Getting It Wrong - Again: Britain Gives Massive Funding to More PACE-Like Studies

Reprinted with kind permission from Invest in ME.

On 16 September 2013 Bristol University issued a press release [1] which announced a grant of £1.2 million for Chronic Fatigue Syndrome research.

The grant to two researchers included one to Dr Esther Crawley - for research that seems to be effectively performing a PACE trial on children.

“The five-year study entitled ‘Investigating the treatment of paediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) has been awarded NIHR funding of over £864,000.”

“Dr Simon Collin, Research Fellow also in the School of Social and Community Medicine, will lead the first study of its kind to investigate CFS/ME in primary and secondary care in England. He will use data from the Clinical Practice Research Datalink (CPRD) to obtain an up-to-date estimate of the number of adults diagnosed with CFS/ME by GPs in England. Dr Collin will collect data from NHS specialist services for adults with CFS/ME, document the different approaches to treatment and investigate long-term outcomes.”

“The three-year study entitled ‘CFS in the NHS: diagnosis of Chronic Fatigue Syndrome in primary care and outcomes after treatment by specialist services’ has been awarded NIHR funding of £321,861.”

IiME comments

After the IIMEC8 conference and the Biomedical Research into ME Collaborative research meeting in London in May there was a real sense of ME entering into mainstream research with new interest from new researchers and focus on collaboration.

To hear of this massive amount of funding to one area, graded exercise - this time on children - is disappointing to say the least and indicates that nothing has been learned from the flawed and non-productive debacle of the PACE trial.

Bristol University still uses the prevalence figures of 600 000 in the press release - an issue that was debated at the MRC/SMC collaborative grouping, of which Dr Crawley is vice chairman. The minutes of that group from 19 July 2013 state that “Charities have met to discuss the information in future press releases re prevalence. This is still being progressed.”[2]

There seems to be no shortage of public funding for GET related studies despite £5 million being spent on the PACE trial which showed no objective improvements in patient outcomes and is clouded in controversy about methods used and claims being made [3].

By now it ought to be self-evident that children should not be coerced into graded exercise when they are ill and unable to attend school. This approach can lead to a great deal of harm - not just for the child but for the whole family.

Even though Invest in ME is not a children’s charity we are contacted by families in distress due to pressures being put on their children to attend school or to perform  activities beyond their capabilities due to the effects of ME.

This often leads to very difficult family situations and instead of listening to and believing the child parents are wrongly led to believe that they are doing the right thing by following a set programme. By the time families realise this is the wrong approach it may be too late and the child’s condition has deteriorated and the families may even break up as a result.

Epidemiological studies are welcomed but one has to be careful as GPs are known to be very poor at diagnosing ME patients. Any data coming out of Dr Collin’s research is likely not going to be accurate without considerable effort being put into trying to find out how patients were diagnosed.

In fact, Dr Clare Gerada, chair of RCGPs, stated at the IiMEC8 conference in June 2013 that GPs know very little about ME.

The adult services in the UK can only offer CBT and/or GET as set out in NICE so Dr Collin's research to document different approaches to treatment is likely to be a simple task. Long term outcomes might be difficult to determine as patients are usually seen by the specialist clinics only for a certain number of times before being sent back to their GPs.

These awards indicate that the understanding of this disease is still poor in those establishment organisations which control funding.

It is a wonder to patients how key funding agencies can get it so wrong.

It seems that in reality there is no shortage of funds available for studies which fit government policy. And this shames those who issue statements talking of funding being available for high-quality studies.

It would indeed be a sad indictment of the society that we ourselves subsidise if what matters is who one knows rather than what one does when it comes to research funding granted for ME - and the devil take the consequences.

Funding more GET-related research into ME, is a fatuous  approach. It is monstrously wasteful to throw funding at poor science, based on false views of this disease.

So what of the real research required - the right stuff?

Funding is scarce and the efforts of our supporters to make up what has been lacking from government agencies and research funding organisations have been awe-inspiring.

Patients have worked tirelessly and imaginatively to raise funds for the research proposed by IiME. Currently Invest in ME and our supporters are actually initiating, organising and funding possibly the two most important ME research studies currently in the UK - the gut microbiome project at UEA and the IiME/UCL rituximab clinical trial.

As mentioned in our article which was published at the beginning of April [5] research into ME needs a strategic approach - but it may be destined to fail completely by attempting to establish the way forward on foundations which include so much of what has been wrong in the past.

We have written in the past that we feel it is impossible to marry the views of those who believe in the deconditioning/behavioural and wrong illness belief model of ME with those from the biomedical side. The failed PACE Trial has demonstrably proven that the behavioural view of ME cannot deliver and should not continue to command more funding.

There is another way - perhaps a better way forward for ME research - a clear case to be made for segregating the biomedical from the psychosocial here and now. This could then force a separation of fatigue research from ME research.

A strategy of biomedical research into ME with a biomedical research collaborative into ME being formed consisting of biomedical researchers, using resources and facilities across continents - hooked up to share research and data and crowd fund new research?

Such is the meaning behind our Biomedical Research into ME Collaborative meetings [6] which have been organised by Invest in ME in cooperation with the Alison Hunter Memorial Foundation. These aim to interest other biomedical researchers to the field of biomedical research into ME, assist those who are undertaking research or planning research into ME, and look for future collaborative projects and funding which could be generated by new ideas. We repeat them in 2014.

Future research into ME must be based on collaboration. But not collaboration at any cost. But it would seem quite meaningless to base the strategy on those failed policies and directions of the past - which have served patients so poorly and caused such suffering [7].

There is the wrong way and the right way to progress research into ME.

For ME research there is the RIGHT stuff [4] - funded by patients.

As the grant to the Bristol University has shown - there is also the wrong stuff.

Sadly, again ME research funding by the establishment is taking the wrong course.

References
1. http://bristol.ac.uk/news/2013/9741.html
2. http://www.actionforme.org.uk/Resources/Action%20for%20ME/Documents/get-informed/CMRC-190713.pdf.pdf
3. PACE Trial Observations
4. Invest in ME Research
5. A Tale of Two Collaboratives
6. http://www.investinme.org/IIME-Newslet-1309-01%20BRMEC4.htm
7. Diane's Story - Lili

Despite Overwhelming Opposition, HHS Going Ahead With Plans to Redefine ME/CFS

September 17 ME Advocacy Action: Urgent!

By Mary Dimmock

Tell HHS to Stop the New IOM Contract. Tell HHS Not to Redefine ME/CFS!

Despite the strong outpouring of patient opposition to HHS’ August 27 announcement to contract the Institute of Medicine (IOM) to “develop clinical diagnostic criteria for ME/CFS,” HHS announced, on September 12, that it is going forward with its contract with IOM to redefine ME/CFS.

HHS plans on signing the contract with IOM before September 30 and has said it will share information with the ME/CFS community only after the contract is finalized and signed.

Adding insult to injury, HHS has announced that the fall CFSAC, long a face-to-face meeting, will not be in person but instead will be held by webinar. We are being told that HHS cannot afford a face-to-face CFSAC meeting, yet it can waste millions of dollars undoing the science that our experts have already established.

HHS is speaking loudly and clearly.

• HHS does not want to hear what we have to say about our disease. 
• HHS has every intention of pursuing its plans to redefine ME/CFS, unilaterally and in secret. 
• HHS dismisses the definitions of our experts and even questions the hallmark symptom of our disease – Post-Exertional Malaise. 
• HHS has repeatedly stated that it wants to use people who have no experience with our disease to develop the criteria for it.

Given the firestorm of criticism the IOM received after devising a vague, and ultimately meaningless, definition of Gulf War Illness, chances are very good the IOM will define ME/CFS out of existence.

The IOM contract is not only a waste of precious time and money. It is a threat to our very lives!

HHS needs to adopt a definition our experts have already created and use that definition to reeducate the medical community. It needs to drive an aggressive and fully funded research campaign to validate biomarkers, understand the pathophysiology of the disease and identify treatment approaches.

Tell HHS to not sign the IOM contract. Tell HHS to stop trying to redefine our disease and start using what our experts have already created!

You can read additional background here.

Immediate Actions You Can Take to Stop the Latest IOM Contract

Send an email to Secretary Sebelius every day to voice your opposition to this contract. Directions and a sample letter are below.

Distribute this action alert to your networks and your family and friends, and urge them to send an email.

We can and must stop HHS from redefining our disease.

If you have questions, please contact MEACTNOW@yahoo.com.

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Instructions for Emailing HHS:

If you are using the sample email provided below, copy the sample email into the body of an email message. If you wish to personalize it, add a sentence or two at the beginning of the letter.

Add your name, city and state (or country if you do not reside in the US) to the end of the letter.

Add the Subject Line “Stop the IOM Contract to Redefine ME". Feel free to change the subject line from time to time to avoid spam filters. Another tip: If you have more than one email account, use one on one day and the other on another.

Copy the following addresses into the ‘TO” and “CC” boxes

TO: Kathleen.Sebelius@hhs.gov

CC: howard.koh@hhs.gov, txf2@cdc.gov, Tomfrieden@cdc.gov, Marilyn.Tavenner@cms.hhs.gov, margaret.hamburg@fda.hhs.gov, Mary.Wakefield@hrsa.hhs.gov, collinsf@mail.nih.gov, richard.kronick@hhs.gov, MEACTNOW@yahoo.com

The CC includes addresses for the heads of all HHS agencies. The email address MEACTNOW@yahoo.com is used to track the number of messages sent.

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Sample Email for HHS - To be copied into the body of an email message.

Dear Secretary Sebelius,

I strongly urge HHS to abandon its plan to employ the Institute of Medicine (IOM) to define its own clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

Researchers and clinicians with years of experience in studying and treating this disease have already created peer-reviewed case definitions – the 2003 Canadian Consensus Criteria (CCC) and the 2011 ME International Consensus Criteria (ME-ICC), which used the CCC as its baseline. These definitions are supported by clinical guidelines for medical practitioners, guidelines also created by experts. These definitions are well regarded by patients, ME/CFS doctors, and ME/CFS researchers. The CCC has been successfully used both clinically and in research for years.

But rather than adopt these expertly defined disease criteria and their associated medical guidelines, HHS has promoted its own overly broad and inaccurate view of ME/CFS. HHS has questioned the hallmark symptoms of ME/CFS (e.g. Post-Exertional Malaise) and misrepresented the disease in its medical education literature. HHS has even unilaterally reclassified ME/CFS to be a subtype of chronic fatigue, in complete opposition to the standards set by the World Health Organization and all other countries that classify this illness as a neurological disease.

Now, HHS is intent on creating new criteria for ME/CFS using the IOM, an organization whose single effort to define a disease has been harshly criticized for redefining the disease too broadly and for using non-experts to define the disease. Repeating the error made in defining Gulf War Illness, HHS has stated its intent to use non-experts to define ME/CFS. This is a very serious concern for patients who face widespread disregard from the general medical and research community. Adding to these concerns, the description of ME/CFS in the January 2013 IOM report failed to accurately represent the illness, listing CBT and GET as treatments, treatments that experts have said can be harmful to ME/CFS patients.

HHS is going ahead with the IOM contract unilaterally, ignoring overwhelming opposition from the ME/CFS community. HHS is undermining the work of our experts while patients are suffering and dying. HHS must stop wasting precious time and dollars. HHS must stop wasting our precious lives.

I strongly urge HHS to abandon its plans to employ the IOM to define clinical diagnostic criteria for ME/CFS. It is time for HHS to adopt the Canadian or International Consensus Criteria and use that definition to drive an aggressive campaign of fully funded research and to reeducate the medical community.

Sincerely,
(Your name)
(Your city and state - or country)

The UK Rituximab Trial for ME

B-cell Targeted by Rituximab

Source: MEActionUK, August 2, 2013

By Professor Malcolm Hooper and Margaret Williams

The charity Invest in ME has provided a truly remarkable opportunity to address one of the biggest medical scandals in history and to remove what in 2007 Alex Fergusson, Presiding Officer (Speaker) of the Scottish Parliament, referred to as "the cold grip of psychiatry" on myalgic encephalomyelitis (ME), which he said was "still far too deeply rooted in the world of ME"

Now, however, despite the power and control of the psychiatric lobby, thanks to Invest in ME and the invaluable support of Jonathan Edwards, Emeritus Professor of Connective Tissue Medicine at University College, London, (world-renowned for his work in B cell immunology and as lead researcher in the clinical trials of rituximab for rheumatoid arthritis), the neuro-immune disease ME is at last about to enter the realm of mainstream medicine in the UK under the guidance of Professor Edwards himself.

Invest in ME are at the forefront of international biomedical research and have by sheer determination and effort managed to put things in place for a trial of rituximab to begin on ME patients in the UK.

They recognise the urgency of the situation and know that many ME patients do not have the luxury of time.

The charity already has the facilities in place, including suitably experienced researchers (Professor Jo Cambridge is now principal researcher at UCL, and the ME trial will involve the same team working under her that carried out the rituximab research in RA).

The Clinical Trials Unit at UCL is already working on the protocol, and Invest in ME have agreed with Professor Edwards that the protocol will be externally reviewed even though the UCL team will make sure it is cast-iron by their own internal reviewers.

Invest in ME have been told this trial could start relatively quickly if the charity had funds available.

Such an opportunity must not be lost. However, this will not happen without substantial funding.

We therefore ask everyone who is able to do so to donate whatever they can afford, in order that the UK rituximab trial can get under way as quickly as possible whilst the excellent facilities and committed staff at UCL and the active support of Professor Edwards remain available, so that ME can finally be recognised as the devastating multi-system neuro-immune disease that it is and - most importantly -- so that sufferers may at last have some hope of alleviation of their suffering.

Invest in ME have assured us that all donations to the rituximab fund will sit in a separate account which is totally ring-fenced, and should the trial not proceed, the following statement on the IiME website will be honoured:

What Happens With These Funds If The Project Does Not Go Ahead:

If the rituximab project does not go ahead for some reason then the funds raised will be transferred to the IiME Biomedical Research Fund to fund other biomedical research projects which are attached to our proposal for an examination and research facility based in Norwich Research park in Norfolk, UK.

These funds will only be used for biomedical research into ME.

Invest in ME: http://bit.ly/18TZN5d

A UK trial of rituximab is essential to move ME out of the realm of psychiatric dogma and into the realm of medical reality.

Information on how to donate can be found on the Invest in ME website: www.investinme.org

Outspoken Activist Tom Hennessy Dead at Age 59

First published on ProHealth as Noted Activist Tom Hennessy Passes Away After 25-Year Battle With ME

On Monday, September 9, 2013, Thomas Michael Hennessy, Jr. passed away in Boca Raton, Florida after a 25-year battle with ME/CFS. He was 59 years old. The family will receive friends at Our Lady of Mercy Catholic Church, 9200 Kentsdale Rd., Potomac, MD on Thursday, September 19, 2013 from 10-11 AM with Mass of Christian Burial following at 11 AM at Interment Gate of Heaven Cemetery. (You can read the obituary here.)

Tom Hennessy's contributions to the ME/CFS community have been enormous. He was the originator of International ME Awareness Day on May 12th, and founded the advocacy organization RESCIND (no longer online). Although he was severely ill, Tom testified eloquently, and passionately, at numerous national and international ME/CFS conferences and meetings, never failing to drive home the point that people with ME aren't tired, but sick.

Before falling ill with ME in 1988, Tom was a successful sales and advertising executive in Marin County, California. In spite of what he described as “chronic mono” following a severe flu, Tom continued to work 12-hour days, until a final collapse left him bedridden for 18 months. He never recovered.

On April 15, 1989, Tom was asked, at the last minute, to speak at the first international CFS conference, held in San Francisco, California. In his own words, Tom gave an “in your face” speech, which stole the show. “We are SICK, often deathly ill, and we are NOT fatigued!” he said. “If you do NOTHING else today, then lock the doors, get together and knock heads and come up with an ACCURATE definition and CHANGE THE GOD DAMN NAME!”

This speech catapulted Tom into the national spotlight, and from that day forward he remained a fierce advocate for legitimizing the illness in the face of government and insurance industry attempts to minimize the devastating effects on individuals who contract ME/CFS, as well as its cost to society as a whole.

No one could have stated the case for the eradication of the demeaning name "chronic fatigue syndrome” better than Tom himself, so I am including the full text of his 2011 CFSAC testimony below. His words deserve to be read, and re-read, many times over. In the wake of worldwide efforts to classify ME/CFS as a psychiatric illness, and of the virtual incarceration of Karina Hansen, on the heels of the recent attempt by HHS to redefine ME/CFS out of existence, in the CDC's continuing failure to adopt an accurate case definition, in the NIH's refusal to fund research, in the black-listing of medical professionals who seek to treat patients with ME/CFS, and in  the subversion of the very agencies and organizations that are supposed to represent our interests, but instead seek to undermine us, Tom's words still ring out loud and true.

"There are NO more excuses. Slow people need to learn by repetition, so I again say, the theme for now and the future is 'NO MAS!' [No More!]"

(Note: You can read Cort Johnson's excellent interview with Tom Hennessy here.)

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Testimony Thomas Hennessy, Jr.

Good Afternoon Chairman Snell, Dr. Wanda Jones, members of the M.E.AC committee, Ladies and Germs, as Charles Dickens once said, "These are the best of times. These are the worst of times..."

I want to PUBLICLY thank Dr. Wanda Jones and entire M.E. Accountability Committee staff for scheduling this meeting on the 10th and 11th of May, so that advocates can both testify to this committee AND try to meet with their respective senators and congressmen on May 12th, the 19th anniversary of ME/CFS/GWS/FMS/MCSS and Chronic Lyme disease Awareness Day. Also, after more than 2 decades of requests from the patient community, HHS has finally made this meeting available on the Internet, so that the millions of sick people around the world can have access to these meetings. I thank you ALL on their behalf.

A lot has changed in the past six months. But, a LOT more needs to be changed. There IS enough research money. it is just going to the wrong places. [Here Tom requests a slide of NIH Categorical Spending.] 

Thanks To Dennis Mangan, Dr. Vivian Penn, Dr. Wanda Jones, Chairman Christopher Snell, NIH Director, Dr. Francis Collins, and HHS Director Kathleen Sebelius and all the folks who participated in the very informative "State of the Knowledge" workshop held at the NIH in April, all the key players now know that we are NOT a bunch of meretricious valetudinarians. We are very sick and in chronic PAIN!! The time for being treated as a piece of dog feces under the shoe of our medical officials and government bureaucrats, and dishonest insurance executives is OVER! NO MAS!

The late, great Eleanor Roosevelt once said, "You can NEVER be a second class citizen without your consent!" AMEN. The time to be referred to as being "chronically fatigued" is OVER! NO MAS!

If patients en masse REFUSE to accept the label "CFS" anymore, and the doctors refuse to DIAGNOSE UNDER THIS ASININE LABEL, IT WILL DIE ON THE VINE! Myalgic Encephalomyelitis has had a valid WHO code as a neurological illness for 40 years! USE IT! There are NO more excuses. Slow people need to learn by repetition, so I again say, the theme for now and the future is "NO MAS!"

Dr. David Bell once referred to this as "the disease of a thousand names". I say the exact opposite. This is 1,000 disease entities under ONE name! Louis Pasteur said more than 100 years ago, "The antigen is nothing, the terrain is everything!"

As I said in my first speech to the very first International "CFS" meeting in 1989, "We are NOT sick of being tired, We are tired of being SICK!" There is a HUGE difference!! Webster's Dictionary says 'to define is to make clear and distinct, to differentiate.' If you do NOTHING else today, lock the doors and come up with an accurate definition and change the God Damn Name! If you do not have the courage to do this today, you will condemn untold millions of people from all over the world to lives of abject misery, premature deaths and a huge economic burden on our societies. Knock heads until you come up with an accurate definition and a proper name."

That Date was April 15th, 1989. the day before my 35th birthday. Despite seeing some of the top doctors in the world, and trying more than 100 different medications, supplements, meditations, prayer groups and more, I still have not been able to work ONE single 8-hour day in the past 23 years! The good news is that we have a good definition, we need to adopt the Canadian Consensus Definition, by Carruthers et al TODAY and scrap every other definition in use anywhere in the world. Period! Go with the name Myalgic Encephalomyelitis, which is not a perfect name, but it describes a CIND (Chronic Immunological and Neurological Disease) which has had a WHO classification for 40 years. The Canadian Consensus Definition must be adopted worldwide immediately. all other definitions and names need to become moot. Immediately. (Sign the petition here.)

The CDC "CFS" website must be taken down and rewritten immediately! The entire staff of the CDC "Viral exanthems" division from Dr. William Reeves and Dr. Elizabeth Unger, Jim Jones et al need to fired immediately and given NO severance whatsoever. Their so called "work product" for the past quarter of a century has been abysmal. What they claimed to be affecting some 4,000 to 10,000 Americans in 1988, they NOW claim affects 1 million to 4 million people! If AIDS, Heart Disease or Cancers went from 4,000 people to 4,000,000 people in 25 years and you worked for the "centers for disease control" in corporate America, they ALL would be fired! No severance, no mercy, NO MAS!

I have read 25,000 letters from all over the world. Hard working, ethical young men and women contract some type of Agent "X", which causes dysfunction of the autonomic nervous system. Many ignorant and arrogant psychiatrists, most from the damn 'Simon the weasel' school in the UK have pushed GET and CBT theories to cure VERY PHYSICALLY SICK PEOPLE by forcing them to exercise their way out of being SICK. This is a crime against humanity! We are for the most part, HARD WORKING, ethical, often even athletic people who have pushed ourselves too hard already. We are NOT deconditioned because we are lazy or fearful of exercise. We are SICK!

I have tried to push Chairman Christopher Snell behind the scenes to film EVERY patient that goes through their "Stevens Protocol." Insurance companies like UNUM Provident will continue to use outdated, dishonest criteria that they bribed weasels like Simon Weaselly to "delay, deny, and hope you die!" as long as we let them. They are out to collect premiums, and then "delay, deny, and hope you die" when sick people make legitimate claims.

Chairman Snell tells me these same patients almost always WIN their disability cases when they reach the Administrative Law Judge stage, which is often 2 to 3 years after filing their disability application. And since 40% of all Americans have net worths less than $2,000 this is a calamity which will only get worse! I believe that most patients will gladly give permission to allow themselves to be filmed which will PROVE that we can NOT do any "sustained physical or mental effort for one, two or three days in a row." This group of conditions is caught between the Autism spectrum disorders in young, immature nervous systems, and Alzheimer's on the other end of the spectrum.

This is an international calamity that will bankrupt the Long Term Disability industry, so they have and they will continue to lie, cheat and steal premiums and then write in the small print in their contracts that if you are diagnosed with "CFS" or "FMS" you only get two years lifetime disability payments. Then they give "VULTURE awards" for the claims adjusters that deny the most "CFS" and "FMS" claims. They all should be given Rodney King style beatings every day of their lives until they "get it."

We are no longer going to be the doormat of the medical industrial complex. We suffer from complex, devastating Neuroimmune diseases. The joke in our community is that knowledgeable doctors who encounter new M.E. patients in their practice say, "I have good news and bad news for you..." When the patient asks, "What does that mean?" the M.E. literate doctor says, "The "good news is that this disease probably won't kill you ... and the bad news is that it probably won't kill you."

Dr. Nancy Klimas, who has treated AIDS, GWS, and M.E. patients, said if she had to contract HIV and AIDS or M.E. in today's world, she would choose to contract HIV! Dr. Marc Loveless, who also treated more than 2500 patients with both diseases, stated under oath in front of the U.S. Congress that his "M.E. and CFS patients are more sick every single day, all day, than his AIDS patients are just two months before they die!" We are like dying Hospice patients every day of our lives and we have been treated as criminals and vagrants. This must end RIGHT NOW! Again, I say "NO MAS!"

I have heard strong, brave people give similar stories of abject misery to this committee and its forerunners for two and one half decades and they have all fallen on deaf ears until the now infamous WPI SCIENCE paper of October 8th, 2009! Some group has to go to the WPI and repay the Whittemore family EVERY single dime they have invested in their WP Institute, for no other reason, than getting the HHS director Sebelius, NIH Director Dr. Francis Collins, and even President Obama to utter the words "CFS" and "serious, devastating, extremely debilitating" in the same sentence. So, there are NO more excuses for delaying, denying and hoping that we will wither away and die, using ignorance as an answer...NO MAS!

I have heard patients who have lost their marriages, their careers, their families, their friends and far too often their very lives to the disease compare it to a life sentence in solitary confinement, without parole. All the while being tortured every single day of their lives. NO MAS!

In 1989, I estimated annual GDP loss to the U.S. economy alone was more than $9 billion! Now, Lenny Jason and others estimate that the losses are somewhere between $18 million and $23 billion. So, our medical establishment is not only cruel, they are STUPID!

Next, Medical Education! Many of the good doctors who have treated us are nearing retirement. With virtually NO curriculum regarding M.E. at major medical schools, this is a disaster that is going from very bad to a true crisis. We need to pay EACH clinician like Dr. Susan Levine, Dr. David Bell, Dr. Paul Cheney, Dr. Nancy Klimas, Dr. Chuck Lapp, Dr. Dan Peterson et al, who have treated at least 1,000 M.E. patients in a clinical setting. Each of them should be given a stipend of $250,000 and given ONE year to rewrite the CDC website and come up with pamphlets that give the Canadian Consensus Definition, and the most effective tests that need to be done, and the most efficacious treatments available. The CDC and NIH need a 24-hour a day hotline that is staffed with knowledgeable people who can answer questions for people who are too poor and too sick to travel to the acknowledged experts.

Public Education! Patients who are doing their best to cope under impossible circumstances are subjected to verbal and physical abuse by people who have been persuaded by the powers that be that patients are either lazy or crazy and can be cured by thinking happy thoughts and rising Lazarus-like from their beds. “Just go back to work!, GET and CBT will cure you.” It's absolutely criminal... NO MAS!

Some 90% of us have one or more documented sleep disorders. When the body cannot get to deep restorative sleep, it cannot repair itself, which disrupts the autonomic nervous system even further. Sleep disorders need to be diagnosed and treated by any and all means necessary.

We need DRAMATIC INCREASES IN FUNDING! Not one penny less than $250 million per year, until we catch up with other serious illnesses. Anthrax research has gotten close to a BILLION dollars in NIH research money since 9/11 and yet the "CFS" budget has decreased. Maybe six to 10 people have been injured by Anthrax...and yet, Anthrax has gotten close to a billion dollars in the past decade! Pat Fero's excellent presentation at the State of the Knowledge workshop meticulously dissected the misallocation of taxpayer funds at the NIH over the past 25 years. [Videos of her presentation can be viewedhere and here.] The funding for M.E. is NOTHING at the NIH. and the dismal funding for the "CFS" crap is less than 1/10 of 1 percent of the annual cost to the economy of having us lying in agony in our beds and contributing nothing to society. If you can get us back to work, we will make that back in income taxes in under a month!

The Centers of Excellence have been defunded. We need to RE-FUND them. The WPI must be reimbursed for every dime that the Whittemore family has INVESTED to help find the causes and treatments for Neuro-Immune Diseases.

When I asked fellow patients if they wanted me to make any specific comments to you six months ago, the biggest response I got was “Why bother?”

This group has made leaps and bounds improvement in the past six months. Keep it up! So, In conclusion I say to you NO MAS!!!

1. Adopt the Canadian Consensus Definition TODAY! Discontinue every other "Definition" on the planet. Declare them null and void.
2. Join the almost 10,000 names on the M.E. Definition that has a link at our Rescindinc.org website. if you have not signed yet, do, so. When we hit 10,000, we are taking the signed petition to the White House in a giant wheelbarrow.
3. Demand NIH funding of not one penny less than $250 million for fiscal year 2012. Take the money from the ANTHRAX budget. That is just slush fund for the Pentagon anyway, and Anthrax has sickened less than a dozen people since 9/11. We have close to 1,000,000 homebound or bedbound people suffering from the WHO neurological and immunological disease of Myalgic Encephalomyelitis.
4. Get clinicians and researchers who have seen at least 1,000 patients in a clinical setting and give the top ten a stipend of $250,000 to completely rewrite the CDC website and decide WHERE and how to spend the $250 million coming out of the Anthrax budget at the NIH.
5. Reimburse the WPI for every penny spent so far by the Whittemore family, and fund trials, PROPER replication trials, for XMRV and the National CFIDS Association of Gail Kansky's ciguatera isotope found by Dr. Hokama, one of the top marine biologists in the world. Virtually every serious M.E. patient they have tested has been positive.
6. Fast Track Ampligen. Look at Mary Schweitzer and Bob Miller. They are living proof that this drug can help people. Dr. Carter and company are poor managers. I say that the Pentagon should declare this disease group a national emergency and they should nationalize HEM and give Dr. Carter a royalty for every treatment of Ampligen, and use the Pentagon funding to do trials on sick Gulf War veterans and any patients who want to enroll.
7. Refund the Centers of Excellence for Dr. Jose Montoya at Stanford, and Dr. Klimas in Miami, Dr. Komaroff at Harvard, Dr. Lucinda Batemen in Utah, Dr. Susan Levine and Dr. Derek Enlander in NYC, and until they are proven WRONG, reimburse the WPI for every penny they have invested. they have gotten us MORE press and medical attention in the past 2 years than in the past 20!
8. Fire the entire CDC "Viral and Exanthems branch" and start hiring competent people immediately.
9. Give a round of applause to Dr. Nancy Klimas, Dr. Lenny Jason, Dr. Susan Levine, Dr. Vivian Penn, Dr. Wanda Jones, Dennis Mangan and all the others who tried to make a silk purse out of a sow's ear over the past 2 decades, and congratulate them on their NEW name of the M.E.A.C. the Myalgic Encephalomyelitis Accountability Committee.
10. Initiate a class action lawsuit against all Long Term Disability companies who have used bad faith, bribery and outright fraud to "delay, deny and hope you die" tens of thousands of very ill people over the past 25 years.

Thank you for your time!

Sincerely, 

Thomas M. Hennessy, Jr.

Dr. Dan Peterson Talks About Aggressive Treatments for ME/CFS

Llewellyn King's ME/CFS Alert: Episode 48.

Deborah Waroff interviews Dr. Dan Peterson about his approach to treating ME/CFS.

Q: You’ve been very aggressive about putting treatments forward for your patients. How many patients do you currently have on Ampligen, and how many have you treated with Ampligen in total?

A: I have 28 people on Ampligen, with a total of 300. With respect to aggressive treatment, for severely disabled patients, and evenly the moderately disabled, unless you introduce some sort of aggressive treatment they don’t spontaneously recover. Symptomatic therapy can be enormously beneficial, but patients don’t recover unless you attack the etiology and pathogenesis directly. We’ve stumbled upon Ampligen, which is very beneficial for a subset of patients.

Q: Vistide (cidofovir) is one of the most difficult drugs to manage. What is your protocol?

A: I have a subset of patients who have evidence of beta herpesvirus reactivation, either CMV or HHV6a or b, and for that subset of patients, particularly if they have it in their spinal fluid, they need a very potent antiviral. For beta herpesviruses we are somewhat limited to a few oral drugs that are not terribly effective, to foscarnet, which is very difficult to administer, and Vistide which is somewhat easier because the infusion is every two weeks. I have treated 65 people according to this protocol, which, relative to the world of chronic fatigue syndrome, is not very many people. But some of those people have had very dramatic responses. Some have been able to go back to work, and to normal lives.

Q: Most doctors do not want to deal with Vistide, isn’t that true?

A: Vistide has to be monitored. You have to monitor kidney function, and liver function, and white blood cell count.  I don’t even think it is generally acknowledged that [beta herpesvirus] subsets of these patients are identifiable.

Q: Have you used Valcyte?

A: I have used Valcyte. I follow the protocol of Jose Montoya at Stanford, with a long course of therapy. It also has to be monitored very carefully, and there are significant side effects such as headache and nausea, etc.

Q: Would you use it again now that you have Vistide?

A: I still use it.

Q: From my personal experience [antivirals] do good for a while, then become ineffective. Is that universal?

A: With the herpesviruses, since we never really cure them, patients go into remission and then they relapse. This pattern also holds when patients are treated with Vistide. Most recently, I have been combining therapies, adding immunoglobulin, or Ampligen, or other agents, with some significant success.

Q: What is the longest you have been able to keep a patient in good shape?

A: So far, three or four years, but I’m talking about almost total remission. I frequently get asked the question, “Is this curable?” I can’t say that it’s curable, but [the combination of therapies] is able to relieve symptoms so that people can return to work full time, which is pretty dramatic.

Q: Are you looking forward to CMX001 [a lipid antiviral used to boost the effectiveness of Vistide]?

A: Biopharma is great when they see a market, so I look forward to better drugs for all the patients with CFS, not just the subsets with immunological abnormalities. But they are not terribly interested, I think because they don’t recognize the market potential. They can’t get their hands on a biological marker and endpoints. All those things are very important when you are trying to interest pharma. And for a drug that’s already licensed there is no incentive for them to do a study.

Q: Are there any other immune boosters you are interested in?

A: IV gammaglobulin. A new area I’m excited about is the cytokine blockers and the immune modulator rituximab, which has gotten lot of press. Hopefully, they will do a much larger rituximab study in the near future. My concern with rituximab is that I don’t know how to predict who will respond. It would be nice to have guidelines, for entrance criteria, etc. where we could give people an idea of whether or not they will respond. The side effects can be very rough.

Q: If you had all the money in the world, in what direction would you be going now?

A: I would invest the money in centers for excellence. The reason is that primary care physicians can’t manage this disease. It’s too complex, too time-consuming, and they have too many other things to do. If we could get primary care physicians to recognize the disease, to qualify the patient, then they must have some place to refer them to. I see a great need all over the world for people to seek specialty care, which is appropriate until the disease becomes simpler to manage. HIV, for example, has become a very manageable disease. CFS /ME is a long ways from that.

Q: What do we need to do to get there?

A: I think it’s clear this is not a homogeneous disease.  I think the CDC is correct in trying to understand subsets and redefine the subsets both biologically and by symptoms. Things would move along more quickly if we did that. As far as a universal definition is concerned, that would be enormously helpful, but we seem to have a great deal of difficulty getting there.

Q: Do you see one or two subsets that predominate over the others?

A: There seems to a real different between people who have an acute onset versus a gradual onset. About 15% of the people I see have active [viral] infections of one sort or another. They are clearly treatable and should be identified. There are people who have had industrial exposures or heavy metal toxicities, or post-vaccination, or post-transfusion onset. Those are all potentially identifiable subsets that might best be treated differently.

Q: Why did chronic fatigue syndrome strike Lake Tahoe? Do you still have people coming in at a high rate?

A:  Not locally. The local thing happened and disappeared. Some virus came through this community at that time, striking susceptible people, and then left. I mostly see people from distant places.

Q: Who do you need to set up centers for excellence?

A: The concept of translational medicine is very good, in which basic researchers work with clinicians –  in this disease particularly, where there is not a lot of understanding between the scientists and the clinicians, or pharma for that matter. It would be doable because there are centers of excellence for breast cancer, for MS, for ALS, just go down the list. You can create that model if there is support for it.

Q: Wouldn’t major medical centers be a good place to start, like Stanford and Duke?

A: Traditionally, major medical centers have been great sources for centers of excellence.  However, they operate very slowly, and they have very high overhead. And funding has been very short term. Some people have started these plans and run out of funds.

Q: As a disease, we get most of our research funding from private funding. Is this an advantage over government funding?

A: Private funding is very efficient. It can be targeted and it is easier to obtain in some circumstances. But this is a national problem that should be supported nationally. But I understand that with budget restrictions there is less and less available, particularly of these orphan diseases.

Q: Couldn’t the same researchers who do research on MS, or lymphoma, or HIV, be doing research on  CFS/ME with very little extra salary?

A: That’s a hard sell. It goes back to the stigma of CFS/ME. The name just trivialized the disease. The lack of a clear-cut biological marker held off researchers, as well as short budget cycles, and low dollar amounts. A small grant gets you nowhere with this disease. You need large numbers of patients, which is why I totally support the OMI, with its idea of putting multiple physicians together, and adding all our patients. If you’re talking about things like genomic studies it takes a large number of patients in order to get a sufficient quantity for statistical validity. The same goes for treatment trials. With small treatment trials it’s very difficult to show efficacy.

Q: Is there any way to get researchers to focus on something other than blood? Lymph glands, for example?

A: The Ian Lipkin studies at Columbia are looking at other tissues – saliva, urine, cerebrospinal fluid. I think he may be one of the first ones to do that. I am really excited about that research. Hopefully, he will help us in terms of biological markers, or pathogens, and possibly autoimmunity, and chemokine and cytokine signaling. I know he is working on all those avenues. We need people with his kind of expertise and quality to be researchers in this field.

Q: How have you stood it all these years, plugging along in spite of an utter lack of support?

A: That’s a question I get asked frequently. The best answer I can give is that there is still an essential truth that we have to find.  Remember, I saw perfectly healthy people become disabled, and nothing can ever convince me that that was not a pathophysiological process. I expected the answer long before now, but I am still looking for answers. The second thing is that discovery comes to the prepared mind. We need intellectual curiosity. We need people asking questions about this, pursuing it. I haven’t seen the end of this story yet, and that’s why I am still in the field.

Don't Stop Now!

Thank you!! All of the emails that you have sent the HHS had an effect. It seems as if the HHS has withdrawn its contract with the OIM. Public pressure really does work. But, don't stop sending email to the HHS. It's very important that they continue to hear from us. It's also important that we let them know that "reinventing the wheel" is not the most constructive means of updating the current CDC case definition. 

We all agree that the "Fukuda" definition is vague and confusing. (Not to mention the name, "chronic fatigue syndrome," which is not only vague, but horrendously misleading.) That is why the most respected ME experts in the world convened to establish the Canadian Consensus Criteria (CCC) for ME/CFS. The CCC has been used successfully for over a decade in ME research and clinical practice.

Tell the HHS to stop spinning its wheels and talk to the experts! Keep sending emails to Secretary Sibelius. And, if you have't already, sign the Change the Name petition!

From Jennie Spotila, Occupy CFS, Sept 4,2013

As of 11:09 Eastern this morning, the sole source contract notice for the IOM case definition was updated to read:

"Because of all of the concern from the public surrounding this potential sole source requisition, we have decided to discontinue this request."

I have reached out to multiple sources to confirm whether the contract has been cancelled (or simply suspended), and to determine what happens next. I will keep you posted.

BUT it is very very important that we continue our email action! We need and want a strong, accurate clinical case definition for ME/CFS! This is essential for any of our other efforts to be successful. So tell HHS that we need an case definition process that is inclusive of the ME/CFS experts and stakeholders to solve this problem once and for all.

Please stay tuned for updates as we work with sources and experts to refine our message and find out what HHS plans to do next. I will share updates with you in real time. Keep emailing HHS. YOUR VOICES ARE BEING HEARD. Don’t stop now!!!!

ME/CFS on Verge of Being Defined Out of Existence

By Mary Dimmock

Tell HHS that you oppose the IOM contract – stop the proposed IOM Study!

On August 27, the Department of Health and Human Services (HHS) announced a proposal to award a contract to the Institute of Medicine  (IOM) on a sole source basis to recommend consensus “clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome.” Due to federal contracting rules, HHS has given other potential contractors until September 11, 2013 to inform HHS of their interest and capabilities before HHS moves forward with signing the contract with IOM.  It is likely that HHS will sign a contract with IOM immediately after the September 11 deadline.

We have good reason to be extremely concerned that this IOM initiative will produce a definition that is as bad or even worse than Fukuda. The VA contracted the IOM to study Gulf War Illness (GWI). In January of 2013, the IOM issued a report, “Gulf War and Health: Treatment for Chronic Multisymptom Illness”. This report recharacterized GWI as chronic multisymptom Illness (CMI), defined “as the presence of a spectrum of chronic symptoms in at least two of six categories—fatigue, mood and cognition, musculoskeletal, gastrointestinal, respiratory, and neurologic—experienced for at least six months.” The creation of CMI muddied the patient cohort and in the words of Anthony Hardie, Gulf War vet, GWI patient and member of the VA Gulf War Research Steering Committee “defined [the disease] so broadly as to include nearly any human health condition.”

Not surprisingly, the IOM report recommended treatment guidelines that focused on anti-depressants, CBT and exercise. The IOM report even included a section on “CFS”, which included erroneous and outdated information and also listed CBT, exercise and anti-depressants as treatments.

Reading about the IOM initiative for GWI is like reading a prequel to the planned IOM initiative for “ME/CFS”. It is not a leap to surmise that if the proposed IOM project goes forward, ME will be completely obliterated and be replaced with CFS as a subtype of chronic multisymptom illness.

Why is HHS spending the time and money to come up with a new clinical criteria for ME when expertly developed consensus criteria and medical education already exist and are in use? Why is HHS using IOM, an organization whose single effort to define a disease has generated so much controversy with GWI advocates? What is the specific statement of work for this initiative? Will the panel be composed primarily of non-experts as was done with GWI? Why is HHS being so secretive? It appears that discussions with IOM regarding development of a case definition have been going on for months, yet HHS has not discussed the IOM initiative with ME clinicians and researchers, the members of CFSAC or the patient advocates.

This initiative is dangerous and will hurt ME patients.

HHS’s proposal to contract with the IOM to “develop clinical diagnostic criteria for ME/CFS” is extremely dangerous and must be stopped.

If the current IOM initiative to define Gulf War Illness is any indication, the “ME/CFS” IOM initiative will use non-ME experts to “define” our disease and will likely result in a definition that is even worse than Fukuda – a vague, non-science based case definition that will set ME science and treatment back for decades.

Immediate Actions You Can Take to Stop This Contract:

1.     Send an email every day to HHS voicing your strong opposition to this initiative as soon as possible but no later than by 5pm on Monday, September 9th. The email should go to HHS Secretary Kathleen Sebelius, Assistant Secretary Howard Koh, and the heads of all the CFSAC ex officio agencies.  The email addresses are provided below along with detailed instructions and a sample email that you can use if you wish.

2.     Distribute this action alert to your advocacy networks and your family and friends, and urge them to send an email every day as well.

The above actions are initial steps to send a strong message to HHS that the ME advocacy community opposes this effort.  But we will not stop there - more actions are planned, including Congressional intervention.  Stay tuned for updates and additional actions you can take.  We can and must stop this destructive initiative!

 If you have questions, please contact MEACTNOW@yahoo.com.
========================================================
Instructions for Emailing HHS:

1.     If you are using the sample email provided below, copy the sample email into the body of an email message.
2.     Add your name to the end of the letter.
3.     Add the Subject Line “Stop the IOM Contract on “ME/CFS” Clinical Criteria”
4.     Copy the following addresses into the ‘TO” and “CC” boxes
TO:     Kathleen.Sebelius@hhs.gov
CC:     howard.koh@hhs.gov; txf2@cdc.gov; Tomfrieden@cdc.gov; Marilyn.Tavenner@cms.hhs.gov; margaret.hamburg@fda.hhs.gov; Mary.Wakefield@hrsa.hhs.gov; collinsf@mail.nih.gov; richard.kronick@hhs.gov; MEACTNOW@yahoo.com

The CC includes the following individuals:
HHS Assistant Secretary Howard Koh
AHRQ Director Richard Kronick
CDC Director Thomas Frieden
CMS Administrator Marilyn Tavenner
FDA Director Margaret Hamburg
HRSA Director Mary K. Wakefield
NIH Director Francis Collins

The Social Security administration is not included because the agency head’s email is not available yet. The email address MEACTNOW@yahoo.com is used to track the numbers of messages sent.

=======================================================
 [email]

Dear Secretary Sebelius,

I am writing to voice my strong opposition to the HHS proposal to contract with the Institute of Medicine (IOM) to develop “clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome.” I am a member of the ME community and have witnessed firsthand the devastation of this disease. I am extremely concerned that this planned IOM initiative will gravely harm ME patients. Note that I am purposely using the term “ME” to distinguish the disease that has affected me from the overly broad “CFS”.

I oppose this proposal for the following reasons:
·       Two peer-reviewed consensus case definitions, developed by experts in this disease, already exist – the 2003 Canadian Consensus Criteria (CCC) and the 2011 ME International Consensus Criteria (ME-ICC), which used the CCC as its baseline. The CCC has been used both clinically and in research. Both are accompanied by clinical guidelines for medical practitioners, and are well regarded by patients, ME doctors, and ME researchers. Given that expertly defined and accepted consensus clinical criteria already exist, the proposed IOM contract wastes scarce taxpayer dollars and is unnecessary.

·       HHS has inexplicably refused to accept the CCC or the ME-ICC and even questions the hallmark symptoms of ME. Instead, it has promoted an overly broad view of the disease called “CFS”, which does not require the hallmark symptoms. This has confounded ME with depression, deconditioning and non-specific chronic fatigue, has severely impeded research, and is the direct cause of the medical skepticism and inappropriate or harmful treatment recommendations to which patients are subjected.

·       IOM has only been involved in one other study to define a disease, the current effort for Gulf War Illness (GWI). Advocates and the Research Advisory Committee for GWI (RAC) have criticized the IOM report that redefined GWI as the overly broad chronic multisymptom illness (CMI). They further criticized the misguided focus on psychiatric issues and the failure to staff the IOM panel with GWI experts. Given this and IOM’s inaccurate characterization of CFS in the January 2013 IOM report on treatments for Gulf War Illness patients, we have no confidence that IOM is capable of producing a clinical consensus criteria that defines ME as described by CCC, ME-ICC and most importantly, the patients themselves.

·       Ironically, the claimed intent of the HHS-IOM initiative is to develop a consensus definition but this effort has been progressed in secret, apparently for many months and without consultation with key ME stakeholders. The timing of the announcement before a holiday weekend and the short response time indicate that HHS was not looking for input from the ME experts and ME community.

·       This IOM initiative does not reflect the October 2012 CFSAC recommendation on the development of a case definition for this disease and in fact is in direct contradiction to that recommendation.  CFSAC recommended that a clinical and research case definition be developed in unison, that the effort begin with the Canadian Consensus Criteria and, most importantly, that it be developed by disease experts only.

I strongly urge HHS to abandon its plan for this ill-advised, wasteful, and unscientific initiative.

Sincerely,
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