In my last blog post, I attempted, based on my preliminary reading of the IOM report on ME/CFS, to flag a potentially crucial issue: that the report does not exclude, in its proposed clinical criteria, patients with primary or major psychiatric disorders present at the onset of ME. I did say that more analyzing of the situation is needed and after giving the issue more thought, here are some (but not all) additional considerations that I think ME patients should be aware of.
Long-Term Disability Benefits (LTD)
The LTD problem actually affects every ME patient that also has a mental-health issue, regardless of whether that was preexisting or developed later. This issue is much broader than that of pre-exising primary or major psychiatric disorders.
I’ll start with an anecdote for which it is important to understand that essentially every private long-term disability policy contains a mental/nervous limitation clause limiting benefits for disability caused by/due to, or contributed to by, a mental or nervous condition. Mental-health disability benefits are limited to two years; benefits for physical disabilities are usually to be paid until the age of 65 of the insured. The mental-health limitation clause is usually very broad. UNUM, for example, defines mental illness as “a mental, nervous or emotional disease or disorder of any type.”
When I came up on two years of disability, my disability carrier required that I undergo an independent medical exam (IME). I was asked to see a rheumatologist who explained to me that his specialty was the logical one in my case since fibromyalgia patients are seen by rheumatologists. According to him, fibromyalgia and chronic fatige syndrome are basically the same thing. So much for his expertise. The good doctor asked me a bunch of questions and asked me to perform certain tasks, such as standing on one foot and squeezing a device measuring my grip strength. At some point, he said something like, “You know, when my alarm goes off in the morning and I really don’t want to get up because I am tired, I do it anyway and after I shower and shave, I actually feel much better. You should try it. I am sure it would work for you.” Then he wrote a report diagnosing me with affective mood disorder because I “looked better” than he would have expected based on my list of “complaints.” Based on this rheumatologist’s “exam,” my disability insurance company denied future benefits as of the 2-year cut-off date for mental-health conditions. This rheumatologist had no psychiatric or psychological training or education and “examined” me for probably less than an hour and, yet, he diagnosed me with a mental-health condition despite the fact that my disability was based entirely on chronic fatigue syndrome. Like all other doctors who perform these IMEs, this was a physician who collects money from insurance companies for every IME he performs and whose likelihood of being assigned more IMEs surely goes up with every psychiatric diagnosis he makes. Of course, I appealed the decision and the insurance company ultimately, after a hard-fought battle on my part, reversed their opinion. It is well known that insurance companies do a risk-benefit analysis. How likely is the claimant going to sue? With me and my husband both being attorneys, they figured it was a losing battle for them. But how many other patients would have won that fight is anybody’s guess.
This happened while I had a diagnosis of CFS under Fukuda, which rules out the existence of any major depressive disorder—and that ultimately forced my insurance company to continue my benefits—and yet I had to fight a drawn-out battle designed to wear me down and make me give up my benefits. Come to think of it, it was very much like the strategy HHS and NIH have been using in my FOIA lawsuit. Fast forward to the IOM criteria. If they get implemented, disability insurance carriers will have a much easier time denying benefits. So far, all an ME patient really had to say was that he or she has a diagnosis of chronic fatigue syndrome and since that automatically ruled out any psychiatric disorders, insurance companies could not rely on the two-year cut-off as long as the CFS diagnosis was intact and could be proven to be justified. That doesn’t mean that CFS claimants haven’t been unjustly denied LTD benefits after two years with the pretext of the existence of a mental-health condition. In fact, it happens all the time in the case of CFS (and other disabling diseases). But with a good attorney and/or good medical records, the road to victory over unjustified denials was much less thorny.
Under the IOM criteria, a diagnosis of SEID does not prevent an insurance company from claiming the existence of a mental-health condition based on an IME. The only argument a patient will have under the IOM rules is, “No really, I don’t have any mental-health problems.” As opposed to, “Look, I have CFS. End of story.” And since there is a fair amount of secondary depression in this patient population and since most patients do not have the money or health for legal action, I can just see the number of denials and disability terminations skyrocket now. As the insurance companies have tried to pin the psych label on ME patients all along, this is highly likely to happen under the IOM criteria, either just based on the file if there is nay mention of any psychotherapy in there or based on an IME. The risk for any patient diagnosed with SEID is much higher than the risk for patients with other diseases because the insurance industry’s default argument, even under Fukuda, has always been that ME is all psychiatric. Imagine how much easier that position is to defend now under IOM, which officially lets SEID and psychiatric conditions coexist.
It is true that in order for disability insurance companies to be able to rely on the two-year cut-off, the mental-health condition has to be a contributing cause of the disability. So, theoretically, secondary depression, e.g., should not be an issue in the case of an SEID diagnosis as long as the disability would be present even without the secondary depression. But in the real world, insurance companies will rely on every dirty trick they can come up with and the IOM just handed them a perfect tool; insurance companies will look a lot more reasonable now in their unjustified denials. After all, it is pretty hard to prove that any potential mental-health condition is not a contributing cause of the disability. Again, many patients will not be able to fight for their rights in court and even if they are, it’s not unheard of to draw a judge who thinks that ME patients are just lazy and crazy. Case closed. The insurance industry’s odds just went way up.
It doesn’t matter one bit that the IOM stressed, during the rollout of the report, that this is a real disease that is not “the figment of patients’ imagination.” That was a nice sound bite for the public-release presentation of the IOM committee chair, Clayton. But that patient-placating language won’t mean a thing in the real insurance world, which will only focus on the hard and fast rules contained in the IOM criteria. All that will matter is that a mental-health diagnosis will be considered a contributing cause of the disability notwithstanding the diagnosis of SEID.
It had been rumored in the patient community that one reason for the IOM effort was to cut down on the liability ME patients pose for disability insurance companies. I had been wondering exactly how that would be achieved by the IOM. Now I know. It has always been a thorn in HHS’s and the insurance lobby’s eye that a Fukuda CFS diagnosis precludes certain major depressive disorders. The problem is now solved. I do not know what percentage of patients receive LTD. But it surely is not an insignificant number of patients.
The potential loss of LTD is a purely financial consequence for many patients. For the patient population’s future in terms of treatment prospects, the dilution of research cohorts (see below) is the crucial issue. But losing one’s LTD benefits is hardly trivial for many affected.
Anyway, the bottom line here is: Say goodbye to your long-term disability, folks. And thank the IOM for it.
Use of the IOM Criteria for Research
The charge of the IOM committee on redefining ME/CFS was to develop a clinical definition, not a research definition. Some have made the point that the definition standard should be more lax for clinical criteria (such as the IOM criteria) than for research criteria in terms of not excluding patients with pre-existing primary or major psychiatric disorders. And in an ideal world, I can see that. But the delineation of the two types of definitions is not that clear. Remember that Fukuda has been used for over 20 years to diagnose patients despite being a research definition only. The CCC and the ICC, clinical definitions just like the IOM criteria, have been used for research purposes, so it’s not a stretch at all to assume that the IOM criteria will be as well.
Also keep in mind that while the P2P’s original goal was to develop a new research definition, that objective has been changed by NIH to addressing the current state of research. So, there will be no new research definition coming out of the P2P process. If you further consider that Fukuda has been criticized for so long, then it is not hard to imagine that NIH will take the opportunity to start requiring IOM-criteria cohorts—which would permit the inclusion of patients with pre-existing primary or major psychiatric disorders—for any future research grants. The IOM plays straight into the hands of HHS, which has been psychologizing ME for so long. This aspect of the IOM report is a huge gift to HHS. According to Hillary Johnson (in her foreword to Heckenlively’s and Mikovits’s book “Plague”), a former NIH scientist, when asked how the agency feels about us, said not long ago, “They hate you.”* Now they have the means to really implement that hatred even more effectively.
This is not just speculation on my part about the potential use of the IOM criteria in research. Rather, despite its limited charge of addressing only the clinical criteria, the IOM has opened the door wide to using the new IOM criteria for research. Nancy Lee let that fact slip out during the CFSAC meeting in June of last year. And here it is, hot off the press from the IOM (page 225 of the IOM report):
“Future diagnostic research will be most instructive when protocols include patients identified using the committee’s proposed diagnostic criteria for ME/CFS ….”
There it is in black and white. The IOM recommends that their criteria be used for future research.
Diluting research cohorts will lead to more bogus science that will “prove” that ME patients are “only” psychiatrically sick. This does not help anybody, not patients with “only” ME and not patients with both ME and psychiatric disorders. If we don’t make any progress on the ME science front and, as a result, can’t get any effective ME treatments, patients with ME and pre-existing primary or major psychiatric disorders will not receive the help they need for their ME either.
While the absence of clean research cohorts has been a problem all along in many instances—although maybe rarely as extreme as with the PACE trial—inviting the use of criteria for US research that explicitly allow for the inclusion of patients with primary or major psychiatric disorders is a disaster for all ME patients whether or not they have a primary or major psychiatric disorder. But that’s exactly what the IOM has done. Without clean research cohorts, this patient population has very little chance of ever seeing any scientific breakthrough. I believe there is a real and not insignificant risk for that. This really is a dream come true for HHS (who paid for the IOM study), insurance companies and the Wessely school.
Solution for Pre-Existing Primary or Major Psychiatric Conditions?
People have asked me what my solution is for those patients who have a pre-existing primary or major psychiatric condition. Should they really be denied treatment for ME just because of their pre-existing psychiatric condition? The answer is that there is no easy solution. It is surely a horrible thing to suffer from a psychiatric disorder and then develop ME on top of it.
First of all, please keep in mind that excluding patients with existing primary or major psychiatric disorders is not something that I came up with. This has been the status quo for over 20 years. Fukuda excludes certain major depressive disorders, the CCC exclude primary psychiatric disorders, the revised CCC exclude certain depressive disorders and the ICC exclude primary psychiatric disorders.
It gives one pause that, out of the five definitions the IOM looked at (Fukuda, CCC and Revised CCC, NICE Guidelines and ICC), only one case definition didn’t contain an exclusion for pre-existing primary or major psychiatric disorders, the UK NICE Guidelines.
It has been argued that the CCC did not mean to prevent a diagnosis of ME in case of the presence of a primary psychiatric condition. The authors of the CCC, the argument goes, instead intended to make sure that patients receive medical care for the primary psychiatric conditions. I would agree with that interpretation to the extent that the CCC experts did indeed intend to ensure that patients get treated for “other active disease processes.” However, the CCC authors then clarified the prerequisites under which somebody with a primary psychiatric disorder can receive an ME/CFS diagnosis:
“If a potentially confounding medical condition is under control, then the diagnosis of ME/CFS can be entertained if patients meet the criteria otherwise.”
The only interpretation of this sentence that makes any sense at all is to exclude confounding conditions that are not “under control.” Again, this has been the rule; I am just pointing it out.
One potential solution that may or may not work, who knows, is to require patients with pre-existing primary or major psychiatric disorders to be treated to the point where they are asymptomatic with respect to their psychiatric condition (sort of along the lines of what the CCC is talking about). Let me use the example of thyroid disease again. If thyroid disease is successfully treated in a patient as evidenced by the lab results, but symptoms persist, then a physician ought to start thinking about an ME diagnosis if the ME criteria are satisfied because the thyroid doesn’t seem to be the only issue. The problem is that many, maybe most, competent endocrinologists look at the clinical picture as much as, if not more than, they do at the labs. And if a patient has ME, then that clinical picture looks as though the thyroid disease is not under control despite hormone replacement therapy because of the overlapping untreated ME symptoms. And round and round we go. This problem is even more complicated in the case of primary or major psychiatric disorders where no blood or other objective test exists. But I suppose it is possible to determine clinically, on a case-by-case basis, that a primary or major psychiatric disorder is under control due to treatment and in that case, maybe it’s appropriate to assign an SEID diagnosis as well.
Of course, this would not fix the research-cohort problem. But it may be a way to rule out diagnosing patients with SEID who really don’t have SEID. But can you imagine, in a time where financial constraints are putting more pressure than ever on doctors to get the patient out of the door quickly, that physicians will take the time to go to all that trouble? It’s just not going to happen in real life, unless you are seeing one of the dozen, or so, ME specialists. This holds true even more since the IOM in its report is discouraging physicians from running tests. The IOM further recommends that doctors who are brand new to the area with no prior knowledge on the subject matter will be making the diagnosis using the IOM criteria. These inexperienced physicians will therefore mainly rely on questionnaires and their untrained observations. I have no confidence at all that they will be able to accurately diagnose PEM or orthostatic intolerance, for example. As a result, it is inevitable that a good number of patients who do not have ME, but rather have a primary or major psychiatric disorder, would from now on fall under the definition that was previously the neuro-immune disease, ME. The combination of abandoning the exclusion for primary or major psychiatric disorders in combination with the failure to make any objective tests mandatory for an SEID diagnosis is a recipe for turning ME officially into a psychiatric condition in no time at all, which seems to have been HHS’s goal all along.
Had the government not successfully stonewalled almost every bit of scientific progress in the area, we would not be in this desperate situation because we would have made enough progress on having objective tests available that, unlike the cardiopulmonary exercise test and the tilt table test, can be safely used for the diagnosis of all patients, and the issue of diluted cohorts would be hugely mitigated.
After my last blog post, emotions were running high and I was painted by some as some intolerant, mental-health-patient hating, superior-acting, barely human being, although most comments were thoughtful and considerate.
Let me assure you that I have zero bias against mental-health patients. After I got sick with ME, I had plans to get my Ph.D. in psychology once I got well again. Not only did I never regain my health, I didn’t even make it through any of the prerequisite classes for a psychology program due to being sick with ME, but, for a while, I was definitely seeing myself as a future clinical psychologist with an office in downtown San Francisco. I know this throws a monkey wrench into the accusations made in response to my last blog. Although there are psychiatrists out there, especially in Europe, who have done tremendous harm to ME patients, the truth is that, if I had a psychiatric diagnosis and the recommended treatments were to help me, I would jump on it and wouldn’t care about the label.
So, I am asking people to hold comments that are along the lines of accusing me of a mental-health bias because what I am trying to do here is to point out an issue that is of crucial importance for ME patients and it’s not born out of any kind of prejudice on my part against the mentally ill. If you want to vilify me or misrepresent my position nevertheless, there really isn’t anything I can do about it. But the usual arguments brought up with people who belittle or stigmatize mental health are misdirected in my case and not helpful.
I realize that the topic of excluding patients with pre-existing major psychiatric disorders is a very sensitive and unpopular one and yet somebody has to bring it up. It’s pretty hard to argue the inevitable negative effects of the IOM’s failure to exclude primary or major psychiatric conditions on ME patients’ LTD benefits and on ME research. So, please don’t shoot the messenger; I didn’t make the rules. Attempting to shame me by mischaracterizing my arguments or by proclaiming I have a bias I do not have or ignoring the issue altogether is just not helpful.