What patients should require before consenting to participate in research…

A bold BMJ editorial  calls for more patient involvement in the design, implementation, and interpretation of research – but ends on a sobering note: The BMJ has so little such involvement to report.

In this edition of Mind the Brain, I suggest how patients, individually and collectively, can take responsibility for advancing this important initiative themselves.

I write in a context defined by recent events.

  • Government-funded researchers offered inaccurate interpretations of their results [1, 2].
  • An unprecedented number of patients have judged the researchers’ interpretation of their results as harmful to their well-being.
  • The researchers then violated government-supported data sharing policies in refusing to release their data for independent analysis.
  • Patients were vilified in the investigators’ efforts to justify their refusal to release the data.

These events underscore the need for patients to require certain documentation before deciding whether to participate in research.

Declining to participate in clinical research is a patient’s inalienable right that must not jeopardize the receipt of routine treatment or lead to retaliation.

A simple step: in deciding whether to participate in research, patients can insist that any consent form they sign contains documentation of patient involvement at all phases of the research. If there is no detailing of how patients were involved in the design of this study and how they will be involved in the interpretation, patients should consider not consenting.

Similarly, patients should consider refusing to sign consent forms that do not expressly indicate that the data will be readily available for further analyses, preferably by placing the data in a publicly accessible depository.

Patients exercising their rights in these ways will make for better and more useful biomedical research, as well as research that is more patient-oriented

The BMJ editorial

bmj-logo-ogThe editorial Research Is the Future, Get Involved declares:

More than three million NHS patients took part in research over the past five years. Bravo. Now let’s make sure that patients are properly involved, not just as participants but in trial conception, design, and conduct and the analysis, reporting, and dissemination of results.

But in the next sentences, the editorial describes how The BMJ’s laudable efforts to get researchers to demonstrate how patients were involved have not produced impressive results:

man with empty pocketsYou may have noticed the new “patient involvement” box in The BMJ’s research articles. Sadly, all too often the text reads something like, “No patients were involved in setting the research question or the outcome measures; nor were they involved in the design and implementation of the study. There are no plans to involve patients in the dissemination of results.” We hope that the shock of such statements will stimulate change. Examples of good patient involvement will also help: see the multicentre randomised trial on stepped care for depression and anxiety (doi:10.1136/bmj.h6127).

Our plan is to shine a light on the current state of affairs and then gradually raise the bar. Working with other journals, research funders, and ethics committees, we hope that at some time in the future only research in which patients have been fully involved will be considered acceptable.

In their instructions to authors, The BMJ includes a section Reporting patients’ involvement in research which states:

As part of its patient partnership strategy, The BMJ is encouraging active patient involvement in setting the research agenda.

We appreciate that not all authors of research papers will have done this, and we will still consider your paper if you did not involve patients at an early stage. We do, however, request that all authors provide a statement in the methods section under the subheading Patient involvement.

This should provide a brief response to the following questions:

How was the development of the research question and outcome measures informed by patients’ priorities, experience, and preferences?

How did you involve patients in the design of this study?

Were patients involved in the recruitment to and conduct of the study?

How will the results be disseminated to study participants?

For randomised controlled trials, was the burden of the intervention assessed by patients themselves?

Patient advisers should also be thanked in the contributorship statement/acknowledgements.

If patients were not involved please state this.

If this information is not in the submitted manuscript we will ask you to provide it during the peer review process.

Please also note also note that The BMJ now sends randomised controlled trials and other relevant studies for peer review by patients.

Recent events suggest that these instructions should be amended with the following question:

How were patients involved in the interpretation of results?

The instructions to authors should also elaborate that the intent is require description of how results were shared with patients before publication and dissemination to the news media. This process should be interactive with the possibility of corrective feedback, rather than a simple presentation of the results to the patients without opportunity for comment or for suggesting qualification of the interpretations that will be made. This process should be described in the article.

partnering with patientsMaterial offered by The BMJ in support of their initiative include an editorial, Patient Partnership, which explains:

The strategy brings landmark changes to The BMJ’s internal processes, and seeks to place the journal at the forefront of the international debate on the science, art, and implementation of meaningful, productive partnership with patients. It was “co –produced” with the members of our new international patient advisory panel, which was set up in January 2014. It’s members continue to inform our thinking and help us with implementation of our strategy.

patient includedFor its efforts, The BMJ has been the first medical journal to receive the “Patients Included” Certificate from Lucien Engelen’s Radboud REshape Academy. For his part, Lucien had previously announced:

I will ‘NO-SHOW’ at healthcare conferences that do not add patients TO or IN their programme or invite them to be IN the audience. Also I will no longer give lectures/keynotes at ‘NO-SHOW’ conferences.

But strong words need an action plan to become more than mere words. Although laudable exceptions can be noted, they are few and far between.

In Beyond rhetoric: we need a strategy for patient involvement in the health service, NHS user Sarah Thornton has called the UK government to task for being heavy on the hyperbole of empowering patients but lacking a robust strategy for implementing it. The same could be said for the floundering effort of The BMJ to support patient empowerment in research.

So, should patients just remain patient, keep signing up for clinical trials and hope that funders eventually get more patient oriented in the decisions about grants and that researchers eventually become more patient-oriented?

Recent events suggest that is unwise.

The BMJ patient-oriented initiative versus the PACE investigators’ refusal to share data and the vilification of patients who object to their interpretation of the data

As previously detailed here  the PACE investigators have steadfastly refused to provide the data for independent evaluation of claims. In doing so, they are defying numerous published standards from governmental and funding agencies that dictate sharing of data. Ironically, in justifying this refusal, the investigators cite possible repercussions of releasing the data for the ability to conduct future research.

Fortunately, in a decision against the PACE investigators, the UK Information Commissioner’s Office (ICO) rejected this argument because

He is also not convinced that there is sufficient evidence for him to determine that disclosure would be likely to deter significant numbers of other potential participants from volunteering to take part in future studies so as to affect the University’s ability to undertake such research. As a result, the Commissioner is reluctant to accept that disclosure of the withheld information would be likely to have an adverse effect on the University’s future ability to attract necessary funding and to carry out research in this area, with a consequent effect on its reputation and ability to recruit staff and students.

But the PACE investigators have appealed this decision and continue to withhold their data. Moreover in their initial refusal to share the data, they characterized patients who objected to the possible harm of their interpretations as a small vocal minority.

“The PACE trial has been subject to extreme scrutiny and opponents have been against it for several years. There has been a concerted effort by a vocal minority whose views as to the causes and treatment of CFS/ME do not comport with the PACE trial and who, it is QMUL’s belief, are trying to discredit the trial. Indeed, as noted by the editor of the Lancet, after the 2011 paper’s publication, the nature of this comprised not a ‘scientific debate’ but an “orchestrated response trying to undermine the credibility of the study from patient groups [and]… also the credibility of the investigators and that’s what I think is one of the other alarming aspects of this. This isn’t a purely scientific debate; this is going to the heart of the integrity of the scientists who conducted this study.”

Physician Charles Shepherd, himself a sufferer of myalgic encephalomyelitis (ME) notes:

  • Over 10,000 people signed a petition calling for claims of the PACE investigators relating to so-called recovery to be retracted.
  • In a survey of 1,428 people with ME, 73 per cent reported that CBT had no effect on symptoms while 74 per cent reported that GET had made their condition worse.

The BMJ’s position on data sharing

A May 15, 2015 editorial spelled out a new policy at The BMJ concerning data sharing, The BMJ requires data sharing on request for all trials:

Heeding calls from the Institute of Medicine, WHO, and the Nordic Trial Alliance, we are extending our policy

The movement to make data from clinical trials widely accessible has achieved enormous success, and it is now time for medical journals to play their part. From 1 July The BMJ will extend its requirements for data sharing to apply to all submitted clinical trials, not just those that test drugs or devices.1 The data transparency revolution is gathering pace.2 Last month, the World Health Organization (WHO) and the Nordic Trial Alliance released important declarations about clinical trial transparency.3 4

Note that The BMJ was making the data sharing requirement to all trials, not just medical and medical device trials.

But The BMJ was simply following the lead of the family of PLOS journals that made an earlier, broader, and simpler commitment to data from clinical trials being available to others.

plosThe PLOS journals’ policy on data sharing

On December 12, 2013, the PLOS journals scooped other major publishers with:

PLOS journals require authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception.

When submitting a manuscript online, authors must provide a Data Availability Statement describing compliance with PLOS’s policy. The data availability statement will be published with the article if accepted.

Refusal to share data and related metadata and methods in accordance with this policy will be grounds for rejection. PLOS journal editors encourage researchers to contact them if they encounter difficulties in obtaining data from articles published in PLOS journals. If restrictions on access to data come to light after publication, we reserve the right to post a correction, to contact the authors’ institutions and funders, or in extreme cases to retract the publication

This requirement took effect on March 1, 2014. However, one of the most stringent of data sharing policies in the industry was already in effect.

Publication is conditional upon the agreement of the authors to make freely available any materials and information described in their publication that may be reasonably requested by others for the purpose of academic, non-commercial research.

Even the earlier requirement for publication in PLOS journals would have forestalled the delays, struggles, and complicated quasi-legal maneuvering to characterized the PACE investigators’ refusing to release their data.

Why medically ill people agree to be in clinical research

Patients are not obligated to participate in research, but should freely choose whether to participate based on a weighing of the benefits and risk. Consent to treatment in clinical research needs to be voluntary and fully informed.

Medically ill patients often cannot expect direct personal benefit from participating in a research trial. This is particularly true when trials involve comparison of a treatment that they want that is not otherwise available, but they risk getting randomized to a poorly defined and inadequate routine care. Their needs continue to be neglected, but now burdened by multiple and sometimes intrusive assessments. This is also the case with descriptive observational research and particularly phase 1 clinical studies that provide no direct benefit to participating patients, only the prospect of improving the care of future patients.

In recognition that many research projects do not directly benefit individual patients, consent forms identify possible benefits to other current and future patients and to society at large.

Protecting the rights of participants in research

The World Medical Association (WMA) Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects spells out a set of principles protecting the rights of human subjects, it includes:

In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.

Can patients pick up the challenge of realizing the promise of The BMJ editorial, Research Is the Future, Get Involved ?

One patient to whom I showed an earlier draft objected that this is just another burden being thrust on medical patients who already have their condition and difficult treatment decisions with which to contend. She pointed out so often patient empowerment strategies ended up leaving patients with responsibilities they could not shoulder and that the medical system should have met for them.

I agree that not every patient can take up this burden of promoting  both more patient involvement in research and data sharing, but groups of patients can. And when individual patients are willing to take on the sacrifice of insisting on these conditions for their consent, they should be recognized and supported by others. This is not a matter for patients with particular illnesses or members of patient organizations organized around a particular illness. Rather, this is a contribution to the well-being of society should be applauded and supported across the artificial boundaries drawn around particular conditions or race or class.

The mere possibility that patients are going to refuse to participate in research that does not have plans for patient involvement or data sharing can have a powerful effect. It is difficult enough for researchers to accrue sufficient numbers of patients for their studies. If the threat is that they will run into problems because they don’t adequately involve patients, they will be proactive in redesigning the research strategies and reflecting it in their consent forms, if they are serious about getting their research done.

just-say-noPatients are looking after the broader society in participating in medical research. However, if researchers do not take steps to ensure that society gets the greatest possible benefit, patients can just say no, we won’t consent to participation.

Acknowledgments: I benefited from discussions with numerous patients and some professionals in writing and revising this blog. Because some of the patients desired anonymity, I will simply give credit to the group. However, I am responsible for any excesses or inaccuracies that may have escaped their scrutiny.

 

Why the scientific community needs the PACE trial data to be released

To_deposit_or_not_to_deposit,_that_is_the_question_-_journal.pbio.1001779.g001University and clinical trial investigators must release data to a citizen-scientist patient, according to a landmark decision in the UK. But the decision could still be overturned if the University and investigators appeal. The scientific community needs the decision to be upheld. I’ll argue that it’s unwise for any appeal to be made. The reasons for withholding the data in the first place were archaic. Overturning of the decision would set a bad precedent and would remove another tooth from almost toothless requirements for data sharing.

We didn’t need Francis Collins, Director of National Institutes of Health to tell us what we already knew, the scientific and biomedical literature is untrustworthy.

And there is the new report from the UK Academy of Medical Sciences, Reproducibility and reliability of biomedical research: improving research practice.

There has been a growing unease about the reproducibility of much biomedical research, with failures to replicate findings noted in high-profile scientific journals, as well as in the general and scientific media. Lack of reproducibility hinders scientific progress and translation, and threatens the reputation of biomedical science.

Among the report’s recommendations:

  • Journals mandating that the data underlying findings are made available in a timely manner. This is already required by certain publishers such as the Public Library of Science (PLOS) and it was agreed by many participants that it should become more common practice.
  • Funders requiring that data be released in a timely fashion. Many funding agencies require that data generated with their funding be made available to the scientific community in a timely and responsible manner

A consensus has been reached: The crisis in the trustworthiness of science can be only overcome only if scientific data are routinely available for reanalysis. Independent replication of socially significant findings is often unfeasible, and unnecessary if original data are fully available for inspection.

Numerous governmental funding agencies and regulatory bodies are endorsing routine data sharing.

The UK Medical Research Council (MRC) 2011 policy on data sharing and preservation  has endorsed principles laid out by the Research Councils UK including

Publicly funded research data are a public good, produced in the public interest, which should be made openly available with as few restrictions as possible in a timely and responsible manner.

To enable research data to be discoverable and effectively re-used by others, sufficient metadata should be recorded and made openly available to enable other researchers to understand the research and re-use potential of the data. Published results should always include information on how to access the supporting data.

The Wellcome Trust Policy On Data Management and Sharing opens with

The Wellcome Trust is committed to ensuring that the outputs of the research it funds, including research data, are managed and used in ways that maximise public benefit. Making research data widely available to the research community in a timely and responsible manner ensures that these data can be verified, built upon and used to advance knowledge and its application to generate improvements in health.

The Cochrane Collaboration has weighed in that there should be ready access to all clinical trial data

Summary results for all protocol-specified outcomes, with analyses based on all participants, to become publicly available free of charge and in easily accessible electronic formats within 12 months after completion of planned collection of trial data;

Raw, anonymised, individual participant data to be made available free of charge; with appropriate safeguards to ensure ethical and scientific integrity and standards, and to protect participant privacy (for example through a central repository, and accompanied by suitably detailed explanation).

Many similar statements can be found on the web. I’m unaware of credible counterarguments gaining wide acceptance.

toothless manYet, endorsements of routine sharing of data are only a promissory reform and depend on enforcement that has been spotty, at best. Those of us who request data from previously published clinical trials quickly realize that requirements for sharing data have no teeth. In light of that, scientists need to watch closely whether a landmark decision concerning sharing of data from a publicly funded trial is appealed and overturned.

The Decision requiring release of the PACE data

The UK’s Information Commissioner’s Office (ICO) ordered Queen Mary University of London (QMUL) on October 27, 2015 to release anonymized from the PACE chronic fatigue syndrome trial data to an unnamed complainant. QMUL has 28 days to appeal.

Even if scientists don’t know enough to care about Chronic Fatigue Syndrome/Myalgic Encephalomyelitis, they should be concerned about the reasons that were given in a previous refusal to release the data.

I took a critical look at the long-term follow up results for the PACE trial in a previous Mind the Brain blog post  and found fatal flaws in the authors’ self-congratulatory interpretation of results. Despite authors’ claims to the contrary and their extraordinary efforts to encourage patients to report the intervention was helpful, there were simply no differences between groups at follow-up

Background on the request for release of PACE data

  • A complainant requested release of specific PACE data from QMUL under the Freedom of Information Act.
  • QMUL refused the request.
  • The complainant requested an internal review but QMUL maintained its decision to withhold the data.
  • The complainant contacted the ICO with concerns about how the request had been handled.
  • On October 27, 2015, the ICO sided with the complainant and order the release of the data.

A report outlines Queen Mary’s arguments for refusing to release the data and the Commissioner’s justification for siding with the patient requesting the data be released.

Reasons the request release of data was initially refused

The QMU PACE investigators claimed

  • They were entitled to withhold data prior to publication of planned papers.
  • An exemption to having to share data because data contained sensitive medical information from which it was possible to identify the trial participants.
  • Release of the data might harm their ability to recruit patients for research studies in the future.

The QMU PACE researchers specifically raised concerns about a motivated intruder being able to facilitate re-identification of participants:

In relation to a motivated intruder being able facilitate re-identification of participants, the University argued that:

“The PACE trial has been subject to extreme scrutiny and opponents have been against it for several years. There has been a concerted effort by a vocal minority whose views as to the causes and treatment of CFS/ME do not comport with the PACE trial and who, it is QMUL’s belief, are trying to discredit the trial. Indeed, as noted by the editor of the Lancet, after the 2011 paper’s publication, the nature of this comprised not a ‘scientific debate’ but an “orchestrated response trying to undermine the credibility of the study from patient groups [and]… also the credibility of the investigators and that’s what I think is one of the other alarming aspects of this. This isn’t a purely scientific debate; this is going to the heart of the integrity of the scientists who conducted this study.”

Magneto_430Bizarre. This is obviously a talented masked motivated intruder. Do they have evidence that Magneto is at it again? Mostly he now is working with the good guys, as seen in the help he gave Neurocritic and me.

Let’s think about this novel argument. I checked with University of Pennsylvania bioethicist Jon Merz, an expert who has worked internationally to train researchers and establish committees for the protection of human subjects. His opinion was clear:

The litany of excuses – not reasons – offered by the researchers and Queen Mary University is a bald attempt to avoid transparency and accountability, hiding behind legal walls instead of meeting their critics on a level playing field.  They should be willing to provide the data for independent analyses in pursuit of the truth.  They of course could do this willingly, in a way that would let them contractually ensure that data would be protected and that no attempts to identify individual subjects would be made (and it is completely unclear why anyone would care to undertake such an effort), or they can lose this case and essentially lose any hope for controlling distribution.

The ‘orchestrated response to undermine the credibility of the study’ claimed by QMU and the PACE investigators, as well as issue being raised of the “integrity of the scientists who conducted the study” sounds all too familiar. It’s the kind of defense that is heard from scientists under scrutiny of the likes of Open Science Collaborations, as in psychology and cancer. Reactionaries resisting post-publication peer review say we must be worried about harassment from

“replication police” “shameless little bullies,” “self-righteous, self-appointed sheriffs” engaged in a process “clearly not designed to find truth,” “second stringers” who were incapable of making novel contributions of their own to the literature, and—most succinctly—“assholes.”

Far fetched? Compare this to a QMU quote drawn from the National Radio, Australian Broadcast Company April 18, 2011 interview of Richard Horton and PACE investigator Michael Sharpe in which former Lancet Editor Richard Horton condemned:

A fairly small, but highly organised, very vocal and very damaging group of individuals who have…hijacked this agenda and distorted the debate…

dost thou feel‘Distorted the debate’? Was someone so impertinent as to challenge investigators’ claims about their findings? Sounds like Pubpeer  We have seen what they can do.

Alas, all scientific findings should be scrutinized, all data relevant to the claims that are made should be available for reanalysis. Investigators just need to live with the possibility that their claims will be proven wrong or exaggerated. This is all the more true for claims that have substantial impact on public policy and clinical services, and ultimately, patient welfare.

[It is fascinating to note that Richard Horton spoke at the meeting that produced the UK Academy of Medical Sciences report to which I provided a link above. Horton covered the meaning in a Lancet editorial  in which he amplified the sentiment of the meeting: “The apparent endemicity of bad research behaviour is alarming. In their quest for telling a compelling story, scientists too often sculpt data to fit their preferred theory of the world.” His editorial echoed a number of recommendations of the meeting report, but curiously omitted mentioning of data sharing.]

jacob-bronowski-scientist-that-is-the-essence-of-science-ask-anFortunately the ICO has rejected the arguments of QMUL and the PACE investigators. The Commissioner found that QMUL and the PACE investigators incorrectly interpreted regulations in their withholding of the data and should provide the complaint with the data or risk being viewed as in contempt of court.

The 30-page decision is a fascinating read, but here’s an accurate summary from elsewhere:

In his decision, the Commissioner found that QMUL failed to provide any plausible mechanism through which patients could be identified, even in the case of a “motivated intruder.” He was also not convinced that there is sufficient evidence to determine that releasing the data would result in the mass exodus of a significant number of the trial’s 640 participants nor that it would deter significant numbers of participants from volunteering to take part in future research.

Requirements for data sharing in the United States have no teeth and situation would be worsened by reversal of ICO decision

Like the UK, the United States supposedly has requirements for sharing of data from publicly funded trials. But good luck in getting support from regulatory agencies associated with funding sources for obtaining data. Here’s my recent story, still unfolding – or maybe, sadly, over, at least for now.

For a long time I’ve fought my own battles about researchers making unwarranted claims that psychotherapy extend the lives of cancer patients. Research simply does not support the claim. The belief that psychological factors have such influence on the course and outcome of cancer sets up cancer patients to be blamed and to blame themselves when they don’t overcome their disease by some sort of mind control. Our systematic review concluded

“No randomized trial designed with survival as a primary endpoint and in which psychotherapy was not confounded with medical care has yielded a positive effect.”

Investigators who conducted some of the best ambitious, well-designed trials to test the efficacy of psychological interventions on cancer but obtained null results echoed our assessment. The commentaries were entitled “Letting Go of Hope” and “Time to Move on.”

I provided an extensive review of the literature concerning whether psychotherapy and support groups increased survival time in an earlier blog post. Hasn’t the issue of mind-over-cancer been laid to rest? I was recently contacted by a science journalist interested in writing an article about this controversy. After a long discussion, he concluded that the issue was settled — no effect had been found — and he could not succeed in pitching his idea for an article to a quality magazine.

But as detailed here one investigator has persisted in claims that a combination of relaxation exercises, stress reduction, and nutritional counseling increases survival time. My colleagues and I gave this 2008 study a careful look.  We ran chi-square analyses of basic data presented in the paper’s tables. But none of our analyses of group assignment on mortality more disease recurrence was significant. The investigators’ claim of an effect depended on dubious multivariate analyses with covariates that could not be independently evaluated without a look at the data.

The investigator group initially attempted to block publication of a letter to the editor, citing a policy of the journal Cancer that critical letters could not be published unless investigators agreed to respond and they were refusing to respond. We appealed and the journal changed its policy and allowed us additional length to our letter.

We then requested from the investigator’s University Research Integrity Officer the specific data needed to replicate the multivariate analyses in which the investigators claimed an effect on survival. The request was denied:

The data, if disclosed, would reveal pending research ideas and techniques. Consequently, the release of such information would put those using such data for research purposes in a substantial competitive disadvantage as competitors and researchers would have access to the unpublished intellectual property of the University and its faculty and students.

Recall that we were requesting in 2014 specific data needed to evaluate analyses published in 2008.

I checked with statistician Andrew Gelman whether my objections to the multivariate analyses were well-founded and he agreed they were.

Since then, another eminent statistician Helena Kraemer has published an incisive critique of reliance in a randomized controlled trial on multivariate analyses and simple bivariate analyses do not support the efficacy of interventions. She labeled adjustments with covariates as a “source of false-positive findings.”

We appealed to the US Health and Human Services Office of Research Integrity  (ORI) but they indicated no ability to enforce data sharing.

Meanwhile, the principal investigator who claimed an effect on survival accompanied National Cancer Institute program officers to conferences in Europe and the United States where she promoted her intervention as effective. I complained to Robert Croyle, Director, NCI Division of Cancer Control and Population Sciences who twice has been one of the program officer’s co-presenting with her. Ironically, in his capacity as director he is supposedly facilitating data sharing for the division. Professionals were being misled to believe that this intervention would extend the lives of cancer patients, and the claim seemingly had the endorsement NCI.

I told Robert Croyle  that if only the data for the specific analyses were released, it could be demonstrated that the claims were false. Croyle did not disagree, but indicated that there was no way to compel release of the data.

The National Cancer Institute recently offered to pay the conference fees to the International Psycho-Oncology Congress in Washington DC of any professionals willing to sign up for free training in this intervention.

I don’t think I could get any qualified professional including  Croyle to debate me publicly as to whether psychotherapy increases the survival of cancer patients. Yet the promotion of the idea persists because it is consistent with the power of mind over body and disease, an attractive talking point

I have not given up in my efforts to get the data to demonstrate that this trial did not show that psychotherapy extends the survival of cancer patients, but I am blocked by the unwillingness of authorities to enforce data sharing rules that they espouse.

There are obvious parallels between the politics behind persistence of the claim in the US for psychotherapy increasing survival time for cancer patients and those in the UK about cognitive behavior therapy being sufficient treatment for schizophrenia in the absence of medication or producing recovery from the debilitating medical condition, Chronic Fatigue Syndrome/Myalgic Encephalomyelitis. There are also parallels to investigators making controversial claims based on multivariate analyses, but not allowing access to data to independently evaluate the analyses. In both cases, patient well-being suffers.

If the ICO upholds the release of data for the PACE trial in the UK, it will pressure the US NIH to stop hypocritically endorsing data sharing and rewarding investigators whose credibility depends on not sharing their data.

As seen in a PLOS One study, unwillingness to share data in response to formal requests is

associated with weaker evidence (against the null hypothesis of no effect) and a higher prevalence of apparent errors in the reporting of statistical results. The unwillingness to share data was particularly clear when reporting errors had a bearing on statistical significance.

Why the PACE investigators should not appeal

In the past, PACE investigators have been quite dismissive of criticism, appearing to have assumed that being afflicted with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis precludes a critic being taken seriously, even when the criticism is otherwise valid. However, with publication of the long-term follow-up data in Lancet Psychiatry, they are now contending with accomplished academics whose criticisms cannot be so easily brushed aside. Yes, the credibility of the investigators’ interpretations of their data are being challenged. And even if they do not believe they need to be responsive to patients, they need to be responsive to colleagues. Releasing the data is the only acceptable response and not doing so risks damage to their reputations.

QMUL, Professors White and Sharpe, let the People’s data go.