CFS- the volume of objective data was narrowed down many times how was it determined it would take more than 18 hours to provide the data.

Kathryn Dickenson made this Freedom of Information request to Queen Mary University of London

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

The request was refused by Queen Mary University of London.

Dear Queen Mary, University of London,

I refer to my request for a copy of the objective raw data from the PACE trial as submitted on the website "What do they know? " that QMUL gave the reference number FOI2017/F158. On 5 June 2017, QMUL advised that it had located the data requested.

I request a copy of the calculations made/information used to determine that it would take QMUL more than 18 hours (more than 450 pounds) to provide a copy of the data on or after each time the original request was narrowed as detailed below.

Yours faithfully,

Kathryn Dickenson

History of narrowing the request.
1. 6 May 2017-KD Submitted an FOI request via What do they know? QMUL gave it the reference number FOI 2017/F158.
The request is entitled: CFS - PACE trial objective data enable comparison with patients own objective data. https://www.whatdotheyknow.com/request/c....

QMUL refused the request, for two reasons, one, the researchers never collected more than ½ of the objective data described in the PACE manual and secondly that the volume of objective raw data obtained by the PACE authors, would take more than 18 hours and cost more than 450 pounds, to provide to the tax payer

2. 6 June 2017 KD narrowed the request and removed the information that QMUL stated that they did not hold. QMUL said that given the time already taking ascertaining what information they already held, it would still be too onerous for QMUL to provide the lesser amount of objective data requested.

3. 8 June 2017 KD narrowed the request yet again, QMUL again refused the request on the basis that the volume of material sought was still too great.

4. 13 June 2017- (FOI 2017/F1589 (b)) KD narrowed the request even further and QMUL refused the request on the basis that the volume of material sought was still too great.

5. 27 July 2017 (FOI 2017/F1589 (c))KD submitted a further narrowed request and QMUL refused the request on the basis that the volume of material sought was still too great.

QM FOI Enquiries, Queen Mary University of London

We acknowledge receipt of your request and will respond as soon as we can.

QM FOI Enquiries, Queen Mary University of London

FOI 2017/F294
 
Dear Kathryn Dickenson
 
Thank you for your email of 6th September.
 
Queen Mary University of London has used s.12 of the Freedom of
Information Act 2000 on three occasions in relation to requests made by
yourself.
 
We have based this on a reasonable estimate of where and how the
information from the PACE trial is believed to be held and the time it
would take one person, with no prior knowledge, locating, retrieving and
extracting the relevant information. However, we have not recorded any
actual calculations, therefore the information you have requested is not
held. It does not matter how little data is requested (or how small the
file may be); at the current time Queen Mary University of London does not
have the ability to provide such information without exceeding the
appropriate limit.
 
If you are dissatisfied with this response, you may ask QMUL to conduct a
review of this decision.  To do this, please contact the College in
writing (including by fax, letter or email), describe the original
request, explain your grounds for dissatisfaction, and include an address
for correspondence.  You have 40 working days from receipt of this
communication to submit a review request.  When the review process has
been completed, if you are still dissatisfied, you may ask the Information
Commissioner to intervene. Please see [1]www.ico.org.uk for details.

Yours sincerely
 
Paul Smallcombe
Records & Information Compliance Manager
 

References

Visible links
1. http://www.ico.org.uk/

Dear QM FOI Enquiries,

I request a review of QMUL's decision NOT to release the calculations that form the grounds for its repeated claims, that it is too onerous to release objective data, from the PACE raw trial, despite my repeated narrowing of my request.

QMUL is reminded, that the decision by QMUL, to continue to hide the objective data from this trial, has serious health implications, for millions of people with the disease chronic fatigue syndrome (CFS) in the UK. This is because in the UK, the health care of people with CFS is based on the PACE authors beliefs and claims, which still form the basis of the NICE Guidelines. The recent review of the NICE CFS Guideline is based on partially completed questionaire's by seven unidentified personal (David Tullers email exchange with NICE: http://www.virology.ws/2017/08/14/trial-...) .

In contrast the USA, after a million dollar review, of more than 9 thousand research papers, about the disease (https://www.cdc.gov/me-cfs/index.html) has determined, that to date there is no treatment and no cure for CFS. Note, in the USA scientists and CFS experts, have a positive and productive relationship with CFS patients, and are carrying out serious biomedical research into the disease in a wide range of disciplines. This in contrast to in the UK where a small number of extremely vocal mental health experts appear to have hijacked the disease and when asked to justify their beliefs and claims, hide behind the non-provision of data, subjective surveys, non-specific questions that ignore the core/key diagnostic symptoms of post exertional exacerbation of symptoms after exertion (often delayed) and even
unsubstantiated/disputed claims of harassment (rejected as spurious by the First Tribunal judge that ordered the release of a small volume of subjective data).

The USA government, has rejected the PACE authors claims of the effectiveness of GET and CBT for treating CFS. The controversial and widely disputed beliefs of the PACE authors, form no part of USA health policies and guidelines for CFS. In contrast claims made by the PACE authors, continue to form the basis of the NICE Guidelines for CFS, despite the failure of the authors to satisfactorily explain the documented flaws and faults in their work (http://www.meassociation.org.uk/2017/07/...).

I put it to QMUL, that the decision not to release the data, has a serious impact on UK CFS patients, their families, and the health care system and as such either is, or needs to be clearly documented and the calculations and associated information on which this decision is made clearly delineated. It beggars belief that such a serious decision is made on an unsubstantiated and undocumented whim. If this is in fact the reality, then I request that QMUL reviews its decision/s to not release the data on the basis that the non-release of the data is unsubstantiated.

It appears that the university has been stringing me along for months and has never intended to provide me with any of the information I am seeking . QMUL stated as follows:
" It does not matter how little data is requested (or how small the file may be); at the current time Queen Mary University of London does not have the ability to provide such information without exceeding the appropriate limit." This statement presumably relates to the fact that the volume of information specified in the narrowed requests was less than 100 kB in size and consisting of a small table of a few pages of results. This statement by QMUL appears to make it clear that the university has never intended to comply with its legal obligation for transparency and the release of data requested under the FOI Act, when the request relates to the PACE trial.

I seek a copy of all documentation, relating to the claims by Paul Smallcombe and QMUL that the release of the PACE objective data will take more than 18 hours/cost more than 450 pounds to provide.

Yours sincerely,

Kathryn Dickenson

Kathryn Dickenson left an annotation ()

http://www.virology.ws/2017/08/14/trial-...

Trial by Error: My E-Mail Exchange With NICE Chief Executive
14 AUGUST 2017
By David Tuller, DrPH

On Friday, I had an e-mail exchange with Sir Andrew Dillon, chief executive of the NICE Guidance Executive. The other seven Guidance Executive members are various directors within the NICE hierarchy, including the communications director. This group will make the final decision about whether to accept the provisional decision of a NICE surveillance review team to leave as is CG53, the guidance for CFS/ME released in 2007. (I have written about the NICE review process on CG53 here, here and here.)

That ten-year-old CFS/ME guidance recommends treatment with graded exercise therapy and cognitive behavior therapy. NICE reaffirmed the guidance after the 2011 publication of the first PACE results, which were taken as evidence that these treatments were effective. As part of the current review process, NICE provided stakeholders with a two-week window last month to submit comments about the provisional decision not to change CG53. Not surprisingly, this recommendation has alarmed many patients and advocates.

I didn’t expect to get answers to my questions from the Guidance Executive, but I felt an obligation to pose them anyway, given the importance of the issues. In fact, Sir Andrew responded to my e-mail within an hour. He explained that no comments would be forthcoming while the Guidance Executive was reviewing the situation. I have posted his response below my initial e-mail.

**********

Sir Andrew Dillon
Chief Executive
National Institute for Health and Care Excellence

Dear Sir Andrew:

I am a journalist and public health researcher at the University of California, Berkeley. I have reported on the current review of CG53, the NICE guidance for CFS/ME, for the science site Virology Blog, which is hosted by Professor Vincent Racaniello, a microbiologist at Columbia University. I have previously reported for Virology Blog on the PACE trial and other issues related to graded exercise therapy and cognitive behavior therapy. Earlier this year, I co-authored a commentary about the serious problems with PACE for the Sunday opinion section of The New York Times.

In my role as a journalist covering this issue, I have some questions for you and the other members of the NICE Guidance Executive about the decision-making process concerning the provisional recommendation to make no changes to CG53:

1) For many years, the U.S. Centers for Disease Control recommended GET and CBT as treatments, citing PACE. In late June or early July, the agency removed all references to these therapies from its main pages on the illness. Does the Guidance Executive plan to consult with American public health officials about what prompted this major “dis-endorsement” of these two therapies that NICE continues to promote?

2) In 2015, both the U.S. National Institutes of Health and the Institute of Medicine (now the National Academy of Medicine) released reports on the illness (they call it ME/CFS). These reports both concluded that it is a serious organic disease involving pathophysiological processes and not a psychological or psychiatric disorder—a determination that would have significant impact on treatment options. Does the Guidance Executive plan to consider these two reports and consult with any of the members of the panels that wrote them?

3) Other fields of medicine have abandoned the use of the trial design favored in this entire body of research, including PACE: open-label studies with subjective outcomes. That’s because other fields of medicine recognize that the combination of those two features in one study inherently produces bias. Does the Guidance Executive share these concerns about results from open-label studies with subjective outcomes, or does it believe that such studies can produce reliable and unbiased evidence suitable for clinical decision-making?

4) In PACE and other studies from this field, objective measures have largely failed to support the subjective results that have generated claims of “recovery” or significant clinical improvement. Does this pattern of sharp contradiction between objective and subjective results raise questions for the Guidance Executive about whether patients are objectively getting better?

5) In the 2011 Lancet paper, 13 % of the PACE participants had already met one of the study’s outcome thresholds at trial entry—that is, although assessed as “disabled” enough in physical function to qualify for the study, they were also found to be “within normal range” for physical function, before any treatment at all. In the 2013 Psychological Medicine paper, the same 13 % were already “recovered” for physical function at baseline, before any treatment at all—that is, they were simultaneously “disabled” for physical function and “recovered” for physical function. These facts were not included in the published papers but emerged later through a patient’s freedom-of-information request. Does the Guidance Executive have confidence in the reported results of a study in which a significant minority of participants have already met a key outcome threshold at baseline? If so, can the Guidance Executive point to other studies in the clinical trial literature in which a significant number of participants have already met a key outcome threshold at baseline? Does the Guidance Executive believe that the published PACE papers should have mentioned the fact that a signifiant minority of participants had already met a key outcome threshold at baseline?

6) In February 2016, forty-two leading scientists and clinicians signed an open letter to The Lancet in which they outlined the methodological lapses of the PACE trial, stated unequivocally that “such flaws have no place in published research,” and demanded an independent investigation. In March 2017, more than 100 experts signed an open letter to Psychological Medicine, asking the journal to retract immediately its core finding that GET and CBT helped patients “recover.” Does the Guidance Executive plan to review these open letters and consult with any of the signatories–from Columbia, University College London, Harvard, Stanford, Berkeley, etc.—about their reasons for publicly dismissing the PACE findings as invalid?

7) Both GET and CBT, as described in PACE and other studies from this field of research, involve telling participants that the treatments can reverse the illness and return them to a state of health. Is the Guidance Executive concerned that telling study participants repeatedly about the effectiveness of the treatments could bias their responses, augmenting any bias already inherent in open-label studies with subjective outcomes?

8) Some defenders of PACE note that CBT is also recommended for patients with cancer and other chronic diseases. But the approach advocated in PACE and related studies is not the kind of CBT focused on helping patients adapt to the reality of their illness. Rather, this form of CBT is specifically designed to alleviate patients of their purportedly “unhelpful” beliefs of having an ongoing medical disease that can be exacerbated by activity and exercise. Is the Guidance Executive aware of this critical distinction between CBT as normally administered in the case of other chronic illnesses and the adapted form of CBT investigated in PACE and other studies in this field?

9) The PACE trial used the Oxford criteria to identify participants. This case definition requires only six months of unexplained fatigue, so its use could result in the selection of participants with depression or other unidentified fatiguing illnesses. Some of these other illnesses might resolve spontaneously or respond to behavioral and psychological interventions like GET and CBT. In fact, the NIH report noted that using the broad Oxford case definition could “impair progress and cause harm,” and recommended that it be “retired.” Is the Guidance Executive concerned that populations derived using the Oxford criteria might contain many participants experiencing prolonged fatigue for a range of reasons unrelated to the illness being investigated? Is the Guidance Executive concerned that such heterogeneity in study samples could lead to erroneous findings about treatments?

10) The U.S. Agency for Healthcare Research and Quality found evidence to support GET and CBT for ME/CFS in its review of multiple studies. However, when the agency subsequently removed Oxford criteria studies from this analysis, it found no evidence that GET provided any benefits and almost no evidence that CBT provided benefits. Is the Guidance Executive considering this AHRQ re-analysis in its decision-making? Does the Guidance Executive plan to consult with officials at the agency to discuss why they conducted this re-analysis and how it subsequently led them to downgrade their assessments of the therapies?

11) The surveillance review team cites Cochrane reviews of GET and CBT to support the recommendation to leave the 2007 guidance as is. Many of the trials included in these Cochrane reviews rely on a broad case definition like the Oxford criteria. Is the Guidance Executive comfortable relying on Cochrane reviews for confirmation of controversial findings when the reviews themselves include the studies that feature the methodological problems being questioned? Will the Guidance Executive consider asking Cochrane to follow the lead of American public health officials and conduct a re-analysis of its GET and CBT reviews with Oxford criteria studies removed from the sample?

12) In the PACE trial protocol, the investigators promised to follow the Declaration of Helsinki, which requires researchers to tell prospective participants about “any possible conflicts of interest.” The three main PACE investigators have had longstanding relationships with insurance companies, advising them to offer GET and CBT to claimants diagnosed with the illness. Yet the investigators did not tell prospective PACE participants about these extensive consulting and financial links with insurance companies or include the information in consent forms. Is the Guidance Executive concerned that this clear violation of the investigators’ protocol promise to disclose “any possible conflicts of interest” to prospective participants means that they did not obtain properly “informed” consent? Does the Guidance Executive believe it should base clinical guidelines on studies that have not obtained properly “informed” consent?

13) More than 15,000 people signed the ME Association’s online petition outlining their concerns with the 2007 guidance and their objection to the provisional decision to leave it unchanged. Is it unusual for that many people to sign a petition protesting a NICE guidance?

14) Surveys of patients who have undergone GET have routinely found that more patients report harms from the intervention than benefits. In making its decision, does the Guidance Executive plan to consider these reports based on the clinical experiences of patients receiving GET in the real world?

15) The conduct and findings of the PACE trial have become a worldwide controversy. The study has been presented as a paragon of bad science at conferences of epidemiologists and statisticians and in graduate-level seminars. Leading scientists and clinicians have publicly denounced the trial’s perplexing irregularities. The CDC has removed references to PACE and has dropped the associated treatment recommendations. In making its decision about the 2007 guidance, does the Guidance Executive plan to consider that large segments of the scientific and public health worlds have already rejected the evidence base for GET and CBT as interventions for CFS/ME, ME/CFS, or whatever the disease entity is called? Given the public health stakes involved, will the Guidance Executive consider commissioning a more extensive, authoritative, independent and unbiased review of the evidence–and perhaps even a review in which the reviewers read the actual studies on which they are basing their recommendations, and not just the study abstracts?

I have other questions, but will leave it at that for now. I would be delighted should you and/or other members of the Guidance Executive choose to respond.

Kind regards–David

David Tuller, DrPH
Senior fellow in public health and journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley

**********

Sir Andrew’s réponse to me:

Dear Dr Tuller,

Thank you for your enquiry.

It looks like you are aware that we have recently concluded a public consultation about our provisional decision on the review of this clinical guideline. We are in the process of reviewing the results of that consultation and will make our final decision in due course. We will make that decision public, together with any other statements we think will be helpful to contextualise it. Until then, we don’t intend to respond to enquiries about the provisional decision. It may be that our final decision, when placed in the public domain, will help you with some of your questions, but if not, we will endeavour to answer them as best we can at that time.

Yours sincerely,

Andrew Dillon
Chief Executive
National Institute for Health and Care Excellence
10 Spring Gardens | London | SW1A 2BU | United Kingdom

Dear QM FOI Enquiries,

Please acknowledge receipt of my request for an internal review of your refusal, lodged on 18 September 2017 and advise when QMUL intends to respond.

Kathryn Dickenson

Queen Mary, University of London FOI, Queen Mary University of London

Dear Kathryn Dickenson

We do not intend to carry out an internal review on this request as we are already carrying out one in relation to FOI 2017/F248.

Yours sincerely
Queen Mary University of London

Kathryn Dickenson

Dear Queen Mary, University of London FOI,

Could you please:
i) Provide a link to/ description of FOI 2017/F248 - as I am not sure which FOI request you are referring to.

ii) Clarify the basis for your refusal to carry out this internal review into how you determined that it would take more than 18 hours to provide the data requested.

Yours sincerely,

Kathryn Dickenson

QM FOI Enquiries, Queen Mary University of London

Dear Kathryn Dickenson

 

i) As requested, here is a link to QMUL's response to FOI 2017/F248:
[1]https://www.whatdotheyknow.com/request/c...
The review is not being conducted on 2017/F255 as you have marked on
WDTK.com because that request was effectively a repeat of F248 and was
refused as such. It seems clear that you do not want us to review whether
or not F255 was repeated, but rather whether Section 12 has been correctly
applied. QMUL cannot change the status of requests on the website.

 

ii) We have already explained why we believe the appropriate limit would
be exceeded. No other information is held. The internal review which is
currently in progress is also considering the application of Section 12.
Please await the outcome of that; in the event that that refusal is
upheld, you will have the opportunity to appeal to the Information
Commissioner.

 

Yours sincerely

 

Paul Smallcombe

Records & Information Compliance Manager

 

References

Visible links
1. https://www.whatdotheyknow.com/request/c...

Kathryn Dickenson

Dear QM FOI Enquiries,

Thank you for your response.
I have 2 FOI requests lodged with QMUL and currently with the internal review team:
i) FOI 2017/F255 - A narrowed down request for objective data from the PACE trial, that was lodged 2 months ago as follows:
7 August 2017: KD submitted a narrowed FOI request via What do they know?
Entitled: CFS- a request for even less objective info from the PACE trial just the STEP test results at baseline and 52 weeks
Link to the request:
https://www.whatdotheyknow.com/request/c...

ii) FOI 2017/F294 - lodged one month ago, QMUL's determination/calculation that it would take more than 18 hours to obtain the objective data from the PACE trial, for each of the FOI requests that QMUL has refused, as follows:

6 September 2017, FOI 2017/F294
Request entitled: “CFS- the volume of objective data was narrowed down many times how was it determined it would take more than 18 hours to provide the data”
Link to the request
https://www.whatdotheyknow.com/request/c...

My request for information on how QMUL determined that it would take more than 18 hours to provide the data specified, in the series of ever narrowing FOI requests, relates to the requests that have been refused by QMUL's internal review staff. This request is independent of and separate to, my request for the small amount of objective data from the PACE trial, specified in FOI 2017/F255.

I trust that this clarify's the information that I am seeking and I look forward to the response from QMUL's internal review staff to FOI 2017/F255 and FOI 2017/F294 .

Yours sincerely,

Kathryn Dickenson

Kathryn Dickenson

Dear QM FOI Enquiries,

Just a note to advise that the request you linked to, in your most recent response was withdrawn on 19th August 2017.

I am assuming that you meant to refer a later request, in which the amount of information requested was reduced:

Entitled: CFS- a request for even less objective info from the PACE trial just the STEP test results at baseline and 52 weeks
Link to the request:
https://www.whatdotheyknow.com/request/c...

Yours sincerely

Kathryn

Kathryn Dickenson

Dear Queen Mary, University of London FOI,

Request now with the Office of the Information Commissioner.

Yours sincerely,

Kathryn Dickenson

Kathryn Dickenson

Dear QM FOI Enquiries,

To update for anyone following this search for the hidden STEP data from the PACE trial.
The Office of the Information Commissioner advises that it has received a response from QMUL and that it is drafting a response.

Yours sincerely,

Kathryn Dickenson

Kathryn Dickenson

UPdate - the Office of the Information Commissioner has advised that some information on how the calculations were worked out will be forthcoming.

QM FOI Enquiries, Queen Mary University of London

Dear Kathryn Dickenson,
 
We have undertaken a search as a result of the Information Commissioner’s
Office’s enquiries about our response to this request* and located a part
of an email from 01/06/2017, which is relevant and so is provided to you
here. This is from correspondence involving one of the Co-Principal
Investigators of the trial who are usually contacted when freedom of
information requests are received to determine whether the requested
information is held, etc.
 
“Including the time I have spent already, this would take more than 18
hours to compile and then check the data that are requested.”
 
This is all of the information held by Queen Mary University of London.
 
Yours sincerely
 
Paul Smallcombe
Records & Information Compliance Manager
 
 
* ‘I request a copy of the calculations made/information used to determine
that it would take QMUL more than 18 hours (more than 450 pounds) to
provide a copy of the data on or after each time the original request was
narrowed as detailed below.’
 

Kathryn Dickenson

The office of the information commissioner is writing up the decision notice on the basis of my dissatisfaction with QMUL's response. The University of Manchester took 2 weeks to provide the raw data from the sister trial to the PACE trial i.e. the FINE trial.

In over a year NOTHING has been provided by QMUL .....