{"id":9599,"date":"2016-08-30T08:01:40","date_gmt":"2016-08-30T08:01:40","guid":{"rendered":"http:\/\/wames.org.uk\/cms-english\/?p=9599"},"modified":"2016-08-30T09:38:40","modified_gmt":"2016-08-30T09:38:40","slug":"lancet-invites-letter-re-pace-then-decides-not-to-publish","status":"publish","type":"post","link":"https:\/\/wames.org.uk\/cms-english\/lancet-invites-letter-re-pace-then-decides-not-to-publish\/","title":{"rendered":"Lancet invites letter re PACE, then decides not to publish"},"content":{"rendered":"

Virology<\/strong> blog post, by Vincent Racaniello, 29 August 2016: Once Again, Lancet Stumbles on PACE<\/a><\/p>\n

Last February, Virology Blog posted an open letter to The Lancet and its editor, Dr. Richard Horton, describing the indefensible flaws of the PACE trial of treatments for ME\/CFS, the disease otherwise known as chronic fatigue syndrome (link to letter<\/a>). Forty-two well-regarded scientists, academics and clinicians put their names to the letter, which declared flatly that the flaws in PACE \u201chave no place in published research.\u201d The letter called for a completely independent re-analysis of the PACE trial data, since the authors have refused to publish the results they outlined in their original protocol. The letter was also sent directly to Dr. Horton.<\/p>\n

The open letter was based on the extensive investigative report written by David Tuller, the academic coordinator of UC Berkeley\u2019s joint program in journalism and public health, which Virology Blog posted last October (link to report<\/a>). This report outlines such egregious failings as outcome thresholds that overlapped with entry criteria, mid-trial promotion of the therapies under investigation, failure to provide the original results as outlined in the protocol, failure to adhere to a specific promise in the protocol to inform participants about the investigators\u2019 conflicts of interest, and other serious lapses.<\/p>\n

Virology Blog first posted the open letter in November, with six signatories (link to letter<\/a>). At that time, Dr. Horton\u2019s office responded that he would reply after returning from \u201ctraveling.\u201d\u00a0Three months later, we still had not heard back from Dr. Horton\u2013perhaps he was still \u201ctraveling\u201d\u2013so we decided to republish it with many more people signed on.<\/p>\n

The day the second open letter was posted, Dr Horton e-mailed me and solicited a letter from the group. (He did not explain where he had been \u201ctraveling\u201d for the previous three months.) Here\u2019s what he wrote:\u00a0\u201cMany thanks for your email. In the interests of transparency, I would like to invite you to submit a letter for publication\u2013please keep your letter to around 500 words. We will then invite the authors of the study to reply to your very serious allegations.\u201d<\/p>\n

Dr. Horton\u2019s e-mail clearly indicated that the letter would be published, with the PACE authors\u2019 response to the charges raised; there was no equivocation or possibility of misinterpretation. In good faith, we submitted a letter for publication the following month, with 43 signatories this time, through The Lancet\u2019s online editorial system (see the end of this article for a list of those who signed the letter). After several months with no response, we learned only recently by checking the online editorial system that The Lancet had flatly rejected the letter, with no explanation. No one contacted me to explain the decision or why we were asked to spend time creating a letter that The Lancet clearly had no intention of publishing.<\/p>\n

I wrote back to Dr. Horton, pointing out that his behavior was highly unprofessional and requesting an explanation for the rejection. I also asked him if he was in the habit of soliciting letters from busy scientists and researchers that his journal had no actual interest in publishing. I further asked if the journal planned to reconsider this rejection, in light of the recent First-Tier Tribunal decision, which demolished the PACE authors\u2019 bogus reasons for refusing to provide data for independent analysis.<\/p>\n

Dr. Horton did not himself apologize or even deign to respond. Instead, Audrey Ceschia, the Lancet\u2019s correspondence editor, replied, explaining that the Lancet editorial staff decided, after discussing the matter with the PACE authors, that the letter did not add anything substantially new to the discussion. She assured us that if we submitted another letter focused on the First-Tier Tribunal decision, it would be \u201cseriously\u201d considered. I\u2019m not sure why she or Dr. Horton think that any such assurance from The Lancet is credible at this point.<\/p>\n

The reasons given for the rejection are clearly specious. The letter for publication reflected the matters addressed in the open letter that prompted Dr. Horton\u2019s invitation in the first place, and closely adhered to his directive \u00a0to outline our \u201cserious allegations\u201d. If outlining these allegations was not considered publication-worthy by The Lancet, it is incomprehensible to us why Dr. Horton solicited the letter in the first place. Perhaps it was just an effort to hold off further criticism for a period of months while we awaited publication of the letter, unaware of the journal\u2019s intention to reject it. It is certainly surprising that The Lancet appears to have given the PACE authors some power to determine what letters appear in the journal itself.<\/p>\n

Dr. Tuller\u2019s investigation, based on the groundbreaking analyses conducted by many savvy patients and advocates since The Lancet published the first PACE results in 2011, has effectively demolished the credibility of the findings. So has a follow-up analysis by Dr. Rebecca Goldin, a math professor at George Mason University and director of Stats.org, a think tank co-sponsored by the American Statistical Association. In short, the PACE study is a sham, with meaningless results. In this case, the emperor truly has no clothes. Dr. Horton and his editorial team at The Lancet are stark naked.<\/p>\n

Yet the PACE study remains in the literature. Its recommendation of treatments that are potentially harmful to patients\u2013specifically, graded exercise therapy and cognitive behavior therapy, both designed specifically to increase patients\u2019 activity levels\u2013remains highly influential.<\/p>\n

Of particular concern, the PACE findings have laid the groundwork for the MAGENTA study, a so-called \u201cPACE for kids\u201d that will be testing graded exercise therapy in children and adolescents. A feasibility study, sponsored by\u00a0Royal United Hospitals Bath NHS Foundation Trust, is currently recruiting participants.\u00a0It is, of course, completely unacceptable that any study should justify itself based on the uninterpretable findings of the PACE trial. The MAGENTA trial should be halted until the PACE authors have done what the First-Tier Tribunal ordered them to do\u2013release their raw data and allow others to analyze it according to the outcomes specified in the PACE trial protocol.<\/p>\n

Today, because of the urgency of the issue, we are posting on\u00a0PubMed Commons <\/a>the letter that The Lancet rejected. That way readers can judge for themselves whether it adds anything to the current debate.<\/p>\n

Please note that the opinions in this\u00a0blog post are\u00a0mine only, not those\u00a0of any of the other signers of the Lancet letter<\/p>\n

Vincent R. Racaniello, PhD
\nProfessor of Microbiology and Immunology
\nColumbia University
\nNew York, New York<\/p>\n

Ronald W. Davis, PhD
\nProfessor of Biochemistry and Genetics
\nStanford University
\nStanford, California<\/p>\n

Jonathan C.W. Edwards, MD
\nEmeritus Professor of Medicine
\nUniversity College London
\nLondon, England, United Kingdom<\/p>\n

Leonard A. Jason, PhD
\nProfessor of Psychology
\nDePaul University
\nChicago, Illinois<\/p>\n

Bruce Levin, PhD
\nProfessor of Biostatistics
\nColumbia University
\nNew York, New York<\/p>\n

Arthur L. Reingold, MD
\nProfessor of Epidemiology
\nUniversity of California, Berkeley
\nBerkeley, California<\/p>\n

******<\/p>\n

Dharam V. Ablashi, DVM, MS, Dip Bact
\nScientific Director \u2013 HHV-6 Foundation
\nFormer Senior Investigator
\nNational Cancer Institute, NIH
\nBethesda, Maryland<\/p>\n

James N. Baraniuk, MD
\nProfessor, Department of Medicine
\nGeorgetown University
\nWashington, D.C.<\/p>\n

Lisa F. Barcellos, PhD, MPH
\nProfessor of Epidemiology
\nSchool of Public Health
\nCalifornia Institute for Quantitative Biosciences
\nUniversity of California
\nBerkeley, California<\/p>\n

Lucinda Bateman MD PC
\nMECFS and Fibromyalgia clinician
\nSalt Lake City, Utah<\/p>\n

Alison C. Bested MD FRCPC
\nClinical Associate Professor of Hematology
\nUniversity of British Columbia
\nVancouver, British Columbia, Canada<\/p>\n

John Chia, MD
\nClinician\/Researcher
\nEV Med Research
\nLomita, California<\/p>\n

Lily Chu, MD, MSHS
\nIndependent Researcher
\nSan Francisco, California<\/p>\n

Derek Enlander, MD, MRCS, LRCP
\nAttending Physician
\nMount Sinai Medical Center, New York
\nME CFS Center, Mount Sinai School of Medicine
\nNew York, New York<\/p>\n

Mary Ann Fletcher, PhD
\nSchemel Professor of Neuroimmune Medicine
\nCollege of Osteopathic Medicine
\nNova Southeastern University
\nProfessor Emeritus, University of Miami School of Medicine
\nFort Lauderdale, Florida<\/p>\n

Kenneth Friedman, PhD
\nAssociate Professor of Pharmacology and Physiology (retired)
\nNew Jersey Medical School
\nUniversity of Medicine and Dentistry of NJ
\nNewark, New Jersey<\/p>\n

Robert F. Garry, PhD
\nProfessor of Microbiology and Immunology
\nTulane University School of Medicine
\nNew Orleans, Louisiana<\/p>\n

Rebecca Goldin, PhD
\nProfessor of Mathematics
\nGeorge Mason University
\nFairfax, Virginia<\/p>\n

David L. Kaufman, MD,
\nMedical Director
\nOpen Medicine Institute
\nMountain View, California<\/p>\n

Susan Levine, MD
\nClinician, Private Practice
\nVisiting Fellow, Cornell University
\nNew York, New York<\/p>\n

Alan R. Light, PhD
\nProfessor, Department of Anesthesiology
\nDepartment of Neurobiology and Anatomy
\nUniversity of Utah
\nSalt Lake City, Utah<\/p>\n

Patrick E. McKnight, PhD
\nProfessor of Psychology
\nGeorge Mason University
\nFairfax, Virginia<\/p>\n

Zaher Nahle, PhD, MPA
\nVice President for Research and Scientific Programs
\nSolve ME\/CFS Initiative
\nLos Angeles, California<\/p>\n

James M. Oleske, MD, MPH
\nFrancois-Xavier Bagnoud Professor of Pediatrics
\nSenator of RBHS Research Centers, Bureaus, and Institutes
\nDirector, Division of Pediatrics Allergy, Immunology & Infectious Diseases
\nDepartment of Pediatrics
\nRutgers \u2013 New Jersey Medical School
\nNewark, New Jersey<\/p>\n

Richard N. Podell, M.D., MPH
\nClinical Professor
\nRutgers Robert Wood Johnson Medical School
\nNew Brunswick, New Jersey<\/p>\n

William Satariano, PhD
\nProfessor of Epidemiology and Community Health
\nUniversity of California, Berkeley
\nBerkeley, California<\/p>\n

Paul T Seed MSc CStat CSci
\nSenior Lecturer in Medical Statistics
\nKing\u2019s College London, Division of Women\u2019s Health
\nSt Thomas\u2019 Hospital
\nLondon, England, United Kingdom<\/p>\n

Charles Shepherd, MB BS
\nHonorary Medical Adviser to the ME Association
\nLondon, England, United Kingdom<\/p>\n

Christopher R. Snell, PhD
\nScientific Director
\nWorkWell Foundation
\nRipon, California<\/p>\n

Nigel Speight, MA, MC, BChir, FRCP, FRCPCH, DCH
\nPediatrician
\nDurham, England, United Kingdom<\/p>\n

Philip B. Stark, PhD
\nProfessor of Statistics
\nUniversity of California, Berkeley
\nBerkeley, California<\/p>\n

Eleanor Stein, MD FRCP(C)
\nAssistant Clinical Professor
\nUniversity of Calgary
\nCalgary, Alberta, Canada<\/p>\n

John Swartzberg, MD
\nClinical Professor Emeritus
\nSchool of Public Health
\nUniversity of California, Berkeley
\nBerkeley, California<\/p>\n

Ronald G. Tompkins, MD, ScD
\nSummer M Redstone Professor of Surgery
\nHarvard University
\nBoston, Massachusetts<\/p>\n

Rosemary Underhill, MB BS.
\nPhysician, Independent Researcher
\nPalm Coast, Florida<\/p>\n

Dr Rosamund Vallings MNZM, MB BS
\nGeneral Practitioner
\nAuckland, New Zealand<\/p>\n

Michael VanElzakker, PhD
\nResearch Fellow, Psychiatric Neuroscience Division
\nHarvard Medical School and Massachusetts General Hospital
\nBoston, Massachusetts<\/p>\n

Mark Vink, MD
\nFamily Physician
\nSoerabaja Research Center
\nAmsterdam, The Netherlands<\/p>\n

Prof Dr FC Visser
\nCardiologist
\nStichting CardioZorg
\nHoofddorp, The Netherlands<\/p>\n

William Weir, FRCP
\nInfectious Disease Consultant
\nLondon, England, United Kingdom<\/p>\n

John Whiting, MD
\nSpecialist Physician
\nPrivate Practice
\nBrisbane, Australia<\/p>\n

Marcie Zinn, PhD
\nResearch Consultant in Experimental Neuropsychology, qEEG\/LORETA, Medical\/Psychological Statistics
\nNeuroCognitive Research Institute, Chicago
\nCenter for Community Research
\nDePaul University
\nChicago, Illinois<\/p>\n

Mark Zinn, MM
\nResearch consultant in experimental electrophysiology
\nCenter for Community Research
\nDePaul University
\nChicago, Illinoi<\/p>\n","protected":false},"excerpt":{"rendered":"

Virology blog post, by Vincent Racaniello, 29 August 2016: Once Again, Lancet Stumbles on PACE Last February, Virology Blog posted an open letter to The Lancet and its editor, Dr. Richard Horton, describing the indefensible flaws of the PACE trial … Continue reading →<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[1],"tags":[1000,2163,2187,310,2284,2155],"class_list":["post-9599","post","type-post","status-publish","format-standard","hentry","category-news","tag-david-tuller","tag-dr-richard-horton","tag-lancet","tag-pace-trial","tag-prof-vincent-racaniello","tag-virology-blog"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p5qkYK-2uP","_links":{"self":[{"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/posts\/9599","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/comments?post=9599"}],"version-history":[{"count":4,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/posts\/9599\/revisions"}],"predecessor-version":[{"id":9616,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/posts\/9599\/revisions\/9616"}],"wp:attachment":[{"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/media?parent=9599"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/categories?post=9599"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/tags?post=9599"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}