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All Is Not Well: The FDA Animal House (Hint, It's About Pigs)

Remain_calm_medium Wade Rankin of Injecting Sense wrote about the Rotavirus vaccine review by FDA earlier this month.

 in his movie career, Kevin Bacon played a character named Chip Diller, in the seventies classic, Animal House. His role was small, but he contributed two scenes that were oh-so-memorable.

During a pledging ceremony at the evil and exclusive Omega house, young Chip is repeatedly paddled on his posterior. With each new helping of pain and potential harm, the new pledge is made to exclaim, “Thank you sir, may I have another.” Later in the movie, we see Chip, dressed in his ROTC uniform, acting as a parade marshal for the homecoming festivities. In response to the mayhem created by those bad boys from Delta house, Chip screams out that everyone should “remain calm; all is well.” Of course, all is not well.

I’ve been thinking of Chip lately while observing the coverage ⎯ or to be more precise, the lack of coverage ⎯ of the disclosures that extraneous DNA from pig viruses (and other foreign bodies) was found in both of the Rotavirus vaccines.

For a good discussion of the problem, see these posts (here, here, here, here, here, and especially here) in Age of Autism.

Here’s the basic background. First, in March GSK’s Rotarix vaccine was found to contain DNA from PCV-1, a pig virus. The FDA suspended its use, pending review. Of course, in the meantime, that left the market clear for the sole competitor, Merck’s RotaTeq (developed by our old pal, Paul Offitt).

Then shortly before the FDA hearings on the Rotarix tainting, it was discovered that the RotaTeq vaccine, in fact, contained DNA from two pig viruses, PCV-1 and PCV-2.

The FDA meeting on the Rotarix fiasco occurred, predictably on a Friday. Traditionally, Friday afternoon tends to be when one releases news that one hopes will never be heard. The FDA’s (in)action was all too predictable. No vote on further suspension of the vaccines was taken. Although the panel did say that further long-range studies were advisable, and that parents should be informed that the errant viruses were found in the vaccines (and, of course, Friday afternoon is the ideal time to disseminate that thought, isn’t it?), the overall impression is that nobody on the panel thought there was any immediate concern.

One of the FDA panel members, Dr. Harry Greenburg, was quoted as saying: “The benefits (of the vaccine) far outweighs the risk.” Apparently there was a script floating around the meeting room, because another panelist, Dr. Melinda Wharton, was quoted as saying, “Based on where we are with current knowledge, to me the known benefits clearly outweigh the risks.”

And that was the theme of the scant attention paid by the media. The benefits outweigh the risks. Remain calm; all is well. That theme was based on two elements: the vaccines are effective, and there is a low risk of infection.  Read the full post at Injecting Sense

Comments

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B's mom

We are in an era fairly new to the dna science, a couple of decades and a whole world away from knowing all there is to know on the subject.I remember a little study on chimeras, and found it so frightening that our own dna can be displaced by anothers, and now I have to look at this vaccine "mess", and think perhaps we've gone too far. We've accepted the dna from another's child, from monkeys, pigs, chickens, cows, I can't be comforted by this new science or telling me this is harmless. I don't believe we can possibly know at this point in the game, that taking on the dna of other animals couldn't leave us victim to zootic plagues that wouldn't/couldn't touch us before. I'm certain when God said to put enmity between the species he was smarter than Offit.

We aren't living longer or healthier, our children are sick, their lives have been altered,we are diseased as a population , yet we follow like sheep led by corporate gods thinking all the while that if we don't do what they say some horrible thing will happen to us.
This week my grandson brought home a paper from the nurse, a child has chickenpox, however he was a vaccinated child, you may want to consider adding another booster to your vaccine schedule. What if he had not been a vaccinated child, would he have had to bear some kind of punishment for being "dirty". What happened to people who could think? Obviously these vaccines are damaging many, and don't work, leaving the question, "why accept the risk for our most precious gifts, our children"?

Paul

When is the last time you have heard of a child in the US dying of diarrhea, to say nothing of the relatively mild rotavirus diarrheal illness. There are now documented xenoviruses in the vaccine. Where is the regulatory concern of the FDA, where is their commonsense? Irregardless of questions of efficacy or other safety concerns there is a documented health risk in the vaccine, of course it needs to be pulled, all previous batches destroyed and the vaccine kept off the market until the problem is demonstrably rectified. However, this won't happen as the FDA is a pig with its snout in the trough of big pharmaceutical companies largess.

http://healthjournalclub.blogspot.com/

nhokkanen

Thanks, Wade. Knowledge IS good.

Gatogorra

This is a really useful analogy! I think many members of the public are becoming less like Chip Diller in terms of passive conformity to an overblown vaccine schedule and stupid reassurances, and more like the character in e.e. cummings poem, which includes a curiously similar theme of military hazing:

Olaf(upon what were once knees)
does almost ceaselessly repeat
"there is some shit I will not eat"

Nonnymouse

Apparently, it doesn't really matter if it started as Type 1 or Type 2 (virus) -- they re-combine. Take a look:


Vet 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.

Abstract
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.

Jim Thompson

They have to play a dual role at the FDA, as doctors and magicians as well, arriving at this unfounded nonsense of a benefits/risk ratio, with no numeric value, by pulling it out of their [hats] during the meeting.

katy

and they wonder why people are backing away from vaccines... i'm appalled and more people should be!! i'm tired of being lied to, but unfortunately it seems to be the way it's done. these "people" have no concern but themselves and pocketbooks, sickening...

Teresa Conrick

Great analogy, Wade. The "remain calm; all is well", CDC/AAP et al. mantra is ridiculous as we watch the autism numbers explode. The other ad nauseam phrase, “The benefits (of the vaccine) far outweighs the risk.” has been so over used and has lost any honest intention that it was ever supposed to convey.


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