“They don’t know. They don’t know anything.”—Susan Maier about the P2P panel members
On January 27, 2014, the Institute of Medicine (“IOM”) held its first out of five meetings relating to the development of diagnostic criteria for ME/CFS. It was a two-day meeting, with half of the first day being open to the public. Several government officials gave reports during the open part of the meeting. Susan Maier, Deputy Director of the Office of Women’s Health of the Department of Health and Human Services, gave the NIH report on the so-called Pathways to Prevention (“P2P”) program currently underway relating to ME/CFS research—parallel to the IOM effort—which will culminate in about 12 months in a workshop in which an appointed panel will (1) receive the report of an evidence-based review/report by the Oregon Health and Science University (“OHSU”) (under a task order from NIH), (2) listen to presentations of the government and experts and (3) then deliberate and write a report of recommendations to the NIH within 24 hours of the end of the workshop.
In response to a question from an IOM committee member, Susan Maier described the workshop as based on the “jury model” that requires the exclusion of any clinician or researcher who has any experience with ME/CFS Here is what she said:
“It’s a jury model. You have the defense, you have the prosecution; they both know the case really well. They know the details, they know what’s going on, they know all the nuance, they know what’s going on in media. Your jury is sequestered. They don’t know. They don’t know anything. … The jury hears the evidence. And they make their decisions based on the evidence. That’s essentially the difference between the workshop speakers, the evidence report and the panelists.” [emphasis added]
Deep breath! So, NIH really believes that designing the P2P workshop to be analogous to a jury trial is a valid method. Experts and government officials with varying points of view will present their views at the workshop, which Susan Maier likened to the prosecution and defense in a trial. Then the P2P panel, made up—by design—of those with no expertise or prior research or opinions on ME/CFS AT ALL, will take the evidence report of OHSU and the comments of the presenters—the “prosecution” and the “defense”— and deliberate and issue their recommendations in writing within 24 hours (!)
I must say, when I heard Susan Maier give that explanation, with a completely straight face and an obvious expectation of everybody to consider this approach sane, I just about fell off my chair. I found myself shaking my head violently. I even uttered the word “Noooo!” under my breath.
I find it hard to capture in words the absurdity of this approach for what Susan Maier described as “focus[ing on the] improve[ment] of science.” Let me add: the improvement of science for an incredibly complex disease, not that I am advocating this model for any other disease. The jury in the American justice system exists in order to assess the facts, not develop or interpret the law. The law is given to the jurors by the judge, who also serves as an impartial screener of the evidence presented by the parties for bias, relevance and many other factors. The outcomes of jury trials do not have any precedential value for future trials or the law.
In the P2P process, the jury model is stood on its head entirely. There is no judge to explain to the P2P panel of non-ME/CFS experts what the “law” is or to screen the evidence presented by the OHSU or the presenters at the workshop. Rather the panel is supposed to determine and confirm what the “law” is from what undoubtedly (or maybe hopefully) will be an abundance of highly technical information presented by OHSU in its evidence review.
This all happens in in an incredibly abbreviated period of time. As Susan Maier said, “We have a enough content for a five-day meeting. We have to cram it into two days.” (emphasis added) Even juries in a trial get to deliberate for several days or even weeks and don’t have to write a detailed report in that time. The powers that be within NIH dragged their feet for 30 years—ignored us, harmed us, tried to sweep us under the rug—and now they can’t spare three additional days on a quality workshop? Not that even five days would be sufficient for a complex disease such as ME/CFS.
According to Susan Maier, the “goal of P2P is … to review the evidence.” This evidence will then be applied to all future government-sponsored research of ME/CFS. This is like asking a jury in a murder trial to listen to the evidence as presented by the prosecution and defense, unfiltered and unclarified by rulings or instructions from the judge, and to develop, within 24 hours, a set of definitions and criteria for what constitutes first degree murder, second degree murder, manslaughter and negligent homicide. These will then be applied in all future murder trials.
This is the opposite of the scientific method! And talk about giving the jury model a bad name! Albert Einstein and Clarence Darrow would turn over in their graves.