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.

Testimony to CFSAC - May 2013

Testimony to the Chronic Fatigue Syndrome Advisory Committee
Department of Health and Human Services
United States Federal Government
Washington, DC - 22 May 2013

Today I want to talk about two facts and one symptom.  The facts are these:

1. Of the more than one million Americans who have CFS, up to 850,000 remain undiagnosed.  Where are they?  What happens to those people?  Why is this not an urgent concern of CDC?

2. Of the more than one million Americans who have CFS, at least one-fourth are homebound, and one-tenth bedridden.  One half cannot work at all.  WHERE ARE THEY?  Who takes care of them?  What happens to them if there is no one to take care of them?   What happens when there is no money because they cannot work and few make it through the social welfare maze?  I can tell you.  They end up on the street.  You think that's an exaggeration?  I personally know people who have ended up on the street because of this disease.  I know others who ended up living in cars.  What happens to a single mother when she is too sick to work and no one can care for her?  She loses her children, and then she ends up on the street.  Why is this not an urgent concern of CDC?  City of Hope in Los Angeles was founded to get patients with tuberculosis off the streets.  Where is the City of Hope for patients with ME or CFS?

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Now I want to talk about one symptom:  the symptom referred to on CDC's CFS website as "Post-exertional malaise lasting more than 24 hours." In the Fukuda (1994) definition, currently the official definition used by the federal government, PEM is one of eight symptoms, four of which have to be present for a diagnosis of CFS.  Obviously it's not considered important.

But if you ask patients, and you ask their doctors, they will tell you it is important.  Post-exertional malaise (PEM) is a defining symptom of this disease.  Maes and Twisk have even suggested it be used to differentiate CFS from M.E.

In three minutes I do not have enough time to explain to you what this is.  The word “malaise” is just as unrepresentative of the symptom as “fatigue” is unrepresentative of the disease.  "Malaise" sounds vaguely ... unwell.   My daughter, who had to take care of me from the age of 13, suggested Post-exertional dysfunction, because I would suddenly become completely dysfunctional.  I could not talk intelligibly, could not understand much of what was said to me, had t o be helped to bed.  I had a sudden increase in symptoms:  light hurt; my head hurt.  The pain behind my eyes and in the back of my neck, which never left me for a moment, got much worse.  My glands ached.  Most important, though, she said, “Mom, you just could not function.”

It does not take much to bring about what we patients all call a crash, depending on the condition of the patient.  Just the activities of daily living - getting up, taking a shower, getting dressed - can do it.  Mental exertion like reading or a long phone call can do it.  But it is sudden, and it is unmerciful, and you are never quite sure how long it will last.

I want to differentiate PEM from post-exertional relapse.  In post-exertional relapse, exercise makes you ratchet down to a worse level of the disease than before, and you stay there.  In roughly 24 hours I had over 50 patients respond to a query about this symptom.  One wrote that she was asked by her doctor to take a half-hour swim several times a week.  She ended up bedridden for two years.  Others told of being asked to take walks, or in one case, to run for 9 minutes a day. They all ended up bedridden.

Surely we already know this.  Christopher Snell made an excellent presentation to the NIH State of the Knowledge Conference on CFS in 2011, describing the drop in performance by ME/CFS patients on the second day of CPET testing, in contrast to deconditioned controls and patients with other debilitating conditions.  Alan and Kathleen Light et al at the University of Utah recently published research showing significant and unusual physiological abnormalities brought about by exercise in ME/CFS.  As my own physician, Dr. Derek Enlander, recently wrote,  “The notion that ME/CFS is caused by poor conditioning is no longer widely accepted.”

Most doctors believe that a patient who is “fatigued” is going to be made better by exercising.  Make it an overweight female and they are even more convinced that exercise is just what is needed.  But that is not true for this disease.

CDC's website on CFS gives the following advice for offering graded exercise to a bedridden patient:

        A subset of patients with CFS are so severely ill that they're
        largely housebound or bedridden. They require special 
        attention, including a modified approach to exercise.  Hand 
        stretches and picking up and grasping objects may be all 
        that can be managed at first.  Gradually increasing activity 
        to the point patients can handle activities of daily living – 
        getting up, personal hygiene, and dressing – is the next step.
[From the CDC's CFS Toolkit for Professionals ]

Listen to yourselves!!  You see a bedridden teenager with a feeding tube, and all you can think of is how to get her to exercise?  Shouldn't you try to find out why she is bedridden in the first place?

Until you have found the 85% of patients you have lost, until you find the patients who are lost because they cannot care for themselves and there is no one to care for them, you have no business talking about telling patients to practice grasping objects.  As long as there are doctors casually telling patients to “just get some exercise and you'll be fine,” you have no business telling bedridden patients what exercise they should do.

If doctors need to know anything about our disease, it is this:  exercise can make us very sick.  It can make us bedridden.  A bedridden patient is a very, very sick patient.  Simple exercise that you think is easy can in fact be dangerous for us.  It could very well be that what is happening with bedridden patients is that every activity sends them into over-exertion, into crash mode.  They are that sick.  Quit trying to figure out what exercise to give them and find out what's wrong with them.

As Irish patient and advocate Tom Kindlon puts it, “If graded exercise therapy were a drug instead of a treatment protocol, it would have long ago been banned by FDA.” There are too many adverse responses, and (frankly) not much evidence of success.

Post-exertional collapse, post-exertional dysfunction, post-exertional crash, post-exertional relapse – whatever you call it, is there really any debate any more over whether it exists?

Shouldn't that be the first thing you tell doctors?

I can tell you that it's the first thing we wish they knew.

And then, let's figure out why you can't find 850,000 missing patients.

Civil Rights

Why did I write yesterday's post? Because we are allowing ourselves to be distracted, energies wasted, by small things. We are in a battle for something much larger - basic human rights.

That is what we are REALLY fighting for. The right to be free of the propaganda and censorship that has stood between our illness, and treatment, since 1988.

Our governments - but most energetically, the governments of the United States and the United Kingdom, have deliberately sought to deny us respect, care, and treatment. Why? The insurance lobby. The cost of treating us. Making a name for themselves. Pathetic, pitiful reasons to ruin the lives of so many.

NIH allocates (at most) $4 a person a year - one percent of what NIH spends on Multiple Sclerosis, hardly an overfunded disease. The UK has just issued special research funding - but who will get that funding? Does anyone really doubt where it will go? More "studies" that portray The Disease as the product of "inappropriate illness beliefs". Imitation research, that blames the victims for their own suffering. More censorship of biomedical information, and propaganda dressed up as psychiatry.

The CDC says we are sick because of some vague childhood abuse. They have joined Peter White in "discovering" that a large number of us actually have major psychiatric illnesses. And CDC's website praises the UK's NICE Guidelines, even including a link - those guidelines that condemned so many sick people to going without any medical care at all out of fear of being forced into Cognitive Behavior Therapy and Graded Exercise. Now the UK is changing the rules for those who are too sick to work, who need government assistance. Shirkers all. How long before the US follows suit?

We deserve more. We deserve an honest appraisal of the peer-reviewed research. We deserve doctors, and treatment centers, and real research. Some have been waiting three decades for this. Some have been living their whole lives, stricken as children, imprisoned in this disease - and all government has to offer them is insinuations that they are sick because they were abused, or because they somehow secretly want to be sick. All government has to offer them is the threat of being removed from their homes. They deserve better. Their parents deserve better.

Our countries can do better.

The campaign of constant psychobabble is just that - a campaign. It is designed to portray us as "the other" - as "different." As not deserving of the medical choices a person with MS is entitled to. As not deserving of the medical choices a person who blew out his knee skiing, is entitled to. As not deserving of the choices a chain smoker gets when lung cancer sets in.

That is the recipe for denying human rights: portraying a person as "the other", not "one of us.". Not human, therefore without rights. In Anglo-American parlance, without the rights of free citizens.

But we are human. We are citizens. We deserve our rights as civilians, as members of the larger community. Our civil rights.

We have the right to be treated as human beings, not "weaklings," as Wessely loves to portray us when not in front of scientists.

All we are asking for is the truth. Disagree over it, come up with alternative theses - but start telling the truth.

Our enemies are the people in power who have portrayed us as "undeserving." Who censor the truth and issue propaganda in its place.

That's a big fight, and it's not easy. It calls for strength. We have that strength. It has been honed in the fires of our pain, suffering, confusion, and despair. Our isolation. Our loneliness. Our dashed hopes. And our cares for each other. We have somehow kept on, in spite of all they have thrown at us.

We cannot win this battle unless we stand together against our real enemies. We can squabble like any family does. But we must stop hurting each other. That also means the strength to allow disagreement - as long as disagreement does not turn into harassment.

We have to stand up to CDC. Stand up to NHS. Stand up to NICE. Even if standing up has to be done from a gurney.

Stand up as young people have in Tunesia and Egypt.

But stand together. With one common goal: we refuse to be invisible any more.

I have a quote from Martin Luther King, Jr., from a speech he gave at the end of the march from Selma to Montgomery, Alabama. In four years, his courage in speaking out for his rights would end in his death. He knew that was likely, but he still spoke up.

Keep this in your heart so that you remember what we are really fighting for. We are fighting for our rights as human beings. We are fighting for our freedom from invisibility. And we are fighting for the truth.

King said:

"I know you are asking today, ‘How long will it take?’ ...

“I come to say to you this afternoon, however difficult the moment, however frustrating the hour, it will not be long, because truth crushed to earth will rise again.

"How long? Not long, because no lie can live forever.

"How long? Not long, because you shall reap what you sow.

"How long? Not long, because the arc of the moral universe is long, but it bends toward justice."

Not long. We will not be invisible forever.