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Vaccines in the News
National Vaccine Injury Compensation Court
rules against autism- vaccine connection
February 12, 2009
 Today the National Vaccine Injury Compensation Program (Vaccine Court) ruled that the combination of the MMR vaccine and thimerosal in other vaccines did not cause or contribute to the cause of neurodevelopmental disorders such as autism in the cases of Cedillo, Hazelhurst, Snyder v. Secretary of Health and Human Services.
"It was abundantly clear that petitioners' theories of causation were speculative and unpersuasive," said the court. Three families - the Cedillos, the Hazelhursts and the Snyders – lost their case as the panel ruled that they had not presented sufficient evidence.
To win, attorneys for the three families had to show it was more likely than not that the autism symptoms in the children were directly related to a combination of the measles-mumps-rubella (MMR) shots and other shots that at the time carried a mercury-containing preservative called thimerosal.
But the court concluded that "the weight of scientific research and authority" was "simply more persuasive on nearly every point in contention."
Under the federal law, citizens do not have the ability to individually sue vaccine makers. Vaccine claims are reviewed by the U.S. Court of Claims. More than 5500 claims have been filed with that court. Today's ruling is a blow to the concept that toxicity from vaccines contributes to neurological disorders. The ruling also diminishes chances that any damages will be paid by the federal Vaccine Injury Compensation Program to parents of children who feel vaccines caused harm. Compensation is capped at $250,000 plus attorney's fees.
The vaccine court, which began operating in 1990, assigns special masters to weigh claims of vaccine injury brought by parents or guardians. In their ruling in the Autism Omnibus, the special masters considered three test cases in which the parents of autistic children alleged damage by two "toxic" vaccine mechanisms acting in concert. Traces of ethyl mercury in several vaccines had weakened their children's immune systems as infants, went the plaintiffs' theory, which allowed the measles-mumps-rubella vaccine to damage their brains when it was administered after their first birthdays.
In one of the cases, Special Master George L. Hastings declared the evidence against vaccines contributing to the injuries of Michelle Cedillo, a severely retarded and autistic wheelchair-bound 14-year-old, was "overwhelming." I have no doubt, he wrote, "that the Cedillo parents and relatives are sincere in their belief that the MMR vaccine played a role in causing Michelle's devastating disorders. Unfortunately, the Cedillos have been misled by physicians who are guilty, in my view, of gross medical misjudgment."
The court still has to rule on separate claims from other families who contend that, rather than a specific vaccine combination, the lone culprit could be thimerosal, a preservative that is no longer in most routine children's vaccines. For each theory, there were to be three test cases.
But in Thursday's rulings, the court may have sent a signal on those future cases: "The petitioners have failed to demonstrate that thimerosal-containing vaccines can contribute to causing immune dysfunction," one of the court's special masters wrote.
The three cases involved some 5,000 pages of transcripts, 939 medical articles and 50 expert reports, and the three decisions ran to more than 650 pages altogether.
 The head of one consumer group that questions vaccine safety, the National Vaccine Information Center, said the court's ruling will do little to change the minds of most parents who suspect a link between vaccines and autism. "I think it is a mistake to conclude that, because these few test cases were denied compensation, it's been decided vaccines don't play any role in regressive autism," said Barbara Loe Fisher, the center's president. The organization issued an editorial saying, "drug companies marketing vaccines have a major influence on what gets published and is said about vaccines in medical journals. It is no wonder that there are almost no studies published in the medical literature that call into question vaccine safety."
"I'm devastated today," said Rebecca Estepp, of the organization Talk About Curing Autism. "But I also know that the decision will be appealed. "As parents, we feel like, OK, we're going to fight even harder to get justice for our children," she added. "In a way this might have reignited our cause... Just because we lost today does not mean we will lose in the future."
Autism advocacy organization SafeMinds said the denial of compensation was based on inadequate vaccine safety science available to the court. The group pointed out the Department of Health and Human Services is the defendant, yet it is also responsible for carrying out the very vaccine safety research that is used for the court's decisions. "This conflict of interest means the deck is stacked against families and is one more reason to doubt the integrity of the National Immunization Program," said Jim Moody, director of SafeMinds and an advisor to the Petitioners Steering Committee of the U.S Federal Court of Claims. "The government does not fund the science to show a connection between vaccines and autism. The Vaccine Injury Compensation Act passed in 1986 gave immunity to vaccine manufacturers and removed the incentive to create safer products. Meanwhile, the law only gives the illusion that parents will have their day in court. The process is dysfunctional."
The plaintiffs have a 30-day window to consider the grounds upon which they may contest the decision, and an appeal is likely.
The ruling was welcomed in statements by the Department of Health and Human Services and the American Medical Association. Public health officials have repeatedly warned that fewer immunizations will endanger children's lives.
Dr. Paul Offit of the Children's Hospital of Philadelphia, said, "This is a real victory for children and a great day for science." "I hope that this decision will finally put parents' fears to rest and that we can once again concentrate on protecting children from the resurgence of deadly vaccine-preventable diseases such as measles and whooping cough." Offit has received compensation from the pharmaceutical industry.
Autism Doc's claims led to witch hunt
September 28, 2008
by Phil Doherty, Sunday Sun, UK
http://www.sundaysun.co.uk/news/north-east-news/2008/09/28/autism-doc-s-claims-led-to-witch-hunt-79310-21917233/
The man at the centre of the triple jab controversy has accused the Government of conducting a witch hunt against him.
Dr. Andrew Wakefield has been pilloried by the medical establishment after he voiced fears 10 yeas ago the Measles Mumps and Rubella inoculation could cause autism in some kids it was given to.
Now working in the USA, he was called back to appear before a General Medical Council disciplinary hearing earlier this year to answer charges of serious professional misconduct.
Speaking for the first time since the hearing was adjourned in July, he said: "What the establishment does is throw stuff at you continuously and then tie you up for years with things like the GMC. It is not a question of not vaccinating. I'm not against vaccinations. I don't know for sure vaccines cause autism but I suspect they do. The opposition just states categorically it does not. But they don't know either."
Dr. Wakefield and two other colleagues, Professor Simon Murch and Professor John Walker-Smith, were summoned to the GMC disciplinary hearing over allegations that research they conducted on children breached ethical codes.
If found guilty, they face being struck off the medical register.
This follows years of being reviled in parts of the medical world after they published a scientific paper in the Lancet that said there could be a link between the MMR vaccine and autism and bowel disease.
At a press conference in 1998, Dr. Wakefield said while further research was conducted to see if there was a link, parents should have the single inoculations instead of the triple jabs. At the time of the research it was claimed he had been paid to carry out another study to find out if parents who said their children were damaged by the MMR had a case.
The Lancet said this was a potential conflict of interest and if they had known they would have rejected the research paper.
Dr. Wakefield said: "I was accused of going beyond the science when I suggested that parents should have single jabs until the MMR had been properly assessed for risk. I had assessed the data and the safety study relied upon by the Department of Health and it was derisory. It was no way as good as the research into the single jabs.
"Bernadine Healy, the former head of the US National Institute for Health, admitted they had altered evidence on the epidemiological studies conducted by the US Government to suit the official line. She admitted the evidence both the US and UK relies on is useless.
"The UK Government has a big dirty secret that it doesn't want the public to know . . . they agreed to under write any compensation claims for the MMR. This is why they can't and won't let their position fail.
"It was inevitable I was going to be dragged in front of the GMC because I dared to question big business. They always come after those who don't toe their line."
A Department of Health spokesman said, "We believe that the vaccine has an excellent safety record and studies have confirmed this belief. Neither population-based studies or studies in individual children have confirmed a link between MMR vaccine and autism."
CDC Misses Target With Flawed MMR/Autism Study
NAA says: Wrong Question Asked. Wrong Children Studied. Wrong Conclusions Reached.
PRESS RELEASE
From the National Autism Association
September 3, 2008
Nixa, MO – A Centers for Disease Control and Prevention (CDC) study released today claims there is no link between the MMR vaccine and autism. The National Autism Association (NAA) says this study does nothing to dispel the growing public concern over a vaccine-autism connection and raises several questions concerning design and methodology.
For years, parents have claimed that MMR triggered their child's subsequent GI (gastrointestinal) disease and autism. In a 2002 paper where the majority of autistic children were found to have measles in their intestines, the children examined showed a clear temporal link between MMR exposure and regression. The CDC's attempt to replicate the 2002 study fell far short of proving the safety of the MMR vaccine.
- The CDC study was designed to detect persistent measles virus in autistic children with GI problems. The assumption being if there is no measles virus at the long delayed time of biopsy, there is no link between autism and MMR. But NAA says this underlying assumption is wrong. The questions should have been: Do normally developing children meeting all milestones have an MMR shot, develop GI problems and then regress into autism? Do they have evidence of measles and disease in their colons compared to non-vaccinated age and sex matched controls?
- In the current CDC study, only a small subgroup of children was the correct phenotype to study. From page 7, "Only 5 of 25 subjects (20%) had received MMR before the onset of GI complaints and had also had onset of GI episodes before the onset of AUT (P=0.03)." The other 20 autistic children in the study had GI problems but the pathology developed before the MMR vaccine. Additionally, the controls all received the MMR vaccine and had gastrointestinal symptoms. The controls should have been free of exposure to vaccine measles in order to make a comparison relevant for purposes of causation.
- Inflammatory bowel disease in the absence of MMR RNA does not mean that MMR shot didn't precipitate the GI disease and didn't precipitate autism. A similar example would be rheumatic fever where the infection is cleared quickly but damage to the heart and/or brain last a lifetime.
Public confidence in the safety of vaccines is at risk until safety studies are performed that are required by law, ethics, and science. NAA calls for a vaccinated vs. non-vaccinated study comparing all health outcomes including autism. The CDC is in charge of vaccine safety, owns patents to vaccines (according to a UPI Investigative Report from 2003) and is in charge of promoting vaccines. The public should demand that vaccine safety be taken away from an agency with such conflicts and support HR#1973, the Vaccine Safety and Public Confidence Assurance Act."
For more information, visit www.nationalautism.org
GROUNDBREAKING SCIENTIFIC RESEARCH SUPPORTS LINK BETWEEN VACCINES AND AUTISM
May 19, 2008
http://www.cnbc.com/id/24715965/
A primate model for autism using the U.S. children's immunization schedule was unveiled at the International Meeting For Autism Research (IMFAR) this weekend.
The research underscores the critical need for studies into vaccine safety and the immune and mitochondrial dysfunction of autistic children. The National Autism Association (NAA) questions why the government hasn't undertaken these vital studies and why researchers have had to depend on private money to perform this critical science that will surely impact the health of millions of children worldwide.
University of Pittsburgh's Dr. Laura Hewitson, Ph.D., described at the IMFAR meeting how vaccinated animals, when compared to unvaccinated animals, showed significant neurodevelopmental deficits and "significant associations between specific aberrant social and non-social behaviors, isotope binding, and vaccine exposure." Researchers also reported at the scientific meeting that "vaccinated animals exhibited progressively severe chronic active inflammation whereas unexposed animals did not" and found "many significant differences in the GI tissue gene expression profiles between vaccinated and unvaccinated animals." Gastrointestinal issues are a common symptom of children with regressive autism.
NAA calls for the NIH to conduct large scale, non-epidemiological studies into the biomedical symptoms surrounding young children and all vaccines, including those containing the mercury-based preservative thimerosal and other additives like aluminum.
"It's time for HHS and Congress to step in and take vaccine safety away from the CDC, " said Scott Bono, National Autism Association Chairman. On June 4th, parents of vaccine-injured children will rally for toxin-free immunizations in Washington, DC.
Contacts: Wendy Fournier (Portsmouth, RI) 401-835-5828 Rita Shreffler (Nixa, MO) 401-632-6452 SOURCE National Autism Association URL: www.nationalautism.org www.prnewswire.com
FDA FOUND CONCERNS AT MERCK VACCINE PLANT
April 24, 2008
http://www.philly.com/philly/business/homepage/18099659.html
Federal inspectors documented unwanted "fibers" on the stoppers of vaccine vials at Merck & Co. Inc.'s vast vaccine plant in Montgomery County.
They also found instances of contaminated children's vaccines and complaints that were not always investigated at the West Point plant.
Inspectors from the U.S. Food and Drug Administration spent 30 days at the plant between November and January and cited 49 areas of concern, including a failure to follow good manufacturing practices.
The findings are detailed in an unpublished 21-page FDA report obtained by The Inquirer under the federal Freedom of Information Act.
Independent experts who reviewed the report say it documents serious concerns in one of the country's premier vaccine plants. They suggested the problems could be a symptom of Merck's cost cutting in the face of rapid growth of its vaccine business.
The report cites cases where bulk lots of PEDVAX and ProQuad were contaminated. Unwanted "fibers" were found on the vial stoppers of MMR, the measles, mumps and rubella vaccine, among others. They were caused by "lesser quality" supplies from a vendor, the FDA report said.
The report noted defective vials had to be rejected twice to be discarded, and that one internal quality investigation went on for more than a year. Several experts said no single finding was horrendous but that the overall pattern was troubling.
THOUSANDS GET REVACCINATED AFTER SHOTS SPOIL
December 19, 2007
http://www.msnbc.msn.com/id/24301679/
DES MOINES, Iowa - Every year, thousands of American children go through the tearful, teeth-gritting ordeal of getting their vaccinations, only to be forced to do it all over again. The vaccines were duds, ruined by poor refrigeration.
By CDC estimates, hundreds of thousands of doses of vaccines against such diseases as flu, diphtheria, tetanus, whooping cough, polio, mumps, measles, chicken pox and the cervical cancer virus are thrown out each year because of poor refrigeration at clinics, hospitals and doctors' offices.
Of greatest concern is the chickenpox vaccine. It must be kept frozen at an average temperature of 5 degrees or lower and should be kept in the dark.
Inadequate refrigeration can cause vaccines to lose their potency, although experts say spoiled childhood vaccines are not dangerous in themselves if given to a youngster.
VACCINE RECALL SPARKS FEARS OVER KIDS' SAFETY
December 13, 2007
http://www.msnbc.msn.com/id/22249901/
TRENTON, N.J. - Pediatricians rushed to stock up on Hib vaccine Thursday, a day after one of the nation's top vaccine manufacturers announced it was recalling 1.2 million doses and suspending production indefinitely.
Health officials are still scrambling over how to address the shortage, caused by a sterility problem at a Merck & Co. vaccine factory in West Point, Pa.
Merck, based in Whitehouse Station, N.J., supplies about half the 14 million doses of Hib vaccine used in the U.S. each year. It said that in addition to the doses recalled – roughly four months of production – it has quarantined nearly a year's worth of other, possibly suspect doses and doesn't expect to supply any more until at least next October. That means roughly two years of its normal production is unavailable.
RUMORS CAUSE RESISTANCE TO VACCINES IN NIGERIA
September 25, 2006
http://www.msnbc.msn.com/id/15005238/
KANO, Nigeria - For Ramatu Garba, the polio vaccine is part of an evil conspiracy hatched in the West to sterilize Nigerian girls.
"Allah used Muslim scientists to expose the Western plot of using polio vaccines to reduce our population," said the 28-year-old Muslim food vendor in Kano.
In 2003, vaccinations were suspended in Nigeria for nearly a year while tests were done to convince local officials that the vaccine was not contaminated with estrogen. Anti-fertility agents were never detected.
But some leaders never fully endorsed the vaccine, and distrust persists in many parts of the country. The number of polio cases in Nigeria continues to rise. There were 355 cases in 2003; so far in 2006, there are more than 800 cases, WHO reports.
Vaccine fears are nothing new. Rumors about the dangers of vaccines date back to the 18th century when the world's first vaccine, for smallpox, was created. Vaccines are frequently credited with saving millions of lives worldwide, but they are still perceived by some as a dangerous medical gamble.
Health officials have often kept quiet about the one obvious adverse effect the polio vaccine can cause: polio. For roughly every 3 million doses of the oral vaccine given, one child is paralyzed by the live virus in the vaccine itself.
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