Occupy CFS blog post, by Jennie Spotila, 10 July 2016: Scandal

Give me 90 minutes. Whoever you are, whatever your connection to or interest in ME/CFS, take 90 minutes to listen to this discussion with academic/journalist David Tuller, DrPH (Lecturer at the School of Public Health and Graduate School of Journalism at University of California, Berkeley) about the PACE trial of Cognitive Behavioral and Graded Exercise Therapies for the treatment of CFS.

The fact that this incredibly flawed study has not been retracted (let alone was published in the first place) is a scientific scandal of epic proportions, and it is harming patients right now.

Take 90 minutes and listen to David Tuller explain it all. It is worth your time. I can only explain it by analogy.

Imagine that there is a clinical trial of a chemotherapy drug for breast cancer. Imagine the following facts about that chemotherapy clinical trial:

• Patients did not give valid informed consent because they were not told about that several of the investigators were consultants for the manufacturer of the drug
• The trial is not blinded, so the subjects and the scientists know who is getting the trial drug and who is not. There is also no placebo in the trial.
• Not everyone in the trial has breast cancer; some have other kinds of cancer.
• To get in the trial, a subject had to have a tumor smaller than 1.5 cm. Post hoc changes in design declared that tumors smaller than 2 cm would be counted as success. In other words, you could enter the trial with a 1.5 cm tumor, the tumor could get bigger, and as long as it was smaller than 2 cm you were counted as successfully treated.
• At the beginning of the trial, 13% of the trial subjects already met the primary outcome measurement of a tumor being less than 2cm in size.
• Subjects treated with the trial drug are more likely to have their cancers progress – either spreading to new sites or getting larger. The scientists insist this is not true.
• Despite all the flaws and other decisions which interpret the data very favorably for the trial drug, only 25% of people getting the trial drug show any improvement at all.

No one in their right mind would believe that this chemotherapy drug should be approved. No Institutional Review Board would even approve such a trial in the first place, and no journal would publish such a paper. The scientists would be investigated for fraud and misconduct.

No medical association or government agency would cite this study, nor rely upon it in formulating treatment guidelines.

Yet this is EXACTLY the level of scientific scandal in the PACE trial.

I am not exaggerating. Every bullet point in that list simply takes problems in the PACE trial and projects them onto a chemotherapy clinical trial. And that is not even the full exhaustive list of PACE flaws.

As I reported in May, twelve ME/CFS organizations asked the Centers for Disease Control remove all recommendations based on the PACE trial from its medical education material, and asked the Agency for Healthcare Research and Quality to examine the issues raised in Dr. Tuller’s investigation and revise its systematic evidence review. To my knowledge, neither agency has taken action on these requests.

Patients are being harmed – right now, today – by recommendations based on the fatally flawed PACE trial and the follow up papers. This study should never have been conducted. Once conducted, it should never have been published. Now published, it should be retracted.

The study was published five years ago.

Listen to David Tuller’s explanation of what he found in his investigation of the PACE trial. If you agree that science can and must do better, if you agree that the PACE trial should be independently investigated, then speak out! Write to The Lancet, as these scientists have done and as more than 12,000 advocates have done, and demand that CFS science be held to the same standard as any other kind of science.