XMRV – ME/CFS Link to be Confirmed by FDA
Yesterday the Reno Gazette-Journal reported that Dr. Judy Mikovits, one of the lead researchers with the Whittemore Peterson Institute for Neuro-Immune Disease in Reno, said their findings of a link between the XMRV retrovirus and ME/CFS (chronic fatigue syndrome) has been replicated and confirmed by the FDA. According to Dr. Mikovits, the FDA's review of their findings is scheduled to be published in September.
You may recall that in early July I told you about the controversy generated when the CDC was allowed to publish the negative results of their XMRV study but the FDA's positive study was pulled so they could conduct additional experiments. (See More XMRV Controversy) Since then a number of scientists have criticized the CDC study as being flawed in its design. From what I've read, among other problems, they apparently used a method of testing that would not be likely to pick up the retrovirus – so it's not surprising they didn't find it.
I'm so pleased to hear the FDA study will be published soon. I believe it is the first study that has truly replicated the methods used by the WPI in their original research. From what I understand, XMRV is a tricky little retrovirus that is difficult to find. It stands to reason that scientists who use a different method of testing may not be able to identify it.
The RGJ quoted Dr. Mikovits saying, "There has been an issue over whether anybody could replicate our study, and it will not only confirm our findings but extend our findings, which is really exciting for us."
A Treatment on the Horizon?
Dr. Mikovits also told the RGJ that they have new, unpublished data on the XMRV retrovirus that could lead to a treatment for ME/CFS. She said they have immune system profiles by which they can tell how XMRV is doing the damage. They are working on a diagnostic test as well as an effective clinical treatment option for XMRV. She expects the new data to be published by the end of the year.
Dr. Vincent Lombardi, lead researcher for the original WPI study, anticipates starting clinical trials on possible treatment options soon. He noted that many drugs have been developed for HIV, which is also a retrovirus. He thinks that some of those drugs may be effective in treating XMRV as well. According to Dr. Mikovits, so far three drugs have been able to stop XMRV in lab tests. Their goal is to begin at least one clinical treatment trial before the end of the year.
I'm trying to maintain a practical, wait-and-see attitude, but it's hard not to get excited about the possibilities. After all these years, patients who have been called lazy or hypochondriacs and have been ignored by most of the medical community may finally be vindicated. And wouldn't it be wonderful to not only know the cause, but also have effective treatment options?
Ok, I admit it – I'm an eternal optimist. But I think, in this case, my optimism has some sound science behind it. And people I've talked with who are close to the WPI say their researchers are incredibly confident about the accuracy of their findings. So as of now, my hopes remain very high.
I'll keep you posted on the latest XMRV news and will let you know as soon as the FDA's research is published.
Source: Powers, Lenita. Reno chronic fatigue findings confirmed by federal agency. Reno Gazette-Journal. August 17, 2010.