Announcing the Formation of a National ME/CFS Advocacy Initiative

Today, a group of patient advocates announced the formation of a national advocacy initiative. 

With the recent announcement that NIH funding is to be increased, this could not have come at a better time. 

The doors are open to anybody who wants to join.


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More than ever before, 2015 has been a year that has brought fresh hope to Myalgic Encephalomyelitis (ME) patients. The Institute of Medicine (IOM) and NIH Pathways to Prevention (P2P) reports confirmed the neglect and disbelief that have held the disease hostage for decades and strongly recommended action to improve patient care. Publications from Stanford, Columbia and Haukeland (Norway) Universities brought new insights into the biology. World-renowned scientists have joined the fight. Stories about severely ill patients like Ron Davis’s son have created more public awareness. And the Tuller series brought greater exposure to the concerns with the PACE trial and psychogenic theories.

For the first time, there’s a sense that we have huge opportunities to change the future for ME patients. And just as importantly, there’s a sense that if we want to turn those opportunities into reality, then we need to find new ways to work together across the community to increase the impact of our voices.

To that end, a number of organizations, bloggers and independent advocates, listed below, have started having discussions to identify those areas where they can agree on goals and work together to achieve what is needed for patients.

Thus far, we have identified common goals to focus on, including the need to dramatically increase funding, to advance the research agenda, to resolve the definitional challenges, and to improve clinical care through quality medical education. We expect that this will lead to actions directed toward Congressional leaders, HHS and its agencies, and public awareness through the media.

To achieve these goals, we are going to need broad participation across the community. We will leverage the Groups feature on the MEAction.net platform to get input on these goals and to share proposals for joint actions. Because we are working as a loose collaboration, groups and individuals will be given the opportunity to opt in or opt out of specific actions.

Working in this way and at this scale is new for all of us and we will be learning as we go. We also know that we won’t all agree on every tactic or policy direction. But we believe there is power in numbers and coordination and are all committed to taking advantage of every opportunity that we can to regain our future.

Please join us and share your ideas and enthusiasm. If you are interested in participating and providing input, you can join in the discussion on MEAction Groups here: http://www.meaction.net/us-action-working-groups/

Signed

Patient Organizations

Connecticut CFIDS Association, Inc.
ImmuneDysfunction.org dba The Vermont CFIDS Association, Inc
Massachusetts CFIDS/ME & FM Association
The Myalgic Encephalomyelitis Action Network (#MEAction)
Open Medicine Foundation (OMF)
New Jersey ME/CFS Association, Inc.
Pandora Org
Phoenix Rising
Simmaron Research
Solve ME/CFS Initiative
Wisconsin ME and CFS Association, Inc.

Patient blogs

Health Rising (Cort Johnson)
OccupyCFS (Jennifer Spotila)
Onward Through the Fog (Erica Verrillo)
Race to Solve ME/CFS (Claudia Goodell)
Speak Up About ME (Denise Lopez-Majano)

Independent Advocates

Lily Chu. MD, MSHS
Mary Dimmock
Sonya Heller Irey
Robert and Courtney Miller
Donna Pearson
Staci R. Stevens, MA
Steve Krafchick, MPH, JD
Rich Carson

The PACE Wars Continue: A request for data, and a denial

The PACE wars are continuing, with James Coyne, David Tuller, Ronald W. Davis, Vincent R. Racaniello, Bruce Levin, and even a former editor of the BMJ on one side, and the authors of the PACE trial (along with their supporting institutions) on the other.

When the former editor of the British Medical Journal characterizes the refusal to release PACE data as "defending the indefensible," you know the tides are turning. (The BMJ published a long-term follow-up on PACE claiming continued benefits of CBT and GET.) Other researchers who, like James Coyne, are not directly connected to ME/CFS are also weighing in on the side of transparency.

In an effort to verify the claims made by PACE, four researchers have now asked for PACE data. Their request is based solely on the basis of getting to the truth. Nothing could be more reasonable.

A similar request by James Coyne was denied on the basis that the data might be "misused" and patients' rights violated. However, in the same denial, the authors conceded that they had indeed released data, but only to researchers who had validated their study.

In short, the PACE authors seem to be saying that as long as you validate their research, patient rights will be protected.

This can't end well for the PACE team.

You can sign a petition to retract the PACE trial HERE.

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A request for data from the PACE trial

Virology Blog, 17 DECEMBER 2015


Mr. Paul Smallcombe
Records & Information Compliance Manager
Queen Mary University of London
Mile End Road
London E1 4NS

Dear Mr Smallcombe:

The PACE study of treatments for ME/CFS has been the source of much controversy since the first results were published in The Lancet in 2011. Patients have repeatedly raised objections to the study’s methodology and results. (Full title: “Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome: a randomized trial.”)

Recently, journalist and public health expert David Tuller documented that the trial suffered from many serious flaws that raise concerns about the validity and accuracy of the reported results. We cited some of these flaws in an open letter to The Lancet that urged the journal to conduct a fully independent review of the trial. (Dr. Tuller did not sign the open letter, but he is joining us in requesting the trial data.)

These flaws include, but are not limited to: major mid-trial changes in the primary outcomes that were not accompanied by the necessary sensitivity analyses; thresholds for “recovery” on the primary outcomes that indicated worse health than the study’s own entry criteria; publication of positive testimonials about trial outcomes and promotion of the therapies being investigated in a newsletter for participants; rejection of the study’s objective outcomes as irrelevant after they failed to support the claims of recovery; and the failure to inform participants about investigators’ significant conflicts of interest, and in particular financial ties to the insurance industry, contrary to the trial protocol’s promise to adhere to the Declaration of Helsinki, which mandates such disclosures.

Although the open letter was sent to The Lancet in mid-November, editor Richard Horton has not yet responded to our request for an independent review. We are therefore requesting that Queen Mary University of London to provide some of the raw trial data, fully anonymized, under the provisions of the U.K.’s Freedom of Information law.

In particular, we would like the raw data for all four arms of the trial for the following measures: the two primary outcomes of physical function and fatigue (both bimodal and Likert-style scoring), and the multiple criteria for “recovery” as defined in the protocol published in 2007 in BMC Neurology, not as defined in the 2013 paper published in Psychological Medicine. The anonymized, individual-level data for “recovery” should be linked across the four criteria so it is possible to determine how many people achieved “recovery” according to the protocol definition.

We are aware that previous requests for PACE-related data have been rejected as “vexatious.” This includes a recent request from psychologist James Coyne, a well-regarded researcher, for data related to a subsequent study about economic aspects of the illness published in PLoS One—a decision that represents a violation of the PLoS policies on data-sharing.

Our request clearly serves the public interest, given the methodological issues outlined above, and we do not believe any exemptions apply. We can assure Queen Mary University of London that the request is not “vexatious,” as defined in the Freedom of Information law, nor is it meant to harass. Our motive is easy to explain: We are extremely concerned that the PACE studies have made claims of success and “recovery” that appear to go beyond the evidence produced in the trial. We are seeking the trial data based solely on our desire to get at the truth of the matter.

We appreciate your prompt attention to this request.

Sincerely,

Ronald W. Davis, PhD
Professor of Biochemistry and Genetics
Stanford University

Bruce Levin, PhD
Professor of Biostatistics
Columbia University

Vincent R. Racaniello, PhD
Professor of Microbiology and Immunology
Columbia University

David Tuller, DrPH
Lecturer in Public Health and Journalism
University of California, Berkeley

Scientific Misconduct and the PACE Trial

Dr. James Coyne has been outspoken in his criticism of the PACE trial. He has publicly described the study as"bad science" using "voodoo statistics" to cover up faulty methodology.

Recently, Dr. Coyne requested a release of the PACE trial data from King's College London, one of the sponsors of the study.

The answer Dr. Coyne received from King's College London (see below) is surprisingly honest. Their concern (as stated in the highlighted portions) is that they may be criticized for their research. In fact, King's College states quite explicitly that anyone who might be critical cannot have access to the data. They also cited an "active campaign" to discredit the PACE trial as justification for denying a perfectly legitimate request for data.

This letter exposes the increasingly obvious reason for refusing to release the PACE trial data. If the data were released, it would be revealed that the results were falsified. Considering that there were 19 institutions participating in the trial, a public examination of the results would be deeply embarrassing. An exposure of outright fraud would also open them up to censure. Rather than face that possibility, the institutions in question have closed ranks, shouted "harassment," and invoked conspiracy theories.

In the world of science, it is not only unacceptable to argue that withholding data is justified because it might be disproved, it is ludicrous. The hallmark of scientific inquiry is reproducibility. If the results of a study cannot be reproduced, its findings are called into question.

Taking that idea one step further, this type of secrecy could be interpreted as outright misconduct. In a post on the London School of Economics blog, Nicole Janz argues that given how few researchers are willing to share data, "classifying data secrecy as misconduct may be a harsh, but necessary step." She cites political science guidelines that state that “researchers have an ethical obligation to facilitate the evaluation of their evidence based knowledge claims through data access, production transparency, and analytic transparency.”  In like fashion, the American Psychological Association has stated that "sharing data within the larger scientific community encourages a culture of openness and accountability in scientific research." [Emphasis mine]

Between conflicts of interest and lack of reproducibility, scientific integrity has been badly damaged over the past decade - to the point that most research findings are demonstrably false. The only way to stem the tide of jerry-rigged results is to enact penalties. Any study that refuses to share its data should be subject to an inquiry. 

James Coyne has requested just that. He has asked that the PACE paper be "provisionally retracted" until the data are shared. Under the standards of good scientific conduct, nothing could be more reasonable.

You can sign the petition to retract the PACE trial here.
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Read the original letter here.

Governance & Legal Services
Information Management and Compliance
Room 2.32
Franklin Wilkins Building
150 Stamford Street
London
SE1 9NH
Tel: 020 7848 7816

Email: legal-compliance@kcl.ac.uk

Professor James Coyne
By email only to: jcoynester@gmail.com

11 December 2015

Dear Professor Coyne,

Request for information under the Freedom of Information Act 2000 (“the Act”)

Further to your recent request for information held by King’s College London, I am writing to confirm that the requested information is held by the university. The university is withholding the information in accordance with section 14(1) of the Act – Vexatious Request.

Your request
You initially requested the information in accordance with the data sharing policies of the Public Library of Science (PLOS). The university has decided to treat this as a request under section 1(1) of the Act, as the information is held by the university. We received your information request on 13 November 2015.

You requested the following information.

“I have read with interest your 2012 article in PLOS One, "Adaptive Pacing, Cognitive Behaviour Therapy, Graded Exercise, and Specialist Medical Care for Chronic Fatigue Syndrome..." 

I am interested in reproducing your empirical results, as well as conducting some additional exploratory sensitivity analyses. 

Accordingly, and consistent with PLOS journals' data sharing policies, I ask you to kindly provide me with a copy of the dataset in order to allow me to verify the substantive claims of your article through reanalysis. I can read files in SPSS, XLS[x], or any reasonable ASCII format.”

Our response

We have given careful consideration to your request and have determined that section 14(1) of the Act applies to your request.

The university has considered, in particular, the following guidance and decisions in coming to this conclusion:

• Information Commissioner v Devon County Council and Dransfield [2012] UKUT 440 (AAC) (Dransfield)
• John Mitchell v Information Commissioner EA/2013/0019 (Mitchell)
• Decision of the Information Commissioner: FS50558352 – 18 March 2015
• Guidance issued by the Information Commissioner’s Office

Background

The article referred to in the request is a cost-effectiveness analysis based on a medical paper titled “Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial”. This is more commonly known as the PACE trial. This is a collaborative project between researchers from Queen Mary University of London, Oxford University and King’s College London. This was a large scale randomised clinical trial testing treatments for chronic fatigue syndrome (CFS) also known as myalgic encephalomyelitis (ME).

The university considers itself to be a joint holder of the requested information with Queen Mary University of London.

It is acknowledged that the project has led to controversy. There have been significant efforts to publically discredit the trial following the release of the first article in the Lancet journal in 2011. Among other public campaigns, there is a Wikipedia page dedicated to criticisms of this project. The campaign has included deeply personal criticism to the researchers involved as well as significant comment around the decisions not to disclose data and information about the project.

This request

The university considers that there is a lack of value or serious purpose to your request. The university also considers that there is improper motive behind the request. The university considers that this request has caused and could further cause harassment and distress to staff.

The university considers that the motive and purpose behind this request is polemical. The university notes the view of the Information Commissioner in decision FS50558352 that the request in that case was ‘more focussed on attacking and attempting to discredit the trial than in obtaining useful information on the topic.’ The requested information relates to economic analysis undertaken by academic staff with considerable experience in this field. External sources were used as part of that analysis and the process took approximately one year to complete. We would expect any replication of data to be carried out by a trained Health Economist.

The university acknowledges the general principle that requests should be considered both applicant and motive ‘blind’. “However, the proper application of section 14 cannot side-step the question of the underlying rationale or justification for the request.” (Dransfield p9 para. 34). The university considers that it is entitled to take into account the wider dealings and publicity surrounding the project when considering the motive behind this request.

The active campaign to discredit the project has caused distress to the university’s researchers who hold legitimate concerns that they will be subject to public criticism and reputational damage. The researchers based at the university were aware of the criticism of the trial and of the comments that have been made publically. They were also aware of the numerous requests for information received by Queen Mary University of London. The researchers involved in this project are experienced and well-used to scrutiny of their work. However, since the receipt of the request, they have reported concern that they will targeted with the same criticisms as their colleagues at Queen Mary University of London.

The university adopts the comments made in the Mitchell case at paragraphs 31-34 in relation to the need to protect academic freedom and protect academic staff who put forward ‘new ideas and controversial or unpopular opinions.’

In conclusion, the university considers that when applying a holistic approach, this request can properly be considered to be vexatious.

This completes the university’s response to your information request.

Your right to complain

If you are unhappy with the service you have received in relation to your information request or feel that it has not been properly handled you have the right to complain or request a review of our decision by contacting the Head of Information Management and Compliance within 60 days of the date of this letter.

Further information about our internal complaints procedure is available at the link below:
http://www.kcl.ac.uk/college/policyzone/assets/files/governance_and_legal/Freedom_of_Information_Policy_updated_Oct_%202011.pdf

In the event that you are not content with the outcome of your complaint you may apply to the Information Commissioner for a decision. Generally the Information Commissioner cannot make a decision unless you have exhausted the internal complaints procedure provided by King’s College London.

The Information Commissioner can be contacted at the following address:
The Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely
Ben Daley
Information Compliance Manager

Our Two Minutes of Fame: Collins talks about ME/CFS on Charlie Rose

Francis Collins, head of the NIH, was interviewed on Charlie Rose on November 23, 2014. It was a long interview, and until now it was available only on Hulu. Some thoughtful person has made a clip of the roughly two minutes Collins talked about ME/CFS.

Two minutes may not seem like much air time, but it's exactly two minutes longer than any head of the NIH has afforded this disease in the last three decades. To his credit, Dr. Collins did not try to soft-pedal the illness.
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Transcript:

Rose: I saw something, it may have been associated with NIH, about chronic fatigue.

Collins: I've been puzzled and frustrated about how little we understand about this condition. Chronic Fatigue Syndrome, people who have that diagnosis, it's a very heterogeneous collection of individuals, but the Institute of Medicine has just sort of defined what it is limited to: people who are profoundly affected by fatigue, oftentimes coming after an acute … you can't get out of bed. You are disabled, you are utterly unable to carry out daily activities. You have other things. Exertion seems to make you worse instead of better, and you have sleep disorders. Sleep is not refreshing as it should be. You may have postural hypotension, where you stand up and your blood pressure drops, and then you pass out. It's serious stuff, and it's particularly frustrating to see cases, and there are hundreds of thousands of them, of people who were healthy, and then have what appears to be a flu-like illness, but they go to bed and then they can't get up for months.

So we just announced that we are going to make a big push to try to get an answer here. Bring some of these new technologies, of genomics, and proteomincs, metabolomics and imaging and figure out what is going on in this condition. And if we understood that maybe we'd know what fatigue of other sorts is all about. Why do people on chemotherapy get fatigue? We don't really know. Wouldn't it be nice to have that answered?