CFSAC Oral Testimony October 2009
"Hello. I’m Dr. Joan Grobstein. I’ve been a physician since 1977, last working at Children’s Hospital of Philadelphia Division of Neonatology. I’ve had Myalgic Encephalomyelitis/Chronic Fatigue Syndrome since 1999. I’m a doctor and a patient. I‘m going to talk about science and ME/CFS.
To be blunt, scientific research on ME/CFS is a mess. Given how little time I have, I’ll focus mainly on the worst offender, the CDC. The CDC has underfunded and underinvestigated this disease since their initial involvement in the mid-‘80s. They’ve also failed to correctly define the disease. In 1994, they created the Fukuda definition, which is flawed but which has been used to define the CFS data set for fifteen years, resulting in a significant body of research. However, oddly, in 2005 the CDC redefined the data set. Perhaps they noticed research using the Fukuda definition seems to suggest physiologic explanations for ME/CFS symptoms. One wonders. In any case, using the new Reeves 2005 “empirical” definition, their estimate of the number of people with CFS in the United States suddenly jumped from one million to 4 million people. Basically, they created a new, unverified definition which defined a new, much larger data set, and they still used the name CFS for this very different data set. This is outrageous! This isn’t science--it’s a shell game.
Dr. Peter White was involved in a similar definitional misadventure in the ‘90s, also muddying the research waters. He helped develop the Oxford definition, which was actually a description of Idiopathic Chronic Fatigue, which is not CFS. Putting a prestigious name on a definition does not necessarily give it a useful meaning.
As Dr. Mikovits and her colleagues have shown so brilliantly in the past month, when researchers look at patients that meet the Fukuda & Canadian consensus criteria, they can quickly begin to discover potential mechanisms and possible treatments for this severe illness.
So how do we find our way out of this mess? We need to tidy up the literature, so we know when we’re talking about apples and when we’re talking about oranges. I suggest the following solution: Until we have a better name, call the cohort of patients who meet the Fukuda criteria: CFS-Fukuda; the Canadian Consensus cohort: CFS/ME; the Ramsey cohort: ME; the Oxford criteria cohort: Idiopathic Chronic Fatigue; and the Reeves definition cohort: Reeves’ disease. After removing CFS-Fukuda, CFS/ME and ME from the Reeves cohort, Reeves’ disease will probably consist of a group of people with Idiopathic Chronic Fatigue, various other undiagnosed conditions, and some, but not all, people with major depressive disorder. These people deserve study and treatment, but they do not have ME/CFS.
It is very important that any ME/CFS study published states in its abstract which group is being studied. A retrospective review of all previous CFS studies should be funded in order to determine what group of patients were actually studied. Research on Idiopathic Chronic Fatigue is not relevant to ME/CFS.
I suggest the following recommendations to Secretary Sebelius:
1. No taxpayer dollars should be wasted on ME/CFS research which uses the Reeves definition. All federally-funded research should use the Fukuda criteria & the Canadian Consensus Definition.
2. Abandon the CDC’s current proposed 5 year plan. Ensure that this Committee’s previous recommendation for a change in the CFS leadership at the CDC actually happens. The new leadership should propose a new 5 year plan which should then be reviewed by an unbiased panel. Meanwhile, make the taxpayer-funded data that the CDC has already collected available to all researchers to analyze.
3. If the XMRV connection to ME/CFS is confirmed, initiate a congressional inquiry into why Elaine DeFreitas’ research into retroviruses and ME/CFS was not pursued in the early ‘90s. Many people may have been harmed by this decision.
Finally,
4. Increase funding for ME/CFS research. Patients and doctors need more information. Designated funding for a collaborative trials network is imperative, as is the retrospective review previously discussed.
I could say much more, but my time is up. I have submitted written testimony. Thank you."
Under the auspices of the NIH, Dr Peterson conducted a follow-up study of his "mystery illness" patients in 1999.
ReplyDeleteThe NIH gave this study and cohort a name, which clarifies the situation immensely, and removes all confusion about subseqent "definitions" of CFS.
The NIH used the appellation:
"The original CFS cohort follow-up study"
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Byron Hydes brief history of CFS:
What did we know about M.E. in 1984 after the Lake Tahoe epidemic?
• The CDC investigators and the physicians of Lake Tahoe were dealing with
a rapidly spreading infectious disease with a short one week or less
incubation period. Obviously this was consistent with the epidemics of
Myalgic Encephalomyelitis already documented in this brief history.
• Like the several epidemics noted that started with children or students, so
did this.
• Like the patients in all of the epidemics discussed, the effects of the
infection involved the Central Nervous System but unlike a stroke caused
by an embolism, or malignancy, or arterial obstruction, the CNS involvement
that occurred in these patients were not focal but consistent with a diffuse
CNS injury.
• In the Lake Tahoe epidemic as in the previous epidemics described, the type
of Central Nervous System involvement was obviously of a more diffuse
nature and the type of peripheral involvement that caused so many troubling
symptoms in all these epidemics was consistent with a very low grade
vasculitis (See Mercy San Juan Hospital Epidemic) or in many cases a
classical radiculopathy (spinal nerve root involvement) or even a very low
grade Guillain-Barré Syndrome as was described by Alberto
Marinacci when he examined the Los Angeles County Hospital
patients. (See Dr Marinacci's book Applied Electromyography. Lea &
Febiger, 1968: Chapter 9). However, I should note that the mere mention
of Guillain-Barré Syndrome drives many neurologists crazy. They say that
GB Syndrome is a severe disease that if not treated effectively may kill or
leave the patient permanently disabled. However, all real diseases have a
wide variety of penetration from so mild that they may be missed to, in
some diseases, having potentially mortal consequences.
If we consider the Lake Tahoe epidemic alone we have the primary definitional
determinant of Myalgic Encephalomyelitis.
I hope the WSJ and NYT journalists are still reading your blog, PA. Apparently they don't know the history of the CDC, politically or scientifically or they'd have a better understanding of why ME patients and their caregivers cannot trust the CDC or the NIH or the US government's response to the disease.
ReplyDeleteBefore writing any more of this "balanced" coverage, they should spend a weekend reading Osler's Web by Hillary Johnson - all of it.
The Congressional hearings 20 years ago found Congressionally mandated money for research into "CFS" was diverted (stolen), the CDC lied to Congress at first, then substituted Bill Reeves as "leadership". He then changed tactics from the diversion of funds to the diversion of attention away from the biomedical facts, essentially morphing the disease into a modern version of female hysteria and/or depression.
This PrimeTime Live video shows that much was known back in 1996 but never followed up by the CDC/NIH and nothing much has improved since then:
http://www.youtube.com/watch?v=AW0x9_Q8qbo&feature=related
Any virologist, biologist or clinician could have seen that the disease was causing distinct neuropathy back in the mid-80's. Peterson and Cheney did the brain scans that showed damage similar to that seen in HIV/AIDS and Alzheimer's.
But to this day, the CDC, following the practices of the disability insurance industry, declares that all tests, biomarkers and treatments for ME/CFS are "experimental" and thus patients can't even get those tests or treatments unless they can pay for them themselves. Yet CDC never does the follow up research to bring those tests, biomarkers, Ampligen, etc., to the point that they can be accessed by patients impoverished and disabled by the disease. To this day, disability insurance companies use the CDC's statements to justify denying claims for lack of "objective" evidence. Like the CDC, they also disdain clinicians who diagnose the disease by listening to the symptoms and, like the CDC, they put more weight on the opinions of those who would rather look at charts and files than actually consult with patients.
ME/CFS was no more a 'mystery' back in the mid-80's than was HIV/AIDS, yet billions of dollars have, and continue to be, dedicated to that retroviral research.
This was obviously not a scientific decision, but rather a political one. Thus all the handwringing about how science takes time and how the patients are diverting precious resources by behaving politically instead of like good little lab rats is just another attempt to blame the disease and the lack of progress on the patients - again.
Chris, I'm so appreciative that you covered DR Grobstein again. I have looked for her testimony a few times and failed. So glad I found it this time.
ReplyDeleteAnd having the transcript is priceless. Thank you for doing it. Many people can now access her incisiveness on the cohort problem, and especially of "Reeves disease"
This testimony from Dr. Grobstein is excellent. I had not seen it before and thought she did an excellent job explaining the different definitions of ME/CFS and why a new and better definition is required. It is sad to see that this is from 2009 and that we seem to be no further ahead with a new and improved definition for this disease.
ReplyDeleteI, by the way, am from Canada and belong to the Canadian cohort, being diagnosed with ME/CFS with the Canadian criteria by a known ME/CFS specialist.
Claire