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Lipkin Study Ends XMRV Saga: Lipkin Promises Progress on ME/CFS

  [ 64 votes ]   [ Discuss This Article ]
By Cort Johnson* • www.ProHealth.com • September 20, 2012


Many thanks to ME/CFS science news analyst Cort Johnson for sharing this informative perspective on the Lipkin study and where we go from here.

_______________________________

"XMRV is simply not there... It is time to move forward" - Dr. Judy Mikovits
 

It's finally over. Few expected anything other than what the study found - no XMRV or pMLV's in ME/CFS patients.

Still, this was the Lipkin study, the most rigorous of them all, and there was always some hope tucked away that it would come up with something new.

But it didn't; the XMRV/pMLV saga is officially  over.

The Study

"The disabling disorder known as chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME)..."

The list of co-authors - Mikovits, Alter, Ruscetti, Peterson, Klimas, Komaroff, Coffin, Hornig and Lipkin and more - was long and impressive. The study started off emphasizing, for those not clear about it (and there are still many) that chronic fatigue syndrome is a disabling disorder, which is also called myalgic encephalomyelitis and 'CFS/ME'.

The study involved six centers (Incline Village, Boston, New York, Palo Alto, Salt Lake City and Miami) run by noted ME/CFS physicians. All participants whose blood was analyzed met both the Fukuda and Canadian Consensus criteria definitions and had viral onset. Dr. Mikovits oversaw the trials in the Ruscetti and Hanson labs, and the CDC and FDA labs ran their own tests.

Pale, bespectacled and with tousled hair, Dr. Lipkin certainly looked like a lab rat as he opened the Press Conference with an overview of the XMRV saga. He emphasized that they tried to hedge the study to favor an infective process by focusing on flu-like symptoms (fevers, lymph node enlargement, etc.), by enrolling people with acute flu-like onset, and by collecting control and patient samples within weeks of each other to capture an infective event.

In what he described as one of the most rigorous studies he's ever been involved in, Dr. Lipkin noted that the 300 people participating in the study came from six geographic centers ('catchment areas'), and extraordinary measures were taken to ensure no contamination was present. Each team was allowed to use methods of their choosing.
 
Results
 
All teams were able to identify which samples had been spiked with XMRV, but no teams found XMRV or pMLV's in any patient or control samples; a clear indication that the initial findings in the Oct 2009 Science paper were the result of contamination either at the WPI or in samples brought into the WPI or both. Dr. Ruscetti stated there was little chance we'll ever know definitively where the contamination occurred.

Dr. Mikovits made it crystal clear that the XMRV saga was over, stating that although she was disappointed with the result, "XMRV is simply not there... We are 100% positive in our results… It is time to move forward."
 
To the question of whether XMRV could be still present in the tissues, Dr. Alter stated that it was highly unlikely that a systemic infection would not show up in the blood stream, and he implored the patient community to resist the temptation to keep the XMRV/pMLV story alive. This study, he said, “was definitive.”

Dr. Lipkin lauded Dr. Mikovits, Dr. Ruscetti and Dr. Alter, stating that participating in the study took extraordinary courage and that he'd never seen researchers put themselves through such a gut-wrenching process to re-examine their own findings. Clearly protective of the three researchers at the table, Lipkin cut off a question to Dr. Mikovits and Dr. Rucscetti asking why it took them so long for them to understand XMRV was not going to work out.
 
No Single Cause for Chronic Fatigue Syndrome

Neither Lipkin nor Alter believe there will ever be a single cause or pathogen for ME/CFS.

Holding out encephalopathy as an example, Lipkin noted it can be caused by a virus, toxicity, cancer, and many other factors (including nutritional problems, bacteria, auto-immune disorders, metabolic problems, etc.). He clearly believes the same will hold true for ME/CFS.
 
Instead of a single cause, Lipkin pointed to "the three strikes theory” which suggests that genes, environment and timing all conspire to create ME/CFS - and referred to animal studies showing that early events can set the stage for problems years later.

While leaving the viral question open, Lipkin suggested the body’s response to viruses may play a larger role than the viruses themselves. People with ME/CFS could be reacting abnormally to normal levels of a virus; or a virus could kick off a chronic response and then completely disappear - leaving a dysregulated system behind. 
 
One focus in the future will be to analyze proteins in the blood to find aberrant pathways that can be targeted by drug therapies. In this scenario, which may be the quickest to produce results, the ultimate cause of the disorder is bypassed, at least early on, in an effort to uncover problems that drug therapies can attack.
 
The Silver Lining

"There will be progress..." - Dr. Ian Lipkin
 
Speaking to what he probably imagined was a dispirited ME/CFS audience, Dr. Lipkin talked about the silver lining the XMRV discovery had produced by propelling ME/CFS to the front of the scientific stage.

He said he had been asked again and again if this is the end of ME/CFS research… but he felt that "Nothing could be further from the truth" and that XMRV put a spotlight on chronic fatigue syndrome he felt was going to shine “for decades” to come.

People were working together on ME/CFS, he noted, who have never worked together before; and he made an emphatic pronouncement, "There will be progress."
 
Looking back at his own 1990 negative Borna Virus/ME/CFS study, Dr. Lipkin emphasized the enormous amount of immune activation he'd uncovered, with two-thirds to three quarters of the patients exhibiting polyclonal B-cell activation. ME/CFS, he said, "is not a psychosomatic disorder.”
 
XMRV did come crashing down like some rogue wave, but in its wake new efforts and new initiatives have popped up regularly.

Since XMRV hit the news, the Chronic Fatigue Initiative, Simmaron Institute, Dr. Montoya's Chronic Infectious Illness program, Dr. Klimas’ Neuro-immune Institute, Dr. Enlander’s Mt. Sinai Research Center, the Open Medicine Institute, and PHANU in Australia have either formed or made big strides forward.
 
Not least of these is formation of the impressive 300-person NIH Biobank, containing the most rigorously characterized, acute onset ME/CFS samples in existence. A potential goldmine for investigators, and it appears that immune biomarker, epigenetic and gene expression studies might already be underway.
 
Encouraging Advocacy
 
Somewhat unusually for a researcher, Dr. Lipkin remarked what a  “huge difference” advocacy and political leadership played in getting autism significant funding - and he encouraged ME/CFS patients to be active in the political arena. If the NIH puts money forward for ME/CFS, researchers will come…

Turning Point for Virologists?
 
The authors of the Lipkin report, many of them virologists, made the extraordinary admission, in the highly visible abstract, no less,  that current pathogen detection methods don't work and need to be refigured before more precious funding is lost on another pathogen that doesn't work out.

Outlining what's become very clear to ME/CFS patients over time, they noted that research communities’ lack of a 'coherent' or strategic' approach to discoveries like XMRV has cost them greatly in terms of time and money.
 
"It is imperative that strategies be developed to rapidly and coherently address discoveries so that they can be carried forward for translation to clinical medicine, or abandoned to focus resource investment more productively." - the Lipkin Report 
 
One senses the XMRV saga may have been big enough and expensive enough to become a defining moment for molecular biologists.

- Cort Johnson, Sep 18, 2012

References:

The full text of the Lipkin et al. XMRV study report, published Sep 18 by mBio, is HERE.

YouTube coverage of the XMRV study press conference, led by Dr. Lipkin, is HERE.

___

* Cort Johnson is an internationally known and respected reporter/analyst whose beat is ME/CFS science, advocacy, and politics. An ME/CFS patient with MCS, Cort conceived, founded and built the patient-run and oriented Phoenix Rising website.



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