Another Ball Drops in PACE Controversy: Cost-effectiveness Conclusions Faulty - Plus Update

Cort

Founder of Health Rising and Phoenix Rising
Staff member
Some past efforts to clear up the controversies around the now notorious PACE trials have requested that the authors release the raw data to researchers to be re-analyzed. Not so this time. In the latest ball to drop for the PACE studies, MEAction reported that five researchers including Ron Davis, two biostatisticians and an epidemiologist requested that the PLOS One Journal simply delete a finding they assert the papers own figures indicate is incorrect.

The paper in question is “Adaptive Pacing, Cognitive Behaviour Therapy, Graded Exercise, and Specialist Medical Care for Chronic Fatigue Syndrome: A Cost-Effectiveness Analysis.”

The finding is not a minor one. It asserts that the authors conclusion that the CBT/GET protocols used in the study were, from a societal perspective, cost/effective was incorrect. One of the main goals of the PACE Trial, was to demonstrate to the UK government and other funding bodies that they would get the most bang from their buck with ME/CFS by employing CBT/GET.

The PACE trial protocols called for sensitivity analyses that examined cost-effectiveness from a several scenario's including CBT/GET's ability to reduce the amount of home care provided by professional home care providers or by family members either paid a minimum wage or no wages.

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[/fright]The paper report that the societal benefits outweighed the costs of CBT/GET under any of these scenario's was inaccurate. CBT/GET was only determined to be cost-effective from a societal perspective if the authors treated family caregivers as if they being paid as if they were home care providers. Under the other scenario's it was not. It was another case of the authors stretching their findings beyond the breaking point.

As with other instances patient advocates played a major role in getting the word out about PACE trial problems.

Simon McGrath,Tom Kindlon and other ME/CFS advocates took the authors to task regarding a number of their conclusions. Using figures from one of the CBT/GET centers used in the trial Kindlon demonstrated that the PACE authors underestimated the cost of GET treatments by as much as 300% (if I'm reading it correctly). At that cost of treatment the CBT/GET doesn't begin to pay for the advantages it provides.

The Davis paper simply asks that the paper be changed to reflect what Davis and other believe the authors have already admitted; that only if you treat the value of family members time as if they were paid home care providers, do the conclusions make any sense.

PACE Controversy Update

The Lancet Study - Over ten studies have emanated from the PACE trial thus far. The first was published in The Lancet; one of the oldest and most prestigious medical journals in the world. In Nov. 2015 Ron Davis, Lenny Jason, Vincent Racaniello and others posted a open letter to Lancet asking that independent analyses of the PACE trial be redone using outside researchers.

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We therefore urge The Lancet to seek an independent re-analysis of the individual-level PACE trial data, with appropriate sensitivity analyses, from highly respected reviewers with extensive expertise in statistics and study design. The reviewers should be from outside the U.K. and outside the domains of psychiatry and psychological medicine. They should also be completely independent of, and have no conflicts of interests involving, the PACE investigators and the funders of the trial.
Horton replied that he was traveling and would get to the issue. Three months later after Horton had still not replied another letter went out with three dozen more signatories. It's now six months later and Horton has still not replied.

The PLOS Study - The complaints began soon after the present paper was published in 2012. In Dec. 2015 PLOS stated that it expected the study authors to share the study data, and that they were doing their own internal investigation using outside experts to help them evaluate the issues.

In March, 2016 PLOS stated they had determined which data they believed should be shared and had requested the authors share it.

University - Jennie Spotila reported that the University sponsoring the study refused, citing the privacy needs of the participants and "prejudice to the programme", to provide the raw study data (was it not anonymized?) to Vincent Racaniello and others. An appeal has been filed.

Conclusion

The PACE trial authors and the journals publishing their studies appear to be engaged in a waiting game in hopes the controversy will simply disappear over time. Until that happens they are ignoring requests or simply ignoring major issues.

David Tuller has tried and failed to have substantive, or in most cases, any conversations with the PACE trial authors. He and others have also contacted the journals the papers were been published in. When they do go on record - which is rare - Tuller reports they are evasive and provide misleading answers.

An investigative reporter of long standing Tuller has seen a lot, but even he seems taken aback by the unwillingness of the PACE authors or their publishers to address the legitimate issues that have been raised.

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They appeared to excel at avoiding hard questions, ignoring inconvenient facts, and misstating key details. I was surprised and perplexed that smart journal editors, public health officials, reporters and others accepted their replies without pointing out glaring methodological problems—such as the bizarre fact that the study’s outcome thresholds for improvement on its primary measures indicated worse health status than the entry criteria required to demonstrate serious disability.
Jenny Spotila reported that Racaniello has little faith in the journals doing the right thing:
“I think they are going to ignore, obfuscate, and give their usual responses until we are all dead. I don’t have hope that the PACE authors, or Lancet, will respond in any meaningful way until there is more of an outcry.” Vincent Racaniello
The battle is not over by an means, however. The key to getting Lancet and the other publishers to act is simply getting more researchers to join in the fray and keeping the pressure on.
 
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weyland

Well-Known Member
Jenny Spotila reported that Racaniello has little faith in the journals doing the right thing
I agree with Racaniello. I think PACE and the whole psychologizing of ME and CFS is one of those 'too big to fail' things. I want to hope that once a breakthrough is found that the biopsychosocial crap will become obsolete overnight, but we can see how they have glommed on to other organic diseases like MS and cancer.
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
I agree with Racaniello. I think PACE and the whole psychologizing of ME and CFS is one of those 'too big to fail' things. I want to hope that once a breakthrough is found that the biopsychosocial crap will become obsolete overnight, but we can see how they have glommed on to other organic diseases like MS and cancer.
You could very well be right; in fact, I don't know how else to explain the Journal's refusal to move given all the evidence they've been presented with. They have to be made to look so bad - to have such a stain on their reputation begin to appear - before, apparently, they will do something.
 

Justin

Active Member
I am just beside myself with this whole PACE situation. The IOM Report and the NIHs Francis Collins view along with 42 of the top physicians on the subject from major academic institutions and still they wont release data.....have they not seen how sick we can get?

This is the #1 Chronic Disease with low QOL Score and it affects many yet they continue to act in such a way.....

I have said it before it makes me sad to be part of the human race some days...
 

cfsStevew

Member
No - I think every UK based ME CFS advocate is not prepared to let this one lie. PACE must be exposed - it is a serious matter of justice. You cannot live in a world where things like this are allowed to happen.
 

Merida

Well-Known Member
Oh, love that letter sent to Lancet. Wow. PACE will not stand the test of time. I am overwhelmed with gratitude for Ron Davis and his colleagues.
 

eilidh

New Member
I have watched the struggles of ME advocates and people with ME trying to break through in the UK for the best part of 3 decades in that time we have done everything possible, we have funded research, demonstrated, critiqued research papers, lobbied parliament, written our stories, made films, appeared in newspaper articles, appealed to the medical journals. In our thousands we have had many relapses, lost lives worth living and some have died along the way, we have given our all and still its not enough.

I have come to the conclusion that the only solution to a break through is an advertising campaign funded by patients such as the one done for MS in the 1970s. This fight is not about science its about publicity and getting the public on our side and we still haven't managed to capture the publics imagination. We are still getting next to no coverage in the papers or media that matters and they have not rallied to our defence they just like constant controversy a good article one week and an appalling one the next. We are in the grip of a corrupt system where wrong doing is plain to see but there seems to be no higher authority able or willing to take action. Unlike the PACE researchers we do not get articles on multiple front pages of the mainstream newspapers or TV for minute pieces of research nor do we get articles that run for months in our defence. It is the PACE researchers who have set the bar so high for our side that it is an impossibility for us to attain the level of research they demand though their own is level is so abysmally weak that they have to manipulate any outcome at all. We already have more than enough to science to be taken seriously but the establishment just chooses not to acknowledge us. I think it may be that a large scale consistent and professional publicity campaign is the only way to force their hand but I'm not holding my breath on that.
 

Merida

Well-Known Member
@eilidh
I sure hear you. I have spent 18 years in this struggle here in Los Angeles. Took me years to even find a sympathetic doctor. But things are going to change. Ron Davis and colleagues can not be ignored. I feel hopeful for the first time.
 

weyland

Well-Known Member
We already have more than enough to science to be taken seriously but the establishment just chooses not to acknowledge us.
This cannot be overstated. Where is the threshold we have to cross where we have reached enough evidence to be taken seriously? Is it going to take 10 more positive studies? 100? Who gets to decide? Why is the combined clinical experience of dozens of doctors over 8 decades not enough?
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
I am just beside myself with this whole PACE situation. The IOM Report and the NIHs Francis Collins view along with 42 of the top physicians on the subject from major academic institutions and still they wont release data.....have they not seen how sick we can get?

This is the #1 Chronic Disease with low QOL Score and it affects many yet they continue to act in such a way.....

I have said it before it makes me sad to be part of the human race some days...
It is fricking hard to understand that's for sure.
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
Now the UK is funding a children's internet CBT/GET study to the tune of 1 million pounds...wow...

http://www.nets.nihr.ac.uk/projects/hta/14192109

£ 994,430.00

AIMS: This is a large trial to test whether FITNET-NHS, a treatment delivered via the internet, is effective and value for money for children with Chronic Fatigue Syndrome or myalgic encephalomyelitis (CFS/ME). Children with CFS/ME have fatigue that stops them going to school or doing other activities for more than 3 months. In England, up to 2 in a 100 children have CFS/ME and 1% of secondary school children miss a day a week or more because of it. Most children with CFS/ME will recover if they receive specialist treatment. (??)

Specialist treatment recommended by the National Institute of health and Clinical Excellence (NICE) includes Cognitive Behaviour Therapy (CBT), Graded Exercise Therapy or Activity Management. However, approximately 90% of children in the UK cannot have treatment because they live too far away from specialist services. For these children, probably only 8% will recover at 6 months.

One solution is for these children to receive specialist CBT for CFS/ME using the internet at home. FITNET-NHS provides internet based CBT for CFS/ME and has been shown to be effective in the Netherlands with 63% of children recovering at 6 months. We cannot use this treatment in the NHS until we know if children find it acceptable, and we know if it is effective and good value for money. We also need to know if FITNET-NHS will work in children with both CFS/ME and mood problems (one third of children with CFS/ME).

In this large trial, children will be randomised to receive either: Activity Management or FITNET-NHS. Those who get Activity Management will receive information on managing activities and sleep. They will have three Skype calls (one assessment and two follow up) with CFS specialist occupational therapist (OT)s to understand and provide advice on sleep and activity. The specialist OT will hand over care to the local GP or paediatrician but will provide support to them with up to three phone calls. Those who get FITNET-NHS (and their parents) will be given information and then work through 21 interactive CBT modules. Children will be asked to do homework (answer questions and complete diaries). CBT-trained therapists will make weekly appointments with children and their parents to review homework and support behaviour change.

We want to recruit 734 children over 42 months to have results on 660 (330 in each arm). We will test whether it is possible to recruit this number in our internal pilot study (12 months). We will interview children, their parents and clinicians and use the results to make changes to the trial. The most important outcome to children is disability. We will test whether FITNET-NHS is effective at reducing disability at 6 months. We will also measure fatigue, pain, quality of life, anxiety and depression at 3, 6, 9 and 12 months as well as information on how much the NHS and families spend on treatment and whether parents return to work.

Both Patients and the Public (healthy teenagers) have helped us design this study. Patient involvement is important to us and this trial will have a patient advisory group to help us run the trial. It will be important that patients, clinicians, those that fund health care and researchers know about the results of this study. We will use the charities and the press (Science Media Centre) to help us inform patients. We will make sure paediatricians and researchers know the results by writing papers and presenting at clinical and scientific meetings and conferences.
 

weyland

Well-Known Member
Now the UK is funding a children's internet CBT/GET study to the tune of 1 million pounds...wow...
Esther Crawley sure is a busy girl isn't she? I assume this is in addition to the MAGENTA trial she has waiting for recruitment. She's just raking in the dough for Bristol U.

No mention of criteria being used to select patients. No mention of objective outcome measures of activity. No acknowledgement that previous FITNET research showed no difference at long term follow up compared to usual care. What an utter waste of money. At least the results won't be published until 2022, hopefully we'll have objective biomedical proof that activity is damaging in ME long before then so they look like fools.
 

Justin

Active Member
Now the UK is funding a children's internet CBT/GET study to the tune of 1 million pounds...wow...
I read about this its just 1 million pounds down the drain....I dont know why they so desperately want to keep us sick and limited.....especially kids instead of helping them find a cure....

The criteria used is not ME and could include a bunch burnt out kids from smoking to much weed, depressed kids, etc.
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
Esther Crawley sure is a busy girl isn't she? I assume this is in addition to the MAGENTA trial she has waiting for recruitment. She's just raking in the dough for Bristol U.

No mention of criteria being used to select patients. No mention of objective outcome measures of activity. No acknowledgement that previous FITNET research showed no difference at long term follow up compared to usual care. What an utter waste of money. At least the results won't be published until 2022, hopefully we'll have objective biomedical proof that activity is damaging in ME long before then so they look like fools.
Finally a silver lining! Thanks for that Weyland :joyful:
 

eilidh

New Member
@eilidh
I sure hear you. I have spent 18 years in this struggle here in Los Angeles. Took me years to even find a sympathetic doctor. But things are going to change. Ron Davis and colleagues can not be ignored. I feel hopeful for the first time.
Thank you, and I would just like to add that I have not forgotten and am so grateful to all the researchers who are challenging the PACE trial data and David Tuller and all of those professionals and scientists who are putting themselves on the front line to try and turn round this awful injustice. Their efforts are keeping hope alive.
 
E

EYAKLLE

Guest
it's a retrovirus
it s OVER for these bad people
OVER
tick tock
 

Who Me?

Well-Known Member
What does a retrovirus have to do with PACE. You are highjacking threads to push your theory which you have zero evidence of except that it helped you.

And stop with the capital letters. I don't need you yelling at me and it kills my brain.
 

Who Me?

Well-Known Member
No one knows what CFS is. Personally I doubt that it is a retrovirus.
Even if it is "a" cause, there is currently no one that I know of studying it.

I have no problem with someone taking it and having positive results. But I know people who got no benefit from. Like those who took Valcyte. If never helped me but it helped plenty others.

One thing we know is that we don't know what causes it mecfs.

And this is a thread about PACE trials not for people to backhand their agendas down others throats
 
E

EYAKLLE

Guest
everything is linked.
It's just a big mess.
Many many ways to make work the appropriate meds with experts on the case
 

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