Sunday, August 12, 2012

Dr. Denise Faustman, researcher

Since 1990, for unspecified reasons, I have been reading every day about diabetes. Over that time, I have followed diabetes research and treatment closely. I have learned a great deal about the illness, but I know very little about the actual science of the research.

Since about 2002 I have been reading extensively about ME/CFS and other immune dysfunction illnesses. Again, I have no scientific knowledge upon which to draw.

While I have no scientific or medical background, I believe that it is possible to gain a "feel" for these illnesses- diabetes and ME/CFS -  in spite of being scientifically ignorant. In both situations I have no built-in prejudices and have no vested economic or career interest in either field that might interfere with my judgements. In other words, I have no connection to the "Industry" of these illnesses. Most importantly I have always tried to connect to gifted people who can flesh out my own "insufficiencies".

Years ago I was privileged to meet Al Mann, the founder of Minimed. With his small, flexible and innovative company, Minimed, Al Mann greatly improved the maintenance possibilities of diabetic patients. Al Mann was an amazing man who cared deeply about patients - and it was a sad day when Minimed was sucked up by the large Minnesota company, Medtronic.

Early on, in learning about diabetes. I stumbled upon the work of Dr. Richard Bernstein. At the time Dr. Bernstein and his ideas about diet and diabetes were highly discredited by mainstream endocrinologists. Since that time, Dr. Bernstein's ideas have gained great currency. His book can be purchased here. There are intimations of Dr. Bernstein's ideas in Dr. Joseph Burrascano's imploring Lyme patients to ditch the carbs.

Diabetes, at the moment, is a maintenance illness. With slightly more information, perhaps ME/CFS can reach this status? More needs to be known about the etiology of ME/CFS.

In this post I am unable to list all the diabetes researchers that I admire and follow. Instead I would like to focus on one of them: Dr. Denise Faustman of Massachusetts General Hospital. I have written a previous blog post on Dr. Faustman here.

Dr. Faustman is back in the news this week with a very small, early stage paper publication in PLoS ONE.  The proposed treatment, a relatively safe tuberculosis vaccine in use for eighty years, is apt to yield no profits for the pharmaceutical industry.

The hope is that this vaccine can shut down the autoimmune reaction in type 1 diabetes (and perhaps other autoimmune illnesses). Perhaps ME/CFS researchers Mella, Fluge, Peterson, and Kolgenik are reading about Dr. Faustman's work? I certainly hope so.

Several articles on Dr. Faustman's paper can be found here and here.

From the Bloomberg article:

"Faustman and her colleagues at Massachusetts General in Boston are working to get the vaccine to market. After their early findings in studies with mice, she said they tried to interest every major drug maker in developing the vaccine as a possible cure for diabetes. All told her there wasn't enough money to be made in a cure that used an inexpensive, generically available vaccine, Faustman said."

This publication is very exciting news for those interested in a solution for type 1 diabetes. However major questions rear their ugly heads. Why is there so much resistance to this research? Why is Dr. Faustman so isolated with this research after so many years? Who is going to finance further research? In the big picture, these questions are disturbing - and yet they are so familiar, familiar also to those who know the history of research into ME/CFS.

Dr. Faustman outlines her research and answers some pressing questions in several youtube videos, the first from 2012, the second from the year before.

Dr. Faustman is a very impressive researcher. She does not look like she is going to be dislodged from pursuing her interests. She gives me hope that there are other individuals out there looking for unique solutions to complicated medical questions - and specifically that there will be some spill-over into ME/CFS/lyme diseases.

Saturday, August 11, 2012

"The Garden"

In the course of my job as patient advocate for my daughter, I travel to various places - CA, London, New York City, Ottawa, Brussels. Most of the time I am mired down in patient advocate work, which is only partially rewarding. One positive reality is that I do get to meet many extraordinary people - and this could certainly be the subject of another and longer post. In these travels there are moments of relief -  ducking into the National Gallery to view my favorite painting (Titian's The Death of Acteon), a hot dog with mustard and sauerkraut on the corner of 69th and Lexington on a sweltering day, checking out the Gauguin painting at the Indianapolis Museum of Art, or going to an Orchestra concert in Minneapolis.

Gauguin, 1889

Throughout the mid-West there are these extraordinary museums reflecting broad and deep collecting interests of past inhabitants of these towns - Minneapolis, Detroit, Cleveland, Cincinnati, and St. Louis.

This summer I had the privilege of visiting with Dr. Dale Guyer at his Institute of Molecular Medicine in Indianapolis. I really admire this clinician. I have learned fundamental approaches to ME/CFS from him. At the end of my time with him, I asked if I could have a picture taken with him. Dr. Guyer suggested that we go out into "The Garden" for the picture.

I stepped out back of his clinic and encountered an astonishing world.

Chris Cairns and Dr. Dale Guyer

In the approximately 1/2 acre behind his clinic, Dr. Guyer has planted a vast array of conifers and Japanese Maples. Dr. Guyer explained to me that the two plants directly behind us in the above photo were recently added and are of a species that is quite rare, yet can exist in the environment of Indianapolis.

I can only assume that Dr. Guyer has made every single decision in regards to the plantings and combinations of this rare and beautiful garden. One can discern from the photos the care taken regarding color, variety, size and placement of each and every plant, stone and path. The reality is very powerful. Everything is calculated to deliver the greatest visual and emotional impact. Nothing is haphazard and the entirety has a sense of oneness, of great unity. It is like a gigantic three dimensional painting.

It occurs to me also that this garden is an extension of Dr. Guyer's skill and experience as a physician. Certainly the garden gives a clear insight into the complexity of his personality. His staff jokes that when he gets really refined in his medical practice, he will just send his patients out back to sit, resonate and heal in the environment.

I spent some time walking around "The Garden" and took a few pictures. My only regret was that I did not stay longer, and I have thought about this space and its effect on me a great deal since then. It is very seldom that I am swept away by a spot and enter into a suspended space where I am lost or do not know where I am. This is the profound effect of this garden as you walk into its midst. Suddenly you are transported to - who knows where? It is another world, a world suspended from the raucous existence of modern life.

Dr. Guyer's garden reminded me of another favorite destination of mine, a place that I have not been for many years, but to which I yearn to return: Bok Gardens and Tower in Lake Wales, FL. Although Bok Tower is much different than Dr. Guyer's garden, it has the same powerful effect on the visitor. Much of the impact comes from not expecting it. Bok Garden takes you into a suspended world where you are suddenly and completely detached from yourself. I suppose many people, like me, return there for solace and removal from life's travails - and to reacquire a bit of peace or peace of mind.

I asked Dr. Guyer what he does in his Garden? He says that he sits there in the evening with a glass of wine.

It is not possible this morning to leave this appreciation of Dr. Dale Guyer and his garden without mentioning a recent article that appeared this morning. The article is found here and concerns gut ecology. Both Dr. Guyer and Dr. Kenny De Meirleir  have emphasized the need to heal the gut. It is a central issue in ME/CFS to both of them. Recent research into the gut environment begins to confirm what a number of ME/CFS physicians and researchers believe - that gut ecology might very well be at the center of this illness. If one wonders - as I do - why MAF 314 brings improvement to the patients who have access to it, this article suggests an answer.

Wednesday, August 8, 2012

Questions for CDC - from Dr. Joan Grobstein

The CFSAC listserv has announced a conference call with the CDC for tomorrow, August 9, from 11:00 am to noon EST.  The toll-free phone number is:  866-705-4314.  The access code is:  78687644.  The full announcement is available on Co-Cure at:

Questions for the CDC can be submitted to:

These are the questions I have submitted to the CDC for discussion tomorrow:

For Dr. Unger:

1)  If this call is patient-centered, why is all the information flowing from you to us, i.e. why are we asking the questions and you are giving the answers? The patient community has demonstrated repeatedly that information disseminated by the CDC about ME/CFS is inaccurate.  Because so little information is available to our doctors, we have been forced to become very informed patients.  Shouldn't you be listening to us?

2)   What did you learn from the last set of calls and what changes have you implemented as a result of them?

3)   Given the importance of a rapid response in epidemiological investigations, have you developed a protocol for identifying and investigating geographic or family clusters of ME/CFS as soon as they are reported to you?

4)   Have you initiated any studies of current geographic or family clusters?

5)   Have you taken any steps to make ME/CFS a reportable disease so that clusters will be identified?

6)   Are there any longitudinal studies of appropriately-defined ME/CFS (not Consensus definition-defined) in progress?

7)   Is the CDC making any efforts to identify the sickest, house-bound patients?

8)   The CFSAC recommended that the Toolkit be removed from the CDC's website and that it should no longer be distributed at its June, 2012 meeting.  Why hasn't this been done?  Why is there no mention of the IACFS/ME Primer as an alternate source of information?  Why is the link to the Toolkit still active on the CFSAC website?

9)   The only definition that is immediately obvious on the CDC website is Fukuda, and this is the only definition mentioned in the CDC's CME activity.  Why is there no mention of other definitions more acceptable to the patient community and of the controversy that surrounds the definition?

10)  When and how do you plan to attempt to resolve the definition issue?  Does CDC think that it alone should determine the definition?  Do you plan to resolve it based on a single study of six (or seven?) practices?  Have you built into the design of that study a method to ensure that the practices are consistent with each other?  If one or more of the practices has looser standards and include(s) patients who only meet the definition for Idiopathic Chronic Fatigue will that practice or practices be separated out as (an) outlier(s)? When will that study be published?  Are you aware of the recent Maes, Twisk and Johnson study (Psychiatry Research, in press, available online) that shows that ME, CFS and CF can be distinguished accurately using post-exertional malaise and inflammatory biomarkers?  Before you try to develop a better definition do you plan to ask for the input of other stakeholders, including patients, who may have additional information to offer?  Will the IACFS/ME be an equal partner?  Will other specialty organizations be involved?

11)  Has the previously-announced five-year strategic plan been shelved?  Has it been replaced by another plan?  If so, where can we find it?

12)  What ME/CFS research projects are currently underway at CDC?  What definition do they use to identify patients?

13)  What is the next study that we can expect to see CDC publish?  Is it designed to imply that ME/CFS is a psychological disorder?

14)  What is the total annual budget for ME/CFS at CDC for the last ten years, and what is the current annual budget as well as the budget for the next two years?  Is, as recently reported, the budget actually decreasing?

15)  The CDC CME program states "Importantly, no scientific evidence exists to indicate that CFS is contagious or that it can be transmitted from person to person."  Would it not be more accurate to state "Given the existence of family and geographic clusters, there is certainly reason to suspect that an infectious agent is involved.  However, no single agent has yet been proved to cause the disease.  Given the high incidence of viral and other co-infections, such as EBV and HHV-6 among others, it is reasonable to test for these pathogens and consider treatment, if present.  Individual clinicians have reported treatment successes with this strategy.  Further research is necessary."?

16)  At the CFSAC meeting in June, 2012, Dr. Peter Rowe reported that over 80% of his patients have orthostatic intolerance.  At what level of prevalence of this potentially treatable symptom will the CDC decide to recommend that all patients be tested and treated for OI?  Do 100% of patients have to have the symptom before CDC recommends testing and treatment?

17)  At the CFSAC meeting in June, 2012, Dr. Peter Rowe reported that over 80% of his patients have post-exertional malaise.  There are now two measures of post-exertional malaise in the literature:  Pacific Fatigue Laboratory testing and gene expression testing.  At what point will the CDC include these tests in its recommendations for lab tests on its website?

18)  What constitutes a biomarker?  Why don't tests for orthostatic intolerance and post-exertional malaise qualify as biomarkers for ME?

19)  At the June, 2012, meeting Dr. Koh stated that the CDC has "made available clinical assessment data"  in its "research data center".  How can this data be accessed?

20)  The CDC CME program repeatedly refers to areas where increased research needs to be done.  What are you doing to make sure that adequate funding is available to make sure this research done?  Presumably, you are participating in the HHS cross-department ad hoc work group for ME/CFS.  If you aren't, who is the representative from the CDC on this panel?  What have these meetings accomplished to date?  Are you personally emphasizing that there are many areas where increased research is vital to improve our understanding and care for ME/CFS patients and funding for these projects must be increased?  Is there any move in these meetings toward a strategic plan for research?  Have there been more than two meetings?

21)  Obviously, there are too many questions here to answer in an hour.  When can we expect to have a longer, more substantive meeting with the CDC to have a bidirectional discussion of the many issues and develop a strategic plan to address them effectively?

For Dr. Jason:

1)  Can you describe the difference between a clinical and research definition?

2)  You are a researcher.  Do you think your opinions of a clinical definition are more valid than a clinician's?

3)  You have done a large amount of very important research about the definitions of ME, CFS and ME/CFS.  Given that no definition is perfect and that you have demonstrated in your research that definitional disputes have had a significant negative impact on progress in researching ME, CFS and ME/CFS, do you think it is useful to propose another definition of ME at this time?  Do you think it is necessary to have a perfect definition or is an adequate defintion adequate?

4)  There is a new study by Maes, Twisk and Johnson (Psychiatry Research, in press, available online) that shows that ME, CFS and CF can be distinguished accurately using post-exertional malaise and inflammatory biomarkers?  How does this article affect your opinion about how to proceed to resolve the controversy over the definition?

Thank you,
Joan Grobstein, M.D.