Host: Vincent Racaniello
Guest: David Tuller
Vincent speaks with David Tuller about flaws in the U.K’s $8 million PACE trial for chronic fatigue syndrome, and efforts to have the trial data released.
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Links for this episode
- Science and journalism (TWiV 111)
- Chronic fatigue syndrome and the CDC (virology blog)
- PACE trial (Lancet)
- Trial by error part one, two, three (virology blog)
- PACE economics analysis (PLoS One)
- All articles by David Tuller at virology blog
- Valerie Eliot Smith’s blog
- Karina Hansen, prisioner of Denmark
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Thank you, Vincent and David, for all that you continue to do for our community. I’m going to listen to this right now!
The failure of UK institutions to deal effectively with PACE have been shameful.
May I ask whether Dr. Richard Horton, the editor of The Lancet, intends to publish the letter that I understand he invited in response (after months of delay) to your joint open letter on Virology Blog, that was signed by 42 scientists?
Thank you so much, David and Vincent.
One error that I’m not sure you mentioned (yes, there are more) — but maybe you’ve since debunked it.
One of the original authors of what’s known as the London diagnostic criteria (1994) states that the PACE study authors did not actually use her criteria, but an unapproved version that was re-worked to give basic knowledge of the criteria to the public. She asks that they not say that they’ve used her criteria to diagnose ME, and state that there are likely many in the trial who don’t have ME.
A mess all around.
Thank you both, so very much, for taking an interest in this issue. Isn’t it remarkable that all of this can go on… and on… with so little outrage and indignation from the general public: It’s just about those tired people, I’m fatigued too. This would be a scandal were it any other illness. But it’s just ME and nobody cares about ME.
Thank you so much for caring about and talking about ME! Vexatious since 1979.
Thank you ao much drs Racaniello and Tuller for your continued work on the issue.
I note that this was recorded in early June and now being the 10th of July, we still have no tribunal decision regarding the pace trial which could easily be quoted as extraordinary.
As a M.E. patient from Canada, I can assure you that the PACE trial is still very much alive, that patients are still suffering greatly from the stigma in health care and in society and physicians can still find out in one click that the evidence-based treatment for ME and CFS are CBT and GET. The core of psych lobby are still writing reviews and meta-analysis centered on these treatment modalities and there is plans for a clinical trial for CBT and GET on children with ME in the UK (MAGENTA trial)
So essentially, it is still business as usual.
Moreover this week Dr Maureen Hanson from Cornell University published a paper on the microbiome abnormalities of patients with ME for which she said it proved that it was not a psychological illness, and one media source titled the article ‘CFS is not a PHYSIOLOGICAL illness’
Science auto-corrects, yes. But the psychiatric lobby will do everything in their power to delay it as much as possible. What is at stakes? Ego, careers, and a whole lot of money.
I gave a copy of Forgotten Plague to my GP and he wasn’t interested b/c of the CDC’s citation to PACE. He said “yeah, I’m not going to go that far” (and watch a documentary about sleepy people)
I need to amend my above comment: my doctor wasn’t going to watch a documentary about sleepy people – who THINK they are sick. Go exercise, eat better, lose some weight and stop thinking about being sick.
Thanks so much for this, and particularly to David Tuller for all of his work. I’m sure it was a bit nerve-racking discussing this in a podcast when there are so many troubling details that need to be remembered and described accurately. The PACE trial is such a mess that it can be quite confusing to criticise properly!
I thought I would add in some extra links that could be of interest.
The details of the FOI request for annonymised PACE data which QMUL and the PACE researchers appealed against is available here: https://www.whatdotheyknow.com/request/selected_data_on_pace_trial_part
QMUL have spent £200,000 on external legal services for just their tribunal appeal against the ruling that this data should be released: https://s31.postimg.org/5uxymhlwb/QMUL.jpg
A copy of the response to Prof Coyne’s request for PACE data is available here: https://dl.dropboxusercontent.com/u/23608059/PACE%20F325-15%20-%20Prof.%20James%20Coyne%20-%20Response-2.pdf
An article focusing on problems with the statistics of the PACE trial from Sense About Statistics: http://www.stats.org/pace-research-sparked-patient-rebellion-challenged-medicine/
A report which examines how misleading medical research has influenced cuts to disability benefits in the UK, and uses the PACE trial as a key example: http://www.centreforwelfarereform.org/library/by-date/in-the-expectation-of-recovery.html
As an example of the evasive way criticisms of the PACE trial is responded to the President of the Royal College of Psychiatrist, Prof Sir Simon Wessely’s attempt to defend of the PACE trial is available here. It largely ignores the issues raised in this podcast in and in the linked to critiques: http://www.nationalelfservice.net/other-health-conditions/chronic-fatigue-syndrome/the-pace-trial-for-chronic-fatigue-syndrome-choppy-seas-but-a-prosperous-voyage/
I’ve seen the same pattern, I had the same shock, indignation, horror. Peter Gubson did the original research on non-celiac gluten sensitivity. Then a few years later he published ‘no non-celiac gluten sensitivity’ and it makes headlines everywhere that gluten intolerance is just made up. Scientists argue in the letters and he makes non sensical replies, builds a whole unit at Monash university. The research continues and it does exist but the publicity from his study had a lasting effect. My email outlining the flaws in his study (EG excluding those with an immune reaction even though NCGS is likely immune) was bounced back that he was travelling, and I never got a response. The kicker? GEORGE WESTON bread company funded his study, around the same time they were in the newspaper announcing their plans to expand their market share and become #1. Yeaaaaah.
If most people with ME are in bed for weeks/ months at a time from the start the deconditioning argument would make more sense. However most pwME are mild to moderate and even a lot of severe ME (eg Whitney Dafoe ) didn’t start as severe. So people whilst they might spend the odd few days in bed are not generally profoundly cutting back normal activity , I started off, after my severe viral trigger, at 70% function with a couple of days in bed a month and other odd days slouching around the house . That doesn’t cause severe deconditioning enough to possibly explain the multiple sickness symptoms including sore throats, night sweats, muscle pain & major exertional crash.
Excellent. It’s very reassuring to know that you guys remain on the case. Thank you.
Hi Vincent, thank you for the pod cast, Thank you to David Tuller too! It was an eye opener for me, I now know that I am not the only one out there having real problems getting people to take me seriously about my condition. I have had ME for 18 months now and it has had an enormous impact on my life. I am hanging on to my home and my employment without any support from the benefits system as I fall through the net so to speak every time I try and claim. I lived in America for nearly two years and got medical treatment for another condition successfully when all else failed in the UK. Its true across the board that the British take forever to answer e mails and are sloppy in medical decisions and research. Anyway, thanks again for the informative pod cast. you have a great day. Nathaniel Moneypenny 🙂
Can I get a transcript of this?
Thank you for this interview. I now have a much greater understanding of the harmful systemic issues that have flowed globally to the detriment of ME patients.
As a relative newcomer to being an ME patient, this interview with Dr. David Tuller has given me much greater context to our challenges in stopping the harm perpetuated by institutional biases and agendas.
Exposing the “cult of CBT and GET” is gaining momentum biological evidence continues to mount and your work is making a significant contribution – that’s why I’ve become a monthly Patron – its an investment in my health.
Thank you so much for all your hard work on this! As a ME/CFS patient who heard from Kaiser Permandente that they only treatment available to me was Physical Therapy and Anti-depressive medication this issue is close to my heart. I’m not depressed. Sometimes I’m shocked that I’m not since I’ve hit so many road blocks, but I’m hanging on to my hope. And my hope is kept alive because there are people, like yourselves, who are fighting these crazy notions that I somehow WANT to be bed-bound. I tried some yoga therapy and I keep trying to move as much as I can… But I’ve had to be super careful because I’ve made myself crash over and over again. The fact that you are getting the word out there that this can be harmful is so so so important! I can’t thank you enough! Thank you for your passion and please don’t give up!
Thank you both for your efforts on the behalf of all of us who are living with CFS/ME. I do have one question for you both. When I go to any credible site, the Mayo Clinic being one, I am still seeing graded exercise and CBT listed as treatments for CFS/ME. In your discussion you talk about leading researchers and doctors here in the US as signatories to your letter to THE LANCET. Has anyone approached the Mayo Clinic, the CDC, the NIH, (the list goes on and on) with your findings, with what has been discussed in your article and in this program?
It is next to impossible to find a doctor familiar enough with CFS/ME to understand what we patients go through. If one is lucky enough to find a Primary Care Provider who is willing to listen and to learn, once they go to the “reputable” sites, what they find is treatment suggestions that, as you so wisely state, only make us worse.
I have written to the Mayo Clinic. The response I got was that they would change what they’ve posted once new data is available. I don’t understand why it isn’t enough for them to know that the data they have is invalid and, even more importantly, not even from research conducted in the US according to US guidelines.
Many of us living with CFS/ME have given up on health care providers, not just in the US, UK and Canada but worldwide. We learn from others in our support groups and from efforts from people like Tom Kinnelon who provide access to research which may or may not work for us. If I may, I would like to suggest that your article, your letters with signatories to THE LANCET and this program be sent to all those who presume to provide guidance to patients living with or recently diagnosed with CFS/ME, if you have not already done so.
Once again, thank you both for your efforts on our behalf. After 14 years of living with this disease it is wonderful to know there are people like you advocating on our behalf.
First. Thank you. Both of you. You really provide a lot of people with hope.
Second. Love the podcast. It’s awesome.
Drs. Tuller and Racaniello,
Thank you from the bottom of my heart for being on our side year after year and making the powers that be accountable. You were spot on when you emphasized that this is about someone’s entire life, not just some whiny first-world problem. I myself have been ill for 22 years and am in pain every single day. I would much, much rather work and be a contributing member of society.
Thank you, thank you, THANK YOU David Tuller and Vincent Racaniello!!! Cannot thank you enough. I’ve had ME/CFS for 18 years, was extremely active before then and would give anything to have my life back and I cannot tell you how happy I am to have advocates like you in our corner! to do our fighting that we don’t have the energy to do – thank you again !!!!! : )
As someone who was harmed by Graded Exercise Therapy I cannot adequately express my gratitude to David Tuller for bringing The PACE Trial issues to the public’s attention. I am bowled over by his dedication and perseverance in detailing the numerous problems in this egregious piece of flawed science that has done a great deal of damage to so many of us. Thank you to Mr. Racaniello for your interest in this as well. I deeply appreciate both of you and your efforts on behalf of ME/CFS patients everywhere.
Thank you David and Vincent. Here in Ireland the PACE tentacles are firmly entrenched. Our Health Service Guidelines for M.E. robustly recommend CBT and GET as per the NICE guidelines. The default referral when diagnosed with this illness is to psychiatry. My healthy, happy, sporty, vibrant young son caught a virus at the age of 12 and never recovered. He’s 16 now. Through my own research efforts and resources and with the help of the M.E. Community, I’ve managed to identify that he has chronic immune activation, low NK cells, reactivation of at least five once dormant viruses in his system. Etc etc. No wonder he hasn’t gotten better. None of these tests are approved for his condition and that’s all down to the stranglehold of psychiatry and the false illness beliefs that they peddle. Shame on them all. Thank you again. One day soon I hope there will be a party to end all parties within the community when these shysters are finally taken down. You both, of course, have a gold edged invitation 🙂
Thank you guys so much. I’m glad you are as pissed off about this as we are David. It’s unbelievable and what’s worse is the reach its had and the guidelines that haven’t questioned it! It’s over here in NZ as guidelines and GET and CBT dished out accordingly. It’s a total screw up as you say. I admire your guts . I’m kinda in battle with my local hospital , what they’ve decided to do is get a doctor to a literature review and a talk at grand rounds , then I can speak as a family member. It’ll b interesting . I’ll probably end up giving a talk on the shortcomings of the guys talk, or be showing them Alan lights data, I doubt v much that they’d stay awake if I just whined as a family member ( actually I have it too – my compliant to them is about my partner who gets dismissed because he’s too ill) . Keep up the good work. You have kept my head up high. Thank you
It just got even worse I’m afraid: First, the GMC imposes limits on Dr Nigel Speight’s license, a (much-loved) paediatrician in the UK who has been involved in many cases throughout Europe where children with ME/CFS are being threatened with removal from their families by the social services. Soon after that, we hear that the Bristol group publish a protocol for the study of Graded Exercise Therapy in children and young people with ME/CFS.
This will be a non-blinded study with self-reported outcomes … IN CHILDREN … who can be so easily coerced.
Dr. Esther Crawley is part of this study. She is involved with AYME which is the only ME/CFS charity in the UK which did not ask for the release the anonymised PACE trial data.
This is such a tragedy.
Thank you David and Vincent for all you are doing to ensure the glaring errors of the PACE trial come to light.
Bravo! I will always appreciate you work on this story!
I look forward to the day when Dr Tuller’s work becomes the foundation for a class action lawsuit against the disability insurers, the Wessely School, and the agencies that have conspired to bury the illness.
There is evidence, on official letterhead, that CDC and NIH intended to re-define the illness out of existence. The letter can be viewed here:
The Gibson Inquiry  called for an investigation of various conflicts of interest TEN YEARS ago:
“CFS/ME is defined as a psychosocial illness by the Department for Work and Pensions (DWP) and medical insurance companies. Therefore claimants are not entitled to the higher level of benefit payments. We recognise that if CFS/ME remains as one illness and/or both remain defined as psychosocial then it would be in the financial interest of both the DWP and the medical insurance companies.”
“[There are] numerous cases where advisors to the DWP have also had consultancy roles in medical insurance companies. Particularly the Company UNUMProvident. Given the vested interest private medical insurance companies have in ensuring CFS/ME remain classified as a psychosocial illness there is blatant conflict of interest here.”
Until the insurers’ grip on policy is smashed, nothing will change for us. All the brilliant research being done by Davis, Lipkin, etc. will end up on the same dusty shelf as the IOM report and the P2P Report unless the people responsible for the policy non-research and non-treatment are exposed and held to account in a court of law,
I think you may underestimate how common this junk science problem associated with regulatory issues (who pays for what treatments in this case) actually is. It is really common in the areas where regulators and their agencies benefit by sloppy and false science and the costs (often hundreds of millions to billions) just get spread over the whole population.
Environmental regulation is rife with junk science, where the regulators reached an organizational beneficial conclusion then produced the science prove the case to the lawyers and judges and justify their regulations. Their science often only has inside review and they seldom publish their results.
If anyone objects and goes to court to fight false science or stirs up a problem, it is easy to get blacklisted so you can’t get anything through that agency and if you are a consultant, any clients.
In my last EPA contract decades ago, they had made an expensive rule for power plants flue gas cleaning sludges (which pass the cost onto the power consumers: everyone), but they forgot to do the study to scientifically justify the rule. I was the PI on the contract to do that study. They did do a 3 million dollars in research relevant to their desired solution through the Army Corps of Engineers. However, when I got into the ACE study, I found I could reproduce their results by only considering the details of their sampling methods and forgetting about the actual samples. Pure false science, but they followed their protocols, which happened to exclude consideration of the fact that the samples were outside and not protected from the rain and they used different sampling details on different samples at different times. The EPA didn’t even consider the fact that this material (CaSO3) reacts with oxygen in the water to become CaSO4, removing O2 from the water. The oxygen demand in even a small temporary storage pond could remove all the oxygen and kill every aerobic life form in the Mississippi river.
When I submitted the study that didn’t back up their conclusions, their in-house bureaucrats objected, but couldn’t prove me wrong and I was even PC enough to not even mention the ACE study with the wasted 3 million dollars. The EPA Contract officer went crazy (he was a scientist, the in-house reviewers were bureaucrats) when they refused to publish the results and got it published by another agency.
I never won any more EPA contracts or research jobs and moved into non-government work and my own business.
Fight junk science all the way, it is part of how science evolves.
Very interesting clarification! Thank you for your sensible, scientific approach from you both. Really appreciate your clearing up the issue of the PACE debacle.
Thank you so much, both of you.
David, hearing your moments of being lost for words out of complete astoundment and frustration was like a B12 IV, particularly on one of the days where I’m so fed up with life with this illness that I would be rather happy for my own end. So thank you. Thank you. It means so much.
Thank you Prof Ranciello and Dr Tuller for your perseverance and tenacity in exposing the PACE scandal.
Many in the medical communities will not be accustomed to and find it hard to believe the level of egregious practices that these PACE trial investigators have gone to as it is unprecedented that licenced medical psychiatrists could have done such things especially with all the checks and balances that should be in place.
As you say good scientists always correct themselves without being asked to so. Science is self correcting in the long run however as we all know we may all be dead in the long run.
This must therefore force us to examine why this PACE case is special. This must be due to the elephant in the room which is …..
I.E. The financial interests that the PACE PIs have.
The scientific community probably needs to see and treat this as an example of tobacco science and it will require further sustained pressure.
The article by Prof Hooper explains the link between these PACE investigators and the Science Media Centre which they have used successfully in the past to prevent science operating properly by promulgating misinformation in the UK media and smearing any critics of the PACE trial.
Your insurance article helpfully explains to understand why this stonewalling is occurring. This needs to be read by everyone in the scientific community.
Thank you for pursuing this matter and justice will prevail to prevent further needless harm to people with ME by the PACE trial and its authors.
I developed a method of treating my own chronic fatigue with an exercise regime between 1976 and 1982 when Tony Sedgwick, the head of the South Australian Institute for Fitness Research and Training put me in charge of designing and co-ordinating a program for other patients.
It was reported as a world first study in 1982, and the success was reported in newspapers throughout Australia in 1983.
I then left the program to solve other problems, with the expectation that if peer review studies recognised the value of the method and it came to be used as a treatment that it would be referred to as my method and I would be paid royalties.
Four years later, in 1987, Simon Wessely of London claims that he started similar research.
A year later, in 1988, the US CDC added the chronic fatigue syndrome to its official list of diseases and a new era of research began.
In 2008 I mentioned my research in Wikipedia, but other editors said I was not qualified and that I only played a minor role in one small study which had no influence on anyone, and they hounded and harassed me relentlessly for a year until eventually banning me with their “ignore all rules” policy.
During that time I found that my methods was described in other pages of Wikipedia with a list of a dozen references below, but no mention of my study.
I therefore wrote a more detailed account of my method on my own website to show it was superior.
About six months later Peter White (Simon Wessely’s colleague) started his five million dollar, five year pace trial.
In 2012? I found that Simon Wessely was awarded the Simon Maddox Prize for his research into chronic fatigue syndrome and exercise, and then the Pace trial results were released.
When I said that I developed that method other people criticised me for the fact that the pace trial was full of false information, but that is not my fault.
They haven’t copied me properly.
If I was to describe all the errors in their method I would expect someone else to do another study and take all the credit, and not mention my name or pay me a cent.
At age 25 my pulse rate at rest was 102bmp. I am now 67, and my pulse rate is 72bpm, and I have complete control of all symptoms
Good article many thanks
Unbelievable pace bullshit — u cud not make it up £5 million wasted and lied about !!!