Wednesday, 23 November 2011

Chronicle of an Embarrassment Foretold

10 months ago I wrote on an internet forum, something that has shown to be prescient:

Progress in science frequently involves two diametrically opposing principles; there's competition between researchers - and there is co-operation between researchers, very often both principles apply to involved research groups at the same time. For this to work, all the participants have to have a degree of confidence in the basis on which each group is working. Where confidence is lacking then a particular laboratory or even a whole institution will be avoided by others working in the field, this will have effects of unwillingness to take on replication, confirmation or validation studies, of unwillingness to peer review and ultimately reduce confidence on the part of publishers. Mikovits and WPI have only themselves to blame if other researchers do not take them seriously, the comments on the ERV blog do represent serious issues for WPI even if the posters are not themselves established researchers the attitudes expressed are likely to be widely held in the medical research field. Mikovits and Whittemore may be happy to wrap themselves up in a Wakefieldesque flag, championing some mythical disease causation - but that will do nothing to advance the cause of M.E/CFS research, in fact it will probably have a highly negative effect because M.E/CFS will once again be associated with 'crank' pseudoscience in the minds of many researchers.

Sadly the damage is already done, and I'm sure that as with Wakefield's followers who refuse to accept the antivax agenda is nonsense, that long after XMRV has been consigned to 'minor interest' status, there will be those invoking mass conspiracy for the research leading nowhere. As Mikovits said - "a negative result doesn't mean you are not [XMRV] positive" - yeah right, just keep buying the tests, we'll get you a positive result eventually !?! What serious scientist would want to associate themselves with that kind of madness, it's a career killer at the very least for anyone committed
to objective investigation.

Shortly after writing those two paragraphs  I completed “Creating a Research base isn’t like buying a Football Team” for this blog and thereafter rather lost momentum in writing about what was looking ever more like a train wreck in slow motion.  For the intervening period the headline M.E/CFS story has been entirely subsumed into the XMRV and WPI charade and while the wreck has been evolving there’s been little to write about other than what was clearly going to be an unpleasant transfer of momentum as the Mikovits/Whittemore skytrain achieved negative motion. Not that I predicted the nature of the collapse, but given the florid nature of the WPI Götterdämmerung, a summary of events might be now worthy of record. 

Too good to be true 

In 2009 the magazine Science published a study Detectionof an Infectious Retrovirus, XMRV, in Blood Cells of Patients with ChronicFatigue Syndrome authored by researchers associated with the Whittemore Peterson Institute.  The study was contentious for a number of reasons, not least of which was that it appeared to offer evidence of a single infective agency common to a large percentage of individuals diagnosed with M.E/CFS, such a position is problematic given the diverse presentation of patients falling within the M.E/CFS ambit. The Science article also raised urgent concern amongst Blood Donation Authorities because it appeared to suggest that a XMRV was a potential pathogen that could be communicated via blood donation – numerous studies were initiated to address these concerns necessitating application of large amounts of research funding. Some 38 studies were carried out, yet none provided any support for the WPI study, Science Magazine took the unusual step of issuing an Editorial ‘expression of concern’ and subsequently part of the article was retracted at the request of two of the co-authors.    

No further publication was offered from the WPI until May 2011 and even then this new article  offered no elucidation of the issues of developing concern regarding the 2009 article, despite the new article being predicated on the testing regime used in the 2009 study. The May 2011 article claimed to identify an inflammatory signature specific to XMRV positively tested M.E/CFS sufferers, however as the XMRV test had never been independently validated it is unclear whether the signature was either XMRV or M.E/CFS specific.

At the end of September 2011, doctoral student Abbie Smith, a consistent critic of the WPI XMRV work, published via the ERV blog  a telling critique of the use of  the contradictory usage of data by Dr Judy Mikovits, the senior researcher at WPI .  The material presented in the ERV blog was soon picked up by other researchers and attracted the attention of sciencejournalists .  The credibility of both WPI as an institution, and Mikovits as individual researcher seemed to be impugned and a mature response in defence of their relative positions from both would have been expected by most observers of science. What happened instead only served to bring further opprobrium upon the WPI and Dr Mikovits.

When science fails, there’s always religion

 In January of 2011 I wrote a blog entry entitled  Saints and demons in the Cult of The Chronically Fatigued where I highlighted what I saw as a deeply unhealthy sanctification by some M.E/CFS affected people of  Dr Mikovits, Annette Whittemore and Andrea Whittemore. I subsequently wrote about what I saw as the inherent failings of the WPI, particularly the role played in the organisation by Annette Whittemore:  Creating a Research base isn’t like buying a Football Team .  While the intemperate adulation exercised by some M.E/CFS affected people and the internal failings of the WPI were not causally linked,  together these two elements created a toxic brew in which the inevitable ‘failure to launch’, and consequent breakdown of professional relationships, produced in turn a cognitive dissonance amongst the formerly adulatory claque.  The ‘patient population'  to which both Dr Mikovits and Annette Whittemore made effusive appeals for support, has now become enthralled to a near religious hysteria in which demonisation and martyristic conspiracy are being invoked to explain ‘the Downfall’. While other ‘devils’ in the M.E/CFS firmament have faded from the excited view of ‘advocates’, a new ‘demoness de jour’ has been revealed in all her evil . Once perceived as a fragrant deity of all that was light in the enshadowed world of M.E/CFS research,  Annette Whittemore confirmed her allegiance  to the Dark Side (© G.Lucas)  by sacking Dr J.Mikovits from the employ of the WPI.

For a researcher to part company with an institution under less than happy circumstances is not exactly a rare occurrence – differences of research direction, management styles or simply clashing egos underly many researcher relocations. However these 'separations of the ways' usually occur with little public pronouncement, and in most cases decorum is the order of the day. This however is not the way with WPI and Mikovits. Within hours of Mikovits being told she was surplus to requirements, a variety of Internet Blogs and Forums were alight with tales of the immoderate way in which Annette Whittemore verbally terminated Mikovits’ employment and the stage was set for an unseemly outplaying of an embarrassing drama.

It’s the money stupid

 The Mikovits/Whittemore split generated especial anxiety amongst those who claim M.E/CFS affectedness and who are strongly wedded to the belief that M.E/CFS is a retroviral disease. The WPI with Mikovits at its helm has been the sole institution to have given the ‘M.E/CFS = retrovirus’ proposition any credence. The expulsion of Mikovits saw ' believers' rapidly invoking conspiracy (evil forces ‘getting at’ the WPI) theories together with expressions for the fear of martyrdom (both figurative and literal) of Dr Mikovits. A key part of the narrative soon emerged  - the question of who would continue to enjoy the Federal Research funds that had been awarded for a further two years.  It appeared, via proxy Blogs, that Mikovits was claiming the grant award was to her in person, while this was contested by the WPI. The contention by Mikovits was particularly strange because there is long established  precedent,  that the research contract is between funder and Institution. Nevertheless Mikovits’ supporters promoted the meme that only Mikovits could be trusted to continue the work on putative retroviruses, which Mikovits called HGRVs - Human Gamma Retroviruses, and on that basis Mikovits and not WPI was the rightful recipient of the funds. 

The final act of this increasing soapy drama was opened by the WPI when it further spiced the narrative with a claim about missing lab materials, something which was to lead to an absurdist peak of  drama – Dr Mikovits being arrested and held in jail prison on charges of theft and conspiracy.  The drama was thus complete, not only is ‘conspiracy’ implied, not only has there been betrayal by a close ally, but martyrdom has occurred. M.E/CFS as a religion finally has the objectification of suffering, not merely by the serried ranks of the poorly masses but it now has its own ‘truth bringer’ brought low by those who would follow 12 pieces of silver (actually $1 million in research funds) and who would sell out the truth to render under Caesar that which belongs to posterity. 


Never Ending Story

Mikovits seems likely to face a full criminal trial in due course, given the content of affidavits published in respect of the Civil case that the WPI has brought against Mikovits. The affidavits published on the WPI website attest to theft of research materials from the WPI by a PhD student acting at Mikovits’ behest.  A criminal trial whether or not it results in conviction, will only further cement Mikovits in the role of martyr in the eyes of her unthinking supporters  and full canonical Wakefieldisation appears entrained. The myths of HGRVs will be stitched irrevocably to Mikovits’ beatification and the believers will be wholly immune to any reasoned argument over the failings of Mikovits work.  M.E/CFS research has now has to face up to a future in which all intelligent debate is perpetually dogged by a crank fringe who in the manner of the anti-vaccination movement’s entryism into ASD advocacy, parasitises every open discussion on the epidemiology and aetiology of M.E/CFS.

 
No ‘get out of jail free’ card 

Mikovits’ travails, whatever her culpability or innocence in criminal matters must not distract from full examination of the apparent egregious systemic failures of the WPI. Mikovits, Lombardi as lead scientists and Annette Whittemore  as the de facto senior manager have at the very least to answer the many questions that M.E/CFS affected people have about the research, testing procedures and finances of the WPI. Mikovits is reported to have claimed at a conference in September,  shortly before her contract with WPI was terminated, that the VIPdx laboratory, which had been providing tests for XMRV under licence to the WPI,  would not continue XMRV-testing because the test had not been shown to be reproducible.  Mikovits statement appears to have prompted a response from  Dr Lombardi .  Lombardi’s statement notwithstanding, patients who in total paid in the region of $1 million to VIPdx for these worthless tests, the results of which confirmed for many that they had a retrovirus for which there was no known treatment, deserve elucidation of:

·       Why the WPI felt confident in issuing the test licence before independent validation had been achieved ?

·       What income accrued to the WPI from the licence agreement ?

·       What profit was made by VIPdx on the processing of XMRV tests ?

·       What financial benefit, if any accrued to Mikovits, Lombardi, members of the board of the WPI or there surrogates, from the operation of VIPdx ?

·       In the light of the VIPdx statement that  The interpretation of the XMRV test results, as with all laboratory tests, is the responsibility of the ordering physician.” What records were kept by WPI/VIPdx of the ordering physician ?


VIPdx operated as private company and there is no legal obligation on VIPdx to make its financial circumstances public, however WPI is a public trust which has operated under claims of acting in the interests of patients. The WPI has a moral obligation to provide transparency , it should not and must not hide behind any wrong doing that may be proved on the part of its employees.

3 comments:

  1. All very good questions. Questions we were asking over a year ago when the testing was being advertised. I wonder what the people that work at VIPdx have to say?

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  2. Re the parallel with autism research. The worst of this is probably behind for CFS. For about 15 years after Wakefield's misrepresentations all research about autism concentrated on its putative link with vaccines. Since there is no such link, nearly everything described as "autism research" was a waste of time and money. However now, whatever the views of vax-denialists, the science has moved on and useful research is being done. I would think that the XMRV hypothesis has been hammered into the ground and no further time, money or scientific brain power will be wasted on disproving it. Judy will obviously be sanctified like Andy -- she even has the big-eyed innocent-persecuted by-a-harsh-world look that he has -- but it won't matter practically

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  3. Good account.

    I hadn't read the statement from Lombardi when he was at VIPdx. Isn't he now Research Director at WPI?

    Anyway, once Mikovits reportedly claimed that those 'tests' were not using the same protocols as the ones she was using in her lab (were not really the same as what they had done in Lombardi et al (note the lead author)) - it gave the 'believers' something else to write home about.

    Again (and as the statement exemplifies) much of the 'religion' is based on internet rumour, speculation and gossip. No one 'camp' wants the other to 'win'. Whilst both seem to have lost perspective and are unable to move on.

    Once upon a time this was perhaps understandable - but the whole CFS/ME = HGRV meme is pathetic.

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