Thread by @SGME_CH

🧵 thread

I never thought we would have to take the old stories out of mothballs again. 🕸🪰

But in 2022, the German institute IQWiG recommends the harmful treatment GET for mild and moderate ME patients.

So here we go again... 😮‍💨 What is Pacegate?

1/23

IQWiG's recommendation to GET in mild and moderate ME will result in many bedridden patients. It refers to the discredited PACE trial. Statistics professor Bruce Levin called PACE "the height of clinical trial amateurism."

2/23

Already the inclusion criteria of the PACE Trial are non-specific. The Oxford criteria are so broad, it is questionable how many participants had ME. In 2015, the US Agency for Healthcare Research and Quality wrote "[The Oxford criteria] may impair progress and cause harm."

3/23

Participants in the PACE trial were intentionally influenced. Before the start of the trial, they received information that "CBT is a powerful and safe treatment" and that "most people with CFS/ME felt either ‘much better’ or ‘very much better’ with GET"

4/23

PACE participants received newsletters where GET, CBT, and the psychosomatic model were promoted, "I really enjoyed being a part of the PACE Trial. It helped me to learn more about myself, […] and control factors in my life that were damaging."

5/23

Bias is extremely high per se in unblinded studies. It is even stronger when the principal invesitgators explicitly favor one treatment over the other. In the PACE trial, bias was intentionally enhanced by influencing the participants.

6/23

Despite the bias, however, the PACE investigators failed to achieve significant results. Therefore, in the middle of the unblinded study, they adjusted the study protocol to achieve the desired result.

7/23

After the protocol changes, a person was considered recovered in the PACE trial if they had the physical functioning of an average 75-year-old. This not only refers to healthy people, but also includes sick 75-year-olds in this average.

8/23

The protocol of the PACE Trial has been adjusted so much that it has even been possible for a participant to deteriorate during the trial and still be considered recovered (entry: SF-36 PF 65, defined as recovered: SF-36 PF 60).

9/23

All objective measures originally planned in the PACE Trial, which had no positive effects, were dropped. Only the six-minute walking distance, for which the authors saw a slight positive effect, was reported.

10/23

PACE was positively reviewed by a Cochrane Review. However, one of the trial's principal investigators admitted: "The Cochrane review does not count as disclosure to independent scientists as all three of the PACE principal investigators sat on the review panel."

11/23

Among many other conflicts of interest in the PACE team, of great concern is that principal investigator Peter White works as a consultant for various insurance companies and that the PACE trial was funded primarily by the UK Department for Work and Pensions.

12/23

The funding of the PACE Trial by the UK Department for Work and Pensions was ultimately a stroke of luck, because according to British law, trials that have been publicly funded must disclose all data. Therefore, patients requested the data for a reanalysis.

13/23

The PACE team refused to disclose the data and orchestrated a smear campaign through its lobby media center SMC that portrayed critics of the trial as militant activists who would flood PACE researchers and participants with death threats.

14/23

The Pace team went so far as to call the trial's critics "young men, borderline sociopathic or psychopathic." The aim of the defamation was to prevent disclosure of the trial data by claiming that they could be misused by the critics.

15/23

The disclosure of the PACE data went to court and the story of the threats was exposed as a lie. Principal investigator Trudy Chalder had to admit: "no threats have been made either to researcher or to participants". All study data had to be released.

16/23

The joy of the court victory against the PACE team was bitter. The patients who contested the disclosure of the study data paid for the effort with severe deteriorations. One of them passed away in 2018.

17/23

Disclosure of the PACE data opened the way for reanalysis with the original protocol, which showed that recovery rates were generally low and there were no statistically significant effects in favor of GET or CBT.

18/23

Thus, PACE Trial not only did not show that CBT and GET work. PACE has shown that they do not work. It is only thanks to the tireless efforts of patients that the hypocrisy of the PACE team has finally been exposed.

19/23

Patients have always known that activity does not help, but can rather cause serious harm. An analysis of patient surveys has shown that more than half of ME patients suffer harm from GET.

20/23

IQWiG prefers to rely on the discredited PACE team, which demonstrably manipulated the study and was exposed as liars in court, rather than on the voice of the patients, which has always been consistent with honest research.

21/23

If IQWiG's GET recommendation remains, it will have fatal consequences for 100'000s of patients, especially now, when the number of patients is rapidly increasing due to the pandemic. It will lead to countless mistreatment and, consequently, to severely disabled patients.

22/23

The discussion about GET is not an abstract debate. It is about the lives of patients - our friends, partners, siblings, children and parents - which are directly threatened by IQWiG's recommendation.

23/23

References 1/2

2/22 virology.ws/2018/09/18/tri…
3/22 acpjournals.org/doi/full/10.73…
4/22 qmul.ac.uk/wiph/media/the…
huisartsvink.files.wordpress.com/2018/09/6-get-…
5/22 qmul.ac.uk/wiph/media/the…
6/22 journals.sagepub.com/doi/full/10.11…
7-9/22 senseaboutscienceusa.org/pace-research-…
10/22 meassociation.org.uk/2015/10/trial-…

References 2/2
11/22 informationtribunal.gov.uk/DBFiles/Decisi…
12/22 me-pedia.org/wiki/PACE_tria…
14/22 me-pedia.org/wiki/PACE_tria…
me-pedia.org/wiki/Science_M…
15,16/22 informationtribunal.gov.uk/DBFiles/Decisi…
17/22 me-pedia.org/wiki/Alem_Matt…
me-pedia.org/wiki/Robert_Co…
18/22 pubmed.ncbi.nlm.nih.gov/29562932/
20/22 ncbi.nlm.nih.gov/pubmed/28847166

Original thread in German:

https://twitter.com/SGME_CH/status/1595497219901325314

#StopTheHarm
#flawedScience

#MyalgicE
#MEcfs
#LongCovid

#PACEgate
#PACEtrial
#IQWIG

#MEawarenesshour

@TomKindlon
@ME_Intl

Danke für die Metapher mit der Mottenkiste @eskabadu! Sie trifft genau, was wir fühlen.😡