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  Final Word on Autism-Vaccines? 


:: While treading into the fierce debate between autism advocacy groups and medical professionals, Therapy Times had the chance to sit down with Paul Orfitt, MD, chief of the Section of Infectious  

  Top Executive Quits Autism Advocacy Group 


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:: While investigating the dangers inherent in vaccines, beyond simply the possible autism-vaccine connection, Therapy Times sat down with Martin Myers, MD, director of the National Network for Immunization  

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::

In a formal statement following the Vaccine Court Ruling on February 12, 2009, the Autism Society of America spoke out to both supporters and those seeking an appeal to the ruling:   



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The Needle in the Haystack


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The Needle in the Haystack
Battling over the autism-vaccine connection
By Bob Stott
04.13.09

Article available online at: http://www.therapytimes.com/041309Vaccine


Working with autism is like something out of a detective story: A theft without fingerprints, forced entry, or even signs of an intruder. Everyone who arrives at the scene agrees that something was stolen, but the authorities are divided on exactly what it was or how much of it. All the authorities have is a timeframe and a narrow list of passersby who have all since become suspects. Years go by and the thief remains unidentified.

In the years since autism was first diagnosed, there has been a distinct line drawn in the sand – namely, between autism advocacy groups and a contingent of the medical community – over the time correlation between childhood immunizing vaccinations and the emergence of autism. While many in the medical community contend that there is no relationship, parents of autistic children stand firm in their beliefs, narrowing this debate to a very fine point of distinction: those whose families are affected by autism, and those whose aren’t.

Into the Fire

While several cases have been presented to the U.S. courts, specifically by parents seeking damages through the National Vaccine Injury Compensation Program, there had not been a decisive victory in the ongoing standoff over autism. However, that stalemate was broken recently, striking a blow against the hopes of parents of autistic children nationwide and igniting a wildfire of controversy among autism advocacy groups.

In a recent ruling in February, three special masters of the U.S. Court of Federal Claims determined that routine childhood vaccination does not cause autism – the end result of three test cases involving three families of autistic children, three theories linking autism and vaccination, and three federal judges. In these cases, the judges noted that the evidence presented in the case contradicts the parents’ claims that the measles-mumps-rubella (MMR) vaccine was to blame for their children’s development of autism – a finding supported by a majority of scientific studies on autism.

“It’s not a medical or scientific controversy; it’s a cultural controversy,” says Paul Orfitt, MD, chief of the Section of Infectious Diseases at Children’s Hospital of Philadelphia. “The science has exonerated vaccines. First, there was the hypothesis that the measles-mumps-rubella vaccine caused autism. That was tested in the only way you can test it, which is to look at hundreds of thousands of children who did or didn’t receive that vaccine to see whether the risk of autism was greater in the vaccinated group. It wasn’t again and again and again. There have been 12 studies that have looked at that.”

He continues, “Then, the hypothesis morphed to thimerosol – this ethylmercury-containing preservative in vaccines – that this was what was causing autism. Interestingly, this is a preservative that was never in MMR, so it was sort of a complete shift in hypothesis, but again that’s a testable hypothesis. So, it was tested and there were six studies that looked at children who received thimerosol-containing vaccines, compared to children who received the same vaccines with either lesser quantities or no thimerosol. And again, there was no increase in the rate of autism in the group that received thimerosol in vaccines.”

The Danger Point

Since their nationwide inception, vaccines have single-handedly led to the containment of some of the most contagious and deadly diseases in the U.S., including rubella, polio, measles, mumps, chicken pox, and typhoid. However, the effectiveness of a vaccine, far from being a cure-all injection, is built upon the model of a healthy immune system.

Sometimes, an immature immune system, as those seen in children, simply does not respond adequately when presented with a weakened viral strain. This may result from a lowered immunity in general, due to an undiagnosed medical condition or infection, or because the child’s immune system is not capable of generating antibodies to that particular antigen. Even when the host develops antibodies, the human immune system is not perfect, and might not be able to contend with a new strain of a virus.


“Every time there’s a new vaccine, they test vaccines in thousands of kids, but not millions,” says Martin Myers, MD, director of the National Network for Immunization Information and professor of pediatrics at the University of Texas Medical Branch in Galveston, Texas.

“Therefore, it’s very important that all the new vaccines be very carefully studied as they’re brought into the system, so we’re sure that we don’t have a rare side reaction that we were unaware of in the pre-licensure studies. I think that’s a very important issue. For example, we now know the measles vaccine causes a drop in the clotting mechanism in some children. It fortunately goes away by itself or with some treatment, but the concerns of parents are not the same ones that are concerning the scientific community.”

In his book, Do Vaccines Cause That?!: A Guide for Evaluating Vaccine Safety Concerns, Myers confronts the reality of vaccine dangers, and also illustrates the limits of scientific understanding about vaccine side effects.

“There are adverse reactions vaccines have caused and it’s important that they be evaluated. For example, we don’t really have the robust data that thimerosol isn’t associated with speech delay or tics. There have been several large studies that suggest that those are probably not causally related, but there is a need for more studies to assure that there are no other associations.”

A “Just in Case” Program?

Many advocates of the autism-vaccine connection have cited the very existence of National Vaccine Injury Compensation Program (VICP) as a reason to doubt the safety of vaccinations – and provide a public foothold for autism advocacy groups, as well as parents of autistic children. The VICP was established in 1986 to pay damages to those who have suffered as a result of vaccines, funded by a 75-cent tax added to the cost of each vaccine dose. Currently, the program’s trust fund balance is more than $2.7 billion.

“The VICP was set up because the tort lawsuits with multimillion dollar awards for vaccine injury were basically chasing vaccine manufacturers from the market,” says Myers. “The intent was that if you receive the oral polio vaccine and you become paralyzed – which happens at a rate of about one in a million or one in 3 million children – it’s not your fault.”

“It was set up to be a no-fault insurance,” he continues. “So, you make a claim and if the claim is felt to be a vaccine injury, then there is a mechanism set up for how you’ll be compensated, since every dose of vaccine that’s covered by the act has a tax on it. And that tax goes in a trust fund and children that have, for example, vaccine-associated paralytic polio were compensated under that – including special care, assuming for how long the injury was going to last and how it was going to affect their life.”

It was from the VICP that more than 4,900 families of autistic individuals were seeking compensation when the U.S. Court of Federal Claims made its controversial ruling earlier this year. While some families have conceded to the court’s decision, many others – like Stephanie DiGuglielmo – refuse to give up the fight.

In 1992, DiGuglielmo took her 15-month old son, Anthony, to a doctor near her home in Philadelphia. After inspecting Anthony, the doctor wrote on the medical records that the patient was cold and clammy, and that a vaccine was administered. The doctor told DiGuglielmo that Anthony probably had a cold or flu, and suggested that – as long as she was there – they go ahead and administer his immunization vaccines.


“The next day, [Anthony’s] leg swelled at the injection site where it looked like he had a sirloin steak attached to it,” says DiGuglielmo. “He had a fever, was very quiet, and he had spots on his face. I called the doctor and they said ‘we probably hit his muscle’ and advised giving him some Tylenol. They said the spots were probably from the vaccines because it was a live virus they injected him with. Anthony never recovered. He remained quiet, but eventually he was active again. But, the words he did have, like ‘mama’, ‘dada’, ‘big blue balloon’, ‘cookie’, ‘juice’, and ‘bye-bye,’ all disappeared.” 

When DiGuglielmo returned to the doctors to inform them of Anthony’s speech losses, the doctors instead told her that boys are different, that they get lazy in their development, and that she should stop doing everything for him. The doctors emphasized that she must be anticipating Anthony’s need for items, such as cookies, so Anthony no longer needed to say the words to get what he wanted.

“I told them that he seemed different since his vaccine and they said, ‘No way – that's not the kind of reactions we see.’ They asked me about paint chips and lead poisoning, and I told them, yes we lived in an old apartment. So, I requested that test and became distracted by that possibility. I was stupid and believed the doctor that it could not be the vaccines, even though I saw it right before my eyes.”

Through some of her own personal research, DiGuglielmo found out that the vaccine in question had been Anthony’s second dose of MMR – typically, a vaccine that is only given two times before 24 months of age if there is an outbreak of measles. Furthermore, the year Anthony was born was also the year doctors started giving hepatitis shots at birth, which culminates in a quite a viral gauntlet for a developing immune system.

“It seems that vaccine reactions are seen as numbers, not people – not as lives. It’s okay that a few get hurt when they do so much good for the masses,” says DiGuglielmo.

Rallying Point

Even in light of the recent February court ruling, another federal case continues to gather supporters and autism-advocacy groups to its banner – a persistent thorn in the side of medical professionals convinced of vaccines’ innocence in the autism trials.

In March of 2008, the same Court of Federal Claims that recently ruled against the autism-vaccine connection conceded that the brain damage and autistic behavior of 9-year-old Hannah Poling stemmed from her exposure as a toddler to five vaccinations on one day in July 2000. Two days after her vaccination, she was overtaken by a high fever and encephalopathy that deteriorated into autistic behavior. In a landmark case, a panel of medical evaluators at the Department of Health and Human Services concluded that Poling had an underlying cellular disorder that was aggravated by the vaccines, causing brain damage with features of autism spectrum disorder – injuries for which her family would be compensated.

Unique among child cases, Poling received an unusually large number of vaccines in 2000 – while thimerosol was still in use – due to a series of ear infections that delayed her vaccination schedule. In one day, Poling was administered five inoculations covering nine diseases, including measles, mumps, rubella, polio, varicella, diphtheria, pertussis, tetanus, and influenza. Compounding this is the fact that Poling suffers from a mitochondrial disorder, which can include symptoms of developmental delays and susceptibility to infection.


Despite the court’s determination that the underlying dysfunction of Poling’s mitochondria put her at an increased risk of injury from vaccines, and she should therefore be compensated, this decision has not sat well with several members of the medical community.

“Poling’s encephalopathy was not caused by vaccines,” says Orfitt. “They’ll award that measles-containing vaccine is the cause of encephalitis despite the absence of any data that this is true. It’s an extremely low standard. All you have to do is provide a biologically plausible mechanism for why one thing caused another, even if epidemiology shows that it doesn’t. It’s a different standard, frankly, than would be accepted in civil court.”

However, there is no doubt that the court's decision to award damages to the Poling family casts a shadow of doubt on vaccine safety in regards to autism. If Poling had an underlying condition that made her susceptible to vaccine infections, it raises the question whether other children – especially those with severe autistic spectrum disorders – might have similar genetic vulnerabilities. And still the debate whether or not to vaccinate rages on.

“Just look at what’s happened over the last year,” says Orfitt. “We’ve had pertussis outbreaks that are greater in number than we’ve had in the past. We had a measles epidemic in 2008 in the U.S. that was larger than anything in more than a decade. And we just had a cluster of Hib meningitis cases in Minnesota, reported by the CDC at the end of January this year.”

Orfitt continues, “It’s not theoretical anymore. We’ve crossed a line, I think. In general, while national vaccination rates are pretty high, there are clearly pockets of children who are under-vaccinated. They serve as a medium for transmission of these serious and potentially fatal infections. That’s the risk.”

— Bob Stott is the editor of Therapy Times. Questions and comments can be directed to bstott@therapytimes.com.



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