Dr. Tuller, of University of California, Berkeley, published a series of damning critiques of the study on Professor Racaniello’s Virology Blog, starting with a lengthy article last October.
In the interview, Dr. Tuller said, “To me it’s astonishing that I could write 14,000 words about a bad trial and not even feel like I’ve touched all the issues that need to be talked about.”
Dr. Tuller described the PACE trial as “preposterous” and “a pack of nonsense”. He said, “This really, truly is ‘the Emperor has no clothes’. These people are stark naked…. The entire UK medical establishment has no clothes. The Lancet has no clothes. They’re all naked, and they don’t even seem to realize it.”[pullquote align=”left” cite=”” link=”” color=”” class=”” size=””]”It’s astonishing that I could write 14,000 words… and not even feel like I’ve touched all the issues that need to be talked about.”[/pullquote]
In the 90-minute conversation, Dr. Tuller placed focus on the damage the trial visited on patients. He said, “This is about their lives. It’s not about their careers…. and these people are just protecting their careers with a terrible, terrible study that’s caused a lot of harm”.
Discussing the impact of PACE on ME/CFS patients in the US, he said, “These treatments, if you look at the Mayo Clinic, Cleveland Clinic, Kaiser Permanente, any treatment guideline in the US — you know, professional medical associations, physicians’ groups — they all include graded exercise therapy and cognitive behavior therapy as the two treatments that have been shown to be effective for treating this, and they cite PACE, for the most part.” In the US, the CDC and numerous key secondary medical education providers, such as UpToDate and WebMD, recommend CBT and GET, using PACE as a reference. Some sites link poor prognosis to patients thinking they have a physical disease.
Dr. Tuller talked about the consequences of PACE and the establishment of its therapies as the standard of care in several countries. He said that a “cult” of CBT and GET was being used, especially in the UK and some other European nations, against parents who didn’t believe that their children with ME/CFS had “a false cognition that they have an illness” and didn’t want them to have the therapies.
He said, “Unfortunately, they get threatened by Social Services. In cases, their kids have been taken away, and forced to exercise. This has happened in Denmark to a young woman named Karina Hansen”. He said that Ms Hansen’s parents’ parental rights had been severed because it had been claimed that they weren’t treating her properly. Also, her ME/CFS had been rediagnosed as “pervasive refusal syndrome”, which diagnosis he assumed she rejected. He said, “And she’s basically – essentially – been kept from her family. And she’s twenty-six. She’s not a teenager.”
Dr. Tuller said that publication of the long-term follow-up results from PACE came a week after publication of his article, which included highly critical comments about the trial from leading scientists. He believed that the new PACE paper’s publication marked the first time that the media response had not been wholly uncritical of its authors’ claims.
He said, “My interpretation is that they’re used to saying whatever they want about patients and they’re used to getting away with that, and not being challenged. And I think they were sort of gobsmacked by having something at this high level confronting them, and having top scientists from Columbia, Berkeley, Stanford, Harvard, wherever, saying publicly and very forcefully, ‘This study’s a piece of crap’.”[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]How do I trust anything in the Lancet now? How do I know if research is valid, if something so obvious could get through and it’s so impossible to fix it?[/pullquote]
Professor Racaniello noted that in response to the open letter to The Lancet from 42 scientists calling for independent reanalysis of PACE, Dr. Richard Horton, the journal’s editor, had said, “This is an important issue, and I think we should publish a letter from you in The Lancet” but had so far failed to do so after many months.
Dr. Tuller said, “I’ve been driven a little bit insane by this, and nobody wants to hear me talk about it any more because I get very agitated, because I’m so upset: one, as a human being, because I feel so bad for the patients; two, I’m not a scientific researcher but I’m an academic researcher and I’m a journalist and a human being, and it’s just unconscionable what they’ve done. And how they’re defending it, I don’t understand.”
He said, “How do I trust anything in the Lancet now? How do I know if research is valid, if something so obvious could get through and it’s so impossible to fix it?”
#MEAction recently reported that the QMUL has spent £250,000 on legal fees in the recent tribunal, fighting against the release of anonymized data from the PACE trial.
Patient-advocate Jennie Spotila praised the interview. She said, “Give me 90 minutes. Whoever you are, whatever your connection to or interest in ME/CFS, take 90 minutes to listen to this discussion… and demand that CFS science be held to the same standard as any other kind of science.”
Jaime Seltzer made contributions to this article.