By David Tuller, DrPH
For those not yet sick of my voice, here are two more chances to hear me reiterate variations of my message:
On Monday morning, I was interviewed in Perth for the radio show Mornings with Gareth Parker, on the 6PR882 Talk Radio network. (Never mind that the description in the link below identifies me as being from Berkley University.)
And last Wednesday, before flying from Adelaide to Perth, I was interviewed for a podcast on Radio Adelaide, along with long-time ME/CFS patients Penelope McMillan and Tania Emms.* [Corrected 4/18/2018 from “Emma”] The podcast was posted on Sunday.
There has been a twitter debate about whether I have “conflicts of interest” because I have sought and am again seeking funding from the patient and advocacy community to continue my investigation into PACE and related matters. Here’s my perspective: I currently have more than 1000 potential conflicts of interest. That’s because I received more than 1000 donations during my crowdfunding campaign last year, and they are all part of the pool of money that Berkeley has been using to pay my half-time salary and benefits since July 1st, 2017. Starting this July, when the funding I am receiving through my current crowdfunding campaign kicks in, I will again have as many potential conflicts of interest as I have donors.
(If anyone wants to add themselves to that list of potential conflicts of interest, here’s where you can do that: https://crowdfund.berkeley.edu/project/9730)
In some quarters, my crowdfunding has been construed to mean that this support is inducing me to write and say the kinds of things that I am writing and saying—that the PACE trial is fatally flawed, for example, and that the investigators have violated basic scientific principles, and that their responses to critics are dishonest and non-responsive, and so on. This criticism is unwarranted, as a fair reading of the facts would reveal.
First, my “conflicts of interest,” such as they are, are completely transparent. More importantly, I spent three years on my efforts to debunk PACE and took multiple trips to Europe without asking anyone for a dime—or a shilling. I wrote a 15,000-word investigation and many tens of thousands of words of follow-up before I turned to crowdfunding.
I am not saying and writing what I am saying and writing because patients and advocates have paid me. In fact, the cause-and-effect relationship goes in the opposite direction—patients and advocates have responded to my campaigns because I had already invested much of my free, unpaid time deconstructing and criticizing PACE. (I did get paid for three pieces in journalism venues–Undark, the MIT-based online science magazine; California, UC Berkeley’s alumni magazine; and the opinion section of The New York Times.)
Why did I do this? Certainly not for financial gain, or for career enhancement. I’d have to have been insane to think that focusing my energies on chronic fatigue syndrome would be a profitable endeavor or a path to professional advancement in either of my two fields—journalism and public health. I pursued this investigation because people with ME/CFS were clearly being harmed by graded exercise therapy. I did it because the CBT/GET ideological brigades had been gaslighting patients for years with their unscientific claims. I did it because I was appalled that such awful research could have been published and then defended at the highest levels of the U.K. academic and medical establishment.
Before I took on this project, I showed the PACE trial to very smart colleagues at Berkeley’s School of Public Health, especially epidemiologists and biostatisticians. They were uniformly shocked at the outcome-switching and data manipulation that were evident from reading the trial papers. So was Professor Racaniello, a microbiology professor at Columbia and the host of Virology Blog. These accomplished scientists were all perplexed that The Lancet, Psychological Medicine and other leading journals had backed what was clearly garbage research.
Needless to say, no one had ever before seen a study in which participants met outcome thresholds at baseline and could be classed as “disabled” and “recovered” (or “within normal range,” per The Lancet) simultaneously. That’s why 42 experts were willing to sign an open letter to The Lancet in February, 2016; the letter declared that the methodological lapses in PACE “have no place in published research.” That’s why 101 experts, including me, signed an open letter to Psychological Medicine requesting retraction of the bogus “recovery” findings.
The PACE authors have repeatedly maintained that they have addressed all questions. Their enablers at the journals apparently have no problems with papers in which participants are simultaneously “recovered” and “disabled” on key measures. They have accepted the PACE team’s non-responsive responses to these criticisms as legitimate. I do not—nor do any of the scientists with whom I have shared the PACE papers. It is silly to suggest that I am criticizing PACE because I have received funding from patients and advocates. I am criticizing PACE because it is, as I have often said, a piece of crap.
Let’s also review the PACE authors’ own serious conflicts of interest. For years, the principal investigators have advised disability insurers that rehabilitative therapies like those investigated in PACE would help get ME/CFS claimants back to work. In their protocol, they promised to abide by the Declaration of Helsinki—an international human rights protocol that is very specific about what researchers need to do in order to obtain informed consent. The declaration requires that prospective participants be told about “any possible conflicts of interest.” Yet for reasons they have never explained adequately, the PACE team ignored that critical provision of the declaration.
That means that the PACE investigators collected data from participants based on false pretenses—they obtained uninformed consent, not informed consent, and therefore had no ethical right to publish any of their data. Every paper that has relied on these data should be retracted on this basis, since it is impossible to go back and retroactively correct this glaring lack of pre-trial disclosure. One participant was so upset at finding out about these insurance industry links after she had already completed the trial that she refused to allow the PACE investigators to include her data in their analysis. Another told me she would have refused to enter the trial had she been informed at the start about these conflicts of interest.
After I raised this concern in my initial “Trial By Error” series on Virology Blog, the investigators provided various excuses to explain away their failure to disclose this essential information. Specifically, they noted that they had mentioned these links in the journal articles, that insurance companies were not involved in the study, and that only a few of the nineteen PACE authors had insurance industry ties. Honest researchers recognize that these answers are irrelevant and not responsive to the concerns raised. That no one in a position of authority in the U.K. appears to be bothered by the investigators’ flagrant violation of their own protocol promise is deeply disturbing.