Dr David Tuller 19th Feb: Trial By Error: A Letter to BMJ Open

[Countrygirl]

http://www.virology.ws/2018/02/19/trial-by-error-a-letter-to-bmj-open/

Trial By Error: A Letter to BMJ Open
19 FEBRUARY 2018
By David Tuller, DrPH

Three weeks ago, Professor Racaniello e-mailed a letter of concern to Archives of Disease in Childhood about its recent study of the Lightning Process as a treatment for ME/CFS in kids. The journal’s editor, Dr. Nick Brown, answered within an hour, assuring Professor Racaniello that he took the matter seriously and that the journal would review the issue. I understand that this process can take time, and I look forward to the response.

In the meantime, I followed up with Dr. Brown over the weekend, after an observant patient alerted me to an interesting statement on the BMJ website. As a BMJ journal, Archives of Disease in Childhood promises on its website to adhere to the organization’s policies and refers readers to the BMJ Author Hub for further information. This hub includes a page about clinical trial registration.

Here’s the key passage: “In accordance with the ICMJE [International Committee of Medical Journal Editors] Recommendations, BMJ will not consider reports of clinical trials unless they were registered prospectively before recruitment of any participants. This applies to trials which commenced after 1 July 2005.”

In my e-mail to Dr. Brown, I noted that the Lightning Process study violated this explicit policy about prospective trial registration. In the study, more than half the subjects were feasibility study participants who were recruited before the official trial registration date—in some cases almost two years before. Therefore, the trial was clearly not registered “before recruitment of any participants,” as required per BMJ’s stated policy.

 

[Countrygirl]

In any event, the BMJ Open paper’s detailed description of the data collection for this “pilot clinical service” provides ample evidence that the study was not “service evaluation” but “research.” It is perplexing that the journal has failed to acknowledge this undeniable fact. This pediatric study should not have been conducted, much less published, without a full ethical review. Since it was conducted and published anyway, BMJ Open must now take prompt steps to clarify what happened and address this serious matter in a fully transparent manner.

Sincerely–

Vincent R. Racaniello, PhD
Professor of Microbiology and Immunology
Columbia University
New York, NY, USA

Ronald W. Davis, PhD
Professor of Biochemistry and Genetics
Stanford University
Stanford, CA, USA

Jonathan C.W. Edwards, MD
Emeritus Professor of Medicine
University College London
London, UK

Rebecca Goldin, PhD
Professor of Mathematics
George Mason University
Fairfax, VA, USA

Leonard A. Jason, PhD
Professor of Psychology
DePaul University
Chicago, IL, USA

Steven Lubet
Williams Memorial Professor of Law
Northwestern University Pritzker School of Law
Chicago, IL, USA

David F. Marks, PhD
Editor
Journal of Health Psychology
& Health Psychology Open
London, UK

Marlon Maus, MD, DrPH, FACS
Director, DrPH Program
School of Public Health
University of California, Berkeley
Berkeley, CA, USA

Patrick E. McKnight, PhD
Professor of Psychology
George Mason University
Fairfax, VA, USA

Zaher Nahle, PhD, MPA
Vice President for Research and Scientific Programs
Solve ME/CFS Initiative
Los Angeles, CA, USA

Philip B. Stark, PhD
Professor of Statistics
University of California, Berkeley
Berkeley, CA, USA

John Swartzberg, MD
Clinical Professor Emeritus
School of Public Health
University of California, Berkeley
Berkeley, CA, USA

Samuel Tucker, MD
Assistant Clinical Professor of Psychiatry (retired)
University of California, San Francisco
San Francisco, California, USA

David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
University of California, Berkeley
Berkeley, CA, USA

William Weir, FRCP
Infectious Disease Consultant
London, UK

 

[andyguitar]

Nice one David Tuller and the rest of the crew.