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 response—post-exertional malaise—in 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.
IOM
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?
***
***
Kathleen.Sebelius@hhs.gov
howard.koh@hhs.gov
txf2@cdc.gov [Thomas Frieden]
Tomfrieden@cdc.gov
cfsac@hhs.gov
eunger@cdc.gov [Elizabeth Unger]
SAMPLE LETTER
Email subject: two-day exercise test (feel free to change subject name; it helps avoid screening of your email)
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.
Sincerely,
(your name,
how long you have had M.E.)
Snell’s
study: http://www.ncbi.nlm.nih.gov/pubmed/23813081
Well done Mindy. Welcome back!
ReplyDeleteThink you made a mistake with the Paragraph that starts with 'Snell and Sol' - I am very sure you meant Snell and Stevens, since Connie Sol is from another team.
Best
I've got a couple of suggestions for the letter [my suggestions are added in square brackets]...
ReplyDelete> We need CDC to do a two-day exercise test in CDC's Cardiopulmonary-Exercise Testing, not a one-day exercise test.
> Previous studies [perhaps include the details of all the studies?], including those by Dr. Chris Snell, have shown that the fatigue [I would say 'post exertional malaise' or 'symptomatic exacerbation' instead of fatigue, as she wouldn't be measuring simple 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 meaningful and patients will appear to be deconditioned. [I would add: "Past results have shown that deconditioned patients have similar results to ME patients during the first CPET test, and that results for deconditioned patients diverge from ME patients only during the second test."] 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.
-------------------------------------------------------------------------------------------------------
I don't agree with making the threat. Making a threat is not constructive, and will not make anything happen. It will probably have the opposite effect than what is intended. If I received a threat like that, I'd just be pissed off about it. By all means report your concerns to Unger's superiors, without a threat. Perhaps it might be better to assume that Unger will consider our letters without the threat?
Thank you for your letter template, Mindy. (I forgot to thank you in my previous comment.) I've changed your template slightly, for my own purposes, and posted my completed letter below, in case helpful for anyone else.
ReplyDelete_________________________________________________
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 post-exertional exhaustion 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 meaningful and patients will simply appear to be deconditioned. Past results have shown that deconditioned patients have similar CPET results to ME patients during the first CPET test, and that results for deconditioned patients diverge from ME patients only during the second test. 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.
If you have ME, you should not be expecting a CFS program to comply. There is no such disease ME/CFS. Valuable information about ME/CFS is an oxymoron.
ReplyDeleteI, for one, and there are countless like me, can't take this BS any more. I'm emailing Unger right now. -- Rivka
ReplyDeleteThank you, Mindy
ReplyDeleteSent it in. Thanks
ReplyDelete