By David Tuller, DrPH
Queen Mary University of London seems to have devised a fail-safe method of avoiding having to comply with more PACE-related freedom-of-information requests, just declare no one is around who can deal with it. Earlier this month, the U.K. Information Commissioner’s Office issued a decision in an appeal of QMUL’s rejection of a FOI request. The ICO found that QMUL had breached provisions of the FOI law–but that even so there was no way to order the university to produce the requested data.
Here’s what happened: On October 18, 2016, a FOI request seeking additional data from the trial was filed. Despite the First-Tier Tribunal decision earlier that year requiring QMUL to release other trial data, the university rejected this request on November 14, 2016. It mainly cited exemption provisions of the FOI law that cover data considered part of an ongoing research project or scheduled to be included in future publications, or data considered to be personal information or information covered by confidentiality agreements.
The complainant appealed the decision internally. QMUL upheld its earlier rejection, and the complainant appealed to the ICO in March, 2017. In the interim, on December 31, 2016, Professor Peter White had officially retired from QMUL.
At some point in the FOI appeal process, according to the ICO decision, QMUL changed its rationale for not providing the requested data. The new argument was not that data were exempt but that they were essentially not available. With Professor White gone, argued the university, no one on staff knew enough about the trial to figure out how to access requested data. QMUL also cited an earlier ICO determination that public agencies should not have to hire staff just to respond to FOI requests.
Here’s how the ICO decision paraphrased QMUL’s defense: While QMUL remains the holder and owner of the raw data from this clinical trial, it has effectively lost the means to locate and extract it because this requires specialist knowledge. There is no longer anyone at QMUL with the ability to produce data from this trial. QMUL no longer employs anyone involved with the PACE trial€¦.It [QMUL] reiterated that it would now have to recruit someone qualified to conduct the required extraction, analysis and preparation to comply with the request.
In its decision, the ICO confirmed that public agencies cannot be expected to hire staff just to respond to FOI requests: In this case QMUL has argued that the technical expertise to provide the information is simply not now available and therefore that it is just not possible to obtain the requested information from the raw data, wrote the ICO. Therefore this case is one of those exceptional circumstances where at the time of the request QMUL did hold the information but as the Chief Investigator has retired, leaving it no way to obtain the information now, it can no longer be said to hold the information for the purpose of FOIA and so no steps can be ordered.
In other words, the ICO determined that Professor White had not yet retired when the request was made, and he could have been called upon to help identify the appropriate data. Therefore, the ICO found that QMUL had violated the FOI law by rejecting the request when it was first made in late 2016. Yet the agency noted that it could not rectify the problem after-the-fact.
Given the enormous negative impact of the PACE trial findings, running into this sort of data dead-end is a frustrating development. Those seeking further unreleased data from the PACE trial might be stymied in their requests, with no apparent recourse. Does the FOI law really contain no provisions to deal with this sort of eventuality? If that’s the case, then the law might need some refurbishing.
This situation raises questions about a related issue: the PACE trial’s ten-year-follow-up feasibility study, which is described on the research site maintained by the U.K.’s Health Research Authority. According to this description, the study is designed to sample some PACE participants to determine whether conducting a full-scale ten-year-follow-up would be possible.
(The description presumes, of course, that such a follow-up would be informative. In reality, it would not be, given that the entire study was a piece of crap. The only interesting aspect of such a study would to see how the PACE team would manage to interpret likely null findings as positive ones, as they did for their first follow-up study in 2015. That study, published in The Lancet Psychiatry, proved that GET and CBT had no long-term benefits, since all four trial arms ended up at the same place. The PACE team interpreted the results in a more favorable but transparently self-serving light.)
The HRA site indicates that the ten-year-follow-up feasibility study received ethics committee approval on January 3, 2017. The listed sponsor is QMUL, and the contact is Professor White.
So is Professor White conducting this new PACE follow-up study under QMUL’s auspices, or not? If so, why can’t he also provide guidance on FOI requests? If not, who is conducting this trial in his place, and why isn’t that person able to provide guidance on PACE-related FOI requests? Why is QMUL even conducting a new PACE-related study if it no longer employs anyone involved in the trial? Or was the new study cancelled after Professor White’s retirement?
I have sent an e-mail to QMUL’s public relations department seeking clarification on Professor White’s role, if any, in this follow-up PACE research.
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The Cochrane systematic reviews of GET and CBT for CFS continue to be a big, big problem. The most recent version of the GET review was published last year. The CBT review was published in 2008. Both reviews include multiple Oxford criteria studies, so they are unreliable as assessments of treatments for patients with more narrowly defined disease, and specifically those with the core symptom of post-exertional malaise. Yet members of the GET/CBT ideological brigades brandish these Cochrane reviews to reinforce their position, as a recent example once again demonstrates.
Last month, Nature published an excellent piece about current biomedical research into ME/CFS, highlighting the efforts of Jose Montoya and Ron Davis, for example, as well as the recent Norwegian rituximab trial and the epidemiologic work of Leonard Jason. The piece reported that the role of GET and CBT as standards of care was under serious challenge. It cited, among other factors, my 2015 Virology Blog investigation.
Not surprisingly, the PACE team pushed back with a letter, which Nature published two weeks ago. I assume there was likely some feverish behind-the-scenes scrambling and strategizing about how to counter the suggestion in a premier British science journal that the biopsychosocial approach was losing favor. The letter is not from Professor White but from the other two principal PACE investigators, Professor Michael Sharpe and Professor Trudie Chalder; Professor Jon Stone, a neurologist at the University of Edinburgh, is also a co-author.
In our view€¦you underestimate the benefits of current treatments: namely, graded exercise and cognitive behaviour therapy, the three professors write in their response.
The letter-writers apparently don’t understand that their view is irrelevant here. Whether or not GET and CBT are effective treatments is not a matter of personal opinion. It is a matter of science. The science does not support the interpretation that these therapies produce anything other than marginal, self-reported benefits consistent with placebo effects–no matter how much Professor Sharpe, Professor Chalder and their colleagues would like to believe otherwise.
The letter-writers do not rebut any specific criticisms of PACE but instead present a simple argument: further scientific evidence, and in particular Cochrane’s systematic reviews, have confirmed that GET and CBT are effective. The letter does not mention that the inclusion of multiple Oxford criteria studies rendered the Cochrane reviews inappropriate for assessing treatments for people diagnosed through other case definitions.
We think that patients deserve the best research and treatments, write the three professors. In our view, there is no place for stigmatizing any avenue of research or therapy that might help us to improve the lives of people with this long-term debilitating illness.
No one would dispute that patients deserve the best research and treatment. But contrary to the letter-writers’ argument, the Nature article was not engaged in stigmatizing their approach. Rather, the article accurately explained what has happened: my investigation critiqued their work, letters of concern were subsequently sent to The Lancet and Psychological Medicine, the U.S. Centers for Disease Control finally dropped the PACE recommendations, and U.K. health authorities are now revising their own guidelines. These are facts. The avenue of research or therapy championed by the letter-writers has already failed to demonstrate that it can improve the lives of patients.
The PACE investigators spent five million pounds in U.K. taxpayer funds on their definitive study of GET and CBT. Based on the poor results for their protocol-specified outcomes as well as the lack of success on all the objective measures, the study definitively proved that the treatments were not effective. Moreover, the re-analyses for improvement and recovery, based on the data liberated by the tribunal in 2016, have documented that the investigators juiced their results by significantly weakening their outcome measures.
Despite the public debunking of their research, the PACE investigators still insist that GET and CBT are effective. But members of the international scientific community recognize this assertion to be nonsense. They know that The Lancet and Psychological Medicine, in refusing to address the obvious failings of the PACE papers they published, have abandoned their editorial responsibilities and damaged their reputations.
So that’s where things are. In responding to Nature, the two PACE investigators have not mounted a robust case for their own study. Perhaps they sense this is no longer a viable option, given how the debate has shifted. But they can still cite Cochrane as support for their unhelpful and anti-scientific beliefs. These flawed systematic reviews of CFS treatments are among the last bulwarks of defense for the GET/CBT treatment paradigm.
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Sometimes good things happen. That’s the only way to describe the $5 million windfall the Open Medicine Foundation has received from the Pineapple Fund, the bitcoin-funded philanthropy that has appeared out of nowhere to lavish unrestricted million-dollar gifts on worthy-sounding groups. OMF conducts fundraising for research projects focused on ME/CFS, and its scientific advisory board is headed by Stanford University geneticist Ron Davis.
Dr. Davis, of course, has devoted himself to ME/CFS research since his son, photographer Whitney Dafoe, became seriously ill several years ago. His research group suffered a serious disappointment last year when it lost out in the competition for multi-year NIH grants to ME/CFS collaborative research centers. Other high-profile groups also failed to get funding. In the case of Dr. Davis, OMF was able to step in to provide at least one-year’s funding to support the proposed collaborative, even before the Pineapple Fund donations.
Dr. Davis’ group at Stanford, along with colleagues at other institutions, have several ongoing projects that will benefit from the influx of funds. They are analyzing the complete genomes of severely ill patients and their family members, seeking possible genetic predispositions. They are focusing on the role of T-cells to identify the disease’s molecular immunology. They are investigating the metabolomics of ME/CFS patients, an effort being spearheaded by Dr. Robert Naviaux of the University of California, San Diego.
As the recent Nature article discussed, Dr. Davis’ team is also investigating various diagnostic technologies. These include a nanoneedle biosensor designed to measure cellular responses to stressors, and a magnetic levitation platform that can potentially discriminate between diseased and healthy cells. Dr. Davis believes that a combination of such tests might be necessary to establish a valid and reliable biomarker for ME/CFS. Although this goal has so far remained elusive, he hopes the new funding will help accelerate the process. I checked in with him about the recent developments.
So how did the new funding come about?
RD: In December we were contacted by several international patients letting us know about this unique grant opportunity from the Pineapple Fund. OMF immediately completed the online application and let the patient community know we were applying. The patients replied on social media to encourage support for OMF’s research, mostly on Reddit, that’s where the Pineapple Fund announced its philanthropic goals. The patients explained how little funding there was over the years for the disease, and what we would do, and so forth. So that precipitated the first donation.
How did you feel about that?
RD: I was just astonished, and of course delighted. We were really disappointed about not getting the NIH grant. One of the nice things about an NIH grant is that they last for five years. You know you’ll get this money this year, and the year after that. And that’s very important when you look at, say, staff. You don’t have to think, are we going to get enough donations to keep everybody? Research is expensive and a lot of it is for salaries. So I’d been worried about how we can keep everybody that we have, with grants coming to an end. It’s hard to find excellent people, and it was just a worry.
And how did the next donation happen?
So the announcement meant that I could now go back and focus on the research, at least for another year, because I didn’t have to worry about funding. The patient community inundated Pine with thanks, because that’s a lot of money. Then Pine reached out to Linda to explore increasing the grant. He said he’d known about ME/CFS for a while, and that he knew it was a serious condition without much in the way of treatment or research. And he increased the grant to a total of $5 million.
How do you deal with an influx of that kind of money all at once?
RD: I’m struggling exactly with how to do this. Do we go the safe route and spread it out over several years, or do we accelerate the spending with the hope we’ll get more money in the future? I could say we’ll spent $1 million for the next five but that makes everything go slow. You don’t want to throw a bunch of people on the same project just to make it go faster. Sometimes you have to do things sequentially. What I’m trying to do now is put things together to make this go faster without decreasing efficiency. We’re not going to waste it doing crazy things.
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