Creating a Research base isn’t like buying a Football Team

The beginnings of the WPI seem to make it inevitable that controversy would dog whatever research product the Institute would lay claim to.

All but the largest scientific Institutions, are by their very nature, forced to focus on narrow fields of enquiry, this in the main is not a handicap to progress and scientists are in the most part accepting of research briefs limited by funding availability and an individual institution’s statement of purpose. Science requires that objectivity of endeavour be paramount, limited research briefs in general actually serve the cause of objectivity, however where there is an institutional presumption of ‘value’ of research product, then objectivity will almost certainly be lost. Of course in the field of medical research many institutions have strategic ambitions, for example Cancer Research UK which funds research in both its own and other facilities, seeks to understand and ultimately cure cancer  but such a strategic ambition can not be allowed to impact upon the science of an individual project.

The reality of medical research is that the vast majority of investigations will produce either no conclusive evidence to support treatment, or will positively identify unrewarding avenues and only rarely will ‘breakthrough’ results be achieved. In such a context it is vital that all research evidence, whether or not leading to treatments or cures, is accepted by the research institution as valid science; the alternative is that the institution itself becomes partial and research evidence is validated only in terms of its ‘breakthrough’ status. When that happens the entire institution moves from being an agency of science to being an agency of propaganda.

How research institutions maintain scientific integrity is a matter of much debate and there is perhaps no absolute model of how impartiality can be ensured within internal validation of outcomes, however there are some aspects of institutional management that could be seen as representing ‘best practice’. Clear separation of roles within the management and oversight structures would seem to be essential, so that while the institution may have advocacy, research and income generation priorities, these potentially competing  aspects have necessarily to be pursued within expressly separated contexts. Without this separation, role confusion within both management and executive structures is inevitable and there is a very great danger that scientific integrity will be compromised by financial or advocacy demands.

The Whitmore Peterson Institute states its goals as:

• To facilitate and advance patient care
• Research the pathophysiology of neuro-immune diseases such as ME/CFS, fibromyalgia, atypical MS, and autism
• Develop therapeutics, diagnostics and prevention strategies for this spectrum of diseases
• To advance and support medical education and physician training

At first reading this may seem an entirely reasonable strategy for a medical institute but the line “Research the pathophysiology of neuro-immune diseases such as ME/CFS, fibromyalgia, atypical MS, and autism” bears closer consideration. What in fact does this apparently authoritative statement actually mean ?

Pathophysiology is a part of the medical lexicon, meaning “the functional changes associated with or resulting from disease or injury, so it seems that the intent of the Institute is clear, but difficulties quickly arise when considering “neuro-immune diseases”. Tellingly entering this phrase into a web browser brings as the first result  - the Whittemore Peterson Institute website which provides the information, without any other reference that:

The spectrum of neuro-immune diseases including: Myalgic Encephalomyelitis (ME/CFS), Atypical MS, Fibromyalgia and Gulf War Syndrome, share common abnormalities in the innate immune response, which result in chronic immune activation and immune deficiency.

 The term Neuroimmune Mechanisms has been used in reference to Alzheimer Disease Pathogenesis, inflamatory diesease and more generally with consideration of health and disease function which yields the description:

A novel scientific discipline that examines the complex interdependence of the neural, endocrine and immune systems in health and disease has emerged in recent years. In health, the neuroimmunoregulatory network is fundamental to host defence and to the transfer of immunity to offspring; the network also plays important roles in intestinal physiology and in tissue regeneration, healing and reproduction.

The term Neuroimmunology has been in use since the 1980s and there is a Journal dedicated to this field of study. , while the term Neuro-Immune Interactions has been used in relation to studies of Multiple sclerosis  and neuroimmunomodulation has been used in relation to psychiatric illness.   Despite these technical uses of terms which are of apparent close, or even cognate meaning with “neuro-immune” there appears to be little in medical reference sources which assist in elucidating what the WPI might mean by “neuro-immune diseases”. This lack of elucidation is compounded by the list of conditions that WPI considers to be neuro-immune in character yet which appear to have no established commonality, or in one case even an agreed medical classification. Atypical MS has no authoritative designation that is separate from the accepted spectra of Multiple Sclerosis while the identification of the developmental disorder Autism (ASD) as an immunity mediated condition appears eccentric to say the least. WPI’s additional reference to Gulf War Syndrome adds further doubt as to the underlying science of the WPI conception of “neuro-immune diseases” given the lack of any evidence of a single causative agent of the now widely recognised spectra of illnesses  affecting Gulf War veterans.  Further there is no apparent data to support the WPI claim that these disparate conditions “share common abnormalities in the innate immune response, which result in chronic immune activation and immune deficiency.” Bizarrely, considering it is much vaunted by WPI, the hypothesis that persistent XMRV infection is the cause of CFS would militate against abnormal innate immune response having a role in CFS, given that ‘normal’ immune response would be sufficient to explain the CFS symptomology in the face of persistent infection.

What any of this may actually mean is impossible to divine, but WPI seems irrevocably confused, either by its own publicity, or by the state of science in the very fields in which WPI seeks to undertake research; certainly it raises many questions about how the Institute arrived at this state.

The Whittemore Peterson Institute is a Private philanthropic foundation with tax exempt status . Since the creation of WPI its President has been Annette Whittemore who is listed as the Institute’s founder and the Whittemore Family Foundation (which shares the same registration address as WPI) donated a total of $309,000 to WPI in the years 2007-2009. WPI also received $540,572 from the Neuro Immune Research Foundation when it closed in 2008; Annette Whittemore was President of NIRF.  In addition to Annette Whittemore, the Board of WPI has only had two consistent members since its foundation, its Secretary Peggy Sullivan and its Director of Government & Public Affairs, Michael D. Hillerby;  Hillerby is a business associate of Harvey Whittemore, Annette Whittemore’s husband.  Annette and Harvey Whittemore are benefactors of the University of Nevada, and were closely involved in the development of the Center for Molecular Medicine  within which the WPI is housed. The Whittemores pledged $5 million to the building of the $77 million Centre although only a little over $1 million of this pledge was actually drawn down by the project managers.

The motivation of the Whittemores seems more than simple philanthropy, and although the various PR material promoting WPI appears explicit  in expounding the history of the Whittemore family’s concern with Chronic Fatigue Syndrome, this doesn’t explain the focus on neuro-immune diseases rather than just the CFS/M.E that affected Andrea Whittemore.  In the 2009 WPI annual statement to the IRS,  Annette Whittemore states that she works 40 hours per week (unpaid) in her role as WPI President, clearly a profound level of commitment, given that the Executive Director (Judy Mikovits) receives $185,000 for a 45 hour week. The role of President and Executive Director of WPI are closely linked, with Annette Whittemore and Judy Mikovits regularly attending conferences in both the US and Europe, and on at least one occasion Whitmore has shared in the presentation of scientific material.

Clearly to understand the nature of the Whittemore Peterson Institute, some account has to be taken of the role of Annette Whittemore, not simply as a parent seeking a Lorenzo’s Oil , or as a disinterested philanthropist distributing personal wealth, but as someone with a particular perspective on disease.  An indication how Whittemore’s own perspective has been shaped comes for her WPI bio: Annette Whittemore graduated from the University of Nevada with a BS Ed in Elementary and Special Education. Teaching children who had neuro-cognitive deficits, like those found in autism, ADD, and learning disabilities, provided her with a unique experience to later use in her pursuit of answers to her daughter's serious illness. It is difficult not to see the speculative neuro-immune disease designation as being a reflection of Annette Whittemore’s personal conception of disease processes rather than a result of a deliberative scientifically informed process.

And what if the Founder of (to give it it’s full title) the Whittemore Peterson Institute for Neuro-immune Disease has provided the Institute’s primary perspective,  does that actually matter ?  From a scientific perspective it is a matter of overwhelming importance. The basis of any scientific institution must be the capacity to address all questions, devoid of prior assumptions which are not supported by scientific certainty. WPI has not set itself the challenge of testing the validity of “neuro-immune” as a disease catergorisation, nor is it presenting hypotheses of  “neuro-immune” processes that may be tested, instead the very existence of the organisation is a statement that neuro-immune disease is an established fact, and that it is a ‘known’ that:  ME/CFS, Atypical MS, Fibromyalgia, Gulf War Syndrome and Autism are neuro-immune diseases. The research context provided by such an ‘a priori’ position must inevitably generate expectations of ‘proof’ that confirm the Institution’s pre stated position; irrespective of the quality of any research, such a context seems doomed to promote exceptional researcher bias, something which is both unnecessary and unjustifiable.    

Saints and demons in the Cult of The Chronically Fatigued

You can't convince a believer of anything; for their belief is not based on evidence, it's based on a deep seated need to believe. Carl Sagan 

 

Cultism seems an inherent human behaviour, probably an evolutionary adaptation selected for as a group cohesion process in the development of the language and culture of our homonin ancestors. Cultism frequently has harmful effects when encountered on a broad social scale but it is likely to be an inevitable group response where the group is experiencing, or (perceives that it is experiencing) external stress. Having an illness which is effectively ‘undiagnosable’, which causes individuals significant social dislocation, which has limited social and scientific acceptance and which leaves the individual feeling permanently ‘crap’, is as an effective a source of individual stress as one could want. Multiply that individual stress amongst a group defined on the basis of a shared experience of that stress and the conditions for a group psychology founded on a sense of external oppression appears ready made. Of course this doesn’t mean that CFS = cult, merely that some people affected by CFS, which may include carers as well as those who are ill, will find a degree of safety in adopting a cultified mindset. This ‘safety’ default position can also be seen in anti vaccination groups, groups of parents of developmentally challenged children and groups advocating exclusive adoption of non scientifically validated medicine and it is notable that across internet forums there is a degree of interchange between these various groups.

Shame the Devils

Cults and cultic thinking are not phenomena which are exclusively religious in character, neither are these phenomena dependant upon the presence of a charismatic founder/originator but there is a very strong propensity for cultic thinking to drive the process of ingroup  bonding by identification of a personified outgroup ‘demon’ and a personified ingroup ‘saint’. Indeed these personifications may multiply into a veritable pantheon of  white hat and black hat wearers, however in the cultified thinking found within the CFS forums there are only two major demon figures, notably one male and one female.  The senior devil, and veritable prince of lies according to the liturgy of his CFS detractors is psychiatrist  Professor Simon Wessely . The demonstration of Wessley’s commitment to the dark side was his co-authorship of a paper on the use of CBT as a treatment for CFS which demonstrated high levels of positive outcomes. CBT is considered by some of those affected by CFS/M.E to be inimical to good illness management and some even claim it is substantially injurious to CFS sufferers. There is a commonly repeated meme that Wessely specifically chose a predominantly psychiatric model of CFS to load his CBT study so as to get a ‘positive’ result.  Ironically not only did Wessley and his colleagues reference their patient recruitment terms to recommendations from a US expert conference which noted the need to exclude psychiatric diagnoses ( It was viewed as essential for the investigator to screen for psychiatric disorder using a combination of self-report instruments followed by at least one structured interview to identify patients who should be excluded from studies or considered as a separate subgroup in data analysis)  as well as to a UK expert conference where psychiatrists were in a minority, but in any case both these recruitment references were superseded by reclassifications by the CDC  and the DOH . The reclassifications rendered the Wessley et al study of CBT largely inapplicable to succeeding patient populations, so even were that study to have been anything other than scientifically sound, it was largely redundant even by the time it was published in 1997 given the CDC adoption of Fukuda et al in 1994. Nevertheless Wessely is code for evil in CFS cultism, and by association, so is psychiatry, all psychiatrists and any treatment they may recommend for CFS.

More recently recruited to be an object of vilification by cultic thinking CFS affected individuals, is Dr Esther Crawley,  Dr Crawley has doubly damned herself, firstly merely by following the guidelines of the National Institute for Health in treating CFS patients, and subsequently by proposing a study involving (in this author’s inexpert opinion, the decidedly un-scientific) Lightening Process© .  Normally a scientist like Crawley could have expected support from the science orientated MEA but even the MEA was drawn to seek a review of the ethics of the less than appositely named SMILE study. Crawley has now been cleared to go ahead with SMILE but her role as cultic hate figure  is assuredly permanent.  

Angels in the Firmament

The early heroes of CFS research have passed on , additionally the disease has never attracted the sort of media whore … cough er ..  celebrity campaigner, to whom the hordes have flocked adoringly and CFS in recent years has especially been a cause in need of a Joan of Arc to publicly suffer vicariously for the afflicted. The cultic inclined of those affected by CFS have found a trinity of Joans in the guise of Dr Judy Mikovits and Annette and Andrea Whittemore . No doubt admirable people these three individuals are now treated as personae mirabilis wholly beyond criticism, as also is the product of their sphere of creation   – the XMRV organism and its supposed role in causation of CFS.

 XMRV has ticked all the boxes for those affected by CFS and who are looking for a miracle, although the nature of the miracle has turned out to be something of a surprise. While the tenuous link between XMRV and CFS offers the hope of a ‘cure’, far more of the enthusiasm of the cultically inclined has been directed toward XMRV’s potential to accord social acceptance. Within the CFS forums the aspect of social acceptance has been mediated via a discourse which favourably compares HIV with XMRV and there is a repetition of statements to the effect that CFS sufferers are worse off than those affected with HIV !  The sheer scale of the dislocation between the perceived status of HIV affected people and the actual reality of living with that disease almost suggests a kind of collective dissociative thinking on the part of some CFS groups, it’s as if herpes suffers were seeking the public and scientific ‘acceptance’ accorded to small pox victims. 

In the way of many cultic phenomena, the force of reasoned external critique has only served to re-inforce the saintly status of the Whittemore Institute, its Director,  its pre-eminent ‘person of treatment’,  its President  and its ‘discovery’ . Every scientific paper that casts doubt on the definitive role of XMRV in CFS is explained away in terms of incompetence on the part of naysayers, contempt on the part of authority and conspiracy on the part of – well everyone from the massed ranks of psychiatry led by the evil Wessely (see above)  to Big Pharma wanting to defend profits from ineffective drugs prescribed to lifetime sufferers of CFS. The dubious positions taken by the WPI – marketing of XMRV tests to desperate CFS sufferers before any test validation has been achieved, ownership of the testing laboratory by the husband of the WPI president, Mikovits sharing a platform with disgraced and apparently medically fraudulent researcher Andrew Wakefield , the WPI President allying the WPI to an anti CBT agenda - only serve to elevate the WPI as the only true voice of the CFS ‘dispossessed’.

No matter what contrary evidence may arise, there is now no hope that the WPI ‘followers’ will be dissuaded that XMRV is the cause of their disease, every challenge to WPI or its science will be treated as an undeserved attack motivated by jealousy or competing financial and  professional interests. The demands for anti viral treatments will grow, pointless testing will take place, patients given positive test results will feel the need for treatment and when conscientious doctors refuse to prescribe dangerous and inappropriate medication, those patients will go to unscrupulous doctors happy to prescribe whatever the patient demands, merely for the consult fee. Mikovits and WPI could do much to rectify the situation – Mikovits could start being positive about all the science of XMRV, instead of perpetually defending her own work, and WPI should withdraw its anti CBT stance given that, no matter how inadequate, CBT based treatments are proven effective in helping CFS sufferers to at least to maintain a level of functionality.  

Hospitals are full of Sick People

Hospitals are full of sick people, and if they were not, what function would they serve ? Of course hospitals are not populated only by people who are ill or who have suffered injury, each institution is a social complex made up of professionals, support staff and visitors, as well as those people who are being treated, investigated or in some way assisted. Within a hospital, the experiences and beliefs of ‘the sick’, are constantly moderated and influenced by all the other social elements operating within and through the institution. And the point of this observation ? :

For most of the three decades since I was given a diagnosis of chronic PVS (Post Viral Syndrome ) I have avoided having regular contact with other people who share this and the umbrella diagnosis CFS (Chronic Fatigue Syndrome ). The truth is I don’t really like the company of ill people, by which I mean, I don’t like the exclusive company of people whose commonality is defined by disease. I also have the same aversion to social groupings based on exclusivity of religion, gender, ethnicity and culture (class and ability are more complicated issues and for sheer pedantry I leave them out of consideration here) so it’s not that I identify ‘illness groups’ as particularly discomforting, it’s just that any club I’d want to belong to needs to have a broad ‘people base’ for me to find it in any way attractive. Over the last few months however I’ve been reading and posting on CFS related forums and it is that experience of communicating within a social group whose members are by necessity self defined as ‘sick’,  that has prompted me to start this Blog.

Clubbing together to provide mutual support, share practical approaches to the management of illness, share information on sources of help and to discuss political and scientific developments that offer hope of better treatment and even cure, would seem a wholly desirable objective. Desirable it may be in principle, but from my recent experience I now question how healthy Internet forums ,  particularly the closed world of the private forums, are for groups based solely on disease commonality. There are three things in particular that have alarmed me about the CFS/M.E / FM  /CFIDS  forums (no forum links provided on this blog !):  Firstly a propensity of posters to promote questionable, even bizarre beliefs that border on a kind of cultism. Secondly, the wide acceptance of the appropriation of science to support anti science agendas. Thirdly the existence of a peculiar caste system of ‘illness qualification’ which allows that a  claim to be ‘more ill’ confers the possession of unchallengeable beliefs and the right to act as arbiters of what is or is not legitimate treatment, research or medical support.

Of course it is not surprising that people suffering chronic health impairment, and who have little effective support from health professionals, should develop ideas about illness and treatment that are poorly related to medical science. Even if one were to accept the certainty of those who advocate a somatic diagnosis (see  http://bjp.rcpsych.org/cgi/content/full/bjprcpsych;185/2/95 ,  http://www.ncbi.nlm.nih.gov/pubmed/10375340 ) there is still no definitive ‘cure’ and those treatment regimes which do exist have been poorly tested across the range of medical specialisms encountering these putative somatic conditions. Individuals who have a diagnosis of CFS or one of its allianced illnesses have, simply to maintain a semblance of sanity, to become their own doctor.  The CFS forums are rife with recommendations and affirmations of supplements, miracle foods and peculiar diets all backed up with the advertising drivel of the naturo/homeo -pathic industry. On the CFS forums these ‘colourful cures’ are acknowledged with enthusiasm, while in contrast the simple advice of qualified medical opinion, (backed by both research and logical assessment) is treated with either weary acceptance or outright disdain.  Beyond this incidental re-broadcasting of quackistry, and of a magnitude of greater concern, is what The Lay Scientist  blogger Dee Tee  accurately described as  “CFS sufferers discussing these powerful drugs [antivirals]  in the manner of kids choosing pick and mix at a candy store”. (see http://layscience.net/node/1052 ) .

That goji berry, flax seeds, mineral supplements or the ever fantastical ‘detoxification’ diets, should be touted as treatments or cures for an (at present) ineffable disease, should be no surprise, but the peculiarity of one single scientifically plausible hypothesis of disease causation attracting comparable tin foil hat  adherence needs some explanation. What is it that has given the ‘viral explanation of CFS’ such credence that people are now willing to expend large sums of money on treatments which themselves can have significant damaging effects ? The potential for CFS to be caused by a persistent viral infection was recognised over thirty years ago, and an incidental link between Epstein Barr Virus infection and subsequent CFS illness is well established, but until recently there had been no collective enthusiasm amongst those affected by CFS to actively seek antiviral treatments. The driver of this new enthusiasm has been the salvationist adoption by many of those affected by CFS (both sufferers and their carers) of the WPI  and the WPI’s championed hypothesised link between CFS and the putative XM Retrovirus (see http://www.sciencemag.org/content/326/5952/585.abstract ).

The character of the WPI and why it and the XMRV hypothesis should have become so attractive to some people affected by CFS are subjects worthy of further exploration and I hope to return to these in a subsequent essay. What I want to underline in drawing this post to a close is the inherent contradiction in the meta discussion being pursued on the CFS forums.  I would go so far as to describe the disjunction between, on the one hand the legitimacy of scientific process that produces reasoned hypothesis (a retrovirus may be causative of CFS) and on the other, snake oil recipe swapping, as a deliberative paradox. The paradox arises within the discursive processes of the online forums where deliberation is subject to an inherent sensibility (science can’t be trusted), but where one element of assumed scientific product (XMRV = CFS) has, in isolation from any reasoned acceptance of scientific principle, been settled upon as an iconised source of salvation. Thus goji berry and magnesium supplements appear side by side with tenofovir and raltegavir  in the proposed curative litany propounded on the CFS forums.

Does any of this matter ? I think it does; because both science and the interests of people affected by CFS (sufferers, their families, their carers) are harmed. Science is harmed by the development of yet another vector of hyperbolic misrepresentation, while those affected by CFS are opened up to multiple harms:  a dissuasion to trust the best available medical advice, the ingestion of damaging inappropriate and ineffective medications in circumstances of poor or even neglectful professional oversight, the adoption of hopeless belief in cures that can never materialise, the misdirection of limited research resources, and potentially, the loss of political and media concern as another overstated hypothesis deflates beneath the weight investigation. Those affected by CFS have a choice, conduct discussion of the illness and its causes on the basis that science is a whole process, not a market of products and suppliers from which the most attractive, fashionable and effectively advertised can be chosen as a matter of taste. Or, risk losing all credibility outside of forums which are in danger of becoming introverted and cultified gripeholes, lacking reference to the wider world and realistic notions of achievable wellness.