25 June 2010

The topography of scientific enquiry, Part Three

"We (FDA & NIH) have independently confirmed the Lombardi group [which published the original Science paper] findings.”  Harvey Alter, chief of the Infectious Disease Department, NIH.

“It’s what we’ve been waiting for" Annette Whittemore, of the Whittemore Peterson Institute.

The publication of a paper in the Journal 'Science', in October 2009, brought about an excited and hopeful response from ME/CFS patients worldwide - even here in New Zealand. Initial research, conducted at the Whittemore Peterson Institute, by a team of retrovirologists, indicated that a retrovirus, XMRV (Xenotropic Murine leukaemia virus-Related Virus) was present in initially 67% of ME/CFS patient blood samples. Subsequent studies by the same researchers, Lombardi, et al., eventually identified the virus in 95% of CFS patient samples.  After decades of lack of treatment, no diagnostic criteria, and apathy and dismissal from the medical community, this was
the moment that few of us had dared to hope for. 

In the past several months since the Lombardi, et al. paper was published, a number of supposed replication studies have been conducted which have challenged the findings of the WPI.  As discussed in the previous blog entries titled 'Topography of scientific enquiry', and 'Topography of scientific enquiry - part two', in response to any new avenue of research, the scientific community has a responsibility to replicate and correlate the results, in order to validate the initial hypothesis and consequent findings.  In this case, there was a responsibility to acquire a cohort of well-defined ME/CFS-positive blood samples, test them for XMRV, and establish if the WPI were plucking at straws, or had indeed really identified something big.  This replication process requires an accurate understanding and implementation of the same techniques, protocols and procedures used by Lombardi, et al., and equally importantly, to have a motive towards understanding the medical mystery which is ME/CFS

Right form the outset, the stakes have been high for everyone involved, careers have been built on the establishment of ME/CFS as a psychosomatism, or Neuralgia, plenty of money has been withheld in the form of benefits for those who cannot work, children have been sectioned, individuals have been put through detrimental graded exercise programs, and worst of all, lives have been lost.  So when the initial, so-called replication study, published in PLoS, came back negative, it wasn't surprising to the patient/advocate community, nor did it contribute any further scientific insight, or hypothesis, to the understanding of ME/CFS.  Instead, what has since followed in the past few months, has been a rather public controversy.  Judy Mikovits, research scientist at WPI suggested that XMRV is unusually difficult to find, McClure, et al., responded that it was their belief that the discrepancies in their published findings indicated a different pathology of the disease in the UK, from that which was in the USA. It was suggested that the samples and/or equipment, used by the WPI was contaminated, WPI publicly offered to send some XMRV-positive samples to the UK, and so on and so on. Meanwhile, ME/CFS patients and advocacy groups, continued to wait, watch and hope.

As of 22 June, 2010, it seems that the exact thing we are waiting, watching and hoping for is about to be officially published.  A press release, dated 22 June 2010, states that  Harvey Alter, a medical researcher, virologist, physician, and chief of the infectious disease centre at the National Institute of Health, made a presentation on blood supply, in May 2010.  Alter made a slide show presentation which addressed potential contamination of the blood supply, and protecting the supply from disease.  The presentation was made in Zagreb, to select individuals, and included a slide that referred to the XMRV-CFS association as "extremely strong and likely true, despite the controversy" (Marcus, 2010).  The slide went on to state that the connection between XMRV and ME/CFS “is very strong, but causality not proved.”.  Furthermore, Alter and his research team estimate XMRV and related viruses to be present in three to seven percent of blood donors, in comparison to the four percent cited in the Lombardi, et al. paper.  At the end of the slide, was the statement “We (FDA & NIH) have independently confirmed the Lombardi group [which published the original Science paper] findings.” (Marcus, 2010). A spokesperson for the NIH has confirmed the authenticity of this presentation, however, there has been no further formal comment or release from the NIH, and Alter himself has made no comment, except to confirm the paper containing this data is to be published soon.


References:

Marcus, A D., (2010). Further Evidence of an XMRV-Chronic Fatigue Syndrome Connection? Retrieved on 25 June, 2010, from http://blogs.wsj.com/health/2010/06/23/further-evidence-of-an-xmrv-chronic-fatigue-connection/

Gendringen, N L (2010). Original Press Release from the Netherlands: FDA and NIH confirm 'XMRV findings'.  Retrieved on 25 June, 2010, from http://www.mmdnewswire.com/xmrv-9040.html

Perry, S., (2010).  An update on the chronic-fatigue-syndrome controversy.    Retrieved on 25 June, 2010, from http://www.minnpost.com/healthblog/2010/06/24/19180/an_update_on_the_chronic-fatigue-syndrome_controversy

Links:

Dr. Harvey Alter's NIH profile: