A Request That Should Not Be Ignored

20120818_boom_volumeSix scientists have sent a joint letter to the Editor of The Lancet asking for an independent re-analysis of the PACE trial data.

The letter, published today on Virology Blog, is signed by Dr. Ron Davis (Stanford), Dr. Jonathan Edwards (University College London), Dr. Leonard Jason (DePaul University), Dr. Bruce Levin (Columbia University), Dr. Vincent Racaniello (Columbia University), and Dr. Arthur Reingold (UC Berkeley). It states:

The PACE study was an unblinded clinical trial with subjective primary outcomes, a design that requires strict vigilance in order to prevent the possibility of bias. Yet the study suffered from major flaws that have raised serious concerns about the validity, reliability and integrity of the findings. The patient and advocacy communities have known this for years, but a recent in-depth report on this site, which included statements from five of us, has brought the extent of the problems to the attention of a broader public. The PACE investigators have replied to many of the criticisms, but their responses have not addressed or answered key concerns.

After summarizing the main flaws of the PACE trial, examined in detail in David Tuller’s series published on Virology Blog, the letter concludes:

Such flaws have no place in published research. This is of particular concern in the case of the PACE trial because of its significant impact on government policy, public health practice, clinical care, and decisions about disability insurance and other social benefits. Under the circumstances, it is incumbent upon The Lancet to address this matter as soon as possible.

We therefore urge The Lancet to seek an independent re-analysis of the individual-level PACE trial data, with appropriate sensitivity analyses, from highly respected reviewers with extensive expertise in statistics and study design. The reviewers should be from outside the U.K. and outside the domains of psychiatry and psychological medicine. They should also be completely independent of, and have no conflicts of interests involving, the PACE investigators and the funders of the trial.

That statement I placed in bold – “Such flaws have no place in published research” – is absolutely true. It is something with which no rigorous scientist can disagree. It is to the advantage of The Lancet and the PACE investigators to have such an independent re-analysis of these data. Unless of course the PACE investigators are concerned an independent re-analysis would not confirm their results. In that instance, I can understand why they would resist. But surely The Lancet would like to have independent confirmation to protect its own reputation.

I am quite certain that I am not the only advocate who, when discussing science, has been dismissed because I do not have “PhD” after my name. This is most definitely true for the advocates who have spent years gathering information, filing requests for data, and conducting their own analyses of the PACE papers based on those data they could actually get their hands on. These advocates have been writing about the PACE defects for years, and they have been ignored. Worse, they have been dismissed as “vexatious,” as a “vocal minority,” or “motivated-intruder.” Some researchers have also published critiques of the PACE trial, but their critiques have not been much more successful than that of advocates.

David Tuller’s investigation of the PACE and FINE trials took this to another level. Nearly 10,000 advocates (as of this writing) have signed the petition calling for the retraction of misleading PACE claims and release of the raw data to independent investigators. Dr. James C. Coyne, blogging for PLOS publications, has urged release of these data. Coyne quotes Dr. Jon Merz, a prominent bioethicist, as saying, “The litany of excuses – not reasons – offered by the researchers and Queen Mary University is a bald attempt to avoid transparency and accountability, hiding behind legal walls instead of meeting their critics on a level playing field.”

Today’s letter from six well-respected scientists to The Lancet turns up the volume yet again. It is time to test the PACE data on a level playing field.

This is no different than the cacophony of calls for replication of the XMRV finding, which turned into demands for retraction when it was clear that those data were deeply flawed. Good science is self-correcting, but it requires rigorous and ongoing testing for assumptions and biases.

ME/CFS has spent most of the last 30 years on very uneven ground in research funding, diagnosis and treatment, and in the quality of some science. We deserve better. The call for an independent re-analysis of the PACE data can no longer be ignored.

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13 Responses to A Request That Should Not Be Ignored

  1. Denise says:

    Many thanks to these scientists (advocates) for their letter!
    I hope it is not considered “vexatious”.

    Here’s hoping that a thorough independent review is conducted.

  2. jane pannell says:

    Once again, you are spotila-on. Thank you, Jenny. Your years of good work are appreciated. (and about to pay offf, maybe????)

  3. Laurel says:

    Hear, hear, Jenny. Well said.

  4. Carollynn Bartosh says:

    I know these are just steps, as you recently wrote Jennie, and not the finish line, but the steps help me to actually see a finish line. Who could have believed there might be a time when our efforts would have positive momentum?

    To that end, something I would add to the thread “…This is of particular concern in the case of the PACE trial because of its significant impact on government policy, public health practice, clinical care, and decisions about disability insurance and other social benefits,” is that this information also (mis)informs family and friends of those of us who suffer with this condition because it is the predominant message found in on-line searches about “CFS.” This misinformation informs key relationships and whether patients will have support of any, every kind from those closest to them. In regard to PACE, the personal really is the political, and vice versa. The results of their flawed science effect the fiber of our deepest relationships.

    Think of all the people who have lost marriages, and all of us have lost friends because of this. A couple of years ago a very well-meaning relative took in an interest in learning about my condition which I discovered only because the conversation they struck up and returned to throughout one Christmas, insisting that I need to get out and exercise and push through it when I don’t feel up to it. I realized she had been reading PACE-spawned information.

    In these personal situations as well as public vetting, any response from from us as sufferers that puts forward the recent real science has, until now, seemed to prove for the psycho-social camp the line of “reasoning” that we have phobias and delusions. No wonder that group has ratcheted up their response to our “vexations.” They see our advocacy as an inflamed symptom.

  5. Mary Dimmock says:

    Thank you, Jennie. Well said.

    And Carollyn, thanks for highlighting the personal impact that falls out of public policy decisions and medical care driven by PACE and similar studies.

  6. Mary Dimmock says:

    Thank you, Jennie. Well said as always.

    And Carollyn, thanks for highlighting the personal impact that falls out of public policy decisions and medical care driven by PACE and similar studies.

  7. Lisa Petrison, Ph.D. says:

    I totally agree that this needs to be addressed immediately. The problem has gone on far too long already.

  8. Jen, I do have Ph.D. behind my name but they don’t pay any attention to me, either. (Maybe I should try calling myself Mark Schweitzer …)

    I always love your posts, AND

    It is SO exciting to see this being discussed OUTSIDE our circles!!! All I could say when I read that letter was WOW. Look at me – I’m still on a contact high. I’m capitalizing words and writing in explanation points!!! WOW!

  9. Patty Hirst says:

    Awesome article! I’m so happy some of our frustration is finally being addressed. Thank you for keeping me informed, and for not deserting the patients and families. God bless you ??????

  10. Kristy says:

    I have a doctorate in psychology, am a licensed psychologist, and I suffer from CFS. As a psychologist I would like to speak to the claim that Cognitive Behavioral Therapy improves patients with CFS. I am embarrassed and mystified that anyone in the psychological field would call this article research and the Lancet should be ashamed of itself for publishing it. This is nothing more than the UK’s attempt to keep from paying benefits and provide appropriate healthcare to those in need. There are so many holes in this study it’s like looking through a piece of Swiss Cheese. Any first year grad student could design a better study. Cognitive Behavioral Therapy (CBT) cannot cure anyone of any medical illness and to claim that it helps people with CFS is absurd. CFS is NOT a mental condition, therefore CBT can do nothing more than assist patients in coping with the devastation this disease has on their lives. It cannot make any of the symptoms of CFS go away or improve to the point of recovery. Before I became disabled with CFS one of my specialties was medical psychology; I worked with people with medical conditions. My job was to help patients cope with their illnesses and the impact they had on them psychologically, the trauma they often experienced due to numerous and often horrifying medical procedures, treatment by medical professionals, grief and loss related to their illness, and other such issues. It is difficult, to say the least, to struggle with a disabling medical condition and my job was to try to make that struggle a little bit easier. It was not to provide therapy to attempt to cure their physical illness. The body and mind work together and it is natural if a person with a disabling medical condition copes better psychologically with their condition they will feel a bit better (because they have more psychological resources to handle the stressors their body is undergoing), but that will never change the symptoms or course of the illness. The goal is to minimize the psychological damage and in turn provide the body with more resources to cope with the physical damage occurring. I apologize for my field. This is a true tragedy and it should have been rectified long ago.

    • Jennie Spotila says:

      This is very well stated, Kristy. I think with Dr. Coyne and others entering the fray, the field of psychology could do us a lot of good by speaking out as you have done.

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