new CFS/XMRV Task Force at Dept of Health & Human Services?

[Marylib]

Thanking Wanda

Just wanted to send Wanda a thank you and can't remember where to find her email addy. Anyone know it?

 

[Marylib]

Thanks Wildaisy.

 

[starryeyes]

Yeah, thanks wildaisy, that made it easy to thank her and she already wrote me a nice letter back.

tee

 

[CBS]

Communication with CDC on Blood Supply Safety

I'm new here but not new to 'CFS.'

I thought some might be interested in the e-mail I sent to my the CDC, my congressman, and my senators:

Dear Dr. Thomas R. Frieden, Director, Centers for Disease Control and Prevention:

I have searched the CDC.gov website and I can find nothing on the recently identified XMRV retrovirus (and the association with either some prostate cancers or Chronic Fatigue Syndrome - there is one brief mention in the CFS 5 year plan, a suggestion by an outside group that XMRV needed to be looked into). The NIH-National Cancer Institute has recently posted a web-page on XMRV: http://www.cancer.gov/newscenter/pressreleases/XMRV_QandA.

Among other issues, the NCI discusses possible routes of transmission (see item #5 - How is XMRV transmitted?) and advises people who may be infected (prostate cancer and CFS patients) that "it might be prudent for potentially infected individuals to refrain from donating blood." Doesn't the CDC have a duty to protect the pubic at large as well as to give guidance to those who, with good intentions, may inadvertently be putting others at risk?

What is the CDC's position on blood donation and this recently identified retrovirus?

I would very much appreciate a response to this e-mail.

I am sending a copy of this e-mail to my Congressional Representative as well as to my Senators.

Sincerely,

XXXXXXX

cc:
Congressman Jim Matheson - UT Second District (c/o Robert Roake)
Senator Orrin Hatch - UT
Senator Bob Bennett - UT (c/o Jessica Christopher)
​

I then followed that with e-mails to each representative:

Dear Senator Hatch,

As you may or may not know, the CDC has a long history with Chronic Fatigue Syndrome and from my perspective, most of it is not something to be proud of. For years, the CDC has ignored and even placed roadblocks in the way of significant and meaningful work on this disorder. Recently the NIH-NCI, Cleveland Clinic and the Whittemore-Peterson Institute at the University of Nevada-Reno published a study in 'Science' showing not only that 67% of a carefully defined group of CFS patients is infected with this new retrovirus but that 4% of the controls (general population) are infected with this retrovirus. The finding of this retrovirus in the general population is consistent with other recent studies of patients with the most aggressive forms of prostate cancer.

WPI - http://www.wpinstitute.org/xmrv/index.html
NCI - http://www.cancer.gov/newscenter/pressreleases/CFSxmrv
Cleveland Clinic - http://my.clevelandclinic.org/news/...ial_retroviral_link_between_xmrv_and_cfs.aspx
Cleveland Clinic Conference - http://www.cleveland.com/healthfit/index.ssf/2009/11/cleveland_clinic_conference_pu.html
Science - "Detection of an Infectious Retrovirus, XMRV, in Blood Cells of Patients with Chronic Fatigue Syndrome" http://www.sciencemag.org/cgi/content/abstract/1179052?ijkey=m3wzKT4yJqEyk&keytype=ref&siteid=sci

While the CDC may not care about a million people in the US that they blithely dismiss as having a psychosomatic disorder, they do have a duty to everyone in this country to protect them from the potential transmission of a communicable disease. This is a responsibly that the NIH-NCI seems to have taken seriously but to which the CDC turns a blind eye as they cling to their presumptions and dogged dismissals of the last several years' worth of research showing a neuroimmune etiology for a large subset of CFS patients. The NIH-Chronic Fatigue Syndrome Advisory Committee Meeting held on 10/29/09 and 10/30/09, while lengthy was nothing short of paradigm changing in that several scientists testified that what they were seeing in their present research was very similar to what they saw in the early days of HIV. On day one of the meeting, the CFSAC felt strongly enough about what they had heard that they invited Dr. Jerry Holmberg, Senior Adviser for Blood Policy, Office of the Secretary of Public Health and Science, HHS (http://www.hhs.gov/ophs/bloodsafety/contacts/contactus.html) to testify the very next day. Dr. Holmberg stated he was well aware of the recent research on XMRV and that the HHS was "taking measures to ensure that we would not have a repeat of what we saw in the early 1980's."

I was diagnosed with 'CFS' in 1994. 'CFS' is not just being tired. The CDC adopted the name 'CFS' in order to downplay the seriousness of this disorder. I am being treated at the Stanford Medical Center's Department of Infectious Disease. According to my doctor and my blood tests, my immune system is failing, I have numerous recurrent opportunistic infections and significant neural damage. Believe me when I say that you do not want this disease. I was a regular blood donor until 1994. At that time I stopped donating because of a concern that I might pass on whatever was causing my health problems. You also need to know that some in the CFS community are angry enough with the CDC to suggest that all CFS patients donate blood to force the CDC into acknowledging this disease and the recent findings. I could not disagree more with this tactic but it does suggest the degree of frustration with the CDC.

I am asking that you and your advisors simply remain aware of the actions of the CDC and while doing so keep an eye on the rapidly emerging changes in what is known about the causes of 'CFS.' Federal funding for this disease has been sorely lacking. We are now at a moment in history when enough has been discovered by private institutions (WPI) to create a solid foundation upon which to build.

I very much appreciate your time.

Sincerely,

XXXXXXXXX
​

Here is the CDC's reply:

> Thank you for your inquiry to CDC-INFO. In response to your request for information on blood donation and the XMRV retrovirus, please refer to the following information. > > Please note that the U.S. Food and Drug Administration is responsible for the safety of the nation's blood supply. Please contact the agency for information on blood donation policies:
>
> You may contact the FDA at 1-888-INFO-FDA or through their website at: http://www.fda.gov
>
> Additional information may be available on the FDA website:
>
> The Center for Biologics Evaluation and Research (CBER)
> www.fda.gov/cber/blood.htm > > FDA/CBER - Blood Frequently Asked Questions (FAQs)
> www.fda.gov/Cber/faq/bldfaq.htm
>
> FDA/CBER - Blood
> www.fda.gov/CbER/blood.htm > > The CDC website provides basic facts about chronic fatigue syndrome (CFS) and ways to treat it. There are materials on the website for patients and doctors as well as scientific publications. We also provide links to other Federal websites for CFS:
> > Understanding Chronic Fatigue Syndrome: A Guide for Patients
> National Center for Zoonotic, Vector-Borne, and Enteric Diseases, Division of Viral and Rickettsial Diseases
> http://www.cdc.gov/cfs/pdf/UnderstandingCFS.pdf
>
> Recognition and Management of Chronic Fatigue Syndrome: A Resource Guide for Health Care Professionals
> National Center for Zoonotic, Vector-Borne, and Enteric Diseases, Division of Viral and Rickettsial Diseases
> http://www.cdc.gov/cfs/pdf/HCPManaging.pdf
>
> CDC Resources
> Chronic Fatigue Syndrome
> National Center for Zoonotic, Vector-Borne, and Enteric Diseases, Division of Viral and Rickettsial Diseases
> http://www.cdc.gov/cfs/
>
> External Resources
> Chronic Fatigue Syndrome Advisory Committee
> Department of Health and Human Services
> http://www.hhs.gov/advcomcfs/
>
> National Women's Health Information Center
> Department of Health and Human Services
> http://www.womenshealth.gov/faq/chronic-fatigue-syndrome.cfm
>
> Health Finder
> United States Department of Health and Human Services
> http://www.healthfinder.gov/scripts/SearchContext.asp?topic=171
>
> Trans-NIH Working Group for Research
> National Institutes of Health
> http://orwh.od.nih.gov/cfs.html
>
> Thank you for contacting CDC-INFO Contact Center. Please do not hesitate to call 1-800-CDC-INFO, e-mail cdcinfo@cdc.gov or visit http://www.cdc.gov if you have any additional questions. >
> CDC-INFO is a service of the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR). This service is provided by Vangent, Inc. under contract to CDC and ATSDR.
>
> ---------------------------------------------------------------------------------------------
>
> Please visit CDC-INFOs Customer Satisfaction Survey and tell us about your recent experience with CDC-INFO. The survey results will help improve our services. The address for the survey is http://www.emtservices.org/cdcinfo/en/email_satisfaction_survey.htm. Thank you.
>
> L3RAM, 5820/vv
> >

And finally, my response to the CDC's response:

Apparently Wanda Jones, Deputy Assistant Secretary for Health (Women's Health), HHS, does not feel that this is simply an FDA issue. In the following e-mail she specifically names the CDC as one of three federal agencies tasked with ensuring the safety of the nations blood supply.

> Sent: Thursday, November 26, 2009
> FDA, NIH, CDC--the agencies responsible for blood safety, as well as
> several non-Federal groups. The team is drawn from the retrovirus
> expertise of the agencies. They are developing several "panels" of
> thousands of samples drawn from blood donors, from CFS patients,
> people with other diagnoses, etc. They are taking fresh as well as
> repository whole blood samples, not serum. They have standardized
> reagents, working with Judy Mikovits. The work is just beginning.
> Wanda K Jones, DrPH Deputy Assistant Secretary for Health (Women's
> Health)
> US Department of Health and Human Services
> 200 Independence Ave SW
> Washington, DC. 20201
> Ph 202 260 4432
> Fx 202 401 4005

Also, your reply states "The CDC website provides basic facts about chronic fatigue syndrome (CFS) and ways to treat it. There are materials on the website for patients and doctors as well as scientific publications."

And yet there is nothing on the 'Science' article linking XMRV to CFS (http://www.sciencemag.org/cgi/rapidpdf/1179052v1.pdf?ijkey=m3wzKT4yJqEyk&keytype=ref&siteid=sci), while a prominent link about a dubious article co-authored by William Reeves remains (News & Highlights - New Publication Linking Sexual Abuse and CFS). Given the 'Reeves 2005' definition of CFS I would expect 'CFS' to be linked with almost anything.

I have to say that the CDC seems more interested in self-promotion than in disseminating current and relevant scientific information.

Most Sincerely,

XXXXXXX

cc:
Congressman Jim Matheson - UT Second District (c/o Robert Roake)
Senator Orrin Hatch - UT
Senator Bob Bennett - UT (c/o Jessica Christopher)
​

Most of this transpired before I came across this group.

Any thoughts?

Shane

 

[fresh_eyes]

Go, Shane, go!

You're doing the kind of advocacy that I've been pondering & hope to get to soon, when I'm able. Of course they demonstrate all the responsiveness of a brick wall, but I know they DO keep track of how much correspondence they receive on an issue, and it does matter. (As an aside, they say Harry Reid is a big WPI/XMRV research supporter, being from Nevada & all...he might be another one to include?)

ps Have you been posting over at the erv blog?

 

[CBS]

I have been known to state an opinion or two on the ERV blog. I have a pretty strong research background and for the last 16 years (at least until 3 or so years ago) I have been so frustrated at the bad science that was hindering progress on whatever it is we're all dealing with.

My pet peeve is poor study design without an appreciation for the need to minimize "noise" and a failure to recognize the difference between statistically stable results and clinically significant results. Bad study design is usually worse than no study at all. Don't get me started!

That's for the supportive words and for noticing.

 

[gracenote]

I'd love to get you started

I have a pretty strong research background and for the last 16 years (at least until 3 or so years ago) I have been so frustrated at the bad science that was hindering progress on whatever it is we're all dealing with.

My pet peeve is poor study design without an appreciation for the need to minimize "noise" and a failure to recognize the difference between statistically stable results and clinically significant results. Bad study design is usually worse than no study at all. Don't get me started!

Hi ComeBackShane,

I'd love to get you started. I think a lot of us would be appreciative of better ways to know what "bad study design" is, and how to spot it. We need "good" science, and we need to be able to recognize "bad" science. So get started. That's my invitation, anyway.

 

[Kati]

Shane, welcome to this forum and thank you for your efforts in making this disease legitimate from the gov. point of view.

CDC is obviously passing the ball, but I think we should keep poking at them until they start reacting a bit more.


Shame on you CDC.

 

[cold_taste_of_tears]

It's hard to change a habit of a lifetime....

 

[fresh_eyes]

I'd love to get you started. I think a lot of us would be appreciative of better ways to know what "bad study design" is, and how to spot it. We need "good" science, and we need to be able to recognize "bad" science. So get started. That's my invitation, anyway.

Ditto. If you're willing to educate us, that would be great.

 

[CBS]

"Learn to say 'I don't know.' If used when appropriate, it will be often." D.R.

Keeping firmly in mind that I am not a doctor or a virologist (a social scientist with an emphasis on health), I'm probably much better at answering questions and carrying on a discussion than I am at trying to give a tutorial (I would have to assume quite a bit about what you already did or did not know and what you wanted to talk about). Is there anything thing specific that you are interested in? No promises except that I'd be happy share my two cents where I can.

Maybe it would help to start out by saying that in my opinion, poorly designed research is usually worse than no research at all because at least with no research you don't walk around thinking you know something that you really don't know ('unknown unknowns?' see below).



My favorite relevant quotes from Donald Rumsfeld:

"If I know the answer I'll tell you the answer, and if I don't, I'll just respond, cleverly."

"...there are known knowns; there are things we know we know. We also know there are known unknowns; that is to say we know there are some things we do not know. But there are also unknown unknowns -- the ones we don't know we don't know."

"There's another way to phrase that and that is that the absence of evidence is not the evidence of absence. It is basically saying the same thing in a different way. Simply because you do not have evidence that something does exist does not mean that you have evidence that it doesn't exist."

In a very surreal manner, he had a point.

Shane

 

[usedtobeperkytina]

I sent

I sent Jones an e-mail:

Thank you for all you do in responding to the needs of CFS patients. I respect you for your courage to enforce laws concerning the CFSAC and its meetings. I also appreciate your providing such quick responses to inquiries and providing a place for patients to be heard and to easily know what CFSAC is doing.



Any news on the testing of the blood supply?

Tina

 

[Sing]

I'm very impressed with the actions you took, ComeBackShane, in writing to the CDC and your Congressmen. The only problem I see with this are the statements that interpret motivations for action. I read an article about Joe Biden's way of handling political conflicts (NYTimes Sunday magazine) that he learned to question judgment rather than motivation.

I understand how easy it is to assign negative motivations that would seem to precede the negative actions, but feel that it makes a stronger, more convincing case to criticize the actions. Showing the contrasts between these acts and the purposes of the organization--like protecting public health--and the scientific record--like the study published in Science magazine, are challenging confrontations which the recipients can't duck. However, once any personal attacks, anger or attributions about motivation come into it, the criticism can much more easily be brushed off, as the critic's personal problem. I felt you did all of the above--the very focused, effective confrontations plus the anger and attributions.

I want to emphasize that I feel you are justified in being angry and that there are grounds for you to believe in the negative motivations you indicate, but "going there" leaves us subject to being dismissed.

Better to fight them on the ground everyone in the public sphere can agree upon--that is, in relation to their mission statement and in relation to the factual record.

We fall headfirst into the soup when we attack someone or some institution personally. I've done this a million times, just gotten myself bloodied and not succeeded in my purpose.

Channelling passion into cold, steady confrontations will help corner these actors most tightly with their contradictions, and I think this is a better way to hasten the advent of good sense and good science.

Forgive my preachiness. I want us to be as powerful as we can be, in self advocacy.

Sing

 

[CBS]

Dear Cecelia,

Thank you! Your comments on the need to stay focused are appropriate and very much appreciated.

Personally, I don't think that it is anger you see finding its way into my comments, it is rage. I don't know that the rest of the world will ever fully appreciate just how much all of us have lost. I've been dealing with this long enough (and my health has now deteriorated to the degree) to have been openly ridiculed by 'health care providers' who were later proven to have been 100% wrong in their presumption that as they were literally laughing I was not in the midst of a life threatening crisis.

I was at a presentation last night (my one trip out of the house this week) given by a very knowledgeable and caring doctor who is actively involved in CFS and XMRV research. She cautioned everyone to please be patient as she expected significant changes in the entire CFS landscape over the next year but the pace of science needed to be deliberate. She then stated that she knew we've all dealt with this for some time but that we could hang on for another 12 months to ensure appropriate diagnoses and treatment.

Intellectually, I know that for the most part she is absolutely right. I also know that the reason she became a CFS physician was because her sister died from complications of CFS. I also know that for myself, until 18 months ago my assumption was that this was probably shortening my life but I did not consider CFS to be an imminent threat. Without going into the details, my autonomic and central nervous system went completely haywire in May 2008. Chest pain, breathing difficulty and significant cardiovascular instability, as well as bouts of sepsis are now just a few of the constant reminders that this body is no longer a safe place.

I no longer see any humor in the adage "I have good news and bad news, the good news is that CFS isn't going to kill you, the bad news is that CFS isn't going to kill you." No one should be lulled in thinking that this is just about quality of life. The co-infections and viral load can, and if given enough time, will kill you!

Setting aside all that is lost as we wait for a cure and even those who take their own lives as the only refuge from the suffering, for me this is no longer something that can wait for another decade or even years. My wife and I talked this morning about how we both felt that it was literally my job to simply keep myself alive for the next eighteen months.

All of that said, I agree that there are venues for passionate rational discourse and that one must find other avenues to confront as well as release the pain of mourning for a life that could have been.

Sincerely,

Shane

 

[CBS]

CDC's latest response.

> Thank you for your inquiry to CDC-INFO.

> Your comments have been forwarded to the appropriate CDC program for their
> information. They will contact you if they have any additional guidance or
> information.

It appears that this may have made it past the CDC-Info service to the CFS Division of the CDC.

 

[Sing]

To ComeBackShane

Thank you so much for your generous, and heartfelt, reply! I was moved by everything you said. Just quoting the last part:

"All of that said, I agree that there are venues for passionate rational discourse and that one must find other avenues to confront as well as release the pain of mourning for a life that could have been.

Sincerely,

Shane"

Yes, there is mourning what is lost. So much has been lost--major parts of life! And the continuing limitations are extreme. Then there is releasing into what is left, finding what is possible now, living from here.

I am grateful, so grateful, we can talk about all of this here. And step up to the plate and take political actions too, sometimes.

I feel it is like being part of a baseball team now and sometimes I feel that a pitch is for me to hit. So I do. I don't have to hit all of them. It is so great to see the teamwork happening here, the different skills and knowledge bases coming into play, people working together for common goals.

Thank you for what you have shared and what you are contributing to our political efforts!

Cecelia

 

[CJB]

Dear Cecelia,

Thank you! Your comments on the need to stay focused are appropriate and very much appreciated.

Personally, I don't think that it is anger you see finding its way into my comments, it is rage. I don't know that the rest of the world will ever fully appreciate just how much all of us have lost. I've been dealing with this long enough (and my health has now deteriorated to the degree) to have been openly ridiculed by 'health care providers' who were later proven to have been 100% wrong in their presumption that as they were literally laughing I was not in the midst of a life threatening crisis.

I was at a presentation last night (my one trip out of the house this week) given by a very knowledgeable and caring doctor who is actively involved in CFS and XMRV research. She cautioned everyone to please be patient as she expected significant changes in the entire CFS landscape over the next year but the pace of science needed to be deliberate. She then stated that she knew we've all dealt with this for some time but that we could hang on for another 12 months to ensure appropriate diagnoses and treatment.

Intellectually, I know that for the most part she is absolutely right. I also know that the reason she became a CFS physician was because her sister died from complications of CFS. I also know that for myself, until 18 months ago my assumption was that this was probably shortening my life but I did not consider CFS to be an imminent threat. Without going into the details, my autonomic and central nervous system went completely haywire in May 2008. Chest pain, breathing difficulty and significant cardiovascular instability, as well as bouts of sepsis are now just a few of the constant reminders that this body is no longer a safe place.

I no longer see any humor in the adage "I have good news and bad news, the good news is that CFS isn't going to kill you, the bad news is that CFS isn't going to kill you." No one should be lulled in thinking that this is just about quality of life. The co-infections and viral load can, and if given enough time, will kill you!

Setting aside all that is lost as we wait for a cure and even those who take their own lives as the only refuge from the suffering, for me this is no longer something that can wait for another decade or even years. My wife and I talked this morning about how we both felt that it was literally my job to simply keep myself alive for the next eighteen months.

All of that said, I agree that there are venues for passionate rational discourse and that one must find other avenues to confront as well as release the pain of mourning for a life that could have been.

Sincerely,

Shane

Bumping this up first to say

WTG :victory: Shane :victory:

and secondly, wondering if anyone has any updates.

 

[starryeyes]

This is great news. I hadn't seen it before. Thank you Shane! Shane! Come Back Shane!

 

[Nina]

Although it has not much to do with the subject of this thread, I just would like to say:

Thank you Shane for this comment. It brought me to tears as I don't allow myself to mourn for all the things I have lost and the life that "could have been" all to often. It hurts so much to even let this hit you with all its impact that I mostly try to keep this door shut. While I keep trying to survive each day and keep hope alive, if we are really going to live to see a change in the landscape of medical opinion and more important, treatment, I remind myself that it will all have been worth it. I can't risk to think of myself one year from now to find out nothing has changed after all.

Apologies for this "emotional outbreak" here, it's been an especially rough day for me and Shane's comment finally opened the gates...

Nina