Did CFSAC’s ‘High Priority List’ Illegally Bypass Public Input?

February 19, 2013

Jody Smith reports on how CFSAC’s “High Priority Recommendations” excluded most of our priorities and our input, in an apparent violation of the Federal Advisory Committee Act

jspotila-o

Jennifer Spotila prompted Public Citizen to write to Acting General Counsel William Schulz of the HHS, asking that CFSAC be compelled to act in accordance with its own charter and with the Federal Advisory Committee Act.

The CFS Advisory Committee has made many recommendations to the Secretary for Health and Human Services in the past. But in January 2013, the ME/CFS community got an unpleasant surprise. The CFSAC had posted the document High Priority Recommendations from CFSAC on their public website.

The surprise? The document was dated January 2012, and listed only seven of 58 recommendations.

CFSAC subcommittees had sent recommendations to HHS officials without opening the matter up to public debate and without getting the entire committee’s approval, in violation of the CFSAC’s charter and of the Federal Advisory Committee Act.

Subcommittees of the CFSAC privately met to compile a list of recommendations for the secretary without input from the full committee, and without any opportunity for public input. The list of recommendations was discussed by Dr. Nancy Lee, the Designated Federal Officer for CFSAC, and Assistant Secretary for Health Dr. Howard Koh.

One of the key goals of the Federal Advisory Committe Act is to facilitate public oversight of advisory committees. Since the public in general, and the ME/CFS community in particular, were deprived of our right to be involved in the advisory committee process, we’ve also lost our opportunity to have any impact on federal policy. If we can’t have input through the CFSAC, do we have it anywhere?

Jennifer Spotila contacted Public Citizen, a non-profit organization intent on providing a voice for the people in Washington D.C. This organization has brought litigation under the Federal Advisory Committee Act in the past. Public Citizen’s Health Research Group advocates for drug and medical device safety, and other health care issues.

A letter for Spotila was sent to Acting General Counsel William Schulz of the Department of Health and Human Services by Public Citizen. Michael A. Carome, M.D., of Public Citizen’s Health Research Group, wrote to Schulz asking that CFSAC be compelled to act in accordance with its own charter and with the FACA. Carome asked that the document from January 2012 be sent back to the full committee, open to public scrutiny, to be reviewed appropriately.

How has this puzzling situation with the CFSAC come about?

During a November 2011 meeting of the CFSAC, Dr. Gailen Marshall, Jr., had suggested that rather than listing all recommendations (58 of them at that time), they should whittle the list down to two or three recommendations. This supposedly was intended to keep the main points from being lost. In a meeting the next day, Dr. Lee expressed agreement with this suggestion.

Minutes of the meeting do not report on how the process was to be carried out. Lee emailed Spotila on January 24, 2013 saying, “CFSAC members worked via the subcommittees to identify the top priority recommendations which are now on the website.” Lee did not shed any light as to how the process unfolded, or when it was done.

The ‘High Priority List’

In effect, only seven out of 76 recommendations, compiled from 2004 to 2012, made the cut. As Spotila detailed in her blog post, Highest Priority, Part One at http://www.occupycfs.com/2013/01/28/highest-priority-part-one/ these are the recommendations that the CFSAC saw fit to retain and recommend:

Clarify the Department’s process for considering the CFSAC recommendations

Recommended in November 2011, and answered in Dr. Koh’s letter of August 3, 2012, the mechanics for transmittal of recommendations and responses were explained.

Classify CFS in the ICD-10-CM in section G93.3 along with myalgic encephalomyelitis

Recommendations on the code classification of CFS were made six times between September 2004 and June 2012. The wording is from November 2011. Dr. Koh’s August 3, 2012 letter noted that rolling out the ICD-10-CM will be delayed, but offers no response to the CFSAC’s recommendation.

The Interagency Working Group should pool resources to enact the Centers of Excellence concept repeatedly recommended by the CFSAC

Recommended frequently by the CFSAC, “Centers of Excellence” was mentioned seven times between September 2004 and November 2011. The specific recommendation was made in November 2011 and partially addressed in Dr. Koh’s August 3, 2012 letter. He described the Ad Hoc Working Group but made no mention of the Centers of Excellence concept.

Fund more research

It was recommended that CFSAC increase research funding for ME/CFS through NIH or CDC. This was brought up at 10 meetings between September 2004 and October 2012. In the High Priority document, the recommendation was modified and rolled in with two others.

Adopt the term “ME/CFS” across HHS programs

This was recommended in October 2010, but as yet no HHS-wide decision has been made. No progress has been reported, though the NIH and FDA have partially adopted the term.

Create a task force to focus on coordinating support for children and young adults with CFS

Recommendations on pediatric issues were brought up at six different meetings from September 2004 to June 2012. The specific wording dated from October 2008. Recommendations included creating pediatric management guidelines and research into the diagnosis, epidemiology and treatment of pediatric CFS.

Public awareness and education

Recommendations on public awareness and public education campaigns were discussed seven times from September 2004 to October 2009. A recommendation from September 2004 and August 2005 went into the document. The fact that this recommendation was marked as “complete” by HHS after the CDC’s public awareness campaign of 2006 begs the question, what was the point of all the subsequent meetings?

What Was Left Out?

Since the High Priority document seems to have been assembled early in 2012, any and all recommendations from meetings later in the year, in June and in October, would have been excluded. What was left out?

Among other things, the CDC Toolkit, the IACFS/ME Primer, and recommendations involving educating educators and school nurses were dropped.

Recommendations for a standing review committee at NIH, funding for research of cluster outbreaks, and bringing together ME/CFS experts to work on the case definition all disappeared.

Recommendations concerning epidemiology of patients who are extremely ill, and concerning biomarker discovery, were dismissed. Provider education was also discarded.

Despite the fact that the CFSAC has focused often on the need for education of health care providers, this area was reduced to barely a mention in the “Centers of Excellence” recommendation.

While the document was finalized in January 2012, through the rest of 2012 until January 2013, it was never referenced or discussed in public by anyone on the CFSAC.

My Head Hurts

I don’t mind telling you that reading up on this situation made my head hurt. Whatever the intentions of the perpetrators, documents have been dispatched in a way that is fast and loose, and it is our lives they are playing fast and loose with.

Committee members were not consulted. Sentences were dropped from records. Meanings have been changed, apparently without a plan in mind. Is the purpose simply to squash the amount of time and attention ME/CFS must be given by the government? Does the meaning no longer matter so long as we don’t take up too much space?

I’ve lived with ME/CFS for two decades. I have seen, first-, second- and third-hand, plenty of slights, insults and injury over those years. I have come to see a side of life that my years of being healthy in no way prepared me for.

This is not the first time I have been disappointed and made more cynical by the (non)treatment we with ME/CFS have received. But seeing this come from “our” advisory committee adds a little extra sting, and knocks what remained of my former naivete and trust a little further off their pins.

Spotila has a wait-and-see attitude as to whether or not Schulz will act in accordance to these requests. As of February 18, 2013 there had been no response from him. The High Priority document did at least come down from the website since the letter was sent.

Spotila expressed her thanks to Public Citizen for their quick, decisive action. She appreciated the fact that, unlike the non-responses we with ME/CFS so often encounter from the rest of the world, Public Citizen recognized the importance of this issue, and understood that correcting this infraction would be in the public interest.

Such deviations should not be tolerated, where advisory committees are allowed to keep the public in the dark, rendered helpless to influence change in public policy.

Spotila encourages everyone who is concerned about this matter to share her blog post and give it as much exposure as possible, e.g. through Twitter, Facebook and other social media. She suggests that people blog about the letter from Public Citizen, and light up the issue in support groups and other contacts.

Keeping everyone informed is vital. Our voices need to be heard.

Further reading

Letter to Department of Health and Human Services Regarding the Chronic Fatigue Syndrome Advisory Committee
http://www.citizen.org/hrg2095

A Public Citizen
http://www.occupycfs.com/2013/02/18/a-public-citizen

Highest Priority, Part One
http://www.occupycfs.com/2013/01/28/highest-priority-part-one

Highest Priority, Part Two
http://www.occupycfs.com/2013/01/30/highest-priority-part-two

 

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24 comments

{ 24 comments… read them below or add one }

Courtney Miller February 20, 2013 at 12:46 am

I'm distressed that you would go to Public Citizen. That organization chose to oppose Ampligen's approval at the FDA Advisory Committee meeting with no regard for the ME/CFS patients Ampligen has helped or could help, even after hearing moving testimony of patients on the drug. Public Citizen has no understanding of the illness, is not motivated to support patients, and put itself in the way of the first medication for ME/CFS, and as a result, all subsequent medications, for their own self-interest, not ours. ME/CFS patients should stay far away from them.

Valentijn February 20, 2013 at 12:49 am

Very frustrating and annoying behavior from CFSAC. Thank you for writing this very informative article about it, Jody.

Nielk February 20, 2013 at 6:02 am

Thank you Jody for this informative article. I will have to read it a few times to fully understand it. (bad brain today)

The first step for any reaction is true knowledge of the problem. Thank you for bringing this issue to light. This sounds like a grave situation that needs to be remedied.

Jody February 20, 2013 at 7:21 am
Valentijn

Very frustrating and annoying behavior from CFSAC. Thank you for writing this very informative article about it, Jody.

Glad to do it, Valentijn.

Jody February 20, 2013 at 7:23 am
Nielk

Thank you Jody for this informative article. I will have to read it a few times to fully understand it. (bad brain today)

The first step for any reaction is true knowledge of the problem. Thank you for bringing this issue to light. This sounds like a grave situation that needs to be remedied.

Nielk,

I had to read it a few times myself to get a handle on it. Jennifer Spotila helped me out with that. I appreciate all she's written on this to make our community — and hopefully others — aware of what's been going on. And I appreciate the time she spent with me helping me put things together.

Sparrow February 20, 2013 at 10:45 am

I respect the concerns of others here, but this doesn't currently upset me. I assume that someone involved with the CFSAC is familiar with the government organizations they're working with, and what they will and won't realistically pay attention to. It's like when I go to the doctor. I have learned very clearly that if I go with one symptom that is bothering me most, it might get investigated or treated. A list of 58 symptoms won't even all get read, and nothing gets actually checked out. The hope is that once that one symptom is dealt with, other symptoms will be next on the list. And I know going into it that certain symptoms are more likely to get sincere attention, while others would just get a sideways look and be brushed off.

There's just no way that 58 things can all actually be "highest priority" and be worked towards in any meaningful and directed way. And I trust that the ones chosen were ones that were both key for future progress and likely to be attainable goals.

I can see where there might be disagreements about exactly which items were highest priority, but I hope that people are also able to focus on the good that's being done here. If any of those things happened, it would be a great step for us. This is not a key problem for me, and in my mind we've got a ton of key things that really do need our efforts.

I think sometimes we get used to be treated very unfairly by doctors, relatives, and the public. We feel like we are often not listened to, and are frequently put on the back burner. That can put us on guard a bit. I would want to give as much support and encouragement as possible to people who are working on our behalf, in meaningful directions, and towards goals that are helpful to us. We want them to continue that, and need their good will and support. Working with ME is not an easy job, and doctors who champion our cause can face a lot of adversity and lack of understanding from their colleagues. Feeling like we are supportive and grateful for their efforts can help to offset some of that and keep other young doctors entering the field. So if they're going in a mostly good direction, I'm inclined to send them a thank you note.

jspotila February 20, 2013 at 11:16 am
Sparrow

I respect the concerns of others here, but this doesn't currently upset me. I assume that someone involved with the CFSAC is familiar with the government organizations they're working with, and what they will and won't realistically pay attention to. It's like when I go to the doctor. I have learned very clearly that if I go with one symptom that is bothering me most, it might get investigated or treated. A list of 58 symptoms won't even all get read, and nothing gets actually checked out. The hope is that once that one symptom is dealt with, other symptoms will be next on the list. And I know going into it that certain symptoms are more likely to get sincere attention, while others would just get a sideways look and be brushed off.

There's just no way that 58 things can all actually be "highest priority" and be worked towards in any meaningful and directed way. And I trust that the ones chosen were ones that were both key for future progress and likely to be attainable goals.

I can see where there might be disagreements about exactly which items were highest priority, but I hope that people are also able to focus on the good that's being done here. If any of those things happened, it would be a great step for us. This is not a key problem for me, and in my mind we've got a ton of key things that really do need our efforts.

I think sometimes we get used to be treated very unfairly by doctors, relatives, and the public. We feel like we are often not listened to, and are frequently put on the back burner. That can put us on guard a bit. I would want to give as much support and encouragement as possible to people who are working on our behalf, in meaningful directions, and towards goals that are helpful to us. We want them to continue that, and need their good will and support. Working with ME is not an easy job, and doctors who champion our cause can face a lot of adversity and lack of understanding from their colleagues. Feeling like we are supportive and grateful for their efforts can help to offset some of that and keep other young doctors entering the field. So if they're going in a mostly good direction, I'm inclined to send them a thank you note.

Sparrow, I actually agree with what you say. The idea of creating a short High Priority List is an excellent one, and the CFSAC should pursue it. My concern, and the reason I acted as I did, is that the Committee abide by the rules and regulations as it does its work. If a pattern is established whereby the Committee does substantive work behind closed doors and never brings it to the public sessions, then that will ultimately hurt us. When I discovered what had happened here, I acted with the hope that the pattern would not be repeated.

I also want to be clear that there is no evidence of malice here. I don't believe that the CFSAC or HHS is out to get us. It seems far more likely that someone dropped the ball on the rules, and now they need to clean it up. As long as it gets fixed, no lasting harm has been done.

jspotila February 20, 2013 at 11:18 am
Courtney Miller

I'm distressed that you would go to Public Citizen. That organization chose to oppose Ampligen's approval at the FDA Advisory Committee meeting with no regard for the ME/CFS patients Ampligen has helped or could help, even after hearing moving testimony of patients on the drug. Public Citizen has no understanding of the illness, is not motivated to support patients, and put itself in the way of the first medication for ME/CFS, and as a result, all subsequent medications, for their own self-interest, not ours. ME/CFS patients should stay far away from them.

I respectfully disagree, Courtney. I understand your concern about the Public Citizen testimony at the Ampligen hearing. But my interactions with the staff have been 100% respectful and they have been completely responsive to my concerns. Personally, I won't shun an organization because of one statement at one meeting.

K2 for Hope February 20, 2013 at 11:54 am
jspotila
Courtney Miller

I'm distressed that you would go to Public Citizen. That organization chose to oppose Ampligen's approval at the FDA Advisory Committee meeting with no regard for the ME/CFS patients Ampligen has helped or could help, even after hearing moving testimony of patients on the drug. Public Citizen has no understanding of the illness, is not motivated to support patients, and put itself in the way of the first medication for ME/CFS, and as a result, all subsequent medications, for their own self-interest, not ours. ME/CFS patients should stay far away from them.

I respectfully disagree, Courtney. I understand your concern about the Public Citizen testimony at the Ampligen hearing. But my interactions with the staff have been 100% respectful and they have been completely responsive to my concerns. Personally, I won't shun an organization because of one statement at one meeting.

The Public Citizen also asked to have Crestor removed from the FDA drug approval list as it can cause kidney damage.

http://www.citizen.org/Page.aspx?pid=3212

I took it not knowing about the kidney damage, as the side effects listed do not state that.

http://www.crestor.com/c/home.aspx

They state "CRESTOR is not right for everyone. Do not take CRESTOR if you are nursing, pregnant or may become pregnant; have liver problems; or have had an allergic reaction to CRESTOR" and "Your doctor should do blood tests to check your liver before starting treatment with CRESTOR and if you have symptoms of liver problems while taking CRESTOR"

I was diagnosed with 3rd stage Kidney failure in Jan 2011. I came off the Crestor after I found the "Public Citizen" document and subsequently it seems my kidneys are getting better (even though I was told that would never happen.)

To date, Crestor has not been removed from the FDA approval listing even due to the clinical trials that had cited worse effects than Ampligen and there are other drugs on the market for the same condition as Crestor.

http://www.citizen.org/Page.aspx?pid=3212

"In opposing the drug’s approval at a July 9, 2003 FDA advisory committee meeting, we pointed to two cases of kidney failure and one case of kidney insufficiency in clinical trials prior to approval in which patients had also experienced both protein and blood in the urine. There were also a large number of patients who had blood and/or protein in their urine but had not suffered from kidney failure. In addition to this kidney toxicity, unique among all of the statin drugs, rosuvastatin is the only one of these drugs in which any cases of the life-threatening muscle destruction known as rhabdomyolysis was found to occur prior to approval. Even cerivastatin (Baycol), which was ultimately banned after at least 31 cases of fatal rhabdomyolysis, had not caused a single case of this adverse reaction prior to approval. In contrast, there were seven cases of rhabdomyolysis in patients receiving rosuvastatin before its approval. Although all were receiving a dose (80 milligrams) that was not approved, a small patient getting even the 40 milligram dose might be receiving the same amount of drug per pound of body weight and we were concerned that cases would occur at this 40 milligram dose or even lower doses. We stated that it was likely, if not certain, that if it were approved, rosuvastatin would have to be banned because of post-marketing cases of rhabdomyolysis and kidney failure that would inevitably occur."

So, the Public Citizen is not there just to make sure a drug doesn't get FDA approval, but that the processes for all government actions are followed.

It also seems ironic to me that Crestor, with clinical trials that were worse than those identified in the safety concerns for Ampligen, is on the FDA approved list and where there are other drugs that could be used. But Ampligen couldn't make the FDA approved list where there are no other drugs that are being offered for ME/CFS.

I'm in support of the CFSAC being responsible to follow the rules as they should be doing but also am even more concerned about how the FDA is choosing the drugs it is adding to the approved lists.

Why is Crestor approved when there are other "cholesterol-lowering" drugs and Ampligen not approved when the clinical trials showed less safety issues and there are no other drugs on the market now or in the near future for ME/CFS?

Molly February 20, 2013 at 12:35 pm

Has anyone discovered why Galien Marshall, Jr., was seated as the Chairman of the CFSAC and not Steven Krafchick as was designated when Christopher Snell ended his term of service from the Board in November of 2011?

It seemed to me that on June 1, 2012 I was as stunned as Mr. Krafchick when Dr. Marshall was surprisingly leading the Committee? Was this change also the result of a closed-door decision that somehow resulted in the name switch of the Committee Chairman Recommendation from Steve to Galien? Somewhere this should all be documented in the Final Meeting Report as to why the change?

Steven Krafchick was to be the preferred name submitted in the recommendation as the current Chair of CFSAC; Galien Marshall was to take leadership only of the “Research Committee”. As Galien Marshall speaks, he refers to Sec. Sibelius as Sec. Sullivan, and implies knowing Sec. Sibelius on a first name basis, but could not master her formal name/title. Therefore, it is interesting that Dr. Marshall is the Chair at this time rather than the person the Committee Voted to recommend for Confirmation. Dr. Snell stated that the Committee Member’s Secret Ballot votes were “fairly counted” with the choice selection.

View CFSAC Fall Meeting on November 9, 2011 from the 2:30 Committee Discussion (1:39:20 to 1:52:32 on video) Turn on your closed captions to follow the dialog:
http://www.youtube.com/watch?v=VclEVvfJYRg&list=PL600CB038194B4593&index=15

jspotila February 20, 2013 at 1:29 pm
Molly

Has anyone discovered why Galien Marshall, Jr., was seated as the Chairman of the CFSAC and not Steven Krafchick as was designated when Christopher Snell ended his term of service from the Board in November of 2011?

It seemed to me that on June 1, 2012 I was as stunned as Mr. Krafchick when Dr. Marshall was surprisingly leading the Committee? Was this change also the result of a closed-door decision that somehow resulted in the name switch of the Committee Chairman Recommendation from Steve to Galien? Somewhere this should all be documented in the Final Meeting Report as to why the change?

Steven Krafchick was to be the preferred name submitted in the recommendation as the current Chair of CFSAC; Galien Marshall was to take leadership only of the “Research Committee”. As Galien Marshall speaks, he refers to Sec. Sibelius as Sec. Sullivan, and implies knowing Sec. Sibelius on a first name basis, but could not master her formal name/title. Therefore, it is interesting that Dr. Marshall is the Chair at this time rather than the person the Committee Voted to recommend for Confirmation. Dr. Snell stated that the Committee Member’s Secret Ballot votes were “fairly counted” with the choice selection.

View CFSAC Fall Meeting on November 9, 2011 from the 2:30 Committee Discussion (1:39:20 to 1:52:32 on video) Turn on your closed captions to follow the dialog:
http://www.youtube.com/watch?v=VclEVvfJYRg&list=PL600CB038194B4593&index=15

Molly, this is really murky. You are correct that Mr. Krafchick was informally elected as the new chair by the committee when Dr. Snell retired. However, the Committee Chairman is selected by HHS, not by the committee. The informal election was a statement of the Committee's opinion, but was never binding on HHS. I do not know how Dr. Marshall was selected specifically, or whether the Committee's preference was considered, but I don't have any indication that there was a violation of procedure.

Molly February 20, 2013 at 3:01 pm
Sparrow

I respect the concerns of others here, but this doesn't currently upset me. I assume that someone involved with the CFSAC is familiar with the government organizations they're working with, and what they will and won't realistically pay attention to. It's like when I go to the doctor. I have learned very clearly that if I go with one symptom that is bothering me most, it might get investigated or treated. A list of 58 symptoms won't even all get read, and nothing gets actually checked out. The hope is that once that one symptom is dealt with, other symptoms will be next on the list. And I know going into it that certain symptoms are more likely to get sincere attention, while others would just get a sideways look and be brushed off.

There's just no way that 58 things can all actually be "highest priority" and be worked towards in any meaningful and directed way. And I trust that the ones chosen were ones that were both key for future progress and likely to be attainable goals.

I can see where there might be disagreements about exactly which items were highest priority, but I hope that people are also able to focus on the good that's being done here. If any of those things happened, it would be a great step for us. This is not a key problem for me, and in my mind we've got a ton of key things that really do need our efforts.

I think sometimes we get used to be treated very unfairly by doctors, relatives, and the public. We feel like we are often not listened to, and are frequently put on the back burner. That can put us on guard a bit. I would want to give as much support and encouragement as possible to people who are working on our behalf, in meaningful directions, and towards goals that are helpful to us. We want them to continue that, and need their good will and support. Working with ME is not an easy job, and doctors who champion our cause can face a lot of adversity and lack of understanding from their colleagues. Feeling like we are supportive and grateful for their efforts can help to offset some of that and keep other young doctors entering the field. So if they're going in a mostly good direction, I'm inclined to send them a thank you note.

Sparrow, I agree with many of your thoughts here, but from a slightly different perspective. When you are trusting of any Organization, Government or otherwise, you become vulnerable to what they want you to know.

For example, you state you are content having 1 out of your 58 major symptom resolved by your physician at an office visit. Chronic Patients only get seen every 3 months unless something else Acute surfaces. That means it will take 14.5 years to resolve the last of your priority symptoms. If that is how we expect the Government Agency assigned to be our Representative at the big table, it is no wonder after 30 years, we have no acknowledgement, no tests, no realistic name identifier, no medications, no funding. If we are trustingly passive, we receive exploitation and seriously denied Patient Rights. We must be persistent to get the most quality of life we can muster when we are so vulnerable with this serious of a pathology within our bodies.

Molly February 20, 2013 at 3:48 pm
jspotila
Molly

Has anyone discovered why Galien Marshall, Jr., was seated as the Chairman of the CFSAC and not Steven Krafchick as was designated when Christopher Snell ended his term of service from the Board in November of 2011?

It seemed to me that on June 1, 2012 I was as stunned as Mr. Krafchick when Dr. Marshall was surprisingly leading the Committee? Was this change also the result of a closed-door decision that somehow resulted in the name switch of the Committee Chairman Recommendation from Steve to Galien? Somewhere this should all be documented in the Final Meeting Report as to why the change?

Steven Krafchick was to be the preferred name submitted in the recommendation as the current Chair of CFSAC; Galien Marshall was to take leadership only of the “Research Committee”. As Galien Marshall speaks, he refers to Sec. Sibelius as Sec. Sullivan, and implies knowing Sec. Sibelius on a first name basis, but could not master her formal name/title. Therefore, it is interesting that Dr. Marshall is the Chair at this time rather than the person the Committee Voted to recommend for Confirmation. Dr. Snell stated that the Committee Member’s Secret Ballot votes were “fairly counted” with the choice selection.

View CFSAC Fall Meeting on November 9, 2011 from the 2:30 Committee Discussion (1:39:20 to 1:52:32 on video) Turn on your closed captions to follow the dialog:
http://www.youtube.com/watch?v=VclEVvfJYRg&list=PL600CB038194B4593&index=15

Molly, this is really murky. You are correct that Mr. Krafchick was informally elected as the new chair by the committee when Dr. Snell retired. However, the Committee Chairman is selected by HHS, not by the committee. The informal election was a statement of the Committee's opinion, but was never binding on HHS. I do not know how Dr. Marshall was selected specifically, or whether the Committee's preference was considered, but I don't have any indication that there was a violation of procedure.

My point is simply that the dialog that we see and hear during these hearings are not carried through in respect of the members who make recommendations on our behalf. There is a lot of work for all of the people setting around that table. It would be a kind gesture if the members earnestly voted for one person to Chair this Committee and something that simple would be acknowledge by the Secretary. I am not suggesting foul play, I am suggesting that if this is an example of a decision that was made and we have no explanation of what made the difference to Sec. Sibelius, then it stands to reason we have no rights to know why the Committee Members Recommendations never get past 5:00.

How many more years will it take to get the Secretary to honor our demise, and become progressive on our behalf? Is the problem too many recommendations; or, is the problem how Government works on the surface when the public is present, is not the same as what we trust will be followed through to help us? Why all the time and money year after year, if the recommendations are not taken seriously? It confuses me, why one group of people are selected to suffer, when so many people are working diligently to bring hope. I would like to believe that these CFSAC Representatives are acknowledged as chosen professionals who are making wise recommendations which are respected enough for the Secretary to accept on occasion. I am working on 7 years of misery, and I really don't want to be counted as having a 30 year wait for proper care as so many valuable other people who suffer with this disease have had to do. It is not right. It simply appears that what we are seeing or hearing at the meetings are not important enough to respect the votes of the members. It is all murky as you have aptly discovered. Yet, the investigation was sparked only by you contacting Public Citizen and their advocacy for us.

taniaaust1 February 20, 2013 at 3:50 pm
Courtney Miller

I'm distressed that you would go to Public Citizen. That organization chose to oppose Ampligen's approval at the FDA Advisory Committee meeting with no regard for the ME/CFS patients Ampligen has helped or could help, even after hearing moving testimony of patients on the drug. Public Citizen has no understanding of the illness, is not motivated to support patients, and put itself in the way of the first medication for ME/CFS, and as a result, all subsequent medications, for their own self-interest, not ours. ME/CFS patients should stay far away from them.

Where should of she put in this complaint then??? Not complaining at all is a far worst thing to do and wont help things.

taniaaust1 February 20, 2013 at 4:04 pm

A big thanks to Jennifer Spotila for makiing all this public and Jody for putting this info all together for us.

Kelly February 20, 2013 at 5:03 pm

I believe there was supposed to be a decision made regarding the ICD CM criteria for CFS in January.

Jody February 20, 2013 at 5:48 pm
taniaaust1

A big thanks to Jennifer Spotila for makiing all this public and Jody for putting this info all together for us.

Thanks Taniaaust1.

Could not have done it without Jennie Spotila.

Sparrow February 20, 2013 at 6:34 pm
Molly

Sparrow, I agree with many of your thoughts here, but from a slightly different perspective. When you are trusting of any Organization, Government or otherwise, you become vulnerable to what they want you to know.

For example, you state you are content having 1 out of your 58 major symptom resolved by your physician at an office visit. Chronic Patients only get seen every 3 months unless something else Acute surfaces. That means it will take 14.5 years to resolve the last of your priority symptoms. If that is how we expect the Government Agency assigned to be our Representative at the big table, it is no wonder after 30 years, we have no acknowledgement, no tests, no realistic name identifier, no medications, no funding. If we are trustingly passive, we receive exploitation and seriously denied Patient Rights. We must be persistent to get the most quality of life we can muster when we are so vulnerable with this serious of a pathology within our bodies.

I completely agree with being persistent and active in seeking the rights we deserve, and that the progress so far has been very poor. I just don't see this incident as evidence of the CFSAC not bothering with us, not working for our benefit, or exploiting us. I see them trying to help, and the seven items they've chosen make sense and are not at odds with our goals. I'm not advocating us being passive. I just don't personally see this particular case as a place where I would focus my energy when there are so many other areas where people aren't currently trying to help and need our persistence to inspire change. Obviously others feel strongly about this particular oversight, and that's fair too.

I wouldn't expect to wait 14.5 years to get those symptoms treated. But I might have more success starting with one or two and getting the ball rolling. If we can get people on board with helping us, every successive step should be much easier than the last. New territory is always more difficult, and people will always be more resistant to the first few changes.

Obviously it would be wonderful to have all 58 items resolved immediately. And that is what would be fair and deserved. But no matter how loud or active we were, I think that's unlikely to happen. Alternately, seven items with enough force behind them might be possible. And might pave the way for the next seven, and fifteen after that, and thirty others. As much as dramatic sweeping changes might be warranted, I would rather choose something likely to happen than pick an immediate goal so high that people will ignore the request completely. A bit of politics, diplomacy, and knowledge of human nature can only help us in actually getting as much of what we're after as possible.

I honestly don't want to argue this, though. I'm sure we've all got plenty of other things to spend our energy on. :)

taniaaust1 February 20, 2013 at 7:25 pm

Out of those 7 things choosen on that high Priority list.. interestingly two of the items Im actually completely against!! as I think if introduced will work "against" what those who have ME need to be happening.

Adopt the term “ME/CFS” across HHS programs

I personally think that completely screws things up for those of us who want ME and CFS to be seen as completely separate things. We have an international consensus ME defination now.. so is lumping the names ME and CFS together the way forward.. doesnt this just confuse between ME and CFS even more? These illnesses need to be seen as separate not lumped. (and lumping them together hasnt helped in the other countries eg Australia who have done that and have been doing that for years but cause its ME/CFS.,. doctors still use the term CFS).

So by this recommendation if implimented will do NOTHING at all for any community… and screw things up for the ME people.

Where's anything in the recommendations which would help instead to separate ME and CFS and the various subgroups which most agree need to be separated as its a well known fact lack of separating the "CFS" subgroups is screwing up research etc.

Classify CFS in the ICD-10-CM in section G93.3 along with myalgic encephalomyelitis

This is another thing which will help lump ME and CFS together even more and how will that help people.. once again.. it wont!!

One would of thought that "priority recommendations" would be ones which could actually bring some very good changes to this community.
………………

I know that many others who fit ME criteria and have ME would be feeling the same way about this lumping together thing. Irronic that almost a third of the recommendations made.. as a ME person Im completely against. (maybe the community should of been consulted more and things which arent splittling community views should of been focused on instead (if they were only going to focus on a few things).
….

and things like "fund more research" is no good as a simple recommendation unless the research is being done well.. eg research on the various subgroups of ME/CFS. Fund more research may well just mean put more money into psych CFS studies. I think the priority recommendations need to be far more specific or they will backfire. They will be achieved but with our actual real needs actually going unmet.

"Fund more research" what does this really mean too? To achieve that goal even funding a couple of thousand dollars more then previously is funding more research (Is this just an exercise is creating a goal which can be easily achieved so will just look good when it is said the goal is met?? but with the government not really doing much more at all? ). They should be calling upon Funding for this illness in a "fair way" compared to similar diabiliting illnesses affecting a similar amount of people and the funding they get. Be more specific about goals and what the high priorities are.

Things like "Public Awareness Campaign" can backfire too.. as often very bad educational ME/CFS advice is put out there. No good putting a ton of money into an education campaign when its just pushing bad info on the illness.

taniaaust1 February 20, 2013 at 8:03 pm

Say the following happens and certain goals are achieved (which it could well happen with those priorities).. what good has it truely done for us

Clarify the Department’s process for considering the CFSAC recommendations"

How's that helped each of us who have ME/CFS individually? that's just helped the committee. Its not really a recommendation for things to improve as far as ME/CFS goes.


Classify CFS in the ICD-10-CM in section G93.3 along with myalgic encephalomyelitis

How will that really help us? It wont really change anything.

Adopt the term “ME/CFS” across HHS programs

how will that really help us? This wont really change anything either.

Fund more research

Say $2000 a year more is put into ME/CFS studies or more money goes into psych studies.. goal achieved. Is that going to really help us? nope.

Public awareness and education


So money will get put into preaching the benefits of GET and CBT? In an actual public campaign to educate the general public ideas such as this. Hasnt more ME/CFS education gone on in England then in America? Look where that has them.
Most of those ideas can be approved and end up not being of help at all.
…..
Yay!! an idea I like

Create a task force to focus on coordinating support for children and young adults with CFS

Is it only me who's seeing how easily those things could be implicated while bringing no real shift to the ME/CFS situation…… (or used to make the situation worst).

Mark February 20, 2013 at 8:16 pm
Sparrow

I completely agree with being persistent and active in seeking the rights we deserve, and that the progress so far has been very poor. I just don't see this incident as evidence of the CFSAC not bothering with us, not working for our benefit, or exploiting us. I see them trying to help, and the seven items they've chosen make sense and are not at odds with our goals. I'm not advocating us being passive. I just don't personally see this particular case as a place where I would focus my energy when there are so many other areas where people aren't currently trying to help and need our persistence to inspire change. Obviously others feel strongly about this particular oversight, and that's fair too.

I wouldn't expect to wait 14.5 years to get those symptoms treated. But I might have more success starting with one or two and getting the ball rolling. If we can get people on board with helping us, every successive step should be much easier than the last. New territory is always more difficult, and people will always be more resistant to the first few changes.

Obviously it would be wonderful to have all 58 items resolved immediately. And that is what would be fair and deserved. But no matter how loud or active we were, I think that's unlikely to happen. Alternately, seven items with enough force behind them might be possible. And might pave the way for the next seven, and fifteen after that, and thirty others. As much as dramatic sweeping changes might be warranted, I would rather choose something likely to happen than pick an immediate goal so high that people will ignore the request completely. A bit of politics, diplomacy, and knowledge of human nature can only help us in actually getting as much of what we're after as possible.

I honestly don't want to argue this, though. I'm sure we've all got plenty of other things to spend our energy on. :)

I have to say, Sparrow, that my initial reaction to this news was the same as yours: I had just the same concerns, and I was unsure as to whether this was the right move, but at the same time I could see that there was something very wrong here. I put just the points you've mentioned to Jennie and I discussed the issue with her and a few other people in the US. I'm now quite convinced it was the right thing to do, and without wishing to argue with you when you've said you don't want to, I'd like to explain why.

I'm from the UK, so I'm an outside observer and I don't have the political context to understand the procedural and legal issues involved here, and perhaps some might think it's none of my business. Nevertheless, I've been very interested in CFSAC for a few years now. One of my first experiences when I joined the Phoenix Rising forums was to watch a live video feed of a CFSAC meeting, while chatting about it on a forum thread, and coming from the UK I found the whole concept of this committee extraordinary. Here was a state advisory committee openly streaming its proceedings live on the internet, welcoming input from the public, genuinely open to input from patients and stakeholders, and behaving in an intelligent, constructive and mature fashion – I couldn't quite believe what I was seeing!

It might sound strange or naive, but that experience actually transformed my understanding of the USA. I felt warmly welcomed by members from the US, almost none of whom felt in the slightest that it was 'none of my business', and I had the sense that I was watching something that was at the very least an attempt at something genuinely democratic. Ever since then I have followed CFSAC with great interest, and I've been impressed by the efforts of the committee and by the understanding and concern of the committee members. So I've developed a kind of affection for CFSAC, and a conviction that it at the very least trying to help ME/CFS patients. Hence my instinctive reaction to the news was just the same as Sparrow's: I felt protective of it.

However, when I talk to my friends in the US, what they tell me is that the very purpose and concept of these committees is to provide for public input and visibility of state processes. They tell me that it is a fundamental breach of the charter and the act for a committee to submit recommendations privately via a sub-committee without publicising them and without providing the publicly visible full committee with knowledge, input or approval of those recommendations. And from what I understand, this is exactly what has happened here.

To remind ourselves what seems to have happened here: a private sub-committee produced a set of recommendations, failed to get them approved by the full committee, submitted them to the secretary, and then failed to even publicise the existence of these recommendations for a full year! Again I'm reliant on my friends from the US when they tell me that this is fundamentally not how the committee may act.

Now, it may be the case the the sub-committee felt that these recommendations were more realistic, more likely to be accepted and acted upon, than the rest of the recommendations made by the full committee over the years. And they may have been right about that. They may even (and there's no available evidence of this either way) have deliberately decided to submit these recommendations secretly, in violation of CFSAC's Charter and of the federal act, with the best of intentions, out of a desire to actually achieve something.

But even if all of this is true, it simply cannot be allowed to stand. This committee, as I understand it, is the best and only official route for patients and patient groups to have both a say in the recommendations made to the relevant state authorities, and some visibility of what is being recommended on their behalf. It has clear rules on how it may conduct its business and these appear to have been disregarded in a way that removed public scrutiny from the equation. I think most people would agree that the concept of a "benign dictator" isn't the model we want in our political life, and if you believe in democracy then I think you have to trust that it is the right thing to do to object when democratic instruments are bypassed.

Phoenix Rising and several other ME/CFS organizations are currently applying for the right to have a non-voting representative on this committee. I think that's a great step forward and an opportunity for the patient community to have a greater say, to tell government what the community wants to happen, to register its concerns. But if sub-committees are going to meet privately and make secret recommendations on behalf of the committee without consulting it, what on earth is the point of non-profits spending donated money to fly non-voting representatives to Washington to take part in the committee if the CFSAC recommendations to government health bodies – its primary outputs – are going to be formulated without the committee even knowing what those recommendations are?

No, if CFSAC is to be of use to us, it surely has to follow its own charter. If it is to be an effective body then it has to conduct itself properly. I believe that Jennie is quite right to report this, and it is in all our interests to draw a clear line here and say: if we are to put up our representatives to this body, then it must be a body that is transparent and correct in its proceedings and if it is not then we will hold it to account.

I know that there is a widespread disillusionment amongst the patient community about CFSAC right now. Great hopes have turned to disappointment in the last few years. The community is aware that while CFSAC has made many excellent recommendations, all of its advice has been consistently ignored, and many have started to wonder whether there's any point in this whole exercise at all. But I don't think this is the time to lose heart; I think this is the time to get even more involved and to back up the committee with mass campaigns and advocacy to support and add to the pressure it can exert.

Perhaps there is a lack of self-confidence going on here, and the same is true across the world when you push and push in every way you can imagine and nothing seems to happen. But I happened to be in Berlin when the wall came down: it was sudden and unexpected after years and years of pressure. When I arrived, the wall was there; by the end of the week, it had gone! Nobody saw that coming, and the week before I'm sure there were plenty of people on the other side of that wall who were completely disillusioned and thought all their efforts over the years had been in vain. When there is pressure, even the strongest walls eventually come down – and here's how:

http://www.lyricsfreak.com/s/style council/walls come tumbling down_20132778.html

So I think maybe we should believe in ourselves a bit more, believe in democracy, and not wait for well-meaning private sub-committees to push through changes on our behalf that may not be what we actually want. I do get that CFSAC has to be pragmatic. It has to recommend realistic and sensible measures, things that might actually happen. The representatives on that committee each have an expert understanding of what is and what is not possible in their different departments, what routes might work and what might not, and it's very important to listen patiently to what they say and work out solutions together with them. I actually believe that the patient representatives can and will do that and they will help the committee to achieve its goals; I am convinced that the ME/CFS community in the US is currently maturing at a rapid rate in its ability to advocate effectively.

I also believe that the expertise of the Phoenix Rising community could have a vital role to play on that committee. If we are able to pool our knowledge and relay it effectively to the committee, we could be a significant help to the committee by bringing hundreds of the best minds in the ME/CFS world to bear on the challenges it faces. And whether Phoenix Rising is chosen to have a seat this time round or not, US ME/CFS non-profits will work together to back up what we campaign for with popular campaigns, and we will play our part in that effort.

I think things are changing for the better in the world of US ME/CFS advocacy right now. Non-profits are coming together and organizing to make sure that our voice is united and make sure that it is heard. Jennie's insistence that CFSAC complies with its own charter and with the federal law is right, because that compliance is necessary if we are to have any chance of our voice being heard.

Maybe nothing to do with me, but that's what I think. :)

Jody February 21, 2013 at 7:04 am

Beautiful post, Mark.

jspotila February 21, 2013 at 12:10 pm
taniaaust1

and things like "fund more research" is no good as a simple recommendation unless the research is being done well.. eg research on the various subgroups of ME/CFS. Fund more research may well just mean put more money into psych CFS studies. I think the priority recommendations need to be far more specific or they will backfire. They will be achieved but with our actual real needs actually going unmet.

"Fund more research" what does this really mean too? To achieve that goal even funding a couple of thousand dollars more then previously is funding more research (Is this just an exercise is creating a goal which can be easily achieved so will just look good when it is said the goal is met?? but with the government not really doing much more at all? ). They should be calling upon Funding for this illness in a "fair way" compared to similar diabiliting illnesses affecting a similar amount of people and the funding they get. Be more specific about goals and what the high priorities are.

Just to clarify, "Fund more research" is my summary of that recommendation. The actual text they used was as follows:

ME/CFS is an illness with enormous economic and human costs. The April 2011 NIH State of Knowledge Workshop identified a number of gaps in what is known about the illness. To address these gaps warrants an interagency effort comprising, but not limited to, NIH, CDC, and AHRQ. Further, the focus should be on interdisciplinary discovery and translational research involving interacting networks of clinical and basic science researchers. Areas to be examined would include the following: identification of patient subsets for detailed phenotyping and targeted therapeutic interventions, biomarker discovery, systems biology approaches and disability assessment. To accomplish this, specific issues would include:
a. Fund specific research for identification of biomarkers and etiology of CFS
b. NIH or other appropriate agency should issue a Request for Applications (RFA) for specific clinical trials research on chronic fatigue syndrome/myalgic encephalomyelitis. (5/11)

The problem is that this recommendation is different from what was originally passed by the Committee. I go into this in detail in this blog post, but the important thing to point out is the change to the main part of the recommendation. The original recommendation passed in May 2011 has another sentence after the "areas to be examined." Specifically, the recommendation said

To facilitate the above goal, CFSAC recommends that ME/CFS research receive funding commensurate with the magnitude of the problem and that the NIH (and/or other appropriate agencies) issue an RFA specifically for ME/CFS.

That sentence addresses your concern, taniaaust1. In my opinion, this sentence changes the whole recommendation because it requires that funding match the magnitude of the problem. But in compiling the High Priority list, someone (subcommittee? chairman? DFO? we just don't know) decided to delete that sentence. THIS is why I want this work to be done in public. We would know who wanted that sentence deleted and why. The committee members could debate the issue. We could have commented on its importance. But the behind-closed-doors approach to choosing priorities deprived us of the opportunity to do so. And I believe that is wrong.

jspotila March 1, 2013 at 6:30 am

There is an update!!!! Public Citizen received a letter from Dr. Nancy Lee, DFO of the CFSAC. She said that the High Priority list will be discussed at the spring 2013 meeting of the CFSAC. This means that all of us will have the opportunity, through public comment, to offer our thoughts on what the priorities should be. Read the letter and other information over on my blog: http://www.occupycfs.com/2013/03/01/swift-response/

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