Saturday, March 26, 2011

Dr. Mikovits in the Big Apple

Regarding the Whittemore Peterson Institute, the news from NYC is strong and clear. The WPI is moving on to treatment, and treatment trials, and drug investigation for ME/CFS. Treatments will revolve around inhibiting pathogens (XMRV and other retroviruses in this family), regulating or strengthening the immune system, and dealing with co-infections. They have various tools at hand to begin this - with more to come. Through their research program they will continue to build data around this disease - as well as research better diagnostics and markers.

None of this is a big surprise.

The Whittemore Peterson Institute are putting the struggles over "contamination" issues behind them and moving on. Frank Ruscetti said in December that it is time to move on. It has been a long series of delays, and the WPI is now insistent on getting to the next level.

A few days ago the Whittemore Peterson Institute issued a press release announcing a change in positions at the top of the organization. "Dr. Mikovits, current Research Director of the Whittemore Peterson Institute, has been named the new Director of Translational Research. In this capacity she will focus on assisting its strategic partners and collaborative translation of the most current research. She will engage in activities which support and promote the development of more effective treatment for all patients with neuro-immune disease." Dr. Vincent Lombardi, the lead author on the Science paper, will be the new Research Director. Dr. Mikovits and Dr. Lombardi have worked together in the research lab for many years now. The mild-mannered Lombardi is fully capable of running the research lab.

Those who are skeptical of this institute and its research might view this change in positions as a rearranging the deck chairs on the Titanic. I do not see it that way. I see it in quite the opposite light. This is an aggressive move to escape the "current trap".

Dr. Mikovits has long had a desire to get into the "translational" aspect of this illness - searching for and testing treatments - based on existing and emerging knowledge. This new position will afford her a better platform from which to do this, one from which she will hopefully take less "flak". It also puts to direct use Dr. Mikovits' extensive past work in drug development. Dr. Mikovits directed the Lab of Antiviral Drug Mechanisms at the NCI, and then served as Chief Scientific Officer and VP of Drug Discovery at Epigenx Biosciences.

On Tuesday March 29, 2011 Dr. Mikovits spoke at the NYAS's "Pathogens in the Blood Supply" conference. Her lecture can be seen online here. It includes a number of new items and covers a lot of ground. The main points of this lecture and discussion are found on various blogs and messages boards - or by watching the video.

In delivering this lecture, Dr. Mikovits seemed more agitated than I have seen her before. She rattled along at her fast typewriter rate. Recently her time slot was shortened in order to add more speakers (Why??). Dr. Mikovits has a great deal that she needed to present, so it seems that she just compressed it into the shorter time period. The talk had this sense of urgency to it. It also might be that she was anxious because of the setting, the hornet's nest of the east coast establishment, with the "Great virus hunter" Dr. Lipkin sitting in the first row. Having seen Dr. Mikovits in other extremely stressful situations, I tend not to give this interpretation any credence. I have never seen her get rattled. Instead I think that Dr. Mikovits was angry - and exasperated that she should have to be giving this talk at all - having to present this data again, and to what can only be seen as a skeptical and detached audience. After all, Dr. Mikovits has many more receptive places to present her work, and increasing numbers of interested scientists, and her invitations to present are growing.

Dr. Ian Lipkin also gave a talk. Dr. Lipkin's talk was quite interesting in general, but had various curious aspects to it - not the least was his statement that he is an "Agnostic" in regards to his position on the NIH trial that he is overseeing. Not being a post-modern relativist, I do not understand Dr. Lipkin's detachment. There are many more humane ways in which he could frame his neutrality, but he seems to be unaware of the moral issue here. Meanwhile a host of patients continue to suffer. I wonder if Dr. Lipkin has a clue about this disease? He seems a clever enough guy, but where is he going to take this, with his "Agnosticisms"?

The struggle over XMRV is a struggle over a larger issue. XMRV is a screen. The larger issue revolves around the WPI's attempt to compile data on this illness, to find an etiology, and to search for treatments - elements that have always been "disallowed" in this illness. These facts are so painfully obvious as to not even need to be stated.

The WPI has recognized this "strategic problem" or "lack of coherence" from their inception. They have noted that there has been no attempt to establish the history of this disease, no significant data accumulation that can be used for research or treatment, no real attempts at etiology, and no sustained research that strikes at the center of the illness. Any observer who pays attention knows that these four items, and more, have been at the heart of the difficulties surrounding ME/CFS. In 2005, the WPI set out to change this, and with the publication of the XMRV paper in October 2009, they encountered very stiff resistance.

From October 2009, great efforts have been made to slow down the WPI. From early reports that the WPI was going to be "taken out", to ongoing tactics regarding various contamination theories, to cutting off funding, these "paralyzing" tactics have been very successful. The WPI has spent a great deal of time - too much time - since October 2009 defending themselves. This has nothing to do with "science" - this is shit. These tactics have manifested themselves in a wide range of maneuvers, some of them predictable, others not. The objective observer has to admire those who set up these obstacles. They are very clever, devilish and persistent in their designs.

The overall effect is that the WPI is frozen out of grant money, younger people wanting to do research in XMRV are being denied research money, older researchers are flinching under the pressure of being shut out for their interest in XMRV. The grant application process has become allergic to XMRV research. Someone somewhere does not want this to move forward.

Academic research is a money game. If you play the game wrong, or if you play another game, you are on your own and suddenly without any funding. It is all a bit unseemly. At least being an artist, your livelihood is not connected to kissing people's asses. As an independent artist you can do whatever you want, at your own pace, guided by circumstances. It is much more difficult to do this in science (in other words, there are no William Herschels), and most scientists are cowards when it comes to the money thing. To them this is serious business - as it involves their livelihood - and their "self-realizations". I am sorry to have to say this, but it is true - such is modern life.

All of these "contentions", all of these struggles are "advertised" in the press (to the extent that they cover ME/CFS at all). It is important to remember Dr. Conant's admonitions, "Do not trust the press" and "The press is not your friend".

One can flip a coin about what this is all about. First, it is to "take out" the WPI. Second, it is to "take out" the WPI and reinvent their discovery for themselves. Take your pick. I go with the second option.

The message is clear. The WPI and those supporting XMRV can expect no help from the government in the foreseeable future - if ever. The WPI are going to have to move forward on their own with private funding. The government's current "involvement" seems to be to "embrace" the WPI with testing probably hundreds of samples to clarify what the WPI already knows ("The Big Squeeze" that suffocates.). This could tie up this small lab for many months, critical months for starting the investigation into treatment possibilities. This is not an acceptable option. While this work might be seen as "necessary", it should not come at the expense of immediate attempts to treat these very sick patients. In this light, it is impossible to accept Dr. Lipkin's "Agnosticism". It is a dead end for those who want to bring relief to this patient population. This is a "moral issue", and somewhere, somehow the moral structure has broken down.

Out in the real world, the "agnostic", detached world, ME/CFS is not recognized as a disease. A serious history of the illness has never been presented. There is very little or no data that is useful on the illness. There is no serious search for etiology. There is no serious research into the infectious nature of this illness. There is very little research into the immunological dysfunction. The illness is presented as confusing, complex, and mysterious. (What infectious illness was not confusing, complex and mysterious prior to being understood?) In the meantime many patients are seriously sick with this illness (Notice that Dr. Mikovits referred to it as an "acquired immune deficiency".) In 2005, along comes the WPI with a desire to cut through all this crap. Their first big strike, unexpected, occurred in October 2009 and touched an exposed nerve. For the last 18 months we have experienced non-stop negative reverberative vibes (Unfortunately these "negativities" extend to the patients. Why so much hostility and disregard?). None of this is so difficult to figure out. Please connect the dots.

From the WPI's perspective, their original hypothesis still stands, and no one has made a dent in it. They are making new and additional friends. They have the courage and the momentum - if not the money. There is an air of inevitability here.

Mikovits: "I am totally confident that XMRV and a family of human gamma retroviruses is playing a role in ME/CFS.....(and) our reorganization reflects confidence and allows me to move forward drug and diagnostic development."

There is a lot more I could write about this, but for the moment I will leave it at this.


  1. What SHOULD have happened when the Lombardi team announced they'd found XMRV, a number of honest scientists should have said to themselves, "This is important. If true it will make a huge difference to millions of people. We need to do an accurate replication study to prove or dis prove it".
    These scientists would need to have the interest, capability, and funding, for the replication study. What happened? No-one stepped up to the plate except Harvey Alter who found XMRV sequences common with similar viruses.
    Perhaps there were not enough scientists, interested and honest enough, who were capable and available to do the work.
    Instead we saw numerous "negative" studies, either doing only partial testing (no cell culture) and then declaring they couldn't find XMRV, or ranting on about "contamination" and later raving about laboratory-generated viruses - all sounding progressively more desperate to decry XMRV as even "associated" with M.E. How sad these people are, who felt they had to publish all this pseudo-research to try and denounce the WPI's XMRV research.

    The reaction by all these denialists writing negative papers, is surely a sign not only of desperation but of sheer panic. This is an acknowledgement that THEY actually BELIEVE that XMRV could be the cause of M.E. They are running scared, and trying to cover their backs and bury XMRV, because if proven, their careers and funding will all be undermined. These are capable guys who should have been doing the careful, exact, replication tests, under the guidance of the WPI - which is what they DIDN'T.

    It's not just the frontline scientists - it's the people behind, or above, them, who control the funding. They have more subtle motives, but they can cut the funding to the scientists, as they did with Elaine DeFreitas twenty years ago. Harvey Alter was different - he is highly respected and, I believe, was able to fund his XMRV work out of his own budget. The funders in Britain (the MRC) won't give funding to any non-psychiatric research, and none of the US Gov't funding institutions will give money to the WPI.

  2. Bless you, Patient Advocate. Thank you for writing this. Every word you wrote is true. I hope you will continue to connect the dots. Some of us are not as good at connecting the dots as you are. I am grateful for your explanations.

    Patricia Carter

  3. We need to keep trying to find out who the people are behind the curtain pulling the levers. Thank you for a good summary.

    And thank you for saying this: "(What infectious illness was not confusing, complex and mysterious prior to being understood?)"

    Confusion is our enemy. It
    is the denialists's friend. It is not an inherent aspect of the disease; rather, it was put there, deliberately, by politics.

    What people -- specifically -- ARE pulling the levers? I don't want to wait until the end of the Stratego game when the pieces are flipped around; I want to use the knowledge we gain now about specific denialist incentives to inform our strategy. IMO we can do this.

  4. Great post Patient Advocate. So sad but so true.

    I agree with we Samuel Wales, we need to find out who is "behind the curtains" pulling the levers. I also agree that existing information (denialist incentives) should direct us to those behind the curtains.

    Thanks for you insightful posts.

    ~ JT

  5. Another clear summary of the facts, thank you.

    There is another aspect to what is happening. Money and advancement come to researchers who publish and are cited. When the annual performance review comes up it is the amount, not the quality that counts.

    Anyone with a collection of blood samples in the freezer can get a research assistant to do a quick, cheap run of PCR for XMRV. In the world of ME peer review is a joke and the usual prejudice against negative studies is reversed so getting published is easy and you will be cited often.

    I believe the result is that people who do not care about us or XMRV are becoming involved. There are not even careers on the line as it will be written off as part of the "confusion" surrounding the issue.


  6. Confusion is the enemy. CFS is the main cause of the confusion. We talk about "our disease?" Which one? And now ME/CFS? People do not recognize ME/CFS as a real disease, because it isn't.

    See ME and terminology:

    "There is no such disease as ‘CFS’ – that is the entire issue. The vast majority of patients misdiagnosed with ‘CFS’ do not have M.E. The only way forward, for the benefit of society and all patient groups involved, is the bogus disease category of ‘CFS’ must be abandoned completely (along with the use of other vague and misleading umbrella terms such as ‘ME/CFS,’ ‘CFS/ME, ’ 'ME-CFS,’ ‘CFIDS,’ ‘Myalgic Encephalopathy' and others)."

    Science, logic and ethics must prevail over mere financial and political concerns.

  7. let the government know, we will not forget these *days* oneday when xmrv is out in the open and all the other retroviruses will wont forget how the wpi were treated. remember that.

  8. Thanks for another great article, it really helps me understand and you say what I wish I could say. Thanks, Lynn.

  9. Great post PA.

    In addition to the arrows from the front, the CFS pioneers, the doctors who stepped to DEFEND us...are also taking daggers in the back from people who seem unaware of what they are doing, and just who they are stabbing.

    Our CFS doctors fought on, DESPITE the application of this intentionally trivializing CFS name.
    Do those who try to tear them down for using the CFS term think our doctors are totally stupid?
    They must, or they wouldn't assert that our CFS doctors are "ignorant" "unscientific" and "harming patients" for defending an illness which "doesn't exist".

    In science, the name doesn't matter, and our guys are smart enough to know it.

    I have some advice for the CFS attackers who think they are doing good for doing this.

    Wise up!

  10. Dr Mikovits' lecture at the NYAS conference 29th March that you referred to, has been removed from youtube ??

  11. I hold a more optomistic view of the progress WPI can make, even without academia or govenment backing. Private industry is worth mentioning. They have the ability to cut red tape and move things along at a faster clip.

    Not much is currently known about how industry is supporting WPI but we do know a few things. Judy has stated that they are working with 3 bio-pharmas, with at least one big pharma is sniffing around. She stated that one pharma has offered to provide as much drug and placebo as she wants (to much applause at San Rosa). We know WPI is working with Hemispherx doing the blood testing for a retrospective on the ampligen 516 trial. And by extension working with Chronix (Hemispherx has an equity position in privately held Chronix and Dr. Strayer sits on the Chronix board). Chronix's high tech NGS testing is not only confirming the validity of VIPdx testing it is probably helping to refine a test for CFS and providing all kinds of additional information on patient genomes in order to custom tailor treatment. The 516 trial database is a valuable database as it is from a double-blind placebo controlled trial and data (xmrv testing, Chronix NGS testing) continues to be added to it.

    WPI is clearly getting some interest and support from industry and I hope this new structuring means that there is enough interest and support that soon academia and government will have no other choice but to follow the lead that the WPI has blazed.

  12. Thank you. I agree with option two, that would be, the NIH wants to 'discover' XMRV themselves which is why there are 6 NIH intramural grants on pathogens/pathogenesis and CFS. Compare this to none, zero, nada from 2003 - 2008, and to 51 of 97 intramural grants 1987 - 2002 ( CFS specific).

    NOW...these are CFS studies. I note on the upcoming ME/CFS NIH workshop and even on fed websites that ME/CFS has been substituted for CFS. I think this is to please the patients and it is a bit patronizing when used in an all or nothing way. I understand that it is the feds, so one can't be choosy. However, NONE of the NIH funded research 1987 - 2011 includes a defined ME population and use of ME should not be used in this context. As we hope to move toward use of the Canadian case definition, some groups, including WIsconsin, use ME/CFS in our name. We had hoped that some money would come for scientists to meet to adopt the Canadian case definition OR that subgrouping would clear up the name issue.

    ENTER XMRV. In looking at events since Oct. 2009, I think there is a clear effort to dismantle any conclusions that link CFS to 'real' illness. The BIG DUDES include insurance companies and the feds, like the US military. WHY? The Veterans insurance is Champva and Tristar. In 1991, a ruling was made to disallow payment for any expense for testing, treatment, and in the end run to support a disability claim based on 780.71. A code does not appear until later on, but the ruling stands in 2011. Payment can be made for ruling out other illnesses and for some treatment of symptoms, but it is clear that CFS is off the table. Think about that. 1991???? As the WPI moves toward testing other neuroimmune patients to include Gulf War vets, the sky will fall if a large percentage of those vets have XMRV. Then what?

    VACCINES. OH SCARY. What if vaccines speed up replication of XMRV? What if? The sky will fall, so better to obliterate the findings than to look at the potential damages. I am not saying that vaccines are the problem. Ah...maybe a more rational approach would be to investigate the problem, find risk factors, and use a different vaccination schedule for kids and for vets needing to have further vaccines. But that would cost..oh...a 100 million dollars? AH...half a billion? Better to make it go away, to make us go away and to further marginalize any scientist interested in CFS research.

    (to be continued in next message)

    Pat Fero

  13. Patients have argued about name for years. Patients have formed groups who have researched various names spending countless hours on the issue. I think it is a red herring that wastes energy. Conceptually, these people are spot on, but we are in such a cave on illness recognition and money to research it, the BIG DUDE, an all encompassing THEY, do not see CFS as anything to be concerned about. For the the reasons stated above as well as others related to big money, the BIG DUDE is fighting against scientific findings to the contrary.

    Within 2 years of the GAO investigation, we were dumped on the ice floe. This is clear by looking at extramural and intramural grant history. How was that decision made? A BIG DUDE way high up decided to make CFS go away. NOT ONE recommendation from the GAO has been followed by NIH or by CDC.

    Translational research. In 2006 when I attended a meeting at WPI, a talk given defined translational research and the need to get back to MD -researchers conceptualizing research hypothesis. Judy M's move to Translational Research comes as no surprise, although I think WPI might have explained it better.

    Lastly, what do we do? I think we keep pressing, pushing, and fighting for people's lives, especially the vast majority, like those in WI who are housebound with no information access. Also, we must continue to speak for the children, our third generation of people who could be diagnosed with CFS. With parents and grandparents sick, who speaks for them? Despite darkness and confusion and tension and fighting within our ranks, I think we all agree that 3 generations is obscene. I welcome all efforts and abhor anyone who would stop patients who might be misinformed, or not meeting some standard of advocate behavior. does not help to chomp on one another, but it is normal given the circumstance of not being able to ID the BIG DUDES who want to keep us silent.

    Pat Fero

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  15. Thanks PA another well written and delivered message. Thank you for speaking for those of us still under the influence of this inhumane retrovirus.

    I think Translational Medicine was already defined pretty well by Annette Whittemore in the "WPI Intro Video" = Research to DR. to Clinic to Meds to Patients reCheck Meds and back= Full Circle under One Facility.. That's
    why they joined in with UNR and the CMM. Even Dr Cheney said in that video how incredible it was... The main point here is that THIS time round... no one is going to wait for Approval from Above.. The CDC did not care about the patients back at Incline Village and they do not care that the Lyndonville kids are also now test XMRV+.
    Well, tough.. No one that care about the patients is going to HALT or be hidden away this time like when the last retrovirus connection was made.. too many other illnesses are being linked now and family trees of illness are forming... Dang right it's the 3rd Generation.. and Enough is Enough. I think everyone BUT the Governments CARES and this time the citizens of the World are speaking and they are backing WPI. So, step down medical dictators cuz we have put up with you long enough.. You have lost your integrity and validity and no one cares about what you supposedly disprove any longer.. cuz you are making your BLT with Miracle Whip and not Best Foods Mayo~ your recipe is not working....and has been rejected By the People....................................
    Anyone that has really spent time living or working with the patients knows that when we talk we mean the CFS that is ME aka the Original Incline Village one... not the later version that has been watered down.. so let's end that debate right here and now, OK ?
    It's TIME to Put the Patients FIRST... and WPI knows it.. Bless our New Capitol Hill in Reno !!!
    This time we are NOT waiting for "Approval"~
    we are "Advocates 4 Answers" now...
    So Let the Next Chapter Begin.. Movem' Out~
    Forward Hoooo-oooooooooo

  16. And at this stage, State of the Knowledge workshop? Sounds more like a Jeopardy challenge than what should be a scientific conference.

    We are concerned that the presenters are a mystery? What is it about? ME/CFS? Which is??? ME/CFS has been glommed onto with great fervor by some groups amid vast objection by much of the patient community. Yet despite the unctuous acceptance, whenever the obvious questions arises, there's an obvious avoidance.

    Why accept another made up term with no agreed upon meaning, which can again be used in different ways to mean different things. The acronym alphabet soup creates more confusion and remains open to interpretation. Just a continuation of the very problems that CFS has created all along.

    A diagnosis of ‘CFS’ in any form does a grave disservice to ME patients. ME/CFS should not be acceptable but viewed as another unscientific obfuscation. Patients need a specific and accurate diagnosis so that their illness (NOT just fatigue or symptoms) can be properly addressed and not be connected to CFS and the psychiatric paradigms.

  17. The CFS term can't be made to disappear by refusing to use it.
    Proposing such an infantile "peek a boo, now I see you, now I don't" strategy is ridiculous.

    Dr Byron Hyde was the first physician to use "ME/CFS". This establishes a precedent for the term. He wrote that where ME and CFS overlap, they are undoubtedly the same illness.

    This is plain enough, most adults can understand it.