actions on CDC empirical definition

Messages
70
Likes
1
Location
near Philadelphia
Please sign the petition against the Reeves definition

I'm starting this thread, because there may be some people who haven't heard of Tom Kindlon's online petition against the Reeves (2005) empiric definition. There are about 1750 signatures on the petition, and it would be great if there were 2000+ by Thursday, the first day of the CFSAC meeting. If you haven't signed, please do. (Link to the petition is at the end of this post.)

My fear is that Reeves is going to do XMRV testing on the patients he's been studying in Georgia using his definition. Because around 75% of those patients don't have ME/CFS, he will find a much lower percentage of people with XMRV than was found by the group at the Whittemore-Peterson Institute. Although I think WPI will ultimately prove Reeves wrong, it could cost precious time and energy and delay finding the answers about transmission and treatment that we all want and need. So I think it's very important that the CFSAC makes a strong statement against the Reeves definition--something they didn't do at their last meeting. We need to push them!

In order to get more signatures, I've been emailing old friends, relatives, colleagues, anybody I can think of who might sign. It's actually been a good excuse to get in touch with people. This is what I've sent out, after saying hi & what's up:


By the way, I'm emailing everyone I can think of to see if anyone is willing to sign a petition about the definition of Chronic Fatigue Syndrome (which I, along with many other people, call Myalgic Encephalomyelitis or ME/CFS). It's a pretty esoteric thing to have to have a petition about, but, unfortunately, it's important. Basically, since there's now a lot of data about infectious and other possible causes for CFS, in 2005 Dr. Reeves of the CDC decided to redefine it (CFS) so it would better fit his theory of a psychological cause. Dastardly! Anyway, there's an online petition against the definition. It's a bit of a slog to get through: there's the petition, then there are references, then there's an explanation, then there are a bunch of additional notices, then there's the place where you "sign". They do want your email address, but you can check a box saying you don't want to be notified about any additional related petitions, and I've never been spammed by them to my knowledge. You can also check a box if you don't want your name showing up on the internet. It only takes a couple of minutes.

You may have heard about the new data that suggests that ME/CFS may be caused by a retrovirus called XMRV. Given that a retrovirus was suggested as the cause in the early 90's but rejected by the CDC, a lot of people think this is a good time to discuss why the science has been so bad. Hence, the petition. If you want more information before considering whether or not to sign, call, email or shout loudly and I'll be happy to explain further. If you know anyone else who might be willing to sign it'd be great to pass it along.

Here's the link: http://bit.ly/nYHy5



If you've seen this post before, I apologize. I've been putting it on threads that seem appropriate. Anyway, if you have the energy to send this to friends, I think it's worth the time.

Also, please feel free to copy & paste and post this anywhere (Facebook, MySpace, Twitter, other forums, any other places you can think of), and to alter it in any way that works for you. If you hate ME/CFS use another name. My goal is to get as many signatures on that petition as possible.

By the way, I think Tom Kindlon has forgiven me for describing the petition as "a bit of a slog". It's a great petition. I just want people not to give up reading before they sign. Some people have short attention spans. I know I do at times. If you want to experience a real slog, try reading the original paper on the Reeves definition. Now that's a slog. :eek:

Here's the link again: http://bit.ly/nYHy5
 
Messages
70
Likes
1
Location
near Philadelphia
I forgot to add: You don't have to be from the U.S. to sign. Tom posted the petition from Ireland. This affects all of us.

Thanks to Cort for providing this forum and to everyone who contributes. I learn so much here.
 

kamina

Retired account
Messages
31
Likes
1
My faith in online petitions actually achieving anything even marginally significant is nill but I signed it none the less. It can't hurt, anyway.
 

Wayne

Senior Member
Messages
3,519
Likes
4,795
Location
Ashland, Oregon
Signing Petitions

Well, I've been putting off signing this because I've never signed an online petition before and didn't know how difficult it would be to figure out. I finally checked it out, and noticed that all you have to do is type in your name and e-mail address at the bottom. Really quite easy.

Anyway, I just wanted to mention this in case others are a bit apprehensive about how difficult it might be to figure out how to do it. If I can do it on a day like today, I would think just about could.

Regards, Wayne
 

Dolphin

Senior Member
Messages
17,555
Likes
28,239
It's up to 1850 now.

Well done to The Phantom and everyone else doing their bit.

If people keep signing and some more people write to a few contacts, there's a good chance we'll make 2000 by Thursday (when the meeting starts) or Friday (CFSAC recommendations aren't decided on until Friday afternoon).

Of course, signatures any time would be good. But at the last CFSAC meeting there was a reference to over 1000 signatures, would be good to be over 2000 this time. I don't make any promises I'll be able to keep pushing the issue for CFSAC meetings after this.
 

Dolphin

Senior Member
Messages
17,555
Likes
28,239
What % of those with Empiric criteria (Reeves 2005) CFS satisfy the Fukuda definition

[This is a bit long but the main point is at the top. I also give
information on the Wichita 2-day cohort (which will also be used to test for
XMRV, near the end). It isn't the most exciting thing ever but should be
fairly easy to read if anybody decides to read it i.e. doesn't involve complicated maths or science.]


Subject: Empiric criteria (Reeves, 2005) and CFS: what do we
know about the percentage of CFS (empirc) patients who would satisfy the
Fukuda definition from random number population studies in the US


[Main point - extract: "Assuming the population is similar one could say that the
prevalence rate for the Empiric criteria (Reeves, 2005) is 9.69 times the
Fukuda rate. Put another way, only 10.31% of those who satisfy the
empiric definition would satisfy the Fukuda definition.
This is relevant
for the XMRV testing of the CDC cohort, for example]


I am often hearing it said that the prevalence of

- CFS (Fukuda definition) is 1 million adults in the US

and for

- the Empiric criteria (Reeves, 2005) (which Reeves says is a version of the
Fukuda definition so the language is confusing) the prevalence is 4 million,
or 4 times the rate

i.e. 1 of 4 of those with the empiric definition would satisfy the normal
Fukuda definition.


However, I don't believe that is really correct - I think there is probably
a much bigger disparity in a random population cohort like the Georgia
cohort.


I thought people might be particularly interested in this now, given the
XMRV testing of the CDC samples.


Of course, I think it is also relevant for dozens of studies that have been
published on the Wichita 2-day study and Georgia study since the end of
2005.


The prevalence rates found in the three random-number population studies
were:

- 235 per 100,000 (Fukuda definition) (95% confidence interval,
0.142%-0.327%)
(Wichita - mark 1 - not to be confused with the Wichita samples from the
2-day study which are almost certainly the ones that will be used for the
testing along with the Georgia samples) (Reeves, 2003)

and

- 422 per 100,000 (Fukuda definition) (95% confidence interval, 290-560 per
100,00)(Chicago) (Jason et al, 1999)

vs

2540 per 100,000 Empiric criteria (Georgia) (Reeves et al, 2007)


Comments:
One reason that may explain a lot of the differences between the two
Fukuda studies (Reeves 2003 and Jason, 1999) is the exclusions the CDC used:


-------
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC419502/pdf/1471-2377-4-6.pdf

Sample characteristics

One subject attending the clinic was dropped from analysis
because missing data did not permit scoring of any factor
in the SAQC. Demographic and clinical characteristics
of the remaining 339 subjects in the sample are shown in
Table 1 along with the distribution of these characteristics
by fatigue group. Over half the fatigued subjects (145/
277, 52.3%) as well as one not fatigued subject had exclusionary
medical or psychiatric conditions identified during
the clinical evaluation. Medical exclusions identified
during the clinic visit included abnormal blood or urine
tests, abnormal Romberg test, adrenal insufficiency, bladder
tumor, BMI = 47, cerebral palsy, chronic hepatitis,
emphysema, heart disease within 2 years of evaluation,
hypertension, hypothyroidism, inflammatory bowel disease,
kidney cancer, lupus, melanoma, uncontrolled diabetes,
rheumatoid arthritis, self-reported sleep apnea and
narcolepsy, and major surgery within the past year. Psychiatric
disorders included anorexia or bulimia nervosa,
bipolar disorder, delusional disorder, and major
depressive disorder with melancholic features.

-----

I believe many clinicians would find it strange to exclude people from the
diagnosis of CFS if they have an abnormal Romberg test - I have heard
clinicians say they use it to help confirm the diagnosis! Other exclusions
seem questionable e.g. hypertension.


So as I say, the exclusions may explain the difference between the two
Fukuda studies.


So possibly the easiest comparison is between the two CDC studies i.e. 235
vs 2540.
The second number is 10.8 times the first!


Technically, it is possibly the Wichita study missed a few people. The
Georgia study also brought in some unwell people who didn't look like they'd
fit the criteria on the phone interview but did fit the criteria eventually.
They said this would increase the prevalence rate by 11.5%. We do not know
if we would get such a jump with a stricter definition.
But if we used those figures, the prevalence for the Fukuda definition would
jump to 262 per 100,000.


In other words, the Georgia prevalence rate is 9.69 times the Wichita rate.
Assuming the population is similar one could say that ***the prevalence rate
for the Empiric criteria (Reeves, 2005) is 9.69 times the Fukuda rate***.


Put another way, ***only 10.31% of those who satisfy the empiric definition
would satisfy the Fukuda definition***.


If we decide to use an (unweighted) average from the Chicago and Wichita
samples, and increase it by 11.5%, then the prevalence rate per 100,000 is
1.115*(235+422)/2=366.28.


So the prevalence rate for the Empiric criteria (Reeves, 2005) is 6.93 times
the Fukuda rate. Put another way, only 14.42% of those who satisfy the
empiric definition would satisfy the Fukuda definition.


And of course, many people think that the Fukuda definition itself isn't
perfect and for example, does not have a specificity close to 100% (i.e.
somebody could satisfy it and not have "ME" or "ME/CFS" (Canadian criteria)
or "proper" CFS).


Tom Kindlon

--------
Appendix 1:
In the 2005 paper that defined the Reeves empiric definition, we were told
that 16 satisfied the Fukuda definition and 43 satisfied the empiric
definition.

It might be tempting to use these numbers to estimate the percentage of
those who would satisfy the Fukuda definition in an empiric definition
cohort.

However, I don't believe one can do it.

For a start, there are question marks over 6 out of the 16 who satisfied the
Fukuda definition: Reeves said these were previously excluded for having
Major Depressive Disorder with melancholic features (MDDm) at some point in
their lives (see Table 2: "Recruitment and Current Classifications of 190
Subjects; 37 participants with medical or psychiatric exclusions other than
melancholic depression excluded"). The Fukuda criteria when published in
1994 said this was an exclusion if somebody ever had it in their lifetime.
The International study changed this to it had to have been resolved for
more than 5 years before the onset of the current chronically fatiguing
illness. Each of these 6 individuals had CFS or ISF on or before 2000, so
the MDDm would have had to have been resolved on over before 1995 (i.e. from
1995 to 2003 at a minimum). It is very doubtful that in all cases this was
the case. Indeed it seems quite possible it wasn't the case in any of the 6
cases.

So one doesn't know if 10, 11, 12, 13, 14, 15 or 16 in the cohort really
satisfy the Fukuda definition (it's 10 if one says they could never have
MDDm). This is of course still a useful figure as it means that if the
samples from the Wichita 2-day study are used for XMRV testing, between
23.26% (10/43) and 37.21% (16/43) of the samples would be from
Fukuda/International definition patients
.


But the main problem with using the data in the 2-day cohort is that they're
not a random population group at all.
"This population-based case control study enrolled 227 adults identified
from the population of Wichita with: (1) CFS (n = 58); (2) non-fatigued
controls matched to CFS on sex, race, age and body mass index (n = 55); (3)
persons with medically unexplained fatigue not CFS, which we term ISF (n =
59); (4) CFS accompanied by melancholic depression (n = 27); and (5) ISF
plus melancholic depression (n = 28)."

Approx 1/4 of them had previously been diagnosed with CFS (Fukuda
definition):

So if one can't really tell anything about what percentage of Fukuda cases
one would find in the Georgia cohort using the Wichita 2-day study.
 

Dolphin

Senior Member
Messages
17,555
Likes
28,239
Reeves criteria - Congratulations to all those who put the issue on the map

[I thought I'd get value out of this post which I wrote for another list. It doesn't have much new information in it, except to point out that the CFSAC criticised the CDC's empiric definition in one of its recommendations which most people here probably know about anyway. Well done to all the people on this forum who got behind the issue and Cort and his team for the forum facility. Tom]


As many people will be aware, at the CFSAC meeting at the end of October, the committee passed a motion along the lines of the following:


"Recommendation 3:
The CFSAC objects to CDC's continued use of the inadequate and inappropriate 2005 "empiric" research definition for CFS. It recommends that CDC abandon the empiric case definition and the fundamentally incorrect conceptualization of chronic unwellness as being equivalent to CFS incorrect."
(source: http://www.cfids.org/cfidslink/2009/110401.asp ).


(I was going to wait till the last recommendations officially came out but
I've to put my head down now for a couple of weeks to work on a newsletter)


As people may or may not be aware, the CDC have used these criteria for
dozens of studies since the end of 2005: All the studies from the Georgia
cohort and all but one from the Wichita 2-day study*. This includes the
Pharmacogenomics studies in 2006 and also the CAMDA studies.


This issue has largely been ignored by the research community until recently. I'm open to correction but I believe that the only two references in the literature are two studies involving Prof. Lenny Jason:


Jason LA, & Richman JA ( 2008). How science can stigmatize: The case of CFS. Journal of Chronic Fatigue Syndrome, 14, 85-103.
http://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind0810C&L=CO-CURE&P=R4166&I=-3&m=11343

Jason LA, Najar N, Porter N, Reh C. Evaluating the Centers for Disease
Control's empirical chronic fatigue syndrome case definition. Journal of
Disability Policy Studies. 2009.


So well done and thanks to those five individuals for their work in the
area.


But in the last 6-7 months, I believe there has been a much greater
awareness of the issue.


I would like to think that is partly due to the petition that was set up last April after I heard the CDC was putting together a 5-year plan:
"Petition CDC CFS research should not involve the empirical definition
(2005)" http://bit.ly/nYHy5 i.e.
http://www.ipetitions.com/petition/empirical_defn_and_CFS_research

This petition would probably win prizes in a category for "most obscure"
petition!


But over 2000 people signed it and I think this has helped to build momentum
to challenge the definition.


So thanks to everyone who signed it and particularly anyone who signed it and who also encouraged other people to sign it or supported it in some ways e.g. linked to it. It's probably bad to mention names as people will be left out but two people who got behind the petition early were Mary Schweitzer and Kasper Ezelius - they had both previously recognised problems with the criteria as of course had some other patient advocates. (I know others in more recent times have plugged the petition heavily on some forums but full names were not given)


One thing that probably focused a lot of minds on the criteria the CDC were
using was the XMRV research so thanks to everyone who brought that
breakthrough about.


Thanks to Marly Silverman of PANDORA (www.pandoranet.info) who submitted the petition to the CFSAC:
( http://www.youtube.com/watch?v=OLnBPGA3Lb4 at around 4.24)

"I am delivering to you a petition by Tom Kindlon, a CFS patient advocate.
As of today, there are 1893 signatures in this petition. The comments are an
eye-opening account of the diversity found within the patient community. It
could be a tool for potential CFS research"



Thanks to all those who testified. Unfortunately I have not seen or heard
all the testimonies but I know Dr Joan Grobstein brought the issue up in her
memorable testimony:
http://www.youtube.com/watch?v=WUDyby8A7tI&feature=related where she coined the phrase, "Reeves Disease", to describe those who satisfy the Reeves (or "empiric") criteria but not other CFS or ME/CFS criteria. Staci Stevens gave a two-paragraph statement from Dr Eleanor Stein (psychiatrist) criticising the definition:
http://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind0911a&L=co-cure&T=0&F=&S=&P=4214


And thanks to the members of the Patient Care Committee for highlighting the
issue as well of course as everyone on the CFSAC.


Fingers crossed that with enough pressure no new studies by the CDC will be
produced using the definition and that eventually the criteria will be so
discredited that any studies using the definition will have low status. But
we're not there yet.


Bye for now,


Tom Kindlon


* It looks like for the Tilt Table study "Orthostatic instability in a population-based study of chronic fatigue syndrome" (Jones JF, Nicholson A, Nisenbaum R, Papanicolaou DA, Solomon L, Boneva R, Heim C, Reeves WC. Am J Med. 2005 Dec;118(12):1415 published the same month empiric definition came out) that they called the patients CFS patients if they had been diagnosed with CFS in 1997-2000 but didn't mention that at the time of the tilt table testing, most of the individuals didn't satisfy the CFS criteria (they talk about more than 43 patients which is more than any of the other studies)]
 
Messages
877
Likes
85
thanks Tom

thanks for all the hard work Tom. I signed both the petition this time around to the CFSAC, and the one earlier in the year that you mentioned.

I also sent in a "write in testimony" to the CFSAC about my story and battle with CFS. THose write in testimonies are available by navigating thru the website of HHS. It is hard to navigate to, but they are there.

I do whatever I can to help out.

Let's not relax now and keep the heat on!

Best Regards,
Mark
 

Dolphin

Senior Member
Messages
17,555
Likes
28,239
thanks for all the hard work Tom.
Thanks.

I signed both the petition this time around to the CFSAC, and the one earlier in the year that you mentioned.

I also sent in a "write in testimony" to the CFSAC about my story and battle with CFS. THose write in testimonies are available by navigating thru the website of HHS. It is hard to navigate to, but they are there.
That's great.

A direct link is:
http://www.hhs.gov/advcomcfs/meetings/presentations/091029.html

I do whatever I can to help out.

Let's not relax now and keep the heat on!

Best Regards,
Mark
That's great. I just replied to somebody there a few minutes ago who asked was I still looking for signatures - I said I was.

But there will be need to do other things. I'm not the sort of person who usually thinks a petition will solve everything but feel it has a value in this case, in a situation where the problem was being ignored.
 

kolowesi

Senior Member
Messages
267
Likes
16
Location
Central Texas
testimony not there

I guess it's probably a good thing my testimony wasn't in there, but maybe some others were missed that would have been a good addition.

Also, I wish the comments on the petition had worked for everyone, mine and several in my family's were the gray boxes. But at least we got the message out and I feel good about it.

Tom, I hope you get some well-earned rest.

Kelly
 

Dolphin

Senior Member
Messages
17,555
Likes
28,239
I guess it's probably a good thing my testimony wasn't in there, but maybe some others were missed that would have been a good addition.
One can ask for it to be put up.
I know one person whose testimony wasn't up who has had it confirmed that there submission was circulated. Mine wasn't up for the last meeting initially but I wrote in and now it's up.

Also, I wish the comments on the petition had worked for everyone, mine and several in my family's were the gray boxes. But at least we got the message out and I feel good about it.
Yes, it is very frustrating and something that hits me every time I look at the new signatures. I'm not sure if I mentioned this above but it is something I am frustrated by. And would like to know of other petition sites for the future (although am in now particular rush to do another one myself).

Tom, I hope you get some well-earned rest.

Kelly
Thanks. Won't be for a while. Am writing a newsletter at the moment which I need to get finished relatively quickly as we sell Christmas/Holiday cards and need to get the forms out there (although did send the forms with the Autumn newsletter already).

Bye.
 
Messages
1,575
Likes
178
ensure CDC uses appropriate defn and samples for xmrv research

I have been trying to clear out my backlog of info from co-cure and came across the following that Tate Mitchell posted to co-cure on Nov 26 09.

I think the reminder to contact all our agencies to ensure the CDC uses appropriate definitions and to offer samples is a good one. I hadn't done it before seeing this.

And I love the list of emails. Its incredibly useful. Thank you Tate!

(my bolds and bullets)
Dear All,

At the October 2009 CFSAC meeting held in Washington D.C., Dr. Nancy
Klimas raised concerns about CDC's XMRV replication effort to CDC
ex-officio Dr. Michael Miller, noting special concern in regards to
potential patient cohorts CDC might be using in their study. Dr.
Klimas noted that the only samples CDC has available to it are from
the Georgia GCRC and Wichita, Kansas population studies, both of which
used the 2005 'Empirical' definition for selecting participants. Dr.
Klimas went on to note that CFS prevalence rates which CDC devised
using the Empirical definition are highly inflated from previous
estimates. This concern is supported by research conducted by Prof.
Leonard Jason of DePaul University on the Empirical definition, which
found the Empirical definition does in fact include people with other
illnesses in place of CFS such as depression.

In his response to Dr. Klimas, Dr. Miller stated that the CDC CFS
program is not in charge of the CDC XMRV replication effort and if Dr.
Klimas had concerns she and others should contact CDC's retroviral
program which is in charge of conducting the study and "be a part of
this" by offering well-defined patient samples. However Dr. Miller's
emphasis seemed to be on the fact that CDC's CFS program was not in
charge of the replication effort which was not the concern raised by
Dr. Klimas, but rather the fact that CDC was using GCRC and Wichita
samples which were obtained using the Empirical definition which
focuses on 'unwellness'.

Dr. Klimas-
"I would ask you please, as the boss, to be careful how this is done,
it could do tremendous damage if it's done badly. Tremendous damage.
To get cohorts that are very cleanly described, very clear, and not
just the population based broad cohorts that you have in your freezer,
which is what you have in your freezer and all that you have in your
freezer, rather you let some of us that also have very well defined
cohorts in our freezers that were defined in a research setting for
comparison."

Dr. Miller's response-
"...we are hoping that for those who are interested, as you certainly
have patient samples available, that if you are interested, I think
you should contact the retrovirus laboratory and offer those samples
and be a part of this. I think you will find an interest there."

I suggest that we as CFS patients, who are the ones with the most at
stake in this matter, approach as many CFS patient, professional and
research organizations as possible
, both in the US and abroad, to
request that they

  • follow up on these concerns with CDC's retrovirology program
  • voice their concern regarding CDC's 'Empirical' patient group
and
  • to offer well defined CFS patient samples for CDC to include in it's XMRV replication effort.
As has been said before, an ounce of prevention is worth a pound of cure.

Email addresses for various organizations-

US- Canada-
CFIDS Association of America- CFIDSLink@cfids.org
National CFIDS Foundation- info@ncf-net.org
IACFS/ME- Admin@iacfsme.org
National ME/FM Action Network- ag922@ncf.ca
UK-Ireland-
25% ME Group- enquiry@25megroup.org
MERUK- meruk@pkavs.org.uk
CFS Research Foundation- cfsresearch@btconnect.com
ME Association- meconnect@meassociation.org.uk
Irish ME/CFS Association- info@irishmecfs.org
Irish M.E. Trust- info@imet.ie
Blue Ribbon for the Awareness of ME- info@brame.org
Tymes Trust(website)- http://www.tymestrust.org/contactus.htm
INVEST in ME- info@investinme.org
AUS-NZ-
ME/CFS Australia- mecfs@mecfs.org.au
Associated New Zealand ME Society- info@anzmes.org.nz
Europe-
European ME Alliance(website)- http://www.euro-me.org/index.html
European Society for ME- post@esme-eu.com
ME/CFS Foreningen- mail@me-cfs.dk
Norges Myalgisk Encefalopati Forening(website)-
http://www.me-forening.no/index.php
Riksfreningen fr ME-patienter- info@rme.nu
Association Francaise du Syndrome Fatigue Chronique et du
Fibromyalgie- cfs-spid-asso@wanadoo.fr
CFS ASSOCIAZIONE ITALIANA- cfs@cro.it
Fatigatio e.V. Bundesverband Chronisches Erschpfungssyndrom- info@fatigatio.de
ME/CVS Vereniging- reactie@me-cvsvereniging.nl
ME-Platform- ME-Platform-beheer@reijenga.xs4all.nl
 

starryeyes

Senior Member
Messages
1,555
Likes
69
Location
Bay Area, California
Excellent post IF and thanks for making this easy for us to do by putting it all in one place. Uno! :O)

We must make sure that we've done everything we can so when the (you know what) hits the fan we will know we tried our best. Who knows, we may really have an effect too.

Could we construct a template letter here for all of us to use? and if so, IF, can you put the sample template letter into your first post here and change it as you see fit? Pretty please? (tee bats her eyelashes). :)

PS. Don't you think the CAA should have been on this already? What do they do for those ginormous salaries they make? (Yes Cort, I've read your lists and there's some good stuff there but they should be on top of stuff like this!) :mad:

Come to think of it, all of these organizations we're supposed to be emailing about this here should already have template letters in place and should already be pushing us to contact the right parties. I'm madder than mad!

tee
 

gracenote

All shall be well . . .
Messages
1,537
Likes
76
Location
Santa Rosa, CA
check out this other thread

PS. Don't you think the CAA should have been on this already?[/COLOR]

tee
This is already being discussed in a thread in General ME/CFS News: "Kim McCleary: Open letter to CFS community" starting around post 36. There is an extensive continuing discussion. Just one of the earlier posts.

Post 38:
Originally Posted by Dr. Yes:
I am very concerned about that too. Could you tell us what the CAA is doing about it?

And your contingency plans in case your first ones prove insufficient? (This is a monumentally important matter, and I assume the CAA has worked out multiple strategies, as any good advocacy group would).

Also, forgive my ignorance, but are the current replication efforts using the same criteria for patient selection the WPI did? (As it would be most un-scientific not too.. and disastrous). If not, I assume the CAA is working overtime to make sure that they change their criteria to match the WPI's, right??
Replied by jspotila: Thank you very much! We are concerned about the patient selection, methodology and assays being used by different groups attempting to replicate the WPI study. CDC is not the only group attempting replication. There is a federal task force on XMRV, CFS and blood safety, and both Dr. Suzanne Vernon and Dr. Judy Mikovits are members.

The Association is trying to push replication studies towards true replication - the cohort selection, methodology and assays used by WPI. Understand that the Association is not funding any of the replication studies, so we have no direct control over how the work is done. We can't force a group to change their methods. What we CAN do is advocate for true replication methods by any group making the attempt, and Dr. Vernon is doing exactly that.

We are awaiting the outcomes of these studies, as well as the work of the federal task force. We will speak out on these studies when results are made public. If a replication effort failed but did not use the WPI's protocol, we will absolutely speak out on that.
 

fresh_eyes

happy to be here
Messages
900
Likes
9
Location
mountains of north carolina
Having read the other thread, I have not gotten the impression that the CAA is prepared to make any pre-emptive statements about what would constitute a bad or good replication effort.

Does anyone have a different impression?

If they are not going to do it, we need to draft a statement ourselves, under our own imprint. I'm hoping that the site I'm starting, CFSOUT, can serve as a platform for those kinds of efforts, by providing a sense of organizational validity to our grassroots efforts.
 

jspotila

Senior Member
Messages
1,099
Likes
778
CFIDS Association is advocating on this

Thanks, gracenote, for linking in the information from the other thread. At the risk of repetition, here is what the Association has been saying since October about replication studies:

This Science paper tells us that XMRV plays a possible role in CFS pathogenesis in these CFS patients. How much we can generalize these findings to other CFS patient populations? That answer will depend on the results of replication studies.

The design of replication studies should include CFS patients who are similar to those reported in the Science study. Dr. Peterson reported at the Oct. 29 CFS Advisory Committee meeting that the 101 patients in the study were drawn from CFS practitioners in Nev., Calif., Ore., Fla., N.C., and N.Y. They ranged in age from 19 to 75 with a mean age of 55. Sixty-seven percent were female. The controls were age, sex and zip-code matched and were not contacts of the patients studied, nor were they lab workers.

Methods used in independent replication studies should also follow the WPI protocol and use similar reagents. We are actively working with several independent research groups in the U.S. and other countries to expedite these studies.
As I stated in another thread, my understanding is that the CDC replication work is part of the HHS XMRV Working Group effort, and will be using samples from WPI.
http://forums.aboutmecfs.org/showpost.php?p=26602&postcount=69
 

Dolphin

Senior Member
Messages
17,555
Likes
28,239
Thanks, gracenote, for linking in the information from the other thread. At the risk of repetition, here is what the Association has been saying since October about replication studies:



As I stated in another thread, my understanding is that the CDC replication work is part of the HHS XMRV Working Group effort, and will be using samples from WPI.
http://forums.aboutmecfs.org/showpost.php?p=26602&postcount=69
The CDC CFS team loves to see its research as superior because it uses random samples from the population. It seems strange if they don't use the samples that cost a lot of money to collect - it would possibly mean they are admitting that the empiric/Reeves criteria are not the Fukuda criteria - they usually say they are a version of them. I know a proper replication might use the Canadian criteria also but I think some studies won't do this.

Anyway, I am not at all convinced that they won't use the samples from their registry, the Georgia study, the Wichita 2-day study, etc (last two cohorts are empiric/Reeves criteria and presumably the registry samples are also as they say the empiric/Reeves criteria are the current criteria the CDC uses).

And of course if they don't use them, it is perhaps admitting that the samples aren't Fukuda criteria samples. But not sure they won't test them given the statment at the CFSAC, etc.

A problem would be if they mixed different samples together e.g. some blood from "proper" CFS patients and then other blood from the Reeves/empiric criteria patients most of whom almost certainly don't have CFS.
 
Messages
1,575
Likes
178
Thanks, gracenote, for linking in the information from the other thread. At the risk of repetition, here is what the Association has been saying since October about replication studies:

As I stated in another thread, my understanding is that the CDC replication work is part of the HHS XMRV Working Group effort, and will be using samples from WPI.
http://forums.aboutmecfs.org/showpost.php?p=26602&postcount=69
Hi Jennie,

I hope I'm not asking you to repeat yourself. Haven't been able to follow this as closely as I'd like to.

Has the CAA sent a formal request to the HHS XMRV Working Group Effort clearly asking:

1. that they follow the same procedures that WPI did, including only using samples that meet the same definiton, the FUkuda and the Canadian - NOT the Reeves adapted FUkuda

This could be supported with research that shows that the definitions are not the same. And also the fact that no international respected research has used the Reeve's definition.

2. that they do NOT use the samples that the CDC has as they do not meet the definition

3. Also, I don't know if the CAA has any samples. If so, you could offer them samples to use. It also might be very useful to supply them with a list of everyone whom you know that has valid samples, along with contact info of course. Even better to contact those agencies first and indicate which would be willing to supply them with samples.

I think including the transcripts and perhaps video of the Klimas /Miller interaction from the CFSAC meeting would help support your message.

I strongly believe that you need to be on record NOW both advising them of the problems with the CDC's definition and samples, and showing that they can obtain valid samples.

Reacting after the fact would accomplish little. If you do this now, it could accomplish a lot.