It's not looking good that anyone in power is taking XMRV seriously enough in this country to do something about the blood supply. The quote below if from the published transcript of a recent meeting with the FDA.
http://www.fda.gov/downloads/Biolog...ts/WorkshopsMeetingsConferences/UCM214030.pdf
UNITED STATES FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
EMERGING INFECTIOUS DISEASES: EVALUATION TO IMPLEMENTATION FOR TRANSFUSION AND TRANSPLANTATION SAFETY (DAY 1)
EVALUATING EMERGING INFECTIOUS DISEASES (EIDs) FOR TRANSFUSION SAFETY
The Hilton Washington D.C. North/Gaithersburg 620 Perry Parkway Gaithersburg, Maryland 20877
Tuesday, May 11, 2010
Starting on page 111
Just infuriating!!
p. 126
Keep reading folks. It just gets better and better.
http://www.fda.gov/downloads/Biolog...ts/WorkshopsMeetingsConferences/UCM214030.pdf
UNITED STATES FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
EMERGING INFECTIOUS DISEASES: EVALUATION TO IMPLEMENTATION FOR TRANSFUSION AND TRANSPLANTATION SAFETY (DAY 1)
EVALUATING EMERGING INFECTIOUS DISEASES (EIDs) FOR TRANSFUSION SAFETY
The Hilton Washington D.C. North/Gaithersburg 620 Perry Parkway Gaithersburg, Maryland 20877
Tuesday, May 11, 2010
Starting on page 111
Now, Lou Katz (phonetic) said "Gosh, if you remember this you must be old." And Matt's already hinted about this, but there was an interesting movie, and it brings me to the topic of XMRV. Everybody's lips, Xenotropic Murine Leukemia virus-Related Virus. It is a Xenotropic retrovirus, that is one that can no longer actively infect its host organism, the mouse, or apparently the mouse, but can infect other species. It's a cell associated virus with an unknown transmission rate to and between humans, and appears from genetic data to be of Murine origin.
It certainly generates asymptomatic infection, and to date we have not observed or indeed even looked for transmission by transfusion. The assumption is that a virus of this nature should be transfusion transmissible, but we have no data to support this. There's no -- equally, there's no information about its survival in blood products. We would assume that it would survive, but we don't know. And to date we don't have any known causative relationship to disease. And I think that this is an important point.
There are data that suggests the virus is responsive to the usual range of antivirals, and the prevalence of infection in the donor population is unknown, or have been scattered observations suggesting somewhere between zero and three or four percent, depending on populations looked at, tests used, and there may be more data coming down the pike in the nearly -- near future.
The epidemiology of this agent is unknown, but there's considerable media interest, and there's a great deal of interest from a patient affinity group, this is the Chronic Fatigue Syndrome patient group, and there's general regulatory concern about retroviruses, and specifically about this agent. Any intervention that we could conceive of at the moment assuming that the decision was made to develop an intervention would be strictly at the research level would be of unknown value and questionable impact, both in terms of its efficacy in preventing a future downturn or downside, or of its impact on the availability of blood and donors.
The current status is that there's highly controversial literature, there have been inconsistent findings for viral markers of infection with XMRV in various prostate cancer populations, and in patients with chronic fatigue syndrome, and healthy controls. But no causality has been established in these cases.
And there are publications that define such a presence; there are many counter-publications that fail to find these associations. So I think at the moment the jury has to be out on what the significance is of infection with this agent.
As I already commented, transfusion transmission is theoretical; we don't see an obvious intervention to prevent such transmission. And test methods, as Steve already pointed out, are not yet standardized. Now, there's certainly very general concern when HIV is seen as the model of an evil retrovirus, with particular focus on two aspects, species jump, and potential for mutation to become a pathogen. But we have to note that to date, in the
published studies, this agent has had a very stable genomic structure, which suggests that it's not out there mutating furiously. As I already commented, the CFS affinity groups and their surrogates are very interested in this agent. And just yesterday, the CFS advisory committee came up with a recommendation to screen blood donors for CFS by a questioning focus. We'll have to see where that goes.
It certainly generates asymptomatic infection, and to date we have not observed or indeed even looked for transmission by transfusion. The assumption is that a virus of this nature should be transfusion transmissible, but we have no data to support this. There's no -- equally, there's no information about its survival in blood products. We would assume that it would survive, but we don't know. And to date we don't have any known causative relationship to disease. And I think that this is an important point.
There are data that suggests the virus is responsive to the usual range of antivirals, and the prevalence of infection in the donor population is unknown, or have been scattered observations suggesting somewhere between zero and three or four percent, depending on populations looked at, tests used, and there may be more data coming down the pike in the nearly -- near future.
The epidemiology of this agent is unknown, but there's considerable media interest, and there's a great deal of interest from a patient affinity group, this is the Chronic Fatigue Syndrome patient group, and there's general regulatory concern about retroviruses, and specifically about this agent. Any intervention that we could conceive of at the moment assuming that the decision was made to develop an intervention would be strictly at the research level would be of unknown value and questionable impact, both in terms of its efficacy in preventing a future downturn or downside, or of its impact on the availability of blood and donors.
The current status is that there's highly controversial literature, there have been inconsistent findings for viral markers of infection with XMRV in various prostate cancer populations, and in patients with chronic fatigue syndrome, and healthy controls. But no causality has been established in these cases.
And there are publications that define such a presence; there are many counter-publications that fail to find these associations. So I think at the moment the jury has to be out on what the significance is of infection with this agent.
As I already commented, transfusion transmission is theoretical; we don't see an obvious intervention to prevent such transmission. And test methods, as Steve already pointed out, are not yet standardized. Now, there's certainly very general concern when HIV is seen as the model of an evil retrovirus, with particular focus on two aspects, species jump, and potential for mutation to become a pathogen. But we have to note that to date, in the
published studies, this agent has had a very stable genomic structure, which suggests that it's not out there mutating furiously. As I already commented, the CFS affinity groups and their surrogates are very interested in this agent. And just yesterday, the CFS advisory committee came up with a recommendation to screen blood donors for CFS by a questioning focus. We'll have to see where that goes.
p. 126
Mr. Dodd: In the context of XMRV, I think that there is an emergency, but it's a perceptual emergency.