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 and 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.

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