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FDA to Investigate Vaccines for XMRV Retrovirus

Posted Aug 01 2011 12:00am

Anti-virus By Kent Heckenlively, Esq.

As part of my continuing series of articles which I think should be subtitled, Official Documents which Scare the Living Daylights Out of Me! I offer this July 24, 2011 publication from the Food and Drug Adminstration.

The release is entitled Investigating Viruses in Cells Used to make Vaccines; and Evaluating the Potential Threat Posed by Transmission of Viruses to Humans.  XMRV is prominently featured as a virus about which they are concerned.  Please feel free to read the entire document at .

For those of you who may be unfamiliar with the question of XMRV and autism, please allow me to give a brief recap.  The xenotropic murine leukemia virus related virus (XMRV) was discovered in 2006 by scientists working for the University of California at San Francisco and the Cleveland Clinic.  It is a human gamma retrovirus and there are many who say we should be referring to this family as XMRVs or HGRVs. 

The retrovirus was originally found in the tumors of men with an aggressive form of prostate cancer, in 2009 the virus was found in high numbers in people with chronic fatigue syndrome/ME, and there has been some very preliminary findings of its presence in children with autism.  In the interest of full disclosure I must note that my daughter with autism/seizures, my wife who has had a number of mysterious health ailments, and my mother-in-law have all tested positive for the XMRV retrovirus.  I've tested negative, as has my father, who is my only surviving parent.

Chronic fatigue syndrome/ME and autism  share many common clinical features including immune dysregulation, increased expression of pro-inflammatory cytokines and chemokines, mitochondrial abnormalities, and chronic active microbial infections.   In my own investigations I've been surprised how many of the mothers of children with autism say they have either been formally diagnosed with chronic fatigue syndrome/ME, or believe they have subclinical indications of the disorder. 

Onto the FDA release of July 24, 2011.  After first describing the need for new vaccines and that the virus-based vaccines require the use of living cells for a substrate, there's this paragraph. 

In some cases the cell lines that are used might be tumorigenic, that it, they form tumors when injected into rodents.  Some of these tumor-forming cell lines may contain cancer-causing (author's note - autism causing?) viruses that are not actively reproducing.  Such viruses are hard to detect using standard methods.  These latent or "quiet" viruses pose a potential threat, since they might become active under vaccine manufacturing conditions.  Therefore, to ensure the safety of vaccines, our laboratory is investigating ways to activate latent viruses in cell lines and to detect the activated viruses, as well as other unknown viruses, using new technologies.  We are also trying to identify specific biological processes that reflect virus activity.

- Hey, the cell lines in which we grow the viruses we want in vaccines, may contain some viruses we don't want!  Including those which may cause cancer!

I don't think most readers appreciate the advances which have been made in pathogen detection by the use of advanced micro-arrays.  As an example I point out the finding made about a year ago of an unexpected pig circovirus found in the rotarix vaccine.  The levels of this unexpected virus were more than ten times the level of the target virus for which the vaccine had been developed.  While the decision to certify that virus as "safe" was in my opinion unconscionable, the fact remains that detection of the unexpected virus was made and its amount quantified with amazing accuracy.

I believe that scientific advances are proceeding at a rate which will allow us to ask and answer some very disturbing questions about vaccine safety.  In my science classes I always try to instill in my students the idea that there's "data" about which we should all agree, but that some of the biggest fights are over "interpretation" and the meaning of that data.  For example, the finding of an unexpected pig virus in a vaccine at a rate ten times higher than that of the target virus is something which all parties seem to agree upon. 

A vaccine with this level of contamination would probably never receive initial approval.   This finding begs the question, why do we allow an already approved vaccine to have this level of contamination, just because we've only recently developed the tools to test its composition?  Even to the average person who doesn't think much about vaccine safety this reasoning is a little bit like saying you'll continue to allow your teenage son to drink and drive because he's done it before and he never got into an accident.

Further on in the article was this paragraph:

Similarly, we are investigating the transmission and infectious processes of a new human retrovirus, xenotropuic murine leukemia virus-related virus (XMRV).  We are pursuing this work both in vitro ("test tube studies) as well as in the monkey model, in order to assess potential safety concerns in vaccine cell substrates and in blood products.

- We're really worried about XMRV!  We're so worried that we're going to test in both test tubes, and in monkeys (very expensive!)  We are spending major dollars on this question!

The article ends with the following paragraph, which makes me think it's XMRV (XMRVs/HGRVs) that has the scientists at the FDA worried.

Xentoropic murine leukemia virus-related virus (XMRV) is a recently discovered human retrovirus that has been found in both chronic fatigue syndrome and prostate cancer patients.  Although the findings need further confrimation, there is a potential safety concern regarding XMRV in cell substrates used in vaccines and in transmission by blood transfusion and blood products.  We are developing sensitive detection assays for XMRV to evaluate cell substrates and investigate virus transmission by blood transfusion in a monkey model.

- We at the FDA are really concerned about  XMRV.   Yeah, we know there's a dispute going on about whether it's an actual virus and whether it's present in people with specific diseases, like chronic fatigue syndrome, prostate cancer, and maybe even autism (CDC is doing that study), but did I mention that the FDA is really concerned about XMRV?  We're concerned about XMRV in vaccines, from blood transfusions from people who already have the virus, and blood products.  Did I mention that we at the FDA are really worried about XMRV? 

I've been following the XMRV story for more than a year and a half and there are a couple things I'd like to say. 

While I understand the majority of the scientific and medical community are avoiding the serious questions and research about vaccines, they are not monolithic entities.  There are people in the research community, some of them very highly placed, who share many of our concerns.  A few are actively and quietly trying to develop the data to help us.  Although the numbers are not large, we do have friends in the research community.

While we fight so hard for our children against the majority of the medical establishment we must remain aware that there are those on the other side who can help us win this battle.  For those on the other side I can only say I understand the risks you are taking.  The forces which oppose your investigations will do things to thwart you which will stagger your imagination.  I am truly sorry for what you will likely be forced to endure as you do honest research.

But despite the roadblocks which are thrown in your way I hope you keep in mind the greater need of hundreds of thousands of children with autism, their families, and the other disease communities which this research might impact.  For my part in the autism community I will do my best to recognize potential friends and allies, even though we may not agree on all things.

In that spirit I must commend the FDA for looking into the question of XMRV contamination of vaccines.  I look forward to the results.

Kent Heckenlively is a Contributing Editor to Age of Autism


Posted by Age of Autism at August 04, 2011 at 5:45 AM in Current Affairs , Kent Heckenlively , Science , Vaccine Safety Permalink

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