenMedNet has yet to go live, but the over 10,000 patients that have registered indicates a strong desire from the ME/CFS community to participate. The CFIDS Association of America is partnering with PatientsLikeMe to enable networking and data sharing between ME/CFS patients and researchers, and another similar venture is expected to come online soon.
Patients aren’t just giving researchers data now, they are starting to directly fund research themselves too. Maria Gjerpe’s incredible MEandYou initiative raised $430,000 in 90 days for the planned Norwegian multi-centre trial of the potential ME/CFS drug Rituximab. The fact that patients were resorting to funding their own research generated huge media and political interest, especially in Norway where Maria says it changed attitudes and helped prompt the Norwegian Research Council to switch direction and fund a large chunk of the Rituximab trial.
Crowdfunding is catching on: Ryan Prior turned to patients to fund his ‘Blue ribbon’ documentary exposing the terrible neglect of ME/CFS – and reached the $12,000 target in half the planned 36 days, and, of course, the Canary in a Coal Mind crowdfunder raised an amazing $200,000 in 30 days.
A raft of opportunities are coming together that could help the medical establishment tackle the major problems faced by ME/CFS patients. The medical establishment is finally beginning to wake up to the need for radical change, no doubt prompted by years of advocacy from patients pointing out that their needs are being ignored in healthcare and research. There is recognition too that patients are central to fixing the system.
Legislation in the UK will, at least in theory, give patients a much greater say. Research is being opened up to patients, while new technology and a can-do spirit from organizations like the Open Medicine Institute creates new ways for patients to contribute.
Not everyone will welcome a patient revolution, and I suspect that the medical establishment will resist more when it comes to ME/CFS than most other diseases. The problems with the IOM contract are an example of the HHS turning a deaf ear to patients and even to CFSAC.
Despite these setbacks I believe the new opportunities created by the movement to put patient views at the heart of health care and research, will make it increasingly difficult for researchers, clinicians and governments to block patients from taking a central role in deciding how their illness is studied and treated.
Credits: Thanks to OCAL at clickr.com for the revolutionary woman icon