The Secret Files

Slogging through the sealed U.K. ME files that have finally been released isn't exactly like combing through Girl with the Dragon Tattoo material. But a few of the many entries--most of which concern disability eligibility--may prove illuminating, despite the fact that the patronizing author of what may be the most problematic entry is unknown: The beginning of the letter and signature are missing. The mystery writer intones, "It is important to avoid anything that suggests that disability is permanent, progressive or unchanging. Benefits can often make patients worse." 

Next, psychiatrist Simon Wessely penned an enlightening letter, writing to the Department of Social Security on June 10 of 1993 that ME is a psychiatric disease but that its "powerful lobby group" has earned ME a coveted slip in the neurological harbor.  Explains Wessely:

"I  regret to say that it seems to me that in order to be fair to the ME Association you have now gone to the other extreme. I am disturbed that this disorder should be listed as a neurological disease. I enclosed an editorial that I had written last year for a neurological journal reviewing the evidence on this subject, and concluding that there was little to point to a neurological origin of symptoms. Since then more research has been published in the leading neurological journals, and nothing has happened to alter those conclusion [sic].

"Instead I feel this decision represents the triumph of an effective lobby over scientific evidence. If CFS/ME is to be listed as a neurological disorder, I for one will begin to campaign via the mental health charities for schizophrenia and manic depression to be also listed under the same heading. Indeed, there is far more evidence suggesting that these disorders have a neurological origin than does CFS/ME.

"I also feel that this decision, if it has been made, reflects an undesirable stigmatisation of psychiatric disorders. The main difference between CFS and the major psychiatric disorders is neither aetiological, nor symptomatic, but the existence of a powerful lobby group that dislikes any association with psychiatry." 

PLAY IT AGAIN, AND AGAIN AND AGAIN

  A New ME Outbreak?

A group of mostly female students aged 12 to 19 in San Antonio, Texas, have come down with a constellation of symptoms physicians are terming unusual. Those symptoms include chronic fatigue, headaches, nausea, vertigo, stomach problems and seizure-like activity. In a recent news segment by San Antonio reporter Sarah Lucero, a mother of one of the girls said that one doctor accused her daughter of faking it—because the symptoms are so uncommon—and urged psychiatric care.

In the segment, other diseases that afflict teenagers are mentioned, including “chronic fatigue syndrome, postural tachycardia syndrome or POTS.”

When will doctors get it that POTS often goes hand-in-hand with chronic fatigue syndrome and that these Texas students probably have CFS?  Perhaps when the name CFS is changed to Myalgic Encephalomyelitis (ME) or something else that explains how serious this disease really is.

One bright light: The San Antonio illness is being termed “neuroimmune syndrome.”

Has CDC gone to San Antonio to investigate?  My bet is no.

Sadly, the mother of the teenage girl in the piece is taking her daughter to the Mayo Clinic for help. Perhaps more than any other hospital in the United States, the Mayo Clinic is known for its dismissal and psychologizing of ME.  The most egregious example that I know of:  Back in the 1980s, Nancy Kaiser, who suffered from a severe case of ME—before she had a name for it—traveled to more than 200 physicians for help until she found ME-literate physician Daniel Peterson. One of her stops along the way was Mayo.

During the visit, Nancy had a seizure—she had multiple seizures every day before going on the experimental drug Ampligen—and fell off her chair. The Mayo physician kicked her and told her that she was faking it.  Nancy, of course, had no memory of the event, but her husband, Jim, who accompanied her, certainly did.  Nancy died of ME in 2008.

To view the San Antonio news segment, click here.

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My thanks to Zac for emailing the clip about the San Antonio students.

The Specificity of the Crazy and A Cattle Prod to the Genitals

Have You Been Served?

Two years ago, when Science published the first study linking the retrovirus XMRV to ME, how many of us yearned to fast forward a few years to see if Dr. Judy Mikovits’s findings would be validated and the cause of ME finally nailed, as we hankered to do 20 years earlier when Dr. Elaine DeFreitas published her landmark study linking ME to another retrovirus?

This heady time around no one could envision the spate of nightmarish events that have been plastered in the media since October 2009: shouting contests on both sides of the Atlantic about the rightness of this study or that study and intimidating researchers in Europe and the U.S. for daring to research the retrovirus XMRV, until they switched sides, washed their hands of ME or were booted out of research altogether.

Blood Working Group

More recently was the failure to distinguish patients from controls in the Blood Working Group's XMRV study, and the relabeling of slides, which caused an uproar. That was followed by a spate of jaw-dropping disclosures, for which I've coined the phrase "the specificity of the crazy"—though that phrase applies to much of ME research during the past 30 years. As many readers know, according to court affidavits by Mikovits's research assistant Max Pfost, Mikovits asked him to take documents from the Whittemore Peterson Institute (WPI), which he stashed in a Happy Birthday bag.  His affidavits also state that Mikovits hid out on a boat to avoid being served with papers from WPI and that the duo created secret email accounts—an oxymoron if there ever was one.

Then, during Thanksgiving week, in a quintessential Upstairs, Downstairs moment, WPI gave public thanks for getting back most of its property.

British researchers Simon Wessely and Myra McClure, who published a negative XMRV study, and the CDC, which did the same, must be licking their lips as they watch the critical XMRV players implode in the media. Under extreme stress, many people become reptilian, but still…. To paraphrase singer Annie Lennox, how long can the ME community go on living in this same sick joke?

Pulling strings

Scientists are supposed to ask: What do we think, what do we know, what can we prove?

I don’t know what to think about most of these events—let alone reflect on what we know and what we can prove. At this point, there are far more questions than answers. Here are some of mine: After working several years on XMRV, did anyone at the Whittemore Peterson Institute know that there were reliability issues with the XMRV assays before the Blood Working Group began its studies? After all, when you conduct scientific experiments, you check known positives at the same time to make sure everything is copasetic.

Another question: Who was pulling the strings? Did Mikovits see a problem early on—perhaps even before the Science study was published? If so, did she share her concerns with Harvey and Annette Whittemore or Daniel Peterson, or did she sweep her disquiet under the proverbial carpet? And if Mikovits voiced unease, what was the response? Did they insist she soldier on, and they’d all figure it out in the rinse cycle—or could that have been, perhaps, Mikovits’s expectation? At any time was there deception? Was there self-deception?

Do the right thing

Contending that the retrovirus is hard to culture from blood is reasonable, but how long can you then confidently rely on that assay? You have to develop an antibody test that works consistently or a better way to find the virus—or something. You have to take a step back and figure it out—because if you don’t, the problem will bite you in the ass—and not in a good way. And with this disease the bite always seems to be particularly vicious, the kind that leads to, say, a methicillin-resistant staph infection, several years in the wilderness, and slashing ME’s already dangerously low street cred.

What should the key players have done if they knew there was a problem? A psychiatrist friend of mine is fond of saying: “Unless someone is planting a cattle prod to your genitals, you walk away when someone is pushing you to do something you find objectionable.” You stand up, you refuse, you do the right thing.

Could that be why Dr. Daniel Peterson left the Whittemore Peterson Institute so abruptly—back when things were ostensibly going along swimmingly, only a few months after the Mikovits study was published? He wasn’t a bit player in this yarn: He’s the Peterson in the Whittemore Peterson Institute. None of the explanations for his abrupt departure have made a whole lot of sense, at least to me.

Intellectual property

Why did Mikovits want her notebooks and other data that research assistant Max Pfost allegedly took at her request? Did Mikovits believe the materials belonged to her? Indeed, Mikovits attorney Lois Hart told Science reporter Jon Cohen, “She [Mikovits] is entitled to a copy of the information she created.”

According to law, does that data legally belong to Mikovits or WPI or to both? In the U.S. and Europe, the institution usually owns the intellectual property, though every contract is different. (In Japan, it’s usually a 50/50 split between the institution and the inventor.) Is keeping a copy of the material different from owning the material?

Did Mikovits or WPI want the material to continue the current research, or to foster other important scientific discoveries and to help patients? Did Mikovits want the data to prevent WPI from continuing its research? Does the WPI want to prevent Mikovits from continuing her research? Where, exactly did the XMRV research go wrong—and is the key to it all in those notebooks? What role did money have in all of this? What role did fame play?

Who the hell knows.

Versions of the truth

In a November 11th post on the Wings of Hope blog, Annette Whittemore wrote: “WPI immediately asked to have the materials returned, but to no avail.” If the Whittemores made that request, how did Mikovits and her lawyers respond? What other options could the Whittemores and their lawyers have utilized short of humiliating Mikovits and leaving her to stew in jail for five days without the possibility of bail? Did the Whittemores need to resort to Draconian measures?

Or did the Whittemores have the fiduciary duty to report to the police that property was taken from its institution and once they did, was the chain of events that followed pretty much out of their hands? Did the Whittemores consider the negative repercussions of putting Mikovits in jail on scientists interested in studying this disease, in the press and on the patients?

I want to know the answers to these questions, instead of blindly pledging allegiance to anyone’s version of the truth. As I’ve commented on this blog in the past, and with apologies to Voltaire for messing with his quote, reason consists of seeing things as they are, not how we want things to be.

However you cut it, the last few months have been a terribly sad coda to such a promising start. I think of all the excitement, good will and hope that floated up the day the prestigious journal Science published Judy Mikovits’s study. Judy Mikovits, Daniel Peterson and the Whittemores seemed an invincible team. But most relationships end, and many end badly—though most not as badly as this. As Dr. Phil is fond of saying, “The person you marry isn’t the same person you divorce.”

JUDY MIKOVITS TURNS HERSELF IN

Neuropsychiatric Versus Multisystem

In an interview on the Cure Talk website,  Chronic Fatigue Initiative and Columbia University researchers Dr. Ian Lipkin, who's a neurologist, and Dr. Mady Hornig, a  psychiatrist, stated that ME is a "neuropsychiatric" disorder because it affects concentration, memory and the autonomic nervous system.  However, Lipkin and Horig don't consider the disease psychosomatic.

Labeling ME a neuropsychiatric disease is problematic for three reasons. First, Parkinson's, MS and other neurological diseases can affect concentration and memory. Yet no one calls them "neuropsychiatric" disorders; they're called neurological disorders.

Second, invariably some researchers--particularly CDC scientists and British psychiatrists--will gleefully misinterpret the term neuropsychiatric and continue to relegate ME patients to the psychiatric arena.

And third, ME is more than just a neurological disease.  For starters, ME also affects the heart, kidneys and the immune system.  In other words, it's a disease that attacks more than the brain.  It's a multisystem disease.  Here's an idea:  Why not just call ME a multisystem disease? 

Rituximab, Genentech, Tony Fauci and Pertinent Pop Culture References

As many readers are aware, a small, newly released Norwegian double-blind study found that rituximab—an IV medication used to treat lymphomas, leukemias, organ rejection and refractory arthritis—is also very effective in treating ME.  And now a bigger rituximab study is under way in Norway.

In the U.S., Genentech markets rituximab (trade name Rituxan).  In Canada, it’s Hoffmann-La Roche. And in Japan, it’s Chugain Pharmaceuticals. Unfortunately, as of this week, Genentech doesn’t appear interested in doing a study on ME. Joseph St. Martin, a spokesperson for Genentech, wrote CFS Central in an email on Tuesday: “We cannot comment on the external data you mentioned [the Norway study], but I can say that Genentech has never studied Rituxan in CFS and currently have no plans to do so in the future.”

I sent a follow-up email yesterday: “Given the success of this small double-blind study, and given the fact that CFS is a serious and sometimes fatal disease that afflicts 1 million Americans and 17 million people worldwide, I find it surprising that Genentech would have no interest in doing a study. Why is there no interest? Is there someone at the company who’d be able to enlighten me on this issue?” 

St. Martin kindly emailed back that he'd track down the right person for me to interview, but then emailed today after I followed up: “As mentioned, Genentech has never studied Rituxan in CFS and currently have no plans to do so in the future. We will not be disclosing [any] additional information on this topic.”

CFSAC
In my five minutes testifying before the Chronic Fatigue Syndrome Advisory Committee (CFSAC) meeting last spring, I asked for, among other things, a meeting with Dr. Tony Fauci, head of the National Institute of Allergy and Infectious Disease (NIAID), the same Tony Fauci who has said many times that ME is a psychological disease. 

I’d love to report that the two of us met over saketinis, where we chatted sotto voce about ME and then braided each other’s hair, during which time the NIAID director finally had the light-bulb epiphany patients have been dreaming about for decades:  ya know, that ME is a devastatingly serious and sometimes fatal disease.  

Alas, however, I heard bupkas from Dr. Fauci.

As Gordon Gekko might say, summer is over and business is business. I’ve been hearing the usual fretting about the toothless CFSAC committee meetings, the semi-annual snorefest of how to accomplish absolutely nothing while spending beaucoup taxpayer dollars, as suspicious guards eye patients who can barely move as if the patients are Al Qaeda operatives and the guards are Claire Danes in Homeland.

There has been some debate where to hold the CFSAC protest this year, and I say wouldn’t it be great if people could protest everywhere—the hotel where the meeting has been moved, Health and Human Services, at the homes of all government officials involved in the disease, from CDC’s Dr. Beth Unger on up. But since that’s not feasible, in my view a protest outside Tony Fauci’s office is what’s needed most to shake things up.  After all, he’s the one who dictates policy; Beth Unger et. al. comprise merely the foot-soldier battalion.

As I’ve blogged before, ACT UP patients addressed Fauci’s indifference to HIV/AIDS 25 years ago; for a time, activist Larry Kramer affectionately dubbed Fauci a “murderer.” Those strong-arm tactics changed everything for the better.  Fauci was just one of the government officials ACT UP gutted and served with fava beans and a nice Chianti. 

Dr. Stephen C. Joseph, the Health Commissioner of New York City from 1986 to1989, was another. After proposing that physicians be required to report HIV/AIDS patients to the state, Joseph became a favorite target of ACT UP. According to the Wall Street Journal, he also reduced by 50 percent the estimate of the number of New Yorkers carrying the HIV virus, a momentous shift ACT UP believed would result in diminished funding.  ACT UP staged sit-ins in Joseph’s office, tortured him with telephone calls, marched outside his house and threw paint on his house.  And, in keeping with Godwin’s Law—in which the probability of a comparison to Nazis/Hitler in a heated debate eventually approaches 1—ACT UP denounced Joseph as a Nazi.

And what did Stephen Joseph do?  When he resigned at the end of 1989, he told the New York Times that he credited ACT UP with helping change aspects of a system that had been “unfair and constraining.”

When you stand up to bullies, they back down. Eventually. Most recently, we’ve seen this caving in occur with the Occupy Wall Street protests, as the republicans began dialing back their disdain and even showed on-camera sympathy as the number of protestors and media coverage grew.

Rituximab redux
Which brings me back to rituximab. Pushing for a study on rituximab now is paramount for four reasons: one, the drug appears to work for ME, which after 30 years still has no drug to treat it; two, drug approval for a disease garners respectability for the disease—and if there’s one thing this disease needs it’s respectability. Three, figuring out exactly how rituximab works on ME may shed insight into the immune abnormalities in the disease and generate more research and effective treatments. And four, at circa $20,000 a year, the drug is prohibitively expensive and insurance won’t cover it for most ME patients, unless they also happen to have cancer, an organ transplant or arthritis.

On the down side, hobbling pieces of the immune system with a drug like rituximab may prove more Band-Aid than magic bullet.  It may thrust ME into the autoimmune world that quashes symptoms with immune suppressors rather than address the underlying disease process. That’s the world in which lupus, MS and rheumatoid arthritis currently reside. And it’s also possible that if enough ME patients improve on the drug, no one will devote much energy to searching for a cure—not that anyone does now, but one can always hope. Moreover, rituximab isn’t benign. It can be toxic to the kidneys and leave patients vulnerable to infections and cancers, as it depletes the B cells, key players in the immune system. 

Most problematic is that it can, in rare instances, reawaken the JC virus, which infects most people in childhood and is benign in healthy people, but in rare instances in immunocompromised patients it can attack the brain and cause progressive multifocal leukoencephalopathy (PML), which leads to death or brain damage. The best way to detect the presence of the JC virus is through spinal-fluid PCR and an antibody test prior to beginning therapy.  However, negative tests don't ensure that patients won’t develop PML due to the drug. For now, it's the jumbled luck of the draw.

All that being said, there’s always a risk-reward ratio for medications, and for some patients rituximab may restore life to their lives. After a disappointing summer, rituximab is huge news and certainly worthy of a bigger study. How do you convince a disinterested drug company or the disinterested U.S. government to conduct a rituximab study on ME?  Perhaps this would work: Patients could contact Genentech, Hoffman-LaRoche, Chugain Pharmaceuticals, their congressman and Tony Fauci with a clear and singular message: ME patients need and want a drug study on rituximab. Period. That could be a key message at the November CFSAC meeting and at the demonstration outside Tony Fauci’s office. 

Which brings me to my final point, Peter Weir’s amazing 1982 film The Year of Living Dangerously, with Sigourney Weaver, Mel Gibson (before he got creepy) and Linda Hunt.  It takes place in 1965 during the political upheaval in Indonesia under then-President Sukarno. Hunt, who plays a male news photographer (and won an Academy Award), plasters a huge banner outside a hotel window at the movie’s climax.  It screams in red letters: “Sukarno, feed your people.”

Tony Fauci, help ME patients.  Fund a rituximab study.

*** 

Rebel Satori Press has just published the novel Beatitude by writer extraordinaire (and my good friend) Larry Closs. The book has nothing to do with ME, but it is a great read. You can purchase the book on the CFS Central Amazon.com store.  Click on the book's yellow book jacket on the right-hand column on this page.  

Larry is also a filmmaker and created a terrific 1 minute 13 second trailer for the novel.  If you look closely, you’ll see a quick shot of the Beat poet Allen Ginsberg and a few shots of actor Johnny Depp (in the goatee): 

From the book jacket: 

New York City, 1995: Harry Charity is a sensitive young loner haunted by a disastrous affair when he meets Jay Bishop, an outgoing poet and former Marine. Propelled by a shared fascination with the unfettered lives of Jack Kerouac and the Beat Generation, the two are irresistibly drawn together, even as Jay’s girlfriend, Zahra, senses something deeper developing.

Reveling in their discovery of the legendary scroll manuscript of Kerouac’s On the Road in the vaults of the New York Public Library, Harry and Jay embark on a nicotine-and-caffeine-fueled journey into New York’s thriving poetry scene of slams and open-mike nights.

An encounter with “Howl” poet Allen Ginsberg shatters their notions of what it means to be Beat but ultimately and unexpectedly leads them into their own hearts where they’re forced to confront the same questions that confounded their heroes: What do you do when you fall for someone who can’t fall for you? What do you do when you’re the object of affection? What must you each give up to keep the other in your life?

Beatitude features two previously unpublished poems by Allen Ginsberg.

Q & A with Scott Carlson ofChronic Fatigue Initiative

Scott Carlson, the executive director of the newly launched Chronic Fatigue Initiative—which has already pledged $10 million to get to the bottom of ME/CFS—agreed to an email interview with CFS Central:

CFS Central:  The Chronic Fatigue Initiative website states, “CFI will offer grants to fund new research guided by five or six general hypotheses formed by a scientific advisory board of leading scientists and clinicians.” Will this research be started immediately or down the road?  Have these hypotheses been decided on?  If so, what are they?

Chronic Fatigue Initiative: Now that the epidemiology study, the cohort recruitment and the pathogen discovery programs have been organized, we are beginning the recruitment of leading scientists and clinicians for the scientific advisory board, which will be funded through the CFI Mechanism of Illness grant program. We plan to finalize appointments and have our first meetings to develop some general hypotheses over the next six to nine months. We expect to publish requests for proposals shortly thereafter. All of this work will be funded through the Mechanism of Illness grant program.

CFS Central:  On the CFI website it says that the “Pathogen Discovery and Pathogenesis Study” will begin following cohort recruitment, creation of the bio-bank and population of the database.  Can you give me an idea how long recruitment and creation of the bio-bank and database will take?  Can you give a ballpark figure on how long the pathogen study will take?

Chronic Fatigue Initiative:  We expect to recruit cohort subjects over the next 12 months. The pathogen discovery project will begin within three months following completion of recruitment, as the first bio-samples are processed. We plan to have results from the pathogen discovery project within the next 18 months.

CFS Central: Would you explain what other research the CFI will undertake over the next year to two years?

Chronic Fatigue Initiative:  We will focus future research efforts through the Mechanism of Illness grant program described above.

CFS Central:  What are the short-term goals of the CFI?  What are the long-term goals? And what’s the time frame for both?

Chronic Fatigue Initiative:  CFI’s goal for the next three years is for the CFI-sponsored researchers to complete and publish the results of the epidemiology study, the cohort recruitment program, the pathogen discovery program, and the various studies funded by the Mechanism of Illness program. We expect that the results of this comprehensive strategy will attract attention and greater funding from larger research foundations and philanthropic organizations.

CFS Central:  Figuring out the cause of the disease is crucial for treatment but has proved elusive. Another piece of the puzzle that’s probably easier to figure out and could potentially lead to treatments quickly is an understanding of the cellular pathophysiology of post-exertional malaise (PEM).  For many patients, crashing after activity is the most problematic aspect to the disease.

There has been some research on ME/CFS patients’ diminished VO2 max levels—the threshold at which the body goes from aerobic to anaerobic—as well as gene-expression changes after exercise.  But researchers still don’t understand what exactly happens to patients 24 to 48 hours after activity, and beyond. Do the muscle enzymes, for instance, become abnormal?  Does the body produce too much lactic acid?  Or is glucose not reaching the muscles? That kind of thing.  Will the CF Initiative examine the PEM problem?

Chronic Fatigue Initiative:  PEM is a medical issue that we are aware of. At the recent IACFSME [International Association for CFS/ME] conference, Dr. Betsy Keller and Dr. Christopher Snell made compelling presentations of PEM. The scientific advisory board of the Mechanism of Illness grant program will consider PEM among other issues in determining the four or five general hypotheses on which to focus.

CFS Central:  Dr. Joe DeRisi of the University of California, San Francisco, has devised a ViroChip.  It’s a DNA microarray on a slide that includes every virus ever discovered—about 22,000 altogether. It works like this: DNA and RNA from a patient are tagged with a fluorescent dye and placed on the chip. If there’s a match between what’s on the chip and the patient’s sample, a particular spot on the chip glows. Using computers, DeRisi can look for thousands of viruses at one time. What’s the difference between Columbia University’s techniques to uncover viruses and DeRisi’s?  Why has the CFI decided to use Columbia’s technique?

Chronic Fatigue Initiative:  Representatives of CFI met with a number of virologists when we were establishing the pathogen discovery study. Dr. Lipkin was selected based on his unquestioned expertise, high-quality team and superior track-record of pathogen discovery.

CFS Central:  What’s your relationship to the Hutchins family? How did the Hutchins family become interested in ME/CFS?

Chronic Fatigue Initiative:  The Hutchins family approached Scott Carlson 18 months ago about organizing and implementing CFI’s comprehensive strategy using business principles and accountability to accelerate medical research. The Hutchins family has several friends who suffer from CFS.

CFS Central: There are many definitions of ME/CFS, which results in confusion and causes a huge problem because researchers aren’t studying the same cohorts. Dr. Leonard Jason of DePaul University has studied the definitions and found that CDC’s definition results in a cohort of mostly depressed patients, not patients with the neuroimmune profile of ME/CFS.

The three most commonly used ME/CFS definitions are the Fukuda definition; the revised Fukuda (AKA Empirical) used by CDC; and the Canadian Consensus Criteria, which is what most patients and ME/CFS-literate physicians endorse.  The newest definition, Carruthers ME International Consensus Criteria, is basically a revise of the Canadian Consensus Criteria. What ME/CFS definition will CFI use in its studies?

Chronic Fatigue Initiative:  The CFI-sponsored cohort recruitment protocol uses the updated CDC definition and the Canadian Consensus Criteria to identify well-characterized subjects. We also noted the new definition presented at the recent IACFSME conference.

CFS Central: On the forums, some patients have voiced concerns about the CF Initiative because the website includes the Centers for Disease Control’s treatment protocol of cognitive behavioral therapy (CBT) and graded exercise therapy (GET). In reality, CBT is not significantly effective for patients with bona fide Chronic Fatigue Syndrome, and GET can be very harmful, resulting in relapses that last for days, weeks, months or even years.

In addition, the CFI website states that according to the National Institutes of Health, “the main symptom of CFS is extreme tiredness (fatigue).”  Seabiscuit and Unbroken author Laura Hillenbrand characterized it this way, “This illness is to fatigue what a nuclear bomb is to a match. It’s an absurd mischaracterization.”  Profound exhaustion is closer to it. Unfortunately, CDC and parts of the NIH have perpetuated the “tiredness” misinformation for decades.  Moreover, other symptoms of ME/CFS are just as problematic, if not more so, particularly the neurocognitive problems, as well as pain, PEM, and autonomic dysfunction, which makes it difficult or even impossible to sit or stand. Would the Chronic Fatigue Initiative consider amending the CBT/GET information and the description of ME/CFS on its website?

Chronic Fatigue Initiative:  CFI will continue to update its website as the science develops, including the definitions of the disease.

CFS Central: The other concern patients have is the name Chronic Fatigue. The patients contend that the name Chronic Fatigue promotes the misrepresentation of the disease—i.e., studying patients who are only tired and/or depressed but who don’t have ME/CFS. Examining the wrong cohort has been a big problem over the years, particularly with the psychiatric school headed up by psychiatrist Simon Wessely in England, and at CDC here in the U.S. This muddying of the cohorts often results in findings that are meaningless.  It’s like doing a study on Alzheimer’s disease but recruiting patients who are tired and depressed.

Patients and researchers had the opportunity to change Chronic Fatigue Syndrome’s name about 10 years ago, but CDC and the CFIDS Association nixed it.  Treatments and research have suffered as a result, and the social stigma of having a terrible disease with a trivial name has continued. The largest patient discussion groups, Phoenix Rising and ME/CFS Forums, have discussed that they’re unhappy with the name Chronic Fatigue Initiative. They’d prefer the ME Initiative. Would you be open to dialoguing with patient groups about the name?

Chronic Fatigue Initiative:  Like many organizations, Chronic Fatigue Initiative developed its name based on common usage among the scientific, clinical, and patient communities, as well as the general public. We decided not to use the word “syndrome” because we believe the illness to be a disease—far beyond a syndrome. Through the CFI-sponsored research, we hope to clearly define the causes of the disease.

Echolalia

BFFs Dr. Jay Levy and Dr. Daniel Peterson have penned a disappointing, ho-hum retread of the ME saga—you know, the serious disease that no one takes seriously?—in tomorrow’s LA Times.  There's Levy’s worn-out theory about immune reactivation as the culprit (presumably perpetrated by Levy’s mysterious hit-and-run virus), and the multiple-cause hypothesis, which is often proposed when the actual cause isn’t known. The duo even suggest a better name for CFS:  CFIDS!  Uh, gentlemen, didn’t we try that once before?

There’s some weird distancing in the article when it comes to the XMRV Science paper, on which Peterson was a coauthor: “The most dramatic example [of theorized causation] came two years ago when a group of researchers reported finding a mouse-related virus called XMRV, a pathogen in the same family as HIV, which causes AIDS. They believed they had identified this virus in the blood of a several patients with chronic fatigue syndrome, raising the hopes of patients everywhere.”

The op-ed piece finishes with the patients being frustrated and more research dollars being needed—fair enough, except that had I read the article knowing nothing about ME, I wouldn't think the disease was particularly serious, but I would think that the patients were kinda whiny. 

It’s one thing when Amy Dockser Marcus of the Wall Street Journal dashes off this kind of piece—she doesn’t see patients all day every day.  But why would Dan Peterson, who understands this disease in every pore of his being, present ME this way?  Why not talk about the patients in wheelchairs, the ones with heart failure and seizures, the ones who can’t stand up, the ones who are too weak to wash their hair or walk to the mailbox, and the ones who have lost their lives to this disease, so the public and researchers can begin to grasp just how disabling ME can be? Why not tell the truth?

OTTAWA CONFERENCE

Anyone at the Ottawa ME/CFS conference who wants to share any news, please send it to: mindykitei.cfscentral@comcast.net or just post a comment the usual way in this post on Blogger. As short as a Tweet, as long as a page.  Thanks. 

TO BE OR NOT TO BE

Tomorrow Science will publish the Phase III study by the Blood Working Group, which includes scientists at the Whittemore Peterson Institute, the Food and Drug Administration, the National Cancer Institute, the Centers for Disease Control, and the commercial labs Abbott and Gen-Probe.  

Tomorrow at 3 p.m. EST, ScienceLive, a weekly live chat hosted by Science's Martin Enserink, will delve into "the science and controversy surrounding Chronic Fatigue Syndrome," explained the show's producer Daniel Strain in an email.  Those interested in participating in the show can click here and post questions to guests Dr. Michael Busch of the Blood Research Institute in San Francisco and Dr. Jay Levy of University of California at San Francisco. Levy's XMRV study didn't find the retrovirus.

The Blood Working Group Phase III study examined whole blood, PBMC’s (peripheral blood mononuclear cells, which are cells with a nucleus, key players in the immune response), and serology (antibody testing). They looked at the blood of ME/CFS patients who were positive in the Lombardi and Lo papers, as well as pedigreed negative control donor samples and spiked positives.  Several samples from about 70 different subjects were tested using at least 15 different assays.

Dr. Michael Busch's Institute oversaw the study and broke the labs' codes.  In an August interview with CFS Central, Busch said, "Our Phase IV and other planned studies of donor and recipient infection are contingent on results from Phase III documenting reproducible and specific detection of virus/antibody." In other words, if Phase III is negative, there won't be a Phase IV.