Today I must report that once again, the CFS Advisory Committee violated federal law. This time, recommendations made by the Committee were illegally altered after the public meeting. The story of what happened, how I got it fixed (hopefully), and who might be responsible is another disturbing chapter in the saga of how HHS tries to disregard the law with impunity.
What Happened
After the recommendations from the March 2014 meeting were posted on the CFSAC website, Mary Dimmock and Denise Lopez-Majano noticed that something was wrong. The recommendations did not match what they recalled from watching the meeting. At first, we thought it was just the omission of references to the Canadian Consensus Criteria, but as I looked more carefully I found the changes went way beyond that.
The minutes of the March 11th CFSAC meeting capture the recommendations as voted on by the Committee. When I compared it to the recommendations actually sent to Secretary Sebelius by then-Chairman Dr. Gailen Marshall, they were dramatically different. The recommendation to increase research funding was completely eliminated, and most of the other recommendations had substantial changes as well. This table shows all of the changes made to CFSAC’s original recommendations.
The Federal Advisory Committee Act is a federal statute that specifies how advisory committees must operate. One of the biggest requirements is that recommendations must be discussed and voted upon in public. Both Dr. Marshall and Designated Federal Officer Dr. Nancy Lee are well aware of this requirement. Dr. Marshall even commented during the March meeting that “But we can’t make, you know, if I misspell something or I juxtaposition a word or two that’s fine, but we can’t change the words once we’re in agreement.” (Transcript, p. 95).
But this is precisely what occurred. At some point after the CFSAC meeting, the recommendations voted upon in public were changed. When CFSAC last violated this FACA provision in early 2013, I got help from Public Citizen to force HHS to correct the violation. This time, I took CFSAC on myself.
Fixing It
First, I contacted Chairman Dr. Sue Levine to ask for her help in restoring the original recommendations and sending them to the Secretary. I have no complaints about Dr. Levine’s attempt to correct the problem, especially because I was asking her to clean up someone else’s mess, but it became clear that she was encountering some difficulty or resistance from HHS. Then HHS posted a response to the illegal recommendations, and it was clear that more direct action was needed.
On September 29th, I wrote to the General Counsel of HHS and presented all the evidence of the FACA violation:
The attachments to this letter establish that the March 2014 recommendations of CFSAC were changed after the Committee’s public meeting and prior to those recommendations being sent to the Secretary, which is a patent violation of FACA’s requirement that recommendations be voted upon in public. This violation of statute is now compounded by the fact that the Department has responded to the illegally altered recommendations instead of the actual recommendations that the committee approved in an open meeting.
Specifically, on March 11, 2014, the CFSAC approved seven recommendations at its public meeting. Chairman Dr. Gailen Marshall sent a different set of recommendations to Secretary Sebelius on April 19, 2014. Dr. Marshall’s letter omits one recommendation in its entirety, and substantive and materially changes five of the remaining six recommendations. In response to my inquiry about these alterations, Dr. Marshall told me he recalls no “heavy editing” of the recommendations, but it is obvious that significant changes were made. . . .
There can be no dispute that changing the publicly approved recommendations of an advisory committee is a violation of FACA. Regardless of who altered the recommendations, or why they did so, the fact remains that the recommendations were altered outside the public view and without the involvement of the full committee. Moreover, the illegal behavior has since been compounded by the fact that the Department has responded to those illegally altered recommendations, not the recommendations actually approved by CFSAC.
I ask that you take immediate action to have the Department restore the committee’s original recommendations as recorded in the meeting minutes, so that it can consider and respond to the committee’s actual advice. I must also ask that you also ensure that CFSAC complies with FACA going forward, as this is the second time I have brought an indisputable FACA violation by the same committee to your attention.
I received no response.
But then on or about October 7th, the CFSAC website was changed. The illegal recommendations and the Department’s response to them was removed. A new version of the recommendations that is very close to what appears in the meeting minutes is now posted. However, I received no information or confirmation that these new recommendations were sent to the Secretary. So on October 17th, I wrote to the General Counsel again. This time, I said:
This letter will confirm my understanding that Secretary Burwell has received the actual recommendations approved by CFSAC at the March 2014 meeting for her consideration and response, If this is not the case, please notify me immediately.
I still have received no response. On November 21st, a letter from Secretary Burwell to Dr. Levine acknowledging receipt of the recommendations was posted to the CFSAC website, but that letter is dated June 20, 2014. That means Secretary Burwell is acknowledging receipt of the OLD recommendations. Neither the General Counsel’s office nor Dr. Levine have confirmed that the corrected recommendations have actually been sent to the Secretary.
Who Is Responsible
At the time I wrote to the General Counsel, I had no evidence about who changed the recommendations or why. To a certain degree, it didn’t matter because the important thing was to get those original recommendations restored. But I filed a FOIA request for documents and correspondence between the March 11th meeting and the April 19th letter to Secretary Sebelius with the illegal recommendations. And here is where it gets interesting.
Among the documents I received in response to that request were two versions of the recommendations. This first one corresponds very closely to what the CFSAC voted upon at the meeting, and it matches the restored version now on the CFSAC website. So there can be no doubt that the recommendations were captured correctly at the meeting.
This second document is a draft version of the letter to Secretary Sebelius. It is dated April 13, and as you can see there are many redactions (which I have appealed). You can see that the recommendations are now different from what the committee had approved. And it is the NAME of the document that is most important: “CFSAC Rec Letter 041314_GDM_NLee Redacted.”
This is strong (but circumstantial) evidence that Dr. Lee and Dr. Marshall cooperated in drafting this different version of the recommendations. We’ll see if I can get the redactions removed and whether that tells us anything more.
Implications and Consequences
It is extremely disturbing to me that this violation of FACA occurred. Dr. Lee and Dr. Marshall are very well aware that changing recommendations after a meeting is illegal. From that draft letter, it appears they did it anyway. I do not know why, but it is completely ridiculous and unacceptable. With Public Citizen’s help, I forced them to correct another FACA violation just the year before. This second violation was not an accident. The correct version existed and was in their possession, but they sent a different version to the Secretary. That April 19th letter went out over Dr. Marshall’s signature, making him responsible for its content. And Dr. Lee’s role as Designated Federal Officer is to ensure that CFSAC operates in compliance with FACA. They failed in fulfilling that responsibility.
I want to be very clear that Dr. Levine was put in the unfortunate position of trying to correct this problem. Furthermore, I have no evidence that any other members of CFSAC were aware that the recommendations were being changed. There is no correspondence indicating that they were consulted about a draft version or any changes. I assume they did exactly what I did when the recommendations were first published: glanced it over and assumed it was correct. It was only because two advocates looked more closely that we ever noticed the problem.
I had to spend an obscene amount of time and energy in accumulating evidence, writing these multiple letters, and trying to work within the system to correct this obvious and apparently intentional violation of federal law. This was time and energy that I did not have to spend. I had to carve out capacity for this matter while I was trying to analyze and respond to the P2P draft evidence review. This is wrong. I am too sick, and I damaged my health in getting this fixed.
Complying with FACA is not difficult, especially the basic requirement of using recommendations voted upon in public. The DFO and Chairman are responsible for ensuring the law is followed, and they are perfectly capable of doing so. And when the problem was brought to their attention, the correct and easy thing to do would be to simply fix it. I gave them every opportunity to do so before going to the General Counsel. A great deal of effort could have been avoided if the DFO and Chairman just did their jobs.
I copied the full CFSAC on both of my letters to the General Counsel, so they are aware of what was done in their names. I sincerely hope that they are as disturbed and outraged about this obvious violation of federal law as I am. I hope they will establish whether the corrected recommendations were actually sent to Secretary Burwell, and that they will do what they can to prevent future violations of FACA. It is beyond ridiculous that a disabled patient has to do this for them.
Thank you for using your time and precious energy for standing up for all of us who are unable to do so. I deeply appreciate you!
Thanks Nita!
I completely agree with Nita. A huge thank you Jennie! Also Mary, Jeanette and all who advocate when others are too sick. Also to Leela as she exposed the harms of P2P from the beginning. If not so insulted by FOIA memos, it would have been comical. Five hours of emails to edit one to Francis Collins as to differences (talking points) between P2P and IOM when experts wanted neither. Thanks again Jennie!
Good catch, folks. Thanks for the efforts, Jennie. Sorry the advocacy is bad for your health. I know the feeling.
Good catch Mary Dimmock and Denise Lopez-Majano ! Thank you so much to all of you bc you all do Stellar advocacy work!!! And thank you Jennie for all the work in regards to general counsel and getting it fixed. It is very sad that we are MEDICALLY disabled. Plus with PEM as a hallmark of our disease this really harms your health with all this advocacy work. I find it very medically unethical – where does medical ethics come to play. Much gratitude!!!!
Thank you to Mary Dimmock, Denise Lopez-Majano, and Jennifer Spotila!! Your work is appreciated very much!!
Unbelievable. I don’t like conspiracy theories but they make it harder every day to not believe there is a hidden agenda…
Thank you very much Jennie for this important work. I hope you can get some rest after all the efforts!
I could elaborate and expound, but my thoughts are bottom-lined at “Thank you, Jenny.” Thank you and bless you for your sacrifices. Someone will hear us. We need to stand with hope. Without hope, we accept defeat.
I am a little confused. Do I have this correctly? As it appears from the two letters, the recommendations that were approved consisted of six paragraphs. (And if I recall correctly, there was frustration that they were not resubmitting ALL the old recommendations that had been ignored, but just a few.).
The SECOND letter, the one that was sent to the Secretary of HHS, added four pages of material, much of it highly selective towards reinforcing the mistaken and harmful recommendations already on CDC’s website, that is, that this is a mysterious disease having a lot to do with past or present stress, and the best recommendations in the current literature are GET and CBT (graded exercise and psychological counseling).
Is that correct, or have I missed something?
(And thanks for doing this.)
Mary
I did find the numbered recommendations in the minutes of the CFSAC meeting. Basically they emphasize using the CCC (2003), while the doctored version provides evidence to continue the harmful recommendations on CDC’s website for CBT and GET (which the CCC treated rather harshly), and describes ME and CFS as the same thing. Nothing is known about the condition except it seems related to past or present stress, and is best treated with CBT and GET.
Is this the gist?
Also, because I am not a lawyer, the frequent appearance of (b)(5) didn’t make sense because I did not understand what they referred to.
I am sorry to be a pest but I need to understand this so I can write my congressional delegation.
You’re not a pest, Mary. I’m happy to answer questions. (B)(5) is a FOIA exemption. It allows the government to withhold anything that is predecisional and deliberative. It’s colloquially known as the “we don’t want to give it you” exemption. I’ve appealed, but it will take time for that to play out.
Okay – now I understand – what I was looking for is up n the second paragraph of this blog, the link to ” Table”:
Uhttps://dl.dropboxusercontent.com/u/57025850/Changes%20to%20March%202014%20CFSAC%20Recs%20Table.pdf
Unbelievable. What is going on over there?
Again, thanks for finding this.
Thank you, Jennie, for all your hard work! Brain fog inhibits me from fully understanding and following all of this. I am deeply grateful to you. ❤️
This is an outrageous offense, especially considering how much time the committee members wasted with wordsmithing the recommendations during the CFSAC meeting. I think it’s important to point out that the illegally revised recommendations have completely omitted all references to the Canadian Consensus Criteria, partly because it clearly demonstrates their intention to reject the CCC in the upcoming redefinition efforts (i.e. P2P, IOM).
Hi Jennie, thank you for spending your precious energy on uncovering some more mishaps from HHS. Along with Jeannette’s work, we are learning about what HHs is all aboutxlies,corruption. neglect, deny, bury and forget.
i haven’t looked at all the documents you have linked yet, but just the difference between the recommendations convened at the public meeting and what has been sent to the secretary. They didn’t seem to like the Canadian Consensus Criteria. Could it be because this is not a definition coming from them americans? Could it be because a new definition (decided by a group of non-experts, likely influenced by psychiatrists) is coming our way? Who are these people (DFO, HHS)serving? The people of America or another group? Insurance companies? Psychiatrists? folow the money, this is where the answer will be
I am disbelieved that so much harm has occured over the last 30 years for an ever growing patient population in the US and around the world and that instead of trying to fix that, governments are still trying to find reasons to ignore us. Obviously our health and financial status are limitating our efforts to uncover the truth and moving forward, and I believe now that HHS finds this extremely convenient.
The government through HHS, NIH, CDC have been controlling the “message” about ME since 1984, the year serious blunders began when the CDC was sent to Incline Village, NV, to “investigate” an outbreak. They have no desire or intention, at least at this point, to acknowledge their mistakes and change direction in their handling of this disease. I have heard advocates call CFSAC meetings a “dog and pony show.” For the longest time I did not want to think along those lines. But after years of watching the futile attempts of CFSAC members to get anything done that would change the fate of those suffering from ME, I now share that opinion. After reading the response and dismissal from the Secretary regarding the latest recommendations submitted, I wondered what Dane Cook and all the other hard working CFSAC members thought. Once again all their hard work, thoughtful recommendations, and supporting material to move the field forward was for naught. It makes me wonder why anyone agrees to serve on this committee. I see new members come on board with enthusiasm and ideas to get something done, only to find out that it is futile. Instead of acknowledging the truth about this devastating disease, HHS, NIH, and CDC are only concerned with protecting their reputations, their jobs, and their “message.”
Thank God there are honest, hard working scientists that are uncovering the pathological mechanisms underlying this disease. They recognize the true nature of this disease and are facing it head on. Thank God for the CFS Research Center at Stanford University, Simmaron Research: Scientifically Redefining ME/CFS, the Open Medicine Institute and the Open Medicine Foundation, the Chronic Fatigue Initiative, the Center for Infection and Immunity at Columbia University, and many, many others both in this country and around the world working to uncover the pathophysiology of this disease which will eventually lead to effective treatments so that we can get our lives back. What outrageous audacity the government has shown by ignoring all the expert ME/CFS researchers and clinicians who have studied this disease up close and personally for many years and instead chooses their bureaucratic mechanisms to reiterate and maintain their faulty perceptions and messages about this disease that began long ago in 1984. Shame on them.
In her November 5, 2014 blog entry (http://cfstreatment.blogspot.com) titled “The Elephant in the Room: Brain Studies, Politics and ME/CFS,” Erica Verrillo made the following statement:
“In one month, the P2P panel will meet to decide the financial fate of ME/CFS research. If the panel decides that ME/CFS can be cured with “a talk and a walk” (CBT and GET), it will be going head-to-head with the Stanford University School of Medicine, which is not only one of the most prestigious institutions in the country, but one that leaves any panel or committee assembled by HHS in the dust.”
I particularly like a statement from a previous blog of hers called “The P2P Posts Its Agenda: Are They Kidding?” In it she says:
“In a game of chicken in which one car is the federal government with all its entrenched mediocrity, and the other is one of the nation’s most prestigious medical schools, who will swerve first?”
In this sentence she sums up my feelings well and worded it better than I ever could. It may take some time, but my money, literally, is on these honest, courageous, hard working scientists that continue to uncover the truth about ME.
Just one afterthought to add to my message above:
In the meantime, the harm being done to those unfortunate enough to come down with ME is incalculable.
Thank you Sandra!! I have such a hard time reading about the horribleness that is the gov`t`and èxperts` and their dealing with all this, in North America and all over the world. It overwhelms me with hopelessness and makes me unable to read anymore! Thank you for this reminder and beam of light 🙂
You are most welcome, Dorothy. It delighted my heart to know that what I said helped someone. We have to hold on to that “beam of light.” I liked the way you worded that and it is a phrase that I will hold on to. We know that there are dedicated people working to help us, with more joining the fight every year. We know the truth of what we are experiencing, and have to believe, trust, that in the end the truth will win out.
Thank you, Jennie Spotila, Mary Dimmock and Denise Lopez-Majano.
It appears certain people think they are above the law. Outrageous.
There may be some that disagree with my comment but I believe for right now the best way for everyone reading this is to immediately contact your Congressional and Senate Representatives to express your outrage! This ship is about ready to dock.
Since this is happening under a Democratic administration, Democrats can ill afford bad publicity since an election is just around the corner. Apparently for some reason, the head of the NIH, Phil Collins and those directly beneath him, did not receive President’s clear and concise executive order in a memo directing all executive heads and agencies to a more open and tranparent government or perhaps they feel they are immune to such excutive orders.
http://www.opencongress.org/wiki/Obama_Transparency_Record#Transparency_and_Open_Government_Memo
Or perhaps the agency and department heads within his administration are in rebellion to Obama’s administration directives?
http://www.bloomberg.com/news/2012-…sclosure-test-with-19-in-20-ignoring-law.html
Then we have Obama’s promise to the ME/CFS community to elevate Chronic Fatigue Syndrome in priority within the NIH and the HSS, assigning his Deputy Chief of Staff to follow their efforts. Well that has certainly backfired! http://phoenixrising.me/archives/13145
I also believe that this could be the best avenue to seek an investigation on abuse and violation of Federal Law by an administrative head!
U.S.House Committee on Oversight & Government Reform (Chairman Rep. Jason Chaffetz, R-Utah) Everyone should Contact Oversight Committee’s secure whistleblower platform here to confidentially report waste, fraud, abuse or mismanagement. https://wb-gop-oversight.house.gov/
Depending on the outcome of P2P, AHRQ Evidence Review and IOM reports, I believe a civil RICO against Francis Collins NIH should be considered. We need to go nuclear if the NIH and the CDC is going to go nuclear against this community.
P2P & AHRQ report will be disemminated to all healthcare providers, to all those within the medical profession and will be added to the curriculum within medical schools.
thanks so much for all your work, and for noticing things like this!
Well-done, Jennie! Bravo to you! Between you and Jeanette, all of the illegalities of the government’s process concerning ME/CFS will be uncovered for the world to see.
I am so glad you did this research and advocacy work, but am sorry it took a toll on your health.
It really is astounding to see the reality of the deception in writing. I wonder what went on with those who changed the recommendations. Were they oriented to do this? If so, by whom? Who is calling the shots here?
I agree with so many of the very incisive comments above. It will eventually come to a showdown with the naysayers and government bureaucrats vs. the scientists who are doing the research and know we are all very sick, and that has a physiological basis, that cannot be treated with GED and CBT.
And I agree on the “follow the money,” too. The government doesn’t want to put more money into researching causes or treatments nor does it want to pay out more disability and medical benefits. Nor do insurance companies.
However, this will help us: David Tuller’s column in Nov. 25’s New York Times in the Science section: “Brain studies offer key to baffling disorder,” about the Stanford and Japanese brain studies showing abnormalities in people with ME/CFS. It’s a good article, to the point and pro-science. Tuller is a good guy, on our side.
He raises that advocacy groups have criticisms of the government meetings coming up with people on committees who have little to no experience in dealing with the disease and will be voting on how the government should deal with it.
Bravo David Tuller! This is another weapon in our arsenal of science. It also clearly states our worries about these committees.
I don’t know. I feel a bit better. Between your and Jeanette’s hard and supremely intelligent legal detection, revelations and advocacy, and the publishing of scientific findings, even written about in the Times, I think we’re having some breakthroughs.
Am I being overly optimistic? Don’t know.
I think if the IOM and other committees are up against the Stanford medical bunch, that Dr. Montoya and his researchers will not blink! That’s my gut feeling.
Thank you again. Get some real rest, please.
When working to advance public health policies re: CFS, what is the key committee recommendation that was omitted in the original report?
The key recommendation omitted was that research be funded commensurate with the burden of illness.
“Health care fraud costs the country tens of billions of dollars a year. It’s a rising threat… [and] Recent cases also show that medical professionals continue, and may be more willing, to risk patient harm in furtherance of their schemes…”
http://www.fbi.gov/about-us/investigate/white_collar/health-care-fraud
Maybe the unethical behavior within HHS is related to a moral decline within contemporary medical culture as a whole? If so, the good (i.e. honest) doctors/researchers are all the more special. Thank you to them and to Jennie, Mary, and Denise for helping to protect their work.
Omigod! That’s a very important omission, maybe the most important thing here.
It is very strange, and I do wonder who is pulling the strings here and doing these misdeeds or directing others to do so.
I feel like we’re in a mystery novel, with the real story unfolding, and that
someday we will know it.
Hi Jennie,
Thanks for doing this work on our behalf. I know it comes with a high personal cost.
Would you consider posting your original FOIA request? It could inspire more folks to write these requests. A flood of requests from a large number of patients would at least aggravate them…
Many thanks to Mary, Denise, and most of all to Jennie for digging this out, and then doing their best to do something about it. And Jennie, don’t drive yourself too hard–we need you around!
We do now seem to have a couple of names that might be involved in what NIH is doing re us, and there seems some consistency to the changes they have made: as others have noted, they don’t like the CCC–maybe partly understandable in view of the OIM and P2P projects underway (heaven help us), but still clearly an illegal deletion;
they have also deleted the reference to the CCC in Recommendation #1, to leave space for the development of a curriculum at US med schools shaped by other definitions–like the Oxford?
In Recommendation#2 “appropriate agencies” becomes “appropriate HHS agencies”–keep control within the HHS (Stanford will not be invited!);
Recommendation#4–“experts and/or multidisciplinary teams with expertise in ME/CFS” is changed to “composed of specialists from different fields that take into account the complexity of this illness”–again we find that deep-rooted distrust of “experts” in ME/CFS that seems endemic in many HHS documents, and the possibility of including lots of psychiatrists….
Recommendation#4–adds a list of “national primary care organizations” with which to financially collaborate, that includes the “American Academy of Family Physicians” (no such list is present in the transcript); I think I recall that the AAFP issued a very disturbing (to us) statement about ME/CFS a while back?
There seem also some disturbing features that remain in the modified list of recommendations–that list of academies, including the AAFP remains, and many of the references seem to have disappeared, including noticeably the “attach funding list from the NIH website for various diseases” which was originally attached to the first recommendation, that funding be commensurate with the burden of the disease….
These are deliberate changes and deletions, made from a discernible perspective intent on maintaining control and keeping open the definition question.
Many thanks again, Jennie! You and Jeannette really are opening windows into the NIH with your intelligence and legal skills!
Wow! Great catch Jennie, I’m so glad you were paying attention to this…just one more piece of information to add to the pile of evidence surmounting against how the government agencies, that are supposed to be there for us, continue to do everything in their power to work against us.
Someday all of this work done by you and Jeannette will pay off. hopefully in time for all of us to benefit, but if not for us, then the next generation of PWME.
Thank You!
Thank goodness for this amazing work you are doing.
We don’t have to take this lying down! We can be heard with a National PR Campaign for ME/CFS. https://meadvocacy.nationbuilder.com/donatepr