Thursday, October 16, 2014

AHRQ Evidence Review - Comments From the Advocates

This post comes via Mary Dimmock, Claudia Goodell, Denise Lopez-Majano, and Jennie Spotila. You are welcome to publish it on your site with attribution and a link back to Jennie's post. You are also welcome to use this (and other material they’ve gathered) as a framework for your own comments on the draft evidence review - due October 20th.

Evidence Review Comments Preview

From Occupy CFS, October 15, 2014

By Jennie Spotila

It’s been a challenging few weeks, digesting and analyzing the AHRQ Draft Systematic Evidence Review on Diagnosis and Treatment of ME/CFS. We continue to be deeply concerned about the many flaws in the review, in terms of both the approach it took and how it applied the study protocol.

Our comments on the Review will reflect our significant concerns about how the Evidence Review was conducted, the diagnostic, subgroup, and harms treatment conclusions drawn by this report, and the risk of undue harm that this report creates for patients with ME. We believe a final version should not be published until these scientific issues are resolved.

Most fundamentally, the Evidence Review is grounded in the flawed assumption that eight CFS and ME definitions all represent the same group of patients that are appropriately studied and treated as a single entity or group of closely related entities. Guided by that assumption, this Evidence Review draws conclusions on subgroups, diagnostics, treatments and harms for all CFS and ME patients based on studies done in any of these eight definitions. In doing so, the Evidence Review disregards its own concerns, as well as the substantial body of evidence that these definitions do not all represent the same disease and that the ME definitions are associated with distinguishing biological pathologies. It is unscientific, illogical and risky to lump disparate patients together without regard to substantive differences in their underlying conditions.

Compounding this flawed assumption are the a priori choices in the Review Protocol that focused on a more narrow set of questions than originally planned and that applied restrictive inclusion and exclusion criteria. As a result, evidence that would have refuted the flawed starting assumption or that was required to accurately answer the questions was never considered. Some examples of how these assumptions and protocol choices negatively impacted this Evidence Review include:
  • Evidence about the significant differences in patient populations and in the unreliability and inaccuracy of some of these definitions was ignored and/or dismissed. This includes: Dr. Leonard Jason’s work undermining the Reeves Empirical definition; a study that shows the instability of the Fukuda definition over time in the same patients; studies demonstrating that Fukuda and Reeves encompass different populations; and differences in inclusion and exclusion criteria, especially regarding PEM and psychological disorders.
  • Diagnostic methods were assessed without first establishing a valid reference standard. Since there is no gold reference standard, each definition was allowed to stand as its own reference standard without demonstrating it was a valid reference.
  • Critical biomarker and cardiopulmonary studies, some of which are in clinical use today, were ignored because they were judged to be intended to address etiology, regardless of the importance of the data. This included most of Dr. Snell’s and Dr. Keller’s work on two day CPET, Dr. Cook’s functional imaging studies, Dr. Gordon Broderick’s systems networking studies, Dr. Klimas’s and Dr. Fletcher’s work on NK cells and immune function, and all of the autonomic tests. None of it was considered.
  • Treatment outcomes associated with all symptoms except fatigue were disregarded, potentially resulting in a slanted view of treatment effectiveness and harm. This decision excluded Dr. Lerner’s antiviral work, as well as entire classes of pain medications, antidepressants, anti-inflammatories, immune modulators, sleep treatments and more. If the treatment study looked at changes in objective measures like cardiac function or viral titers, it was excluded. If the treatment study looked at outcomes for a symptom other than fatigue, it was excluded.
  • Treatment trials that were shorter than 12 weeks were excluded, even if the treatment duration was therapeutically appropriate. The big exclusion here was the rituximab trial; despite following patients for 12 months, it was excluded because administration of rituximab was not continuous for 12 weeks (even though rituximab is not approved for 12 weeks continuous administration in ANY disease). Many other medication trials were also excluded for not meeting the 12 week mark.
  • Counseling and CBT treatment trials were inappropriately pooled without regard for the vast differences in therapeutic intent across these trials. This meant that CBT treatments aimed at correcting false illness beliefs were lumped together with pacing and supportive counseling studies, and treated as equivalent.
  • Conclusions about treatment effects and harms failed to consider what is known about ME and its likely response to the therapies being recommended. This means that the PACE (an Oxford study) results for CBT and GET were not only accepted (despite the many flaws in those data), but were determined to be broadly applicable to people meeting any of the case definitions. Data on the abnormal physiological response to exercise in ME patients were excluded, and so the Review did not conclude that CBT and GET could be harmful to these patients (although it did allow it might be possible).
  • The Evidence Review states that its findings are applicable to all patients meeting any CFS or ME definition, regardless of the case definition used in a particular study.
The problems with this Evidence Review are substantial in number, magnitude and extent. At its root is the assumption that any case definition is as good as the rest, and that studies done on one patient population are applicable to every other patient population, despite the significant and objective differences among these patients. The failure to differentiate between patients with the symptom of subjective unexplained fatigue on the one hand, and objective immunological, neurological and metabolic dysfunction on the other, calls into question the entire Evidence Review and all conclusions made about diagnostic methods, the nature of this disease and its subgroups, the benefits and harms of treatment, and the future directions for research.

As the Evidence Review states, the final version of this report may be used in the development of clinical practice guidelines or as a basis for reimbursement and coverage policies. It will also be used in the P2P Workshop and in driving NIH’s research strategy. Given the likelihood of those uses and the Evidence Review’s claim of broad applicability to all CFS and ME patients, the flaws within this report create an undue risk of significant harm to patients with ME and will likely confound research for years to come. These issues must be addressed before this Evidence Review is issued in its final form.

Thursday, October 2, 2014

How to Oppose the P2P (Without Chaining Yourself to the White House Fence)

Disability rights activists chained themselves to the White House fence in 2009
There is no doubt in the minds of those who have been following the various means by which the HHS has consistently and callously acted against the interests of patients with ME/CFS over the last thirty years that the latest government initiatives - the P2P and IOM - do not bode well for us.

In spite of its seeming interest in our welfare, we should keep in mind who saddled us with a vague, inaccurate case definition, and a demeaning name, to start with.

The P2P is potentially the more damaging of the two initiatives, because it was sponsored by the NIH, which controls all major funding for medical research. (Find out more ... click HERE.)

ME/CFS is already grossly underfunded. Once this group of non-experts is done with their review, we will most certainly follow in the footsteps of Great Britain in its wholesale and uncritical adoption of CBT and GET as the only effective treatments for the disease. We will, in fact, no longer have a disease, but will be permanently and irrevocably reduced to having a mental condition that can be cured with a better attitude and a little fresh air.

There is no single right way to oppose the P2P. But there is a wrong way.

Saying nothing at all.

Silence on this important matter equals agreement. If we don't weigh in, nobody will do it for us. Even if you believe that resistance is futile, you will feel better if you express yourself than if you don't.

Does protesting really make a difference?

During my anti-war activist days, we were told repeatedly that nobody was paying attention to us. Years later we learned that public outcry - our public outcry - had prevented Nixon from dropping an A-bomb on Vietnam. History has demonstrated time and time again that protest can topple even the most entrenched institutions.

People with ME/CFS often feel as if nobody listens because physicians, friends, and even family members dismiss us. Government officials and representatives don't know that. They only know that an issue is important enough for you to tweet or send an email - and that you vote. They realize that for every citizen who bothers to communicate with them, there are a hundred who haven't. Sending a thousand tweets can have a huge effect.

Each of us may only be a single drop in an ocean - but an ocean is made up of nothing but drops. The important thing is to continue gathering those drops together until we've made a wave.

What we can do

Here are four things we can do that don't require much effort (see template below), and take up very little time.

1) Comment. The P2P has invited comments on its draft report. I really love it when people on these committees ask for comments. It gives me an opportunity to put my opposition on record, and to tell them all the ways in which they are wrong. Comments will be closed after October 20.  CLICK HERE to make a comment.
Need ammunition for your comment? Jennie Spotila has posted a critique of the review stressing three main problems. Feel free to use her points in your comments: 
A Review of the P2P Systematic Review 
You can also use any part - or all - of my critiqueThe AHRQ Draft Report
2) Tweet. Every Saturday there is a "Stop P2P for ME" tweetstorm. Tweeting is fast, and it's fun. Use the hashtag: #StopP2P4ME. CLICK HERE for sample tweets that you can copy and paste, along with @ targets.

3) Email your representatives. This is still a democracy, and our representatives are supposed to represent us. That means they must listen to what we have to say. Even if you get a form letter in reply, somebody had to read your email to send it. Remind your representative that you vote.
Find your representatives hereYou can get their phone numbers here.

4) Boycott. Boycotting the process is fine, but boycotts are useless unless you tell people about it. You need to explain why you aren't participating - otherwise you are simply remaining silent, which is not constructive. You can email Dr. Francis Collins letting him know that the entire P2P Workshop on ME/CFS needs to be canceled.

Below is a template for a letter to your representative, and/or to Dr. Francis Collins (head of the NIH): collinsf@mail.nih.gov

Feel free to copy and paste, and to add anything else you have to say.
.................................................................

I am writing to request the cancellation of the P2P Workshop on ME/CFS. I believe that the P2P Workshop will not advance us towards the much needed ME/CFS research case definition or strategy, for the following reasons:
  • ME/CFS experts have already adopted the Canadian Case Definition for research. No new definition is needed.
  • The Workshop is examining the wrong illness. They are examining "medically unexplained fatigue," not ME/CFS.
  • NIH has not engaged or involved stakeholders in a substantive way.
  • The Workshop panel consists of non-ME/CFS experts.
  • HHS has made numerous contradictory statements about the purpose of the Workshop, so its goal is unclear.
  • The recent draft report from AHRQ is inaccurate, self-contradictory, and reflects a poor understanding of ME/CFS research
Careful consideration of the above issues raises legitimate concerns about whether the P2P Workshop will produce good science and sound recommendations.

I hope you will give my concerns a fair hearing, and that you will cancel the P2P Workshop.

Sincerely,

[Your name]

Monday, September 29, 2014

The AHRQ Draft Report - Fundamentally and irredeemably flawed

The Jury, by John Morgan
The Agency for Healthcare Quality and Research (AHRQ) has released its draft report on the Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

For those who find it hard to keep track of the plethora of reports, committees, panels, and reviews currently underway, the AHRQ report provides the basis for the Pathways to Prevention, or P2P Workshop. The P2P Workshop has been convened by the NIH for the purpose of making a report that will be used to evaluate research grants for ME/CFS, and upon which pharmaceutical companies will base their clinical trials.

The P2P panel is composed entirely of non-experts. The preference for non-experts was intended, according to Susan Maier, Executive Secretary for the NIH Advisory Committee on Research on Women’s Health, to act like a “jury,” by which she meant the composition of the panel was meant to be unbiased.

Leaving aside for a moment the absurdity of consigning a research case definition for a disease to people who aren't even physicians, the jury system itself does not work. Trial by jury is one of the most inefficient systems of justice in the world. Swayed by bombastic arguments, prejudice, and crocodile tears, juries of twelve unbiased peers routinely find innocent people guilty, and allow the guilty to go free. As a method for determining who gets grants for medical research, anything even remotely resembling the jury system is entirely inappropriate.

I have touched upon some of the short-comings of the draft report below. I've tried to keep it brief. (There is so much wrong with this report that if I were to write a thorough critique, it would be longer than the report itself.)

You can read the AHRQ draft report and appendices here

You can make comments (until October 20) here.

You can read more about the P2P in these posts:

A Review of the P2P Systematic Review
Jennie Spotila gives a great overview of how the AHRQ report will be used, and explains why the draft report is bad science.

All the reasons why the P2P is dangerous

Jennie Spotila explains why the AHRQ report is a recipe for disaster, and how they pulled a “bait and switch” by changing their Key Questions.

Mary Dimmock and Jennie Spotila explain how refusing to consider how CFS and ME differ will affect the results of the P2P Workshop.

Note: Anyone who wishes to reprint this blog post may do so. (Remember to link back to the original and provide attribution.)
_______________________

A BRIEF CRITIQUE OF THE AHRQ DRAFT REPORT

By Erica Verrillo

Point 1: The draft report shows limited understanding of the illness

The report begins with the erroneous statement that “The term ME was first used in the 1930s after an outbreak of neuromyesthenia ...”

A quick google search would have revealed that “myalgic encephalomyelitis” was first used in a letter to the editor entitled, “A New Clinical Entity?” published in the Lancet in 1956. The authors – Emile Nihoul, Lise Quersin-Thiry, S.Chalmers Parry and Robert A. Good – were referring to what became known as Royal Free Disease, an outbreak that occurred in London's Royal Free Hospital in the 1950s. Obviously, none of the members of the panel felt inclined to check their facts.

The report goes on to say that “Uncertainty persists regarding the etiology and whether the condition reflects a single pathologically discrete syndrome, subsets of the same illness, or a nonspecific condition shared by other disease entities.” This statement reflects a thorough misunderstanding of how the illness is perceived by people who investigate and treat it. There are no experts in ME/CFS who would claim that it is a “nonspecific condition shared by other disease entities.” There are, however, numerous researchers who author papers on “chronic fatigue” and “fatiguing illnesses” such as cancer and MS. The authors of the AHRQ draft report, unlike experts in the field, do not have enough background to be able to distinguish between “chronic fatigue” and ME/CFS.

While the introduction to the report is not crucial, it does indicate that the people writing it not only had no knowledge of the illness, but that they did not want to spend any time acquiring it. The willful ignorance that is demonstrated in the introduction permeates the entire report.

Point 2: Problematic Search Methods

In order to find abstracts and articles, the AHRQ searched three main databases using the terms: fatigue; Fatigue Syndrome, Chronic; and Encephalomyelitis. With the notable exception of PsycINFO, a database of abstracts of literature in the field of psychology produced by the American Psychological Association, these are the same databases used by the Drug Class Review: Drugs for Fibromyalgia: Final Original Report published by the Oregon Health & Science University in 2011. Ovid and EBM/Cochrane are large medical databases, though they don't necessarily include every study conducted on a given illness or condition. Only controlled trials are included in the Cochrane databases.

The most glaring problem with the search is that it included studies on “fatigue.” Indeed, a number of studies included in the review were on “fatiguing illnesses” rather than ME/CFS. Like the introduction, the search reflects a state of confusion on the part of the authors. The confusion is not altogether surprising, given that researchers also appear to be confused about the difference between CFS and chronic fatigue. Nonetheless, experts in the field are not confused. They are aware that while ME has been used abroad since the 1950s, it has not been used as a diagnosis here in U.S. Specialists have been limited to CFS as a diagnosis, like it or not. 

A second problem is that with the perennial lack of NIH funding for ME/CFS controlled trials, much of the information about treating the disease is based on clinical observations. None of these were included. nor were studies that were controlled, but which did not meet the set of criteria for inclusion in the review – such as addressing the Key Questions.

Point 3: Studies used for the report are inadequate to address the Key Questions

The studies that the reviewers included were not only too few, they were completely inadequate to properly address the Key Questions.

The Key Questions to be addressed by the report are as follows:

1. What methods are available to clinicians to diagnose ME/CFS and how do the use of these methods vary by patient subgroups?

a) What are widely accepted diagnostic methods and what conditions are required to be ruled out or excluded before assigning a diagnosis of ME/CFS?

b) What is the accuracy and concordance of diagnostic methods?

c) What harms are associated with diagnosing ME/CFS?

2. What are the (a) benefits and (b) harms of therapeutic interventions for patients with ME/CFS and how do they vary by patient subgroups?

a) What are the characteristics of responders and non-responders to interventions?

There are problems with the wording of some of these questions. For example, in a country in which 80% of the physicians don't believe that CFS is a real disease, what could "widely accepted" be referring to? And, "What harms are associated with diagnosing ME/CFS?" seems to have an a priori assumption that diagnosing the disease may in itself cause harm. But aside from the oddness of the wording, the studies they chose do not adequately address the questions.

The criteria for exclusion from the review included, among others, that the study did not last not long enough (therapeutic trial of less than 12 weeks), was published before 1988, had wrong study design, or did not address a Key Question. (There were 8 more exclusions.)

From among the thousands of studies that have been conducted, the criteria limited the review to a scant 64 studies. Some of the landmark studies that were excluded were all of the studies demonstrating immune dysfunction (e.g. NK cell deficiency studies by Brenu et al.), studies of viral reactivation and antiviral treatments (e.g. all Lerner and Jessop studies, Kerr parvovirus B19 study), studies documenting brain abnormalities (e.g. Lange's MRI study), and all of the papers published by Tom Kindlon on harms associated with GET and CBT. Not even appearing on the excluded list were the ground-breaking 2-day CPET studies conducted by Keller, Stevens and Snell, Peckerman's cardiac insufficiency studies, and the recent Watanabe study on CNS inflammation.

The fact that some of the most significant studies in the ME/CFS literature did not even appear on the excluded list was mind-boggling. Of the studies that appeared on the exclusion list, the reasons given were various, but among the most frequently cited were that the studies did not address the Key Questions. Yet, several studies that directly addressed the Key Questions were omitted (for example, 2-Day CPET studies were not even considered), while studies that did not directly address the Key Questions were included. This arbitrariness permeated the entire study selection process.

(Going though the studies that were accepted I found three that did not meet the criteria for inclusion without reading further than the first page. I also found studies in the excluded section that met the criteria. Having no experience with ME/CFS, the panel lacked the ability to distinguish relevant from irrelevant studies.)

Point #4: Contradictory and unsupported conclusions

In terms of treatment, the report was heavily weighted toward psychological studies. Out of the 36 studies used to address Key Question 2, 14 concerned CBT. Considering that the PACE trial was included, but not any of its critiques, it is not surprising that the report favored CBT:
"Based on 13 trials, cognitive and behavioral therapy (CBT), either group or individual; self-instruction booklets; pragmatic rehabilitation: peer-to-peer counseling: and symptom consultation provide improvement in fatigue, function, quality of life, and employment in adult patients with ME/CFS."
Yet, after a detailed examination of the actual results of the trials, the report went on to conclude that:
"In summary, head-to-head trials had mixed results with two trials finding improvement with GET, two trials finding improvement with CBT, and one trial finding no differences between CBT, GET, and usual care. In considering non-head-to-head trial data, there is low strength evidence that CBT and GET provide similar improvement in measures of fatigue and/or functioning."
Those reading this report will base their recommendations on the first statement, as the second statement requires wading through a lot of statistics. They won't even realize that the conclusion that CBT provides "improvement in fatigue, function, quality, and employment" is ultimately derived from the results of a single, deeply manipulated, study. (The PACE trial.)

In terms of Key Question 1, the report suffered from similar inconsistencies, For example, the report concludes with the statement that “the negative effects of being given a diagnosis of ME/CFS appear to be ... universal.”

I could not find a single study from among the list of included studies that would support the conclusion that the diagnosis of ME/CFS had negative effects universally.

In the Asbring and Narvanen study entitled “Women's experiences of stigma in relation to chronic fatigue syndrome and fibromyalgia,” the authors concluded that “ The women experienced stigmatization primarily before receiving a diagnosis.” [Emphasis mine] In addition, they stated that “Stigma consisted of questioning the veracity, morality, and accuracy of patient symptom descriptions and of psychologizing symptoms.”

The Dickson et al. study, “Stigma and the delegitimation experience: An interpretative phenomenological analysis of people living with chronic fatigue syndrome,” reported that “participants reported delay, negotiation and debate over diagnosis: further, they perceived their GPs to be sceptical, disrespectful and to be lacking in knowledge and interpersonal skills.” [Emphasis mine]

In the Green et al. study, “Stigma and Chronic Fatigue Syndrome,” the authors state that “Most subjects (77%) were labeled as ‘psychological cases’ by one or more of the physicians (mean = 8) consulted, but of the 4 stigma measures, only disclosure was related to physician labeling.” This means that patients only felt stigmatized by their physicians after they attempted to educate them about ME/CFS.

There was nothing in these studies to support the claim that the diagnosis itself had negative effects. Rather, it was the delay in diagnosis, and subsequent debate on the part of family and physicians – as well as the delegitimation resulting from a trivializing name – that led to negative effects.

In sum

The conclusions reached in this review were the result of a poorly framed set of key questions, a literature search that managed to exclude the most fundamental research studies, and a misinterpretation of the studies that were eventually deemed acceptable for inclusion. As a whole, this report is fundamentally, and irredeemably, flawed - even given its narrow search results.

These major shortcomings are the inevitable result of appointing a group of people who have no expertise in ME/CFS to evaluate 26 years of research. ME/CFS is a disease that demands expertise. It cannot be evaluated be a panel of non-experts.

To find out what you can do to oppose the P2P, click HERE.

Monday, September 22, 2014

To the 21st Century Cures Initiative - Include Ampligen!

The following message is from Billie Moore. She has included an email address and a template letter.

I can't stress how important it is that Ampligen be approved as a treatment for ME/CFS. Not only would patients who are currently being helped by Ampligen reap the benefits - we all would. 

Approval of Ampligen would effectively undercut the current campaign to limit treatments to exercise and CBT, and it would permanently silence the proponents of "it's all in their heads." 
_____________________________


The announcement below is from Fred Upton, Chairman of the Energy and Commerce Committee, U.S. Congress, and explains the urgency of this reply. Following that is the form email. You can send it or modify it as you wish. But please send something.

Congress is working on something that has promise of having a good effect on getting Ampligen approved - legislation through the 21st Century Cures initiative. If Ampligen is approved, even conditionally, other drug companies will take note; ME/CFS automatically becomes a "real disease"; physician and public respect follows. Ampligen helps people. Let's work to help many others receive it. It's not a panacea, but it's a very good start. It's the only thing out there likely to get FDA approval in the next 10 years. The email stresses, however, that these three requests for inclusion in the legislation are appropriate for many other under-valued, underfunded diseases.

Billie Moore
Patient Advocate

_______________________

More Valuable Ideas Shared on the #Path2Cures

21st Century Cures continued today with another blockbuster roundtable discussion to review the ideas that have been shared with the committee over the past several months and discuss next steps for the initiative. The President and CEO of the Biotechnology Industry Organization, Jim Greenwood, recently took to The Hill to share some of his ideas for accelerating the pace of cures and treatments, noting specifically the impact that Alzheimers has on our nation. Greenwood explains how accelerating this process will not only provide hope for patients and families but also will have an enormous economic impact.

As Energy and Commerce Committee Chairman Fred Upton (R-MI) noted at this morning’s event, 
“We intend to release a Cures legislative discussion draft in early January 2015 and will look to swiftly move the legislation early in the next Congress. If you want your idea considered, please send it to cures@mail.house.gov as soon as possible. The more specific the idea, the better.”

*****************************************************************************

The following is to be sent to cures@mail.house.gov

Subject line: Please include Ampligen in the 21st Century Cures Legislation

To the Members of 21st Century Cures,

On behalf of the more than 1 million Americans suffering and dying from Myalgic Encephalomyelitis (sometimes referred to as Chronic Fatigue Syndrome but preferably as ME/CFS by government agencies and patient groups) we ask that the following be included in your 21st Century Cures Legislation.

1) The 2015 NIH budget should be commensurate with the size of the disease and/or the cost to the nation. For example, Multiple Sclerosis (MS), a disease the FDA states is similar in seriousness to Chronic Fatigue Syndrome but with only 400,000 patients - receives a $115 million per year in NIH funding - and there are already nine existing drugs for MS. People with ME/CFS have NO approved treatments yet more than 1 million people are sick (versus 400,000 for MS), and it receives only $5 million from the NIH. That is only $5.00 per patient! This is a ridiculously small amount. Yet CDC studies estimate it costs the nation $22 billion per year. Other funding levels for 2014:

~ Anthrax $72 million (who gets anthrax?)
~ Attention Deficit Disorder $50 million (not life threatening)
~ Smallpox $31 million (no one gets smallpox anymore)

2) One drug – Ampligen - has shown promising results against ME/CFS. There were significant improvements in approximately 40% of the patients on Ampligen! Many patients in the trials have been safely on this drug for years. Yet the FDA continues to drag its heels in approving it. We request that the legislation reflect that if a drug shows promise and the top experts in the disease believe the drug should be on the market, then FDA should use its existing regulatory authority to approve the drug, and in collaboration with the experts and the sponsors develop the appropriate follow-up studies and REMS program. The expert physicians that work with the patients and the drug have the expertise and knowledge needed to provide sound judgment. This will allow for a large proportion of new ME/CFS patients’ lives (and those with other similarly ignored diseases) to improve. Leaving patients without treatment is NOT in the best interests of public health; ME/CFS patients die early deaths from cancers, heart disease, suicides (because there are no drugs and no hope).

3) FDA should be required to provide the same type of flexible approach to chronic illnesses with few or no FDA-approved treatments that it does to those considered fatal (able to cause "imminent death"), to rare disorders, or to disorders that produce epidemics. ME/CFS falls between the two as do many chronic illness, yet cost families and the nation greatly. The fact that 1,000,000 people with ME/CFS have suffered for decades without a single FDA-approved drug requires the FDA recognize that a new approach with more flexibility is called for in this disease and other diseases which the FDA has failed to support. After DECADES of inaction, IT IS TIME.

Thank you for your attention.

(your signature and date)

Friday, September 19, 2014

Why we need more lawsuits ...

It is often said - in a somewhat disapproving tone - that we are a litigious society. 

Usually, this statement comes after a report about a "frivolous lawsuit" - a woman suing McDonalds because her coffee was hot, a man suing Anheiser-Busch because drinking beer didn't make him more attractive to women, a physical therapist suing his local nudie bar, claiming whiplash from a lap dancer. And so on.

These lawsuits are good for a laugh, but the truth is that lawsuits are what enable us to enforce laws. Without them, laws would remain "on the books," unenforced and unenforceable until a judgment upholds them.

Jeannette Burmeister's recent success in securing the support of the justice system to obtain HHS documents regarding the IOM study of diagnostic criteria for ME/CFS underscores the importance of lawsuits. Craig Maupin spent a year attempting to obtain documents regarding ME/CFS through legitimate channels without success. It took a lawsuit to enforce FOIA laws.

Britain, unfortunately, is not as litigious as we are. In 2013, Mr. Courtney attempted to gain access to the complete results of the PACE trial through FOIA. He was refused on the basis of "intellectual property rights," a position upheld by the courts. In like fashion, Mr. Matthees has spent months trying to obtain the full results of the PACE trial, only to be refused time and again. (See below for the most recent refusal.)

There is a very good reason to make the full results of the PACE trial available to the public: It is a matter of human rights. All patients have the right to obtain information about potentially harmful treatments. When medical studies performed on behalf of pharmaceutical companies withhold information about harmful side effects, patients have the right to sue. Successful lawsuits have been launched against tobacco companies based on the same principle.

There can be no doubt that the secrecy surrounding the PACE trials is not only to mask the fact that the trials were not as successful as their proponents claim, or that they were rigged, but that patients may have been harmed by the treatments that are now universally accepted in Great Britain (and increasingly in the US) as the best way to treat ME/CFS. ME/CFS patients have a right to know how many patients deteriorated after a year of graded exercise therapy and cognitive behavioral therapy.

What the citizens of Great Britain need is more lawsuits. Unfortunately, the British interpretation of common law is that nothing need ever change.

What we can do

AllTrials, a campaign spearheaded by Dr. Ben Goldacre, is calling for "all past and present clinical trials to be registered and their full methods and summary results reported." Their petition, which has garnered 80,000 signatures, states:
"All trials past and present should be registered, and the full methods and the results reported. We call on governments, regulators and research bodies to implement measures to achieve this."
The AllTrials campaign has - somewhat ironically - gained support in the UK. The Chair of the National Institute for Health and Care Excellence (NICE), told MPs on the House of Commons Health Select Committee that "when clinical trial results are kept hidden, the contribution of patients gets ignored." Oxford University Hospitals and the Open University, the largest academic institution in the UK, have also supported AllTrials.

When individuals cannot obtain the results of clinical trials, it is time to exert organized public pressure on the institutions that can effect a change in policy. Please sign the AllTrials petition, and please ask your representatives - wherever you happen to live - to support the campaign.

You can sign the AllTrials petition here.

Find your MP - British Parliament - here.

Find your Senators and Congressional representatives here
_____________

Keeping PACE: Patients Denied Access to Full Data from PACE Trial 


How is That Recovery?

___________________


From: QM FOI Enquiries

Queen Mary, University of London

16 September 2014

Dear Mr. Matthees

Queen Mary has now concluded its internal review procedures on this request.

The decision of the internal reviewer is to uphold the original decision to withhold the information you requested.

We apologise for the delay, which was down to staff leave and the commencement of the new academic year.

If you remain dissatisfied you have the right to appeal to the Information Commissioner’s Office. Please see [1]www.ico.org.uk for details.

Yours sincerely

Queen Mary University of London

Tuesday, September 9, 2014

How Great Britain Fails 250,000 Patients with ME/CFS

Last June, Clare McDermott et al. published a study entitled "What is the current NHS service provision for patients severely affected by chronic fatigue syndrome/myalgic encephalomyelitis? A national scoping exercise" (published in the BMJ, a subsidiary of the British Medical Association).

The study, which was part of McDermott's PhD fellowship, evaluated specialist care for patients with severe ME/CFS in 49 specialist centers in Great Britain via an email survey.

All 49 centers replied, providing an accurate picture of the range of services available to the severely ill ME/CFS population.

(You can read the full paper here.)

Survey results

The results of the survey were disheartening. One-third of specialist ME/CFS centers provided no service at all for housebound patients. A little over half (55%) of the centers treated patients with severe ME/CFS. The remaining centers (12%) offered occasional or minimal support "where funding allowed." There was only one NHS unit providing specialist inpatient ME/CFS care in the entire country.

The authors' final remarks concerning the paucity of care were that "findings highlight substantial variation in access to specialist care for patients with severe presentation of CFS/ME. Where treatment was provided, this appeared to comply with NICE recommendations for this patient group."

Available treatments - The not-so-NICE guidelines

An additional component of this paper was a brief analysis of the type of care provided to patients with ME/CFS. In Great Britain, services for severely ill patients are supposed to follow the NICE guidelines:
  • Management of severe CFS/ME is difficult and complex and healthcare professionals should recognise that specialist expertise is needed when planning and providing care for people with severe CFS/ME. [emphasis added] 
  • Diagnosis, investigations, management and follow-up care for people with severe CFS/ME should be supervised or supported by a specialist in CFS/ME. 
  • When making decisions about prolonged bed rest, healthcare professionals should seek advice from a specialist experienced in the care of people with severe CFS/ME. The significant physical and psychological risks associated with prolonged bed rest should be taken into account. 
  • Healthcare professionals working with people with severe CFS/ME who are in bed most (or all) of the time, should explain the associated risks (such as postural hypotension, deep venous thrombosis, osteoporosis, pressure sores and deconditioning) and monitor these.
  • People with severe CFS/ME should be offered an individually tailored activity management programme as the core therapeutic strategy, which may be delivered at home, or using telephone or email if appropriate, drawing on the principles of cognitive–behavioural therapy (CBT) and graded exercise therapy (GET). [emphasis added]
(NICE 2007 guidelines on severe chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) extract, page number 305)
While the guidelines state quite clearly that management of severe CFS/ME is "difficult and complex," specialist care, as defined by the guidelines, is quite simple. Core therapeutic strategies consist of CBT and GET, which may or may not be overseen by a physician (telephone calls and emails are considered sufficient).

Although the guidelines state that diagnosis, management and follow-up care should be supervised by a specialist, compliance with this provision is not consistent. For example, some services stated that while they used CBT, they did not have a qualified CBT therapist on the clinical team.

Even when centers reported having a physician on their staff, or other trained professionals, the question remains of whether the treatments and therapies offered by these centers have any real value for the population they are supposed to be serving.

One Size Fits None

Below is a detailed list of the treatment strategies employed by the specialist care services offered by NHS (taken from the McDermott study).

Table 1

Therapeutic approaches used (in combination) by CFS/ME services for severely affected patients
TherapyNumber of services using this approachPercentage of services using this approach
Activity management2893
CBT2583
Graded activity2480
Mindfulness therapy2273
Lifestyle management2273
Dietary advice2170
Pacing (within graded activity, not adaptive pacing)1757
Graded exercise therapy1343
Counselling1033
CBT = cognitive–behavioral therapy

Anyone who is familiar with ME/CFS - whether they be researchers, experts, or patients - would consider the list of "treatments" employed by these services to be ludicrous. Most, if not all, of these therapies are useless for a population that is bedbound. Exercise therapy, including graded activity as part of GET, is harmful for ME/CFS patients (Twisk and Maes 2009). Given the cardiac abnormalities experienced by ME/CFS patients, exercise could even prove fatal. (Dr. Melvin Ramsay reported that the only ME patients who had died under his care were former athletes who had gone out on the playing field while ill.)

Aside from the far-fetched claim that these therapies are "individually tailored," there is no evidence that these therapies are beneficial treatments for any patient with ME/CFS, regardless of illness severity. For that matter, there is no evidence that the therapies on this list are appropriate treatments for patients suffering from any illness. The dietary advice offered to ME/CFS patients, for example, "Drinking enough fluid, [eating] adequate fruit and vegetables, [and] reducing caffeine intake" is something physicians recommend to everybody, regardless of their state of health.

The advice to exercise is also non-specific, and is a component of the general set of recommendations given by every physician to all patients. In contrast to previous medical advice - now considered antiquated - current medical dogma considers exercise to be a panacea that cures all. (As evidenced by the "harms" associated with bed rest mentioned in the NICE guidelines.) Meditation, counseling and CBT are also currently in fashion. However, neither meditation nor counseling will reverse the course of an illness, or slow its progression. While they may make a patient feel better by reducing anxiety, so will a chat with a caring friend, watching a distracting comedy, or taking anxiolytics.
If a physician in the U.S. limited his or her treatments to those on the NICE guidelines for their cancer or heart disease patients (like ME/CFS, neither has a cure), he/she would have his or her medical license revoked, and possibly face a civil lawsuit.
The McDermott et al. report indicates that severely ill patients are underserved by the NHS, even when there is care. However, the evidence also suggests that none of the patients in the UK with ME/CFS have state-sponsored access to effective treatment (e.g. antivirals, immune modulators, treatment for secondary infections, mitochondrial support, palliation of symptoms, such as insomnia and pain, and so on).

One can only conclude that when psychiatrists and proponents of the "it's all in their heads" theory hijack medical care, all patients will suffer the consequences of institutionalized neglect.

Friday, September 5, 2014

Burmeister Wins Lawsuit: Court Rules Government Must Produce IOM Documents

On January 9, 2014, Attorney Jeannette Burmeister filed a federal lawsuit against HHS and NIH in the U.S. District Court for the Northern District of California for failure to comply with the requirements of the Freedom of Information Act (FOIA) regarding documents she requested relating to the Institute of Medicine (IOM) study of diagnostic criteria for ME/CFS. On September 2, the Court ordered the government to comply with Attorney Burmeister’s request. (You can read the full complaint here.)

The court's decision is a landmark in ME/CFS advocacy. Past efforts to obtain documents through FOIA have been problematic. In 2012, Craig Maupin completed a year-long investigation into FOIA compliance with CFS programs within the NIH. His requests were denied numerous times on the basis that records were "not found." However,
"In each case, the request was able to pinpoint the location of the files. Second, after responding to a request that "files could not be found", several appeals seemed to fall back on the "too broad" defense. Inconsistency between initial denials and appeals could raise speculation as to whether required records are missing, lost, destroyed, or simply not applied to FOIA, particularly, as an earlier request was denied on the basis that the records were not available." (CFS Report)
Maupin gave the ORWH, the department currently responsible for ME/CFS, a D- for their lack of compliance with FOIA regulations.

Kudos to Jeannette Burmeister for succeeding where so many have encountered nothing but official obstruction and denial.
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Reprinted with the kind permission of Jeannette Burmeister.

US District Court: HHS/NIH Violated Federal Law in Response to FOIA Request for IOM Documents


I am pleased to give an update on my FOIA lawsuit:

Yesterday, the United States District Court for the Northern District of California ruled that HHS and NIH (government) violated the Freedom of Information Act (FOIA) when they improperly withheld documents from me in response to my FOIA request regarding HHS’s contract with the Institute of Medicine (IOM) for the study of diagnostic criteria for ME/CFS.

Accordingly, the Court granted my motion for summary judgment and ordered the government “to produce, within 60 days, all documents responsive to [my] request that are not covered by any exemption to FOIA’s disclosure requirements.” [emphasis added] The Court also denied the government’s motion for summary judgment asking for a dismissal of my lawsuit.

I believe that holding HHS and NIH legally responsible for their violation of federal law is a tremendous victory for our patient population. However, since this litigation is ongoing, I will not, at this time, be able to comment further or answer any questions beyond the following details and quotes from the Court’s ruling. Although there will hopefully be more good news before the case is over.

In January of this year, I sued the government under FOIA for failure to respond to my FOIA request for documents regarding the HHS-IOM contract. I have been represented in this legal action by the global law firm of Baker & McKenzie LLP. Only after my filing of the lawsuit (and after the statutory time period for their response had lapsed) did the government produce a meager amount of documents despite the fact that my FOIA request was very broad.

It was apparent that the government’s search for responsive documents was woefully inadequate, as obviously existing documents covered by my request that would have been easily available to the government and that a reasonable document search would have uncovered were not provided. The Court agreed and held that the search was the result of “obviously an unreasonably narrow interpretation of Burmeister’s request.” [emphasis added] The Court further states, “Indeed, [the HHS FOIA specialist] explains in her supplemental declaration that a broader search (the one the government should have conducted given the actual language of Burmeister’s request) ‘is a completely different type of search and presumably would have resulted in a much larger production.’” [emphasis added]

The Court goes on to address the unreasonably narrow interpretation of my FOIA request by the government in more detail:
“And [the HHS FOIA specialist] is correct about that. For example, without listing every document that could be responsive to Burmeister’s actual request, it is obvious that all records relating to the original effort by HHS to enter into a sole-source contract with the Institute of Medicine, and documents relating to the subsequent decision to change course and proceed with a task order in response to expressions of concern by members of the public about the manner in which HHS was proceeding, would be responsive. Such records exist, but the government did not provide them to Burmeister.
“Because [the HHS FOIA specialist’s] supplemental declaration demonstrates that the government adopted an unreasonably narrow interpretation of Burmeister’s request, because [the HHS FOIA specialist] concedes she would have performed a much broader search had she interpreted the request correctly, and because that search would have uncovered additional records responsive to the request, the government has ‘improperly withheld agency records’ in violation of FOIA.” [emphasis added]
The Court then addresses the government’s meritless claim that my lawsuit is moot due to the government’s production of some documents after the complaint was filed despite the fact that the document search was inadequate:
“To avoid this conclusion, the government argues that Burmeister’s lawsuit should be dismissed as moot. Specifically, the government contends that even if Burmeister had the right to file her lawsuit because HHS failed to respond to her request within the time period required by FOIA, its subsequent production to Burmeister moots the lawsuit, even if the production was deficient. At the hearing on this motion, counsel for the government insisted that the case law compels this result – he argued that even if the production was deficient, the case law required that the lawsuit be dismissed as moot and that Burmeister be left to submit a response to the government’s production explaining how she believed it was deficient, so that the government would have a chance to remedy the deficiencies. However, the case law says exactly the opposite of what counsel for the government represented at the hearing,” namely, “To moot a FOIA claim, however, the agency’s production must give the plaintiff everything to which he is entitled. [emphasis added] Otherwise, there remains some ‘effective relief’ that can be provided the plaintiff, and the case is not moot.”

According to the Court, the government’s argument that I did not exhaust my administrative remedies and, thus, my lawsuit should be dismissed also fails:
“The government also contends Burmeister’s lawsuit should be dismissed for failure to exhaust her administrative remedies with respect to her claim that the agency’s search was inadequate. Specifically, the government argues that it responded to Burmeister’s request on January 7, two days before Burmeister sued, and that Burmeister should have objected to HHS about the adequacy of the response before filing the lawsuit. But the government’s response was not postmarked until January 8, and Burmeister credibly asserts she did not receive it until several days after she filed her complaint. Nor, in any event, was the government’s response a final or complete one – in other words, it was not a real response. The real response (which was, as discussed above, inadequate) came on February 3. Because the government failed to timely respond to Burmeister’s records request, and because Burmeister did not receive a final decision from the government until after she filed this lawsuit, her case is properly before the Court.” [emphasis added]
The 60-day period the Court allowed for the government to produce all documents responsive to my request (and not exempt under FOIA from production) runs on November 3. Let’s hope that the Court’s ruling will be a wake-up call for the government and a reminder that it is not above the law.
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Jeannette Burmeister is an Attorney at Law licensed to practice law in California and Germany. Before contracting ME in 2006, she was an attorney at Baker & McKenzie, LLP. (She was disabled at age 34.) Ms. Burmeister writes a blog, “Thoughts About ME,” in which she discusses topical issues concerning the ME/CFS community.