Monday, September 30, 2013

Frequently Asked Questions About the IOM Contract

As patients, we all have a number of questions about the September 23 letter from the ME/CFS experts to Secretary Sebelius. We also have questions about HHS’ announcement that they are moving forward with the IOM (Institute of Medicine) contract to redefine ME/CFS. The following is intended to provide a patient perspective on the situation as it appears today. It is not intended to speak for the ME/CFS experts who signed the letter or for HHS.

Q: What will happen, now that the experts have urged HHS to drop the IOM contract?

A: HHS has said that it is responding to our concerns. But clearly our experts disagree. HHS needs to immediately adopt the CCC as the sole definition for ME/CFS, as the experts have called for. HHS needs to cancel the IOM contract, which is completely unnecessary, wasteful and a step backwards scientifically. We need to support our experts and insist that our congressional leaders tell HHS to follow the lead of our experts and abandon this contract.

(Read how to contact your representative HERE. You can sign the petition to support the physicians' letter HERE.)

Q: Why didn’t the experts select the ME-ICC (International Consensus Criteria) as the case definition in their letter to Secretary Sebelius? It incorporates important scientific knowledge that has been learned since the CCC was developed in 2003.

A: The letter stated that the authors reached consensus on the CCC because “there is sufficient evidence and experience to adopt the CCC now for research and clinical purposes.”

While ME-ICC does incorporate more recent scientific knowledge, unfortunately, there isn’t much practical experience with it clinically or in research. So, at this point, we have two choices. We can continue using the CDC "Fukuda" criteria, which are too broad and don't require the hallmark symptoms of ME/CFS. (The IOM definition will not be any better.) The other choice is the CCC, the only criteria that accurately describes ME/CFS, and has been adequately tested in research and clinical care.

Q: We need a better definition than either the CCC or the ME-ICC, one that includes objective markers and describes the subtypes. We need more studies and more data to get the definition we need. Shouldn’t we wait for those studies to be done?

A: Everyone agrees that we need a case definition that includes objective markers for things like diagnostics and disease progression. And we need to better understand the subtypes of ME/CFS as this could drive treatment approaches.

But we can't conduct meaningful scientific studies using the current criteria.

At the May 2013 CFSAC meeting, Dr. Fletcher said that in order “to do the research, we have to be able to identify patient populations that are the same… Fukuda’s not going to do it.” Dr. Bruce Carruthers, lead author on both the CCC and the ME-ICC stated it simply “Patient sets that include people who do not have the disease lead to biased research findings, inappropriate treatments and waste scarce research funds.“

Continuing to study this disease using patients who do not have the disease is like studying the nature of birds by looking at anything that flies - birds, bats, bugs, flying fish. Studies based on inaccurate cohorts are guaranteed to produce conflicting and unexplainable results that make the validation of objective markers, as well as the identification of effective treatment approaches, impossible.

Q: Won’t the use of the Canadian Consensus Criteria result in the inclusion of more depressed patients?

A: It is actually the Fukuda defintion that allows the inclusion of clincially depressed patients, along with patients who have other causes of chronic fatigue.

Post-exertional malaise (PEM) is a hallmark symptom not seen in depressed patients or in other mental illnesses. Fukuda does not require that patients have PEM or other hallmark criteria. This allows a variety of unexplained fatiguing illnesses, including psychiatric illness, to be included. Dr. Bruce Carruthers has stated “Some symptoms of the Fukuda criteria overlap with depression, whereas the Canadian Consensus Criteria differentiate patients with ME from those who are depressed and identify patients who are more physically debilitated and have greater physical and cognitive functional impairments.” Dr. Leonard Jason, in a presentation available on the CFIDS Association site, made a similar statement.

Q: Some people say that the CCC is too complicated for doctors to use and that they need a simple checklist.

A: ME/CFS is a complex illness that needs to be understood and appreciated for the breadth of dysfunction that it creates in multiple body systems. Doctors need information that describes the disease in its complexity. Using a simple checklist to diagnose and treat such a complex disease is akin to expecting a general practitioner to treat stage 4 cancer using a simple checklist. Doctors do not expect to do that for stage 4 cancer and will not expect to do that for ME/CFS, once they understand the nature of the disease.

Q: Don’t the medical societies need to be involved in defining the disease?

A: For other diseases, it’s experts who have spent years studying and treating a disease who define that disease. It should be no different for ME/CFS. Our experts have already defined this disease.

That being said, it’s important to reach out to medical societies and educate them on ME/CFS, so they can recognize it and either make referrals to specialists or apply their specific expertise to its treatment. But that is far different from asking them to define the disease. We have seen too many doctors who think a diagnosis of ME/CFS is nonsense and that these patients are just depressed and need to exercise and have a round of CBT. Having those doctors define this disease would be disastrous.

Q: How is this going to affect my disability and health insurance? Will health insurance companies stop paying for office visits and tests? Will I have to go through disability all over again?

A: In the short term, neither health insurance or disability will be affected as neither relies exclusively on the case definition. The initial and continued eligibility for disability is based on your level of functional capacity.

But over the longer term, having HHS adopt the CCC will have a positive effect on both health insurance and disability coverage, by driving the kind of research that is needed to validate diagnostic tests and treatment alternatives. It also will make it harder for insurance companies to only support CBT and GET as treatment options.

Q: How does this affect the medical education materials that HHS currently uses?

A: If HHS does not change its medical education, we will still face a disbelieving and misinformed medical community. CDC’s current medical education material for ME/CFS is largely based on the Fukuda definition, which is centered on medically unexplained fatigue. As such, it contains information that is inaccurate and potentially harmful for ME/CFS patients. For instance, ME/CFS patients can be significantly harmed by exercise. But current CDC medical education identifies exercise as a treatment. How many patients have been harmed, sometimes irrevocably, by a doctor who recommended exercise without understanding PEM? The current medical education material will need to be replaced with material that reflects the CCC.

Q: Okay, so the experts have said they have reached consensus on the CCC. But the letter didn’t say anything about what will be done to implement this. How will that happen?

A: To achieve any change, the first thing is to make a clear statement of the desired outcome. Then everyone can work together to achieve that goal. Our experts have made a clear statement - use the CCC - now it is up to HHS and other government agencies to follow their lead. Updating medical information and educating doctors will be two essential steps in implementing the change.

In 1961, President John F. Kennedy announced the ambitious goal of sending an American to the moon before the end of the decade. It was a bold, even audacious, statement. But there were very few details on how this would be achieved. The president’s statement created a beacon, a target that people then worked to achieve. And they did.

The letter from our experts is like that declaration from JFK.

The details on how this will happen can't be worked out yet, but at least we all know where we are going. The next step is for HHS to follow the lead of our experts, abandon its own plans to redefine the disease and adopt the CCC. Then all can work together to quickly put in place all the details needed to make that happen. As the letter signatories stated, “We look forward to this accelerated progress and stand ready to work with [HHS] to increase scientific understanding of the pathophysiology of this disease, educate medical professionals, develop more effective treatments, and eventually find a cure. “

Q: What happens to patients who have been diagnosed with CFS but do not meet the Canadian Consensus Criteria?

A: Given the range of patients who have been given a CFS diagnosis, there will certainly be some who do not meet the CCC. A plan will need to be put in place to address these patients so that they can be given a proper diagnosis and treated for the disease they actually have.

Q: When will the CCC be adopted and implemented?

A: The first step is for HHS to follow the lead of the experts and agree to adopt the CCC. Until then, it is anyone’s guess as to when the CCC – and other necessary changes, such as medical education - will be implemented.

Q: What can we do right now to make sure HHS listens to our experts?

A: To ensure that HHS listens to ME/CFS experts, it is absolutely critical for U.S. residents to contact their congressional leaders and call for the adoption of the CCC. When it comes to making social change, elected representatives can accomplish more than anyone else.

You can send your representative an email, or call. Instructions are HERE.

You can sign the petition to support the immediate adoption of the CCC HERE.

Friday, September 27, 2013

Why the IOM Contract Is So Dangerous

If you have been following the ME/CFS news lately, you may be wondering what all this IOM fuss is about. Why is everyone so upset about yet another government initiative that probably doesn't mean anything anyhow?

This is what the fuss is about:

The IOM contract to redefine ME/CFS is the most dangerous thing that could possibly happen to the ME/CFS community. It is worse than no funding, worse than bad research, worse than having all your friends think you are malingering. Once the IOM defines ME/CFS as a subset of "fatiguing illnesses" (which it will) and recommends GET and CBT as treatments (which it will), ME/CFS will be permanently transformed into a mental illness.

There will be no NIH funding for any research unless it supports the notion that ME/CFS is "all in our heads."

There will be no FDA-approved treatments - ever - other than antidepressants.

In short, once HHS (and the CDC, FDA, NIH and Social Security) accepts the IOM "definition" we can kiss everything good-bye. That is why 35 physicians and researchers stepped up to the mat and wrote to HHS.

You can help by exercising your rights as a U.S. citizen. This is a participatory democracy, which means elected officials have to listen to you. Write to your representative. (I just wrote a letter to my Senators, following Mary Dimmock's instructions below. It only took a minute or two,)

You can sign the petition to support the physicians' letter HERE
________________________________________________

Tell Congress to Listen to Our Experts! Adopt the CCC - Cancel the IOM Contract!

By Mary Dimmock

On September 23, HHS announced that it will begin working with the Institute of Medicine (IOM) to develop “clinical diagnostic criteria” for ME/CFS.

That same day, 35 of the leading researchers and clinicians in the field of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) sent an open letter to Health and Human Services Secretary Kathleen Sebelius announcing that they had reached a consensus on adopting the Canadian Consensus Criteria (CCC) as the research and clinical case definition for ME/CFS. They called for HHS to follow their lead by using the CCC as the sole case definition for ME/CFS in all of HHS’s activities related to the disease and strongly urged HHS to abandon its plans to work with Institute of Medicine staff to develop clinical diagnostic criteria for an illness the IOM knows nothing about.

Our ME/CFS experts have spoken. We need to support them and call on HHS to follow their lead. Adopt the CCC. Cancel the IOM contract as wasteful, unnecessary and harmful.

For U.S. residents: Please contact your congressional leaders and the President’s science advisor today and ask them to tell HHS to adopt the CCC and cancel the IOM contract. Please ask your family and network to do the same.

Instructions and a sample letter are below.

Additional background can be found HERE.

The petition in support of the physicians' letter can be found HERE.
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Instructions to Email or Call Your Representative (U.S. only)

Senators and members of the House of Representatives need to hear directly from their constituents. You can get the contact information for your congressional leaders HERE.

Type your zip code into the form and click on “Submit It”. The website will return the names of your two senators and one representative along with their phone numbers and a link to their contact form.

If you are calling, ask to speak to the legislative aide who deals with healthcare issues. You can use the sample letter as talking points.

If you are sending an email, click on the link to the web contact form for your senators and representative. This will bring up the web contact form for that legislative leader.

If you are using the sample letter, copy it into the box provided for your message.

Use “Stop the IOM Contract to Redefine ME/CFS" as the subject.

If the online form indicates that you need to choose the nature of the issue, select a choice dealing with healthcare.
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Instructions for Contacting President Obama’s Science Advisors

Click HERE.

Scroll down to “PCAST” on the menu and fill out the rest of the required information.

Copy and paste the sample message into the body of the content form.

Add your name to the end of the message.
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Sample Message

To be copied into the web contact form and/or used for phone calls:

Dear [ Your Representative],

Please contact the Department of Health & Human Services (HHS) today. Tell HHS to:
  • Adopt the Canadian Consensus Criteria for ME/CFS and
  • Cancel its contract with the Institute of Medicine (IOM) to redefine ME/CFS. 
On September 23, HHS announced that it had contracted the IOM to develop clinical diagnostic criteria for ME/CFS, rejecting the use of criteria created by ME/CFS experts. HHS pursued the contract unilaterally with no involvement of ME/CFS medical experts or patients. Further, HHS has stated that it intends to use people with no expertise in ME/CFS to redefine the illness. Adding to these concerns, the IOM’s only other effort to define a disease – Gulf War Illness - has been harshly criticized for using non-experts, emphasizing psychiatric issues over evidence of chemical injuries, and proposing a vague definition that encompasses virtually all chronic illnesses. For all these reasons, ME/CFS patients have been protesting the IOM contract for weeks but HHS went ahead with the contract anyway.

On the same day that HHS announced that IOM would begin work, thirty-five of the leading ME/CFS researchers and clinicians responded by writing to Health and Human Services Secretary Kathleen Sebelius. The ME/CFS experts urged HHS to abandon its plans to hire the Institute of Medicine to create its own definition. They called for the Canadian Consensus Criteria (CCC), which experts have long considered to be the most accurate case definition, to be used as the sole case definition for ME/CFS.

As their letter states, “[S]ince the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort (the IOM study) is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease. Worse, this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.”

I have been personally affected by ME/CFS. It is a debilitating disease that causes neurological and immunological dysfunction and leaves patients bedridden, housebound and unable to work. The CDC estimates that over a million people in the U.S. suffer from the illness. ME/CFS costs the U.S. economy an estimated $17-23 billion dollars a year in lost productivity and direct medical costs. Due to the overly broad ‘case definition’ used for this disease by HHS since 1994, patients with ME/CFS are lumped together with patients with depression, deconditioning, and unspecified chronic fatigue. This broad case definition has also led to the misdiagnoses of thousands of patients with MS, incipient heart disease, and genetic disorders. The use of overly broad definitions, like the one now being developed by the IOM, has impeded ME/CFS research and held back medical care for patients like me.

Given the overwhelming opposition to HHS’ plans by both patients and experts, I am asking you to contact HHS today and tell them to follow the lead of ME/CFS disease experts.

Tell HHS to adopt the Canadian Consensus Criteria. Tell HHS to cancel the contract with IOM.

LINKS

Link to the September 23 announcement from HHS on the IOM contract. http://bit.ly/18m7XlJ

Link to the September 23 letter to Secretary Sebelius from the 35 ME/CFS experts http://bit.ly/15npS9B

Link to additional background http://bit.ly/16qOLY3

Thursday, September 26, 2013

For Everyone Out There Who is Hopelessly Confused By The Events of the Past Few Weeks, Mary Schweitzer Explains the 2-Day CPET, the CDC, and the IOM

In case you are suffering from acronym overload (CPET, PEM, CDC, IOM, CFSAC, HHS) this excellent blog post written by Mary Schweitzer, a veteran ME/CFSer and patient advocate, puts it all into perspective. The post originally appeared on her blog Slightly Alive on September 16. 2013. Reprinted with permission.

Why CDC must use two-day CPET testing - and specialists must define the disease, not bureaucrats

So Dr. Elizabeth Unger and the CDC have decided against a two-day exercise test in their supposedly all-encompassing, supposedly cooperative, upcoming CFS study.

Why am I not surprised?

When normal people go walking or bicycling or jogging, it is called "aerobic exercise" because while their body is exercising, it's using normal amounts of oxygen from air with carbon dioxide being expelled through their lungs. If you do aerobic exercise regularly, it is good for you. You get stronger and can go longer times or distances. For a normal person, aerobic metabolism can be measured with heart rate: (220 - your age) times 60% for the lower bound, (220 - your age) times 80% for the upper bound.

If your heart rate exceeds the upper bound, you're no longer operating in aerobic metabolism - your body will shift into what is called anaerobic exercise.

Weightlifting is an example of anaerobic exercise - you go past the point where the muscles can get enough oxygen from the lungs, and they start breaking down muscle to get it. That's okay - the muscle rebuilds stronger. But if you have to give the muscles a two-day rest, so in training, you either alternate working on upper body one day and lower body the next, or do weightlifting every other day.

If you push harder than that - even as an athlete - if you go too far with the supposedly aerobic exercise that your body switches into anaerobic, or do anaerobic exercises (like weightlifting) too frequently, the body starts living in anaerobic metabolism, and that is bad, because breaking down too many proteins this way poisons the body. If you don't have the good sense to stop, your body does - eventually it will MAKE you rest.

A gung-ho young athlete who is improperly trained can screw himself up with too much anaerobic exercise, and then his/her body will just refuse to keep going - for up to 3 weeks. That is called "over-training syndrome."

Professional and collegiate trainers keep close tabs on their athletes because of this.

For some reason our bodies shift into anaerobic metabolism (generally anything that sends our heart rates over 100) too soon. In my case, just walking does it when I'm sick. So you could say that our bodies are responding to "normal" activities as if we were athletes pushing too hard, that is, to a certain degree we are perpetually in the midst of "overtraining syndrome."

They use the VO2 MAX test (or CPET - Cardio-Pulmonary Exercise Testing) to measure this.

People with a bad heart have the same problem, and again they turn to the VO2 MAX stress test to measure it.

A recent set of studies* have found that those of us who are REALLY sick score badly on just one day of exercise - which then makes you wonder about the over-prevalence of heart attacks among us. So a score in the danger range (that would be me off Ampligen) should be taken seriously.

Most patients in this study are not going to score THAT low - they will score low-normal. The problem is, so do couch potatoes.

The amazing thing Staci Stevens and Chris Snell found was that high-functioning patients may score the same as deconditioned controls (the afore-mentioned couch potatoes) in one day of exercise - but on the SECOND day, the controls' scores don't change, whereas the patients' scores plummet IN HALF.

Which makes sense if you have a good understanding of this disease. But is really quite an astonishing finding for outsiders.

AND it is the best argument we have with which to make the case that graded exercise programs can hurt patients. Can make them worse. In some cases, can leave them paralyzed (something no one in government wants to talk about).

So if you want to measure that cardinal symptom of our disease that is often called post-exertional malaise (PEM), or post-exertional worsening of symptoms, you need a TWO-DAY test. Otherwise, we don't come off any different than someone who is not in shape.

Which means that by refusing to do the two-day test, CDC's results will make it look as if graded exercise was a good idea.

And that is bad. Bad enough that I think we are being set up. You can't say CDC doesn't KNOW that the two-day test has a different meaning - Chris Snell used to be president of CFSAC. And I've attended FDA meetings where Dr. Unger and Dr. Snell sat on the same dais. She knows. She is CHOOSING not to do the two-day test, knowing full well that it is the TWO-day test that demonstrates PEM.

Now, you're CDC. Supposedly the best in the world. You'd want to use the best methods, wouldn't you?

CDC's explanation for not dong the two-day test is that it would be an imposition for patients. But both Staci and Chris found that while the deconditioned controls could get whiney about having to do the test, patients with ME/CFS (Canadian) would walk on hot coals if it would move the science of this disease further along. So the supposition that the patients wouldn't want to have to come two days in a row does not fit what we already know.

The only time I ever saw Dr. Unger get angry in a CFSAC meeting was when we were all calling for a change in the CDC's recommendation of graded exercise. We asked not only that they quit recommending it, but also that they openly WARN physicians about the dangers. She was furious. She said that the emphasis on graded exercise was supported by scientists and was not negotiable. Those very words. Not negotiable.

Thus, by constructing this new study in such a way that patients will look like couch potatoes, Dr. Unger and CDC preserve their nonnegotiable stance of promoting graded exercise.

Why do I feel like I am being set up?

I think I'll ask Dr. Unger about that at the next CFSAC meeting. Oops! No can do - I'm not invited. The public is being excluded from the next CFSAC meeting, except for our pathetic little five-minute phone-in testimony.

I also noticed in the latest CFSAC announcement that CDC has returned to the IOM, where nobody knows anything about this disease except what CDC tells them, for the "new definition." The community of ME/CFIDS patients and clinicians had strenuously protested this through appropriate channels; CDC responded that they they heard us and were backing off - but not two weeks later, they have already gone back on their word.

Our position remains that it is currently active ME and CFIDS specialists and clinicians who should be drawing up that new definition. Like the ones on CFSAC. Not, well, strangers. They should put together a committee with John Chia (USC), Jose Montoya (Stanford), Dan Peterson (Simarron Institute), Lucinda Bateman (U of Utah), Alan and Kathleen Light (U of Utah), Nancy Klimas (Nova University), Mary Ann Fletcher (Miami), Martin Lerner, Paul Cheney, Maureen Hanson (Cornell), Gordon Broderick (U of Alberta), Charles Lapp (Duke), Anthony Komaroff (Harvard), Ben Natelson (NJ College of Medicine), Susan Levine, Ian Lipkin (Columbia), Derek Enlander (Mt. Sinai NYC) - and Chris Snell or Stavi Stevens. As a start. Not hired strangers.

These are VERY VERY BAD developments that roll things backwards to the early 1990s.

At least the insurance companies will be happy.

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*For the most recent, see Christopher R. Snell, Staci R. Stevens, Todd E. Davenport, and J. Mark Van Ness. "Discriminative Validity of Metabolic and Workload Measurements to Identify Individuals With Chronic Fatigue Syndrome." Physical Therapy (2013). Click here for the abstract:
http://ptjournal.apta.org/content/early/2013/06/26/ptj.20110368.short

My apologies to those I missed, and those whose affiliations I missed. The larger point is that these are clinician-scholars working at top-level institutions. They should not be ignored.

Wednesday, September 25, 2013

"Our ME/CFS Experts Have Spoken on the Case Definition"

By Mary Dimmock

On September 23, 2013, HHS announced that it has entered into a contract with the Institute of Medicine to begin work to develop “clinical diagnostic criteria” for ME/CFS.

That same day, 35 of the leading researchers and clinicians in the field of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) wrote an open letter to Health and Human Services Secretary Kathleen Sebelius to announce that they have reached a consensus on adopting the Canadian Consensus Criteria (CCC) as the research and clinical case definition for ME/CFS. They called for HHS to follow their lead by using the CCC as the sole case definition for ME/CFS in all of HHS’s activities related to the disease and strongly urged HHS to abandon its plans to reach out to groups like the Institute of Medicine to develop clinical diagnostic criteria.

Acknowledging that the case definition will be refined as science advances, the authors unambiguously endorsed the Canadian Consensus Criteria as the baseline criteria, stating:

“The expert biomedical community will continue to refine and update the case definition as scientific knowledge advances, for example, this may include consideration of the 2011 ME International Consensus Criteria … As leading researchers and clinicians in the field, however, we are in agreement that there is sufficient evidence and experience to adopt the CCC now for research and clinical purposes, and that failure to do so will significantly impede research and harm patient care.”

Just as directly, the authors stated their strong opposition to the IOM initiative, stating:

We strongly urge [HHS] to abandon efforts to reach out to groups such as the Institute of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for ME/CFS. Since the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease. Worse, this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.”

Wow! Could our experts have spoken any more clearly, loudly and collectively?

More than any other issue, HHS’ decades long failure to adopt a definition that actually reflects our disease has confounded research and forestalled drug development. It has caused doctors to dismiss their patients’ illness or attribute it to depression. It has bred the widespread stigma and misunderstanding that ME/CFS patients face every day. By its actions, HHS has abandoned ME patients to lives of terrible debility and suffering with no treatments, no care and no hope that anything will ever change. In the face of such suffering, some patients have chosen suicide.

Compounding its mistakes, HHS unilaterally entered into a contract with the Institute of Medicine (IOM) to develop clinical diagnostic criteria and has repeatedly stated its intent to use non-experts to define our disease. We need only look to the Gulf War Illness experience with IOM's vague, overly broad definition to know that this would be disastrous.

But today, thanks to our experts, the time for pretending ME/CFS doesn’t exist is OVER! The time for burying this devastating disease inside of a vague collection of unexplained fatiguing illnesses is OVER! To quote advocate Tom Hennessey, NO MAS!

HHS can no longer claim that there is a lack of consensus amongst disease experts. As with every other disease, it is time for HHS to follow the lead of our disease experts and adopt the CCC for research and clinical purposes. In particular, HHS must now stop wasting taxpayer dollars on misguided efforts that, in the words of the letter authors, “threaten to move ME/CFS science backwards.”

For patients who have suffered the negative effects of "research" on ‘false illness beliefs” and "maladaptive coping styles," this is finally a way out of the morass, an escape route from all that wasted time and effort. As the authors stated, adopting the CCC will “jump start progress and lead to much more rapid advancement in research and care for ME/CFS patients.” It gives hope that our ilness will be treated as the terrible disease that it is and that progress will now come quickly. It gives hope that we will soon rise up from our beds!

This letter is remarkable and historic for the ME/CFS community.

But what does this letter mean in terms of the IOM contract that HHS has just signed? Typically, like most contracts, government contracts have mechanisms built into them to allow the contract to be cancelled when the contract no longer makes sense.

Now that the ME/CFS experts have spoken, the path forward is clear. It does not make sense to waste money and time redefining the disease when the experts have now agreed upon the immediate adoption of the CCC.

We need to send two strong messages to HHS.
  • First, HHS needs to immediately adopt the CCC as the sole definition for ME/CFS as the experts have called for.
  • Second, HHS needs to cancel the IOM contract, which is completely unnecessary, wasteful and a step backwards scientifically. 

We need to forcefully engage our congressional leaders on this issue. Further information along with the actions to take with congressional leaders will be provided tomorrow.

The Sept 23, 2013 open letter from ME/CFS researchers and clinicians to Secretary Sebelius can be found here.

The Sept 23, 2013 CFSAC announcement on the IOM can be found here - http://bit.ly/18m7XlJ

Tuesday, September 24, 2013

ME/CFS PHYSICIANS REJECT IOM CONTRACT, DEMAND IMMEDIATE ADOPTION OF CANADIAN CONSENSUS CRITERIA

The following letter represents a milestone in the ongoing struggle to define ME/CFS. Although the 2003 Canadian Consensus Criteria (CCC) have been endorsed by ME/CFS physicians and researchers worldwide as being more accurate and more practical than the CDC's Fukuda case definition, ME/CFS experts have not - until now - made a direct appeal to HHS to formally adopt the CCC. 

The 35 signatures on this letter represent the top researchers and clinicians in the field, speaking with one voice to demand that the HHS stop trying to bury this illness under a case definition that will undo a decade of scientific research.

You can support this letter by signing the petition to change the definition - change the name!


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An Open Letter to the Honorable Kathleen Sebelius, U.S. Secretary of Health and Human Services

September 23, 2013

Dear Secretary Sebelius,

We are writing as biomedical researchers and clinicians with expertise in the disease of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to inform you that we have reached a consensus on adopting the 2003 Canadian Consensus Criteria (CCC) as the case definition for this disease.

The 1994 International Case Definition (Fukuda et al, 1994), commonly known as the Fukuda definition, was the primary case definition for ME/CFS for almost two decades. However, in recent years expert researchers and clinicians have increasingly used the CCC, as they have recognized that the CCC is a more scientifically accurate description of the disease.

The CCC was developed by an international group of researchers and clinicians with significant expertise in ME research and treatment, and was published in a peer-reviewed journal in 2003 (Carruthers et al, Journal of Chronic Fatigue Syndrome, 2003). Unlike the Fukuda definition, the more up-to-date CCC incorporates the extensive scientific knowledge gained from decades of research. For example, the CCC requires the symptom of post-exertional malaise (PEM), which researchers, clinicians, and patients consider a hallmark of the disease, and which is not a mandatory symptom under the Fukuda definition. The CCC was endorsed in the Primer for Clinical Practitioners published by the International Association of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (IACFSME). This organization is the major international professional organization concerned with research and patient care in ME/CFS.

The expert biomedical community will continue to refine and update the case definition as scientific knowledge advances; for example, this may include consideration of the 2011 ME International Consensus Criteria (Carruthers et al, Journal of Internal Medicine, 2011). As leading researchers and clinicians in the field, however, we are in agreement that there is sufficient evidence and experience to adopt the CCC now for research and clinical purposes, and that failure to do so will significantly impede research and harm patient care. This step will facilitate our efforts to define the biomarkers, which will be used to further refine the case definition in the future.

We strongly urge the Department of Health and Human Services (HHS) to follow our lead by using the CCC as the sole case definition for ME/CFS in all of the Department’s activities related to this disease.

In addition, we strongly urge you to abandon efforts to reach out to groups such as the Institute of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for ME/CFS. Since the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease.

Worse, this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable. ME/CFS patients who have been disabled for decades by this devastating disease need to see the field move forward and there is no time to waste. We believe that our consensus decision on a case definition for this disease will jump start progress and lead to much more rapid advancement in research and care for ME/CFS patients. We look forward to this accelerated progress and stand ready to work with you to increase scientific understanding of the pathophysiology of this disease, educate medical professionals, develop more effective treatments, and eventually find a cure.

Sincerely,

United States Signatories

Dharam V. Ablashi, DVN, MS, Dip Bact.
Scientific Director of HHV-6 Foundation
Co-founder of IACFS/ME
Santa Barbara, California

Lucinda Bateman, MD
Director, Fatigue Consultation Clinic
Executive Director, OFFER
Salt Lake City, Utah

David S. Bell, MD, FAAP
Researcher and Clinician
Associate Professor of Pediatrics
State University of New York at Buffalo
Lyndonville, New York

Gordon Broderick, PhD
Professor, Center for Psychological Studies
Director, Clinical Systems Biology Lab
Institute for Neuro Immune Medicine,
Nova Southeastern University
Fort Lauderdale, Florida

Paul R. Cheney, MD, PhD
Director, The Cheney Clinic, PA
Asheville, North Carolina

John K.S. Chia, MD
Researcher and Clinician
President, EV Med Research
Lomita, California

Kenny L. De Meirleir, MD, PhD
Professor Emeritus Physiology and Medicine (Vrije Universiteit Brussel)
Medical Director, Whittemore-Peterson Institute
University of Nevada
Reno, Nevada

Derek Enlander, MD, MRCS, LRCP
Attending Physician
Mount Sinai Medical Center, New York
ME CFS Center, Mount Sinai School of Medicine
New York, New York

Mary Ann Fletcher, PhD
Schemel Professor of NeuroImmune Medicine
Institute for Neuro Immune Medicine
Nova Southeastern University
Fort Lauderdale, Florida

Ronald Glaser, PhD, FABMR
Director, Institute for Behavioral Medicine Research
Kathryn & Gilbert Mitchell Chair in Medicine
College of Medicine - Distinguished Professor
Professor, Molecular Virology, Immunology and Medical Genetics
Professor, Internal Medicine
Professor, Division of Environment Health Sciences, College of Public Health
Institute for Behavioral Medicine Research
Columbus, Ohio

Maureen Hanson, PhD
Liberty Hyde Bailey Professor
Department of Molecular Biology and Genetics
Cornell University
Ithaca, New York

Leonard A. Jason, PhD
Professor of Psychology
DePaul University
Chicago, Illinois

Nancy Klimas, MD
Director, Institute for Neuro Immune Medicine
Professor, Nova Southeastern University
Fort Lauderdale, Florida

Gudrun Lange, PhD
Clinical Neuropsychologist
Professor, Rutgers New Jersey Medical School
Newark, New Jersey

A. Martin Lerner, MD, MACP
Professor, Infectious Diseases
Oakland University William Beaumont School of Medicine
Emeritus Director, Infectious Diseases, Wayne State University School of Medicine
Master, American College of Physicians
Reviewer, Viral Diseases, Medical Letter
Beverly Hills, Michigan

Susan Levine, MD
Researcher and Clinician, Private Practice
New York, New York
Visiting Fellow, Cornell University
Ithaca, New York

Alan R. Light, PhD
Professor, Department of Anesthesiology and Department of Neurobiology and Anatomy
University of Utah
Salt Lake City, Utah

Kathleen C. Light, PhD
Researcher
Professor, Department of Anesthesiology
University of Utah School of Medicine
Salt Lake City, Utah

Peter G. Medveczky, MD
Professor, Department of Molecular Medicine
College of Medicine
University of South Florida
Tampa, Florida

Judy A. Mikovits, PhD
Researcher, MAR Consulting, LLC
Carlsbad, California

Jose G. Montoya, MD, FACP, FIDSA
Professor of Medicine
Division of Infectious Diseases and Geographic Medicine
Stanford University School of Medicine
Stanford, California

James M. Oleske, MD, MPH
Fran├žois-Xavier Bagnoud Professor of Pediatrics
Director, Division of Pediatrics Allergy, Immunology & Infectious Diseases
Department of Pediatrics, Rutgers New Jersey Medical School
Newark, New Jersey

Martin L. Pall, PhD
Professor Emeritus of Biochemistry and Basic Medical Sciences
Washington State University
Portland, Oregon

Daniel Peterson, MD
Founder and President of Sierra Internal Medicine
Incline Village, Nevada

Richard Podell, MD, MPH
Clinical Professor, Department of Family Medicine
UMDNJ Robert Wood Johnson Medical School
New Brunswick, New Jersey

Irma Rey, MD
Clinician
Institute for Neuro Immune Medicine
Nova Southeastern University
Fort Lauderdale, Florida

Christopher R. Snell, PhD
Professor, Health, Exercise and Sport Sciences
University of the Pacific
Stockton, California

Connie Sol, MS, PhDc
Clinical Exercise Physiologist
Institute for Neuro Immune Medicine
Nova Southeastern University
Fort Lauderdale, Florida

Staci Stevens, MA
Exercise Physiologist
Founder, Workwell Foundation
Ripon, California

Rosemary A. Underhill, MB BS, MRCOG, FRCSE
Independent Researcher
Palm Coast, Florida

Marshall V. Williams, PhD
Professor, Departments of Molecular Virology, Immunology and Medical Genetics; Microbiology
The Ohio State University
Columbus, Ohio

International Signatories

Birgitta Evengard MD, PhD
Professor, Division Infectious Diseases
Umea University
Umea, Sweden

Sonya Marshall-Gradisnik, PhD
Director, National Centre for Neuroimmunology and Emerging Diseases
Griffith Health Institute

Professor, Griffith University Parklands Gold Coast
Queensland, AustraliaCharles Shepherd, MB BS
Honorary Medical Adviser to the ME Association
London, United Kingdom

Rosamund Vallings MNZM, MB BS
IACFS/ME Secretary
Clinician, Howick Health and Medical Clinic
Auckland, New Zealand

Cc:
Dr. Howard Koh, Assistant Secretary for Health
Dr. Richard Kronick, Director, Agency for Healthcare Research and Quality
Dr. Thomas Frieden, Director, Centers for Disease Control and Prevention
Ms. Marilyn Tavenner, Administrator, Centers for Medicare and Medicaid Services
Dr. Margaret Hamburg, Commissioner, U.S. Food and Drug Administration
Dr. Mary Wakefield, Administrator, Health Resources and Services Administration
Dr. Francis Collins, Director, National Institutes of Health
Ms. Carolyn W. Colvin, Commissioner, Social Security Administration

Monday, September 23, 2013

Foremost Virus Hunter Finds Biomarkers, Few Viruses in Big Chronic Fatigue Syndrome Study

Reprinted with kind permission of Simmaron Research.

By Cort Johnson, Simmaron Rising, September 11, 2013

A Surprise Presentation

You don’t usually get study results in talks like the one put on by the CDC yesterday but this time Dr. Ian Lipkin spilled the beans on the results from the big pathogen studies sponsored by the Chronic Fatigue Initiative (n=200) and Dr. Montoya (400). (From notes taken on the talk)

Virus Study Results Revealed

Viruses have always been the elephant in the room in ME/CFS; everybody has wondered about them but until the Chronic Fatigue Initiative came along, few major studies had been done. This landmark study, using the one of the top virus hunters in the world and epidemiologist Mady Hornig, and containing hundreds of patients from ME/CFS specialists (Dr. Peterson, Klimas, Montoya, Levine, etc.) from across the country, sets a benchmark for pathogen research in ME/CFS.

A special feature of the study involved Simmaron Research’s spinal fluid samples. The Simmaron Foundation provided a rare resource: sixty cerebral spinal fluid samples. Called a ‘unique resource’ earlier by Dr. Mady Hornig, these samples allowed the researchers to get as close to the brain – long thought to be a key area in chronic fatigue syndrome – as they could. And the spinal fluid results were spectacular.

The Studies

This study funded by the CFI, using top labs, and involving hundreds of people with ME/CFS, is a benchmark in ME/CFS research. The studies looked at both pathogen presence and the immune response in hundreds of people with chronic fatigue syndrome.

Pathogens

First Phase - Screens for 18 specific pathogens already implicated in ME/CFS (herpesviruses, HTLV, enteroviruses, West Nile Virus, etc.) were done on blood from Montoya’s patients and the CFI’s group (Drs. Peterson, Klimas, Bateman, Levine, etc.). Dr. Lipkin was looking for the virus, not a indication it was present, but the virus itself. Any finding of a virus in the blood would indicate it was active. The same screen was done on Dr. Peterson’s sixty spinal fluid samples.

Second Phase - The second phase involved sequencing all the DNA/RNA in the blood to identify known and unknown viruses. Dr. Lipkin’s lab has been able to identify hundreds of novel viruses using this technique.

Third Phase - Any finds in the second phase are confirmed/denied by more accurate testing.

Immune Response

A ‘multiplexed immunoassay’ looked at 50 proteins associated with immune activation/inflammation and oxidative stress.

Active Viruses Strike Out

Four of the 285 ME/CFS blood samples tested positive for HHV-6B. One of the sixty spinal fluid samples tested positive for a virus (HHV-6B). None of the other viruses commonly associated with ME/CFS (Epstein Barr-Virus, enteroviruses, the cytomegalovirus, etc.) commonly associated with ME/CFS showed up in the first pathogen screen.

The high throughput screening designed to look for any viruses including novel viruses drew a blank as well. Dr. Lipkin was confident in his results stating his lab had found over 500 new viruses using this technique.

Lipkin’s search for 18 viruses and for novel viruses in hundreds of people with chronic fatigue syndrome largely turned up empty

The news – that fewer than 2% of patients with infectious onset – tested positive for viruses in the blood was stunning but not without precedent. Dr. Unger reported earlier that the first stage of the CDC’s BSRI pathogen study drew a blank. A spinal fluid study also turned up no viruses, and PCR analyses done by the Dubbo group were unable to find evidence of a virus in their post-infectious cohort.

With two large sample sets turning up negative in the lab of one of most acclaimed virus hunters on the planet, it’s probably safe to say that the hunt for a virus in the blood of people with ME/CFS is over.

(Lipkin did report 85% of pooled samples possibly showed evidence of a retrovirus but believes they will not be related to CFS. He also dismissed earlier rumors that a novel infectious agent had been found.)

Infectious Agent Still Proposed

That doesn’t mean an infectious agent is not involved. In fact, Dr. Lipkin stated he didn’t doubt that an infectious agent was involved. He didn’t say where and he didn’t say it was still present. His allusion to the importance of finding evidence of a past infection (“researching the shadows”) suggested he could be leaning to the ‘hit and run’ hypothesis where a pathogen sweeps in, does its damage, and then gets removed by the immune system.

The Dubbo studies’ finding that high cytokine levels early in the infection were strongly associated with getting ME/CFS later on suggested an overactive immune system may have a blown a few fuses somewhere.

On the other hand, Dr. Lipkin specifically alluded to an ‘agent’ driving the immune activation he found in both the blood and spinal fluid of ME/CFS patients (but not the healthy controls).

Localized Infections Still Appear to Be a Possibility

Dr. Lipkin didn’t discuss this possibility. The blood is the most convenient place to search for an virus and active viruses usually do travel through the blood but central nervous system or localized infections may not show up in the blood or the spinal fluid.

Some evidence of localized infections in the gastrointestinal tract has been found in ME/CFS. A De Meirleir team found evidence of HHV-6, EBV and parvovirus B-19 in 15-40% of gut biopsies. Eighty-two percent of stomach biopsies tested positive for a protein associated with enteroviruses in Dr. Chia’s 2008 study. Dr. Chia reports enteroviruses are found much more readily in the stomach than the blood (but he is able to find it in the blood). No enteroviruses were found in the present study.

Vanelzakker proposes that a localized vagal nerve infection is causing the symptoms in ME/CFS. It’s not clear what these results mean for Dr. Lerner’s theory that an aborted EBV infection is spilling viral proteins into the blood that are sparking an immune result.

The Three-Year Breakpoint

Data suggests there may be substantial differences in biomarkers in people with less than 3 years of disease and those with more than 3 years of disease. Dr. Lipkin

Two recent research findings suggest the immune systems of people with recent onset and longer duration ME/CFS are significantly different.

Echoing similar recent findings from the Broderick/ Klimas team at NSU, Dr. Lipkin stated the immune system in ‘newbies’ (patients with recent onset), and patients with a longer case of ME/CFS was different. Dr. Lipkin’s ability to independently differentiate ‘newer’ from ‘older’ patients using cytokine results is pivotal, and points to the central and progressive role the immune may play in this disorder.

With Broderick suggesting that two distinct illnesses emerge over time, and Lipkin proposing treatment options should reflect illness duration, it was clear these changes were significant indeed.

Natelson, on very different track, is finding changes over time as well with more POTS in his adolescents and a different kind of orthostatic intolerance in older patients. Studies are underway to understand why this might be so.

An Early Allergic Response

Allergy is not usually mentioned in association with ME/CFS but eosinophils and other markers suggested to Dr. Lipkin that the allergic response was enhanced in ME/CFS early on. The cast of immune characters Lipkin’s biomarker search fleshed out was refreshingly familiar with IL-17, IL-2, IL-8 and TNF-a leading the list.

Levels of Il-17 were raised in recent onset ME/CFS patients. Lipkin suggested immunomodulators able to bring IL-17 levels down might be a treatment option at some point.

No mention, interestingly, was made of autoimmunity, but Lipkin, pointing at the high IL-17 levels in the newbies, embraced the idea (only after further validation) of using immunomodulators in some ME/CFS patients to turn down the fire in the immune system. Immunomodulators exist now, he said, that can bring that IL-17 cytokine down. (He stressed, however, that there is not enough research to start using them on patients.)

The spinal fluid, interestingly enough, showed a very different pattern. It showed a consistent profile of immunological dysregulation in CFS, regardless of duration of illness. Dr. Lipkin identified increased IL-10 and IL-13 levels suggesting enhanced Th2 activation and increased IL-1B, IL-5 and IL-17 suggesting Th1 (proinflammatory) activation. Dr. Lipkin was obviously intrigued by the differences in cytokine findings between spinal fluid and blood.

A Focus on the Gut

Lipkin’s prime focus at this point is the gut and fecal matter. He believes the gut microbiome is going to play perhaps the key role in ME/CFS.

The Hornig/Lipkin team has had considerable experience with the gut microbiome. They’ve been successful finding gut abnormalities in autism, a disorder that shares some intriguing commonalities with ME/CFS, including low natural killer cell functioning. Noting that the gut can modulate immune functioning, not just in the gut, but across the body he asserted the gut is going to be ‘where the action is’ in ME/CFS.

Unfortunately, the fecal samples originally collected didn’t provide enough material for analysis so they’re restarting that part of the study.

Even more unfortunately, characterizing the bacteria in fecal matter is extremely expensive and Lipkin, with just 10% of the money needed to do the job, evidenced considerable frustration at having his hands tied by lack of money.

Stating that he was not pointing fingers, he then proceeded to point them everywhere: at federal politics of funding, at NIH budget cuts, and at the paucity of research funding in our field. As at his last public talk, he urged patients to get active and enlist their congressman in their cause. Oddly enough, he also said Dr. Fauci, long considered a kind of ME/CFS nemesis by patients, was supportive of more work in this area.

Reiterating his belief that chronic fatigue syndrome has pathophysiological roots, Lipkin noted his history with it. Dr. Lipkin’s 1999 ME/CFS study did not find the virus he was researching but it did find a great deal of immune (polyclonal B-cell) activation. This was a pattern that was recently repeated when he didn’t find XMRV, but did find evidence of immune activation.

Next Up

Lipkin, in close collaboration with his ME/CFS experts, Dr. Peterson, Dr. Montoya. Dr. Klimas, Dr. Komaroff, etc. is following these results with deep sequencing of samples, completion of fecal matter analysis and larger studies to confirm and deepen the understanding of cytokines as biomarkers. Protein analysis was not mentioned but it was part of the original project. Tracking down evidence of past infection was also on the agenda.

Conclusion

The Chronic Fatigue Initiative’s pathogen study set a benchmark for rigor and size in the ME/CFS research field, not the least because of Dr. Lipkin’s leadership. Surprisingly few viruses were found in the blood of ME/CFS patients, yet Lipkin asserted that an infectious agent was likely driving the immune activation he found in the blood and spinal samples. Cytokine analyses of the blood suggested a different pattern of immune dysregulation was present in newer onset patients (<3 years) and patients with a longer duration of illness.

Dr. Lipkin believes the “primary cause is likely to be an infectious agent” and the gut microbiome is where ‘the action’ will be in ME/CFS.

Note: The Australian study is complementary to the Lipkin studies and should produce results in the first half of 2014.

Friday, September 20, 2013

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

Tuesday, September 17, 2013

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.

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)

Monday, September 16, 2013

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

Friday, September 13, 2013

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.)

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.
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