False Prophet: Rotateq, Created By Paul Offit, Responsible for at Least One Death

By J.B. Handley

Paul Offit, the vaccine industry's well-paid spokesperson, has been on quite a roll lately. Recruiting Amanda Peet to be a spokesperson for the Wyeth-funded Special Interest Dot-org (SID) called Every Child By Two seems to have given him some new energy in talking to the press. Consider his comments yesterday to the Orange County Register:

"I asked him whether, given how much money he made because of a vaccine, he is the best person to advocate for vaccine. Even if we assume he's never done anything improper, does he have the credibility to convince the public? He says yes, because he has the knowledge of how vaccines are tested and created, because he's been behind the curtain at pharmaceutical companies — things a strictly academic scientist wouldn't have access to. He admits his vaccine made him wealthy, but he says he spent 25 years trying to develop it because he wanted to save kids."

So, Paul Offit admits the Rotateq vaccine has made him wealthy? Offit goes on to clarify the "a child can tolerate 10,000 vaccines" comment that CBS News attributed to him:

"Asked whether any specific facts in the story were wrong, he said it was primarily the tone he objected to. But he did say that the hospital owns the patent, not him (though he received a share of royalties from it). Also, when Attkisson noted that he had been quoted as saying children could safely take up to 10,000 vaccines at once, "what I actually have said is at least 10,000. It's probably closer to 100,000."

Oh, so it's actually 100,000 vaccines a kid can tolerate?

As many of you know, Paul Offit has a book due this fall called Autism's False ProphetsL Bad Science, Risky Medicine and the Search for a Cure. Here's a summary from Amazon:

"A London researcher was the first to assert that the combination measles-mumps-rubella vaccine known as MMR caused autism in children. Following this "discovery," a handful of parents declared that a mercury-containing preservative in several vaccines was responsible for the disease. If mercury caused autism, they reasoned, eliminating it from a child's system should treat the disorder. Consequently, a number of untested alternative therapies arose, and, most tragically, in one such treatment, a doctor injected a five-year-old autistic boy with a chemical in an effort to cleanse him of mercury, which stopped his heart instead.

Children with autism have been placed on stringent diets, subjected to high-temperature saunas, bathed in magnetic clay, asked to swallow digestive enzymes and activated charcoal, and injected with various combinations of vitamins, minerals, and acids. Instead of helping, these therapies can hurt those who are most vulnerable, and particularly in the case of autism, they undermine childhood vaccination programs that have saved millions of lives. An overwhelming body of scientific evidence clearly shows that childhood vaccines are safe and does not cause autism. Yet widespread fear of vaccines on the part of parents persists.

In this book, Paul A. Offit, a national expert on vaccines, challenges the modern-day false prophets who have so egregiously misled the public and exposes the opportunism of the lawyers, journalists, celebrities, and politicians who support them. Offit recounts the history of autism research and the exploitation of this tragic condition by advocates and zealots. He considers the manipulation of science in the popular media and the courtroom, and he explores why society is susceptible to the bad science and risky therapies put forward by many antivaccination activists."

Let's try and put all these pieces together:

1. Paul Offit has been made wealthy from Rotateq, according to him.
2. A child can tolerate 100,000 vaccines at one time, according to him.
3. In his book summary, he misstates the facts surrounding the death of a child to bolster his argument that biomedical treatment for autism is quackery.

So, I just have one simple question. For all the ink Paul Offit gets, how come not a single journalist covered the death of a child from Paul Offit's vaccine?

And, I guess I have one more question, this one for Dr. Offit. If a child can tolerate 100,000 vaccines, how did just one of your vaccines kill a child?

Below, please find a letter from the FDA to Merck & Co. updating the label to include "death due to intussusception that has occurred after vaccination with RotaTeq®."

April 30, 2008

Our Submission Tracking Number (STN): BL 125122/443
Merck & Co., Inc.
Attention: Paul L. Koser, Ph.D.
P.O. Box 1000
UG2D-68
North Wales , PA 19454-1099

Dear Dr. Koser:

We have received your April 14, 2008, Supplement to your Biologics License Application for Rotavirus Vaccine, Live, Oral, Pentavalent, to include changes to the post-marketing experience section of the label to include a post-marketing report of a death due to intussusception that has occurred after vaccination with RotaTeq®. The patient package insert has also been updated to include this information.

This Supplement has been reviewed under STN 125122/443 and is approved effective this date.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy.

This information will be included in your License Application File.

Sincerely yours,

/Loris McVittie/
Loris D. McVittie, Ph.D.
Acting Director
Viral Vaccine Branch
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics Evaluation and Research

J.B. Handley is co-founder of Generation Rescue and Managing Editor of Age of Autism.

Comments

[Twyla]

Regarding comment from john (August 09, 2008 at 09:02 AM):

Dr. Offit's comments at the PBS site are remarkable in that what he is saying about the small pox vaccine is exactly what so many parents are saying about other vaccines, namely that the risks of the vaccine currently outweigh the benefits. Dr. Offit says that when people receive the smallpox vaccine:

"they can get an infection of the brain, called encephalopathy or encephalitis. If they have eczema, they can have sometimes a severe and occasionally fatal disease called eczema vaccinatum. And this is very common that one can inadvertently touch the site that was inoculated and then touch the eye and have an infection of the eye, which can rarely be quite severe. In patients who have decreased capacities to fight infection, there is a disease called 'progressive vaccinia' where in fact the disease is overwhelming and it is the cause of death.

"So, there are side effects which are quite severe, which when you start to immunize as many as 500,000 people you're going to see. And what I think is sobering is that this is a vaccine which has eliminated disease, that was probably one of the most important causes of death in this world. Probably about 300 million people have died of smallpox. This vaccine has eliminated it."

In the case of small pox, the risks of the vaccine were acceptable when this very serious disease was epidemic, but today the risk of the vaccine is not outweighed by the risk of contracting the disease.

Encephalitis, eczema, and coming down with the virus being vaccinated against are some of the same adverse events that so many parents have reported in their children with autism after receiving other vaccines such as the MMR and DPT. Measles, mumps, rubella, and whooping cough are still prevalent in our environment, but the question is whether the risks of these diseases outweigh the risks of the vaccines, and whether the vaccines can be made safer (such as by separating and spacing them out), and whether high-risk populations can be identified. These questions cannot be answered if the adverse events are denied instead of being tracked and studied.

I just don't understand how Dr. Offit can make this cogent analysis of the risks and benefits of the small pox vaccine, but not apply this same thought process to other vaccines.

[John Stone]

It does strike that the 10,000 vaccines doctrine is an effective strategy for softening people up for 50 or 100. It is insane but you can always turn on people and say "what are you making the fuss about?"

The Offit doctrine is, by the way, firmly part of British Government health ideology, but it is interesting to probe what is actually meant. Some years ago I had an email exchange with UKs vaccine supremo, Dr David Salisbury and this what he wrote:

"Turning to my comments on Newsnight - I suggest you read Paul Offit's paper - as I have done. On page 126, he states: "Current data suggest that the theoretical capacity determined by diversity of antibody variable gene regions would allow for as many as 109 (1,000,000,000) to 1011(100,000,000,000) different antibody specificities". And "... then each infant would have the theoretical capacity to respond to about 10,000 vaccines at any one time" - not antigens. I was speaking very specifically about the infant immune system's ability to respond, in the context of the ridiculous suggestion that the new vaccine combination, containing far fewer antigens than the one it will replace, would overload the immune system. My words were "The immune system of a baby has got huge spare capacity to deal with challenge. If we didn't, the human race wouldn't survive. But let's look specifically at vaccine. This has been studied carefully. A baby's immune system could actually tolerate perfectly well 1,000 vaccines". At no point did I suggest that 1,000 vaccines would not increase the probability of adverse reactions - a quite different matter."

http://www.theoneclickgroup.co.uk/documents/vaccines/What%20Is%20Going%20On%20In%20SE%20London.pdf

So, it doesn't matter whether it is 1000, 10,000 or 100,000 - it is just a boggling number which makes light of 50 or a 100. But also, the spare capacity claim is a straw argument, and has no apparent bearing on the actually greater risk of exposure to a greater number of vaccines.

[john]

He is the master of Doublespeak:

"I think without question the smallpox vaccine has severe adverse events that occur at a rate far greater than any of the other vaccines that we use today. Which means that the smallpox vaccine, is I think, without question, our least safe vaccine. But it is absolutely safe if one defines 'safe' as benefits outweigh risks in a situation where the disease is present. When the disease isn't present, then one only is frankly aware of the risks, because there are no benefits." http://www.pbs.org/newshour/bb/health/july-dec02/offit_smallpox.html

[Elucidatus]

The Mesiah was also considered a false profit because the non-believers were concerned that those who followed him would eventually see the truth and would forever change the status-quo.

[Elucidatus]

Paul Offit... This is one book that will never be on the top 10 best sellers!!! Take your book somewhere else like the comic book section or comedy section because it lacks evidence that vaccines ever saved lives...

[Gatogorra]

Offit is beginning to smell like death. It's no wonder considering what's in his wake, but it's more than that- it smells like profound failure. At first I was wincing and didn't want to read whatever is being said to promote the book, but by the end of reading that bit I was smirking. That was the lousiest promo to a book release that I've ever read. Not just the point of view and misinformation but the typos and nonsense statements (the therapies themselves threaten the vaccine program? Howzat?). It kind of makes me wonder whether there are senior editors or blurb writers within Offit's own publisher who are picking up the grave scent emanating from Offit and are demuring to pen the promotion and handing it down to some Junior Jr. who doesn't have a child and doesn't have a clue. Something's wrong with his machine.

[Heidi]

The obvious answer is that the death was well under the "3% collateral damage is okay" rule stated today by Rene Jenkins of the AAP. Are total VAERS claims above 3% because I'm thinking I want to point this out to Rene. How many times can they say "Nothing to see here folks, just move it along"? Thanks for making this point JB.

[David Johnson]

The 100,000 safe vaccinations that Dr. Offit gets should also be weight adjusted to be equivalent to what the 15 lb babies get. That will be even more interesting.....

[John Stone]

Just three years after the introduction of Offit's Rotateq there are 2,919 associated events on VAERS, 696 associated hospitalisations and 78 deaths. This is a high proportion of hospitalisations to events, and deaths to hospitalisations.

http://tinyurl.com/3a5n9t

http://tinyurl.com/3ysn8g

http://tinyurl.com/3xstxj

Of course, inclusion in VAERS does not prove causation, but is also quite likely to underascertain.

It is deplorable that when questioned Offit hides behind personal wisdom rather citing data.

[Cathy]

Let's see how many of these vaccinations Offit can withstand. May I administer the 10,001st? or the 99,999th? Make sure they have the thimerosal and aluminum. I love the idea about the inserts in the offitt books and rearranging the shelves...

[Anne Dachel]

Paul Offit continues to champion vaccines as safe. He claims he "wants to save kids," yet everything I've ever read by him completely ignores the autism epidemic. This is what will be his legacy.
This is what the public will demand to know:
How could you be so blind to this disaster? You were a national expert cited in hundreds of news stories denying a link between vaccines and autism. You pretended that a generation of children with neurological disorders was normal.

When America wakes up to cost of this disaster, they will demand to know why the medical community could defend vaccines, yet ignore what was happening to hundreds of thousands of children before their eyes. I hope you will be around Paul Offit to explain your motives and defend your actions.

Anne Dachel
Media editor

[L Land]

If a child can handle 10,000 nay 100,000 vaccines then how can just 1 virus cause illness, much less death? Why do we even need a vaccine regiment?

[Kelli Ann Davis]

"Instead of helping, these therapies can hurt those who are most vulnerable, and particularly in the case of autism, they undermine childhood vaccination programs that have saved millions of lives."

How hypocritical is that? Replace *these therapies* with *mercury* and you've got the explanation on *why* the vaccination program is tanking.

When individuals question the *safety* of special diets and can't grasp the fact that injecting a neurotoxin directly into an infant is dangerous, you've seriously got to wonder what could possibly blind them to the obvious -- really, how hard is that to understand Offit? You're supposed to be a man of *science* and yet you reject a basic, fundamental truth about mercury to promote your own, ideological agenda.

Pathetic.

[Is Autism Infectious]

From the CHOP website. This is Dr. Offit's department. So, can you catch autism when you travel? Does he have any treatments for autism up his sleeve? Does he even SEE patients with autism in his daily practice? Why is he writing this book indeed. Which pharma company put him up to it and who is publishing it?

Overview
The Infectious Diseases Section offers consultation and diagnosis in the management of children with any type of infectious disease. Laboratory assistance in diagnosis of infections and assistance in the selection of antibiotics, antivirals or other forms of therapy are also provided. International travel advice is available.

[Jack]

If, God forbid, this book actually shows up in the Barnes and Noble (as opposed to being bought by Merck and disturbed to doctors as I suspect) I can't wait to hide it behind copies of Jepson's or Cave's books like my wife recently did with Harvey Karp's book.

In fact, we re-organized the whole shelf so the "right" books were very dramatically displayed.

I'm also thinking about making some index cards to slide into the middle of all of the Offit books that happen to appear in the bookstore.

[Scott Taylor]

Why is self-described "infectious disease specialist" writing a book about Autism. Is Autism a disease that you can "catch".

Vaccines have made him wealthy and he's guarding his turf. Oh yeah, and now he's trying to profit from the Autism Epidemic... the cure for which (honest and open science) he continues to thwart for his own personal gain.

Vax vs. Un-Vax: If the volume of science is on your side, what are you afraid of?

[ObjectiveAutismDad]

We should start a campaign to get Dr. Offit to demonstrate -- himself -- that a child's body can tolerate 100,000 vaccines. If a child's body can tolerate it then his certainly should be able to. Oh, and make sure they're the ones with at least 25mcg of thimerosal in them.