‘We don’t share data.’ Why Peter White’s Wall Street Journal letter can be ignored

 

A few posts back, I discussed how the push for sharing of data from the PACE for chronic fatigue syndrome trial got a boost from an article in the Wall Street Journal (WSJ) by Amy Dockser Marcus.

Amy headlineQueens University of London would not make the PACE investigators available to the journalist for comment. I’m sure they think that this was a strategic error.  An article in a major US newspaper has become an embarrassment for them.

Peter White has now responded with an ineffectual letter to the editor.

Those of us pushing for release of the data should not be concerned. In this blog post I’ll explain why.

Here is White’s complete letter [Please click to enlarge]:

peter white wsj letter

The features  to notice are that the PACE investigators are “unable” to release their data to “the public” because they don’t have the “consent” of the patients. Peter White concedes the data can be anonymized, so that’s not the problem. Yet, the investigators’ withholding the data is an ethical imperative. The investigators have already shared the data with other researchers, but they can’t do so with the public.

So, the public is left with the investigators’ claim that the PACE chronic fatigue trial data are the “best available,” with cognitive-behavioral therapy and graded-exercise therapy now have more evidence than any other treatment for chronic fatigue syndrome. We just have to trust the investigators.

I’ll get back to these claims, but first a bit of context.

 Dr. Anna Wood

A number of us were interviewed for the WSJ, but the article will be remembered for its portrayal of Dr. Anna Wood. She has a doctorate in physics and happens to be a patient. She requested a small bit of the PACE objective data. She wanted to determine if she could validate with objective data the investigators claims that were based on only manipulating subjective data.  Specifically, she wanted to see if these subjective self-report data had any relationship at all to the more meaningful six-minute walk test.

I would gladly bet the PACE investigators a decent bottle of scotch that the treatments don’t register on the six-minute walk test. That would be truly embarrassing, because most scientists consider such objective data more meaningful. But I’m sure the PACE investigators know all this. They don’t want anybody to take a look, so there’s no way that Dr. Wood will get the data.

Dr. Wood was quoted as saying that she would look at the data with “an open mind, as a scientist.”

That’s not particularly extraordinary. Except that the PACE investigators under the direction of Simon Wessely and the Science Media Centre have worked hard to enforce the meme of angry, vexatious, and even dangerous patients who should not be trusted with the data.

Richard Horton, editor of The Lancet was trotted out with his tired old warning for the WSJ. It is an exact quote of what he has said numerous times elsewhere.

 “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.”

Anna Sheridan Wood

But this objection was neutralized by the quote from Dr. Wood and a photo portraying her as a pleasant, demure professional, not a raving loony. This is a PR problem for the PACE investigators.

With the PACE investigators having opted out, Dr. Stephan Lewandowsky was recruited as a foil.

 

 

smaller stephenIn contrast, the photo provided by the University of Bristol of Lewandowskywas a lot less appealing . Posing with his hand on his hip in an ill-fitting dark suit, dark blue shirt, and Donald Trump tie, he looks like the bouncer from Tony Sopranos strip club, Bada Bing.bada bing

Comparing photos should be irrelevant to whether we should get the PACE data released, but such images are a part of effective communication.

Really, coming in off the street and knowing nothing more, with which of these individuals would you side?

A cultural theorist would also point out an obvious additional feature disadvantaging the PACE investigators. The American presidential campaign has brought into the limelight rough men bullying women and treating them like objects. It is particularly bad timing for the PACE investigators to have Lewandowsky with his hand on his hip squaring off against a pleasant woman.

We shouldn’t be noticing this, but we do: The struggle for the PACE data has up until now largely been a struggle between domineering old white men versus patients, who are a varied group, but disproportionately, very ill women confined to bed with insufferable pain.

 Digression: what is a foil?

In fiction, a foil is a character who contrasts with another character (usually the protagonist) in order to highlight particular qualities of the other character.[2][3][4] In some cases, a subplot can be used as a foil to the main plot…The word foil comes from the old practice of backing gems with foil in order to make them shine more brightly..[6]

Think the Harry Potter series, particularly the book. Consider Draco Malfoy as the foil of the Harry Potter character.

 Harry Potter and Draco Malfoy are similar enough…to make their differences meaningful. They are both Slytherin potentials, and reasonably good students. However, while Draco chose Slytherin, Harry chose Gryffindor. Harry is brave, and Malfoy is a coward and a tool.

 Back to Peter White’s letter to the editor

 Left to a brief comment in the wake of the WSJ article already having been published, Peter White wisely vacates any claim he is dealing with vexatious patients, at least for now. So, it’s a matter of keeping the data from the public. But the problem is that Dr. Wood is not just the public, she’s a scientist.

Hey, Peter, I’m a scientist – that that – I’m still waiting for the data that you promised would be available as a condition of publishing in PLOS One.

Peter White then concedes that anonymizing the data is not a problem. We already know that anonymizing is readily done with a variety of available techniques. But for Peter White to concede it here is a big admission that he will regret later. I’ll make a point of repeatedly pointing that out to him.

Peter White: Staunch champion of Patient Rights?

 Let’s look at that ‘respect for the patients who participated in the trial.’ Peter White had gross conflicts of interest in running the trial. He and the insurance companies for whom he worked would benefit from a particular spin on the results.

tied double bindThe Declaration of Helsinki, the international rules for recruiting patients in the clinical trials and gaining their informed consent requires that patients be told of such conflicts of interest. But this information was kept from the patients participating in the PACE trial so they couldn’t take it into account in deciding whether to participate. Not much respect for patient rights there.

So, Peter White claims he is ethically bound to respect patients, but when it is convenient, he gets unbound.

It gets worse. When Peter White and colleagues collected the data they used to write their papers, they didn’t anonymize it and store it in secure places where it could be matched up against the names of participants. Some of the data actually got stolen. So again, Peter White and colleagues violated the rights of patients. But here they are claiming the dedication of those rights prevents them from sharing the data.

 Are Peter White and the PACE investigators good at sharing data with colleagues?

 Readers of the WSJ have no way of evaluating Peter White’s claim. But he is referring to his co-authoring of a Cochrane review. He did not just share the data.  He became an author, maintaining control of what would be said about the data.

In doing so, he is violating some fundamental checks and balances. Any trial investigators, particularly those with financial conflicts of interest, should not be involved in what should be a more disinterested and dispassionate integration of their data with others’ data in a systematic review. Peter White has created a major mess for Cochrane. We are awaiting how they will deal with a violation of their own standards.

The UK Freedom of Information Act Commissioner has considered Peter White’s arguments and rejected them.

 Most readers of the WSJ have no way of knowing that Peter White has already tried out his arguments about an ethical imperative before the UK Freedom of Information Act Commissioner and lost.

 Here is the full summary of the decision.

But let’s jump to page 11:

The University went on to explain that as the release of individual data would cause it to break its specific agreement with the patients who consented to participate in the study on that basis, this would erode trust and cause people to withdraw from any future new studies that it might plan to undertake.

And page 14:

 “… the information sought here remains the sensitive medical information of 640 patients, who although consented to participate in a research study, received medical treatment from medical practitioners subject to obligations of confidence and as QMUL has further noted, their participation in the study was subject to specific assurances of confidentiality, raising clear expectations, reasonably held, that such information would be kept private. A disclosure without consent of the patients’ medical data would seem to breach both data protection, the medical obligation of confidence and Article 8 ECHR.”

 On page 21 the Commissioner summarizes the questions that the testimony from the University raised. On page 22 the Commissioner concluded:

 In order for section 41 to apply it is necessary for all of the relevant  elements of the test of confidence to be satisfied. Therefore if one or more of the elements is not satisfied then section 41 will not apply. The Commissioner has explained, in relation to the application of section 40(2), why he does not consider it possible to reliably identify an individual as the subject of the withheld information from its contents or if it is linked with other material available to the general public. In such circumstances he does not consider that there can be an expectation of confidence or that disclosure would cause detriment by way of an invasion of privacy. Therefore it follows that there can be no breach of confidence to action and section 41 does not apply.

 So, where does Peter White’s letter to the editor leave us?

 The PACE investigators are well practiced at fielding challenges with stock answers and saying nothing new. But I think in this letter, Peter White has ceded some ground in acknowledging that the data can anonymized. Maybe he didn’t embarrass himself by dragging in the old meme, but claiming he could release the data to “the public” will not serve him well.

I am a scientist, but so what? Patients are significant stakeholders affected by how the data are interpreted. By contemporary standards –as promoted by The BMJ– they should be involved in the design of clinical trials, participate in their interpretation, and have access to the data.

Not that it matters, but a number of the patients who have requested the data have demonstrated capacity to analyze and interpret data in peer-reviewed articles. One of them is awaiting an April 22 decision concerning Peter White’s appeal of the Commissioner’s earlier rejection of his arguments.

Over 100 days after I made my initial request, I’m still waiting for PLOS One to hand over the PACE data or retract their paper . I will settle for either. We already know that the PACE investigators are hiding something or they would’ve already given me (and others) the data.

 Three bits of advice from Bertrand Russell to Peter White

 Peter White doesn’t like to answer to anyone outside of his circles of friends and family. However, if he were around, British philosopher, mathematician, historian, and social critic Bertrand Russell (May 18, 1872–February 2, 1970) could offer him some useful advice:

  • Do not think it worth while to proceed by concealing evidence, for the evidence is sure to come to light.
  • Do not use power to suppress opinions you think pernicious, for if you do the opinions will suppress you.
  • Be scrupulously truthful, even if the truth is inconvenient, for it is more inconvenient when you try to conceal it.