Professor Vincent Racianello of Columbia University has said of the PACE trial controversy, “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.”
Racianello’s comment appeared in a blog post by ME/CFS advocate Jennie Spotila which provided updates on a number of current attempts to bring PACE to book.
Microbiologist Racianello, host of Virology Blog, was among several scientists who requested raw data from the PACE trial under the Freedom of Information Act and were refused by Queen Mary University of London (QMUL). The team includes public health scientist Dr. David Tuller of the University of California, Berkeley, geneticist Dr Ron Davis of Stanford University and biostatistician Dr Bruce Levin of Columbia.
Tuller told Spotila that they appealed against QMUL’s decision but QMUL declined to undertake a review. The group then filed an appeal with the Information Commissioner’s Office, but expect that the decision will take many months.
Racianello, Davis and Levin were among six scientists who wrote an open letter to The Lancet — who published the PACE trial — in November 2015 criticising the study and requesting an independent re-analysis. The letter was ignored and resubmitted in February, this time with signatures from a total of 42 scientists and specialist clinicians.
Racianello told Spotila that The Lancet’s editor, Dr. Richard Horton “invited us to submit it as an ‘official’ letter to Lancet, which would be published; and we did that. No response from him or Lancet yet.” Spotila asked Dr. Horton when the letter would be published but he did not respond.
Professor James Coyne of Pennsylvania University also requested raw data from PACE, but under the data-sharing policies of the science journal PLoS One, in which some of PACE’s results were published. The study authors refused to supply the data and, six months after his request, he told Spotila, “I am leaving things in PLoS’s hands. I am considering a range of responses if the journal does not produce the data or retract the paper.”
Commenting to Spotila on the state of the controversy about PACE, Tuller said, “I have to believe that the scientific community will gradually demand that it get retracted or the pressure to release the data will be so overwhelming that QMUL will finally decide that its institutional interests diverge from those of the authors.”
Racaniello told Spotila, “I don’t have hope that the PACE authors, or Lancet, will respond in any meaningful way until there is more of an outcry” and recommended that patients “share David Tuller’s articles on what is wrong with the study. If these are too complex, use his bullet point summaries. The patient community has been active but we need more scientists and physicians to weigh in on the problem.”
Spotila concluded that “All scientists who care about strong peer review, open data, and verification of results should care about PACE, even if they don’t give a hoot about ME/CFS… we should do everything we can to communicate about the PACE issues to scientists outside the ME/CFS community. They can help boost the signal enough to get the Lancet, PLoS, PACE authors and universities to pay attention and take the necessary actions to bring PACE-Gate to the correct conclusion.”
In August, we shared with you that we and six other ME/CFS organizations had submitted a proposal to the National Center of Health Statistics (NCHS) to fix the coding of ME/CFS in the US International Classification of Diseases (ICD-10-CM). Today, we are writing with an update on that proposal and asking that you sign the