Friday, 21 September 2018

Open Medicine Foundation Delivers Hope to Millions of Patients

https://www.omf.ngo/2018/09/20/omf-sponsors-second-annual-community-symposium-stanford-university/

For Immediate Release

Sept. 20, 2018 (Los Angeles, CA) – Open Medicine Foundation (OMF), the premier nonprofit organization investing in research to cure myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), sponsors the Second Annual Community Symposium on the Molecular Basis of ME/CFS on September 29, 2018, at Stanford University. This event is expected to draw more than 300 scientists, clinicians, patients, and caregivers as well as over 3,000 attendees globally via livestream.

OMF is working to put an end to ME/CFS – estimated to afflict 20 million globally — by funding a global research effort to identify diagnostic biomarkers, effective treatments, and ultimately a cure. As part of its efforts to foster open, collaborative research, the Foundation is funding a three-day scientific working group meeting in which over 50 world-class scientists with diverse expertise will share their latest results and chart a path forward, followed by the Community Symposium, at which highlights of these results will be shared with the public.

Linda Tannenbaum, OMF founder and CEO/President, will welcome guests at this year’s Symposium and highlight the importance of open collaboration to fast track solutions. The keynote address will be delivered by Oystein Fluge, MD, PhD, of Norway. Additional scientists speaking include the Symposium Chair Ronald Davis, PhD; the Symposium Moderator Raeka Aiyar, PhD; Maureen Hanson, PhD; Jonas Bergquist, MD, PhD; Wenzhong Xiao, PhD; Alain Moreau, PhD; Ronald Tompkins, MD, ScD; Jared Younger, PhD; Michael Sikora, graduate student; and Rob Phair, PhD, who will speak about the new metabolic trap hypothesis.

OMF currently funds ME/CFS Collaborative Research Centers at Stanford and Harvard. Scientists from both Centers will present their research at this year’s symposium.

To register for the Symposium Livestream, click here.

Tuesday, 18 September 2018

Trial By Error: Bruce Levin on “How Not to Conduct a Randomized Clinical Trial”

http://www.virology.ws/2018/09/18/trial-by-error-bruce-levin-on-how-not-to-conduct-a-randomized-clinical-trial/ 

18 September 2018

By David Tuller, DrPH

When I first began examining the PACE trial in detail, I turned to clinical trial experts to vet my concerns. One of them was biostatistician Bruce Levin, a professor at Columbia University’s Mailman School of Public Health, to whom I was referred by a mutual colleague. After he reviewed the trial, he pronounced it to be a mess—a conclusion that fueled my determination to investigate the matter.

Professor Levin identified many faults in the PACE trial’s design and conduct. In particular, he found the overlaps between the entry and outcome thresholds for the key outcomes of physical function and fatigue to be unacceptable peculiarities of the study. “I have never seen a trial design where eligibility requirements for a disease alone would qualify some patients for having had a successful treatment,” said Levin told me for my initial series of articles. “It calls into question the diagnosis of an illness whose patients already rate as ‘recovered’ or ‘within normal range.’ I find it nearly inconceivable that a trial’s data monitoring committee would have approved such a protocol problem if they were aware of it.”

Levin also said the mid-trial publication of a newsletter featuring glowing testimonials from earlier participants and positive news about interventions under investigation created legitimate concerns that subsequent responses might have been biased, especially in an unblinded study with subjective outcomes like PACE. “It is highly inappropriate to publish anything during an ongoing clinical trial,” he told me. “To let participants know that interventions have been selected by a government committee ‘based on the best available evidence’ strikes me as the height of clinical trial amateurism.” (In fact, “the height of clinical trial amateurism” is probably one of my favorite quotes of all time.)

Anyway, last week Professor Levin took his criticism a step further with a public talk about PACE at Columbia. The talk was called, appropriately enough, “How Not to Conduct a Randomized Clinical Trial.” For the last couple of years, I have been pointing out that PACE has been used at Berkeley as a case study of bad science in epidemiology courses. Now it is legitimately possible to say that it has been presented at multiple major American universities as a case study of bad science. Thanks, Bruce!!!

Here is a link to his slide presentation:


Thursday, 13 September 2018

This Man receiveth sinners


C H Spurgeon’s Evening Devotional for 13th September 

"This Man receiveth sinners."

Luke 15:2

Observe the condescension of this fact. This Man, who towers above all other men, holy, harmless, undefiled, and separate from sinners-this Man receiveth sinners. This Man, who is no other than the eternal God, before whom angels veil their faces-this Man receiveth sinners. It needs an angel's tongue to describe such a mighty stoop of love. That any of us should be willing to seek after the lost is nothing wonderful-they are of our own race; but that He, the offended God, against whom the transgression has been committed, should take upon Himself the form of a servant, and bear the sin of many, and should then be willing to receive the vilest of the vile, this is marvellous.

"This Man receiveth sinners"; not, however, that they may remain sinners, but He receives them that He may pardon their sins, justify their persons, cleanse their hearts by His purifying word, preserve their souls by the indwelling of the Holy Ghost, and enable them to serve Him, to show forth His praise, and to have communion with Him. Into His heart's love He receives sinners, takes them from the dunghill, and wears them as jewels in His crown; plucks them as brands from the burning, and preserves them as costly monuments of His mercy. None are so precious in Jesus' sight as the sinners for whom He died. When Jesus receives sinners, He has not some out-of-doors reception place, no casual ward where He charitably entertains them as men do passing beggars, but He opens the golden gates of His royal heart, and receives the sinner right into Himself-yea, He admits the humble penitent into personal union and makes Him a member of His body, of His flesh, and of His bones. There was never such a reception as this! This fact is still most sure this evening, He is still receiving sinners: would to God sinners would receive Him.

Thursday, 6 September 2018

Complaint Report offers hope for those living with ME in Ireland

https://meadvocatesireland.blogspot.com/2018/09/complaint-report-offers-hope-for-those.html?m=1

[This is a long article but well worth reading. I'm posting some of it here; to read the rest, click on the link.]

Christine Fenton

In this post MEAI Advocate Christine Fenton describes her journey with ME and the HSE, elements of which we'll all recognise. The Result? Recommendations for actions by the HSE.

I was diagnosed with Myalgic Encephalomyelitis (ME) in 1990 and retired from my career in teaching, a Deputy Head of a high school in the UK, in 2000. Two years later I moved to Ireland to renovate a derelict house and enjoy my passion for dogs and horses.

In 2003 I deteriorated and was surprised that my then GP was dismissive of the ME diagnosis and regarded it as a mental health issue.

By 2006 I was losing the use of my arms and legs, I'd suddenly find myself sitting on the ground as my legs gave way, often with a horse above me! My arms couldn't manage any repeated use of muscles. I collapsed at an out of hours GP surgery and became paralysed for a short period. The attending GP said she'd never seen anything like this and I should go to Dublin to find the cause.

By chance I had an Out-Patient appointment the week after the collapse and was fortunate to meet with a Consultant new to the local hospital. He was willing to listen and regarded my presentation as an 'interesting challenge'.

My health continued to deteriorate and from 2011-2016 I was spending approx. 3 months annually in acute care.

The difficulties in achieving a home care package to enable me to access the very limited life I was capable of were legion.

Given the limitations of my body, I needed everything available within arms-reach of my resting place. At that time a wooden steamer chair with settee cushions on it was my bed and day chair.

I also needed a consistent temperature as overheating caused me to be unwell very quickly. If my fingers got cold it would trigger severe pain throughout my body, then my legs would give way and I would end up sitting on the floor, sometimes in an unheated room with no ability to return to a warm, comfortable space. I had to resort to pulling ‘something’ from nearby to cover me to increase my core temperature so that I could recover and crawl/push myself, back to safety.

On the days I was too unwell to move, food had to be beside me, small, easy to digest quantities, taken when I had the energy to put food to my mouth, chew, swallow and digest – you’d never believe how hard the action of eating is, something I took for granted when healthy.

At home, as stairs were beyond me and the bathroom was upstairs I had no facilities available to me. Initially I tried a camping cassette toilet, but it was too heavy to empty and needed emptying too frequently. Often it was full on a day I was struggling to use it, never mind empty it. I needed a better solution which met my needs and capability. I decided to use coal buckets as my toilets. When you live in one room and everything, including eating, is done in that room, a steaming commode is just not welcome - we all know the gut problems which accompany ME. There are some indignities I am not willing to contemplate!

The HSE ‘experts on disability’ were nowhere in sight. My request for support at home had been refused without a visit or an assessment being undertaken, no reason was given to explain why I was not worthy of an assessment. Just a refusal letter from an HSE disability manager who made a judgement without any evidence of my needs on which to base it.

So, I was on my own and had no choice but to create a system which allowed my needs to be met, within the resources available to me.

To continue reading the article, click on –

Saturday, 1 September 2018

Letter to Professor Watt of MRC



This letter from Professor Fiona Watt of the Medical Research Council in support of the PACE Trial appeared a few days ago in response to the Times article about the growing pressure on The Lancet concerning the trial:

CHRONIC FATIGUE

Sir, Further to your report “Call for review of ‘flawed’ ME research”(Aug 21), as funders of the Pace trial we reject the view that the scientific evidence provided by the trial for using cognitive behavioural theory and managed exercise in the treatment of chronic fatigue syndrome (also known as ME) was unsound. The Pace trial was funded following expert peer review, was overseen by an independent steering committee, and its published findings have also been independently peer-reviewed. Other research groups have drawn similar conclusions. Chronic fatigue syndrome/ME remains a priority for the Medical Research Council (MRC), and it is important that researchers are not discouraged from working on the disease because of concerns that they could be subject to the level of hostility that Pace researchers have experienced. Medical research can only flourish when there is mutual respect between all parties.

Professor Fiona Watt Executive chairwoman, Medical Research Council

There have been other responses from patients. Here is mine, which I decided to send directly to Prof Watt.

Maybe she will see it. Maybe she will read it. Maybe she will do as I ask! I’ve sent it anyhow. You don’t win the lottery if you don’t buy a ticket…

Dear Professor Watt,

Like many patients with M.E. I was surprised and disappointed by your letter to The Times wholeheartedly supporting the PACE trial. There are so many misconceptions in the letter that it is clear that you have not investigated this matter yourself but have – apparently- assumed that what the PACE authors tell you about it is correct and what patients tell you is not. I can only assume that this is because they are doctors and we are merely patients.

Yet you say in your letter that ‘medical research can only flourish when there is mutual respect between all parties’. I would certainly not disagree with that. Please then show patients the respect of being open to the possibility that what we (and indeed many distinguished researchers and other informed parties) say about PACE may actually be correct.

I am not asking you to take us at our word, but please look into the matter yourself instead of simply believing what you are told by the PACE authors and their friends. It will not take you long. I have provided a few references at the end of this letter which you will find useful. For the sake of the patients you say you wish to respect, please take the trouble to do this.

Thank you,

Useful references:

Rethinking the Treatment of Chronic Fatigue Syndrome – A Reanalysis and Evaluation of Findings from a Recent Major Trial of Graded Exercise and CBT by Wilshire et al. – Jan 2018 (A comprehensive re-evaluation of PACE following the release of data from the Freedom of Information Act Tribunal.)

Journal of Health Psychology Vol 22 No.9 Aug 2017 – A Special Issue on PACE. “On the basis of this Special Issue, readers can make up their own minds about the merits and demerits of the PACE Trial,” writes Editor David F Marks.

A letter to The Lancet signed by over a hundred scientists, clinicians, academics, MPs and other experts plus over sixty local, national, and international patient organisations, calling for an independent re-analysis of PACE and setting out the reasons why.

The August 2016 PACE Trial Freedom of Information Tribunal Judgement has useful information about so called hostility to PACE researchers, an unfounded allegation which your letter unfortunately perpetuates.

Two notes relating to this issue:

Allegations were made at the Tribunal by a representative of the PACE proponents that ME patients, described as ‘activists’ were ‘borderline sociopathic and psychopathic’ and posed ‘a serious threat of violence to trial participants and researchers’ but the Commissioner described these as ‘wild speculations’ which did the representative ‘no credit’ (see pages 22 and 36). PACE researcher Prof Chalder accepted that ‘there had been no threats made either to researchers or participants’ The Commissioner stated that the ‘assessment of activist behaviour was grossly exaggerated. The only actual evidence was that an individual at a seminar had heckled Prof Chalder.’ (see page 40)
Your letter also suggests that researchers might be ‘discouraged from working on the disease because of concerns that they could be subject to the level of hostility that PACE researchers have experienced’. The idea that researchers are being discouraged in this way is another often repeated misconception which seems to be intended to vilify patients. Working for the MRC, you will be fully aware of how little funding M.E. has received over the years. Nevertheless there is research going on worldwide, strongly supported by patients and often funded by them. (Many of these researchers are critical of PACE and have signed the letter to The Lancet requesting its independent reassessment – see above.) Patients do however object – in the form of letters such as this and other peaceful means – to the squandering of funds on poorly conducted research such as PACE, money which is desperately needed for high quality biomedical research into the condition.