These are historic times. We are witnessing an unprecedented true watershed moment in ME history. With that comes a tremendous responsibility for our “advocates.” In one corner are the already existing, very sophisticated Canadian Consensus Criteria (CCC) that are a quantum leap forward from the current Fukuda definition and that are supported by pretty much every reputable ME expert in an open letter to Secretary Sebelius. In the other corner is the $1 million dollar Institute of Medicine (IOM) study contracted for by HHS to create a new disease definition that is all but guaranteed to bring us antidepressants, cognitive-behavioral therapy and graded-exercise therapy courtesy of co-opted and/or ignorant or naïve IOM committee members most, if not all, of whom with little or no expertise. Nobody can hide anymore. Not picking a side is not an option and, in fact, a huge red flag indicating potential ambitions for a position on the committee. Having a wishy-washy position is not going to cut it either because, logically, one can be on only one side or the other of this particular issue. There is no gray zone here. This is the moment of truth.
Dr. Terese Michelle of the FDA, the person responsible for burying Ampligen by making sure it didn’t get approved earlier this year, was lobbying for patient support of the IOM study on today’s FDA patient call. This is the answer right there about whether any good can come from the IOM study should anybody have any doubts.
As Hillary Johnson recently tweeted, “IOM contract has nothing to do with science. Once you understand that you will know how to play this. No cooperation, only resistance.”
Sadly, instead of showing solidarity with the experts and the patient community it is asserting to represent, PANDORA, following in the CFIDS Association of America’s (CAA) footsteps, chose not to stand with the ME experts regardless of what it is claiming. After much speculation last week by patients on the position of PANDORA on the IOM contract and silence for days, PANDORA went into full-blown damage-control mode on October 14, 2013. It finally released an official statement on the IOM contract (“position paper”). In it, PANDORA concedes that it “turn[ed] in a list of expert nominations.” Even though we pretty much knew, from the information that leaked last week, that this was going on, many patients’ hearts sank.
PANDORA vowed to “do all [it] can to avoid an IOM definition disaster…” This grandiose announcement shows an utter lack of grasp of reality. Once the IOM committee convenes, there is nothing any outsider can do. Remember the latest CFSAC meeting in May 2013? There was an aggressive attempt to silence the patient representative simply by invoking Robert’s Rules of Order. When she had something important to say and even though she had been given less time than those on the committee who toe the party line, she was declared to be out of order. It was only due to her courageous determination not to be sidelined at the whim of the committee chair that she wasn’t cut off from speaking at that particular moment. PANDORA is kidding itself if it thinks that it will have any say in the outcome of the IOM study or even the make-up of the committee. The IOM will probably make sure that there will be a few token ME experts and patients on the panel, but definitely not a majority, which is needed. PANDORA is merely being used right now to discourage people from opposing the IOM study. Does it really take somebody who grew up in East Germany to see that PANDORA is being played here, and it seems quite willingly so?
There are assurances in the position paper that PANDORA does not support the IOM contract. But the way PANDORA has gone about the whole issue raises some serious concerns about the sincerity of that statement.
First and foremost, PANDORA’s position begs the following question: What’s in it for PANDORA? A patient organization that assists in obtaining nominees for the IOM committee would have to expect that, by doing so, its reputation would be tarnished and its patient support would (further) dwindle? In light of such drastic negative effects, there had to be something to be gained by the organization and/or the people running it. In the case of the CAA, these gains are likely future government contracts, participation in governmental activities and possibly future government grants. What could it be for PANDORA and other “advocacy” organizations? Is it prestige and influence they are after by being perceived as being connected to the institutional bureaucratic sphere of influence and other powers that be? Such egocentric quest for power and standing would be in direct opposition to the interests of the patients. CAA history seems to be repeating itself.
On the bright side, this is a unique opportunity for the majority of ME patients and advocates to stand united in opposition to the IOM study.
Given the extremely charged controversy around the IOM contract, with many, if not most, patients, advocates and even experts being opposed to it, one can’t help but wonder why PANDORA’s president and communications consultant chose to even attend the IOM forum in D.C. last week after finding out about the IOM contract on September 23, 2013, if not earlier. As far as I know, the event was a free event, so canceling it wouldn’t have cost anything. It would have seemed appropriate—sort of a litmus test—for an organization that has faced many questions about its integrity over the years, to withdraw from the IOM forum while issuing a public statement giving the reason. That would have been an ideal opportunity to raise awareness within the IOM and with the public about this crucial matter and, most importantly, to support our experts. Isn’t that what an organization that is holding itself out as representing ME patients is supposed to do: support the patients by supporting the experts? I am afraid PANDORA failed the test pitifully, and it seems, cluelessly. There seems to be no self-awareness here. No recognition of how much its cozying up with the IOM has hurt this patient community, literally and in terms of morale. Or is there?
Why Play Nice?
Ok, so they went. One would think that they might have done so to use the opportunity to let the IOM know about the patients’ desperate outcry against, and disapproval of, the IOM contract and to show strong support for the experts. The situation is as dire as it gets. If the IOM contract proceeds, we all might as well make appointments with psychiatrists and physical therapists now. Because there will be no more effective clinical treatments, such as with antivirals, immune-modulators, etc., because health-insurance companies won’t pay for them anymore after the IOM recommends antidepressants, cognitive-behavioral therapy and graded-exercise therapy as the only appropriate clinical interventions for ME, as it has done with Gulf War Illness (GWI). And our experts will get a taste of what Lyme Literate Doctors have been facing: discipline for prescribing medications other than psychotropic drugs once the IOM is done with us. Quite understandably, patients are in complete despair over the IOM situation and, yet, PANDORA “inquired,” “shared,” “recommended” and “expressed.” It played nice with those who will be responsible for burying us even further for decades to come if we let them. PANDORA missed the opportunity to take a strong stand against the IOM contract. What kind of advocacy organization does that? Once you claim to work for patients, you have a responsibility. In this disease, the responsibility is overwhelming at times. But if one is not fit to shoulder the challenge, it’s irresponsible to take it on.
Did it even occur to PANDORA, since it claims to be such loyal representative of the patients, to ask those patients how it should conduct itself at the IOM forum or whether it should cancel the event altogether? Why be so secretive about attending it? Why not let patients know in advance? Could it be that PANDORA knew very well that patients would insist on PANDORA either passing on the event or emphasizing that, speaking for patients and experts, it is staunchly opposed to the IOM study? Without the patients’ outburst last week about PANDORA’s secrecy, would there even be a position paper now? I feel almost mocked to read in the position paper that PANDORA recommended to the IOM that it “provide as much transparency as possible.” PANDORA does not seem to have much credibility on the question of transparency.
Why Make Nominations?
But not only did PANDORA attend the IOM forum and fail to adamantly oppose the IOM contract while in D.C., they did indeed, as had been rumored, make nominations of experts to be on the ME IOM committee. Assuming that PANDORA does not have any ulterior motives in doing so—an assumption that cannot be safely made—this is such a rookie mistake. Attending “Negotiating 101” might have done PANDORA’s president and communications consultant more good than attending the IOM forum.
I have worked on several multi-billion dollar transactions. In any negotiating situation, it is best to come in with the strongest position and hold as firm as possible to make the other side bid against itself or move more toward your own position. If you eventually have to surrender a point, it will be from a much stronger position resulting in fewer overall concessions. By conceding the fact that the IOM contract will go forward and buying into the illusion of being able to influence the nomination and study process, PANDROA conceded the committee’s legitimacy and any movement to get a better outcome for the patients is already compromised.
And again, why not notify the patient community of the fact that these nominations are being sought? Why only admit to it after the information leaked? PANDORA tries to explain the delay in informing the public by their need to “find out the facts, seek out advice … and involve [its] board …” before announcing “actions or decisions to the public.” This is a cop-out at best. Clearly, a decision on the “action” of nominating experts had been made early last week. At that point, the patients should have been informed without delay. The pledge of transparency in the position paper couldn’t be more disingenuous.
PANDORA explains that it was given only three days’ notice to present a list of nominees to the IOM. I believe that to be true. What I don’t understand is why PANDORA simply complied with that ridiculously short deadline. Why not ask questions about the urgency? Why go along with this ambush-type approach? Why not publicly raise concerns about this rushed process? Why not ask the hard questions instead of simply giving in and cooperating? What about trying to slow things down in the interest of patients?
Is it possible that the fact that the open expert letter was about to be sent to Secretary Sebelius was somehow leaked to HHS, which would explain that the agency changed its mind after promising not to engage the IOM and why it is now in such a hurry to seal the fate of the patients? Why does a patient organization like PANDORA not ask these inconvenient questions? Why is PANDORA so eager to please?
In an obvious CYA move, PANDORA states that it “will be us to blame then and not the IOM or the government” if we don’t nominate potential panel members. Patient blaming is pretty much as low as one can go under the circumstances. HHS and the IOM are putting unconscionable pressure on the patient population knowing full well how sick people are and that they cannot react quickly. This is clearly being exploited here. And PANDORA is endorsing that despicable tactic by putting it back on the patients.
Why this Tone?
But what struck me the most about the position paper—more so even than the fact that PANDORA officially accepted, in their position paper and by nominating experts, that the IOM study was a done deal—was its tone, which is a dead give-away of PANDORA’s true position. The position paper may claim that PANDORA supports our experts and does not support the IOM study. However, the language in the position paper betrays these statements many times over:
What I find most disturbing is the speculation that other experts have changed their position after they signed the open expert letter. We have no indication that that is, in fact, the case. Why speculate? Why not stand strongly and unflinchingly behind our experts? The language in the position paper really gives it away: “So, it was not surprising to hear of one of the experts changing her position …” Who in support of the expert letter talks like that? We know of one (!) expert who has changed her mind, yet that’s enough for PANDORA to exclaim “it is now not clear what the majority of our experts think on the issue of the IOM contract.” This almost sounds like enthusiasm about the possibility that others have dropped off, something we have no indication for whatsoever. Somebody who really supports the expert letter and the CCC would never describe the facts like the position paper did. A true supporter of our experts would applaud them for coming to a consensus instead of chiding them for showing “no leadership or initiative on the definition.” The position paper’s words show very clearly where PANDORA stands and it’s not with the experts or the patients.
The other big red flag here is the likely untrue statement that the IOM contract cannot be canceled. The position paper claims, “The legally binding contract cannot be stopped.” Really? Has PANDORA seen the contract and had it analyzed by legal experts? Or did it just take the word of the IOM, an organization with a $1 million dollar interest in the contract? It is a very rare contract that cannot be terminated. Moreover, the government pretty much always reserves the right to rescind a contract. There may be some damages for the efforts of the IOM that were already undertaken, such as seeking nominations. But I would be shocked if more than $10,000 or $20,000 have been spent already. PANDORA should not be surprised if making this likely untrue statement with such certainty is perceived as the ultimate betrayal of a very vulnerable and desperate patient group. I see no other purpose than to demoralize the patients into resignation. Patients should demand to get access to the IOM contract as soon as possible before any more money is being spent and see for themselves whether PANDORA and other powers that be are telling the truth in alleging that the contract is iron-clad.
The position paper later states, “… all indications are the contract is unstoppable …” Unlike the foregoing statement, this is less of a legal assertion and more just propaganda not backed up by any facts. Why try to hammer it into patients’ heads that we can’t do anything about the contract? It doesn’t jibe with the assurance that PANDORA doesn’t support the IOM contract. It’s the same tactic that the CAA and its supporters are using: brainwashing us into thinking our opposition won’t make a difference, as I pointed out in my two prior blog posts, “Principled Approach: Fighting the IOM Contract is a Moral Imperative” and “More Propaganda: Still no Explanation from CAA for Disagreeing with Experts and Patient Majority.”
Conveniently, two unnamed GWI advocates allegedly confirmed PANDORA’s assertion that an IOM contract cannot be stopped. We know nothing about these advocates, their expertise, their credibility, their agenda. We are just supposed to take the position paper’s and these advocates’ word for it.
Furthermore, these advocates blame the VA’s bad IOM contracts for the bad GWI IOM outcomes. So, let’s see and compare the GWI and the “ME/CFS” IOM contracts. What makes PANDORA so sure that our contract is any better? Plus, the IOM’s name is still on these bad GWI reports and the IOM has not given any indication that it doesn’t stand behind its work. So, why make excuses for the IOM?
PANDORA is thankful that no decision about the disease’s name has been made yet. It doesn’t get much more sycophantic than that. It would be entirely inappropriate and against procedure if such decision had been made already. The IOM committee hasn’t even been formed yet—and hopefully never will be—let alone met. Of course, there is no name decision yet. Why be thankful that something that would be highly improper hasn’t occurred yet?
Why No Outrage?
PANDORA gives us some information about the IOM process and a lot of it is alarming, yet it doesn’t seem to faze PANDORA:
Out of the five committee meetings, three would be private. Is this even legal? And is this really not concerning to PANDORA? Private meetings permit the minority of true ME experts to be marginalized without transparency. Given the IOM’s track record, this should set off very loud alarm bells. But no, PANDORA takes no issue.
“The report will go through an independent external review process.” By whom? I would venture a guess that it won’t be by our experts. Again, not alarming to PANDORA.
Due to the fact that committee members are not paid, clinicians in private practice are often not willing to serve on the committee because, well, they have to pay their bills and feed their families. This is a huge flaw when it comes to creating a disease definition. This is one reason that the IOM contract is an unmitigated disaster. Clinicians arguably know the disease better than anybody, even researchers, because they have a broader picture of the disease. Yet, this seems to be not a problem in PANDORA’s mind. Or if it is, PANDORA kept it to itself.
The IOM prefers committee members “who do not have a strong bias and do not have a financial conflict of interest (ex. [sic] their income is largely dependent on the agency funding the study).” I think (but can’t be sure) the latter point means that members who do have an outside source of income (outside the study) are considered to be biased. This seems to be saying that every ME clinician and researcher is going to be considered biased and, thus, unfit to serve on the committee—the ultimate irony—although something tells me that the IOM will make exceptions for Suzanne Vernon and Fred Friedberg et. al. Even the FDA, on today’s patient call, confirmed that it considers clinicians biased who have been involved in ME research. And yet PANDORA claims to believe that their submitting ME-expert nominations will have a real impact on the composition of the committee. You watch: Our experts will be excluded as biased. Meanwhile, PANDORA and others have given credibility to the nomination process by getting involved.
In deciding who will serve on the committee, the IOM first looks to their own members, whether or not they are experts. This is preposterous. Why are PANDORA’s “advocates” not alarmed?
The GWI advocates told PANDORA that, out of nine GWI IOM studies, one had a good outcome. One out of nine! That is an abysmal track record for the IOM and yet PANDORA is using this as an argument in favor of the IOM contract.
Why So Inaccurate?
Pointing out that ME science has advanced since the CCC were created in 2003 is attempting to set up a false choice. By going with the IOM study, we do not stand to gain a more sophisticated definition that reflects current science more accurately than the CCC. Our only choices are the CCC or an IOM definition that will leave us much worse off than Fukuda ever could. It is naive to think that the IOM case definition could possibly be an improvement of the CCC.
According to the position paper, those GWI advocates I mentioned earlier did not know who would be on their committee until after the members were appointed. This makes it sound as if we will know. That is highly misleading because, in its very nature, an appointment is the point in time when the decision will be made. No outsider will know who will be appointed until after the fact. There is no difference here compared to the GWI proceedings, no improvement.
To claim that “no conclusions have been formed and no report has been released” by the GWI committee is again misleading. The current GWI study is being performed under the GWI IOM contract about the disease definition. The prior study regarding treatment was completed and the report published earlier this year. The treatments recommended were antidepressants, cognitive-behavioral therapy and graded-exercise therapy. In addition, the report changed the name GWI to Chronic Multi-Symptom Illness (CMI), something that is most likely in store for ME as well if the IOM study proceeds. And you thought “chronic fatigue syndrome” was bad!
Why does the position paper tell us that GWI patients were against the IOM study because “patients know that there aren’t any effective treatments?” This is completely irrelevant here because there most definitely are effective treatments for ME, just no FDA-approved ones. This is an argument against the IOM study, not for it. It makes no sense.
Naïve or Co-Opted?
I have no idea what lead to PANDORA’s position: naiveté or having been co-opted or maybe a combination of the two. All I know is that PANDORA acted contrary to the clear wishes of the patient community and our experts. Its actions and even its words speak louder than its transparent propaganda.
As in Greek mythology, today’s-age Pandora has, perhaps (and I hope) unwittingly, unleashed many evils of the ME world and releasing the position paper is its futile attempt to close Pandora’s box.