TO: Iowa Public Department of Health

FROM: Heather Adams, Assistant Attorney General

Date: October 28, 2009

RE:  Public Readiness and Emergency Preparedness (PREP) Act for H1N1 Vaccination and Emergency Use Authorizations (EUAs) for H1N1 Countermeasures

 
Top News arrow Children's Safety arrow Elias Tembenis, Another Vaccine-Injury Case
Elias Tembenis, Another Vaccine-Injury Case Print E-mail
Thursday, 20 January 2011
"the prevailing medical opinion is that vaccines are scientifically linked to encephalopathy, but not scientifically linked to autism."

CBS News reports (below)  about  "yet another vaccine injury case you probably won't hear much about... the tragic death of little Elias Tembenis."

According to court and medical records, Elias was born on Aug. 23, 2000 and appeared healthy until Dec. 26 when he received his second dose of diphtheria, tetanus, pertusis DTaP vaccine, developed a fever and began having seizures, followed by epilepsy and death.

On November 29, 2010, the US Court of Vaccine Compensation ruled in favor of his parents against unpersuasive arguments by the government.

Elias' case becomes quietly filed away in vaccine court archives with nearly 1,300 other vaccine brain injuries-none of them apparently being pooled for study. An undetermined number of them, like Elias', involving autism diagnoses.  But to win a case in the Vaccine court, the condition, autism, cannot be cited.

Indeed, in an earlier report, CBS investigative reporter, Sharyl Atkisson , who had examined federal vaccine court decisions over the years, reported:  

"Children who end up with autistic symptoms or autism have won vaccine injury claims over the years-as long as they highlighted general, widely-accepted brain damage; not autism specifically. But when autism or autistic symptoms are alleged as the primary brain damage, the cases are lost."

The debate over the links between vaccines and autism -which is triggered by brain damage - is extremely contentious.  The great majority of medical opinion contends that vaccines don't cause autism. However, many of the same experts concede that vaccines can, in rare instances, cause brain damage.  For example, Dr. Brian Strom, of the University of Pennsylvania, who has served on Institute of Medicine panels advising the government on vaccine safety,  says "the prevailing medical opinion is that vaccines are scientifically linked to encephalopathy, but not scientifically linked to autism." 

If so, why is the medical profession--including and especially, government health officials--so resistant to examining the problem and the evidence to ascertain what may be the cause of sudden developmental regression--emergence of autism-- in previously healthy infants?

Why are doctors who do try to examine the problem, shunned as pariahs?

Surely, the charade of turning a blind eye by deliberately obfuscating the terminology--i.e., putting the head in the sand as if to protect against the evil eye--is especially egregious within the context of legal proceedings whose purpose is to determine the medical-scientific merit of the arguments set forth by two parties to a dispute. 

Who, exactly is being protected by the refusal of the medical profession to examine the possible link between childhood vaccines and autism, and by the Court to refuse to entertain the possibility that a connection may exist? This issue is far from being settled.

 

Vera Hassner Sharav

 

The Search for Safer Vaccines

Posted by Sharyl Attkisson

 

The tragic death of little Elias Tembenis is yet another vaccine injury case you probably won't hear much about. Yet some medical experts believe it could teach us something about how to make vaccination safer.

It could also add to the limited body of knowledge as to why the vast majority of kids are vaccinated safely, but a minority become seriously ill, brain-damaged or even die. Still, government officials have said they have no plans to study cases like Elias': cases that victims are winning against the government in the little-known federal vaccine court.

http://www.uscfc.uscourts.gov/sites/default/files/LORD.TEMBENIS112910.pdf

According to court and medical records, Elias was born on Aug. 23, 2000 and appeared healthy until Dec. 26 when he received his second dose of DTaP vaccine. His parents noticed some swelling around the injection site. According to court records:

"Early in the morning on December 27, 2000, Elias's parents found him seizing in his crib and took him to the emergency room ("ER")...Within one day, he developed a fever, which led to a complex febrile seizure. Subsequently, Elias developed epilepsy. This fact pattern is commonly seen in the Vaccine Program."

According to court records, after the DTaP reaction, the once-healthy baby ended up with debilitating medical problems, including features of autism, ear infections and developmental delay. His parents first filed their case as one of the "omnibus" group of autism cases to be heard in federal vaccine court.

According to those familiar with the case, the couple felt their chances of winning with the autism cases was slim because the idea of a link between vaccines and autism is so controversial. So they separated their case from the autism group and filed on the basis of their son's epilepsy and seizures.

They recently prevailed in court. It's one more example where vaccine-injured children who end up with autism are quietly winning their cases, but only when they focus on the more general argument of seizures or brain damage rather than autism.

Some victory. On Nov. 17, 2007 Elias' illnesses became too much for him. The little seven year old boy died. If the right people bothered to study the medical details of the case, they might learn something about why Elias got so sick from his vaccines, and how to identify ahead of time what babies might have the same problem. The former head of the National Institutes of Health, Dr. Bernardine Healy, has said such study would actually protect the integrity of the vaccine program, rather than threaten it (as she says many government officials fear). So far, though, no takers. Elias' case becomes quietly filed away in vaccine court archives with nearly 1,300 other vaccine brain injuries-none of them apparently being pooled for study. An undetermined number of them, like Elias', involving autism diagnoses.

What made these children get sick? Why couldn't they tolerate their vaccines when most kids can? Unanswered questions.

Read both sides of Elias' case, including the government's argument against it.

 ~~~~~~~~~~~~~~~~

Vaccines, Autism and Brain Damage: What's in a Name?

Vaccines have saved untold millions of lives, and the vast majority of people who get them suffer no major problems.

But there's a trade-off: occasionally, vaccines cause injury or death. Very rarely, patients are left with what's known as "encephalopathy", the medical term for brain damage.

In fact, CBS News has found nearly 1,300 cases in which vaccine-related brain damage has been compensated in court over the past 20 years.

The debate over any links between vaccines and autism - a behavior problem triggered by brain damage - couldn't be more contentious. The great majority of medical opinion holds that vaccines don't cause autism. However, many of the same experts don't dispute that vaccines can, in rare instances, cause brain damage.

Family to Receive $1.5 Million + in First-Ever Vaccine-Autism Court Award

Learning From a Previous Vaccine-Autism Case

Our examination of federal vaccine court decisions over the years reflects this. Children who end up with autistic symptoms or autism have won vaccine injury claims over the years-as long as they highlighted general, widely-accepted brain damage; not autism specifically. But when autism or autistic symptoms are alleged as the primary brain damage, the cases are lost.

That doesn't make sense to families who see autism as a specific form of encephalopathy. But it makes perfect sense to the University of Pennsylvania's Dr. Brian Strom, who has served on Institute of Medicine panels advising the government on vaccine safety. He says the prevailing medical opinion is that vaccines are scientifically linked to encephalopathy, but not scientifically linked to autism.

"The fact that a person suffers autism and encephalopathy does not mean that the vaccine caused both of them," says Dr. Strom. "Even if it caused the encephalopathy, that may or may not have been the cause of the autism--those are two different questions."

Still, some families who believe vaccines caused autism in a loved one are circulating these words of advice: use "encephalopathy" in vaccine court and you're more likely to win. Argue "autism" and you're sure to lose.

"I purposely avoided mentioning 'autism' in the claim," says the attorney for a child diagnosed with brain damage and autism after her DTaP vaccination at 18 months. The lawsuit alleged only encephalopathy. "Using (the child's) autism diagnosis would have dragged out the lawsuit for years. The point wasn't to try to win the autism debate, it was to get this family the compensation they need to take care of their injured child." They promptly won a significant award.

Sharyl Attkisson's 2007 Report on Michelle Cedillo

The case of Michelle Cedillo, now 16, couldn't have turned out more differently. Her autism claim was a "test case" in federal vaccine court. If she'd won, it could have opened the floodgate for thousands more vaccine-autism claims to be paid. Michelle's attorney argued that an MMR shot on Dec. 20, 1995 directly caused her severe autism. But the federal vaccine court couldn't have been firmer in smacking down the claim last year, saying there was no credible proof that vaccines caused her autism. Michelle is also diagnosed with severe encephalopathy. Her mother, Theresa Cedillo, feels they could have won if they had simply based their case on encephalopathy. Mrs. Cedillo doesn't regret her daughter being a landmark autism case, even though they lost. But for future families, she says: "if you want to be compensated, I would say stay away from the 'autism' word."

Since the late 1980's, more than 2,100 families have received compensation for vaccine injuries under the federal program designed to help in rare instances of severe vaccine side effects. And more than half of those awards are for brain injuries.


Total Number of Brain Injury Cases Compensated in Federal Vaccine Court

(as of May 2010 and including the newly-released settlement of the Hannah Poling autism case)

Encephalitis/Encephalopathy: 639

Seizure Disorders: 656

Autism 1*

Total: 1,296

Source: HHS-HRSA (Health and Human Services Health Resources and Services Administration)

*In this case (involving Hannah Polling), though the government conceded before trial, it took the position that vaccines didn't "cause" autism, but rather that the vaccines aggravated an unknown and previously undiagnosed mitochondrial disorder the child had which "resulted" in autism. It's unknown how many other children have similar undiagnosed mitochondrial disorder.


Neither the court nor the government is tracking how many vaccine-brain damage cases involve children who also ended up with autism or autistic-like behavior. When we asked for the statistics, vaccine compensation officials told us: "The government has never compensated, nor has it ever been ordered to compensate, any case based on a determination that autism was actually caused by vaccines. We have compensated cases in which children exhibited an encephalopathy, or general brain disease. Encephalopathy may be accompanied by a medical progression of an array of symptoms including autistic behavior, autism, or seizures."

When we asked why government officials aren't looking for the rate of autism among the brain damage victims who have been given compensation, vaccine compensation officials told us: "Anticipating large numbers of claims, the Court allowed the filing of 'shortform' petitions, but without medical records. As a result, a very small number of the pending 5,000 claims have medical records, making it impossible for us to review and compare commonalities, patterns, or any general trends among all of the petitioners. Over time, we may learn more about patterns of pre-existing conditions and the role vaccines play, if any, in their progression. As we have done in the past, the VICP medical staff will look at the court findings and any new scientific information, and may publish scientific articles as appropriate."

Dr. Brian Strom adds that unless an association between vaccines and autism is scientifically proven, it simply doesn't exist, as far as scientists are concerned. "One can always hypothesize that an exposure is linked to an outcome. The question for science is to prove whether or not that truly occurs more often than one would expect by chance. Absent that, a scientist assumes there is no association. It is analogous to a courtroom, where you are innocent until proven guilty. In science, there is no link, unless or until there are data proving a link."

More information

Vaccine Adverse Event Reporting System

Special Federal Vaccine Court

The National Vaccine Injury Compensation Program (VICP)

Vaccine Table of Injuries

 

 

 
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