By David Tuller, DrPH
David Tuller is academic coordinator ofÂ the concurrent masters degree program in public health and journalismÂ at the University of California, Berkeley.
Last week, a commentary in Nature about the debate over data-sharing in science made some excellent points. Unfortunately, the authors lumped â€œhard-line opponentsâ€ of research into chronic fatigue syndrome with those who question climate change and the health effects of tobacco, among othersâ€”accusing them of engaging in â€œendless information requests, complaints to researchers’ universities, online harassment, distortion of scientific findings and even threats of violence.â€
Whatever the merits of the overall argument, this chargeâ€”clearly a reference to the angry response of patients and advocates to the indefensible claims made by the PACE trial–unleashed a wave of online commentary and protest on ME/CFS forums. Psychologist James Coyne posted a fierce response, linking the issue specifically to the PACE authorsâ€™ efforts to block access to their data and citing the pivotal role of the Science Media Centre in the battle.
The Nature commentary demonstrated the degree to which this narrativeâ€”that the PACE authors have been subjected to a wave of threats and unfair campaigning against their work and reputationsâ€”has been accepted as fact by the UK medical and academic establishment. Despite the studyâ€™s unacceptable methodological lapses and the lack of any corroborating public evidence from law enforcement about such threats, the authors have wielded these claims to great effect. Wrapping themselves in victimhood, they have even managed to extend their definition of harassment to include any questioning of their science and the filing of requests for dataâ€”a tactic that has shielded their work from legitimate and much-needed scrutiny.
Until recently, complaining about harassment worked remarkably well for the PACE team. Maybe thatâ€™s why they tried claiming victimhood again last October, when Virology Blog ran â€œTrial By Error,â€ my in-depth investigation of PACE. The series was the first major critique of the trialâ€™s many indefensible flaws from outside the ME/CFS patient and advocacy community. Afterwards, the investigators complained that â€œmisinformationâ€ and â€œinaccuraciesâ€ in my stories had subjected them to â€œabuseâ€ on social media and could cause them â€œa considerable amount of reputational damage.â€
These claims were ridiculousâ€”an attempt to deploy their standard strategy for dismissing valid criticisms. The PACE authors amplified this error in December, when they rejected Dr. Coyneâ€™s request for data from a PACE paper published in PLoS One as â€œvexatious.â€ They had called previous requests from patients â€œvexatiousâ€ without attracting negative comment or attentionâ€”except from other patients. But applying the term to a respected researcher backfired, drawing howls from others in the scientific community with no knowledge of ME/CFSâ€”the PACE teamâ€™s action was â€œunforgivable,â€ according to Columbia stats professor Andrew Gelman, and â€œabsurd,â€ according to Retraction Watch.
(In fact, the PLoS One data, when ultimately released, will show that the paperâ€™s main claimâ€”that the PACE-endorsed treatments are cost-effectiveâ€”is based on a false statement about sensitivity analyses, as I reported on Virology Blog.)
How did this theme of harassment and â€œvexatiousnessâ€ become part of the conversation in the first place? Starting in 2011, a few months after The Lancet published the first PACE results, top news organizations began reporting on an alarming phenomenon: Possibly dangerous chronic fatigue syndrome patients were threatening prominent psychiatrists and psychologists who were researching the illness. These reports appeared in, among other outlets, the BMJ, the Guardian, and The Sunday Times of London. The Times headline, a profile of Sir Simon Wessely, a longtime colleague of the PACE authors, was typical: â€œThis man faced death threats and abuse. His crime? He suggested that ME was a mental illness.â€
One patient had supposedly appeared at a PACE authorâ€™s lecture with a knife. Other CFS researchers had received death threats. Sir Wessely famously said that he felt safer in Afghanistan and Iraq than in the UK doing research into the diseaseâ€”a preposterous statement that the press appeared to take at face value. News accounts compared the patients to radical animal terrorists.
According to the news reports, the patients objected to the involvement of these mental health experts because they were anti-psychiatry and resented being perceived as suffering from a psychological disorder. Editorials in medical journals and other publications followed the news accounts, all of them defending â€œscienceâ€ against these unwarranted and frightening attacks.
In fact, the Science Media Centre orchestrated the story in the first placeâ€”not surprising, given its longtime association with the PACE team and its uncritical promotion of the various PACE papers. According to a 2013 SMC report reviewing the accomplishments of the first three years of its â€œmental health research functionâ€: â€œTom Feilden, science correspondent for BBC Radio 4â€™s Today programme, won the UK Press Gazette’s first ever specialist science writing award for breaking the story the SMC gave him about the harassment and intimidation of researchers working on CFS/ME. The SMC had nominated him for the award.â€
Itâ€™s great that the SMC not only spoon-fed Feilden the story but was so pleased with the reporterâ€™s hard work that it nominated him for a prestigious award. In a brochure prepared for SMCâ€™s anniversary, Feilden himself thanked the centre for its help in organizing the scoop about the â€œvitriolic abuseâ€ and the â€œcampaign of intimidation.â€
Of course, patients were attacking the PACE study not because they were anti-science or anti-psychiatry but because the study itself was so terrible, as I reported last October. Luckily, a growing number of scientists outside the field, like Dr. Coyne and the top researchers from Columbia, Stanford and Berkeley who signed an open letter to The Lancet demanding an independent review, have now recognized this. How are patients supposed to react when a study so completely ignores scientific norms, and no one else seems to notice or care, no matter how many times it is pointed out?
The PACE studyâ€™s missteps rendered the results meaningless. Letâ€™s recap briefly. The investigators changed their primary outcomes in ways that made it easier to report success, included outcome measures for improvement that were lower than the entry criteria for disability, and published a newsletter in which they promoted the therapies under investigation. They rejected as irrelevant their own pre-selected objective outcomes when the results failed to uphold their claims, and used an overly broad definition for the illness that identified people without it. Finally, despite an explicit promise in their protocol to inform participants of â€œany possible conflicts of interest,â€ they did not tell them of their work advising disability insurers on how to handle claimants with ME/CFS.
Patients and advocates have raised these and other legitimate concerns, in every possible academic, scientific and popular forum. This effort has been framed by the investigators, The Lancet and the Science Media Centre as a vicious and anti-scientific â€œcampaignâ€ against PACE. The news reports adopted this viewpoint and utterly failed to examine the scientific mistakes at the root of patientsâ€™ complaints.
Moreover, the reports did not present any independent evidence of the purported threats, other than claims made by the researchers. There were no statements from law enforcement authorities confirming the claims. No mention of any arrests made or charges having been filed. And little information fromÂ actual patients, much less these extremist, dangerous patients who supposedly hated psychiatry [see correction below]. In short, these news reports failed to pass any reasonable test of independent judgment and editorial skepticism.
Despite their questionable scientific methods and unreliable results, the PACE authors have widespread support among the UK medical and academic establishment. So does the Science Media Centre. Media reports, including last weekâ€™s Nature commentary, have presented without question the PACE authorsâ€™ perspective on patient response to the study. The reality is that patients have been protesting a study they know to be deeply flawed. Sometimes they have protested very, very loudly. Thatâ€™s what people do when they are desperate for help, and no one is listening. To call it harassment is disgraceful.
Update 2/3/16:Â After reading some of the comments, I thought it was important to make clear that I donâ€™t doubt the PACE investigators and some of their colleagues might have received very raw and nasty e-mails or phone calls. Perhaps some of these felt threatening, and perhaps they called in the police. (Iâ€™ve worked as a reporter for many years and have also received many, many raw and nasty e-mails, so I know itâ€™s not enjoyableâ€”but pissing people off is also part of the job.) The news accounts, however, provided no independent verification of the investigatorsâ€™ charges. And the point is that, whether or not they have been the recipient of some unpleasant communications, the investigators have repeatedly used these claims to justify blocking legitimate inquiry into the PACE trial.
Correction: I reviewed the three major articles I linked to, not every single article about the issue, so my description of the coverage applies to those three. I originally wrote that the articles contained â€œnoâ€ interviews with actual patients. However, theÂ SundayÂ TimesÂ article did include a short interview with one ME/CFS patient–a convicted child-molester who blamed his crime on fall-out from his illness. I apologize for the mistake, although I leave it to readers to decide if interviewing this person represented a sincere effort on the reporterâ€™s part to present patientsâ€™ legitimate concerns.