I don’t know about you, but I don’t like being lied to. Yes, the word “lie” is very accusatory, and I better have some damn good evidence to back up any accusations of lying. So, like Jack the Ripper once said, “Let’s take this one piece at a time.”
“Paul Offit is a doctor at Children’s Hospital of Philadelphia, and is very often seen in vaccine autism stories making claims that vaccines are safe and have no relationship to autism. But what those stories do not tell the audience is that Paul Offit is a vaccine patent holder and consultant for Merck Pharmaceuticals. He is a co-creator of the Merck RotaTeq vaccine that is on the CDC’s current vaccine schedule. It is a vaccine that prevents Rota Virus, a benign virus under which subjects experience a miserable day or so of diarrhea and vomiting, and from which you usually gain immunity after having it twice. The CDC recommends treating it at home with Pedialyte to prevent dehydration. In third world countries, Rota virus can be a more serious threat to children’s health, because death can occur from severe dehydration due to lack of infrastructure, clean water and basic sanitation. But in the US, it is not a serious health threat to any one with indoor plumbing or within driving distance to a 7-11.”
Note that this person mentions the Centers for Disease Control and Prevention (CDC), making it read like she has reviewed the information from CDC. Note that she minimizes the burden of rotavirus, calling it a “benign virus.” Here is what CDC says about the rotavirus disease:
“During the pre-rotavirus vaccine era, four of five children in the US had symptomatic rotavirus gastroenteritis,, [28, 29] one in seven required a clinic or emergency department (ED) visit, one in 70 was hospitalized, and one in 200,000 would die from this disease, within the first 5 years of life.,  The direct and indirect costs of these 410,000 physician visits, 205-272,000 ED visits, and 55-70,000 hospitalizations was estimated to be approximately $1 billion (Figure 2). Relatively few childhood deaths have been attributed to rotavirus in the US (approximately 20–60 deaths per year among children aged <5 years). However, in developing countries, rotavirus gastroenteritis continues to be a major cause of severe childhood morbidity; responsible for approximately half a million deaths per year among children aged <5 years.“
So, according to the anti-vaccine activist, rotavirus is a benign virus and you just have “a miserable day or so of diarrhea and vomiting.” Would she look in the face the parents of the 20-60 children that die from it each year in the US? Did she miss that part of the CDC information, posted clearly on the CDC website? I’m not convinced that she isn’t lying to us. Yet, I’ll give her the benefit of the doubt, for now.
“In addition, Paul Offit’s RotaTeq can cause a very serious, life threatening condition called intussusception in which the intestine actually folds up, telescoping in on itself. The FDA has confirmed that RotaTeq killed one child in such a manner this year. A previous Rota virus vaccine, Rota Shield, was taken off the market for causing the same problem. And this far [July 2008, ed.], RotaTeq has more reported incidences of intussusception than it predecessor that was removed from the market. RotaTeq also causes Kawasaki Disease.”
See that? RotaShield® was taken off the market because it raised the risk of intussusception. She claims that RotaTeq® is worse but remains in the market. What are the facts?
Yes, RotaShield had problems:
“In the United States, some infants developed intussusception soon after RotaShield® was licensed in August 1998. At first, it was not clear if the vaccine or some other factor was causing the bowel obstructions. CDC quickly recommended that use of the vaccine be suspended and immediately started two emergency investigations to find out if receiving RotaShield® vaccine was causing some of the cases of intussusception.
The results of the investigations showed that RotaShield® vaccine caused intussusception in some healthy infants younger than 12 months of age who normally would be at low risk for this condition. The risk of intussusception increased 20 to 30 times over the expected risk for children of this age group within 2 weeks following the first dose of RotaShield® vaccine. The risk increased 3 to 7 times over the expected risk for this age group within two weeks after the second dose of RotaShield® vaccine. There was no increase in the risk of intussusception following the third dose of RotaShield® vaccine, or when three weeks had passed following any dose of the vaccine.
Intussusception from all other causes is most common among infants in the first year of life; 1 child in 2,000 children to 1 child in 3,000 children is affected before one year of age. Based on the results of the investigations, CDC estimated that one or two additional cases of intussusception would be caused among each 10,000 infants vaccinated with RotaShield® vaccine.”
And it was removed, despite claims that Big Pharma would never allow such a thing to happen. But what about the activist’s claims that RotaTeq® causes more intussusception than RotaShield® did? Here is what CDC says (and remember that our activist cites CDC for her claims):
“Scientist observed in VAERS data 47 intussusception cases (29%) occurred during the first 21 days after vaccination, including 27 intussusception cases (17%) during the first 7 days after vaccination. From VSD data, the expected number of intussusception reports was 151 cases during the first 21 days after vaccination, including 50 cases during the first 7 days after vaccination.
Please note: In comparison to the previous rotavirus vaccine, more than 60% of the intussusception cases occurred between 1 and 7 days after vaccination.
Based on scientific assumptions from the actual vaccine doses distributed, estimated 75% of the intussusception cases that occurred during these time periods were reported to VAERS and that 75% of the vaccine doses distributed were administered, the observed rate of intussusception was not higher than the age-adjusted background rate of intussusception.”
“Available data do not indicate that RotaTeq is associated with intussusception. With more than 9 million doses of vaccine distributed during the first 19 months after licensure, data from VAERS and the VSD Project do not associate RotaTeq with intussusception. Although an intussusception risk similar in magnitude to that of the previous vaccine can be excluded, continued monitoring is necessary to assess RotaTeq’s safety completely.”
Remember that she wrote that letter in 2008, and this info on RotaTeq® is from a review of the data published in June 2008. Again, I’ll give her the benefit of the doubt and maybe assume that she had old information that predated this report. But then she mentioned that “RotaTeq also causes Kawasaki Disease.” No citation, no nothing. So does RotaTeq® cause Kawasaki Disease? This is what the FDA wrote (my emphasis in bold):
“Today, FDA approved a revised label for Merck’s vaccine to prevent rotavirus infection, RotaTeq, to include information on Kawasaki disease. The Kawasaki disease finding is contained in the Biologics License Application (BLA). In addition, three reports of Kawasaki disease in children receiving routine pediatric vaccines, including RotaTeq, were detected through routine monitoring of the Vaccine Adverse Event Reporting System (VAERS). There is not a known cause and effect relationship between receiving RotaTeq, or any other vaccine and the occurrence of Kawasaki disease. The cases reported to date are not more frequent than what could be expected to occur by coincidence. Healthcare practitioners and parents should remain confident in using RotaTeq.”
So do we have yet another case of an anti-vaccine activist looking at VAERS data as evidence of harm? I don’t know. I can’t get into her head, nor do I want to. But here we have three distinct claims by her about rotavirus and RotaTeq®, all of which are counter to the evidence. Is she lying?
She then adds one more “fact” to her letter:
“He actually sat on the ACIP, the CDC committee that decides what vaccines go on the US schedule, and voted for RotaShield® to be added to the schedule, knowing full well that it would pave the way for his own vaccine, Rotateq to be added and be immediately put into wide spread use as soon as it came to market. Which is exactly what happened.”
So did he make that vote? Did the activist get into his head in order to know what he knew “full well”? Well, like the previous three statements of fact, this last one is also wrong, and could very well be a lie. The always awesome Liz Ditz dispels this myth:
“In an email to Kim Wombles, Dr Paul Offit wrote (emphasis added):
1) Although I was brought onto the [Advisory Council on Immunization Practices ] ACIP because of my expertise in rotaviruses and intestinal immunology, I didn’t first vote until October 1998. So I didn’t get to vote RotaShield onto the infant vaccine schedule. However, I did vote to approve RotaShield for the VFC [Vaccines for Children] program, which in those days could follow the vote to put a vaccine onto the schedule by several months. I was allowed to vote because I was not involved with a competing vaccine (our vaccine was still years away). Ironically, when I voted to approve RotaShield for the VFC program, I couldn’t imagine how anyone could declare a conflict of interest because the product would only compete with the vaccine we were working on. But I guess I was dammed if I did and dammed if I didn’t.
2) I left the ACIP in June 2003, three years before our vaccine (RotaTeq) was voted onto the schedule (which was in February 2006).”
So there you have it, ladies and gentlemen. This very outspoken anti-vaccine activist made four very distinct claims about rotavirus, the vaccine against rotavirus, and the physician who helped develop the vaccine currently in use. She wrote that rotaviruses are benign, but we see that it causes 20-60 deaths and hundreds of trips to the emergency department and thousands of cases of diarrhea (in the US). It’s a whole different story in the rest of the world, where it kills over half a million children a year. If all we needed was better sanitation and a trip to 7-eleven for an electrolyte drink, why did the incidence of rotavirus cases and deaths drop precipitously after vaccines against it came online? What giant leap in sanitation and electrolyte replacement did we make in the late 1990’s and early 2000’s?
She also wrote that the current vaccine, RotaTeq®, causes more intussusception than the predecessor vaccine. The evidence counters this claim, making it clear that the background rate of intussusception remained unchanged once the old vaccine was discontinued and the new vaccine came online. It will continue to happen because of other reasons, but the vaccine doesn’t increase the rate. She then followed-up with a claim that RotaTeq® causes Kawasaki Disease. The FDA added a statement about it to the vaccine insert, but it made it clear that the vaccine doesn’t cause it. It added it to the insert because all reported bad outcomes during trials — and even after the vaccine is out — must be included in the vaccine insert. (So much for an omnipotent Big Pharma that keeps things hidden.)
Finally, she perpetuated the myth that Dr. Paul Offit voted himself rich when we can verify that he did not. Further, when he voted the RotaShield® vaccine to be added to the VFC program, his own vaccine was years from being licensed, if it was to be licensed at all at the time. Like he wrote, if he voted against, the anti-vaccine forces would say that it was because he was voting against a competitor. When he voted for it, it was because he knew it would open the market to his yet-to-be-maybe-if-everything-came-into-place vaccine? It doesn’t make any sense.
At any rate, I’ve gone through the activist’s blog and other sites where she posts “information,” and I can’t find any retractions to the statements she made in this letter. If anyone finds them, please feel free to let me know. Absent that, I can only give her the benefit of the doubt… In fact, I want to give her the benefit of the doubt. Why?
Because I hate being lied to. It’s the kind of theatricality and deception I’ve come to loathe from the anti-vaccine crowd.
(RotaTeq® and RotaShield® are registered trademarks of their respective owners.)