[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.