Book Is Rallying Resistance to the Antivaccine Crusade

Book Is Rallying Resistance to the Antivaccine Crusade

A new book defending vaccines, written by a doctor infuriated at the claim that they cause autism, is galvanizing a backlash against the antivaccine movement in the United States.

But there will be no book tour for the doctor, Paul A. Offit, author of “Autism’s False Prophets.” He has had too many death threats.

“I’ll speak at a conference, say, to nurses,” he said. “But I wouldn’t go into a bookstore and sign books. It can get nasty. There are parents who really believe that vaccines hurt their children, and to them, I’m incredibly evil. They hate me.”

Dr. Offit, a pediatrician, is a mild, funny and somewhat rumpled 57-year-old. The chief of infectious diseases at the Children’s Hospital of Philadelphia, he is also the co-inventor of a vaccine against rotavirus, a diarrheal disease that kills 60,000 children a year in poor countries. …

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So now he’s  playing the ‘victim’.  Maybe now he can feel what it’s like to walk in others shoes?  Naw, I doubt it…

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Nancy Snyderman: “Vaccines Do Not Cause Autism”

Dr. Paul Offit: Fox in a Henhouse, the ACIP Years (1998-2003)

Dr. Paul Offit: Fox in a Henhouse, the ACIP Years (1998-2003)    By J.B. Handley

 

The screaming started four hours after 8-month-old Chaise Irons received a vaccination against rotavirus, recommended in June 1998 by the Centers for Disease Control and Prevention for every infant to prevent serious diarrhea. Within a day he was vomiting and eliminating blood. Doctors performed emergency surgery, saving him by repairing his intestines, which were folding in on one another. A doctor later figured out the vaccine caused Chaise’s problem. In October 1999, after 15 reports of such incidents, the CDC withdrew its recommendation for the vaccination — not because of the problem, the agency claims, but because bad publicity might give vaccines in general a bad name. But a four-month investigation by United Press International found a pattern of serious problems linked to vaccines recommended by the CDC — and a web of close ties between the agency and the companies that make vaccines.”

….The Rotashield introduction and withdrawal was such a fiasco it triggered a Congressional investigation, and a blistering report from the Committee on Government Reform which was released on August 21, 2000 and titled, Conflicts in Vaccine Policy (HERE).
 
And who would you guess was at the center of the Congressional report’s criticism? You guessed it: Dr. Paul Offit.

 
People often ask me how the Centers for Disease Control (CDC) went from recommending 10 vaccines for children in the mid-1980s to the bursting-at-the-seams 36 vaccine schedule of today. My answer, which always surprises people, is a four-letter acronym: ACIP.
 
ACIP? Most people have never heard of it, the Advisory Committee on Immunization Practices. Locked away inside a single page on the CDC website, the ACIP is described as:
 
“15 experts in fields associated with immunization who have been selected by the Secretary of the U.S. Department of Health and Human Services to provide advice and guidance to the Secretary, the Assistant Secretary for Health, and the Centers for Disease Control and Prevention (CDC) on the control of vaccine-preventable diseases. The Committee develops written recommendations for the routine administration of vaccines to children and adults in the civilian population; recommendations include age for vaccine administration number of doses and dosing interval, and precautions and contraindications. The ACIP is the only entity in the federal government that makes such recommendations. [emphasis added].”
 
The ACIP is a remarkably powerful committee of appointees. Let’s say you’re Merck, a giant pharmaceutical company with vaccines as a primary business line. And, let’s say you have invested several hundred million dollars in developing a vaccine. Just for fun, let’s imagine the vaccine you have developed is for Rotavirus. Let’s say you would like to sell your vaccine to as many people as possible.
 
Well, if you’re Merck, and if you want to sell your new Rotavirus to as many people as possible, you can pass through one door and one door only: the ACIP. If the ACIP approves your vaccine, you can write your ticket. If the ACIP denies your vaccine? Zero. As Congress’ report notes:
 
“The recommendation [by the ACIP] for routine use of a vaccine is tantamount to a Federal mandate for vaccine use.”
 
It’s almost hard to comprehend the amount of pressure pharma would be under to “manage” the ACIP and give their vaccines the best possible chance for approval – there are literally billions of dollars at stake for a single vaccine.
 
Enter Dr. Paul Offit. With Merck’s funding and support, he filed a patent for a Merck-sponsored Rotavirus vaccine on December 9, 1994. Four years later, as his own vaccine was going through trials and no Rotavirus vaccines were YET on the U.S. vaccine schedule, Offit was appointed to the ACIP as a voting member of the committee.
 
Of course, Offit was well aware that a competing vaccine for Rotavirus made by Wyeth was years ahead of his own vaccine and preparing for a presentation to the ACIP in the near future. In fact, he joined the ACIP only three weeks before the committee voted to approve Wyeth’s Rotashield vaccine for the Vaccines for Children program (Offit voted “yes.”). What’s so bad about voting for another company’s vaccine for Rotavirus vaccine when you are developing a competing product? Congress explains:
 
“Members of the ACIP are allowed to vote on a recommendation for one company’s
vaccine even if they have financial ties to a competing firm developing a similar vaccine.
For example, in the case of the rotavirus vaccine, the vaccine before the advisory committee was developed by Wyeth-Lederle. However, Merck and SmithKline29 Beecham had rotavirus vaccines under development. A recommendation for Wyeth- Lederle’s vaccine would help pave the way for future recommendations for the products of Merck and SmithKline-Beecham. While ACIP members with ties to Wyeth-Lederle were not allowed to vote on recommendations for the rotavirus vaccine, those with ties to Merck and SmithKline-Beecham were allowed to vote.
 
This stands in stark contrast to the policies of the FDA. In discussions with FDA staff on this specific issue they informed the Committee staff that when the VRBPAC is deliberating the licensure of a vaccine, a company is considered affected [an affected company is one with a direct interest] if they are direct competitors of the manufacturer of the vaccine being considered. They further clarified that that this policy was in place because of the competing interest of the affected company and not because of concerns about the release of proprietary information.”
 
Dr. Paul Offit joined the ACIP three weeks before they voted on a Rotavirus vaccine manufactured by Wyeth to be added to the vaccine schedule. He held a patent on a competing vaccine. 
 
It’s almost incomprehensible, and certainly shows the worst of how pharma games the US Vaccine system. It’s hard to believe, but this story actually gets worse.
 
As we know from above, this initial vaccine that Paul Offit voted to approve was pulled from the market one short year later because of the level of adverse events affecting children. From the report:
 
“A product was placed on the market that had to be withdrawn within one year because it was injuring the children it was meant to protect.”
 
Perhaps worse, and even more shocking, was the timing of the ACIP vote to approve Rotashield:
 
“A particularly troubling aspect of the deliberations on the ‘RotaShield’ vaccine is the sequence of events. The ACIP Committee voted to recommend universal vaccinations of infants before the FDA licensure of the vaccine. Officials of the CDC acknowledged that they knew of no other instance where this has happened.”

 
Wait a minute. They approved the vaccine for universal use in kids before the FDA licensed the product? Why, that stands in rather marked contrast to the reassuring words of Dr. Renee Jenkins, President of the American Academy of Pediatrics:
 
“The vaccine schedule undergoes vigorous scientific and evidence-based review each year…The vaccine schedule has evolved over the past 50 years based on scientific evidence.”
 
It appears Paul Offit joined the ACIP to ensure he could influence the approval of the Rotavirus vaccine, from which he would later benefit greatly when his own version of rotavirus vaccine was approved. Not surprisingly, Paul Offit voted yes on every action he could relating to the approval of Wyeth’s vaccine. But, when the vaccine was being pulled from the market, Offit abstained:
 
“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. He stated at the meeting, ‘I’m not conflicted with Wyeth, but because I consult with Merck on the development of rotavirus vaccine, I would still prefer to abstain because it creates a perception of conflict.'”
 
Approve it? “Yes.” Approve it? “Hell yes!” Approve it? “Absolutely.” It’s hurting a bunch of kids, we need to pull it! “Umm….I have a conflict, gotta go.”
 
Unbelievable.
 
On February 23, 2006 the ACIP voted to add Paul Offit’s vaccine, Rotateq, to the U.S. Immunization schedule. As we all know, Dr. Offit has conceded this vaccine “made him rich.” An analyst for Merck notes, “At a cost of $187.50 for the three-dose series, RotaTeq is one of the most expensive vaccines to date; by 2009, the company forecasts that the vaccine could bring in as much as $500 million in annual revenue.”
 
In May 2008, it was reported that, “Later in 2007, the Centers for Disease Control and Prevention reported that there were 117 confirmed cases of intussusception among recipients of Rotateq between March 2006 and June 2007.”

Also, in 2008 it was reported that, “The U.S. Food and Drug Administration approved an update to the product label for Merck & Co.’s Rotateq vaccine to include the report of a death of a recipient due to an intestinal obstruction.”
In 2008, Medical Science Monitor published a study critical of Paul Offit’s vaccine (HERE).
 
It stated: “This study found that, after a significant decline in intussusception adverse events entered into VAERS after the withdrawal of RotaShield, the previous rotavirus vaccine, a significant, rapid increase in intussusception adverse-event reports was observed after the licensing of RotaTeq, the current rotavirus vaccine, on February 3, 2006… From February 3, 2006 through July 31, 2007, a total of 160 (of the 165 reported) intussusception and 11 (of the 16 reported) Kawasaki disease adverse event reports were identified when RotaTeq was administered or co-administered with other vaccines. Time-trend analyses showed that there were significant increases in the total number of intussusception and Kawasaki disease adverse events entered into VAERS in comparison to previous years.”
 
And the study concluded:
 
“Based on the preceding realities, it would seem that the ACIP recommendations for the universal use of RotaTeq were, at best, premature and unwarranted. It is important that healthcare providers continue to report adverse events that occur following RotaTeq vaccine so that more information may be gleaned about its safety profi le, and those patients that may have experienced an adverse effect of RotaTeq vaccination should be advised that they may be eligible for compensation from the no-fault National Vaccine Injury Compensation Program (NVICP).
 
The acceptance of RotaTeq vaccination for the US market may be significantly limited by its apparent lack of economic savings, and given the fact that it may alter disease patterns of intussusception/ Kawasaki disease, so that they occur with greater frequency among segments of the population that previously had only limited experience with such conditions. Moreover, if the serious adverse events being reported following vaccination with RotaTeq are indeed vaccine related, then, like the previous rotavirus RotaShield, RotaTeq should be immediately withdrawn from the US market.”

 
As of January 2009, Rotateq remains on the market.

Secret British MMR Vaccine Files Forced Open By Legal Action

Secret British MMR Vaccine Files Forced Open By Legal Action

The UK’s Daily Mail newspaper reports today that the British government was desperately trying to prevent secret files on the proven dangerous Pluserix MMR vaccine from being released publicly under the UK’s Freedom Of Information laws.  In a recent case they have been forced to open the files up to scrutiny:-

And here is some of what will be discovered.

British Government’s Reckless Disregard for Child Health Safety

The UK’s Department of Health and others appear to have been reckless as to the safety of British children over the manner in which Glaxo company, Smith Kline & French Laboratories Ltd’s Pluserix MMR was introduced and used on British Children in 1988

  • the problems with Pluserix MMR were known to the supplier, Glaxo company Smith Kline & French Laboratories Ltd from the experience of its introduction to Canada, in 1986, where Pluserix was marketed under the name “Trivirix”
  • Trivirix (Pluserix) was withdrawn from use in Canada in 1988 because it was dangerous, causing high levels of adverse reactions in children
  • the high levels of British adverse reactions to the vaccine were apparent and known about at British Ministerial level in 1990, as shown by ministerial correspondence
     

  • Pluserix/Trivirx are the identical vaccine manufactured in the identical Smith Kline factory in Belgium and with the exact same component parts and constituents
     

  • despite the Canadian position and contemporaneously with the final withdrawal of Pluserix/Trivirix in Canada the UK signed the contract to purchase Pluserix MMR from Glaxo company, Smith Kline & French Laboratories Limited in July 1988, even though it was known by then to be too dangerous for use on our children
     

  • SK&F was provided with a blanket indemnity in that contract by the NHS Procurement Directorate
     

  • the contract was signed up by the backdoor through the North East Thames Regional Health Authority as agent for the NHS Procurement Directorate rather than being a contract directly entered into with the NHS Procurement Directorate which negotiated the contract or the NHS Executive of the time
     

  • there was no Parliamentary scrutiny of this and it seems to have been effected in a manner Ministerially deniable
     

  • similar problems were experienced in Japan with the Japanese MMR vaccine which, in common with Pluserxi/Trivirix, contained the Urabe strain of mumps virus
     

  • the Japanese MMR was also withdrawn by 1992 on safety grounds having caused high levels of adverse reactions
     

  • the British government continued the licence for Pluserix MMR after 1992, which enabled it to be supplied overseas
     

  • even today, because it is cheaper than safer alternatives, organisations like UNICEF continue supplying urabe strain containing MMR vaccine to the more adverse reaction vulnerable and less well nourished third world children
     

  • since 1998, statistical paper after paper has been published in a blaze of publicity, claiming no evidence of an association between the MMR vaccine and autism, but when all the noise has died down, on subsequent careful examination, each one has been found to be flawed
     

  • other than the Royal Free’s paper, no clinical studies of the MMR child litigants were undertaken or published
     

  • after being put under financial pressure by the British Government, in 2005 the Oxford based Cochrane Collaboration published a systematic review of all prior papers and its authors claimed to conclude the MMR vaccine was safe:-
       

    • it was shown the authors had violated the standards of evidence-based medicine and
    • their conclusions were not supported by the body of the review
    • and it later was discovered that the British Department of Health had increased the funding for Cochrane’s Oxford administration by £1 million per annum and extended the contracts of its British groups.

 

 

Autism Explosion Followed Big Change in MMR Shot

Olmsted on Autism: Autism Explosion Followed Big Change in MMR Shot

By Dan Olmsted

In 1990, Merck & Co., manufacturer of the mumps-measles-rubella vaccine known as the MMR, made a significant but little-noticed change: It quadrupled the amount of mumps virus in the combination shot, from 5,000 to 20,000 units. Then in 2007 it reversed course, reducing the amount to 12,500 units. Neither the measles nor the rubella (German measles) component of the MMR was changed at all — each remained at 1,000 units throughout.
 
Merck also makes the single-component mumps shot, and in 1990 it also increased the potency of that shot by the same amount, from 5,000 to 20,000 units. But unlike the MMR shot, the standalone mumps shot’s potency was not scaled back in 2007. It remains at 20,000 units.
 
These changes were mentioned in passing recently during an informal conversation with a Merck scientist. I started looking for an explanation for the sequence of events, but Merck did not respond to a detailed written request for comment.
 
Absent such an explanation, simple logic dictates the reduction had something to do with the MMR in particular rather than the mumps vaccine in isolation. But what? And what about the timing — the increase in 1990 and the decrease in 2007?

 
The huge rise in autism cases began about the time the mumps component in the MMR was raised in 1990. One theory, dismissed by Merck and federal public health officials, is that viral interference between the components in the MMR could create a persistent sub-clinical measles infection in a subset of vulnerable children; and because the measles virus can cause brain damage, that could lead to autism.
 
A study released last week by the M.I.N.D. Institute at UC Davis reported that most of the fivefold increase in full-syndrome autism — from 9 in 10,000 children in 1990 to 44 in 10,000 children in 2000– is real and cannot be accounted for by broader categories or diagnostic substitution. And from 1990 to 2007, the mumps portion of the MMR was higher by roughly the same amount — quadruple.
 
Merck’s decision to cut back on the increase in the mumps vaccine also is surrounded by interesting timing.  The cutback, in 2007, came at the same time Merck announced it was suspending its recently introduced, much-hyped four-in-one shot, ProQuad — the MMR with the chickenpox vaccine added to it. In suspending ProQuad, Merck cited a shortage of chickenpox vaccine; subsequently, a study showed ProQuad caused twice as many fever-induced seizures as separate MMR and chickenpox shots given at the same time, and a CDC advisory committee withdrew its preferential recommendation of the vaccine. Merck won’t say when ProQuad will return to the market.
 
An investigation I conducted while at UPI in 2006 found two cases of regressive autism in one small city — Olympia, Wash. — in clinical trials leading up to approval of the vaccine. Merck said the parents originally failed to report those cases to it (though the pediatricians paid to conduct the studies for Merck certainly knew about them and would have been expected to report them); the company alerted the FDA only after my inquiry.

The Merck scientist I spoke with recently also acknowledged that viral interference can affect the potency of individual MMR ingredients; that explains why the company added a whopping dose of chickenpox vaccine to the ProQuad shot, several times more than the standalone chickenpox vaccine contains. Using the same amount of chickenpox vaccine in the MMR shot as the standalone vaccine simply wouldn’t have protected children against the disease, because more virus was needed to offset the interference from the other components.
 
A significant number of parents of children with regressive autism cite the MMR as the proximate cause — they say their child was developing normally until the shot, then in many cases had a serious physical reaction within a short period of time and began losing developmental milestone and showing typical signs of the disorder. Some also developed severe gastrointestinal problems, an ailment first described in cases of regressive autism following the MMR shot by Dr. Andrew Wakefield in Britain in 1998; he named it autistic enterocolitis and found measles RNA in the children’s GI tract, suggesting persistent infection.
 
In looking at whether the increase in mumps potency in 1990 could buttress this theory of the autism epidemic, two questions arise: Is there evidence that increasing the mumps portion of the MMR could have any impact on measles infectivity or create symptoms consistent with those described by Wakefield and parents? And, could ProQuad’s higher rate of measles rash and fever-induced seizures be a warning sign that something is amiss with the MMR itself, especially beginning in 1990 when Merck tinkered with the proportions of the components?
 
The answers seem to be, yes and yes.
 
In the real world, children rarely get two viral illnesses at once — for instance, chickenpox and rubella. But when they do, viruses tend to interact — or interfere — with each other in unpredictable and synergistic ways. One example: Studies in the UK and Iceland showed that when mumps AND measles epidemics hit these populations in the same year, the risk of inflammatory bowel disease spiked. That’s an epidemiological argument for immune interference, and a striking fit with the observations by Wakefield, and thousand of parents, that a similar condition occurs in many children with regressive autism after they get the measles-mumps-rubella shot.
 
A related finding comes from a study funded by Merck.  In 2005, the study reported that the four-in-one ProQuad shot — the MMR and chickenpox — was “generally well tolerated” and had a safety profile similar to the MMR and the chickenpox shot (also made by Merck and called Varivax) when given separately.
 
But there were a couple of interesting differences. First, “Measles-like rash and fever during days 5-12 were more common after the first dose of MMRV [ProQuad]” than after the MMR and Varivax given separately. The difference was substantial — 5.9 percent who got the MMRV had the rash and 27.7 percent had fever, compared to 1.9 percent with rash and 18.7 fever after getting separate shots. While that did not alarm the researchers, it could be a foreshadowing of the doubled rate of fever-induced seizures that was spotted after ProQuad was approved.
 
Second, even though the new element in ProQuad was the chickenpox portion, something new and unexpected was also going on with the mumps and measles components. “Geometric mean titers to measles and mumps were significantly higher after 1 dose of MMRV than after administration” of MMR and Varivax separately, according to the study’s summary. Later, the authors state: “This suggests that the measles and mumps virus replication is greater after MMRV than it is” after the MMR and Varivax given separately.
 
In non-scientific language, it looks like the addition of another live virus — chickenpox — potentiated the measles and mumps components: It kicked both viruses into higher gear and they replicated at rates higher than in the MMR. At the same time, the researchers observed a greater incidence of measles-like rash, and fever, in those who got ProQuad. Were the increased measles and mumps viruses interacting in some unexpected and potentially dangerous way?
 
Then, for whatever reason, sometime between February and December of last year Merck reduced the mumps component of the MMR from 20,000 units to 12,500 while leaving the standalone mumps shot as it was. During that same period, it decided to suspend production of ProQuad. In April 2007, it announced the suspension, and said no more would be available after July. Then in early 2008, Merck’s study showing the doubled risk of seizures in ProQuad was unveiled and the CDC withdrew its recommendation.
 
And just last month, Merck said it would stop making the individual MMR component shots including, of course, the mumps shot. That leaves the MMR as the only vaccine in town, and it means there will no longer be a mumps vaccine formulation on the market with the dose the MMR contained from 1990 to 2007.
 
None of this might matter if not for the fact that measles is capable of causing cause catastrophic brain damage and death; that’s an argument for the measles vaccine. In medical parlance, it’s a neurotoxic virus.
 
“The invasion of the CNS [central nervous system] by MV [measles virus] is apparently not an uncommon event, as reflected by the finding of genomic sequences in normal autopsy cases and the widespread distribution of MV in in neurons, glial cells and vascular endothelial cells of the diseased brain,” according to “Measles Virus Infections of the Central Nervous System” by Uwe G. Liebert of the University of Leipzeig, Germany, published in Intervirology in 1997. “The susceptibility of the host as well as his age and immune status at the time of infection constitutes significant factors for disease progression.”
 
Merck acknowledges the three viruses can indeed interact to affect a child’s immune system, although in ways it says are not harmful.
 
A Merck scientist publicly discussed the interference issue at a CDC meeting in 2004, the year before ProQuad was approved, according to agency minutes. Dr. Florian Schodel “confirmed the possibility that the chickenpox virus component of ProQuad was causing a local immune suppression and an increase in measles virus replication. … The current hypothesis is that the varicella and measles virus are co-infecting the same or proximate areas of the body and engaging in a specific interaction, but how that works is as yet unknown.
 
“He said the interference appeared to involve only the chickenpox and measles viruses – ‘there is no such effect for the mumps or rubella vaccines administered locally at the same time.'”
 
Yet based on Merck’s own 2005 study cited above, ProQuad triggers an increase in mumps virus replication, too. Live viruses in ProQuad seem to be behaving in ways “as yet unknown” that cause immune suppression, co-infection, interaction and increased replication. Even without ProQuad on the market, interaction between the MMR components and the chickenpox virus remains a possibility. The CDC started recommending the chickenpox shot in the mid-1990s at the same 12-month well-baby visit as the MMR. 
 
That suggests the pattern highlighted by ProQuad could be at work through the increased mumps component of the MMR and the addition of chickenpox to the childhood immunization schedule in the mid-1990s. The lesson could be that combining live viruses, and then increasing them or adding new ones, is inherently dangerous, especially when invasion of the brain by one of them “is not an uncommon event.”
 
As Andy Wakefield told me when I was working on the series in Olympia describing the children in the ProQuad clinical trials who became ill after the vaccination and subsequently regressed into autism: “It’s actually heartbreaking, listening to these parents, for more than just the immediate reasons their child has met this fate. It’s that you’re staring into an abyss,” Wakefield said. “You’re listening to stories which reflect the fundamental misconception of vaccine manufacturers of what viruses are and what they do.”
 
Two additional points worth noting: After the increase in 1990 and decrease in 2007, there is still more than twice as much mumps virus in the MMR as there was in 1990.
 
The changes in the mumps virus component of the MMR serves as a potent reminder of something else: MMR is not one thing but three different exposures. And over the period 1980-2009 the MMR has changed significantly at least twice, making epidemiological studies even more difficult to interpret.