Wall Street Journal article,  by Amy Dockser Marcus, 7 March 2016: Patients, Scientists Fight Over Research-Data Access

Some scientists balk at disclosing details in study of chronic fatigue syndrome

A controversy surrounding a study of chronic fatigue syndrome is prompting some scientists to push back against demands that they make medical research data more widely available to other researchers and patients.

Data from clinical trials and other studies are increasingly open to public scrutiny.

Proponents of open access say it can aid other scientists seeking to check research conclusions, and patient groups say it can help determine how useful potential new treatment options may be. The National Institutes of Health requires researchers it funds to make data available to other scientists and the public. And some medical journals have begun making open release of data a condition for publication.

But some scientists are concerned that research data in the wrong hands may be misused or misinterpreted. They also fear they may face harassment from other scientists or patients who disagree with the findings.

The debate recently boiled over regarding the long-running study in the United Kingdom of ME/CFS, a debilitating and poorly understood condition also known as myalgic encephalomyelitis or chronic fatigue syndrome. The study found that either a program of gradually increasing exercise, or cognitive behavioral therapy, led to modest improvements in patients’ fatigue and physical functioning compared with standard medical treatment, which consists mainly of educating patients about the condition and treating symptoms such as pain. The study, which is commonly known as Pace and involved 640 chronic fatigue patients, was first published in the journal the Lancet in 2011.

Some patients and other scientists have doubted the study’s conclusions. “These theories presume and insist that patients are not medically sick but simply suffering from dysfunctional cognitions that need to be changed,” said David Tuller, a lecturer in public health and journalism at the University of California, Berkeley. Dr. Tuller wrote an extensive analysis describing methodological problems with the Pace study that ran in October in “Virology Blog,” a widely read scientific blog.

On Monday, 43 scientists and clinicians sent a letter to the Lancet asking it to seek an independent reanalysis of the Pace study data. A petition disputing the trial results, and signed by 11,000 patients, caregivers and doctors, was submitted to the university, medical journals and posted online last week asking the researchers to release the data. And in October, the Information Commissioner’s Office, a U.K. independent authority that rules on public access to information, said Queen Mary University of London, which ran the Pace trial, must turn over research data to a patient who requested it; an appeal by the university will be heard next month.

Controversy has long surrounded ME/CFS, including how to define it and treat it. The National Institutes of Health in October said it was going to strengthen efforts to study the condition and find better prevention and treatment approaches. The Institute of Medicine found in a 2015 report about ME/CFS that exertion can make patients’
symptoms worse.

Queen Mary University declined to make the Pace investigators available for an interview. In a statement it said: “We have supplied requested, anonymized data to independent scientists, as part of the normal research collaboration.” It added it is also concerned for “the rights and welfare of trial participants.” The university said it is seeking further ethical, scientific, and patient advice on the matter.

Richard Horton, editor in chief of the Lancet, said he generally supports making data available to other scientists and patients. But, he said, “When you see some things written on social media [about the ME/CFS trial and the investigators], it makes you anxious that the claims for rational scientific debate based on access to the data may not be fully delivered.” Dr. Horton says the Lancet stands by the trial findings.

James Coyne, a professor of psychology at the University of Pennsylvania School of Medicine, in December asked another journal, PLOS One, which published a follow-up paper based on the Pace trial, to get the researchers to turn over their data. Among his concerns, Dr. Coyne said the researchers changed their outcome measures after the trial began and he wants to see if patients would have shown improvement under the original criteria. A spokesman for PLOS said the journal has contacted the study authors.

Tom Kindlon, 42 years old, of Dublin, and assistant chairman of the Irish ME/CFS Association, says he agrees patient confidentiality must be protected but that the research data he and others want access to “is not the sort of information that would identify people.” A concern he has is that patients in the trial might have reported feeling better, but that objective measurements of their performance, especially how far they could walk in six minutes, may not have shown actual improvement.

Anna Sheridan Wood, 40, a patient from Glasgow, also filed a request for data on the six-minute walking tests, but says the university turned her down. She has filed an appeal. She feels some scientists believe patients cannot be objective when assessing data because of their personal stake in the matter. But she will look at the data with “an open mind, as a scientist,” says Dr. Sheridan, who has a Ph.D. in physics.

Patients who request data aren’t subject to the same rules or controls that professional scientists are, says Stephan Lewandowsky, a cognitive scientist at the University of Bristol, in England, who co-authored a commentary in the journal Nature earlier this year arguing that open access to research data can be abused. Under certain conditions, “you have to say no,” he says. Dr. Lewandowsky has proposed creating an independent body that can weigh in on data requests either from scientists or members of the public “when things are contested.”