Information about the Lipkin Study, (Needed, grins)

[George]

I was sitting here thinking about the "Lipkin" study.

Exactly what do we know about the study. . . . .anybody, anybody???

 

[Otis]

Here's a link to a post Bob made on the subject. Sadly all we know seems to come from the New York Times which is a fine newspaper but has a very low impact factor.

http://www.forums.aboutmecfs.org/sh...ses-Can’t-Hide&p=139153&viewfull=1#post139153

 

[Mark]

The main thing I know about it is that it's all very hush-hush.

And that they held a big secret meeting about it and didn't respond to our calls for a statement about what was going on, causing fear, paranoia and feverish speculation amongst our community, which was expecting the promised results of the phase II trials and is impatient for information about what is happening behind closed doors. The merest statement of progress made, or an estimate of when information would be available, would have been enough for me in this case - but we didn't even get that.

So as far as I am concerned, the Lipkin study has already pretty much guaranteed that it will fail to meet its objectives - unless it proves that the WPI were right and explains why the 0/0 studies failed.

Lipkin's remit is to definitively resolve the controversy once and for all. He cannot now do so unless he confirms WPI findings because his group has failed to be transparent and so it cannot and will not be trusted by the patient community.

If Lipkin confirms WPI findings in a way that the McClures of this world accept 100%, then that is the only possible way he can now definitively resolve the controversy. But if Lipkin fails to confirm WPI findings then - unless WPI were to accept his verdict and explain where they went wrong in a way that we can all believe - and probably even then - this controversy will linger on across the decades, just as DeFreitas' work was never forgotten. Lipkin may manage to convince a large proportion of the scientific community to turn away and forget the whole business, but without the necessary transparency he can never convince the sceptical sections of the patient community for whom all trust in the authorities broke down long ago. That trust can only be regained through openness, honesty, engagement with the public, and maximum transparency.

The pressure for this revolution of open information is a wider modern phenomenon than just being about ME/CFS, and wider even than the medical or scientific communities. It is a problem that runs right through our society, and it is critical that our current power structures manage to evolve beyond their current culture if the wider global battles of our time are to resolve satisfactorily.

In the next few days, Wikileaks is set to expose huge quantities of diplomatic communications between the US and the rest of the world's governments - the exposure will surely rewrite the history we have been fed up until now and the global implications could be sudden, seismic, and totally unpredictable in their effects. This disastrous outcome for the world's governments ought to be the most salutory lesson imaginable to anyone in a position of authority as to what happens when they fail to be maximally transparent in their work.

These cultures of secrecy have to end. Democracy is a sham if the information people need in order to make intelligent choices is hidden from them. And the population has become increasingly ignorant because they have been treated like children, and not the other way around. The modern phenomenon of rampant conspiracy theories is created by government secrecy: when the people know they are being deceived and misled they will fill the information void with their own reasoned speculation and theorising because there's nothing else they can do to try to get the answers to their questions.

Those institutions that fail to adapt to this new reality of the imperative of openness will face disasters just like the approaching diplomatic scandals - so whether they have something to hide or not, they had better stop behaving as if they do because the people they are supposed to serve won't stand for it any longer.

 

[George]

Mark you are definitely feeling better these days. (really big grins and a hug) This is just what I thought this thread might be good at doing. Partially dispelling the BS surrounding this study. Fauci is making it sound like something it isn't and I think it's important to get as much factual info together in one place.

I asked bob if we could repost his post or if he would be kind enough to post his post so that we have that info on here.

Until Bob finds us and posts I thought I'd ask a few important questions.

1) When will the blood draws happen? I'm wondering if they are going to take new draws or if they are going to used blood from patients taken over the last few months perhaps?
2) If Dr. Lipkin is using the Phase II "gold standard" test to do the initial testing before setting up and sending out the "sets" to the other labs then he has to wait on the test from the Phase II to be completed. Does anyone know if he or his lab is planning to run any other "tests", PCR, blots or other on the blood samples?

3) As you pointed out Mark all the Lipkin stuff seem like it's all super high pay grade. Anyway we can bring it back down to earth? Anyone we can hit up for information or anyone who will help to get the patient groups in the loop???? Anyway we can get any media on our side on this???

4) Does anyone know if we can get The absolutely divide Dr. Sighn involved???

Just a few questions and hopefully Bob will post his knowledge list and we can start to get crawl out from under the rock that seems to have been dropped on us. (grins) Think of the shadow of the anvil getting bigger and bigger as it races towards Wile E Coyote. That seems to be the kind of information black out we are currently in. (blehhh)

 

[WestOzGirl]

"Like"
Well said Mark!
Without Wikileaks and Julian Assange, who else will keep our Governments' honest?

 

[alex3619]

HI everyone and especially Mark,

I agree with your viewpoint Mark. We are being fed little real info, info is managed and has spin doctors rewriting stuff. The foundation of democracy is accurate information. Over that we can hear opinion, but opinion without any accurate information has little value. You are right that we are trying to fill in the blanks when we are lied to, misinformed or kept ignorant. We care, we care enough that we would vote on these issues if we knew all the details.

I do think that the culture of cover-up is here to stay for at least the next several years, depending on what happens with Wikileaks fallout. No major government wants to rock the boat when the world is still struggling with a major economic crisis and Europe is still on the verge of a financial meltdown. Part of this is due to attitudes about government debt. In my opinion, and only my opinion, government debt is only for emergencies, not for business as usual.

What concerns me more is that the X virus could turn the world upside down politically, and precipitate another financial crisis. This provides additional incentive for governments and spokespersons to manage information about it. I don't like this, I want it to stop, I just don't think it will.

On the flip side we have to remember that the actual X virus research scientists are not political animals, or they wouldn't be scientists. The same cannot be said for government institutions they interact with.

Bye
Alex

 

[floydguy]

HI everyone and especially Mark,

On the flip side we have to remember that the actual X virus research scientists are not political animals, or they wouldn't be scientists. The same cannot be said for government institutions they interact with.

Bye
Alex

I have to disagree with you. The world of medical research is at least as fraught with political shenanigans as other pursuits. And most medical research is conducted through Federal entities or with Federal dough. I would say Gallo, McClure, Wessley, Reeves, Fauci, Reeves are quite talented political animals. Perhaps at the lower levels there isn't corruption but at that point they are likely just following procedures for a poorly defined and constructed study, ie use Reeves' empirical CFS criteria.

 

[Bob]

I asked bob if we could repost his post or if he would be kind enough to post his post so that we have that info on here.

Good idea to start this thread, George...
Maybe we should have a separate thread on the BWG as well? Or maybe there is one already?

Here's my post from the other thread, reposted as requested...

Lipkin Study

Basically, Lipkin says that even if the WPI are the only group, in his study, who can detect XMRV in the samples, and they can detect it at consistent rates with blinded samples, then that's the only result he needs. And I imagine that a generous margin of error will be allowed for the initial study, so they won't have to be 100% correct for all the blinded samples.

Lipkin, on his way to Vietnam for a conference on emerging infections, tells the Health Blog that in addition to different definitions of CFS, possible explanations for the conflicting findings include the way labs process the blood samples or the tests they use.

The new study, Lipkin says, will involve fresh blood samples from 100 CFS patients and 100 similar, but healthy people — 25 of each group from four different sites around the country, to provide geographic diversity. The samples will be processed, blinded and sent to the FDA, the CDC and the Whittemore Peterson Institute, which led the team that published the original Science paper. If a lab finds a sample is positive for XMRV, further tests will be needed to confirm the result. If one lab finds a positive sample but another lab doesn’t, the same samples can be shipped again, with a new blinded code, to be tested again. “If you get the same result, it is valid,” Lipkin says.

He adds that it may turn out that certain labs are simply more proficient than others at finding XMRV and related viruses. And he says he’s open to whatever the outcome is, which is one reason why NIAID asked his group to run the study. “We have no horse in this race,” he says.

http://blogs.wsj.com/health/2010/09...atest-xmrv-study/?KEYWORDS=amy+dockser+marcus

And I also read that the patients he is using will fit the Canadian consensus criteria, and the patients would have to have had sore throats or tender lymph nodes when they got ill (I'm not clear about the details here, but I think that Judy basically insisted that the patients have what we recognise as definite ME, and not another type of fatiguing illness.)

Ah, I've found the quotes:

...the study will seek to enroll people who in addition to meeting criteria for two widely used, symptom-based definitions of CFS, showed signs of infection — such as a sore throat or tender lymph nodes — around the time they developed CFS. The thought is that if there is a viral link to CFS, it’s most likely to show up in those patients.

http://blogs.wsj.com/health/2010/11...-search-for-xmrv/?KEYWORDS=amy+dockser+marcus

And here's the other source of info that I was looking for...
It's one of Cort's recent 'XMRV Buzz' entries...

Nov 18th

Amy Dockser Marcus recently told us that Dr. Lipkin called together representatives to discuss his study about 2 weeks ago. Now we're getting a few telling details - or rather we can infer a few telling details. She notes that clinicians from Miami, Boston, Palo Alto and Salt Lake City will be involved which can only translate to four of our top physicians: Dr. Klimas, Dr. Komarroff, Dr. Montoya and Dr. Bateman. (Do you think they know a person with CFS when they see one?)

Dr. Lipkin will be taking a broad sweep of the viruses - looking for XMRV and all over viruses in the same family. Patients will have to meet two criteria, which given the physicians involved, can only mean the Fukuda AND the Canadian Criteria PLUS they will have to have infectious onset which means the patient cohort will closely duplicate the original patient cohort in the Science study - which is, of course, what we want. Three labs will test the blood -the WPI, the FDA/NIH (Alter/Lo) and the CDC.

ME/CFS experts providing 'good' ME/CFS patients and using two of the only labs to actually find XMRV? This looks like an excellent study.

http://aboutmecfs.org/Rsrch/XMRVBuzz.aspx

http://blogs.wsj.com/health/2010/11...-search-for-xmrv/?KEYWORDS=amy+dockser+marcus

I also thought that I'd read that Lipkin will be using samples from Cheney's and Bell's patients, but I can't find a quote for that, and I'm not 100% sure that I did read it... If I find the quote, I'll post it here.


Blood Working Group

I think that the blood working group is carrying out similar, and even more thorough work than Lipkin, and they intend to do it on a larger scale...

And remember that the BWG is well past it's initial phase now... They've already detected XMRV in phase I, and they couldn't have done this if XMRV does not exist or if it's just a fantasy rumour virus... From the quote below ("All the labs were able to detect at least some amount of XMRV"), it seems evident that the researchers involved in the BWG know that this is a real virus they are dealing with.

The quotes, below, also show how the WPI are intrinsically involved with the BWG, and show how reasuringly thorough the BWG research is.

In this phase, six labs — two from FDA plus labs at the NCI, the CDC, the Blood Systems Research Institute and the Whittemore-Peterson Institute — used a panel of blood samples spiked with different amounts of XMRV to establish if the labs’ tests are sensitive and reliable enough to detect the virus in blood. They are. All the labs were able to detect at least some amount of XMRV. (Some of the labs have been involved in the dueling research on a link between the virus and CFS.)

The presentation — which the Health Blog previewed ahead of the meeting — suggests that the first phase of the study has some limits. As researchers continue to study XMRV, there is a growing sense that virus taken from patients may be different than the virus the labs studied. That’s why, researchers say, it’s important to start looking at what’s going on in actual people.

That will happen in future phases of the working group’s investigation. In a pilot study of the second phase, WPI collected blood from four CFS patients they had found to be XMRV-positive and sent the samples to CDC and NCI for testing. Results are expected soon. In the third phase, WPI will collect 25 samples from XMRV-positive CFS patients and send them — as well as XMRV-negative samples from healthy people — to all the other labs for testing.

Phase four will analyze blood from 300 blood donors, 25 confirmed XMRV-positive patients, and 30 XMRV-negative samples from 10 independent blood donors. This data will finally get researchers a little closer to answering at least one of the key questions in the still-unfolding drama: Is XMRV widespread in the nation’s blood supply?

http://blogs.wsj.com/health/2010/07...e-to-hear-about-xmrv-working-groups-research/

...the Blood XMRV Scientific Research Working Group is taking a three-stage approach to its handling of the issues related to XMRV and the possible link to human disease. The first stage will be to standardize and validate laboratory methods and reagents for XMRV testing. This is important since variations in sample collection and laboratory procedures can produce discrepant results. These standardized approaches will be used initially to test 1,200 healthy donors’ blood samples and 100 CFS patients’ blood samples collected by Dr. Judy Mikovits of the Whittemore Peterson Institute. Stage two will assess the prevalence of XMRV in the general population and blood supply, as well as in other CFS patient cohorts. The third stage will be a series of studies to understand how XMRV is transmitted, whether it causes human disease, and how it affects various subgroups of the population.

http://www.cfids.org/cfidslink/2009/120203.asp

According to CDC, their studies using samples obtained from the Whittemore Peterson Institute have HHS attention. The Laboratory Branch in CDC’s Division of HIV/AIDS Prevention is doing the XMRV testing and not the CDC CFS research group in the Division of Viral and Rickettsial Diseases.

http://www.cfids.org/cfidslink/2009/120203.asp

 

[Bob]

1) When will the blood draws happen? I'm wondering if they are going to take new draws or if they are going to used blood from patients taken over the last few months perhaps?

Unfortunately, I muddle up in my mind what I've read about Lipkin and the BWG, and so it's hard for me to remember what I've read about each of the studies...
I think I read somewhere that at least one of the studies is taking fresh patient blood draws... But I can't remember if it was Lipkin, or the BWG, or both...

So I'm not much use there! If I find any more info, I'll post it... But I can't remember if I've seen any other sources of info, other than what I posted in my previous post.

2) If Dr. Lipkin is using the Phase II "gold standard" test to do the initial testing before setting up and sending out the "sets" to the other labs then he has to wait on the test from the Phase II to be completed. Does anyone know if he or his lab is planning to run any other "tests", PCR, blots or other on the blood samples?

I read that Lipkin was giving blood samples to various labs to test (e.g. WPI, FHA, CDC?), but I didn't read anything about him doing his own testing... But reading that NYT article about him, and about the cutting edge technology and knowledge that he has access to, it would seem a bit daft if he didn't use his own scientists and labs to do further research... He does seem to have a lot of knowledge about detecting and isolating hard-to-detect viruses.

But like everyone has been saying, there's just no info about his study available for us, and I only know what I read in the NYT article and the WSJ blogs, as far as I can remember.

 

[Bob]

The pressure for this revolution of open information is a wider modern phenomenon than just being about ME/CFS, and wider even than the medical or scientific communities. It is a problem that runs right through our society, and it is critical that our current power structures manage to evolve beyond their current culture if the wider global battles of our time are to resolve satisfactorily.

In the next few days, Wikileaks is set to expose huge quantities of diplomatic communications between the US and the rest of the world's governments - the exposure will surely rewrite the history we have been fed up until now and the global implications could be sudden, seismic, and totally unpredictable in their effects. This disastrous outcome for the world's governments ought to be the most salutory lesson imaginable to anyone in a position of authority as to what happens when they fail to be maximally transparent in their work.

These cultures of secrecy have to end. Democracy is a sham if the information people need in order to make intelligent choices is hidden from them. And the population has become increasingly ignorant because they have been treated like children, and not the other way around. The modern phenomenon of rampant conspiracy theories is created by government secrecy: when the people know they are being deceived and misled they will fill the information void with their own reasoned speculation and theorising because there's nothing else they can do to try to get the answers to their questions.

Those institutions that fail to adapt to this new reality of the imperative of openness will face disasters just like the approaching diplomatic scandals - so whether they have something to hide or not, they had better stop behaving as if they do because the people they are supposed to serve won't stand for it any longer.

I agree with you Mark...
I think that all government proceedings, including cabinet meetings, should be videoed and streamed live onto the internet...
Why should they be held in secret? What is there to hide if all government decisions are being made in the best interests of the public?
Parliaments hold their meetings in public, so why can't governments?
They would say that there are too many security issues and diplomatic sensitivities, but it's not because of this at all... it's only because so many governments are duplicitous and make decisions for party political reasons, and not for the good of the country.
I think that a lot of stupid and dangerous decisions would be avoided if the public had access to all government information and decision making...
It would eliminate corruption, for a start, and lead to far better decision making.

Government ministers arrogantly think that they should have some sort of elite right of access to national information, and that the masses have no right to be involved in any decision making... It used to be kings and queens who had a monopoly on making decisions "in the interests of king and country", and now it's the 'democratic' representatives.

I think it will change, very slowly, over the course of this century, as it becomes more and more impossible to keep information from the people... I think that Wikileaks is just the start of this process... It seems to be impossible to keep much information hidden these days.

And I have no idea why non-security issues, like the work of the UK's Medical Research Council, which decides on UK research funding, should be hidden and kept secret from the public... They have locked information about ME away from FOI requests for 70 years, which is more than they do for most national security issues and cabinet discussions... It's scandalous.

 

[George]

Here are a couple more bits that a nice person past on to me that may be helpful.

First it does not appear that blood has been drawn yet for this study. Possibly because the study was designed to test the Phase II assay and the BWG (per Mikovits) will hopefully have that available by December 14 th.

Second Dr. Singh and Dr. Lipkin are, if not buds at least good colleges.

I'm thinking, since Fauci billed this study as being the end all be all that perhaps we should ask him to provide transparency. If Dr. Lipkin is just a guy who got roped in to being the "third" party at this little shin dig the we may want put pressure on Fuaci to explain himself a little more clearly.

Think about it. Meanwhile who can we ask for information on this? The usual suspects?

 

[alex3619]

I have to disagree with you. The world of medical research is at least as fraught with political shenanigans as other pursuits. And most medical research is conducted through Federal entities or with Federal dough. I would say Gallo, McClure, Wessley, Reeves, Fauci, Reeves are quite talented political animals. Perhaps at the lower levels there isn't corruption but at that point they are likely just following procedures for a poorly defined and constructed study, ie use Reeves' empirical CFS criteria.

Hi floydguy,

On Wessley and Reeves, I have no regard for them at all as research scientists. They don't deserve the title. McClure strikes me as politically inept. I have little to say about Gallo or Fauci, as I don't know enough about them. My point is not that scientists don't engage in politics, more that the are ineffective at it. Reeves was a bureaucratic appointee, and not an effective researcher. Wessley is politically effective, but this comes at the price of being scientifically biased. He also gets too much funding from the insurance industry if I can trust what I hear on the web.

Real researchers like Mikovits, Singh etc are focussed on science not politics. Political activity from either is likely to be less effective as a result. This is good for science however - politics has a different mindset to science.

So while some so-called scientists are politically savvy, most scientists aren't. These all need to be considered on a case by case basis, without generalizing, and hard scientists need to be given more than a little leeway in our opinions, even if they make political mistakes.

Bye
Alex

 

[floydguy]

Hi floydguy,

On Wessley and Reeves, I have no regard for them at all as research scientists. They don't deserve the title. McClure strikes me as politically inept. I have little to say about Gallo or Fauci, as I don't know enough about them. My point is not that scientists don't engage in politics, more that the are ineffective at it. Reeves was a bureaucratic appointee, and not an effective researcher. Wessley is politically effective, but this comes at the price of being scientifically biased. He also gets too much funding from the insurance industry if I can trust what I hear on the web.

Real researchers like Mikovits, Singh etc are focussed on science not politics. Political activity from either is likely to be less effective as a result. This is good for science however - politics has a different mindset to science.

So while some so-called scientists are politically savvy, most scientists aren't. These all need to be considered on a case by case basis, without generalizing, and hard scientists need to be given more than a little leeway in our opinions, even if they make political mistakes.

Bye
Alex

Alex,

Yes, I mostly agree with what you say. However, I do feel that Mikovits and Singh are the exception not the rule. And I do feel even if most researchers aren't playing politics it just makes it easier to be manipulated by those that do. Controlling the money spigot is controlling the outcome.

Andrew

 

[Bob]

I'm thinking, since Fauci billed this study as being the end all be all that perhaps we should ask him to provide transparency.

Yes, if this Lipkin study is being billed as the "end game" for XMRV, then it's important that we, the ME community, aren't shut out of the process...

 

[Bob]

George, the WSJ blog answers some of your questions:

The new study, Lipkin says, will involve fresh blood samples from 100 CFS patients and 100 similar, but healthy people 25 of each group from four different sites around the country, to provide geographic diversity. The samples will be processed, blinded and sent to the FDA, the CDC and the Whittemore Peterson Institute...

http://blogs.wsj.com/health/2010/09/08/world-class-virus-hunter-to-head-up-the-latest-xmrv-study/

 

[Bob]

I've just come across this article from Science magazine, dated 17th September...
It's the first feedback I've heard about the Blood Working Group results:

Hoping to figure out what’s going on, a federal working group involving labs at FDA, CDC, WPI, and elsewhere has compared results for blood samples to which various amounts of XMRV had been added. (All six labs detected it.) The group has also tested four WPI samples from CFS patients but isn’t ready to discuss the results because “we’re still confused by them,” says Coffin, who is part of the working group.

http://cii.columbia.edu/documents/Science_Lipkin_XMRV.pdf

It's not very enlightening! But it's the most I've heard so far.

It sounds like they might not be getting consistent results with the different groups, and maybe the results with the WPI samples were not what they were expecting, based on the results from the spiked samples (maybe we could have told them that, if they'd asked us!)... I suppose the positive thing to take from this is that they are still working on the discrepancies.

 

[Bob]

Sorry, I'm a bit off topic here, but I'm hunting around for further information about Lipkin's study, and finding these little titbits of information that i've never seen before...

Here's a bit of info about work that Lo is doing...

Among the matters still to be determined are how these viruses interact with humans and whether they cause disease, said Monroe. Lo noted that he and his colleagues have already begun designing studies that may help answer such questions.

http://cii.columbia.edu/documents/JAMA_CFS.pdf

So it looks like Lo might be preparing to do some complex studies looking to see if XMRV is causal, and how it causes disease.

 

[George]

Sorry, I'm a bit off topic here, but I'm hunting around for further information about Lipkin's study, and finding these little titbits of information that i've never seen before...

Here's a bit of info about work that Lo is doing...



So it looks like Lo is preparing to do some complex studies looking to see if XMRV is causal, and how it causes disease.

Nice one Bob! Thanks for digging around on this I really appriciate your reaserach skills.

 

[Bob]

Nice one Bob! Thanks for digging around on this I really appriciate your reaserach skills.

Thanks George...
I only used Google!

I think that my "digging around" skills will never match your superior doggy-paw digging skills! :Retro smile:

 

[alex3619]

Alex,

Yes, I mostly agree with what you say. However, I do feel that Mikovits and Singh are the exception not the rule. And I do feel even if most researchers aren't playing politics it just makes it easier to be manipulated by those that do. Controlling the money spigot is controlling the outcome.

Andrew

Hi Andrew,

On this we are in agreement. However, money is only a part of it. There are two other parts. The first is control of publication - CFS research is hard to publish unless its biopsychosocial, there is entrenched bias in many publications. How many unpublished studies are the WPI sitting on? The second is political will. No government, of any flavour, anywhere, has ever taken CFS seriously. Now the consequences of a half century of neglect are becoming very serious, and will only get worse. We, the patients, need to mobilize politically, we can't expect scientists to do that for us.

The internet may yet save us by giving us a voice even if we are too sick to protest, but this needs to come to the attention of the general public. The fact that so many large institutions are now involved is also to our favour. The very conservative forces that held us back will resist research from being diverted to a new path once we have a little momentum. My only concern is we don't have enough momentum yet - but I get the feeling we will know the general direction things are going by the middle of next year, and the next big boost is likely to be the BWG phase 2 results (hopefully next month).

Bye
Alex