Hoping that everyone can relax a little, here’s yesterday’s song that I couldn’t figure out how to post from my iPhone. We could use a little levity, I think.
When I started writing this blog, it was with a sense of astonishment that the physicians treating the patients, Lyme and CFS, didn’t seem to recognize that they had a new quiver for their arrows. The few that did were quickly censured, or swore a few patients to secrecy. I had been housebound, sometimes bedbound, for years and never expected to return to work, so I didn’t care who I pissed off. Anything was better than the isolation. The good thing about not caring was that I learned to write authentically.
During my 25 years in practice, I didn’t interface at all with the scientific community. Doctors only. I had no idea about the realities of this parallel universe that so impacts what clinical choices are open to us. I thought that the Science paper would be hailed as a great breakthough; scientists and doctors would come together, bringing different things to the table. The pace of progress would accelerate. If only that had happened!
The scientists that I’ve criticized by name were Coffin, Stoye and Racaniello. The first two put themselves out there very early on in a way that appeared designed to stop progress. They also have a long history of publishing things together that minimized the risk, so aren’t clean on the issue and their opinions shouldn’t carry much weight. Dr. Coffin also took it upon himself to try to limit treatment options, my pet peeve.
Professor Racaniello is a media figure, so fair game. I admit to being influenced by hurt feelings in his case, because I wrote to him when I started arv’s, in the midst of the first blush of excitement, wanting to have a discussion with him about the science and he shut me down, much the way Jason did. And to me, the tee-shirt still seems over the top thoughtless, though I think now that he probably didn’t understand what he was doing. There are signs that he is growing, e.g. publishing Dave Tuller’s important piece on his blog.
I was angry at Dr. Singh when she published her negative paper, for the reasons I expressed back then, but essentially the same thing again; scientists trying to call the clinical shots, though in this case I understand that she felt that her former paper was too strongly in favor. I sent her testimonials from patients improving on arv’s at that time. My understanding from Dr. Enlander is that she is back on the case. I thought her a lovely person when I met her and I am glad she is again working on our behalf. The Mt. Sinai initiative is very exciting. It is difficult not to fantasize about Dr.’s Shadt and Lipkin putting their heads together.
And Jason. Sorry Jason, I didn’t mean to hurt your feelings. I hope you learned something from our scuffle. No hard feelings on my end.
I hope I haven’t forgotten anyone. A virtual olive branch offered to all, even those most aghast at my choices…
Believe it or not, there are scientists that share with me, and I protect their privacy. I swear I’ll disavow knowledge of our friendship to my dying day if that’s what any scientist willing to share wants. At risk of scaring off the people we want to be here, there is a tracker on the blog, that allows me to see the IP address, location and the name of the server that loads each blog page, as well as how many prior visits from that address. Institutional servers give the name of the institution. There are at least a dozen readers at the NCI and another dozen who connect from NIH servers in a few different cities. A couple at the CDC in Atlanta. Readers at many universities and teaching hospitals, including a few at Columbia and Harvard. Cancer institutes around the country. Only a few of these people participate in the discussion. This is a potentially powerful thing. When I worked for the WPI, one of things I most wanted to do was establish lines of communication between physicians and scientists with all kinds of points of view. There is little to be learned from consensus when the truth isn’t even on the table. If there is a way to salvage some part of that dream, I’d like to.
Many of the scientists came to read about Dr. Mikovits’ travails, but I am asking them to think about the science with us. In particular, I’d like to know your reactions to Dr. Snyderman’s data. Please adopt a handle and share with us. Your secret is safe with me. I ask you for the sake of the patients that you are now beginning to know, be bold. I realize that you are constrained by the knowledge that a patient community can do what we did, but there are 17 million patients worldwide in the ME/CFS cohort alone, who need creative thinking from you. There is every indication that our disease is reversible until it is very advanced. The unclaimed talent in the patient community is staggering, if only the disease could be calmed, not even cured. Look at me. I am productive after years of being almost unable to care for myself, let alone anyone else.
I would like to put an end to the discussion about the lab science in the Science paper, the WPI, VIP Dx. Nobody knows the answers, including the protagonists. I certainly have no basis for evaluating any of it. I defer to the scientific community to figure it out; discussing it here is not productive. At this point, it is non-contributory and boring. Take it someplace else. This is also not the place to argue about whether Dr. Mikovits should be canonized or not, though she is my friend, and I am very sorry for what is happening to her. But from a clinical point of view it is irrelevant. This blog is about developing a model for treatment and how to best live with the disease.
Thank you to our mold warriors for giving it another shot here, and for keeping it appropriate this time. I for one, think that your experiences of improvement without medication are significant. I also understand why you feel the need to tell others in the hope of reducing their suffering, as well as your frustration when you feel you aren’t being heard. I have been interested in Ritchie Shoemaker’s pioneering work, since 2002 when we shared a couple of patients with Ciguatera poisoning.
And a big thank you to In Vitro Infidelium for the considered comment this morning. No invective or politics at all. Just a reply about the scientific discussion at hand. It was a breath of fresh air. Thank you for the excellent paper by Voisset et al. The quote you lifted in your comment is precisely the point. Although it clearly isn’t a simple, straight forward infection, there is epidemiological evidence that it is an emerging disease of very great proportions, not a stable situation. AIDS isn’t simple and straightforward either, without a test, in that infected people can remain apparently healthy for a long time, or even indefinitely. Only a small percentage of people with HTLV ever become clinically ill from it. Inbred sick mice don’t get sick from their MLV’s, but wild mice and some other rodents can. All I am asking for is that it be studied, not shut down if this attempt fails. Also, that our therapeutic options not be limited by how slow the science will be to unfold, even in a best case scenario in which Dr. Lipkin finds something.
My hat is off to Dr. Lipkin. His finely worded communication to the patient community brought tears to my eyes. The only thing I would take exception with at all was the use of the word definitive. If by some quirk of fate, this study is completely negative, we beg you, use those specimens to take the next step.
Today’s song: Learning to Fly: by Tom Petty
>No, I do not.
The CDC put in this one little "detail" to ensure that the syndrome really was delicately poised "en pointe" in pointing back at the original entity under consideration.
Any doctor skilled enough to make it through the whole rigmarole and master "the dance" could stand on his toes and accomplish this complicated feat of finding the "possibly unique clinical entity".
The displaced the onus of "error" away from the CDC and back upon doctors who failed the test.
Deliberately!
____________________________
The 1988 Holmes Definition for CFS
Chronic Fatigue Syndrome: A Working Case Definition
Ann Intern Med. 1988; 108:387-389
Gary P. Holmes, M.D.; Jonathan E. Kaplan, M.D.; Nelson M. Gantz, M.D.; Anthony L. Komaroff, M.D.; Lawrence B. Schonberger, M.D.; Stephen E. Straus, M.D.; James F. Jones, M.D.; Richard E. Dubois, M.D.; Charlotte Cunningham-Rundles, M.D.; Savita Pahwa, M.D.; Giovanna Tosato, M.D.; Leonard S. Zegans, M.D.; David T. Purtilo, Ivi.D.; Nathaniel Brown, M.D.; Robert T. Schooley, M.D.; And Irena Brus, M.D.;
Quote:
This definition is intentionally restrictive, to maximize the chances that research studies will detect significant associations if such associations truly exist. It identifies persons whose illnesses are most compatible with a possibly unique clinical entity; persons who may have less severe forms of the syndrome or who have less characteristic clinical features may be excluded by the new definition.
The chronic fatigue syndrome is currently an operational concept designed for research purposes that physicians must recognize not necessarily as a single disease but as a syndrome – a complex of potentially related symptoms that tend to occur together – that may have several causes. Periodic reconsideration of conditions such as those listed under major criteria, part 2, should be standard practice in the long-term follow-up of these patients.
>Ok, so would you agree then that ME patients cannot get diagnosed with ME in the US and end up being told they have CFS. In general this being in accordance with the fukuda criteria?
>It encourages me to know that Dr Jamie has readers at the NCI, NIH, CDC and many universities and teaching hospitals.
I especially like the post by Anonymous 3:57 PM, who wrote that "Fredricks and Relman[10] have suggested the following set of Koch’s postulates for the 21st century…" Thank you, Anonymous 3:57 PM.
I also like the request by D.Y. for "next generation sequencing on tissue samples from ME patients (including severe cases and/or those who became ill during epidemics), looking for any retroviruses or other pathogens." Actually, I hope that some researcher will ferret out a cohort that doesn't merely include severe patients, but is limited to severe patients. (See Patient Advocate's latest blog.)
Like Kathy D., "I really appreciate the hard work and determination of all of these scientists who seem committed to helping those of us with this horrific disease."
Flo
>Much worse than that!
Many doctors don't bother make the slightest effort to conform to the transparently obvious Fukuda-trivialization, and will confer "CFS" on anyone with a headache who says they get tired sometimes.
It was very tempting to use the diagnosis of ME that I have, to just "let them have CFS", but that would not be an honest representation of the true events, and would require "buying into The Lie". Doing so makes someone part of the obfuscation, which I am not willing to do.
The same doctors who care nothing about CFS are equally lax about "ME", and if anyone who calls their illness CFS inquires as to whether they can go ahead with calling it ME, these doctors go "Sure, why not? Suit yourself"
In confronting the ignorance, any attempt to alter the history is bound to end up in a self defeating contradiction.
Better to just tell it straight.
>So Erik if you think the real CFS and ME are different, but are both entangled within the CFS label as generally used. What do you think needs to occur so that observations can me made that are unique to the diseases, instead of being changeable dependant on the group gathered by CFS?
>Remind doctors that according to the rules of language and science, terminology, first and foremost is to represent the entity to which the term is actually applied.
When this is done, "CFS" is magically lifted away from whatever misconceptions doctors had, or would like to believe about it, and is forced to BE the actual illness that Hyde, Parish and Shelokov declared to possess all the primary determinants of ME.
Yes, I know this makes for millions of mess-ups, perhaps almost as many as ulcer patients who were misdiagnosed as having stress instead of H Pylori… but that's how science works.
>Flo wrote:
"Actually, I hope that some researcher will ferret out a cohort that doesn't merely include severe patients, but is limited to severe patients. (See Patient Advocate's latest blog.)"
Chris Cairns posted in his latest blog:
"Most people do not want to take a look in this direction. Most people turn away, including doctors. It is time to toughen up – and to consider these patients, and what they are going through, especially since they might hold the key. Testing of the half-sick (no disrespect here) has not brought clarity."
I whole-heartedly agree with flo & Chris Cairns. It's about time we had a cohort consisting only of the sickest.
>The problem is Erik, if you think that real CFS and ME are different, using a criteria such as the Holmes definition is still going to mix those those two together due to the subjective nature of the terms used. It is also likely to include others who have fatigue for other reasons.
>It's only a problem for those who treat the definition as "being the disease", rather than as a means to identify persons with a possibly unique clinical entity… and go out of their way to find out what is known about that entity.
>The really unfortunate thing is that bedridden and even housebound patients have been systematically excluded from virtually all studies of CFS or ME patients, for reasons of convenience to the researchers.
Thus, regardless of how "ME" or "CFS" is defined, the illness in the literature is not the same one that the most severe sufferers experience.
I think that this community's number one priority right now thus should be to get some studies of ONLY bedridden patients (meeting the ICC ME) done.
This would not have to be anything fancy, I don't think. Based on the information that I've seen, it seems likely that specific laboratory tests already suspected to be related to the illness (such as low natural killer cell function and skewed cytokine profiles) will show really dramatic and consistent results in these bedridden patients — thus putting an end to the "No Biomarkers" mantra.
At that point, we can consider whether other patients who are not bedridden have the same or a different illness as these severely ill ones, based in part on whether they have those same biomarkers. First things first though.
Of course, the problem with this sort of study is twofold. 1) No CFS doctors likely have enough bedridden patients to do a full study (in part because many of these people are so sick that they have no doctor at all). 2) It's expensive to do studies of bedridden patients, because by definition they have a difficult time getting to the lab to have their blood drawn.
I would think that in order to successfully complete this kind of study, all of the leading CFS doctors (e.g. Myhill, Cheney, Peterson, Klimas, Kogelnik, etc.) would need to encourage their own bedridden patients to participate. In addition, some funding would need to be raised.
Of all the things that we as a community could rally around at this point, this seems like something that everyone could agree upon as a meaningful project. Considering the likely benefits of such a study, it seems worthwhile for us to work to make it happen.
Thoughts?
>"I think that this community's number one priority right now thus should be to get some studies of ONLY bedridden patients (meeting the ICC ME) done."
Yes.
This is the top priority.
>Kathy, you can email me at pj7@cox.net.
Erik,
I continue to value your brilliance and perseverance. It just gets so counfounding though.Here are some of the confounders.
We were not all in outbreaks that spread in afew days. But I did have the classic symptoms you describe at onset.
A large percentage of us clearly have Lyme but not all of us.
Those of us with mycoplasma incognitus wonder why we did not die, nor have we fully recovered.
IF a new retrovirus or three is THE cause why was there a RAPID outbreak in Tahoe?
Always questions. Never answers.
>"It's only a problem for those who treat the definition as "being the disease", rather than as a means to identify persons with a possibly unique clinical entity… and go out of their way to find out what is known about that entity."
How then do you expect to find abnormalities common to the disease when the criteria people use for research is subjective?
>I completely concur with the severest of severe cohort.
>Remember, it is much more difficult for severe sufferers to post.
So they never get represented online.
A lot of those who are half-sick now will be full-sick in the future.
Why not study your future self now?
>I agree that the sickest people should be studied.
However, the problem arises that many cannot go outside of their homes and travel. When one is in a state where one cannot go downstairs or stand up to make meals, it is nearly impossible to travel to a doctor or a lab.
What would be best is if medical personnel could go to their homes and take blood and interview and examine them.
I'm in a cancer study and a technician came to my home to interview me and draw blood. And this is part of a federal program. So it is possible to do this.
>The illness that was called CFS possessed all the primary determinants of ME plus all the new evidence accrued by Cheney, Peterson, Komaroff and Caligiuri.
I see no reason to accept any "CFS concept" as valid which makes no attempt to address this evidence. Why should I? If it doesn't, it can't possibly be the same thing.
My repetitions of "CFS happened exactly as described in Osler's Web" should make it plain that I am referring back to this evidence-base.
I just saw a really fascinating phenomenon that was in addition to published material regarding the Tahoe illness, and thought it would be worthwhile to pursue.
>Erik you are representing the CDC as blameless for the damage that their political invention of CFS has done to scientific understanding of the disease. You are not an authority and I defer to Byron Hyde's account of events as he was present and aware of the politics at the definitonal meeting that invented CFS.
The Tahoe outbreak, one of many outbreaks of historically defined ME, was further confirmed by diagnostic evidence of neurological and immune dysfunction and that was a political problem for the CDC scrambling to deal with the AIDS situation. Unlike AIDS, people with ME were not dying so the patients could be rendered invisible with some political creationism. "CFS happened" because the CDC conspired to cover up the disease with a trivial name and definition, that excluded the known pathology of the disease and the historically studied pattern of outbreaks, to give the appearance of a new psychiatric fatigue syndrome. They were aided by the CAA who supported the cover up and helped the CDC brand the problematic name. The Pandora group has also aided in this deception.
The name and definition deprived Americans of the truth about this infectious disease that was officially accepted by WHO and well-known in Britain. The CDC’s actions allowed various fatigue states to be included in studies to distort the results, and gave psychiatrists an invitation to exploit psychogenic explanations for the benefit of governments and insurance companies. Any doctor reading such an inadequate definition for the trivially named CFS can hardly be blamed for concluding that it is a psychiatric fatigue state best referred to psychiatrists, as the CDC knowingly intended. Any person who pretends that the displacement of ME by CFS was not a political coup to cover up this serious infectious disease is either ignorant of the historical facts or conspiring to keep the truth quiet.
Your repetitions of how CFS happened are misleading and fanciful. Erik you are an exceptionally fit man who spends all his time infiltrating forums and blogs to repeat your special belief in CFS and quote numerous sections of Osler’s Web ad nauseum as if that is the only source of information about the truth of ME. Your persistence and aggressive behaviour towards other patients who don’t agree with your special version of CFS raises some red flags.
>Erik, it doesn't now matter how CFS happened. Governments health authorities have suffocated any chance of finding bio markers by forcing everyone to use criteria which do include anyone and everyone.
There was nothing I see special about the Tahoe outbreak compared to other ME outbreaks. From your perspective I think we can agree ME and your real CFS are both neuro immune.
If we are to prevent the Candian and International criterias, and ok Holmes, even though no one is using it, being manipulated so that the intended cohorts described are no longer those with a neuro immune disease. We must get an objective diagnostic test attached.
>Anonymous 1:04 a.m. raises some very good points about the CDC, which not only is guilty of inertia and inaction, but of misinformation, misleading the public, doctors, researchers, but also of deliberately diverting CFS research funds to other projects.
David Tuller's excellent article which has been posted around the blogosphere and has been referred to on this blog, exposes much of the CDC's absurd behavior and history on CFS.
The misnomer of "Fatigue" is so ridiculous, when many people can't go out of their homes, often out of their bedrooms, can't prepare meals, walk dogs, go to a grocery store, go outside on a nice day, listen to music, read.
>@kathy d
The CDC is only following the UK model. Reduce everything to fatigue, move the criteria that selects people with fatigue to the same classification as ME, and when no abnormalities can be confirmed move it all to into a mental health category. All to hide retroviruses that will keep spreading.
>"Your persistence and aggressive behaviour towards other patients who don’t agree with your special version of CFS raises some red flags."
Isn't there an old expression involving a pot and a kettle that seems oddly applicable here?
>My version is the same as Dr Hydes.
The CDC's coverup consisted of painting a very poor picture of the illness, and allowing the lazy and careless disinclination of people to look at what was being depicted, as in.. by simply asking someone who was there.
"Definitions are not diseases" -Byron Hyde
————————————————-
http://www.nightingale.ca/ICaustralia2.html
Nightingale Research Foundation
Paper Presented by Byron Marshall Hyde M.D. –
New South Wales, February 1998
Are Myalgic Encephalomyelitis and Chronic Fatigue Syndrome Synonymous Terms?
Abstract: At the 1998 M.E. /CFS conference in Australia, both Myalgic Encephalomyelitis and Chronic Fatigue Syndrome were used to describe a chronic illness. This paper is a discussion on the similarities and differences in these two terms that may lead to scientific difficulties. The author suggests that the definitional criteria and epidemic history of Myalgic Encephalomyelitis (M.E.) and the inclusion criteria are significantly different from the CDC definitions and history. The three typical phases of M.E. are discussed. A brief review of some of the known deaths in phase 2 of M.E. are also mentioned.
In 1988, it was this often-amorphous phase #3 that the CDC labeled Chronic Fatigue Syndrome (CFS). Where M.E. and CFS overlap, they undoubtedly represent the same illness, however, due to the considerable definitional and conceptional differences, CFS and M.E. should not be considered to be the same illness.
>Erik, ignoring what ever occurred then what do you think should happen now?
>I stumbled over something that helped.
Since people said they were looking for anything that helps, and information about CFS, I thought they would want to know.
I'm exploring the amazing phenomenon that in reality… neither of these are true.
>Allay ignorance.
>Allay ignorance.
>Happy new year to Jamie and thanks for the opportunity to post.
It is vital that the diagnosis of ME is at onset of disease and hence immediate instiution of management of aggressive rest and therapeutics which will not make the patient worse. The enterovirus connexion was established thirty years ago, both by autopsy and on live ME patients.
Lipkin on cii site says using his own group's consensus criteria for definition, but then cites the nih cfs fukuda definiton
so any case of ME, especially frank unequivocal ME is excluded from the Lipkin study by definition, and the results cannot be applied to ME patients.
same problem with canadian consensus and international consensus criteria of cfs/me which is still a fatigue definition, sloppy and excludes ME.
see the nice guidelines blog….me is abnormally delayed recovery fr trivial muscle use… this is primary and just not weakness or extreme fatigue as cfs on lipkin cii site..
applaud lipkin indeed for looking for clarity of the virus connexion in cfs, but condemn him and his group for deliberately extending the obfuscation by making his group's work scientifically worthless by using neither cfs nor me criteria for the 123 patients. this is useless and a waste of time, money, and our lives.
>Fukuda = "Horse-like animal"
ICC = "Stripes"
When you hear hoofbeats, think horses.
But when you see the stripes, it must be zebras.
>A few difference between earlier outbreaks of ME and 1985 Lake Tahoe.
Global publicity.
Massive documentation.
Novel lab test methods.
A new name.
>If no ME patients are in the multi lab study then Mikovits and Ruscetti will only get even distribution amongst what are said to be patients and controls. A simple SPECT scan could have avoided this.
>@anon 1:30
What simple SPECT scan is that? I am not aware of any simple SPECT scan that will distinguish CFS from mono or Lyme disease for that matter. Please give a link and documentation. Thanks.
>The 'Lipkin Study' is looking for XMRV/MLVs and allowing those who believe they had found something in patient blood before to try and do so again using whatever methods they have used in the past.
Cohort selection need not be any more thorough than that employed for the Lombardi or Lo papers – though I believe it will be but based only on the limited information that has been provided in the media and garnered from Lipkin himself.
Mikovits, Hanson and others have said that this study will be the last chance – meaning that it is the only fully funded, large-scale study in town at the present time.
If the 'Lipkin Study' had not already been gathering steam then I doubt if it would have been granted funding in this way after the results from the BWG.
With Lombardi and Lo retracted there is now a dearth of papers supporting these theories. New papers will need to be published if XMRV/MLV theory is to survive past Lipkin.
Komaroff (who provided the samples) on Lo et al.:
“If the same laboratory cannot reproduce the findings on the same patients that it had previously found positive on two different occasions, then it is necessary to retract the original publication.
The reported association between XMRV and these other murine leukemia retroviruses (MLVs) and CFS just hasn’t held up. It is time to move on from that theory.
“At the same time, even in the past two years since this controversy erupted, the evidence that CFS involves abnormalities of the brain and autonomic nervous system, the immune system, and energy metabolism has grown stronger.
And there is good evidence that certain infectious agents may trigger CFS (not including XMRV and MLVs). This research points the way to future research.” '
Update: http://www.research1st.com/2011/12/26/pnas-retraction/
It will be interesting to learn how Lipkin et al. deal with contamination and of course if the participants can this time determine controls from patient positives – but I believe this study will mark the end for this line of specific research.
RetractionWatch indicated there have been nearly 400 retractions this year alone. This is not some conspiracy against the theories purportedly established by Lombardi and Lo. It is science.
>'In an e-mail to Science Insider, Hanson writes that she has not submitted those results for publication, "because we cannot determine whether or not these findings were due to contamination." Hanson believes a second large multilab study, led by Ian Lipkin of Columbia University, will provide the final answer. "I am reserving judgment until it is completed," she says.'
http://news.sciencemag.org/scienceinsider/2011/12/authors-pull-the-plug-on-second.html?ref=hp
>'Dr. Mikovits said in a telephone interview that she remained confident of retroviral involvement in chronic fatigue syndrome and believed that any retraction should have waited until the N.I.H. study was completed.
“That will be the definitive answer,” she said. “If we’re wrong and we can’t reproduce it, then we’ll be wrong, and that’s how science works.” '
http://www.nytimes.com/2011/12/23/health/research/science-journal-retracts-chronic-fatigue-syndrome-paper.html
>@Paula Carnes
A SPECT scan to prove the patients included have a neurological disease. If they don't have signs then they should be included as they do not meet what is defined as a neurological disease. Otherwise the cohort is entirely subjective.
>@Anon 5:03
There is no evidence that the Canadian criteria used in Lombardi et al is being used. The criteria used in Lo was Holmes. There is no evidence this is to be used either.
MLVs are mouse viruses. Will they be looking for human viruses other than XMRV? These are termed MRVs. VP62/XMRV is a fake man made virus, so they cannot used that and the viruses detected in both studies were polytropic.
The NIH clearly do not want the ME community to know what is happening in this study with criteria or procedures. If they did full disclose would be made before testing begins.
"Mikovits, Hanson and others have said that this study will be the last chance "
Hanson has not said this will be the last chance and Mikovits was wrong to have said a single study "will be the definitive answer" no matter how confident she is in the findings of multiple labs and assays. Science never ever works on absolutes or definitive studies. That is a political term. It would be the high of stupidity to have two positive papers for PRMVs, several negative papers on VP62/XMRV, and this single study preventing scientists discovering what they truth is.
The BWG is a prime example of how not to conduct a study. You do not claim to be finding clinically validated assays and then allow those involved to use assays that have no evidence they are proven to detect wild-type viruses. Controls should also have been included in the blood study by having PBMCs pre-screened but they were not and therefore could not have been ruled as being negative. A blood study should not have been confined to only 30 people either.
"dearth of papers supporting these theories."
Not true if you were paying attention. Other MRV papers linking the viruses to ME are still published.
"The reported association between XMRV and these other murine leukemia retroviruses (MLVs) and CFS just hasn’t held up. It is time to move on from that theory."
As you do know it hasn't been tested. If the negative studies had replicated or optimised to positives and not VP62 then they could claim to have been looking for PMRVs, but without they cannot.
"It will be interesting to learn how Lipkin et al. deal with contamination and of course if the participants can this time determine controls from patient positives"
If Lipkin wants to deal with it he should not allow anyone to use VP62 plasmid or VP62/22Rv1. They are not polyropic viruses and whenever they are used they are blamed for contamination. He would also not allow contact controls for obvious reasons and would have PBMCs pre-screened so that this time, unlike the blood study, people could really be said to be negative. The lab that Mikvoits and Ruscetti have been given would also be guaranteed not to have ever been used for mice. So where are the reassurances that these minimum requirements are occurring? The NIH doesn't seem to think they are. Lipkin himself has always stated that clinically validated assays should be used in such studies.
"Positive and Negative Controls
Ideally, patient specimens containing the target nucleic acid are used as the positive control, but this is often not practical or feasible. An acceptable positive control is pooled negative specimens spiked with whole organisms or if that is not available, a representative sample of the nucleic acid to be detected. The positive control should be at a concentration near the lower limit of detection of the assay to challenge the detection system yet at a high enough level to provide consistent positive results."
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1360278/
>"RetractionWatch indicated there have been nearly 400 retractions this year alone. "
Then you need to provide the list of why each study was retracted, but also provide one for the retraction of Lombardi and Lo. So far they have used political excuses. That is not science. You don't retract because you are "encouraged" to do so or because you have no faith. The latter is the equivalent of a religious statement. Then again I guess that is how people want to view Lipkin as some kind of messiah that can do no wrong, despite the fact he is not ultimately in charge of the NIH study set up by Fauci and Collins.
>No, Lipkin is no messiah. Leave God out of this study. Lipkin is an experienced highly thought of virologist, who has made important discoveries and found treatments of obscure viruses, too.
He seems to be principled and is determined to find out if there is a viral cause of CFS. He's willing to stick his neck out for Mikovits and Ruscetti and wait for the study to be finished.
He is a mere mortal, when last I checked. What he and the others find will be meaningful. I'll wait, but while I wait, I'll be checking the other CFS studies for biomarkers, the Rituximab, and everything else. Don't put all eggs in one basket and leave no stone unturned.
>"Then you need to provide the list of why each study was retracted, but also provide one for the retraction of Lombardi and Lo."
The Lo study was retracted voluntarily by the authors, Lo and Alter, so that is based on pure science not politics. Lombardi was retracted because every other author on the study sans Mikovits agreed to retract it. Those other authors are scientists, not politicians.
>The authors of Lo et al. stand by the integrity of the data and they were "encouraged" to retract though no other study used an assay optimised to PMRVs, but the assays of Mikvoits and Ruscetti, and though not other study replicated their proven assays from that paper.
The Ruscetti's and Mikvoits did not agree to retract Lombardi et al. The only lead scientist from the three labs who did was Silverman, who made an error when full sequencing leading to other labs looking for XMRV, not the viruses found in ME which are PMRVs.
There has been no conspiracy by those labs or the others around the world to find HGRVs infecting people with ME and prostate cancer.
"Lipkin is an experienced highly thought of virologist, who has made important discoveries and found treatments of obscure viruses, too."
Lipkin has not conducted any research into ME before and has never found a human retrovirus, he is also not the authority in charge of the multi lab study, the NIH is. It matters not if he is principled if mistakes are made or the study is not robustly designed.
"Don't put all eggs in one basket and leave no stone unturned."
We'll said Kathy d. No study is definitive in science. Lipkin should know that as this is a gamma retrovirus and according to the Koch postulates they should be looking in tissue, specifically lymph tissue for the viruses.
>@Kathy D.
Lipkin is not taking part in the NIH study, he is only the spokesperson hired by the Fauci and Collins at the NIH.
>'Alberts says the Blood Working Group finding was the final straw that led Science to request the full retraction. "The blood group study to me was dramatic evidence of poor science," says Alberts. "It gave us absolutely no confidence in the ability of the major labs involved to do the assays. I find that enormously disturbing."
'NCI's Francis Ruscetti, a prominent retrovirologist and one of the co-authors, attempted to coordinate a retraction with his colleagues but a dispute arose over wording that suggested some of the findings in the original paper were still valid.'
"We tried to get all of the authors to agree, but it got endless," says Alberts. "The responsibility that Science magazine has to the scientific community is to make a strong statement that we don't think anything in that paper can be relied on."'
http://news.sciencemag.org/scienceinsider/2011/12/in-a-rare-move-science-without-a.html
To assume anything more than is said above – unless you have spoken to those involved – is daft.
The 'Lipkin Study' is about the claims made in Lombardi and Lo period. It is I believe quite standard to not know the exact protocols of a study before it is published though I am happy to be proven wrong – and Lipkin et al is under no obligation to reveal more than he has unless he wants to (given his recent statement he may well chose to do so shortly).
If following this study's publication there is believed to be 'loose ends' then those who wish to do so will no doubt follow them up and publish further papers.
Oh and Hanson said what she said – see quote above for more context –
'Hanson believes a second large multilab study, led by Ian Lipkin of Columbia University, will provide the final answer. "I am reserving judgment until it is completed," she says.'
If you would like to read more about Hanson and what she said about her work at the Ottawa Conference I believe an account was made available on Phoenix Rising at the end of November.
>No the Ruscetti's did not ask for a retraction. Frank Ruscetti tried to explain that the viruses are polytropic, as Silverman had made a mistake in full sequencing. You will have to live with that I'm afraid. It is a nicely worded article but ignores this fact.
"It gave us absolutely no confidence in the ability of the major labs involved to do the assays."
Editors of Science journals are not there to use their beliefs in dictating what will and will not be studied and if he again reads the Lombardi paper and the blood study he can see that the assays are different.
The "NIH study" is about the claims made by Mikovits and the Ruscetti experiments, not Silvermans, that is if there is no change in the processing and collection or samples, or mistakes made in coding. If Lo uses the assay in the blood study or any other novel assay other than the one that detected positive patients then it is not about the claims in Lo et al. either.
The blood study announced what methods were to be used before they tested as did the PACE trial, but both then changed them, the bloody study part way though and the PACE trial for publication. Singh also attempted to say what she would do and then didn't stick to that. It appears many change the design to fit the results, which is hardly a scientific method. If they believe the design is suitable it can and should be published on the NIH website.
The NIH in the interest of transparency is obligated to reveal the protocols and methods to be used if they want patients to have any faith that the results will be accurate. Otherwise why should they expect anything better than the blood study or the PACE trial.
"If following this study's publication there is believed to be 'loose ends' then those who wish to do so will no doubt follow them up and publish further papers."
Again there is no definitive study in science. One reason for this is because there are always loose ends.
Oh and Hanson only talked about reserving judgement. But judgement on what? Has she lost faith in her own abilities? In science you should be able to design a study that is robust enough to not have to rely on the results of others when you are consistently, with certain assays, finding the viruses, but with other assays in the same samples cannot.
Dr Vallings made a report on the Ottawa conference and the abstract of Hanson's positive results can be found on the IACFSME site.
>@Jack
Do you not think it is wrong that scientists are being told it is no longer "safe" to not study these viruses?
>That should be that is is not longer "safe" to study these viruses?
>You will have to provide some sources for those quotes/snippets of information. Hunches don't cut it I am afraid.
The Lipkin Study is about XMRV/MLVs and their alleged association with CFS. If this multi-lab large scale investigation does not support the claims made and findings alleged in Lombardi and Lo et al. then it will be over in that respect.
The participants are being afforded another chance to prove their assays and methodology work on 150 new samples. They are participating fully by all accounts and have agreed wholeheartedly with the study itself and with the conclusions – whatever they may be.
Anything else – any further theories in regard to retroviral involvement with CFS and/or ME – whichever way you want to call it – will require more research and the publication of more papers that will be subjected to scrutiny. That is how it works.
This whole business has always been about Lombardi and Lo period. They made the claims that thus far have failed to be substantiated even when they themselves have participated in further studies.
Lipkin does not mark 'the end' of retroviral involvement with my condition – but it does mark the end for Lombardi (XMRV) and Lo (MLVs).
Those who cling to the notion of retroviral involvement will have to wait until further papers are forthcoming.
This is not a conspiracy – this is science. And science has addressed the papers concerned and the claims alleged. Retractions were made by the authors and the Lombardi paper would have been retracted in full if the remaining authors had pulled together in a timely fashion.
>"Do you not think it is wrong that scientists are being told it is no longer "safe" to study these viruses?"
Really? Where is your proof of this? Who was told this? Please name names. Who told them this? Again, please provide specific names. Otherwise your comments are no more than unsubstantiated rumors and gossip, and there is far too much of that going around these days.
>"Really? Where is your proof of this? Who was told this? Please name names. Who told them this? Again, please provide specific names. Otherwise your comments are no more than unsubstantiated rumors and gossip, and there is far too much of that going around these days."
Dr Synderman.
>@Jack
What quotes/snippets of information?
"The Lipkin Study is about XMRV/MLVs and their alleged association with CFS."
If the NIH multi lab study is about only XMRV and MLVs then they are not looking for the viruses detected which are polyropic. MLVs are mouse viruses, the correct term is MRVs.
Jack where did you learn about the scientific method? Science works on probabilities not absolutes.
"The participants are being afforded another chance to prove their assays and methodology work on 150 new samples. "
Only if they do use their clinically validated assays that found patients positive, only if the cohort contains CCC ME patients and only if no mistake are made in study design or execution. This is another reasons why nothing is definitive in science. If it was HIV would have been declared a contaminate and you can imagine the disaster of that.
"They are participating fully by all accounts and have agreed wholeheartedly with the study itself and with the conclusions – whatever they may be."
A situation has been created where they have no choice but to do the study, but they are not the only voices on how the study is to be designed and again we still don't know what that is. For some unknown reason they are letting clinicians and people who have never detected anything dictate the design. If there was any faith it would obtain solid results then it would be published upfront on the NIH website.
"even when they themselves have participated in further studies."
Only Lo has published further work using the failed assay from Lo et al.
"Lipkin does not mark 'the end' of retroviral involvement with my condition – but it does mark the end for Lombardi (XMRV) and Lo (MLVs)."
All four labs in those two papers found PMRVs, not XMRV or MLVs. MLVs are mouse viruses. Have you looked at the sequencing?
Those who cling to anti-science will end up watching the diseases associated spiral out of control if they choose to do nothing now.
There is not been a conspiracy between those who have found the viruses and proven they are integrated and replicating.
" the Lombardi paper would have been retracted in full if the remaining authors had pulled together in a timely fashion."
The Ruscetti's and Mikvoits never agreed to a retraction. The particle retraction removed any association to XMRV and leaves the viruses as polytropic.
There are also other MRV papers still published that found the virus in ME patients. The viruses will not be disappearing only because you close your eyes really tight and wish them away. It cannot be hidden forever. Setting up a paper to close the door speaks volumes to how dead the field of virology now is. Kill science and you will kill people, which everyone conveniently chooses to ignore.