Monday, September 16, 2013

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.


*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:

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.


  1. This is so depressing, I can barely stand it. Plus I'm really angry. I'm knew to this disease (2009) and sometimes the bad new devastates me.

  2. Thank you, Mary for a very well written overview of all the recent scheming actions by CDC, NIH and HHS.

    Each one of these are crucial -
    -the two day exercise test to be included in the CDC study
    -the denial by HHS to give us a "live" CFSAC fall meeting
    -the dangerous course of HHS drafting a contract with IOM to redefine this illness as THEY wish.

  3. I meant I'm *new* to the disease. Cognitive impairment is bad for me today.

  4. The striking feature in the two-day test results I've seen is the drop in the anaerobic threshold for exercise, even when maximum output does not decline. Is there any evidence at all that patients can manipulate this? You might hold your breath, like a sprinter, but this would immediately be flagged by monitoring equipment.

    GET may be supported by scientists with an interest in counseling. This is not the same as being supported by science. Maybe Unger would like to respond to questions about the redefinition of harms during the PACE trial, or the decision to drop the use of actimeters at about the time it became clear from other studies that patients in GET were displacing activity from a fixed budget.

    Am I surprised at these official maneuvers? Hardly. This is of a piece with setting up surveillance for a problem reported around Lake Tahoe and Yerington, NV in Wichita, KS and Bibb county, GA. (Trick question: which parts of the U.S. are least like Lake Tahoe, California or Nevada?)

    1. PS - no, you cannot manipulate the results of the test. That's yet another reason to use it.

  5. In the 1990s, there was a period set aside during CFSCC meetings where you could ask direct questions of the "ad hoc" (government) representatives, such as Bill Reeves of CDC. And I did. But when the charter for CFSAC was created in 2003, they omitted the period for direct questions from the public. They said we could put it in our 5 minutes of testimony. Well, (a) that meant pitching something else from the testimony; (b) you could give your testimony before they gave theirs and then you couldn't say anything at all; or (c) you could try to get someone on the committee to ask your question - oops, no, the public members were threatened with some type of sanctions if they took notes from audience members.

    I would love to ask Beth Unger about the failures of the PACE trial - for that matter, I'd like to ask why CDC was taking the advice of the Chief Medical Officer for two insurance companies (Peter White in this particular case) and ignoring the work of American researchers. There has never been a venue where I could ask her a direct question.

    I'm not surprised but I am disappointed.

  6. Does Dr. Unger not know that the only 2 labs in the country that perform this type of test do not get any results to support PEM unless a 2 day test is performed. That was sarcasm and Dr. Unger knows that there will not be any confirming evidence of PEM with a 1 day test. She is doing her best to sabotage our plight and undermining us for the simple reason she can without consequences.

  7. Great post. I read these things, I get angry, I want to do something, then I realize I can't do anything, I love Jose Montoya, I am thinking about making an appt. with his clinic. I am in MN. and he is in CA. I want to be diagnosed somewhere, where they KNOW what they are doing. It will cost a lot physically just to get there as well as financial. I saw him on a video, get up and say, "one day Drs. all over the world will need to apologize to these patients they have not believed" amen Jose, amen....I hope I am alive to hear it. This is an excellent piece Mary, I am so happy I got to read it, you sit and you think (when you can) what is going on here, you suspect not the right things, but you are too sick to really get the info., now my suspicions were well's not about helping it's about money, power and prestige...It sickens me, but not physically, but in my heart, it so cruel...Thankyou again Mary! Keep writing I will keep reading.

  8. Mary, you have read (and written down) my thoughts exactly. Thank you.

    Despite the new name and hype, the primary feature of the IOM's report is fatigue, not PEM. Fatigue is the symptom that must be present to begin the process, PEM isn't mentioned until at least month 6 (and, according to the graphic, perhaps a multiple of 6 months, depending on the physicians viewpoint). It is fatigue, not PEM, which is discussed in great detail. The multitude of possible surveys all discuss fatigue, not PEM. The take-away of time-pressed physicians will be this is a disease of chronic fatigue.

    An even greater failing is the treatment (or lack thereof) of the 2 day exercise test (CPET). It is given a brief mention, almost in passing. It is not discussed in detail.

    The information given borders on irresponsibility and perhaps even medical malpractice. The report only cautions (quoted in full), "(note that this test may induce severe exacerbation
    of symptoms in these patients)." Physicians unfamiliar with this illness would be unlikely to realize how severe that exacerbation could be or that such an exacerbation could last months, perhaps even bring about a permanent decrease in functioning.

    In cardiac patients, any problems are seen immediately, generally while the patients is still connected to monitoring equipment. If there are problems, the test can be halted before serious harm results. In this disease, the problems will continue to grow over days in and unknown and unpredictable pattern. This presents a very real risk and absolutely should be covered during the "risk/benefit" discussion prior to any testing.

    Furthermore, there is no mention that severe and very severe patients may be too ill to tolerate testing. This is very important for physicians to understand so that they don't try it on inappropriate people in the name of thoroughness.

    It is also very important for insurance companies to understand because it is conceivable that long-term disability insurers might require this objective test as a condition of receiving benefits. If they were to do that (and that would be in keeping with requirements for other illnesses), severe and very severe patients would be found ineligible for benefits that they clearly deserve.

    Finally, there is no mention whatsoever of how this test is administers, specifically the equipment required. It looks like any cardiac lab could immediately do it. In fact, the calibration of the equipment is apparently quite tricky.

    Most labs calibrate every few months or less. Any variances are unimportant for normal cardiac testing. For the 2 day, however, a much finer calibration is needed. The author of these key studies told me he not only calibrates every single day, he calibrates using the same test subject.

    My understanding is that others, quite competent in cardiac testing, have worked directly with him and have still been unable to correctly set up the equipment and run the test. Testing sites for thousands or tens of thousands (if every patient is required by insurance and/or Medicare to be re-diagnosed) is an entire herd of elephants in the room.