Showing posts with label VICP. Show all posts
Showing posts with label VICP. Show all posts

May 9, 2011

The Next Chapter in the Vaccine Autism Story Begins Tomorrow

In 2008 Johns Hopkins Neurologist Jon Poling went public with the news that his daughter Hannah, who regressed into autism following her 18 month vaccines, was paid by the Vaccine Injury Compensation Program.

CDC, in a public statement, claimed that the Hannah Poling case was "rare" and should not be generalized to "normal" children. Days after the Poling's announcement, the Hiatt family also went public with their VICP ruling that their autistic daughter Madison was also a vaccine injury victim. Then the Banks family went public. Finally, CBS News reported finding 7 more vaccine/autism cases that dated back to 1991, the very beginning of the autism epidemic.

So the autism community wanted to know... just how many cases of autism have been paid by the program that was established in 1986, how "rare" is this, and what did the government know about vaccine injury and autism causation that they were not telling the public and the medical community. After being questioned by a journalist, the department of HHS that oversees the VICP issued the following statement on whether this was an admission that the government was now paying children for vaccine induced autism. The "official response" from HRSA:

"From: Bowman, David (HRSA) [mailto:DBowman@hrsa.gov]
Sent: Friday, February 20, 2009 5:22 PM
To: 'dkirby@nyc.rr.com'
Subject: HRSA Statement

David,

In response to your most recent inquiry, HRSA has the following
statement:

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.

Some children who have been compensated for vaccine injuries may have
shown signs of autism before the decision to compensate, or may
ultimately end up with autism or autistic symptoms, but we do not track
cases on this basis.

Regards,

David Bowman
Office of Communications
Health Resources and Services Administration
301-443-3376"

This admission of a link to autism, and the disturbing revelation that the government was not even planning on counting how many autism cases it had paid from the vaccine injury fund, made it clear that HHS's claims of concern for the rise in autism rates and concern for vaccine safety were less than sincere, and that it was time for an investigation into the VICP to find out how many of the cases of vaccine induced encephalopathy (brain damage) resulted in "autistic behavior, autistic symptoms or autism" as Bowman had referenced.

Tomorrow the results of this two year investigation will be revealed and we will get a better look into what the government knows about vaccine/autism causation and how long they have known it.


Live Broadcasting by Ustream

Please tune in to the press conference tomorrow (streaming live on the internet at USTREAM), Tuesday, May 10 at Noon Eastern to the announcement take place on the steps of the US Supreme Court, that ruled only two months ago that vaccine injury cases would never be heard in a court of law, but must go through the corrupt Vaccine Injury Compensation Program.

The EBCALA Press Release:


FOR IMMEDIATE RELEASE
ELIZABETH BIRT CENTER FOR AUTISM LAW AND ADVOCACY (EBCALA)

CONTACT NICOLE WILLIAMS
(301) 625-7772
OR
DANIELLE ORSINO
(480) 200-4411

Investigators and Families of Vaccine-Injured Children to Unveil Report Detailing Clear Vaccine-Autism Link Based on Government’s Own Data

Report Demands Immediate Congressional Action

Directors of the Elizabeth Birt Center for Autism Law and Advocacy (EBCALA), parents and vaccine-injured children will hold a press conference on the steps of the U.S. Court of Federal Claims (717 Madison Place, NW in Washington, DC) on Tuesday, May 10 at 12:00 PM to unveil an investigation linking vaccine injury to autism. For over 20 years, the federal government has publicly denied a vaccine-autism link, while at the same time its Vaccine Injury Compensation Program (VICP) has been awarding damages for vaccine injury to children with brain damage, seizures and autism. This investigation, based on public, verifiable government data, breaks new ground in the controversial vaccine-autism debate.

The investigation found that a substantial number of children compensated for vaccine injury also have autism. The government has asserted that it “does not track” autism among the vaccine-injured. Based on this preliminary investigation, the evidence suggests that autism is at least three times more prevalent among vaccine-injured children than among children in the general population.

The federal government has called autism a “national health emergency,” conservatively affecting 1 in 110 children and costing the country billions of dollars each year.

Because almost all children in the United States are required by law to receive between 30-45 vaccines in order to attend public school, it is crucial that the VICP decide cases with justice and transparency.

EBCALA and the families of the vaccine-injured call on Congress to investigate the VICP, the only forum in which parents may bring claims of vaccine injury on behalf of their children.

WHERE: United States Court of Claims
717 Madison Place, NW
Washington, DC

WHEN: Tuesday, May 10
12:00 PM noon


--
Thank you,
EBCALA Host Committee

January 19, 2011

CBS Takes Notice of the Governments Admission of the Vaccine Induced Death of Elias Tembenis

Last month the Vaccine Injury Compensation Program ruled the death of Elias Tembenis a vaccine injury. Elias was the son of Harry Tembenis, board member of the National Autism Association.
The Search for Safer Vaccines

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.

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....

Elias was vaccinated and developed autism with seizures. He was almost fully recovered from his "autism" when a seizure took his life.

The message has been received that if you file in the VICP under "autism"... well it would not really work PR wise for more Poling cases to come out of the vaccine protection program... so straight up autism cases now get filed for every symptom the child has... just don't call it "autism".

"Conclusion: Petitioners have satisfied the legal requirements for proving that Elias’s December 26, 2000 DTaP vaccination was a legal cause of his epilepsy and death."

Should have filed for my son's "vaccine encephalopathy" when I had the chance, eh?

All my respect and gratitude to our friend Harry and Gina for all they have done, even in the depths of their grief, for our children who are still struggling. If you have met them, you understand how exceptional they are and how much love they have. It is an honor for Scott and I to call them friends.

Rest in peace Elias.

December 22, 2010

Death of Elias Tembenis Ruled Vaccine Induced



The Vaccine Injury Compensation Program has ruled that the death of Elias Tembenis, son of Harry and Gina Tembenis, board members of the National Autism Association, was a DTaP vaccine injury.

"Conclusion: Petitioners have satisfied the legal requirements for proving that Elias’s December 26, 2000 DTaP vaccination was a legal cause of his epilepsy and death."

The ruling can be found here.

September 28, 2010

The Government Knows How Vaccines Cause Autism, But Won't Tell Us

Over the last few years, the federal government has made several statements that they know that there is a scenario by which a seemingly healthy, fully functioning child can be vaccinated and regress into autism. But instead of telling the medical community and the public what that is, they have decided to withhold that information and make parents guess.

In the Hannah Poling case, a panel of HHS doctors were forced to admit that her vaccines cause her autism. Her father was a Johns Hopkins neurologist, her mother a nurse and a lawyer, they gave her every test under the sun and closed any hole that the government could wiggle out of in trying to deny that her autism was a vaccine injury. The government has tried its damnedest to wordsmith both the concession document and every other statement that they have been forced to make on the case to make it sound like vaccines really don't cause autism, but they have frankly done a sucky job of it, and each of these non-denial denials concocted by lawyers and pr men is more embarrassingly bad than its predecessor.

First we had the concession document itself which would not refer to what Hannah has as "autism", which is what she has, but called it, "features of autism spectrum disorder", which is both factually correct and complete bullshit. Any person diagnosed with any disorder also has the features of that disorder. Hannah Poling has DSM diagnosed full syndrome autism.

Then out came the vaccine program apologists who tried to blame the victim and make it sound like it wasn't really the vaccines fault that Hannah got sick, it was that Hannah was a poor receptacle for the super wonderful vaccine.

Then Julie Gerberding appeared on CNN to tell Dr. Gupta that vaccines can cause autism in children with mitochondrial disorders, but that vaccines could not cause autism. And he let her get away with that. Julie stressed that this occurrence is "rare". This is difficult for families to swallow since there are tens of thousands with the same story as Hannah.

She went on to claim that the fact that mitochondrial disorders and vaccine induced autism are linked should not be generalized to "normal" children, but fails to tell us which babies are the "normal" ones. Hannah seemed "normal" before her shots. So did my son. If you are not looking for abnormal, aren't ALL children considered "normal" before their vaccine induce regressive autism? If not, it wouldn't be regressive, would it.

HRSA's David Bowman let us know that vaccines don't cause autism, they just cause brain damage that may turn into autism, but that they don't check to see how often that happens. This statement not only beats Clinton's CYA for hanging his testimony on what the definition of the word "IS" is, it also torpedos Gerberding's "rare" claim, as he admits that they don't even check to see how often this happens.

So now the government's position is that vaccines don't "cause" autism, the just "result" in autism.

But since the beginning of this revelation two years ago that they know of a scenario in which a seemingly "normal" child can be vaccinated and regress into autism, have they shared that with the medical community and the public so that children can be screened to see if they are the ones that are vulnerable? No. Anne Schuchat of CDC says that would be to expensive.

Instead, they have withheld that information and are now making autism families actually GUESS at why and how their children regressed into autism from their vaccines.

Last week HRSA issued a letter to autism families in the vaccine program letting them know that they were rejecting the previously submitted MMR and thimerosal claims, and that families had to come up with a new theory or risk their cases being thrown out. (Because they are the government, that's why).

Mary Holland, appearing on Fox News this week:








So for two years HHS has been open with us that they know what vaccine induced autism is, but they are not going to tell families with children what it is... they have to guess.

These people do not deserve to hold positions in government, they deserve jail time.

September 19, 2010

Media Becoming More Alert: Becky Estepp Schools Dr. Mark Segiel on Fox

This is why parents are not usually allowed on TV to debate docs. Because they expose the ignorance of the physicians whom the networks are trusting to bring them accurate health information.

And Becky was even too polite to point out that the study was in Pediatrics, not the New England Journal of Medicine.

Which one of these two people would you turn to with your vaccine questions?

September 17, 2010

Vaccines Don't Cause Autism, and Guns Don't Kill People



A few days ago I posted a letter from HRSA responding to a media inquiry into the question of whether or not the Hannah Poling case showed that the government believed that vaccines caused autism.

[note: "encephalopathy" is a medical term for brain damage or a change in brain functioning.]

From: Bowman, David (HRSA) [mailto:DBowman@hrsa.gov]
Sent: Friday, February 20, 2009 5:22 PM
To: 'dkirby@nyc.rr.com'
Subject: HRSA Statement

David,

In response to your most recent inquiry, HRSA has the following
statement:

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.

Some children who have been compensated for vaccine injuries may have
shown signs of autism before the decision to compensate, or may
ultimately end up with autism or autistic symptoms, but we do not track
cases on this basis.

Regards,

David Bowman
Office of Communications
Health Resources and Services Administration
301-443-3376

I have decided to play "If someone else said it", to show the sheer fraud at play in this statement, and of course, to ask the media if such poor quality lying and frank admissions of dereliction of duty would pass muster were it not coming from the government, and about such a sacred cow as childrens' vaccines.

From: Heston, Charlton(HRSA) [mailto:CHeston@hrsa.gov]
Sent: Friday, February 20, 2009 5:22 PM
To: 'citizen@usa.com'
Subject: HRSA Statement

Citizen,

In response to your most recent inquiry, HRSA has the following
statement:

The government has never compensated, nor has it ever been ordered to
compensate, any case based on a determination that death was actually
caused by gunshot. We have compensated cases in which people
exhibited a perforation, or general hole in the body. Perforation
may be accompanied by a medical progression of an array of symptoms
including bleeding, organ damage, or death.

Some people who have been compensated for gunshot injuries may have
shown signs of dying before the decision to compensate, or may
ultimately end up dead or with fatal symptoms, but we do not track
cases on this basis.

Regards,

Charlton Heston
Office of Communications
Gunshot Injury Compensation Program
Health Resources and Services Administration
301-443-3376

What Bowman is saying is that 'vaccines don't really cause autism, they cause brain damage that may cause autism. And we don't pay attention if it does.'

When this PR failure ran in 2009, no one else in the media picked up on it.

This week, two mainstream journalists have actually reported on the ridiculous position that the government has taken that 'vaccines don't "cause" autism, vaccines merely "result" in autism'. The first is Sharyl Attkisson at CBS, who wrote about it here and whose interest apparently was piqued enough for her to take a hard look at the "encephalopathy" shell game that HHS is playing which led to a follow up piece here: Autism, Vaccines and Brain Damage: What's in a Name? Atkisson is the latest journalist to figure out that just calling the autism cases in the VICP "encephalopathy" is their very transparent attempt to maintain some sort of denial of the widespread damage the vaccine program is doing.

She reports:

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.

1,300 hundred cases of vaccine brain damage paid by the government more than blows away the made up statistic parroted far and wide that serious vaccine damage is "ONE IN A MILLION". Because for that to be true, there would need to be 1,300,000,000 vaccinated people in the US. Which is one billion too many people.

And this 1,300 number ONLY includes brain damage, not other injuries or deaths. The total number of cases paid is 2,503. Let's say we have 300 million people vaccinated in this country in the last twenty years. That would mean that if the government has actually found, recognized and compensated every serious vaccine adverse reaction (and we know that ain't happening) then vaccine injury is about 1 in 120,000. Given that only about 1 percent of vaccine injuries are ever even reported, and that few people who fall seriously ill are ever told that their circumstance might be a vaccine reaction, if we factor that in, then we are looking at 1 in 12,000.

Keep in mind that 1 in 100 has autism, and 1 in 6 children have a developmental disability or delay, and those populations are not exactly scoured to see how many of them are vaccine injuries, and well... that is how you get a citizenry that stops believing the government.

So as there has been no research comparing vaccinated people to unvaccinated people, we can't really know the true rate of vaccine injury. My estimate is somewhere between 1 in 120,000 and 18% of the population. Lets hope someone with time and money can narrow that down for us someday.

The second journalist to have a light bulb pop in over her head, is Alisyn Camerota at Fox News, who points out the "fishy legal language" the government is using. Dr. Manny also seems to be coming to grips with the hard truth, because as I recall, years ago he was ruling out vaccines in autism.






Let's see if any other reporters are woken up by the VICP announcement of paying a child around twenty million dollars for "autism-like symptoms". (You know because people with autism have autism like symptoms, a man with no legs is also missing his big toe, I am five pounds overweight, my great, great, great grandfather currently has a mitochondrial disorder where his cells just don't make enough energy to properly power his brain, or any other small subset of a larger more dramatic condition that is both completely true and completely misleading to the listener who expects the government to tell them the truth. Did I mention that Hannah Poling has full syndrom, DSM diagnosed Autism, with a capitol "A"?)

And if you check that HRSA National Vaccine Injury Compensation Program Statistic Report page one more time, you will note that there is now a "1" in the "Compensable" column of the Autism Omnibus Proceedings. Of course HRSA has added an asterisk next to it with the following note:

"HHS has never concluded in any case that autism was caused by vaccination."

And now you can go back to the beginning of this article to remind yourself that HHS only compensates for bullet holes, not for bleeding or death.

Update:

I missed this one

Karen DeSoto at MSNBC also gets the wake up call and wants to know what the hell is going on.  She  notes that it is the government that has sealed the case when the Polings had requested it be open to the public so it could be of value in answering the questions we all have.

With all the attacks on them since the concession was made public, including people stalking their daughter, would they still be open to that? I don't think it matters. With out even mentioning the name Poling or one detail about Hannah, HHS could say, "Here is one process by which a seemingly neurotypical child can get autism from vaccination". Or if they want to maintain their BS legal word game cover, "This is a process by which a child with an undiagnosed mitochondrial disorder may develop autism like symptoms as a result of vaccination".




I hope that DeSoto follows up on this. She is right. Parents every where should be screaming WTH? at HHS.

Update:

Fox News follows up a week later. Becky Estepp of SafeMinds and TACA is on, and has to give Dr. Mark Siegel a lesson in vaccines.




Update:

This post is generating much traffic, so I will go ahead and add the news piece that really exposed how badly the government was lying to try to keep people from waking up to the fact that HHS has been paying these cases for almost twenty years. Julie "Vaccines Cause Autism and Do Not Cause Autism" Gerberding.


September 11, 2010

AJC: Settlement Reached in Autism-Vaccine Case

A curious thing happened in Atlanta. The AJC posted a story on the Poling case, then some sort of internet sewer alligator monster must have climbed up from the depths and eated it or somethin', because today it was gone.

Fortunately, I still had my browser open when I heard about the disappearance of the poor missing article, so I saved a copy. You are welcome AJC. Hope you catch that creature who is stealing your stories.


Update... I have taken the article down, because apparently it take of the AJC site because it contained several inaccuracies. I don't know what they were, but I don't wanna spread misinformation, so said article goes down.

September 9, 2010

Vaccines Don't CAUSE Autism, They Just RESULT in Autism

(looking at my stopwatch) aaaaaaaaand time!

Hannah Poling finally gets paid for her vaccine induced resulted autism.

So if a brilliant Johns Hopkins neurologist and his super smarty nurse/lawyer wife file a vaccine injury claim for their daughter, that is such a slam dunk case that the government does not even bother to fight it but concedes the case, they can expect to wait, let see... add the four, carry the three, divide by pain and suffering and... oh, thats not bad... ONLY ten years, one month and two weeks or so after the child is injured to be paid by the government. Yep! That is one compassionate program alright!

Mind you the Polings have been dragged through the mud, personally and professionally, for daring to file in the VICP and win to get money to help their daughter. Oh... and they also had the bad taste to tell people. In public even. Bastards.

But at least we have finally gotten a straight answer from the government on whether or not vaccines cause autism. Turns out that vaccines don't "cause" autism, they just "result" in autism. From CBS News:

In acknowledging Hannah's injuries, the government said vaccines aggravated an unknown mitochondrial disorder Hannah had which didn't "cause" her autism, but "resulted" in it.

THANK GOD! Parents, you can go back to blindly trusting their government. All your questions and concerns about the safety of the vaccine program have been asked and answered with the utmost integrity and with thorough thoroughness.

Sleep in peace citizens. All is well.

Government heath care is awesome.  More government health care please.

(And I hope Hannah fully recovers and buys a Ferrari with whatever is left of her 1.5 mil)


Update:

I thought I might include this email from David Bowman at HRSA. He sent it to David Kirby last year in response to an inquiry.

From: Bowman, David (HRSA) [mailto:DBowman@hrsa.gov]
Sent: Friday, February 20, 2009 5:22 PM
To: 'dkirby@nyc.rr.com'
Subject: HRSA Statement

David,

In response to your most recent inquiry, HRSA has the following
statement:

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.

Some children who have been compensated for vaccine injuries may have
shown signs of autism before the decision to compensate, or may
ultimately end up with autism or autistic symptoms, but we do not track
cases on this basis.

Regards,

David Bowman
Office of Communications
Health Resources and Services Administration
301-443-3376

So again... vaccines cause encephalopathy which progresses into autism, but vaccines don't cause autism. And by the way, HHS does not track whether or not vaccines cause autism, they just pay attention to cases where vaccines cause encephalopathy. Then they stick their fingers in their ears and yell "la la la, I'm not listing", when parents come back a month later and say their child has been diagnosed with autism.

Why does anyone take vaccine advice from these people? Why did I?


Nostalga Update:

Oh alright... one more time just for fun.



And for those of you who would like to reminise more about the absurdity of the governments position on the Poling decision: Spinning the Hannah Poling Case

HOLY CRAP UPDATE: Hannah is not getting 1.5 mil, she is getting around 20 million dollars!

CBS has updated their post to read:

"The first court award in a vaccine-autism claim is a big one. CBS News has learned the family of Hannah Poling will receive more than $1.5 million dollars for her life care; lost earnings; and pain and suffering for the first year alone.

In addition to the first year, the family will receive more than $500,000 per year to pay for Hannah's care. Those familiar with the case believe the compensation could easily amount to $20 million over the child's lifetime".

The government is paying Hannah Poling 20 million dollars for a vaccine injury that the same government claims does not exist.

I am speechless.

June 13, 2010

Why were Merck's Lawyers at the Cedillo Appeal Last Week

Someone pointed out to me that Merck's lawyers were in the gallery listening to the Cedillo hearing last Thursday. This brings up a few questions for me.

What is Merck's interest here? (duh.) Is Merck helping out the DOJ in their defense? If so, what help are they offering?

And what of the rumors of Pharma payouts to families in the vaccine court? It is legend that on occasion, when a family has a slam dunk case, the pharmaceutical company that made the vaccine in question steps in privately, offers the family a shocking amount of money, and the case is quietly withdrawn from the VICP. Non-disclosures of course would be iron clad.

This of course protects companies like, let's say Merck, from having their product linked publicly to autism in a court ruling, and prevents precedent from being set.

Was Merck in DC to help out the DOJ? Or are they worried that this will get remanded back to the Special Master with instructions that read: "Do it again, this time with out corruption" and Michelle will win the case, so they are trying to figure out how big a check it would take to keep the Cedillos happy and quiet?

So... to the DOJ... are Merck's lawyers assisting you on this case?

And Merck (or any pharma willing to speak out) have you been paying families to leave the vaccine court to cover your billion dollar assets?

This is supposed to be a non-adversarial process. Is there anything on the planet more adversarial than a Pharma lawyer?

March 15, 2010

Call for Congressional Hearings into CDC/HHS/VICP and Vaccine Shenanigans

From the Autism Action Network:

Vaccine “Court” Denies Justice to Vaccine-Injured Children

Take Action!

Mercury-Autism Link Not Found Because of Government Policy, not Science

Click on the Take Action link to send emails to your Representatives calling for Congressional hearings

In a decision released last Friday afternoon, the Autism Action Network, a founding member organization of the Coalition for Vaccine Safety (CVS), believes that the Special Masters of the Court of Federal Claims (the Vaccine Court) wrongly decided that mercury-containing vaccines do not cause autism. The decision was the last of three test cases selected to

"The government is completely inconsistent, we know from the Hannah Poling and the Bailey Banks cases that vaccines can cause autism," said John Gilmore, executive director of the Autism Action Network. "It is as if they are saying, 'Vaccines never cause autism, except when they do.'"

The Special Masters appear to have based their decisions on the government policy to protect the vaccine program rather than to fulfill their role to do justice by vaccine-injured children. In these three 'test case' decisions in the Omnibus Autism Proceeding, petitioners William Mead, Jordan King and Colin Dwyer developed normally through the first year of life and then regressed into autism. They presented thousands of pages of scientific documentation and testimony. Their evidence showed that thimerosal, a mercury-laden vaccine preservative, more likely than not contributed to their autism.

"The deck is stacked against families in Vaccine Court. Government attorneys defend a government program, using government-funded science, before government judges. Where's the justice in that?" asked Rebecca Estepp, a CVS steering committee member and mother of a petitioner in the Omnibus Autism Proceeding.

"This has been a huge, but legally necessary, waste of time for the injured kids and their families," said Gilmore, "At least now we will have a chance in a real court where we have the basics rights denied in the Vaccine court."

Mercury is a known neurotoxin and that damages the developing brain and the immune system. All three boys' health improved through medical interventions to reduce mercury toxicity and immune dysfunction. Nonetheless, the Special Masters concluded that petitioners failed to meet their burden of proof, even though Health and Human Services (HHS), the respondent in the proceeding, offered no alternative explanation other than genetic predisposition.

The Coalition for Vaccine Safety (CVS) is an alliance of organizations dedicated to vaccine safety representing over 75,000 families. In recent letters to the Chairmen and Ranking Members of House and Senate Committees charged with oversight of the Department of Health and Human Services (HHS), the Coalition called for hearings to investigate HHS, the CDC and other government agencies. Those federal agencies have failed to comply with the terms of the 1986 Vaccine Injury Compensation Act (VICA). Specifically they have failed to provide critical vaccine safety science, including from the taxpayer-funded Vaccine Safety Datalink, on thimerosal, autism and other neurodevelopmental disabilities.

Vaccine court decisions and revelations about Dr. Thorsen's actions only strengthen the Coalition's resolve in calling for immediate Congressional action to investigate vaccine safety - an issue that potentially affects every person in the country.

"We are confident that the truth will win out. We hope that Congress will intervene in what is clearly a miscarriage of justice to vaccine-injured children," said Jim Moody, an attorney and CVS steering committee member.

Please join the Autism Action Network and the Coalition for Vaccine Safety in calling for Congressional hearings in to the may failures of the federal vaccine program. To send an email to your Representative in the House and your to Senators please click on the Take Action

March 12, 2010

The VICP Autism Omnibus: How The Government is Killing the Vaccine Program

... and their credibility right along with it.

Today, yet again, the Kangaroo Court Vaccine Injury Compensation Program found that, surprise, surprise, vaccines don't cause autism. Exactly what we expected that their propaganda finding would be. (See the statements by the Coalition for Vaccine Safety, TACA, SafeMinds and the National Autism Association at the end of this post).

A few weeks back, after I posted my chart of the 20 billion dollar vaccine industry and their Wakefield Witch Hunt, Steve Kette, an autism dad, sent me a flow chart that he had done illustrating just how the public/private partnership (Government/Pharma/MSM entity here to for referred to as "The Empire") that is the US vaccine machine program is running itself into the ground.

We have had story after story illustrating the revolving doors between CDC and Pharma/vaccine industry, painful experiences on just how biased the media is, and now an admission straight from the horses mouth that the Secretary of Health, Kathleen Sebelius, is asking for the media for favorable coverage on the vaccine issue. The role of the MSM is to do critical analysis of the government, not hold Kathleen's purse.

And another thing that MSM outlets are supposed to do is compete with one another, right? Not so if you are all a part of one giant conglomco like the Tribune Company Corporation Incorporated. Here is an email exchange that took place today between the two notorious "reporters" Trine Tsouderos from the Chicago Tribune who has spent the last few months trashing our community, and Thomas Maugh from the LA Times who has spend the last few years trashing our community, (and who once responded to an earnest inquiry from me with the oh so respectful, "Wrong, wrong, wrong, wrong!") collaborating on VCIP Ruling story today:

From: Tsouderos, Trine
Sent: Friday, March 12, 2010 12:39 PM
To: Dennis, Tami
Subject: Vaccine court story

Hi Tami,

Kaarin said you guys were going to write the vaccine court story – she said to let you know if you need anything, I’m happy to help. My autism sources have been contacting me all day wanting to talk about it, so it would be easy to get quotes.

Anyway, let me know! Best wishes,

Trine

Trine Tsouderos
Chicago Tribune
Science and Medical Reporter
312 222 5648 (w)
312 927 7986 (cell)
ttsouderos@tribune.com



From: Dennis, Tami
Sent: Friday, March 12, 2010 12:43 PM
To: Maugh, Thomas
Subject: FW: Vaccine court story

They did good stuff. Don’t hesitate to use them if you need comment.



From: Maugh, Thomas
Sent: Friday, March 12, 2010 2:47 PM
To: Tsouderos, Trine
Subject: FW: Vaccine court story

Please. Anything you can send me would be helpful. I'm gong to be listening in to the Every Child by 2 Press conference.

Thomas H. Maugh II
Science/Medical Writer
Los Angeles Times
202 West First Street
Los Angeles, CA 90012
310 649-1300



From: Tsouderos, Trine
Sent: Friday, March 12, 2010 1:02 PM
To: Maugh, Thomas
Subject: RE: Vaccine court story

Do you want me to get JB Handley at Generation Rescue? I have his email.



From: Maugh, Thomas
Sent: Friday, March 12, 2010 3:02 PM
To: Tsouderos, Trine
Subject: RE: Vaccine court story

Whoever you think would give a good, rational quote. Some of the responses on the PR newswire seem rather irrational.

Thomas H. Maugh II
Science/Medical Writer
Los Angeles Times
202 West First Street
Los Angeles, CA 90012
310 649-1300

FYI... For the "irrational" response on the newswire... see below. He means the responses from our community. So sweet how Trine and Maugh are there for each other in their battle against the forces of darkness vaccine injured children.

The whole circle is corrupt. Because there is no way to sue Pharma or the Government for vaccine damage, and certainly no way to sue biased media sources, the public is penned in and once vaccine injury takes place... well... to bad... you're screwed. You are also evil and want children to die from polio because you said out loud that a vaccine injured your child. You are also anti-vaccine, even if you continue to vaccinate your other children. (Did I mention desperate and scientifically illiterate? Also you probably have mental health issues. Oh... and Thomas Maugh thinks you are irrational.)

And the public is starting to get that this whole thing is bullshit. There has been speculation today as to why these VICP rulings were dropped on a Friday afternoon, burial ground for media pieces. Is it that the government gets that people think they are full of crappola and don't want these rulings to feed another cycle of vaccine program bashing? That is my guess. (Or are they trying to prevent more stories on Thorsen?)

Because, as Mr. Kette has illustrated below, the Government/Pharma/MSM shenanigans like the rulings today only serve to discredit themselves in the public's eyes, and add fresh, stinky fertilizer to the growing suspicion and distrust of the vaccine program.


The Life Cycle of a Failed Public Vaccination Program
(click to enlarge as pdf)



Kette is quite insightful in placing "Empire Paternalism" at the head of this death spiral, because it begins when the public forgets the profound axiom that "Power corrupts, and absolute power corrupts absolutely". The warm feeling of security that comes from allowing yourself to believe that governments and billion dollar multinational corporations are earnest, righteous and working in your personal best interest is seductive. But Big Brother does not love you... he doesn't even know you. History ONLY illustrates the cycle of powerful governmental/corporate entities falling into corruption and either destroying society OR eventually being held accountable by the people either by the vote or by pitchfork. Powerful entities like these are only held in check when people turn their brains on, stop pretending that the government, or the corporation can fix our problems and heal the world.

Be clear, the corporation exists to make money, the government is not doing its job to hold the corporation accountable, and the media is not doing its job of holding them both accountable. They are all becoming very powerful and very rich by working together. The ONLY accountability for vaccine damage will come directly from the public saying "NO MORE!".

In vaccination, the government is not your friend.

Ronald Reagan's words were never truer than in the case of the story of American Vaccine Injury:

"The nine most terrifying words in the English language are, 'We're from the government and we're here to help.'"


UPDATE:

I, along with most of the people who have been writing about the VICP decisions, have been corrected by one of my readers who makes a good poing:

"...Anyone looking closely at the accumulative decision(s) of MEAD, KING and DWYER (plus, 595 Pages) will be hard pressed to find the Special Master(s) (Patricia Campbell-Smith, George L. Hastings, Jr., and Denise K. Vowell) saying, Thimerosal Does Not Cause Autism,  It's Official: Vaccines Don't Cause Autism or Vaccines Could Not Have Caused Autism, U.S. Court Says, and yet, incredibly, that's exactly what being broadcast and reported across the nation by the media.

What the Special Master(s) did say was the Petitioner(s) respectively failed to satisfy the burden of proof , CAUSE AND EFFECT, or by a PREPONDERANCE OF 'CAUSATION-IN-FACT" EVIDENCE under the articulated legal standards. Consequentially, all three petitioners failed to establish their clear entitlements to compensation.

In other words, it appears the full weight and burden of proof to establish a "link" between Autism and vaccines (including the preservative, Thimerosal) was entirely placed on the families of WILLIAM P. MEAD, JORDAN KING and COLIN R. DWYER.

Not an easy task for the family struggling with a sick kid at home, even the family was armed with equal resources and a league of brilliant litigators with law degrees from the Harvard School of Law.

These families faced lawyers hired by the vaccine makers with unlimited resources and truckloads of paper. No reasonable person would call that a fair fight.

There is a huge difference in saying Vaccines Could Not Have Caused Autism, and in saying, by the Preponderance of Evidence the families failed to prove a "link" to the satisfaction of the court, a story broadcasters and media unjustly prejudiced, be it out of ignorance or by intent..."
-Larry


Read the press released from:

The Coalition for Vaccine Safety:

Special Masters Protect Vaccine Program and Deny Justice to Vaccine-Injured Children

Mercury-Autism Link Not Found Because of Government Policy, not Science

Washington, DC - The Coalition for Vaccine Safety (CVS) believes that the Special Masters of the Court of Federal Claims wrongly decided that thimerosal-containing vaccines (TCVs) do not cause autism. The Special Masters appear to have based their decisions on the government policy to protect the vaccine program rather than to fulfill their role to do justice by vaccine-injured children. In these three 'test case' decisions in the Omnibus Autism Proceeding, petitioners William Mead, Jordan King and Colin Dwyer developed normally through the first year of life and then regressed into autism. They presented thousands of pages of scientific documentation and testimony. Their evidence showed that thimerosal, a mercury-laden vaccine preservative, more likely than not contributed to their autism.

"The deck is stacked against families in Vaccine Court. Government attorneys defend a government program, using government-funded science, before government judges. Where's the justice in that?" asked Rebecca Estepp, a CVS steering committee member and mother of a petitioner in the Omnibus Autism Proceeding.

It is universally accepted that mercury is a neurotoxin and can damage the developing brain and the immune system. All three boys' health improved through medical interventions to reduce mercury toxicity and immune dysfunction. Nonetheless, the Special Masters concluded that petitioners failed to meet their burden of proof, even though Health and Human Services (HHS), the respondent in the proceeding, offered no alternative explanation other than genetic predisposition. The Special Masters appear to be following a misguided government policy that if they acknowledge a mercury-autism link, parents will stop vaccinating their children.

The breaking story of fraud at the Centers for Disease Control and Prevention (CDC) involving Dr. Poul Thorsen, a leading member of a Danish research group that wrote studies supporting the CDC's claims that there is no mercury-autism link, casts further doubt on the Special Masters' decisions. The emerging evidence of Dr. Thorsen's embezzlement of $2 million, falsehoods about his employment, and serious questions about his research throw into question the validity of the science at the heart of HHS's claim of no mercury-autism link.

The Coalition for Vaccine Safety (CVS) is an alliance of organizations dedicated to vaccine safety representing over 75,000 families. In recent letters to the Chairmen and Ranking Members of House and Senate Committees charged with oversight of the Department of Health and Human Services (HHS), the Coalition called for hearings to investigate HHS, the CDC and other government agencies. Those federal agencies have failed to comply with the terms of the 1986 Vaccine Injury Compensation Act (VICA). Specifically they have failed to provide critical vaccine safety science, including from the taxpayer-funded Vaccine Safety Datalink, on thimerosal, autism and other neurodevelopmental disabilities.

The Special Masters' Omnibus Autism Proceeding decisions and revelations about Dr. Thorsen's actions only strengthen the Coalition's resolve in calling for immediate Congressional action to investigate vaccine safety - an issue that potentially affects every person in the country.

"We are confident that the truth will win out. We hope that Congress will intervene in what is clearly a miscarriage of justice to vaccine-injured children," said Jim Moody, an attorney and CVS steering committee member.

For more information on the Omnibus Autism Proceeding and vaccine safety, visit www.coalitionforvaccinesafety.org.

SafeMinds:

Government's Refusal to Fund Sound Science Stacks Deck Against Vaccine-Injured Children and Casts Doubt on the Integrity of the National Immunization Program says SafeMinds.


Washington, D.C. - March 12, 2010 - Autism and mercury advocacy organization SafeMinds regrets today's ruling by the U.S. Court of Federal Claims against three families who argued that vaccines which contained the mercury based preservative thimerosal contributed to their child's autism. The denial of reasonable compensation to families was based on inadequate vaccine safety science and poorly designed and highly controversial epidemiology studies supported by the Centers for Disease Control and Prevention.

The Department of Health and Human Services (HHS) is the defendant in vaccine injury cases and is also responsible for carrying out the very vaccine safety research that should be integral to court decisions. This conflict of interest means the deck is stacked against families when they enter "vaccine court" and is yet one more reason for parents to doubt the integrity of the National Immunization Program.

"The government has its thumb on the scales of justice," said Laura Bono, parent of a vaccine injured child whose case was dismissed. "The Vaccine Injury Compensation Act passed by Congress in 1986 gave immunity to vaccine manufacturers and diminished 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 and many families will not see justice done."

Two HHS agencies, the Centers for Disease Control (CDC) and the National Institutes of Health (NIH), are responsible for conducting vaccine safety research. Calling into question the scientific integrity of this research, a top CDC funded vaccine researcher, Poul Thorsen, responsible for the oversight of some of the most influential and controversial studies that have been claimed as evidence for no link between autism and thimerosal, is alleged to be under investigation when funding documents were found to be forgeries and millions of dollars were missing.

The director of the NIH institute in charge of autism studies has admitted that HHS has a conflict of interest in conducting autism-vaccine research due to the court cases. Last year, the government dominated Interagency Autism Coordinating Committee blocked critical vaccine-autism research studies from moving forward. "The government must fund an extensive vaccine safety program, including studies of the health outcomes of vaccinated and unvaccinated children," stated Lyn Redwood, Vice President of SafeMinds. "Trust in the immunization program will continue to deteriorate without adequate and unbiased safety science."

Over 5,000 petitions have been filed in the vaccine court alleging that vaccines caused a variety of damage to the developing brain, immune system, and other metabolic pathways ultimately giving rise to a diagnosis of autism. Already, the court has awarded approximately $5 million in compensation for such cases, of which the Hannah Poling case is the most well-known. Many of these cases were quietly settled by the government so the public is not aware of them. Thus the court has already decided that vaccine injury is linked to autism.

Today's ruling against families demonstrates that the process is arbitrary. The question is not whether some cases of autism have a vaccine etiology. The government has admitted that. The only remaining question is how many kids have been injured - and what must be done now to treat these kids and prevent further injury.

SafeMinds wishes to recognize the bravery and perseverance of the families who now may face a lifetime of inadequate support for their disabled children.

The Coalition for SafeMinds (Sensible Action for Ending Mercury-Induced Neurological Disorders) is a nonprofit organization founded to investigate and raise awareness of the risks to infants and children of exposure to mercury from medical products, including thimerosal in vaccines. Further information about SafeMinds and the harmful effects from mercury exposure may be found at www.safeminds.org

Talk About Curing Autism:

Second Round of Autism Omnibus Court Cases Decided

Legal update By Rebecca Estepp, TACA.

March 12, 2010

Today in Washington DC, the Special Masters of the Court of Federal Claims released their decisions in the second round of Omnibus Autism Proceeding (OAP) claims. Once again, the OAP has failed children with autism that exhibited regression after their routine childhood vaccinations. All three cases: Mead, King and Dwyer were denied compensation.

First off, what is the OAP?

The National Childhood Vaccine Injury Act of 1986 (Public Law 99-660) created the National Vaccine Injury Compensation Program (VICP) in 1988. The VICP was created to ensure there was an adequate supply of vaccines and stabilize vaccine costs. Prior to this Act, there were only a handful of drug companies that producing vaccines. These companies faced lawsuits in civil court when their vaccines caused injuries. The drug companies lobbied for liability protection and the Act was passed.

A responsibility of the VICP was to establish and maintain an accessible and timely venue for individuals found to be injured by vaccines. The VICP was developed to be a no-fault alternative to the traditional tort system for resolving vaccine injury claims that provides compensation to people found to be injured by certain vaccines. The U. S. Court of Federal Claims that decides these claims in court is commonly referred to as vaccine court. Damages are paid to individuals from a government-maintained fund. Drug companies can no longer be sued in a civil court of law until the claim has gone through the VICP. For more information go to: HRSA Vaccine Compensation.

The VICP was set up for individuals who suffered an “on-the-table” vaccine injury. That is an injury that happened within minutes or hours after receiving a vaccine.

In 2001, parents of children with autism started filing claims with VICP. These claims were considered “off-the-table,” meaning the vaccine injury did not occur “on-the-table” or at the time of injection. In July of 2002, the Special Masters (the term used for “judges” in vaccine court) established the procedure for addressing these claims and the Omnibus Autism Proceeding (OAP) was born. It was at that time that parents started flooding OAP with claims. More than 5500 claims have been filed in the program to date.
For more information on the Omnibus cases & decision click HERE.

Who are the Mead, King and Dwyer families?

The Mead, King and Dwyer are families with many similarities. All three families have boys with autism. All of the boys in these cases are the same age, 12 years old. Each family reported that their sons developed typically during the first year of their lives and then suffered a regression after their routine pediatric vaccines were administered. William Mead and Jordan King are both from Portland, Oregon while Colin Dwyer is from Queens, New York. Interestingly, William Mead was developing so typically that he was a model for Pottery Barn.

TACA would like to take this time to recognize the extraordinary efforts of the Mead, King and Dwyer families along with their attorneys. These brave families put their children on the line for more than 5500 children in the OAP. Their attorneys fought a brilliant battle in a very rigid court. These courageous families and their attorneys are truly our heroes.

When were these cases heard? What was the causation theory behind these cases?

These cases were heard in May and July of 2008. These three families were chosen as test cases number four, five and six in the OAP under the causation theory number two. Theory number two states that the thimerosal contained in the vaccines these boys were administered was the sole reason for their injuries.

Weren’t there decisions in the OAP last year? What was the causation theory in those OAP Cases?

Last February the same court denied compensation to the first three OAP cases (Cedillo, Hazlehurst and Snyder) which had a different theory of causation. Those cases theorized that the first three children had suffered an injury due to the combination of thimerosal containing vaccines and damage done from the measles, mumps and rubella (MMR) vaccine.

Read more information on the first OAP cases at TACA HERE.

Analysis of all OAP decisions

Hindsight is always 20/20. The analysis I wrote for the first round of OAP decisions was far too optimistic. I mistakenly theorized that the reason the first verdicts took 19 months to conclude was due to a close call the Special Masters must have had when coming to their decisions. I no longer hold that opinion.

While I recognize that the Special Masters had the herculean task of sifting through thousands upon thousands of pages of evidence, I believe it took over a year for the Special Masters to carefully choose the language in their verdicts to send the message that the OAP will not award compensation to children with autism. The Vaccine Court seems to be more concerned about protecting the perception of safety in the current vaccine schedule than compensating the children who were harmed in the immunization program.

This opinion change was confirmed today when the Special Masters concluded that Mead, King and Dwyer families did not meet their burden of proof. I’d like to point out that the government did not offer any other explanation for these boys’ regressions, other than to claim that it was a vague, nonspecific genetic cause for which there was not a shred of evidence.

I attended the OAP hearings in 2007 and 2008. I was full of hope this was the venue that would finally lead to justice for vaccine-injured children. I was optimistic as I watched the parents testify and watched their dedicated attorneys fight for their clients. Unfortunately, I now view the OAP as a program where government attorneys defend a government program using government-funded science before government judges. This is hardly fair and I am afraid we never had a chance for justice for these children.

Is there any hope?

I know this all sounds very bleak. However, there are many reasons why there is still hope for children with autism who suffered vaccine reactions.

1. These three decisions will be appealed. The appeal process begins immediately in the OAP.

2. Bruesewitz v. Wyeth—On March 8, the Supreme Court voted in favor of hearing this vaccine injury case. The issue in this case is not whether or not the child was harmed by a vaccine, rather the Supreme Court will decide on whether or not parents have the right to sue a drug company outside of the VICP. Mary Holland, Esq. and Jim Moody, Esq. wrote a wonderful article on this upcoming case for the Age of Autism. Read more HERE.

3. Theresa Cedillo and Michael Cedillo v. Secretary of Health and Human Services—This amicus curae brief was filed in February backed by twenty-three autism organizations in the US Court of Appeals for the Federal Circuit. Read more HERE.

4. The above legal cases will take many months to move forward which allows more time for science to develop. This could possibly help our side of the argument.

5. The Dr. Poul Thorsen situation is still evolving. Dr. Thorsen was a lead scientist in the Danish studies conducted in 2003 that showed that vaccines and autism were unrelated. Dr. Thorsen is now missing with $2 million of Danish Universities’ money. Read more of this explosive story HERE.

6. The Hannah Poling and Bailey Banks cases. These two children with autism were awarded compensation for damage done to them during their routine childhood vaccinations. The difference for these two children was their cases were heard outside of the OAP and were compensated for conditions like seizure disorder and encephalopathy. Read more about Hannah Poling and Bailey Banks: Poling HERE and Bailey-Banks HERE.

7. One in four parents now believes in the autism/vaccination connection! And no wonder. There is substantial evidence that a susceptible set of children have reacted to their vaccines. The number of children with autism has been skyrocketing for years and there is still no explanation from the government or the medical establishment for the increase. Read more at CBS News HERE.

8. The newly formed Coalition for Vaccine Safety is spear heading many new vaccine safety initiatives including the call for Congressional Hearings on this topic. For more information on this coalition click HERE.

I ended last year’s decision analysis with “this fight is not over.” I feel even more devoted to that statement this year. While I do think the OAP is broken, needs reform and provides very little chance that any child will receive compensation from it, I don’t think the vaccine and autism connection issue is dead. This fight is far from over.

Rebecca Estepp is Media Relations Director for TACA.


NAA:


Justice Once Again Denied to Vaccine Injured Children

The National Autism Association is disappointed but not surprised by the decisions made public March 12, 2010 in the U.S. Court of Federal Claims in three thimerosal test cases. These decisions reflect the corruption of a broken system that is rooted in protecting the country’s vaccine program at all costs, and not in compensating children who have been injured by vaccines.

Ironically, it is the government’s negligence in maintaining proper oversight of vaccine safety issues, and then refusing to compensate those injured by vaccines, that is eroding public confidence in the vaccine program. Our government health agencies continue to demonstrate complete loyalty to a vaccine program known to have caused autism and other serious injuries to children.

Because these latest decisions in vaccine court are the end result of a corrupt legal process and a blatant disregard for vaccine safety, we are asking Congress to investigate the Department of Health and Human Services and its subordinate agencies for their role in overseeing vaccine safety issues. These agencies are charged by both federal law and ethical responsibility to ensure that vaccines are as safe as possible. To become a part of this crucial effort to hold federal health agencies accountable for vaccine safety, please visit NAA's Autism Action Center at http://naa.kintera.org/actioncenter.

July 18, 2009

Legal Immunity Set for Swine Flu Vaccine Makers

Just one more product that they can make, that even when used correctly can kill someone, or many someones, and they have no responsibility what so ever.

The article does not state whether or not the shots will be covered under the Vaccine Injury Compensation Fund, but I will assume for the time being that they are unless I find out otherwise.

But it is of little comfort as the VICP is not known for speedy justice. If one gets justice at all, it can take years (or decades in the case of Hannah poling who was injured almost ten years ago, got a judgment in her favor in November of 2007, still has not seen dime one, and whose parents don't anticipate seeing the first payments until at least 2010). Then that "justice" is doled out one scoop at a time by the court, whom you have to go to and ask for said cash for expenditure X and they say yes or no. My favorite story was of a child who was in a wheelchair and grew out of that wheelchair and petitioned the court to get some of her money to buy a new wheelchair and the court said "no, we already bought you a wheelchair" which was the wheelchair that she had just grown out of.

I guess the court cannot be too careful with all those crafty crippled tweeners running their little "street wheelchair" rackets.

Keep in mind, that the plan as of now is to dispense tens of thousands of doses of vaccine in September BEFORE THE SAFETY TESTING IS IN, and then go back and reformulated the next round according to the safety testing.

If you get the shot before mid October, you are assured of getting one that has no studies to back it up, and for which the people making it hold NO liability.

This for a disease which is killing around 1 in 400,000 people who catch it, and probably less than that.

(Just a reminder that the autism rate reported by the DOD of their dependents is 1 in 88. I believe that the government is spending 8.5 billion on Swine Flu this year. Proportional response?)

Legal immunity set for swine flu vaccine makers
By MIKE STOBBE, Ap Medical Writer – Fri Jul 17, 8:15 pm ET

ATLANTA – The last time the government embarked on a major vaccine campaign against a new swine flu, thousands filed claims contending they suffered side effects from the shots. This time, the government has already taken steps to head that off.

Vaccine makers and federal officials will be immune from lawsuits that result from any new swine flu vaccine, under a document signed by Secretary of Health and Human Services Kathleen Sebelius, government health officials said Friday.

Since the 1980s, the government has protected vaccine makers against lawsuits over the use of childhood vaccines. Instead, a federal court handles claims and decides who will be paid from a special fund.

The document signed by Sebelius last month grants immunity to those making a swine flu vaccine, under the provisions of a 2006 law for public health emergencies. It allows for a compensation fund, if needed.

The government takes such steps to encourage drug companies to make vaccines, and it's worked. Federal officials have contracted with five manufacturers to make a swine flu vaccine. First identified in April, swine flu has so far caused about 263 deaths, according to numbers released by the Centers for Disease Control and Prevention on Friday.

The CDC said more than 40,000 Americans have had confirmed or probable cases, but those are people who sought health care. It's likely that more than 1 million Americans have been sickened by the flu, many with mild cases.

The virus hits younger people harder that seasonal flu, but so far hasn't been much more deadly than the strains seen every fall and winter. But health officials believe the virus could mutate to a more dangerous form, or at least contribute to a potentially heavier flu season than usual.

"We do expect there to be an increase in influenza this fall," with a bump in cases perhaps beginning earlier than normal, said Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases.

On Friday, the Food and Drug Administration approved the regular winter flu vaccine, a final step before shipments to clinics and other vaccination sites could begin.

The last time the government faced a new swine flu virus was in 1976. Cases of swine flu in soldiers at Fort Dix, N.J., including one death, made health officials worried they might be facing a deadly pandemic like the one that killed millions around the world in 1918 and 1919.

Federal officials vaccinated 40 million Americans during a national campaign. A pandemic never materialized, but thousands who got the shots filed injury claims, saying they suffered a paralyzing condition called Guillain-Barre Syndrome or other side effects.

"The government paid out quite a bit of money," said Stephen Sugarman, a law professor who specializes in product liability at the University of California at Berkeley.

Vaccines aren't as profitable as other drugs for manufacturers, and without protection against lawsuits "they're saying, 'Do we need this?'" Sugarman said.

The move to protect makers of a swine flu didn't go over well with Paul Pennock, a prominent New York plaintiffs attorney on medical liability cases. The government will likely call on millions of Americans to get the vaccinations to prevent the disease from spreading, he noted.

"If you're going to ask people to do this for the common good, then let's make sure for the common good that these people will be taken care of if something goes wrong," Pennock said.
___

AP Medical Writer Lauran Neergaard contributed to this report from Washington.

May 27, 2009

Contradictory Rulings in the Vaccine Court

[An alternate version of this piece was written in response to an article in Utah Stories.]

Many have cited three cases in which The Health and Human Service's vaccine court ruled out vaccines as a cause of a child's autism, but don't mention the 10 cases (discovered by CBS News) that were won in that court by children with autism.

Three of those 10 families have gone public, The Polings, The Banks and The Hiatts.

The Poling case is the only one that received mainstream media coverage.

Only ten days after we heard that the court said MMR doesn't cause autism, we heard that the same court said that MMR caused Baily Banks autism.

"In his conclusion, Special Master Abell wrote:

The Court found that Bailey's ADEM was both caused-in-fact and proximately caused by his vaccination. It is well-understood that the vaccination at issue can cause ADEM, and the Court found, based upon a full reading and hearing of the pertinent facts in this case, that it did actually cause the ADEM. Furthermore, Bailey's ADEM was severe enough to cause lasting, residual damage, and retarded his developmental progress, which fits under the generalized heading of Pervasive Developmental Delay, or PDD. The Court found that Bailey would not have suffered this delay but for the administration of the MMR vaccine, and that this chain of causation was not too remote, but was rather a proximate sequence of cause and effect leading inexorably from vaccination to Pervasive Developmental Delay.

And he added this:

Petitioner's theory of PDD caused by vaccine-related ADEM causally connects the vaccination and the ultimate injury, and does so by explaining a logical sequence of cause and effect showing that the vaccination was the ultimate reason for the injury.

Shouldn't we be shouting a collective, "WHAT?!" to The Department of Health and Human Services for their contradictory positions?

Here is the thing, when the Department of Health and Human Services puts the Department of Health and Human Services on trial, and the Department of Health and Human Services wins, that is not news. When they put themselves on trial and loose, as in the Poling, Banks and Hiatt cases THAT IS NEWS!

THOSE are the cases we should be demanding answers from the government on.

The Poling family has requested that their daughters case files can be made public so everyone can know the reasoning behind HHS's decision, but HHS isn't sharing any of their insight into WHY Hanna deserves a million 20 million bucks for her vaccine injury.

So let's not boil this debate down to scientist v. tv stars. There are MANY in the scientific and public health community who believe that vaccines are involved in the autism epidemic.

And apparently HHS itself does too because it keeps paying claims for autistic kids.

Please take a moment and check out the VICP's vaccine injury table for yourself. You will note that "encephalopathy" is listed as a compensated injury for DTaP and MMR.

Then scroll down to the middle of the page and look at the symptoms of encephalopathy for 18 month olds:

1. Loss of eye contact
2. Unresponsive to stimuli except for loud shouts
3. Seems disconnected from the world around him

THAT is a description of a child with "autism".

THAT was a description of MY son after his DTaP shot for which he was diagnosed with "autism".

The government has ruled that vaccines do and do not cause autism. Are You ok with that solid, definitive, case closed argument?

I REALLY hope not.

It is time for HHS to make the Poling documents public, and to answer to the public for their untenable, illogical position.

June 23, 2008

Sharyl Attkisson Reports on the Governmnets "See No Evil" Behavior

CBS is catching on to the fact that the government does not ask the questions that one would naturally ask if they actually wanted to know if and how vaccines cause autism.

And she correctly points out that the question of "Do vaccines cause autism" is now off the table with the Hannah Poling case. The question now in play is "How to vaccines cause autism".


Vaccine Watch
by Sharyl Attkisson
June 19, 2008, 10:34 AM
(AP)

After a decade of denying any possible association between vaccines and autism, the government quietly settled a vaccine-autism case last fall. When news of the case leaked out to the public months later, government officials labelled the case of Hannah Poling an "anomoly." The truth is, nobody is in a position to know whether Hannah's case is an exception. Government officials have told CBS News that they have not tracked vaccine-autism claims to see how many of them might involve children with the same undetected mitochondrial disorder Hannah had... one that may have made her susceptible to side effects from vaccines, triggering her autism. Government officials have also acknowledged to CBS News that they haven't looked for common denominators in other autism-related cases which have been compensated in federal vaccine court. Yes, there are other cases that have been paid. As CBS News has reported, the government has been settling vaccine injuries that resulted in autism and/or autistic symptoms since at least the early 1990's, while at the same time telling the public there is no cause for concern. Not all of the cases are published, but some of them are and can be found by searching legal case databases. That... with the help of some well-placed sources... is how CBS News turned up at least nine more cases... and counting. Considering that only a tiny fraction of vaccine-autism claims find their way to the little-known vaccine court, these cases are just a sampling of the total that may actually exist in the population. Further, according to knowledgeable sources, vaccine injuries compensated in the past due to encephalopathy (or brain damage) "often" resulted in autism, but the autism label was not used. Again, the government does not track how many of the encephalopathy cases involved children who got autism or ADD after their vaccinations.

One important factor is often lost in the discussion of a handful of cases: the fact that the debate has shifted from whether vaccines have any relationship to some cases of autism... to what is the role of vaccines in some cases of autism. And how big is the pool of cases. If vaccines can trigger autism in any way, directly or indirectly, that contradicts all the rhetoric and dogma heard from many public and government health officials for the past decade. And it supports what many other researchers have been saying for a decade, often to deaf ears, even after they published in peer-reviewed scientific journals.

Which is probably why Hannah's case is resonating under the radar in the medical community. A government conference has now been scheduled for later this month to examine mitochondrial disorders like hers and autism or neurological "triggers" (i.e. vaccines). See below.

Workshop

Mitochondrial Disorders of Childhood: Testing, Potential Relationships to Autism Spectrum Disorders, and Triggers for Neurological Deterioration June 29, 2008

Workshop Goals and Objectives

"Mitochondrial Disorders of Childhood: Testing, Potential Relationships to Autism Spectrum Disorders, and Triggers for Neurological Deterioration" is a workshop to be held on Sunday June 29th after the close of the United Mitochondrial Disease Meeting in Indianapolis at the Hyatt Regency Indianapolis. The workshop will convene 11 experts in mitochondrial disorders or autism to discuss how the neurology of mitochondrial disorders might inform autism research.

The conference is sponsored by a number of Federal agencies including DHHS, CDC, FDA, NINDS and NIMH. Observers are welcome as seating allows.

Location

Hyatt Regency Indianapolis

April 10, 2008

US News and World Report Gets Reasonable

Dr. Healy ends with a great point about the IOM 'show's over, nothing to see here, move along decision'. It is almost like the IOM didn't want our advance our understanding.

UPDATE: Dan Olmsted's comments from AOA:

"More and more mainstream experts are standing up for the vaccine court and Hannah Poling and her parents -- and deserve our thanks and support. The latest is Dr. Bernadine Healy. Her bio from U.S. News & World Report, where the article we're pointing out is appearing in the current issue: "Dr. Bernadine Healy is Health Editor for U.S.News & World Report and writes the On Health column. She is a member of the President's Council of Advisors on Science and Technology and has served as director of the National Institutes of Health and president and CEO of the American Red Cross."

Here's the beauty part from her column: "Pediatricians were concerned enough about mercury, which is known to cause neurological damage in developing infant and fetal brains, that they mobilized to have thimerosal removed from childhood vaccines by 2002. Their concern was not autism but the lunacy of injecting mercury into little kids through mandated vaccines that together exceeded mercury safety guidelines designed for adults."

So by definition, the former head of the NIH says people like Paul Offit -- who calls it a mistake to take mercury out -- and organizations like the CDC, the World Health Organization and their ilk who are keeping mercury in flu shots in the U.S. and in standard immunizations around the world ... the former head of the NIH says they're lunatic(s).

That's about as harsh as anything we've ever said, isn't it? -- Dan Olmsted"

Fighting the Autism-Vaccine War
US News and World Report
By Bernadine Healy M.D.
Posted April 10, 2008

One of the most vitriolic debates in medical history is just beginning to have its day in court—vaccine court, that is. Without laying blame, the independent Office of Special Masters of the Court of Federal Claims—with a 20-year record of handling vaccine matters—recently conceded that the brain damage and autistic behavior of Hannah Poling stemmed from her exposure as a toddler to five vaccinations on one day in July 2000. Two days later, she was overtaken by a high fever and an encephalopathy that deteriorated into autistic behavior. Even though autism has a strong genetic basis, and she has a coexisting rare mitochondrial disorder, I would not be too quick to dismiss Hannah as an anomaly.

At some level, the decision was a vindication for families who have been battling with the vaccine community, arguing that some poorly understood reaction to components of vaccines or their mercury-based preservative, thimerosal, could cause brain injury. Yes, vaccines are extraordinarily safe and bring huge public health benefit. (Remember the 1950s polio epidemics?) But vaccine experts tend to look at the population as a whole, not at individual patients. And population studies are not granular enough to detect individual metabolic, genetic, or immunological variation that might make some children under certain circumstances susceptible to neurological complications after vaccination.

A trigger? Families are not alone in searching for a trigger that might explain why autism and autism spectrum disorders have skyrocketed; now they reportedly affect about 1 in 150 kids. No doubt some of the increase is soft, due to broader diagnostic criteria, greater awareness, and—now that the notion of a detached "refrigerator" mom as a cause has blessedly fallen by the wayside—greater openness. But the rise of this disorder, which shows up before age 3, happens to coincide with the increased number and type of vaccine shots in the first few years of life. So as a trigger, vaccines carry a ring of both historical and biological plausibility.

Go back 40 or 50 years. The medical literature is replete with reports of neurological reactions to vaccines, such as mood changes, seizures, brain inflammation, and swelling. Several hundred cases of the paralytic illness Guillain-Barré after the swine flu vaccine were blamed on the government and gave Gerald Ford heartburn—but eventually led to the vaccine court.

Pediatricians were concerned enough about mercury, which is known to cause neurological damage in developing infant and fetal brains, that they mobilized to have thimerosal removed from childhood vaccines by 2002. Their concern was not autism but the lunacy of injecting mercury into little kids through mandated vaccines that together exceeded mercury safety guidelines designed for adults. But as in all things vaccine, this move too was contentious. Both the Centers for Disease Control and Prevention and the World Health Organization remain unconvinced that thimerosal puts young children at risk.

There is no evidence that removal of thimerosal from vaccines has lowered autism rates. But autism numbers are not precise, so I would say that considerably more research is still needed on some provocative findings. After all, thimerosal crosses the placenta, and pregnant women are advised to get flu shots, which often contain it. Studies in mice suggest that genetic variation influences brain sensitivity to the toxic effects of mercury. And a primate study designed to mimic vaccination in infants reported in 2005 that thimerosal may clear from the blood in a matter of days but leaves inorganic mercury behind in the brain.

The debate roils on—even about research. The Institute of Medicine in its last report on vaccines and autism in 2004 said that more research on the vaccine question is counterproductive: Finding a susceptibility to this risk in some infants would call into question the universal vaccination strategy that is a bedrock of immunization programs and could lead to widespread rejection of vaccines. The IOM concluded that efforts to find a link between vaccines and autism "must be balanced against the broader benefit of the current vaccine program for all children."

Wow. Medicine has moved ahead only because doctors, researchers, and yes, families, have openly challenged even the most sacred medical dogma. At the risk of incurring the wrath of some of my dearest colleagues, I say thank goodness for the vaccine court.

March 11, 2008

Dr. Poling Responds To Autism/Vaccine Nay Sayers

Dr. Stephen Novella on his blog NeuroLogica has posted his evaluation of the Poling case and why he believes it does not support the vaccine autism connection.

Dr. Jon Poling has responded as seen on The Age of Autism countering the arguement and expanding on the information that has been available publicly on the case.

It is a discussion between two neurologists and I will need to read them each 5 times before I can even begin to comment on the conversation.

But I will note two things.

First, I am impressed that Dr. Poling lists his potential conflicts of interest at the end of his letter. I think that every medical professional should do that as a part of their signature (For example I would sign Ginger Taylor, B.S., M.S., Mother of regressive autistic child who suspects vaccines had a causal relationship to ASD, Has Google Ads on her autism blog).

Second, for all of his in depth analysis of the medical facts in this case, Dr. Novella failed to correctly discern the sex of the child in question. He refers to Hannah several times as "he" and "the child", never as a female. He criticizes David Kirby's articles about the case, but did not read them thoughtfully enough to see that Mr. Kirby was clearly talking about a girl.

I will reserve this space for further comment as I come to understand this case further.

I will post both pieces:

Has the Government Conceded Vaccines Cause Autism?
Published by Steven Novella

No. But David Kirby and other anti-vaccinationist ideologues and members of the so-called mercury militia would like you to think so. For background, the Autism Omnibus refers to a set of hearings before the Vaccine Injury Compensation Program regarding claims by about 5000 parents that their childrens’ autism was caused by vaccines. These claims are primarily based upon the various hypotheses that the MMR vaccine, or thimerosal in some vaccines (but not MMR), or the combination of both, is a cause of autism.

So far there have been hearings, but only one final decision. In November the US government settled one case in favor of the petitioner. This is the case those who have supported the failed hypothesis that vaccines cause autism now point to as admission that they were right all along (or at least as a means of stoking the flames of fear about vaccines.) But the US government did not admit vaccines cause autism - they conceded one case that is highly complex and not necessarily representative of any other case and cannot be reasonably used to support the vaccine/autism connection.

David Kirby, author of Evidence of Harm, wrote a highly misleading article the other day in the Huffington Post on this issue. Orac has already done an excellent job of tearing down Kirby’s claims. He points out that legal cases are often decided for legal - not necessarily scientific - reasons. That the government only conceded that “compensation is appropriate.” That is all - they conceded nothing about the larger question of vaccines and autism. Orac also points out that if this case were a concession of a connection why would the petitioner’s lawyers settle and give away a case that could win them all their other cases?

David Kirby has also written a follow up article, where he publishes verbatim the US government’s decision. Kirby asks his readers:

If you feel this document suggests that some kind of link may be possible, you might consider forwarding it to your elected representatives for further investigation.

But, of course, if you feel that this document in no way implicates vaccines, then let’s just keep going about our business as usual and not pay any attention to all those sick kids behind the curtain.

I think Kirby is hoping that most people will not have the patience or medical background to read and understand the entire document, and that they will come away with a vague notion that there must be something to all this vaccine fear-mongering. What does the document really tell us?

To summarize the case history, the child in the case appeared normal and healthy, except for chronic otitis media, until about 20 months of age at which time he had a series of vaccines according to the routine vaccination schedule. Two days later the child had a fever to 102.3, was lethargic, irritable, and would arch his back when he cried. The child then developed a rash. It was later determined that the child had: “encephalopathy progressed to persistent loss of previously acquired language, eye contact, and relatedness.” The child regressed and developed symptoms similar to those of autism spectrum disorder. However, the child does not have autism - he has a regressive neurological disorder that includes blood and muscle abnormalities not seen in autism, and any clinical resemblance to autism is not a reflection of a common cause.

Six years after symptoms began the child also developed partial temporal lobe epilepsy that required treatment.

During this time the child also had an extensive workup, which discovered:

A CSF organic acids test, on January 8, 2002, displayed an increased lactate to pyruvate ratio of 28,1 which can be seen in disorders of mitochondrial oxidative phosphorylation.

A muscle biopsy test for oxidative phosphorylation disease revealed abnormal results for Type One and Three.

In February 2004, a mitochondrial DNA (”mtDNA”) point mutation analysis revealed a single nucleotide change in the 16S ribosomal RNA gene (T2387C)

It if often difficult or impossible to draw firm conclusions from a single case, so I will lay out what I see as all the possible alternative hypotheses to explain this information.

1) One possibility is that the child was perfectly normal prior to the vaccines, which caused an encephalitis (inflammation of the brain) which caused brain damage, including the later seizures. The metabolic disorder and mutation may be a red herring and have no bearing on the child’s clinical condition.

2) The mitochondrial disorder predisposed the child to have a reaction from the vaccines, resulting in encephalitis. The subsequent neurological regression was due to some combination of the vaccine-induced encephalitis and the underlying mitochondrial disorder.

3) The child’s mitochondrial mutation is the primary cause of their neurological regression, but that this regression was exacerbated by the vaccine-induced encephalitis (this seems to be the US government’s conclusion).

4) The child has a mitochondrial encephalopathy which is the sole cause of all of the child’s neurological signs and symptoms. The reaction to the vaccines may have played no role at all in the subsequent regression, and the child’s current neurological condition is exactly what it would have been had they never been vaccinated. It is even possible that the encephalitis was merely the first manifestation of the mitochondrial disorder and the timing after the vaccines was merely coincidental.

That lays out the spectrum of possibilities in this case. At this point in time we do not have (or at least I am not privy to) sufficient scientific information to say definitively where along this spectrum the truth lies. The US government’s decision was based partly on this uncertainty - erring on the side of compensating the child and family.

But we can discuss the plausibility of each scenario. Kirby dismisses anything resembling option 4, but his dismissal is naive and unjustified. In fact the patient’s clinical syndrome resembles what is called a mitochondrial encephalopathy - with increased lactic acid, abnormal muscle biopsy, neurological regression, appropriate age of onset, even seizures. It is probably not a coincidence that the child has a point mutation in a gene that has been previously linked to these very mitochondrial disorders. Kirby incorrectly argues:

While it’s true that some inherited forms of Mt disease can manifest as developmental delays, (and even ASD in the form of Rhett Syndrome) these forms are linked to identified genetic mutations, of which T2387C is not involved. In fact little, if anything, is known about the function of this particular gene.

This is misleading. Kirby refers to “this particular gene” which makes me think that he believes T2387C is a gene. It’s not - it describes a point mutation (at location 2387 a thymidine has replaced a cytosine). The gene is the 16S ribosomal RNA gene. Mutations in this gene have been identified to cause mitochondrial encephalopathy. So Kirby is just wrong. It is true that I could not find that this specific mutation has been identified before, but that is common in genetics - a disease is linked to point mutations in a specific gene (or perhaps specific regions of a gene) but most or all families identified have their own specific mutation.

This makes option 4 very plausible - it would be an incredible coincidence if this child just happened to have a mutation in a gene that was known to cause their exact constellation of neurological signs and symptoms and yet the mutation was not the sole or primary cause of those symptoms.

But it does not rule out option 3 - that the mitochondrial disorder was the primary cause of the child’s neurological disorder but that a reaction to the vaccines worsened the ultimate symptoms. Therefore the government’s decision was reasonable - but is absolutely not a concession about any claim made by the petitioners concerning a link between vaccines an autism.

It does, however, make any hypothesis resembling option 1 or 2 extremely unlikely. Further testing regarding the physiological effects of this child’s specific mutation would be helpful, and such testing may be under way but I could find nothing published to date. It is theoretically possible that the identified mutation does not cause a change in the gene product or mitochondrial function, and is therefore just a coincidence. But this is unlikely given the clinical features in this case are a good match to known mutations of that gene.

Kirby, however, apparently wants to wring as much fear and confusion out of these events as he possibly can. So now he speculates wildly that maybe children diagnosed with autism really have this mitochondrial disorder combined with vaccines (he has to keep vaccines in the loop). Given the rarity of such mutations, and the fact that there were specific features in this case that would likely be uncovered in the routine evaluation of a child with autism (like an elevated lactic acid), it is highly unlikely that there are many children with vaccine-triggered mitochondrial encephalopathy mimicking autism out there.

It has been found that some children with autism have mitochondrial dysfunction - one study found that 7.2% of subjects with autism had “definite mitochondrial respiratory chain disorder.” Poling et al, in response to this child’s case, did a retrospective study of children with autism and with other neurological disorders and found that “Aspartate aminotransferase was elevated in 38% of patients with autism compared with 15% of controls.” Such findings are preliminary - the only conclusions that can be drawn is that the association between autism and metabolic disorders requires further investigation. However, these studies did not look at the incidence of suspicious mitochondial mutations in autism, and these findings may not be relevant to this case.

Kirby also wildly speculates that perhaps the evil toxins in vaccines caused the mutation in the first place. He writes:

Use of the AIDS drug AZT, for example, can cause Mt disorders by deleting large segments of mitochondrial DNA. If that is the case, might other exposures to drugs or toxins (i.e., thimerosal, mercury in fish, air pollution, pesticides, live viruses) also cause sporadic Mt disease in certain subsets of children, through similar genotoxic mechanisms?

Among stiff competition, this is perhaps the most absurd and scientifically ignorant thing Kirby has every written. AZT does NOT cause a genetic disorder. AZT blocks DNA replication (it blocks the copying of DNA) - that is its mechanism as an anti-retroviral drug. In patients it can also block mitochondrial DNA replication, thereby causing mitochondrial depletion. This results in there being too few mitochondria (the energy factories of cells) in some cell populations and causes dysfunction in tissue that is especially susceptible to the effects of this dearth of mitochondria. This is a side effect of AZT and also other retrovirals because of sustained use at doses designed to inhibit DNA replication. This does result in some effects that are similar to mitochondrial genetic disorders - because both result in insufficient mitochondrial activity. But that is the only similarity. AZT does not cause a disseminated somatic mutation, which is the incredible analogy that Kirby is making.

What Kirby is suggesting is that in infants and toddlers toxins can cause the same point mutation in millions of different cells throughout the body. Toxin-induced mutations do not cause genetic diseases, unless they occur in a germ cell in which case a mother or father can pass the mutation onto their children. If it occurs in the womb then large cell populations may be affected (whatever cells derive from the cell that had the mutation). But in a child a point mutation would affect only one cell and any cells that derive from it. A toxic mutagen would cause different random point mutations in different cells. This could not cause the mitrochondrial encephalopathy in this child. It can increase the risk of cancer, because cancer can develop from a single mutation in a single cell that causes it to become neoplastic.

Conclusion

This is a unique and idiosyncratic case that raises more questions than it answers. In my opinion as a neurologist, with the information provided, the child has a mitochondrial encephalopathy. The role of the vaccines is unclear, but at worst a rare vaccine reaction exacerbated the underlying mitochondrial disorder. This case has no clear implication for the larger question concerning vaccines and autism, which is likely why both sides agreed to settle.

Yet those who insist, despite the evidence, on claiming that vaccines or mercury are linked to autism are likely to add this permanently to their litany of misinformation and fear-mongering.

Note: I am searching for any follow up information pertinent to this case and will post any addendum here.



DR. JON POLING TO DR. STEVEN NOVELLA ON AGE OF AUTISM

PolingsBy Dr. Jon Poling, father of Hannah Poling.

OPEN LETTER TO DR. STEVEN NOVELLA
IN RESPONSE TO "Has the Government Conceded Vaccines Cause Autism?"

Dr. Novella,

Thank you for generating interesting discussion regarding my little girl, Hannah Poling. I would like to give you additional information in order to generate further productive discussions on this matter amongst the neurology community. This information should assist you, Dr. DiMauro, and Dr. Trevethan, who have also commented publicly, to formulate better theories as to the significance of Hannah’s mitochondrial dysfunction in relation to her autism.

1. Mito Dysfunction or Mito Disease? Chicken or Egg?

To begin with, I would like to point out that the spectrum of mitochondrial dysfunction is probably considered more broad and complex than the spectrum of neurobehavioral abnormalities seen with autism. Dysfunction of the mitochondria, specifically dysfunction of the oxidative phosphorylation pathway, most likely contributes, but may not be the cause of many diseases—including Parkinson’s disease, Friedreich’s Ataxia, Alzheimer disease, etc. Thus, it is probably incorrect to refer to mitochondrial dysfunctional and mitochondrial disease interchangeably. Indeed, the role of the dysfunctional mitochondrial are yet to be clarified in these diseases. Thus, I will refer to Hannah’s metabolic condition as a mitochondrial dysfunction, not a mitochondrial disease.

2. Mito Genetic Finding? Mito mtDNA ‘red herring’ ?

ADDITIONAL GENETIC TESTING NOT AVAILABLE IN THE J CHILD NEUROL CASE REPORT: Dr. Shoffner performed genetic testing on both Hannah’s muscle and her mother’s leukocytes subsequent to our case report. Hannah (muscle mtDNA) and her mother (leukocyte mtDNA) were both found to be HOMOPLASMIC for the mtDNA T2387C transition mutation.
Our analysis of this genetic finding in the mtDNA was significantly different than those of other physicians that I’ve seen in scientific blogs or commentary. I suspect it would have been fatal to both Hannah and her mother if this homoplasmic mutation was pathogenic since (as I am sure you are aware) the mutation is on the 16S ribosomal subunit which is highly conserved. Thus, this mutation probably represents a benign polymorphism rather than pathogenic mutation. It is unlikely, but possible, that the mutation is significant to Hannah, but in such a case, it must work in concert with other nuclear genes to cause her mitochondrial dysfunction. To our knowledge, this point mutation has not been reported in cases similar to Hannah’s.

3. Encephalitis? Metabolic Encephalopathy? Or “Regressive Encephalopathy with Features of Autism Spectrum Disorder”

The other interesting term you used was encephalitis rather than encephalopathy. We are not sure that she had an “-itis” but we did clearly document a regressive encephalopathy based on not only our parental reporting, but also based on the pediatrician’s documents, affidavits from other family members, and the growth curve measurements (injury pattern). Early on in the regression we did note back arching (opisthotonus), fever, and disrupted sleep. Although fever occurred a lumbar puncture was not performed.

An interesting developing story in autism research is the immune/inflammatory connection. In her senior resident thesis, Dr. Anne Comi, a former JHU colleague, along with Dr. Andy Zimmerman, reported, the increased prevalence of autoimmune disease in families of autistic offspring. Interesting, Hannah also has a maternal family history of autoimmune disease. Dr. Carlos Pardo, another one of my former chief residents, along with Andy and Dr. Vargas, published a beautiful study in the Archives of Neurology, demonstrating neuroinflammation on autopsy of brain samples and inflammation cytokine markers in the CSF of individuals with Autism. The interesting thing was that inflammation was demonstrated in autopsy specimens from adults as old as 44 years of age. The conclusion was that further research would be required to determine if inflammation was a primary disorder in autism or; alternatively, if inflammation and microglial activation was secondary to neurodegeneration. Dr. Sudhir Gupta at UC Irvine has a nice model of how the two pathways of neuroinflammation and mito dysfunction may not be mutually exclusive. This remains to be seen; however, study of mitochondrial dysfunction and neuroinflammation hold the promise of treatment development. The two avenues of research deserve funding at the highest levels.

4. How many Hannah Polings are out there?

The short answer is that nobody knows. However, there is emerging data to suggest that she is not alone.

Dr. Shoffner will be presenting his experience with 37 patients with combined autism and mitochondrial dysfunction at the AAN meeting in Chicago this April. 65% of his referrals are positive for mitochondrial dysfunction. Of course, his yield is subject to referral bias as a mito expert, so the prevalence of mitochondrial dysfunction in Autism is surely less than 65%.

The best estimate to date of the prevalence of mitochondrial dysfunction in autistic patients comes from Oliviera et al. in a population of 120, 5 of 69 (or 7.2%) showed mitochondrial dysfunction. If this is generalized to the US estimate of 1 million patients with ASDs, then the number of kids like Hannah could be 72,000! Isn’t this worth further study?

Dr. Shoffner furthermore advocates, along with us, that vaccination is important even for kids with mitochondrial dysfunction. I would argue that you should not give nine at one time and that none of them should contain Thimerosal (mercury).

5. Thimerosal—On or Off the Table?

I don’t want to dwell on mercury, as this theory is not why HHS conceded Hannah’s case (imo). Dr. DiContanzo just wrote an interesting blog about how his opinion of mercury in vaccines has changed (http://drugs.about.com/b/2008/03/08/mercury-in-vaccines-and-autism-the-burden-of-proof-may-shift.htm).

My opinion is that mercury is a potent neurotoxin. Therefore, don’t inject it into kids! Interestingly, basic research studies have shown that Thimerosal toxicity occurs through mitochondrial pathways. Officials point to the large epidemiology studies as proof that there is no link between thimerosal and autism. However, these studies are not powered to disprove the null hypothesis when considering that the mitochondrial autistic population may be just a small percent of the case totals. Remember that while the CDC sponsored Verstraten study is hyped as a negative study, it DID find a statistically significant increase in childhood tics in those exposed to higher doses of thimerosal.

6. Hannah was destined to regress? Or was she?

Some experts have already stated that ‘mitochondrial disease’ is degenerative so the vaccine reaction was just the start of an inevitable decline. This was neither the opinion of Dr. Richard Kelley at KKI nor Dr. John Shoffner. In fact, the markers that led us down the mitochondrial trail (inc AST but not ALT, low serum bicarbonate, and slight increased CK, increase in the alanine to lysine ratio on PAA) are no longer present. Furthermore, in our pilot study (unpublished but mentioned in the J child neurol paper), Dr. Frye (the statistician for our study and also a child neurologist) found a non-significant trend that AST decreased toward normal with increasing age. With further studies we hoped to examine the hypothesis that this abnormality may be representative of a developing/immature biochemical pathway present in some children.

7. Triple Hit Hypothesis—#1Underlying genetic susceptibility #2Insult must occur during specific developmental period #3 A certain vaccination or combination thereof is the environmental trigger (?vaccine component like thimerosal ?direct immune stim/fever reaction ?live virus reaction?)

The implication is that Hannah’s type of autism requires a genetic susceptibility and properly timed insult to manifest disease. We have not subjected Hannah to another muscle biopsy or re-examined ox phos functional assays that were published in the paper. I can inform your readers though that the serum biochemical markers have resolved, growth resumed and continues along a normal trajectory, and there have been no other episodes of regression since 2000. We are however left with autism and later in 2006, epilepsy.
It is recommended that studies be initiated immediately to screen siblings of cases to identify biochemical markers so as to identify potential screening tests.

I agree with the mainstream that my daughter’s case has raised many intelligent discussions and questions. I’m very proud of her for starting this discussion. Our hope is that further research into this case and others like it, we will be also to find screening tests to prevent what happened to my daughter from happening to anybody else.

(Dr. Poling acknowledges the editorial comments and insightful suggestions of Dr. Richard E. Frye. He also would like to declare his conflicts of interest. First of all, he is the father of Hannah Poling. Dr. Poling has also accepted consultancy or speakers honoraria from Pfizer, Eisai, Ortho-McNeil, Biogen, Teva, Immunex (now Amgen), and Allergan.)

PS While I thought it useful to clarify some of the neurological issues raised by the government's concession of my daughter's case, please understand that I will not be able to respond to individual comments posted. Thank-you. Jon