Thursday, 1 October 2015
Patients battle for justice
By Leonard A. Jason
Is it possible that a disease as impairing as Type II diabetes mellitus, congestive heart failure, multiple sclerosis, and end-stage renal disease could be repeatedly belittled and delegitimized by scientists and health care professionals? Tragically, this is the case for a devastating illness affecting over one million Americans, and these patients have been deprived of their basic rights to respect, appropriate diagnosis, and humane treatment.
In the beginning, patients with this illness had a credible name, myalgic encephalomyelitis (ME), and diagnostic criteria that had been developed by the distinguished British physician, Dr. Melvin Ramsay. Yet, in 1988, the Centers for Disease Control (CDC) renamed this illness chronic fatigue syndrome (CFS). Patients were unanimous in their disdain for this trivializing term, but they were no match for the supreme power and authority of the CDC. The new name placed patients around the world in a compromised position, as they were now forced to use a degrading and stigmatizing term in explaining their illness to family members, friends, work associates and medical personnel.
Patients were next characterized as having a relatively rare “Yuppie Flu” disease, and flawed epidemiology was responsible for these inaccurate and biased characterizations. If this were not enough, the CDC in 1994 developed a case definition that did not require the cardinal symptoms of this illness (such as post-exertional malaise and neurocognitive impairments). When this porous case definition was used to select patients, the resultant heterogeneity increased the risk of failing to consistently identify biomarkers, which contributed once again to dismissing those affected as having a psychiatric illness. Misguided psychiatrists then developed treatment approaches focusing on increasing exercise, even though the patients’ chief complaints were muscle weakness and exercise-induced fatigue.
Rarely in the annals of recorded medicine has there been such a David and Goliath-like battle, with impaired and sick patients trying to defeat an entrenched medical and scientific establishment. Their story of resistance is not one of an epic skirmish, but rather a veritable war with health care professionals and scientists that has endured for decades, as has been so well documented by Hillary Johnson.
This past year, in an effort to rectify these tragic abuses, the Institute of Medicine (IOM) released a report that not only clearly emphasized the debilitating nature of this illness, but also strikingly rejected the stigmatizing name CFS and the defective case definition. Unfortunately, particularly in light of decades of past disastrous scientific blunders, the IOM once again imposed an inappropriate name (i.e., systemic exertion intolerance disease) on the patient community, but patients valiantly challenged this recommendation by collecting data that exposed the spuriousness of this foolish name change effort. Even a federal panel called the Chronic Fatigue Syndrome Advisory Committee at its recent meeting in August has rejected this new name.
The IOM also released a new case definition to replace CFS, and our published work now suggests that these new criteria would almost triple the prior CFS prevalence rate, and this is in part due to the inclusion of individuals who formerly had been excluded. Unwittingly, this inadvertent action accomplished much of what Bill Reeves and the CDC had attempted to do a decade ago when they proposed an ill-fated expansion of the case definition.
Is there any way to salvage the damage inflicted on the larger patient community by well-intentioned scientists from the IOM? Perhaps we might consider re-activating the brilliant scholarship of Dr. Melvin Ramsay and the term Myalgic Encephalomyelitis, which would identify a smaller more homogenous group of patients as having ME. In contrast, those meeting the broader IOM criteria, which we might call neuroendocrine dysfunction syndrome (which had been recommended by the patient inspired Name Change workgroup over a decade ago) could replace CFS and this category would represent a larger group captured by the key IOM symptoms. Those that do not meet the ME criteria or the broader IOM criteria could be classified as having chronic fatigue, which is the most general category, and represents those with 6 or more months of fatigue. Such a tripartite classification system would eliminate the detested term CFS, validate the original respected name ME, differentiate ME from the IOM criteria, and provide a new nonstigmatizing term for those not meeting the more restrictive ME criteria. In addition, the broader IOM criteria could be used for clinical purposes, whereas the more restrictive ME criteria could be used for research purposes. Some scientists might prefer to consider this tripartite grouping a matter of severity rather than categorical differences, but all agree that differentiations of this type occur with many diseases, and such a classification system has the potential to clarify discrepant findings from epidemiologic, etiologic, and treatment studies.
Ultimately, whatever decisions are made on the names and criteria, the vetting process needs to be open, inclusive and transparent, with patients playing a prominent, decisive, and leadership role in these deliberations.