Sam: Annette, can we just start out with a brief simple explanation of what neuro-immune diseases are, including ME and CFS?
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1 Sam: Annette, can we just start out with a brief simple explanation of what neuro-immune diseases are, including ME and CFS? Annette: They are systemic diseases that impact the nervous system and immune system. ME/CFS is a very, very complex disease and we believe that it is infectious, that there are very many organisms involved, and that it will require a comprehensive set of treatments to bring about (clinical) change. Sam: The retrovirus XMRV that has showed up in research was found to be in a majority of folks not only suffering with ME/CFS but also prostate cancer. What has been the result in terms of the worldwide reaction to this? Judy: We have had a very exciting year, interactions with Norway, Spain, Belgium. Different groups throughout the US, in the US in the SE and NE. Many groups are into the research, excited about the research, and actually detecting XMRV in their patient populations. Sam: 4 papers were published this week in the journal Retrovirology and according to the WSJ it demonstrated according to the authors how easy it could be for mouse contamination to skew results on XMRV. Thoughts on Retrovirology papers? Judy: We ve shown in the paper that we published last year, and in a confirmation study by Harvey Alter and Dr Lo at the FDA that it s necessary to do multiple different kinds of tests, and one single test (PCR) won t give you clear detection of XMRV. And because XMRV is so closely related to some mouse viruses, it s very important not to do work in mouse lab, and to actually isolate the virus and show an immune response to the virus. We were well aware that it is possible to potentially skew results (with contamination). And hence multiple tests required. Sam: Were you surprised at the response to these papers? Annette: I was. I thought it was a well concerted effort by this group to make sure that everyone knew about it prior to our being able to have a response. We weren t notified about it and given the opportunity to respond. We want to thank you for this opportunity to respond and pretty much calm everyone down. It really doesn t change the findings (of XMRV in ME/CFS). It doesn t change the work that we ve done whatsoever. And that we re moving forward in very positive way.
2 Sam: What do u think the motivation was, that they didn t contact you, as you were the prime research centre? Judy: It s difficult to comment on the motivation of others. It is an attempt to make certain that the patients maybe aren t served, and that XMRV is not important. I think there is great fear about the public health risk of this virus in this disease and cancers. Sam: Would you explain that more deeply. Judy: If our results and the confirmatory results hold true, as many as 20 million Americans could be infected with a new human retrovirus of uncertain pathogenic potential. That means you don t have to get sick, but you might. And that s 20 M Americans, and that s 20x the amt of HIV that was in this country in the height of the HIV epidemic in So there is great concern about public health. And that s why everything that gets published about XMRV gets great attention each time. Sam: One of the easiest ways to understand this retrovirus is AIDS, correct? Annette: That s a good example, and the other one is HTLV1 certainly looking at those viruses we can learn something, and we can learn how they integrate and so forth.. But this (XMRV/MRV's) is a brand new family (of human retroviruses). But there s a lot to be learned, and before we make any clear statements we want to do the good hard research. I am very proud of our group, and the fact that they didn t take their first results and simply go with those, but looked long and hard at this, and used 4 methods to be absolutely sure they knew what they found. Sam: Whenever there s a discovery like this, and this is a huge discovery, there will always be a huge fight in the medical community when you have these kinds of changes. Judy: Absolutely. It is a huge discovery. And as I said, of potential public health high significance. So it will always be a level of understanding we have to learn how to detect the virus. There is a lot to be learned. There will always be a lot of push-back. The best science generates more questions than answers, and that s certainly what s happened here. Continued at 11:08
3 Sam: Your research is published in the past year that the reasons that other scientists have trouble recreating the results is that they are not doing the research in the same way. Why? That just seems to be illogical. Why are they not doing the research in the same way? Judy: Scientists usually do things that they do well, and the advances that we ve had in the past decade, that is in molecular testing, high throughput, with an instrument to measure is it (the virus) there or not, have really replaced the old fashioned way of culturing. It s very difficult to culture virus, do antibody testing which we ve done, and it takes a lot of time and significant resources. It s the hope and perhaps bias of other researchers that since we can detect HIV with these nucleic acid testing (fast throughput), we should be able to do so with XMRV. But it s too early in the discovery process for XMRV. So we have to do the very labor intensive isolation of the virus from patients and it s very difficult. Annette: I wanted to make another comment and I think it got glossed over in these last (contamination) papers. But really what you re talking about is researchers at the NIH that have done this work, the Cleveland Clinic, the U of Utah, Cornell University, (the FDA), and WPI. So there are others that are very successful at this and are moving their research forward as well. So we re lucky to have those significant groups of researchers working on this. Sam: What s the role of politics in all of this Annette: Laughs there is certainly a lot of politics in medicine. I think whenever there s money, prestige, power, change, there s going to be a lot of interest. Certainly in this case, there is a lot of money involved. Pharma, disability companies, insurance companies, government run health care systems. And they all have a stake in this. It s going to create a massive change in the way things are done and the way these people are treated. And it s going to cost. So the pushcback right now can be related to political issues. Sam: Blood supply around the world. People are giving blood, and they are not being tested for this (XMRV/MRV's). Judy: Blood donors are not being tested because we have not been able to develop the high throughput tests yet. We ve been working with NHLBI and various Blood Working group that was set up the day our paper was published last year, and we had a very successful meeting (BP Advisory Council) last week, and it was voted on last week that there was enough concern and enough data to suggest that CFS patients NOT give blood.
4 So until we can learn more, a question is asked, and if you have ever had CFS, you are not permitted to give blood. So in light of new discoveries we are erring on the side of caution and working very hard to develop those (high throughput) tests. Sam: People CAN get tested now for XMRV? Annette: Yes. The clinical lab is called VIPDx. Ours is a research lab at WPI, but the clinical WPI lab is getting ready to open but we re not yet set up. But VIPDx is the current lab, and if a physician requests that test (for XMRV), they will get that test. Can go to VIPDx website to learn more. Judy: And we culture virus, and determine if the patient has an antibody to the virus, and that is the Gold Standard assay. Culture test can take 45 days, but we re not in a hurry. The key is to get the answer right. Sam: How is the new institute? Annette: Very excited. We re up and running. We ve been working closely with physician this past week to set up medical practice. Meanwhile getting instrumentation up and running in research lab has taken some time. All going smoothly now. We re very excited. Anyone that wants to come by can come by and see what s happening there. We re very very proud of it. We re very excited to have all of the pieces in one home. Sam: I guess bottom line from this entire discussion today is for people not to panic. Things are still moving forward. Nothing has changed it s just that there are simply different opinions. Annette: Absolutely. Judy: As one would expect (that there would be different opinions). And this is really a great time of HOPE. Because we ve also determined in our research this year - and that will be coming out published very soon - we re understanding WHY the (XMRV) virus hurts the immune system. We re
5 understanding what s going wrong to make you sick, and that s another step to making people well. So it s a great time of excitement and research around the world. We expect treatments next year (2011). Sam: Can t wait!
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