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FDA to Investigate Vaccines for XMRV Retrovirus

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 FDA.gov.

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.

Translation for the average reader - 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.

Translation - 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.

Translation - 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

 

Comments

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Thank you for your reporting on the FDA getting interested in XMRV. I take this as a good and bad sign. I appreciate that individual scientists really are doing their best to seek out answers, in the face of much political turmoil. I am grateful because I know that such people really do exist, and that some have even managed to keep their jobs.

That said, my doubts are in regard to the FDA, a regulatory body that seems to be run by the people it is supposed to be regulating. I have read articles about the revolving door thing, where the CEOs of pharmaceutical companies and other medical manufacturers will leave their job and go work for the FDA, keeping in tact all their connections to the companies they now regulate. We don't know how close the relationship is... We don't know if they are actually being paid off, but we do know that often the decisions by FDA officials tend to lean away from common sense to protect people's health, and in favor of the desires of industry to keep profits moving upward. At very least, they don't get rid of all their old friends when they move jobs. It is called a revolving door because often when their time at the FDA is over they head right back to similar industry executive positions as they held before. It is hard for me to believe the FDA is making decisions for the sake of MY health when supplement manufacturers, food co-ops, and small farms have in recent years been having to fight horrible battles to keep providing healthy foods and nutrients to people. They recently raided a private co-op in California, SWAT team style, for selling raw milk products, and arrested the managers, even though it was a private buying club paying for milk from private farms, i.e., not illegal according to current laws. (Not to mention raw milk is proven to be far less dangerous than most processed products approved by the FDA, and in fact highly beneficial!) It sometimes seems to me that the FDA would much rather humans not be allowed to have much choice about what we put in our bodies, or don't put in our bodies. They have exerted tremendous power that is more along the lines of a governing body over the people, which really is pretty scary to me, because that is not what they were created for... quite the opposite.

I am a CFS/ME patient, and I have also been following the XMRV issue for awhile. I have read the abstracts of most of the studies that have come out, and there is a key issue not being reported on in the media... Many of the studies that say they can't find XMRV never duplicated the same techniques created by WPI who originally found it in CFS patients in 2009. Some of the same scientists who couldn't find it in CFS patients' blood, later found the virus in testicular cancer patients' tissues. Maybe they are just looking in the wrong place. It is likely the virus is hiding in our neurological system, which is very hard to test in live humans.

@David: By the way, the original study on XMRV is not being retracted, but was requested to be withdrawn. It was around the time that the Lancet prematurely declared that the CFS/XMRV thing had been disproved, which really shows you how much certain people want this quashed. The CDC and private institutions are still studying it, and the jury is still out! In spite of all the pressure, the Whittemore Peterson Institute is standing strong behind their research, and continues to work to find the link between XMRV and CFS. I applaud their efforts because they have really become champions behind our cause, speaking out in television and radio interviews and responding publicly about the studies that "disprove" their work. I don't understand every last bit of it, but WPI has been able to show that these studies have serious flaws... flaws that are going under-reported or not reported at all. The media has really twisted the facts about CFS in many different directions over the years, and it is hard to know the truth unless you stick to the hard science. Here is a link to the latest research on CFS: http://www.co-cure.org. There is not much discussion, just hundreds of posts of the latest studies, from all different viewpoints.

I look forward to the FDA research into XMRV, because at least they are moving in the right direction... but I have major doubts that pharmaceutical companies will relax their stranglehold on our economy and government anytime soon, and allow themselves to lose profit to save lives... It is really time to evaluate the FDA and put new people in who are not biased, to really put their foot down against products or services that harm people.

Oops! I meant mesothelioma, not emphysema.

Hi, Kelly. I don't think Kent is suggesting that CFS = XMRV, just that XMRV can be part of the cause of CFS (and possibly other diseases).

Not everyone exposed to SV40 gets emphysema, but SV40 is part of the mechanism of the disease for many people who do get emphysema. What makes the difference? It could be that multiple factors are required to cause CFS (or cancer or whatever), or the timing of the exposure, or the health of the person (levels of antioxidants, etc.) at the time of exposure...

The places on earth with the most direct sunlight are not the places with the most skin cancer; however, exposure to sunlight can be part of what causes skin cancer for some people.

I hope this helps!

I think it's important for the FDA to investigate all contaminants in biological products. I haven't formed any solid opinion on the role of XMRV in human disease, but I think it's an area ripe for scientific inquiry, particularly as so many people are exposed to the virus through government-sanctioned and virtually government-mandated products.

Oops -- typo alert. I meant to say...

"Assuming that 1-2 million in the US have CFS/ME..."

Can some of you please answer this question?

How come XMRV is about 10 TIMES more prevalent in the HEALTHY population, based on the 2009 Mikovitz study?

In other words, they found that 67% of those with CFS/ME had the virus, while 3.7 percent of healthy controls.

Assuming that 1-2 million in the US have XMRV, that would suggest about 1.5 million have XMRV.

On the other hand, 3.7 percent of the US population equals approximately 11-12 million people.

That to me suggests that XMRV does not equal CFS/ME, nor aggressive cancers. But I'd like to hear from others.

I just watched "Refrigerator Mothers" (http://www.snagfilms.com/films/title/refrigerator_mothers/#.TjzcEtWRvpg.facebook)

and it really brought home the similarities between the way that autism and CFS have been "handled". A mysterious, debilitating illness appears, a psychiatrist is brought in to lay blame, and then the disease is treated as a psychiatric illness for the next 30 odd years. Is this just coincidence or have these been orchestrated attempts to discourage biological research, especially regarding vaccines?

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.
-----------------------
Maybe something like what's the autism rates among pig farmers?


Aye, I am Space kitty.

Benedetta,,, I assume you are being sarcastic... a healthy dead fetus

@ David.

What an absurd statement by you. If YOU are a scientist, you would know that the contamination with a whole raft of murine viruses has been discussed since the 80's, because they were in all the monoclonal antibodies used in people with cancer, and they also knew that those people spewed out vast quantities into their home environment. So any family of any member who had these monoclonal antibodies in it, would be potential contactees. Go read the documentation. In some of the FDA workshops the scientists were verbally blanching at the potential consequences.

Go and do some homework.

The other alternative, if we are to believe your load of bollocks, is that FDA are serially incompetent, and should be relieved of their duties.

@David, I have to say as a scientist that you are the one mistaken. Why do you think that the FDA is investigating viral contamination in cell lines used for vaccine production if there is nothing to look for? Your logic is very poor. You want us to believe that it is easy to contaminate samples in the lab with XMRV when it is from CFE/ME patients but not vaccine cell lines?
In the first case, the researchers were extra careful because they knew what they wanted to avoid. Vaccine makers don't even know about the many potential viral contaminants that can contaminate their cell lines!!!
As for a potential connection between XMRV and autism. I don't think anyone can say for sure. What we know for sure is that viruses can lower the body's antioxidant defenses, the same system that is crucial for removing other toxic substances including heavy metals.

David;
Well done studies?
Trust is an important thing.
If trust is lost, even if it was well done studies - can we trust they were well done?

Esp when it is done by people that have a lot to lose if it turns out the vaccines are to blame?

The XMRV connection with CFS/ME is falling apart due to several well done studies showing its most likely contamination. The paper first proposing the link is likely to be retracted. Its likely that detecting it in the author's family is also contamination.
To even suggest a connection between XMRV and autism is absurdly misleading. There is nothing to suggest this is even something to consider.
Perhaps most shocking is that the author of this post teaches a science class!? I hope that he starts the class by telling his students he doesnt actually understand the scientific process.

If you think about it; some families that find themselves in crisis because of behavior problems, and bad choices from those behaviorial choices - give up their kids more through adoption or abortion.

So do these families harbor something in their bodies that make them that way and we could all get?

So much about the choices of good and evil for these poor people.

And the use of this aborted baby may have caused a whole lot of pain on down the line.

But Space kitty;
The child was declared healthy! So why are you questioning that?
I know it was dead and all but other than that it was healthy!

There must be some people with a conscience in positions of power in our government. It's up to them to navigate around the politics and money to protect the public.

I'm not exactly filled with confidence that the government is working on this. Check out what the CDC has to say about SV-40 today:

http://www.cdc.gov/vaccinesafety/updates/archive/polio_and_cancer_factsheet.htm

"The majority of scientific evidence suggests that SV40-contaminated vaccine did not cause cancer; however, some research results are conflicting and more studies are needed."

And don't forget that after PCV-1 and PCV-2 were found in the rotavirus vaccines, the government and the drug companies (Merck and GSK) decided that the risk of rotavirus to American children was so great that it justified the continued use of the contaminated vaccines.

So... Thank you, Kent, for this update, but I am not filled with hope (yet).

So is it hiding in the dead baby DNA... Ooops.. I mean the human diploid cells that came from 2 legally aborted fetuses in the 1960s. I called the CDC ages ago to ask what recent sort of testing has been done on the dead baby dna being used in vaccines lie MMR. I asked for documentation to show that they have tested the lines since the 1960's with up to date and contemporary tools. They had no answer and were mad at me,,, sent me to some other group that lobbies for them,,, and then told me there was no need for this line of questioning. I wish someone would do a story about this topic, and get to the bottom of my questions. Since I wasn't a reporter and I confessed I was a Catholic, they then sent me to a website where some bishop has proclaimed to the world that it is ok to shoot your chilren up with legally aborted dead baby dna. No dispect to the fetuses sacrificed. But it must be said blatantly that we are shooting up our children with dead babies and that the people in charge of it have no science to show that these poor innocents have normal dna.

Have just had a chance to read the FDA document. Putting on the tinfoil apron for a moment, i have to say this paragraph gave me concern:
"These methods will enable FDA scientists to help manufacturers to determine whether their specific cell substrate is safe to use for vaccine production. The methods our laboratory are developing and testing will help to ensure the production of safe and effective vaccines in two ways: 1) FDA will be able to develop testing guidelines for manufacturers who use new cell substrates for producing vaccines; and 2) FDA will publish the new methods it develops in peer-reviewed scientific journals, thus making them readily accessible to all manufacturers."

This is all well and good if it is a warning shot over the bow to manufacturers and the FDA goal is to actually get to the bottom of what's in vaccines that can make people sick, admitting there's a terrible problem and mistakes have been made, and getting those things out of vaccines. But what if the goal is to CYA, develop testing guidelines that are guaranteed not to find anything, and then publish those guidelines in peer-reviewed scientific journals so that the ineffective testing then becomes the only testing accepted legally under Daubert? Also, they talk about "new" cell substrates, but say nothing about existing lines. Will the old toxic substrates be grandfathered in? Voluntarily phased out just like thimerosal (wink wink)? They have so much history of doing the wrong thing, it's hard to hope.

keep up the excellent reporting, kent. we need you. -- rivka

Good news to hear somebody might be trying to do the right thing.

Thank you for your article. I am currently reading about the pollution of the polio vaccine from the book, "The Virus and the Vaccine" by Debbie Bookchin & Jim Schumacher. In the book they speak about how "between 1954 and 1963, 98 million Americans received polio vaccinations contaminated with a carcinogenic monkey virus, now known as SV40."
I wonder how the headlines will read in 2054...."xxx million people received xxx vaccinations contaminated with XMRV" Very scary.

I knew that the truth would appear after the vaccine damage liability was taken away, I just didn't realize how quickly it would come about. Waiting to see the media play though.

Kent, do you know who the investigators are? Thank you for this coverage on XMRV.

Also, re: HERVs and the tyrosine kinase Teresa mentioned in her post:

"Furthermore, we found that the 3' untranslated region of the human transmembrane tyrosine kinase gene FLT4 is probably derived from a partial HERV-K-T47D LTR sequence. Taken together, our data suggest that LTRs of the HERV-K-T47D family display biological function by mediating polyadenylation of cellular sequences."

Thank you, Kent. Thank you, scientists at FDA, whoever you may be, for pushing for this from the inside as you must have been doing. I can't imagine the past year has been easy for those on the inside who actually care about preventing disease. CBER's webcast meeting about vaccine contamination last year was a farce and you are right, the decision to "let it ride" by failing to withdraw the contaminated vaccines was unconscionable.

I can only hope that the study extends not only to XMRV but also to the HERV-K that was found by Delwart et al. Does injected HERV-K from the human diploid tissue in vaccines lead to recombination and/or activate expression of HERV-K we all carry? Does an adjuvant in a separate vaccine given concomitantly with one containing human proteins trigger autoimmunity? Does a live virus like influenza given concomitantly activate the HERV contaminants or our native HERV? HERV activation has been linked to schizophrenia, MS and cancer; viral triggers (including influenza and HSV-1) have been mentioned as precursors to activation.

"In addition, among all the HERV families present in the human genome, HERV-K(HML2) is the only one with potentially fully coding gag and pol genes (16, 22). Along this line, it is noteworthy that HERV-K-related particles have been detected in culture supernatants from several cell lines derived from tumors, including teratocarcinomas and melanomas (6, 10, 13, 19). It is therefore conceivable that infectious retroviruses are produced, provided that they incorporate the HERV-K108 ENV protein. The present results lend credence to this hypothesis, and the search for HERV-K copies with active gag-pol genes (possibly within K108 alleles) could lead to the unraveling of a fully competent, infectious, endogenous human retrovirus."

"In general, based on the evolving understanding of
both endogenous retroviruses and schizophrenia and
our findings, a new possible role of HERV in the pathogenesis
of recent-onset schizophrenia was postulated.
The specific hypotheses are as follows.
1. Schizophrenia results from aberrations in neurodevelopmental processes caused by an interaction between environmental and genetic factors preceding the onset of clinical symptoms.34,56
2. Early exposure to several infectious agents (such as virus, T. gondii, etc) might be associated with the later
development of schizophrenia.8–12,19,57
3. The recent-onset schizophrenia is related to the aberrant
expression of endogenous retroviruses within the
CNS.8–12,19
4. Infectious agents (such as virus, etc), environmental factors (such as UV, etc), and genetic variation are responsive to the endogenous retrovirus expression.48–52,55
5. The expression of HERV proteins (such as HERV-W
env) increases the promoter activation of some genes,
such as BDNF, NTRK2, and DRD3, etc (figure 7), and increases the expression of these genes (figures 5 and 6) in neuroglia cells.
6. The expression of these genes contributes to the pathogenesis of the recent-onset schizophrenia.3,33–36"

It bears repeating: Vaccine manufacturers cannot be sued for the effects of their products. Sure, vaccines may impart you with partial immunity to the target virus, but they might also give you cancer - and you cannot hold anyone accountable.

Imagine if a blood pressure medicine was found to contain ingredients that very likely cause cancer. Do you think that the drug would be recalled? Damn right it would. But vaccines that may contain "unintended" virus components that are likely very harmful to humans can remain on the market. Simply amazing!

Ken, are you aware of Michael Goldberg's work regarding NIDS? If you are, can you comment on its validity? He mentions XMRV in his book, "The Myth of Autism."

Thank you.

Thank you so much again Kent, for keeping our community informed on XMRV. I am actually very relieved to hear that we have allies on 'the other side'. I had feared all those trying to go to the bottom of the potential problem of vaccine contamination and HGRVs had been systematically hushed and crushed and flushed out of the system.

To them, thank you from the bottom of my heart for helping us, for helping humanity.

I hope they'll be wise and stay safe and fly under the radars.

I still hope we'll get some answers soon. No matter how bad the situation is, ignoring it is much worse than facing it and trying to deal with it!

Karin

Thank you very much for your clear reporting on a possible XMRV/autism connection, and for recognizing the courage of the good scientists at the FDA.

Thanks for this article, Kent.
Translation: Wow! This is a terrific piece, kent.
BTW-Is there any standard test now for CFS? My daughter has been tested a number of times(as she has symptoms)for it in the past and the doctors have said her tests are negative.
Maurine

Thank you for this article, its a scary subject but people need to know and hopefully be made to understand. Its too bad this story is not hitting the major news networks as I believe it is far more important to talk about than some of the nonsense currently covered. If you do another piece to this subject I would like to learn what if any treatment for this virus exists and/or if the CDC will be working along side to develop a treatment.

Just found out yesterday that it was one of the twins that burned down the house. Apparently even though they are identical twins and both have autism - one seems to cope better than the other by far while the other must have Schizoprhenia because he said a voice told him to throw gas on the stove.

I am glad there are good people working on this in our federal agency, but considering what is going on out here in the back country as these kids start ageing out and more problems continue to pop up - these kids all have the potential to burn down the bigger houses (federal agencies that stood around and did nothing).

I hope the research into XMRV does not suffer the same fate as that of the SV40 virus that contaminated the early polio vaccines and possibly is still contaminating them. It seems to turn up in several types of tumors and blood disorders,but we still aren't told much about it. In the VIRUS and the VACCINE , the authors tell about what happened to the researchers who raised the alarm about this viral contamination before the vaccines were widely distributed. They were marginalized and their careers ruined of course. The contaminated vaccines were then injected into millions of children(me included)in the 1950's. Voila--autoimmune disorders, leukemia, childhood cancers, neurological disorders...the list goes on and on.

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