Paul Offit, Rotateq, Pig Viruses, and the Rest of the World
By J.B. Handley
As the facts surrounding Friday’s decision by the FDA to keep Paul Offit’s Rotateq vaccine on the market despite being contaminated with two pig viruses known to cause fatal wasting disease, the fragility of the current vaccine schedule and the control that profits appear to have on our regulator’s decisions are clearly emerging for the world to see.
A glaring fact never discussed by the FDA advisory panel that met Friday was why so few other first world countries even require a rotavirus vaccine for their children. Of 30 first world countries analyzed by Generation Rescue, only three—USA, Canada, and Austria—recommend some sort of Rotavirus vaccine. If the FDA is so sure the “benefits outweigh the risks” of keeping Offit’s vaccine in circulation, why have 27 first world countries like the UK, France, Germany, Japan, Italy, Denmark, Sweden, and Norway never even bothered to add a rotavirus shot to their immunization schedules in the first place?
Discussing Offit’s vaccine on Friday, Reuters reported that “in 2009, sales of Merck's vaccine [Rotateq] totaled $522 million, including $468 million from the United States.”
Let me help you all do the math here, because it’s so egregious. Of all the sales of Paul Offit’s Rotateq vaccine, 90% come from the United States, because so few other first world countries even buy the shot. 90%!! If the FDA bans Rotateq, Offit’s shot is out of business. Have you ever heard Offit talk about how proud he is of his vaccine? How proud he is to be helping the third world? With 90% of his shot being sold right here in the USA, it’s all a bit of a stretch, no?
Looking at the FDA’s actions more closely, it’s darkly comical to see what a tough spot they’re now in. In March, the FDA advised doctors to stop using Rotarix, a competitor to Rotateq, because it contained a virus known as PCV-1.
Now, the same testing has revealed PCV-1 and, additionally, PCV-2 in Offit’s shot. By all accounts, PCV-2 is a far more dangerous virus with far less known about it. Yet, somehow, the existence of PCV-2 is causing the FDA panel to recommend keeping both of the brands of the shot on the market, including reversing the original Rotarix decision! (Of course, the other shoe to drop, and this one is an enormous shoe, is what happens when all the other vaccines in the schedule are tested?)
Here’s a quick background of PCV-2:
“Postweaning multisystemic wasting syndrome ("PMWS") is a porcine disease. This disease causes illness in piglets, with clinical signs including progressive loss of body condition, visibly enlarged lymph nodes, difficulty in breathing, and sometimes diarrhea, pale skin, and jaundice. PMWS has been reported from most pig-producing countries of the world at huge cost to agriculture. PMWS is caused by porcine circovirus type 2 (PCV2).”
What parent on the planet would want that virus put into their child?
Perhaps a proper analogy would go something like this: Parents, please stop your kids from drinking Coke, we found some lead in it. Oh, never mind, they can drink Coke & Pepsi, we just discovered Pepsi is filled with lead and mercury, too!
When will the destruction wrought by the Rotavirus vaccines end? In the late 1990s, the original Rotavirus vaccine called Rotashield was pulled from the market for injuring kids. Soon after, Paul Offit appeared on the ACIP, the advisory panel of the CDC that has the sole power to add new shots to the CDC’s schedule. Offit’s behavior on the ACIP, which facilitated the addition of his own Rotateq vaccine to the US vaccine schedule, was later memorialized by this critical document from our U.S. Congress, which stated:
“Dr. Offit began his tenure on ACIP in October of 1998. Out of four votes pertaining to the ACIP’s rotavirus statement, he voted yes three times, including voting for the inclusion of the rotavirus vaccine in the VFC program. Dr. Offit abstained from voting on the ACIP’s rescission of the recommendation of the rotavirus vaccine for routine use.”
The Rotateq vaccine is used in only 3 of 30 first world countries. 90% of its revenues come from the United States alone. It contains a virus, PCV-2, known to kill pigs, and a more benign virus that contaminated its competitor’s vaccine was enough for the FDA to recommend not using Rotarix just 2 months ago.
A scientist friend wrote me the following regarding the FDA and the newly-discovered PCV viruses in the Rotateq vaccine:
“Before any of these contaminated vaccines are given to another child the FDA should arrange for urgent, comprehensive analysis of tissues (particularly lymphoid tissues) – not blood alone – from individuals exposed to the vaccines…
PCV 2 in and HRV in particular are lymphotropic viruses and persistent or latent infection of lymphoid tissues must be excluded. This is where HIV hides during latentcy…
Infectivity of contaminating viruses is but one biohazard and they should not be allowed to dismiss the problem on the basis of “a lack of replicating virus” argument. The PCV is a DNA virus, fragments of which can integrate into the human genome with multiple potential problems. This is more likely to happen in rapidly dividing cells e.g. those of the immune system responding to a simultaneously administered (vaccine) virus. Reactivation of intact or relatively intact virus is another possibility. Viral peptides encoded by sub-genomic fragments acting as a trigger for autoimmunity is another.
For the human retrovirus (HRV) contaminants, the prospects are equally bad. Retroviruses have the enzymatic machinery to convert RNA into DNA. Given simultaneously with three RNA viruses (M, M and R) that should have no DNA forms, there is the potential to generate DNA forms of these viruses or recombinants thereof, which could integrate into the human gene or produce highly pathogenic re-assortments. This RNA to DNA transformation has been shown by Klennerman and Zinkernagel for lymphocytic choriomeningitis virus (LCMV), an RNA virus, that can persist in the infected host in a DNA form due to the action of endogenous retroviral reverse transcriptase, turning it to DNA.”
Do those sound like viruses that should be allowed to remain as contaminants in the Rotateq and other live viral vaccines and placed into American infants? Parents, the FDA is no longer putting the safety of children first--please forward this article to every lawmaker you know.
J.B. Handley is co-founder of Generation Rescue.
Have any recipients of Rotatix or Rotateq been tested for live pig virus ? Is there any proof that the human system kills the virus or does it remain live in the guts of these infants ?
Posted by: Kristy | February 06, 2015 at 11:00 AM
Who cares if Pfizer created a new porcine circovirus for a vaccine which is now loose in the Babes and Charlottes of the world? Does it make them any less delicious?
For more about this see my previous post which should be right below this one.
From "Emergence of a new type of porcine circovirus in swine (PCV): A type 1 and type 2 PCV recombinant," Gagnon 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."
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TD6-4Y4PVM3-3&_user=10&_coverDate=07%2F29%2F2010&_rdoc=1&_fmt=high&_orig=search&_origin=search&_sort=d&_docanchor=&view=c&_searchStrId=1616784461&_rerunOrigin=scholar.google&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=5bb5e2c03aa06ad4fa007dad31230755&searchtype=a
Posted by: Carol | January 23, 2011 at 10:39 AM
Something a little funny going on with these piggy viruses:
"Recently a chimeric PCV1-2a isolate was identified by PCR in Canadian pig tissue homogenates (Gagnon et al., 2010). This has raised concern about the possibility that this isolate originated in the FDAH/Pfizer Suvaxyn PCV2 vaccine. As a precautionary measure, Pfizer Animal Health has taken action to temporarily remove the vaccine from the market to further investigate this possibility. As the industry and profession work through this process it is important to consider some history and information that may not be widely known. The FDAH/Pfizer product is based on a chimeric virus which means it is part PCV1 and part PCV2. It was constructed in this manner originally so that it could be used as a modified live vaccine thereby giving it the non-virulent characteristics of PCV1 and the antigenic portion (ORF2) of PCV2 to provide broad cross-protection."
http://vetmed.iastate.edu/pcv2-vaccines
Posted by: Carol | January 22, 2011 at 03:42 PM
It would be great if Dr. Offit would show up on the Today Show with Dr. Nancy and take a few doses his contaminated pig virus Rotateq vaccine.
(6-8 doses would be nice, plus 6-8 Swine flu shots to protect him)
What a great way for this medical professional to "show the world" of some of the wonder he has created.
Posted by: cmo | May 12, 2010 at 10:38 AM
The self-regulating finance industry brought us the financial meltdown and a worldwide economic crisis leading everyone including themselves to near disaster. The self-regulating oil drilling industry (drill, baby, drill) brought us what will be the largest oil spill in history leading everyone including themselves to near disaster. Of course, we all know that the self-regulating pharma industry (shoot, baby, shoot) brought us the worse child health crisis in history, includign autism but not only, leading everyone to near disaster ... but they haven't paid the price yet for now. I see disaster looming in the future for them because if we have learned anything from recent events is that lying big for self profit eventually leads to disaster.
Posted by: we shall overcome | May 12, 2010 at 08:11 AM
Porcine viral wasting disease = swine flu.
Posted by: Amanda Blinn | May 11, 2010 at 11:39 PM
yeah!, what GH said:
"it makes me wonder if viral and cell wall deficient bacterial contamination will turn out to be the major factor causing vaccine reactions, rather than necessarily heavy metal toxicity."
MAKE AUTISM STOP
Posted by: MAKE AUTISM STOP | May 11, 2010 at 11:25 PM
Funny how gov't/BigPharma only worry about pig viruses when they are trying to sell billions of dollars worth of Swine Flu vaccine...
ask your doctor if pig virus is right for you.
Posted by: Janet Sheehan | May 11, 2010 at 09:38 PM
Question for J.B. or Kim...or anyone who can answer this one.
The Thoughtfull House website talks about Phase I and Phase II of Wakefield's monkey study. It states that Phase II will be completed in 2012. Do you have any idea if and/or when they are going to publish (somewhere) any preliminary results from this second study? (or at least make them available for public reading??) Thanks.
Posted by: Jill Fenech | May 11, 2010 at 07:51 PM
Sanitation is the key to preventing water borne diarrhoeal diseases - World Health Organization.
"The importance of sanitation is indisputable. It is a crucial stepping stone to better health: sanitation offers us the opportunity to save the lives of 1.5 million children a year who would otherwise succumb to diarrhoeal diseases,and to protect the health of many more."
http://www.who.int/water_sanitation_health/monitoring/jmp2008.pdf
Posted by: Universal Family Church | May 11, 2010 at 07:40 PM
J.B.
A great report on this craziness. Your analogy is perfect and says it all:
"Parents, please stop your kids from drinking Coke, we found some lead in it. Oh, never mind, they can drink Coke & Pepsi, we just discovered Pepsi is filled with lead and mercury, too!"
Thank you.
Posted by: Teresa Conrick | May 11, 2010 at 07:24 PM
Christine - please research all you can before injecting any vaccines into your infant. No vaccine is safe. No vaccine gives immunity. And there is nothing safe about a slowed-down or delayed schedule
http://vaccinationdangers.wordpress
This vaccine is only one of many contaminated - others are contaminated with mercury or aluminum or mycoplasma bacteria or MSG or phenol or any of a number of other chemicals as well as DNA and RNA and other animal viruses
Posted by: Sheri Nakken, RN, MA, Homeopath | May 11, 2010 at 04:26 PM
It will be interesting to see what FDA will say and do should ever a humble over-the-counter medicine, or God forbid a dietary supplement (one without a firm big pharma name behind it) be found contaminated with PCV.
Posted by: Natasa | May 11, 2010 at 04:08 PM
GH thinks one thing only is the cause of vaccine reactions.
In fact the causes are very numerous and this is not the latest problem but an old problem returning.
monkey virus - remember that in polio vaccines? No one knows the cause of AIDS/SIDA but it almost certainly dates after the contamination in the 1950's of polio vaccine with this animal virus that at the time had NO KNOWN effect on humans.
Today we are being asked to inject another animal virus into our one day infants ( not in every other country in the world bar 2).
We do know that this virus which does not affect humans (so the FDA, WHO say - well they would wouldn't they?) we do KNOW it sustains and replicates in human tissue. UNDISPUTED fact.
Quite what a virus does when it replicates and sustains itself in humans we don't know (says FDA, WHO et al).
I suggest you ask SID.
And while the USA mandates 100 per cent of babies to get this virus with their vaccines lets also remember the H1N1 debacle when for example 95 per cent of French adults REFUSED this VERY SAFE vaccine (again FDA and WHO says so).
One law for adults and one for babies led to slaughter (well only one million dead so far after vaccines in their first abortive year of life)
Posted by: john fryer chemist | May 11, 2010 at 03:44 PM
Not that I think they ever were, but as JB said "Parents, the FDA is no longer putting the safety of your children first..." Now there is no doubt. Absolutely sickening.
Posted by: 4Bobby | May 11, 2010 at 03:44 PM
I'm with you GH, been saying that all along. That and reactivation of latent viruses already present in the host.
Posted by: Natasa | May 11, 2010 at 03:20 PM
I'd like to hazard a guess, maybe JB can address this. If diarrheal diseases mainly kill 3rd world children, are these high priced vaccines ever given in these countries that likely cannot afford them?
I suspect I already know the answer...
Posted by: quarlie | May 11, 2010 at 02:27 PM
Yes, sooooo very odd that they suspended rotarix but not rotateq. The reason for this is quite Merck-y, isn't it? Why do I have a mental picture of Julie Gerberding running around the halls of FDA like Oprah yelling "YOU get a new car! YOU get a new car!" And all we get is the shaft. Again.
Posted by: Garbo | May 11, 2010 at 01:53 PM
Not that I have much hope for them, but technically I don't believe the FDA weighed in yet. The meeting Friday was to review the science and get the opinion of the advisory committee. Certainly the advisory committee was recommending continued use, but that doesn't necessarily mean that's what the FDA will rule.
Posted by: Jack | May 11, 2010 at 01:30 PM
As a 1st time parent of a 6 week old baby I am terrified! I'm glad I did my research and found out about this pig virus before I blindly let his pediatrician give this vaccine 2 weeks from now. Why do so many Drs insist on following the government recommended vaccine schedule without looking at all the facts? My son's Dr insists this vaccine and all others are safe and questions why I am refusing Rota and want to slow down the rest of the schedule. The FDA wants us to give our children this vaccine while they do research into the side effects of the contaminants? OUR children are the research and it's disgusting.
Posted by: Christine | May 11, 2010 at 01:29 PM
I can second what Jenna said. No way in the world a new product could get away with this. Preventing this has been a huge deal with the FDA, their main focus along with BSE/TSE. They've ignored everything else important in my opinion to focus on being able to say vaccines are manufactured safely so that they are free of adventitious agents and sterile. Most of the cost of production centers around this.
If they back away from that they really don't have any credibility. What you have here is an "adulterated vaccine" and if that doesn't matter any more, then nothing does.
It truly may be that its presence doesn't have any impact at all, but you've never been able to argue that to the FDA. Now you can, I guess.
In that meeting they talked about all the right science. They are doing all the right science, but yet, amazingly, they just threw their hands up at the end and said, "Eh, it's probably fine."
Posted by: Jack | May 11, 2010 at 01:16 PM
I don't understand much of the biology behind this, but it makes me wonder if viral and cell wall deficient bacterial contamination will turn out to be the major factor causing vaccine reactions, rather than necessarily heavy metal toxicity.
Posted by: GH | May 11, 2010 at 01:10 PM
It *is* good to see solid science info being used to tell folks what's going on. It would be nice if there was a footnote for folks who don't understand though! How about linking to explanation? You won't have to weigh down the article, but people will still get a decent explanation. I think if more people understood just how promiscuously they swap genetic information (and therefore how fast microbes evolve), they'd back off considerably on the vaxes. And maybe on the "antibacterial" products, which amount to serious selection pressure driving microbial evolution towards virulence. Just use *soap*, folks! Triclosan is toxic, and microbes are already becoming immune to it. Unfortunately, WE are NOT immune.
Posted by: Karen Eliot | May 11, 2010 at 01:05 PM
The AASV (American Association of Swine Veterinarians) noticed the earlier recall of Rotarix:
http://www.aasp.org/news/story.php?id=4106
I wonder if all those huge pork raising CAFOs will be comfortable with the FDA decision this time?
Posted by: Should I hope they 'raise a stink?' | May 11, 2010 at 12:50 PM
In my over half a century on this planet, I have never ever known anyone to have a problem with rotavirus. Supposedly most people in the developed world simply fight off this virus with a fleeting case of diarrhea. Supposedly some babies come down with severe cases of diarrhea and are hospitalized to prevent dehydration -- treatable, and passes without longterm sequelae. So what about rotavirus would make it worth taking any risk with a vaccine? Why would even a small risk of intussusception or porcine viral wasting disease be acceptable?
The children I know with serious GI issues are vaccine injured, not rotavirus injured.
Posted by: Twyla | May 11, 2010 at 11:45 AM
UGH!! Thank goodness my only vaccinated child was spared this vaccine, since he was born in 2005!
You know damn well that when illnesses start to come out, and this vaccine is blamed, nothing will be done! Maybe some useless hearing to waste more of our money. Perhaps even an apology....maybe....
But with blanket immunity, vaccine makers won't pay a cent for the damage they are causing. And the not so "special Masters" will likely rule against these poor victims in their joke of a court room.
Makes me very ill...
Posted by: Judith, RN | May 11, 2010 at 11:32 AM
Wow, thanks JB. I feel like I'm coming closer to understanding the RNA/DNA transfer and how viruses share genetic material.
Not that the knowledge is any comfort in light of the current debacle, though it's better to know. There's something disturbingly familiar about the symptoms of PMWS...
“Postweaning multisystemic wasting syndrome ("PMWS") is a porcine disease. This disease causes illness in piglets, with clinical signs including progressive loss of body condition, visibly enlarged lymph nodes, difficulty in breathing, and sometimes diarrhea, pale skin, and jaundice. PMWS has been reported from most pig-producing countries of the world at huge cost to agriculture. PMWS is caused by porcine circovirus type 2 (PCV2).”
It will indeed be interesting when (if) they check the other vaccines on the schedule for rogue viral tainting. My children never had Rotateq or Rotarix, but post vaccination, they had...
Loss of muscle tone-- check.
Visibly enlarged lympth nodes (base of skull)-- check.
Pale skin-- check.
Respiratory problems-- check.
GI problems-- check.
Posted by: Gatogorra | May 11, 2010 at 10:40 AM
Further proof that the FDA is in business to assist industry, not protect consumers.
Anyone who thinks the FDA, CDC or AAP are looking out for the best interests of our children are smoking some SERIOUS dope!
Posted by: Sylvia | May 11, 2010 at 10:25 AM
Only on this web site have I read about contaminated vaccine.
Only here have I read about Offit voting himself rich.
Only here has someone respected me enough to tell me about a RNA virus can be able to replicate itself by enzymes back into the DNA of its host. No, I do not know what it means - but - yes - as a human being I can pretty much guess it means that something they some viral scientist says is just in the shot and we will excret it is not true - it will end up in our cells and become part of us -deep inside our cells messing up our mitorchondrial cycle.
Only here have I been respected for someone to say "retoviral reverse transcriptase" No, I don't know what that means either, but I can guess and it is a good guess too. I means about the same thing.
Posted by: Benedetta | May 11, 2010 at 10:09 AM
i am SO happy that i had started my research on vaccines before this one was suggested for our son... it just makes me so disgusted... how incidental our children are in their grand scheme.
Posted by: Col | May 11, 2010 at 09:38 AM
Hi JB-
I have an industry scientist friend too, who told me that Genzyme has a biologic that is not being allowed on the market (by FDA) right now for this very reason-viral contamination. And apparently the contamination is thought to be completely benign (unlike in this situation), but still the FDA will not issue approvals until they obtain clean testing. She also told me that this is a mess--it is monumentally difficult to eradicate contamination like this, and doubly hard when you are dealing with a vaccine (because processes used to kill viruses will destroy efficacy).
Posted by: Jenna | May 11, 2010 at 09:30 AM
I presume that is the previously unknown Trojan pig at the top?
Posted by: John Stone | May 11, 2010 at 09:02 AM
I am so, so grateful that my children are too old to have been "required" to get a rotavirus vaccine.
I do seem to remember an ad campaign in the late 90's-early 2000's about how deadly rotavirus was for premature infants.
It's really scary how the pharma industry operates.
Posted by: Parent | May 11, 2010 at 08:53 AM
public experimentation
Posted by: stop experimenting on children | May 11, 2010 at 08:21 AM
WOW!!! That's all I got...........
Posted by: debbie voss | May 11, 2010 at 08:10 AM
At a 95% gross profit margin, these vaccines (and their cash flow) pay for a lot of bills (executive profit sharing plans, industry confabs, research grants to ethically compromised scientists, K street lobbyists, politician reelection campaigns, etc.). Of course, all in the name of "good science" and "shareholder value" and "the greater good." Let's call it for what it is...our public health and safety institutions have been co-opted (taken over) by the pharma and vaccine industry...heck, it wasn't even a hostile takeover. It was done in plain sight of 300 million Americans who said and did nothing. What a sad legacy to leave our children and future generations to clean up.
Posted by: david | May 11, 2010 at 07:39 AM
J.B. wonders... (Of course, the other shoe to drop, and this one is an enormous shoe, is what happens when all the other vaccines in the schedule are tested?)
Exactly. Not only do vaccine manufacturers have to worry over new technology that allows "science" to identify contamination in vaccines that has gone undetected for decades .. so do the manufacturers of "over the counter" products. Who knows what this new technology is going to uncover .. in how many products .. which is why I suspect .. our government will be tardy in requiring the FDA use it.
I suspect we will begin getting the standard "plausible denials" about the contaminants being so small .. nothing to worry about ....
Posted by: Bob Moffitt | May 11, 2010 at 07:00 AM
An amoral decision to keep giving this to kids. I saw in a newspaper that they are "recommending" parents should be "warned" of the risk. Kind of like how it is "recommended" that doctors report vaccine adverse reactions to VAERS when a great many of them never do. Good gosh people, these are children....other people's children!!!!!!
Posted by: AnaB | May 11, 2010 at 06:57 AM
Another blaring example of "Callous Disregard" for the safety of our children.
Good job JB.
Posted by: Charlie | May 11, 2010 at 06:56 AM