Health rising blog post, by Cort Johnson, 31 May 2016: Another Ball Drops in PACE Controversy: Cost-effectiveness Conclusions Faulty – Plus Update

Some past efforts to clear up the controversies around the now notorious PACE trials have requested that the authors release the raw data to researchers to be re-analyzed. Not so this time. In the latest ball to drop for the PACE studies, MEAction reported that five researchers including Ron Davis, two biostatisticians and an epidemiologist requested that the PLOS One Journal simply delete a finding they assert the papers own figures indicate is incorrect.

The paper in question is “Adaptive Pacing, Cognitive Behaviour Therapy, Graded Exercise, and Specialist Medical Care for Chronic Fatigue Syndrome: A Cost-Effectiveness Analysis.”

The finding is not a minor one. It asserts that the authors conclusion that the CBT/GET protocols used in the study were, from a societal perspective, cost/effective was incorrect. One of the main goals of the PACE Trial, was to demonstrate to the UK government and other funding bodies that they would get the most bang from their buck with ME/CFS by employing CBT/GET.

The PACE trial protocols called for sensitivity analyses that examined cost-effectiveness from a several scenario’s including CBT/GET’s ability to reduce the amount of home care provided by professional home care providers or by family members either paid a minimum wage or no wages.

The paper report that the societal benefits outweighed the costs of CBT/GET under any of these scenario’s was inaccurate. CBT/GET was only determined to be cost-effective from a societal perspective if the authors treated family caregivers as if they being paid as if they were home care providers. Under the other scenario’s it was not. It was another case of the authors stretching their findings beyond the breaking point.

As with other instances patient advocates played a major role in getting the word out about PACE trial problems.

Simon McGrath,Tom Kindlon and other ME/CFS advocates took the authors to task regarding a number of their conclusions. Using figures from one of the CBT/GET centers used in the trial Kindlon demonstrated that the PACE authors underestimated the cost of GET treatments by as much as 300% (if I’m reading it correctly). At that cost of treatment the CBT/GET doesn’t begin to pay for the advantages it provides.

The Davis paper simply asks that the paper be changed to reflect what Davis and other believe the authors have already admitted; that only if you treat the value of family members time as if they were paid home care providers, do the conclusions make any sense.

PACE Controversy Update

The Lancet Study – Over ten studies have emanated from the PACE trial thus far. The first was published in The Lancet; one of the oldest and most prestigious medical journals in the world. In Nov. 2015 Ron Davis, Lenny Jason, Vincent Racaniello and others posted a open letter to Lancet asking that independent analyses of the PACE trial be redone using outside researchers.

We therefore urge The Lancet to seek an independent re-analysis of the individual-level PACE trial data, with appropriate sensitivity analyses, from highly respected reviewers with extensive expertise in statistics and study design. The reviewers should be from outside the U.K. and outside the domains of psychiatry and psychological medicine. They should also be completely independent of, and have no conflicts of interests involving, the PACE investigators and the funders of the trial.

Horton replied that he was traveling and would get to the issue. Three months later after Horton had still not replied another letter went out with three dozen more signatories. It’s now six months later and Horton has still not replied.

The PLOS Study – The complaints began soon after the present paper was published in 2012. In Dec. 2015 PLOS stated that it expected the study authors to share the study data, and that they were doing their own internal investigation using outside experts to help them evaluate the issues.

In March, 2016 PLOS stated they had determined which data they believed should be shared and had requested the authors share it.

University – Jennie Spotila reported that the University sponsoring the study refused, citing the privacy needs of the participants and “prejudice to the programme”, to provide the raw study data (was it not anonymized?) to Vincent Racaniello and others. An appeal has been filed.

Conclusion

The PACE trial authors and the journals publishing their studies appear to be engaged in a waiting game in hopes the controversy will simply disappear over time. Until that happens they are ignoring requests or simply ignoring major issues.

David Tuller has tried and failed to have substantive, or in most cases, any conversations with the PACE trial authors. He and others have also contacted the journals the papers were been published in. When they do go on record – which is rare – Tuller reports they are evasive and provide misleading answers.

An investigative reporter of long standing Tuller has seen a lot, but even he seems taken aback by the unwillingness of the PACE authors or their publishers to address the legitimate issues that have been raised.

They appeared to excel at avoiding hard questions, ignoring inconvenient facts, and misstating key details. I was surprised and perplexed that smart journal editors, public health officials, reporters and others accepted their replies without pointing out glaring methodological problems—such as the bizarre fact that the study’s outcome thresholds for improvement on its primary measures indicated worse health status than the entry criteria required to demonstrate serious disability.

Jenny Spotila reported that Racaniello has little faith in the journals doing the right thing:

“I think they are going to ignore, obfuscate, and give their usual responses until we are all dead. I don’t have hope that the PACE authors, or Lancet, will respond in any meaningful way until there is more of an outcry.” Vincent Racaniello

The battle is not over by an means, however. The key to getting Lancet and the other publishers to act is simply getting more researchers to join in the fray and keeping the pressure on.