Thursday, 17 February 2011

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.    

4 comments:

  1. Whittemore has made in clear, numerous times, in numerous independent interviews that she 'just knew' what was wrong and 'just knew' CFS was connected to Gulf War Syndrome and Autism and everything else under the sun, she just didnt have the science to back it up (enter Mikovits).

    As much as I love the retroviruses I work with, I do not have a psychic connection with them.

    Also, yeah, lol-- weird how as an immunology grad student being paid by an immunology NIH grant has never heard the phrase 'neuro-immune disease' used the way WPI uses it. But Ive also never heard the word 'quasispecies' used the way Mikovits has used it, either. So either my education and reading of publications in PubMed are profoundly deficient, or theyre just making shit up, lol.

    ReplyDelete
  2. Great article with many important points to consider. I especially appreciate that you point to actual facts rather than inventing a conspiracy theory (of which there are more than enough on both sides of the issue). I'm adding your blog to my RSS feed.

    ReplyDelete
  3. There was a poster presentation by the WPI at the first XMRV conference. They studied (from memory) 17 children and related adults with "neuro-immune" disorders. Eleven were autistic (or related to autistic people). The conclusion "no significance can be drawn from these results". Kent Heckenlively's wife and autistic daughter were studied. His wife was positive and his daughter negative (chance, we all know that now). For a while this research was quoted by the WPI and supporters as proving a connection between XMRV and autism. I'm afraid the scientific awfulness of this goes very deep

    ReplyDelete
  4. 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.

    It would be nice if we could do this "blank slate" type of scientific inquest, but we every researcher needs to have a "paradigm" he/she follows. Well, from the looks of it, the paradigm of the WPI is wrong. But what about the paradigm behind the MS research? Or Autism? Or any other of those other "neuro-immune" diseases mentioned by the WPI? I would argue that one has to have a *different* paradigm and follow it, in order to make progress in any of those diseases. That different can be (and probably is) wrong, but unless we follow new lines of inquest, we will not make real progress towards understanding and curing these diseases (improved medication/treatment withstanding).

    ReplyDelete