ME Awareness Day: Ain't no force on earth can make you crawl back underground

It's that time of year again. May 12 is ME Awareness Day, when advocates for people with myalgic encephalomyelitis, aka CFIDS, aka "chronic fatigue syndrome," tell the masses what this disease is, and why it's more serious than they think.

For those of you who are new to ME, here are the basics.

The past year has been discouraging for patients and advocates, to say the least. Promising research on a retrovirus called XMRV has been called into question. Some believe they've found proof that there is absolutely no link between XMRV and ME. Others believe the jury is still out ... but it may not be the slam dunk we had hoped for.

On top of that, internal politics within an previously trusted organization reached levels that were as brutal as they were absurd.

And yet, while it seems as though we've taken huge steps backward, there is a glimmer of light. XMRV research has elevated the conversation. Virologists who expressed skepticism about XMRV have said the cause looks to be some kind of virus. Dr. Ian Lipkin, who is agnostic about XMRV and doing a study on it, has said that it smells viral.

I'll take the "XMRV vs. another virus" debate over the "real disease vs. it's all in their heads" debate any day.



Standing in the Light
Lyrics by Susan Wenger
Music by Cinder Bridge

Overdrawn
Got no ransom high enough to pay
For just a little peace
Drift along
Day flows into night flows into day
No purpose, no release

All the cheerful multitudes proclaim
Tomorrow will be brighter, wait and see

CHORUS
But the morning brings no solace
People let you down
Time and again you're proven wrong
But there ain't no use in giving up
And turning 'round
You're headed for the light where you belong
Where you belong


While you sleep
They move their pieces, play their little games
With all that you hold dear
Makes you weep
To learn what they've been doing in your name
Where do we go from here?

You thought you knew better than to wait
For someone else to come and set you free

CHORUS
And the morning brings no solace
People let you down
Time and again you're proven wrong
But there ain't no use in giving up
And turning 'round
You're headed for the light where you belong
Where you belong


Right on cue
The masters of the universe declare
There's nothing more to know
What a coup
They turn their backs, they leave you lying there
Noplace else to go

Hear the voices rising with your own
You're crazy if you think we'll let this be

CHORUS
Oh the morning brings no solace
People let you down
Time and again you're proven wrong
But there ain't no use in giving up
And turning 'round
You're headed for the light where you belong

Yeah the morning brings no solace
Even heroes let you down
And you get so tired of being strong
But there ain't no force on earth
Can make you crawl back underground
You're standing in the light where you belong
You're standing in the light where you belong
You're standing in the light
Where you belong

------------------------------------------------------------------
Copyright 2012 Cinder Bridge. All rights reserved.

Thanks to the Tucson Kitchen Musicians Association and Tucson Folk Festival volunteers who recorded our performance on May 5, 2012.

XMRV: Frequently asked questions

Every now and again, I write about XMRV research as it pertains to ME/CFS (myalgic encephalomyelitis, aka "chronic fatigue syndrome"). Readers who are part of the ME community understand why it's important, but others may wonder why I keep writing about the medical thingy with the funny name. If you're one of those people, this little FAQ is for you.

What is XMRV?

A retrovirus, similar to HIV. Xenotropic murine leukemia virus-related virus was first discovered in 2006.

What's the connection to ME/CFS?

In October 2009, the Whittemore Peterson Institute for Neuro-Immune Disease and the Cleveland Clinic found that a significant majority of ME/CFS patients tested positive for XMRV, as compared to only 3.7 percent of healthy subjects. Another study by Alter and Lo found a link between this disease and MLVs—other retroviruses related to XMRV.

Does XMRV cause ME/CFS?

Unknown. It may be the cause, in the same way that HIV eventually leads to AIDS, or it may be one of many opportunistic infections that occur because ME/CFS patients' immune systems are already compromised. We'll need further research to tell cause from effect.

Why are you even writing about this? I read that recent studies showed there was no real link between XMRV and ME/CFS—that the positive results happened because of a lab contaminant.

Not exactly. Those four studies—by amazing coincidence all published on the same day—showed that it's possible to get false positives via contamination if you use a method of testing called PCR. They didn't disprove the studies that had previously been done.

OK, but don't the "contamination" studies at least cast doubt on the link between ME/CFS and XMRV?

Again, not exactly. The Whittemore Peterson Institute was keenly aware of the potential problems with PCR and used multiple methods to detect XMRV. Antibody testing, for instance, revealed that patients had antibody responses to XMRV. It isn't possible for a lab contaminant to cause antibody responses.

You can read a more in-depth explanation from a virologist here.

Has XMRV been linked to any other diseases, or just ME/CFS?

Some studies have found XMRV in patients with prostate cancer (where it was first discovered), chronic Lyme disease, and autism.

No offense, but I don't have any of those diseases. Why should I care?

Because it's infectious. There's a chance that you can contract XMRV the same ways you do HIV.

No problem. I always use condoms, and I don't shoot up with dirty needles.

That definitely helps! Unfortunately, there's a pretty good chance XMRV is also in the blood supply. Try not to need a transfusion.

If it's that big a problem, I'm sure there's already tons of grant money rolling in for XMRV research. We'll have treatments soon, right?

Remember how funding for AIDS didn't take off until it was a full-blown epidemic ...?

Yeah, but certainly we've learned from our mistakes.

It would appear not. As yet, the Whittemore Peterson Institute receives NO federal funding to study XMRV.

Gah! Do they take donations?

Thought you'd never ask!

... before the dawn

Two things made me happy today.

The first was a blog post from Vincent Racaniello. Dr. Racaniello was the virologist who told the Chicago Tribune that four new papers on XMRV were "probably the beginning of the end" of XMRV and ME/CFS." In other words, he believed the latest research showed that XMRV had nothing to do with ME/CFS. Bad news for anyone hoping that XMRV research could lead to treatment for an as-yet incurable disease that causes unimaginable suffering.

Anyway, he changed his mind. After reading the papers more carefully ...

My conclusion is that these four papers point out how identification of XMRV from human specimens can be complicated by contamination, but they do not mean that previous studies were compromised.

Will the media report Dr. Racaniello's retraction and apology as widely as they did his initial assessment? Probably not. But you'd better believe that people in the ME/CFS community will be quoting him when new articles about the papers are published.

The second thing to make me happy was an interview in Nevada Newsmakers with Annette Whittemore and Judy Mikovitz. Interviewer Sam Shad asked the right questions, and they gave intelligent, articulate replies. Moreover, their delivery was perfect. They managed to discuss all the politics around ME/CFS without coming off to the casual viewer as paranoid conspiracy theorists. Believe me, that's not easy to do.

A heartfelt thank you to everyone above. You all made Tuesday a much better day than Monday.

Onward!

Always darkest ...

While idly scrolling through Facebook Monday morning, I encountered a number of links like this:

Study finds contamination in virus link to fatigue | Reuters

Scientists conclude mouse virus does not cause ME | Society |
The Guardian

Chronic Fatigue Syndrome is not caused by XMRV |
Wellcome Trust Blog

This looked bad. The headlines implied that some new discovery had invalidated all research linking ME/CFS (myalgic encephalomyelitis, aka "chronic fatigue syndrome") to a retrovirus. That contamination in the laboratory had skewed the results. Was it time to throw up our hands and look elsewhere for answers and possible treatments?

Eh. Not exactly. Despite the definitive tone of those headlines, and despite the researchers' bold claims, the latest studies only show that contamination is possible with a particular kind of test. They didn't refute the positive studies, which used four different methods of detection.

From Amy Dockser Marcus of the Wall Street Journal:

Robert A. Smith, a research assistant professor at University of Washington in Seattle who wrote a commentary in Retrovirology summarizing the studies ... said he is unwilling to state that the reported link between XMRV and CFS or prostate cancer is no longer viable.

The papers focus on various problems associated with a specific kind of test used to detect XMRV but does not examine every method used to detect XMRV. Smith pointed out that some of the previous papers on prostate cancer found XMRV integrated into the patients’ DNA and "I can’t come up with a mechanism where there would be contamination there.”

(Full story here.)

In other news, today marks the winter solstice—the shortest day of the year.

After today, bit by bit, the days grow longer and lighter.

XMRV: One year on

One year ago today, we saw the publication of the Science paper linking ME/CFS to a retrovirus called XMRV.

Since then there have been a bunch of studies that failed to replicate the Whittemore Peterson Institute's results—none of which were true replication studies. Since then we have seen one study that linked ME/CFS not with XMRV, but other MLVs.

Since then, the Whittemore Peterson Institute opened its new facility at the University of Nevada School of Medicine.

The pace is picking up. Progress makes me hopeful.

It also makes me impatient.

Donate.

Full transcript of the XMRV conference

... is here.

Big thanks to XMRV Global Action for doing this. The transcript is incredibly handy for those of us who aren't medical experts, and want to revisit segments to better understand them.

ME/CFS and the blood supply

With evidence of a link between ME/CFS and a family of retroviruses, there's been talk of potential contamination to the blood supply. 7 percent of the healthy controls in the recent Alter study tested positive for an MLV (murine leukemia virus). All of them were blood donors.

Remember why this kind of thing is a big deal?

Anyway, Canada, New Zealand, and the UK have already banned ME/CFS patients from donating blood (though the UK is saying it's to protect the health of the donors). The United States hasn't followed suit, at least not yet. From the Associated Press:

No one knows how people become infected, but Alter said a major study is under way to see if there's any evidence of transmission through blood.

In the meantime, federal regulations require that blood donors be in good health, said FDA's Dr. Hira Nakhasi.

So apparently we aren't worried about those healthy donors who have MLVs yet.

ME/CFS in the media: M-O-U-S-E

Journalists writing about ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome) generally strive to appear fair, balanced, and neutral. But when you read a lot of articles about "chronic fatigue syndrome" (which is what they usually call it) you start to notice subtle shifts in tone.

A more skeptical piece will note that many physicians consider ME/CFS to be psychological in nature. In and of itself this is a perfectly true and neutral statement: many physicians DO think it's all in patients' heads. Unfortunately, the writers almost never question this information, leaving the reader to believe that it's a matter of opnion—that there's no scientific evidence to prove those doctors wrong.

Other articles will mention that lots of people consider the disease controversial, but that now, in light of [insert most recent scientific discovery here], it looks like ME/CFS is actually a real thing! While this is better, such articles usually fail to mention all the previous research which also indicated that ME/CFS is actually a real thing.

With the publication (finally!) of the Alter et al paper, the language is becoming friendlier. Take this exposition from the New York Times:

Chronic fatigue syndrome, estimated to afflict at least one million Americans, has no known cause and no accepted diagnostic tests, although patients show signs of immunological, neurological and endocrinological abnormalities. Besides profound exhaustion, symptoms include sleep disorders, cognitive problems, muscle and joint pain, sore throat and headaches.

Note the lack of the word "psychological." Note how the language implies that the failure to find a cause is merely a failure to find a cause, not a lack of a real effect.

And what about the visuals?

Traditionally, almost every time stock art has accompanied an article about ME/CFS, it's been a person (usually female) looking very sad and kind of tired, often with her head in her hands. Because people with "chronic fatigue syndrome" are really tired, and very sad about that ... right?

OK, I realize we can't blame the journalists too much for this one. They need some kind of picture to depict a disease with the name "fatigue" in it, and maybe that's as creative as they can be on tight deadlines. It just gets on my nerves.

The tired-sad-person photo hasn't vanished completely. However, with the release of a study about how murine leukemia viruses (MLVs) are linked to ME/CFS, papers now have a brand new go-to image!

Photo by animalphotos.info

It's a mouse virus! Get me a picture of a cute mouse!

I'm going to call this an improvement.

Alter paper released!

It's here.

Detection of MLV-related virus gene sequences in blood of patients with chronic fatigue syndrome and healthy blood donors

The whooshing sound you've been hearing all day? That would be the collective exhales of everybody in the ME/CFS community. The paper is out, and the results are positive.

Highlights:

• Alter et al did NOT find XMRV (xenotropic murine leukemia virus-related virus) in either the ME/CFS subjects or the healthy controls. However ...
  
  
• XMRV is a member of the MLV (murine leukemia virus) family, and they did find other MLV-related viruses in 87 percent of the ME/CFS subjects, as compared to 7 percent of the healthy controls.

The Whittemore Peterson Institute, which found a XMRV-ME/CFS link back in October 2009, is psyched.

For a more in-depth review of the findings, the implications, and the backstory, jump over to CFS Central.

Onward!

Alter press embargo ends in 3 ... 2 ... 1 ...

At 3:01 p.m. EDT (about 10 minutes from now at this writing), there will be a teleconference by experts from the FDA, NIH, and CDC to answer questions about the Alter et al paper that was put on hold in June.

Reporters should call 1-888-677-4212 and enter passcode 9258555. For those unable to participate, the briefing will be available on replay approximately two hours after briefing concludes. For replay, dial 1-866-373-4990 and enter passcode 5711. [Emphasis mine.]

Full press release available at Dancing with the Sandman.

I don't hold out much hope that mainstream media reporters will ask the hard questions, like why this paper was on hold for so long when the CDC's negative results were published relatively quickly. But this is still good news. Fingers crossed.

A retrovirus by any other name

According to Dr. Joe Burrascano, participants at the first Whittemore Peterson Institute scientific symposium have proposed a new name for XMRV, the retrovirus that may cause ME/CFS.

XMRV stands for xenotropic murine leukemia virus-related virus. Says Dr. Burrascano:

This virus is a human, not mouse virus, and it is the first and so far only gamma-retrovirus known to infect people. Also, it is clearly not an "endogenous" retrovirus (one that is present in all genomes due to ancient infection). Because of all of this, and because of the desire to begin on the right track:

• The new name of the virus is HGRV - Human Gamma Retro Virus.
  
  
• The illness caused by this infection is named HGRAD - Human Gamma Retrovirus Associated Disease.

Source: ProHealth

As an advocate, this seems like hopeful news. Longtime ME/CFS researcher Nancy Klimas once gave a talk in which she said she expected the name "XMRV" to change as we learned more about the retrovirus. So a new name reflecting a better understanding feels like progress.

As a songwriter, someone who spends a great deal of time contemplating the shapes of words, I confess that I'm a little let down by the new names. HGRV? Sounds like a cable company and doesn't roll off the tongue. HGRAD? Also awkward to say. (I'm guessing everyone will default to pronouncing it "aich-grad." Others have suggested "hagrid," which rolls better but doesn't make a lot of sense.)

Oh well. I realize it's not a scientist's job to make stuff sound good, and that they must value accuracy over all things. With any luck, the progress this represents will far outweigh any of my petty concerns over poetics.

In press

According to CFS Central, the Alter paper is in press. That is, it's being printed and will soon be published in Proceedings of the National Academy of Sciences.

I don't know how soon "soon" is. I don't know if the paper has been changed in any way since the powers that be put it on hold. I won't exhale until I actually see the damn thing in print.

Still, it's refreshing to get any news about this at all. I'm tired of waiting.

I know I'm not the only one.

Waiting

Apologies for the lack of posts this week. There hasn't been a whole lot going on. Just waiting.

Last Saturday we sent a bunch of songs to our producer. He will listen to them and give us feedback, telling us which ones he thinks are good enough for the upcoming album. But we gave him a lot to listen to, and he has a gazillion other things going on, so it will take a while to hear back.

I'm trying not to think about it until then.

On the ME/CFS front, we're still waiting for the release of the FDA/NIH paper, the one that supposedly confirmed a link between XMRV and ME/CFS. It's been weeks since we've heard it would be published within weeks.

Here's hoping there will be something to report on soon—something that is actually happening.

Here's hoping it's good.

Word from PNAS

According to Mindy Kitei at CFS Central, the editor-in-chief of the Proceedings of the National Academy of Sciences has gone on record saying the FDA/NIH paper on XMRV would be published within weeks.

www.cfscentral.com/2010/07/fdanih-paper-update.html

Nice to hear. I find news more credible when a named source stands behind it. That said, I'm still not celebrating until I see the paper with my own eyes, and find that it hasn't been watered down.

Weeks

Apparently, the NIH/FDA study on XMRV will be published within weeks.

Apparently.

From CFIDS.org:

The study pending from NIH/FDA attracted a lot of attention in June after news of its conclusions was leaked by a Netherlands news agency. The researchers have conducted additional experiments as requested by the reviewers and their paper is expected to be published in the Proceedings of the National Academy of Sciences within weeks.

From Mindy Kitei of CFS Central:

Sources to CFS Central say that the researchers' conclusions have not changed.

I am cautiously hopeful, but I'm not celebrating until I see the damn thing in print.

XMRV: Still in the dark

This in from Mindy Kitei of CFS Central

CFS Central has learned that it was the CDC that made the initial request to pull the FDA/NIH XMRV paper after the Proceedings of the National Academy of Sciences (PNAS) accepted it. Sources have told CFS Central that higher-ups in the Department of Health and Human Services (HHS) made the ultimate decision to hold up the study. In addition, insiders said that HHS can keep any government study from being published—no matter how solid—and that it is anyone’s guess whether the FDA/NIH paper will eventually be published.

Full article here.

My hope is that CFS Central's anonymous sources begin stepping out of the shadows. To those of us who are familiar with the history, all of the above sounds absolutely credible. To everyone else it's the stuff of tinfoil hats. We need solid evidence that Department of Health and Human Services is censoring scientific research.

Or, if we really are just being paranoid, then we need clearer explanations as to what's going on. Because the information we've been getting is contradictory.

How about it, NIH? How about it, PNAS?

An XMRV primer for the folks who lightly skim my ME/CFS posts

From a conversation I had with a friend yesterday (highly paraphrased):

Friend: I've been reading your blog lately. What's the big deal about these XMRV studies?

Me: Remember how last year, someone discovered a link between the retrovirus XMRV and ME/CFS? Now other scientists are trying to figure out if the link really exists.

Friend: What if it does? What difference would it make?

Me: Because if there's a link, then they can help ME/CFS patients by treating the retrovirus. Like with HIV. Y'know how AIDS used to be a death sentence? AIDS is still something you really don't want to have, but now if you're on the retrovirals you can live with it.

Friend: But is there a treatment for XMRV?

Me: No. But if there's definitely a link, they'll have a reason to develop one.

Friend: Ah.

Dueling studies: One down

On Tuesday, we learned that the publication of two contradictory XMRV studies were on hold. Today, we finally have published results ... of the CDC paper.

I could speculate about why the NIH study is still awaiting release, but all the information has been confusing and contradictory, so I'll hold off for now. Instead, let's look at the results of the CDC study. Did they fail to detect a link because there isn't one, or because their methods were flawed?

The cohort problem

The CDC defines ME/CFS very broadly. As a result, their previous research includes many people who probably don't have ME/CFS. Though this paper is touted as a replication study of the Whittemore Peterson Institute's research, they didn't define their population using the same criteria. Here's an excerpt (all emphasis mine):

The 1994 International CFS case definition [used by the CDC] and the Canadian Consensus Criteria [used by the Whittemore Peterson Institute] 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.

These are all common symptoms of ME/CFS.

Detection techniques

According to Dr. Suzanne D. Vernon, the CDC did not replicate the WPI study's techniques:

[T]he samples from these three study cohorts were collected using different types of tubes, each of which has a distinct way of being processed. As if this weren’t bad enough, none of the blood tubes used were of the same type used in the Lombardi study. (They used tubes containing sodium heparin that are intended for use with virus isolation). The blood tubes from the 18 Georgia registry patients are designed to collect whole blood and preserve nucleic acid; it is not clear where the plasma came from for these subjects since plasma cannot be obtained using these blood tube types. So the explanation for not finding XMRV in these samples is simple – this was a study designed to not detect XMRV using a hodge-podge sample set.

You can read Vernon's critique at CFIDS Association of America's site. It's worth noting that the CFIDS Association of America is regarded with suspicion among many members of the ME/CFS community, who view it as the CDC's lapdog. In other words, the criticisms that the CAA now levels at the CDC are in no way knee-jerk responses to news it didn't want to hear.

So, it seems as though the CDC paper has some serious issues. Now we need to convince the powers that be to release the NIH study. Only then will we be able to see if it holds up to similar scrutiny.

Protest the suppression of XMRV research

Yesterday we learned that publication of the latest XMRV studies is on hold. Today there is a petition on Change.org to stop the Department of Health and Human Services from suppressing the studies.

Sign the petition here.

For updates on the situation, check out CFS Central.

XMRV papers on hold

We're going to have to wait to see the results of the latest XMRV studies.

Last week, the FDA and NIH announced that they had independently confirmed the Whittemore Peterson Institute's original findings linking ME/CFS with the retrovirus XMRV. And there was much rejoicing among all of us who hope the link will lead to treatment, even a cure someday.

The CDC had also wrapped up an XMRV study. Though they didn't officially announce their results, CFS Central reported that they were negative. Disappointing, but not surprising to anyone familiar with the history. The CDC defines ME/CFS very broadly, and their research likely includes patients who don't actually have the disease.

There was nothing to do but wait for the release of both studies. Then we could examine the methodology and draw conclusions about the discrepancies.

According to the Wall Street Journal, however, both reports are being held from publication.

Kuan-Teh Jeang, editor-in-chief of Retrovirology, said the Switzer paper went through peer review and was accepted for publication when he got a call from the authors earlier this month. They asked that the Retrovirology paper be held.

"My understanding was HHS [Department of Health and Human Services] wanted to get it straightened out. Both reports are from different branches of the government," Dr. Jeang said.

In an email between scientists familiar with the situation, viewed by the Wall Street Journal, a researcher said the two teams were asked to put their papers on hold because senior public-health officials wanted to see consensus—or at least an explanation of how and why the papers reached different conclusions, said the people familiar with the situation.

Entire article here.

I don't want to don the tinfoil hat and immediately call shenanigans. I do want to know what's going on. Both of these papers were peer-reviewed; both were accepted by their respective journals. For the government to suddenly step in and suppress the results is a little bizarre, and it makes me nervous.