Invest in ME/UCL Rituximab Clinical Trial for ME

Jo Best

From Invest in ME September newsletter, out now.

Invest in ME/UCL UK Rituximab Trial for M.E.

One Event Can Change Everything

We are pleased to announce that in a very short time we have now, with the help of our supporters, raised £57,000 (now £58,000) for the Invest in ME/UCL UK rituximab trial.

IiME received a very generous matching donation of £25 000 from a charitable foundation that wishes to remain anonymous but has asked us to keep them updated of the progress being made.
This extraordinarily generous support now means that the first part of the trial can start without delay.

The UCL team is working on a study to confirm and expand Dr Bansal’s B cell results in a different cohort of ME patients. You can read Invest in ME’s full announcement here http://www.ukrituximabtrial.org/Rituximab%20news-Aug13%2002.htm

Our advisor, Professor Jonathan Edwards, will be visitng Bergen, Norway, soon to discuss with the Haukeland team of Professor Olav Mella and Dr Oystein Fluge. This is a wonderful example of the collaboration and cooperation that came from the IiME Biomedical Research into ME Collaborative meeting which we organised in May this year in London [http://www.investinme.org/IIME-Newslet-1305-03.htm

].

A pdf document has been added so that the UK rituximab study status may be downloaded and given to healthcare professionals if required. We will update this as we progress - http://bit.ly/1cN4GzB

To accompany the fundraising efforts we have two posters available, which can be downloaded or obtained from IiME. These are available here. http://www.ukrituximabtrial.org/Rituximab%20news-Sep13%2002.htm

The Funders page contains those groups who have supported Invest in ME by donating. Recent additions have been Richamond and Kinston ME Group and Network MESH West London - who have made kind donations in support of the charity and the trial.
http://www.ukrituximabtrial.org/IIMEUKRT%20Funders.htm

For any groups or companies or organisations or individuals who wish to contribute to the funding of the IiME/UCL rituximab project then we have devised a new fundraising scheme - The MATRIX.

We are pleased to see more and more people taking the challenge of owning a matrix slot and aiming to raise £1000 for the rituximab project. See how the matrix is shaping up here http://www.ukrituximabtrial.org/IIME%20UK%20Rituximab%20Trial%20Matrix%2001.htm

This has been a truly international collaboration with participation from USA, Australia, New Zealand, Sweden, Norway, Belgium, Ireland, Germany and UK.

We thank all those who are supporting us in making this important clinical trial a reality.

Sign up to receive these free newsletters by email here.
http://www.investinme.org/IIMENewslettersubs.htm

Past newsletters are on the website here.
http://www.investinme.org/IIME%20newsletter.htm

PS 24 September 2013 !!!!!!!!!!!!:

We can now announce that IiME have been given a pledge of £200,000 from a foundation to supplement the amount we have raised already.

This would bring our rituximab fund to almost £260,000 – that is over two-thirds of the requirement for the clinical trial to proceed.

The foundation has two conditions to this pledge

• That IiME continue to be the lead patient organisation steering this trial
• That IiME continue to raise funds for the remaining £90,000 that is required for the full trial to proceed

 

The trustees of IiME have accepted these conditions willingly.

We are thankful and grateful for this extraordinarily generous offer from the donating foundation. It is an amazing gesture from compassionate and caring people who want to make a difference. It allows the hopes of many patients to become a reality – allows a vision to be maintained that there is a future for ME patients and that we, patients and families, can make a difference.

We have communicated this to the UCL team with whom we are working to make this trial a reality.

We are now distributing this information to our supporters.

There were many who doubted that IiME and our supporters could achieve this. Though we knew this would be a daunting task we have never doubted it was possible.

We continue our efforts to raise the remaining funds.

To our supporters who have been with us since the beginning and everyone who has contributed in so many ways to this trial we want you to know this is your result. It is what you have achieved. It is what we have achieved together.

We thank all those who are supporting this trial and we will continue to provide information on the status of the trial as we progress.

We continue to welcome support. Please contact IiME directly if you or your organisation would like to assist or contribute. 

If anyone would like to ask any questions about the UK rituximab trial then please use the Contact form on the rituximab web site [4].

A status is available [5].

With this trial we can take a huge leap forward in ME research.

If you are also interested in the other research projects that Invest in ME is  organising and/or funding please see our main website and free newsletter [6].

Let’s Do Research! Let’s Do It For ME!

 

Thank You.

References:

1	http://www.investinme.org/Rituximab%20news-Aug13%2001.htm
2	http://www.ukrituximabtrial.org/IIMEUKRT%20Summary.htm
3	http://www.ukrituximabtrial.org/IIMEUKRT%20Matrix.htm
4	http://www.ukrituximabtrial.org/IIMEUKRT%20Contact.htm
5	http://www.ukrituximabtrial.org/IIMEUKRT%20Summary.htm
6	http://bit.ly/1f7k9y7

 Invest in ME                                            September 2013

Professor Stephen Hawking

the greatest enemy of knowledge is not ignorance, it is the illusion of knowledge. - Stephen Hawking

 and if governments are involved in the cover up , they are doing a much better job of it than they seem to do at anything else. -Stephen Hawking

Unreserved government apology for Camelford water poisoning and Simon Wessely's CBT

The government has apologised to people in Cornwall affected by the Camelford water poisoning in 1988.

When 20 tonnes of aluminium sulphate were tipped into the wrong tank at Lowermoor treatment works it contaminated the water to 20,000 homes.

Health Minister Anna Soubry and Environment Minister Richard Benyon said they apologised "unreservedly" on the government's behalf.

Local MP Dan Rogerson said the apology was welcome but 25 years late.

Read more>>

Camelford water poisoning: Apology 'took too long'

http://www.bbc.co.uk/news/uk-england-cornwall-24172635

Carole Cross had high levels of aluminium in her brain when she died in 2004Health Minister Anna Soubry and Environment Minister Richard Benyon said sorry on Thursday.

But Lord Tyler, the area's MP at the time, said he was not satisfied with the apology.

Some 20 tonnes of aluminium sulphate were tipped into the wrong tank at a treatment works, contaminating the water to 20,000 homes.

'Cover-up'

Lord Tyler said: "You can't be satisfied when it has taken 25 years for ministers to admit the appalling negligence that took place all those years ago.

"We still do not know who was precisely responsible for what. We do certainly know there was a cover-up and that's the scandal that we're now a little bit closer to addressing."

Government ministers said they apologised "unreservedly" on the government's behalf.

However, the widower of a woman whose death was "very possibly" linked to the poisoning said the apology was "meaningless".

Carole Cross, who died in 2004 aged 59, was living in the area at the time, and a post-mortem examination found abnormally high levels of aluminium in her brain.

Mrs Cross's husband, Dr Doug Cross, said: "The apology doesn't go nearly far enough. What I want to know was who was responsible within the departments themselves.

"I think the apology opens the door to a more positive response. We need to be able to look at people who are still concerned about their health, whether they are still carrying excessive aluminium in their body and whether we can take some of it out."

The aluminium sulphate was tipped in the wrong tank by a relief delivery driver at the unmanned plant

A report - published in April by the Lowermoor subgroup of the Committee on Toxicity (CoT) of Chemicals in Food, Consumer Products and the Environment - said the incident was "unlikely" to have caused long-term health effects.

The water poisoning happened when the chemical, which is used to treat cloudy water, went straight into the main water supply.

People in the area at the time reported a range of health issues, including stomach cramps, rashes, and diarrhoea.

Despite the apology, Dan Rogerson, the Liberal Democrat MP for North Cornwall, has called for Devon and Cornwall Police to heed a request from the coroner in 2007 to reopen an investigation into the possibility of a cover-up.

Dr Cross backed the call for a police investigation, but has also called for a ministerial inquiry.

Devon and Cornwall Police said in a statement: "Devon and Cornwall Police await a formal request [for an investigation] and any decision on this matter would be taken at that time."

yet Simon Wessely and Anthony David wrote, in their paper 'The Legend of Camelford':

" We suggest that the most likely explanation of the Camelford findings is that the perception of normal and benign somatic symptoms (physical or mental) by both
subjects and health professionals was heightened and subsequently attributed to an external, physical cause, such as poisoning ...


... there can be no doubting the substantial effect that
the prospect of litigation has on distress, particularly of the ill-defined sort present at Camelford...

  Read more Simon Wessely's CBT (Camelford Bullshit Telling )

URGENT: ACT NOW To Stop ME Redefinition part 2 !

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.

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.

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)

---

exercise physiologist prof Betsy Keller: ME/CFS patients will respond abnormally to 2-day cardiopulmonary exercise tests

By Cort Johnson on September 17, 2013:

 While I cannot predict exactly how those with ME/CFS will respond to the cardiopulmonary exercise tests (CPET), I do know that the response is likely to be abnormal in one of several ways. Most often, ME/CFS patients are unable to reproduce maximum oxygen consumption (VO2max) achieved on test 1 during test 2.

It is well documented that healthy subjects are able to reproduce VO2max within 6-7% variation or less, whereas ME/CFS patients usually exhibit a drop in VO2max presumably due to metabolic anomalies that follow test 1, which we call post-exertional malaise (PEM). We don’t know why this occurs; but for one with ME/CFS, it certainly helps to validate claims of fatigue, brain fog, pain, etc., when this VO2max decrement occurs.

 The gas exchange measurements made during the CPET also provide a metric of the functional decrement experienced by the ME/CFS patient after post-exertional malaise has occurred, which is why a two-test CPET protocol is necessary if one wants to document a PEM-related decrease in physical function.

Other abnormal responses sometimes include a decrease in anaerobic threshold (AT) from test 1 to test 2, which means that, when fatigued, a person with CFS will have an even lower threshold for physical activity. 

Additionally in some cases, because the nervous system does not communicate appropriately with the cardiovascular system in ME/CFS (autonomic dysregulation), differences in the hemodynamic response (heart rate, blood pressure) to exercise can occur from test 1 to test 2 as well. In healthy subjects, these variables are quite stable from test 1 to test 2. Read more>>

Dr. Betsy Keller is an exercise physiologist who regularly puts ME/CFS patients seeking disability through two-day exercise tests. A professor in the Department of Exercise and Sport Science at Ithaca College in New York, Dr. Keller received her M.S and Ph.D in exercise science.

See also: Revalidation Update: why doctors who use or promote CBT or GET for ME/CFS will fail their revalidation

See also: Dr Snell, University of the Pacific, California: ME/CFS patients have a reduced capacity to exercise when they repeat a maximum exercise test one day on – unlike healthy controls

See also: Another cracker from the CBT school of denial: “The bastards don’t want to get better”…

Rest in Peace Thomas Hennessy Jr, Rest in Peace

Deb B: How many have to die before we are taken seriously? So horrible to hear this sad news. 

International Myalgic Encephalomyelitis/ME Awareness Day Founder ~ Thomas Hennessy Jr. He also founded R.E.S.C.I.N.D.

eye movement dysfunction in ME/CFS patients

@ pubmed:

Graefes Arch Clin Exp Ophthalmol. 2013 Aug 6. [Epub ahead of print]

Characterising eye movement dysfunction in myalgic encephalomyelitis/chronic fatigue syndrome.

Badham SP, Hutchinson CV.

Source

School of Psychology, College of Medicine, Biological Sciences and Psychology, University of Leicester, Leicester, UK, s.p.badham@warwick.ac.uk.

Abstract

BACKGROUND:

People who suffer from myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) often report that their eye movements are sluggish and that they have difficulties tracking moving objects. However, descriptions of these visual problems are based solely on patients' self-reports of their subjective visual experiences, and there is a distinct lack of empirical evidence to objectively verify their claims. This paper presents the first experimental research to objectively examine eye movements in those suffering from ME/CFS.

METHODS:

Patients were assessed for ME/CFS symptoms and were compared to age, gender, and education matched controls for their ability to generate saccades and smooth pursuit eye movements.

RESULTS:

Patients and controls exhibited similar error rates and saccade latencies (response times) on prosaccade and antisaccade tasks. Patients showed relatively intact ability to accurately fixate the target (prosaccades), but were impaired when required to focus accurately in a specific position opposite the target (antisaccades). Patients were most markedly impaired when required to direct their gaze as closely as possible to a smoothly moving target (smooth pursuit).

CONCLUSIONS:

It is hypothesised that the effects of ME/CFS can be overcome briefly for completion of saccades, but that continuous pursuit activity (accurately tracking a moving object), even for a short time period, highlights dysfunctional eye movement behaviour in ME/CFS patients. Future smooth pursuit research may elucidate and improve diagnosis of ME/CFS.

PMID:

 

23918092

 

[PubMed - as supplied by publisher]

Interview: Professor Jonathan Edwards on the UK Rituximab trial

SEPTEMBER 3, 2013 by Sasha:

The charity Invest in ME’s plans for a UK Rituximab trial got a substantial boost at the end of July when Jonathan Edwards, Emeritus Professor of Connective Tissue Medicine at University College London (UCL), agreed to act as their advisor for the study.

‘No UK expert is better placed than Professor Edwards to advise us on setting up a Rituximab trial for ME patients’, stated the charity, and it’s hard to argue with that. Drs Fluge and Mellabelieve that the timing of ME patients’ response to Rituximab-induced B cell depletion indicates that ME may be an autoimmune disease, and it was none other than Professor Edwards who proposed, in a 1999 paper in Immunology, that self-perpetuating B lymphocytes drive human autoimmune disease. He followed that up with Phase I and ‘proof of concept’ Phase II studies of Rituximab for rheumatoid arthritis published in the New England Journal of Medicine in 2004 that established empirically the role of B cell depletion in autoimmune disorders.

In order to set up the Rituximab studies for rheumatoid arthritis in 1998, all he had to do, he says, ‘was to write a letter saying I was wanting to do it and get a letter back that just said, in effect, “in this case we will not say no”.’ But by 2010, ‘the bureaucratisation and commercialisation of the NHS had got to such a stage that I concluded I would never be able to get involved in anything as productive again. So I took early retirement to do other things.’ And with the ME Rituximab trial? ‘I am now hoping to prove myself wrong.’

Professor Edwards has suggested his old Rituximab research team, led by Dr Jo Cambridge, to run a small trial of about 30 patients at University College London. He clearly understands the need for this research in this most neglected of diseases. In a statement to Invest in ME, he said, ‘After the Invest in ME Conference I began thinking about my personal experience of patients and friends with ME/CFS. I was sent a copy ofLost Voices by Invest in ME, which made me think more. It struck me that, whether or not results are positive, further trials of Rituximab for ME/CFS should be encouraged not only because impact on life for those affected can be so severe but also because further trials could give clues to disease mechanism.’

We’ve been very fortunate on Phoenix Rising in that, shortly after making this statement, Professor Edwards joined the forum here and has been generously answering questions and explaining the science behind the effects of Rituximab. He very kindly agreed to be interviewed about the trial, and the questions below include those from members of Phoenix Rising posted in response to an earlier article about the study.

*****

Sasha: How does Rituximab make sense as a treatment for ME?

Prof. Edwards: Illnesses due to immune system malfunction tend to look like infections but with no persistent infection to find. ME would seem to fit that. True autoimmune diseases are due to B cells making antibodies against the body’s own molecules. In many we have found the autoantibodies, but that was not always so and some have only been discovered recently. There are also common conditions like polymyalgia that may well be autoimmune but for which no autoantibodies have been found. Even in multiple sclerosis we know antibodies are being made in the wrong place but not exactly what they are against. In several autoimmune diseases the antibodies cause inflammation with a rise in blood tests like CRP but not in all. So it would not be so surprising if ME included one or more diseases due to autoantibodies that have not yet been discovered and for which we have no good markers for effects, like CRP.

If this is so we might expect to find some changes in B cell life history in ME and although the findings are subtle, we do have such evidence from Dr Bansal’s work. There is also some evidence of altered NK function but I think this is more difficult to interpret. Moreover, it is hard to see why NK function should suddenly change in a person who was previously well, unless secondarily to some other immune problem. In contrast we know that B cell malfunction often starts up in previously well people.

Many autoimmune diseases respond to Rituximab and we would not expect anything other than B cell related diseases to respond, so the Norwegian finding of a response to Rituximab is strong evidence for an autoimmune basis in at least some patients.

Sasha: How does the way that Rituximab might work for ME relate to the design of the planned trial?

Prof. Edwards: What I am currently thinking is that plans for a trial should focus on trying to link the evidence from Norway for a B cell basis for at least a proportion of cases with the evidence for B cell dysregulation from the study from Dr Bansal. Dr Bansal’s work suggests that young B cells are coming out of bone marrow under different rules. That fits well with an autoimmune process. Changes in immune regulation can make numbers either go up or go down and it can be difficult to see why it is one rather than the other. So my feeling is that what is important here is not so much the particular change seen but the suggestion that there may be some consistent change that we could use as a clue and a marker to relate further research to.

Sasha: Is a study of only 30 patients large enough to be of value, when there will be 140 in the Haukeland trial?

Prof. Edwards: I think the second Haukeland trial is big because there are specific requirements for numbers of patients being treated for licensing authorities. There is no good scientific reason for requiring these numbers but all regulators like rules. I think it may be largely a safety issue. I think a good small study can take the science forward. I also think it would be wrong to recruit more patients than we need for a specific purpose. In some ways I see the important objective not so much as ticking license boxes as getting scientific evidence that makes it so clear that B cells are involved (if they are) that further research will have a rock-solid base from then on. It would also be much more easy to justify compassionate, off-label use for severe cases pending formal licensing.

Read more>>

URGENT: ACT NOW To Stop ME Redefinition !

Posted by Liz Willow:

TELL HHS THAT YOU OPPOSE THE IOM CONTRACT – STOP THE PROPOSED IOM STUDY!

The US Department of Health & Human Services  is about to contract with the Institute of Medicine to "develop clinical diagnostic criteria for ME/CFS”.  This is extremely dangerous and must be stopped.

Why be concerned with this IOM initiative? The January 2013 IOM report on treatments for Gulf War Illness (GWI) redefined GWI as the non-specific chronic multisymptom illness (CMI) and recommended CBT, exercise and anti-depressants as treatments for severely ill and dying veterans with GWI. In addition, IOM is now conducting a study to “define a consensus case definition for chronic multisymptom illness (CMI) as it pertains to the 1990-91 Gulf War Veteran population.” This effort has come under fire by GWI advocates for failing to include sufficient expertise in Gulf War Illness on its panel.

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.

The sample letter to HHS and the background section below provides more information on the dangers of this initiative and on the IOM initiatives on GWI.

Immediate Actions You Can Take to Stop This Contract:

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.

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

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

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,
<Name>
________________________________________________________________


ADDITIONAL BACKGROUND FOR THE ME COMMUNITY

This section is intended to let you know why this is important.  It is not intended to be included in the letter to DHHS.

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.”

Chronic multisymptom illness is even broader than Fukuda and we know how Fukuda has buried ME.

GWI Advocates also charge that the IOM study and report obscured the science. In testimony in front of the House Committee on Veterans Affairs, Hardie further stated:

“The [IOM treatments] panel was charged by VA to conduct a literature review rather than to consult with knowledgeable medical practitioners experienced in treating ill Gulf War veterans.  And nearly all of the first presenters focused on "stress-as-cause", psychological, and psychosomatic issues – all debunked years ago.”

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.

Since then, the VA has contracted with IOM to constitute another IOM panel to “develop a consensus case definition for chronic multisymptom illness (CMI) as it pertains to the 1990-91 Gulf War Veteran population.” GWI advocates have criticized the composition of the panel and its inadequate expertise in Gulf War Illness. Jim Binns, chairman of the federal research advisory committee for GWI stated “the panel includes members that “represent discredited points of view” as well as psychosomatic and mental illness experts.”

Its important to note that Dr. Kenneth Shine, the previous president of IOM, has stated that he does not remember another time when IOM has been involved in defining a disease.

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, money and risk to come up with a new clinical criteria for ME - and the associated medical education material that will be required - 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
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This initiative is dangerous and will hurt ME patients. We must oppose it.

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Additional Resources:

HHS Announcement of the Solicitation for “Study for Diagnostic Criteria for CFS” https://www.fbo.gov/index?s=opportunity&mode=form&tab=core&id=7fafc35816ee932dc44d6c319937b366&_cview=1
Forbes. “Inside the effort to define Gulf War Illness” 6/28/2013 http://www.forbes.com/sites/rebeccaruiz/2013/06/28/inside-the-effort-to-define-gulf-war-illness/
USA Today. “Gulf War illness advocates skeptical of institute panel. 6/26/2013 http://www.usatoday.com/story/nation/2013/06/26/veterans-institute-of-medicine-gulf-war-illness/2458745/
March 13, 2013 testimony by Anthony Hardie, Gulf War vet and member of the VA Gulf War Research Steering Committee, before the House Committee on Veterans Affairs, http://veterans.house.gov/witness-testimony/mr-anthony-hardie-0              
Video - http://www.youtube.com/watch?v=OuNJbPMfrYo
IOM Initiative to define Gulf War Illness: “Development of a Case Definition for Chronic Multisymptom Illness” http://www8.nationalacademies.org/cp/projectview.aspx?key=49546
91outcomes.Com collection of documents related to the IOM panel to define a consensus criteria for chronic multisymptom illness. Published by Anthony Hardie. http://www.91outcomes.com/2013/06/uploads-iom-gulf-war-chronic.html