Manualised protocol of integrated CBT and GET

Research abstract:

BACKGROUND: Medically-unexplained chronic fatigue states are prevalent, and challenging to manage. Cognitive behavioural therapy (CBT) and graded exercise therapy (GET) are effective in clinical trials. Evaluation of delivery in a standard health care setting is rare. An integrated treatment program with individualised allocation of resources to patients’ needs, was developed and implemented though an academic outpatient clinic. It was hypothesised that the program would result in similar responses to those observed in the clinical trials.

AIM: To evaluate the outcomes of an integrated, 12-week CBT and GET program delivered by exercise physiologists and clinical psychologists.

METHODS: Consecutive eligible patients (n = 264) who met diagnostic criteria for chronic fatigue syndrome (CFS) or post-cancer fatigue (PCF) were evaluated with self-report measures of fatigue, functional capacity, and mood disturbance, at baseline, end-treatment (12-weeks), and follow-up (24-weeks). A semi-structured interview recording the same parameters was conducted pre- and post-treatment by an independent clinician. Primary outcome (fatigue) was analysed by repeated measures ANOVA and predictors of response was analysed by logistic regression

RESULTS: The intervention produced sustained improvements in symptom severity and functional capacity. A substantial minority of patients (35%) gained significant improvement, with male gender and higher pain scores at baseline predicting non-response. A small minority of patients (3%) worsened.

CONCLUSIONS: The manualised protocol of integrated CBT and GET was successfully implemented confirming the generally positive findings of clinical trials. Assessment and treatment protocols are available for dissemination to allow standardised management. The beneficial effects described here provide the basis for ongoing studies to further optimise the intervention and better identify those most likely to respond.

Outcomes and predictors of response from an optimised, multi-disciplinary intervention for chronic fatigue states, by CX Sandler, BA Hamilton, SL Horsfield, BK Bennett, U Vollmer-Conna, C Tzarimas, AR Lloyd in Intern Med J. 2016 Sep 13 [Epub ahead of print]

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PACE trial results were grossly exaggerated

Occupy ME blog post, by Jennie Spotila, 21 Sep 2016: PACE: Grossly Exaggerated

On September 9, 2016, Queen Mary University of London released data from the PACE trial in compliance with a First Tier Tribunal decision on a Freedom of Information Request by ME patient Alem Matthees. The day before, the PACE authors had released (without fanfare) their own reanalysis of data using their original protocol methods.

Today, Matthees and four colleagues published their analysis of the recovery data obtained from QMUL on Dr. Vincent Racaniello’s Virology Blog.

These two sets of data reanalysis blow the lid off the PACE trial claims.

The bottom line? The PACE trial authors’ claims that CBT and GET are effective treatments for ME/CFS were grossly exaggerated.

Improvers

First, take a look at what the PACE authors’ own reanalysis showed.

When they calculated improvement rates using their original protocol, the rates of improvement dropped dramatically.

pace-per-protocol

As shown in the above graph by Simon McGrath, the Lancet paper claimed that 60% of patients receiving CBT or GET improved. But the reanalysis using the original protocol showed that only 20% of those patients improved, compared to 10% who received neither therapy. In other words, half of the people who benefited from CBT or GET would likely have improved anyway. Remember, the PACE authors made changes to the protocol after they began collecting data in this unblinded trial.

Those changes, used in the Lancet paper, inflated the reported improvement by three-fold.

One would think that the PACE authors would be at least slightly embarrassed by this, but instead they continue to insist:

“All three of these outcomes are very similar to those reported in the main PACE results paper (White et al., 2011); physical functioning and fatigue improved significantly more with CBT and GET when compared to APT [pacing] and SMC [standard medical care].”

Sure, twice as many people improved with CBT and GET compared to standard medical care. But 80% of the trial participants DID NOT IMPROVE. How can a treatment that fails with 80% of the participants be considered a success?

Not only that, but the changes in the protocol were like a magic wand, creating the impression of huge gains in function: 60% improved! The true results, however, are close to a failure of the treatment trial.

Recovery

Today’s publication on Dr. Racaniello’s blog presents the analysis of the recovery outcome data obtained by Alem Matthees. Once again, the mid-stream changes to the study protocol grossly inflated the PACE results.

post-trial-changes

Source: Matthees, et al.

As the graph from the Matthees paper shows, the PACE authors claimed more than 20% of subjects recovered with CBT and GET. Using the original protocol, however, those recovery rates drop by more than three-fold. Furthermore, there is no statistically significant difference between those who received CBT or GET and those who received standard care or pacing instruction. In other words, the differences among the groups could have easily been the result of chance rather than the result of the therapy delivered.

Matthees, et al. conclude, “It is clear from these results that the changes made to the protocol were not minor or insignificant, as they have produced major differences that warrant further consideration.”

In contrast, long time CBT advocate Dr. Simon Wessley told Julie Rehmeyer that his view of the overall reanalysis was, “OK folks, nothing to see here, move along please.”

Taken together, the reanalysis of data on improvement and recovery show that the changes in the protocol resulted in grossly inflated rates of improvement and recovery. Let me state that again, for

clarity: the PACE authors changed their definitions of improvement and recovery and then published the resulting four-fold higher rates of improvement and recovery without ever reporting or acknowledging the results under original protocol, until now. Furthermore, the PACE authors resisted all efforts to obtain the data by outside individuals, spending £250,000 to oppose Matthee’s request alone.

Conclusions

Tuller’s detailed examination of the PACE trial and these new data analyses raise a number of questions about why these changes were made to the protocol:

  • Were the PACE authors influenced by their relationships with insurance companies?
  • Did they make the protocol changes after realizing that the FINE trial had basically failed using its original protocol?
  • Why did they change their methods in the middle of the trial? (Matthees, et al. note that changing study endpoints is rarely acceptable)
  • Were they influenced by the fact that the National Health Service expressed support for their treatments before the trial was even completed?
  • Since data collection was well underway when the changes were made, and because PACE was an unblinded trial, we have to ask if the PACE authors had an idea of the outcome trends when they decided to make the changes?
  • Was their cognitive bias so great that it interfered with decisions about the protocol?
  • Did the PACE authors analyze the data using the original protocol at any point? If so, when? How long did they withhold that analysis?

The grossly exaggerated results of the PACE trial were accepted without question by agencies such as the Centers for Disease Control and institutions such as the Mayo Clinic. The Lancet and other journals persist in justifying their editorial processes that approved publication of these grossly exaggerated results.

The voices of patients have been almost unilaterally ignored and actively dismissed by the PACE authors and by journals. We knew the PACE results were too good to be true. A number of patients worked to uncover the problems and bring them to the attention of scientists.

Their efforts went on for years, and finally gained traction with a broader audience after Tuller and Racaniello put PACE under the microscope.

For five years, the claim that CBT and GET are effective therapies for ME/CFS has been trumpeted in the media and in scientific circles.

Medical education has been based on that claim. Policy decisions at CDC and other agencies have been based on that claim. Popular views of this disease and those who suffer with it have been shaped by that claim.

But this claim evaporates when the PACE authors’ original protocol is used. Eighty percent of trial participants did not improve. Not only that, but we do not have any data on how many people in that group of 80% were harmed or got worse. CBT and GET may not be neutral therapies worth trying in case you fall in that lucky 20% who improved spontaneously or due to the treatment. We don’t know how many people got worse with these therapies, so we cannot assess the risks.

The end result is this: the PACE authors made changes to their protocol after data collection had begun, and published the inflated results. But when the original protocol is applied to the data, CBT and GET did not help the vast majority of participants. The PACE trial is unreliable and should not be used to justify the prescription of CBT and GET for ME patients.

As Matthees, et al., stated in their paper:

“The PACE trial provides a good example of the problems that can occur when investigators are allowed to substantially deviate from the trial protocol without adequate justification or scrutiny. We therefore propose that a thorough, transparent, and independent re-analysis be conducted to provide greater clarity about the PACE trial results.

Pending a comprehensive review or audit of trial data, it seems prudent that the published trial results should be treated as potentially unsound, as well as the medical texts, review articles, and public policies based on those results.”

The reanalysis:

Virology blog: No ‘Recovery’ in PACE Trial, New Analysis Finds, by David Tuller, 21 Sep 2016

More articles:

Stat news: Bad science misled millions with chronic fatigue syndrome. Here’s how we fought back, By Julie Rehmeyer, 21 Sep 2016

ME Action: Patients’ reanalysis sinks PACE’s “recovery” claims 21 Sep 2016

Solve ME/CFS initiative: Preliminary analysis of newly released PACE trial data confirms initial publication results were unsound 21 Sep 2016

Health rising: Data analysis Puts PACE Trial on Slippery Slope to Retraction 22 Sep 2016

Virology blog: Trial By Error, Continued: The Real Data David Tuller 22 Sep 2016

Newsworks blog: Was advice for people with Chronic Fatigue Syndrome all wrong? Julie Rehemeyer 6 Oct 2016

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Patient perceptions regarding possible changes to the name & criteria for CFS & ME

Research article abstract:

For decades, researchers and patients have been debating the terms and criteria for chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME).

This has led to considerable difficulties in clearly communicating to the public the nature of these illnesses, and has produced considerable methodological challenges for researchers who study these illnesses.

If different laboratories do not employ comparable criteria to select patients, this will have negative consequences for understanding epidemiology, etiology, diagnostic and treatment approaches.

In part due to this ongoing controversy, the Institute of Medicine in 2015 recommended new criteria and a new name.

The present study surveyed a relatively large sample of patients both in and outside the US to determine attitudes toward the primary names and criteria that have been used to characterize these patients.

Assessing patient opinions is an activity that might help provide gatekeepers (i.e., federal officials, scientific and patient organizations) with valuable input for ultimately clarifying this debate regarding names and criteria.

Tble 3: Opinion of current names: #CFS, #ME/#CFS, #NDS, #SEID, #ME

Table 4: Opinions of current case definitions.

Patient Perceptions Regarding Possible Changes to the Name and Criteria for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, by Leonard A. Jason, Laura Nicholson, and Madison Sunnquist in Journal of Family Medicine & Community Health [18 Sep 2016]

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Get your MillionsMissing twibbon

Download the #MillionsMissing twibbon.

twibbon-example

Add the #MillionsMissing filter to your photo on Facebook and Twitter!  All it takes is the click of a button. The page also provides:

  • easy-to-use tweets and Facebook posts announcing your support for the #MillionsMissing protest
  • a place to create an email about the protest, with a form-letter and a place where you can add a personalized message
  • a widget for your site in easy to copy-and-paste htmla forum to discuss the campaign with others

Please share widely!  Help get the word out about the #MillionsMissing protest.

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CBT in CFS: a narrative review on efficacy and informed consent

Review abstract:

Cognitive behavioural therapy is increasingly promoted as a treatment for chronic fatigue syndrome. There is limited research on informed consent using cognitive behavioural therapy in chronic fatigue syndrome. We undertook a narrative review to explore efficacy and to identify the salient information that should be disclosed to patients.

We found a complex theoretical model underlying the rationale for psychotherapy in chronic fatigue syndrome. Cognitive behavioural therapy may bring about changes in self-reported fatigue for some patients in the short term, however there is a lack of evidence for long-term benefit or for improving physical function and cognitive behavioural therapy may cause distress if inappropriately prescribed.

Therapist effects and placebo effects are important outcome factors.

Cognitive behavioural therapy in the treatment of chronic fatigue syndrome: a narrative review on efficacy and informed consent, by Keith J Geraghty, Charlotte Blease in Journal of Health Psychology, 15 September 2016

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ME/CFS history, diagnostic criteria & prevalence – new e-book

E-book by Mary Gloria C. Njoku, 1 Sep 2016: Myalgic, Encephalomyelitis/Chronic Fatigue Syndrome:  History, Diagnostic Criteria and Prevalence
ISBN: 978-1-4689-7326-6         Foreword by Prof Leonard Jason

Overview:

This work is a comprehensive review of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) studies that were conducted with both community-based and hospital-based samples. A review of the prevalence of fatiguing illnesses in varied countries of the world shows evidence that the rates of fatigue and its syndromes vary across settings and countries, and that the methodology used impacts findings.

Studies have also shown the presence of a severe and disabling form of fatigue that affects the ability of individuals to engage in normal occupational, educational, social and personal daily activities.

The history, definition and research findings in ME/CFS are presented to promote an understanding of the work that has been accomplished in this research area in varied continents of the world. It is hoped that some of the issues addressed in this work will help people to better understand ME/CFS and fatiguing illnesses reported in varied countries.

Perhaps, the understanding that ME/CFS is a global condition might encourage both scientists and practitioners to work towards streamlining the definition and diagnostic criteria to strengthen work in this area and ultimately improve the treatment of persons with ME/CFS.

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Choosing wisely Wales: patients in Wales urged to take more control

BBC news article, by Owain Clarke, 16 September 2016: Choosing Wisely aims for doctor-patient ‘culture shift’

Patients in Wales are being urged to take more control of decisions about the care and treatments they receive, as part of a new medical movement.

Choosing Wisely Wales aims for a more equal doctor-patient relationship.

It comes amid worries up to 20% of treatments at best do no good but at worst could harm patients – something a top doctor has called “clearly unacceptable”.

But there are fears the move might be interpreted as an effort to cut costs.

Those behind the movement, which already operates in 18 countries, want clinicians to have “open and honest conversations” about treatments, and say patients should be less passive, have more input and explore all alternatives.

Dr Paul Myres, programme leader and chairman of the Academy of Medical Royal Colleges in Wales, said:

“Amazingly, I think in Wales in particular there’s still the idea that ‘doctor knows best’ and, interestingly, some clinicians who come to work here say patients are that little more passive, not so assertive.

“We’re encouraging them to be a bit more questioning in discussions with their clinicians.”

It has been argued that if patients have “greater ownership” of the care they receive, they are more likely to follow a course of treatment, reject treatments that have little benefit, and may be less likely to return to the doctor. The approach, it has been argued, could also lead to significantly better results for patients.

Central to the idea are four questions a patient needs to ask:

_91182928_choosewiselyDr Myres admitted “there was likely to be reluctance on both sides” and said the approach could be interpreted as an attempt to save money.

“It’s not about cost-cutting, it’s about reducing waste,” he said.

“If something is wasted on a patient, then a person who really needs that treatment could face a delay.”

It is also hoped the approach could help reduce the number of “unnecessary tests and treatments”, which could result in shorter waiting times for patients with a genuine need.

This could include patients demanding antibiotics for colds and sore throats or those expecting scans for basic back pain.

But it could also involve serious diseases such as cancer, where patients might feel under pressure to accept invasive treatment which could leave them with a worse quality of life.

WHAT DO PATIENTS THINK?

John Skipper, a retired serviceman, was formerly on the board of Community Health Councils in Wales. In 2011, aged 60, he was diagnosed with prostate cancer, which he described as “a wake up call”.

“I needed to know more about my condition, I needed to know what might be the best outcome for me and be part of a team looking after me and not be on the outside looking in,” he said.

“With cancer there are many interventions possible and some carry more risks than others. Removing the prostate gland can have some real side effects.

“I was talking with my consultant and with other professionals about what other options were available to me.

“They found that useful and for me it took away a lot of the stress and I felt empowered and part of the team looking after me.”

He said the Choosing Wisely concept meant patients were part of their own care.

“It enables the doctor to do what they’re trained to do. You’re guiding them to an option that they can perform, but at least you can say ‘this is what I would prefer’,” he said.

“We often have that discussion about our car when we take it in for a service, so why can’t we have that discussion about our body?

“I think this whole culture has to be win-win for the NHS. It’s not a bottomless pit of money but it has capability and it’s about optimising the capability you have and dealing with realism.”

Physiotherapist Graeme Paul-Taylor said giving every patient with back pain a MRI scan was not the answer

WHAT DOES THE MEDICAL PROFESSION THINK?

Graeme Paul-Taylor, a physiotherapist and lecturer at Cardiff University, has a lot of experience working with patients with lower back pain.

He said there was a growing belief that sending people for a MRI scan was the “gold standard” to provide all the answers.

“What’s important is to exercise and to get moving and for a lot of people that gets them the results they need,” he said.

“But over the last couple of decades, with the real quality and sensitive scanning and imaging that can be done, people are starting to believe that the structural changes that are seen on a MRI scan are the cause of the pain.

“We know if you were to scan people with no symptoms of back pain you’re still likely to see those changes.”_91211282_choosewisely3

Dr Ffion Williams, from Prestatyn, Denbighshire, said the initiative was all about sharing information with patients.

“It’s allowing people to make their own decisions so we’re a conduit for information. It’s not the old system that we’re the doctor and ‘you do what we tell you’,” she said.

“Sometimes it’s going to be a decision from a patient that I’m not going to agree with but it’s also allowing the patient to make the decision but knowing they’ve had the right information to make it.”

Dr Myres, a former Wrexham GP, concedes consultation times may need to be lengthened.

“Really good conversations need more time up front – even though research suggests actually it can be done in 10 minutes,” he said.

“But the payback is if a patient fully understands and is involved in the decisions, they are more likely to comply and less likely to come back.”

Choosing Wisely Wales is the first campaign of its type to be launched in the UK and is being led by the Academy of Medical Royal Colleges Wales, in partnership with Public Health Wales and Community Health Councils.

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Viruses and CFS: statement by Prof Robert Naviaux

Open Medicine Foundation blog post, 9 Sep 2016: Viruses and CFS: Statements by Ron Davis and Bob Naviaux

RobertKNaviaux

Dr Bob Naviaux:

Question – Many ME/CFS experts have improved the symptoms in some patients by treating with antivirals and Ampligen (polyIC double stranded RNA). I think this proves that ongoing viral infections are causing our symptoms. It is not merely “tired patients” who are stuck in a lowered metabolic state because of a past trigger (which now is gone).

First of all, it is important that people actually read our paper first before drawing conclusions from news reports and blogs and criticizing something that we never said. I have seen a number of generalizations starting to appear in blogs and reports by journalists in even good newspapers and magazines that are starting to drift too
far afield from the actual science in our paper.

We devoted a section of the paper to this and related questions about infections. The section title was: “A Homogeneous Metabolic Response to Heterogeneous Triggers”.

It concluded with the sentence:

“Despite the heterogeneity of triggers, the cellular response to these environmental stressors in patients who developed CFS was homogeneous and statistically robust.”

As background for this conclusion, I recommend reading our paper on this topic entitled, “Metabolic features of the cell danger response” (PMID 23981537).

Second, many people do not understand that the first response our body mounts against a viral, bacterial, or any kind of infection is metabolic. Yes, our chemistry is our first line of defense. Our chemistry reflects our instantaneous state of health. Innate immunity is coordinated by mitochondria and is an essential first step in developing adaptive immunity to any infectious agent. Without innate immunity there can be no antibodies and no NK cell activation, no mast cell activation, and no T cell mediated immunity.

In addition, all antivirals have metabolic effects that have nothing to do with inhibiting viral DNA or RNA synthesis directly. Many antiviral drugs inhibit the key metabolic enzyme SAdenosylhomocysteine Hydrolase (SAHH).

Inhibition of SAHH causes an increase in intracellular SAH levels. SAH is a potent inhibitor of DNA, RNA, protein, and small molecule methylation. This affects both viral and host cell epigenetics, gene expression, mRNA translation, and protein stability.

The inhibition of methylation reactions in the cell also affects neurotransmitter (dopamine, norepinephrine, and serotonin) and phosphatidylcholine membrane lipid
synthesis, folate and B12 metabolism, and many other reactions. So by giving antivirals, doctors are not just inhibiting viruses, they are also inhibiting many host cell metabolic functions.

Sometimes the inhibition of host cell functions can attenuate ME/CFS symptoms for a time, but in other cases, using potent antiviral drugs inhibits mitochondrial and methylation reactions and can delay a full recovery from ME/CFS.

Ampligen is a form of double stranded RNA called poly(IC), for poly inosinic:cytosinic acid. We have studied the action of polyIC extensively and have published this in our studies of autism and virology. It acts by binding to an innate immune receptor called TLR3, creating a simulated viral infection.

If you expose a pregnant animal to a single dose of polyIC at the beginning of the second trimester, she develops a 24-hour flu-like illness then completely recovers. However, her pups have social and cognitive abnormalities similar to autism for life. If you look at their brains, you find that they have activated microglia and brain inflammation for life.

In adults, Ampligen also binds the TLR3 receptor, and activates an incomplete antiviral response characterized by a non-MyD88 dependent activation of interferon and
other cytokines. Long-term use of polyIC carries a risk for toxicity because of chronic innate immune stimulation. In certain clinical situations like cancer or Ebola virus infection, the toxicity is actually part of the therapeutic effect.

Chronic interferon release causes flu-like symptoms, and the inhibition of mitochondrial protein translation. This can lead to secondary mitochondrial dysfunction. As I noted in an earlier Q&A response, sometimes the inhibition of mitochondrial function can make some
people with ME/CFS feel better temporarily because some symptoms can come from unbalanced overactivity of some of the hundreds of functions mitochondria perform. However, in the long term, any pharmacologic inhibition of mitochondrial function will delay a full recovery.

Third, latent and reactivated viral and bacterial infections can occur, but in the case of ME/CFS that has lasted for more than 6 months, this may be the exception rather than the rule.

Some doctors and scientists have not done a good job at educating patients and other scientists about the difference between serological evidence of infection in the form of antibodies like IgM and IgG, and physical evidence of viral replication like PCR amplification of viral RNA or DNA, or bacterial DNA.

We have learned in our autism studies with Dr. Judy Van de Water that supertiters of antibodies do not mean new or reactivated viral replication. Supertiters of IgG antibodies mean that the balancing T-cell and NK cell mediated immune activity is decreased.

This is a functional kind of immune deficiency that causes an unbalanced increase in antibodies. This is like the famous figure-and-ground illusion that shows the silhouette of two faces that also create the form of a vase.

Both things happen. But which is cause and which is effect? Increased IgG antibodies to CMV, EBV, HHV6, Coxsackie, etc. are not good evidence of a reactivated viral infection. This can be proven in most cases by trying to measure viral DNA or RNA by PCR in the blood or swollen lymph nodes. In most cases, supertiters of IgG are PCRnegative. There
are exceptions to this generalization.

Chronic PCR surveillance studies in healthy humans are showing that little waves of viral replication happen periodically throughout our lives. We have been, and are regularly infected by hundreds of viruses over a lifetime.

Sometimes this is obvious and causes a symptom like blisters or an ulcer around the mouth. However, most of the time these waves of viral replication are silent and produce no symptoms at all because they are handled in the background by the innate and cell-mediated immune system.

Even the deadly poliovirus infected 150 to 1800 people, producing only mild or unnoticed infections, for every one person who developed paralytic disease.

In most of the cases of ME/CFS that I have seen where IgG antibody titers have been measured before, during, and after antiviral therapy, the antibody titers remain high after treatment, even though the patient may report symptomatic improvement.

I believe the symptomatic improvement after antiviral treatment may have more to do with the metabolic effects of antivirals in ME/CFS than their action on viral replication. The good news is that this hypothesis can be studied scientifically and put to the test easily using the tools of PCR and metabolomics.

Good science needs to remain open, ask the questions without bias, design good experiments, take careful measurements, then have the courage to follow the data wherever they may lead.

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Viruses and CFS: statement by Prof Ron Davis

Open Medicine Foundation blog post, 9 Sep 2016: Viruses and CFS: Statements by Ron Davis and Bob Naviaux

Prof Ron Davis:

dr-ronald-davis-stanford

There is a great deal of evidence that a variety of viruses can initiate ME/CFS, but it is less clear that a virus is involved in sustaining the disease. However, some patients may have a continuous problem with viruses, especially those viruses we always carry like EBV and HHV6.

These viruses are usually kept in check by the immune system. Any suppression of the immune system can cause reactivation of these viruses (e.g., shingles). It is possible (we have new supporting data on this) that the immune system is somewhat impaired in ME/CFS, which will make it difficult to keep these viruses suppressed. If we can find the cause of this disease and cure it, this virus problem should go away.

Also, there is a common misunderstanding about viral infection among some patients and even some doctors. Most viral assays used by doctors test for the presence of antibodies to viruses, not the viruses themselves. The presence of antibodies shows that the person had a viral infection in the past, but does not constitute evidence that it is still present.

A direct assay for a virus is needed in order to find out if any virus is present. The current state-of-the-art assay is a PCR test for DNA or RNA from a virus. (Serology tests are tests for antibodies, not viruses.)

We are conducting these direct PCR assays in the Severely Ill Patient Study, as well as extensive DNA sequencing for any as-yet-undiscovered viruses. We need to keep an open mind and have all ideas on the table and follow the data.

Our goal is to find an accurate biomarker, find the cause, find a treatment for the cause, find a cure and then prevent the disease.

 

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MPs call for medical cannabis to be made legal

BBC news article, by Michelle Roberts, 13 September 2016: MPs call for medical cannabis to be made legal

Taking cannabis for medical reasons should be made legal, says a cross-party group of UK politicians.

canabis

The All Party Parliamentary Group on Drug Policy Reform says there is clear evidence cannabis could have a therapeutic role for some conditions, including chronic pain and anxiety.

It says tens of thousands of people in the UK already break the law to use the drug for symptom relief.

But the Home Office says there are no plans to legalise the “harmful drug.”

‘I know cannabis is illegal, but it is medicinal’

Plant cannabis contains more than 60 chemicals.

The All Party Parliamentary Group wants the Home Office to reclassify herbal cannabis under existing drug laws, from schedule one to schedule four.

This would put it in the same category as steroids and sedatives and mean doctors could prescribe cannabis to patients, and chemists could dispense it.

Patients might even be allowed to grow limited amounts of cannabis for their own consumption.

People with multiple sclerosis can legally take a cannabis-based medicine.

This licensed medicine, called Sativex, is a mouth spray and contains two chemical extracts (THC and CBD) derived from the cannabis plant.

Under current laws in England and Wales, cannabis is not recognised as having any therapeutic value and anyone using the drug, even for medical reasons, could be charged for possession.

Meet the man curing sick kids with cannabis

The NHS warns that cannabis use carries a number of risks, such as impairing the ability to drive, as well as causing harm to lungs if smoked and harm to mental health, fertility or unborn babies.

The All Party Parliamentary Group on Drug Policy Reform took evidence from 623 patients, representatives of the medical professions and people with knowledge of how medical cannabis was regulated across the world.

Medicinal cannabis use        (Source: APPG/UPA survey)

  • 37   average age of patient
  • 67%  try conventional medicines first
  • 37% don’t tell their doctor
  • 72% buy street cannabis
  • 20% grow their own

Risks and benefits
Co-chair Baroness Molly Meacher said: “Cannabis works as a medicine for a number of medical conditions.

“The evidence has been strong enough to persuade a growing number of countries and US states to legalise access to medical cannabis.

“Against this background, the UK scheduling of cannabis as a substance that has no medical value is irrational.”

The group commissioned a report by an expert in rehabilitation medicine, Prof Mike Barnes, which found good evidence that medical cannabis helps alleviate the symptoms of:

  • chronic pain (including neuropathic pain)
  • spasticity (often associated with Multiple Sclerosis)
  • nausea and vomiting, particularly in the context of chemotherapy
  • anxiety

And there was moderate evidence that it could help with:

  • sleep disorders
  • poor appetite
  • fibromyalgia
  • post-traumatic stress disorder
  • Parkinson’s symptoms

But there was limited or no evidence that cannabis helps:

  • dementia mood problems
  • epilepsy
  • bladder function
  • glaucoma
  • Tourette’s syndrome
  • Huntington’s disease
  • headache
  • depression
  • obsessive compulsive disorder
  • gut disorders
  • curb cancer growth

It found short-term side-effects of cannabis were generally mild and well tolerated, but that there was a link with schizophrenia in some long-term users.

“There is probably a link in those who start using cannabis at an early age and also if the individual has a genetic predisposition to psychosis. There should be caution with regard to prescription of cannabis for such individuals,” says the report.

Also, there is a small dependency rate with cannabis at about 9%, “which needs to be taken seriously but compares to around 32% for tobacco use and 15% for alcohol use”.

The evidence for cognitive impairment in long-term users is not clear but “it is wise to be cautious in prescribing cannabis to younger people, given the possible susceptibility of the developing brain”, says the report.

Smoking cannabis in a joint rolled with tobacco can make asthma worse and probably increases the risk of lung cancer.

Prof Barnes said:

“We analysed over 20,000 scientific and medical reports.

“The results are clear. Cannabis has a medical benefit for a wide range of conditions.

“I believe that with greater research, it has the potential to help with an even greater number of conditions.

“But this research is being stifled by the government’s current classification of cannabis as having no medical benefit.”

Cannabis is currently classified as a Class B drug, with possession carrying a maximum sentence of five years in jail or an unlimited fine.

Those supplying or producing cannabis face tougher penalties, with a maximum of 14 years in jail.

The drug comes in many different forms – hash is cannabis resin, while marijuana is the dried leaves and flowers of the plant.

A Home Office spokesman said:

“There is a substantial body of scientific and medical evidence to show that cannabis is a harmful drug which can damage people’s mental and physical health.

“It is important that medicines are thoroughly trialled to ensure they meet rigorous standards before being placed on the market.

“There is a clear regime in place, administered by the Medicines and Healthcare Products Regulatory Agency, to enable medicines, including those containing controlled drugs, to be developed.”

About 24 US states, Canada, Israel and at least 11 European countries already allow access to cannabis for medical use.

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