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Friday, 18 May 2012

Profit and Loss

For patients to have confidence in the doctors treating them, it is essential that each patient is certain that treatment recommendations given by their doctor, are made on the basis of an absolute absence of conflict of interest. Where a physician includes in their prescribed treatment, products which directly benefit a doctor financially, doubt must arise as to whether the doctor is prescribing the best option, or simply the most profitable one. Similarly when medical researchers move from involvement in scientific investigation to the provision of tests sold for profit, trust in the researchers’ motivations are likely to be lost on the part of those who are looking to the researchers for answers to serious medical problems – a circumstance aptly illustrated by the XMRV tests offered by the VIPdx/Redlabs(US) company under licence from the Whittemore Peterson Institute. 

Medical research is expensive and it is inevitable that research organisations will seek to protect their investments of time and money by lodging patents and by licensing products and methods. There is however a need for full transparency in such arrangements if there is not to be the suspicion that research has been constructed to promote the financial interests of the researchers, rather than to produce meaningful data.    

The relationship between VIPdx/Redlabs(US) and the Whittemore Peterson Institute had always suffered from a confusion and lack of transparency and this problem appears to extend to a European group of companies with which VIPdx/Redlabs(US) and the Whittemore Peterson Institute have connections.

The Suhadolnik Connection 

In 1998  Robert J.Suhadolnik , with  Daniel L Peterson , Paul R Cheney about, Susan E. Horvath, Nancy L Reichenbach, Karen O'Brien, Vincent Lombardi , Suzanne Welsch, Elizabeth G. Furr, Ramamurthy Charubala, and Wolfgang Pfleiderer produced a paper:  BiochemicalDysregulation of the 2-5A Synthetase/RNase L Antiviral Defense Pathway inChronic Fatigue Syndrome  Also in 1998 a business was incorporated in Belgium under the name of R.E.D Laboratories , the partners in which included Suhadolnik, Peterson, Charubala, Reichenbach and Pfleiderer. The current partner list comprises: 
Catherine Suzanne Armande Bisbal

Pascale Josse Florence de Becker

Isabelle Willie Luce Campine

Ramamurthy Charubala

Charles Vincent Taylor Herst

Bernard  Lebleu

Kenny de Meileir

Daniel  Peterson

Wolfgang Pfleiderer

Nancy L Reichenbach

Tamim Salezada

Robert J. Suhadolnik


Data from Coface Services

Red not R.E.D Laboratories

Although the two businesses have a similar name, there’s no public record of there being any corporate financial involvement between Redlabs(US) and R.E.D Laboratories. The ownership of Redlabs(US) is somewhat obsure being part of the Whittemore/Seeno corporate debacle , there is however a partner level connection between Redlabs(US) and R.E.D Laboratories, and that is via Charles Herst who according to a 2006 version of  Redlabs(US) website  was the company’s Laboratory Supervisor. Dr Herst parted company with Redlabs(US) in 2006, interestingly Dr Herst notes his involvement with Redlabs as dating from 1998 (being both President and Lab Director), which is sometime before the Nevada business register gives a date for incorporation of Redlabs, the business may therefore have operated under a different name and ownership prior to 2004, with possible closer links to R.E.D Laboratories than are currently evident. In 2006 Redlabs(US) listed as its Director of Operations, Vincent Lombardi, who is one of the listed authors of the 1998  Suhadolnik  paper, Lombardi was subsequently employed by the WPI and is now its Principle Investigator.

The Redlabs(US) website previously carried an ordering guide prepared by Dr Kenny de Meileir of R.E.D Laboratories. Dr de Meileir and Carine Muyldermans were the managers of a now revoked  Nevada registered company  called 8 Diamonds  the Registered Agent for which was Carli West Kinne, who is now the Senior Vice President and Legal Counsel of the Whittemore Peterson Institute and who has also served  as Registered Agent for many businesses in the Whittemore/Seeno owned corporate structure.  According to the European Society for ME, in 2010 R.E.D Laboratories(Belgium) entered into a licence agreement with the Whittemore Peterson Institute to provide the unvalidated WPI XMRV test, to European clients.

R.E.D Laboratories (Belgium) has two subsidiaries, a supplements supplier called Protea Nutraceuticals Ltd and product developer Protea Biopharma. Protea Nutraceuticals Ltd is listed by the Dutch Chamber of Commerce as being wholly owned by R.E.D Laboratories, with its Assignee being Marc Fremont, who is also listed as the Managing Director of Protea Biopharma (data Coface Serices) as well as being Chief Scientific Officer at R.E.D Laboratories. The listed address of Protea Nutraceuticals (Noordstraat 3, 4641SE Ossendrecht) is also that of Kalida B.V which is also a supplements business, the director of which, the Dutch Chamber of Commerce records as being Carine Jean Rosa de Meirleir-Muyldermans, who is apparently the spouse of Dr Kenny de Meileir. The domain listing of kalida.be and kalida.nl records the registrant as being Peter van Oosterhout, whose email links to the website of an engineering company at the same Noordstraat 3 address. The Share, Posted and Paid-In capital of Protea Nutraceuticals Ltd is exactly the same as for Kalida – EUR 90,000, EUR 18,000, and EUR 18,000 respectively.

Listed as Managing Director alongside Marc Fremont at Protea Biopharma is Christian Roelant, who has published research with Kenny de Meileir and with de Meileir and Fremont, these research papers appear to underpin products marketed or planned to bemarketed by R.E.D Laboratories.

Bernard  Lebleu, Catherine Bisbal,  Pascale de Becker, Isabelle Campine have published with de Meileir A 37 kDa 2-5A binding protein as apotential biochemical marker for chronic fatigue syndrome, all the authors being listed as from Department of Human Physiology and Medicine, Vrije Universiteit Brussels. Lebleu, Bisbal and Tamim Salezada are elsewhere listed as being at  Universit√© Montpellier.  Charles Herst is listed  as having 6 co publications with De Meileir and 3 with Marc Fremont who like Lebleu, Bisbal and Tamim Salezada is also listed as associated with Universit√© Montpellier.   

Transparency of researcher and treating physician interest 

Exploitation of research is of course the point of a company like R.E.D Laboratories, however it may be considered that there are legitimate questions about why a science based company would involve itself in the marketing of nutritional supplements, about the apparent lack of relevant statements of conflict of interest in published articles authored by the R.E.D Laboratories partners, and the potential conflicts of interest that Professor de Meirleir, or indeed Dr Peterson may potentially face in their prescribing practices when engaged in treating patients. Of course there may be no impropriety involved at all, but transparency is desirable. The  National (US)CFIDS Foundation has published a highly critical statement about Professor de Meirleir  . The criticism centres on Professor de Meirleir’s role as editor of TheJournal of Chronic Fatigue Syndrome and his delay in publishing research that the National (US) CFIDS Foundation considered was fundamental to progress in understanding CFS. The contention being that the delay was mediated by Professor de Meirleir’s wish to obtain patents on various aspects of the research.

The Journal of Chronic Fatigue Syndrome is no longer published and the research about which the National (US) CFIDS Foundation was concerned no appears to have been less promising than was first thought, however the issue of conflict of interest, where private business is involved remains an issue, and as the VIPdx/WPI XMRV testing issue demonstrates, transparency is vital if patients are to be able to make informed choices of where to medical advice and what interventions may indeed be justified, whether those interventions involve tests or claimed treatments.

Saturday, 18 February 2012

A Nasty Case of Infection

When Richard Dawkins developed the idea of the meme he considered them as behaving like free floating viruses infecting human cultures at will, the meme hypothesis is by no means universally accepted but it’s certainly an attractive explanation of human behaviour  in the face of the adoption of notions which patently offer no reasoned advantage to those individuals and groups who absorb these ‘memes’ and make them their own. A particularly virulent infection is sweeping through groups of people who are affected by M.E/CFS – the condition known as  antivax .

 A loss of Immunity 

The death knell of the XMRV hypothesis of M.E/CFS causation, tolled by accumulating evidence and culminating in the BWG study has caused a significant degree of cognitive dissonance  amongst a proportion of M.E/CFS affected people.  There has long been an element of collective concern about vaccination amongst M.E/CFS affected people because of reports of the illness having been initiated by a vaccination, or of vaccination having initiated a relapse, although these reports are rarely tested against the metric of  “correlation does not equal causation” .  Following the demise of XMRV however, there has been a definitive move to describe M.E/CFS as a vaccine induced illness and to link with antivax voices from the Wakefield  inspired “autism as vaccine damage” school of unthought.  Embracing the antivax position seems bizarre, both from a perspective in which M.E/CFS advocacy has long sought scientific and medical acceptance in the face of (at times undue) profound, scepticism, and from a perspective which advocates speculative treatment of M.E/CFS with drugs of significant toxicity. Being seen by the medical profession to be openly supportive of an antivax position can only reduce further, the already low regard that many medical professionals accord the validity of M.E/CFS as a definitive organic illness. It is in simple public relations terms, the equivalent of voluntarily stuffing one’s head in a toilet bowl, taking pictures and posting them on the Internet – a way to ensure perpetual derision. 

Why Oh Why Oh Why ? 

Apart from unalloyed desperation to fill the void of the lost hope of XMRV, why are M.E/CFS affected people willing to throw their lot in with an activist position such as antivax, that itself has so singularly failed to achieve any credibility amongst scientists and medics and indeed serves only to alienate all but scientific frauds or those determined to ply a trade unburdened by the demands of logic and scientific discipline   

Direct appeals to antivax authority are actually rare on the M.E/CFS dedicated forums, pro antivax positions are usually limited to quotes of approval for Wakefield and his supporters and allusions to ‘vaccine harm’. Somewhat typical is the defensive approach taken in the case of  Prof. John Walker-Smith who is currently seeking the support of the High Court in London in turning over his being struck of the medical register following an inquiry into his part in the Wakefield study . Walker-Smith is discussed on various M.E/CFS forums by some contributors as though he were a victim of an establishment conspiracy instead of someone found guilty of significant professional failings.

In a ‘break from the usual cover’ adopted by antivax sympathetic M.E/CFS affected people, Dr J. Deckoff-Jones , formerly of the Whittemore Peterson Institute and an advocate of antiretroviral treatment for the assumed (not XMRV) ‘retrovirus’ that is a supposed causative of M.E/CFS, has posted Blog entries which have included:

But then, introduce vaccines, and lots of them, from many different animal sources, plus killed vaccines containing adjuvants. Isn’t there a significant risk of unanticipated recombination events, not to mention persistent immune activation favoring virus?”

and

“Pretending it isn’t happening because the MMR vaccine doesn’t “cause” autism, is about as idiotic as saying that our disease isn’t retroviral in origin because XMRV was probably a contaminant.”

these comments  have brought approving responses and encouragement for Dr Deckoff-Jones.

There is perhaps some explication in Dr D-Js posts as to why antivax, might be an attractive position for some M.E/CFS affected people.  In the face of a sense of having been rejected by ‘main stream’ science, and being only of determined interest of psychiatry,  the notion of ‘outsider science offers both apparent safety and legitimacy (of a sort) , a place where the renegade scientist breaks with convention and achieves cures denied to a dispossessed patient population by a venal ‘establishment’. Antivax is attractive because it offers an alliance of the self described dispossessed.  The wish to belong 'somewhere' is a powerful motive but in the case of 'antivax',  if acted upon it will leave M.E/CFS perpetually locked into an ‘anti science’ association of outsiders, lacking any real purchase on either the administration of science or the realm of political oversight. It is a motive of emotion, that appears more suicidal than constructive, and raises a substantial question mark over the legitimacy of future M.E/CFS advocacy.     

Sunday, 29 January 2012

Good Science can't happen in Bad Institutions

When I started this blog it wasn’t with the intention of becoming slewed with the dubious nonsense of Mikovits’ XMRV non disease or the diabolically misbegotten organisational debacle of the Whittemore Peterson Institute. Scientific attention is thankfully moving on from XMRV and key funding agencies are breathing new life into M.E/CFS research, what is essential though is that the whole horrible story of the WPI needs to be told as a warning to the future. March will bring some edification via Mikovits’ appearance in Court on theft charges following a complaint by her former employer the Whittemore Peterson Institute.  Hopefully this case will elucidate why Mikovits felt compelled to commit acts which appear potentially criminal,  and also to expose whether there were indeed failings of science at the WPI. In the mean time the whole WPI edifice appears to be in a state of potential collapse.


Really, I mean, really, really – It was the money stupid !

Lets just recap – the Whittemore Peterson Institute is a non profit organisation, its funds have either come from public donation, large individual donations, or Government Grant; the only public records of large single donations are those from the Whittemore family via the Whittemore Family Trust. From the creation of the WPI its president has been Annette Whittemore who has also held the unpaid position of CEO; the Board of WPI has had up to five members but on occasion that has been down to just two, with Annette Whittemore the only constant presence. All other Board members have been close associates of the Whittemore family. I’ve written previously about how this lack of breadth of Board representation is problematic in that it exposes both the members and the organisation to concerns about lack of broad perspective and issues of conflict of interest. Such concerns now appear substantiated because Annette Whittmore along with her husband has been named in a Lawsuit that implicates the Whittemores in a multimillion dollar, multifaceted fraud to which the WPI itself is linked.

You think it couldn’t get worse ? Think again   

The most interesting aspect of the claims against Harvey Whittemore is that not merely has he defrauded his business partners, but that he has acknowledged this as fact and that the case now only comes to Court because he has failed to fully recompense those he has defrauded despite having previously promised to do so. However the Whittemores are contesting the allegations, describing them as entirely false.

It is beyond the scope of this blog to cover all the intricacies of the 41 page legal suit, in simple terms however the complaint is that: Harvey Whittemore, in part, and in cooperation with Annette Whittemore and up to ten as yet unidentified individuals and ten as yet unidentified corporations plus a limited partnership called The Lakeshore House Limited, is alleged to have defrauded his partners in three companies, Wingfield Nevada  Holdings Company LLC (Wingfield), Tuffy Ranch Properties LLC and The Foothills at Wingfield LLC.  

The Document of Complaint lodged with the Court provides an impressive depth of detail and scope of the alleged misconduct by the Defendants, an item of particular interest to M.E/CFS affected people is a mention of Redlabs, the company that marketed the  XMRV test licensed by WPI. Redlabs is not recorded as being a particular focus of any fraudulent activity but the Plaintiffs do claim that in 2004 Harvey and Annette Whittemore, via their The Lakeshore House Limited partnership sold 50% of several businesses including Redlabs to one of two companies owned by Thomas Seeno. The remaining interests in these companies held by The Lakeshore House Limited partnership together with Mr Seeno’s previously purchased interests were then, in 2005, transferred to either the Wingfield Nevada Holdings Company LLC or The Foothills at Wingfield LLC. From 2005 Redlabs was therefore wholly owned by Wingfield, its registration in the name of Harvey Whittemore  being in accord with Whittemore being the manager (but not sole owner) of Wingfield .  An important aspect of the complaint against Harvey Whittemore is that he withheld information from his business partners, it is therefore appropriate to ask, whether his partners were aware of the License agreement with the WPI for the XMRV tests, whether they considered sale of the non FDA approved tests to be ethical business and whether they considered the $226,652  paid to the WPI in licensing fees in 2010, to be justified ?   Further questions will no doubt be asked by the Plaintiffs in respect of how the operational activities of the Redlabs (operating as VIPdx) commercial business was seemingly transferred to the benefit of the WPI, via creation of UNEVX as a for profit corporation owned by the WPI.

Don’t Mix Business with Charity  

Aside from the ‘for profit’ Redlabs/VIPdx company, the Document of Complaint against Whittemore and others, lists amongst numerous charges of alleged fraud, a number of incidences which directly involve the Whittemore Peterson Institute. These are:

  • Diversion and donations of assets and equipment from a Wingfield called Wild West Sound Company Inc. (renamed – Western Electronics Inc.) to (amongst others) the WPI. 
  • Diversion of funds disguised as donations to WPI.
  • Improper and abusive use of Wingfield personnel for WPI purposes.
  • Harvey Whittemore caused aircraft leasing costs of over $2 million to accrue to Wingfield accounts in support of private use made by him and Annette Whittemore and others, including travel related to WPI activities which it is claimed alone amounts to $346,546 remains unreimbursed. 
  • Annette and Harvey Whittemore directed employees of Wingfield to work on WPI at Wingfield’s expense, it is specifically alleged that Annette Whittemore represented herself as having management authority at Wingfield.
  • A 'PR' Agency retained by Wingfield was directed to do work for the WPI without any recompense being paid to Wingfield.  It I claimed that Wingfield’s Director of Marketing Angelina Wyss-Gordon [Angelina Gordon] who at the same time was the WPI Director of Marketing and Events http://www.wpinstitute.org/about/about_execboard.html, instructed the Agency that all work carried for WPI should be charged to Wingfield.
  • Harvey Whittemore permitted Annette Whittemore to charge compensation and other employee expenses of the WPI to Wingfield.
  • Specifically Annette Whittemore caused 75% of Dr J.Mikovits’ salary ($185k) to be charged to Wingfield as was the $42,000 relocation expenses paid to Dr Mikovits.
  • Currently unnumerated expenses of other WPI staff and consultants were paid for by Wingfield.
  • A Wingfield owned company, the Redhawk Golf Course and Entertainment facility was used at the direction of Harvey and Annette Whittemore for fundraising events for the WPI for which fees were not paid, the costs are claimed to exceed $157,000.
  • Harvey Whittemore solicited grants and donations from businesses dealing with Wingfield, which were of benefit to the WPI, but which were undeclared to the owners of Wingfield, to their detriment.
Should any of these claims be true then huge embarrassment would be attached to the WPI, and by association, the wider cause of M.E/CFS research. 

Fall Out 

The Plaintiffs are seeking a court hearing in front of jury, in addition copies of the documents are with the Nevada police and it seems highly likely that criminal investigations will now follow, such  investigation would necessarily involve the WPI as an institution. While apportionment of criminal blame or civil liability remain to be properly tested, it is abundantly clear that the management structure of the WPI leaves it profoundly exposed, and there must be serious questions about it’s long term future despite it having been recipient of  millions of dollars in public funding in the last 4 years. The positions of both Annette Whittemore and  Angelina Wyss-Gordon are to be tested in public if a trial goes ahead, but it would seem likely that all those who have served on the WPI board since WPI was first set up will be called upon to give evidence to investigatory authorities – and those may be multiple. The position of  Carli West Kinne , current Vice President and long term General Council at WPI would seem to be potentially quite difficult given her listing as Registered Agent for many Whittemore ventures, including Wingfield, as well as the Whittemore Family Trust. 

Other investigatory authorities seem likely to have a great interest in the Wingfield case, some of what is alleged would seem to have Federal relevance, and in respect of the WPI there are aspects which are likely of concern to the IRS in respect of WPI’s annual returns. For example should the WPI have declared costs for fundraising or airfares, and those costs have not been paid then a false declaration has been made. And questions then arise as to what has happened to the unaccounted funds. The role of Federal Grant giving agencies must also be in question – was there due diligence to ensure that WPI was fit and proper recipient ? 

XMRV was a disastrous association for M.E/CFS in terms of research credibility – the associated publicity has in fact been played well by a few effective advocacy organisations and the harm that could have resulted has been largely mitigated. The possible implosion of the WPI, a consequent association with illegality and with it a loss of credibility for M.E/CFS fundraising and advocacy would be a further blow that M.E/CFS affected people should not have to endure. How organisations are structured matters – good intentions are not enough, nor are smiling lobbyists with promises of donations beyond dreams the stuff of long term research stability.  M.E/CFS affected people and their advocacy organisations must ensure that in future support is only given where sound institutional practices are demonstrated and guaranteed by external measures.