700,000 GB Pounds extra given by the (UK) Medical Research Council to the PACE Trial

[Dolphin]

(This is just a copy of a Co-Cure post (I corrected a few typos))

[5,000,000 GB pounds = 7,627,791.38 US dollars = 5,537,638.53 EURO; 4,000,000.00 GB pounds = 4,430,118.61 EURO = 6,102,208.33 US dollars]

I don't believe it has been widely highlighted that an extra 702,975 was granted by the UK Medical Research Council (MRC) to the PACE Trial in the last two years.


It is unclear to me what the final cost of the trial is but it seems to be safe to say it is over 4m and may be approaching 5m as there may be extra NHS costs as well.


Back in 2004, in a piece for the Edinburgh MESH Spring 2004 newsletter, Michael Sharpe (one of the principal investigators) said: "The trial will cost nearly four million pounds."
There was no knowledge at that time it would need an extension.


I am appending some information on the cost issue. Don't forget that there are four governmental bodies funding the trial: the Medical Research Council (MRC), the Department of Health (DH), the Department for Work and Pensions (DWP) and the Scottish Chief Scientists' Office (CSO).


I'm not sure I have ever seen how much the Department of Work and Pensions (DWP) is contributing. It is highly unusual that they are giving money at all.


The article,:
"MAGICAL MEDICINE: HOW TO MAKE A DISEASE DISAPPEAR Background to, consideration of, and quotations from the Manuals for the Medical Research Councils PACE Trial of behavioural interventions for Chronic Fatigue Syndrome / Myalgic Encephalomyelitis, together with evidence that such interventions are unlikely to be effective and may even be contra‐indicated"http://meactionuk.org.uk/magical-medicine.htm has plenty of other information on the PACE Trial.


Tom


http://meactionuk.org.uk/magical-medicine.htm

The cost of the PACE Trial (and cost‐effectiveness)

It is now known that additional funding was granted by the MRC but the cost of the PACE trial to the MRC was originally stated as being 1,921,883.00 and the cost to the NHS as being 1,179,909.00, an initial total of 3,101,792.00 (this figure may exclude the usual 40% add‐on which is awarded with Class I grants moreover, it is known that this figure has increased substantially.

As noted in Section I above, the cost of the PACE Trial is said by Professor Sharpe to have risen to about 4 million :Co‐CureACT:RES:22ndOctober2008), a cost that many people regard as scandalous.

The MRC component consisted of research staff costs (1,097,266.00); Overheads(504,742.00); Equipment, including Actiwatch Plus activity sensors (the use of which was abandoned because Peter White deemed it to oonerous for participants to wear one strapped round an ankle at the end of the trial, but many people believe it was because there would be no objective evidence of improvement shown by the Actiwatch sensors, a finding that would be inconvenient to the Investigators, therefore no objective data were to be collected), computers and software, heart rate monitors, stop watches, 18 audio machines and 3,150 audiotapes (36,360.00); Staff Travel (64,880.00), and Consumables, (218,635.00); this figure includes Action for MEs consultancy costs of 4,312.00. The NHS component consisted of the cost of therapists.

When recruitment to the trial proved to be such a problem, an additional amount of 702,975.00 was granted by the MRC (MRC PACE Trial extension 2009‐2010).

http://www.mrc.ac.uk/ResearchPortfolio/Grant/Record.htm?GrantRef=G0200434&CaseId=1429

The PACE trial; A RCT of CBT, graded exercise, adaptive pacing and usual medical care for the chronic fatigue syndrome

Reference: G0200434

Grant Category: Grant

Status: Live

Start date: 14 Jun 2004

End Date: 13 Sep 2010

Overall value: 2,779,295

Board Portfolio: Late Phase Trials

http://www.pacetrial.org/docs/participantsnewsletter3.pdf

Medical Research Council grants further funds

The Medical Research Council (MRC)
has granted the PACE trial team further
funding to allow the study to continue
recruiting until the end of November 2008. This will allow the team to achieve the aim set out in the protocol of recruiting 600 participants. The ethics committee has also agreed to allow the team to recruit over the 600 mark if possible by this end date.

The trigger to increase time to the trial came when it was noticed that recruitment had begun to slow down. This came about for a number of reasons. One of these was the establishment of the CFS Clinical Network Coordinating Centres
(CNCC) which has allowed greater local
access to services for CFS/ME to participants in England. This has allowed people to seek services closer to home where previously they may have had to travel to a secondary care centre such as those hospitals participating in the PACE trial.

Another possible cause of slowed recruitment may have been as a consequence of the release of the NICE guidelines for CFS/ME. The document detailed the review of previous research for treatments for CFS/ME. This has allowed people to make more informed choices about what treatments they may wish to try based on the available research evidence.
The PACE trial retains a significant role as the largest trial ever for comparison of rehabilitative therapies for CFS/ME and the results will add important new information to the pool of previous studies.

As well as increasing time and funding to PACE, we also increased the number of our centres. As announced in the last newsletter a sixth hospital was invited to join the PACE trial and Bristol Frenchay have been successfully recruiting since April of 2007. We are very excited to able to welcome staff and participants from the South West to take part.

With all of these extensions, the PACE trial is now well on course to achieve the target of 600 participants by the end of November 2008, and the ethics committee have also granted us permission to recruit more by this date if we can.

SCOTTISH PARLIAMENT - WRITTEN ANSWER

2 December 2005

Health Department

Janis Hughes (Glasgow Rutherglen) (Lab): To ask the Scottish Executive what funding it has awarded for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) services or research since the CFS/ME short-life working group reported in 2002.

(S2W-20924)
Lewis Macdonald:

NHS Boards are given unified budgets, increased by an average of 7.6% in the current financial year, from which they are expected to meet the costs of services for people with CFS/ME and all other chronic conditions. It is for NHS Boards to decide how their unified budgets should be distributed, based on their assessments of local needs.

The Chief Scientist Office (CSO), within the Scottish Executive Health Department, has responsibility for encouraging and supporting research into health and health care needs in Scotland. CSO is currently contributing 250,000 to the Medical Research Council project 'Pacing, Activity and Cognitive behaviour therapy: a randomised Evaluation (PACE)' which compares different approaches to the clinical management of patients with CFS/ME.


SCOTTISH EXECUTIVE

=========
Costs to the NHS (from early in the 2000s) These were listed in a document posted on the internet called the PACE Trial Identifier
http://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind0404B&L=CO-CURE&P=R3461&I=-3

as

"Costs to the NHS: 1,179,909
Costs of therapists: We have approached our NHS providers for these costs.
We need 7 WTE therapists in the 6 centres: 2.5 WTE of CBT, 2 WTE physiotherapists, and 2.5 WTE OTs. Considering different costs in and out of London, this amounts to 241,424 p.a. over 4.5 years (including 6 months training), a total of 1,086,359. Service costs amount to 93,550. Total:
1,179,909."

 

[Kati]

It is unbelieveable that the UK government injects this much money into a project that is not going to change anything in people's life- what a waste of money!

 

[Dolphin]

It is unbelieveable that the UK government injects this much money into a project that is not going to change anything in people's life- what a waste of money!

I agree.
But it would have been sold to them by Peter White and co that people can just exercise themselves better, they just have maladaptive beliefs and/or are unfit.

 

[Min]

This is a scandalous waste of taxpayers money - 'research' into patients with vaguely defined fatigue, studying psychological interventions - done by the very people who developed and financially benefit from those very interventions. The biased result is a foregone conclusion.

Let's not forget the FINE trial - run by a psychologist specialising in hypochondria, and supposedly 'researching' the severely affected - all of whom can use a computer or the telephone. Yeah right.

If this money had gone into biomedical research of patients with neurological M.E. there might have been a breakthrough.

 

[fingers2022]

This is a scandalous waste of taxpayers money - 'research' into patients with vaguely defined fatigue, studying psychological interventions - done by the very people who developed and financially benefit from those very interventions. The biased result is a foregone conclusion.

Let's not forget the FINE trial - run by a psychologist specialising in hypochondria, and supposedly 'researching' the severely affected - all of whom can use a computer or the telephone. Yeah right.

If this money had gone into biomedical research of patients with neurological M.E. there might have been a breakthrough.

When it's all over we can have some war crimes trials. I can't wait.

Anyone seen a response to Malcolm Hoopers missive yet? Or is that too much to expect?

 

[biophile]

Dolphin posted: I don't believe it has been widely highlighted that an extra 702,975 was granted by the UK Medical Research Council (MRC) to the PACE Trial in the last two years. It is unclear to me what the final cost of the trial is but it seems to be safe to say it is over 4m and may be approaching 5m as there may be extra NHS costs as well.

Horton of the Lancet is now claiming these were for legal fees etc due to criticism: "And indeed the study costs $4 million pounds to undertake but the allegations and the freedom of information requests and the legal fees that have been wrapped up over the years because of these vexatious claims has added another 750,000 pounds of taxpayers' money to the conduct of this study."

http://www.abc.net.au/rn/healthreport/stories/2011/3192571.htm#transcript

 

[Enid]

Bet they are all trying to cover up now. Seems to be much ducking and diving and changing of positions as research findings reveal real ME.

 

[Dolphin]

Horton of the Lancet is now claiming these were for legal fees etc due to criticism: "And indeed the study costs $4 million pounds to undertake but the allegations and the freedom of information requests and the legal fees that have been wrapped up over the years because of these vexatious claims has added another 750,000 pounds of taxpayers' money to the conduct of this study."

http://www.abc.net.au/rn/healthreport/stories/2011/3192571.htm#transcript

I think that is most likely other money (or else money from the total pot for the trial). It was announced the extra money was to help recruitment (too tired/busy to look up links). But it was very interesting to hear the figure of 750,000 pounds of legal fees being mentioned. The other possibility I had was that this was actually money NICE spent on the court challenge and that has been mentioned to Richard Horton at some stage as a waste of taxpayers' money that ME patients/activists have caused!? Or perhaps NICE and other stuff!?? It would be interesting to find out more.

 

[SilverbladeTE]

It's like funding "Phrenology", hell once upon a time, classifying people by the bumps on their head WAS "science" according to the same kind of pinheaded, stupid, arrogant SOBs!

 

[Snow Leopard]

If they wanted to save taxpayers money, they could have just relied on the study by the Belgian government. It is pretty disingenuous to blame those who have legitimate legal complaints and criticisms as 'costing taxpayer money'.

 

[Sean]

Poor and unreliable results from PACE are going to cost the taxpayer a damn sight more.

 

[justinreilly]

Horton of the Lancet is now claiming these were for legal fees etc due to criticism: "And indeed the study costs $4 million pounds to undertake but the allegations and the freedom of information requests and the legal fees that have been wrapped up over the years because of these vexatious claims has added another 750,000 pounds of taxpayers' money to the conduct of this study."

http://www.abc.net.au/rn/healthreport/stories/2011/3192571.htm#transcript

That's outrageous of him to say that! Vexatious claims are frivolous claims considered unethical to litigate. What a jerk!

 

[justinreilly]

18 audio machines and 3,150 audiotapes

are "audio machines" cassette players? i didn't know they even made audiotapes and cassette players anymore. They could have gone to some yard sales and saved thousands of pounds.

 

[justinreilly]

Norman Swan: So tell me about the reaction.

Richard Horton: Well we have been deluged with dozens of letters raising serious objections to the conduct and interpretation of the study, most recently a 43-page diatribe calling for the paper to be retracted based upon the fact that it is entirely invalid and unethical.

Norman Swan: What's the nature of the criticism?

Richard Horton: Pretty much every aspect of the study you can think of is being impugned. First of all the population is biased, it's dealing with a predominately young, healthy population, whereas the chronic fatigue syndrome, ME, population our critics claim contains a substantial number of people who are bedridden. Given the fact that treatments are being offered which do regard chronic fatigue as reversible, then that somehow undermines the view that ME is a neurological condition. There is this feeling that ME, being an organic disease in the views of some patients, that means that any view that contradicts that and offers a treatment against that particular perspective must therefore by definition be unethical. So this study is, we are told, breaching the Declaration of Helsinki.

Norman Swan: Of course the researchers are not saying it's not organic, they are just saying that you can do something about it.

Richard Horton: This is why I think the criticisms about this study are a mirage. They obscure the fact that what the investigators did scrupulously was to look at chronic fatigue syndrome from an utterly impartial perspective.

Norman Swan: And of course this reflects the fear that advocacy groups for people with chronic fatigue syndrome have that they're going to be blamed; that they've just got psychiatric illness; you know, it's all in the head and this is an invented disease is what they fear being accused of.

Richard Horton: The issue here which I still fail to understand is that nobody is claiming that chronic fatigue syndrome is an invented illness. It's taken just as seriously as any other condition.

Norman Swan: Have you had a response like this before to a paper?

Richard Horton: Not this kind of orchestrated response trying to undermine the credibility of the study from patient groups, but also the credibility of the investigators, and that's what I think is one of the other alarming aspects of this. This isn't a purely scientific debate; this is going to the heart of the integrity of the scientists who conducted this study.

Norman Swan: What are they saying?

Richard Horton: The accusations that are being made about them is that they have behaved unethically, breached international standards of ethics, and indeed in a few examples allegations have been made to professional authorities, the General Medical Council here in the UK, about the work of these scientists, on the basis of the flimsiest and most unfair allegations. And indeed the study cost 4-million pounds to undertake but the allegations and the freedom of information requests and the legal fees that have been wrapped up over the years because of these vexatious claims has added another 750,000 pounds of taxpayers' money to the conduct of this study.

Norman Swan: Yet patients' groups were involved, engaged in the study all the way through.

Richard Horton: Indeed, and I think this is where one sees a real fracture in the patient community. One is seeing a very substantial number of patients very willing to engage in this study, desperate to get good evidence on which to base their future treatment. But one sees a fairly small, but highly organised, very vocal and very damaging group of individuals who have, I would say, actually hijacked this agenda and distorted the debate so that it actually harms the overwhelming majority of patients.

Oh My God, what a Scumbag Piece of Sh!t this Horton is!!!!!!!!!

I hadn't actually listened to this yet. Unbelievable!!!!! Rot in Hell, with your confrere Dr. Mengele!