From the 1st annual XMRV conference

[julius]

Another one of the big things I got from this is that we don't need any more confirmation studies per se. What we need is to not have any more negative studies.

That is why the idea that the collection problem being finally resolved will translate into a big leap forward.

 

[Mark]

Scientists need to realise that pretending their work has no political context doesn't free them from political considerations, it just makes it more likely that the political nature of their work will be poorly thought through.

Very nicely put Esther12: in a nutshell. I've long thought that more ethical and political education should be mandatory requirements for scientists to practice. I suspect such considerations really do distract them from being good scientists, but if they assume they can be ignored, they can end up as pawns in somebody else's game.

Your further post explains well why you were a bit disappointed with the lack of info...you're right there wasn't a whole lot of new stuff, and you had picked up a couple of earlier snippets that I'd missed and so thought were news.

I'm going to try to summarise all the newish snippets I can find before I turn in...

 

[ixchelkali]

(can't you just measure functioning? How about activity levels?)

I think the problem with that, at least from the viewpoint of a scientist like Dr Coffin, is that those things are pretty subjective to measure, plus with a relapsing and remitting disease, it's hard to say if it's the result of the drug. That sort of fuzziness is what has caused problems with the case definitions and patient cohorts. He's looking for an objective measure. But he's looking at it from a research perspective. We patients don't care so much about being able to measure it, if it means we can get out of bed and out of the house!

 

[Mark]

I had the sensation that all this experts , except Judy, were most worried for the retrovirus itself
than for the people who has the XMRV in his body.They dont realize that his mission is to save lifes and not to protect his papers or studies.Clearly they are defending his reputation.

It certainly does feel that way sometimes Rita. That's maybe a bit unfair though. I expect they all have good intentions in the work they do. But also when they are working they are focused on the technique, which is necessary to work well. They certainly get upset when their reputation is questioned. I think it is very unfair of anybody to attack the motives of these scientists though. I have done it myself but it is wrong. We don't know enough to know who is really to blame. And we all need their work.

I think maybe the real difference here is between the researchers who know something about ME/CFS, and who have actually spent time with those patients, and the ones who don't.

 

[illsince1977]

I agree with you Cort. Why can't functionality be a measure of success with ARV trials?

Probably because doctors are trained these days to assume patients are lying and tests are G-d! Of course they never carry that to its logical conclusion, which is the scientific community and the tests keep picking up more and more stuff. To me it's just Philosophy of Science 101! How can one possibly claim to be a scientist while denying the basic tenet that science is always building on prior knowledge and there always remain unknowns that are worthy of investigation!:Retro smile:

In that, I think that life has taught all of us CFS/ME sufferers a boatload more than most of those technically proficient MDs and PHDs in that room. It may be a lesson that only compassion can teach.

 

[ixchelkali]

Originally Posted by Mark
we are all guinea pigs making sacrifices for new science and many people in the world

I know this a downer topic on an upbeat day- but your post has tapped into what I've been thinking lately- namely that the slow, conservative approach of ample replication studies without a sense of urgency is being calculated as the better long term scientific approach. In other words our relatively short term suffering and lives are accepted casualties for the long-term benefits of science and future sufferers.

What's a decade here or there if it helps mankind? type rationalization.

It's kind of like a mirror image of the same idea. I've seen it both ways, depending on my mood. But most of the time, feeling like the canary in the mineshaft is okay with me, because it means that maybe somewhere, sometime, something good can come from my suffering, even if it's just to prevent someone else from going through it. Perhaps not a rational thought, but some days I take my comfort where I can find it.

I'm not sure if I would say that our short term suffering and lives are "accepted casualites" so much as they are unavoidable casualties, or necessary casualties. It's like when Holmberg was talking about how the matched donor and hemophiliac blood samples could be used to determine whether XMRV meets Koch's postulates. I don't think he means that those hemophiliac's lives are an acceptable price to pay for the information, just that they can be a source of the information. Information that will help us.

 

[Recovery Soon]

most of the time, feeling like the canary in the mineshaft is okay with me, because it means that maybe somewhere, sometime, something good can come from my suffering, even if it's just to prevent someone else from going through it.

Yeah- that's all good. But this canary wants to get the f&%k out of the coal mine!

 

[Jim]

glaxo smithkline?

was the 1 questioner from glaxo? isn't that the drug company that was setting up a drug trial? if so, i wonder if they will push things back now until things are clearer.

 

[illsince1977]

I think the problem with that, at least from the viewpoint of a scientist like Dr Coffin, is that those things are pretty subjective to measure, plus with a relapsing and remitting disease, it's hard to say if it's the result of the drug. That sort of fuzziness is what has caused problems with the case definitions and patient cohorts. He's looking for an objective measure. But he's looking at it from a research perspective. We patients don't care so much about being able to measure it, if it means we can get out of bed and out of the house!

I think you're right about functionality being subjective and the spontaneous seeming remissions would confound that, however statistically they could look at functionality across the study population I think to get around that problem, couldn't they?

 

[Otis]

But individual patients using off-label antiretrovirals doesn't take money away from the common pot. Especially since insurance won't cover it so the patients themselves are paying up the wazoo for them. I suppose you could make the argument that they should donate that money to the common cause, but that's a stretch.

When he was talking about whether it makes sense to start clinical trials now, what you say applies, but he seemed to also condemn individual use. He may be right that for most of us it's ill-adviced at this point, but as long as it is a fully informed decision, I think the severely ill shouldn't be judged if they decide to try it. You can't say, don't judge us until you've walked a mile in our shoes, because if we could walk a mile it wouldn't be an issue!

Well said. I won't be buying new sneakers for quite a while.

And for some of the worst off, hope is a paper thin barrier between choosing life, or not. And I while I hope to all hell they hang on, I respect any decision people make with their limited energy, time and money.

Today's Q&A didn't leave one such person with much hope. It breaks my heart. I don't know how to impress upon the general public or the research community the urgency and compassion needed here.

Telling people what to do isn't going to help, it's probably going to hurt. We have MLVs but we are not mice.

 

[Lynn]

ETA:

I've seen that in quite a lot of posts. What does that mean?

Lynn

 

[SA2]

One nagging concern that I have is that it is very clear that the current center of attention is XMRV and not CFS. This would be like saying that 25 years ago the center of attention was HIV and not AIDS. If HIV turned out to be just another co-infection of AIDs 25 years ago and not its cause would they have abandoned research on AIDs simply because it wasn't caused by the newest retro-virus. Of course not. AIDs was the disease and a very serious one, not just the cause. It was research into AIDs that was being funded not research into HIV per se. Identifying HIV and demonstrating that it caused AIDs was an effort to understand, prevent, and treat AIDs.

As I mentioned in another post, it is CFS that we must be pushing the NIH to fund research for, regardless of its cause. There is plenty of evidence (as I mentioned in the other post, link to Dr Komaroff's latest video) that this is a serious, physical, disabling, permanent illness without a known cause, with an unknown means of transmission, and with at least one million US citizens suffering from it. Whatever worries the world blood supply has about XMRV continues if XMRV is not the cause of CFS, since some other unknown pathogen is likely still lurking in the supply. But the problem is not just with the blood supply, the problem that this disease continues to destroy the lives of new people every day, regardless of blood transfusions.

I got this disease 21 years ago and have suffered severely ever since. When none of my family got sick I was relieved, at least it was only me. Then 7 years later my daughter got sick with it, suddenly, just like me. She went from being the top student in her high school to being bedridden, and chronically ill. She barely made it through school. Struggling to do her school work from her bed.

Now I help my wife care for some of our grand children. What about them? What next?

XMRV has gotten CFS in the lime light but it is up to us to make sure that it is CFS that is funded and researched. If the XMRV causes CFS, then great, we are all the closer to preventing CFS and treating and curing CFS. If XMRV is not the cause of CFS then let's move on quickly and find the cause, whatever it is.

This is the difference between WPI and most of the other researchers investigating XMRV. The WPI is committed to finding the cause, prevention and cure for CFS. Most of the other researchers, including the NIH are focused on XMRV.

The key to making this happen lies with ourselves, those who suffer from CFS. We know better that anyone the physical reality of this disease and its terrible devastation. Like Annette Whittmore who knows this illness through her daughter's suffering, it is up to us to let others know, before they too perhaps become its victims.

This is the best opportunity to get attention and research funds focused on research for CFS that has ever happened. We should be taking every opportunity to make it clear, to the NIH, and whoever else we can, that we want CFS to be researched, now, whatever its cause.

 

[Mark]

You know, until today I really, really tried to give McClure the benefit of the doubt, in spite of some of the, um, unenlightened remarks she's made about ME/CFS patients and about other researchers. But today I decided she really is a _____ and I don't like her. Although the catfight did add some excitement to the proceedings. I think at this point she's much more concerned with besmirching Judy Mikovits than she is in good science (MUCH less, those of who are sick).

That seems fair to me. These two clearly don't communicate at all well, and have had problems lost in translation from the beginning - probably dating back privately even before McClure started her study, I imagine. They have desparate need of an independent mediator, but there's some fundamental difference between them that I can't quite put my finger on. But for all the criticism that's been levelled at Mikovits, some of the things that McClure has said publicly have been clearly out of order.

Almost from the word go she was running beyond her findings and suggesting wild conclusions in the press which took a quite extreme position, casting doubt on the WPI from the word go. Yet her study was completed in double-quick time, the first in the world, using extremely limited assumptions and an extremely narrow methodology, not to mention the world's 2nd most politically suspect cohort (after the CDC's telesales effort), with no peer review, a highly suspect positive control, and making no effort to go beyond the simple interpretation of Lombardi et al. And yet there she is in the press, telling everyone her techniques are state of the art, highly sensitive, and would have found it if it was there - in effect telling everyone the WPI's work was wrong.

I doubt they would even have dared publish that pay-as-you-go study if they hadn't heard that Kerr's group weren't finding XMRV, giving them the confidence to pre-empt that far more detailed study - and Wessely even hinted at those results for maximum PR: so much for scientific protocol and integrity! They stuck their neck on the line for the far too easy default "these things are always rubbish" position, and if they're proved wrong their reputations deserve to fall.

And the point was made today that the negative studies have the effect of scaring away researchers round the world from getting involved in the field - there have been many times in the past year when that effect has seemed close to shutting down the entire field of research, it has certainly slowed it down, and she will be judged culpable for all those effects if HMRV realises the worst case scenarios that Dr Mikovits fears.

She even made a statement to the effect that "this is it, I won't be having anything more to do with XMRV research". Having thrown her toys out of the pram like that, somebody really should hold her to her word and take her out of the equation. Arguing past history of who sent what to who when is hardly taking the science forward. I could only really understand it if, as an innocent associate of Wessely, she was misled and unfairly treated from the beginning. But even if so, she has had ample chance now to understand her place in the political landscape - and her carping from the sidelines is helping nobody at all.

 

[Dainty]

...he seemed to also condemn individual use. He may be right that for most of us it's ill-adviced at this point, but as long as it is a fully informed decision, I think the severely ill shouldn't be judged if they decide to try it. You can't say, don't judge us until you've walked a mile in our shoes, because if we could walk a mile it wouldn't be an issue!

Well said, ixchelkali! I agree. As I said earlier...

I understand that for scientists, the name of their game is caution, replication, and ensuring they fully understand something before "jumping ahead" to treatment. I get that. What they don't get is that the name of our game is trial and error, anecdotes, and personally acceptable risks. It isn't ideal, but it's what we've got and it's how we live, and until we're presented with another option that's what we'll continue to do no matter what the scientists tell us. Don't like it? Then give us an alternative. We can't wait another decade or two for you to make up your minds.

 

[Lynn]

Ya think so?!

That's why it's so great to get them in the same room and thrash it out...TV debate Mikovits v McClure would be entertaining...

Are you thinking of roller derby? That would be a sight to see!

 

[Daffodil]

was mcclure that dark haired british one? she clearly had a bone to pick. couldnt stand her.

i thought judy was absolutely amazing. she was careful not to step on coffin's toes, which was good..we need him. when he talks, people listen.

i was actually impressed that coffin didnt completely throw out the idea of a small clinical trial..he just wants a way to measure viral load first.

he is probably legally/ethically obligated to tell us to stay away from ARV's. i dont know..maybe staying away from them and taking immunovir and LDN is the smarter thing to do for those who can wait a while.

i wonder if andrea is on ampligen or the ARV's..i keep hearing conflicting rumors.

i was certainly disappointed in the lack of concern among some of the researchers towards those of us who are severely ill now. it is true that every new disease will have a lot of casualties (although this should not be new at this point) and researchers must remain somewhat emotionally removed....but it made me feel like nothing more than a specimen.

 

[Sean]

Thanks to those who put up summaries.

Having Francis Collins attend the sessions is a major political boost. This is clearly now being taken as seriously as it can.

(Though I too wish they would not use the 'chronic fatigue' shorthand. Makes me cringe.)

enormous amount of scientists are diverting from their usual work to get involved with this virus.

I hear the sound of research floodgates and funding purse strings starting to open up.

The big news for me was Judy saying that with the blood working group, just over the last few weeks have figured out that collection and processing issues are almost certainly the reason for diverging results of different studies.

This was always the most likely explanation.

How naive of the chair to assume (and close the dicussion because of his belief) that there is nobody who WANTS to find a negative XMRV result!... ...Scientists can be so naive when it comes to the politics in their trade.

Wrong. They understand politics very well, that is exactly why they are sticking to the objective technical science. If they started on the politics and motives it would quickly degenerate into an open shit fight. It is hard enough keeping it civil with just the straight technical issues.

Is the discussion perfect? Does it address every technical problem? No. But neither should it. The big issue for them right now is getting a reliable test up and running. They cannot help us much until they can detect HMRVs reliably, and hence accurately define and target the relevant population. This is their first priority. As it should be. Let them get on with it.

Coffin disagreed to emphasise that without a standardised quantitative assay that approach will only help that handful of patients and will not yield any data that anybody will accept.

And he is right. This is the priority for now. Everything else flows from a reliable accurate test.

Yes - it's kind of freaky that the very definition of CFS is "off-topic" and "political" just because highlighting that point implies criticism of the CDC.

But it's clearly because drawing attention to this issue opens the whole can of worms of how, who, when and why CFS was defined in this way despite everybody from the patient side screaming "foul!" at deaf ears for decades.

Developing a reliable accurate test for HRMVs will do more to cut through most of these definition problems than anything else they could do. Political slanging matches between competing research teams at critical conferences will not advance our situation one bit, quite the contrary in fact.

The chair of that session was quite right to kill of political stuff. Hard but necessary.

I think John Coffin and Judy are not that far apart on clinical trials--but Coffin is right, one has to be very careful or they could backfire. Mindy was great, but it seems clear that we see a bunch of professionals who will not countenance open attacks on the CDC, but who are probably smart and wily enough to bypass and negotiate around them to get where they want to. I think in a while it won't matter if the CDC puts out another negative study--and I don't think they will. Reeves is past history. Let the smart folks get on with business--and I think and hope they will. Chris

Agree. There is more than one way to skin a cat. Sometimes direct confrontation and frontal attack is not the best approach. These guys deserve a lot more credit for their political nous than we are giving them. They did not get so high up in their respective institutions by being politically naive.

 

[caledonia]

ETA = edited to add
In other words, the person made a post, and submitted it. But then they had another thought to add, so instead of making a new post, they went back and edited their old post.

 

[Hope123]

I'm going to watch the archived video later but from reading people's comments, here are some thoughts I had:

1. How can single person ARV trials help everyone else? Through case reports -- many medical journals have a section where doctors/ researchers can report on findings/ observations from a single patient. If anyone here is taking antiretrovirals with success, I would suggest you encourage your doctor to write a case report about you and submit it to the IACFS/ME bulletin (International Association of CFS/ME -- umbrella group of known CFS clinicians/ researchers like Bell, Klimas, etc.) Case reports essentially tell the medical story of one (or a few) patients. Names are kept anonymous.

http://www.iacfsme.org/BulletinArchives/tabid/309/Default.aspx

The history of HIV/ AIDS began partly with case reports written by doctors who were taking care of gay men coming down with unusual infections. Some researchers started taking note of this case reports and that is partly how HIV research began. Similarly, if there are multiple case reports of people improving with antiretrovirals, someone will sit up and take note.

2. Re: FM patients in Swedish study and how to chart improvement in patients.

IMO, FM group likely contains a mixture of different people [like not well-defined CFS] since it too is a clinical diagnosis without lab biomarkers. There are some FM patients who can exercise without the same after effects as CFS; indeed some FM patients feel better after exercise. This is partly why exercise is recommended for FM. If we switch to lab findings, I remember reading the Light cytokine studies where more than 70% of their subjects had cytokine testing and levels were close to healthy controls. This is in sharp contrast to Klimas' and Mikovits' cytokine studies of primarily CFS patients where there were marked elevations in cytokine levels compared to healthy controls. I think that, to be clean, initial studies should consider taking patient with only CFS.

In addition, John Kerr's studies on patients with acute parvovirus infection followed by CFS showed marked decrease of cytokine levels with IVIG
treatments. This decrease in cytokine levels correlated with improvement in function. This says to me different cases of CFS might be cause by different viruses and also that cytokine levels might be one way to track improvement objectively, perhaps even before people start feeling better.

3. Re: mice having different MLVs. Polytropic means that the virus infects both mice and humans. Someone (sorry forgot who!) had mentioned hantavirus on the forum a while back. Well, guess what they did in investigating hantavirus? They captured mice around outbreak areas and examined them for the virus. Someone should look at the mice in areas where CFS outbreaks have occurred. This doesn't get at questions of treatment but might get at the question of transmission.

 

[SA2]

I found Dr Coffin's comment about HIV being one of the only known viruses to benefit from anti-retrovirals interesting. That HIV is one of the few viruses whose symptoms are related to continued replication, and that this came as a surprise to researchers. His point, that there is a good chance that XMRV may not respond to anti-retrovirals in the same way as HIV is well taken. That the symptoms may not be directly related to the viral load. I can understand how some others feel about this, but for myself, I have suffered with this illness for 21 years, and I can wait for a few more until they get a reasonably safe, effective treatment regimen nailed down.