For the last few weeks, there’s been a rumor that HHS might actually respond to questions about the Institute of Medicine study. PANDORA urged HHS to address specific questions about the contract during phone calls and emails with HHS officials. The CFIDS Association also “contacted the CFSAC urging them to respond to a myriad of questions,” although they provide no other details about the context of that communication or the questions submitted.
In addition to the efforts of these two organizations, HHS has been buried in a deluge of organized petitions, letters signed by more than two hundred (combined) experts and advocates, and individual emails and letters.
The overall response to this deluge? A brick wall of silence. Since the announcement on September 23rd and the release of the Statement of Work on September 30th, HHS has officially said nothing about it. There have only been individual communications between IOM or HHS employees and advocates. Until now.
On November 15th, an email titled “FAQs Regarding the IOM Contract” went out via the CFSAC listserv. The email has been published in its entirety in a variety of places, but the CFIDS Association posted it first. I encourage you to read the entire document, but here are my standout raising-more-questions-than-answers-FAQ-moments.
TL;DR (Too Long, Didn’t Read?)
- The IOM study is aimed at the wrong target audience.
- They think they’re implementing a recommendation but they’re making it worse.
- They don’t explain why HHS can’t adopt the CCC.
- They ignore one of PANDORA’s most important questions.
- They contradict their own written descriptions of the NIH workshop.
But Who Is Answering?
Some people have questioned the authorship of the document (with good reason), specifically whether the CFSAC itself wrote or approved this document. Although the FAQ is not signed, I think we can safely assume that most CFSAC members had nothing to do with it.
How can I be so certain? Because if the CFSAC approved such a document – even if the vote was by email – it would be a violation of the Federal Advisory Committee Act which requires all meetings of the full Committee (electronic or otherwise) to be held in public. Given the Public Citizen smack down of the Committee for a similar violation earlier this year, I think that the CFSAC staff are more careful about these things.
The CFSAC listserv has become an all-purpose communication tool, in part because it is an effective way to get information out to the interested public. Announcements on behalf of other agencies, such as FDA meetings or CDC PCOCA calls, are routinely disseminated this way, although frequently days or even a week after we’ve already found out.
I think it is reasonable to assume that these answers were drafted by Dr. Nancy Lee and her staff, and sent out through the CFSAC listserv without even consulting the full committee. That is, of course, the pattern at the Office of Women’s Health. The entire IOM contract was conceived and developed by HHS staff, with only ONE member of the CFSAC consulted early in the process for input (and told to keep it confidential). I would be very surprised if something as sensitive (and rare) as public statements from HHS about the IOM contract were previewed or approved by the CFSAC itself. This is an HHS staff statement.
The Wrong Target Audience!
The first question of the FAQ is “Who is the target audience for the Institute of Medicine (IOM) study?” This was not one of the questions posed by PANDORA, and hasn’t really circulated in advocacy circles, so I’m not sure why this is the first question answered. But the answer is disturbing: the target audience is primary care providers because they don’t know how to diagnose ME/CFS, and patients have to see lots of doctors to finally get the diagnosis.
On the face of it, this seems reasonable. After all, my primary care doctor, and the first two doctors he referred me to, all failed to properly diagnose me.
But my primary care provider can’t diagnose cancer either. He might know I had a malignancy, but he would immediately refer me to an oncology specialist for diagnosis and treatment. My primary care doc can’t definitively diagnose artherosclerosis or rheumatoid arthritis or multiple sclerosis, either. He could suspect any of those diseases, maybe even screen me for them, but then my doctor would refer me to the cardiologist, rheumatologist, or neurologist best suited to diagnose the disease.
Saying that primary care physicians should be able to diagnose ME/CFS rests on two assumptions: that there is no medical specialty better suited to make the diagnosis and treat patients; and that ME/CFS is not so complex a disease that it requires care beyond what a general internist can provide. WRONG and WRONG.
I want primary care providers to know enough about ME/CFS to recognize when someone may need to be carefully evaluated for it, to know what tests might be helpful in screening, and to know which specialists are best suited to make the final diagnosis. A clinical case definition can help with this.
But I absolutely oppose the assumption that all we need is a quick checklist that any general nurse practitioner can use to label someone with ME/CFS and send them on their way to physical therapy. NO.
We Can’t Workshop Because . . . . ?
The October 2012 CFSAC recommendation states that HHS should convene a workshop of ME/CFS experts to reach consensus on a case definition beginning with the 2003 CCC. PANDORA asked why HHS could not convene the workshop and turned to the IOM instead.
In answering, HHS says it relies on professional societies and institutions like the IOM to develop guidelines and recommendations, and then disseminates those guidelines. HHS also says that making a clear distinction between clinical diagnostic criteria and a research definition will improve clinical care and research.
Never mind that the recommendation said that HHS should sponsor a meeting, not create a definition by itself. Never mind that the recommendation said that a single case definition for research, diagnosis and treatment was needed, not separate definitions. So not only has HHS not followed the recommendation, it has still not explained why.
But rest assured! The October 2012 recommendation has been addressed! The FAQ says, “as a direct result of the CFSAC recommendation, HHS’ contract with the IOM requires it to host public meetings and to include in the expert advisory committee ME/CFS experts (which could include members of CFSAC).” No, actually not. This contract only requires one public meeting, and we have no guarantee or information about meeting content.
And did you notice the last part of the sentence? As a direct result of the CFSAC recommendation, the IOM study will include ME/CFS experts which could include members of CFSAC. Several members of the CFSAC roster have been nominated to the IOM panel, including Dr. Levine, Dr. Marshall and Dr. Fletcher (all nominated by PANDORA).
In my opinion, even CFSAC members who are recognized experts in ME/CFS clinical care and research like Drs. Levine and Fletcher should not be on the panel. There has been so much rancor, division, controversy, and disagreement in CFSAC about the case definition recommendation, both publicly and privately, that I believe CFSAC members are biased on the issue. That’s just my personal opinion, but I will oppose the appointment of any current CFSAC member to the panel.
Why Not CCC?
PANDORA asked why HHS could not adopt the 2003 CCC, especially in light of the letter from the 50 experts to Secretary Sebelius. The answer? HHS can disseminate but not endorse guidelines made by nongovernmental groups and besides, the CCC is ten years old. I’m not buying it.
The Institute of Medicine is a nongovernmental group. That’s the POINT. Remember how I pointed out that the government cannot use IOM recommendations if it exerted influence over the development of them?
Yeah, so . . . . the government CAN and DOES both endorse and enact recommendations coming from nongovernmental organizations like IOM. Actually, they do it all the time and not just with IOM.
For example, Dr. Koh recently said that HHS was implementing recommendations from an IOM report on epilepsy that was co-sponsored by federal agencies and non-profit groups. The CDC recommends the American College of Rheumatology’s criteria for diagnosing fibromyalgia, and refers people to the Lyme disease treatment guidelines from the Infectious Disease Society of America.
In all three cases, HHS is endorsing recommendations and guidelines created by nongovernmental groups, not merely disseminating them. I’m sure HHS has its reasons for refusing to adopt the CCC, but those reasons are not the ones offered in this FAQ.
I Could Drive a Truck Through These Holes (if I could still drive)
One of PANDORA’s questions was, “Can the IoM contract be canceled? If not, why not?” The FAQ does not answer the question.
Instead, the FAQ answers a different question: “If the IOM contract is cancelled, will the contract funds go to ME/CFS research?” HHS says, “There is no way for HHS to recover or repurpose these funds.” Fine, but that’s not what we need to know.
First, where did the funding come from? Did it actually come from NIH’s research budget? I assumed the answer to that was no, and that there was never a chance that the money could be used for research regardless of what happened to the IOM contract.
Second, IOM says that HHS and the Social Security Administration funded the study. This FAQ says, “Almost all of the agencies that have efforts involving ME/CFS contributed Fiscal Year (FY) 2013 funds to this study.” Presumably this means HHS agencies, but it still does not tell us which agencies and how much they contributed. I would like to see the full breakdown, and I’m hoping that one of my FOIA requests will provide it.
Another question from PANDORA was completely ignored in the FAQ: “[W]hat guaranteed [sic] can you give that [IOM] won’t come back with something more broad, and thus more harmful, than Fukuda?”
THIS is the question we all want the answer to. In fact, it is arguably the MOST IMPORTANT question of all.
*insert sound of crickets chirping here*
The Shifting Sands of NIH
From the very beginning, advocates have been concerned about how multiple case definition efforts would be coordinated. At first, we were worried about the CDC multi-site study and the scope/coordination of the NIH Evidence-based Methodology Workshop (EbMW).
Our concerns were heightened after the announcement of the IOM effort, and alarm bells went off in my head when the Statement of Work said that IOM should coordinate with EbMW “to minimize overlap and maximize synergy. . . [and] assure that relevant information is shared and that key messages are coordinated.”
The FAQ attempts to address this by quoting an unnamed person at NIH:
The expected outcome from the Evidence-based Methodology Workshop for ME/CFS is to identify research gaps in ME/CFS, identify methodological and scientific weaknesses in the ME/CFS field, suggest research needs that will advance the ME/CFS field, and move the field forward through an unbiased, evidence-based assessment of this complex public health issue.
Do you notice what is MISSING from this description of the EbMW? There is nothing in there about a research case definition.
Which is funny, actually, because in a statement on the CFSAC listserv on September 3rd, HHS said “NIH will be convening an Evidence-based Methodology Workshop, which would address the issue of case definitions appropriate for ME/CFS research“. (emphasis added) The same description appeared in the CFSAC listserv announcement on September 23rd.
That phrase – “address the issue of case definitions appropriate for ME/CFS research” – seems to have originated from Dr. Koh’s written statement to the CFSAC in May 2013 describing the EbMW.
Despite all these statements in writing that the EbMW will address the issue of case definitions for ME/CFS research, this FAQ now (presumably) quotes someone (presumably) at NIH as describing the EbMW in a way that does not even mention the case definitions appropriate for ME/CFS research.
Any number of possible explanations come to mind: the EbMW purpose and approach has shifted; Koh’s written statements about the EbMW were wrong; this FAQ is wrong; different people at HHS have different understandings of the EbMW, some or all of which are wrong; this is an attempt to mislead the public; or no one has any idea what they’re doing.
I am becoming accustomed to written statements from HHS that add to the questions I have, rather than actually answering any of them. This FAQ document is just another example. According to the draft agenda for the CFSAC meeting on December 10th, Dr. Lee will discuss the IOM study for 30 minutes. The agenda does not indicate whether the Committee members will be permitted to ask questions or comment.
One can only hope that Dr. Lee’s presentation will clear up the confusion and address the long list of concerns about the contract. This FAQ has not succeeded in doing so.
Denise Lopez-Majano assisted with research for this post.