BRITISH INVASION

Here's my published letter on "Fighting for a Cause," the recent profile on XMRV researcher Dr. Judy Mikovits in the British publication Nature News.

I have to address the odd comment by [British retrovirologist] Greg Towers, who said of Harvey Alter: "He doesn't get variation, he gets a totally different virus." Harvey Alter would beg to differ. I interviewed him about his XMRV study for my blog, CFS Central. 

Alter [the NIH researcher who, along with Shyh-Ching Lo, found XMRV related viruses in CFS patients] said that he does indeed believe that his group and Mikovits’s group are looking at the same retrovirus.  “Viruses tend not to be homogeneous,” Alter explained.  “The fact that we didn’t find XMRV doesn’t bother me because we already knew that retroviruses tend to be variable. They mutate a lot, basically. This is true of HIV and HCV [hepatitis C virus]. It’s not one virus. It’s a family of viruses.” 

Alter is far more than “a hepatitis expert” that [reporter] Callaway describes.  He's a Lasker Award winner--his NIH research led to the discovery of hepatitis C--and he developed methods to screen for hepatitis, essentially eradicating the risk of acquiring hepatitis from donor blood.  Clearly, Harvey Alter is capable of speaking for himself, so it certainly begs the question:  Why didn’t Ewen Callaway ask him?

Earlier in his article, Callaway wrote: “The authors delayed publication of both papers for several weeks to assess discrepancies.” This statement is not correct. The authors didn’t delay publication. In a highly unusual move, as reported in the Wall Street Journal on June 30, 2010, higher-ups at Health and Human Services (HHS) put these two XMRV studies on hold, one by the CDC and another by Alter and the FDA’s Shyh-Ching Lo.

HHS officials wanted the two groups to reach a consensus, the Wall Street Journal reported, or at least determine how they arrived at different conclusions, a highly unusual move. 

Scientists disagree all the time, especially with new findings. That’s one reason why pulling the Alter/Lo paper appears to be more about politics than science, particularly because in an abrupt about-face the CDC, which didn’t find XMRV in CFS patients, published its study a day after the Wall Street Journal article, on July 1. So much for reaching consensus.

Alter and Lo, who did find XMRV-related retroviruses, were asked to conduct more research, and their study was finally published August 23.

What makes this case even more unusual is that the Alter/Lo paper had already been accepted by Proceedings of the National Academy of Sciences when it was pulled. I interviewed the journal's editor-in-chief, Randy Schekman, for CFS Central. He said that putting a paper on hold had occurred only one other time that he knew of in his nearly four-year tenure at the journal.  

Given these highly unusual events, the Chronic Fatigue Syndrome community is concerned that government health officials have been behaving more like politicians than scientists. Indeed, Bill Reeves, the former head of CFS research at the CDC, told the New York Times after the Mikovits paper came out: “We and others are looking at our own specimens and trying to confirm it [XMRV]. If we validate it, great. My expectation is that we will not.” 

As far as the XMRV negative papers are concerned, Nature News missed key facts.  For instance, rather than do a true replication study that reproduces precisely the methods and patient cohort of the Science study--something students learn in 9th grade science--the CDC as well as the Dutch and British researchers chose not to.

In addition, many of the patients these researchers are studying don’t have CFS, but have in fact idiopathic fatigue and depression, as confirmed by the research of Leonard Jason of DePaul University.

Mikovits’s study as well as Alter and Lo’s, however, did look at patients with bona fide CFS.

No one yet knows the role of XMRV in CFS, and no one will ever know until scientists examine the correct cohort and reproduce precisely the methods of the Mikovits study.

CD57: A Marker for ARVs?

 

One of the biggest problems in monitoring ME/CFS patients on antiretroviral therapy is the lack of markers to evaluate the drugs’ effects on the immune system.  For patients on medications to treat diseases like HIV and hepatitis, often their immune markers improve and the viral loads decrease well before the patients feel better.  This phenomenon is particularly common in patients with longstanding illness.

CD57

However, as there is no commercial viral-load test yet for XMRV and as immune markers haven’t been established, patients on antiretroviral (ARV) cocktails are flying blind.  One patient who’s been on ARVs for six months reports to CFS Central that although she isn’t feeling significantly better physically, two markers have been steadily rising:  CD57 and Vitamin D.  CD57 is a natural killer cell often depressed in Lyme and CFS patients.  The norm is 60 to 360, but some Lyme-literate physicians believe the count should be at least a hundred, and that the curve has been skewed due to so many Lyme patients getting tested. 

Prior to her initiating therapy, this patient’s CD57 hovered around 25—and it had been stuck there for several years since a serious crash that left her mostly housebound.  Prior to that crash, she was ill but more functional, and her CD57 count registered between 55 and 60. After six months on ARVs her CD57 is 74, an increase of 49 points. 

Vitamin D

Her vitamin D levels have jumped from 31, where they had been for several years, to 47.  Optimal is considered 50 to 125 nMol/L.  Prior to her being on ARVs, five thousand IUs of Vitamin D daily for three years had improved her vitamin D status only from 29 to 31.

Of course this patient’s findings are purely anecdotal, but they shouldn’t be dismissed either.  Vitamin D is easy to test, and in the U.S., Labcorp tests for CD57.

Cholesterol and blood sugar

Two other interesting tidbits:  A few patients have reported to CFS Central that their blood sugar has normalized on ARVs and their cholesterol has dropped.  One pre-diabetic patient forced to eat an Atkins diet of mostly protein and fat to avoid spikes in blood sugar after meals no longer has that problem on ARVs and can eat carbohydrates without any increase in blood sugar.  This is in contrast to the more common reaction of HIV patients on ARVs, who can experience both an increase in cholesterol and blood sugar.

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I'd be interested in hearing from patients who've had significant changes in their vitamin D or CD57 status on ARVs—or anything else noteworthy.  mindykitei.cfscentral@comcast.net

THE CROI INSIDER

An HIV clinician who attended last week’s CROI (Conference on Retroviruses and Opportunistic Infections) in Boston told CFS Central that it was pretty much a bust all around, but that would be par for the course with CROI, which is “notoriously good at keeping out those they don’t want in.”  As far as the XMRV presentations, the physician said it was glaringly obvious to him and to others that the opposing side—those who have found the retrovirus XMRV in ME/CFS patients and in prostate cancer patients—wasn’t being heard. 

His impressions of the discussions in the hallways were that the HIV researchers thought XMRV was a joke, but that many clinicians were taking XMRV seriously.  It reminded him of the early days of HIV when the doctors who were treating these sick patients knew something was seriously wrong with them, while the official word from government was much ado about nothing. “The feeling that I got,” he said, “was the same underlying sense of information being tightly controlled.”

THE DEVIL MADE ME DO IT

Below is my response to CFIDS Association board member Jennifer Spotila's comments from yesterday.  Spotila was responding to my "Bad Company" blog post, particularly to my commentary on CAA President Kim McCleary's statement to CNN about the PACE trial.  McCleary told CNN:  “I think it would be challenging, at least in the U.S. system, to purchase the services that they've tested in this trial,” 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: “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.” 

Spotila's comments are below mine.

Jennifer Spotila,

If McCleary hadn't made those comments to CNN, CNN wouldn’t have included those comments. No one held a gun to McCleary’s head or laid a cattle prod to her feet and forced her to utter those problematic remarks. She did that all on her own. Granted, it’s difficult to articulate a string of perfect quotes, but McCleary’s endorsement of cognitive behavioral therapy (CBT) and graded exercise therapy (GET) was inexcusable in my view and the view of many patients. After all these years, there is no excuse for defending these ineffective therapies.

Defending McCleary’s statements, you wrote: “Both reporters had also been prepped by the authors of the PACE trial to expect and dispute the objections raised by McCleary and other advocates to the study.”  Prepped?  Says who?  Jennifer, each side makes his or her case.  You’re an attorney.  Think of it like the defense and the prosecution in a murder trial. That’s how it works.  McCleary’s job was to make her points, not to endorse those of the opposing side.

Kim McClearly could have told CNN something like this:  “The PACE trial is problematic, and here are some reasons why. The selection process eliminated most bona fide CFS patients.  Instead, the PACE patients had idiopathic fatigue and depression. Cognitive behavioral therapy and graded exercise therapy are primarily helpful for those with idiopathic fatigue and depression, not those with Chronic Fatigue Syndrome. In fact, the hallmark of CFS is post-exertional crashing, so graded exercise therapy would make the symptoms of most CFS patients worse.

“Many patients with CFS are severely ill and suffer from seizures; swollen lymph nodes; fevers; autonomic dysfunction that makes it difficult or impossible to sit or stand; heart failure; immune dysfunction, including reactivation of herpes viruses; and rare cancers. Some patients are dying, others are consigned to a living death, and compelling evidence points to a newly discovered retroviral infection in these patients that’s similar to the one that causes HIV. 

"Despite its trivial name, this is not a trivial disease.  To suggest that patients can power through CFS through GET or CBT would be as incorrect as suggesting that those with Parkinson’s disease or multiple sclerosis or AIDS can be restored to health simply with exercise and a positive attitude.”

Jennifer Spotila, even if I had been on hallucinogens, I couldn’t have said something as unhelpful as what McCleary told CNN.

On another note, you wrote, “The Association did make changes to its website and operations in response to feedback we received through Khaly's postings and other venues.”  Khaly Castle posted a reply to you that said in her view there were no significant changes (see her response, below). Jennifer, I would appreciate if you would tell the readers of CFS Central what those changes were, and let the patients weigh in on their significance.

The CAA survey on the patient forum Phoenix Rising gives patients the choice of voting that the CAA is doing great, or needs some minor changes, or needs changes in direction, or needs changes in both direction and leadership.  So far, 143 out of 153 patients—that’s 93 percent—have voted for changes in direction and leadership.  I would argue that the CAA is doing poorly on the Phoenix Rising survey because it’s not representing what the patients want and need. 

Patients deserve better representation.  Patients deserve a CAA that strongly opposes the money spent on CBT and GET studies/treatment for ME/CFS. Patients deserve bona fide biomedical research, not this appalling, make-believe, psychoneurotic PACE study.  Patients, in my view, deserve an advocacy organization that actually advocates for them.

You wrote: “I strongly encourage you to balance your reporting on the advocate point of view by interviewing a diverse sample of us.”  Jennifer, I strongly encourage you to hear what the patients are saying and to stop defending the indefensible:  McCleary’s statements to CNN are inexcusable.

Jennifer Spotila's remarks:

Mindy, If you had contacted me, I would have been happy to answer any questions you have about the Association or the incidents you cite here. I did respond to Khaly Castle in 2009. The Association did make changes to its website and operations in response to feedback we received through Khaly's postings and other venues. 

Kim McCleary gave a very lengthy interview on PACE to CNN, and another to NPR. Both reporters chose to use only one quote from those interviews. Both reporters had also been prepped by the authors of the PACE trial to expect and dispute the objections raised by McCleary and other advocates to the study. Their questions to McCleary and the pieces they produced reflect this. 

I strongly encourage you to balance your reporting on the advocate point of view by interviewing a diverse sample of us. Reasonable minds can and do differ on many aspects of CFS advocacy. I continue to believe that dialogue serves us better than monologue.   

Khaly Castle's response to Jennifer Spotila:

Jennifer, to say that the CAA responded would be accurate. To say that the CAA responded in a meaningful way would be inaccurate. In 2009, a thread was started on Phoenix Rising. The discussion over there continues to this day, about basically the same issues.

After we tried to have a meaningful dialogue, CAA was asked to help us fight the DSM5 issues. The response was meager and meaningless, basically boiling down to the suggestion that we should go ask the IACFS/ME as CAA did not feel informed enough to take a stance. I notice the same conversation evolving regarding ICD codes right now.

Mindy already cited and linked to two of my articles voicing some of the concerns we had in 2009. We are still facing the same concerns...lack of adequate response to ill-defined cohorts in X-negative studies, inability to take a stand that CFS is NOT what the CDC likes to describe, inability to advocate for the sickest of us, inability to verbalize a distinction between this illness and the grab bag of fatiguing illnesses....on and on.

For more on some of these issues, see: http://www.cfsuntied.com/archivedblog4.html#caaxmrv

You will notice that not much has changed.

A few months ago, after the "Inside Voices" article was presented to us, I asked the CAA on Facebook if the CAA still considered itself an advocacy organization, or if it had decided to become a science and research organization. You answered, that they were indeed an advocacy organization, but that there were many ways to advocate. The conversation and surrounding events are documented here: http://cfsuntied.com/blog2/2010/10/07/be-vewy-vewy-quiet-im-hunting-wabbits/

This can no longer be about promotion of promotion. It has to be promotion of what will save us. Many of us are facing not only the end of our ropes, but the end of our time. The clock is ticking. 

FLIP WILSON on ED SULLIVAN: THE DEVIL MADE ME DO IT