Tag Archives: Myalgic Encephalomyelitis

Excellent Podcast Featuring David Tuller Discussing the Flaws of the PACE Trial

An excellent podcast was released recently regarding the egregious flaws of the PACE Trial, an $8 million study published in The Lancet in 2011 that purported to compare the effectiveness of adaptive pacing therapy, graded exercise therapy (GET), cognitive behavioral therapy (CBT), and ‘standardized specialist medical care’ in treating ME/CFS.  The tale is long and twisted, and this podcast presents the controversy in an easy-to-digest narrative.  

The PACE study was run by a group of psychiatrists in the UK who believe ME/CFS is the result of maladaptive thought processes regarding exercise that cause patients to avoid activity after an illness and thereby become deconditioned.  There are lots of studies to refute this biopsychosocial model, but that’s a blog post for another day.  

Both CBT and GET strategies emphasized to patients that they do not have a biological illness and encouraged them to increase activity levels even in the face of worsening symptoms.  A primary component of ME/CFS is something called post-exertional malaise in which exertion can trigger a significant physical decline.  

In practice, encouraging increases in activity can cause devastating setbacks for patients.  A survey of over 1,400 patients conducted by the ME Association found 74% of respondents reported worsening symptoms after a course of GET.  In contrast, the PACE authors reported that CBT and GET can each lead to recovery in 22% of ME/CFS patients.  

Upon close examination, the PACE Trial reads like a cautionary tale of how NOT to science.  Just a few highlights include failure to obtain fully informed consent, conflicts of interest, setting ‘recovery’ criteria worse than the criteria required for a patient to be included in the study such that 13% of the patients were considered ‘recovered’ before they even entered the study, throwing out all objective outcome measures mid-way through the non-blinded trial, weakening all 4 recovery criteria midway through the non-blinded trial, and using a flawed diagnostic criteria that likely lead to the inclusion of individuals with other fatiguing illnesses such as primary depression.  In addition, the study’s cutoffs for ‘recovery’ were ludicrous, with patients scoring similar in physical functioning to individuals with congestive heart failure qualifying as ‘recovered’ based on study criteria.  

This particular podcast features David Tuller, a health journalist and lecturer at Berkeley who has devoted countless hours of unpaid time and effort to lead the charge outside of the patient community against the paper’s unsupported claims.  It is hosted by Vincent Racaniello, a microbiology and immunology professor at Columbia University’s College of Physicians and Surgeons who runs a virology blog and does several weekly science podcasts in addition to his scientific research.  It’s worth the listen even if you have kept up with Tuller’s writings.  

Alarmingly, there is so much wrong with this study that it can’t all be covered in an hour and a half long podcast.  If this were any other disease, this journal article would not be allowed to stand.  Had this been a study on MS, I have no doubt the article would have been retracted within a month of publication.

My primary goal in writing this post is not to perform my own analysis.  I only wish to add one more arrow pointing towards the work that has already been contributed by others, and to share this important issue with my own small corner of the science world.

Included in the ranks of ME/CFS patients are qualified statisticians, mathematicians, and medical researchers.  Many sharp critiques have been published by skilled patients, journalists, and other prominent scientists regarding PACE and its follow-up publications.  

This battle has been waging for the last five years, and there is more than ample justification to call for the retraction of the paper.  Despite this, the authors continue to evade questions and Freedom of Information Act requests for them to release the anonymized data so it can be reanalyzed based on their original recovery criteria.  At this point, Queen Mary University of London, one of the study’s parent institutions, has spent over $300,000 in taxpayer money to keep publicly funded data from the public.  *facepalm*  

“It’s not a benign academic dispute, it’s a dispute that has incredible impact on people’s lives.”

In David Tuller’s words, “What they’ve done has been established in the UK and other countries as the standard of care…They’ve applied a standard of care [of GET and CBT] on families with really sick kids and it’s very harmful…It’s not a benign academic dispute, it’s a dispute that has incredible real impact on people’s lives.”  

Prominent sources of medical information such as the CDC and Mayo Clinic still recommend GET and CBT  in their clinical treatment guidelines. Chances are if you go to the doctor as a ME/CFS patient, the only ‘help’ they will offer you is to strongly advise you to exercise or “go to the gym”.  Following this advice risks triggering worsening of symptoms and potentially months- or years-long relapses.  And if you don’t follow the recommendation, you are labeled a malingerer who is unwilling to fix their own health.  We have the PACE Trial to thank for this.

 As a scientist, I’m disgusted.  As a patient, I feel wronged.  May we keep fighting until this article is retracted.  

You can find the podcast here

Many of David Tuller’s pieces on ME/CFS are housed at Virology Blog.  They can be found here

CDC Eliminates CFS/ME Funding in Proposed 2017 Budget

I was alarmed to discover today that for the 2017 fiscal year, the CDC is proposing to eliminate its ME/CFS programs, totaling cuts of $5.4 million.  The only other place I have seen these cuts referenced is in the #MillionsMissing Me/CFS protest demands.  How did this slip under the radar?  I will be contacting CFS/ME advocacy groups and members of congress regarding this issue, and I urge you to do the same.  This is not the first time elimination of the CDC’s CFS/ME funding has been proposed.  During congress’s review of the proposed 2016 CDC budget, the $5.4 million set aside for CFS/ME was gutted to $0.  The CFS/ME patient and advocate community responded in uproar, resulting in the reinstatement of the full $5.4 million in funding.  Much of this effort was lead by the Solve ME/CFS Initiative, #MEAction, and MassCFIDS.  The CFS/ME community has yet to discover the original reasoning behind the proposed cuts to the 2016 budget.  I think it would be valuable information given that the same cuts have been proposed for the second year in a row.  The CDC publishes a justification of their budget request for congress each year.  The 2017 budget request included the cuts to CFS/ME, making me wonder if the proposed funding changes in 2016 were also directed by the CDC rather than by congress.  The CDC budget justification for 2016 did, however, include CFS as part of its infectious disease budget on page 112 but did not list a dollar amount.  It would have been a convenient way out for the CDC if they wanted to end their CFS/ME work.  In the document, the CDC lists its reasoning for eliminating its CFS/ME program on page 587:

The FY 2017 budget request reflects the elimination for Chronic Fatigue Syndrome (CFS). The goal of CDC’s current CFS program is to develop tools to gather and analyze surveillance data and to educate clinicians and the population based on the results of evidence-based studies. Over the past five years, NIH has been funded at a similar level to conduct biomedical research on CFS. CFS affects between one and four million people in the US, and this funding could be used to have a greater programmatic impact across CDC.”

If I’m understanding this correctly, their sole rationale for eliminating the program is that the money can be put to better use elsewhere.  Lovely.  One more indication of how seriously the CDC is treating this debilitating disease.  Perhaps this is an indication that the CDC has declared ‘mission accomplished’ on its educational campaigns regarding CFS/ME.  Let’s run through a quick progress report on the results of their efforts:

Is it still harder to find a CFS/ME literate doctor than tracking down Carmen Sandiego?  YES

Is the dismissal, belittlement, and subjugation received from most doctors when your world is falling apart because of this disease more traumatizing than a hurricane destroying your home?  YES  (True story, courtesy of Dr. Nancy Klimas)

Has the CDC modified its recommendations and educational campaigns in response to the Institute of Medicine’s 2015 report which recommended post exertional malaise be a primary diagnostic criterion and declared CFS/ME a severe and definitively biological disease?  NO, unless proposing to cut funding is considered a response.

To put it mildly, the CDC does not have the best track record regarding its treatment of CFS/ME.  The CDC is a primary reason most physicians are inadequately and incorrectly educated about CFS/ME, but they appear to be shifting towards the right direction.  Beth Unger, MD, PhD, Chief of the Chronic Viral Diseases Branch at the CDC, referenced planned efforts to update educational materials to include the Institute of Medicine recommendations in a public conference call in October 2015, according to solvecfs.org.  If the CDC cuts funding to CFS/ME, I doubt this update will ever take place.  Jennie Spotila at Occupy CFS made her own interesting case against reinstating CDC funding when the story broke regarding 2016 cuts.  Her argument focused on the organization’s history of failed and misguided attempts at addressing CFS/ME awareness in the public and medical community.  I can understand this line of reasoning, but I feel strongly that we as a community need to hold tightly to any sources of funding we can get.  I think it is more productive to advocate to maintain and increase current funding while pushing to improve the programs the CDC is running rather than eliminate the CDC’s involvement in CFS/ME altogether.  The CDC remains a mainstay in the dissemination of medical information to the public and the medical community.  The CDC has also been conducting the Chronic Fatigue Syndrome Multisite Studies.  The studies aim to combine the data of hundreds of patients from seven of the best CFS/ME treatment clinics in the United States to learn more about the disease, determine subcategories, and hopefully direct future treatments.  It is the largest study of its kind in CFS/ME research, involving over 400 patients, and has been underway since 2012.  The CDC has made no statement regarding the impact eliminating funding would have on this currently underway study.  I fear it could result in the last 4 years of work on the project going to waste.

Last year’s success in reinstating the CDC’s budget for CFS/ME was an encouraging reminder that patient advocacy can have a tangible impact.  It often feels like we are screaming into the cavernous dark, our voices and our efforts dissipating into the ether.  But sometimes, just sometimes, our requests fall on receptive ears.  It’s time to put on our advocacy hats, or capes, and write to our congress members.  This community has done it before, and we can do it again.  Members of the Senate or House Committee on Appropriations are the most productive people to contact, as they are the ones who will vote to approve or make alterations to the CDC’s proposed budget.  It is important to note that even if Congress recommends allocating funding towards CFS/ME, the CDC can choose to use the money for unrelated causes.  For this reason, we should also contact CDC officials.  One thing is certain, inaction will bring a swift and deadly axe down on the CDC’s CFS/ME work, and it will be no easy task to reinstate CFS/ME funding once it is gone.

*In an earlier version of this piece, I said I would post contact information of members of the Senate and House Committees on Appropriations and a form letter to use when contacting them.  Unfortunately, I fell into a prolonged crash after writing this piece and was unable to do that.  I can only offer my sincere apologies.

Graduating College Despite Chronic Fatigue Syndrome: The Neuroimmune Disease and Why You Should Care

Graduation Cap and TasselThis Spring, I graduated Summa Cum Laude with highest honors and Phi Beta Kappa with a Bachelor of Science in Biology and Neuroscience and a Master of Science in Biology, all of which I completed in four years.  This is a moment of triumph and relief, but also of grief at the physical and mental trauma that I have experienced in the last two years at the hands of a crippling disease.  I feel like I have just finished a marathon with a broken leg.  I have had Chronic Fatigue Syndrome (C.F.S.), known outside of the U.S. as Myalgic Encephalomyelitis (M.E.), for the last two years.  Only those close to me have been aware of this, but I have struggled to adequately communicate my experience even to them.  Hardship is capable of great destruction, but it can also galvanize determination and expose ties of support made visible only under its revealing light.  To the friends and family who have supported me, the people who have let me laugh, cry, vent, and sleep in socially unacceptable places, thank you from the bottom of my heart.  Your support has meant more than you realize, and I never would have made it to graduation without you.

The gravity of this moment in time feels hidden.  I don’t want to hide anymore.  By hiding I do a disservice to myself and others with invisible illnesses.  Like so many with this disease, I cringe at the name ‘Chronic Fatigue Syndrome’, with its strong association by the public and many physicians as a ‘yuppy disease’ of the lazy and hysterical.  This damaging misconception is despite over 4,000 peer reviewed journal articles demonstrating severe biochemical pathology in C.F.S./M.E. patients, classification by the FDA as a “serious or life-threatening disease”, and the conclusion of a year-long investigation by an Institute of Medicine committee that C.F.S./M.E. is indeed a severely debilitating biological illness.  I have personally encountered several physicians who have given me unhelpful, irrelevant, and potentially physically damaging medical advice (were I not an informed patient).

There were so many times that I considered taking a medical leave of absence, risking never being able to return to my education if my health did not improve.  I went from loving backpacking and sailing to struggling to make it to a 50-minute lecture, from being able to recall nearly any dialogue I had heard to having the short-term memory of a goldfish.  Simple tasks like grocery shopping or cooking dinner can lay me flat for over a week.  Every day I get out of bed, I am fighting with every fiber of my being. I can’t remember what it feels like to not be exhausted, foggy, and in pain.  I struggle to identify with a self I do not recognize.  If you see me out and about, you can be sure that I am pushing myself and will be paying for it later.  I am a prisoner to the whims of my health, always resisting arrest but inevitably crashing into a bed-ridden flu-like state.  I shift clumsily between the able-bodied and disabled community, feeling like an imposter in both.

So many people are forced to wage their invisible wars alone, the battle scars of which the rest of the world may never realize.  To be seen and understood is a basic human need.  I have found that trying to conceal these invisible battles only serves to further isolate and distance oneself from the social support and understanding that is so desperately needed during hard times.  I am done being silenced and dismissed by such a large faction of the medical community.  I have no way of knowing what the future holds, but my journey with this disease is far from over.  It can last decades if not indefinitely.  There is no known treatment.  Patients are left to fend for themselves in a world that dismisses their experience.  C.F.S./M.E. is not of debate in the scientific community, and it shouldn’t be of debate in the medical community.  There is a woeful paucity of research regarding the biological cause.  This is not surprising when the total annual governmental funding for C.F.S./M.E. in the U.S. is roughly $6 million.  C.F.S./M.E. effects 0.4-3% of the population, placing it on par in prevalence with MS, Parkinson’s, and HIV/AIDS.  A prominent CFS and HIV/AIDS physician (Prof. Mark Loveless, head of the AIDS and M.E./C.F.S. Clinic at Oregon Health Sciences University) has likened the everyday condition of a C.F.S./M.E. patient to that of an AIDS patient two months before death, the primary difference being that C.F.S./M.E. drags on for decades.  It seems every bodily system examined has some critical flaw, and with so many intertwining leads it is difficult to differentiate between cause and effect.  C.F.S./M.E. patients show a decrease in white matter in the brain, increased ventricular size, reduced grey matter volume, mitochondrial dysfunction, altered immune marker levels in the cerebrospinal fluid, EEG abnormalities, neuroimmune hyperactivity, autonomic nervous system dysfunction, increased levels of activated T cells, increased production of pro-inflammatory cytokines, increased susceptibility to infections, substantially decreased aerobic capacity, and the list goes on.  This field is in dire need of more scientific research and funding.

I want to be able to salsa dance the night away, sail around the world, and become a physician scientist who improves the lives of patients and adds to our understanding of human biology.  Because of this illness, these dreams are indefinitely postponed.  As we graduate, we all face hard decisions and unknowns.  My unknowns are if I will ever be able to live independently, if I will be able to pursue the life and career goals that are important to me, or be trapped in a non-compliant body for the rest of my life.  I don’t want you to pity me, I want you to see us, to see the millions of people with C.F.S./M.E. who’s lives have been stolen from them by this poorly understood disease.  25% of C.F.S./M.E. patients are housebound, few are able to work full time, and only 20% are able to work part-time.  It is time to upend the damaging misconceptions of C.F.S./M.E. and for a dramatic increase in research funding.  Based on current governmental research funding, the loss of a year of my life and my contribution to the annual GDP is worth only $6 to my government.  The CDC estimates the economic burden of C.F.S./M.E. in the U.S. to be $19-51 billion per year.  Our society’s failure to address this illness is a social tragedy, but also an economic blunder.  Instead of starting medical school next fall, this illness has necessitated my returning to live with my parents to focus on resting, researching my condition, and trying everything under the sun to get better.  During this time of convalescence, I hope to become an advocate for other patients through social support and scientific involvement.  I will write to communicate and to compile scientific ideas regarding this illness, but also to maintain my sanity.  I will write to remind myself I still have a voice and agency, although they manifest differently now than in the past.  I am here.  This is M.E.