Richard Smith: QMUL and King’s college should release data from the PACE trial

richard_smith_2014Several times when I was the editor of The BMJ the journal was declared the worst medical journal in the world by an ME association. Sometimes we shared the award with The Lancet. At another time my wife was telephoned and told that if I didn’t take a different line on ME (which is better known as chronic fatigue syndrome) then “something horrible” would happen to me. So I know something about the emotion that surrounds chronic fatigue syndrome, but I still think that Queen Mary College London (QMUL) and King’s College London are making a serious mistake in refusing to release the data behind a controversial trial of treatments for chronic fatigue syndrome.

The emotion stems from sufferers from the condition resenting greatly the idea that it may have psychological causes with the stigma that implies. The resentment seems to be that psychological problems are not seen “real” in the way that physical ones are and that they may result from “moral weakness” rather than a morally neutral virus. I’ve always disliked the stigma that goes with mental illness and any idea that it is not as real or serious as physical illness. But at the same time neither I nor The BMJ had a line on the causes or treatments of chronic fatigue syndrome. We simply published what we thought was the best research on the subject that we were sent and commissioned material from the people we thought best informed on the subject. It’s true that several of those people were psychiatrists, but that didn’t mean that we thought chronic fatigue syndrome to be a psychological condition. We had open minds.

The trial that has evoked huge controversy—a Wikipedia page filled with criticisms and even questions in parliament—is called the PACE trial and was published in The Lancet in 2011. The trial compared adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome in 641 patients. Its conclusion was that cognitive behaviour therapy and graded exercise therapy moderately improved outcomes if added to specialist medical care but adaptive pacing therapy did not. These findings conflict with what many sufferers believe—that adaptive pacing therapy helps, but cognitive behaviour therapy and graded exercise therapy may lead to deterioration.

Many questions were raised about the validity of the trial, but the Medical Research Council, which funded the trial, and The Lancet stood by the trial. The authors have been not only criticised but abused.

In 2012 the cost effectiveness study from the PACE trial was published in PLOS One and found that cognitive behavioural therapy was the most cost effective treatment followed by graded exercise therapy and that adaptive pacing therapy was probably less cost effective than specialist medical care alone. Long term results were published in Lancet Psychiatry this year and showed continuing benefit from cognitive behavioural therapy and graded exercise therapy.

Kings College London and Queen Mary University of London (QMUL) own the raw data of the trials as they are the employers of the researchers. QMUL has already been asked to release the data under the Freedom of Information Act but declined, arguing that among other things that it would be possible to identify individual patients. The complainant appealed to the Information Commissioner’s Office, which dismissed the university’s arguments and ordered that the data be released. QMUL had 28 days to appeal the ruling and has presumably appealed.

In the meantime, James Coyne, a professor of psychology and a blogger for PLOS, has asked King’s College to release the data from the PLOS One study “consistent with the PLOS journals’ data sharing policies.” He wrote that he was “interested in in reproducing your empirical results, as well as conducting some additional exploratory sensitivity analyses.” These are wholly legitimate scientific practices.

King’s College on 11 December wrote to Coyne saying that it would not release the data because they considered his request “vexatious”; The Freedom of Information Act has a clause that allows a public body to decline to release data for this reason. The King’s letter is long and legalistic and comes from the Information Compliance Officer.

QMUL and King’s are making a mistake. As somebody who has been abused by people who care passionately about chronic fatigue syndrome, I can sympathise with their decision, but I still think it wrong.

Firstly, the inevitable conclusion is that they have something to hide. This is the age of transparency, and, whether people like it or not, what is not transparent is assumed to be wrong, corrupt, or biased until proved otherwise. I think of a scene from Not the 9 O’Clock News where we see pictures of a house with its roof blown off by a hurricane. “We rang the Gas Board, and they answered “no comment.’” We are led to think that the Gas Board is responsible for the hurricane.

Secondly, QMUL and King’s are going against basic scientific principles. In Popperian science we pose falsifiable hypotheses and then do all we can to tear them down. Hypothesis are never true, they are simply not falsified. This process should include other scientists being able to manipulate the data. Now it is true that “if you torture the data enough they will confess,” and those who disbelieve the results of the PACE trials will probably be able to come up with analyses that contradict the results of the trial authors.

But critics finding results that contradict those of the authors doesn’t mean they are right. Supporters of the original authors and neutral scientists can also work with the data. It’s at this point that I always wheel out my favourite quote from John Milton: “Truth was never put to the worse in a free and open encounter…. It is not impossible that she [truth] may have more shapes than one…. If it come to prohibiting, there is not ought more likely to be prohibited than truth itself, whose first appearance to our eyes bleared and dimmed with prejudice and custom is more unsightly and implausible than many errors….Where there is much desire to learn there of necessity will be much arguing, much writing, many opinions; for opinion in good men is but knowledge in the making.”

The refusal of two universities to release data relates to the current debate within universities over freedom of speech. In several universities students have stopped the appearance of speakers who have views—on, for example Islam or transgender people—that the students don’t like. This is a dangerous development. Democracies depend on free speech, and universities should be bastions of free speech—and the whole point and value of free speech is that you hear views that may disgust, distress, and anger you.

Finally, the universities may have failed to notice that customs around sharing data in science are changing rapidly. We have recognised that huge value is lost by scientists taking their datasets to the grave with them. More and more funders of research require the release of data they have funded, and journals like F1000Research require authors not just to make their data available on request but actually to submit their data with their study so that anybody can use the data either to confirm or refute the study or do other studies.

I fear that QMUL and King’s are defending the indefensible and like King Canute failing to stop a tide that is coming in fast.

Competing interest: RS was on the board of the Public Library of Science for eight years and is consulting for a fee for F1000Research.

Richard Smith was the editor of The BMJ until 2004.

Correction: The text of this blog was changed on 4 February 2016. Previously it said that “Several times when I was the editor of The BMJ the journal was declared the worst medical journal in the world by the ME (Myalgic Encephalomyelitis) Association.” The MEA pointed out that I was mistaken in saying this and that they never used this description. My apologies to the MEA.