Wall Street Journal Reports on Wasting Disease Pig Virus DNA in Paul Offit Merck RotaTeq Vaccine
TODAY: FDA Public Meeting To Discuss DNA From PCV1 in Rotavirus Vaccines

FDA Said RotaTeq Did Not Contain PCV1 Pig Virus DNA Snips Seven Weeks Ago

Gerberding Rotarix, a rotavirus vaccine from the UK's GlaxoSmithKline that competes with Merck's RotaTeq, was suspended for use by the FDA over seven weeks ago, having been found to contain DNA from the porcine (pig) virus known as PCV1. At that time, Merck's vaccine was recommended in its place. 
 
Dr. Gerberding is now the head of the Merck vaccine division where Dr. Paul Offit's RotaTeq vaccine is under scrutiny for containing snips of both PCV1 and PCV2 (known to cause wasting disease in pigs) virus DNA fragments. This, despite an FDA report issued on March 23 when Rotarix was suspended for use that, "Preliminary testing by both the academic researchers and FDA scientists of another licensed vaccine against rotavirus infection, RotaTeq, has not detected components of PCV1."

We ran posts about Dr. Gerberding's move from the Federal Government to Merck last December. Here is the announcement from Reuters.

WASHINGTON, Dec 21 2009 (Reuters) - Dr. Julie Gerberding, former director of the U.S. Centers for Disease Control and Prevention, was named president of Merck & Co Inc's (MRK.N) vaccine division, the company said on Monday.

Gerberding, who led the CDC from 2002 to 2009 and stepped down when President Barack Obama took office, will head up the company's $5 billion global vaccine business that includes shots to prevent chickenpox, cervical cancer and pneumonia. [Editor's note: Gerberding will begin her new job on January 25th, 2010. One year is the minimum time allowable for former Federal officials to take such a job with companies they used to regulate]

She had led CDC from one crisis to another, including the investigation into the anthrax attacks that killed five people in 2001, the H5N1 avian influenza, the global outbreak of severe acute respiratory syndrome, or SARS, and various outbreaks of food poisoning.

"As a preeminent authority in public health, infectious diseases and vaccines, Dr. Gerberding is the ideal choice to lead Merck's engagement with organizations around the world that share our commitment to the use of vaccines to prevent disease and save lives," Merck Chief Executive Officer Richard Clark said in a statement.

She may be charged with reigniting flagging sales of Merck's Gardasil vaccine to prevent cervical cancer by protecting against human papillomavirus or HPV. After an encouraging launch Gardasil sales have been falling and were down 22 percent in the third quarter at $311 million.

http://www.reuters.com/article/idUSN2124506920091221 

Comments

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patrons99

@ Theresa O - "Sure, just mix part of one virus with part of another, and cross your fingers. I'm sure no one will get hurt."

Hmmmmm. Sounds a bit like a witch's cauldron, doesn't it! "Science" at it finest! : - (

They are welcome to keep their toxic sh*t to themselves!

Here's a recent example of what the "miracle" of genetic-engineering is doing to our food supply:

http://www.i-sis.org.uk/newPathogenInRoundupReadyGMCrops.php

Theresa O

...and now it appears that PCV can be a valuable part of a vaccine against HIV! How felicitous!

http://www.virologyj.com/content/8/1/51

"We identified a novel PCV-1 genome-derived enhancer sequence that significantly increased antigen expression from plasmids in in vitro assays, and improved immunogenicity in mice of the HIV-1 subtype C vaccine plasmid, pTHgrttnC. This should allow significant dose sparing of, or increased responses to, this and other plasmid-based vaccines. We also report investigations of the potential of other circovirus-derived sequences to be similarly used."

Sure, just mix part of one virus with part of another, and cross your fingers. I'm sure no one will get hurt.

patrons99

Eliza from across the pond - "There's a good article to be written by someone with a more detailed knowledge of Autism in the USA than I have."

Please feel free to contact me. I would seriously consider giving up my daytime job to tackle the type of project you describe, either experimentally or in documentary fashion or both. I am a practicing Internal Medicine physician, former bio-organic, analytical research chemist, former Associate Medical Director for DuPont Pharma's Radiopharmaceutical Division. My first board-certification was in Nuclear Medicine. I believe in most of the tenets of orthomolecular medicine and currently practice an integrative medicine style.

I am in need of a like-minded benefactor, sponsor, or partner to facilitate such an endeavor. Preferably, someone who sees what I see, feels as I feel, and seeks as I seek.
It's a long story as to why. Contact me, even if only to "brain storm".

http://www.opednews.com/author/profile/author41030.html

http://www.scribd.com/patrons99

ElizaCassandra

From "across the pond":- I should be in bed already but ..... Somewhere in Wikipedia there's an entry on "the law of unintended consequences" which I find applies to many situations in History/Medicine/Politics/Warfare (all applicable to the World of Autism as we know it).

There's a good article to be written by someone with a more detailed knowledge of Autism in the USA than I have.

patrons99

Theresa O - Very nice update. The article you cite is potentially VERY important.

Based on their inglorious track-record, pharma's mainstream medical media, CDC, and FDA could probably care less about potential risks to humans of PCV-2 and PMWS. Our FDA still thinks the rotavirus vaccines are "safe" for GSK and Merck to market. After all they were FDA "approved".

http://bipolar-stanscroniclesandnarritive.blogspot.com/2010/03/big-pharma-wants-fda-to-create-seal-of.html

Shouldn't the millions of rotavirus vaccine inoculated kids worldwide be screened NOW for the presence of PCV2 viruses in their lymph nodes and thymus? Is there risk of multisystemic wasting syndrome in humans? Dare we assume there is ZERO risk? What about the Precautionary Principle?

http://en.wikipedia.org/wiki/Precautionary_principle

It appears to me, a non-virologist, that this article has demonstrated horizontal transfection of DNA from species to species. Dr Mae Wen Ho warned about this type of risk. Is anyone listening?

"Genetic engineering involves designing artificial constructs to cross species barriers and to invade genomes. In other words, it enhances horizontal gene transfer – the direct transfer of genetic material to unrelated species. The artificial constructs or transgenic DNA typically contain genetic material from bacteria, viruses and other genetic parasites that cause diseases as well as antibiotic resistance genes that make infectious diseases untreatable. Horizontal transfer of transgenic DNA has the potential, among other things, to create new viruses and bacteria that cause diseases and spread drug and antibiotic resistance genes among pathogens. There is an urgent need to establish effective regulatory oversight to prevent the escape and release of these dangerous constructs into the environment, and to consider whether some of the most dangerous experiments should be allowed to continue at all."

http://online.sfsu.edu/~rone/GEessays/horizgenetransfer.html

Theresa O

Didn't see this in any mainstream media: species other than pigs can catch porcine circovirus after intramuscular inoculation. Wonder if the CDC cares...

http://www.virologyj.com/content/7/1/158/abstract

Theresa O

Informed voter, it does appear that PCV2 and the wasting disease (PMWS) are not 1:1 correlated. There are pigs with PCV2 who do not develop PMWS. It also appears that, as Garbo noted, infection or inoculation with multiple viruses is more likely to trigger PMWS:

"Young experimentally inoculated colostrum deprived pigs given Type 2 alone sometimes, develop typical lesions. However, they are more likely to develop lesions if another virus, such as porcine parvovirus (PPV) or porcine reproductive and respiratory syndrome virus (PRRSV), is inoculated at the same time. Naturally occurring clinical cases in the field seem always to have a dual infection with PCV Type 2 and some other virus but most pigs which are infected with PCV and PRRS do not develop clinical PMWS."

(from http://www.thepigsite.com/diseaseinfo/86/post-weaning-multisystemic-wasting-syndrome-pmws)

Apparently, pigs develop GI distress (among other things) when their immune systems are subjected to multiple viruses at the same time. Who knew?

patrons99

Teresa - your comment is beautifully understated! "that could be interpreted as...unhelpful to the consumer". No kidding! This whole matter is a microcosm of worse things yet to come. There are literally hundreds of "innovative" new inoculations in the pipeline. The time may be at hand for a Constitutional amendment to outlaw forced inoculations of any kind. Ditto, for RFID chip implants and nanotech devices. The issue should be one of informed consent. This is still a free country, isn't it?

Informed voter

Garbo?
So, in your last post are they saying that a pig may have the PVC -2 virus and be okay but if a vaccine that stimulates the immune system is added then the wasting disease is triggered????

Is that it in a nut shell?

So the wasting disease is more or less an immune response?

Cherry Sperlin Misra

The Rotarix situation reminds me of what should be the Golden Rule of New Medical Products. Let me explain:
Years ago there were newspaper articles about a new insulin product that could be inhaled. It sounded great, so my husband and I asked our friend who did research in diabetes if he would use that product if he were diabetic. (We expected a Yes) His answer was "No, I would not- I would wait for 10 years " Surprised, we said, "But What would you DO!?" He replied simply, "I would inject myself with insulin. There is a possibility that this new product contains something that could cause cancer"

Garbo

Check out this, from the Canadian Journal of Veterinary Research 2006 October v. 70(4): 269-276.

The Role of Immunostimulation in the development of postweaning multisystemic wasting syndrome in pigs under field conditions:

"To date, few studies have been conducted under field conditions to evaluate the effects of immunostimulation on the development of PMWS. In 1 study of 7-d-old piglets, characteristic clinical signs of PMWS developed in 43% of 28 pigs receiving Mycoplasma hyopneumoniae vaccine, 50% of 28 pigs receiving adjuvant, and only 11% of pigs in the control group (21). In another study performed on a farm that had suffered consistent losses associated with PMWS, M. hyopneumoniae vaccination scheduled for 1 and 3 wk of age was withheld from half of 1393 piglets from 5 batches. Among the 696 nonvaccinated pigs, PMWS-associated losses were reduced significantly in 2 of the 5 batches studied over 4 mo (22). The results of these field experiments support the hypothesis that stimulation of the immune system may trigger PMWS in PCV-2-infected pigs. The present study was conducted to test the hypothesis that stimulation of the immune system either specifically with M. hyopneumoniae vaccine or nonspecifically with common adjuvants can increase the incidence of PMWS under field conditions."

"Gross pathological changes characteristic of PMWS were observed in all 5 groups. In order of decreasing frequency (Table II) the lesions included mild to moderate wasting, various degrees of gastric ulceration (pars esophagea), generalized skin pallor, mild to moderate mesenteric lymphadenopathy, and partially collapsed, rubbery lungs with or without cranioventral consolidation. Other gross findings, not characteristic of PMWS but occurring as primary or secondary disease processes in some pigs from all experimental groups, included bronchopneumonia (in 7 pigs), valvular endocarditis (in 5), fibrinous pericarditis (in 3), suppurative meningitis (in 3), proliferative enteropathy (in 3), mesenteric torsion (in 2), and fibrinous peritonitis, INTESTINAL INTUSSUSCEPTION, fibrinosuppurative arthritis, ventricular septal defect, or umbilical hernia (in 1 each)."

Hmmm...intestinal intussusception...where have I seen that one before? Oh yeah. Possible AE for rotavirus vaccine.

thislittlepiggy

.
Here is some interesting reading about PCV1 and PCV2 from PubMed. These are not necessarily related to each other; rather, each is related to the contaminated-vaccine issue as background.

- - - - - - - - - - - - - -

Virus Res. 2009 Aug;143(2):177-83. Epub 2009 Feb 26.
Porcine circoviruses--small but powerful.
Finsterbusch T, Mankertz A.

Abstract
When porcine circovirus type 1 (PCV1) was isolated more than 40 years ago as a non-pathogenic contaminant of a porcine kidney cell line, enthusiasm and curiosity kept within reasonable limits.

Virologists became more interested, when a second variant was isolated and termed PCV2, because PCV2 is linked to post-weaning multisystemic wasting disease (PMWS), a new emerging multifactorial disease in swine.

Both PCV1 and PCV2 are small and rather simply organized and express only few proteins. Therefore, it was expected that the factor(s) triggering PMWS should be easily identified, but more than one decade of PCV research has not yet singled out a molecule inducing the disease onset.

- - - - - - - -

Microbiol. 2010 Jan 11. [Epub ahead of print]
Emergence of a new type of porcine circovirus in swine (PCV): A type 1 and type 2 PCV recombinant.
Gagnon CA, et al.

In late September 2008, tissue samples from piglets experiencing an acute outbreak of porcine reproductive and respiratory syndrome (PRRS) were submitted to the Veterinary diagnostic service of the University of Montreal. Several diagnostic assays were performed including a multiplex real-time quantitative PCR assay (mrtqPCR) for the detection and differentiation of porcine circovirus (PCV) type 2a and 2b genotypes in the lung and lymph nodes.

The pig samples were found to be positive for PCV2a using the mrtqPCR but odd results were obtained. The Ct values obtained with mrtqPCR probes targeting the ORF1 and ORF2 of PCV2 were not as expected, which suggested the presence of genomic variations in the PCV2 viral genome.

Ultimately, a total of three diagnostic cases with mrtqPCR unusual results were investigated. After virus isolation and sequence analyses, a new type of PCV was identified in those three cases.

Based on sequence analyses, this new PCV genome contains the ORF1 of PCV1 and the ORF2 of PCV2a and its entire viral genome nucleotide identity compared to PCV1, PCV2a and 2b are 86.4%, 88.7% and 86.5%, respectively.

It is proposed to name this new PCV by taking into account the nomenclature of Segales et al. (2008) and by indicating the origin of the ORF1 at first and the origin of the ORF2 in second. Consequently, the name proposed for this new PCV is PCV1/2a. The prevalence of PCV1/2a seems to be very low in Quebec, Canada (2.5% of PCV positive cases), and its origin is now in debate.

- - - - - - - -

Vet J. 2006 May;171(3):570-3. Epub 2005 Jan 19.
Detection of porcine circovirus type 1 in commercial pig vaccines using polymerase chain reaction.
Quintana J, et al.

Abstract
The absence of extraneous viruses is a requirement in the quality control of vaccines for veterinary use in the European Pharmacopoeia.

A polymerase chain reaction (PCR) assay for the detection of porcine circovirus type 1 (PCV1) and type 2 (PCV2) was evaluated in 18 commercial porcine vaccines.

Since vaccine components may contain PCR enhancers or inhibitors, 13 of the studied vaccines (used as diluents) were subsequently spiked with different dilutions of PCV2 and tested by PCR.

Although PCV2 DNA was not detected in any of the vaccines tested, PCV1 was detected in 2/18 vaccines (11%). Eleven out of 13 PCV2 spiked vaccines showed a positive PCR result.

The lack of amplification observed in two spiked vaccines suggested that use of the PCR assay to detect PCV2 could depend on vaccine composition.

The results of this exploratory study have demonstrated that PCR is a rapid and fairly sensitive method for the detection of porcine circoviruses as extraneous agents in vaccine products and can be used in the quality control of pig vaccines.

The study has also indicated the need for optimising the sensitivity of PCR methods for PCV genome detection in vaccine products.


- - - - - - - -

J Virol. 2003 Sep;77(18):9885-93.
New reporter gene-based replication assay reveals exchangeability of replication factors of porcine circovirus types 1 and 2.
Mankertz A,et al.

Abstract
Two types of porcine circovirus (PCV), which differ in their pathogenicity, are known.

PCV type 2 (PCV2) is the etiological agent of postweaning multisystemic wasting syndrome in swine, while PCV1 has not yet been linked to a disease.

Corroborating earlier observations in PCV1, transcript mapping revealed that the rep gene of PCV2 encodes two products, the full-length protein Rep and the spliced version Rep' and that the simultaneous expression of Rep and Rep' proteins is essential for initiation of replication of PCV2.

The interchangeability of the replication factors of PCV1 and PCV2 was examined. The rep gene products of PCV2 were not only able to bind the PCV2 origin but also the origin of PCV1 and vice versa.

To investigate the competence of the Rep/Rep' proteins to initiate replication at the heterologous origin, a new replication assay was developed. It measures the expression of a luc reporter gene present on a plasmid carrying the origin of the investigated replicon.

Replication is initiated by expression of the appendant replicase from a second plasmid and results in replication of the origin plasmid coupled with an increase in the Luc activity.

Using this method to compare replication of PCV1 and PCV2 in cell culture, it was shown that the Rep/Rep' protein of PCV2 initiated replication at the origin of PCV1, as did the reciprocal combination.

Our results indicate that the cis- and trans-acting replication factors of the two viruses are functionally exchangeable.

.

Angus Files

murderer`s all of them..

Angus

Bob Moffitt

Teresa .. there is no reason to "wonder" about a possible "conflict".

The Patriot Act erased all pretense that public health agencies and the vaccine industry are anything less than full partners .. working hand in hand to develop a very strong vaccine industry .. to protect our nation should we suffer a biological attack. Indeed, under the Patriot Act .. the Secretary of Health and Human Services has gained extraordinary power to mandate vaccines by force if necessary.

So .. it is highly doubtful public health agencies are going to do ANYTHING that may weaken a vaccine industry they believe to be critical in fighting TWO wars.

The war on disease as well as the war on terror.

Gatogorra

How hard would it be to find out whether Rotateq had these viral fragments 7 weeks ago? Some green peds offer vaccines to those who want them and are sure to have stock on the shelves from a few months back and the samples could be sent in. Chain of possession could be an issue, but where would pediatricians get these exact fragments of pig viruses which are sure to be in the samples?

Not an MD

Well, there must be one heck of a sweetheart deal being made, considering Rotarix has "only" PCV1 contamination and was withdrawn, but you have RotaTeq with both PCV1 and PCV2 contamination, yet RotaTeq continues to be recommended as the preferred vaccine. There is something really wrong, and really corrupt, about this.

Teresa Conrick

Well, this sure looks rather not good. It makes one wonder if there could be any conflict or possible symbiotic relationship that could be interpreted as ...unhelpful to the consumer?

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