BAD COMPANY

Why Some Patients Have Had Enough 
of the CAA

When it comes to the CFIDS Association of America, patients Khaly Castle, Otis Quila and Liz Willow have reached critical mass.  They’ve just devised a “Petition to disassociate from CFIDS Association of America as our advocacy representative” because they believe that the CAA isn’t doing its job.  In one day, 205 patients have signed the petition, with a goal of one thousand signatures from all over the world.

Castle, Quila and Willow will present the petition at the May 2011 Chronic Fatigue Syndrome Advisory Committee meeting and also let the NIH and the CDC know that the CFIDS Association no longer speaks for the majority of patients. Explains Liz Willow, “[NIH administrator] Dennis Mangan realizes the patient community is diverse and reaches out to a number of individual advocates, Facebook page founders and bloggers on a regular basis.  But the CAA still seems to be perceived by many government officials as representative of patient wishes.  We didn't feel we could wait for a new organization to establish itself before rolling out the petition.  Patient sentiment for this type of petition is high, and we wanted to capture that momentum.”

Brewing dissatisfaction
The dissatisfaction with the CAA has been brewing for a long time but deepened after the first paper linking XMRV to ME/CFS was published in October of 2009.  Khaly Castle observed that the CAA maintained “an air of skepticism when they could have instead taken this new piece of science and turned it into a platform for some pretty powerful advocacy. In my mind,” Castle contends, “it just confirmed that this group is nothing but an arm of the entity it had contracted itself to for so long:  the CDC.”

Brian Smith and Jennifer Spotila 
A blogger as well as a patient, Castle in 2009 wrote two articles on the CAA that garnered huge response from patients.  (To read the articles, click here and here.)  After Castle posted them, CAA board member Brian Smith told her on Facebook that the CAA was listening.  “Then I never heard from him again, despite friend-requesting him,” Castle recalls.  However, Jennifer Spotila, who at the time was board president, contacted Castle directly, asking her to forward whatever patients wanted to tell the CAA. 

That’s when Castle started a new post, “CFIDS Association— What do you want to say to them?”  Gathering the hundreds of patient comments and questions that resulted, she forwarded them to Spotila.  But in the end, says Castle, “We got very little feedback and little or no visible change from the CAA.”

McCleary's response to the PACE trial
Most recently, it’s been CAA President Kim Kenney McClearly’s reaction to the PACE trials that Castle, Quila and Willow have found problematic. Of the PACE trial, which endorsed cognitive behavioral therapy and exercise for CFS, McClearly rattled off to CNN a peculiar commentary that appeared to endorse the bogus findings: “I think it would be challenging, at least in the U.S. system, to purchase the services that they've tested in this trial,” McClearly stated, adding this:  The alphabet soup of acronyms that represent the interventions used in Britain is “just not something that our health care service offers, is reimbursable, or is really available here.” And, finally, this lackluster shrug: “It's kind of a shame that we're still limited to talking about approaches to coping mechanisms as the only therapy that's available.”

Castle says that with McCleary’s response to the PACE trial, it’s clear that the CAA’s advocating for a chronic fatigue light kind of illness that’s primarily about generalized fatigue—as opposed to the serious neuroimmune disease that ME/CFS really is.  The result is “muddying the diagnostic waters,” Castle says.  “This is not only unhelpful, it's extremely harmful.”

Suzanne Vernon and spinal fluid
McCleary isn’t the only CAA representative who’s been a problem.  Last week Dr. Steven Schutzer’s team at the University of Medicine and Dentistry of New Jersey published on a distinct abnormal protein signature in the spinal fluid of ME/CFS patients, which apparently was a yawn to CAA Scientific Director Suzanne Vernon, who told the Wall Street Journal’s Amy Dockser Marcus: “It’s difficult to have a diagnostic test based on spinal fluid. You can’t just go poking everyone in the spine.” 

Vote to be heard
On the Phoenix Rising patient forum, so far 147 patients have participated in a new CAA poll, with 138 voting that it’s time for a change in direction and leadership. Cast your vote on Phoenix Rising and be heard.  If you believe the CAA doesn’t speak for you, cast your vote on the “Petition to disassociate from CFIDS Association of America as our advocacy representative.”

Training Day

Dog day afternoon at the NIH as Dr. Fred Gill, who hails from the psychoneurotic school of CFS, questions whether CFS is even a disease.  He’s pitted against Dr. Harvey Alter and Dr. Shyh-Ching Lo, who believe in science.

By Charlotte von Salis

Curious to find out the National Institute of Health’s take on CFS these days, I attended the agency’s in-house lecture "Chronic Fatigue Syndrome:  Is there a virus?" on February 22.  One in a series in the NIH’s Demystifying Medicine presentations, the lecturers were the NIH’s Harvey Alter and the FDA’s Dr. Shyh-Ching Lo, co-authors of the 2010 paper "Detection of MLV-related virus gene sequences in blood of patients with Chronic Fatigue Syndrome and healthy controls.”   

The third speaker was Dr. Fred Gill, a medical doctor and chief of the Internal Medicine Consultation Service at the NIH.  He’s the self-proclaimed protégé of NIH psychobabbler extraordinaire, the late Dr. Stephen Straus.  In addition, Seabiscuit author Laura Hillenbrand is a former patient of Gill’s.

So there I was, the sole member of the public, along with about fifty other NIH attendees.  The good news:  Lo and Alter were terrific.  Lo, in particular, went to great lengths to explain how they carefully ruled out contamination in their study. 

Gill: worse than expected

The bad news:  Gill was even worse than I expected, touting graded exercise therapy as the best treatment for CFS.  That wasn’t terribly surprising, as Gill worked with Stephen Straus and treated Straus's patients. Gill remarked that when he was in private practice, he asked his patients to exercise, and they improved. He noted that many patient advocates feel that exercise exacerbates their symptoms, but he believes exercise is the right treatment for CFS.

Gill gave kudos to the just-released PACE study. "For those of us who've been preaching this [graded exercise therapy],” he said, “it's nice to show this study." Gill was particularly pleased that the same fatigue questionnaires used by the CDC were also used in the PACE study.

Gill’s a big fan of the Centers for Disease Control’s Empirical case definition, AKA the Reeves definition. He loves the—gasp—"excellent" questionnaires that the Reeves definition used, as well as the CDC's 2006 gene study.

The clinician's approach, he said, should mirror the CDC's toolkit recommendations.  Gill’s big on reassuring the patient, avoiding unnecessary tests, avoiding debate over whether it’s psychological, and above all, getting patients to remain active and exercise no matter what.

And the topper?  Gill’s condescending presentation of a CFS patient whom he called Velma (a pseudonym).  A middle-aged former pharmacist, Velma had a sudden CFS onset in 2006.  She reported the classic CFS symptom of suddenly needing to sit down and then lie down.  The next day Velma said she could barely get out of bed to go to the bathroom. Like many patients, she saw several doctors before getting a diagnosis, including physicians at the Mayo Clinic.  (Given the center’s piss-poor track record with CFS, it’s not surprising that they couldn’t find anything wrong.)

Velma admitted to secondary depression.  “It’s depressing when you’re debilitated, but I’m not a depressed person,” she summed up to the audience.  While she’s better than she was five years ago, she still has crashes. She’s not concerned whether CFS is caused by a virus; she just wants to get well.

Velma explained that she takes fludrocortisone— a steroid that treats low blood pressure and neurally mediated hypotension, common autonomic nervous system problems in CFS.  However, the patronizing Gill deemed this drug “useless” for CFS patients—despite that Velma said the drug helps her. 

Velma reported feeling feverish and having swollen lymph glands, but Gill said he found no discernible fever or lymphadenopathy.

Pushing herself to exercise

Velma isn’t the typical CFS patient, as post-exertional crashing isn’t a big issue for her.  She claimed, for instance, that she feels “much better” after she pushes herself to exercise on her “bad days.”  That made Gill smile.

Gill, who looks to be well into his 60s, went through a series of ancient slides from the 1980s. Oh joy—he started by pointing out that CFS was first recognized as neurasthenia by Beard in 1869, and it went downhill from there.  He went through the different names for CFS and selected case definitions (ignoring the Canadian).

Just in case anyone in the audience still thought there might be a real disease buried under the CFS construct, Gill ran through all the studies done by Straus that rebutted any positive treatment trials. Resurrecting his BFF Straus once again, he gave a big thumb’s up to studies done on stress and CFS. As to "pacing,” Gill oddly claimed that “he didn't fully understand pacing.”

Gill concluded his presentation by recommending the CDC's CFS website as well as that of the CFIDS Association of America (CAA). Gill said that he has a high regard for the CAA because he agrees with their views.  So now it’s abundantly clear the kind of scientists whose thinking dovetails with the CAA’s. 

I quickly and loudly called out that for real information, as opposed to misinformation, attendees should check out mcwpa.org and iacfsme.org. I actually got the attention of those present, many of whom copied down the URLs.

Alter’s talk

Alter explained that XMRV and related murine leukemia viruses (MLVs) aren’t yet accepted as human invaders or pathogens by most of the scientific community. (Sad, but true.)  Alter also noted that scientists are still debating whether CFS is physiological or psychological. (Sad, but true.)  He went through his slides, which unfortunately have been taken down from the course material website.  My favorite was the last slide, which indicated that clinical trials with antiretroviral drugs could potentially prove whether XMRV causes CFS.

Alter said that XMRV is a simple retrovirus (compared to the more complex HIV) that could be passed on to progeny.  He didn’t specify whether this infection occurred in utero, during breastfeeding or both.

Infection with XMRV, Alter said, can lead to viremia, which affects the immune and neurological systems.  Alter explained that it made sense to look for XMRV in CFS because many patients have an acute onset that leads to a chronic illness, cluster outbreaks had been reported, concomitant herpes infections are common, and defects in the antiviral RNASE-L pathway have been found. He briefly addressed the XMRV and MLV studies to date, including the negative ones. To my relief, everything he said indicated that he continues to believe CFS is a serious, physiological disease.

Lo’s talk

Lo, too, followed his slide presentation.  I'm kicking myself for not downloading the slides—I was surprised to find them gone from the course material website.  Lo reviewed the methodology and findings in the joint FDA/NIH study in extreme detail (to this non-scientist).

His research team, Lo explained, developed a "highly sensitive assay targeting mitochondria DNA, mouse DNA, that are well-conserved in multiple copies" and used that assay to re-test the positive samples before publishing the study. Lo then brilliantly rebutted the contamination articles.  As to the negative studies, he pointed out that differences in methodology, assays, and sample preparation were among the contributing factors that could explain the disparate results.  He noted that two CDC samples tested positive for MLVs using the FDA assay.

Questions and answers

In the Q & A session that followed the talks, Gill was hopelessly out of touch, invoking the Simon Wessely school of misinformation about CFS, circa 1988, by insisting that the disease is "not common" in children.

During the Q & A, I said that the Canadian Consensus Criteria (CCC) should be used to select patient cohorts and that audience members should read it as well as Dr. Lenny Jason's "Development of a Revised Canadian Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Case Definition.”

I was cut off as I was making a statement rather than asking a question.  So I don't know if what I said will make it to the edited videotape.

I did ask Gill a detailed question (mainly for the audience's benefit) about the Pacific Fatigue Lab's findings with repeat exercise testing, as well as the Lights’ exercise studies in CFS patients.  Both groups of researchers found objective, measurable and significantly abnormal biomarkers that distinguished the sick from the healthy controls after exercise.  Their findings allowed me to bring up post-exertional malaise as the hallmark of CCC-defined patients.

Gill replied that he disagreed with those studies but didn’t explain why.

In the Q & A, I told Gill that I was on the drug Midodrine for neurally mediated hypotension, and that was the only reason I was functional enough to attend the lecture.

Gill’s response was that studies have shown that there’s no orthostatic intolerance in CFS.  Earth to Gill:  Have you not read any of the formidable research by cardiologist Hugh Caulkins’ and pediatrician Peter Rowe’s group at Johns Hopkins?

Harvey Alter spoke again, pointing out that CFS has a viral-like “picture.” 

Gill asked Alter, “Is CFS a real disease—and if so, what’s its etiology?”  

Alter replied cryptically, as if he were the wisest of fortune cookies:  “The answer depends on the effort to find the cause.”

--------------

Charlotte von Salis, an attorney, has lived with ME/CFS for 20 years.

GET FAUCI

Stop hunting the puppets.

Hunt the puppet master.

“Nationwide—my God, they were frightened of Muskie and look who got destroyed.  They wanted to run against McGovern, and look who they're running against. They bugged, they followed people, false press leaks, fake letters, they canceled Democratic campaign rallies, they investigated Democratic private lives, they planted spies, stole documents, on and on.  Don't tell me you think this was all the work of little Don Segretti.”

  —Deep Throat to Washington Post reporter Bob Woodwood in All the President’s Men 

on why Nixon and his top aides were the Watergate masterminds, not lawyer Don Segretti, 

a foot soldier for the Committee to Re-Elect.

 

Frequently, I get emails from patients asking my advice on whom they should target in their protests, and I always say the same thing:  the higher up the better.  For instance, tremulous Dr. Beth Unger, who heads up “CFS” research at the Centers for Disease Control, has about as much power as the popcorn girl at my neighborhood movie theater.  In my view, pleading with Unger will have as much effect on ME/CFS policy as playing Barbies will have on instilling world peace.

To change anything, it's my view that you have to change the mindset of the people in charge and forget about the mid-level sump-pump bureaucrats with their cheap brown suits and Payless shoes who do as they're told.  And stop trying to make anybody in the government like you, like something out of Sally Field's "you like me" Oscar acceptance speech for Places in the Heart (watch it at the end of this post).

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (NIH), would be number one on the list of targets. He's incredibly powerful.  If ME/CFS patients could cause him enough grief, maybe the 70-year-old Fauci will cry uncle or just drop dead.

Fauci has been firmly in the psychobabble CFS camp for more than 20 years.  As evidence, on July 28, 1988, New York Times health reporter Jane Brody interviewed Dr. Stephen Straus, who headed up psychological CFS research at the NIH until his death in 2007.  Brody wrote that Straus said he and "his colleagues at the National Institutes of Health had demonstrated that many patients were psychologically 'different' long before they developed the syndrome. He described some patients as having been anxious and depressed with various neurotic symptoms for years before becoming ill. In other cases, patients were motivated, dynamic, driven individuals who were functioning at peak levels when stricken. Some may be under an undue amount of stress trying to maintain busy lives."

What does this have to do with Fauci?  After the piece appeared, journalist Hillary Johnson reported in Osler's Web and later on her blog that a dentist stricken with ME/CFS wrote an irate letter to Fauci, demanding that Straus be fired from the NIH because of his false statements to the press.

According to Johnson, Fauci responded to the dentist with a cordial letter that invoked the name Dr. Peter Manu, who agreed with Straus that neuroses and stress caused the disease. Fauci’s letter delivered Manu’s stinging supposition that 50 percent of CFS patients had an underlying mental illness and, Johnson wrote, Fauci provided the journal citation for that statistic and signed his “best regards.”

***

So when people ask why British retrovirologist and Simon Wessely colleague Dr. Myra McClure was appointed to the Center for Scientific Review Special Emphasis Panel, which approves NIH grants for ME/CFS, there is, ultimately, one reason why:  Anthony Fauci. 

Force Fauci to change his mindset about ME/CFS, and like a flip of a switch, the energy changes.  That's when quavering Beth Unger—and the rest of them—will see ME/CFS for the serious and sometimes fatal neuroimmune disease that it really is.  And that's not because Unger will have had a change of heart. It'll be because like all good government foot soldiers, she'll do as she's told.

ISLAND OF LOST LUGGAGE

UFO Sightings and Wastebasket Diagnoses

 

Right now, CFS is classified in the “G” category on the International Classification of Diseases (ICD).  "G" indicates diseases of the nervous system.  The planned move in 2013 is to reclassify the disease in the “R” category, the island of lost luggage, also known as:  “Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified.”  In other words, CFS will slither to the wastebasket of ill-defined, unexplained and generally inconsequential diseases.

This change would be detrimental.  Assigning CFS to the “G” category in the ICD is respectable and accurate.  By moving it to UFO territory of “R,” CFS will become a bigger joke than its flimsy name has conferred.  Doctors will be less inclined to treat an ill-defined disease than a neurological one, or prescribe medications.  Besides, “R” is probably just a pit stop before hitting rock bottom, from which there is no escape:  Mental and behavioral disorders, the "F" category.

A patient on the Phoenix Rising forum queried CFIDS Association board member Jennifer Spotila, “Would you explain what the CAA is doing about ICD-10-CM plans to move CFS to R53: Malaise and fatigue? (See http://wp.me/pKrrB-Un.) This has to be stopped, as it would be a big step backward in our ability to get proper diagnosis and treatment.”

Spotila responded, “Unfortunately, we have neither the time nor expertise to engage on this issue. We have no clinicians on staff, and no expertise in making the case for how diagnostic codes will have a negative impact on reimbursement. The IACFS/ME or CFSAC might be in a better position with the right expertise.”

Jennifer Spotila, how can the CAA pass the buck on this one?  How can the CAA not issue a position statement?  This isn't about diagnostic codes. This is about stating what the disease is and what it isn’t and protecting what little credibility CFS still has left.  Surely CAA Scientific Director Suzanne Vernon and CAA President Kim Kenney McCleary can pen a robust paragraph that explains why the classification should remain in the neurological camp, widely distribute it to the media and stand firmly behind it.

How about this for starters:  CFS is a serious neuroimmune disease that affects the brain, the immune system and the autonomic nervous system.  The “G” classification is accurate and should not be changed to an “R” classification.

Come on guys.  Step up to the plate, stand up for the patients, and do your job.

If readers of this blog feel the same, here’s the contact info for Vernon and McCleary.  Tell them, if you agree, to take a firm position that endorses the G classification.

KKMcCleary@cfids.org

sdvernon@cfids.org

1-704-365-2343

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