Thunderclap to Oppose the IOM, Support the CCC: Let Our Voices be Heard Loud and Clear

The next IOM meeting will be held on May 5th and 6th.  A whooping one fourth of the meeting is open to the public’s listening in. No public participation is allowed, except for comments by a few, hand select people. But we can still make our opposition to the IOM “study” and our support for the CCC heard loud and clear during that meeting by participating in the Thunderclap campaign that will run on the morning of the first day of the next IOM meeting. It’s very easy. Below are step-by-step instructions.

What is Thunderclap?

Thunderclap is a crowd-speaking platform that amplifies messages by allowing large groups of people to share a single message together at the same time by pledging to Twitter and/or Facebook and/or Tumblr a message that will be broadcast at the exact same time in order to achieve maximum effect. It’s like an online flash mob. By using Thunderclap, our reach on social media will be far broader than it would be if we were simply posting on Twitter, Facebook and Tumblr without Thunderclap.

Thanks to Wendy Boutilier and Sally KeelaToo Burch for the graphic and to Fred Smith for allowing us to use her YouTube video. And thanks to everybody who has already participated and is promoting this effort. It’s very much appreciated.

Instructions

Go to the Thunderclap page here https://www.thunderclap.it/projects/10666-stop-the-iom-adopt-the-ccc

Facebook

Click on “Support with Facebook.” If you are signed into Facebook, click on “Add my support.” (If you are not signed into Facebook, Thunderclap will ask you to do so as one of the required steps.) If you wish, you can personalize the message that will appear on your FB wall on May 5th under “Make it your own! Add a custom message” or you can just leave the message unedited, which is a good option for folks with cognitive impairment or healthy friends and relatives with busy lives or are not totally familiar with the issue.

The next window that opens requires you to agree to the Thunderclap app. Simply click “okay” if you are in fact ok with that.

If you want to get updates about this Thunderclap campaign (from me), you can then enter your email address. That will allow me to let you know of milestones we achieved. This is entirely optional. If you do not wish to receive updates, just click on “No thanks.” If you do want to sign up for updates about this particular Thunderclap campaign, I suggest you opt out of “Keep me updated on other news and developments from Thunderclap” simply by unchecking that box in order to keep your inbox clutter down.

The last step is to share with your Facebook friends that you supported the Thunderclap campaign. Promoting the campaign that way goes a long way in gaining additional supporters. Again, you can simply click on “Share” or customize your message. (This is a different message than the one that will go out on May 5th, which you can find towards the end of this post. The message in this step just lets people know about the upcoming Thunderclap on May 5th.)

If that was successful, the blue Facebook button will turn grey indicating that you no longer have the option of supporting this campaign using FB. This way, Thunderclap prevents people from cheating by supporting the cause more than once using the same platform, in this case Facebook.

Some people have reported that their support “didn’t take.” So, it’s a good idea–after refreshing the page–to scroll down on the Thunderclap page and check under “Recent Supporters.” If your name does not appear there, something went wrong and you should try again. Your name will get pushed down as others support the campaign, so it’s best to check right away after you completed the above steps.

Twitter

If you have a Twitter account, please support the Thunderclap using Twitter AS WELL, i.e., even if you already supported via Facebook. Simply click on the Twitter button on the Thunderclap page under “Support With.” You can either just click on “Add my support” and leave the tweet that will go our on May 5th as is or customize it and then click on “Add my support.”

You then have to authorize the Thunderclap app.

Then “spread the word” on Twitter that you are participating in this Thunderclap by clicking on the “Tweet” button. You can customize the message that goes out to your followers to let them know about your participation or leave the tweet as is. Click “tweet” again in the window that opens and you are done. (This is a different message than the one that will go out on May 5th, which you can find towards the end of this post. The message in this step just lets people know about the upcoming Thunderclap on May 5th.)

And once more, you get the choice of receiving updates from the campaign and Thunderclap. Both are optional and I would recommend you un-check the button for Thunderclap developments. Please see above under “Facebook” for more info.

Then refresh the page and if all went well, the Twitter button will now be grey. You can confirm that your Twitter support “took” by checking if your name appears under “Recent Supporters.”

Note

If you used both Facebook and Twitter, your name should appear under “Recent Supporters” twice. Most people use a different profile picture for Facebook than for Twitter (avatar). This is a good way to tell which method of support might not have worked if there was a problem and try again.

Tumblr

I do not have a Tumblr account, so I can’t walk you through the steps for that. But I imagine it is similarly easy as Facebook and Twitter.

Keep Sharing

Please keep sharing this Thunderclap campaign between now and May 5th. If everybody tries to get at least three additional people to sign up and those people, in turn, try to get at least 3 people involved, we can make a real splash during the IOM meeting. Send emails to friends or family members that you know are supportive. Share on Facebook and Twitter frequently. This is a very easy way for healthy folks to help our cause. The Thunderclap website explains the reason for our opposition to the IOM “study” and our support of the CCC.

What happens on May 5th?

At 9am on May 5th, the morning of the first day of the next IOM meeting, the following message will be shared on your Facebook wall and/or your Twitter feed:

“Stop IOM non-experts from defining #MECFS! Adopt CCC per experts! Stop org COI. #StopIOM #AdoptCCC #HHS http://thndr.it/1i99XF3

Question?

Please do not hesitate to contact me with questions you might have regarding this campaign or if you run into trouble with the Thunderclap website. It’s easier than it looks, but brain fog can play tricks on us sometimes. I am very happy to help.

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Now You See It, Now You Don’t: HHS Covers Up Flawed IOM Contracting Procedure

In January of this year, I questioned the compliance of the IOM task order with the requirements of the NIH/NAS umbrella contract under which the task order was issued. I had found information on a website of the Office of Science Policy and Analysis—which I linked to in my blog post about the issue—according to which any task order to be awarded under that contract must “[r]esolve all questions about the scope … of the activity.” Yet, one of the first IOM meeting’s agenda items was to “clarify the scope of the charge.” So, it would seem that at least one of the requirements of the umbrella contract wasn’t met with respect to the IOM task order, which would explain the secrecy and manufactured urgency regarding the contracting process.

Imagine my surprise when I clicked on that link [http://ospa.od.nih.gov/nac.html] today and got automatically redirected to a completely unrelated site of the Office of Science Management and Reporting [http://osp.od.nih.gov/office-science-management-and-reporting] that contained no information about the umbrella contract. That information completely disappeared. But guess what! I have a scanned print-out: Office of Science Policy and Analysis_Umbrella_K_RequirementsHere is a screen shot of what you see when you click on the original link now:

Office_Science_Management_Reporting

Is anybody still denying that something fishy is going on with this IOM contract? And is anybody still arguing that there is any way that this over-the-top secrecy is innocent? Why would HHS make the information disappear from the Internet after I pointed out the contracting-process issue? What else are they hiding?

One thing that comes to mind is that the request for proposal, which is also clearly required under the umbrella contract (see requirements in the first image above), seems to have never been prepared. Why else would the statement of work be titled “Statement of Work/Request for Proposal.” Logically and from a proper contract-drafting perspective, the request for proposal has to come before the statement of work by necessity. It is ludicrous to have both sets of terms be in the the same legal document.

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IOM-OCI-OIG … OMG!

The organizational conflict of interest (OCI) of the Institute of Medicine (IOM) in the ME/CFS case-definition study is as obvious as it gets. The IOM, as an institution, has given its opinion about the diagnostic criteria for ME/CFS various times in the past in its Gulf War Illness reports. The IOM’s objectivity is therefore impaired, the definition of an OCI. Every lawyer with any analytical skills can see that.

However, the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) whose mission it is “to protect the integrity of [HHS] programs” continues to provide cover for the IOM by stonewalling and simply replying in an evasive manner and dodging the problem altogether, at the taxpayer bill of $1 million, despite my raising it three times in the past. Please see here, here and here for my prior letters.

Here is my latest attempt to at least get some kind of substantive reply from the OIG. Several congressional offices have started to show real interest in the issue. Stay tuned.

April 4, 2014

Re: Organizational Conflict of Interest of the IOM in ME/CFS Study, Second Follow-up Request

Dear Ms. Cummings:

I note your failure to reply to my letter of January 7, 2014 (attached), almost three months ago, specifically requesting that your office address the organizational conflict of interest (“OCI”) of the Institute of Medicine (“IOM”) with respect to the IOM study for diagnostic criteria for ME/CFS (“ME/CFS IOM Study”) in a substantive way, as opposed to providing a mere conclusionary statement without giving any valid explanation of how you arrived at your conclusion—as you have done in your letter of December 30, 2013—taking into account the analysis of the OCI that I am providing to your office for the third time now. You prior letter was entirely non-responsive to that issue and, in fact, dodged it altogether.

I want to assure you again that this issue is of the utmost importance, as the ME/CFS IOM Study presents the very real potential for disastrous consequences for the ME/CFS patient community, as I described again in my letter of January 7, 2014. Members of Congress and the media have been, and continue to be, made aware of this crucial issue and your failure to respond.

On page 2 of my initial letter to your office of November 11, 2013 (attached), I gave you several examples of how the IOM addressed the case definition, symptoms and treatment modalities for ME/CFS in its 2013 Gulf War Illness (“GWI”) report.[1] While the IOM ME/CFS Study’s scope does not include treatment, my letter explained how treatment recommendations inform the case definition for ME/CFS and how the two issues are inseparably intertwined due to the complex nature and the particulars of the disease.

I want to raise for your further consideration, in evaluating the IOM OCI with respect to the ME/CFS IOM Study, the issuance of yet another IOM report on GWI since my last letter to you, this one reviewing the case definition, just like the currently ongoing ME/CFS IOM Study. On March 12, 2014, the IOM released its report “Chronic Multisyptom Illness in Gulf War Veterans: Case Definitions Re-examined” (“IOM 2014 Gulf War Illness Report”).[2] This report—the final content of which, according to the report itself, “rests entirely with the author committee and the institution [IOM],” as have the previous IOM GWI reports—again contains specific findings with respect to diagnostic criteria for ME/CFS, the very topic the IOM is charged with under the ME/CFS IOM Study. You will find the relevant discussion mostly on pages 26-27 of the IOM 2014 Gulf War Illness Report, which, among other statements, asserts the following:

  • There are no “confirmatory physical signs or laboratory findings” for ME/CFS.
  • There is “no accurate diagnostic test or proven treatment” for ME/CFS. (The latter point is of particular interest, as there are a number of effective treatments for the disease. Any assertion to the contrary constitutes bootstrapping of the failure of the FDA’s approval of such treatments. The FDA’s failure to act and approve available treatments is detrimental to the patient community enough without making it part of the official case definition for ME/CFS and, thus, giving insurance companies an excuse to deny coverage for effective treatments.)
  • “There is no validated diagnostic test” for ME/CFS.
  • ME/CFS should be considered both a mental and physical disorder.

The foregoing conclusions are part of what the ME/CFS IOM committee is currently tasked with determining under the ME/CFS IOM Study. And yet, the IOM, as an institution (see above), has already reached its conclusions regarding ME/CFS in the IOM 2014 Gulf War Illness Report. Because the ME/CFS IOM committee members will have easy access to the IOM 2014 Gulf War Illness Report and its findings on the case definitions for ME/CFS, this situation clearly presents a case of impaired objectivity with respect to the current ME/CFS IOM Study. The IOM cannot avoid assessing its conclusions under the prior contract, the very embodiment of an OCI manifested as impaired objectivity.

The proper case definition of ME/CFS is not only the principal charge under the ME/CFS IOM Study, it is a highly contentious issue that is at the heart of the future diagnosis and treatment of a million ME/CFS sufferers.

It is entirely unrealistic to expect the IOM to retract or modify its prior findings on ME/CFS. To do so would undermine the credibility of the IOM with respect to the highly contentious and publicized series of reports on Gulf War Illness. Here is another way of putting it. Don’t you think specific findings regarding ME/CFS in an IOM report issued less than a year before the scheduled release of the ME/CFS IOM Study, which findings played an integral part in the IOM reaching its conclusions regarding the case definition for GWI, would create a lack of objectivity in evaluating these same issues (case definition for ME/CFS) in the current $1 million ME/CFS IOM Study? Any legal analysis reaching a different conclusion is not defensible, plain and simple.

Certainly you can recognize this situation as reflecting impaired objectivity of the IOM. Isn’t it much better to halt this study in its early stages to avoid the criticisms and challenges or worse, which will, no doubt, be raised should a final report be issued? If the current ME/CFS IOM Study follows the findings in the IOM 2014 Gulf War Report with respect to ME/CFS, it and HHS will be held to public ridicule and likely legal challenge based in large part on the OCI. This is particularly the case given the fact that the IOM basically admitted its own lack of expertise when it comes to developing diagnostic criteria for complex diseases—no surprise after the admission of the committee chair for the IOM 2014 Gulf War Illness Report, Dr. Kenneth Shine[3] that the IOM does not have any experience with this type of task (see my attached letter to your office of November 16, 2013)—because the IOM had to admit that it was incapable of developing a new consensus definition of GWI according to the IOM 2014 Gulf War Report. How is HHS going to defend a year from now—when the current IOM committee on ME/CFS will have no choice but to come to the same conclusion regarding the diagnostic criteria for ME/CFS—having wasted another $1 million of taxpayer money given that it is altogether obvious at this point that the IOM lacks the required expertise for the ME/CFS IOM Study?

Given the importance of this issue, I would hope that you would at least afford me the courtesy of a reply that substantively and thoroughly addresses the OCI issue in a way that is logical and legally defensible.

Sincerely,

 

Jeannette K. Burmeister

Attorney at Law

 

Attachments:

My letter to your office of November 11, 2013

My letter to your office of November 16, 2013

My letter to your office of January 7, 2014

 

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

Tom Coburn, Oklahoma, Ranking Member, Senate Committee on Homeland Security and Governmental Affairs

Secretary of Health and Human Services Kathleen Sebelius

 

[1] http://www.iom.edu/Reports/2013/Gulf-War-and-HealthTreatment-for-Chronic-Multisymptom-Illness.aspx

[2] http://www.iom.edu/Reports/2014/Chronic-Multisymptom-Illness-in-Gulf-War-Veterans-Case-Definitions-Reexamined.aspx

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

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IOM Meeting: Open? Participate At Your Own Risk

The third IOM meeting of the committee tasked with the development of a new case definition for ME/CFS will be held on May 5th and 6th, 2014.

According to the IOM’s listserv message from yesterday, “[on the afternoon of May 5, the committee will hold an information-gathering session that will be open to the public. Interested individuals will be able to attend the open session in person at the National Academies of Science building or virtually via webcast.” [emphasis added] Written comments may be submitted prior to the meeting. If they are submitted by April 23, 2014, the “will be distributed to the committee before the meeting.”

“Open” Meeting

Before people get too excited about the fact that parts of the meeting are open to the public, let’s be clear that the IOM’s understanding of what constitutes a public meting is peculiar at best. There will be no opportunity for the public to participate in the meeting, other than for a few pre-selected, invited speakers. They can hardly be considered “the public.” The public is only welcome to attend the meeting in person (up to a very limited number of people) and via webcast, but there won’t be an open mic for comments or questions and dissenting opinions by the public will definitely not be allowed.

One has to wonder why the IOM deviated from its January 27, 2014 meeting format. The afternoon session of that meeting was also open to the public. But the big difference there was that 15 uninvited speakers were allowed to make comments of 3 minutes each. Could the IOM really not find 45 minutes in its schedule to allow for true public participation? Or was it so threatened by the fact that most speakers expressed their strong opposition to the “study” and the whole IOM process in January that it had to shut that down this time? Is the oh-so powerful and, as we keep hearing, prestigious IOM really that afraid of hearing what patients have to say? Limiting public input to a select few and relegating everybody else to quiet listeners is just another indicator for the disdain that the process has for patients. The IOM is not even trying to give the appearance that it genuinely cares about patients’ opinions. But, then again, we already knew that. The body language of the panel members at the January meeting spoke volumes.

And the possibility to submit written comments is nothing but a red herring. Written comments can be submitted to the committee at any point in time. They will become part of the public record no matter when submitted. Allegedly, if submitted by the deadline, the committee members will read them before the meeting. That may or may not actually happen. But it doesn’t even matter because the real question is whether those comments will carry any weight; more on that below. Spoiler alert: NOT.

So, creating an “open” comment session is the IOM’s way of merely going through the motions. It’s a big charade. But it sure looks good and it’s clearly a great PR move on the part of the IOM.

Comments

The “open” IOM session will address the following questions:

1) In your opinion, what are the most important issues that healthcare providers should be educated about when it comes to diagnosis of ME/CFS?

 2) What are your thoughts on the current terminology used to describe this disease: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome? If you could suggest new terminology, what would you suggest and why?

There has been some chatter on the Internet among patients about whether they should indeed submit comments. People have said that they feel like they are between a rock and a hard place. If they submit comments, their participation could be interpreted as cooperation with the IOM despite many, if not most, patients opposing the IOM “study.” At the same time, patients are concerned about missing an opportunity to educate the panel.

As I have said before, this is a very personal decision and, at the end of the day, we all have to live with our choices. Having said that, it is my strong conviction that cooperating with the IOM by providing substantive comments will do nothing but lend legitimacy to a flawed process that has the very real risk and is, in fact, designed by HHS, to harm this patient population greatly. Why else would the committee be stacked with a majority of non-experts? These non-experts have no business defining a disease that they have no prior experience with.

I truly mean no disrespect to these non-expert panel members. I am sure they are all accomplished in their area of expertise. I am not questioning that, but they are not experts in THIS disease. The Gulf War Illness committee members probably had similarly impressive credentials and good intentions, but we’ve seen the disastrous results of their efforts. The foremost experts for this disease have stated that this effort will harm patients. And yet, here these non-experts are, not having treated a single patient with this disease or researched the disease in any meaningful way or in any way at all. This is not a purely intellectual exercise. It has taken the experts decades to accumulate their expertise by treating and researching this disease and the non-experts are not going to become experts capable of producing an accurate definition by reading about this extremely complex and very unique disease for a bit more than a year in their spare time. What they have been asked to do is simply not feasible to do competently no matter how much they might want to believe it is or how good their intentions or credentials are.

But back to the comments. There is a snowball’s chance in hell that patients’ comments will have the slightest impact. First of all, how did that work out for us when some members of our community provided input on the provisional panel members and their potential conflicts of interest? In short, it didn’t.

Potential conflict-of-interest issues of panel members were supposed to be discussed during the first meeting, on January 27, 2014. That sure did not occur during the open afternoon session. Maybe there was a closed morning session that day. We don’t know because of the secrecy surrounding this “study.” And if that vetting indeed took place in the morning of January 27, 2014, did we hear about how the panel overcame the concerns some patients raised about some committee members? No. All that was achieved by raising conflict-of-interest issues with the IOM was that the IOM and HHS now are able to claim that patients had a say in the make-up of the committee when it fact we did not. We were duped, as many patients predicted. Not a single panel member was replaced as a result of patients’ concerns. The facts speak for themselves.

Providing comments now will be as effective, as in not effective at all. It serves no other purpose than to legitimize a grossly flawed process. It will allow HHS to claim that the IOM “study” had patient buy-in although the vast majority of patients continue to oppose this “study.”

You still don’t believe me? Ok, let me try to convince you some more. It is true that the Statement of Work provides for patient input. However, the clear task spelled out in the Statement of Work is an evidence-based review of the literature. By definition, that rules out taking into account anecdotal patient stories or comments. The Statement of Work, in effect, prohibits giving weight to patient input because that would be outside the scope of the evidence-based review. Clever, isn’t it?

Also, are patient comments reflected in the Gulf War Illness IOM reports? Remember, the best predictor for future behavior is past behavior.

Providing written comments or, if invited, giving comments at the meeting will not make a single difference in the outcome of the “study.” All it will accomplish is for HHS to be able to claim that patients were given a voice and were on board with this farce when most patients familiar with the issue are not.

I know it’s unsettling to feel helpless and to have no control. But submitting comments is not the way to gain any control. The only thing we can control is not to legitimize this “study” by refusing to participate and by continuing our protest.

Therefore, I will not send in substantive comments. I will, however, send a note repeating my strong and unconditional opposition to the “study” and the process. I urge others to resist the temptation to cooperate by answering the questions posed by the IOM. If you do send comments expressing your opposition (if you, in fact, do oppose), I caution against falling into the trap of adding on, “Should the worst happen and this study continue, then I would like the committee to consider the following.” That is still participating substantively. Remember that HHS does not have good intentions as evidenced quite obviously in many ways.

CFSAC patient representative, Eileen Holderman, who clearly understands the danger of cooperating with the IOM declined to speak at the May IOM meeting in her message to the IOM: “For numerous reasons stated below, I must decline your speaking invitation.  I am part of a vast patient advocacy movement that opposes the HHS/IOM Contract to redefine Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).  There are many reasons for my (and other advocates’) opposition …” I encourage everybody to read Ms. Holderman’s entire message to the IOM. It’s powerful and inspirational. It explains the reasons for patients’ and advocates’ opposition to the IOM “study” clearly and convincingly.

Latest GWI Report and New GWI Legislation

Remember that, earlier this month, the IOM was unable to come up with a new case definition for Gulf War Illness: a big $850,000 oops. When it comes to dealing with complex diseases and particularly case definitions, the IOM’s lack of expertise is clearly and painfully exposed. The ME/CFS IOM committee is not more qualified to define our disease than the GWI committee was to define GWI.

Recently, new legislation, the Gulf War Health Research Reform Act of 2014, was introduced. The new legislation proposes “not [to] disseminate or use for research, clinical care, benefits, or any other purpose the results of the report of the Institute of Medicine titled Gulf War and Health Report: Volume 9. Treatment for Chronic Multisymptom Illness.”

All of a sudden the IOM is not that prestigious and respected anymore, is it? I believe that there is a real risk to the reputation of the IOM in the long run if it continues to accept tasks that are clearly outside the scope of its expertise. Although I see the clear dilemma for the IOM here. Most of its work is commissioned by the federal government. The IOM is in a precarious position. If it does not deliver the results ordered by the government, it could lose its biggest source of income.

One can only speculate how the careers of those who serve(d) on IOM panels delivering sub-standard reports will be affected. But I do believe in holding people accountable for their actions, especially when these actions affect hundreds of thousands, if not a million, of sick patients and their families.

Of additional interest is that the Gulf War Health Care Reform Act also requires that any future IOM studies of GWI convene committees consisting of only medical professionals who are experienced in treating GWI patients, an obvious common-sense requirement that is blatantly being cast aside in the case of the ME/CFS IOM “study” as it has been in the GWI IOM “studies.” Should any further GWI studies be contracted for with the Institute of Medicine, the Act would also require (1) obtaining the advice of the Research Advisory Committee on Gulf War Veterans’ Illnesses, a FACA committee, regarding the scope of work and the charge and (2) including not less than three members of the Research Advisory Committee on Gulf War Veterans’ Illnesses.

IACFS/ME Conference in San Francisco

It has been reported that two staff members of the IOM assigned to the IOM study attended last week’s IACFS/ME conference in San Francisco. One would have to assume that the associated expenses were covered under the HHS/IOM contract. It is not immediately apparent why IOM staff members who, as such, are not members of the IOM committee would benefit from learning about the science of ME/CFS. But more importantly, did any of the non-experts on the committee attend the conference? They probably could have learned more about ME/CFS by doing so than by reading the literature of only replicated studies for a few months.

 ***

It’s becoming clearer every day that the IOM needs to be reined and that its dangerously absolute, yet unwarranted, power needs to be limited.

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The IOMperor Has No Clothes: IOM Admits Lack of Expertise

Apparently, Kenneth Shine, former president of the Institute of Medicine (IOM) and chair of the IOM committee that was tasked by the VA with the development of a case definition for Gulf War Illness, had a gut feeling about the outcome of the study.  Shine stated last year that he “could not recall when the IOM was last charged with defining a disease.” Guess what:  The IOM hadn’t developed a case definition then and–even though the report was released today–it still hasn’t! Wait! What? Well, at the price tag of $850,000, the IOM was “unable to develop a new consensus definition of CMI given the lack of uniform symptoms, the variety of symptoms, and the long onset and duration,” according to the  report. That’s a big taxpayer “oops,” wouldn’t you say?

The VA [had] asked IOM to develop a case definition for CMI as it pertains to the veteran population who served during the 1990-1991 Gulf War, as well as recommend appropriate terminology for referring to CMI.” The IOM simply couldn’t do it. In its report, it basically admitted to not having the required expertise.

Now, is everybody convinced about the IOM’s lack of expertise to define ME/CFS? A literature review by a majority of non-experts is as a flawed a process as one can imagine for the definition of an overwhelmingly complex disease, such as ME/CFS. It cannot be done competently. The latest IOM report makes it a point in a number of places to compare the complexity of GWI with that of ME/CFS. Expecting a different result from the IOM in the case of ME/CFS is the stuff Harry Potter books are made of (no offense to R. K. Rowling). The only difference will be that the taxpayer bill, at $1million, will be even higher.

Jim Binns, chair of the Research Advisory Committee on Gulf War Veterans’ Illnesses, a FACA committee, like CFSAC, commented, “The conclusions of the report show that it was a waste of money.” He further stated, “The committee never had the expertise or the process to do a case definition. It’s good they didn’t do one.” No kidding!

According to Binns “[i]t is hardly surprising that based on a literature review alone, the committee was not able to develop a new case definition … this fruitless process cost VA $850,000.

Remember the following right-on quote by Byron Hyde, renowned ME/CFS expert from Canada?

Definitions are not diseases, they are often simply the best descriptions that physicians and researchers can offer, with their always imperfect knowledge, to describe a disease.  Good definitions are good because they correspond closely to the disease state being described.  It is thus important that those that attempt to define any disease or illness … have long term clinical experience with patients with this illness.  There is simply no place for the bureaucrat in defining illness.  All definition of epidemic or infectious illness must be based upon persistent clinical examination of the afflicted patient, an understanding and exploration of the environmental factors producing that illness, and pathophysiological examination of tissue from those patients.  For similar reasons, I believe that the inclusion of psychiatrists in the defining of an epidemic and obviously disease of infectious origin, simply muddies the water for any serious understanding of that disease. (emphasis added)

It takes expert clinicians to define ME/CFS. The IOM ME/CFS committee consisting of a majority of non-experts does not have the required expertise, just like the IOM GWI committee didn’t. The emperor just doesn’t have any clothes, plain and simple.

I have not reviewed the report in detail, but one thing that struck me on a cursory review was that the report seemed quite repetitive and, one might say, without even an overlay of the kind professionalism that one would expect from an institution that is being touted by HHS as one with utmost credibility.

Speaking of credibility, Simon Wessely, arguably the most controversial figure in medicine and science of our time, reviewed the latest IOM report. Studies that Wessely co-authored are also cited on numerous occasions, so he basically reviewed and signed off on his own “research.” Even if Wessely were right with his psychobabble and pseudo science—and we all know he is not—I cannot imagine what could have possibly gone on in the minds of those who chose him as a reviewer. By doing so and allowing his name on the report, the IOM lost all credibility, whether it be due to indifference to the tremendous controversy surrounding Wessely or due to the lack of due diligence, i.e., ignorance of the controversy.

HHS, can you hear us now?

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CFSAC Meeting December 2013: Webinar from Hell

There is no way to sugar coat this. The December 2013 CFSAC webinar was a colossal middle-finger salute to the patient community. Despite the webinar format having been a complete disaster in December, we will be treated to another CFSAC webinar tomorrow; patients can hardly wait, so it seems like a good time to recap.

What was wrong with the December meeting? Well, how much time do you have? This is not a rhetorical question. The sheer number of glitches, the unmistakable indifference exhibited by CFSAC’s Designated Federal Officer (DFO), Dr. Nancy Lee, to the many patient concerns raised in advance and during the meeting, and the mind-boggling degree of incompetence in running and mishandling the meeting will make this a long blog post. It will outrage you. The DFO’s statement that the snags were “extremely sub-optimal” was a massive trivialization. After attending that CFSAC webinar, it was no surprise to me anymore that HHS botched the Obamacare website as badly as it did; it can’t even run an old-fashioned webinar halfway competently. But there was a consolation prize and that was the unintentional and unexpected entertainment value of the meeting. So, make yourself some tea, get comfortable on the couch or in bed and brace yourself for the ride.

The Watered-Down Format for the “Chronically Tired”

The reason we were given for the new “webinar” format was budget constraints due to the Sequester. We were told that all federal advisory committees had been asked to move to the webinar format, though we have yet to be given examples of other committees having done so. But then again, we, the “chronically tired” ones, are used to receiving only the absolute minimum. Here is a question for everybody: How much money do you think was saved by not having an actual in-person meeting? True, there were no travel or hotel costs for the committee members. However, I bet there were a number of test webinars for the committee members and the IT people before the live webinar to make sure everything would run smoothly. Sadly, the test runs were sorely inadequate, as became painfully evident on December 11, 2013, the day of the meeting. Picture the worst webinar you can possibly imagine and then multiply that by ten. That’s how bad it was. More about that later.

Also, one could speculate whether the “post-production” cost of synchronizing the audio with the slides and making both available on the CFSAC website aren’t aren’t similar to simply putting up the video that is recorded during an in-person meeting and, thus, readily available right after the meeting. Certainly the fact that the audio and slides have not been uploaded to the CFSAC website yet, nearly three months after the meeting, suggests that there is more work than normal involved. But here is the kicker: As I said, there is going to be another CFSAC webinar tomorrow. If anybody is inspired, maybe an FOIA request inquiring about the alleged cost savings of having two webinars vs. one in-person meeting is in order. Although, unless you can afford to front thousands or tens of thousand of dollars in attorney’s fees for a federal lawsuit, don’t bother because HHS seems to view the federally mandated deadline of complying with FOIA requests as optional, which is why I was forced to file a lawsuit against HHS and NIH in federal court in January of this year. So, an FOIA request may well be ignored (again) and chances are good that a lawsuit will be required to enforce your federal right against HHS. But I think we can all guess whether there are any real cost savings with the new format even without seeing the numbers. However, if HHS wants to make the numbers publicly available, I am sure that would be welcomed by the patient community.

Bad Weather: The Missed Opportunity for an Out

The December webinar was cut from two days to one day because of a snowstorm in DC that shut down the federal government. Can’t blame anybody for that. These things happen. But the way the situation was handled was repugnant. Instead of rescheduling the entire meeting, the already truncated meeting was further shortened to one day.

In the past (until May of last year), we had two 9 to 5 meetings, a total of 16 hours. By refusing to reschedule the meeting, it got cut to five hours, less than one third of the normal duration of the meeting. Furthermore, the five-minute public-comment slots for the second day were slashed to three minutes. HHS couldn’t be more obvious about being entirely dismissive of patients’ cognitive limitations if it tried. Requiring patients to—overnight—essentially cut their comments in half was the opposite of accommodating a disability. It made it impossible for some patients to participate in the meeting in a meaningful way for no other reason than their disability, which you’d think HHS is aware of. You’d think.

The weather gave HHS the perfect opportunity to save face and resume the original in-person format. HHS had been given a second chance here to do the right thing. Because the huge elephant in the room was that the DFO chose to hold this meeting as essentially a teleconference at the, by far, most critical time in this patient population’s history: the IOM “study” proceeding despite overwhelming protest by experts and patients alike and despite an unprecedented unity among experts and patients in that regard. HHS had a chance to avoid appearing as egregiously disenfranchising patients more and more at mind-blowing, accelerating speed by returning to a two-day in-person meeting using the weather as an excuse. It did not do so despite the fact that HHS had already rescheduled the meeting once, and this time, it was much more appropriate to do so.  The reason given for the prior rescheduling was the government shutdown. Mind you, the November 2013 meeting was scheduled for about four weeks after the end of the government shutdown. Plenty of time to proceed with the meeting as planned. Postponing then till December, as HHS did, was a lot less justified than it would have been in December.

Tomorrow’s meeting is a make-up meeting for the canceled day in December. Those members of the public who had a speaking slot on the day that the meeting had to be canceled in December will get to speak at tomorrow’s meeting. However, what’s most curious is that back in December, the speaking slots for the public were initially slated for five minutes and only cut to three minutes when the first meeting day got canceled altogether. Tomorrow’s public-comments slots are for three minutes only as well. Does that make sense to anybody? If five minutes were planned in December, why only three minutes now?

Video Testimony Without, Wait for it, Video

For the first time, pre-submitted videos were allowed as public comments. However, only the audio portion of those comments was streamed. Of course, the public was not informed of that not-so-small detail before the deadline for the video submission. Not showing the video portion of video comments is so much beyond bizarre that I at first didn’t believe it when I heard it. Which reasonable person in their right mind would assume that the video part of video testimony (!) will be excluded? It was 2013 and even though D.C. is not Silicon Valley, I am sure proper webinars—you know, with audio and video—have been provided by government agencies in the past.

The reason given by HHS: The webinar platform is not compatible with playing videos. Why in the world was this webinar platform chosen then? And, yes, patients reported that Seamon Corporation, the company whom many aspects of the running CFSAC meetings is outsourced to, confirmed that HHS had the choice of running a proper webinar. You know the kind that everybody is using these days and has been for over a decade: the kind that allows for video streaming. HHS chose to go with the rudimentary audio-plus-slides-only version. You’d think that reducing the meeting to a webinar is enough of a slap in the face. But in case patients didn’t get that not so subtle point, HHS made sure to basically hold a teleconference only, yet calling it a webinar.

The CFIDS Association of America Disseminating Official Government Information?

The CFSAC listserv sent an email with the updated agenda for the second day of the CFSAC meeting 1.5 hours before the start of the meeting. This was our only official (coming from HHS) indication that the second day of the meeting would indeed take place. Interestingly enough though, the CFIDS Association of America (CAA) was not only informed the previous day that the second day was indeed on, it was also either tasked with notifying the public of official government business or took it upon itself to do so because it published on its Facebook site, at around 5:30pm Pacific, the revised agenda the night before the meeting. See the screen shot below, courtesy of Leela Play. The Facebook post didn’t stay up long. In what seemed to be a cowardly move, the post was deleted fairly quickly without any explanation when people started asking questions about whether the CAA is now not even pretending anymore to be separate from the government. But maybe more importantly, does the disseminating of official government information by a non-government agency, before HHS did, constitute a violation of federal law or regulations?

That CAA Facebook post also stated, “As always, ALL are welcome to join in.” This was particularly ironic because until the previous day, when HHS opened up the meeting to everybody regardless of registration, the meeting was limited to 500 pre-registered participants. Some serious questions were raised by patients whether limiting the meeting so drastically still qualified it for a public meeting. Those questions remain even after opening up the meeting to everybody at the last minute, as many people likely did not know about that change, which was buried in a CFSAC listserv message sent the day before the meeting. I know there were patients who did not sign up for the meeting although they were interested because they didn’t want to take a slot away from folks who are more actively involved in advocacy than they are. In light of all this, CAA’s cheerleading seems particularly tone-deaf, even for  CAA standards.

CAA Screen ShotIOM

After Dr. Koh’s remarks, which I (and many others) missed entirely due to the unclear audio instructions (see below), the DFO talked about the IOM-study process and answered questions. I am not going to go into detail about that part of the meeting. I addressed some of those issues—those relating to the DFO’s threatening emphasizing of the dangers for the community in criticizing the IOM process, namely the likelihood that such criticism would backfire on patients—in a prior blog post, “HHS and the IOM Saga: The Definition of Insanity and a Bad Case of Stockholm Syndrome.” There is much more to say about this part of the meeting, but I will leave that for a future blog post.

Government Intimidation

However, one point cannot go unanswered, as it was disgraceful for any democracy and certainly the democracy of the United States. I did not live in East Germany for 18 years, see the Berlin Wall fall and become a proud and upstanding U.S. citizen to stand idly by while the U.S. government is trying to suppress free speech and, even worse, attempting to recruit fellow patients to do their handiwork for them.

Here is what I am talking about: The DFO made a strong point to accuse some advocates of “much vitriol and personal attacks in emails and in blogs around the IOM study.” She talked about some unnamed advocates apologizing for “the vitriolic behavior of another advocate” whom she also didn’t name. Maybe the most appalling statement the DFO made was to call for the advocacy community to “call out and reel in,” in the future, those advocates whose comments and opinions she doesn’t approve of.

Ms. Eileen Holderman, the patient advocate on CFSAC, who has reported having been threatened (together with two other CFSAC members) by the DFO, swiftly called out the DFO for indicting the advocacy community with her comments. Dr. Marshall, CFSAC’s Chair, tried to shut Ms. Holderman down citing time constraints, but Ms. Holderman insisted that she “could not let [the DFO’s statement] stand” and the Chair relented by giving her one minute. Ms. Holderman pointed out that most, if not all, of the discourse around the IOM “study” had been civil and constructive and called the DFO’s accusation unfair.

Being one of the advocates who has been very vocal about the IOM “study,” I can firmly say that I stand by everything I wrote. I can also say with certainty that I have not seen any vitriolic behavior on the part of other advocates nor have I seen personal attacks on anybody. In fact, the patient community, even those of its members who don’t agree on many issues, seems to be pretty much in agreement that advocates have behaved nothing but professionally. I don’t know if it’s more amusing or disturbing to see government officials whining when their position, competence, expertise, action or anything else related to their official capacity is criticized, especially in a field where patients have been harmed by government agencies for decades, as pointed out by Ms. Holderman. It’s bad enough that the government is not listening to, but, in fact, is harming, patients—the latest and maybe the worst example being the shoving down our throats of the IOM “study”—but it’s adding insult to injury to be accused of being vitriolic just as a result of appropriately expressing criticism. Not that the ad-hominem-attack charge is a new tactic at all. HHS took a page out of Simon Wessely’s playbook of unsubstantiated death-threat accusations.

Should there be any doubt, advocacy is politics and politics, if it’s to be effective, is not always pretty. Imagine a U.S. president whining about attacks from the other side of the aisle. A pretty ridiculous thought, no? ME patients are fighting for their lives. The kid gloves came off a long time ago, maybe when the CDC misappropriated funds for our disease in the 1990s? It’s unfortunate that a member of the administration would feel the need to use the power of her position and the platform it bestows—CFSAC meetings she tightly controls—to call people out who are availing themselves of their First Amendment rights, whether it’s due to being overly sensitive or using a tactical ploy.

This should be obvious, but since it’s apparently not, let’s be very clear. If you are a government official and your work is being criticized, even if harshly (with very few exceptions, such as comparisons to Nazi Germany), that is not an inappropriate or personal attack. Everything that has to do with official government business—as opposed to the private life, the appearance, the personal choices, such as religion, etc. of government employees—is most definitely fair game.  The DFO’s comments at the meeting in that regard were quite frankly contemptible and reprehensible and one can only hope that they were not blessed by her superiors. But they were not off-the-cuff statements. Rather, they were clearly prepared well in advance, as the DFO was anxious to read them at the end of the session. Trying to split the patient community by inciting attacks on inconvenient advocates is inexcusable and pretty much as low as it gets.

By the way, I don’t know this for sure, but I have a feeling that those inconvenient advocates might be even more resolved in their will to continue fighting the good fight as a result of the DFO’s shameful comments. If they were easily intimidated, they probably wouldn’t have taken a strong stance on the IOM issue in the first place. Like I said, just a hunch. So, it remains to be seen if this attempt by HHS to quiet some advocates will be successful and if other advocates will be complicit in it.

In that context, you might find the recent articles by Glenn Greenwald, “Internet Trolls May be Trained Government Agents According to Leaked Document” and “How Covert Agents Infiltrate the Internet to Manipulate, Deceive, and Destroy Reputations” interesting. Greenwald talks about a number of tactics the government utilizes to disrupt online discourse, such as the use of online trolls with fake personalities who infiltrate online communities as well as attempts to destroy the reputation of advocates.

The Most Incompetently Run “Webinar” in the History of, well, Webinars

Many emails were sent to the DFO on the days before and of the meeting imploring her to reschedule the meeting and pointing out the many problems with the webinar format and the truncating of the meeting to one day. Here and here are my pleas. I don’t know if others were luckier than I was, but none of my emails to he DFO and/or the CFSAC mailbox were replied to, neither before, during or after the meeting.

Others have written about the multiple problems with the webinar format for patients and about the technical glitches, so I will just mention a few examples:

  • Many patients cannot afford to spend five hours of cell-phone minutes on a webinar. This patient community is predominantly poor. To borrow from one of Dr. Peterson’s examples, many patients live in their parents’ basement because of their poverty level.
  • For the same reason, some patients use a dial-up Internet connection. That means that they can either be on the phone or on the Internet. Since one had to call in for the audio portion of the “webinar” (see below), those patients were not able to follow the slides on their computer screen.
  • Again, due to the financial realities for patients, some do not have fancy phones with speakers.  Yet, many patients are too sick to hold a phone up for five hours.
  • It wasn’t always clear who was speaking because speakers didn’t always identify themselves.
  • It was impossible to follow the text on the screen, as it was quite choppy and patients started complaining about nausea soon after the webinar began.

Many of these problems were pointed out to the DFO via emails after the beginning of the meeting to no avail, despite the fact that they made it impossible for people with disabilities to participate, which raises additional questions regarding the open nature of the meeting.

In order to see the slides on the screen, one had to be in full-screen mode. There were no instructions to that point and patients missed many or all of the slides because of that. That may have just been as well because of the unbelievable IT difficulties in advancing the slides. At some point, it seemed that everybody on the committee was able to advance the slides and since many committee members did so in an attempt to help out, it took minutes to get the situation under control by finally putting Paul, the IT guy, in charge. It was most comical, but understandably seemed quite frustrating to the speaking committee members.

One of the “highlights” of the webinar was the fact that one had to actually call in to get the audio portion of the meeting. So, not only did the “webinar” platform not allow videos, it also didn’t allow audio. Quite the “webinar,” huh?!

This was not explained anywhere in the instructions ahead of time. As a result, I (and many others) missed the first part of the meeting trying to figure out what was going on by emailing with the Seamon Corporation and the CFSAC mailbox. After I, and probably others, made the DFO aware of this via email, the meeting was not halted to send an email from the CFSAC mailbox to everybody and to give people time to figure this out. This would have been especially important because the by far most crucial topic of the meeting, the IOM “study,” was the first agenda item after Assistant Secretary’s, Dr. Koh, short opening remarks.

About 25 minutes into the meeting and after complaining about the missing sound component in an email to the DFO, I received an email from Seamon Corporation notifying me of the requirement to dial into the meeting with my phone. There never was a CFSAC listserv announcement to that effect. Although, at some point during the meeting, the meeting website instructions were quietly updated. Below are screen shots showing the before and after.

Before:

Audio Instructions Screen Shot BeforeAfter:Audio Instructions Screen Shot AfterSeamon Corporation has in the past contacted speakers about their public comments, e.g., to confirm or change the comment time. However, here, where it was probably more crucial than ever because people’s comment time was cut to three minutes at the last minute, no such calls were made. Commenters who might not have checked their emails would have been unaware that they now only had three instead of five minutes for their comments.

The technical difficulties the DFO had trying to call the public-comment speakers resulted in a lot of wasted time during an already extremely short meeting. We had to wait for about a total of 15 minutes for the DFO to call seven patients who had three minutes each to comment and some patients did not use the full three minutes, so that makes a total of less than 21 minutes of comments. I believe nothing else needs to be said here.

There also didn’t seem to be an effective mechanism in place for the Chair to keep track of who on the committee raised their virtual hand first and in what order to allow committee members to speak. There certainly was no accountability for the Chair to be fair and honest in that regard since the public did not actually see in what order the hands went up.

The Chair and the DFO seemed to struggle to figure out how to get the wording for a proposed recommendation drafted by Susan Levine to all committee members for a vote. Put it in a slide? Send it as an attachment to the DFO and the Chair? That’s the problem when you don’t have an in-person meeting. Again, a lot of time was lost just figuring that out at a meeting that was already inadequately short.

Finally, we didn’t get an update from the FDA on the number and types of new drug applications for ME/CFS despite a non-committal comment during the last FDA-patient call that such update might be provided at this CFSAC meeting.

CFSAC’s Patient Advocate Ms. Eileen Holderman

The term of our patient representative on CFSAC, Ms. Eileen Holderman, will sadly be up in May of this year. As always, Ms. Holderman was a very strong advocate for us throughout the meeting.

She voiced her concern about the continuing medical education (CME) videos on the CDC website, as the physicians in them used the Fukuda definition as opposed to the more appropriate (because much newer and more sophisticated and accurate) Canadian Consensus Criteria (CCC) and as cardio-pulmonary exercise testing (CPET) wasn’t mentioned in them at all. Dane Cook, another voting CFSAC member, called Ms. Holderman’s criticism armchair quarterbacking and said that it would have been more reasonable for Ms. Holderman to ask for additional videos. I fail to see the logic in that. If a video contains wrong information, especially regarding a mostly misunderstood disease, it would seem appropriate to pull the video altogether instead of being worried about hurting the egos of the physician who participated in the making of the video, which is what Mr. Cook seemed worried about. CFSAC member Steve Krafchick on the other hand agreed with Ms. Holderman, citing the emphasis of the CME videos on orthostatic intolerance, their lack of mention of CPET, their use of the Fukuda definition, their lack of mention of the IACFS/ME primer and their reference to the CDC toolkit.

Ms. Holderman later stated her disappointment in the attempt by Dr. Elizabeth Unger of the CDC to rein Ms. Holderman in with respect to her CDC-website review, which has been very extensive over the last three years. According to Ms. Holderman, Dr. Unger informed her in two emails that she was deemed to have overreached in her mission and that such comprehensive review was never envisioned by the agency. It came as no surprise then when Ms. Holderman stated that she felt that, despite some progress having been made with respect to the CDC website, for the most part, change has been resisted by the CDC.

Ms. Holderman further pointed out that addressing the education of health-care providers, the subject of a working group report by Susan Levine, was “putting the cart before the horse,” as logically, we first need a consensus on a case definition. Otherwise, health-care providers are potentially being taught the Oxford or Empirical case definition (both defining the condition of fatigue as opposed to the neuro-immune disease ME/CFS) or the Fukuda definition, which does not require the hallmark symptom of ME/CFS, post-exertional malaise.

In addition, Ms. Holderman objected to the formation of the working groups because those were never voted on by CFSAC and, in her opinion, were imposed on CFSAC by HHS. Her concern is that these working groups undermine the sub-committees, which she sees as very functional.

She also mentioned, but didn’t elaborate, that she wasn’t allowed to be involved in establishing the agenda for the meeting as she had been in the past in her role as a member of CFSAC’s leadership committee.

In her parting comments, Ms. Holderman said that she felt that CFSAC’s recommendations have unfortunately largely been dismissed—no surprise to anybody who has been following CFSAC over the years—and that she is hoping that that will change in the future. She also expressed concern about the leadership committee being in peril and the fact that Assistant Secretary, Dr. Koh, is no longer participating in the leadership-committee meetings. The latter in particular certainly is alarming and seems to warrant looking into. Whoever will succeed Ms. Holderman in her role as patient advocate on CFSAC most definitely has some very large shoes to fill.

Other Committee Members

Dr. Ken Friedman, a CFSAC liaison member, reminded everybody of the “institutional reluctance” to allow ME/CFS research, which still seems rampant. He cited several cases of CFS researchers at academic institutions having been discouraged from doing ME/CFS research or having been told that, if they did not cease doing ME/CFS research, their academic positions would be imperiled.

In his parting remarks, Dane Cook, whose term is also almost up, said that he feels that in-person meetings are important and should be implemented again because “people need to be held accountable on a face-to-face basis.”

Even the Chair conceded that webinars are not the best format for CFSAC meetings and that in-person meetings would be preferable. But astonishingly he still, for reasons known only to him, called the December meeting “very professional.” He also made excuses for the mishandling of the meeting by referring to the fact that [they] didn’t anticipate that the meeting would be that problematic. I confess that I find this disingenuous. How do you not notice during the practice runs that you’ve got a big problem? But more importantly, why do you choose the same dysfunctional format for tomorrow’s meeting? What’s the excuse going to be if tomorrow is equally as excruciating?

At some point during the meeting, the DFO apologized and explained the glitches with the fact that the webinar format was new to [them] and the IT people, which begs the question why they chose a format they so obviously couldn’t handle. The attempt to disenfranchise patients backfired painfully for HHS. And this once, the pain was not only on the patients’ side.

What to make of it all?

I have rarely seen Facebook and Twitter explode that much in this patient community as it did on that day. Patients could not have felt more disrespected and disenfranchised, which was remarkable given the community’s low expectations in HHS. They were angry and completely exhausted early on during the meeting due to all the confusion and glitches. But then something interesting happened pretty quickly. People, even those who don’t always agree on every issue, bonded. They united. They had a strong voice on social media. And they made the most of this disaster. They used humor to get through it. The material was endless and would have done a Daily Show or Colbert Report segment justice. One of my posts on Facebook that day:

The words of the day: “Can I have the next slide, please? Next slide? Next slide? Hello? Can anybody hear me? Can I have the next slide?”

Somebody else quipped:

Three minutes for comments. Five minutes for Dr. Lee to learn how to throw the switch.

(I’d like to give credit to the person who said that, but can’t remember who it was. If it was you and you feel comfortable being named, please do let me know.)

On a more serious note, the disrespect that HHS has demonstrated with regard to the handling of this meeting is unprecedented and truly astounding. The meeting was run so poorly that patients called for the DFO to be replaced by somebody with more competence and appropriate behavior and less bias towards the ME/CFS community. Of course, Assistant Secretary Koh blew off those requests and complaints with platitudes, just like he had with respect to Ms. Holderman’s report of the DFO’s threat towards her and two other committee members.

The link on the CFSAC website to tomorrow’s meeting, “View the presentations and listen to the webinar,” is not working (see screen shot below), which definitely doesn’t bode well for a successful meeting tomorrow. Yet, the December meeting set the bar so low that it is hard to imagine that it will be worse tomorrow, but I certainly don’t want to jinx anything.

Screen Shot Faulty Link

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P2P: “Patients to Purgatory” or the Jury Model Stood on its Head

“They don’t know. They don’t know anything.”—Susan Maier about the P2P panel members

On January 27, 2014, the Institute of Medicine (“IOM”) held its first out of five meetings relating to the development of diagnostic criteria for ME/CFS. It was a two-day meeting, with half of the first day being open to the public. Several government officials gave reports during the open part of the meeting. Susan Maier, Deputy Director of the Office of Women’s Health of the Department of Health and Human Services, gave the NIH report on the so-called Pathways to Prevention (“P2P”) program currently underway relating to ME/CFS research—parallel to the IOM effort—which will culminate in about 12 months in a workshop in which an appointed panel will (1) receive the report of an evidence-based review/report by the Oregon Health and Science University  (“OHSU”) (under a task order from NIH), (2) listen to presentations of the government and experts and (3) then deliberate and write a report of recommendations to the NIH within 24 hours of the end of the workshop.

In response to a question from an IOM committee member, Susan Maier described the workshop as based on the “jury model” that requires the exclusion of any clinician or researcher who has any experience with ME/CFS  Here is what she said:

“It’s a jury model. You have the defense, you have the prosecution; they both know the case really well. They know the details, they know what’s going on, they know all the nuance, they know what’s going on in media. Your jury is sequestered. They don’t know. They don’t know anything. … The jury hears the evidence. And they make their decisions based on the evidence. That’s essentially the difference between the workshop speakers, the evidence report and the panelists.” [emphasis added]

Deep breath! So, NIH really believes that designing the P2P workshop to be analogous to a jury trial is a valid method. Experts and government officials with varying points of view will present their views at the workshop, which Susan Maier likened to the prosecution and defense in a trial. Then the P2P panel, made up—by design—of those with no expertise or prior research or opinions on ME/CFS AT ALL, will take the evidence report of OHSU and the comments of the presenters—the “prosecution” and the “defense”— and deliberate and issue their recommendations in writing within 24 hours (!)

I must say, when I heard Susan Maier give that explanation, with a completely straight face and an obvious expectation of everybody to consider this approach sane, I just about fell off my chair. I found myself shaking my head violently. I even uttered the word “Noooo!” under my breath.

I find it hard to capture in words the absurdity of this approach for what Susan Maier described as “focus[ing on the] improve[ment] of science.” Let me add: the improvement of science for an incredibly complex disease, not that I am advocating this model for any other disease. The jury in the American justice system exists in order to assess the facts, not develop or interpret the law.  The law is given to the jurors by the judge, who also serves as an impartial screener of the evidence presented by the parties for bias, relevance and many other factors. The outcomes of jury trials do not have any precedential value for future trials or the law.

In the P2P process, the jury model is stood on its head entirely.  There is no judge to explain to the P2P panel of non-ME/CFS experts what the “law” is or to screen the evidence presented by the OHSU or the presenters at the workshop.  Rather the panel is supposed to determine and confirm what the “law” is from what undoubtedly (or maybe hopefully) will be an abundance of highly technical information presented by OHSU in its evidence review.

This all happens in in an incredibly abbreviated period of time. As Susan Maier said, We have a enough content for a five-day meeting. We have to cram it into two days.” (emphasis added) Even juries in a trial get to deliberate for several days or even weeks and don’t have to write a detailed report in that time. The powers that be within NIH dragged their feet for 30 years—ignored us, harmed us, tried to sweep us under the rug—and now they can’t spare three additional days on a quality workshop? Not that even five days would be sufficient for a complex disease such as ME/CFS.

According to Susan Maier, the “goal of P2P is … to review the evidence.” This evidence will then be applied to all future government-sponsored research of ME/CFS. This is like asking a jury in a murder trial to listen to the evidence as presented by the prosecution and defense, unfiltered and unclarified by rulings or instructions from the judge, and to develop, within 24 hours, a set of definitions and criteria for what constitutes first degree murder, second degree murder, manslaughter and negligent homicide.  These will then be applied in all future murder trials.

This is the opposite of the scientific method! And talk about giving the jury model a bad name! Albert Einstein and Clarence Darrow would turn over in their graves.

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Who is Causing Facebook to Block Tuller’s Article?

On Monday, January 27, 2014, David Tuller published, on Buzzfeed, a well-researched and factual article”—How “Chronic Fatigue Syndrome” Obscures A Serious Illness“—on ME/CFS and the government’s efforts to redefine the disease. As of right now, 78,331 people have viewed the article. Also, almost 8,000 people “liked” the article directly from the Buzzfeed site by using the Facebook like button.

Some time last night or this morning, the Facebook share button for this article was disabled by Facebook and Facebook blocked any direct sharing of the piece from the Buzzfeed site. The error message I (and others) received from Facebook when I tried to share the article to confirm the reports of the blocking said, “Your message couldn’t be sent because it includes content that other people on Facebook have reported as abusive.”

Screen Shot 2014-02-01 at 9.38.55 PM

Facebook also deleted all postings of this article shared directly from the Buzzfeed website, which means that the many Facebook conversations about the piece are lost as well.

Everybody who will read the article will agree that is has no content that even comes close to being abusive. It is an entirely professional piece written by an acclaimed journalist, David Tuller, who has been writing for the New York Times and other reputable publications.

I am putting this out there because I am completely flabbergasted by how anybody could have found this article abusive and would have felt the need to shut it down. This is a slap in the face of the patient community and, frankly, it’s unacceptable to abuse Facebook policies in that manner.

Copying and pasting of the article’s URL on Facebook is still possible, but it is important to note that Buzzfeed pays close attention to the number of Facebook shares from its site (as opposed to copying and pasting of the URL, which Buzzfeed has no way of keeping track of) in its determination of whether to feature an article more prominently and also of whether to cover an issue again in the future, something that ME/CFS needs desperately. So, whoever is responsible for getting the article in essence censored by Facebook has done a tremendous disservice to the patient community. It makes one wonder about the person’s or persons’ agenda.

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Jeannette Burmeister’s IOM-Meeting Comments

IOM Meeting January 27, 2014

In-Person Comments by Jeannette Burmeister

Hello.  I’m Jeannette Burmeister and I’m an attorney.

I’ve heard some people at HHS are confused about patients’ deeply-felt opposition to your project.  Let me explain in simple terms why:

  • HHS hijacked the federal CFSAC recommendation and ignored an unprecedented and impassioned request by 50 international M.E. experts to cease and desist
  • The majority on your committee are non-experts.  Insanity!
  • HHS insured bio-medical research will be not be funded or replicated and yet ordered an evidence-based review. You are hurtling down the psychological rabbit hole, repeating the Gulf War Illness anti-science debacle.
  • HHS hired an institution without experience or authority to develop case definitions.
  • An excellent case definition, based on science, already exists and the experts endorsed it.
  • The IOM has a fatal organizational conflict of interest. I have filed a complaint with the Office of the Inspector General.  A formal investigation is under way.
  • HHS has broken federal law as to FOIA compliance. 2.5 weeks ago, I filed a lawsuit against HHS and NIH in U.S. district court.
  • To circumvent competition rules, HHS moved from seeking a standalone contract to issuing a task order without a clear scope, violating umbrella contract terms.
  • HHS issued misleading statements about the nature and terms of, and parties to, the contract.
  • And finally, hundreds of thousands of patients’ lives were ruined or ended by a federal consensus definition in 1994.  We have long memories.  Patients are furious and alienated by what can only be called state-sponsored bullying.

Given your time frame and the meager “budget-dust” sum provided to you, not even a thorough literature review is possible.  Do you really expect anyone to consider the definition you produce to be science-based? Everything about this is lose-lose.

You may attempt to serve as oracle of the biased and obstructive NIH/CDC, but your conclusions will be rendered meaningless soon enough. Academic scientists are closing in on the cause of this disease. In due time, your consensus “fairy dust” will be headed for Ripley’s “Believe It Or Not”—next to the entries about the earth being flat and the sun revolving around the earth.

My husband, who is an attorney with the world’s largest law firm, and I will not hesitate to bring additional lawsuits. We are supported by thousands of patients who are ready to fight you at every step, in federal court and in the court of public opinion.

Thank you!

The following are comments I had initially planned on giving, but I completely rewrote them the day before the meeting and gave the comments above instead. But the original comments have some additional points, so I’ll post them here, too:

jeannette burmeister iomMy name is Jeannette Burmeister. I am a patient and I am here to oppose this IOM study in the strongest possible way.

Please know that nothing I have to say is in any way personal to any of you.

For patients, this is the fight of our lives and if this sounds overly dramatic to you, then this may indicate that you are not fully aware of the irreparable harm you are about to do. I respectfully suggest that you research the disgraceful IOM history with Gulf War Illness. Because if there is one thing I am sure of, it is the fact that this committee will psychiatrize this disease by endorsing antidepressants, psychotherapy and exercise, as the IOM did for Gulf War Illness. Your report is a foregone conclusion given the IOM’s issued opinions about our disease in the past, which create an organizational conflict of interest that is currently the subject of a formal investigation by the Office of the Inspector General.

I am sure you eight non-expert panel members are all accomplished in your area of expertise. I am not questioning that, but I am reminding you that you are not experts in THIS disease. The Gulf War Illness committee members probably had similarly impressive credentials and good intentions, but we’ve seen the disastrous results of their efforts. The foremost experts for this disease have stated that this effort will harm patients. And yet, here you are, not having treated a single patient with this disease or researched the disease in any meaningful way or in any way at all. This is not a purely intellectual exercise. It has taken the experts decades to accumulate their expertise by treating and researching this disease and you are not going to become experts capable of producing an accurate definition by reading about this extremely complex and very unique disease for a bit more than a year in your spare time. What you have been asked to do is simply not feasible to do competently no matter how much you might want to believe it is or how good your intentions are.

I’d like to suggest to ALL committee members that you are being played. This study is a set-up because it is designed as an “evidence-based” review. HHS knows full well that replication studies of bio-medical research of this physical disease are basically non-existent in the absence of government funds for them, whereas research (quote, unquote) of the alleged psychological aspects or of coping mechanisms abounds thanks to HHS funding. For example, ask yourselves why Dr. Unger of the CDC is kicking and screaming resisting a 2-day exercise test, despite overwhelmingly strong research by Staci Stevens and Dr. Chris Snell establishing the test as a very reliable biomarker. I bet some of you have never even heard of Stevens and Snell. That right there should give you pause.

I am asking you to go home tonight and really think about whether you could live with yourselves if you did to us what the IOM has done to Gulf War veterans. Because if you go forward, you will be accomplices in a process designed to do just that and it WILL stay on your conscience for the rest of your lives. Patients are watching and we WILL hold you accountable if you proceed down this path. Do the right thing and refuse to be part of this diabolic plan to, once and for all, bury this disease and its patients.

Thank you!

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David Tuller on the IOM Saga: Must Read

David Tuller just published an excellent piece on the IOM saga on Buzzfeed, just in time before the IOM meeting today. Please, everybody, help to have it go viral. Tweet about it and put in on your FB wall, ideally linking from the Buzzfeed site. Leave comments. And like it on the Buzzfeed site. Thanks!

Here is the link to the piece.

Soundbite from Dr. Peterson: “I can’t imagine being on a committee for some disease I don’t know about.”

 

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Comments to the IOM by Edward Burmeister

My husband’s written comments for the January 27, 2014 IOM meeting:

My name is Edward Burmeister.  I am an attorney with the world’s largest law firm.  My wife, Jeannette Burmeister, is also an attorney who worked at the same firm until she became disabled with ME eight years ago.

I am writing to express, in the strongest terms possible, my objection to the IOM contract to recommend clinical diagnostic criteria for ME/CFS (“IOM Contract”).  Moving forward with this IOM Contract is directly against the interests of ME/CFS patients, is in direct opposition to the opinion of 50 ME/CFS experts and is in disregard of the recommendation of the Chronic Fatigue Syndrome Advisory Committee (“CFSAC”).  The only reasonable and sensible step to take at this time would be to terminate this ill-advised contract now.

One has to ask the following question:  Why would HHS enter into the IOM Contract for $1 million, 20% of the annual NIH budget for ME/CFS in light of (1) the CFSAC recommendation to convene a stakeholders’ meeting of ME/CFS patients, experts and advocates, working in consultation with CFSAC members, to reach a consensus for a case definition for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition, (2) the clearly stated opposition of 50 ME/CFS experts to HHS reaching out to the IOM for developing such criteria and (3) the pitiful lack of any meaningful government funding for ME/CFS?  Moreover, why was this done behind closed doors without consultation with CFSAC, other than notice to its chair?

Add to this question the following: Why was the IOM Contract entered into quickly and secretly? To this date, HHS/NIH have refused to release a copy of the IOM Contract and surrounding documentation, despite multiple FOIA requests and an FOIA lawsuit filed by my wife to obtain these documents.

Why the obfuscation by HHS? In a statement by Dr. Nancy Lee, Designated Federal Officer of HHS to CFSAC, and in FAQs issued by HHS, there is a clear reference to a contract between HHS and the IOM, but in the “National Academics Umbrella Contract Statement of Work/Request for Proposal,” released to a patient by HHS, the IOM Contract appears to be a “task order against the NIH umbrella contract” with the National Academies.

Why does this Statement of Work recite that the project to be undertaken by IOM is in support of the Chronic Fatigue Syndrome Advisory Committee (CFSAC), when it runs directly contrary to CFSAC’s recommendation?

Why does the proposed IOM committee include a majority of non-ME/CFS experts, as acknowledged by HHS, in a project to develop diagnostic criteria for one of the most complex diseases that exist?

Why is there only one public meeting required under the IOM Contract and why are the IOM recommendations in its final report to NIH to be developed in secret without any opportunity for public or expert comments on the final report?

Why is the IOM the appropriate entity to perform this project given its organizational conflict of interest (the subject of a formal complaint to the HHS Office of Inspector General) presented by its prior ME/CFS findings in its reports on Gulf War Illness and its lack of experience in developing case definitions for diseases, as confirmed by Dr. Kenneth Shine, former president of the IOM.

When one ponders these questions, the answers are quick to suggest themselves.  There are key players within HHS who do not want ME/CFS to be elevated to a serious, physical disease demanding substantially increased funding, approval of research grants, approval of disability claims, approval of Medicare claims, etc.  Once the CFSAC recommendation was made in October 2012, these players set in motion a behind-the-scenes process that resulted in the announcement of the IOM Contract in September 2013, without prior public consideration or comment and, as noted above, in direct opposition to ME/CFS experts and CFSAC.

The process has been structured to (1) minimize public and patient input, (2) insure the ME/CFS experts will be in the minority, (3) ensure the final recommendation will be developed in secret without public comment and (4) ensure NIH control of this process through a secret monthly meeting of the IOM with the NIH Task Leader, contrary to the IOM’s normal procedures.

If one is sceptical of my conclusions, I would suggest researching the series of IOM reports on Gulf War Illness, where the VA was in the same role HHS/NIH is in the IOM Contract.  I would commend to your reading the testimony of Mr. Anthony Hardie, a Gulf War veteran, given on March 13, 2013 to the House Veteran’s Affairs Committee on Oversight and Investigations at http://veterans.house.gov/witness-testimony/mr-anthony-hardie-0.

The IOM Contract cannot be “saved” by tinkering around the edges.  In light of the essential facts—(1) NIH control, (2) organizational conflict of interest, (3) majority of non-experts and several IOM “regulars” as committee members and (4) very little by way of public meetings or review, particularly of the ultimate recommendation—the only appropriate course of action is to terminate this contract or task order now before the inevitable damage to the ME/CFS patient community becomes permanent.

Edward Burmeister is listed in Best Lawyers in America, Northern California Super Lawyers and Chambers America’s Leading Lawyers for Business (#1 ranking). In 2011, Mr. Burmeister was recognized as Best Lawyers’ San Francisco Employee Benefits Lawyer of the Year. Mr. Burmeister served as managing partner of the San Francisco/Palo Alto office of Baker & McKenzie LLP twice.

Mr. Burmeister is past Chairman of the State Bar of California – Taxation Section. He is a member of the Advisory Board of the National Association of Stock Plan Professionals, the Certified Equity Professional Institute (past board member), Santa Clara University, and the Global Equity Organization (past board member).

Mr. Burmeister is a graduate of Stanford University (A.B.) and Stanford Law School (J.D.) where he was Order of the Coif and Managing Editor of the Stanford Law Review. He is admitted to practice in California and before the U.S. Tax Court and Claims Court.

Mr. Burmeister is a veteran of the Vietnam War, having served as a Lieutenant in the U.S. Navy from 1966 through 1970.

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Want to Help in the IOM Fight? Sign This Petition!

Several patients and advocates will travel to D.C. to attend the January 27, 2014 IOM meeting, potentially the only IOM ME/CFS meeting that will be open to the public. This trip will come at great cost to folks, not only financially, but more importantly in terms of the consequences to their health. The patients and advocates who will attend the meeting will do so representing the many patients who are sadly unable to do so.

If you want to help, here is something you can do. Please sign the petition linked to here. The petition asks HHS for the following:

We, the undersigned people suffering from Myalgic Encephalomyelitis, along with our families, carers and friends hereby ask Secretary Kathleen Sebelius to cancel the contract HHS signed with the Institute of Medicine (IOM) to develop “clinical diagnostic criteria” for ME/CFS. We further urge Secretary Sebelius to respect the consensus reached by a group of experts and adopt the Canadian Consensus Criteria (CCC) as the research and clinical case definition for ME/CFS.

Remember, even if you believe that this IOM “study” is inevitable, which is just a government talking point so far, protesting it increases the chances for a better outcome.

Thank you!

 

 

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Does the IOM Task Order Comply with Requirements of NIH/NAS Umbrella Contract?

Remember, everybody, that HHS is refusing to comply with the FOIA requests from patients (which is why a lawsuit was filed in federal court to enforce rights under the FOIA)? Because of that, we don’t know for sure what the NIH/NAS umbrella contact provides for. However, it appears that there is some (although little) information about that contract at this link, which talks about a standing contract between the NIH and the National Academies of Science, “which allows funding of the Academy activities to support the NIH mission.” It would seem likely that the IOM “study” falls under this umbrella contract.

Now, here is what’s peculiar about this find. One of the identified required “steps to using the contract” is to “[r]esolve all questions about the scope … of the activity.” [emphasis added] This is where it gets really interesting: The listserv message from the IOM of December 26, 2013 informed us that one of the objectives of the afternoon session of the January 27th/28th, 2014 IOM meeting, which is open to the public, is to “clarify the scope of the charge.” [emphasis added] In other words, the scope of the IOM “study” is not clear yet, despite that being a requirement under the NIH/NAS umbrella contract.

[Edit April 7, 2014: HHS has deleted the information referenced above in an apparent attempt to cover up their failure to comply with the requirements of the umbrella contract. For a discussion and an image of the information previously found at the above link, please see my blog entry from today here.]

Because of HHS’s secrecy surrounding this “study” and it’s refusal to provide the pertinent documents in a timely manner, in violation of federal law, we can only speculate, but I question whether the IOM task order to develop new diagnostic criteria for “ME/CFS” follows the umbrella contract’s requirements and if it doesn’t, whether the task order is legally valid and, thus, whether the “study” was validly commissioned.

Regarding the lawsuit I filed last week and for people who have been wondering: No, I am not litigious. I have only brought one lawsuit in my life and that was against the State of Berlin, Germany. I won.

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Federal Lawsuit Filed Against HHS and NIH Relating to IOM “Study”

I’m m mad as hell and I’m not going to take this anymore!—Movie “Network” (1976)

Today, I filed a lawsuit against HHS and NIH in the U.S. District Court for the Northern District of California for failure to comply with the requirements of the Freedom of Information Act (FOIA) regarding documents I requested relating to the Institute of Medicine (IOM) “study” of diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome.  I have asked for my costs and attorney’s fees. The complaint can be found at this link.

I am not claiming that this is the only time a government agency has failed to comply with the FOIA. However, this case seems particularly appalling given its context:

  • Patients with this disease have been harmed, dismissed, ridiculed, abused, neglected and completely abandoned by the government, and as a result, by the medical profession, insurance companies, friends, family, neighbors, colleagues; in other words, by society at large. This is largely due to the unscientific government-sponsored case definitions, another one of which was ordered from the IOM, which is the issue at the heart of my FOIA request. In light of this crucial reality, it simply boggles the mind that the government would arrogantly ignore their duties under the FOIA.
  • The IOM “study” is a highly contentious issue and the secrecy game the government is playing at the expense of violating federal law leads many to believe that the government has something to hide. It certainly isn’t worried about giving that impression.
  • At least two other patients have filed FOIA requests similar to mine.
  • The documents requested are readily available to the government, as they have been publicly referred to by HHS and quite frankly, it’s callous to force patients to have to go to the effort of filing FOIA requests given the toll that takes on their health.
  • I followed up on my initial request 3 times and I sent one last letter to the government 5 days ago warning them that my lawsuit is imminent if they don’t comply immediately.

I don’t understand why other patients find this kind of mistreatment acceptable and continue to seek a seat at the table when it is clear that the game played at the table is rigged (to borrow Lisa Petrison’s terms). The government feels comfortable violating federal rights of patients for whom they should go above and beyond at this point to atone for their decades of abuse. Yet, the opposite is true. What will it take for people to see that the bureaucrats will not move an inch, unless we make them by suing them or by making them look bad in public? Cooperation clearly hasn’t worked for us because doing the right thing is not a variable that factors into the equation for the government. Remember, the best predictor of future behavior is past behavior, especially when there is a clear indication, as there is here, that somebody, the government, is doubling down on their prior infractions.

Complying with our clear and basic federal rights is about the least respect towards the patients the government should be able to muster. Looking at these facts, one can only guess the level of disgust the government must have for us patients. I have heard from many patients that the feeling is mutual at this point.

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IOM in Full Stealth Mode: No Information on Potentially Only Meeting Open to Public

The first IOM meeting to develop diagnostic criteria for “ME/CFS” is scheduled for the 27th and 28th of this month. The afternoon of the first day is open to the public and will include a public-comment period.

So, what’s the problem with this? The statement of work requires merely one out of the five IOM committee meetings to be public. Given how HHS and the IOM have (mis-)handled matters so far and given the tremendous backlash from the expert and patient communities, I would venture a guess that this will be the only meeting that will be open to the public. And yet, here we are, less than three weeks away from the meeting, and no instructions on the registration process have been given and more importantly, no information is available on the public-comment session. But hey, this is only the most important issue for this patient population in our lifetime. So, maybe we shouldn’t be so sensitive to all the secrecy and lack of consideration. I keep raising the fact that the secrecy surrounding this “study” raises red flags left and right and the IOM (in addition to HHS) is making my point for me. But who says that acting this unreasonably and expecting severely ill people to travel at a moment’s notice without any regard for their disability is proof of bad faith? Actually, I do!

How many people will get to comment? How will the IOM determine who will get to speak if there are more people interested in speaking than available speaking slots? Something tells me that members of the public who have been the most vocal against the IOM “study” and the entire process will get to make a public comment at the meeting when hell freezes over, despite the fact that we have been as closely involved in the IOM discourse as one can be since the very beginning. I can pretty much predict at least some people who will get a public-comment slot and I am sure you can, too, without me having to spell it out.

By the way, I do not encourage commenting substantively, e.g., on potential biases of committee members, or engaging in the IOM process in any way other than to reject it unequivocally and to make that point every step of the way. The message needs to be that the community objects to the “study” altogether for the various reasons I listed in my recent blog post.

Maybe HHS and the IOM are not familiar with this (After all, the IOM just got $1 million from HHS to burn on a literature review.), but this is how air travel works: The later you book your ticket, the more expensive it will be. This kind of matters for a patient population that is rather poor, often because of wrongly denied disability claims, ironically due to inadequate government-sponsored disease definitions. Full circle.

Update: I have heard from several patients that only organizations are being invited by the IOM to send representatives to give public comments. If this is true (and it would explain the absence of a sign-up process for comments or even attendance), this really isn’t a “public” comment session. It’s a session for people to speak who HHS and the IOM seem to think want a seat at the table so badly that they’ll play ball.  Although they may be in for a surprise with some of those folks. I have to say, for an organization allegedly as esteemed as the IOM, there certainly seems to be a strong desire to control the process entirely down to what is being said at the public meeting and a lot of fear of letting people give their honest opinion. And if that’s the case, we can all imagine why.

Again, this has already been going on and yet, us mortals have not heard about this officially. This information just happened to be leaked. Why is the IOM not forthcoming about the process? From an institution with supposedly impeccable reputation, one would expect more integrity than has been evident so far.

Updated Update: More information leaked and it appears that at least two individuals who have no official affiliation with any organization have been invited to speak. It’s getting more and more disturbing. It’s like elections in East Germany where the Communist Party would always win by a landslide … of 99.9%.

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After OIG Dodges Charge of IOM’s Conflict of Interest, Meaningful Reply Demanded

I received a response from the Office of the Inspector General (OIG) to my request to investigate the IOM’s organizational conflict of interest. Unfortunately, the OIG completely dodged the issue I had raised by merely stating that no such conflict exists without any explanation of how it arrived at that conclusion. In fact, the letter was entirely unresponsive to the conflict issue that I raised, which is  unacceptable since the organizational conflict of interest is as clear as the light of day. Any accurate legal analysis would come to no other conclusion than that the IOM has a clear organizational conflict of interest.

Therefore, today, I sent a follow-up letter to the OIG requesting to receive a meaningful reply with a sound legal analysis:

Dear Ms. Cummings,

Thank you for your reply dated December 30, 2013 and postmarked January 2, 2014 to my letters of November 11, 2013 and November 16, 2013 with regard to the contract between the Department of Health and Human Services (“HHS”) and the National Academy of Sciences’ (“NAS”) Institute of Medicine (“IOM”) to conduct a study and produce a consensus report with recommendations for new diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”).

Your letter—in addition to incorrectly analyzing the legal arguments—indicates that the Office of the Inspector General does not seem to appreciate the severity of the issue that is about to be studied by the IOM. Therefore, before, addressing specific legal issues relating to this contract, I thought it might be useful to provide some background and context, which inform the legal issues.

The issue of the case definition for ME/CFS, including a proper and respectful name for the disease, is at the very heart of the shockingly inadequate treatment of this disease and the patient community by the federal government over decades. Patients have suffered and even died largely due to the various unscientific government-sponsored case definitions that have prevented scientific and clinical progress, most recently the so-called Fukuda definition of 1994, developed and adopted by the CDC, the same agency that misappropriated millions of congressionally mandated taxpayer money allocated to the research of ME/CFS, as your office might remember. Diagnostic criteria determine whether ME/CFS patients will receive proper treatment for their numerous physical abnormalities leading to severe debilitation that is equal to that of HIV/AIDS, end-stage renal failure, chronic obstructive pulmonary disease or that caused by chemotherapy, even by the admission of the federal government. The majority of ME/CFS experts—clinicians and researchers—have specifically warned, in an open letter to Secretary Sebelius of October 25, 2013 (copy provided in my November 11, 2013 letter), that a definition originating with an inexperienced institution such as the IOM “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.” In addition to the lack of funding for ME/CFS research by the government, in a largely successful attempt to completely abandon severely ill patients, the unscientific approach HHS has taken to developing case definitions has lead to unspeakable suffering of hundreds of thousands of patients and their families for 30 years. The current IOM study follows in the anti-science footsteps of the Fukuda definition etc., against the experts’ strong opposition and despite the following recommendation of the Chronic Fatigue Syndrome Advisory Committee (“CFSAC”) to Secretary Sebelius made at the October 2012 CFSAC 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.”

The overwhelming number of ME/CFS experts adopted the Canadian Consensus Criteria (“CCC”) (and, in fact, has been using them for years) and, in their open letter to Secretary Sebelius, urged HHS to do the same. Rather than following CFSAC’s and the experts’ recommendation, HHS worked, largely in secret and with unprecedented speed, to head off the adoption of the CCC by involving the IOM. As soon as the plan to engage the IOM in the definition effort became public, it was strongly opposed by ME/CFS patients and advocates, which is the reason HHS canceled the sole-source solicitation; it was trying to avoid the mounting of even stronger opposition by lulling the public into thinking that the effort had been abandoned. I strongly object to your mischaracterization of the reason for the public outcry. Patients were never concerned about the nature of the solicitation. Instead, they were strictly opposed to the IOM approach altogether, whether through a sole-source solicitation or through a task order under an existing umbrella contract. To suggest that the public concern was addressed by proceeding with a task orders is simply preposterous. Changing the contracting mechanism, in secret, serves nobody other than HHS because it allowed the agency to circumvent the usually applicable competition rules.

Even after the task order was issued, HHS continued to lead the public to believe that it had entered into a stand-alone contract with the IOM. FAQs disseminated through CFSAC’s listserv, which were presumably drafted by HHS (although authorship was never claimed and the FAQs were not signed), were titled “FAQs on an HHS contract with the IOM to recommend clinical diagnostic criteria for ME/CFS.” During the December 2013 CFSAC meeting, Dr. Nancy Lee, CFSAC’s Designated Federal Officer, stated, “HHS has signed a contract with IOM.” One would hope that these misleading statement were not intentional. It is simply unconscionable to send patients on a wild goose chase by having them analyze the wrong set of federal regulations. These factually incorrect official statements by HHS raise serious red flags

It is clear that deception is taking place here. This is further demonstrated by the failure of HHS to provide to the public any documents (other than the statement of work) relating to this contract and task order in response to several FOIA requests by patients, which clearly asked for these documents. Under the rules of the FOIA, I should have received the documents in November of last year. It is indefensible to force patients to jump through the FOIA hoops at the expense of worsening their health, when the documents are readily available. But to not even comply with the requirements of the FOIA is indicative of the fact that HHS seems to have something to hide with respect to this IOM study. For example, does the task order even come within the scope of the NAS umbrella contract? Were corners cut in the contracting process? The first IOM meeting is scheduled for less than three weeks from now. Part of that meeting is open to the public. The statement of work allows for the remainder of the meetings to be held in secret. Meaningful comments by the public at that, potentially only open, meeting are impossible without having access to the relevant documents. We should have received the requested HHS documents relating to the study many weeks ago. Why is HHS stonewalling?

Turning to your letter dated December 30, 2013, it is clear, with all due respect, that you have not fully nor adequately addressed the issue of the IOM’s organizational conflict of interest (“OCI”) and have also misinterpreted or misunderstood the process that the IOM follows with this type of study.

The ultimate report of the IOM will be developed in secret, without any opportunity for public comments and it will be endorsed by the IOM, as an institution, as was done recently in the IOM’s report on the treatment of Gulf War Illness:

“Responsibility for the final content of the report rests entirely with the authoring committee and the institution.” (Emphasis added.)[1]

It is true, as you pointed out, that a review of the draft report is planned by an independent report-review committee consisting of non-ME/CFS experts, but there is no requirement that the reviewers’ concerns be addressed nor publicly responded to by the IOM nor that these concerns are made public at all. Hence, there is no scrutiny, as a practical or legal matter, of the substance of the final report of the IOM.

You have acknowledged that an OCI as defined in applicable regulations includes “impaired objectivity,” which would include a firm’s work under one government contract being evaluated by the same firm under another government contract. You further acknowledge that the contracting officer shall exercise “common sense, good judgment and sound discretion.”

In the case of the IOM contract/task order, the impaired objectivity could not be more obvious. The IOM in 2013 (and on numerous occasions prior to that), has issued and expressly endorsed a report that includes specific findings on ME/CFS that are at the heart of the issues surrounding diagnostic criteria for ME/CFS to be studied under the new contract/task order at issue here. I pointed out those findings in the IOM’s report on Gulf War Illness in my letter of November 11, 2013

Your letter simply dodges this issue by stating, without any support or justification, that the ME/CFS study does not require the IOM to assess its performance under another contract. This is simply not true. If the IOM were to reach conclusions regarding ME/CFS other than the ones it arrived at in the Gulf War Illness report, upon which its findings regarding Gulf War Illness were largely based, that would, at best, be a major embarrassment and humiliation to the IOM and, at worst, could call into question the validity of its Gulf War Illness conclusions. Remember that the Gulf War Illness report triggered Congressional hearings and serious accusations of the report being tainted due to an undue influence on the report by the Department of Veterans Affairs. A high-level government epidemiologist, Steve Coughlin of the VA, went public with criminal allegations under the Whistleblower Protection Act.

The provisional IOM panel consists of mostly professionals without any ME/CFS expertise, as admitted by HHS.  The chair of the provisional IOM committee and several of the other proposed committee members are regular members of the IOM or its committees and would be expected to be concerned about the consequences of the IOM taking inconsistent positions under separate contracts, which creates a substantial risk of biasing the panel towards supporting the earlier ME/CFS findings. After all, we keep hearing from HHS about the impeccable reputation of the IOM and how much weight a report on ME/CFS from the IOM would have.

A conclusion of common sense, good judgment and sound discretion, as required to have been made by the contracting officer, would, without a doubt, have determined that a major contractor with HHS would not risk its reputation by coming to inconsistent conclusions on an essential issue of public health in near simultaneous reports. This is about as clear an example of impaired objectivity as can be imagined.

Of course, as are you aware, case law provides for an even broader definition of “impaired objectivity” than the one you quoted. I am sure you are familiar with the cases on point, but please do let me know if you wish me to cite them to aid in your analysis.

Your letter acknowledges the example I provided regarding an individual conflict of interest of a committee member in an IOM study of the adverse effects of Pertussis and Rubella vaccines, but dismisses it as addressing individual, not organizational, conflicts of interest. In my prior correspondence, I acknowledged that difference. But it would seem to be common sense that if an individual committee member is deemed to have bias or impaired objectivity if he has previously indicated his views on the topic to be studied by the IOM, then surely an organization’s objectivity would be impaired if it has, as an institution, quite publicly and prominently taken a position on the central issue to be addressed in a proposed study.

As noted above, there are no institutional or legal restraints on the IOM potentially issuing a biased report. The screening of individual committee members and the review by the report-review committee simply do not address the OCI here.

The impaired objectivity of the IOM is of heightened concern given the background and context in which this contract/task order was entered into/issued and the complete refusal by HHS thus far to comply with FOIA requests for documents that may shed more light on the potential OCI.

Ms. Cummings, I think it’s time that your office take the issues raised seriously. Legal avenues are actively being evaluated by patients at the current time and lawsuits are about to be filed, as early as this week. If the Office of the Inspector General wishes to avoid a major embarrassment to HHS and Secretary Sebelius (on the heels of the disastrously mishandled implementation of the Affordable Care Act), it would be advisable to conduct a serious investigation immediately, the only reasonable conclusion of which would be to determine that an OCI exists.

I specifically request that your office address the OCI issue in a meaningful way, i.e., with a defensible (not merely conclusionary) analysis in light of my comments above. Your previous letter is not responsive to my OCI points in any way.

Sincerely,

Jeannette K. Burmeister

Attorney at Law

Enclosure:

IOM report “Gulf War and Health: Treatment for Chronic Multisymptom Illness,” page viii

Cc:

Barack Obama, President of the United States of America

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

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

Rush Holt, U.S. House of Representatives, Committee on Higher Education and Workforce Training, Subcommittee on Health, Employment, Labor and Pensions

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

Ms. Jennifer Cannistra, Executive Secretary, Department of Health and Human Services

Mr. Oliver Potts, Deputy Executive Secretary, 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. James M. Anderson, Deputy 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

Kathleen Sebelius, Secretary of Health and Human Services


[1] IOM report “Gulf War and Health: Treatment for Chronic Multisymptom Illness,” page viii (copy of page attached), http://www.iom.edu/Reports/2013/Gulf-War-and-HealthTreatment-for-Chronic-Multisymptom-Illness.aspx

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HHS and the IOM Saga: The Definition of Insanity and a Bad Case of Stockholm Syndrome

[I have borrowed somewhat from my prior blog posts and my legal complaints for this piece, but I’ve added on, so to speak, based on recent events and I thought it might be helpful to have all the arguments in one place, at least those that I could think of. Additional arguments are most welcome in the comment section.]

Like many patients, I crashed badly after that CFSAC “webinar” from hell last month, which forced me to be MIA for a while. I’ve got lots to say about that “meeting” and its many irregularities, but I’ll save that for my next blog post. In the meantime, I thought it might be helpful to summarize why the “study” by the Institute of Medicine (IOM) remains a frightening prospect for ME patients and why it is crucial to continue our opposition to it. After all, the relentless government propaganda on the alleged blessing that is the IOM—either directly by HHS or through its surrogates—is designed to make the most resolved patient feel defeated.  Here is why the IOM “study” is indeed bad news for patients, why this saga is far from over and why being resigned only plays into the hands of those determined to bury us: HHS and the insurance companies.

Not a “done deal.”  Let’s start with the most ridiculous argument the other side keeps trying to brainwash us with, the “done-deal” talking point. We recently heard it again from Dr. Nancy Lee at the December 2013 CFSAC “meeting” at which she called the IOM contract, in a rather irritated manner, an “irrevocable contract.” She stated firmly that the money, $1 million, cannot be recovered from the IOM by HHS because the agency used year-end money for the IOM contract.

I’ll talk more about this in my next blog post, but let me preface the following comments with my sincere assurance that they are not intended as a personal attack on Dr. Lee. Advocacy is political discourse and, like it or not, the government’s spokespeople don’t get to whine about taxpayers’ voicing their opinions when when their agency is doing a hack job or, worse, potentially misinforming the public, intentionally or not. This is especially true in the context of a patient population that has been ridiculed, short-changed, neglected, harmed, dismissed and thrown to the wolves by the government for decades. This is obvious to most people, but apparently not to all. I am not naive enough to think that Dr. Lee is the only player in this horrific game. There are other folks involved here who are likely much higher up in the HHS hierarchy. However, Dr. Lee accepted the task of attempting to placate the patient community.

Legally, the concept of revocation—the unilateral withdrawal of an accepted offer—does not even come into play here. Nobody is asking to have the contract (an accepted offer) revoked, a mechanism that is not provided for by the law when it comes to contracts. Patients are asking that the contract be terminated by the government. Maybe Dr. Lee thought that using a big term, such as “irrevocable,” would be more intimidating. (Sense a pattern here?) Or maybe Dr. Lee wasn’t briefed (sufficiently) by HHS’ legal department. Either way, her statement is not sensible legally.

I don’t know if Dr. Lee has been legally trained, so let’s give her the benefit of the doubt and assume that she meant that the contract cannot be terminated. The veracity of such statement is highly questionable. As has been pointed out in this context by others many times, government contracts can pretty much always be terminated for the convenience of the government, i.e., for any or no reason.

To give an example, in October of last year, HHS announced it was cancelling a no-bid contract it had entered into with a Chicago-based organization to increase health enrollment for prisoners, following an inquiry from Congress through Senator Jeff Sessions from Alabama.  Although that contract was later reinstated, this example demonstrates that HHS does have the authority to cancel contracts.

The IOM contract subject matter being “other scientific and technical consulting services” and the contract being for the fixed price of $1 million, 48 CFR 49.502(c) likely* applies according to which

[t]he contracting officer shall insert the clause at [48 CFR] 52.249-4, Termination for Convenience of the Government (Services) (Short Form), in solicitations and contracts for services, regardless of value, when a fixed-price contract is contemplated and the contracting officer determines that because of the kind of services required, the successful offeror will not incur substantial charges in preparation for and in carrying out the contract, and would, if terminated for the convenience of the Government, limit termination settlement charges to services rendered before the date of termination.

In other words, HHS would, under federal regulations, have been required to include the following termination-for-convenience clause in the IOM contract (from 48 CFR 52.249-4):

Termination for Convenience of the Government (Services) (Short Form) (APR 1984). The Contracting Officer, by written notice, may terminate this contract, in whole or in part, when it is in the Government’s interest. If this contract is terminated, the Government shall be liable only for payment under the payment provisions of this contract for services rendered before the effective date of termination.

Therefore, based on federal regulations, the termination for convenience by HHS of the IOM contract merely requires the government’s paying to the National Academy of Sciences (who sub-contracted with the IOM) for the services rendered and expenses incurred prior to the termination (plus possibly a reasonable profit on the work already performed). In this case, the IOM committee members have not even been appointed yet. So the amount owed by HHS is probably minimal; I would be very surprised if it exceeded $50,000. Even if it does, do we want to accept a botched definition affecting the lives of hundreds of thousands of patients and their families most likely for decades merely in order to justify the expenditure of a relatively small amount of taxpayer money compared to the cost to the U.S. economy in the tens of billions every year? I know I don’t. No reasonable person would.

Even if the recovered money won’t be re-allocated to HHS’ budget, it’s not like the IOM would get to keep it. It will go back to Treasury, and, thus, the taxpayers. And maybe HHS can re-direct the money to other IOM-related tasks, such as fixing the defective Gulf War Illness (GWI) report(s) by, at a minimum, reversing the name change from Gulf War Illness to the outrageous name Chronic Multi-Symptom Illness and by clarifying that antidepressants, cognitive behavioral therapy (CBT) and graded-exercise therapy (GET) are inadequate band aids at best, not treatments of the underlying serious disease.

[*Of course, we cannot be entirely sure what the IOM contract provides for—maybe it’s in violation of the federal regulations—since it has not been made available to the public despite at least three Freedom-of-Information-Act requests by patients. More about that below.]

On a separate, but related note, I am still intrigued by the fact, which I feel warrants an explanation, that the government was somehow able to locate $1 million for a literature review for “ME/CFS” when it just, for the life of it, cannot seem to come up with any meaningful amount for the research of the disease. HIV/AIDS just was allocated an additional (!) $100 million from NIH over the next three fiscal years. That is on top of the $3.1 billion that HIV/AIDS will receive from NIH for research in 2014 as opposed to the meager $5 million in research money NIH will provide for “ME/CFS.” In other words, NIH’s budget for HIV/AIDS is over 600 times that of the agency’s budget for “ME/CFS” despite the fact that the debilitation experienced by a significant number of ME patients rivals that of untreated AIDS patients shortly before their death. Anybody who is trying to convince patients that the government is finally coming around and ready to help us just needs to look at those numbers to realize how out of touch that kind of thinking is and what a stretch it is to expect patients to buy into this mirage.

As I’ve said before, you’ve got to think of this whole thing as a psych op. It has been psychological warfare from the beginning: talking points of questionable accuracy disseminated by the government and its allies designed to make patients feel powerless, full-court press to push this “study” through without any accommodation of the patient community’s or CFSAC’s concerns, complete secrecy and potential misleading of the public, etc. I know the situation is scary because if the IOM study goes through, ME patients are sunk. So, the stakes are high. But don’t be fooled into thinking that we are powerless just because that’s what the government is trying to make us believe. We are anything but. There have been a number of indications that HHS is quite nervous about the patients’ strong and unparalleled opposition to the IOM. For example, do you really think there would not be more mental-health professionals on the panel, similar to the last GWI IOM committee, without all the patient pressure? In fact, do you really believe there would be any ME experts on the committee without our opposition? HHS has flinched. Let’s keep that pressure on. We’ve got absolutely nothing to lose by resisting all the way (as opposed to cooperating) because the sham input we are given is a transparent ploy.

Who wants to bet that the comments that patients submitted regarding the “provisional” IOM committee members will lead to absolutely zero change in the committee’s membership?  I understand and respect why patients provided feedback. It’s the desperate hope of influencing the outcome of this frightening process. But, in my opinion, such cooperation will only give HHS cover in claiming that patients were heard and included in the process when, in reality, it’s a set-up and it won’t work, which leaves us with one option only: continuing our uncompromising complete resistance. It’s not hard to imagine the content of the final report. Just look at the IOM’s reports on GWI. That’s what our report will look like. For example, exercise was mentioned as a treatment for “ME/CFS.” So, if exercise helps, then clearly, exercise intolerance or post-exertional malaise, the hallmark feature of “ME,” can logically not be part of the definition.

There will be no influencing of this train wreck by patients through cooperation. No changes will be made to help us get our desired outcome. Any changes the IOM might make to pacify us are most likely merely cosmetic. But let’s assume for a minute, for argument’s sake, that some of the particularly worrisome provisional committee members will be replaced based on the public’s feedback. Then HHS would have a strong argument in asserting that patients have been accommodated, except that there is a snowball’s chance in hell that ME experts would be placed on the committee instead. What would be gained for patients by exchanging one non-expert for another? Of course, in reality, every committee member who is not an ME expert is unacceptable, not just those that seem to stand out like a sore thumb as being biased and especially unfit to serve on the committee.

Think about it! If the IOM really wanted our input, would it have set a December 23 deadline for feedback, right before a major holiday? Of course not. The fact that it did so is a dead give-away. There is not even an attempt at pretense that the patients’ degree of disability is taken into account. After a grossly mishandled and, thus, for patients, extremely draining CFSAC “meeting,” public comments for which were due the day after Thanksgiving, patients barely had time to recover for the committee-comments deadline and then crashed again right before Christmas. Scheduling these important deadlines close to holidays is either intentionally cruel or frighteningly ignorant. Either way, it doesn’t give me any comfort as to the outcome of the “study.”  All that lip service about how much HHS cares! Patients are cognitively impaired, but not to a degree that complete contempt and total lack of respect and consideration would go unnoticed. In any event, had I recovered in time to have the cognitive wherewithal by the deadline, my comment would have been, “I object to the IOM “study” because the IOM is, by its own admission, not qualified to perform the contracted-for task and because it has an institutional conflict of interest.” Full stop. No engaging on particular panel members because the IOM itself and all non-experts are unqualified and/or biased.

Some patients have been taken in by the “done-deal” argument; they feel that any opposition to the IOM contract is likely futile. I respectfully disagree. This is an 18-months “study.” With an effective date of September 23, 2013, we are very early in this process. As I said, the committee members haven’t even been appointed yet. This is like calling a nine-inning baseball game as soon as the first batter is on deck. So many things can happen here. The media could pick up this incredible saga. Numerous journalists are currently researching, and interviewing patients and experts for, this story of a majority of non-experts defining the potentially most complex disease of our time. One or more ME experts on the panel may resign in a vocal manner due to moral concerns. That government employee might just be getting close to blowing the whistle on potential HHS misconduct. We might find out that the contract has a serious, maybe fatal, defect. Legal avenues are being evaluated by a good number of patients working with lawyers because there clearly seems to be something fishy going on with respect to this contract. Patients are actively engaged with Congress on this issue and are pushing for a Congressional investigation. Sizable demonstrations are being planned. Until the final IOM report is published—which, if the majority of patients has anything to say about it, will never happen—this deal is not done by a long shot.

The IOM “study” is contrary to CFSAC’s October 2012 recommendation. At its meeting in October 2012, CFSAC, following considerable discussion and analysis, recommended the following to the Secretary:

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.

So, what was recommended was to hold a stakeholders’ meeting—in consultation with CFSAC members—with ME/CFS experts, patients and advocates to reach consensus on a case definition based on the Canadian Consensus Criteria (CCC). Instead what did we get? A “study” by the IOM that includes no patients or advocates nor CFSAC, but instead involves a majority of eight professionals without any prior experience with ME/CFS versus a minority of seven ME/CFS experts, as admitted by HHS through Dr. Lee during the last CFSASC meeting. Everybody who watched that October 2012 CFSAC meeting was quite clear that the recommendation referred to ME/CFS experts. For good reason. 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 professionals with ME/CFS expertise only. The IOM “study” is quite obviously not what CFSAC recommended. It is actually the exact opposite.

In a letter by Secretary Sebelius to our experts, she claims that the IOM study was necessary because “HHS does not generally develop diagnostic criteria for disease conditions.”  If anybody ever needs an example of somebody insulting others’ intelligence, this one is as perfect as it gets.  I mean, really!? We have been harmed for almost 20 years by the Fukuda definition developed and adopted by … wait for it … the CDC! We may be cognitively impaired, but people within and outside the patient community can see right through this complete lack of even a hint of sincerity in the Secretary’s letter.

It’s one thing for the Secretary to disregard a recommendation; CFSAC is used to that. But to hijack it for purposes clearly contrary to CFSAC’s intent, that’s taking it to a different level entirely. It’s adding major insult to injury. There seems to be no concern on the part of HHS about having dropped the pretense that CFSAC is an independent and respected advisor to HHS. This is how badly the government wants this “study.”

In responding to CFSAC member, Eileen Holderman, at the December 2013 CFSAC meeting, Dr. Lee informed us that, among the CFSAC membes, only Dr. Gailen Marshall, CFSAC’s chair, and CFSAC’s ex-officio members were involved in the development of the statement of work while, at the same time, explaining that only federal “people” can be involved in the contracting process. That begs the question of the justification of Dr. Marshall’s involvement.

According to three CFSAC members, Ms. Holderman, Mr. Steve Krafchick and Dr. Mary Ann Fletcher, the ten other CFSAC voting members (other than Dr. Marshall) had no input in, or knowledge of, the IOM process until the contract was signed. Ms. Holderman stated for the record that CFSAC’s recommendation was ignored and not implemented. She called for the termination of the IOM contract and the adoption of the CCC because the majority of stakeholders reject the IOM “study.” Dr. Lee’s response to that was that CFSAC is an advisory committee, not an oversight committee. In other words: “Buzz off!” She then stated, “We took the advice and we put it through our public-health experience.” I believe that is code for giving the powers that be within HHS that are intent on burying or trivializing the disease the opportunity to closely control the process.

The IOM “study” is contrary to the experts’ clear opposition to it. Remember, 50 ME/CFS experts remain opposed to this “study” and warned specifically that a “study,” such as the one to be undertaken by the IOM, “threatens to move ME/CFS science backwards by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.”

The open experts’ letter to the Secretary also urges the adoption of the CCC. The experts decided that the CCC—reflecting about 400 years of clinical and teaching experience, hundreds of peer-reviewed publications and about 50,000 ME cases—are more than good enough. HHS has always said that a definition must originate within the medical community. Well, the CCC did and the experts called the Secretary’s bluff. Are the CCC perfect? No, but they are a very sophisticated starting point and a quantum-leap improvement over Fukuda and the experts have already committed to refining it over time.

The IOM contract completely disregards the majority of ME experts. It also ignores the unconditional support by the vast majority of patient advocates of the experts in their opposition to any IOM-like effort and in the adoption of the CCC.

Secrecy: big red flag. HHS officially first announced its intent to contract with the IOM in a no-bid, sole source solicitation on August 27, 2013.  One week later, on September 4, 2013, HHS stated, “Because of all the concern from the public surrounding the sole source solicitation, we have decided to discontinue this request.” Less than three weeks later, on September 23, 2013, HHS announced that it had, in total secrecy, entered into the contract with IOM. Makes you wonder whatever happened to the issue of “the public concern” because that certainly hadn’t and still hasn’t been resolved. So, I can’t help but feel that HHS pulled the solicitation to finalize the contract in secret, thereby preventing any chance of the public to mount any opposition. I think the expression for this is “pulling a fast one.”

But wait! It gets worse. At least three patients (Ms. Patricia Carter, Ms. Jennie Spotila and myself) have asked for copies of the contract under the Freedom of Information Act shortly after it was signed. But, to my knowledge, none of the requests have been honored within the 20-business-day deadline, which in my case was November 25, 2013, more than a month ago.  I know for a fact that Ms. Carter hasn’t received the contract and neither have I. I don’t know about Ms. Spotila, but since she hasn’t posted it, I doubt she has a copy. As my husband, Ed, put it,  “If HHS has nothing to hide, why put sick patients through the time and effort required to put together such an FOIA request?” It’s unconscionable. Ed continued, “This stonewalling and lack of transparency by HHS, along with the rush in finalizing this contract, raise serious questions about the contracting process [and I will add: the contract terms] itself.”

If you think about it, if you are HHS and you are trying to get patients on board—because they so obviously aren’t—wouldn’t you opt for as much transparency as possible? Oh right! That would require that HHS actually care about what patients think. Silly me!

The Secretary, in her letter to the experts, assured them of HHS’s commitment to fostering open dialog.  This is nothing short of gag producing given the secrecy and manufactured urgency 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 yet despite being legally obligated to under federal law. And if an open dialog is so desired by HHS, why not reply in kind, with an open letter, to the experts?

Urgency: big red flag. One of the $1 million questions is the reason for the extreme speed at which this study is forced down our throats.  After all—in cases other than national-health crises, like a threat to the blood supply—this kind of urgency is highly unusual, if not completely unprecedented.

Potential non-compliance with competition rules. Furthermore, HHS seems to have entered into the contract without complying with federal-contract acquisition requirements applicable to a no-bid contract. I filed two complaints regarding this potential violation, one with the Inspector General (radio silence despite my following up) and one with HHS’ Competition Advocate. The latter forwarded my request for investigation to HHS’ legal department.

What’s also interesting in this regard is Dr. Lee’s admission of HHS having used year-end money to enter into the IOM contract. This is intriguing because government-acquisition rules prohibit their circumvention based on urgency when the urgency was artificially manufactured by an agency’s waiting until shortly before the end of the fiscal year (September 30) when its appropriations are about to expire. The IOM contract was announced on September 23, 2013, a week before the end of HHS’ fiscal year. Cutting it pretty close, wouldn’t you say? Even Dr. Lee acknowledged what a challenge it was to get the contract finalized on time. Since the stated reason for going down the other-than-full-and-open-competition route and instead awarding a no-bid contract was that the IOM is the only game in town (single source) is on very shaky grounds—as in: it’s not true just because HHS says so—this becomes very relevant.

Institutional conflict of interest. As I pointed out in my requests for investigation with the Inspector General and the Competition Advocate, the IOM has a clear and blatant institutional conflict of interest with respect to this contract, which conflict-of-interest checks of the panel members can’t cure.

Throughout the recent GWI 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 GWI. 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 GWI 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 GWI report.

When you also take into account the tremendous backlash the recent IOM report has triggered in the GWI population, it becomes even more obvious that the IOM cannot afford to backtrack on any of its previous findings regarding “ME/CFS” because the GWI report rests largely on those. The GWI report triggered Congressional hearings and serious accusations of the report being tainted due to an undue influence on the report by the Department of Veterans Affairs. A high-level government epidemiologist, Steve Coughlin of the VA, went public with criminal allegations under the Whistleblower Protection Act.

Do you think it is likely that a panel composed on mostly non-ME/CFS experts and several IOM “regulars,” including the committee chair, will abandon these conclusions regarding “ME/CFS” and undermine the findings of the GWI report? Not a chance since that would give its detractors more ammunition for invalidating that report. Consider the embarrassment and potentially even serious legal consequences for the IOM and/or HHS. It’s just not going to happen.

The GWI report from earlier this year clearly stated on page viii, “Responsibility for the final content of the report rests entirely with the authoring committee and the institution.” (Emphasis added.) The IOM expressly endorsed the report and cannot credibly claim now that only the GWI committee took ownership of it. It specifically stated otherwise in the report.

Based on prior precedent laid out in my first call for investigation with the Inspector General, this situation creates an institutional conflict of interest, i.e., a bias of the entire institution of the IOM. Notice that neither HHS nor the IOM has addressed this issue! Instead they keep referring to conflict-of-interest checks of the panel members, which is completely non-responsive to the serious concern of the bigger, organizational conflict.

The institution: amateur hour. The IOM itself acknowledged 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 Multi-Symptom Illness (the new name created for 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.”

The committee: amateur hour. I mean no offense to some of our more esteemed experts who were nominated, but the concept of convening a committee with any non-experts, let alone with a majority of non-experts, is nothing short of ludicrous. It’s insanity that is not even in the realm of reasonableness. The rationale reportedly given by the IOM, i.e., that the definition “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 mind-boggling. In no other area of any significance or in any complex field would the definition of a crucial issue, such as a disease definition, be turned over to non-experts. It’s unthinkable and would be ridiculed to no end.

This is like tasking a group of tax lawyers with the development of trademark law because, you know, one day, a non-trademark lawyer’s client might have a trademark question. To give the non-experts the ability to develop the diagnostic criteria through a secret majority vote is absurd and puts the “ME/CFS” patient community at serious risk.

Dr. Byron Hyde, ME expert from Canada, has this to say about who is fit to define a disease:

Definitions are not diseases, they are often simply the best descriptions that physicians and researchers can offer, with their always imperfect knowledge, to describe a disease.  Good definitions are good because they correspond closely to the disease state being described.  It is thus important that those that attempt to define any disease or illness … have long term clinical experience with patients with this illness.  There is simply no place for the bureaucrat in defining illness.  All definition of epidemic or infectious illness must be based upon persistent clinical examination of the afflicted patient, an understanding and exploration of the environmental factors producing that illness, and pathophysiological examination of tissue from those patients.  For similar reasons, I believe that the inclusion of psychiatrists in the defining of an epidemic and obviously disease of infectious origin, simply muddies the water for any serious understanding of that disease. (Emphasis added.)

(Hat tip to Danny Ze-dog for this find.)

At the last CFSAC “meeting,” various CFSAC members, including Ms. Holderman, raised their serious concern about non-experts being involved in defining this disease. Mr. Krafchick, who made the October 2012  motion resulting in the CFSAC recommendation to the Secretary, and Dr. Fletcher made it clear that the recommendation made by CFSAC related to a consensus workshop with experts in the community and that it wasn’t intended that professionals outside “of the field [would be] given the task of revising a good definition, the CCC.” Dr. Fletcher flat out stated, “I am really not happy with this.”

Evidence-based approach leading to disastrous criteria. Another tip of the hat for some of the following points to Danny Ze-dog:  One argument by HHS is that the CCC are ten years old and don’t reflect the latest research. However, one problem with the IOM, and any evidence-based approach towards ME, is that there has been almost no funding for replication studies of biological findings, but plenty for repetitions of CBT and GET trials, so the ‘evidence base’ is skewed towards the psychological dimension. You know who likes evidence-based approaches? Insurance companies. And if that doesn’t scare you, then I don’t know what will.

A not well understood disease can only be defined by experts in the field based on their total clinical knowledge, most of which is NOT published. For that reason alone, they should be the ones defining the disease.

What do you think the odds are that this panel can agree on a definition at least as accurate as the CCC? Even if the CCC become the starting point for the experts, they are in the minority and, therefore, will have to compromise FROM that position. Are patient advocates and experts really willing to accept a process that, even if our side fights its hardest, is likely to result in a definition weaker than the CCC?

So, while HHS’ argument is that the IOM can do better than the CCC, the reality is that it is bound to do worse. Much worse. At the last CFSAC meeting, both Mr. Krafchick and Dr. Fletcher emphasized that the the-CCC-is-ten-years-old argument by HHS is a red herring. After all, 50 ME/CFS experts agree that the CCC are the appropriate case definition to adopt. Clearly, the experts know better than the government, which remains mostly ignorant or dismissive about the disease. During the CFSAC meeting, Mr. Krafchick called the CCC “alive and well.” And Dr. Fletcher confirmed that the experts are, of course, open to examining and updating the CCC.

Dr. Lee stressed her excitement about the possibility of the IOM-generated diagnostic criteria being published as a lead article in the Journal of the American Medicine Association, JAMA, in a couple of years.  Talk about a nightmare for ME patients: antidepressants, CBT and GET endorsed by one of the leading medical journals of the country. Farewell antivirals, immune-modulators, aminos, etc.

Secret meetings. Keep in mind that, once the panel is finalized and the “study” proceeds, it will largely be conducted in secret. The statement of work calls for only one public meeting, and there is no requirement that the panel respond publicly to any concerns or issues raised at this meeting.  The final meeting to reach consensus on the report and the review of that report will all be secret.

Especially if you’ve got a majority of professionals who are largely, if not completely, ignorant about a very complex disease whose fate they are about to decide, it is crucial to have the scrutiny of non-panel ME/CFS experts and the public. Private meetings permit the minority of ME experts to be marginalized without transparency. Given the IOM’s track record, this should set off very loud alarm bells.

The afternoon of the January 27, 2014 meeting, the first day of the first two-day IOM committee meeting, is open to the public. That’s the meeting where they will attempt to figure out what they are supposed to do. Any takers for a bet that this quarter of one meeting will be the only public part of the whole process?

What are they “studying” anyway? Without going into depth on the issue because it is beyond the scope of this post, let me just mention that studying two completely different disease entities, ME and CFS, together, is as unscientific as it gets. ME is not CFS and vice versa. The name Chronic Fatigue Syndrome was deliberately chosen by the CDC to muddy the waters because it can be, and is, used interchangeably with fatiguing conditions, such as deconditioning, psychological diseases, such as depression, as well as conditions that are not even illnesses, but produce fatigue as a symptom.

Many patients do not understand the difference between ME and CFS because the government has done a good job at creating confusing around the two. Even some experts do not keep them separate. Worse, they use the dreaded term “chronic fatigue” for ME all the time, a source of never-ending frustration for patients suffering form the debilitating effects of ME. Some experts openly admit that they are treating people fatigued due to medical conditions other than ME or due to mere deconditioning. With an unscientific status quo like that, how could the non-experts on the panel possibly understand the distinction? It’s just not conceivable that a decent, scientifically accurate definition of ME could be produced by this particular IOM committee.

As if to confirm the point, the IOM, via its listserv, announced that the first IOM meeting will be held on January 27-28, 2014 during which one objective for the committee is “to clarify the scope of the charge ….” In other words, the IOM is unclear about what it got hired to do, which is outrageously pathetic and mind-blowingly unprofessional. So the IOM is wondering what the heck they are going to be paid the sum of $1 million for. I might be cognitively impaired, but I am quite certain that I have never advised a client to enter into a contract with an uncertain scope.

How does one even pick a panel for the “study” without knowing what the panel will be doing? Seriously, this is not a rhetorical question.

Intimidation by the government. Dr. Lee stated, at the last CFSAC meeting, in a quite patronizing manner, that nobody on the IOM staff or a committee member has any bad intentions and that suggestions to the contrary “could backfire” on the patient population. Excuse me, but this is not a grade-school soccer game where mere attendance is rewarded and everybody receives a trophy regardless of performance. This is about the lives of severely ill patients. Not being hostile, even trying hard, isn’t good enough. This is about competence, which can only come from experience with the relevant subject matter, and fitness to get the job done well. That is what’s being questioned by patients. Not having ill intentions is a ridiculously and unacceptably low standard by HHS and I am puzzled by the fact that Dr. Lee felt comfortable admitting to that.

What’s more alarming about Dr. Lee’s statement, however, is the fact that it was a thinly veiled threat during a public-comment period regarding the provisional committee members. Insinuating that unfavorable public opinion will be detrimental to patients is like a police officer abusing his or her discretion by giving a ticket to a motorist just because the driver argued the justification of the citation. “I was gonna let it slide, but since you talked back, I will give you that ticket. There! That’s how much power I have and I am not afraid to abuse it.” It’s a disturbing and potentially illegal abuse of power.

Attempted intimidation of the public by a government official has a chilling effect on free speech. One has to wonder if the fact that Assistant Secretary, Dr. Howard Koh, basically blew off serious allegations by two (correction: three) CFSAC members of Dr. Lee’s intimidation tactics (and thereby endorsed them)—by dismissing the charges without any meaningful response—made Dr. Lee feel omnipotent and untouchable. If Dr. Lee is this comfortable threatening patients in public with consequences of their speaking out—and she made other alarming comments at the CFSAC meeting, which I will address in my next blog post—just imagine what she might have said in private to those  CFSAC members! It seems to me that she lent a whole lot more credibility to the complaining CFSAC members, not that their integrity was in question before. This is the potential disturbing pattern I alluded to above.

Bottom Line. To suggest, as the Secretary has done, that 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 GWI 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 government’s woefully inadequate Fukuda definition?

I have been asked if I am 100% sure that the IOM outcome will be bad? Well, no, I am not. But I am also not 100% sure that I’d be killed if I jumped off the Golden Gate Bridge, yet I don’t plan on jumping to test the hypothesis.

I have also been asked what my ultimate goal is in fighting the IOM contract. This is like asking somebody who is trying to stop nuclear war what he or she will do afterwards to end world hunger. We don’t have to worry about what happens after an IOM “study” because it would be the end of the road for patients and science if it proceeds. If we lose this battle, we will have lost the war for decades to come, maybe forever.

However, it’s not like the experts in their open letter to the Secretary only opposed an IOM-like effort to develop yet another flawed government-sponsored definition without suggesting how to proceed without the IOM.  Instead, they offered a path forward by urging HHS to adopt the CCC, like they themselves have, as the clinical and research definition and once that occurs, we will see a surge in much more scientifically-accurate research of the disease that is based on clearly defined cohorts meeting accurate criteria for the disease and no more research of tired people. Of course, even though the CCC are a very strong case definition as is, the experts would refine it. That’s what frequently happens with other case definitions. So, the experts have, in their open letter, clearly laid out a plan and it’s disingenuous to suggest that they are merely saying no the IOM.

Even if you think that an IOM report on “ME/CFS” is inevitable, which is merely a government talking point, what do you think will motivate the IOM committee members more to do right by ME patients: (1) keeping the pressure on and continuing to create a real risk that that the IOM “study” will be stopped altogether or completely discredited by one of the means mentioned above, which would not look so good on any of the committee member’s resume or (2) conceding that the “study” will proceed and, thus, surrendering any leverage? It’s a no-brainer, don’t you think? Seriously, let’s not give up our power by capitulating!

If the government really had a change of heart, it has a hell of a way of showing it. Like a battered spouse, some patients have gone back for more, over and over for decades, all the while hoping that this time, it would be different. And as in abusive relationships, the abuse has gotten worse and worse. Just look at the last CFSAC “meeting.” Remember Albert Einstein’s definition of insanity: “Doing the same thing over and over again and expecting different results?” Most ME patients who are involved in any kind of advocacy or raising awareness are very informed, proactive and engaged and they do understand that we have nothing good to expect from HHS. Any excuse being made by a minority of patients for HHS’ open contempt for the ME community can only be explained by a bad case of Stockholm Syndrome. Instead of listening to the majority of patients who is telling the government that it doesn’t want yet another harmful government-sponsored disease definition, HHS sadly takes full advantage of a small minority of the patient population who seems less informed or maybe overly trusting by trying get them to cooperate and comply, be spokespeople or give them a seat at the table.

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New Advocates’ Letter to Secretary Sebelius Re IOM Contract Open for Signatures

Following is a letter regarding the IOM contract that will be sent to HHS Secretary Kathleen Sebelius and other government officials this coming weekend.

We hope that everyone who signed the first advocates’ letter to Secretary Sebelius will choose to sign this one (and that we pick up some additional signatures as well!).

Due to time limitations and a severe health crash, we are asking that those wishing to sign send notice of this by Friday, December 20, to our email address at:

advocates2sebelius@gmail.com

You also can help out by letting others know about this letter and encouraging them to sign it.

Note that as in the past, this letter is open only to people acting as advocates for the disease (in a volunteer or professional capacity), rather than to all patients or to the public at large.

However, especially since the limitations of this illness make it difficult for many patients to do very much work, we are defining the word “advocates” broadly. If you have provided information about this disease to others, or answered questions from newly diagnosed patients on a forum, or shared your views or experiences publicly, or discussed with other patients strategies about how to make the world a better place for people with this disease, or helped out in other ways — then you count as an advocate.  Please join us!

The basic format for signatures is as follows:

Name

Degree, School

Former Job (age or year disabled)

Advocacy Position (or “Patient Advocate”)

Website or Email Address (if desired)

Here is the link related to the discussion in the letter of the IOM committee advising the government about the disease formerly known as Gulf War Illness:

http://www.iom.edu/~/media/Files/Report%20Files/2013/Gulf-War-and-Health9/GulfWarandHealthVol9_RB.pdf

Here is the link related to the budget disparities between ME/CFS and other diseases with similar prevalence and severity:

http://report.nih.gov/categorical_spending.aspx

Thanks much to everyone for participating.

Lisa Petrison

Jeannette Burmeister

*****

 An Open Letter to the Honorable Kathleen Sebelius,

U.S. Secretary of Health and Human Services

 

December 22, 2013

Dear Secretary Sebelius,

We are writing as researchers, physicians, authors, filmmakers, patient forum leaders, not-for-profit organization managers, bloggers and other advocates working on behalf of individuals with Myalgic Encephalomyelitis (ME), a disease that the U.S. government has historically referred to by the misleading name of Chronic Fatigue Syndrome (CFS) and more recently has called ME/CFS.

The purpose of this letter is to inform you that our previously expressed position regarding the government’s plan to redefine this disease through the Institute of Medicine (IOM) remains unchanged.

Since the September announcement of the contract with the IOM, concerned stakeholders have conveyed to you their opposition to the involvement of the IOM in the re-definition of the disease in a number of ways (including an experts’ group letter, an advocates’ group letter, multiple petitions and many individual emails).

IOM has now released a slate of proposed committee members, asking for comments. This proposed list is unacceptable for a number of reasons. The majority of the named individuals are not experts in ME/CFS; the committee chair appears to have no ME/CFS experience at all; and several of the proposed members have backgrounds focusing on mental health issues.

These problems reinforce the concerns generated by the initial report from the IOM committee charged with providing guidance to the government on Gulf War Illness, released earlier this year. That committee gave the disease an inappropriate new name; mentioned that it has symptoms overlapping with those of “Chronic Fatigue Syndrome”; and discussed the effectiveness or need for study only of treatments that are appropriate for depression but have been shown to be ineffective or harmful for ME/CFS patients (including antidepressants, cognitive behavioral therapy and aerobic exercise). Considering that this IOM panel also was dominated by non-experts in the disease being discussed and included a number of members with backgrounds in mental health, our concerns about the likely outcome of the IOM effort to redefine ME/CFS remain very high.

We again request that the IOM contract be cancelled and that the government adopt the Canadian Consensus Criteria as the definition for this disease.

In addition, we request that the government increase the budget for biomedical research into this disease to become more equitable with the budgets for other diseases with a similar level of prevalence and severity. For instance, NIH spends more than 600 times as much on HIV/AIDS as it does on ME/CFS (with a 2014 budget of $3.1 billion for HIV/AIDS vs. a trivial $5 million for ME/CFS). Considering that the number of U.S. patients living with ME/CFS (1 million) is roughly the same as the number of people in this country living with HIV, and considering that the level of suffering endured by many ME/CFS patients is equal to that experienced by untreated AIDS patients prior to their deaths, ME/CFS is woefully underfunded. This needs to be rectified immediately.

Finally, we request that the government consistently refer to this disease by its proper name, Myalgic Encephalomyelitis (ME).

Thank you for your attention to this matter.

Sincerely,

(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

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Ampligen: The FDA’s Unequal Treatment of a Second-Class-Citizen Drug

On December 11, 2013, I wrote a letter to the FDA’s Director of the Center for Drug Evaluation and Research, Dr. Janet Woodcock. I pleaded with her to use her considerable discretion and potentially accelerated procedures regarding the approval of drugs for life-threatening or severely-debilitating diseases that lack alternative treatments to finally approve Ampligen for the treatment of myalgic encephalomyelitis (ME). I asked Dr. Woodcock for the reason of the jarring unequal treatment of Bexsero and Ampligen. Bexsero is a drug that is not approved in the US and yet the FDA allowed its  use in the vaccination of 8,000 students at Princeton University. Ampligen, on the other hand—a drug found to be safe by a majority of the FDA advisory committee and effective by a substantial minority of the committee—was denied approval in February of this year for ME, a severely debilitating disease without any approved drug treatment and none on the horizon.

One does not have to look far to realize that the preferential treatment of Bexsero over Ampligen is no exception. Below are further examples (not an attempt at a complete list) of drugs that have been approved by the FDA—one under an accelerated approval procedure—despite questionable safety and/or efficacy profiles and despite the fact that, in most cases, alternative drug treatments exist. In the case of the two weight-loss medications, there are also other treatments, such as improving one’s diet and increasing one’s amount of exercise. The latter is, of course, something ME patients would love do to, but are unable to due to the dire consequences most forms exercise would have on them, which adds to the irony.

We can all speculate as to the reason for the inequality. But see for yourself:

Type 2 Diabetes: Canagliflozin, sold as Invokana (Johnson & Johnson)

Canagliflozin, a new class of Type 2 diabetes drugs, was FDA-approved on March 29, 2013 despite serious concerns by the FDA advisory committee about elevated stroke risk and an increase in heart attacks and other cardiovascular problems. In addition, the drug raises LDL levels (so-called “bad” cholesterol) and increases the risk of side effects for patients with moderately impaired kidney function, a patient group for which the drug also isn’t as effective as it is for those with normal kidney function. Despite several committee members finding an unfavorable risk/benefit ratio for that patient group, the FDA approved the drug for patients with both normal and impaired kidney function. The reason cited by the majority of the panel members for their support of the drug was the unmet need “for new agents to treat the growing population of patients with type 2 diabetes.” Does “unmet need” ring a bell for ME patients? And I don’t mean unmet need for “new agents,” but for ANY agent.

Alzheimer’s: Aricept (Pfizer)

Mindy Kitei reported about the apparent double standard in the FDA’s denial of approval for Ampligen versus the agency’s refusal to ban the highest dose of the Alzheimer drug, Aricept, despite the lack of increased efficacy and in spite of the increased mortality rate of the higher dose of the drug compared to its lower doses.

Tuberculosis: Sirturo (Johnson & Johnson)

As Bob Miller pointed out during the FDA’s April 2013 Drug Development Stakeholder’s Meeting, the FDA approved on December 31, 2013,—under an accelerated approval program—Sirturo, a drug to treat multidrug-resistant tuberculosis that is five times more likely to kill patients than the standard drug treatment for the disease without proof of increased efficacy.

Weight Loss: Belviq (Arena Pharmaceuticals GmbH)

On June 27, 2012, the FDA approved the weight-loss drug, Belviq for the use in obese adults (BMI of at least 30) and overweight adults (BMI of at least 27) who also have at least one weight-related medical condition, such as high blood pressure, type 2 diabetes, or high cholesterol. The approval was granted despite the FDA’s advisory committee’s concerns about the potential risk of breast tumors and heart-valve problems and despite the proven increased risk of  other serious side effects, such as serotonin syndrome (especially when taken together with medication for depression and migraines) and disturbances in attention or memory.

Weight Loss: Qsymia (Vivus Inc.)

In September of 2012, less than three months after approving Belviq, the FDA approved a second weight-loss drug, Qsymia, for overweight people despite concerns that the drug causes an increased heart rate; a condition called metabolic acidosis, which can lead to hyperventilation, fatigue and anorexia; and birth defects, such as cleft lip and cleft palate and despite the fact that the FDA advisory committee initially voted against the approval of this drug. The FDA and the drug maker both acknowledged that the clinical trials designed to assess the drug’s safety and effectiveness did not properly assess cardiovascular risks. Qsymia most likely has to be taken long term, a factor that seemed to weigh heavily against Ampligen in the FDA’s decision not to approve it.

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Dr. Woodcock: Please Approve Ampligen Now!

My letter to Dr. Woodcock from earlier this week:

Jeannette K. Burmeister

[email]

[phone]

[street]                                                                                                                  [street]

[city, state, zip code]                                                                                          [city, state, zip code]

December 11, 2013

Via U.S. Mail & Email ([email])

 

Dr. Janet Woodcock

Food and Drug Administration

Director, Center for Drug Evaluation and Research

[street]

[city, state, zip code]

Re: Unequal Treatment of Ampligen and Bexsero

Dear Dr. Woodcock,

I am writing to you on behalf of myself and the vast number of patients who suffer from myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”), a disease classified by the FDA in the category of serious or life threatening.  The arbitrary application by the FDA of the rules relating to drug approval seems to give more weight to the front-page news than the actual gravity of a disease. I am confounded at the FDA’s decision to approve the use of Bexsero at Princeton University to prevent further cases of meningococcus B causing meningitis while at the same time failing to provide Ampligen for ME/CFS patients earlier this year.

As an attorney who practiced at the world’s largest law firm, I am familiar with the application of laws and regulations, as well as the use of fair and responsible judgment.  Unfortunately, I was forced to leave my position when I got sick with this mercilessly debilitating and unrelenting disease, ME/CFS.

The FDA’s decision to allow the import of Bexsero into the United States for the use in a vaccination campaign for approximately eight thousand students at Princeton University in an effort to prevent potential mass deaths, or other tragic cases, like serious complications such as the amputations in the case of one UCSB student, from meningitis implies one of two things. Either the FDA is concerned for the health and welfare of patients in the face of a serious and potentially life-threatening disease or the FDA applies the law in an egregiously unequal and arbitrary manner when it comes to severely ill patient populations. My question to you, Dr. Woodcock, is why the FDA did not apply same concern and medical judgment it is demonstrating for the Princeton cohort to its decision about Ampligen.

Ampligen was denied approval by the FDA in February of this year, even though the FDA’s advisory committee voted in December of last year that the drug was safe. The committee split its vote on the question of efficacy, in all likelihood due to a lack of understanding by the agency of the severity of the disease and the significance of clinical improvements for patients receiving the drug as part of clinical trials. In fact, Dr. Theresa Michele, FDA clinical team leader for the Ampligen decision, admitted and stressed, at the April FDA Drug Development Meeting, that she had not previously been aware of the symptoms of ME/CFS 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.

There is no doubt in the mind of the majority of those fortunate ME/CFS patients who have had the benefit of Ampligen as trial participants that the drug is efficacious. Improvement in exercise capacity and recovery times as well as in immune-system markers show the efficacy of the drug objectively.

To give the unequal treatment of meningococcus B-caused meningitis and ME/CFS some perspective, to date, eight Princeton students have contracted meningitis. There have been no deaths and yet all affected students will have access to treatment.  On the other hand, about one million patients have been severely ill with ME/CFS—with 25% of them living at the brink of death—not for weeks, but decades. Only very few of patients who live near one of a handful of clinical-trial sites—or move to one while leaving their families behind—and who can afford Ampligen (and in most cases also the added living expenses) have access to the drug.

In weighing the benefits and risks of receiving Ampligen—a drug ruled safe by the FDA—ME/CFS patients without access to Ampligen have no hope for improvement, unlike the eight Princeton students hospitalized with meningitis. In fact, ME/CFS patients have received a life sentence of daily suffering and frequent severe crashes (worsening of the multitude of their debilitating symptoms) after only minimal physical or mental activity, such as performing tasks of daily living like showering or grocery shopping. Patients can also count on multiple hospitalizations and shortened life spans.

The Princeton students have now the option of receiving the Bexsero vaccine. ME/CFS patients have been given no such option even though Ampligen, a safe and effective drug, is readily available.

I am one of the lucky few who are able to receive Ampligen twice a week.  As a result, I now function at a much higher level than before I started Ampligen treatment, at the expense of having to live at an approved Ampligen infusion site, more than two hundred miles apart from my three-year old little girl and my husband.  I only get to visit my family about every two to three weeks for three days. The fact that my husband and I are wiling to make such tremendous personal and financial sacrifices shows clearly that the benefit of Ampligen to my health and the quality of life for my family outweighs the cost in our lives, despite the heart-wrenching separation.

The FDA has the regulatory authority to approve treatments for ME/CFS, such as Ampligen, using less-stringent-than-normal rules, such as fast track, accelerated approval and priority review. The requirements for these avenues are met in the case of Ampligen. ME/CFS is a serious or life-threatening disease with an unmet need, as no approved treatments exists. Improvements in exercise capacity and recovery times as well as improvements in immune-system markers are appropriate surrogate end points.

Moreover, the FDA also has significant discretion at its disposal in determining whether applications have met the bar of “substantial evidence of effectiveness” of a drug (21 CFR §314.126(c)). The regulations in 21 CFR §314.105(c) state that the “FDA is required to exercise its scientific judgment to determine the kind and quantity of data and information an applicant is required to provide for a particular drug to meet the statutory standards.”

Regulations in 21 CFR §312.80 reinforce the need for flexibility in the case of life-threatening and severely-disabling illnesses by addressing “procedures designed to expedite the development, evaluation, and marketing of new therapies intended to treat persons with [such] illnesses, especially where no satisfactory alternative therapy exists,” as is the case with ME/CFS. The regulations state that the “FDA has determined that it is appropriate to exercise the broadest flexibility in applying the statutory standards, while preserving appropriate guarantees for safety and effectiveness. These procedures reflect the recognition that physicians and patients are generally willing to accept greater risks or side effects from products that treat life-threatening and severely-debilitating illnesses, than they would accept from products that treat less serious illnesses. These procedures also reflect the recognition that the benefits of the drug need to be evaluated in light of the severity of the disease being treated.”

Furthermore, the FDA has the ability to waive any or all of the criteria outlined as required for “adequate and well-controlled studies.” The regulations in 21 CFR §314.126(c) state, “The Director of the Center for Drug Evaluation and Research may, on the Director’s own initiative or on the petition of an interested person, waive in whole or in part any of the criteria [for adequate and well-controlled studies] with respect to specific clinical investigation, either prior to the investigation or in the evaluation of a completed study.”

I implore you and the FDA to take the long overdue step of approving Ampligen for the treatment of ME/CFS—if necessary by expediting the approval process and keeping in mind that ME/CFS is in the category of life threatening or severely debilitating diseases and lacks any alternative treatments—and, thereby, finally improving the lives of hundreds of thousands of patients and their families and giving them some hope.

Sincerely,

Jeannette Burmeister

Attorney at Law, California and Germany

cc:

Margaret Hamburg, Commissioner of the Food and Drug Administration ([email])

Joseph Pitts, U.S. House of Representatives ([email])

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