Vaccine Court Ruling Won't End Autism Debate

By DAN CHILDS
ABC News Medical Unit

Some autism advocacy groups say that despite a ruling that appears to exonerate MMR vaccines as the cause of autism in children, they will continue to push to raise awareness that such a link may exist.

Autism advocacy groups that support the idea of a link between vaccines and the development of autism said a ruling handed down Thursday by a special court was devastating -- but that it will not sway them from their cause.

In the ruling, three special masters of the U.S. Court of Claims note that the evidence presented in the case overwhelmingly contradicts the parents' claims that the measles-mumps-rubella (MMR) vaccine was to blame for their children's development of autism. The finding is in line with the majority of scientific studies on autism.

Doctors and other medical experts overwhelmingly applauded the ruling, maintaining that it reinforces the message that vaccination does not lead to autism. "This is a real victory for children and a great day for science," said pediatrician Dr. Paul Offit, chief of Infectious Diseases and the director of the Vaccine Education Center at the Children's Hospital of Philadelphia, during a Thursday press conference sponsored by the vaccination advocacy group Every Child by Two. "I hope that this decision will finally put parents' fears to rest."

Related

Doctors Debate 'Delayed Vaccine' Schedule

Study: Autism Not Linked to MMR Vaccine

And some doctors said that the ruling may even end the decade-old debate that has swirled around the idea that measles-mumps-rubella MMR vaccines are somehow linked to autism.

"This should settle the issue of MMR vaccine -- by itself or 'combined' with thimerosal from other vaccines -- as an alleged cause of autism," said Dr. Max Wiznitzer of Rainbow Babies and Children's Hospital in Cleveland.

However, the issue remains far from settled for the groups that maintain such a link exists.

"I'm devastated today," said Rebecca Estepp, national media manager for 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."

Another autism advocacy group, Autism Speaks, issued a statement saying the ruling does not erase the questions they say still surround vaccine safety.

"These latest rulings are limited and do not mitigate the need for further scientific investigation," the statement reads. "While large-scale studies have not shown a link between vaccines and autism, there are lingering legitimate questions about the safety of vaccines that must be addressed."

Not the Last Day in Court

The legal fight could be far from over for the approximately 4,900 families involved in the cases, who together have filed more than 5,500 claims that vaccines harmed their children. All of the families seek compensation through the government's Vaccine Injury Compensation Program, a no-fault fund set up to administer awards to families who can show that their children were harmed by vaccines.

The cases directly affected by the special court's ruling involved three families who claimed that the mercury-containing preservative thimerosol in vaccines set their children's immune systems up for damage from other components of the MMR vaccine, resulting in autism.

Related

Families Seek $$ for Autism-Vaccine Link

Mumps Strikes Back: New Vaccine Needed?

Debate Rages Anew on Vaccine-Autism Link

Tom Powers, the Oregon attorney who leads the litigation steering committee for the plaintiffs, said it is too early to close the book on the three test cases affected by today's ruling. The plaintiffs have a 30-day window to consider the grounds upon which they may contest the decision, and an appeal is likely.

"It's a little premature to say that even for these three families the process is over," he said.

Powers added that the theory scrutinized in this case was just one of two theories that will be brought before the special court. The other theory maintains that thimerosol alone brought about autism in some children.

"There is no doubt that this is disappointing news," Powers said. "On the other hand, the message to the families is that we will continue to prosecute the cases... follow the science, and see where it leads us."

Vaccine Experts Claim Victory

Still, most in the medical community feel that the preponderance of scientific evidence has already led to the conclusion that vaccines are not responsible for autism.

"It is completely understandable that parents who are desperately looking for a cause of why their child turned out this way will focus on the vaccine," said Dr. Shlomo Shinnar, professor of neurology and pediatrics at Montefiore Medical Center, in Bronx, N.Y. "But there is a large body of scientific data that has refuted this association... It is reassuring that the special masters who are dealing with this were guided by the weight of the available scientific evidence on this important public health issue."

"I am thrilled that this ruling will enable the medical community to speak with conviction about the importance and safety of childhood vaccination," said BethAnn McLaughlin of the Vanderbilt University School of Medicine's department of neurology in Nashville, Tenn. "We recognize that while we are under-funded to study many of the chemicals our families and children come in contact with every day, that the debate about vaccination causing autism should be ended."

Joanna Schaffhausen and Audrey Grayson contributed to this report.

What are your thoughts about the latest court ruling?

Share your comments with CARD.

ASA Statement on Cedillo, Hazelhurst, Snyder v. Secretary of Health and Human Services

Today the National Vaccine Injury Compensation Program/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.

Though the litigation on which vaccines may have caused autism in some children varies, this ruling only affects those who claim the interaction of the MMR vaccine and thimerosal-containing vaccines cause autism. There are still 5,000 cases still to be decided, and many unanswered questions for the thousands of families affected by autism.

ASA believes that the science of autism causes and treatments need to be more vigorously researched. We hope that primary decisions on medical research and comprehensive treatment and services will be reached through thoughtful dialogue by parents and professionals. Individuals living with autism need help today, and this case illustrates the need for the medical community to probe further into environmental causes of autism. Like all families affected by autism, these families deserve to be heard and supported in their journey raising their children.

What this ruling doesn’t address is the continuing need of these families for services and supports throughout their children’s lifespan, regardless of what caused their autism. While we don’t know the cause for autism, or its interaction with other conditions or environmental aggregators, we need to focus today on what works to maximize the potential of people with autism to help them live meaningful, productive lives.

This has always been ASA's mission and we will continue to advocate for research, family and individual support, and lifespan services for people across the autism spectrum.

U.S. Vaccine Court Denies Family's Autism Case

By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) - A special U.S. court ruled against three families on Thursday who claimed vaccines caused their children's autism.

The Vaccine Court Omnibus Autism Proceeding ruled against the parents of Michelle Cedillo, Colten Snyder and William Yates Hazlehurst, who had claimed that a measles, mumps and rubella vaccines had combined with other vaccine ingredients to damage the three children.

"I conclude that the petitioners have not demonstrated that they are entitled to an award on Michelle's behalf," Special Master George Hastings, a former tax claims expert at the Department of Justice, wrote in the Cedillo ruling.

The families sought payment under the National Vaccine Injury Compensation Program, a no-fault system that has a $2.5 billion fund built up from a 75-cent-per-dose tax on vaccines.

No judges but instead three "special masters" heard the three test cases representing thousand of other petitioners.

They asked whether a combination vaccine for measles, mumps and rubella, or MMR, plus a mercury-containing preservative called thimerosal, caused the children's symptoms.

"The evidence does not support the general proposition that thimerosal-containing vaccines can damage infants' immune systems," Hastings wrote, after reviewing tens of thousands of documents and hours of oral arguments.

Michelle's parents argued that she was a normal baby until she received the vaccine.

Experts say parents often link vaccines with their children's symptoms because they are vaccinated at an age when autism and related disorders are often first diagnosed.

NO EVIDENCE

Two Institute of Medicine reports, in 2001 and 2004, reviewed the evidence and determined there was no link between vaccines and autism. Many other studies have also shown no link, but a small and vocal group of parents continue to press the cases.

"Considering all of the evidence, I found that the petitioners have failed to demonstrate that thimerosal-containing vaccines can contribute to causing immune dysfunction, or that the MMR vaccine can contribute to causing either autism or gastrointestinal dysfunction," the ruling from Hastings said.

"I further conclude that while Michelle Cedillo has tragically suffered from autism and other severe conditions, the petitioners have also failed to demonstrate that her vaccinations played any role at all in causing those problems."

Hastings also rejected an argument that some children may be genetically "hypersusceptible" to mercury.

More than 5,300 cases had been filed by parents who believed vaccines may have caused autism in their children and were seeking payment under the National Vaccine Injury Compensation Program. Under the program, someone injured by a vaccine does not have to prove the vaccine actually caused his or her injuries.

All they need to do is establish that vaccines sometimes cause that particular condition or injury, as the three test cases sought to prove. The no-fault payout system is meant to protect vaccine makers from costly lawsuits that drove many out of the vaccine-making business.

(Editing by Alan Elsner)

Scientific Review of the Immunization Action Coalitions Guidelines to Vaccination Policies

The issue of whether vaccines are related to autism in any manner remains a controversial and divisive one. The tremendous financial and public health ramifications of the issue render it difficult to imagine that individuals from any community, be it scientific, pharmaceutical, governmental, or parental, can remain unbiased while addressing it.

The following article, which is slated to be published soon, is by Dr. Andrew Wakefield, one of the most active and controversial players in the debate, and consists of a response to the document entitled “Clear Answers and Smart Advice About Your Baby’s Shots” by Dr. Ari Brown, published by the Immunization Action Coalition.

Among the primary points of the paper is the fact that the debate can only be solved by sound scientific research, not strong opinion, a point with which we firmly agree. We encourage a careful reading of the paper and we encourage the reader to assess the levels of evidence presented for the various claims on both sides.

This is not a debate that will be solved by faith in one’s own position, nor by acrimony toward others, but by scientific research alone.

CLICK HERE TO DOWNLOAD A PDF OF THE DOCUMENT

Autism Linked to Vaccines?

By Author David Kirby

Hannah Poling was the first child with autism to be paid from the vaccine injury compensation fund. In the months following the Poling story, it was discovered that she was actually at least the tenth child with autism compensated for her vaccine injuries by the government, but only the first to go public.

Her case caused a profound shift in the public recognition of vaccination as one of the causes of autism. On Friday (December 05, 2008), another story of equally profound weight will be breaking. Specifically that the Department of Defense now holds the position that autism is one of the adverse reactions to the DTaP vaccine. In addition, The US Armed Forces Institute of Pathology holds that thimerosal is likely a cause of autism and recommends methyl B12 and chelation as the course of treatment for this mercury exposure.

The article breaking the story will likely be appearing in the Huffington Post and and may be the subject on tomorrow's Anderson Cooper 360. Cooper blogged about the piece that is the lead up to tomorrow's revelation (below).

DOD and CDC: Studies Suggest a Possible Link Between Multiple Vaccines and Injury
By David Kirby

It looks like the CDC may have missed a memo to itself on vaccine safety. One very contentious issue in the vaccine-autism debate has been whether a certain subset of genetically susceptible children is unequipped to handle the early and intensive US immunization schedule – including kids like Hannah Poling, who developed autism after receiving nine vaccines at once. The theory is that some people with abnormal immune or metabolic systems might become overtaxed by the fever, inflammation and/or other stresses sometimes caused by multiple vaccines.

Many doctors and scientists scoff at the notion that someone could be injured by getting too many shots at once. They say that people of all ages, including babies, can handle multiple exposures at any given moment.

For example, the CDC’s website says that simultaneous multiple immunizations are safe for children with “normal” immune systems. And Dr. Paul Offit, a prominent pediatrician and wealthy vaccine co-inventor, says that kids can handle simultaneous exposure to the antigens contained in 100,000 vaccines - without any harm coming to them. So, the CDC says that multiple vaccines are safe for everyone (at least in infants).

But now, we learn that a collaborative program between the CDC and the Department of Defense says that multiple vaccines may not be safe for everyone (at least in adults being inoculated for military service).

“We have preliminary findings from one of our many on-going research studies that suggest a relationship between adverse events and multiple vaccinations exist. These findings will require validation, but heighten our concern for the current clinical practice of multiple vaccinations.”
That rather remarkable statement came from US Army Colonel Renata J. M. Engler, MD, director of the Vaccine Healthcare Centers Network (VHCN) a “collaborative network” of the Defense Department - and the CDC.


She went on to say this:


“The more drugs one is exposed to, the greater the likelihood of having an adverse event so as vaccine numbers increase, and (sic) we will see more people who have efficacy or safety issues.”

And later, this: “The standard of care (ie, when mixing vaccines) is to minimize drug exposures because of the recognition that the more drugs being used, the greater the chance of a reaction and potentially a serious adverse event.”

Col. Engler’s candid statements (I’ve never heard anything like them from any other senior vaccine official), were included in a November 26 letter to Rep. Carolyn Maloney (D-NY). Maloney had written to inquire about a 2007 VHCN presentation suggesting that 1-2 percent of all service members were suffering serious adverse effects from their shots.

I first reported on this presentation in August, when someone alerted me to a Government Accounting Office report saying that VHCN and CDC officials “estimate that between 1 and 2 percent of immunized individuals may experience severe adverse events, which could result in disability or death. Some of these events may occur coincidentally following immunization, while others may truly be caused by immunization."I had never heard of the VHCN, so I went to their website, where I found this Power Point presentation, and this slide in particular: The slides suggested that, among active duty and reserve service members, up to 48,000 individuals may have sustained serious vaccine injuries which might need to be classified as "casualties,” and may require teaching "new skills" to some of those injured.<br>But Col. Engler wrote that the slides had been misinterpreted.“Our program is not in a position to provide incidence data but rather to refine case definitions and research questions to address the serious and the rare adverse events questions,” she wrote. The 1-2% figure was merely an estimate of “who may need an immunization healthcare consultation to address clinical questions raised,” she said.

“The consultation does not prove or disprove causality association but it is from these consultations that we have refined our understanding of the questions, a critical first step to future refinement of research agendas. It is our firm belief that increased research into side effects that are more severe but may be short duration, may help us understand more severe adverse events (more rare at 1 in 10-100,000). However, our work over the past years has been humbling in relation to the knowledge gaps.”

And what about the slide mentioning that up to 48,000 service members might require ”new skills” following vaccine injury?

“This statistic refers to the potential number of service members, experiencing more serious side effects (not serious disease with prolonged duration), that may need a medical consultation about next dose and/or pre-treatment to reduce the severity of the side effects, etc.,” Col. Engler explained, (I think).

So what does any of this have to do with autism? Perhaps nothing. As Col. Engler herself wrote: “The belief that vaccines are safe to mix is based largely on pediatric experience and with a much more limited spectrum of vaccines.” (In other words, apples and oranges, here folks).
Now, it’s hard to imagine how 35-to-40 or more shots in the US childhood schedule could be “much more limited” than the military’s regime. But then again, babies don’t get vaccinated against anthrax and smallpox.

But it’s also hard to imagine that there might be a “relationship between adverse events and multiple vaccinations” in adults healthy enough to fight a war, and yet, among babies and infants with immature immune systems and developing brains, the practice is universally harmless – even for kids like Hannah Poling who had an underlying mitochondrial dysfunction.

In the meantime, let’s hope the DOD and the CDC and get their message straight. If they want to convince parents that multiple vaccines might be risky for some soldiers but safe for all little kids, well, good luck.

Or maybe, the government is finally going to look into the percentage of people (however small) who might be genetically programmed against the ability to withstand more than one or two shots at any given time.

As Col. Engler notes, more work is needed in this regard: “The recommendation for more research on subpopulation risk factors in relation to multiple vaccine combinations has been included in the Institute of Medicine Report on Multiple Vaccines ."”


David Kirby is author of Evidence of Harm, a contributor to Age of Autism and blogs for Huffington Post.