Thoughts About M.E.

Sebelius “Responds” to the Experts: “You Mean This Is Not What You Wanted?”

Posted on November 28, 2013 by Jeannette Burmeister

On November 12, 2013—as I found out just yesterday—more than seven weeks after the original open expert letter was sent to her, Secretary Sebelius finally provided a brief “response” mirroring the talking point provided in the FAQs of November 15, 2013 about the IOM contract. Here is the link to the Secretary’s letter.

To remind everybody, the expert letter (1) made a compelling case for the adoption of the Canadian Consensus Criteria (CCC) as the case definition for ME/CFS, (2) strongly urged HHS to use the CCC as the sole case definition for ME/CFS in all HHS activities relating to this disease and (3) strongly urged HHS to abandon efforts to “reach out to” (i.e., contract with) the Institute of Medicine (IOM) to develop clinical diagnostic criteria for ME/CFS.

Abandon the IOM Effort

Let me start with the last request by the experts. The Secretary’s letter “responds” to it by asserting incorrectly that (1) HHS does not generally develop diagnostic criteria for disease conditions and (2) the IOM study was the most appropriate response to the CFSAC recommendations at its October 2012 meeting:

Because HHS does not generally develop diagnostic criteria for disease conditions, an IOM study was determined to be the most appropriate response to the recommendation made by the Chronic Fatigue Syndrome Advisory Committee (CFSAC) during its October 2012 meeting.

HHS does not generally develop diagnostic criteria

Let’s look at the first part of the sentence:

Because HHS does not generally develop diagnostic criteria for disease conditions …

HHS does not generally develop diagnostic criteria for disease conditions? When I read this, I couldn’t decide whether to start laughing hysterically or beating my head against the wall repeatedly. I mean, really? Correct me if I am wrong, but have we not been suffering tremendously for almost 20 years under the Fukuda definition developed and adopted by the CDC? In light of this reality, the letter’s assertion is outrageous.

And one more time, HHS does not generally develop diagnostic criteria for disease conditions? You mean unlike the IOM? According to Dr. Kenneth Shine, former president of IOM and chair of the current IOM committee tasked with the development of a case definition for Chronic Multisymptom Illness (formerly Gulf War Illness), developing disease definitions is such “a unique task” for the IOM that that Dr. Shine “could not recall when the IOM was last charged with defining a disease.”

Most appropriate response to the CFSAC recommendation

This sentence also reflects an apparent and puzzling misunderstanding of the October 2012 CFSAC recommendation:

… an IOM study was determined to be the most appropriate response to the recommendation made by the Chronic Fatigue Syndrome Chronic Advisory Committee (CFSAC) during its October 2012 meeting.

Here is what CFSAC recommended at its October 2012 meeting:

CFSAC recommends that you will promptly convene (by 12/31/12) or as soon as possible thereafter) at least one stakeholders’ Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS) experts, patients, advocates workshop in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition for discussion purposes.

Everybody who watched that October 2012 CFSAC meeting was quite clear that the recommendation referred to ME/CFS experts. Nevertheless and quite disturbingly, it has been widely reported by patients who have been in touch with the IOM that the IOM is recruiting professionals without ME/CFS experience. Would you trust a heart surgeon, maybe even the world’s foremost one, with your potentially fatal brain surgery? Of course not. This not only makes no sense, but it’s also contrary to the obvious intent of the CFSAC recommendation as it relates to the involvement of professional with ME/CFS expertise only. In addition, despite the CFSAC recommendation, patients and advocates will not be included in the IOM committee according to the November 15, 2013 IOM contract FAQs:

Does the HHS contract with the IOM to include a patient as a committee member?

No.

Adopt the CCC

HHS asked that the committee consider the 2003 ME/CFS Canadian Consensus Definition (CCC) as well as other published definitions and guidelines during it’s deliberations.

The Secretary’s letter addresses the first and second request of the experts (to adopt the CCC and use it as the sole case definition for all HHS activities relating to ME/CFS) by essentially dismissing this recommendation, which couldn’t have been any clearer or stronger. How did it do that? By lumping it in with “other published definitions and guidelines” to be considered by the IOM. This would presumably include the NICE Guidelines and the Oxford criteria, which have a heavy unscientific psychological bias. The experts were very clear: Adopt the CCC now. To pretend that “considering” them even comes close to the experts’ recommendation is baffling.

A few more points about the Secretary’s letter

Furthermore, it is in the best interest of patients and clinical providers that the IOM consider recent scientific advances as it develops recommendations.

To suggest that going with an IOM “study” is in the best interest of the patients, after the IOM threw veterans—a group of citizens that pretty much everybody is supportive of, even those folks who are against the wars—under the bus is at best disingenuous. Personally, I find it insulting. If the IOM has no sleepless nights over the IOM Gulf War Illness fiasco, what do you think they will do to patients who have historically been neglected, abused and labeled as lazies crazies by the government, the medical establishment and the insurance companies in part due to the botched Fukuda definition?

HHS is committeed to fostering open dialog on this topic and values your expertise. The IOM study is a topic of discussion for the November 2013 CFSAC meeting, and the informations about the study is available on the IOM website (link).

Moreover, the “discussion” of the IOM “study” referenced in the Secretary’s letter at the upcoming CFSAC meeting will consist of 30 minutes (!) given to the designated federal officer, Dr. Nancy Lee. A committee discussion of the issue is not on the agenda and, thus, presumably will not be allowed during the meeting. The referenced information on the IOM website is so rudimentary as to be meaningless. Finally, assuring us of HHS’s commitment to fostering open dialog is gag producing given the secrecy and lightning speed with which this “study” is being forced down our throats as well as the tardiness in “replying” to the experts and the complete ignoring of the advocates. Open dialog? HHS has not even produced the contract under which this IOM “study” is being performed. And if an open dialog is so desired by HHS, why not reply in kind, with an open letter, to the experts?

One could speculate as to the real motivation behind the hastily and secretly entered-into IOM contract. After all, this kind of urgency, relating to health issues, coming from the government is highly unusual, if not unique, in cases other than national-health crises, like a threat to the blood supply. But in any event, HHS’s four-paragraph letter is an outright dismissive and perfunctory statement in response to a dramatic, unprecedented and unified plea from virtually all ME/CFS experts. It’s a seemingly calculated slap in the face of not only the experts, but also everybody suffering from this debilitating disease and their families.

Posted in Uncategorized | Tagged 2013, CFS, CFSAC, CFSAC October 2012 recommendation, Chronic Fatigue Syndrome, Diagnostic Criteria ME/CFS, Dr. Kenneth Shine, HHS, IOM Contract, ME, ME/CFS, ME/CFS Experts, Myalgic Encephalomyelitis, Sebelius Letter November 12, Secretary Sebelius | 15 Comments

Call for the HHS Competition Advocate to Investigate the IOM Contract

Posted on November 25, 2013 by Jeannette Burmeister

I have sent today to the so-called “Competition Advocate” for HHS a request to investigate what appears to be a dramatic failure of HHS to follow applicable federal law and regulations regarding full and open competition in its award of the $1 million contract to the Institute of Medicine.

This in some respect duplicates my second request to the Office of Inspector General of HHS, but I thought it would put additional pressure on HHS to have another position within the agency looking into deficiencies in the way this contract was awarded. The Competition Advocate is something like an ombudsman responsible for overseeing the Department’s adherence to the full-and-open-competition requirements of federal contracting law and regulations.

Dear Ms. Griffin,

I am writing to you in your capacity as Competition Advocate for the Department of Health and Human Services (“HHS”) with respect to what appears to be a dramatic failure of HHS to follow applicable federal law and regulations regarding full and open competition in its award of a $1 million contract to the Institute of Medicine (“IOM”) on September 23, 2013 to conduct a study on diagnostic criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (“IOM Contract”). The Statement of Work for the IOM Contract is attached. I have requested the IOM Contract under the FOIA, but have not received it to date.

I have written to HHS’s Office of Inspector General twice with respect to the IOM Contract asking for his investigation of the (1) potential conflict of interest of the IOM regarding its contracted-for study of diagnostic criteria for ME/CFS under the IOM Contract and (2) apparent failure of HHS to follow open-competition requirements in awarding the IOM Contract. My two letters to the Inspector General are attached as well.

On August 27, 2013, a sole-source-solicitation notice was published by HHS on FedBizOpps.gov (attached)[1] without any other announcement by HHS. That notice gave potential vendors only seven (7) days, until September 3, 2013 (one day after Labor Day) to respond, far short of applicable requirements. Following an outcry from the patient population about the proposed contract with the IOM and the woefully inadequate response time, this notice was amended on August 29, 2013 to provide an additional seven (7) days to respond (attached).[2] Later that same day, the notice was again amended to extend the period to respond by one (1) additional day with a revised response date of September 11, 2013 (attached).[3]

On September 4, 2013, the solicitation request was discontinued “[b]ecause of all the of the concern from the public surrounding this potential sole source requisition”[4] (attached). Later on the same day, HHS confirmed the cancellation of the request and stated that “HHS will continue to explore mechanisms to accomplish this work”[5] (attached).

Following this and without further notice other than a message on September 3, 2013 (before the cancellation of the solicitation) from the CFSAC listserv stating that “HHS is actively pursuing a contract with the [IOM]” (attached), HHS entered into the IOM Contract on September 23, 2013.

The Competition in Contracting Act (“CICA”) governs competition in federal procurement agreements, unless the procurement is permitted by a particular statute. No particular procurement statute seems to authorize the IOM Contract. Therefore, CICA applies to the IOM Contract. Under CICA, “full and open competition” requires that “all responsible sources are permitted to submit sealed bids or competitive proposals.”[6]

Under CICA, any procurement contract entered into without full and open competition is non-competitive.[7] In order not to be in violation of CICA, one of seven exceptions allowing HHS to use procedures that are not competitive must apply to the procurement.[8]

Only One Responsible Source and No Other Services Available

A secondary source, USA Spending (attached),[9] indicates that HHS relied on the first exception to the competitive-bid requirements as set forth in 10 U.S.C. § 2304(c)(1) and 41 U.S.C. § 253(c) (single-source contract). None of the other seven exceptions would seem applicable here. However, in order for HHS to be permitted to enter into a non-competitive procurement contract under that first exception, HHS must (1) demonstrate not only that the services are available from only one responsible source, but also that no other type of service satisfies the agency’s needs, (2) in case of contracts over $650,000 such as the IOM Contract, (a) provide written justification for the use of non-competitive procedures as well as (b) obtain approval from your office for using non-competitivprocedures, (3) post the justification and approval within 14 days of contract award and (4) post the procurement notice before contract award.

In my requests to the Office of Inspector General dated November 11, 2013 and November 16, 2013, I set forth the basis for my conclusion that the reliance by HHS on the sole-source justification was unwarranted in light of the readily available alternative of an ad hoc committee of ME/CFS experts, HHS representatives and ME/CFS patient representatives that could develop diagnostic criteria for ME/CFS, similar to what has been done with the Panel on Antiretroviral Guidelines for Adults and Adolescents, a working group of the NIH Office of AIDS Research Advisory Council, which provides regular updates on HIV treatment recommendations. [10][11] Given the broad consensus among ME/CFS experts, such an ad hoc panel could relatively easily and expeditiously approve diagnostic criteria for ME/CFS to replace the outdated and discredited Fukuda definition without the delays, expense, conflict-of-interest and non-competition issues represented by the IOM Contract. This, unlike the IOM Contract, would be in line with the October 2012 CFSAC recommendation to hold a case-definition workshop with ME/CFS experts, advocates and patients.[12]

It is obvious that HHS did not, in fact, seriously explore this or other alternatives to the IOM Contract despite its assurances made to the public on September 4, 2013 that it “will continue to explore mechanisms to accomplish this work,” a seeming misrepresentation because on the day before, September 3, 2013, it announced it was actively pursuing a contract with the IOM, and, in fact, awarded the contract to the IOM on September 23, 2013. To my knowledge, there is no public indication of any consideration by HHS of the viable alternative described above or any other means of satisfying HHS’s needs supposedly to be fulfilled by the IOM Contract.

Furthermore, a “responsible source” under CICA is a prospective contractor who, among other requirements, has the necessary experience.[13] The IOM itself acknowledges that it is not experienced in developing case definitions or diagnostic criteria for particular diseases. In fact, according to Dr. Kenneth Shine, former president of IOM and chair of the current IOM committee tasked with the development of a case definition for Chronic Multisymptom Illness”[14] (formerly Gulf War Illness), developing disease definitions is such “a unique task” for the IOM that that Dr. Shine “could not recall when the IOM was last charged with defining a disease.”[15]

Written Justification and Approval and Publication of Both

Under CICA, HHS must justify any non-competitive procurements in writing and certify the accuracy and completeness of its justification. Moreover, the justification must be approved by your office.

The justification and the approval are to precede the contract award, unless HHS relies on the second exception, the unusual-and-compelling-urgency exception, but, even in that case, HHS must have determined the existence of the unusual and compelling urgency prior to awarding the contract. However, HHS may not cause unusual and compelling urgency by poor planning,[16] such as waiting until the end of the fiscal year to procure services and, as a result, claiming unusual and compelling urgency because its appropriations are about to expire. HHS entered into the IOM Contract on September 23, 2013, just 7 days before the end of its fiscal year on September 30, 2013. Therefore, HHS would not have been able to rely on the second exception and, in any event, it seems that it indeed did not do so.

Therefore, HHS was required to provide the written justification and obtain the approval of your office before September 23, 2013, unless HHS’s head determined that the public interest warranted the use of non-competitive procedures, in which case, HHS’s head would have had to document the existence of such circumstances in writing and notify Congress accordingly, which does not seem to have occurred.

Accordingly, HHS was obligated to publish, within 14 days of contract award, both its written justification and your office’s approval on (1) FedBizOpps.gov[17] and (2) HHS’s website.[18]

To my knowledge, no written justification by HHS or approval by your office of the sole-source nature of the IOM Contract was published on FedBizOpps.gov or on HHS’s website to this date of the IOM Contract, much less within the required 14-day limit (by October 7, 2013). I have spent a considerable amount of time looking for both the justification and approval on FedBizOpps.gov and HHS’s website and wasn’t able to find either, so I am assuming neither was published on either site. If it is impossible for a member of the public, like myself, to find this information, then it is not public even if it were located somewhere on these websites, but buried in such a way to make it impossible to find.

Therefore, I have to assume that neither the justification nor the approval exist or has been published as required. This leads one to speculate that the written justification does not exist and/or that the required approval from your office was not obtained.

Procurement Notice on FedBizOpps.gov

According to CICA, HHS is also required to publish a procurement notice on FedBizOpps.gov announcing requests for proposals for contracts exceeding $25,000. The IOM Contract is for more $1 million. Notice on FedBizOpps of the solicitation for the IOM Contract was therefore required. Moreover, under CICA, HHS may not issue solicitations earlier than 15 days after the publication of the notice or establish a deadline for submission of bids or offers earlier than 30 days after issuance of the solicitation.[19]

Again, I was unable to locate any procurement notice for the IOM Contract on FedBizOpps.gov. The only notices that are published on FedBizOpps.gov regarding an HHS contract with the IOM on the diagnostic criteria for ME/CFS is the cancelled notice originally posted on August 27, 2013 and modified numerous times. However, as that notice was cancelled on September 4, 2013, it does not satisfy the CICA requirements for the IOM Contract. Moreover, even that cancelled sole-source solicitation did not comply with the federal lead-time requirements for sole-source solicitations. Although steps in an apparent attempt to remedy that situation were taken by repeated amendments/modifications to the initial solicitation notice, even these fell far short of the applicable 30-day requirement.

Ms. Griffin, it seems as if there has been a total disregard of the competition requirements for federal contracts by HHS in many respects regarding the IOM Contract, as laid out above. This is particularly astounding given (1) the availability of a superior alternative recommended by CFSAC and (2) the tremendous controversy surrounding the IOM Contract, which would lead one to expect that HHS would take extraordinary measures to ensure that it conduct all steps relating to the award of the IOM Contract in accordance with all applicable rules. These numerous potential violations of federal law appear to fall squarely within your jurisdiction.[20]

I therefore request that you investigate this matter as one of extreme importance and urgency—especially given the history of DHHS with ME/CFS— and provide a reply of your findings. As you may be aware, DHHS was investigated by the Office of the Inspector General as well as the Government Accountability Office in the 1990s and it was determined that the CDC misappropriated millions of congressionally mandated taxpayer money allocated to the research of ME/CFS. This prior malfeasance of DHHS with respect to ME/CFS mandates special attention to the current matter. Given this alarming history, it is imperative that my request for investigation be treated with the utmost urgency and seriousness. The IOM has begun with the ME/CFS study process and taxpayer money is spent on this potentially tainted federal contract every day. If you find violations of federal law in entering into the IOM Contract, as I believe you will, it is imperative that any further waste of taxpayer money is stopped immediately.

I would be pleased to respond to any questions you might have in this regard.

Sincerely,

Jeannette Burmeister

Attorney at Law

Attachments:

IOM Contract Statement of Work

My letter to Inspector General, Mr. Levinson, of November 11, 2013

My letter to Inspector General, Mr. Levinson, of November 16, 2013

Sole-source solicitation notice by HHS, August 27, 2013

Sole-source solicitation notice by HHS, August 29, 2013, 12:14pm

Sole-source solicitation notice by HHS, August 29, 2013, 2:16 pm

Sole-source solicitation notice by HHS, September 4, 2013, 11:09 am (Cancellation)

Sole-source solicitation notice by HHS, September 4, 2013, 4:12 pm (Cancellation)

CFSAC Listserv Message, September 3, 2013

USA Spending information regarding the IOM Contract

Forbes article, June 28, 2013

cc:

Barack Obama, President of the United States of America

Daniel R. Levinson, Inspector General, Office of Inspector General, U.S. Department of Health and Human Services

Adam Trzeciak, Inspector General, U.S. Government Accountability Office

Senator Harry Reid, Majority Leader in the U.S. Senate

Senator Tom Harkin, Chairman, Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Senator Jerry Moran, Ranking Member, Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Jack Kingston, Chairman, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Rosa DeLauro, Ranking Member, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Lucille Roybal-Allard, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Barbara Lee, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Mike Honda, California, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Secretary of Health and Human Services Kathleen Sebelius

[1]https://www.fbo.gov/index?s=opportunity&mode=form&id=fb67835096d2486592952c90cd3acee7&tab=core&_cview=0

[2]https://www.fbo.gov/index?s=opportunity&mode=form&tab=core&id=3686db9a0a968520e84a4b443bffdd1c&_cview=0

[3]https://www.fbo.gov/index?s=opportunity&mode=form&tab=core&id=7fafc35816ee932dc44d6c319937b366&_cview=0

[4]https://www.fbo.gov/index?s=opportunity&mode=form&tab=core&id=e8dcdf547b36edd9b51a36e1a16af35e&_cview=0

[5]https://www.fbo.gov/index?s=opportunity&mode=form&tab=core&id=dfb4054e6f31df6d3969feea989825b8&_cview=0

[6] 41 U.S.C. § 403(6).

[7] 10 U.S.C. § 2304(c) and 41 U.S.C. § 253(c).

[8] 10 U.S.C. § 2304(c) and 41 U.S.C. § 253(c).

[9]http://www.usaspending.gov/explore?fiscal_year=all&comingfrom=searchresults&idvpiid=HHSN263201200074I&piid=HHSN26300036&typeofview=complete#section

[10]http://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv-guidelines/2/introduction

[11]http://www.nih.gov/news/health/nov2013/oar-14.htm

[12] CFSAC Recommendations, October 3-4, 2012 meeting: http://www.hhs.gov/advcomcfs/recommendations/10032012.html

[13] 41 U.S.C. § 403(7).

[14]http://www8.nationalacademies.org/cp/projectview.aspx?key=49546

[15]http://www.forbes.com/sites/rebeccaruiz/2013/06/28/inside-the-effort-to-define-gulf-war-illness/ (attached)

[16] 10 U.S.C. § 2304(f)(5)(A) and 41 U.S.C. § 253(f)(5)(A).

[17] 48 C.F.R. §6.305(a)(1)

[18] 48 C.F.R. §6.305(a)(2)

[19] 14 U.S.C. § 416(a)(3).

[20] 48 C.F.R. §6.304(a)(2).

Posted in Uncategorized | Tagged Approval by Competition Advocate, CFS, CFSAC, Chronic Fatigue Syndrome, Chronic Multisymptom Illness, CICA, CMI, Competition in Contracting Act, Daniel Le, Deborah Griffn, DHHS, Dr. Kenneth Shine, FedBizOpps.gov, Federal acquisitions, Forbes, Full and open competition, Gulf War Illness, GWI, HHS Competition Advocate, Inspector General, Institute of Medicine, IOM, IOM Contract, Justification, ME, ME/CFS, ME/CFS Case Definition, ME/CFS Diagnostic Criteria, Myalgic Encephalomyelitis, Open-Competition Requirements, Procurement Notice, Responsible Source, Sole-Source Solicitation | 10 Comments

The CFSAC Plot Thickens: A Tone-Deaf, Disrespectful State of Affairs

Posted on November 24, 2013 by Jeannette Burmeister

The next CFSAC meeting, which was supposed to be held earlier this month, but got postponed to December, brings with it so many changes that one has to wonder: Is this the beginning of the end for CFSAC, maybe not an all-bad outcome? For years, the consensus has been—due to the ineffectiveness of the committee and the recent change in tone and infantilizing treatment of “inconvenient” committee members—that this committee has served no other purpose than to build a record for judgment day. But that’s an expensive record at about $230,000 of taxpayer money yearly.

The most concerning change is the format of the meeting. It went from being two full days of in-person meetings with an unlimited number of people able to watch on their computers at home to two half-day web meetings. People can “attend” either via phone or via the Internet. The web meeting, allowing people to watch the video-comment submissions, is limited to 500 web participants. When I say “web,” I really mean mostly audio, because “there will be no live video,” just some video comments from patients. According to Dr. Leonard Jason’s research, there are nearly 1 million Americans afflicted with this disease. So, only 0.05% of the patient population is allowed to participate in the “webinar.” Restricting the number of participants that much, does that even still qualify as a public meeting, as is required by federal law?

Here is the official reason we were given via the CFSAC listserv on September 12, 2013 for holding a web meeting instead of an in-person meeting: “Because of budget constraints and the government-wide Sequestration, federal advisory committees have been told to conduct at least some of their meetings as webinars or use other similar formats.” Ok, so it’s a financial issue. Ok, maybe. But even if other advisory committees have substituted their in-person meetings with webinars—something I would be extremely interested to hear about—whoever thought of saving money at this particular meeting at this pivotal time of this disease, which costs the taxpayer billions every year, seems to have either really bad judgment, no respect for patients or an agenda that we all can speculate about. Or maybe all of the above.

First off, at the last meeting, two brave committee members, Eileen Holderman and Dr. Mary Ann Fletcher stated on the record that they have been intimidated by the designated federal official, Dr. Nancy Lee, a very serious charge. An official investigation into the matter is under way. These charges were brought to light in the middle of the discussion of the case definition, which is at the center of the crucial IOM debate now. One can’t help but think that Dr. Lee’s trying to avoid another encounter with Eileen played a role in holding this particular meeting via the Internet. Eileen’s term is up in May of next year. This is her last CFSAC meeting as a committee member. It seems highly unlikely that this is a coincidence.

Secondly, and in the big scheme of things, more importantly, the IOM/HHS-contract issue—arguably the most important issue this disease population has ever faced— has been reaching its climax. Patients are as involved in the politics surrounding this disease as they have ever been. Am I the only one who feels that this was a convenient time to squash any potential big patient demonstrations surrounding an in-person meeting?

And why the change from two full-day to two half-day meetings? Clearly it’s not cost. There would be no significant additional costs associated with having a few more hours of web meeting on both days. Right at the time when so many patients have so much to say about the IOM contract, an issue, which by the way, got allotted a whooping 30 minutes on the agenda. These 30 minutes, by the way, are assigned to Dr. Lee alone; no committee-member discussion is planned, which is unfathomable given the likely grave outcome of the IOM Contract if not stopped. There is not even an attempt to pretend anymore, it seems.

The other big change seems to be the way of submitting public comments. In the past, one could submit written comments and still comment either via phone or in person. Now, when you go to the registration website, you get three choices in the pull-down menu to deliver public comments: by phone, in writing or via pre-recorded video (video instead of in-person due to the meeting being held over the web). It seems that there is no option of submitting written comments in addition to phone or video comments. This not insignificant change is disguised with the following comment: “You are no longer required to submit a written copy of your testimony as in past years unless you wish to have it included in the public record.” But what if I want to provide written comments in addition to phone or video comments?! After all, comments delivered over the phone do not become part of the official record of the meeting. Is this really an oversight?

Let’s give the government the benefit of the doubt for a second and assume that this is just a website-design error and the outcome was unintentional. How do we find out? Well, not from CFSAC: “[T]he CFSAC mailbox will not respond to questions about specific public comment requests. These requests and/or inquiries should be directed to CFSACDec2013@seamoncorporation.com.” That is exactly what I did. I sent an email to Seamon Corporation asking if this is an intentional change and if so, what the reasoning is. I am not holding my breath for a reply. For one thing, Seamon Corporation is unlikely to be privy to, or free to talk about, government policy as it relates to its advisory committees. But CFSAC itself will not answer any questions regarding public comments, just like Dr. Lee (CFSAC DFO) and Dr. Marschall (CFSAC Chair) never replied to my email inquiring about the authorship of the IOM FAQs. It’s a catch 22. That’s why I am bringing it up here.

Now, about the written or video comments. They are due this coming Friday, November 29, 2013, a day after Thanksgiving! Patients keep stressing how hard the holidays are for them—getting ready for them and recovering from them—due to this crippling disease. I guess HHS hasn’t listened to our narratives for the past 10 years, as we painstakingly described the hardships of even the pleasures of life, such as the holidays.

The other paradox is that people who submit a video or who wish to give comments over the phone will not be notified before December 4, 2013 whether they will get accommodated. Unfortunately, that is five days after the deadline for written comments. So, if your preference is to give comments over the phone or by video—as is mine—but you are concerned about receiving a time slot—as am I—you really have no other choice but to settle for written comments when you register—as did I. For the record, I would strongly prefer to provide written comments AND comments via phone or video, but I am NOT given that option by the registration website. And just like that, another way for patients to voice their opinions and concerns has been stripped from us without as much as the hint of an explanation.

Posted in Uncategorized | Tagged CFS, CFSAC, Chronic Fatigue Syndrome, December 2013 Meeting, Dr. Lee, Dr. Marshall, Dr. Mary Ann Fletcher, Eileen Holderman, ME, ME/CFS, Myalgic Encephalomyelitis, Public Comment, Seamon Corporation | 44 Comments

Supplemental Request for Investigation by OIG: Did DHHS Violate its No-Bid-Contract Requirements for IOM Contract?

Posted on November 17, 2013 by Jeannette Burmeister

[Updates:

2014/01/08: After OIG Dodges Charge of IOM’s Conflict of Interest, Meaningful Reply Demanded

2014/04/04: IOM-OCI-OIG … OMG!

2014/05/28: OIG Fails to Investigate IOM Conflict of Interest & Tells ME/CFS Patients to Buzz Off]

Today, I supplemented my request for investigation by the DHHS’s Office of Inspector General (OIG). My previous claim from earlier this week is that the IOM has a conflict of interest that disqualifies it from being engaged in the study of ME/CFS. My additional charge is that DHHS violated the open-competition requirements by awarding a no-bid contract to the IOM without satisfying any of the required exceptions for such award.

Special thanks goes to Leela Play for finding the reference to the DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents.

My plea to folks is not to bombard or drown the Inspector General with identical or additional, but not substantially different requests. This is not a letter-writing campaign. One request for investigation is as good as many. If we annoy the OIG, we will lose any good will we might have. There is no upside to it and it might jeopardize this effort. I appreciate everybody’s giving this project the space and respect it requires to be successful.

However, if you are able to follow up with members of Congress and the media regarding this investigation, that would indeed potentially be very helpful. Call them, meet with them, use social media …

Here is my letter to Mr. Levinson:

Dear Mr. Levinson:

I am writing to supplement my request contained in the above-referenced letter of November 11, 2013 to include additional claims regarding the recently concluded $1 million contract (“IOM Contract”) between the Department of Health and Human Services (“DHHS”) and the Institute of Medicine (“IOM”) to conduct a study on diagnostic criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS”) discussed in my prior letter. Specifically, I am claiming that the IOM Contract should be terminated for the additional reason that DHHS failed to follow applicable federal law and regulations and its own DHHS Project Contracting Officers’ Contracting Handbook (“DHHS Handbook”) in entering into the IOM Contract.

As indicated in Section II.D.1 of the DHHS Handbook entitled “Competition in Contracting”, “By Statute (10 USC.2304 and 41 USC.253 [now contained in 41 USC.3301 et. seq.]) and Regulation (FAR Part 6), ‘full and open’ competition is required with certain limited exceptions, and Contracting Officers shall promote and provide for full and open competition in soliciting offers and awarding Government contracts. ‘Full and open competition’ means that all responsible sources are permitted to compete (FAR 2.101).” (DHHS Handbook, p. II-5)

In the case of the IOM Contract, there was no full and open competition. In fact, there was no competition at all, through bids or otherwise, in the hurried and alarmingly secretive award of this contract to the IOM.

The Federal Acquisition Regulation (“FAR”) and the DHHS Handbook recognize that, in some contracts, it may not be possible or practical to have full and open competition and for those contracts, “Other Than Full and Open Competition” will suffice. According to Section II.D.1. of the DHHS Handbook, “Such situation are, however, a fall back choice and an exception to the usual requirement for full and open competition. As such, generally, they require a robust ‘Justification for the Other Than Full and Open Competition (JOFOC).’ The JOFOC, signed by the Contracting Officer or higher authority, if the acquisition is over $500,000, must demonstrate that the acquisition that it supports fits clearly into the description of one of the seven statutory/regulation exceptions[1] that permit other than full and open competition.” (DHHS Handbook, p. II-7)

In an FOIA request, I have asked for various documents, including both the IOM Contract and the JOFOC for the IOM Contract, but to date I have not received them. Assuming there is a JOFOC for the IOM Contract, which would appear to be required, presumably it relies on the first exception, namely “only one responsible source and no other supplier or services will satisfy agency requirements,” because none of the other exceptions seem potentially applicable.

For the reasons discussed below, I do not believe the IOM Contract satisfies this exception. First of all, in assessing whether there is only one responsible source and no other supplier or services that would satisfy the agency’s needs, DHHS does not seem to have taken into account the following entirely responsible, reasonable and much less expensive alternative recommended by the Chronic Fatigue Syndrome Advisory Committee (“CFSAC”) to Secretary Sebelius at its October 2012 meeting:

“CFSAC recommends that you will promptly convene (by 12/31/12) or as soon as possible thereafter) at least one stakeholders’ Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS) experts, patients, advocates workshop in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition for discussion purposes.”[2] This approach is strongly favored not only by CFSAC, but also by virtually all U.S. and a significant number of international ME/CFS experts in their open letter to Secretary Sebelius of October 25, 2013,[3] an overwhelming majority of patient advocates in their open letter to Secretary Sebelius of November 9, 2013[4] and the vast majority of patients.

There is an apt example of this type of approach that demonstrates quite clearly that the IOM contract was not the only responsible source or supplier for DHHS’ need to develop new diagnostic criteria for ME/CFS.

DHHS established a Panel on Antiretroviral Guidelines for Adults and Adolescents (“Panel), a working group of the NIH Office of AIDS Research Advisory Council (“OARAC”). OARAC advises the Secretary of Health and Human Services. The Panel is charged with regular updates on HIV treatment guidelines for HIV-care practitioners based on advances in HIV therapy. The Panel reviews new evidence and updates recommendations when needed. These guidelines generally represent the state of knowledge regarding the use of antiretroviral agents and serve as the standard of medical care for treating HIV-infected patients in the United States. Recommendations in these guidelines are based upon scientific evidence and expert opinion.[5] The Panel consists of HIV/AIDS researchers and clinicians, representatives from various DHHS agencies and HIV/AIDs community representatives.[6] It does not involve the IOM, which has no expertise in the matter.

Given the broad consensus among ME/CFS experts, an ad hoc panel of ME/CFS experts, DHHS representatives and ME/CFS patient representatives could relatively easily and expeditiously approve diagnostic criteria for ME/CFS to replace the outdated and discredited Fukuda definition without the delays, expense and conflict-of-interest represented by the IOM Contract. This, unlike the IOM Contract, would be in line with the October 2012 CFSAC recommendation to hold a case-definition workshop.

Moreover, the IOM itself acknowledges that it is not experienced in developing case definitions or diagnostic criteria for particular diseases. In fact, according to Dr. Kenneth Shine, former president of IOM and chair of the current IOM committee tasked with the development of a case definition for Chronic Multisymptom Illness”[7] (formerly Gulf War Illness), developing disease definitions is such “a unique task” for the IOM that that Dr. Shine “could not recall when the IOM was last charged with defining a disease.” [8]

So not only is the IOM not the only responsible source or supplier for DHHS, it is actually not even one of the responsible sources or suppliers because it is, by its own admission, not qualified to conduct the ME/CFS study. DHHS violated the open-competition requirements by awarding a no-bid contract to the IOM without satisfying any of the required exceptions for such award.

Mr. Levinson, this matter warrants the immediate attention by your office given the history of DHHS with ME/CFS. As you might remember, DHHS was investigated by your predecessor, June Brown, as well as the Government Accountability Office in the 1990s and it was determined that the CDC misappropriated millions of congressionally mandated taxpayer money allocated to the research of ME/CFS. This prior malfeasance of DHHS with respect to ME/CFS merits special attention to the current matter. Given this alarming history, it is imperative that my request for investigation be treated with the utmost urgency and seriousness.

Should scarce taxpayer money be wasted again on a tainted DHHS contract, I can assure you that, this time, the ME/CFS community would be eager to take legal action against DHHS for misuse of taxpayer dollars as well as to revisit the misuse of funds by the CDC in the 1990s. Patients are much more educated, better organized, well connected—to each other and to influential members of society—and financially more robust these days. The patient community raised almost $40,000 in just 3 days and over 160,000 in just a few weeks for a documentary about the disease, “Canary in a Coal Mine.” Imagine the outpouring of financial support for widely called-for legal action. In addition, several attorneys have indicated a willingness to assist, on a pro-bono basis, with legal action on behalf of the ME/CFS patient community.

For the reasons set forth in my original letter of November 11, 2013, and supplemented herein, I specifically request that you investigate the IOM Contract and reach a determination that it should be immediately terminated due to (1) the organizational conflicts of interest of the IOM and (2) the failure of DHHS to comply with the open-competition requirements of federal law and regulations and the DHHS Handbook.

Sincerely,

Jeannette Burmeister

Attorney at Law

cc:

Barack Obama, President of the United States of America

Adam Trzeciak, Inspector General, U.S. Government Accountability Office

Senator Harry Reid, Majority Leader in the U.S. Senate

Senator Tom Harkin, Chairman, Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Senator Jerry Moran, Ranking Member, Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Jack Kingston, Chairman, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Rosa DeLauro, Ranking Member, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Lucille Roybal-Allard, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Barbara Lee, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Mike Honda, California, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Secretary of Health and Human Services Kathleen Sebelius

[1] The seven exceptions are:

(1) Only one responsible source and no other supplies or services will satisfy agency requirements;

(2) The agency’s need is of such an unusual and compelling urgency that the Government would be seriously injured unless the agency is permitted to limit the number of sources solicited;

(3) Industrial mobilization; engineering, developmental, or research capability; expert services;

(4) An international agreement or treaty between the United States and a foreign government or international organization;

(5) A Federal statute authorizes or requires acquisition through certain sources (e.g., Federal Prison Industries, Qualified Nonprofit Agencies for the Blind or other Severely Disabled, Small Business Act, Section 8(a) non-competitive, HUBZone non-competitive, the Robert T. Stafford Disaster Relief and Emergency Assistance Act);

(6) Disclosure of the agency’s needs would compromise the national security unless the number of solicited sources is limited;

(7) An agency head determines that it is not in the public interest to have full and open competition—this determination must be made by the Secretary, who must notify Congress 30 days before contract award.

(DHHS Handbook, pages II-7 and II-8)

[2]CFSAC Recommendations, October 3-4, 2012 meeting: http://www.hhs.gov/advcomcfs/recommendations/10032012.html

[3]https://dl.dropboxusercontent.com/u/89158245/Case%20Definition%20Letter%20final%2010-25-13.pdf (attached to my letter of November 11, 2013)

[4] Advocates’ Letter (attached to my letter of November 11, 2013)

[5]http://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv-guidelines/2/introduction

[6]http://www.nih.gov/news/health/nov2013/oar-14.htm

[7]http://www8.nationalacademies.org/cp/projectview.aspx?key=49546

[8]http://www.forbes.com/sites/rebeccaruiz/2013/06/28/inside-the-effort-to-define-gulf-war-illness/

Posted in Uncategorized | Tagged CFS, CFSAC, Chronic Fatigue Syndrome, DHHS, DHHS Handbook, Dr. Kenneth Shine, FAR, Inspector General, Investigation, IOM Contract, JOFOC, ME, ME/CFS, Mr. Daniel Levinson, Myalgic Encephalomyelitis, No-Bid Contract, Secretary Sebelius, Violation of open-competition requirements | 26 Comments

Inquiring Minds Want to Know: Who is Behind the IOM FAQs?

Posted on November 16, 2013 by Jeannette Burmeister

Today, somewhat mysterious—and maybe (based on the quality and the formatting) hastily drafted—FAQs regarding the IOM contract (“FAQs”) appeared on the Internet. I say mysterious because the authorship of these FAQs is unclear. Is this statement an official pronouncement of CFSAC or did it originate with HHS? Maybe Wanda Jones finally delivered her statement relating to the IOM contract, as promised by PANDORA. We don’t know. Here is the chain of events:

At 1:32 pm Pacific time, I and others received a message containing the FAQs from the CFSAC mailbox (CFSAC@hhs.gov) sent to the CFSAC listserv. The message will be reproduced in its entirety at the end of this post.

There is no signature under the FAQs and no introduction in the listserv message telling us who wrote them. The use of the words “we” and “us” in the FAQs frankly seems to be referring to HHS, not CFSAC. Furthermore, it would seem inconsistent with CFSAC’s charter, which states its objectives and scope of activities as “provid[ing advice and recommendations to the Secretary of Health and Human Services (HHS),” to make public announcements such as the FAQs. Finally, it seems unlikely that CFSAC would have voted to endorse these FAQs, given the obvious bias of the FAQs in favor of the IOM contract and the diversity of opinion among CFSAC members. That in turn causes me to wonder if the FAQs are an HHS document that was merely forwarded by CFSAC through its listserv as a public service without approval or endorsement. At 1:56pm Pacific time (24 minutes after receiving the listserv announcement), I sent an email to Dr. Nancy Lee (Federal Designated Official of CFSAC) and Dr. Gailen Marshall (CFSAC chair) asking for clarification of the open-authorship question of the FAQs. I have not received a reply yet and am therefore now wondering out loud.

The CAA, on the other hand, purports to have the inside scoop on where the FAQs originally came from. At 12:55pm Pacific time (before the listserv message went out!), a link to the CAA’s website with the FAQs was posted on the CAA’s FB with the following comment: “After much controversy and a long silence, the CFSAC has finally released answers to many questions about the IOM contract concerning clinical diagnostic criteria development.” Using the phrase “the CFSAC” instead of plain “CFSAC” seems to suggest that a Washington outsider or newcomer wrote this comment, maybe Carol Head, new CEO of the CAA. Who knows.

The use of the word “release” is vague enough. The title of the CAA website post, however, “CFSAC Responds to Questions Concerning the Contract with the IOM” leaves no room for doubt that the CAA is claiming that CFSAC is the author of the FAQs. Furthermore, the intro to the FAQs on the CAA’s website reads, “Because so many have expressed concerns, we contacted the CFSAC [again, “the”] urging them to respond to a myriad of questions. Below is their FAQ that was released to the full listserv and posted to their website today.” (Emphasis added)

So, the CAA is stating, as a fact, that these FAQs originate with CFSAC. Even if true, which is entirely possible, I question why the CAA would have such insider knowledge. And if they don’t, it would seem highly inappropriate for the CAA to make the misleading statement of fact they did.

Amusingly, both the CAA and PANDROA seem to want to take credit for the government’s release of the FAQs because PANDORA stated on its Facebook page today that the “FAQ […] addresses most of the questions we asked.”

Be that as it may, if the FAQs were not approved by CFSAC—and that does seem questionable based on the FAQs’ language , CFSAC’s charter and the CFSAC’s members’ diversity in opinion—then the listserv message is highly misleading and should be amended as soon as possible to (1) accurately reflect the authorship of the FAQs, (2) indicate that the posting on the CFSAC website is merely a public service and (3) clarify the fact that CFSAC has not formally endorsed or approved the FAQs in an way.

There is much to say about the content of the FAQs as well:

1. The FAQs state, “The IOM process of developing consensus recommendations is widely accepted by professional societies and other medical institutions that disseminate clinical guidelines.”

This is directly contrary to Dr. Kenneth Shine’s, former IOM president, statement that developing disease definitions is “a unique task” for the IOM. So unique, in fact, that Shine “could not recall when the IOM was last charged with defining a disease,” according to Forbes article from June of this year.

2. The FAQs didn’t even get the date of the open expert letter to Sebelius right. The original date is indeed September 2013, as stated in the FAQs. But this letter was updated in October with additional signatures, something that the author of the FAQs surely knows. Or does (s)he? Or does (s)he not want other to know? The open advocates’ letter wasn’t mentioned at all.

3. The FAQs also state that “[h]aving the right expertise is not sufficient for success.”

This may be why the IOM—according to an email that patient Ms. Pante is reporting to have received from Ms. Kate Meck, Associate Program Officer at the IOM, on November 8, 201— is planning on including in the ME/CFS committee “those who are less familiar with the disease, but capable of objectively approaching and understanding the scientific evidence and experiences of the ME/CFS experts and the patient community.” The rationale reportedly given to Ms. Pante by Ms. Meck that “[u]ltimately, the diagnostic criteria recommended by the committee will be used by physicians/clinicians with and without experience in ME/CFS, so the participation of committee members from both perspectives is very important” is, of course, both preposterous and frightening.

4. One has to wonder how familiar the author of the FAQs is with the IOM issue given that (s)he refers to a “Statement of Task” in the FAQs when the document is actually entitled “Statement of Work.” One is beginning to ponder how big of an effort was made to have the FAQs drafted by somebody who is up to speed on the IOM-contract issue.

5. Finally, the often-heard disingenuous argument that “HHS has a legally binding agreement with the IOM” and that “[t]here is no way for HHS to recover or repurpose those funds.” Contracts 101: All contracts are legally binding. If they are not, they are not contracts. The issue is on what basis may they be terminated.

As Lois Ventura has pointed out, government contracts are generally required to contain a termination-for-convenience clause. If the government were to terminate the IOM contract, as it clearly should, it would be on the hook only for the expenses the IOM has already incurred, such as Ms. Meck’s past salary and maybe for a bit extra for IOM’s trouble and to smooth things over. Not a whole lot of money at this point. The exact amount would most likely be determined by a settlement agreement. Moreover, since the IOM clearly has a conflict of interest as laid out in my request for investigation to Inspector General, Mr. Levinson, the government may even determine that recovery of all funds paid under the IOM contract is appropriate.

Here is the listserv message:

“Below you will find the answers to some frequently asked questions (FAQs) regarding the IOM study. They will be posted on the CFSAC website soon.

FAQs on an HHS contract with the IOM

to recommend clinical diagnostic criteria for ME/CFS

Who is the target audience for the Institute of Medicine (IOM) study?

The target audience is primary care clinicians (which include physicians, nurse practitioners, and physician assistants) throughout the US. Too many providers are unaware how to diagnose myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Patients often tell us that they consult with many clinical providers before finally getting a diagnosis.

Why did the Department of Health and Human Services (HHS) not follow the Chronic Fatigue Syndrome Advisory Committee (CFSAC) recommendation to host a workshop in consultation with CFSAC and ME/CFS experts, but instead contracted with the IOM to do a study?

HHS relies on professional societies and medical institutions such as academic centers and the IOM to develop clinical guidelines and recommendations. The IOM has a singular reputation for providing biomedical recommendations on difficult, complex and controversial questions in medicine. It routinely brings together scientific experts, patients, and other stakeholders to develop recommendations.

As public health professionals, we have many years of experience in disseminating health information to clinical providers in the US. Such an effort takes partnerships with medical professional societies that rely on up-to-date scientific evidence to guide the information that they disseminate. The IOM process of developing consensus recommendations is widely accepted by professional societies and other medical institutions that disseminate clinical guidelines.

We believe that widely accepted clinical diagnostic criteria and a clear distinction from case definitions used for research and disease surveillance will aid in advancing clinical care, drug development, and basic research for ME/CFS.

Importantly, as a direct result of the CFSAC recommendation, HHS’ contract with the IOM requires it to host public meetings and to include in the expert advisory committee ME/CFS experts (which could include members of CFSAC). HHS also provided the IOM with a copy of a September 2013 letter to Secretary Sebelius from ME/CFS experts urging adoption of the 2003 Canadian Consensus Criteria, to inform it of experts who may be appropriate for the committee.

Can HHS, and all associated agencies, endorse the 2003 Canadian Consensus Criteria based on the recommendation of ME/CFS experts, patients and the International Association of CFS/ME? If not, why not?

HHS often helps disseminate clinical recommendations made by nongovernmental groups, but does not generally make formal endorsements of these guidelines. Additionally, the 2003 Canadian Consensus Criteria (CCC) do not account for scientific evidence developed since 2003. In order to ensure that the IOM considers all relevant information, HHS has requested specifically that the IOM consider the 2003 CCC in its review and deliberation, in addition to other clinical criteria for ME/CFS and recent scientific evidence.

What is the standard process that the IOM uses to develop its recommendations?

From the IOM’s website:

The IOM applies the National Academies’ rigorous research process, aimed at providing objective and straightforward answers to difficult questions of national importance. Our consensus studies are conducted by committees carefully composed to ensure the requisite expertise and to avoid conflicts of interest.

The committee’s task is developed in collaboration with the study’s sponsor, which may be a government agency, a foundation, or an independent organization. However, once the statement of task and budget are finalized, the committee works independently to come to consensus on the questions raised. In fact, while committees may gather information from many sources in public meetings, they carry out their deliberations in private in order to avoid any external influence.

As a final check for quality and objectivity, all IOM reports undergo an independent external review by a second, independent group of experts whose comments are provided anonymously to the committee members.

… The Institute of Medicine is exempt from the Federal Advisory Committee Act except for Section 15 of that law. Applied under this section, this law governs the interactions between sponsors and the National Academies, and especially describes the public release of information concerning the study activities and results. …

In accordance with federal law and with few exceptions, information-gathering meetings of IOM committees are open to the public, and any written materials provided to the committee by individuals who are not officials, agents, or employees of the National Academies are maintained in a public access file that is available for examination.

IOM committees deliberate in meetings closed to the public in order to develop draft findings and recommendations free from outside influences. The public is provided with brief summaries of these meetings that include the list of committee members present. All analyses and drafts of the report remain confidential.

Further information can be found here.

What criteria does IOM use for selection of committee members?

From the IOM’s website:

Careful steps are taken to convene committees that meet the following criteria:

An appropriate range of expertise for the task. The committee must include experts with the specific expertise and experience needed to address the study’s statement of task. One of the strengths of the National Academies is the tradition of bringing together recognized experts from diverse disciplines and backgrounds who might not otherwise collaborate. These diverse groups are encouraged to conceive new ways of thinking about a problem.
A balance of perspectives. Having the right expertise is not sufficient for success. It is also essential to evaluate the overall composition of the committee in terms of different experiences and perspectives. The goal is to ensure that the relevant points of view are, in the National Academies’ judgment, reasonably balanced so that the committee can carry out its charge objectively and credibly.
Screened for conflicts of interest. All provisional committee members are screened in writing and in a confidential group discussion about possible conflicts of interest. For this purpose, a “conflict of interest” means any financial or other interest which conflicts with the service of the individual because it could significantly impair the individual’s objectivity or could create an unfair competitive advantage for any person or organization. The term “conflict of interest” means something more than individual bias. There must be an interest, ordinarily financial, that could be directly affected by the work of the committee. Except for those rare situations in which the National Academies determine that a conflict of interest is unavoidable and promptly and publicly disclose the conflict of interest, no individual can be appointed to serve (or continue to serve) on a committee of the institution used in the development of reports if the individual has a conflict of interest that is relevant to the functions to be performed.
Point of View is different from Conflict of Interest. A point of view or bias is not necessarily a conflict of interest. Committee members are expected to have points of view, and the National Academies attempt to balance these points of view in a way deemed appropriate for the task. Committee members are asked to consider respectfully the viewpoints of other members, to reflect their own views rather than be a representative of any organization, and to base their scientific findings and conclusions on the evidence. Each committee member has the right to issue a dissenting opinion to the report if he or she disagrees with the consensus of the other members.
Other considerations. Membership in the National Academy of Sciences, National Academy of Engineering, or IOM and previous involvement in National Academies studies are taken into account in committee selection. The inclusion of women, minorities, and young professionals are additional considerations.

Does the HHS contract with the IOM specifically require the IOM to use ME/CFS experts as committee members?

Yes.

Does the contract require the IOM to include a patient as a committee member?

No. The contract does require that input be sought from patients, family members, and other caregivers during public meetings.

How can patients, family members and other advocates provide input into the IOM study process?

The IOM has set up a listserv and website to keep stakeholders informed about the progress of the committee and opportunities for input. Interested individuals can register for the listserv at this link.

What is the Statement of Task in this contract with the IOM?

From the contract:

An Institute of Medicine (IOM) committee will comprehensively evaluate the current criteria for the diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The committee will consider the various existing definitions and recommend clinical diagnostic criteria for the disorder to address the needs of health providers, patients and their caregivers.

The Committee will also distinguish between disease subgroups, develop a plan for updating the new criteria, and make recommendations for its implementation. Any recommendations made by the committee will consider unique diagnostic issues facing people with ME/CFS, specifically related to: gender, across the lifespan, and specific subgroups with substantial disability.

Specifically the Institute of Medicine (IOM) will:

Conduct a study to identify the evidence for various diagnostic clinical criteria of

ME/CFS using a process with stakeholder input, including practicing clinicians and patients;

Develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians, using a consensus-building methodology;
Recommend whether new terminology for ME/CFS should be adopted;
Develop an outreach strategy to disseminate the definition nationwide to health professionals.

Over the 18 months, the committee will consider 4 topic areas and produce a consensus report with recommendations. The recommendations will have a domestic focus; however, major international issues may be identified. As the committee reviews the literature, efforts that have already been completed on this topic area will be considered, including the 2003 ME/CFS Canadian Consensus Definition, the 2007 NICE Clinical Guidelines for CFS/ME, the 2010 Revised Canadian ME/CFS definition, the 2011 ME International Consensus Criteria, and data from the ongoing CDC Multi-site Clinical study of CFS. In an effort to minimize overlap and maximize synergy, the committee will seek input from the NIH Evidence-based Methodology Workshop for ME/CFS.

Will the IOM study address treatment for ME/CFS?

No. The Statement of Task does not ask the IOM to develop recommendations about treatment of ME/CFS nor to develop a research agenda for ME/CFS.

What is the total cost of the IOM contract?

One million dollars were obligated for this IOM contract. Almost all of the agencies that have efforts involving ME/CFS contributed Fiscal Year (FY) 2013 funds to this study.

If the IOM contract is cancelled, will the contract funds go to ME/CFS research?

HHS has a legally binding agreement with the IOM and has committed FY2013 funds to this study. There is no way for HHS to recover or repurpose these funds.

What is the difference between the IOM committee charge and the NIH Evidence-based Methodology Workshop for ME/CFS?

According to NIH:

The expected outcome from the Evidence-based Methodology Workshop for ME/CFS is to identify research gaps in ME/CFS, identify methodological and scientific weaknesses in the ME/CFS field, suggest research needs that will advance the ME/CFS field, and move the field forward through an unbiased, evidence-based assessment of this complex public health issue.

According to the HHS contract with the IOM:

The Institute of Medicine (IOM) will:

Conduct a study to identify the evidence for various diagnostic clinical criteria of ME/CFS using a process with stakeholder input, including practicing clinicians and patients;
Develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians, using a consensus-building methodology;
Recommend whether new terminology for ME/CFS should be adopted;
Develop an outreach strategy to disseminate the definition nationwide to health professionals.

________________________________________________________

The CFSAC Support Team

http://www.hhs.gov/advcomcfs/index.html

Sign up for the CFSAC listserv to receive the latest updates about CFSAC:

http://www.hhs.gov/advcomcfs/cfsac_email_list.html

Learn more about the Health Insurance Marketplace at HealthCare.gov!

To unsubscribe from the CFSAC-L list, click the following link:
http://list.nih.gov/cgi-bin/wa.exe?SUBED1=CFSAC-L&A=1“

Posted in Uncategorized | Tagged CAA, CFIDS, CFS, CFSAC, CFSAC Charter, CFSAC listserv, Chronic Fatigue Syndrome, Conflict of Interest, Daniel Levinson, Dr. Kenneth Shine, FAQs, HHS, Inspector General, IOM Contract, Kate Meck, ME, ME/CFS, ME/CFS Diagnostic Criteria, Myalgic Encephalomyelitis, PANDORA, Request to Investigate Conflict of Interest, Sebelius, Termination for Convenience | 6 Comments

Call for Investigation by the Inspector General of the IOM’s Conflict of Interest With Respect to ME/CFS

Posted on November 11, 2013 by Jeannette Burmeister

[Updates:

2013/11/17: Supplemental Request for Investigation by OIG: Did DHHS Violate its No-Bid-Contract Requirements for IOM Contract?

2014/01/08: After OIG Dodges Charge of IOM’s Conflict of Interest, Meaningful Reply Demanded

2014/04/04: IOM-OCI-OIG … OMG!

2014/05/28: OIG Fails to Investigate IOM Conflict of Interest & Tells ME/CFS Patients to Buzz Off]

To use a poker analogy, I see your argument, PANDORA and a few others, that all ME/CFS experts who signed the open experts’ letter of October 25, 2013 are biased—merely due to signing that letter—and cannot, as a result, serve on the IOM ME/CFS committee and I raise you the claim that the IOM as an institution has a conflict of interest and bias—based on its report on Chronic Multisymptom Illness from earlier this year—that cannot be remedied and that clearly disqualifies the IOM from being engaged in the study of ME/CFS.

Today, I sent the following letter to Mr. Daniel R. Levinson Inspector General at the Office of Inspector General, U.S. Department of Health and Human Services calling for an investigation by the Inspector General of the IOM’s conflict of interest:

Jeannette K. Burmeister

[street]

[town, state, zip code]

[email address]

[phone number]

November 11, 2013

Via Registered Mail and [Email]

Daniel R. Levinson

Inspector General

Office of Inspector General, U.S. Department of Health and Human Services

[town, state, zip code]

Re: Conflict of Interest of the Institute of Medicine With Respect to Its Contract with DHHS Regarding ME/CFS

Dear Mr. Levinson,

I respectfully request your review of a serious conflict of interest in a recently concluded $1 million contract (“IOM Contract”) between the Department of Health and Human Services (“DHHS”) and the Institute of Medicine (“IOM”) to conduct a study on diagnostic criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS”).

I am a patient who has suffered from this disease since 2006.

The IOM Contract was announced on September 23, 2013. It was entered into on a rushed and alarmingly secretive basis despite a deafening outcry by the patient community against it. The IOM Contract has so far not been terminated despite the agreement of virtually all U.S. and a fair number of international ME/CFS experts to adopt the 2003 Canadian Consensus Criteria (“CCC”) as the case definition (or diagnostic criteria) for ME/CFS and the opposition to the IOM Contract by these experts (both also on September 23, 2013) and by over 170 representatives of the patient advocacy community (on November 9, 2013). The experts’ consensus negates the need for the IOM Contract and the waste of $1 million in taxpayer money. Nevertheless, Secretary Sebelius has, to this date, not had the courtesy to reply to the experts and advocates. To the contrary, the IOM Contract is being pushed through at an unprecedented speed.

The Federal Acquisition Regulations, an in particular 48 C.F.R. section 9.504, require the [government] contracting officer “to

(1) Identify and evaluate potential organizational conflicts of interests as early in the acquisition process as possible; and

(2) Avoid, neutralize, or mitigate significant potential conflicts of interest before contract award.”

48 C.F.R. section 9.505 sets up the underlying principles in avoiding or mitigating organizational conflicts of interests, including “preventing the existence of conflicting roles that might bias a contractor’s judgment.”

In this case, the IOM has clearly and unabashedly demonstrated its bias relating to the ME/CFS diagnostic criteria. It did so just earlier this year in its report on Chronic Multisymptom Illness (Gulf War and Health: Treatment for Chronic Multisymptom Illness (“CMI Report”)).

Just to give a few examples, the CMI Report unconditionally accepts antidepressants (page 119) as well as cognitive-behavioral therapy and graded-exercise therapy (page 99) as recommended treatments for ME/CFS even though these “treatments” are viewed by most if not all credible experts as not just unhelpful, but potentially quite harmful for most ME/CFS patients. Exercise is said, in the CMI Report, to have been shown to improve ME/CFS symptoms (page 99) when the potential harm of exercise to ME/CFS patients has been clearly established. At best, if you take into account “research” that has not followed the scientific method, this form of “treatment” is controversial, with most experts agreeing that it is harmful. But it is definitely not a “treatment” recommended by credible ME/CFS experts. This ties directly into the diagnostic criteria for ME/CFS because exercise triggers a post-exertional worsening of symptoms—the hallmark feature of ME/CFS—which is why it is even part of the current woefully inadequate 1994 CDC Fukuda case definition. The CMI Report also opines that there are no biomarkers for ME/CFS (page 203) when the IOM-contract study is to determine whether there are biomarkers and what they are. Furthermore, the CMI Report opines that ME/CFS is not “an organic disease” (page 22).

Throughout the CMI Report, the IOM references ME/CFS and, in particular, its case definition, symptoms and treatment modalities. These are all used as critical building blocks in reaching the IOM’s conclusion regarding treatment of Chronic Multisymptom Illness. The case definition and symptoms and possibly treatments of ME/CFS are at the heart of the IOM Contract. The conflict here is obvious. The IOM is wedded to the CMI Report’s conclusions from just earlier this year that is based in part on its assumptions and conclusions about ME/CFS. That represents a substantial bias in favor of not contradicting its prior assumptions and findings and prejudices the IOM against adopting findings that are inconsistent with the CMI Report.

When you furthermore take into account the tremendous backlash the CMI Report has triggered in the Gulf-War-Illness population, including congressional hearings and serious accusations of the CMI Report being tainted due to an undue influence on the report by the Department of Veterans Affairs, it becomes even more obvious that the IOM cannot afford to backtrack on any of its findings in the CMI Report regarding ME/CFS because the CMI Report rests largely on those.

In a much less significant conflict situation, your office has determined that a conflict of interest exists if a member of an IOM committee under a DHHS/IOM contract has previously stated a position on the issues to be analyzed under the contract (Memorandum dated January 3, 1992 from Richard P. Kusserow, Inspector General, to James O. Mason, Assistant Secretary of Health, regarding the “Review of Alleged Conflict-of-Interest in Institute of Medicine Study of the Adverse Consequences of Pertussis and Rubella Vaccines (A-15-90-00054) and attachments). In that case, the contract with the IOM was to study the adverse consequences of the Pertussis and Rubella vaccine. The committee member in question had stated his position on this issue in a deposition.

If a position on the contract issues stated in a deposition creates a conflict of interest for an IOM committee member, then surely when the organization itself, the IOM, has publicly stated such a biased position in an official report, the entire organization is unavoidably tainted by a conflict of interest.

The IOM might argue that their prior position regarding ME/CFS does not represent an organizational conflict of interest because the CMI Report was authored by a committee convened specifically for that report. That argument is not tenable because the CMI Report expressly states that the IOM along with the IOM committee assumes entirely all responsibility for the content of the CMI Report (page vii of the CMI Report). It cannot escape responsibility for statements by an IOM committee that the IOM, as an organization, has fully and unconditionally endorsed.

This bias towards the nature of ME/CFS creates an organizational conflict of interest that cannot be remedied and that clearly disqualifies the IOM from being engaged in the study of ME/CFS. The positions on ME/CFS previously stated by the IOM pre-judges any IOM conclusions at the very heart of the IOM Contract.

I specifically request that your office investigate this serious conflict of interest as soon as possible, so that government funds will not be unnecessarily expended on an unavoidably tainted contract.

I would be pleased to respond to any questions you may have.

Sincerely,

Jeannette K. Burmeister

Enclosures:

Open Letter to Secretary Sebelius by 50 ME/CFS Experts of October 25, 2013

Open Letter to Secretary Sebelius by ME/CFS Advocates of November 9, 2013

Memorandum dated January 3, 1992 from Richard P. Kusserow, Inspector General, to James O. Mason, Assistant Secretary of Health regarding the “Review of Alleged Conflict-of-Interest in Institute of Medicine Study of the Adverse Consequences of Pertussis and Rubella Vaccines (A-15-90-00054) and attachments

cc:

Senator Harry Reid, Majority Leader in the U.S. Senate

Senator Tom Harkin, Chairman, Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Senator Jerry Moran, Ranking Member, Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Jack Kingston, Chairman, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Rosa DeLauro, Ranking Member, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Lucille Roybal-Allard, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Barbara Lee, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Mike Honda, California, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Adam Trzeciak, Inspector General, U.S. Government Accountability Office

Secretary of Health and Human Services Kathleen Sebelius

Posted in Uncategorized | Tagged 2013, 48 C.F.R. section 9.504, 48 C.F.R. section 9.505, Bias, Case Definition, CFS, Chronic Fatigue Syndrome, Chronic Multisymptom Illness, CMI, Conflict of Interest, DHHS, Diagnostic Criteria ME/CFS, Gulf War Illness, GWI, Inspector General, Investigation, IOM, IOM CMI Report, IOM Contract, ME, ME/CFS, Mr. Daniel Levinson, Myalgic Encephalomyelitis, Open Advocates' Letter November 9, Open Experts' Letter October 25, organizational conflict of interest, Secretary Sebelius, \ | 47 Comments

Overwhelming, Growing Support of ME Experts by Advocates in Opposition to IOM Contract: Advocates’ Open Letter Re-Sent With Additional Signatures

Posted on November 9, 2013 by Jeannette Burmeister

As was the case with the experts’ open letter to Secretary Sebelius—which was first published on September 23, 2013 and then updated on October 25, 2013—the October 28, 2013 advocates’ letter now has been updated with additional signatures and re-sent to Secretary Sebelius and other government officials.

An additional 105 active U.S. and international advocates signed on to support our experts, for a total of 171 active advocates. No signatures were withdrawn from the original version of the letter.

This is an overwhelming show of support by advocates for our experts. With virtually no exceptions, the only prominent advocates who declined to sign the letter were several journalists (who could not participate for professional reasons), the current leaders of the CFIDS Association of America (CAA) and of PANDORA, and a few other individuals with particularly close connections to those two organizations.

Here is a link to the updated advocates’ letter, sent to Sebelius and other officials, including the president of the Institute of Medicine (IOM) today. Note: If you get a black screen when you go to the link, just press “Download” and you will be able to read the letter.

The body of the updated letter from advocates that was sent earlier today can be found at the end of this post. For a complete copy of the letter, including all signatures, please click on the link or attachment above.

This updated version of the advocates’ letter contains no revisions to the text of the original advocates’ letter. In addition to the added signatures, it includes some additional recipients (including members of the Congressional subcommittee that oversees financial spending by the Department of Health and Human Services, the DHHS Inspector General, and the Inspector General in the U.S. Government Accountability Office).

To maximize the impact of this unprecedented coming together of advocates worldwide, please help spread the word by sharing the letter on Facebook, on your blog, in emails and, most importantly, on your Twitter feed.

An important goal at this point is to draw government officials’ attention to the letters sent by the experts and the advocates, and in general to let these people know that our community is very involved in this issue.

Unfortunately, this disease makes it difficult to arrange a March on Washington to demonstrate our concern. However, since many influential officials (including Secretary Sebelius) maintain an active presence on Twitter, the next step in this effort is to use that forum to make sure that they know that many people care about this issue.

Please copy and paste the following tweets and tweet them on Twitter today—and then again every day until this situation is resolved to our satisfaction!

@Sebelius Overwhelming, growing # of #MECFS advocates united behind 50 experts & against $1M #IOMContract waste [link]

@JackKingston Overwhelming, growing # of #MECFS advocates united behind 50 experts & against $1M #IOMContract waste [link]

@rosadelauro Overwhelming, growing # of #MECFS advocates united behind 50 experts & against $1M #IOMContract waste [link]

@RepRoybalAllard Overwhelming, growing # of #MECFS advocates united w/ 50 experts & against $1M #IOMContract waste [link]

@RepBarbaraLee Overwhelming, growing # of #MECFS advocates united behind 50 experts & against $1M #IOMContract waste [link]

@RepMikeHonda Overwhelming, growing # of #MECFS advocates united behind 50 experts & against $1M #IOMContract waste [link]

@SenatorHarkin Overwhelming, growing # of #MECFS advocates united behind 50 experts & against $1M #IOMContract waste [link]

@JerryMoran Overwhelming, growing # of #MECFS advocates united behind 50 experts & against $1M #IOMContract waste [link]

@theIOM Overwhelming, growing # of #MECFS advocates united behind 50 experts & against $1M #IOMContract waste [link]

@HHS_DrKoh Overwhelming, growing # of #MECFS advocates united behind 50 experts & against $1M #IOMContract waste [link]

@DrFriedenCDC Overwhelming, growing # of #MECFS advocates united behind 50 experts & against $1M #IOMContract waste [link]

@NIHDirector Overwhelming, growing # of #MECFS advocates united behind 50 experts & against $1M #IOMContract waste [link]

@NIAIDNews Overwhelming, growing # of #MECFS advocates united behind 50 experts & against $1M #IOMContract waste [link]

@theNCI Overwhelming, growing # of #MECFS advocates united behind 50 experts & against $1M #IOMContract waste [link]

@BarackObama Overwhelming, growing # of #MECFS advocates united behind 50 experts & against $1M #IOMContract waste [link]

If you wish to write your own tweets, here is the URL to the advocates’ letter: [link]

Obviously, people with severe cognitive difficulties may have a hard time helping out with this. For most people though, It shouldn’t take more than a few minutes a day to post these tweets.

Please consider not just participating yourself, but asking others to help out as well. If the tweets come from many different people, it will demonstrate that there is widespread interest in this issue.

Thank you for your participation in helping to make our community’s Twitter campaign a success!

A few more notes about the letter from advocates sent out today:

In order to facilitate a broad consensus, the advocates’ letter mirrors the experts’ letter almost word for word. There were basically no substantive changes to the experts’ letter, just changes to reflect the fact that our letter is coming from advocates rather than clinicians and researchers. A redline version showing the minor, non-substantive changes can be found in this attachment: Redline_Sebelius_Letter_Advocates_Updated

The goal of the advocates’ letter was to demonstrate that advocates stand united behind our experts in their adoption of the Canadian Consensus Criteria (CCC) and in their opposition to the IOM involvement. The experts clearly and thankfully realized that this is a crucial juncture for this disease, one from which we may not recover if we don’t fight. If the experts were able to put their disagreements on certain other points aside and come together for this one pivotal issue, then surely, we figured, we can and must do the same for ourselves. And we indeed are doing that!

Please note that this project has been somewhat overwhelming. If we overlooked an email with your signature in our inboxes, please let us know and we will add it to the letter if your email was sent before we finalized the letter yesterday. Also if we accidentally made a mistake in reproducing your signature, we apologize and are happy to correct that. Undertakings like this and the cognitive dysfunction of this illness don’t mix well.

More background on this very important topic can be found in prior posts on this blog. A link to some additional information will be posted here later today.

The experts’ letter to Sebelius is at this link.

Many sincere thanks to all of those individuals—experts, advocates and patients—who have participated in this important effort thus far.

Lisa Petrison

Jeannette Burmeister

An Open Letter from ME/CFS Advocates to the Honorable Kathleen Sebelius,

U.S. Secretary of Health and Human Services

Original Letter – October 28, 2013

Update with additional signatures – November 9, 2013

Dear Secretary Sebelius,

We are writing as patient forum leaders, not-for-profit organization managers, scholars, authors, filmmakers, bloggers and other advocates working on behalf of individuals with the disease of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), to inform you that we stand united in support of the positions expressed in the letter to you dated September 23, 2013; updated October 25, 2013; and currently signed by 50 biomedical researchers and clinicians with expertise in ME/CFS.

https://drive.google.com/open?id=0B50f6QRZgC7kUElhYWVzaGpZYlk

As you know, the 1994 International Case Definition (Fukuda et al, 1994), commonly known as the Fukuda definition, was the primary case definition for ME/CFS for almost two decades. However, as our experts wrote to you, in recent years expert researchers and clinicians have increasingly used the Canadian Consensus Criteria (CCC), as they have recognized that the CCC is a more scientifically accurate description of the disease. Unlike the Fukuda definition, the more up-to-date CCC incorporates the extensive scientific knowledge gained from decades of research, our experts explained.

As described in the letter from our experts, there is sufficient evidence and experience to adopt the CCC now for research and clinical purposes, and failure to do so will significantly impede research and harm patient care. This step will facilitate efforts to define the biomarkers, which will be used to further refine the case definition in the future, our experts agreed.

We strongly urge the Department of Health and Human Services (HHS) to follow our expertsʼ lead by using the CCC as the sole case definition for ME/CFS in all of the Departmentʼs activities related to this disease.

In addition, we strongly urge you to abandon reliance on groups such as the Institute of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for ME/CFS. Since the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease. In addition, as our experts wrote, this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.

ME/CFS patients who have been disabled for decades by this devastating disease need to see the field move forward and there is no time to waste. We believe that our expertsʼ consensus decision on a case definition for the disease will jump start progress and lead to much more rapid advancement in research and care for ME/CFS patients. We look forward to this accelerated progress and urge you to work with the people who know the most about this disease — our experts — in order to effectively increase scientific understanding of the pathophysiology of this disease, educate medical professionals, develop more effective treatments, and eventually find a cure.

Sincerely,

United States Signatories:

(see link above for signatures)

International Signatories:

(see link above for signatures)

Cc:

Barack Obama, President of the United States of America

Senator Tom Harkin, Chairman, Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Senator Jerry Moran, Ranking Member, Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Jack Kingston, Chairman, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Rosa DeLauro, Ranking Member, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Lucille Roybal-Allard, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Barbara Lee, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Mike Honda, California, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Danile R. Levinson, Inspector General, U.S. Department of Health and Human Services

Adam Trzeciak, Inspector General, U.S. Government Accountability Office

Dr. Harvey Fineberg, President, Institute of Medicine

Dr. Howard Koh, Assistant Secretary for Health, Department of Health and Human Services

Dr. Wanda Jones, Principal Deputy Assistant Secretary for Health, Department of Health and Human Services

Dr. Richard Kronick, Director, Agency for Healthcare Research and Quality

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

Ms. Marilyn Tavenner, Administrator, Centers for Medicare and Medicaid Services

Dr. Margaret Hamburg, Commissioner, U.S. Food and Drug Administration

Dr. Mary Wakefield, Administrator, Health Resources and Services Administration

Dr. Francis Collins, Director, National Institutes of Health

Dr. Harold Varmus, Director of the National Cancer Institute

Dr. Anthony Fauci , Director of the National Institute for Allergy and Infectious Diseases

Ms. Carolyn W. Colvin, Commissioner, Social Security Administration

The 50 Expert Signatories of the Open Letter to Secretary Sebelius, Dated September 23, 2013, and Updated October 25, 2013

Posted in Uncategorized | Tagged Canadian Consensus Criteria, CCC, CFS, Chronic Fatigue Syndrome, DHHS, HHS IOM Contract, IOM Contract, IOM Controversy, ME, ME/CFS, ME/CFS Advocates, ME/CFS Experts, ME/CFS Open Letter to Secretary Sebelius, Myalgic Encephalomyelitis, Open Advocates' Letter, Secretary Sebelius, Tweets, Twitter Campaign | 19 Comments

66 ME/CFS Advocates Send Letter to Secretary Sebelius in Support of their Experts

Posted on October 28, 2013 by Jeannette Burmeister

Today, 66 ME/CFS advocates sent a letter to Department of Health and Human Services Secretary Kathleen Sebelius, joining 50 ME/CFS experts in calling for the adoption of the Canadian Consensus Criteria (CCC) as the definition of the disease as well as for the abandoning of the efforts to involve organizations such as the Institute of Medicine (IOM) in any case-definition effort.

The complete letter can be found here.

The body of the letter (without the signatures) is reproduced at the end of this post. Please note that this letter was modeled after the open expert letter to Secretary Sebelius of September 23, 2013, updated on October 25, 2013. It mirrors it almost word for word. Changes only were made to reflect the fact that this letter is coming from advocates and not clinicians and researchers.

The letter is being cc’d to a number of other government officials (listed at the end of the letter) and to the 50 experts who had written to Sebelius.

Many thanks to all the advocates who signed the letter! This was a Herculean joint effort.

It is our goal over the next week or so to use Twitter to tweet Sebelius and some of the cc’d government officials as many times as possible, from as many people as possible, in order to draw attention to the letter.

Please join in and help out (and get all your friends to help out too!).

Here are Tweets to eight influential government officials copied on the letter to paste and send. Please repeat often!

@Sebelius #MECFS Patient advocates stand united behind 50 MECFS experts and against waste of $1mill on #IOMContract. [link]

@SenatorHarkin #MECFS Patient advocates stand united behind 50 experts and against waste of $1mill on #IOMContract. [link]

@JerryMoran #MECFS Patient advocates stand united behind 50 MECFS experts & against waste of $1mill on #IOMContract. [link]

@theIOM #MECFS Patient advocates stand united behind 50 MECFS experts and against waste of $1mill on #IOMContract. [link]

@BarackObama #MECFS Patient advocates stand united behind 50 experts and against waste of $1mill on #IOMContract. [link]

@HHS_DrKoh #MECFS Patient advocates stand united behind 50 MECFS experts and against waste of $1mill on #IOMContract. [link]

@DrFriedenCDC #MECFS Patient advocates stand united behind 50 experts and against waste of $1mill on #IOMContract. [link]

@NIHDirector #MECFS Patient advocates stand united behind 50 experts and against waste of $1mill on #IOMContract. [link]

Also, just as the experts updated their letter with more signatures, we will be sending an updated letter with more advocate signatures as well. This initial letter was put together over the course of just a few days, and so many people who have been terrific advocates for the disease were unfortunately and unintentionally left out. We sincerely apologize for that, but we had to move quickly for maximum impact.

If you have been an advocate for the disease, or if you would like to be, please send your signature for the update.

The format is:

Name (First and Last) Degree, School Degree, School Previous Job (year or age disabled) Advocacy Work (or just “Patient Advocate”) Internet Link ? Email Address?

Please send your signatures to the following address:

advocates2sebelius@gmail.com

The signatures will be added to the same letter linked above and sent to the same government officials as well as to the 50 experts.

Thanks much for participating in this community effort!

And a special thanks to Mary Dimmock for helping to reach out to some of the advocates for their signatures.

Lisa Petrison

Jeannette Burmeister

An Open Letter from ME/CFS Advocates to the Honorable Kathleen Sebelius,
U.S. Secretary of Health and Human Services

October 28, 2013

Dear Secretary Sebelius,

We are writing as patient forum leaders, not-for-profit organization managers, scholars, authors, filmmakers, bloggers and other advocates working on behalf of individuals with the disease of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), to inform you that we stand united in support of the positions expressed in the letter to you dated September 23, 2013; updated October 25, 2013; and currently signed by 50 biomedical researchers and clinicians with expertise in ME/CFS.

As you know, the 1994 International Case Definition (Fukuda et al, 1994), commonly known as the Fukuda definition, was the primary case definition for ME/CFS for almost two decades.

However, as our experts wrote to you, in recent years expert researchers and clinicians have increasingly used the Canadian Consensus Criteria (CCC), as they have recognized that the CCC is a more scientifically accurate description of the disease. Unlike the Fukuda definition, the more up-to-date CCC incorporates the extensive scientific knowledge gained from decades of research, our experts explained.

As described in the letter from our experts, there is sufficient evidence and experience to adopt the CCC now for research and clinical purposes, and failure to do so will significantly impede research and harm patient care. This step will facilitate efforts to define the biomarkers, which will be used to further refine the case definition in the future, our experts agreed.

We strongly urge the Department of Health and Human Services (HHS) to follow our experts’ lead by using the CCC as the sole case definition for ME/CFS in all of the Department’s activities related to this disease.

In addition, we strongly urge you to abandon reliance on groups such as the Institute of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for ME/CFS. Since the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease. In addition, as our experts wrote, this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.

ME/CFS patients who have been disabled for decades by this devastating disease need to see the field move forward and there is no time to waste. We believe that our expertsʼ consensus decision on a case definition for the disease will jump start progress and lead to much more rapid advancement in research and care for ME/CFS patients. We look forward to this accelerated progress and urge you to work with the people who know the most about this disease — our experts — in order to effectively increase scientific understanding of the pathophysiology of this disease, educate medical professionals, develop more effective treatments, and eventually find a cure.

Sincerely,

United States Signatories

…

International Signatories

…

Cc:

Barack Obama, President of the United States of America

Senator Tom Harkin, Chairman, Senate Appropriations Subcommittee on Labor, Health

and Human Services, Education, and Related Agencies

Senator Jerry Moran, Ranking Member, Senate Appropriations Subcommittee on Labor,

Health and Human Services, Education, and Related Agencies

Dr. Harvey Fineberg, President, Institute of Medicine

Dr. Howard Koh, Assistant Secretary for Health, Department of Health and Human

Services

Dr. Wanda Jones, Principal Deputy Assistant Secretary for Health, Department of Health

and Human Services

Dr. Richard Kronick, Director, Agency for Healthcare Research and Quality

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

Ms. Marilyn Tavenner, Administrator, Centers for Medicare and Medicaid Services

Dr. Margaret Hamburg, Commissioner, U.S. Food and Drug Administration

Dr. Mary Wakefield, Administrator, Health Resources and Services Administration

Dr. Francis Collins, Director, National Institutes of Health

Dr. Harold Varmus, Director of the National Cancer Institute

Dr. Anthony Fauci , Director of the National Institute for Allergy and Infectious Diseases

Ms. Carolyn W. Colvin, Commissioner, Social Security Administration

The 50 Expert Signatories of the Open Letter to Secretary Sebelius, Dated September 23, 2013, and Updated October 25, 2013

Posted in Uncategorized | Tagged Canadian Consensus Criteria, CCC, CFS, Chronic Fatigue Syndrome, Dr. Anthony Fauci, Dr. Francis Collins, Dr. Harold Varmus, Dr. Harvey Fineberg, Dr. Howard Koh, Dr. Margaret Hamburg, Dr. Richard Kronick, Dr. Thomas Frieden, Dr. Wanda Jones, HHS IOM Contract, IOM, ME, ME/CFS, ME/CFS Advocates, ME/CFS Experts, Ms. Carolyn W. Colvin, Ms. Marilyn Tavenner, Myalgic Encephalomyelitis, Secretary Sebelius, Senator Jerry Moran, Senator Tom Harkin | 12 Comments

16 Additional ME/CFS Experts Added Signatures to Open CCC/IOM Letter to Sebelius

Posted on October 26, 2013 by Jeannette Burmeister

On September 23, 2013, thirty five ME/CFS experts sent an open letter to HHS Secretary Sebelius informing her that they have come to a consensus about the use of the Canadian Consensus Criteria (CCC) as the official disease definition and urging HHS to also adopt the CCC as the sole case definition as well as to abandon efforts to engage the Institute of Medicine( IOM)—an organization completely inexperienced in developing disease definitions and in the disease itself—to create a case definition. Secretary Sebelius has shown the experts no respect at all and has, in fact, not even found it necessary to respond to them, let alone heed their advice. Yesterday, the experts doubled down and added sixteen more signatures to the letter.

As a—somewhat insignificant—side note, this calls into question PANDORA’s statement that “at least one other [expert besides Dr. Batemen told them] privately that he has changed his position” blatantly wrong and as well as their reasons for trying to create doubt about the experts’ resolve.

The additional experts are:

Lily Chu, MD, MSHS

Todd E. Davenport, PT, DPT, OCS

Kenneth J. Friedman, PhD

Betsy Keller, PhD, FACSM

Konstance Knox, PhD

Malcolm S. Schwartz, DO, FAOCP

Julian M. Stewart, MD, PhD

J. Mark VanNess, PhD

Alison C. Bested, MD, FRCPC

Nicoletta Carlo-Stella, MD, PhD

Øystein Fluge, MD, PhD

Malcolm Hooper, PhD, BPharm, MRIC, CChem

Olav Mella, MD, PhD

Kunihisa Miwa, MD, PhD

Nigel Speight, MA, MB, BChir, FRCP, FRCPCH, DCH

Eleanor Stein, MD, FRCP(C)

The experts published an updated letter:

An Open Letter to the Honorable Kathleen Sebelius, U.S. Secretary of Health and Human Services

Original Letter – September 23, 2013

Update with additional signatures – October 25, 2013

Dear Secretary Sebelius,

We are writing as biomedical researchers and clinicians with expertise in the disease of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to inform you that we have reached a consensus on adopting the 2003 Canadian Consensus Criteria (CCC) as the case definition for this disease.

The 1994 International Case Definition (Fukuda et al, 1994), commonly known as the Fukuda definition, was the primary case definition for ME/CFS for almost two decades. However, in recent years expert researchers and clinicians have increasingly used the CCC, as they have recognized that the CCC is a more scientifically accurate description of the disease.

The CCC was developed by an international group of researchers and clinicians with significant expertise in ME research and treatment, and was published in a peer-reviewed journal in 2003 (Carruthers et al, Journal of Chronic Fatigue Syndrome, 2003). Unlike the Fukuda definition, the more up-to-date CCC incorporates the extensive scientific knowledge gained from decades of research. For example, the CCC requires the symptom of post-exertional malaise (PEM), which researchers, clinicians, and patients consider a hallmark of the disease, and which is not a mandatory symptom under the Fukuda definition. The CCC was endorsed in the Primer for Clinical Practitioners published by the International Association of Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (IACFSME). This organization is the major international professional organization concerned with research and patient care in ME/CFS.

The expert biomedical community will continue to refine and update the case definition as scientific knowledge advances; for example, this may include consideration of the 2011 ME International Consensus Criteria (Carruthers et al, Journal of Internal Medicine, 2011). As leading researchers and clinicians in the field, however, we are in agreement that there is sufficient evidence and experience to adopt the CCC now for research and clinical purposes, and that failure to do so will significantly impede research and harm patient care. This step will facilitate our efforts to define the biomarkers, which will be used to further refine the case definition in the future.

We strongly urge the Department of Health and Human Services (HHS) to follow our lead by using the CCC as the sole case definition for ME/CFS in all of the Department’s activities related to this disease.

In addition, we strongly urge you to abandon efforts to reach out to groups such as the Institute of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for ME/CFS. Since the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease. Worse, this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.

ME/CFS patients who have been disabled for decades by this devastating disease need to see the field move forward and there is no time to waste. We believe that our consensus decision on a case definition for this disease will jump start progress and lead to much more rapid advancement in research and care for ME/CFS patients. We look forward to this accelerated progress and stand ready to work with you to increase scientific understanding of the pathophysiology of this disease, educate medical professionals, develop more effective treatments, and eventually find a cure.

Sincerely,

United States Signatories

Dharam V. Ablashi, DVN, MS, Dip Bact. Scientific Director of HHV-6 Foundation Co-founder of IACFS/ME
Santa Barbara, California

David S. Bell, MD, FAAP
Researcher and Clinician
Associate Professor of Pediatrics State University of New York at Buffalo Lyndonville, New York

Gordon Broderick, PhD
Professor, Center for Psychological Studies Director, Clinical Systems Biology Lab Institute for Neuro Immune Medicine,
Nova Southeastern University
Fort Lauderdale, Florida

Paul R. Cheney, MD, PhD Director, The Cheney Clinic, PA Asheville, North Carolina

John K.S. Chia, MD Researcher and Clinician President, EV Med Research Lomita, California

Lily Chu, MD, MSHS (Added 10/25/2013) Independent Researcher
Burlingame, California

Todd E. Davenport, PT, DPT, OCS (Added 10/25/2013) Associate Professor, Physical Therapy
University of the Pacific
Stockton, California

Kenny L. De Meirleir, MD, PhD
Professor Emeritus Physiology and Medicine (Vrije Universiteit Brussel) Medical Director, Whittemore-Peterson Institute
University of Nevada
Reno, Nevada

Derek Enlander, MD, MRCS, LRCP
Attending Physician
Mount Sinai Medical Center, New York
ME CFS Center, Mount Sinai School of Medicine New York, New York

Mary Ann Fletcher, PhD
Schemel Professor of NeuroImmune Medicine Institute for Neuro Immune Medicine
Nova Southeastern University
Fort Lauderdale, Florida

Kenneth J. Friedman, PhD (Added 10/25/2013)
Associate Professor of Pharmacology and Physiology, New Jersey Medical School (retired) Research Associate, Green Mountain College
Adjunct Instructor, Castleton State College
Pawlet, Vermont

Ronald Glaser, PhD, FABMR
Director, Institute for Behavioral Medicine Research
Kathryn & Gilbert Mitchell Chair in Medicine
College of Medicine – Distinguished Professor
Professor, Molecular Virology, Immunology and Medical Genetics
Professor, Internal Medicine
Professor, Division of Environment Health Sciences, College of Public Health Institute for Behavioral Medicine Research
Columbus, Ohio

Maureen Hanson, PhD
Liberty Hyde Bailey Professor
Department of Molecular Biology and Genetics Cornell University
Ithaca, New York

Leonard A. Jason, PhD Professor of Psychology DePaul University Chicago, Illinois

Betsy Keller, PhD, FACSM (Added 10/25/2013)
Professor, Department of Exercise & Sport Sciences, Ithaca College Ithaca, New York

Nancy Klimas, MD
Director, Institute for Neuro Immune Medicine Professor, Nova Southeastern University
Fort Lauderdale, Florida

Konstance Knox, PhD (Added 10/25/2013) Director of Research, Coppe Healthcare Solutions Wisconsin Viral Research Group
Waukesha, Wisconsin

Gudrun Lange, PhD
Clinical Neuropsychologist
Professor, Rutgers New Jersey Medical School Newark, New Jersey

A. Martin Lerner, MD, MACP
Professor, Infectious Diseases
Oakland University William Beaumont School of Medicine
Emeritus Director, Infectious Diseases, Wayne State University School of Medicine Master, American College of Physicians
Reviewer, Viral Diseases, Medical Letter
Beverly Hills, Michigan

Susan Levine, MD
Researcher and Clinician, Private Practice New York, New York
Visiting Fellow, Cornell University
Ithaca, New York

Alan R. Light, PhD
Professor, Department of Anesthesiology and Department of Neurobiology and Anatomy University of Utah
Salt Lake City, Utah

Kathleen C. Light, PhD
Researcher
Professor, Department of Anesthesiology University of Utah School of Medicine Salt Lake City, Utah

Peter G. Medveczky, MD
Professor, Department of Molecular Medicine College of Medicine
University of South Florida
Tampa, Florida

Judy A. Mikovits, PhD Researcher, MAR Consulting, LLC Carlsbad, California

Jose G. Montoya, MD, FACP, FIDSA
Professor of Medicine
Division of Infectious Diseases and Geographic Medicine Stanford University School of Medicine
Stanford, California

James M. Oleske, MD, MPH
François-Xavier Bagnoud Professor of Pediatrics
Director, Division of Pediatrics Allergy, Immunology & Infectious Diseases Department of Pediatrics, Rutgers New Jersey Medical School
Newark, New Jersey

Martin L. Pall, PhD
Professor Emeritus of Biochemistry and Basic Medical Sciences Washington State University
Portland, Oregon

Daniel Peterson, MD
Founder and President of Sierra Internal Medicine Incline Village, Nevada

Richard Podell, MD, MPH
Clinical Professor, Department of Family Medicine UMDNJ Robert Wood Johnson Medical School New Brunswick, New Jersey

Irma Rey, MD
Clinician
Institute for Neuro Immune Medicine Nova Southeastern University
Fort Lauderdale, Florida

Malcolm S. Schwartz, DO, FAOCP (Added 10/25/2013)
Clinical Associate Professor of Pediatrics, Drexel University College of Medicine Philadelphia, Pennsylvania
Pediatric Endocrine LLC.
Long Branch, New Jersey

Christopher R. Snell, PhD
Professor, Health, Exercise and Sport Sciences University of the Pacific
Stockton, California

Connie Sol, MS, PhDc
Clinical Exercise Physiologist, Institute for Neuro Immune Medicine Nova Southeastern University
Fort Lauderdale, Florida

Staci Stevens, MA
Exercise Physiologist Founder, Workwell Foundation Ripon, California

Julian M. Stewart, MD, PhD (Added 10/25/2013)
Director, Center for Hypotension, Associate Chairman of Pediatrics, Professor of Pediatrics,

Physiology and Medicine New York Medical College Vahalla, New York

Rosemary A. Underhill, MB BS, MRCOG, FRCSE Independent Researcher
Palm Coast, Florida

J. Mark VanNess, PhD (Added 10/25/2013)
Associate Professor, Department Health, Exercise and Sport Sciences – College of Pacific Adjunct Professor, Department of Bioengineering – College of Computer Sciences and

Engineering University of the Pacific Stockton, California

Marshall V. Williams, PhD
Professor, Departments of Molecular Virology, Immunology and Medical Genetics; Microbiology The Ohio State University
Columbus, Ohio

International Signatories

Alison C. Bested, MD, FRCPC (Added 10/25/2013)
Medical Director, Complex Chronic Diseases Program
British Columbia Women’s Hospital and Health Centre
Clinical Associate Professor, Faculty of Medicine, University of British Columbia Vancouver, British Columbia, Canada

Nicoletta Carlo-Stella, MD, PhD (Added 10/25/2013) Clinician
Nazzani Studio
Pavia, Italy

Birgitta Evengard, MD, PhD
Professor, Division Infectious Diseases Umea University
Umea, Sweden

Øystein Fluge, MD, PhD (Added 10/25/2013) Consultant in Oncology, Department of Oncology Haukeland University Hospital
Bergen, Norway

Malcolm Hooper, PhD, BPharm, MRIC, CChem (Added 10/25/2013) Emeritus Professor of Medicinal Chemistry, University of Sunderland Sunderland, Tyne and Wear, United Kingdom

Sonya Marshall-Gradisnik, PhD
Director, National Centre for Neuroimmunology and Emerging Diseases Griffith Health Institute
Professor, Griffith University Parklands Gold Coast
Queensland, Australia

Olav Mella, MD, PhD (Added 10/25/2013) Professor, Director, Department of Oncology Haukeland University Hospital
Bergen, Norway

Kunihisa Miwa, MD, PhD (Added 10/25/2013) Director, Miwa Naika Clinic
Toyama City, Toyama Prefecture, Japan

Charles Shepherd, MB BS
Honorary Medical Adviser to the ME Association London, United Kingdom

Nigel Speight, MA, MB, BChir, FRCP, FRCPCH, DCH Pediatrician
County Durham, United Kingdom

Eleanor Stein, MD, FRCP(C) (Added 10/25/2013) Psychiatrist
Assistant Clinical Professor, University of Calgary Calgary, Alberta, Canada

Rosamund Vallings, MNZM, MB BS IACFS/ME Secretary
Clinician, Howick Health and Medical Clinic Auckland, New Zealand

Cc:

(Added 10/25/2013)

Dr. Howard Koh, Assistant Secretary for Health
Dr. Richard Kronick, Director, Agency for Healthcare Research and Quality
Dr. Thomas Frieden, Director, Centers for Disease Control and Prevention
Ms. Marilyn Tavenner, Administrator, Centers for Medicare and Medicaid Services Dr. Margaret Hamburg, Commissioner, U.S. Food and Drug Administration
Dr. Mary Wakefield, Administrator, Health Resources and Services Administration Dr. Francis Collins, Director, National Institutes of Health
Ms. Carolyn W. Colvin, Commissioner, Social Security Administration

Posted in Uncategorized | Tagged 16 Additional Signatories, Canadian Consensus Criteria, CCC, CFS, Chronic Fatigue Syndrome, HHS IOM Contract, IOM, ME, ME/CFS, Myalgic Encephalomyelitis, Open Expert Letter, PANDORA, Secretary Sebelius | 13 Comments

November 2013 CFSAC Meeting: 3 Weeks before Meeting, Information for Patients Still Outstanding

Posted on October 22, 2013 by Jeannette Burmeister

I sent the following email inquiring about the November 2013 CFSAC meeting, which is scheduled for November 12th and 13th, 2013, less than 3 weeks from now. I’d encourage other patients who have questions about the upcoming meeting to email CFSAC at cfsac@hhs.gov for clarification as well.

Dear CFSAC Members,

I am writing to inquire about the video submissions for the upcoming November CFSAC meeting. What format and length do the videos have to be? How do they have to be submitted? What will be the deadline for submitting videos?

We are less than 3 weeks away from the meeting and it does not seem like any instructions regarding the pre-recorded patient videos are yet on the CFSAC website. As you know, patients are very sick and need potentially substantial lead time to be able to record their statements and submit them. I ask that you consider that when you determine the deadline for the submissions.

Also, is a registration required–and if so by when–or is simply logging on according to instructions, which will presumably be posted at some point before the meeting, sufficient? If a registration is required, when will instructions on that be posted and what is the deadline for registering?

The page linked to in the below email of September 12, 2013 from CFSAC announcing the November 2013 meeting does not provide the above or any other information about the meeting (e.g., the deadline and other instructions for written comments). If the information is already somewhere else on the CFSAC website and I merely overlooked it, would you be so kind as to send me a link to the correct page.

Thank you!

Sincerely,
Jeannette Burmeister

On Sep 12, 2013, at 3:06 PM, OS OPHS CFSAC (HHS/OPHS) <CFSAC@hhs.gov> wrote:

The Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold its fall meeting as a webinar on November 12 and 13, 2013, from 12:00 noon – 5:00 pm ET each day. This will not be an in-person meeting. Because of budget constraints and the government-wide Sequestration, federal advisory committees have been told to conduct at least some of their meetings as webinars or use other similar formats.

We will use webinar technology to accept questions to the committee submitted in real time, similar to the questions received on note cards from the last meeting. For the first time, we will accept prerecorded videos as public comment for the fall 2013 meeting. As in the past, we will have “live” public comment via phone and will accept written public comments. Detailed instructions for joining the webinar and providing public comment will be posted on the CFSAC website www.hhs.gov/advcomcfs/ at a later date. Agenda items will be posted on the CFSAC website by October 28.

The 2014 CFSAC spring meeting will be in-person in Washington, DC; exact dates will be announced in 2014.

We continue to work on a contract with the Institute of Medicine (IOM) to develop recommendations for clinical diagnostic criteria. When the contract is finalized, we will provide additional information via the CFSAC listserv and website. This topic will be included as an agenda item for the November webinar.

If you have any questions, please email cfsac@hhs.gov.

Thank you,

________________________________________________________
The CFSAC Support Team
http://www.hhs.gov/advcomcfs/index.html

Sign up for the CFSAC listserv to receive the latest updates about CFSAC:
http://www.hhs.gov/advcomcfs/cfsac_email_list.html

To unsubscribe from the CFSAC-L list, click the following link:
http://list.nih.gov/cgi-bin/wa.exe?SUBED1=CFSAC-L&A=1

Posted in Uncategorized | Tagged CFS, CFSAC, Chronic Fatigue Syndrome, Instructions, ME, ME/CFS, Myalgic Encephalomyelitis, November 2013 Meeting, Registration, Video Submissions, Written Comments | 10 Comments

Principled Approach: Fighting the IOM Contract is a Moral Imperative

Posted on October 13, 2013 by Jeannette Burmeister

“If patient advocates sit on the committee, they will be played. The government will then be able to say the patient sector was represented in the committee’s actions and the outcome of the work.”—John Herd, veteran patient advocate, October 10, 2013

The patient community is frustrated by persistent statements of a small minority of patients/advocates to the effect that the IOM contract is going to become reality no matter what we do. We are being sold the illusion that nothing will make a difference. Might as well just give up, folks. Really? Not! Not at all, in fact. It’s a dangerous, but potentially effective technique: You just keep repeating a statement over and over and eventually it will stick. It’s effective, that’s for sure. Just look at the number of people in this country who believe that Obama was born in Kenya or that Obamacare will create death panels. There! Very effective to repeat these falsehoods. The danger in the IOM situation lies in the potential to demoralize folks when what we need is to fight more than ever.

Conceding that the IOM study will proceed would be to negotiate like Obama used to do until very recently. And how well has that worked for him?! It would mean giving up our position entirely to be left with no leverage at all and without having received any concessions from the government, e.g., about the IOM committee members, the rigor of the study, avoiding a GWI-like disaster, etc. To remind everybody, the GWI IOM committee changed the name “Gulf War Illness” to the unrecognizable and offensive name “Chronic Multi-Symptom Illness,” a name that could not be less descriptive or more all-inclusive. The “treatments” the IOM committee report recommended for GWI—a physical illness—are antidepressants, Cognitive-Behavioral Therapy and Graded-Exercise Therapy. The report also suggested the same clinical interventions for “ME/CFS.”

If something is morally wrong, one needs, as a matter of principal, to oppose it even if the chances of changing it are marginal (and I am not saying they are marginal here). Of course, one would go to plan B (trying to have a say about committee members to be appointed, trying to affect the outcome of the study, etc.) if plan A (opposing the study tooth and nail) falls through. We are not faced with a choice between plan A or plan B right now. Going with plan A does not, by any means, foreclose plan B here.

What do we have to lose by opposing the IOM contract unflinchingly? Not a thing. In fact, we may succeed and the contract may get rescinded! After all, Secretary Sebelius has not even responded to the open expert letter yet. And if you think about it, proceeding with the contract after our experts recommended abandoning it, really is not a reasonable route to take for her given that about $1 million of tax-payer money would be wasted when we’ve been told time and time again that there is no money for bio-medical research into the disease and that we are in the middle of a government shutdown and sequester. But since the government is not known to make rational or humane decisions when it comes to ME, it is indeed possible that HHS will decide to just push the IOM study through. So, let’s assume for a minute that that will happen. Surrendering in this battle still would make absolutely no sense. If we roll over easily now, it will signal that the IOM, for HHS, can throw us under the bus like they did with GWI patients. Our vets are a group that basically has the entire country’s support. Most people, even those opposed to the wars, want to see our vets treated decently. And yet, GWI patients got a shockingly raw deal from the IOM. ME patients are very likely to be treated even more abysmally.

The stronger our opposition now, the more we will show that we are not going to take any hack job lying down and that the IOM will not get away with a GWI-type outcome. Putting up a fight now will put us in a stronger position in the future. We need to fight every step of the way. Fighting costs us nothing. In fact it gains us strength and bargaining power down the road. Make no mistake: Fighting now WILL affect the outcome either way. As a matter of integrity and as a matter of survival, we need to take a principled approach. And that means not accepting the IOM contract as a done deal.

Jennie Spotila recently “confirm[ed] through multiple sources that the IOM has reached out to multiple ME/CFS organizations for nominations to the clinical case definition committee” and that those nominations were due on October 11, 2013. There have been rumors that certain patient organizations or its members contacted some experts as well as a few advocates and patients for their input regarding those nominations. Could it be that those rumors are indeed true? If so, this would certainly seem like a major betrayal given the clearly stated desire of the vast majority of the experts, patients and advocates to abandon the IOM efforts and to proceed with the CCC, as suggested by the experts. I guess we will probably find out in the near future who was involved in soliciting nominations for the IOM committee. I just hope that patients will not have reason to be shocked and disappointed to learn that their favorite ME organization or advocate has worked behind their backs against their stated and obvious interests. I really do.

And what’s with this lightning speed in obtaining nominations, less than three weeks after the IOM contract was announced on September 23, 2013? Nothing the government does, even when outsourced, like here to the IOM, ever happens fast. Especially in times of a government shutdown. Call me paranoid, but this really smells like somebody is determined to push this through as quickly as humanly possible in light of the overwhelming experts’, patients’ and advocates’ opposition before any real counter movement can be formed. And if that is the case, it begs the questions why. And what a revolting approach to exploit the fact that we are too sick to react quickly.

Jennie also lets us know that “the public will be given twenty days to comment on the provisional appointment list, although [she] do[es] not know when that list will be posted.” So, we will get a chance for input after the fact. How very generous! Is it just me or does anybody else have any questions about why the public was not even informed that this was going on? There has been zero transparency with respect to the nomination process or even just the fact that nominations were being sought. The latter did leak, but we did not get any details and definitely got nothing from any official source. Curiously, we were given this information through Jennie on the day of the deadline, October 11, 2013. Why all this effort to keep the main stakeholders—the patients—in the dark?

I guess we shouldn’t be too surprised given how the government has gone about the whole IOM situation from the start. Even Jennie admits, “I am insulted by how [the IOM study] was created in secret and concealed not just from advocates, but from all but one voting member of the CFSAC. The way HHS has treated the advocacy community, and failed to show the 35 experts even the basic courtesy of an acknowledgement of their letter, is simply outrageous.” You’ve got to give the HHS credit for one thing: They are consistent in their complete lack of respect for patients and experts. The disdain they have for us is clearly palpable.

Now about Jennie’s take on the matter. She says, “if the canoe is pointed at our goal of the right clinical definition for ME/CFS, how do we coordinate the paddling?” Clearly, if the IOM contract stays in place, the canoe is headed for the Niagara Falls. Grabbing a paddle by getting involved in the IOM process is only going to lend credibility to a sham exercise designed to burry ME even further for decades to come. By paddling, we would give the impression that we had a chance of avoiding the drop of 173 feet and being annihilated. The IOM canoe is doomed and that’s why patients shouldn’t and aren’t getting in.

Ok, so the government has never rescinded an IOM contract in the past. “We’ve always done it this way” does not get very close to convincing me. Has there ever been a situation where about $1 million dollars are going to be wasted on an outcome that has the overwhelming potential of leaving patients much worse off? I don’t know the answer for sure, but I would bet some serious money on “no.” And to expect the patient community to be understanding of the fact that the government puts its relationship with the National Academies above the wellbeing of patients who have been, by HHS, disenfranchised, ridiculed, neglected and victimized for decades is peculiar. How about the “politically loaded action” of awarding an expensive contract that the patient community clearly doesn’t want nor need? There seems to be a total acceptance by a few of the fact that the patients are ALWAYS the last group whose interest is being taken into account. Why is that not objectionable to everybody?

According to one of Jennie’s “highly placed source at HHS, … the government will not accept a definition without their own thorough assessment, if not influence [because] HHS will want to get its hands on any definition before accepting it.” This is exactly what’s going on, but why be so understanding about it? Given that HHS has no expertise in the ME area, it is outrageous that it wants to influence the disease definition and “get it’s hands” on it. Plus, this is completely inconsistent with Secretary Sebelius’s letting us know, through CFASC DFO Lee, that the definition must come from the medical community, not HHS. I guess Sebelius didn’t really mean it then.

I am glad that Jennie doesn’t just want to throw in the towel and stay out of it altogether. I agree with her on this point. Getting involved is a matter of conscience. But even Jennie does not “have confidence that [she] can have meaningful influence over the panel selection or how it does its work.” To be really clear, unlike Jennie, I do believe that my choice not to grab a paddle or even get into the IOM canoe—by fighting the IOM process altogether instead of merely trying to influence the IOM process—is better. I do believe that opposing the IOM contract and lobbying for the acceptance of the Canadian Consensus Criteria (CCC) is morally superior to giving up and putting our fate into the hands of the IOM. And I do believe that there is absolutely a real chance of stopping the IOM study from going forward. If I didn’t, I wouldn’t have run my health into the ground over the last two weeks trying to stop the IOM contract. If I felt either choice—to fight proceeding with the IOM study or merely to try and influence its outcome—were equally good or bad, I would have just enjoyed my family and my effective medical treatment.

PS: After getting all this this out of my system, I feel the need to say the following. I do not enjoy disagreeing with people. I struggled with the decision to explain why, in my opinion, Dr. Bateman’s change of position regarding the IOM contract vs. the adoption of the CCC, as recommended by our experts, was misguided. It was hard for me because of her many contributions and her dedication to the patients over many years. But her changing teams after being prompted by Suzanne Vernon was very damaging to the patient community and, at the end of the day, if I want to be an effective advocate with my integrity intact, I need to make it about the issues and not about the people involved.

I do not have too many sleepless nights over calling out officials, government or private. They get paid for what they do and if it’s against the interests of the patient community, which it typically is with ME, they need to hear about it. Suzanne Vernon’s actions and positions are so very objectionable to me that speaking my mind about them does not cause me any distress whatsoever. The fact that I have no ambitions of cozying up to people who are perceived, sometimes just by themselves, as influential is helpful.

Other patients are a whole different story for me though. Stress is so very bad for us and I make it a point to try and be gentle with fellow patients. However, what I said about Dr. Bateman holds true here as well. Trying to get along cannot trump discussing the issues or else there is no point to any of it. It is in this spirit that I wrote this. I hope both Jennie—whose intellect and writing skills I respect very much—and other patients will understand that this is in no way personal, even though our opinions on this particular issue couldn’t be more conflicting.

Posted in Uncategorized | Tagged Canadian Consensus Criteria, CCC, CFS, Chronic Fatigue Syndrome, HHS, IOM Contract, ME, ME/CFS, Myalgic Encephalomyelitis, Secretary Sebelius | 31 Comments

More Propaganda: Still no Explanation from CAA for Disagreeing with Experts and Patient Majority

Posted on October 9, 2013 by Jeannette Burmeister

Based on context and substance, we have to assume that the latest blog entry posted on the CFIDS Association of America’s (CAA) website was written by Suzanne Vernon although it was not signed and the author wasn’t identified.

Suzanne Vernon is assuring us that she is not benefitting financially from being on an IOM committee. That is one of the most disingenuous statements I could imagine on the subject. There are many ways to benefit that are not financial. The currency here may not be money in any direct way (and I believe that to be true). It is power. It is about being connected. It is about building a resume, credentials, a career. All of those have the strong potential to indirectly benefit the CAA and/or Suzanne Vernon financially in the future, even if it will just be a matter of the CAA still being in existence, which looks more and more questionable.

As I pointed out in my prior blog post, Suzanne Vernon—who spent a majority of her career at the CDC where her “CFS” research with Bill Reeves was mainly into the psycho-social aspects of the disease—is on the NIH’s Special Emphasis Panel (SEP), a committee that reviews grant applications for “ME/CFS.” That position alone bestows an incredible amount of influence over ME research and, thus, politics and treatment. Let’s remember that at least some of the 35 ME experts who signed the open letter to Secretary Sebelius felt they were being pressured by Suzanne Vernon—the scientific director of the CAA, a member of the SEP and a member of the IOM committee—into changing their position. It is simply not believable that Suzanne Vernon does not view her being on the IOM panel as a benefit to her and/or the CAA because it gives her and the organization, without a doubt, more power in times of very little patient support and dwindling staff and contributions.

This is a woman who accepted compensation of about $138,000 per year in the last two years from a non-profit whose revenue was only about $1.2 million in 2011 and about $1.1 million in 2012 and that received a two-star rating due its financials. Kim McCleary was paid around $167,000 per year for those two years. The total cost to the non-profit is even higher than that because of payroll taxes and state disability and unemployment taxes, which also come out of the organization’s pocket book. So, just for the services of Suzanne Vernon and Kim McCleary in 2012 alone, the CAA paid about $305,000+ while having an income of under $1.1 million. In other words, this non-profit organization, which claims to aim for advancements in a disease that is ridiculously underfunded, spent more than a than a quarter of its revenue on its two key employees, one of them being Suzanne Vernon. So, forgive me if I don’t believe that Suzanne Vernon is serving on the IOM committee out of the goodness of her heart.

Now, about that pressure signatories reportedly felt. Suzanne Vernon had this to say on the subject: “There is speculation that I asked them to rescind their signature. I did not ask anyone to rescind their signature or change their mind.” She said she was merely asking if the signatories still agreed with their expressed position. Again, this strikes me as insincere at best. Given that the email was triggered by merely one signatory changing her position (and not even officially withdrawing her signature), it would have made sense to ask Secretary Sebelius if she still wants to go forward with the IOM efforts since the majority of experts were against it and given the great tax-payer expense involved, but not to ask the experts if they wished to change their minds.

The email that Suzanne Vernon sent to the signatories is analogous to the following hypothetical: Let’s say a Democratic Congressman has stated that he or she is not going to vote party line and Nancy Pelosi sends an email to that Congressman asking if he or she still stands by his or her position: “If you have any misgivings about [your previously stated position]”, or feel that the party line should prevail, “[I] need to hear from you.” Seriously, could there be any doubt about the fact that this is not just a friendly “hello, just checking in,” but ever-so-slight pressure and that the support of the Democratic Party during the next primaries was seriously in jeopardy? I think not. So, how about when a member of the panel that will decide whether your next grant application will get approved (SEP) asked you whether you have changed your mind on a very contentious issue, a question that only makes sense as a suggestion that you do change your mind? No pressure to withdraw your signature? Really?

We still haven’t heard why the CAA is in favor of the IOM contract when pretty much all of the respected experts are not and when the patients have made it abundantly clear that they do not want the IOM contract to go forward. If an organization is so removed in its position from that of the group of people it purports to represent, is it too much to ask for a genuine explanation?

Still no word of comfort on why we should be confident that the “ME/CFS” IOM committee will do a better job than the GWI IOM committee. GWI patients are outraged by the results of the first IOM contract on treatment. They were thrown under the bus by the committee. It seems that the CAA’s PR tactic continues to be to acknowledge the patients’ fears without addressing them. Vernon went from “while we understand ….” to “we believe it is in the patients [sic] best interest to continue …” She then states the following: “We must have the cooperation and involvement of the various federal agencies to increase research funding and achieve real progress.” This makes no sense for two reasons: 1. It certainly was not progress, but a huge step back, to involve the IOM in the case of GWI. 2. Why and how will an IOM disease definition generate more federal funding?

Seriously, a member of the GWI IOM committee, a panel that has done an abysmal job for GWI patients, is defending the need for an IOM committee for “ME/CFS!” This is, on its face, outlandish. It’s as if the fox is pretending that it wants only the best for the hens. I find it highly improper that, Suzanne Vernon, as a member of the IOM committee, would even get involved in that discussion. It is a conflict of interest.

And finally the “explanation” for why a research organization is interested in the disease definition: “It is precisely because we are focused on research that case definition is important to us. … The diagnostic criteria is essential to advance research because it provides us with the disease-defining concepts – the core signs and symptoms – needed to identify and validate biomarkers and to provide evidence of treatment benefit.” This talking point was entirely predictable. At first glance this even makes sense, until you remember the GWI IOM disaster. The GWI committee changed the name “Gulf War Illness” to the unrecognizable and offensive name “Chronic Multi-Symptom Illness,” a name that could not be less descriptive or more all-inclusive. The “treatments” the IOM committee report recommended for GWI—a physical illness—are antidepressants, Cognitive-Behavioral Therapy and Graded-Exercise Therapy. The report also suggested the same clinical interventions for “ME/CFS.” It is being reported by GWI researchers that vets are turned away at the VA now due to the changed name and broadened disease definition. Broadening the already overly inclusive definition of “ME/CFS”—something we can be sure will happen if the IOM is involved—will do the opposite of what Vernon claims the result of the IOM contract will be. It will make research less scientific and more meaningless.

Let’s keep in mind that the IOM contract will cost about $1 million of scarce government funding, when the experts have already settled on a very effective definition. Does anybody have confidence that this $1 million dollar contract will produce a better definition or advance the interests of the ME community more than spending the money on bio-medical research? Or is this just job security for a few folks?

Posted in Uncategorized | Tagged CAA, CCC, CFIDS Association of America, CFS, Chronic Fatigue Syndrome, chronic multi-system illness, CMI, Compensation, Gulf War Illness, GWI, Institue of Medicine, IOM, Kim McCleary, ME, ME/CFS, Myalgic Encephalomyelitis, Salary, Secretary Sebelius, Suzanne Vernon | 27 Comments

Please Sign Petition: Thank You to Our ME Experts

Posted on October 5, 2013 by Jeannette Burmeister

Link to Petition: http://www.thepetitionsite.com/898/238/310/thank-you-to-mecfs-experts/

Our experts have taken a brave and trailblazing stand for ME patients by agreeing, in an open letter to Secretary Sebelius, on an official definition for “ME/CFS,” the Canadian Consensus Criteria (CCC). This is what Secretary Sebelius has been asking for, a consensus on the disease definition coming from the medical community. It’s here now. When HHS entered into the IOM contract to produce a case definition, it was not aware that our experts had already agreed on one. Therefore, the only reasonable response from Secretary Sebelius to the open expert letter is to rescind the IOM contract, as the experts strongly urged, and to use the about $ 1 million dollars in tax-payer money set aside for that contract where it is much more urgently needed and far more efficiently utilized: for bio-medical ME research.

Our experts deserve our deepest gratitude for uniting and standing up for us in this monumental way and, maybe even more importantly, for not wavering in the face of unrelenting, if subtle, pressure from the CFIDS Association of America and most likely other powers that be to change their position. That has taken some real integrity. We are witnessing a truly groundbreaking moment!

Please show your gratitude by signing the petition linked in the first sentence above. If you are comfortable using your name, as the overwhelming majority of people who have signed so far have done, that will be so much more meaningful to our experts and carry a lot more weight than signing anonymously. Please ask friends, family, neighbors, colleagues, etc. to sign as well. It literally takes less than a minute. When you sign, make sure to opt out of receiving further emails from the petition site if don’t wish to receive those.

Here is the petition language:

“Myalgic Encephalomyelitis (ME), also called chronic fatigue syndrome (CFS) or ME/CFS is a debilitating disease that causes profound neurological and immunological dysfunction. The disease is accurately described by the Canadian Consensus Criteria (CCC), created and used by experts for both research and clinical care.

But Health and Human Services (HHS) has rejected the Canadian Consensus Criteria. Instead, HHS has characterized ME/CFS as unexplained fatigue and lumped it together with conditions like depression and deconditioning. This has stalled research and drug development and left too many doctors not even believing that patients are really sick.

But no more! On September 23, thirty-five of the leading ME/CFS experts sent a letter to Secretary Sebelius announcing that they had reached consensus on the use of the Canadian Consensus Criteria as the sole definition for ME/CFS and urging HHS to abandon its plans to contract the Institute of Medicine to develop its own criteria for ME/CFS.

This is a remarkable and unprecedented letter.

We applaud these experts for showing exactly the kind of leadership and courage that is needed to change the future for ME/CFS patients. Please join us in sending them a note to thank them and show them our support.

Additional background

The letter from ME/CFS experts to Secretary Sebelius is here – http://bit.ly/15npS9B

HHS has contracted with the Institute of Medicine (IOM) to develop its own clinical criteria for ME/CFS. The description of the IOM contract is here http://bit.ly/18m7XlJ.

In the letter to Secretary Sebelius, the 35 leading ME/CFS experts rejected the IOM contract as wasteful and unnecessary since there was consensus on the use of the Canadian Consensus Criteria as the sole definition. Further, they raised concerns that the IOM initiative would set ME/CFS science backwards.

More about ME/CFS

ME/CFS has been described as a one way ticket to hell. ME/CFS affects up to one million Americans. Patients can be as young as 5 years old and can be sick for 20, 30, 40 or more years. ME/CFS leaves an estimated 25% of patients housebound or bedridden and 50-85% of patients are unable to work. Patients can die many years prematurely due to cancer, cardiac disease and suicide. The estimated impact to the U.S. economy $17-23 billion dollars annually in lost productivity and direct medical costs.
The following thank you message will be sent to the signatories of the letter sent to Secretary Sebelius once at the end after signatures have been collected

Thank you for your letter to the Department of Health & Human Services (HHS) stating your consensus on the use of the Canadian Consensus Criteria as the sole definition for ME/CFS, for calling on HHS to adopt CCC for all its activities, and for urging HHS to abandon its Institute of Medicine (IOM) study to develop it’s own clinical diagnostic criteria for ME/CFS.

For decades, the stunning lack of clarity on the nature of ME/CFS has severely impeded research, perverted clinical care, stigmatized patients and left our country with a huge economic burden. We applaud you for showing exactly the kind of leadership and courage that is needed to change the future for ME/CFS patients and their families. We stand ready to support you and follow your leadership in achieving this. We call on HHS to do the same, starting with immediate adoption of the Canadian Consensus Criteria and abandonment of HHS’ plans to create its own criteria.

Posted in Uncategorized | Tagged Canadian Consensus Criteria, Case de, CCC, CFIDS Association of America, CFS, Chronic Fatigue Syndrome, HHS, IOM Contract, ME, ME experts, ME/CFS, Myalgic Encephalomyelitis, Petition, Secretary Sebelius, Thank You to Our ME Experts | Comments Off

Spinning Around-CAA Putting Political Spin on the IOM

Posted on October 3, 2013 by Jeannette Burmeister

“A “spin room” …. is an area in which reporters can speak with debate participants and/or their representatives after a debate. The name refers to the fact that the participants will attempt to “spin” or influence the perception of the debate among the assembled reporters.”—Wikipedia

Today, the CFIDS Association of America (CAA) released a statement about its position on the HHS IOM contract. I know people will tell me (again) to stop being surprised. But I do like to give folks the benefit of the doubt and I do tend to be taken aback when something does not add up. And things certainly do not add up here.

First of all, as an organization that announced 2.5 years ago to be “transforming from a patient support and advocacy organization to one laser-focused on stimulating and supporting research,” it sure is knee-deep (emails, phone calls, blog post, Facebook posts) in this advocacy issue, as it has been with others since its big transformation announcement.

But what mainly piques my interest is the fact that the CAA quite obviously is assuming that the IOM contract will go forward despite the fact that the open expert letter is still in place. It is true that Dr. Bateman has, in her statement of yesterday, changed her support for the adoption of the CCC and her opposition to the IOM contract. But apparently, none of the other 34 signatories of the expert letter have followed suit. The letter is still in place and all the other experts are presumably still very much standing by it. One person changed her mind. One! It seems to be an overreaction of the CAA to go from that to “ok, we are done here.” A reaction that is not at all in the patients’ best interest!

Moreover, we have not heard from Secretary Sebelius yet in response to the open expert letter. Why assume that she will not be convinced by the overwhelmingly persuasive argument that it’s unreasonable to spend—in the case of a grossly underfunded disease—around $1 million on an IOM contract (that’s usually a ballpark estimate for IOM contracts) for the creation of a definition by non-experts for which there is no need since we have the expert-endorsed CCC readily available? The CAA is jumping the gun here and one can’t help but wonder if this is an attempt to demoralize patients and advocates and cause them to drop their support of their experts. If the CAA just repeats often enough that the IOM contract is a done deal, it will become a self-fulfilling prophecy because opposition will dwindle.

My plea to patients and advocates out there: Don’t fall for it! The open expert letter is the strongest tool we’ve had in years, maybe ever. Finally, our experts have come together and a majority agrees that the CCC should be adopted (and updated from time to time based on the latest findings) and that the IOM contract should be abandoned. Our experts need our support and gratitude now more than ever. Starting to think about which patient representative should be on the IOM committee is dangerous and exactly what the CAA wants us to do. It’s counter-productive. Instead, it is in our best interest that there be no IOM committee for the creation of a disease definition. Our energy needs to go into making sure of that.

I questioned the CCA’s position on its Facebook page hours ago, but the CAA has not replied. In fact, my comment seems to be no longer on the page. Granted, with the slew of Facebook issues, this could be merely a technical or temporary problem. I don’t know.

The CAA expressed understanding today of patients’ and advocates’ opposition to the IOM contract. However, it does not address the most obvious reason for this opposition, the terribly botched work of the Gulf War Illness (GWI) IOM committee on treatment, which turned a perfectly fine name, Gulf War Illness, into a completely offensive, non-descript, meaningless and, thus, harmful name, chronic multi-symptom illness (CMI), for which it recommended graded-exercise therapy, cognitive-behavioral therapy and antidepressants and which mentioned the same “treatments” for “ME/CFS.” Both Suzanne Vernon, Scientific Director of the CAA, and Fred Friedberg, President of the IACFS/ME, are on the IOM committee for the disease definition of what’s tragically now called CMI. Neither Vernon nor Friedberg are experts on the disease. Both are on the NIH Special Emphasis Panel (SEP) that reviews grant applications for “ME/CFS,” an extremely powerful position to hold. Fred Friedberg is a psychologist who has been receiving signifiant amounts of money from various NIH institutes for the study of coping techniques for “ME/CFS”:*

Fiscal year 2008: $230,603 from NINR, “Fatigue Self Management in Primary Care, Efficacy, Credibility and Economics,” project #: 1R01NR010229-01A1, State University of New York Stony Brook

Fiscal year 2009: $230,603 from NINR, “Fatigue Self Management in Primary Care, Efficacy, Credibility and Economics,” project #: 5R01NR010229-02, State University of New York Stony Brook

Fiscal year 2010: $228,297 from NINR, “Fatigue Self Management in Primary Care, Efficacy, Credibility and Economics,” project #: 5R01NR010229-03, State University of New York Stony Brook

Fiscal year 2011: $259,641 from NINR, “Efficacy of Home-Based Self-Management for Chronic Fatigue,” project #: 2R42NR010496-02, Warren Stress Management”

Fiscal year 2011: $66,864 from NICHD, “Efficacy of Home-Based Self-Management of Chronic Fatigue, ” project#: 2R42NR010496-02, Warren Stress Management

Fiscal year 2013: I am unaware of the amount of funds Dr. Friedberg may have received for fiscal year 2013.

[Update November 1, 2013:

Fiscal year 2007: $99,885 from NINR, “Efficacy of Home-Based Self-Management of Chronic Fatigue, ” project#: 1R41NR010496-01A1, Warren Stress Management

Fiscal year 2012: $340,383 from NINR, “Efficacy of Home-Based Self-Management of Chronic Fatigue, ” project#: 5R42NR010496-03, Warren Stress Management

Fiscal year 2012: $28,041 from NINR, “Efficacy of Home-Based Self-Management of Chronic Fatigue, ” project#: 3R42NR010496-02S1, Warren Stress Management

These amounts are possibly, maybe even likely, not the entire amounts Fred Friedberg received for his study of coping strategies.]

I find it astounding that our government who basically has no money to award to our researchers for bio-medical research has spent these incredible amounts on the study of coping mechanisms, an area that is pretty much “researched out” when what we desperately need is bio-medical research. Can you imagine what Dr. Peterson, e.g., would have been able to do with these kinds of grants researching pathogens, NK cells or cytokines?!

Suzanne Vernon is reportedly about to be appointed to the IOM committee for the “ME/CFS” disease definition, which, if true, creates a conflict of interest for the CAA to have an official position on the issue of the IOM contract at all. Yet, this is also not addressed by today’s CAA statement. If it’s not true, why not say so? I’d love to be wrong on this. If it’s true, why not comment on why, in the CAA’s opinion, this does not create such a conflict? But most importantly, why the quest for so much power over the fate of ME patients in the hands of just two individuals, Suzanne Vernon and Fred Friedberg? With such concentration of power without any checks and balances, why would patients possibly be concerned? Without addressing any substantive concerns, the CAA’s statement is meaningless. It’s spin.

The CAA also, after a lot of pressure from the patient community, made available the letter it sent to the experts. According to the CAA letter, Suzanne Vernon spoke to Dr. Bateman and Dr. Bateman explained her reasoning for changing her position and suggested that Suzanne Vernon contact the other signatories. Curiously (as noted by another alert patient), the copy of the posted letter was addressed to “Cindy.” No other Cindy or Lucinda or Cynthia signed the letter. It seems implausible that Dr. Bateman would have been sent this letter given that it referred to her own position. Just saying.

*****

* I am quoting these numbers and other data to the best of my abilities. The cognitive challenges of this disease make it entirely likely that I transposed some numbers/letters or otherwise not quoted some of the grant information correctly. Should that be the case, please be assured it wasn’t done intentionally.

Posted in Uncategorized | Tagged CAA, CCC, CFIDS Association of America, CFS, Chronic Fatigue Syndrome, chronic multi-system illness, CMI, Dr. Bateman, Fred Friedberg, Gulf War Illness, GWI, HHS, HHS IOM Contract, IACFS/ME, IOM Contract, ME, ME/CFS, Myalgic Encephalomyelitis, Secretary Sebelius, SEP, Special Emphasis Panel, Spin Room, Suzanne Vernon | 26 Comments

Perfect is the Enemy of Good

Posted on October 2, 2013 by Jeannette Burmeister

[Disclaimer: I am not in very good shape and I do not, at the moment, have the stamina some other advocates do. But the recent developments are so monumental that I felt I nevertheless should give my impressions as best as I currently can.]

“Perfect is the Enemy of Good.”—Voltaire

In my last blog post about the CAA putting pressure on the 35 ME experts who, on September 23, 2013, signed an open letter to Secretary Sebelius urging her to adopt the CCC, I predicted that the CAA’s strategy was to get at least one signatory to change his or her mind and to get everything to unravel from there. Because if just one person falters, the unity of the expert community would be broken. Sadly, we just found out that that tactic worked. Dr. Bateman withdrew her support of the open letter this morning. Do I know for sure whether Dr. Batemen changed her mind because of CAA prodding? Of course not. But if the CAA was working in the interest of patients, it would have encouraged the experts to stick to their guns instead of implying that they might want to change their minds.

Dr. Bateman is now “support[ing] the IOM contract instead of advocating that [they] adopt the CFS Canadian Criteria as [their] official clinical definition.” I have to say this is hugely disappointing given that the expert letter “strongly urge[d] [Secretary Sebelius] to abandon efforts to reach out to groups such as the Institute of Medicine (IOM).” So, one could ask oneself why Dr. Bateman signed the letter in the first place then, especially since she is now, in essence, saying that the CCC are not good enough and that “we can do better.” So, basically, she changed her opinion on the entire substance of the letter by 180 degrees in one week. Her decision severely undermines any chance of HHS’s adoption of the CCC without attaching any strings to her support of the IOM contract, like a commitment by HHS to only have ME experts on the committee and nobody from the psych lobby.

I do not mean to call out Dr. Bateman because I have some kind of underlying issue with her. Quite the opposite. I respect Dr. Bateman very much. I even like her. She was there for us all the way in December of last year to testify at the Ampligen advisory committee meeting. I am very sorry about her tragic loss to this terrible illness and I do not believe that she has any agenda here. But that doesn’t make her move any less disappointing or painful or harmful. I would like to acknowledge, and express my gratitude for, Dr. Bateman’s substantial contributions to, and sacrifices for, the ME community in the past. I believe that she is actually coming from a good place trying to effect positive change. Nevertheless, I believe she is misguided and unfortunately, her decision changed the political landscape dramatically, for the worse for patients.

Naïveté about politics will never cease to amaze me. It’s common and it’s deadly. I have seen the we-can-do-better-than-the-CCC argument floating around the Internet. But I am afraid that option is not on the table here. Instead, we have exactly two options:

1. We will convince HHS to adopt the CCC ME disease definition.

2. We will get an ME disease definition by the IOM that revolves around “chronic fatigue” and that will make a mess of things for decades to come.

Are the CCC perfect? No, but perfect is not an option presented to us. The experts already said that the disease definition will continue to be updated over time, like it is with other illnesses. And clearly, the CCC are a much better starting point than “chronic fatigue,” which is what we’ll get from the IOM.

Does anybody really think that the IOM contract is an opportunity to create “evidence based [sic], broadly accepted clinical and research tools, [sic] that can accurately include or identify all subsets of the broad heterogeneous group that present under any case definition of CFS” using biomarkers, as Dr. Bateman suggests? Granted, that would be ideal. But given the history this patient group has with various government agencies, committees, etc., it must be abundantly clear to everybody who has been around this illness and its politics for a while that our best interest is not on the officials’ agenda. This is their opportunity to burry us, like they did with Gulf War Illness (GWI).

There have been two IOM contracts for GWI, the second one currently under way to create a disease definition. Suzanne Vernon of the CAA and Fred Friedberg of the IACFS/ME (both organization are represented on CFSAC) are on the IOM committee for GWI. Note that neither are experts on GWI. There is an unconfirmed rumor that Suzanne Vernon has a relative with GWI and it is conceivable that she has been and will be testifying on the committee as a caregiver. But given that there are 500,000 patients with GWI, the odds that she just happened to be picked as a caregiver “expert” are astronomical, especially since there are said to be plans for her to also be on the IOM committee to define “ME/CFS.”

The first IOM contract addressed treatment for GWI. The committee determined that the best clinical practices for GWI are graded-exercise therapy (GET), cognitive-behavioral therapy (CBT) and antidepressants. The committee’s report of January 2013 also mentioned those same clinical practices for “Chronic Fatigue Syndrome.” The report furthermore introduced the name “chronic multi-system illness (CMI)” to be used instead of GWI. An incredible slap in the face of the men and women who have given up their health and often their families, homes, friends and ability to earn a livelihood, all for this country.

Does any of this sound familiar to anybody? If the government has no problem throwing veterans under the bus, why would they hesitate to do the same or worse to us, given the huge nuisance we are to them. Make no mistake: The IOM contract has the overwhelming potential of leaving us worse off than Fukuda ever did! Let’s not sacrifice “much better” for an illusory “perfect!”

[I asked Dr. Bateman in an email whether she wished to try to change my assessment of events or whether she wanted to comment on my post. She has not replied.]

Posted in Uncategorized | Tagged Canadian Consensus Criteria, CCC, CFS, Chronic Fatigue Syndrome, chronic multi-system illness, Dr. Bateman, Fred Friedberg, Gulf War Illness, GWI, HHS, IOM, ME, ME/CFS, Myalgic Encephalomyelitis, Open Expert Letter, Secretary Sebelius, SMI, Suzanne Vernon | 21 Comments

CFIDS Association Asking Signatories to Withdraw Endorsement of CCC

Posted on September 28, 2013 by Jeannette Burmeister

I know this for a fact, but can’t disclose my source:

The CFIDS Association of America (“CAA”) has contacted at least some, maybe all, of the 35 signatories of the letter addressed to the HHS regarding the adoption of the CCC asking them to withdraw their endorsement of the Canadian Consensus Criteria (“CCC”). Also, Suzanne Vernon/the CAA is a beneficiary of the IOM contract. The CAA sent their requests yesterday and asked the signatories to comply by noon today.

This is puzzling not only because it is directly and brazenly adverse to the patients’ interest, but also because the CAA claims to be purely a research organization now and not an advocacy group anymore. Yeah, right. And the deadline: I mean, really?!

Ms. Vernon’s involvement with the IOM contract is a blatant conflict of interest in asking the signatories to reverse course.

I have to say: It would be hard for me to be more disgusted at this point.

Posted in Uncategorized | Tagged CAA, Canadian Consensus Criteria, CCC, CFIDS Association of America, CFS, HHS, IOM Contract, ME, ME/CFS, Myalgic Encephalomyelitis, San Francisco Chronicle, Suzanne Vernon | 30 Comments

ME Experts Agree on a Case Definition, Call Secretary Sebelius’ Bluff

Posted on September 24, 2013 by Jeannette Burmeister

Those of you who have followed the HHS’ CFSAC meetings know that Secretary Sebelius has, through Dr. Lee, CFSAC’s Designated Federal Official, told the patient community and CFSAC time and time again that HHS is not the proper institution to develop an official case definition for ME. Secretary Sebelius also made it very clear that she and HHS would not accept a case definition suggested by CFSAC. Instead, she insisted on a case definition that comes from the medical community.

So …. yesterday, 35 of the world’s foremost clinicians and researchers have agreed on the use of a case definition (see open letter below), the Canadian Consensus Criteria (CCC), that has been used more and more frequently for years worldwide. The CCC were adopted by an International Consensus Panel consisting of “members [who] have approximately 400 years of both clinical and teaching experience, authored hundreds of peer-reviewed publications, diagnosed or treated approximately 50 000 patients with ME.”

Well, Secretary Sebelius, the ball is in your court now. Ignoring the adoption of an ME case definition by this vast body of ME experts would confirm what most ME patients have long assumed, i.e., that you do not have any interest in advancing research and treatment options for ME. I guess the experts called your bluff. What’s your next move?

And are you really going to waste tax-payer money on the IOM contract for a disease that is absurdly underfunded for a task that is redundant? This would serve no other purpose than to continue the government’s policy and tactic of muddying the waters to prevent any meaningful progress in the field of ME, for a long time to come. You have a chance to prove the patient community wrong by pulling the IOM contract. But do you have the integrity to do so?

An Open Letter to the Honorable Kathleen Sebelius, U.S. Secretary of Health and Human Services

September 23, 2013

Dear Secretary Sebelius,

We are writing as biomedical researchers and clinicians with expertise in the disease of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to inform you that we have reached a consensus on adopting the 2003 Canadian Consensus Criteria (CCC) as the case definition for this disease.

The 1994 International Case Definition (Fukuda et al, 1994), commonly known as the Fukuda definition, was the primary case definition for ME/CFS for almost two decades. However, in recent years expert researchers and clinicians have increasingly used the CCC, as they have recognized that the CCC is a more scientifically accurate description of the disease.

The CCC was developed by an international group of researchers and clinicians with significant expertise in ME research and treatment, and was published in a peer-reviewed journal in 2003 (Carruthers et al, Journal of Chronic Fatigue Syndrome, 2003). Unlike the Fukuda definition, the more up-to-date CCC incorporates the extensive scientific knowledge gained from decades of research. For example, the CCC requires the symptom of post-exertional malaise (PEM), which researchers, clinicians, and patients consider a hallmark of the disease, and which is not a mandatory symptom under the Fukuda definition. The CCC was endorsed in the Primer for Clinical Practitioners published by the International Association of Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (IACFSME). This organization is the major international professional organization concerned with research and patient care in ME/CFS.

The expert biomedical community will continue to refine and update the case definition as scientific knowledge advances; for example, this may include consideration of the 2011 ME International Consensus Criteria (Carruthers et al, Journal of Internal Medicine, 2011). As leading researchers and clinicians in the field, however, we are in agreement that there is sufficient evidence and experience to adopt the CCC now for research and clinical purposes, and that failure to do so will significantly impede research and harm patient care. This step will facilitate our efforts to define the biomarkers, which will be used to further refine the case definition in the future.

We strongly urge the Department of Health and Human Services (HHS) to follow our lead by using the CCC as the sole case definition for ME/CFS in all of the Department’s activities related to this disease.

In addition, we strongly urge you to abandon efforts to reach out to groups such as the Institute of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for ME/CFS. Since the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease. Worse, this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.

ME/CFS patients who have been disabled for decades by this devastating disease need to see the field move forward and there is no time to waste. We believe that our consensus decision on a case definition for this disease will jump start progress and lead to much more rapid advancement in research and care for ME/CFS patients. We look forward to this accelerated progress and stand ready to work with you to increase scientific understanding of the pathophysiology of this disease, educate medical professionals, develop more effective treatments, and eventually find a cure.

Sincerely,

United States Signatories

Dharam V. Ablashi, DVN, MS, Dip Bact. Scientific Director of HHV-6 Foundation Co-founder of IACFS/ME
Santa Barbara, California

Lucinda Bateman, MD
Director, Fatigue Consultation Clinic Executive Director, OFFER
Salt Lake City, Utah

David S. Bell, MD, FAAP
Researcher and Clinician
Associate Professor of Pediatrics State University of New York at Buffalo Lyndonville, New York

Gordon Broderick, PhD
Professor, Center for Psychological Studies Director, Clinical Systems Biology Lab Institute for Neuro Immune Medicine,
Nova Southeastern University
Fort Lauderdale, Florida

Paul R. Cheney, MD, PhD Director, The Cheney Clinic, PA Asheville, North Carolina

John K.S. Chia, MD Researcher and Clinician President, EV Med Research Lomita, California

Kenny L. De Meirleir, MD, PhD
Professor Emeritus Physiology and Medicine (Vrije Universiteit Brussel) Medical Director, Whittemore-Peterson Institute
University of Nevada
Reno, Nevada

Derek Enlander, MD, MRCS, LRCP
Attending Physician
Mount Sinai Medical Center, New York
ME CFS Center, Mount Sinai School of Medicine New York, New York

Mary Ann Fletcher, PhD
Schemel Professor of NeuroImmune Medicine Institute for Neuro Immune Medicine
Nova Southeastern University
Fort Lauderdale, Florida

Ronald Glaser, PhD, FABMR
Director, Institute for Behavioral Medicine Research
Kathryn & Gilbert Mitchell Chair in Medicine
College of Medicine – Distinguished Professor
Professor, Molecular Virology, Immunology and Medical Genetics
Professor, Internal Medicine
Professor, Division of Environment Health Sciences, College of Public Health Institute for Behavioral Medicine Research
Columbus, Ohio

Maureen Hanson, PhD
Liberty Hyde Bailey Professor
Department of Molecular Biology and Genetics Cornell University
Ithaca, New York

Leonard A. Jason, PhD Professor of Psychology DePaul University Chicago, Illinois

Nancy Klimas, MD
Director, Institute for Neuro Immune Medicine Professor, Nova Southeastern University
Fort Lauderdale, Florida

Gudrun Lange, PhD
Clinical Neuropsychologist
Professor, Rutgers New Jersey Medical School Newark, New Jersey

A. Martin Lerner, MD, MACP
Professor, Infectious Diseases
Oakland University William Beaumont School of Medicine
Emeritus Director, Infectious Diseases, Wayne State University School of Medicine Master, American College of Physicians
Reviewer, Viral Diseases, Medical Letter
Beverly Hills, Michigan

Susan Levine, MD
Researcher and Clinician, Private Practice New York, New York
Visiting Fellow, Cornell University
Ithaca, New York

Alan R. Light, PhD
Professor, Department of Anesthesiology and Department of Neurobiology and Anatomy University of Utah
Salt Lake City, Utah

Kathleen C. Light, PhD

Researcher
Professor, Department of Anesthesiology University of Utah School of Medicine Salt Lake City, Utah

Peter G. Medveczky, MD
Professor, Department of Molecular Medicine College of Medicine
University of South Florida
Tampa, Florida

Judy A. Mikovits, PhD Researcher, MAR Consulting, LLC Carlsbad, California

Jose G. Montoya, MD, FACP, FIDSA
Professor of Medicine
Division of Infectious Diseases and Geographic Medicine Stanford University School of Medicine
Stanford, California

James M. Oleske, MD, MPH
François-Xavier Bagnoud Professor of Pediatrics
Director, Division of Pediatrics Allergy, Immunology & Infectious Diseases Department of Pediatrics, Rutgers New Jersey Medical School
Newark, New Jersey

Martin L. Pall, PhD
Professor Emeritus of Biochemistry and Basic Medical Sciences Washington State University
Portland, Oregon

Daniel Peterson, MD
Founder and President of Sierra Internal Medicine Incline Village, Nevada

Richard Podell, MD, MPH
Clinical Professor, Department of Family Medicine UMDNJ Robert Wood Johnson Medical School New Brunswick, New Jersey

Irma Rey, MD
Clinician
Institute for Neuro Immune Medicine Nova Southeastern University
Fort Lauderdale, Florida

Christopher R. Snell, PhD
Professor, Health, Exercise and Sport Sciences University of the Pacific
Stockton, California

Connie Sol, MS, PhDc
Clinical Exercise Physiologist Institute for Neuro Immune Medicine Nova Southeastern University
Fort Lauderdale, Florida

Staci Stevens, MA
Exercise Physiologist Founder, Workwell Foundation Ripon, California

Rosemary A. Underhill, MB BS, MRCOG, FRCSE Independent Researcher
Palm Coast, Florida

Marshall V. Williams, PhD
Professor, Departments of Molecular Virology, Immunology and Medical Genetics; Microbiology The Ohio State University
Columbus, Ohio

International Signatories

Birgitta Evengard MD, PhD
Professor, Division Infectious Diseases Umea University
Umea, Sweden

Sonya Marshall-Gradisnik, PhD
Director, National Centre for Neuroimmunology and Emerging Diseases Griffith Health Institute
Professor, Griffith University Parklands Gold Coast
Queensland, Australia

Charles Shepherd, MB BS
Honorary Medical Adviser to the ME Association London, United Kingdom

Rosamund Vallings MNZM, MB BS IACFS/ME Secretary
Clinician, Howick Health and Medical Clinic Auckland, New Zealand

Cc:

Dr. Howard Koh, Assistant Secretary for Health
Dr. Richard Kronick, Director, Agency for Healthcare Research and Quality
Dr. Thomas Frieden, Director, Centers for Disease Control and Prevention
Ms. Marilyn Tavenner, Administrator, Centers for Medicare and Medicaid Services Dr. Margaret Hamburg, Commissioner, U.S. Food and Drug Administration
Dr. Mary Wakefield, Administrator, Health Resources and Services Administration Dr. Francis Collins, Director, National Institutes of Health
Ms. Carolyn W. Colvin, Commissioner, Social Security Administration

Posted in Uncategorized | Tagged An Open Letter to the Honorable Kathleen Sebelius, Canadian Consensus Criteria, CCC, CFS, Chronic Fatigue Syndrome, Institute of Medicine, IOM, ME, Myalgic Encephalomyelitis, Secretary Sebelius | 12 Comments

Thoughts on the May 2013 CFSAC Meeting

Posted on May 25, 2013 by Jeannette Burmeister

I’ll have a lot more thoughts about this week’s CFSAC meeting in Washington, D.C. once I get a chance to watch the videos because I wasn’t well enough to take notes or attend (or closely follow) the entire meeting. But here are a few comments about some profound moments I witnessed that stuck in my head even without notes.

The Preparation

First, let me explain why I have been quite sick since Monday and, therefore, missed parts of the meeting. I signed up for in-person testimony at the CFSAC meeting on May 1^st, 2013, on the same day the CFSAC mailing list notified folks that the Federal Register Notice was up online. (The notice itself is dated April 30^th, 2013.) The deadline for registering was May 15^th. Almost immediately after signing up for my in-person testimony, I received the following confirmation email:

From: CFSACMay2013@seamoncorporation.com

Subject: Registration Notification – Chronic Fatigue Syndrome Advisory Committee (CFSAC) Meeting: Jeannette B.

Date: May 1, 2013 2:40:27 PM PDT

To: Jeannette.B@xxx

Jeannette B.:

Thank you for your registration.

We look forward to your attendance at the Chronic Fatigue Syndrome Advisory Committee (CFSAC) Meeting being held May 22–23, 2013 at the Hubert H. Humphrey Building in Washington, DC.

Should you have any questions or require additional assistance, please contact CFSACMay2013@seamoncorporation.com.

According to the Federal Register Notice, speakers were to be notified by May 17^th, 2013, a Friday, of their assigned speaking time. Moreover, the notice stated, “We will give priority to individuals who have not provided public comment within the previous year.” Since I had never spoken at CFSAC, I figured there would be no issue with my getting a speaking slot. When I didn’t hear anything by the end of business on the 17^th, yet had heard that other patients who have testified within the last year and many times before did get an email notifying them of their time slot, I sent an message to the above CFSAC email address inquiring about my time slot. Here it was Friday night and I was going to leave on a $3,000 trip on Monday evening and yet did not know whether I would even get a chance to speak.

The next morning, Saturday, I received a reply in an unsigned email claiming that I had signed up for written testimony only, that the anonymous sender of the reply would check with the CFSAC support team to see if they could fit me in and let me know on Monday. I replied to that email as soon as I woke up on Saturday clarifying that it is absolutely not true that I only signed up for written testimony and that, in fact, I had indicated a preference for speaking on the first day during sign-up. I am 100% certain that I signed up for in-person testimony and the above email proves it. The language, “We look forward to your attendance at the Chronic Fatigue Syndrome Advisory Committee (CFSAC) Meeting being held May 22–23, 2013 at the Hubert H. Humphrey Building in Washington, DC” can hardly be interpreted as “We look forward to reading your written testimony.” Having followed the sign-up instructions perfectly and having received an email basically confirming that I would get to speak, I was stunned. I waited for hours, but didn’t hear back.

Finally, I sent emails to Dr. Nancy Lee, designated federal officer at CFSAC, Dr. Gailen Marshall, chair of the committee and Dr. Howard Koh, assistant secretary for health asking that this be straightened out right away, as I could not possibly wait until Monday with packing given that I would get my Ampligen infusion that morning and then had to rest up for the remainder of the day before leaving that evening. It would seem obvious to everybody who knows anything about ME that patients cannot wait with their packing for a several-days, across-country trip until the day of travel. I wasn’t going to make the exhausting and expensive trip without a confirmed speaking slot and I wasn’t going to waste precious energy on packing and unpacking should it turn out that I would not get to speak.

I received no reply from Dr. Lee or Dr. Koh. Dr. Marshall replied quite graciously on Sunday afternoon; apparently he had been away from his email and, in any event, the decision about who gets to speak falls, according to him, into Dr. Lee’s purview, but he was going to see what he could do. This gave me enough comfort to assume that I would be able to give my testimony in person, so that afternoon I started packing. Long story short, that was way too late and I ended up overdoing and woke up very sick with PENE (PEM) on Monday. I seriously considered canceling the trip, but was hoping that I would feel better on Tuesday or the following days, but that never happened. I had to ask friends to drive me to and from the airport because I was unable to do so myself. The whole trip and time spent in D.C. and even now still, I feel so much sicker than I did a week ago.

Bob Miller made this point in Bethesda last month and proof that he was right was staring me straight in the fact: No matter how often they tell us that they get it, they really have no clue. First of all, notifying participants on a Friday with no way of reaching the people who organize CFSAC, the Seamon Corporation, over the weekend regarding a meeting for which folks will leave on Monday or Tuesday is a recipe for disaster. Also, may I suggest that the confirmation email after sign-up in the future specifically spell out whether somebody is signed up for written testimony only, for testimony via phone or for testimony in person. That way, “misunderstandings” (i.e., mistakes) can be corrected in a timely manner without causing patients any bodily or financial harm. I did not appreciate being made to feel like they were doing me a favor fitting me. There was no apology for what I was put through by being forced to pack way too quickly for what my body can handle and for what ultimately caused a flare-up of my symptoms, merely a “sorry for the confusion.” Unfortunately, the mistake caused a lot more than confusion. It caused a deterioration of my health. There seemed to be no appreciation of, or regret over, that.

In CFSAC’s defense, the issue was ultimately resolved and I did get to speak. And the mistake seems to have been made by the Seamon Corporation, the company that the organization of the meeting is outsourced to. But hiring a third-party to do a government job doesn’t indemnify the government from liability for mistakes made by the third party

The Meeting

Again, these are just some highlights of the meeting for now:

Dr. Unger

Some people say that Dr. Unger would like to do more for us, but her hands are tied by her boss. I have no way of knowing whether that is true, but she did vote “yes” on one of the four Ampligen questions during the December FDA Advisory Committee. I do see her actively engaged in the conversation and often responding intelligently. Dr. Unger is not a case of not getting it, I don’t think. Having said that, she has a talent for saying things that are absolutely infuriating and/or classic government hot hair.

Two things come to mind from this last meeting. It was reported that she defended inappropriate pictures used for continuing medical education on ME purporting to portray ME patients, pictures that are misleading and outright harmful because they downplay the seriousness of the disease. You know the kind of pictures I am talking about: Employees with well-coiffed hair collapsed into their filing cabinet—whether or not from a hang-over or a serious neuro-immune disease is anybody’s guess, although the latter is unlikely given their well-groomed appearance. Dr. Unger’s rationale for using those types of pictures was said to be an attempt to portray a more positive side of the illness. Come again? What positive side? Have I missed out on the perks of having this crushing illness all these years?

Dr. Unger outdid herself with her comment that the CDC is not endorsing the Canadian case definition because physicians are frightened by its complexity. Wow! I nearly burst out laughing when I heard that. How did these poor physicians make it through medical school? And did Dr. Unger ever consider that getting the point across to medical doctors that ME is a very complex illness is actually a good thing?! It might keep them from harming patients by prescribing the wrong treatment, something that happens every day and damages people’s health irreparably. Maybe those “frightened” physicians are more likely to refer their very sick patients to a specialist who knows how to treat ME properly. And some may even learn a thing or two. Is that too straightforward of a concept for the CDC?

Dr. Maier

Dr. Maier crossed the border to surreal a couple of times. She kept insisting that the low level of NIH funding for the disease was merely due to the fact that not enough grants were applied for. Yet, we have heard from many (potential) investigators that their ME grant applications are almost always, and pretty much reliably, denied. Dr. Klimas gets one out of eight ME grants approved, which is in stark contrast to her Gulf War Syndrome research work, which gets funded at a much higher rate. And what kind of argument is this anyway: Let’s assume ME researchers submit for a bunch of ME grants that are not of high quality. Are they going to get more money just because of the higher volume of applications? I may be too exhausted from the trip, but this makes absolutely no sense to me.

Later, Dr. Maier delivered an extremely disingenuous “explanation” for why the NIH has not been funding any Ampligen studies: Because Ampligen is under patent and nobody but Hemispherx is legally in a position to study the drug. I felt like I was being talked to like a first-grader. Of course, Ampligen is patented. The patient community’s suggestion has been for the NIH to work with the sponsor, Hemispherx, or get its permission to do the FDA-required trial. Does Dr. Maier really think that the company would turn down NIH money if offered. Now, in all fairness, some strange things have come out of Hemispherx, so maybe it would, unlikely as it is. But how about making the funding of an Ampligen trial by the NIH an option given that the drug will likely disappear without it? That would be a good way of getting advocates of the NIH’s back. Just saying.

Maybe the second most disturbing moment of the meeting (the most disturbing one to be mentioned below) came when Dr. Maier, seemingly in response to something Dr. Fletcher had said (but I need to watch the recordings to make sure I am correct here) that it has been hard for her to be on the committee and that she is sick of being misquoted and then pretty much lost it by saying, “I have worked every freakin’ weekend since February.” I know a thing or two about working every “freakin” day of the year. But I would have never made that point to my clients because, frankly, that would have been unprofessional. Such self-pitying outburst in the face of unending patient suffering—suffering that doesn’t take a break for weekends, that lasts for weeks, months, years, decades—was plain grotesque.

“Chronic Fatigue”

On the second day, Eileen Holderman, the patient representative on the committee, made a very eloquent and passionate, yet professional plea to the committee to stop using the phrase “chronic fatigue,” a point I had made in my testimony a day earlier. It is bad enough to be labeled with “chronic fatigue syndrome,” but “chronic fatigue” is such a crushing insult. Eileen wondered out loud how diabetes patients would feel if one of the symptoms of diabetes, chronic thirst, was taken and turned into the disease name, “chronic thirst syndrome” despite having a number of other serious symptoms, maybe even amputeed limbs. This was a powerful analogy and yet the committee went on to use “chronic fatigue” for the rest of the day, as they had done before. Surreal.

Eileen Holderman

The most troublesome moment started when Dr. Marshall called Eileen “out of order” and Eileen disagreed. I missed the beginning of that interaction, so I don’t know exactly what was going on right then. But Eileen, visibly shook up, proceeded to talk about feeling threatened (together with two other committee members, one of whom is Dr. Fletcher) by lawyers and the designated federal officer (Dr. Lee) and afraid to speak out. She said she felt shut down whenever her viewpoint was inconvenient. It was quite obvious that Eileen was speaking from the heart and that a lot had gone on behind the scenes that we don’t know about. But Eileen did seem genuinely scared.

I don’t know Dr. Marshall, but he seems like a reasonable man who is often on our side. And in his defense, it was towards the end of the meeting and he was rushing to get through the required agenda items. Yet, this exchange was probably not one of his prouder moments, especially since he didn’t call Dr. Maier out during her inappropriate, and clearly out of order, pity party.

Take-Away

I got the strong feeling that there are at least some members on the committee, e.g., Alaine Perry, Dr. Mary Ann Fletcher and Steve Krafchick, who are fighting for us, besides Eileen. I know patients are frustrated with CFSAC and how little it has accomplished over all these years. I imagine that some of the committee members are frustrated, too, by being completely ignored by Secretary Sebelius. So, I would caution against alienating everybody who is genuinely trying to help us. Let’s remember that Dr. Marshall voted for Ampligen all the way. That was huge. Let’s see how things shake out between him, Dr. Lee and Eileen. I hope whatever is going on can be solved amicably to everybody’s satisfaction. But if our patient advocate is being intimidated, then this committee has lost all its integrity.

PS (added May 26th): The more I think about the fact that at least some of the committee members continued to use “chronic fatigue” after having been told by at least two patients during the meeting how derogatory and harmful it is, the more it makes me wonder what the point of it all is. If we can’t even get “our” committee to “go the extra mile” and add on one little word, “syndrome,” then how much hope is there that they are really interested in helping us? How hard is it to use the full name after having just been told that it is a matter of respect and integrity and responsibility?

And here is a radical idea: What if all of our clinician and research experts just started using the term “ME,” as recommended in the recent International Consensus Criteria supported by an “International Consensus Panel consisting of clinicians, researchers, teaching faculty and an independent patient advocate” representing “thirteen countries,” “approximately 400 years of both clinical and teaching experience” as well “hundreds of peer-reviewed publications.” Those folks have diagnosed or treated approximately 50,000 patients with ME!

If they (and we) all just started using it, then the media would follow suit and the many non-experts would as well if for no other reasons than the fact that we live in the age of political correctness. We could solve the “name debate” almost over night. This is how powerful it would be if CFSAC and our experts were putting a little more effort into being disciplined when it comes to the name. This is not rocket science. Imagine how much credibility this patient population could gain almost instantaneously?! Given how much harm the name “CFS” has caused, it is hard to believe that all these smart folks would fail to recognize their responsibility here. Sometimes, somebody has to stick their neck out even if it’s not comfortable. But it’s the right thing to do.

The same really applies to the case definition. We have two sophisticated case definitions, the CCC and the ICC, and yet everybody seems to be insisting on the much more harmful Fukuda or Oxford definitions while fully aware of how much this holds us back and how much real harm it does. All Dr. Unger seems concerned about is to protect physicians from complexity. I think in that spirit, we should stop doing open heart or brain surgeries because, surely, that is very taxing on physicians as well. This all just so grotesque.

Posted in Uncategorized | Tagged Alaine Perry, Ampligen, Bob Miller, Case Definition, CFS, Chronic Fatigue Syndrome, Dr. Elizabeth Unger, Dr. Gailen Marshall, Dr. Howard Koh, Dr. Mary Ann Fletcher, Dr. Nancy Lee, Dr. Susan Maier, Eileen Holderman, FDA, Hemispherx, May 2013 CFSAC, ME, ME/CFS, Myalgic Encephalomyelitis, NIH, out of order, Seamon Corporation, Steven Krafchick | 38 Comments

Mary Dimmock’s May 2013 CFSAC Testimony

Posted on May 23, 2013 by Jeannette Burmeister

Patients have been asking where they can find Mary Dimmock’s CFSAC testimony from today and she has graciously agreed for me to publish it here.

I have a few things to say about this CFSAC meeting, but I need to decompress a bit for now. In the meantime, here is Mary’s testimony:

Mary Dimmock CFSAC Meeting Testimony May 2013

Good morning.

First, I wish to thank the FDA for creating an opportunity with the potential to change the future for ME. We look forward to seeing your action plans. Please share them in a follow-up teleconference modeled after your fall teleconference.

I especially want to thank all the patients who participated at a considerable cost to their well-being. Through you, people began to see how hellish this disease really is.

For me, the biggest lesson of the FDA meeting is that we are not going anywhere until we address the fundamentals – the definition and funding for needed research.

About the definition…

We have all heard the story of babel – people of the world divided because of different languages. Different words for the same thing. But there is a different kind of babel that is more insidious because it is harder to recognize. The babel when you use the same word but mean very different things. And that is exactly the situation we have with “CFS” – the same label applied to very diverse definitions and conditions.

CDC states that Oxford, Fukuda, Canadian and the ME-ICC “identify similar pools of patients”. But Fukuda does not require PEM and Oxford only requires 6 months of fatigue and allows psychiatric illness. Numerous studies have shown that these definitions are not all the same patients. Yes, ME is heterogeneous but this heterogeneity is a manufactured artifact of inappropriately combining all these diverse definitions and conditions into one clinical entity called CFS.

Beyond that, there is a mixing and matching of studies across definitions with the CDC using Oxford studies to support recommendations like CBT for all “CFS” patients. There are evidence based literature reviews that do the same. And then there are all those diverse theories of what CFS is – false illness beliefs, deconditioning, maladaptive personalities, bad nutrition, excessive rest, any unexplained chronic fatigue. You may say you reject these extreme views. But the reality is that patients live in a world that indiscriminately absorbs all these views, leaving their doctors, employers and families thinking that “CFS” is psychiatric, not real, not serious and perpetuated because patients are unwillingness to exercise. Even an FDA Advisory Committee member asked how the efficacy of Ampligen compared to CBT. Would he have asked that of a cancer drug?

I worked for a pharmaceutical company for 31 years and with all due respect to those present, this is sloppy science. It has impeded ME research, stalled ME drug development and negatively impacted clinical guidance for ME patients. Worse, patients have paid a terrible price in harmful treatments, stigma and disbelief. They continue to pay the price every single day.

Do any of us sitting here really believe that we need more study before we accept that PEM has been proven as real and measurable? Before we accept that PEM differentiates a group of very sick patients who need to be studied and treated separately from patients whose only symptom is 6 months of chronic fatigue or Fukuda without PEM? We must stop this confusion – this babel – immediately.

To that end, a group of patient organizations and advocates sent a letter to Secretary Sebelius and Drs. Frieden, Collins and Koh calling on DHHS to resolve this issue. Stop using the term “CFS” as a “one size fits all” umbrella for so many diverse definitions and conditions. Adopt the Canadian Consensus Criteria as a disease appropriate definition now and work to improve it. We look forward to a considered dialog and response on this. And if you are going to progress CFSAC recommendations with workgroups, then I’d recommend it would be wise to look at all DHHS definition efforts, not just CFSAC’s definition recommendation.

The second issue from the FDA meeting was the need for research to validate outcome measures, agree to biomarkers and perform the initial clinical trials in order to fuel pharmaceutical interest. And that is going to require money.

We have heard that the science isn’t ready, that researchers are not interested, that good proposals are not being submitted, that NIH doesn’t fund those kinds of studies, that money is tight. But with what we learned at the FDA, from our researchers and from other disease areas, we don’t believe these barriers cant be readily overcome with leadership.

About tight budgets and sequestration… At $3.7M, 2012 funding for this disease is 3% of the funding for multiple sclerosis, a disease with a similar level of disease burden. Funding for this disease is far, far below what would be expected based on burden of disease or economic impact. This is about a fair share of what funding is available.

The opportunities to change the future are palpable. But contrary to Mr. Munos’s suggestion at the FDA meeting, patients are too stigmatized, impoverished and terribly ill to come up with the funding to solve these challenges on their own. They already pay with their lives and with $18-23B a year in lost productivity and direct medical costs. If there ever was a time for the NIH to step up to the plate, it is now. Use the approaches used in other disease areas to foster the needed investments and collaborations. Use RFAs to encourage applications and get the needed studies done. Provide funding that is commensurate with the disease burden and economic impact. Use your power, influence and position to make it happen. Today. No more excuses.

Thank you for the opportunity to talk to you.

The NIH testimony above was shortened to read the following comments that came in from a patient expressing her frustration with the meeting:

The disconnect between my sense of urgency for treatments and a cure to get my life back after 23 years with this disease and their totally lackadaisical manner and approach to everything discussed makes me totally feel like giving up. This meeting is a stark reminder that I am alone. I’m stuck with this illness for the rest of my life, just staring at my ceiling from my bed.

Posted in Uncategorized | Tagged Canadian Consensus Criteraia, CFS, CFSAC May 2013, definition, FDA, Mary Dimmock, ME, ME/CFS, NIH, Oxford, PEM | 5 Comments

My Oral May 2013 CFSAC Testimony

Posted on May 22, 2013 by Jeannette Burmeister

My name is Jeannette B. I am relatively new to the advocacy world and I don’t have all the Washington insider lingo down yet. So, instead of “FDA” or “NIH,” I will probably say “the FDA” or “the NIH.” And since I am new here, let me just quickly explain that I personally cannot bring myself to use the demeaning, dismissive and ridiculing name “CFS” or even worse, “chronic fatigue,” for a disease that robs patients of virtually everything that makes life worth living

There are three reasons for the fact that I am able to be here today and that I am able to be play any role at all in Aimee’s life, my almost 3-year old daughter: 1. Ampligen. 2. My husband, Ed, who insisted that I give Ampligen a try when I was ready to give up. 3. Dr. Dan Peterson.

There are two people in this room whom I could not feel more grateful towards and they are Alaine Perry and Dr. Gailen Marshall. Ms. Perry and Dr. Marshall, you voted “yes” on all four questions regarding the recommendation for the approval of Ampligen during the FDA advisory committee meeting on December 20 of last year. The committee opined that the drug is safe. You were part of a minority on the committee that also found that the drug is effective. Many of those on the committee who weren’t convinced of its efficacy—after a very antagonistic FDA presentation that, among many other things, counted symptoms of the disease and even a pre-existing case of cancer, as side effects, that faulted Ampligen for not being a cure (unlike diabetes, blood pressure, thyroid and other meds, I guess) and that denied the sponsor the opportunity for a rebuttal—felt that there is something there that is worth looking into further. Why are some patients responding to Ampligen and others are not, something that, by the way, can be said for many, if not all, drugs? Clearly, what we have here is a sub-group of patients and I am blessed to be a model responder. Why is nobody interested in digging deeper into this potentially game-changing break and finding out why I respond and a friend of mine does not? All this talk about the government’s commitment to making progress for ME: show us that you mean it! We have a huge piece of the puzzle right in front of us and that piece is Ampligen. Let’s run the course with it. It’s not like there are all these other exciting drugs waiting in the wings that Ampligen would take resources away from.

Are we really going to watch a safe drug that is extremely effective for a sub-group of patients go away forever? We are talking about a drug for a disease that has no other treatment and none on the horizon, for a disease that is gravely disabling. Could this possibly make sense to anybody? I mean really! Anybody?

Is the sponsor of Ampligen, Hemispherx, the perfect drug company, whatever that means? Maybe not. But does the drug work? Absolutely, for a maybe significant sub-group. And is it safe? You bet! Even the FDA’s own advisory committee said so. So, for crying out loud, FDA, work with the sponsor to get the efficacy information that you wish to see. And since the sponsor doesn’t have the financial resources for a new trial, let’s get the NIH to help finance that trial that will produce that information. Because if you don’t, future suicides are all but guaranteed!

I attended a very impressive FDA Drug Development Meeting for ME last month and I want to express my sincere gratitude to RADM Kweder and her team for a job very well done. But what we need now are concrete results and some tangible progress. I do feel like we made some ever-so-slight progress at the April meeting. The avalanche of epiphany moments being had by the FDA officials trying to take in the patients’ description of the suffering and the symptoms was oddly shocking and gratifying at the same time.

As an Ampligen patient with astonishing results on the drug, it was quite bittersweet to hear the clinical team leader of the FDA division responsible for not approving Ampligen in February of this year, Dr. Theresa Michele, admit, and stress, that she had not previously been aware of the symptoms of ME as clearly as she was as a result of listening to patients’ testimony at the April meeting. I cannot help but wonder if the decision not to approve Ampligen might have differed had there been a clearer understanding of the seriousness of the disease by the FDA before the decision was made. Given that Ampligen is in grave danger of disappearing as a direct result of the denied FDA approval and the resulting very real risk of the sponsor’s bankruptcy, a predicament the FDA is well aware of, it’s almost intolerable to think that thousands or maybe hundreds of thousands of patients could be helped by an existing safe and effective drug had there just been more understanding of the disease.

Posted in Uncategorized | Tagged Alaine Perry, Ampligen, CFS, CFSAC, Chronic Fatigue Syndrome, Dr. Gailen Marshall, Dr. Theresa Michele, May 2013 CFSAC, ME, ME/CFS, Myalgic Encephalomyelitis, RADM Kweder | 10 Comments

Thoughts About M.E.

Sebelius “Responds” to the Experts: “You Mean This Is Not What You Wanted?”

Call for the HHS Competition Advocate to Investigate the IOM Contract

The CFSAC Plot Thickens: A Tone-Deaf, Disrespectful State of Affairs

Supplemental Request for Investigation by OIG: Did DHHS Violate its No-Bid-Contract Requirements for IOM Contract?

Inquiring Minds Want to Know: Who is Behind the IOM FAQs?

Call for Investigation by the Inspector General of the IOM’s Conflict of Interest With Respect to ME/CFS

Overwhelming, Growing Support of ME Experts by Advocates in Opposition to IOM Contract: Advocates’ Open Letter Re-Sent With Additional Signatures

66 ME/CFS Advocates Send Letter to Secretary Sebelius in Support of their Experts

16 Additional ME/CFS Experts Added Signatures to Open CCC/IOM Letter to Sebelius

November 2013 CFSAC Meeting: 3 Weeks before Meeting, Information for Patients Still Outstanding

Principled Approach: Fighting the IOM Contract is a Moral Imperative

More Propaganda: Still no Explanation from CAA for Disagreeing with Experts and Patient Majority

Please Sign Petition: Thank You to Our ME Experts

Spinning Around-CAA Putting Political Spin on the IOM

Perfect is the Enemy of Good

CFIDS Association Asking Signatories to Withdraw Endorsement of CCC

ME Experts Agree on a Case Definition, Call Secretary Sebelius’ Bluff

Thoughts on the May 2013 CFSAC Meeting

Mary Dimmock’s May 2013 CFSAC Testimony

My Oral May 2013 CFSAC Testimony

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