Does the PACE trial represent professional misconduct?

World exclusive: picture of one of the "recovered" patients in the PACE trial

Once again a study demonstrating physical abnormalities in ME/CFS decides to ignore their own findings

By Ruth R Miller1 , W Darlene Reid2 , Andre Mattman3 , Cristiane Yamabayashi4 , Theodore Steiner5 , Shoshana Parker6 , Jennifer Gardy7 , Patrick Tang and David M Patrick, Published online: 20 May 2015:

Conclusions

This submaximal exercise testing protocol revealed attenuated changes in oxygenated and deoxygenated hemoglobin, which may be attributable to poor exercise tolerance and rapid fatigue seen in ME/CFS compounded by decreased fitness. Because of the variable responses among participants, it does not provide a clear distinction between cases with ME/CFS and healthy controls and is therefore not a useful diagnostic marker. However, testing did reveal a disproportionate level of perceived exertion and lower force production in cases with ME/CFS, and in two cases, adverse responses to low levels of exercise. The repetitive handgrip protocol may be useful to screen individuals for adverse responses and other conditions, including mitochondrial disease. It may also be useful for stratifying ME/CFS sufferers to determine appropriate levels of exercise prescription.


There are a number of issues with this study. I'm just going to mention a few.

Obviously the first one is "This submaximal exercise testing protocol revealed attenuated changes in oxygenated and deoxygenated hemoglobin, which may be attributable to poor exercise tolerance and rapid fatigue seen in ME/CFS compounded by decreased fitness."
So you find abnormalities which you don't want to find and and then you just come up with some nonsense to say they're not important. Typical Pinocchio doctoring.

If you look at the average BMI of the healthy controls and patients then there is a massive difference.
In patients it's on average 25.1 and in healthy controls 20.8. Simply put, I'm 175 cm. If my BMI was 25.1, my weight would be 76.9 kg and if my BMI was 20.8 it would be 63.7 kg. And that's a difference of 13.2 kilo which is 17.2 percent and that's a massive difference. And you cannot use healthy controls who are very slim and compare those with patients that are not.

If you look at the following sentence, "All cases and no healthy controls fit both the Canadian case definition and the CDC Fukuda definition of ME/CFS" it actually means that healthy controls can actually have ME/CFS as defined by Fukuda or defined by CCC but not by both. Which means that the healthy controls might not be healthy controls at all and they might actually have ME/CFS.

The researchers selected 25 ME patients and 25 healthy controls but they only analysed 16 of both. In the patient group they explained why they couldn't use 6 of the 25, which means that 3 were unaccounted and in the healthy controls 5 were accounted and 4 unaccounted. And in a small group that's a large percentage which is unaccounted. That should not happen but that is something which happens a lot in denial doctoring as Frank Twisk has shown repeatedly when he analysed studies by Nijmegen etc

There is one other interesting thing I would like to mention. "The CCD study pre-screened 102 people and excluded 52:24 with another diagnosis (e.g., sleep apnea, hypothyroidism, etc.), three who did not meet the case definitions, 11 that declined to participate, and 14 eligible patients that could not be matched to a control."

So 102 patient had a diagnosis of ME/CFS and after checking with the CCC criteria, in 24 of them, which is 23.5 %, the diagnosis was wrong. Which shows once again that doctors are not very good at diagnosing ME/CFS.

So once again a study demonstrating physical abnormalities in ME/CFS decides to ignore their own findings because it doesn't fit with their own ideas about ME/CFS for which they do not have any proof and they use psychoblahblah to do as if these physical abnormalities are not important. Whereas these abnormalities are actually "pretty diagnostic of impaired oxidative phosphorylation which is presumably where the "fear " of excercise comes from. Many patients with syndromic mitochondrial diseases fear excercise because their symtoms can worsen dramatically during or following the activity." As GJ rightly wrote on Facebook.


Their conclusion should have been something like: this clearly shows physical abnormalities related to exercise pointing towards mitochondrial problems in patients with ME/CFS which might aid doctors in diagnosing this condition

FDA plans drug development to treat Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME/CFS)

 

Drug Development for Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME/CFS)

 

FDA will be planning a series of activities focused on drug development to treat the symptoms of Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME/CFS) in order to explore:

• The burden of disease that impacts the quality of life for ME/CFS patients;
• The quantitative outcome measures or endpoints that determine if disease symptoms improve with intervention; and
• How drug efficacy should be clinically tested based on these endpoints or measurements.

Please send correspondence regarding ME and CFS to ME-CFS-Meeting@fda.hhs.gov.

Read more>>

White blood cells as serial killers save patients lives

By Robert Bazell, Chief science and health correspondent:
NBC News updated 8/10/2011 7:20:14 PM ET Doctors have treated only three leukemia patients, but the sensational results from a single shot could be one of the most significant advances in cancer research in decades. And it almost never happened.

In the research published Wednesday, doctors at the University of Pennsylvania say the treatment made the most common type of leukemia completely disappear in two of the patients and reduced it by 70 percent in the third. In each of the patients as much as five pounds of cancerous tissue completely melted away in a few weeks, and a year later it is still gone. The results of the preliminary test “exceeded our wildest expectations,” says immunologist Dr. Carl June a member of the Abramson Cancer Center's research team. Dr. Edgar Engleman, a cancer immunologist at Stanford University School of Medicine who was not involved in the research calls the results “remarkable ... great stuff.”

The Penn scientists targeted chroniclymphocytic leukemia (CLL), the most common type of the blood disease. It strikes some 15,000 people in the United States, mostly adults, and kills 4,300 every year.

Chemotherapy and radiation can hold this form of leukemia at bay for years, but until now the only cure has been a bone marrow transplant. A bone marrow transplant requires a suitable match, works only about half the time, and often brings on severe, life-threatening side effects such as pain and infection. In the Penn experiment, the researchers removed certain types of white blood cells that the body uses to fight disease from the patients.

Using a modified, harmless version of HIV, the virus that causes AIDS, they inserted a series of genes into the white blood cells. These were designed to make to cells target and kill the cancer cells. After growing a large batch of the genetically engineered white blood cells, the doctors injected them back into the patients. In similar past experimental treatments for several types of cancer the re-injected white cells killed a few cancer cells and then died out. But the Penn researchers inserted a gene that made the white blood cells multiply by a thousand fold inside the body. The result, as researcher June put it, is that the white blood cells became “serial killers” relentlessly tracking down and killing the cancer cells in the blood, bone marrow and lymph tissue.

Professor Hooper: Wessely’s Words Revisited

Malcolm Hooper 30th July 2011

with acknowledgement to members of the ME community

Tom Feilden’s notably excited introduction to his interview with Professor Simon Wessely about the disorder ME on the BBC’s Today programme on 29th July 2011 exemplified a failure to exercise the requisite journalistic neutrality when reporting a “story” (http://news.bbc.co.uk/today/hi/today/newsid_9550000/9550947.stm).

Feilden seemed excessively eager to inform the nation about Wessely’s claims of how he, a genuine scientist, is harassed and threatened by patients with ME to the extent that his mail has to be routinely scanned before he is allowed to access it and how he needs police protection as he has received death threats.

A dramatic and disturbing story by Wessely, but is it true or is it, as some people believe, an attempt to denigrate sick people and direct attention away from the ever-growing body of biomedical evidence which invalidates his own now-disproven beliefs about the disorder?

When challenged in the past to provide actual evidence – corroborated by the police -- of such threats to his life, did Wessely produce any evidence? The police take death threats seriously so each would be allocated a crime incident number. Have any of these alleged death threats been substantiated? Have there ever been any prosecutions and have they ever been reported in the press?

Insurance companies are watching Facebook and Twitter

Insurers are scouring social media for evidence of fraud

If someone receiving disability benefits for a bad back brags on Facebook or Twitter about finishing a marathon, chances are their insurance company will find out and stop the checks.

By Shan Li, Los Angeles Times, January 25, 2011:

Now there's another reason to be careful about what you post on Facebook: Your insurance company may be watching.

Nathalie Blanchard found out the hard way.

Struggling with depression, the 30-year-old from Quebec, Canada, took a medical leave in early 2008 from her job as an IBM technician. Soon after, she began receiving monthly disability benefits from her insurer, Manulife Financial Corp.

A year later and without warning, the payments stopped.

A representative of the Toronto insurance company told Blanchard that Manulife used photos of her on Facebook — showing her frolicking at a beach and hanging out at a pub — to determine she was depression-free and able to work, said Tom Lavin, Blanchard's attorney.

"They just assumed from the pictures that she was a fraud," Lavin said, "without investigating further before terminating Nathalie's benefits."

Blanchard sued Manulife, accusing Manulife of failing to talk to her doctor and neglecting to inform her before cutting off payments. The case is scheduled for trial ... Read more>>

Sick and Disabled people in the UK will loose a BIG part of their income

contribution by Sue Marsh:

I know there are lots of cuts happening all at once and group after group must be lobbying for column inches or news slots.

Students, middle income child benefit recipients, housing benefit claimants frightened they are about to become homeless, nurses, fire fighters, police, local councils – we all want you to take our cause to heart, to tell people what is really happening on our behalf.

But there is a group who might as well not exist. We have no-one but ourselves, yet our voices are probably the weakest in society.

Most of us can’t physically march, some can’t even speak at all and others don’t know what is being done to them. We have no networks of influential contacts, most can’t attend rallies or flash-mobs.

Sick and Disabled people are now facing cuts of up to a third in their incomes. Since George Osborne’s Comprehensive Spending Review last October, there has been a steady drip-drip of almost daily announcements that have stripped away decades of hard-fought dignity in just a few short months.

Employment Support Allowance (ESA) will now be time limited to 1 year (Cost : £4752.80 pa)

2.27 Million of the 2.5 million claiming ESA will now be considered fit for work (91%)

Up to 750,000 of the most profoundly disabled who claim DLA will also be found fit and have their benefits stopped (25%)

Benefit rates have been frozen (Potential loss of up to 15% of income over 5 yr parliament)

Housing benefit caps will make many disabled people homeless

Work support schemes are being scrapped at a time when unemployment is already creeping towards 3 million. The “Access to Work” programme will be scrapped, which helped small and medium sized businesses adapt premises, job centres face cuts and a private, American firm (ATOS) have been given an almost total monopoly in forcing us into work, paid commission for each “success”

Local councils face cuts so vast (27% over 5 yr parliament) that they have already started to cut vital support services – pulling funding for hospices, axing specialist school provision, closing hospital wards, cutting care packages – the list goes on and on. This article might help to put things into perspective http://diaryofabenefitscrounger.blogspot.com/2011/01/nowhere-to-turn-for-vulnerable.

Disability Living Allowance is to be scrapped and replaced, whilst adults needing full time residential care and children in hospital will have the basic right of mobility taken away from them, with the scrapping of mobility payments for these groups.

In exactly one month, DLA is due to be slashed by parliament.

By the 14th February, if sickness or disability come for you or your loved ones, (and sadly, the statistics are that one day, in some form, they will) you may find that all those NI payments and tax contributions have been for nothing.

You may find yourself totally dependent on a partner financially, unable to get treatment, care or equipment to make your already unrecognisable life liveable.

If you have no partner, you may find yourself in abject poverty, or even homeless as you try to face the un-faceable. Read more>>

No XMRV Detected in tiny group of Fibromyalgia Patients but ONLY PCR used

By Luczkowiak J, Sierra O, González-Martín JJ, HerreroBeaumont G, Delgado R.:

During January 2010, blood samples were collected from 15 patients in whom
fibromyalgia had been previously diagnosed according to American College of
Rheumatology criteria (www.rheumatology.org/practice/clinical/classification/
fibromyalgia/1990_Criteria_for_Classification_Fibro.pdf). Ten healthy blood donors served as controls.

<--->

Using highly sensitive PCR tools and a multiple set of primers to detect xenotropic
and polytropic MLV–related sequences, we found no evidence of MLV-related sequences in blood cells from fibromyalgia patients or controls.

<--->

Nevertheless, with this relatively small population we cannot absolutely exclude an association of XMRV or polytropic MLV–related viruses with fibromyalgia.
Source: http://www.cdc.gov/eid/content/17/2/pdfs/10-0978.pdf

XMRV Testing in the UK & Europe

Tests currently offered at RED Laboratories:

• Co-culture
• Serology
• Detection of MLV-related viruses by PCR and sequencing

Co-culture is very sensitive and most importantly, is the only test that can distinguish active infections from latent ones. One limitation is the fact that it is performed from blood cells, it may therefore not be able to detect a virus which is present in another part of the body.

Although it is likely that most virus variants are able to infect this target cell line, this has not yet been demonstrated; therefore there is a possibility that certain viruses (like MLVs) can not be detected by this technique.

What Professor Simon Wessely does not want you to know ...

"Simon Wessely is a British psychiatrist. He is professor of epidemiological and liaison psychiatry at the Institute of Psychiatry, King's College London and head of its department of psychological medicine, as well as Director of the King's Centre for Military Health Research. He is also honorary Consultant Psychiatrist at King's College Hospital and Maudsley Hospital, as well as Civilian Consultant Advisor in Psychiatry to the British Army.[Witapedia] .

What is not repoerted in Witapedia is Simon Wesselys association with the insurance industry..........

You may be aware that there is considerable controversy surrounding the subject of ME/CFS and that patient groups have acquired a reputation for being at loggerheads with a group of UK psychiatrists, collectively known as the Wessely school, who state that ME/CFS is a somatoform/functional disorder (i.e. psychiatric)

Somatoform / functional disorders have no scientific basis whatsoever. By contrast..."

Bending the rules

"Critics of new medical tests aimed at getting claimants off benefits and into work say they are target-driven measures that penalise genuinely ill people."

By Melissa Viney
The Guardian, Wednesday 28 October 2009

"Had Anna Wood realised that by bending down to pick up an object off the floor she would be deemed fit to work, perhaps the 33-year-old former academic would have thought twice. Wood, who had been forced to give up a prestigious fellowship position at Strathclyde University last year after developing severe ME, was made to perform the exercise as part of a medical test that all claimants of the new sickness benefit for ill and disabled people have to undertake.

"The doctor came and asked me lots of questions and filled in a form," she recalls. "I then got a letter saying, 'You've only got 12 points. We need 15. You don't qualify.' He had asked me to bend down and pick something off the floor and I did it. The point is I can't do it repeatedly, and I don't see how that can mean I can work. There was nothing in the test that related to my stamina and energy.

"How any normal person could read my medical report and think, 'Oh yes, she can work', is absolutely beyond me."

Wood points out a section in the report that states: "The healthcare professional opined that Dr Wood is likely to have significant instability regarding walking, standing and using stairs. She cannot hoover, wash dishes, make a bed and struggles to stand in the kitchen and needs to hold onto the rail using stairs ... due to fatigue and pain."

This tough medical test, called the work capability assessment (WCA), is at the heart of controversial changes to sickness benefit that were introduced last October when employment support allowance (ESA) replaced incapacity benefit (IB) for new claimants.

The test contains a series of questions, called "descriptors", that relate to physical and mental functions, and from which claimants score points. The test fails ..."

Mind and body

Source: The Scotsman: Published Date: 27 October 2009

"Thanks for your excellent, informative article on the possibility that the newly discovered retrovirus xmrv causes myalgic encephalomyelitis (Living, 10 October).

The UK's quarter of a million sufferers finally have some hope of effective treatment.

ME has been classified as a physical, neurological illness by the World Health Organisation since 1969. Despite this, for 25 years all UK taxpayer research and treatment funding has gone to psychiatrists, who insist it is an "abnormal illness belief".

The time is overdue for research funding into ME to be placed in the hands of immunologists. Research into psychological treatments should be cancelled to fund this.

HILARY PATTEN

Beaconsfield Way

Frome, Somerset"

Health Secretary clarifies Government position on disability benefits

careandsupport.direct.gov.uk:

"22 October 2009
The Secretary of State for Health has made it clear that Disability Living Allowance for the Under 65s will not be affected by Government plans to create a National Care Service.

Speaking at the National Children and Adult Services Conference in Harrogate, Andy Burnham MP said: "I am encouraged by the response to our Big Care Debate and welcome the fact that other political parties are beginning to put their ideas on the table. There are big differences between what we are saying but we are beginning to create what I wanted to see - unstoppable momentum for legislation in the next Parliament.

"But, while the debate is moving quickly, I do want to stress that the door is wide open for discussion. We are still in a consultation period. No decisions have been made on funding options. We are still listening – about funding, about structures, and about how to build a forward-looking system of care.

"One avenue I do want to close down, however, is the debate and controversy over Disability Living Allowance.

"We recognise that this is an important benefit for disabled people, and I can state categorically that we have now ruled out any suggestion that DLA for under-65s will be brought into the new National Care Service.

"This is because, whilst there will be increases in the numbers of disabled people of working age who need care, the majority of the people needing care in the future will be older people.

"However, we do think there may be a case for bringing together elements of some disability benefits, such as Attendance Allowance, with social care funding, to create a new care and support system to provide for the needs of older and disabled people.

"But the important principle is that people receiving any of the relevant benefits at the time of reform would continue to receive an equivalent level of support and protection under a new and better care and support system.

"And let's not forget, everyone - regardless of wealth or asset base – will benefit from the protection and peace of mind that the National Care Service will provide."

The Government is currently carrying out a consultation – the Big Care Debate - on the new National Care Service, a vision for which was set out in July’s Green Paper Shaping the Future of Care Together. The Big Care Debate continues until 13th November."