Saturday, October 12, 2013

Don't Let Petition Fatigue Set In:
Contact Congress to Stop the IOM Contract and Adopt CCC

Patient advocates, including Mary Dimmock and Patricia Carter, sent this call to petition Congress to stop the IOM contract and adopt the Canadian Consensus Criteria. Patients no doubt are experiencing petition fatigue, but the signatures of 34 key ME researchers and clinicians on the petition to HHS Secretary Kathleen Sebelius to stop the IOM contract have been one of the most important advocacy moves of the past 30 years. Congress, unlike HHS and CDC, is much more likely to listen to the patients and these experts--and that's why advocates have drafted this petition to Congress.

Given the situation, despair is understandable, but despair won't change anything. This is usually the time that patients fold and let the government have its way--and patients get shafted yet again. This is usually the time when patients say maybe it will be different this time and try to work within the system, but so far that hasn't worked. This is usually the time when patients let the CFIDS Association, HHS, CDC and their minions say soothing things--but walk all over them. But this time can and should be different: This time patients have 34 experts supporting their cause, and that should make Congress take notice.

Here's step-by-step directions to contact Congress:

For U.S. residents only
Please contact your congressional leaders as soon as possible within the next two weeks 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. Note that while the government is still shutdown, the web contact forms still work and the messages from constituents will be recorded. Sending in messages now will ensure that they are logged and available for staff members.

For U.S. and international members of the community
If you have not done so, please sign the two attached petitions calling on HHS to adopt the CCC and cancel the IOM contract. Ask your family and friends to do the same.

1. October 7, 2013 petition calling on HHS to stop the HHS/IOM contract and accept the CCC definition.

2. June 2013 petition calling on HHS to adopt the CCC and stop using the name ‘chronic fatigue

General background can be found here. Additional facts about the HHS/IOM contract for ME/CFS can be found here.

Instructions to email or call your congressional leader (U.S. only) 
1. 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 at this website.

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.

2. 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.

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

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

c. If the online form indicates that you need to choose the nature of the issue, select a choice dealing with healthcare.                                             

Sample message 
To be copied into the web contact form:

I am asking you to contact the Department of Health & Human Service (HHS) today and tell them to follow the lead of Myalgic Encephalomyeltis/Chronic Fatigue Syndrome (ME/CFS) disease experts. Tell HHS to adopt the Canadian Consensus Criteria and cancel its contract with the Institute of Medicine (IOM) to redefine ME/CFS.

On September 23, thirty-five of the leading ME/CFS researchers and clinicians wrote to Health and Human Services Secretary Kathleen Sebelius calling for the Canadian Consensus Criteria (CCC) to be used as the sole case definition for ME/CFS. These experts also urged HHS to abandon its plans to contract with the Institute of Medicine (IOM) to use non-experts to create its own definition. On the same day, despite an outpouring of patient opposition, HHS announced that it was going forward with the IOM contract to develop its own clinical diagnostic criteria for ME/CFS, instead of adopting the 2003 Canadian Consensus Criteria (CCC) created and endorsed by ME/CFS experts.

Regarding the IOM contract, the thirty-five experts stated,“[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.”

The use of non-experts is especially concerning because, thanks to the bad definitions that HHS has promoted, the disease is so poorly understood that the medical community at large believes the disease is either not real or is a form of depression or deconditioning. ME/CFS is not deconditioning or depression. It is a devastating disease that causes neurological and immunological dysfunction and leaves patients bedridden, housebound and unable to work. ME/CFS costs the U.S. economy an estimated $17-$23 billion dollars a year in lost productivity and direct medical costs.

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

For more information, see the following links or send an email to
– Link to Sept 23 announcement from HHS on the IOM contract.
– Link to Sept 23 letter to Secretary Sebelius from the 35 ME/CFS experts.
– Link to additional background.

Tuesday, October 8, 2013

Stop the IOM; Team Up with Gulf War Veterans

Patient advocate Wildaisy has started a petition to stop the Institute of Medicine (IOM) contract to redefine ME. If the IOM contract goes forward, chances are good that ME will go the way of Gulf War Syndrome, which was pathetically redefined at the beginning of the year as chronic multisymptom illness (CMI).  The recommended treatments included cognitive behavioral therapy, graded exercise and antidepressants--the same recommendations CDC gives ME patients now.

CFIDS Association Suzanne Vernon is supposed to be appointed to the IOM committee to study ME. On September 28, I wrote to Suzanne Vernon for a comment. She did not respond. 

Bona fide ME experts have already signed an earlier petition to halt the IOM and adopt the Canadian Consensus Criteria to define ME. Despite the impressive effort, there has been no response from HHS Secretary Kathleen Sebelius. 

If you want to join the effort to stop IOM, here is what the new petition says and the link to it:

"We, the undersigned people suffering from Myalgic Encephalomyelitis, along with our families, carers and friends hereby ask Secretary Kathleen Sebelius to cancel the contract HHS signed with the Institute of Medicine (IOM) to develop “clinical diagnostic criteria” for ME/CFS. We further urge Secretary Sebelius to respect the consensus reached by a group of experts supporting the adoption of the Canadian Consensus Criteria (CCC) as the research and clinical case definition for ME/CFS."

Many Gulf War veterans have been enraged by the IOM's redefinition of their disease.  If ME patients could team up with Gulf War veterans, perhaps their combined voices will be heard.

Tuesday, September 24, 2013

CDC's Two-Day Exercise Test: Not Negotiable

Center for Disease Control's head of CFS research Dr. Beth Unger is slated to do a problematic one-day ME exercise study called the Cardiopulmonary-Exercise Testing, instead of the two-day test favored by most patients and ME-educated researchers. What’s wrong with Unger's study? 

The problem is that studies show that defects in ME patients' exercise capacity aren't evident until the second day of testing. With one-day testing, ME patients resemble deconditioned controls, a fancy phrase for couch potatoes. 

In a letter discussing her reasons for favoring the one-day study, Unger says two days would be an “unnecessary burden” for patients. Would most patients prefer a difficult one-day study that makes ME sufferers out to be indolent grumblers or a grueling two-day study that shows just how sick ME patients are? Do I really have to answer that question? Besides, the very sick patients who can't handle the second-day exercise test provide helpful data for researchers. The fact that they can't do a second day would become part of the study's findings.

Could Unger just not know about second-day crashing in ME patients?  Dr. Chris Snell, an expert in the field of exercise testing for ME patients and a proponent of two-day testing, served as president of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). Unger attends its meetings, so she's aware of his work.

In citing other reasons for her decision to go ahead with one-day testing, Unger said more patients could be tested in a one-day study. To which I say: Quality, Dr. Unger. Not quantity. 

Exercise Not Negotiable 
When the one-day study shows most ME patient to be just deconditioned—not sick—the phony prescription will be, of course, exercise. Patient advocate Mary Schweitzer, in a terrific post on Unger's proposed study, calls it a set-up; I call it rigged.  

Unger believes in graded exercise for ME patients the way Republicans believe in the late Ronald Reagan. In fact, Mary Schweitzer makes this trenchant point about Unger:  

"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.' "

Patients need a CDC researcher who understands how dangerous exercise can be. How does Beth Unger get off telling patients that she knows best, that graded exercise is good for them, when it's the patients—not she—who understand this disease, who've been suffering for years if not decades? 

Patient advocate Cort Johnson has also written an in-depth piece arguing for a two-day exercise study. He points out that instead of enlisting the experts in the field to conduct the study—Snell and Stevens—CDC is calling upon Connie Sol, who, he writes, has done only one study.

Chris Snell's Studies
The way I see it, it's clear to most patients, advocates and ME-educated researchers that a two-day exercise test is necessary. In a letter, Unger explained that she had consulted Snell on which he thought was the better approach—one-day or two-day exercise testing. Snell said two-day testing. 

When asked to comment on Unger's proposed study, Snell wrote in an email to CFS Central: "
Unfortunately I do not feel able to comment on the proposed CDC study at this point. I am not involved in the study and do not know much about the design, measures, or any hypotheses they intend to test. My views on exercise testing for ME/CFS are well-documented, including a number of presentations available on the WWW. The most recent is the FDA ME/CFS drug development workshop earlier this year. Please feel free to cite any of our work or public comments."

Snell and Steven's most recent study, published in June, found that two-day testing is vital in ME patients, with emphasis added:

"The objectives for this study was to determine the discriminative validity of objective measurements obtained during CPET to distinguish individuals with CFS from non-disabled sedentary individuals. Methods Gas exchange data, workloads and related physiological parameters were compared between 51 individuals with CFS and 10 control subjects, all females, for two maximal exercise tests separated by 24 hours.  Results  Multivariate analysis showed no significant differences between controls and CFS for Test 1.  However, for Test 2 the individuals with CFS achieved significantly lower values for oxygen consumption and workload at peak exercise and at the ventilatory/anaerobic threshold. Follow-up classification analysis differentiated between groups with an overall accuracy of 95.1%. Conclusions The lack of any significant differences between groups for the first exercise test would appear to support a deconditioning hypothesis for CFS symptoms. However, results from the second test indicate the presence of a CFS related post-exertional fatigue. It might be concluded that a single exercise test is insufficient to reliably demonstrate functional impairment in individuals with CFS. A second test may be necessary to document the atypical recovery response and protracted fatigue possibly unique to CFS, which can severely limit productivity in the home and workplace."

In other words, according to Snell's study, it takes two days of testing to see the poor recovery responsepost-exertional malaisein patients. 

Which brings me back to Unger's study. I believe the study must be changed. The data from a big CDC two-day study would be a game-changer. The data from a big one-day study will inevitably show patients are lazy and need exercise.

We have seen the government ignore hundreds of letters from patients and ME-literate researchers and clinicians and sign the Institute of Medicine (IOM) contract anyway. That way, in a crazy-making move, researchers who know absolutely nothing about ME will redefine the disease to the tune of one million dollars when we already have a good working definition of the ME with the Canadian Consensus Criteria. Researchers, clinicians and advocates fired back yesterday in a letter to Kathleen Sebelius, the secretary of Health and Human Services (HHS) explaining just that.

Now, I believe we need to do the same thing with Unger and her bosses (see their emails below this post). We need patients to explain to HHS and CDC that a one-day test is not acceptable. 

If CDC won't change the test to two days, and/or if HHS is unable to see the wisdom of the CCC for diagnosing ME, then the next step is to take the long and sordid, heavily documented history of disregard for patients' well being and good research and approach Congress, asking for a subcommittee to look into these abuses.

Tom Hennessy
On another note, Tom Hennessy, a ME patient I’ve know for 19 years who lived with debilitating pain, committed suicide on September 9th. If Beth Unger, CDC and HHS spent more time doing legitimate research and stopped spewing out crap, perhaps patients like Tom wouldn’t feel the need to end their lives.  

Patients can't let Beth Unger and CDC screw things up yet again with this shortsighted exercise study. 
If Unger remains resistant to a two-day test, she needs to be put where she belongs:  on the unemployment line.

Don't feel sorry for her. Unger's collecting a good salary, fabulous health-care benefits and amassing a pension—and doing research that's damaging to patients. Meanwhile, patients like Tom Hennessy die or commit suicide after years of illness and pain.

Who can endure another 20 years of this bullshit?

                                                                   *** [Thomas Frieden] [Elizabeth Unger]

Email subject:  two-day exercise test (feel free to change subject name; it helps avoid screening of your email)

Dear Dr. Unger:

We need CDC to do a two-day exercise test in CDC's Cardiopulmonary-Exercise Testing, not a one-day exercise test.

Previous studies, including those by Dr. Chris Snell, have shown that the fatigue ME/CFS patients experience is not felt immediately upon exercise; it develops 24 to 48 hours after exercise. If you test patients for only one day, your results will not be accurate and patients will appear to be deconditioned. If you test patients for two consecutive days, their PEM will be measurable.

That is why CDC must do a two-day study.

If patients are too ill to complete the second day of exercise, then the test can be stopped.  If the test has to be stopped, that will also give CDC valuable information about ME/CFS.

We need to know in a timely fashion that CDC is willing to do the study correctly with a two-day test. If the CDC continues to ignore patients, we will escalate this matter to your superiors, the press and Congress.


(your name, how long you have had M.E.) 

Monday, August 26, 2013

What’s the Matter with Meghan?

It appears that Meghan O’Rourke may have ME, but The New Yorker writer doesn’t know it. 

In the current edition of The New Yorker, writer and poet Meghan O’Rourke pens in the readable piece "What's Wrong with Me?" that she's been sick for years with an autoimmune disorder that no one can identify, but the illness has the classic symptoms of ME.

Her early blood work showed recent exposure to Epstein Barr, cytomegalovirus and parvovirus. Her lymph nodes "ache," she’s developed Hashimoto’s thyroiditis, she forgets words, transposes words and can’t think. She’s been plagued with neuropathy, migraines, terrible fatigue, hives, low blood pressure, dizziness, bruises, fevers. These are textbook ME complaints. But it's not just the litany of symptoms that is so familiar. It's the way she describes them, from her brain being "enveloped in a thick gray fog" to this description of an evening out: “Sitting upright at my father’s birthday dinner required a huge act of will."

O’Rourke also has a family history of several autoimmune illnesses, including rheumatoid arthritis, ulcerative colitis and thyroid disease. She has two cousins who, like her, are “inexplicably debilitated.”  

Her illness has doctors baffled. One theorizes that, in addition to her Hashimoto's, she has an autoimmune disease attacking her hypothalamus. And while she's improved on a gluten-free, specific carbohydrate diet, her symptoms persist.

As O'Rourke has vacationed in New England, where she enjoyed walking under the “tall New England sugar maples," she should also consider the new culture test for Lyme disease as well. Some cases of Lyme masquerade as ME.

My advice to O'Rourke would be to first read reporter Hillary Johnson's seminal work on ME, Osler's Web. My bet is O'Rourke will see herself reflected in the stories of these patients.

If you believe that O'Rourke may have ME, why not let her and The New Yorker editors know with a letter to the editor? The issue is available for free with an android device, and for 99 cents with most Kindles (except the Kindle Fire, which will cost you $5.99 for the issue).