Study that 'solves' chronic fatigue syndrome blocked
A study that supports the controversial link between chronic fatigue syndrome and a new type of virus has been blocked from being published in a leading scientific journal even though it had been accepted for publication by its editors. The study, by virologists working for the US Government's Food and Drug Administration (FDA), is believed to support earlier findings published last October claiming that patients with the syndrome, also known as ME, are likely to be infected with a virus called XMRV, which some scientists believe may trigger the condition.
However, American government officials have persuaded the journal, the Proceedings of the National Academy of Sciences, to hold off from publishing the scientific paper because it contradicted a second study by other government scientists at the Centres for Disease Control and Prevention (CDC), which like the FDA is also an arm of the US Department of Health and Human Services.
The CDC study did not find evidence for the presence of XMRV in patients with chronic fatigue syndrome, which led officials to postpone the paper's publication until the two government groups could clarify the discrepancy. However, the CDC paper has been published online by the journal Retrovirology after intervention by senior virologists concerned about it being held up.
Patients' groups fear there has been a conspiracy to suppress data in support of the idea that chronic fatigue syndrome is caused by a viral infection. However, scientists who have seen the FDA study have told The Independent that it is seriously flawed and should not be published in its present form because it cannot support its assertion of a link between chronic fatigue syndrome and XMRV.
Chronic fatigue syndrome affects about three in every 1,000 people – some 250,000 Britons – and results in severe physical and mental exhaustion. For many years it went unrecognised as a genuine medical condition and many doctors today would say that it has a psychological as well as a physical basis, but few believe it is caused solely by a viral infection.
However, last October the journal Science published dramatic findings suggesting that XMRV – murine leukaemia virus-related virus – could be infecting the vast majority of chronic fatigue patients. The work was carried out by a team led by Judy Mikovits, director of research at the Whittemore Peterson Institute in Reno, Nevada, who said that the discovery of a viral cause of the condition could revolutionise the treatment of ME.
Nevertheless, several attempts to replicate the findings by Dr Mikovits failed to establish a link between XMRV and the condition. Two groups in Britain and one in the Netherlands published studies showing no links to the virus, and three other groups, two in the US and one in Europe, have reported negative findings at conferences.
But in May, at a blood safety meeting in the Croatian capital of Zagreb, a respected virologist, Harvey Alter of the US National Institutes of Health Clinical Centre, gave a talk where he told the audience that he and his colleagues have independently confirmed the Mikovits' study, which is "extremely strong and likely [to be] true".
It is this study, led by Shyh-Ching Lo of the FDA laboratory in Bethesda, near Washington DC, that was submitted to and initially accepted by the Proceedings of the National Academy of Sciences. However, when officials from the Department of Health and Human Services heard about it they took fright that it would contradict the only other American study into XMRV and the syndrome that was ready for publication, according to sources.
William Switzer of the CDC failed to find any evidence for the presence of XMRV in 51 patients with chronic fatigue syndrome and a similar number of healthy people. "These data do not support an association of XMRV with [chronic fatigue syndrome]," the researchers concluded in their paper published in the journal Retrovirology.
Dr Mikovits said that the study was flawed because it failed to use patients that had been formally diagnosed with chronic fatigue syndrome and it failed to use "positive controls" in the form of blood from people who were known to be diagnosed with XMRV infection.
"We've now got more than 1,000 individual patients from around the world in whom we've detected and isolated the virus ... no, I haven't changed my mind on this," Dr Mikovits said.
XMRV was originally found in men suffering from prostate cancer and it was this discovery that led Dr Mikovits and her collaborators at the US National Institutes of Health to test blood samples stored from patients with chronic fatigue syndrome.
Shelly Burgess of the FDA said: "The FDA/NIH paper has not yet been accepted for publication. The paper is currently undergoing a rigorous scientific review process."
The Proceedings of the National Academy of Sciences declined to comment
ME: the facts
* Chronic fatigue syndrome, or ME as it is often called, affects about 250,000 people in Britain and is estimated to have blighted the lives of some 17 million people worldwide.
* It was originally known by the derogatory term "yuppie flu" and was dismissed by many medical authorities as not a genuine condition with a physical basis.
* The condition seems to affect more people in their 40s and 50s although it can affect children and adolescents. More women than men report having the symptoms which can range from relatively mild tiredness to severe physical and mental exhaustion.
* Common symptoms can include impairment of short-term memory, sore throat, tender lymph nodes, muscle and joint pain, headaches and unrefreshing sleep. The main symptom however is chronic fatigue lasting for four months or more.
* Treatment can include cognitive behavioural therapy, a psychological approach to treat people with the severest symptoms. Physical treatment can include graded excercise therapy, where patients are encourage to gradually do more to combat their feelings of exhaustion.
* There is no strong evidence that the condition is infectious, although close relatives of a sufferer are at higher risk, possibly because of a genetic predisposition.
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