Maldarelli XMRV Study Underway

Angela Kennedy · Jan 29, 2011

eric_s said:
I agree more negative studies won't help us, but also it won't help to make enemies out of capable researchers, give a bad impression of the ME/CFS population and have no studies done at all. We need as many good studies as possible.

The second clause of the first sentence here does not raise a suitable counter-argument to the first clause (or indeed the last sentence).

More methodologically flawed negative studies, will not help this community. You, community members, may have to 'make enemies' out of researchers (who may or may not be capable), if they are trying to use your blood in ways that damage scientific progress, and you don't let them, or you call foul. But your alternative is to follow like lambs to the slaughter of that scientific progress.

No studies, ironically, IS better than bad studies. But GOOD rigourous, honest studies are what is needed. No-one here should be settling for anything else. By raising the objections it has recently, this community might just be sending out the right message- that it is not here to be played any more, after years of being played/shafted (whatever term denoting exploited and abused you like) by the 'scientists'.

eric_s · Jan 29, 2011

Well, you see, English is not my native language...
What i wanted to say, and think i have said, is this: Yes, we should try to avoid getting more negative studies (in case the positive ones are right, which in my opinion is not entirely sure yet), but we should be careful too, not to make enemies out of people that could have been of great help.
Yes, we definitely have to avoid people doing what you have described in the second paragraph, but i'm not at all sure, Dr. Miller fits that description. Btw, one of the first questions i have asked Ecoclimber was wheter Dr. Miller is or will be consulting with the WPI about the methodology, if i remember correctly. I don't think every researcher should only use the WPI methods, i even think it would be better for us if a lab could confirm the XMRV/CFS connection using another methodology, but i think they should certainly talk to each other, at least as soon as a lab fails to find XMRV.

Anyone who knows me would not think i am a lamb or lemming type of person, so don't worry there.

At this moment, i agree that no studies are better than bad ones. But the future is always uncertain, so how do you recognize a bad study before it has even started? I don't think this is an easy task, so i would be careful not to shoot down every effort even before take-off, as it will also destroy your chance for a good study. There is mostly a risk one has to take, i think.
Btw, i remember people even on this forum here have had great concerns about Dr. Lo, because he used to work for the Department of Defense. Anyone remember? Since the publication of Lo et al. i have not heard anything of that sort anymore. Now that i'm thinking about it, i remember how many people did expect that study to finally come out with a zero result. It did not happen that way. Not saying the Miller or Maldarelli studies are flawless, i can't judge that and as i have said, i would follow the WPI's recommendation on these, but i would also try to work towards getting those studies done in a good way, rather than trying to boycott and kill them.

Cort · Jan 29, 2011

This is not quite correct. I entered the Forum as MEMan and starting posting when Dr. Miller's proposed study was being attacked. I was able to post until I posted a letter from Dr. Mikovits to me that she requested that I post on the Forum. Within an hour of posting that letter - which had my name on it - I was banned from the Forum.

I don't know if anybody knows that over there - but that is why I was unable to return any private messages sent to me or participate in any more discussions about Dr. Miller's work.

There are several of us who hold dual membership, as I think you do as well. ME/CFS forums has been in existence since June of 2010 and there has been plenty of exchange between members of both, sometimes heatedly. In fact, the person you refer to a red rag, charming locution that, Cort, is a member of both and has participated in some recent arguments on ME/CFS, as is his right.

I found that some of the discussions were helpful and other were 'challenging' to say the least. Ecoclimber did contact Dr. Mikovits and I was told all the issues had been settled. As I posted on the Forms Ecoclimber has a very severe case of ME/CFS and he sees his window for health closing - that is what prompted him to contact Dr. Miller.

Because as a person with ME/CFS Ecoclimber naturally wants XMRV to succeed (what drew him to Miller was not finding XMRV but Dr. Millers work with XMRV in nerve cells) - he went Dr. Miller and to Dr. Mikovits to try and figure out a study that worked or everyone.

He was unprepared or the wave of suspicion and the attacks on the project and himself personally - as was Dr. Miller. Dr. Miller and a graduate asst went on the forum and other blogs to try and respond to some peoples concerns. I thought they had answers to most of the questions but they didn't help. They clearly stated that they were going to follow the protocols of the WPI study and they were going to add some others. It was going to be an intense search for the virus from one of the top labs in the country.

That initial post should have been pulled immediately. A similar post went up here but when Dr. Miller informed us he did not have IRB approval for the study yet (we thought he did) we pulled it. It was going to be replaced in a few hours with an interview with him and a description of the study - unfortunately it stayed up.

Everybody learned something; we learned that it wasn't enough to contact a noted gamma retrovirologist in the field - that we should have contacted the WPI as well. The problem, as I understood it, did not concern the issues presented in the Forum about the IAP test - Dr. Mikovits had concerns about that test based on a paper that was not mentioned and recent presentation. It's not clear that the IAP test is faulty or would introduce issues but there is the possibility that it might. (In any case at one point Dr. Miller was willing to use both tests altho I don't know what the final resolution of the issue was). Whatever happens neither of them will be participating in that Forum again - it was a rather painful experience for everyone associated with that attempt.

Cort · Jan 29, 2011

Angela Kennedy said:
No studies, ironically, IS better than bad studies. But GOOD rigourous, honest studies are what is needed. No-one here should be settling for anything else. By raising the objections it has recently, this community might just be sending out the right message- that it is not here to be played any more, after years of being played/shafted (whatever term denoting exploited and abused you like) by the 'scientists'.

I agree with this completely - so long as we realize that every complaint is not necessarily a good one and that strongly held beliefs should not be retained if evidence is presented to the contrary...which is not what I found, for the most part, with the Dusty Miller situation. The issues need to be looked at clearly and objectively. The fact that those complaints sometimes went hand in hand with personal attacks - didn't help at all.

I know some people won't trust me but I can tell you sincerely that Dusty Miller would LOVE to find that virus. If he could do that he turn his studies on XMRV's effects in nerve cells to gold..He's ahead of everybody in that area - nobody is looking at that - but first he had to prove XMRV was there. That was what Ecoclimber - was going to help fund. Basically Miller saw a clear path to explain the pathophysiology of ME/CFS.....(When the nerve cell study came up he was accused by someone of wanting to develop drugs to treat ME/CFS as a psychosomatic condition?? ).. That just took never took hold....For sure there were people who felt he was an honest player and said so from the get go but as things got more intense they tended to fade away. They just didn't want to deal with it.

One post by Gerwyn stated Miller had no history at all of research with gamma retroviruses and didn't know anything about them....A quick look at Pubmed indicated he has 20 years of interest in gamma retroviruses and Dr. Mikovits emailed me a wonderful description of him citing his connections to the Ruscetti's....which I posted...which didn't seem to make any difference. There was nothing the matter with Gerwyn's investigations or other peoples investigations in my opinion - people should search around and figure out what's going on and that did help us realize that we should talk with the WPI - and that turned out to be very valuable thing to do.

We had no idea that Dr. Mikovits had an issue with the IAP test. I actually emailed her in an attempt to get her to tell everyone the IAP test was OK! It turned out that she did have a problem with it...which astonished me actually...and then Ecoclimber went to work to resolve that issue.

Dr. Mikovits did not support the study as it was originally configured - which was posted. The study right now is not happening and I'm unsure if it's because of the IRB Board or need for funding or if Miller just isn't as interested as he was.

That's my take - from the 'other side'

Cort · Jan 29, 2011

As I've pointed out many times, this bizarre idea that all scientists are out for scientific truth pervades this forum. It underlies the false equivalency frequently applied to the negative XMRV studies. This belief shows up in statements like "Everyone seems to believe their own science is solid, so I guess the picture is really confusing right now and we really know very little about XMRV" (this is an example, not an actual quote).

But the truth is that not all studies are created equal. To treat them as equal, based on the assumption that everyone is striving for the same truth, is nonsense.

I think you're misrepresenting what I'm proposing. What I'm proposing is that it's always been in the best interests of the retrovirology community to find this virus. This doesn't have anything to do with whether one study is better than the other. It has everything to do with the supposition that if a retrovirologist is unable to find the virus - he/she must not have wanted to find it...there will always be better and 'worser' studies...but a more poorly done study does not necessarily mean that someone doesn't want to find the virus. It could simply mean they don't have the funds or tools to do better.

(I do get that some people have now settled onto positions...that's different)

Coffin does bring up the issue of contamination up but he also says that no one has proved contamination is present in the WPI study. He also called the findings of the main retrovirology paper 'subtle and indirect' while other authors jumped on board and said, based on that paper, it was all over. I think he's very careful. XMRV is NOT proven and it will not be proven until outside labs can consistently duplicate the first studies results...

This belief shows up in statements like "Everyone seems to believe their own science is solid, so I guess the picture is really confusing right now

It IS confusing right now. None of the labs with the BWG except the CDC (ironically) and the WPI - on day II for the most part! were able to find XMRV.....You don't think that's confusing? I think that's pretty darn confusing....Why would it choose to show up on Day II?

The WPI started off using nested PCR - no culturing...and they were able to find it using VP62 (Look at the back of the supplemental section)....It didn't seem that hard at the beginning...It's just turned out to be more difficult than anyone expected. The WPI was calling for treatment trials to start in six months. It sounds like they expected that the finding would be quickly validated - using any number of means - and we would all move on. Unfortunately that hasn't happened.

The idea of culturing has apparently thrown alot of people for a loop. They expect, rightly or wrongly, to find everything using PCR. Maybe XMRV is the pathogen that shows them they are wrong....the pathogen that opens up new directions in looking for rare viruses...Maybe it will change testing paradigms.... in the meantime, though, its confusing people....Singh's study started almost a year ago....it was supposed to be finished up in summer of last year.......I don't know if anyone thinks its gong to come out soon....

eric_s · Jan 29, 2011

God d* it... here http://www.mecfsforums.com/index.php/topic,5094.msg56368.html#msg56368 you can read this:

I had time to call Dr. Maldarelli this afternoon about the study the CAA announced. I first got his voice mail, but he returned my call quickly and spent about 1/2 hour on the phone with me, answering my variety of questions. No arrogance whatsoever, VERY kind and easy to converse with. I would have preferred a 2-3 hour conversation with him, of course, but kept my questions at this point to those of greatest concern to me.

My "report" of the conversation below is based on my understanding of his answers, not a verbatim transcript of what he said. And please don't construe anything below as an "official" NIH, NCI or BWG position on any topic -- this is just my understanding of what we discussed. For anyone who doesn't want to wade through it all, I've bolded what I think are the most important points.

The sample collection is not being "sponsored" by the BWG per se, but is related. The samples to be drawn for this study will be blinded and sent to the labs involved in the BWG, including Judy at WPI, Frank Ruscetti's group in Frederick and Lo/Alter, as well as others who are participating in the search for testing methods that are sensitive, specific and support high throughput. Again, the labs who will be testing the fresh samples will use their own preferred methods (me - aargh), to include serology as well as the various PCRs and other testing methods being developed or currently in use. Switzer at the CDC is also participating.

And then here http://www.mecfsforums.com/index.php/topic,5094.msg57115.html#msg57115 this:

Some additional confirmation: in an email to me last night, Dr. Mikovits stated that the WPI is not participating in any way with Dr. Maldarelli on this study.
So if Val and Jean were correct, it is mysterious that Maldarelli would say otherwise. It is nearly impossible to understand how a study coordinator or principal investigator in this situation could be so misinfomed or mistaken about who his collaborators are. It is not as simple as being wrong about a yes/no; in order to have established a collaboration there would have to have been communications and discussion between his associates and the WPI, of which he surely would have been aware.

Also, Val's account of Maldarelli's intentions obviously conflicts with the statement issued by the CAA on the issue of whether or not their study aims to compare their assay results with those of the WPI, VIPDx, or the FDA/NIH study. Even if the CAA statement somehow got it wrong, the fact remains that any study that purposely re-tests people previously tested by another lab will, if it reveals their original test results, inherently create comparisons. Under these circumstances, and in the absence of any collaboration between the labs, concerns about political motivations would indeed be valid.

Somebody is not telling the truth here, the only other explanation i can come up with would be that the WPI was initially part of that study but has dropped out, but i think that's rather unlikely.
So what the f* is going on here???
We have the CAA and the NCI involved and there seem to be lies? Now this seems serious.
I want to know who is not telling the truth here and for what reason. I don't like people

ing with my health and my life. Sorry for the language but i'd say this is the only appropriate terminology. We have suffered from this illness for long enough, there is absolutely no room for playing games with us. Not funny. Do we have to buy guns or what? Don't take this last sentence literally, but i'm really starting to wonder now what's going on. Either there is a good explanation for this or there really is something major wrong. It's 2 in the morning here, so i'm not at my best and might overlook something, but this is how it seems to me.

eric_s · Jan 29, 2011

Cort, would you mind sharing those letters or emails:

I was able to post until I posted a letter from Dr. Mikovits to me that she requested that I post on the Forum. Within an hour of posting that letter - which had my name on it - I was banned from the Forum.

A quick look at Pubmed indicated he has 20 years of interest in gamma retroviruses and Dr. Mikovits emailed me a wonderful description of him citing his connections to the Ruscetti's....which I posted...which didn't seem to make any difference

I actually emailed her in an attempt to get her to tell everyone the IAP test was OK! It turned out that she did have a problem with it...which astonished me actually...

?

Of course, i'd only want you to do it, if Dr. Mikovits agrees with posting them here. But at least for the two first ones she seems to do so.

Thank you.

jspotila · Jan 29, 2011

An educated, proactive patient community is a good and necessary thing. We should ask discerning questions, individually and collectively. We should make careful choices about our participation in studies, individually and collectively. We must continue to demand well-designed and well-conducted studies, and we must be knowledgeable enough to recognize whether a proposed study meets that criteria.

Looking at every proposed study through rose-colored glasses while singing Kumbaya is counter-productive. That is one end of a continuum. The other end of the continuum is also counter-productive. Publicly hurling obscenities at a researcher is counter-productive. Discouraging participation in research by alleging that there is a conspiracy is counter-productive. Publishing unsubstantiated allegations of scientific fraud is counter-productive.

Studies are conducted, published and critiqued every day. That is the scientific process. It is an iterative process. That iterative process has proven the fundamental necessity for clean CFS cohorts, and how easy it is to screw up cohort selection. As a result, Singh collaborated with Dr. Bateman to identify a clean cohort and we will be able to judge that cohort selection when the results are published. The BWG study has been iterative, and the Lipkin study is being designed based on what other studies have already shown and not shown.

What truly frightens me is not an alleged conspiracy to cover up XMRV. Too much money is being invested in the BWG Phase III and IV, the Red Cross study, and the Lipkin study for all of them to be intentional snow jobs.

What truly frightens me is a return to a time when researchers believed studying CFS was the kiss of death to their careers. What truly frightens me is that in our haste to boycott studies out of fear that results will be used against us, we might boycott studies that would have helped us if we had participated.

SOC · Jan 29, 2011

jspotila said:
An educated, proactive patient community is a good and necessary thing. We should ask discerning questions, individually and collectively. We should make careful choices about our participation in studies, individually and collectively. We must continue to demand well-designed and well-conducted studies, and we must be knowledgeable enough to recognize whether a proposed study meets that criteria.

Looking at every proposed study through rose-colored glasses while singing Kumbaya is counter-productive. That is one end of a continuum. The other end of the continuum is also counter-productive. Publicly hurling obscenities at a researcher is counter-productive. Discouraging participation in research by alleging that there is a conspiracy is counter-productive. Publishing unsubstantiated allegations of scientific fraud is counter-productive.

Studies are conducted, published and critiqued every day. That is the scientific process. It is an iterative process. That iterative process has proven the fundamental necessity for clean CFS cohorts, and how easy it is to screw up cohort selection. As a result, Singh collaborated with Dr. Bateman to identify a clean cohort and we will be able to judge that cohort selection when the results are published. The BWG study has been iterative, and the Lipkin study is being designed based on what other studies have already shown and not shown.

What truly frightens me is not an alleged conspiracy to cover up XMRV. Too much money is being invested in the BWG Phase III and IV, the Red Cross study, and the Lipkin study for all of them to be intentional snow jobs.

What truly frightens me is a return to a time when researchers believed studying CFS was the kiss of death to their careers. What truly frightens me is that in our haste to boycott studies out of fear that results will be used against us, we might boycott studies that would have helped us if we had participated.

Well said, jspotila! It's always a pleasure to read a clear, calm, and concise statement of the situation. Thank you.

Cort · Jan 29, 2011

eric_s said:
Cort, would you mind sharing those letters or emails:

?

Of course, i'd only want you to do it, if Dr. Mikovits agrees with posting them here. But at least for the two first ones she seems to do so.

Thank you.

Here's the letter that got me banned. She asked me not to post it but then when someone, who will remain nameless, posted the first part of it - she asked that the whole thing be posted.

from Judy Mikovits <judym@wpinstitute.org>
to Cort Johnson <phoenixcfs@gmail.com>
date Tue, Jan 11, 2011 at 7:29 AM
subject Re: Dusty Miller's Pilot XMRV Study
hide details Jan 11
Hi Cort
Please post the entire comment. this taken out of context is misleading. It implies I endorse the study and I do not!

Dear Cort
I can only say positive things about Dusty Miller. He is an excellent scientist with more than 30 years experience in gamma retrovirus study. I met him at the NCI closed meeting on XMRV in July 09 when we first presented these data prior their publication in Science. I don't know him well because our paths did not cross until that meeting. He is a long time colleague of Sandy Ruscetti (I would encourage you to contact Sandy or Frank) if you would like support from co-authors of the science paper. Our work could not have been done without the expertise of Sandy Ruscetti and I have no doubt that Dr Miller's lab is fully competent and can add significant insight into the potential mechanisms of neuropathogenesis as Sandy's lab has done.

As for the IAP assay, I strongly advise not to use the IAP assay as a measure of mouse contamination. Dr Evans showed that the mobilization of endogenous retroviruses in mice after infection with an exogenous retrovirus (J Virol 83:2429, 2009, attached). This occurs with great frequency even after one day of infection. Dr. Evans recently presented at a meeting that IAPS can be packaged and mobilized. This says that a human infected with XMRV might also be infected with co-transferred mouse IAP sequences or polytropic sequences. Moreover, infectious retroviruses can continue to package these sequences at a high level. My concern is that the finding of IAP sequences may not be evidence of contamination but of real infection (or unrelated).Since the mitochondrial DNA in the Lo et al. publication is every bit as sensitive as the IAP assay, and has been used for all studies at the WPI as well, why not use it?

Given my scientific concerns about mouse based viral sequences, which can easily be packaged and moved by XMRV/MRVs being used in any study as an assay for contamination, I cannot advise any patients in good conscience to participate in such a study. I would be happy to discuss anything in this email with Dr Miller at any time but would politely ask that you not post this email. It would be better for Dr MIller, the Ruscettis and I to talk directly and in that way we can all present a unified front to the entire patient community. It is so important that the patients concerns be heard given how politicized this complex problem has unfortunately become. I have cc'd Dr Miller.

Kind regards
Judy

I was later told that the problems had been worked out. I was not told that from Dr. Miller or Dr. Mikovits. I do not believe the Miller study is continuing at this point, however. He is still investigating XMRV in some fashion, I believe.

Cort · Jan 29, 2011

Well said Jennie!

What truly frightens me is not an alleged conspiracy to cover up XMRV. Too much money is being invested in the BWG Phase III and IV, the Red Cross study, and the Lipkin study for all of them to be intentional snow jobs.

What truly frightens me is a return to a time when researchers believed studying CFS was the kiss of death to their careers. What truly frightens me is that in our haste to boycott studies out of fear that results will be used against us, we might boycott studies that would have helped us if we had participated.

We have one of the top virologists in the world looking or XMRV (Lipkin), we have a suite of top labs in the BWG study (which includes the WPI) we have Dr. Singh, Glaxo Smith Kline (and you know they'd LOVE to find the virus), Dr. Montoya, we have the Univ of Alberta, Dr. Joliceur, Dr. Alter/Lo, Dr. F. Ruscetti and others at the NCI, Dr. Hansen and I'm probably missing some. Yes, it's true the WPI has not received any grants - which is bad - but there is alot of money invested and alot of good researchers who want to find this virus.

Dusty Miller stood out in this crowd to some extent. Neither Alter/Lo or Hansen or Lipkin are retrovirologists and in particular gamma retrovirologists...Singh and S. Ruscetti and Miller is...In our minds he was going to be the guy who knew the field well enough to do the things that were necessary to find the virus....After all he was already testing it out in nerve cells.....That's how it played out in our minds anyway. If he doesn't do the study, it's nothing but a loss in my opinion.

eric_s · Jan 30, 2011

Cort said:
Here's the letter that got me banned. She asked me not to post it but then when someone, who will remain nameless, posted the first part of it - she asked that the whole thing be posted.

I was later told that the problems had been worked out. I was not told that from Dr. Miller or Dr. Mikovits. I do not believe the Miller study is continuing at this point, however. He is still investigating XMRV in some fashion, I believe.

Thanks, Cort. I appreciate it. I have wanted to know Judy Mikovits' stance on the IAP assay for some time now and now for the first time i could read what she really thinks. It's also interesting to hear what she says about Dr. Miller.

eric_s · Jan 30, 2011

jspotila said:
An educated, proactive patient community is a good and necessary thing. We should ask discerning questions, individually and collectively. We should make careful choices about our participation in studies, individually and collectively. We must continue to demand well-designed and well-conducted studies, and we must be knowledgeable enough to recognize whether a proposed study meets that criteria.

Looking at every proposed study through rose-colored glasses while singing Kumbaya is counter-productive. That is one end of a continuum. The other end of the continuum is also counter-productive. Publicly hurling obscenities at a researcher is counter-productive. Discouraging participation in research by alleging that there is a conspiracy is counter-productive. Publishing unsubstantiated allegations of scientific fraud is counter-productive.

Studies are conducted, published and critiqued every day. That is the scientific process. It is an iterative process. That iterative process has proven the fundamental necessity for clean CFS cohorts, and how easy it is to screw up cohort selection. As a result, Singh collaborated with Dr. Bateman to identify a clean cohort and we will be able to judge that cohort selection when the results are published. The BWG study has been iterative, and the Lipkin study is being designed based on what other studies have already shown and not shown.

What truly frightens me is not an alleged conspiracy to cover up XMRV. Too much money is being invested in the BWG Phase III and IV, the Red Cross study, and the Lipkin study for all of them to be intentional snow jobs.

What truly frightens me is a return to a time when researchers believed studying CFS was the kiss of death to their careers. What truly frightens me is that in our haste to boycott studies out of fear that results will be used against us, we might boycott studies that would have helped us if we had participated.

Hi Jspotila

I appreciate the fact that you are here on the board and answer to people. I have always had a good opinion of the CAA, in fact i have always wished the organisation in my country would have the same motto like yours, "to conquer CFS". I like this attitude. Also i have just recently made a donation to the CAA, a very small one though. I also have respect for you, personally, especially since exchanging a couple of messages.

If you read my messages on the board, you can see that i have always citicized people daming researchers or studies quickly. I have had a couple of arguments because of this. I also think we should be careful not to scare people away, even though that now where there is XMRV with all it offers to a researcher, i don't think this would be easy to happen.
If you were referring to me, when you mentioned hurling obscenities, then i have to say that in this case i mean it this way. But of course i would have to respect the right of moderators or admins to say that this is not tolerated here. But i am human and also of course not every culture has the same way of expressing oneself and i personally think it is right for us to be upset by certain things. Because only from the right mindset will come the mobilization and action i think we need and have been lacking to some degree. We need mobilization and some fighting spirit, i think, because the challenge is big. But yes, we should also try to keep a clear mind. Some days earlier, i was even commended by some people for remaining polite in an argument, so i don't do this all the time.
I have never propagated any conspiracy theory. I think from my posts anyone can see that i often try to avoid them. What i say is that i see some things that worry me and which i can't explain.

So i would like to ask you this:
If it is true that Dr. Maldarelli has said that the Mikovits lab and potentially other labs like Lo's and Ruscetti's are involved, even though this is not the case, what is your opinion regarding such a behaviour?
How would you explain it and what would you do about it? What would you advise ME/CFS patients to do?

I would also like to know in what way the CFIDS Association is involved with the Maldarelli study. Will it change your involvement/endorsement (if there is), if indeed Dr. Maldarelli was not telling the truth?

I am sorry i have to ask those questions.

Eric

Angela Kennedy · Jan 30, 2011

jspotila said:
.

What truly frightens me is not an alleged conspiracy to cover up XMRV. Too much money is being invested in the BWG Phase III and IV, the Red Cross study, and the Lipkin study for all of them to be intentional snow jobs.

Click to expand...

That belief is untenable in the light of all the flawed but trumpeted 'negative' studies, and the ludicrous but unfettered spin on those and the 'contamination' studies. You must surely understand that there is SOME vested interests in suppressing the possible link between MXRV and ME/CFS? On the copious evidence available that demonstrates that, even available here on this forum?

What truly frightens me is a return to a time when researchers believed studying CFS was the kiss of death to their careers.

Click to expand...

I'm sorry- but what does this mean? This appears to be an urban myth with no basis in reality. This myth has been propagated by those who wish to silence objections from the community. But the key evidence that demonstrates this myth are the people who have been making careers out of- guess what?- research into CFS.

What truly frightens me is that in our haste to boycott studies out of fear that results will be used against us, we might boycott studies that would have helped us if we had participated.

Click to expand...

Well that is a risk. But do you understand, at all, that what should be frightening you (and all of the community) are the prospective flawed studies that appear likely to find 'no xmrv' in XMRV positive patients, thus inappropriately scuppering the work done before?

Do you understand that transparence, political integrity and ethical soundness in science is a must, and do you understand why both Miller and Malderelli themselves have caused people to question this in the way they have attempted to canvass patients for their trials?

These are key issues I would expect an advocacy organisation to understand. And I think your organisation needs to demonstrate its ability to understand these key issues at the very least.

Click to expand...

taniaaust1 · Jan 30, 2011

What a saga.. I hate all the infighting between CFS/ME patients and the groups

Im so glad Dr Mikovits clarified things. Thanks.
.....

I really hope Dr Miller continues his XMRV researching but with more awareness of things.

I think the CFS/ME community needs to be careful not to be scaring researchers away from researching CFS/ME, Im worried that that is happening.

We NEED new ones coming into CFS/ME research field, is every new researcher going to be jumped on or regarded in a "highly" suspicious way? (yeah we do need to be a bit careful, but i think we also need to be open minded that many are genuine and not out to get us! unlike Wessley and that in the past).

Angela Kennedy · Jan 30, 2011

taniaaust1 said:
What a saga.. I hate all the infighting between CFS/ME patients and the groups

Im so glad Dr Mikovits clarified things. Thanks.
.....

I really hope Dr Miller continues his XMRV researching but with more awareness of things.

I think the CFS/ME community needs to be careful not to be scaring researchers away from researching CFS/ME, Im worried that that is happening.

We NEED new ones coming into CFS/ME research field, is every new researcher going to be jumped on or regarded in a "highly" suspicious way? (yeah we do need to be a bit careful, but i think we also need to be open minded that many are genuine and not out to get us! unlike Wessley and that in the past).

But the fact that this community HAS been treated so badly in the past means that you have got to stop making the same mistakes, over and over again, of inappropriate deference and uncritical trust. Having an 'open mind' should not mean you should just put your trust in any scientists and their studies.

Nor should disagreements be referred to as 'infighting'. These are serious issues that need involved discussion and analysis. People raising objections or concerns are not petulant children fighting over who gets to play with the Ker-plunk.

And yes- people should be suspicious of every new researcher coming in. You would think nothing of checking out potential employees, nannies, personal assitants etc. Why should this community of, historically and contemporarily, vulnerable, institutionally (the state, the medical establishment) abused people just go with anybody who says they have sweeties in their car? I'm not really trying to compare scientists to child abductors, but I think the principle of careful suspicion, avoidance of deference, and determination to keep the community's interests at stake are crucial. That is why people have been raising objections, and, as it turns out, with good reason.

Using 'Wessely' or his colleagues as a straw man doesn't help either. He's not the 'black hat' to the 'white hats' of all other scientists. They ALL have interests which may not be your interests, and people need to understand that.

And researchers are NOT being 'scared' away by patients! Scientists aren't knights in shining armour going in to rescue snarky recalcitrant damsels (the mean, scary old ME/CFS community) through the goodness of their hearts. Most are seeing prestige and status and security in new fields of research. They are not going to REALLY be 'scared away' by knowledgeable or bolshy patients. What MIGHT scare them away is the stranglehold of the proponents of psychogenic explanations, lack of funding from the funding institutions, and constant negative and contamination studies being spun as if they are 'scientific truth' leading other scientists to be intimidated into following the nebulous status of 'science by consensus'.

eric_s · Jan 30, 2011

I agree, Tania, and if Judy Mikovits talks in this way about Miller, he seems to be ok. If you read my posts, you will see that i have never attacked him.

But Maldarelli possibly lying about something as crucial as which labs are involved in this study made my jaw drop. This is too serious to be ignored and we must know the truth here. And since the CAA has helped "promoting" this study i think they have to take a position as well.

Dr. Yes · Jan 30, 2011

As to the study proposal as it has reported to this point, I like others have many concerns based on what we so far know about its proposed design and observance of protocol. [For the anecdotal reports from people who spoke to him, see the thread previously linked by eric s.] Among them:

-Whose idea was this study/ who designed it? I wonder also why they appear to be repeating the concept of the BWG Phase III without the same degree of collaboration in study design. Are they integrating the findings of the BWG on sample processing into their protocol? How is this study any different than the planned Phase III of the BWG? So far it sounds like a less intensive, less well designed version of that (except for the probable additional use of high throughput-suitable assays).

-A lot of people have tested XMRV positive and we don't know if they all have the same illness. In order to be sure, assuming this is actually a study on CFS patients and not merely on XMRV detection itself, they will have to have some selection criteria to specify CFS patients...what criteria will be used?

- Dr. Maldarelli reportedly told one of the members at ME/CFS forums that they want to test patients who've previously been tested for XMRV in order to get the 'sickest of the sick' in their cohort. However, they require that participants travel to Bethesda, Maryland to contribute their samples. Unless they live locally, few if any of the 'sickest of the sick' can travel that far or at all, period. Even most of the moderately sick probably wouldn't be able to make the trip.

Seems to me that their rationale for testing previously tested people is all wrong - if they want the sickest of the sick, they should find them either with the help of ME/CFS clinicians or the WPI, then have their blood drawn independently and sent to their lab and to any participating labs.

Also, the report by Val, who spoke to Dr. Maldarelli (http://www.mecfsforums.com/index.php/topic,5094.msg56368.html#msg56368) conflicts with the statement issued by the CAA on the issue of whether or not their study aims to compare their assay results with those of the WPI, VIPDx, or the FDA/NIH study. Even if the CAA statement somehow got it wrong, the fact remains that any study that purposely re-tests people previously tested by another lab, and discloses that they are doing so, inevitably creates comparisons.

floydguy · Jan 30, 2011

Angela Kennedy said:
jspotila said:

.

That belief is untenable in the light of all the flawed but trumpeted 'negative' studies, and the ludicrous but unfettered spin on those and the 'contamination' studies. You must surely understand that there is SOME vested interests in suppressing the possible link between MXRV and ME/CFS? On the copious evidence available that demonstrates that, even available here on this forum?

Click to expand...

I completely agree. At this point, our biggest vulnerability are more flawed studies using tired people out of the Georgia phone book and lab procedures designed not to find XMRV. When researchers such as Singh, WPI, Hanson, Lo et al make an earnest effort and use a proper cohort then are few problems from the patient community. I think most will accept whatever findings (even highly negative ones) are revealed by these researchers.

But when researchers use bogus cohorts, known flawed lab procedures and throw their opinions about how they are horrified that patients are taking ARVs then there are going to be problems. Frankly, I am appalled at how un-professional many of these so called top researchers seem to be.

Yes, it's possible that a few people might be discouraged. But I would argue that most of those would be researchers not adding any new value to the research. Those that are truly interested and have something to add will take the time to do it right. In the end, I think it is rare to learn anything from these fly-by-night studies that are done with 5 patients on the back of an envelope on a Friday afternoon. And as we know they get as much play in the media as a well funded and thoughtfully executed one.

So the message should be if you want to do ME research than you'd better be prepared for the firestorm if you do it half-a****. Quality not quantity!

Click to expand...

eric_s · Jan 30, 2011

Hi Dr. Yes

I'm not sure if there is a misunderstanding in many reactions to this study. People always talk about the Maldarelli study wanting to test XMRV positive patients (the sickest of the sick). But in the "advertisement" (this is not meant to be sarcastic, i don't know how you call this), it says they are looking for positive as well as for negative patients, all that matters is that you have been tested, the way i understand it.

Here is the text:
http://www.mecfsforums.com/index.php/topic,5094.msg56042.html#msg56042

The researchers are specifically trying to reach individuals who have already been tested for XMRV so they can compare the results of their new tests with the results obtained using other tests. People with positive or negative results will be eligible to participate. The NIH will share samples obtained in this study with other laboratories that have tests for XMRV. The goal is to determine which kind of test is best to detect XMRV. All participants will understand and give written consent before any samples are obtained, tested or shared. Participants have the right to withdraw from the study at any time.

Dr. Yes:

By the way, the notion someone posted earlier that medical researchers would not knowingly misinform potential study participants is, unfortunately, more than a bit fanciful. My own experience is that some of them will give as enthusiastic - and ethical - a pitch as any car salesman. I am not claiming that Dr. Maldarelli was doing this; I am making one general statement in response to another.

If something like this happens that would quite likely mean that anything a participant has signed could be contested (please tell me the correct legal term in english). I might mean they literally have to give your blood back to you, because in case you successfully contest the contract they have gotten anything you have given to them without any obligation on your part (since the contract is then regarded as never having existed). If anything of that sort is ever to happen with ME/CFS i hope we could take any form of action possible. That sort of practice has to be denounced.
Once again, i believe we need to organize as well as possible and take matters into our own hands. Not be paranoid, not blindly attack researchers (how crazy would that be), definitely not, but i want "us" to be able to fight back against anything "untidy" being done, in case something untidy happens. No more BS.

Now i will try keep the thread free, so the CAA can reply to the questions raised.

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