Friday, 24 August 2012

Servants of the Lord

Whilst listening to an online service recently, mention was made of a series of talks about figures from church history, both preachers and missionaries. I made enquiries with the result that I purchased a set of 10 talks on 10 CDs. The talks were given by Mr Roger Jack between 2004 and 2008; they are excellent – and also very challenging - and I would highly recommend them.

The subjects are as follows –

1. Martin Luther Part 1

2. Martin Luther Part 2

3. Thomas Charles

4. John Calvin

5. Revival in Pest

6. William Grimshaw

7. Adoniram Judson Part 1

8. Adoniram Judson Part 2

9. The Countess of Huntington

10. Henry Martyn

You can listen to and download these talks from the W V Higham Trust website – click here.

They are also available as a set of CDs – contact Tabernacle Cardiff for further details - www.tabernaclecardiff.org/  

Monday, 13 August 2012

The PACE Trial: an analogy

http://apaththroughthevalley.wordpress.com/2012/08/05/the-pace-trial-an-analogy/

There were reports in the media announcing the results of the PACE trial, with ecstatic claims about treating a widespread and deadly disease. And then, there were more reports – this time confused, not ecstatic – reporting the outrage of patients with this disease at those claims of being able to treat them.

I can fully understand why people are confused. I mean, what it looks like, is they found a cure but we all want to stay sick. Let me assure you, things are not at all the way the media make them to appear.

The whole area of Myalgic Encephalomyelitis and Chronic Fatigue is a dank and dangerous politico-medical mire. I won’t go into the politics/medical side of it (if you’re interested, see HFME and the rest of that site), or the myriad of scientific reasons that the PACE trial was a fraudulent, unethical waste of money and effort (again, if interested, see Invest in ME: Magical Medicine, A Review on CBT/GET, A Reporting of Harms). Oh, and the fact that the PACE trial actually dis-proved the theories it was based on (Pace Results Undermine)

Instead, I want to paint a picture of what’s going on in a way that regular people might understand – by comparing it to an illness that most people actually know about: Diabetes. You do know about it right? Good. Now, diabetes is nasty when it’s not treated. It can cause people to go blind, need amputations, have organs fail, and even die. So, if you’ve got it, treating it is pretty important. In the same way that diabetes can be thought of as the body being unable to handle sugar properly, ME can be thought of as the body being unable to handle activity properly, in every and any form.

So, instead of ME, lets think diabetes – here’s what the PACE trial would be if it was dealing with diabetes instead:

There’s a group of doctors, mostly psychiatrists, who’ve noticed that diabetes is a pretty dangerous and nasty disease. So they’ve taken a look at diabetes patients to see if they can work out a treatment to help them (so far so good).

Now, one of the characteristics they notice about your average severe diabetes patient is this: they avoid sugary foods. They go so far as to specifically purchase food that would usually contain sugar, but has been manufactured in a way to leave as much as possible out. Their whole eating lifestyles revolve around keeping sugar out of their food.

“Gosh!” says one of the doctors “I think I understand the cause of their illness! These people are ill because they are major sugar avoiders.

“You’re right!” chips in another: “Sugar is an important part of the diet, in the right quantities. We should see if a steady increase of their sugar intake improves their symptoms”.

“Yes” adds a third, “but we need to deal with the root of the problem too. I suggest that we try cognitive behavioural treatments, to free them of their pathological sugar avoidance. If they can learn that sugar is safe, they’ll not need any further treatment at all.”

“We should also use this opportunity to see if dietary management actually helps the diabetes patients” returns #2 “after all, it’s what they’re all doing already. But since we know sugar-avoidance is a no-no, we’ll add sugar, instead of taking it away!”

So, they come up with a trial to test these out. Except, it turns out that diabetics aren’t allowed to eat sugar in large quantities, and there are some serious ethical problems with forcing them to.

“That’s alright” says doctor #1, “we can use patients who are diabetic-like. As long as they don’t actually have diabetes, we have no barriers to the trial.”

Thus they petition their friends in government for £5million to carry out the trial. Here’s the details of it:

They take a group of patients who are at risk of diabetes, but don’t actually have it.
1/4 of them receive care from a doctor, then go about life as usual
1/4 receive care from a doctor, then CBT to get rid of their sugar-avoidance
1/4 receive care from a doctor, then steadily replace the sugar-free foods in their diet with ones that contain sugar
1/4 receive care from a doctor, then are prescribed regular spoonfuls of sugar in steadily increasing amounts.

Originally, they were going to take lots of measures of insulin levels etc. throughout the trial, but they soon discovered that the results didn’t reflect their original idea, so they dropped that. Instead, they got patients to rate whether they thought sugar was good for them, and how they felt. They also did a single test of blood-sugar levels at the end of the trial.

The trial results were as follows:
The patients just receiving care from their doctors had high blood sugar levels, but below the level of diabetes. However, their attitudes towards sugar and their general sugar-avoidance did not improve at all! These were the control group, to compare other groups to.

The patients who received CBT had very high blood sugar levels, but they were below the level of diabetes. Hurrah! Their attitudes towards sugar were slightly improved; they were willing to, on their own initiative, increase the sugar in their diet. Conclusion: CBT is an effective method of treating diabetes.

The patients who increased the sugar-containing foods had very high blood sugar levels, but they were below the level of diabetes. Hurrah! Their attitudes towards sugar were not very good, they were willing to incorporate a little more sugar into their diets but not enough to have much effect on them. Conclusion: Dietary management is not an effective method of handling diabetes.

The patients who took increasingly large quantities of sugar had very high blood sugar levels, but they were below the level of diabetes! Hurrah! Their attitudes towards sugar were much better, they were comfortable incorporating a lot more sugar into their diets. Conclusion: Increasing amounts of sugar is an effective method of treating diabetes.

Looking at the costs for each treatment, it was clear that spoonfulls of sugar were the cheapest to finance, followed by a short course of CBT to counter sugar-avoidance behaviour.

Thus they released the trials conclusions to the press: We can cure diabetes through giving patients large amounts of sugar on a regular basis, and by giving them CBT to counter their sugar-avoidance behaviour! Both of these treatments are cost-effective and can be offered on the NHS!

I hope now, you can understand why we’re angry about PACE.


Friday, 3 August 2012

The PACE Trial in the media

Sadly there is further publicity for the PACE Trial in the media at the moment, promoting psychological based treatments for ME, a serious, debilitating illness which has been classed as a neurological condition by the World Health Organisation for over 40 years and is in reality a multi-system failure. The “treatments” being promoted are Cognitive Behavioural Therapy (CBT) and Graded Exercise Therapy (GET), both of which have been repeatedly found over many years to be at best unhelpful to those with ME and, in the case of GET, at worst positively harmful. Just to cite one example, in a survey carried out in 2004 by the 25% M.E. Group, a group for the 25% of M.E. sufferers who are severely affected by the illness, 93% of sufferers found CBT to be unhelpful, with 95% finding GET unhelpful. Worryingly, of those who tried GET, 82% reported that they were worse afterwards.

Would “treatments” such as these be offered (to put it kindly) as first-line – or indeed as the only – treatment options to those with other neurological conditions such as multiple sclerosis and motor neurone disease? Of course not! Doing so would be seen as an insult, and rightly so. Yet, interestingly, when the Chief Medical Officer’s Report on ME was released in January 2002, the then CMO, Professor Sir Liam Donaldson, said that ME “should be classed as a chronic condition with long term effects on health, alongside other illnesses such as multiple sclerosis and motor neurone disease”.

A response by Invest in ME to the current publicity has been posted as follows -

False results from a flawed trial

Posted by IiME on 01 August 2012 at 21:41 GMT

From Professor Malcolm Hooper's summary of the Pace trial - prepared for "Briefing Notes for Meeting with BIS Officials About Incorrect Answers to Parliamentary Questions re: the MRC-funded PACE Trial and ME/CFS" -
http://www.investinme.org/Article%20432%20-%20PACE%20Trial%20Update%20July%202012.htm

The PIs [Principal Investigators] themselves concede that:

“Our trial had limitations. We excluded patients unable to attend hospital”;

that

“Results cannot be extrapolated to those who are severely affected”;

that

“primary outcomes were subjective”

and that

“What this trial isn’t able to answer is how much better are these treatments than really not having very much treatment at all”.

What the PIs failed to acknowledge was that their ignoring of the biomedical evidence about the disorder they were supposedly studying (breaching the Declaration of Helsinki B11) invalidated the entire trial in that it was not grounded on the existing evidence-base and thus contravened the most basic principle of scientific research.

After a trial lasting nine years and costing £5 million, the PACE Trial has not taken us forward: not only have the results been misrepresented, but safe guidance on management options must address the needs of all patients with ME/CFS and it is not the case that the PACE Trial results are generalisable to all people with the disorder as claimed by the PIs.

The problematic analysis and selective presentation of data means that the PACE Trial has failed to provide “high quality evidence”, which is an unacceptable outcome: patients, clinicians and tax-payers have a right to expect higher scientific standards from the MRC.

The PACE Trial failed on a fundamental aspect of clinical research in that the benchmarks used to judge suitability for entry to the trial and successful outcomes are patently contradictory.

The need for independent statistical re-evaluation of the raw data is overwhelming as, without such an independent assessment, doubts over the veracity of the claims made by Professor White et al cannot be resolved.

Furthermore, the post-publication admission by the Chief Principal Investigator that the study was ‘not purporting to be studying CFS/ME’ invalidates the whole study which claimed to be addressing CFS/ME.

Given (i) the inability of the recruitment criteria to distinguish between ME/CFS and psychogenic fatigue, (ii) the illogical overlap of the entry criteria with “the normal range”, (iii) the failure of CBT to achieve a clinically useful difference for one of the primary outcomes and the trivial improvement produced by GET, (iv) the failure to recognise that an “averaged” improvement often masks very different responses to an intervention, and (v) the fact that around two thirds of participants who received CBT/GET remained in the lowest functioning 10% of the general population, the international ME community wonders why the PACE Trial is being hailed as a “gold standard” study which demonstrated the efficacy of CBT and GET for ME/CFS patients (as noted above, although the Protocol refers to it as an RCT [randomised controlled trial], The Lancet paper at no point describes PACE as a controlled trial, yet it was described in the press release as “the highest grade of clinical evidence” and as “extremely rigorous (and) carefully conducted”), which by any standards is risible.

Despite the irrefutably poor results of the trial, CBT and GET are being actively and inappropriately applied to people with ME/CFS; the PACE press release stated that the results suggest: “everyone with the condition should be offered the treatment” and that every patient “who wishes to be helped” should be willing to take part in such regimes.  Non-compliance (for example, if a person has already found that exercise exacerbates their condition) is deemed to demonstrate lack of desire to recover, which in some instances has already led to the withdrawal of state and/or insurance benefits.

The PACE Trial was not a scientific study and defies reason but, given the considerable investment (Governmental, financial and professional) in its success, it could not be allowed to fail.

Magical Medicine!

No competing interests declared.

(Magical Medicine can be found here, pdf file, 6mb file size)

Wednesday, 1 August 2012

Great is the gospel

Time for another favourite hymn -

Great is the gospel of our glorious God,
Where mercy met the anger of God’s rod;
A penalty was paid and pardon bought,
And sinners lost, at last to Him were brought:

O let the praises of my heart be Thine,
For Christ has died that I may call Him mine,
That I may sing with those who dwell above,
Adoring, praising Jesus, King of Love.

Great is the mystery of godliness,
Great is the work of God’s own holiness,
It moves my soul, and causes me to long
For greater joys than to the earth belong:

The Spirit vindicated Christ our Lord,
And angels sang with joy and sweet accord;
The nations heard, a dark world flamed with light –
When Jesus rose in glory and in might:

W V Higham, 1926 -