Okay, after one “loser-length” post, here we are with another.
On the web chat’s comments I copied into the previous post? It occurred to me that I might have conveyed the impression that Trine did not adequately respond to my last two posts. In fairness I should point out that my posts were off-topic and made well after the chat was over, with the last two not going up until the day after the chat. Not long afterward, all the comments were pulled from that page, so it wouldn’t be fair to assume that Mrs. Tsouderos simply avoided my comments and questions, especially since she did respond to me directly once or twice.
I can say that a phone message I left on her voicemail following her web chat on XMRV last June was not returned, and that while I had left one comment on the Tribune site on one of her pieces at some point last year, a second was not posted, for whatever reason.
Given what she did offer the other day as a response to me, and others, I would be interested in seeing a response, but who knows? Maybe I’ll get one at some point. Maybe I’ll get one to THIS. We’ll see.
Lastly, before I get back to the topic at hand, a reminder that I am trying to do this in good faith, with as little snark as possible, as much fairness as I myself can muster, and with no animus whatsoever directed at Trine Tsouderos as a person or a journalist. And in spite of what I see as unfairness in her coverage, I don’t want to see any ad hominem attacks in my comments sections; if I do, I’ll remove them, if I can figure out how. As it is, friends of mine are having difficulty commenting presently, so I’ll have to take a look at that, when I get a chance.
Now…moving forward…the last blog ended with my analysis of Trine’s piece on Dr. Oz.
Some weeks later, in mid-June, we were graced with "The Push And Pull Over Chronic Fatigue Syndrome."
Let's see...
"Five research teams trying to confirm the finding have reported in journals or at conferences that they could not find the retrovirus, known as XMRV, in patients diagnosed with chronic fatigue syndrome, casting grave doubts on the connection."
That would be the three I previously mentioned, the Brigitte Huber study, and, most likely, the CDC study.
"Trying to confirm the finding."
Unmentioned is that none studied the same patient cohort as Lombardi et al—CDC 1994 Fukuda International Criteria (which, flawed as it is, and it’s the most-used, is not the worst of the various criteria), AND the far-stricter (and far more specific--I don't think one can easily describe this as a diagnosis of exclusion) Canadian Consensus 2003 Criteria (CCC). Most XMRV studies on CFS patients since Lombardi et al have been on Fukuda-defined cohorts, with at least one on the even-broader Oxford cohort, and one on the precursor to Fukuda—CDC’s 1988 Holmes criteria. That criteria is probably the closest to the CCC, and, probably not coincidentally, the study using the Holmes CFS cohort was the only other one that did not produce a negative result.
So, all in all, I think there’s some significance here, an issue to be considered. Granted, the question of why no study besides Lo et al found XMRV/non-XMRV MLVs in healthy controls is a thorny one, but there we get into issues I choose not to speak to (some who do, offer explanations that sound, at the very least, somewhat credible to my admittedly untrained eye). Some patients do—and a few do possess some relevant knowledge and qualifications, but probably not all who choose to argue with scientists in comments threads and on message boards. That aspect of what I see as a cacophonous mess doesn’t thrill me, but what can you do. I stick to what I’m comfortable speaking on, and others will do what they feel best. I think the discussion of the cohort issue is valid and under-represented in talk of assays and primers and different PCR techniques.
But, although I feel it’s an issue that deserves to be aired more than it has been, the truth is, I have no idea how significant it is. Really. But the more this goes on, the more days have passed on the calendar where no research team has chosen to study patients as sick as the patients in the Science study. Does Trine Tsouderos know anything about the Wichita or Georgia cohorts that the CDC study, and have been for years? I realize this and other negative studies have no bearing on the findings in healthy controls, as they all find zero, zip, nothing. Still, I pose this question. Does she know the first thing about it? These people are 'unwell!'
Does she know that these patients were diagnosed with CFS after answering 'yes' when a random phone call came in from a government researcher asking if they were 'fatigued,' and having little more than a basic workup at a hospital?
http://www.biomedcentral.com/1741-7015/3/19
“At least a quarter of those suffering from CFS are unemployed or receiving disability because of the illness”
As many as ¾ capable of employment? That’s not the illness I know and live.
Take a look at the comments on that piece of, um, research. (Some subsequent research, especially by the CDC, which cites that paper...the methods by which they assembled their 'population base...' oh, brother...) I wonder, considering her apparent ongoing interest in writing about CFS, if Trine Tsouderos has?
Does she know that Leonard Jason has published research showing that as many as 40% or so of these patients are likely not CFS patients, but suffering from depression (which, as many know, can produce "CFS"-like symptoms)?
Did she care enough to find out before writing about this?
Is this some piddling detail, to compare patients bedridden for years with folks suffering from idiopathic chronic fatigue, either capable of at least part-time work in many cases, or, at the least, of attending 'fatigue clinics' on a fairly regular basis--physical commitments not remotely within the physical reach of CCC-defined ME/CFS patients like the ones in the Science study?
I guess so.
"This would be welcome news to patient advocates who are concerned about how patients were classified in Switzer's study. Fred Friedberg, president of the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME), says the CDC used an assessment that could lump together those with chronic fatigue syndrome and those with other conditions, such as major depression. And Kim McCleary, president of the Chronic Fatigue and Immune Dysfunction Syndrome Association of America, notes that the study included only three patients with 'acute onset' chronic fatigue syndrome; the rest had gradual onset of the condition. "That is a very low number," says McCleary. "If you're looking for a virus, it seems like you would have wanted to screen [people with] the acute cases."
Kim McCleary of all people points this out (acute cases in a chronic illness? You don't say...). Now, I'm not a fan of the CAA, or its CEO, but it would be unfair to not point out when she offers up a quote that we patients find helpful, even if it was in true 'inside voice' style.
Conspiracy theories about what happened with the withholding of both--sorry--the paper that actually meant something...no, thanks. It's been too long, and this isn't a short blog to begin with. No comment, even though that excerpt began with 'if.'
A list of the BS we saw from the CDC over the summer is notable, but not the point of this blog.
What did the Tribune family of newspapers do during this time?
Well, on July 27th, they ran a reprint of the piece they published on June 14th.
Is this verbatim? A quick skim...sure looks like it. So...why?
Why not mention the slides presented in Zagreb? Or the implications for the blood supply?
Or that both XMRV papers were withheld? Or, most strangely, that the CDC paper had been published nearly a month before this piece was recycled?
I'm going to take a wild guess that Trine Tsouderos is not to blame for this. I mean, does this make her look good? Uh...no. So it's entirely possible that she was embarrassed by it, while some of us were befuddled by it, containing absolutely no new information on a story that had seen explosive developments in the six weeks since the original had run.
Developments that included ME/CFS patients being banned from blood donations in several countries, including Canada, Australia, New Zealand, and, eventually, the UK.
Oh, well.
Four more weeks pass. PNAS published Lo et al on August 23rd. Harvey Alter states that their findings are 'highly confirmatory' of the WPI's XMRV paper.
Trine Tsouderos was not the only one who did not cover this; see my previous blog for a detailed rundown on how sparsely it was covered in the UK.
But, wait--XMRV was somehow necessary to hammer Dr. Oz; Judy Mikovits is hyperbolic, or worse; patients are taking dangerous antiretrovirals. Of course, I can't know if Trine Tsouderos wanted to cover this & was not allowed the assignment.
I'll tell you what, though: if I'd written what she'd published, up to that point, on XMRV, I sure would've wanted to cover it. Badly.
But I'm not a journalist, so what I would do is not necessarily relevant.
Now, there is the issue that, wait a second, Lo et al did not detect XMRV in CFS patients.
They only detected something very, very like it.
This distinction has led a number of bloggers to announce that this, um, hair-splitting, meant that the XMRV/CFS connection was...disproved! (Some virtually dismissed it as meaningless, which is…um…terrific. For them. Really.)
Of course that paper received widespread coverage, at least outside the UK (and Chicago). There was some fair coverage of the First International XMRV Workshop at the NIH in early September, as well. But what did we see next from Trine?
"Five different teams, including one led by the U.S. Centers for Disease Control and Prevention and another from the National Institutes of Health and the U.S. Food and Drug Administration, have published papers failing to find such evidence.
"One of the teams, from the NIH and FDA, found evidence of a different retrovirus, one also associated with mice, in the patients, but nobody knows what that could mean.* [Updated Sept 30, 12:35 p.m.: In an earlier version of this article, the reference to the "different retrovirus" omitted the word "also," implying that XMRV is not associated with mice; it is.] It does not confirm the original paper."
No mention that no teams studied the same patient cohort. No mention that the lead author on the paper emphatically stated several times the exact opposite of the last sentence I excerpted. Um, I dislike the idea of stooping to an argument that appeals to authority, but...well, I don't have to even go there. What's clear is that Trine Tsouderos has decided that a paper whose publication she did not cover, does not quote from, and does not list the names of even one author on it, has flatly rendered a conclusion that...well...
When Judy Mikovits criticizes other researchers, oh, boy. Look out.
When Robin Weiss does it...
...crickets.
Now, I suppose I wouldn't know a double standard if I fell over it, so I should probably just move on. I could offer all sorts of silly reasons why this looks like one to me, but...
"I would be happy to accept that if XMRV is associated with CFS, so could polytropic MLV be. What I find extraordinary, however, is that only XMRV was found by Lombardi et al. [1], whereas only polytropic MLV was detected by Lo et al. [6]. Given that the samples analyzed by Lo et al. were collected over several years from persons with no contact with each other and widely dispersed across states in New England [6], it does not make epidemiological sense that the two types of CFS-associated MLV segregate according to the laboratory performing the tests."
Well, again, as a layman, I cannot comment on this, except to mention that I've long heard that CFS represents an epidemiological nightmare, for decades, in no small part due to differences in diagnostic criteria. But while Weiss dismissed the differences in criteria fairly brusquely, he nevertheless found it easy to speak on what 'does not make epidemiological sense' in CFS.
"It is noteworthy that positive findings are often published in high profile journals, while the negative ones find their way to specialist journals. In the case of XMRV, two of the negative reports were accepted by BMC Biology's sister journal Retrovirology [4,5], which is becoming well established as the standard-bearer of its field. The recent paper by Switzer et al. [5], which examined properly blinded samples, perhaps has too modest a title: 'Absence of evidence of XMRV virus infection in persons with CFS and healthy controls in the United States'. I would go further and suggest that they found firm evidence of absence."
Well, there may be a fair point in this paper about 'rumor viruses.' But...'persons with CFS?' did Weiss read Switzer's criticism of the CCC in that paper?
Title: "New study casts doubt on retrovirus link to cancer and chronic fatigue syndrome"
Let's see--is the selling of the test mentioned? Yes. Is the issue of the hordes of CFS patients apparently taking antiretrovirals mentioned? Yes. Is it mentioned that the negative studies are piling up? Yes.
Is it addressed that "Chronic Fatigue Syndrome" is in the headline yet the study being reported on was done exclusively on prostate cancer?
No.
Granted, it's my understanding that the reporters don't write the headlines, but still...you know, if I didn't know any better...I'd say this is becoming familiar.
But not tiresome!
That’s all for tonight, folks, but while I’m sure you’re breathlessly awaiting the final installment of my airing of this grievance, let me just mention that there is a comment someone tried to leave on part 1 but couldn’t; so here is a link to her blog.
Part 3 of 3…to be served up shortly.
"Grave doubts."
(This is where I begin taking things "out of context," folks.)
Unmentioned is that none studied the same patient cohort as Lombardi et al—CDC 1994 Fukuda International Criteria (which, flawed as it is, and it’s the most-used, is not the worst of the various criteria), AND the far-stricter (and far more specific--I don't think one can easily describe this as a diagnosis of exclusion) Canadian Consensus 2003 Criteria (CCC). Most XMRV studies on CFS patients since Lombardi et al have been on Fukuda-defined cohorts, with at least one on the even-broader Oxford cohort, and one on the precursor to Fukuda—CDC’s 1988 Holmes criteria. That criteria is probably the closest to the CCC, and, probably not coincidentally, the study using the Holmes CFS cohort was the only other one that did not produce a negative result.
So, all in all, I think there’s some significance here, an issue to be considered. Granted, the question of why no study besides Lo et al found XMRV/non-XMRV MLVs in healthy controls is a thorny one, but there we get into issues I choose not to speak to (some who do, offer explanations that sound, at the very least, somewhat credible to my admittedly untrained eye). Some patients do—and a few do possess some relevant knowledge and qualifications, but probably not all who choose to argue with scientists in comments threads and on message boards. That aspect of what I see as a cacophonous mess doesn’t thrill me, but what can you do. I stick to what I’m comfortable speaking on, and others will do what they feel best. I think the discussion of the cohort issue is valid and under-represented in talk of assays and primers and different PCR techniques.
But, although I feel it’s an issue that deserves to be aired more than it has been, the truth is, I have no idea how significant it is. Really. But the more this goes on, the more days have passed on the calendar where no research team has chosen to study patients as sick as the patients in the Science study. Does Trine Tsouderos know anything about the Wichita or Georgia cohorts that the CDC study, and have been for years? I realize this and other negative studies have no bearing on the findings in healthy controls, as they all find zero, zip, nothing. Still, I pose this question. Does she know the first thing about it? These people are 'unwell!'
Does she know that these patients were diagnosed with CFS after answering 'yes' when a random phone call came in from a government researcher asking if they were 'fatigued,' and having little more than a basic workup at a hospital?
http://www.biomedcentral.com/1741-7015/3/19
“At least a quarter of those suffering from CFS are unemployed or receiving disability because of the illness”
As many as ¾ capable of employment? That’s not the illness I know and live.
Take a look at the comments on that piece of, um, research. (Some subsequent research, especially by the CDC, which cites that paper...the methods by which they assembled their 'population base...' oh, brother...) I wonder, considering her apparent ongoing interest in writing about CFS, if Trine Tsouderos has?
Does she know that Leonard Jason has published research showing that as many as 40% or so of these patients are likely not CFS patients, but suffering from depression (which, as many know, can produce "CFS"-like symptoms)?
Did she care enough to find out before writing about this?
Is this some piddling detail, to compare patients bedridden for years with folks suffering from idiopathic chronic fatigue, either capable of at least part-time work in many cases, or, at the least, of attending 'fatigue clinics' on a fairly regular basis--physical commitments not remotely within the physical reach of CCC-defined ME/CFS patients like the ones in the Science study?
I guess so.
As an aside, this should not be shocking in a field where the sickest patients are almost never tested, where questionnaires are routinely used in lieu of objective physical testing (much of which the CDC considers 'unhelpful' in diagnosing CFS), and where patients who begin a study at the "most-fatigued" end of a "fatigue scale" cannot provide any data if in the course of the study, they get worse.
Where patients unable to continue participating in "treatment" studies aren't counted in final results if they drop out, where researchers are advised to steer clear of this area of study, where such research is ridiculously underfunded, and where most of the recipients of research funding are...okay, enough, I'll stop there.
The CCC is a clinical criteria, not a research criteria, granted. Does that mean nobody besides WPI can assemble a cohort?
"In response, Mikovits has accused other researchers of bias and amped up efforts to sound the alarm over what she views as an epic health crisis. Invoking the world's slow response to AIDS, she warned that XMRV infection "could be the worst epidemic in U.S. history." Though her published findings address only chronic fatigue syndrome, Mikovits also has publicly linked the retrovirus to autism, atypical multiple sclerosis and other disorders."
Wow--Judy must be a horrible person. She's gone off the rails (wasn't that said by the guy who called a patient a 'loser?' Not unprovoked, but still…outrageous.). She's another "Wakefield." She's this. She's that. Oh, the crimes she has committed against science and medicine.
She stomps on puppies and kittens, too, while her critics keep repeating the mantra that science will sort it all out in the end. Which makes sense, of course.
Unless you have ME/CFS, in which case “Science” has accomplished what, exactly?
Since Incline Village?
Since Royal Free?
Since Los Angeles in 1934?
I have to admit that when what Tsouderos describes in this piece was transpiring, I was not happy to see it: I cringed at some of it. I found it difficult to give Judy Mikovits the benefit of the doubt on it. I had issues with the PR approach that WPI seemed to be engaged in.
Since that time, I believe the public behavior and actions of those criticizing Mikovits are far more egregious than anything anyone can accuse her (or anyone else at WPI) of. Period.
Perhaps it was not the best move not to criticize the other researchers or the other research (not that this stopped those who have offered their own criticisms, apparently without fear of rebuke). But how much credence are we to give to the seven week study Wessely seemingly snookered Myra McClure into?
(Of course, now, it doesn't really seem that way, but who reading this remembers McClure's interview in Australia a year ago where it sure sounded as though she were attempting to distance herself from Wessely's influence on the study?)
Was Jonathan Kerr working with untold pressures that may have influenced that study? (Take a look at the 10th paragraph)
And wouldn't some people find it strange that the BMJ chose to, in their own words, 'fast-track' the negative study they published, versus perhaps having reviewers take a closer look at it?
The headline is “Let’s Proceed With Caution.” Yet they “fast tracked” it.
Does THAT make ANY sense? Especially when peer review on Erlwein et al was all of three days on a seven-week study? (Groom et al, which, it should be pointed out, was financed in part by the MRC—guess they don’t only invest in psych research after all—underwent a review period of one month)
As to XMRV being the 'worst epidemic in U.S. history...' Unless Lombardi et al is a false finding, 10 million, infected, and asymptomatic. The Harvey Alter paper? Double that number.
No, if they represent completely different findings, as some have suggested, we don't add together the percentages on the infected controls. Yes, we are told, these are two completely different events…which would mean (assuming the findings of Lombardi et al and Lo et al are valid) three and a half percent healthy controls infected with XMRV and 6.8% healthy controls infected with non-XMRV MLVs, which would bring us to 10%, 30 million Americans? Hell no! Why, that would be unscientific.
What else? Oh, yeah--Judy Mikovits publicly linked XMRV to other conditions, based on unpublished research.
Okay...do her statements--one that I heard was qualified, when offered, that it represented speculation--represent unsupportable, irresponsible claims? I don't know. Maybe.
Maybe not.
Maybe she made a ‘claim’ she shouldn’t have.
In my view, any such claim is mitigated, even if only slightly, because I actually have the audacity to believe that, thanks to the Whittemores, Judy Mikovits sees letting us rot as being worse than risking irritating other scientists who haven’t done much to change our status quo, which, let's be honest, almost nobody gives a sh*t about.
But we already have a sense of Judy Mikovits. As seen by Trine Tsouderos.
"Meanwhile, some people with chronic fatigue syndrome already are getting tested for XMRV and taking toxic drugs intended to treat the retrovirus that causes AIDS — an idea Mikovits does not endorse but declines to oppose."
For every negative remark one might aim at this revelation, I will counter with a rebuttal, including statements above. And I would do so knowing that taking ARVs might not be the best idea--might be completely wrong, and for a variety of reasons. People take controversial drugs off-label. Get over it; we're not talking about great numbers of patients here, or there really would be a story. If this is the worst wrongdoing that ever occurs in the history of our Republic, it does not compare to how patients have been mistreated.
The CCC is a clinical criteria, not a research criteria, granted. Does that mean nobody besides WPI can assemble a cohort?
"In response, Mikovits has accused other researchers of bias and amped up efforts to sound the alarm over what she views as an epic health crisis. Invoking the world's slow response to AIDS, she warned that XMRV infection "could be the worst epidemic in U.S. history." Though her published findings address only chronic fatigue syndrome, Mikovits also has publicly linked the retrovirus to autism, atypical multiple sclerosis and other disorders."
Wow--Judy must be a horrible person. She's gone off the rails (wasn't that said by the guy who called a patient a 'loser?' Not unprovoked, but still…outrageous.). She's another "Wakefield." She's this. She's that. Oh, the crimes she has committed against science and medicine.
She stomps on puppies and kittens, too, while her critics keep repeating the mantra that science will sort it all out in the end. Which makes sense, of course.
Unless you have ME/CFS, in which case “Science” has accomplished what, exactly?
Since Incline Village?
Since Royal Free?
Since Los Angeles in 1934?
I have to admit that when what Tsouderos describes in this piece was transpiring, I was not happy to see it: I cringed at some of it. I found it difficult to give Judy Mikovits the benefit of the doubt on it. I had issues with the PR approach that WPI seemed to be engaged in.
Since that time, I believe the public behavior and actions of those criticizing Mikovits are far more egregious than anything anyone can accuse her (or anyone else at WPI) of. Period.
Perhaps it was not the best move not to criticize the other researchers or the other research (not that this stopped those who have offered their own criticisms, apparently without fear of rebuke). But how much credence are we to give to the seven week study Wessely seemingly snookered Myra McClure into?
(Of course, now, it doesn't really seem that way, but who reading this remembers McClure's interview in Australia a year ago where it sure sounded as though she were attempting to distance herself from Wessely's influence on the study?)
Was Jonathan Kerr working with untold pressures that may have influenced that study? (Take a look at the 10th paragraph)
And wouldn't some people find it strange that the BMJ chose to, in their own words, 'fast-track' the negative study they published, versus perhaps having reviewers take a closer look at it?
The headline is “Let’s Proceed With Caution.” Yet they “fast tracked” it.
Does THAT make ANY sense? Especially when peer review on Erlwein et al was all of three days on a seven-week study? (Groom et al, which, it should be pointed out, was financed in part by the MRC—guess they don’t only invest in psych research after all—underwent a review period of one month)
As to XMRV being the 'worst epidemic in U.S. history...' Unless Lombardi et al is a false finding, 10 million, infected, and asymptomatic. The Harvey Alter paper? Double that number.
No, if they represent completely different findings, as some have suggested, we don't add together the percentages on the infected controls. Yes, we are told, these are two completely different events…which would mean (assuming the findings of Lombardi et al and Lo et al are valid) three and a half percent healthy controls infected with XMRV and 6.8% healthy controls infected with non-XMRV MLVs, which would bring us to 10%, 30 million Americans? Hell no! Why, that would be unscientific.
What else? Oh, yeah--Judy Mikovits publicly linked XMRV to other conditions, based on unpublished research.
Okay...do her statements--one that I heard was qualified, when offered, that it represented speculation--represent unsupportable, irresponsible claims? I don't know. Maybe.
Maybe not.
Maybe she made a ‘claim’ she shouldn’t have.
In my view, any such claim is mitigated, even if only slightly, because I actually have the audacity to believe that, thanks to the Whittemores, Judy Mikovits sees letting us rot as being worse than risking irritating other scientists who haven’t done much to change our status quo, which, let's be honest, almost nobody gives a sh*t about.
But we already have a sense of Judy Mikovits. As seen by Trine Tsouderos.
"Meanwhile, some people with chronic fatigue syndrome already are getting tested for XMRV and taking toxic drugs intended to treat the retrovirus that causes AIDS — an idea Mikovits does not endorse but declines to oppose."
For every negative remark one might aim at this revelation, I will counter with a rebuttal, including statements above. And I would do so knowing that taking ARVs might not be the best idea--might be completely wrong, and for a variety of reasons. People take controversial drugs off-label. Get over it; we're not talking about great numbers of patients here, or there really would be a story. If this is the worst wrongdoing that ever occurs in the history of our Republic, it does not compare to how patients have been mistreated.
Meanwhile...although, from what I can tell, few believe that any great numbers of patients are taking these drugs, anecdotal evidence does suggest that some of these patients are actually improving. Not miraculously, mind you, it can't be claimed that such controversial treatment is curative, or anything, but, yes, improving.
I'm with Judy on this: not endorsing it while declining to opposing it--we're talking about desperation that's probably just about impossible to describe, not some gladhanding pharmaceutical misadventure--sounds about right to me.
In fairness I have to say the rest of this piece is relatively balanced. At least compared to what was to follow. Although, to be truly fair, it's worth pointing out that the very same day, the Wall St. Journal had this...
...that's a very different piece.
Now, something interesting happened shortly afterward. The slides from a presentation Harvey Alter gave in Croatia at a blood products conference were leaked by a European publication. They indicated that Dr. Alter had undertaken research that, in his words, showed the findings WPI published in the Science paper to be 'likely true, despite the controversy.' Most of you reading this probably know all about this. And it was pretty stunning news, especially since we already knew that Dr. Huber had pronounced XMRV to be a contaminant, and I don't think there was one ME/CFS patient who thought CDC would ever test a CCC cohort (would they, even now, if not for the Lipkin study?). Which means nobody really had any inkling if there were any studies forthcoming showing a positive result. So this was a startling report.
Now, I have to point out that this proves nothing, and further research is needed. But this was a pretty significant development. And it rated a blog post by Amy Dockser Marcus in the WSJ.
What happened next? Of course. The CDC paper and the NIH/FDA paper were both withheld.
Yet the following morning (5 am EDT or thereabouts, or was it 4? Details, details…), the CDC's negative paper was published, while the other paper was not...for nearly two months.
It gets a trifle redundant posting everything the WSJ has run; let's just say they're on top of it. But the day after, this appeared in Nature News:
It had a very interesting observation:
"If the PNAS paper is published, it will be the first published study to back up the work reported last year by Mikovits.
I'm with Judy on this: not endorsing it while declining to opposing it--we're talking about desperation that's probably just about impossible to describe, not some gladhanding pharmaceutical misadventure--sounds about right to me.
In fairness I have to say the rest of this piece is relatively balanced. At least compared to what was to follow. Although, to be truly fair, it's worth pointing out that the very same day, the Wall St. Journal had this...
...that's a very different piece.
Now, something interesting happened shortly afterward. The slides from a presentation Harvey Alter gave in Croatia at a blood products conference were leaked by a European publication. They indicated that Dr. Alter had undertaken research that, in his words, showed the findings WPI published in the Science paper to be 'likely true, despite the controversy.' Most of you reading this probably know all about this. And it was pretty stunning news, especially since we already knew that Dr. Huber had pronounced XMRV to be a contaminant, and I don't think there was one ME/CFS patient who thought CDC would ever test a CCC cohort (would they, even now, if not for the Lipkin study?). Which means nobody really had any inkling if there were any studies forthcoming showing a positive result. So this was a startling report.
Now, I have to point out that this proves nothing, and further research is needed. But this was a pretty significant development. And it rated a blog post by Amy Dockser Marcus in the WSJ.
What happened next? Of course. The CDC paper and the NIH/FDA paper were both withheld.
Yet the following morning (5 am EDT or thereabouts, or was it 4? Details, details…), the CDC's negative paper was published, while the other paper was not...for nearly two months.
It gets a trifle redundant posting everything the WSJ has run; let's just say they're on top of it. But the day after, this appeared in Nature News:
It had a very interesting observation:
"If the PNAS paper is published, it will be the first published study to back up the work reported last year by Mikovits.
"This would be welcome news to patient advocates who are concerned about how patients were classified in Switzer's study. Fred Friedberg, president of the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME), says the CDC used an assessment that could lump together those with chronic fatigue syndrome and those with other conditions, such as major depression. And Kim McCleary, president of the Chronic Fatigue and Immune Dysfunction Syndrome Association of America, notes that the study included only three patients with 'acute onset' chronic fatigue syndrome; the rest had gradual onset of the condition. "That is a very low number," says McCleary. "If you're looking for a virus, it seems like you would have wanted to screen [people with] the acute cases."
Kim McCleary of all people points this out (acute cases in a chronic illness? You don't say...). Now, I'm not a fan of the CAA, or its CEO, but it would be unfair to not point out when she offers up a quote that we patients find helpful, even if it was in true 'inside voice' style.
Conspiracy theories about what happened with the withholding of both--sorry--the paper that actually meant something...no, thanks. It's been too long, and this isn't a short blog to begin with. No comment, even though that excerpt began with 'if.'
A list of the BS we saw from the CDC over the summer is notable, but not the point of this blog.
What did the Tribune family of newspapers do during this time?
Well, on July 27th, they ran a reprint of the piece they published on June 14th.
Is this verbatim? A quick skim...sure looks like it. So...why?
Why not mention the slides presented in Zagreb? Or the implications for the blood supply?
Or that both XMRV papers were withheld? Or, most strangely, that the CDC paper had been published nearly a month before this piece was recycled?
I'm going to take a wild guess that Trine Tsouderos is not to blame for this. I mean, does this make her look good? Uh...no. So it's entirely possible that she was embarrassed by it, while some of us were befuddled by it, containing absolutely no new information on a story that had seen explosive developments in the six weeks since the original had run.
Developments that included ME/CFS patients being banned from blood donations in several countries, including Canada, Australia, New Zealand, and, eventually, the UK.
Oh, well.
Four more weeks pass. PNAS published Lo et al on August 23rd. Harvey Alter states that their findings are 'highly confirmatory' of the WPI's XMRV paper.
Trine Tsouderos was not the only one who did not cover this; see my previous blog for a detailed rundown on how sparsely it was covered in the UK.
But, wait--XMRV was somehow necessary to hammer Dr. Oz; Judy Mikovits is hyperbolic, or worse; patients are taking dangerous antiretrovirals. Of course, I can't know if Trine Tsouderos wanted to cover this & was not allowed the assignment.
I'll tell you what, though: if I'd written what she'd published, up to that point, on XMRV, I sure would've wanted to cover it. Badly.
But I'm not a journalist, so what I would do is not necessarily relevant.
Now, there is the issue that, wait a second, Lo et al did not detect XMRV in CFS patients.
They only detected something very, very like it.
This distinction has led a number of bloggers to announce that this, um, hair-splitting, meant that the XMRV/CFS connection was...disproved! (Some virtually dismissed it as meaningless, which is…um…terrific. For them. Really.)
Of course that paper received widespread coverage, at least outside the UK (and Chicago). There was some fair coverage of the First International XMRV Workshop at the NIH in early September, as well. But what did we see next from Trine?
"Five different teams, including one led by the U.S. Centers for Disease Control and Prevention and another from the National Institutes of Health and the U.S. Food and Drug Administration, have published papers failing to find such evidence.
"One of the teams, from the NIH and FDA, found evidence of a different retrovirus, one also associated with mice, in the patients, but nobody knows what that could mean.* [Updated Sept 30, 12:35 p.m.: In an earlier version of this article, the reference to the "different retrovirus" omitted the word "also," implying that XMRV is not associated with mice; it is.] It does not confirm the original paper."
(Emphasis mine)
No mention that no teams studied the same patient cohort. No mention that the lead author on the paper emphatically stated several times the exact opposite of the last sentence I excerpted. Um, I dislike the idea of stooping to an argument that appeals to authority, but...well, I don't have to even go there. What's clear is that Trine Tsouderos has decided that a paper whose publication she did not cover, does not quote from, and does not list the names of even one author on it, has flatly rendered a conclusion that...well...
"It does not confirm the original paper."
Not "might not." Not "probably does not." Not "in spite of remarks issued by its authors..."
"Does not."
Did she reach out to Professor Racaniello for his opinion on this?
No.
No.
She did, however, devote the second half of the piece to something advancing the opposite point of view.
"One esteemed retrovirologist, Dr. Robin Weiss of University College London, has just published his thoughts on the situation. They are worth a look."
Unlike Lo et al. That wasn't even worth a mention, let alone a link as was provided directly to the Weiss paper.
Weiss' paper states:
"Most recently, to add to the confusion, a new paper [6] reports an association between CFS and a different retrovirus -
a report erroneously described in some of the press coverage as confirmation of the original report of Lombardi et al."
"One esteemed retrovirologist, Dr. Robin Weiss of University College London, has just published his thoughts on the situation. They are worth a look."
Unlike Lo et al. That wasn't even worth a mention, let alone a link as was provided directly to the Weiss paper.
Weiss' paper states:
"Most recently, to add to the confusion, a new paper [6] reports an association between CFS and a different retrovirus -
a report erroneously described in some of the press coverage as confirmation of the original report of Lombardi et al."(emphasis mine)
When Judy Mikovits criticizes other researchers, oh, boy. Look out.
When Robin Weiss does it...
...crickets.
Now, I suppose I wouldn't know a double standard if I fell over it, so I should probably just move on. I could offer all sorts of silly reasons why this looks like one to me, but...
"I would be happy to accept that if XMRV is associated with CFS, so could polytropic MLV be. What I find extraordinary, however, is that only XMRV was found by Lombardi et al. [1], whereas only polytropic MLV was detected by Lo et al. [6]. Given that the samples analyzed by Lo et al. were collected over several years from persons with no contact with each other and widely dispersed across states in New England [6], it does not make epidemiological sense that the two types of CFS-associated MLV segregate according to the laboratory performing the tests."
Well, again, as a layman, I cannot comment on this, except to mention that I've long heard that CFS represents an epidemiological nightmare, for decades, in no small part due to differences in diagnostic criteria. But while Weiss dismissed the differences in criteria fairly brusquely, he nevertheless found it easy to speak on what 'does not make epidemiological sense' in CFS.
"It is noteworthy that positive findings are often published in high profile journals, while the negative ones find their way to specialist journals. In the case of XMRV, two of the negative reports were accepted by BMC Biology's sister journal Retrovirology [4,5], which is becoming well established as the standard-bearer of its field. The recent paper by Switzer et al. [5], which examined properly blinded samples, perhaps has too modest a title: 'Absence of evidence of XMRV virus infection in persons with CFS and healthy controls in the United States'. I would go further and suggest that they found firm evidence of absence."
Well, there may be a fair point in this paper about 'rumor viruses.' But...'persons with CFS?' did Weiss read Switzer's criticism of the CCC in that paper?
"The 1994 International CFS case definition and the Canadian Consensus Criteria are different and do not necessarily identify similar groups of ill persons. Most notably, the Canadian Criteria include multiple abnormal physical findings such as spatial instability, ataxia, muscle weakness and fasciculation, restless leg syndrome, and tender lymphadenopathy. The physical findings in persons meeting the Canadian definition may signal the presence of a neurologic condition considered exclusionary for CFS and thus the XMRV positive persons in the Lombardi et al. study may represent a clinical subset of patients [11]."
Please, someone correct me if I'm wrong: Tender lymphadenopathy is one of the eight symptoms beyond fatigue, of which four are required, according to the CDC's (Fukuda) Criteria.
If I'm not wrong, please, nobody correct Dr. Switzer or the journal Retrovirology; it's already been tried, and I honestly don't think they're interested, in spite of what appears to be a rather obvious contradiction.
Never mind all the reasons why it's just absolutely surreal that an expert researcher would use the CCC to suggest that a patient is exclusionary for a CFS diagnosis. As they say here in the big city, that horse is out of the barn, even if it leaves us with some unanswered questions.
Beyond all this, we're supposed to accept that if XMRV and the related viruses detected by Alter & Lo are lab contaminants, then...only Alter/Lo and WPI (as well as Robert Silverman at Cleveland Clinic and Frank Ruscetti at NCI) are the ones who contaminated their samples; everyone else managed to avoid this problem except the people who were, yes, published in the higher-profile journals. And Huber, who, apparently recognized it.
(On the Huber study...patient samples were provided by Dr. Susan Levine, who currently sits on CFSAC. I have been a patient of Dr. Levine's and I respect her. But it's worth pointing out that even the Huber study was done on samples from a cohort defined by CDC criteria. That is not a knock on Dr. Levine, only an observation; there may well have been some CCC patients in that cohort)
Only Mikovits/Silverman/Ruscetti (but especially Mikovits—always) and Alter/Lo were blind to contamination—and although we’ve heard countless times over the past year or so not only how easy it is to contaminate samples in a study, but also how ubiquitous this contamination is—from a variety of potential sources—it wasn’t a problem for any of these other labs.
I'm sorry...scientist or no, that doesn't really make sense to me. And that's said by someone who has maintained all along that if the XMRV link to CFS is disproven, than we all have to live with that; and I do not fear reality. But in expecting reality...well, why am I writing this? It's because what I've seen looks like an awful lot of bias.
So a debunking of the association, when it's purportedly based on those with suspect cohorts knowing what they're doing, while those with the CCC patients (or the closest thing to them) don't...no, I'm sorry, that really does not make sense. How many doctors even know what the CCC is, and how different it can be from Fukuda, and how much worse it can be? A few dozen?
Everybody else gets it wrong, but we're supposed to go with those who aren't even willing or able to assemble a proper cohort.
Okay.
So what happened next?
A smattering of negative XMRV papers, mostly studying possible associations to prostate cancer and autism. Maybe there was a positive paper in there somewhere on prostate cancer. I can't recall at the moment & don't keep a handy list on those. Sorry.
Next were two October reports on negative studies:
"Before this week, six teams, including scientists from the U.S. Centers for Disease Control and Prevention, the National Institutes of Health and the U.S. Food and Drug Administration, have reported in scientific journals that they were unable to find XMRV in patients with chronic fatigue syndrome."
Am I boring anybody?
Yes, it was a negative study. And, once again, it was...well, this cohort was "revised CDC."
What does that even mean?
Is it Fukuda, which is "revised" from Holmes? Or is it Empirical, which is "Revised Fukuda?”
Well, either way, it's most definitely not CCC, but here's one byline I have come to associate with zero focus on such an issue.
(On the Huber study...patient samples were provided by Dr. Susan Levine, who currently sits on CFSAC. I have been a patient of Dr. Levine's and I respect her. But it's worth pointing out that even the Huber study was done on samples from a cohort defined by CDC criteria. That is not a knock on Dr. Levine, only an observation; there may well have been some CCC patients in that cohort)
Only Mikovits/Silverman/Ruscetti (but especially Mikovits—always) and Alter/Lo were blind to contamination—and although we’ve heard countless times over the past year or so not only how easy it is to contaminate samples in a study, but also how ubiquitous this contamination is—from a variety of potential sources—it wasn’t a problem for any of these other labs.
I'm sorry...scientist or no, that doesn't really make sense to me. And that's said by someone who has maintained all along that if the XMRV link to CFS is disproven, than we all have to live with that; and I do not fear reality. But in expecting reality...well, why am I writing this? It's because what I've seen looks like an awful lot of bias.
So a debunking of the association, when it's purportedly based on those with suspect cohorts knowing what they're doing, while those with the CCC patients (or the closest thing to them) don't...no, I'm sorry, that really does not make sense. How many doctors even know what the CCC is, and how different it can be from Fukuda, and how much worse it can be? A few dozen?
Everybody else gets it wrong, but we're supposed to go with those who aren't even willing or able to assemble a proper cohort.
Okay.
So what happened next?
A smattering of negative XMRV papers, mostly studying possible associations to prostate cancer and autism. Maybe there was a positive paper in there somewhere on prostate cancer. I can't recall at the moment & don't keep a handy list on those. Sorry.
Next were two October reports on negative studies:
"Before this week, six teams, including scientists from the U.S. Centers for Disease Control and Prevention, the National Institutes of Health and the U.S. Food and Drug Administration, have reported in scientific journals that they were unable to find XMRV in patients with chronic fatigue syndrome."
Am I boring anybody?
Yes, it was a negative study. And, once again, it was...well, this cohort was "revised CDC."
What does that even mean?
Is it Fukuda, which is "revised" from Holmes? Or is it Empirical, which is "Revised Fukuda?”
Well, either way, it's most definitely not CCC, but here's one byline I have come to associate with zero focus on such an issue.
Next?
Title: "New study casts doubt on retrovirus link to cancer and chronic fatigue syndrome"
Let's see--is the selling of the test mentioned? Yes. Is the issue of the hordes of CFS patients apparently taking antiretrovirals mentioned? Yes. Is it mentioned that the negative studies are piling up? Yes.
Is it addressed that "Chronic Fatigue Syndrome" is in the headline yet the study being reported on was done exclusively on prostate cancer?
No.
Granted, it's my understanding that the reporters don't write the headlines, but still...you know, if I didn't know any better...I'd say this is becoming familiar.
But not tiresome!
That’s all for tonight, folks, but while I’m sure you’re breathlessly awaiting the final installment of my airing of this grievance, let me just mention that there is a comment someone tried to leave on part 1 but couldn’t; so here is a link to her blog.
Part 3 of 3…to be served up shortly.
Loved it!
ReplyDeleteI have been following the CFS and XMRV story and I have to say Trine Tsouderos's reporting seems to be of very poor quality. She has gottem many facts incorrect in her articles. She does not seem to have researched the topics thoroughly. Her articles have an uniformed, amature blogger feel to them. I highly recomend articles By Amy Dockser Marcus of the WSJ. She puts more research into her work.
ReplyDelete