PACE trial's principal investigator Peter White has retired from clinical practice with immediate effect to avoid ...

PROOF POSITIVE ? (REVISITED)

Margaret Williams, 14th September 2016  

"The role of Professor Peter Denton White OBE
In 2004, Professor Peter Denton White was awarded an OBE for “services to medical education”;
notices circulating at the time proclaimed him as leading the research into “CFS/ME” and said his OBE was “a well-deserved honour and acknowledgement of his contribution to work on CFS/ME”.

He was born in November 1952: aged only 64, he suddenly retired from clinical practice just before he was compelled by an order of the court to release the raw data from the PACE trial, so any
investigation by the General Medical Council for alleged professional misconduct is unlikely to be
pursued, but is he guilty of misfeasance in public office?

According to the Crown Prosecution Service (CPS) website, misfeasance in public office is a cause of
action in the civil court against the holder of public office, the allegation being that the office-holder
has misused or abused their power: such misuse or abuse is an affirmative act that causes harm to
another party without reasonable justification. The NHS is a State body as it provides public health
care, so this matter is one in which the public has a significant interest.

Facts to be considered
1. Peter White has used his own money, as well charitable money and public money, in order to
lobby support for his belief that ME/CFS is a psycho-behavioural disorder that can be
overcome through “cognitive restructuring” and graded aerobic exercise
2. he has egregiously used large sums of public money (£250,000) to prevent the disclosure of
data that would falsify his belief
3. for nearly 30 years, he has ignored evidence that disproves his belief, including evidence from
his own trials
4. he has failed to correct errors of fact after being alerted to them
5. he has consistently failed to disclose significant financial, institutional and ideological
conflicts of interest
6. he has been in breach of his NHS contractual obligations in that he has persistently ignored
mandatory directives and has wilfully encouraged other clinicians to do the same
7. as a consequence of his actions:
 money which should have been used for biomedical research into the aetiology of
ME/CFS has been diverted to fund studies into therapies which were already known
to be ineffective and even harmful
 patients have been stigmatised as sociopaths and malingerers who refuse to accept
they have a behavioural disorder
 patients have been denied financial support from private insurers for whom Peter
White and his colleagues work (for example, he was Chief Medical Officer for the
giant re-insurer Swiss Re and was also CMO to Scottish Provident) and from the" ...

Proof positive (revisited) .pdf

That moment you realize there is an overlap in entry and recovery criteria in the 8 million dollars costing thing of beauty

The real thing of beauty is the review of the PACE trial, which amongst things showed that the real outcome of this trial, contrary to the published conclusions, is that:

1. CBT and GET are ineffective to treat people with ME (also known as CFS or ME/CFS) also called a NULL effect
2. A discovery by the trial which proves yet again that ME/CFS is a physical disease
3. The disproval of the biopsychosocial model favored by the British (PACE trial) psychiatrists

The full article "The PACE Trial Invalidates the Use of Cognitive Behavioral and Graded Exercise Therapy in Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome: A Review" is available free of charge.

Just when you think it can't get worse, more shocking PACE trial revelations‏

From Margaret Williams : further details about PACE Trial data security. Permission to repost.

"Two points merit further consideration: (i) the matter of guaranteed confidential storage of PACE trial data and (ii) the Principal Investigators’ undeclared conflict of interest until after the consent forms were signed by participants.

The PACE trial Protocol published in BMC Neurology on 8 March 2007 was an abridged version
but, as noted by Alem Matthees, the Full Protocol (226 pages) states on page 110:
“Your GP and any other doctors you are consulting will be told you are joining our study. And occasionally, other researchers will need to see your notes so they can audit the quality of our work. An audit might be run by one of the universities helping with our study or hospital regulatory authorities, or by one of the organisations funding our study” http://www.meactionuk.org.uk/FULL-Protocol-SEARCHABLE-version.pdf

What Matthees did not mention was the fact that one of the organisations funding the study was the UK Department for Work and Pensions (DWP). How many participants looked at the funding bodies before signing the consent forms and realising to what they were giving their consent?
Quite how “confidentiality” could be guaranteed if the DWP had access to the data has never been explained, especially as ME/CFS is known to be a targeted disorder for the withdrawal of state benefits, with patients being harassed by the DWP who required a 60-page form to be completed because the DWP menacingly informed such patients: “We have reason to believe that you are capable of work”.
If the PACE trial therapists and Investigators deemed a participant “recovered” enough to resume work, then might that participant quickly discover that the DWP stopped paying benefit? The PACE Trial has been described as a “Trojan horse” for the DWP.
Regarding the secure storage of data, the Full Protocol is unambiguous:
“Will you keep my details confidential?”
“Yes. All your details and all recordings will be kept strictly confidential and held in a locked filing cabinet or on a secure computer. People on our research team will only see your records if they need to for the research”.
The DWP was not involved in research but still had participants’ signed permission to access their records/data.

From the outset, recordings were not kept in a locked filing cabinet: some were stolen and thus lost to review (see previous post on 19th December 2015: https://jcoynester.wordpress.com/2015/12/18/kings-college-london-stalls-some-more-reiterating-refusal-to-release-the-pace-trial-data/#comment-1375
 ).

The Consent Form 1 for baseline assessment which participants were required to sign was clear:

“3. I understand that any of my medical notes may be looked at by responsible individuals from either the trial or regulatory authorities where it is relevant to my taking part in research.

4. I give permission for these individuals to have access to my records.
…

14. I understand that information collected about me for the trial, including my personal details, a copy of this consent form and all of the questionnaires I complete for the trial, will be held securely by the local trial staff and at the PACE trial centre at Queen Mary, University of London. I give permission for this to happen”.
The PACE PIs obtained participants’ consent on the promise of keeping trial data secure, yet they had made no provision to do any such thing.
When the PACE Trial had been running for two years, the Participants’ newsletter (Issue 1, June 2006) reaffirmed that the trial data was safe: “The information is being entered onto a large and secure database, designed and maintained by an independent clinical trial unit at King’s College, London”. This was provided for participants even though the PIs knew that trial data had already been stolen (see previous post #‎comment
-1375).

In relation to the PIs’ undeclared conflict of interest, one of the pre-trial assessments was at Baseline Visit 1; this set out to collect personal data that seems to have little bearing on a clinical trial but could be of value to the DWP and the permanent health insurance industry because the collected data included not only the customary demographic details, date of birth, age, sex, ethnicity, marital or partner status, years of education, occupation (the latter would obviously afford information about a participant’s earnings) but also very detailed questions about participants’ permanent health insurance payments, for example, questions on page 172 ff of the Full Protocol included the following:
“Do you currently receive income protection benefit (income protection or total and permanent disability)?”
“ If yes, how much annually do you receive? £”
“If the participant chooses not to give an answer, please use the prompt card to show income brackets, and record the letter [an alphabetical letter designating an income bracket] that corresponds to the participant's income”.

“Do you currently receive a private medical / retirement pension?”
“If yes, how much weekly do you receive? £
OR
If yes, how much monthly do you receive? £
OR
If yes, how much annually do you receive? £”

“If the participant chooses not to give an answer, please use the prompt card to show income brackets, and record the (alphabetical) letter that corresponds to the participant's income”.

“In the past six months, have you received any one-off payments from income protection or insurance schemes as a result of your health?”

Such specific questions have no clinical relevance but would be of interest to the Chief PI of the PACE trial in his dual role as the re-insurer Swiss Re’s Chief Medical Officer.
As detailed by David Tuller, participants could not give fully informed consent because the PIs’ Iong-standing involvement with the permanent health insurance industry was never disclosed to them. Indeed, it appears that this significant conflict of interest was not initially disclosed even to the Trial Steering Committee: at the meeting on 22nd April 2004, all members present were asked to declare any conflict of interest. It was minuted that no financial conflicts of interest were declared and it was agreed that no-one present had any other substantial or material conflict relevant to their work on the PACE Trial. Amongst those present were Professors Peter White, Michael Sharpe and Trudie Chalder, all of whom worked for the permanent insurance industry. There was a brief mention of paid consultancy work done by the PIs in the BMC Neurology version of the Protocol, which was long after signed consent forms had been obtained."

At last, a powerful and reliable Honda for Fernando Alonso

Dr Gary Hartstein provides in-depth insight into Michael Schumacher's head injury

Gary Hartstein was Formula 1's official medical delegate from 2005-12. He has been following news of Michael Schumacher's head injury closely, he provides in-depth insight into the clinical situation at present.

Let's take a look at what's happened to Michael Schumacher, from his fall until roughly now. It goes without saying that this is based on what we've been told at the press conferences, viewed and interpreted through my eyes.

I will not speculate, but will rather read between the caring physicians' lines and put this into the context of the treatment of severely head-injured patients.

It's useful to think of the impact against the rock as having done two things: it essentially immediately created a series of severe lesions, and it set into motion processes that, left to themselves, would aggravate the damage already done.

What about the initial lesions? There were probably at least four types of injury produced by the fall.

The first is formation of haematomas. Torn and damaged blood vessels let blood escape in sufficient quantity to coalesce. They are dangerous both because they are markers of severe impact as well as because they cause the intracranial pressure (ICP) to rise.

Gary Hartstein
Gary Hartstein © XPB
We've been told that Michael had a right-sided extradural haematoma (between the skull and the dura, a membrane surrounding the brain) that was evacuated surgically, and a series of intracerebral (within the brain tissue itself) haematomas. One of these, on the left, was evacuated during the week after the fall, but there are several others, located on the left, on the right and in the centre.

The second type of injury is contusions. These are bruises, just like when you bang your arm or leg. Tiny quantities of blood seep from the vessels, but not enough to collect. This gives that black-and-blue look. There's also swelling of course, which adds to the ICP increase caused by the haematomas.

Third is the possibility of damage to the long 'cables' in the brain. Injury to these axons is harder to see with modern imagery, but is often associated with poor neurological outcome.

Last, I have heard insistent stories of damage to one of the four arteries feeding the brain. Even if true, the significance of this is hard to assess, as most people have extensive connections between the four arteries, allowing flow through one to compensate for blockages in another.

What about the vicious circles I alluded to above? The most important revolves around the ICP. Increased ICP compresses the tiny blood vessels nourishing the brain.

The problem is, when the brain isn't receiving enough blood, what do you think it does? Right - it swells. This aggravates the already high ICP, and the already low blood flow.

Taking care of severely head-injured patients involves rigorous adherence to a few principles. Basically, the brain needs to consistently receive adequate amounts of oxygen and nutrients.

For this to happen, the air passages are maintained open and secure by a tube placed in the windpipe. Oxygenation and ventilation are provided by sophisticated ventilators, and adjusted to values as close to normal as possible. In order to ensure proper brain blood flow, it is urgent to control elevated ICP.

Ferrari fans pay tribute to Schumacher outside the hospital
Ferrari fans pay tribute to Schumacher outside the hospital
The first step in controlling high ICP was done on the Sunday and Monday after Schumacher's accident. The surgically accessible haematomas were evacuated.

In addition, the bone flaps opened by the surgeon weren't closed, allowing the brain to physically swell a bit before the pressure rises.

It turns out that cooling the patient just a few degrees can help make sure that energy delivery is adequate. This is because cooling slows the brain's metabolism. That means that any given level of oxygen and nutrient delivery is more likely to be sufficient for the brain's needs. Hypothermia is also very effective against elevated ICP.

It's also important to understand what is meant by, and the role of, the 'medically-induced coma'.

I mentioned controlling the airway with a tube in the trachea, controlling breathing with a ventilator and reducing body temperature. Now, realistically you just can't do this to a patient, even a severely head-injured patient (especially not a head-injured patient!) without anaesthetising them. So all these patients are put to sleep.

This also helps ensure that the patient doesn't shiver during the period of hypothermia (usually 48-72 hours). If despite all the above the ICP stays elevated, the anaesthesia is deepened significantly. This aims at temporarily abolishing electric activity in the brain, in order that all available energy be used for vital cellular maintenance, not 'superfluous' activity.

The future? A long, long road. Months at least. Short term, the anaesthetic needs to be lightened when the ICP is normal and stable. That's the next big step.

Respect Felipe !

Happy Birthday Champ ! We're all praying for you ! get well soon Mr. Schumacher !

autosport.com:

Michael Schumacher's family say they have been "overwhelmed" by fans' support for the seven-time Formula 1 world champion as he continues to be treated in hospital following his skiing accident.

On the German's 45th birthday on Friday, more than 200 Ferrari fans joined a silent tribute outside the University Hospital in Grenoble where Schumacher remains in a critical condition.

With those attending the event wearing Ferrari red team kit, and unfolding a large Prancing Horse banner, the Schumacher family said it was in no doubt how deep the feeling of support was.

"We are overwhelmed!" said a short statement on Schumacher's official website. "The incredible sympathies shown today by the Ferrari fans outside the hospital has utterly overwhelmed us and moved us all to tears.

"We are deeply grateful for it and also for all the heart warming and heartfelt wishes for Michael to get well soon, which have reached us from all over the world."

Schumacher suffered serious head injuries in the crash last weekend, and although his condition is now stable, he remains in an induced coma following two brain operations.

@jimmyvasser: "I had the honor of presenting my dear friend @lxznr into the Hall of Fame"

jimmy vasser and alex zanardi

Indy 500 winner Wheldon dies after massive wreck

By JOHN MARSHALL - AP Sports Writer:

LAS VEGAS (AP) — Every race car driver heads onto the track understanding this race could be the last and hoping it won't be.

On Sunday, IndyCar drivers got a harsh reminder when the worst happened to one of their own. 

Two-time Indianapolis 500 winner Dan Wheldon died when his car got caught up in a 15-car pileup, sailed over another vehicle and smashed into a catch fence at IndyCar's season-ending race at Las Vegas Motor Speedway.

 "Things happen in this kind of racing," said Wade Cunningham, also caught up in the wreck. "It's so close. Not much room for error. I was near the front of what caused all this, so I'm not thrilled about it. At this point, whose fault it was is kind of immaterial."

The green flag had barely stopped waving when disaster struck. Wheldon, driving from the back of the field for a chance at $5 million, was moving through the pack when he drove into a tangle of cars careening off each other in every direction. Unable to avoid the massive wreck unfolding before him, Wheldon clipped another car and went hurtling through the air, his car bursting into flames as it flew into a fence. After just 11 laps, the race was over.

Two hours later, track officials announced that Wheldon was dead. The Englishman was 33.

Sky News the PACE trial way: Ayrton Senna photo ...

Absolutely brilliant! Badger's guide to the utterly confusing world of GP2 liveries

by Jimmy Von Weeks on Apr 22nd, 2011, badgergp.com:

GP2: it's the now-dominant F1 feeder series that can lay claim to great racing, exciting young talents and some of the most confusing liveries in the world of motorsport. Not sure what we're on about? Then listen up - it's a bit complicated.

The casual fan - indeed, anyone who hadn't done some digging on the situation - would assume that the green and gold Lotus-livered ART car below was linked to Tony Fernandes' Team Lotus. After all, they run in the same iconic livery as the F1 squad. That just makes sense.

But actually they're not connected to Tony's lot at all. French powerhouse ART now run in green and gold following a sponsorship link-up with Group Lotus, the car company who are also backing Nick Heidfeld and Vitaly Petrov's black and gold Renaults this season. And yes, that is a bit confusing.

But let's make it even more confusing. Read more>>

Motorshow Shanghai 2011: Nico Rosberg presents the new SLK

AA's topless Reptile

By Tristan Hankins: If the KTM X-Bow and Ariel Atom have taught us anything, it is that simple, stripped-down cars with go-kart like handling and supercar performance are the shiz.

With that in mind, Mexican industrial designer Arturo Arino presents us with the Reptile, an imaginary hybrid racer that can also be driven on the streets.

Equipped with a 2.7 L Wankel rotary producing a theoretical 700 hp (552 kW) at 9,000 rpm, a 4-pole electric induction motor and regenerative braking to recharge the batteries, this lightweight / topless roadster epitomizes the long held motoring philosophy that, “less is more”. Read more>>

The Dark Side of ME

Carscoop: Challenging the notion that a true Ferrari has to be red, Anderson Germany has whipped up a murdered out 458 Italia with both styling and mechanical upgrades.

Starting with the visible modifications, Anderson Germany's Ferrari 458 is finished in a black color and features a carbon fiber package that includes a pair of vents on the front hood, spoiler lips, rear diffuser and exterior mirrors.

The German tuner also tinted the Italian supercar’s windows, headlamps and taillights.

The exterior look is rounded off with a new set of 21-inch alloy wheels in a carbon finish that are shod in tires size 245 up front and 345 at the rear, and brake calipers finished in a contrasting yellow color. Read more>>

Professor, are you a hardcore Schumacher fan as well?

Professor, who is better looking, sorry faster, Nico or Keke ?

A cheese slicer or another angle of the MP4-26 rear wing ?

Source: Adam Cooper, Journalist on the FIA F1 World Championship trail, been to every single Grand Prix since Japan 1994

Professor just to let you know ...

The Vodafone McLaren Mercedes Teddy has returned, softer and cuddlier than ever! http://bit.ly/fneEyJ

Quick Nick is QUICKEST

Press Releases | 12/02/2011, lotusrenaultgp.com:

Nick Heidfeld got his first taste of the R31 today in Jerez and ended session at the top of the timesheets.

Driver: Nick
Chassis: R31-01
Fastest Lap: 1:20.361
Position: P1
Total laps: 86

Eric Boullier: “Today we had the chance to give Nick time in the car and we carried out a big evaluation. Our first feelings are very positive: he worked well with the team, gave good feedback and improved the car during the day. We managed to cover 86 laps and the times are encouraging, which is also thanks to Robert and Vitaly’s early feedback and the hard work of everybody in the team.” Read more>>

Send your get well messages to Robert Kubica

James Allen:

Send your get well messages to Robert Kubica to fans@lotusrenaultgp.com - they will be passed to him.