Come to a TACA Meeting!

TACA holds monthly meetings in many locations throughout the United States that feature educational speakers on important topics and allow family members to connect with one another and stay on top of the latest information in the autism world. Each TACA group maintains a resource library of the latest autism books and tapes that can be checked out by members at no charge.

Check out our group listings: each contains information on TACA meetings and special events as well as a contact form.

Are you wondering what happens at a TACA meeting? Watch our video.

Of the 291.1 million people in the population in 2005, 54.4 million (18.7 percent) had some level of disability and 35 million (12 percent) had a severe disability; of the population aged 21 to 64, 28.1 million people (16.5 percent) had a disability, and 45.6 percent of this group was employed.

The employment rate was 30.7 percent for people with a severe disability, compared with rates of 75.2 percent for people with a non-severe disability and 83.5 percent for people with no disability.

The report is available at: http://www.census.gov/prod/2008pubs/p70-117.pdf

Awareness and detection have grown over the years, but is that the whole story? It’s an issue made timely by insurance debate

By Marshall Allen

The disorders are difficult to identify in children because there is no biological test to confirm their presence. Thus, “autism spectrum disorders” emerge as an ominous specter during early childhood years. An autistic child may respond to the sound of a refrigerator, but not his mother’s voice. He may stare off into space, but never make eye contact with his sister. His senses may by hypersensitive, to the degree that he throws tantrums around bright lights or loud noises.

Identifying the disorders is complicated by the fact that they share characteristics ‹ often causing an impairment in socialization ‹ but don’t share the level of severity. A child with Asperger syndrome may look and sound normal but be unable to recognize social cues, while a severely autistic child may be totally unable to speak.

In hindsight, the signs are clear. But in the course of discovering the problems they are muddled. It can take years before parents realize a child has an autism-related developmental disorder, though experts say it can be reliably diagnosed by age 3.

Once the disorder is diagnosed, early intervention is essential to ensure a child’s development isn’t stunted. Usually this takes the form of occupational and speech therapy that may cost parents tens of thousands of dollars a year out of pocket.

Democrats in the Nevada Assembly introduced a bill this week that would require insurance companies to cover the cost of therapy. Similar legislation has passed in other states. Insurance companies complain that providing autism coverage would increase premiums, which may prompt some employers to stop providing insurance.

Autism spectrum disorders have received increased national attention as their diagnosis has increased. When autism was first described, in 1943, it was assumed that it was a low-incidence disorder, and initial studies in the 1960s suggested the disorders affected perhaps five in 10,000 children, said Catherine Rice, director of the Center for Disease Control and Prevention’s national center for birth defects and developmental disabilities.

In the early years, however, only severely impaired children were placed in the autism spectrum. As researchers have learned more about the diseases, they have broadened the definition of what qualifies as an autism spectrum disorder - and today studies suggest about one in 150 children have some type of autism spectrum disorder.

So are there more autistic children, or is the broadening definition causing more children to be classified as autistic?

It’s impossible to say for sure, Rice said. Awareness of autism is increasing, which leads to more effective identification, but it’s also possible that it’s increasing. Even with the more inclusive definition, the number of autistic children seems to be on the rise, Rice said.

It’s not known what causes autism.

Researchers say environmental factors could contribute to the onset of the disorders. Studies have linked autism to air pollutants, pesticides, pet medications and even drugs used in the birthing process, such as Pitosin, Rice said.

“It could be anything from the exposures in our physical surroundings ‹ chemicals around us in homes, clothes, products, medications we take and food we eat,” Rice said.

Rice said the recognition that environmental factors play a role in causing autism shows that there is common ground in the debate about whether vaccines play a role in the disorders.

“The debate has been more polarizing than it is in reality,” Rice said. “Hopefully there is common ground in recognizing that autism is more complex. It’s not going to be solely explained by biology or genetics or a single environmental cause.”

Child with PDD-NOS (Autism Spectrum Disorder) Compensated for Damage from the MMR Vaccine

TACA statement prepared by: Rebecca Estepp
Contact # (949) 640-4401

February 25, 2009

Who is Bailey Banks?

Last night the world learned of another child, Bailey Banks, (who is on the Autism Spectrum) has received compensation under the National Vaccine Injury Compensation Program. Robert F. Kennedy, Jr. and David Kirby reported on Bailey’s explosive story in the Huffington Report. Read their stories.

The history of Bailey Banks’ case

In June of 2007, Special Master Richard Abell ruled that Bailey, now age 10, should receive compensation for an injury he received from a MMR vaccine administered when he was a toddler. Special Master Abell concluded that the evidence presented in court demonstrated that Bailey suffered from a brain inflammation illness called Acute Disseminated Encephalomyelitis (ADEM). ADEM had been linked to the MMR vaccine in previous cases and it was linked again in Bailey’s case. The Special Master then determined from the testimony heard in court that ADEM could ultimately result in Pervasive Developmental Delay—Not Otherwise Specified, commonly referred to as PDD-NOS. Read the ruling here.

Is PDD-NOS Autism?

According to the National Institutes of Mental Health (NIMH) – yes. For a description from their resource materials here is how NIMH describes Autism Spectrum Disorders:

What are Autism Spectrum Disorders?

Autism Spectrum Disorders (ASD), also known as Pervasive Developmental Disorders (PDDs), cause severe and pervasive impairment in thinking, feeling, language, and the ability to relate to others. Read reference.

This sounds familiar, why?

Last year at this time, we learned about a little girl named Hannah Poling. Hannah’s vaccine injury case was conceded by the Department of Health and Human Services. Hannah was awarded compensation without going to trial, presumably because the evidence was so great that her routine vaccinations contributed to her autistic-like symptoms that there was no other choice but to award compensation. The Concession Report declared that Hannah had an underlying mitochondrial condition which contributed to her “autistic-like” symptoms.

Is Bailey Banks’ case different than Hannah Poling’s?

Yes. It is important to point out that Bailey Banks’ case was a decision, not a concession. In this case, there was a trial. Following the trial there was a ruling that gave this little boy over $810,000 for his care over his lifetime.

Is the cause of these two children’s condition the same?

Yes and no. As stated above, Hannah received a concession under the hypothesis that her vaccines aggravated an underlying mitochondrial disorder which caused “autistic-like” symptoms. Bailey Banks’ received a favorable ruling under the hypothesis that the MMR vaccine caused his ADEM condition which triggered his development to be significantly altered and manifest into PDD-NOS. So yes, vaccines were linked to these children’s conditions but Hannah’s involved mitochondrial problems and Bailey’s involved brain inflammation. These are two different mechanisms of injury.
For more information on Hannah’s case – please see these links:

• Hannah Poling Case - Significance for Families

• Hannah Poling Concession Analysis

Was Bailey Banks’ case in the Omnibus Autism Proceedings (OAP)?

No. Bailey’s case was heard in vaccine court but his attorney opted out of the OAP. It was a stand alone case that was not lumped into the 5300 cases in the OAP.

Why not?

For a very unfortunate situation—a vaccine injury, Bailey had something very fortunate occur. His parents were able to obtain a MRI several days after his MMR adverse reaction which determined that Bailey had sustained a brain injury. This evidence set Bailey’s case apart from the other thousands of families in the OAP.

On the front page of the Bailey Banks’ decision the term “non-autistic developmental delay” is used, what does that mean?

My son was diagnosed on the autism spectrum almost nine years ago, since that day I have lived and breathed everything autism and its related disorders. Until today, I have never heard of “non-autistic developmental delay.” From this statement, I googled the term. I got13 hits. Half of the “hits” were from Robert F. Kennedy and David Kirby’s Huffington Post. A couple of other entries were from Bailey’s Court decision. One or two were from obscure academic papers that I have never heard of. I am beginning to think that “non-autistic developmental delay” is much like Hannah Poling’s “autistic like symptoms” that was stated in her concession report from the court. In Hannah’s case, the court would not link her autism to the vaccines she received. The court would only link her “autistic like symptoms” to her vaccines. As a parent of a child with autism, I learned long ago that there is no genetic test for autism, there is only a list of symptoms. If your child has those symptoms, your child has autism. The court split hairs on that statement and it really outraged the Autism Community. Mark Blaxill wrote a fantastic article about this very subject. Read it here.

No link to Vaccines & Autism

While the press and several vocal scientists continue to quote there is no link between autism and vaccines, we encourage individuals to continue to do their own research. There appears to be a pattern in a susceptible group of children receiving adverse reactions to their vaccines leading to regressive autism.
Medical abstracts that review the link of autism and vaccine injuries including other co-morbid features often found in children affected by autism can be found at these links:

• Medical Studies About the Autism-Vaccine Link

• Autism Studies and Related Medical Conditions

So what does this Bailey Banks decision mean?

Here is the significance as I see it: In the past year, we have learned of five outcomes from the Vaccine Court. Hannah Poling’s case was conceded. Bailey Banks’ case was decided in his favor. Then we have the Cedillo, Snyder and Hazlehurst cases that were ruled in favor of the respondents. The scoreboard is currently set at:
Vaccines leading to autism theory = 2
Vaccines not leading to autism = 3

This is a close game. And as I ended my last statement, this fight is not over.

Related TACA Links for Families

Vaccine Choices:

• Vaccine Choices

• Greening Vaccines Program

Omnibus Hearings

One of the little-noticed reasons that Wyeth was attractive enough to command a $68 billion price for rival Pfizer Inc.'s planned takeover sits in a building catty-corner from the White House across Pennsylvania Avenue. That is where a special "vaccines court" hears cases brought by parents who claim their children have been harmed by routine vaccinations.

The court -- and the law that established it more than two decades ago -- buffers Wyeth and other makers of childhood-disease vaccines from much of the litigation risk that dogs traditional pill manufacturers and is an important reason why the vaccine business has been transformed from a risky, low-profit venture in the 1970s to one of the pharmaceutical industry's most attractive product lines today.

The legal shield, known as the National Childhood Vaccine Injury Compensation Program, was put into place in 1986 to encourage the development of vaccines, a mainstay of the nation's public-health policy. A spate of lawsuits against vaccine makers in the 1970s and 1980s had caused dozens of companies to get out of the low-profit business, creating a public-health scare.

The strategy worked and the public-health implications have been sizable. Vaccines have driven huge reductions -- and in the case of smallpox, for instance, complete eradications -- of major childhood diseases. Paul Offit, chief of infectious diseases at the Children's Hospital of Philadelphia, who developed a vaccine for rotavirus with Merck & Co., says, "If that Act didn't happen, I think American children would have been at risk."

Vaccines have also become big business. They are poised to generate $21.5 billion in annual sales for their makers by 2012, according to France's Sanofi-Aventis SA, a leading producer of inoculations. At a time when pharmaceutical companies are being battered by generic competition to their best-selling drugs, vaccines offer an appealing alternative because they are biologic products that can't yet be copied. Another big draw is the partial protection from liability risk offered by the vaccines court, officially known as the Office of Special Masters at the U.S. Court of Federal Claims.

Such immunity makes a product like Wyeth's Prevnar enormously attractive. Designed to protect children against seven strains of pneumoccocal disease, Prevnar had sales of $2.7 billion last year that are projected to grow to $5.5 billion in 2015, according to Sanford C. Bernstein & Co.

Pfizer spokesman Ray Kerins acknowledges that Wyeth's strength in vaccines was an important factor behind Pfizer's interest in the company, but he adds that the deal made sense for a number of other reasons.

Vaccines' transformation into a lucrative business has some observers questioning whether the shield law is still appropriate. Critics say the vaccine court's ruling this month that routine childhood immunizations aren't linked to autism underscored the limited recourse families have in claiming injury from vaccines.

"When you've got a monopoly and can dictate price in a way that you couldn't before, I'm not sure you need the liability protection," said Lars Noah, a specialist in medical technology at the University of Florida's law school who has written about vaccines.

Many plaintiffs' lawyers would prefer to take their lawsuits directly to civil court because the vaccine court limits compensation in death cases to $250,000. They also think that juries could give them a more sympathetic hearing.

Kevin Conway, an attorney at Boston law firm Conway, Homer & Chin-Caplan PC, which specializes in vaccine cases and brought one of the recent autism suits, says the lack of liability for the pharmaceutical industry compromises safety.

"The dire straits of the 1980s do not exist anymore and it calls into question the need for the program, since the ability to sue the pharmaceutical companies would provide a different level of oversight," Mr. Conway says.

Even if they had won their cases, the families of autistic children wouldn't have been paid by the companies that make the vaccines, as is common in other pharmaceutical-liability cases. Instead, the government would have footed the bill, using the funds from a tax levied on inoculations.

The pharmaceutical industry, for its part, argues that the vaccine shield is still necessary. "The Act remains an important and relevant protection against baseless litigation that may dissuade parents from having their kids receive important vaccines," says Wyeth's outside counsel for vaccine litigation, Daniel Thomasch, of Orrick, Herrington & Sutcliffe LLC.

Mark Feinberg, vice president for medical affairs and policy at Merck's vaccine division, says companies need the government's protection to shoulder the risk of pricey clinical trials. "Today, there are a number of important infectious diseases that don't have vaccines," he says. "The program does provide clarity for manufacturers as they go forward with new development."

To be sure, the vaccine court has been friendly to some plaintiffs. About $970 million has been awarded in its two decades of existence, and 12,890 cases have been filed. The court has relaxed standards about which witnesses and evidence can be admitted, because its judges -- called special masters -- are better equipped to navigate dubious science than a jury.

And injured parties can still sue vaccine makers in civil court if they reject the vaccine court's decision, if the court dismisses the claim or if the claim is stalled in the court for more than 240 days. Rep. Henry Waxman, who introduced the 1986 bill, hails those limits to the liability shield.

"Vaccines are products that are completely different from any others. We need to encourage companies to develop vaccines in order to protect the public health," he says. "The manufacturers have long fought for total immunity from lawsuits, but I have fought back hard to ensure that the law preserves access to courts in cases of true negligence or misconduct." But vaccine suits, when they do get to civil court, face restrictions there on punitive damages and failure-to-warn arguments.

Barbara Loe Fisher, the co-founder of a nonprofit parents' group called the National Vaccine Information Center, says the inclusion of high-priced new vaccines, like Merck's Gardasil, which aren't vital to preventing pandemics, runs counter to the spirit of the original law, which she worked on in the 1980s.

Write to Avery Johnson at avery.johnson@WSJ.com

Incredible... college students asking the questions that members of the press never do...

Students protest flu vaccine

Ball State Daily News, IN

A group of Ball State University students are worried a preservative found in a flu vaccine meant to keep you healthy could lead to harmful side effects.

Tony Farmer, president of Ball State's Truth Movement, has been leading his group in a protest against faculty in the Amelia T. Wood Health Center over the preservative thimerosal. Farmer says multiple studies indicate thimerosal, used in the flu vaccine Fluzone, can lead to Alzheimer's disease and autism.

Farmer believes the evidence found in the study is convincing, but not enough is being done to rid Fluzone of the potentially harmful preservative.

"The problem is, most people don't examine the evidence either because the FDA has convinced them it doesn't exist," Farmer wrote in an e-mail to DayWatch. "Some are putting more trust in their government than in their own eyes."

Fluzone is one of two flu vaccines offered at the Health Center. The other, FluMist, costs $13 more expensive.

We want to know what your experiences are with Fluzone. Have you taken the vaccine from the Health Center? Were you told of the potentially dangerous side effects of thimerosal? What is your opinion about the Truth Movement's protest?

Send us your thoughts to DayWatch editor Ryan Wood at daywatch@bsudailynews.com.

In August and October 2007, Ashley was given doses of Gardasil, a vaccine recommended for adolescent girls to prevent cervical cancer. Her first Gardasil shot was given in conjunction with a meningitis vaccine.

The combination is said to be safe - and is commonly administered - but Gardasil was never clinically tested with the meningitis vaccine.

. . . Ashley didn't receive any other shots with her second dose of Gardasil. It was a month or so after the second Gardasil vaccine that she started getting sick.

"She didn't go to the doctor at all, then after she got the shots, it's boom, boom, boom," Holtman said. "We haven't stopped."

Across the country, there are reports of girls like Ashley becoming chronically ill, and even dying, after being vaccinated with Gardasil - raising questions about whether the vaccine is indeed safe and if there has been enough testing done on its side effects.

As a follow-up to the recent Vaccination Choice Rally in Trenton, a group of parents who believe their children have been injured by vaccines got a chance to meet with Heather Howard of the New Jersey Department of Health and Senior Services (NJDHSS).

The five parents who are also members of the New Jersey Coalition for Vaccination Choice (NJCVC) were invited on Dec. 3 to meet with Howard and seven senior members of her department at the NJDHSS building in Trenton.

Gov. Jon Corzine promised in September to hold the meeting, when he was addressing a large group of parents gathered on NJCVC member Louise Habakus' front lawn in Middletown after attending a Democratic National Committee fundraiser.

Public pressure has been steadily mounting in support of the parental vaccination choice bill currently in the health committees of the state Assembly and Senate.

A260/S1071 would provide for a conscientious exemption to mandatory vaccinations. More than 10,000 people have signed a petition in support of this bill.

The NJDHSS publicly opposes the bill in a statement on its Internet Web site. The department contends that broad exemptions to mandatory vaccination weaken the compliance and enforcement structure mandating vaccines for school entry and continued attendance.

The department states that if parents can waive vaccination requirements, the dissolution sets precedent for other mandatory health screenings or services to become optional. The department also believes that New Jersey has numerous characteristics that make it particularly vulnerable to vaccine-preventable diseases, including a large population, a past history of preventable disease outbreaks, a high number of immigrants, and New Jersey's "corridor state" nature.

The department believes the highest number of children possible should receive vaccines to protect themselves and others due to these characteristics.

The NJDHSS states that all vaccines currently licensed in the United State are safe and effective and that New Jersey only mandates vaccines licensed by the Food and Drug Administration and recommended by the Centers for Disease Control and Prevention, the American Academy of Pediatrics and other government and professional organizations.

The department also contends that many vaccine-treated diseases do not have other effective treatments and that the resurgence of vaccine-prevented diseaseswould cause economic and human costs related to time lost from work, medical care and public health interventions. Finally, the department believes the more exemptions it allows, the more difficult it would be to prevent vaccine-preventable diseases in the state's communities.

New Jersey children who attend any public or private school or day care facility are currently required to have 35 doses of 13 vaccines, including an annual flu shot starting at the age of 6 months. The New Jersey government mandates more vaccines than any other state in the country and is the first government in the world to mandate flu and meningococcal shots.

New Jersey parents currently have two means of objecting to the state's vaccination schedule for children. They can provide a medical exemption from a licensed physician or nurse practitioner that indicates a specific time period in which the child cannot receive specific vaccinations, and reasons for medical contraindication enumerated by the Advisory Committee on Immunization Practices and the American Academy of Pediatrics.

Parents can also seek religious exemption by explaining how immunizing agents conflict with the bona fide practice of their religious tenets.

Parents who violate the vaccination mandate can fall subject to penalties of not less than $50 or more than $1,000, recovered by the state in a civil action in any court of competent jurisdiction.

The proposed conscientious objection bill would give parents the option of objecting to all or some of the mandated vaccines and more control over their children's vaccination schedule.

According to Habakus, the NJCVC considers the flu shot a controversial vaccine because it has never been proven effective and is no better than a placebo for children under the age of 2.

"There are no adequate safety tests performed, in large part because the vaccine must be reformulated annually," she said. "And the vast majority of doses contain 25 micrograms of a devastating neurotoxin— thimerasol."

Habakus said New Jersey should have waited to make its new vaccine mandates, which include the flu shot, to allow time for hearing what the Office of Special Masters of the U.S. Court of Federal Claims finds with regard to recently submitted vaccination research.

"In view of existing and emerging science linking vaccines to neuro-developmental and chronic disease, why wouldn't we err on the side of caution?" Habakus said, referring to nearly 1,000 studies and findings submitted to the court, which administers a no-fault system for litigating vaccine injury claims. Habakus said Howard met with the parents for two hours, and her staff continued the meeting for an additional 30 minutes.

"Our objective for the meeting was to make sure they fully understood not only the reasons behind the profound trust gap that exists between parents and our health department, but the ramifications of this distrust," Habakus said.

"I wanted them to hear, in no uncertain terms, that they are creating the very thing they fear the most — that, faced with an increasing number of vaccine mandates and absolutely no answers and no leadership behind the epidemic of autism and chronic disease facing our children, parents will increasingly abandon vaccines. Faced with all or none, more are choosing none," she said.

The parents showed state officials how many more shots children are given now vs. 25 years ago and noted the increase in chronic, autoimmune and neurodevelopment disorders during precisely the same time frame.

"We reviewed the gross underreporting in Vaccine Adverse Event Reporting System and how it ensures we will always be behind the eight ball in identifying vaccine-related problems," Habakus said. "We shared the government's list of vaccine-related complications for which families are compensated. We used the Physician's Desk Reference to list many dozens of ways to die and be harmed by vaccines."

The parents also discussed disease transmission via live virus vaccines, inappropriate test cohorts for Food and Drug Administration licensure, failure to use true placebos, suitability of using experimental control groups, and the complete absence of studies on carcinogenic, mutagenic potential or the impairment of fertility.

"We reminded them that licensed vaccines are routinely withdrawn, that vaccine makers never adequately studied the simultaneous administration of so many shots, that there has never been any therapeutic benefit to doing so, and that our doctors advise it anyway to increase compliance," Habakus said. "We provided research that links vaccines to diabetes, asthma and anaphylaxis."

The parents also told state officials about Dr. George Lucier, the former director of environmental toxicology from the National Institutes of Environmental Health Sciences, who has conducted research and found that the thimerosal in vaccines causes some cases of autism.

"We reminded them that our government has made massive mistakes in the past, bad drugs are approved, and many people are killed and harmed before they are removed from the market," Habakus said.

The parents also noted that California and Texas, which are also densely populated, have already passed philosophical exemption bills that have not compromised vaccine compliance in those states.

The group asked the state to acknowledge the public health crisis in New Jersey and to commit to working with parents in an open and transparent process to address the trust gap. They asked the NJDHSS to remove its opposition to A260/S1071 and to ask the governor to put his political support behind passage of the bill.

They asked for the repeal of the four new vaccine mandates and for the state to provide informed vaccination consent literature, which would include full discussion of the risks, not just the benefits of vaccines.

The groups also asked the state to initiate and participate in a series of legislative vaccine roundtables that present all sides of the vaccination debate to help educate legislators on the issues. Similar discussions have just started in New York where a similar conscientious objection bill has been presented.

Howard told the group that the dialogue on the issue has begun and that the state's door is open to concerned parents, according to Habakus. The officials said they would not remove their opposition to A260/S1071 or repeal the new mandates, but would evaluate new science regarding vaccines.

Habakus said several of those in attendance voiced support for increased effort behind vaccine education and outreach and for a state-appointed doctor to participate in any vaccine roundtable that is organized.

"The bottom line is that we did not get what we wanted," Habakus said. "The NJDHSS continues with business as usual. Our state appears unwilling to exercise independent judgment to protect the health and welfare of its residents It seems we are more of a test case and an incubator for the Centers for Disease Control and Prevention's agenda. And our instinct remains true. Real change must come from the parents. Are we ready, New Jersey? We have our work cut out for us."

The NJCVC held a series of open houses in Little Falls, Princeton and Summit in an effort to gain more support for the vaccination choice bill, which currently has 38 cosponsors in the Assembly and Senate. Habakus encouraged those in support of the bill to make calls and to write to legislators, as well as signing the petition.

For more information visit the Internet Web site at www.njvaccinationchoice.org.

An English doctor who linked childhood vaccines to autism, "changed and misreported results in his research," reports the London Times.

In 1998, a group led by researcher Andrew Wakefield reported in The Lancet medical journal that eight children out of a dozen who received Measles-Mumps-Rubella vaccinations developed autism symptoms days afterward.

However, investigative reporter Brian Deer says that medical records of the children shows all but one had such symptoms before the shots, and that journal reports of inflammatory bowel disease linked to the shots were untrue.

Measles inoculation rates dropped nationwide in the United Kingdom following the report; two children there last year died of the disease. All of the researchers involved in the study deny misconduct, says the Times. "Through his lawyers, Wakefield this weekend denied the issues raised by our investigation, but declined to comment further."

By Dan Vergano

With the vaccines available in the U.S. today, parents can avoid vaccines preserved with thimerosal (50% mercury) for their newborns and infants. This is not the case with aluminum, which has been linked to impaired neurological development in children.

Aluminum has not replaced thimerosal as a vaccine preservative; it has always been used in vaccines.

Its purpose is to generate an immune response, thus providing a person the ability to produce adequate levels of antibodies to the vaccine being administered. Unlike thimerosal, if aluminum is removed, the vaccine will not work.

In the recent past, most kids got exposed to both thimerosal and aluminum simultaneously with the hepatitis B, Hib, DTaP (diphtheria, tetanus and pertussis) and pneumococcal vaccines. Combining mercury with aluminum increases the likelihood that the mercury will damage human tissue.

While aluminum is in the food we eat at much higher levels, it is not absorbed well through the gastrointestinal tract. When this protective gastrointestinal mechanism is bypassed, aluminum toxicity can cause serious problems.

There are currently eight childhood vaccines that contain aluminum ranging from 125 to 850 micrograms (mcg). These vaccines are administered 17 times in the first 18 months of life, an almost six-fold increase compared to the vaccine schedule of the 1980s.

According to the American Society for Parenteral and Enteral Nutrition, based on IV feeding solutions, a child should not exceed a maximum daily dose of 5 mcg of aluminum per kilogram of weight per day. That means if a child weighs 11 pounds, the child should not exceed 25 mcg in a day. This level was determined to be the maximum safety limit based on a study published in the New England Journal of Medicine titled "Aluminum Neurotoxicity in Preterm Infants Receiving Intravenous Feeding Solutions."

The hepatitis B vaccine, administered at birth, contains 250 mcg.

In a 1996 policy statement, "Aluminum Toxicity in Infants and Children," the American Academy of Pediatrics states, "Aluminum can cause neurological harm. People with kidney disease who build up bloodstream levels of aluminum greater than 100 mcg per liter are at risk of toxicity. The toxic threshold of aluminum in the bloodstream may be lower than 100 mcg per liter."

So let's say an infant receives 1,250 micrograms at 2 months of age (three vaccines). Assuming a child's body contains a half liter of blood, this would put the blood level 25 times higher than the above mentioned levels.

Now people will argue whether an intramuscular injection (such as vaccines) would introduce aluminum into the bloodstream at the same level as an IV feeding solution. Unfortunately, the purpose of direct intramuscular injection is to provide rapid access to the bloodstream. This provides direct access to all target organs such as the brain.

The real eye-opener is a recently published paper where the authors investigated Gulf War syndrome based on the fact that soldiers were getting sick without deployment to the Persian Gulf region. They eventually focused on aluminum used in the anthrax vaccine. Injecting mice with aluminum at levels equal to what the soldiers received induced motor neuron death. The dose, per body weight, given to children easily exceeds what the soldiers received.

One must question whether exposing newborns to aluminum is worth the risk to protect them against a sexually transmitted disease (hepatitis B). If aluminum can cause injury to an adult, combat-ready soldier, what is it doing to newborns?

Michael Wagnitz of Madison is a chemist.

By Dan Olmsted and Mark Blaxill

Dr. Paul Offit of the Children’s Hospital of Philadelphia (CHOP) took home a fortune of at least $29 million as part of a $182 million sale by CHOP of its worldwide royalty interest in the Merck Rotateq vaccine to Royalty Pharma in April of last year, according to an investigation by Age of Autism. Based on an analysis of current CHOP administrative policies, the amount of income distributed to Offit could be as high as $46 million.

There is nothing improper about receiving compensation for a patented innovation; but the extraordinary valuation placed on CHOP’s patents raises concerns over Offit’s use of his former position on the CDC’s Advisory Committee on Immunization Practices to help create the market for rotavirus vaccine -- to effectively vote himself rich.

Offit has steadfastly refused to say how much he made from the vaccine. Based on the income distribution guidelines set forth in CHOP’s current administrative policy manual (HERE) entitled “Patent and Intellectual Property Policy,” Offit’s share of this transaction -- the “inventor’s share of net income” -- would have earned him a personal distribution of 30%. In a Moody’s report dated June 2008, CHOP reported net proceeds from the Rotateq transaction of $153 million, a deal basis that would put the value of Offit’s 30% share at $45.9 million.

Although the royalty transaction amounts and current CHOP inventor shares are publicly known, several factors complicate a precise calculation of Offit’s income. Royalty Pharma paid $182 million for the Rotateq royalty stream, but CHOP reported proceeds of only $153 million. Since most universities calculate income based on net royalties, the lower number might more closely reflect the basis for calculating Offit’s income. If CHOP applied an inventor share of 30% to a transaction value of $153 million they would have then been required to distribute $45.9 million to Offit.

CHOP’s 30% policy for inventor share is consistent with the current practices of other children’s hospitals. But depending on what standard was in effect when the patents were filed and how it was applied to Offit’s proceeds, the amount could be lower. For example, the $29 million difference between the payment made by Royalty Pharma and the proceeds received by CHOP comprises 15.9% of the Royalty Pharma payment (15% is the lowest inventor share percentage we uncovered in our investigation) and could reflect the distribution to Offit,

So although it is clear that Offit’s personal share of CHOP’s royalty transaction was large, the exact amount could range from as little as $29 million to as much as $55 million. Age of Autism chose to feature the smaller amounts in this report.

CHOP spokeswoman Rachel Salis-Silverman, contacted by Age of Autism about Offit’s income from the vaccine, first said, “I don’t even know. That’s not public information.” She initially refused to provide an e-mail to which Age of Autism could send a detailed account of how it determined Offit’s income, but subsequently sent an e-mail saying she was expecting the information.

“We are declining comment to your questions,” she then replied after receiving our inquiry. Offit did not respond to an e-mail sent to his Children’s Hospital address.

While refusing to disclose his personal profit from this transaction, Offit told Newsweek reporter Claudia Kalb last year that he got a “small percentage” of the payment and confessed that “it’s like winning the lottery.”

The $29 million-$55 million range is consistent not only with CHOP’s published royalty arrangements but with typical medical patent standards:

-- At Boston Children’s Hospital, inventors get 25% of “net lifetime revenues” for all income over $500,000. For royalty amounts smaller than $500,000 inventors receive 45-100% of revenues.

-- At Arkansas Children’s Hospital, inventors get 35% of “net royalties” after the first $200K and 50% before that.

-- At the University of Virginia, inventors get 15% of “total royalty income” over $1 million and a sliding scale of 25-50%for amounts smaller than that.

-- At the University of California, inventors get 35% of “net royalties.”

Offit’s claim to a share of the profits from Merck’s Rotateq revenues is based on his role as a listed inventor on the cluster of patents that protect Merck’s vaccine. These patents share the title “Rotavirus Reassortant Vaccine” and include four granted US patents -- US5626851, US5750109, US6113910 and US6290968 — and two granted European patents — EP323708 and EP493575.

All of the patents are jointly owned by CHOP and the Wistar Institute. Offit is one of the three listed inventors on the vaccine patents but holds 100% of CHOP’s inventor rights. The other two inventors, Fred Clark and Stanley Plotkin, are both affiliated with the Wistar Institute (in a December 2005 transaction that was similar to CHOP’s deal with Royalty Pharma, the Wistar Institute sold its royalty interest in Rotateq to Paul Capital for $45 million).

The CHOP policy manual that delineates the distribution of income for inventions owned by CHOP can be found (HERE) (see section III B). Clearly, based on the distribution of income rights outlined in this manual, Paul Offit had a greater personal interest in Rotateq’s commercial success than any other single individual in the world. And more than other individual in the world, he found himself in a position to directly influence that success.
--

Unlike most other patented products, the market for mandated childhood vaccines is created not by consumer demand, but by the recommendation of an appointed body called the Advisory Committee on Immunization Practices (ACIP). In a single vote, ACIP can create a commercial market for a new vaccine that is worth hundreds of millions of dollars in a matter of months. For example, after ACIP approved the addition of Merck’s (and Offit’s) Rotateq vaccine to the childhood vaccination schedule, Merck’s Rotateq revenue rose from zero in the beginning of 2006 to $655 million in fiscal year 2008. When one multiplies a price of close to $200 per three dose series of Rotateq by a mandated market of four million children per year, it’s not hard to see the commercial value to Merck of favorable ACIP votes.

From 1998 to 2003, Offit served as a member of ACIP. Before and during his ACIP term, Offit was involved in rotavirus vaccine development activities, the value of which ACIP influenced. Shortly before his term began in October 1998, Offit’s first two rotavirus patents were granted by the U.S. Patent and Trademark Office, the first on May 6, 1997 and the second on May 12, 1998. During his ACIP term, Offit received two additional patents in 2000 and 2001.

Receiving a patent provides the potential but not the certainty of financial reward. In most cases, when an inventor’s employer receives a patent, the commercial value of the patent award is highly uncertain. In the case of Rotateq, the business uncertainty revolved around three factors: 1) the creation and eventual size of the rotavirus vaccine market, 2) the market share of competing products such as Wyeth’s RotaShield vaccine and 3) the success of Merck’s clinical trial for Rotateq and subsequent FDA approval. For the first two of these three factors, Offit’s ACIP membership gave him a direct opportunity to favorably influence his personal financial stake in Rotateq.

Four months before Offit was appointed to ACIP in October 1998, the committee had voted to give the rotavirus category a “Routine Vaccination” status, in anticipation of an FDA approval of RotaShield (oddly, ACIP made this vote before the FDA approved Wyeth’s RotaShield vaccine on October 1, 1998). Shortly after Offit’s term began, there were several additional votes involved in establishing the rotavirus vaccine market and Offit voted yes in every case. In May of 1999, the CDC published its revised childhood vaccination schedule and rotavirus vaccine was included. This series of favorable votes clearly enhanced the monetary value of Offit’s stake in Merck’s rotavirus vaccine, which was five years into clinical trials.

Nevertheless, Merck’s Rotateq vaccine was several years behind Wyeth’s RotaShield, which stood to be the market leader based on its lead in making its way through clinical trials. But when the widespread administration of RotaShield to infants started producing a high incidence of intussusception reports, including numerous fatalities, ACIP was forced to reverse itself. On October 22, 1999, ACIP voted to rescind its recommendation of the RotaShield vaccine.

Offit recused himself from this vote, although he participated in the discussion. In the meeting in which ACIP discussed RotaShield, Offit remarked, "I'm not conflicted with Wyeth, but because I consult with Merck on the development of rotavirus vaccine, I would still prefer to abstain because it creates a perception of conflict.” CDC records make it clear that Offit was not silent on RotaShield. By 2001, he was actively advancing a “unique strain” hypothesis, an argument that RotaShield was formulated in a way that did increase intussusception risk whereas other formulations (e.g. Rotateq) would not.

In commercial terms, Offit had a clear stake in the earlier RotaShield decision. As a competitor to Rotateq, RotaShield’s withdrawal provided a financial opportunity for Offit’s partner, Merck. Not only did RotaShield’s withdrawal give Rotateq an opportunity to gain 100% of the rotavirus vaccine market Offit had voted to create (until April 2008, when GlaxoSmithKline’s Rotarix vaccine was approved, Merck held a monopoly on the rotavirus vaccine market), but the absence of competition enabled Merck to charge a premium price for its vaccine, significantly more than Wyeth had charged for RotaShield.

With RotaShield out of the market and the favorable rotavirus policy precedent established, when the FDA approved Rotateq on February 3, 2006, the path to profitability for Merck was set. And for CHOP, which had licensed its patent rights to Merck, the valuation of its patent portfolio soared. Faced with this newly valuable asset, CHOP chose not to take their profits in the form of a series of smaller royalty checks. Instead, they opted to sell off their rights to the income stream and receive a lump sum payment in its place. Royalty Pharma -- an intellectual property investment firm that “provides liquidity to royalty owners and assumes the future risks and rewards of ownership” -- stepped in to pay CHOP for the rights to its Merck royalties. CHOP, in turn, paid Offit his inventor share. Although neither CHOP nor Merck has disclosed Merck’s royalty obligation around CHOP’s patents, the fact that Royalty Pharma was motivated to pay CHOP $182 million for the right to receive the Rotateq royalty stream suggests that obligation was significant.

Other news organizations, most notably CBS News, have asked Offit to disclose the financial details of his Merck relationship. CBS New reporter Sharyl Attkisson wrote last July that, “future royalties for the [Rotateq] vaccine were just sold for $182 million cash. Dr. Offit's share of vaccine profits? Unknown.”

Offit protested loudly over the CBS News report and went so far as accusing Attkisson of unethical conduct. “Did [Attkisson] lie about whether or not we provided materials? Of course,” Offit claimed in an August interview with the Orange County Register. He argued that in responding to a CBS News investigation of his financial ties to Merck, he readily provided full details of the payments that CBS asked for including: “the sources and amounts of every grant he has received since 1980”; “the details of his relationship, and Children’s Hospital of Philadelphia’s relationship, with pharmaceutical company Merck”; and “the details of every talk he has given for the past three years.”

A personal profit of at least $29 million seems like more than a small detail to leave out.

--
Dan Olmsted is Editor and Mark Blaxill is Editor At Large of Age of Autism.

Jay Gordon, MDPediatrician

It took fifty years before the courts finally acknowledged that cigarette smoking causes cancer.

There were billions of dollars at stake.

The dozens of court decisions that there "was no proof" were supported by physicians, expert witnesses of all types and hundreds of millions of dollars spent on attorneys.

Experts and doctors alike stated over and over again that we need not continue studying this issue because there was just no proof.

Let me state very simply, vaccines can cause autism.

No real scientist would encourage us to stop studying this possibility.

The proof is not there yet. It will be found. Let's hope it doesn't take another fifty years and hundreds of court cases to convince the government and the public. Private industry is once again duping the FDA, doctors and the public. The conflicts of interest are obscene and illegal.

The diseases against which we vaccinate are still dangerous and still present in other countries and in America but simple risk/benefit analysis would show that the risks from the way vaccines are manufactured and administered far outweighs the risks of harm from these relatively rare illnesses.

If Dr Offit had been a witness back then, might he have suggested that people could smoke 10,000 cigarettes?

Children's lives are at risk and we can't allow this whitewash.

An increasing number of Ohio parents are using religious exemptions to delay or refuse immunizations for children amid fears that vaccines contribute to autism.

Ohio Department of Health data shows the number of religious or philosophical exemptions nearly quadrupled in Ohio between 1998 and 2008, though that figure still represents fewer than 1 in 100 children.

All states require children to be immunized for school. Most allow religious exemptions, and Ohio and 19 others also permit exemptions for personal reasons.
Doctors say they're concerned that more exemptions could lead to outbreaks of preventable illnesses among children who haven't had the measles-mumps-rubella vaccine.

For years, scientists have debunked earlier reports of a link between children's vaccines and autism.

Read more about the issue at the Cincinnati Enquirer:

The rising rate of Ohio exemptions is "a big concern," says Dr. Patricia Manning-Courtney, a pediatric developmental specialist and medical director of the Kelly O'Leary Center for Autism Spectrum Disorders at Cincinnati Children's Hospital Medical Center. "It doesn't take a lot of unvaccinated kids to start a little pocket of infection and epidemic," she says.

She points to Minnesota, where last year five children became sick with Haemophilus influenzae type b, also known as Hib. Three of the cases, including one death, were in infants whose parents refused to vaccinate them. Before a vaccine became available in 1988, about 1,000 children died of Hib each year.

"Even though it's a blip ... compared to what we used to have, it makes us worried [that] this a harbinger of things to come," says Dr. Robert Frenck, an infectious diseases expert and professor of pediatrics at Cincinnati Children's.

A Wichita teen and her mother want a popular vaccine taken off the market. Doctors say Gardasil is killing the 16-year-old.

Sixteen-year-old Gabi Swank used to be a cheerleader, a gymnast and a 4.0 student at Wichita's South High, but after getting the Gardasil vaccination last year, her health deteriorated quickly.

She's had two mini strokes, seizures and swelling of all the tissues in her body. She even has paralysis on the right side of her face. After months of testing, doctors finally pointed to Gardasil as the cause.

"I want this drug off the market. I want it off the market," said Swank from her home.

The CDC and the FDA say they have received thousands of reports of adverse reactions to the vaccine, but the government adds, it continues to find that the benefits of Gardasil outweigh the risks.

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

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

"I'm devastated today," said Rebecca Estepp, national media manager for the organization Talk About Curing Autism. "But I also know that the decision will be appealed.

"As parents, we feel like, OK, we're going to fight even harder to get justice for our children," she added. "In a way this might have reignited our cause... Just because we lost today does not mean we will lose in the future."

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

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

US Court Rejects Vaccine Connection to Autism, Wall Street Journal

Rebecca Estepp, the mother of an 11-year-old boy with autism who is one of the claimants seeking compensation from the government's Vaccine Injury Compensation Program, said she is "devastated" by the decisions. "I listened to the test case and I honestly felt it was a strong case," said Ms. Estepp, who is the national manager of a family-support group called Talk About Curing Autism.

"It puts us at an enormous disadvantage when the first three test cases are found for the Department of Health and Human Services," said Ms. Estepp. "It's tough when you're taking parent support calls and you hear the same story day after day. When does anecdotal evidence become enough?

Vaccines don't cause autism, court finds, Minneapolis Star Tribune, MN

. . .  In December 2007, the Minnesota Department of Education identified 11,314 students younger than 21 who qualified for special-education services under the criteria for autism spectrum disorder

Autism-vaccine link rejected by court, Chicago Tribune, United States

The rulings in the test cases make it unlikely many of the more than 5,000 families seeking compensation from the National Vaccine Injury Compensation Program for their children's autism will receive any. Some families vowed they would appeal and take the battle to civil court.

"I find it very disappointing," said one of the claimants, Sara DiFucci of Lake in the Hills, who says her daughter Amanda developed autism after receiving vaccines. "But the families can now go to civil court. I wish that had happened from Day One. I never wanted the government to have a hand in this in the first place."

.. . . "I would relinquish my right to sue if I knew the people who knew this was a problem would go to jail," DiFucci said. "Our government made the decisions today. The fight is far from over."

Parents with autistic children still wary of vaccinations, WKOW-TV.com, WI

Like them, however, the Spring Green mom is convinced a measles-mumps-rubella shot contributed to her son's autism diagnosis.
"I knew something happened," Larson said. "He started losing skills isntead of gaining skills."

"Within a week or two of that vaccine, it was such a big crash," she added.

. . . Either way, it appears more parents are not getting their kids vaccinated. A study from the Wisconsin Medical Society showed the percentage of students receiving exemptions for vaccines has quadrupled since 1992.
Of those, 57-percent of parents said they were worried their children might be harmed.

Autism claims denied due to lack of evidence, Washington Times

"Today we learned yet another government system has failed the families affected by autism," the group Talk About Curing Autism said.
Jim Moody, director of SafeMinds, said it "only heightens the controversy."

"Cases will continue through the process and out into civil court, which is not what Congress wanted," he said. "Vaccination companies should be very worried that one day, hopefully not too soon, juries will get to review the evidence. This is a scientific work in progress."

Parents of Autistic Children Dealt Legal Setback, First Coast News, FL

For seven years Leslie Weed has been looking for justice from the vaccine manufacturer she says caused her daughter Lanier's autism.

But Thursday she and dozens of other Jacksonville families with autistic children were dealt a legal setback.

. . . Thousands of cases, including Weed's and around 50 other First Coast families', are still pending and many of them have been waiting years.

"That would never happen in a U.S. Court but it's happening right there smack dab in the middle of Washington, D.C., while we all sit here with our suffering, sick, ailing children and they're saying your just going to have to wait your turn," says Weed.

"We've been asking for safer vaccines for years without the neurotoxins being injected into our kids. So is it a fair system? No, I don't think it is," says Jacksonville mom Sarah Hoiberg.

Hoiberg was successful in vaccine court in showing her child Caitlyn, although not autistic, was injured by a vaccine.

But she still sees the flaws in the system.

Leslie Weed will still continue to pursue her case, and eventually hopes to see changes in the entire vaccination system.

"I am hoping that someone is going to understand that 36 vaccines to a child before they're 3 or 4 years old is insane without safety testing," says Weed.

Court Rules Against Vaccines-Autism Claims, NPR

Rebecca Estepp, parent support and media relations manager with Talk About Curing Autism, a group representing families of people with autism, believes vaccines caused autism in her son, who is now 11. Her son is among those who have filed through the National Vaccine Injury Compensation Program.
"I'm devastated, and I'm trying to figure out how in the world this decision came about today," Estepp says.

US vaccine court denies autism cases, Reuters UK, UK

The advocacy group Autism Speaks said the ruling did not necessarily clear vaccines, or any other potential cause.
"We will continue to support authoritative research that addresses unanswered questions about whether certain subgroups of individuals with particular underlying medical or genetic conditions may be more vulnerable to adverse effects of vaccines," the group said in a statement.

Court rules vaccines not the cause of autism, MSNBC

Rulings on vaccination. austim link, MSNBC

"She was normal and healthy, and then she got the vaccination," said Theresa Cedillo.

Vaccines are not to blame for autism, a special court rules, MSNBC

Autism not caused by specific vaccines, special court rules, CNN

Autism ruling fails to convince many, CNN

Meanwhile, some autism advocacy groups such as SafeMinds also criticized the HHS saying the "deck is stacked against families when they enter 'vaccine court.'"
National Autism Association president Wendy Fournier agreed.

"If you have a vaccine injury, you're forced to sue Health and Human Services instead of suing the manufacturers. It's the government that oversees these court cases," said Fournier, who is the mother of a 9-year-old girl with autism. "The conflict of interest is so huge in so many levels by having the government responsible for not only promoting vaccine program, but also responsible for overseeing the safety."

Fournier said her daughter was a happy, healthy toddler who developed autism after receiving shots. She said she's heard countless similar stories from other parents.

The special court denied Mike and Theresa Cedillo's claim that vaccines caused autism in their daughter, Michelle, 14, who can't walk without help and receives nourishment from a feeding tube.

"We're obviously really disappointed," Theresa Cedillo said.

Court finds no autism-vaccine link: Will it matter? Chicago Tribune,

"I think you're going to find a large part of the autism community isn't going to be swayed by this decision," said Karen McDonough, head of the Autism Society of Illinois. "Parents want the link between vaccines and autism to be better studied. There's too much that hasn't been looked at yet."

Health Buzz: Court Rules on Vaccines and Autism, and Other Health News, U.S. News & World Report, DC

Vaccines don't cause autism, special court says, The Associated Press

Court: No link between measles vaccine and autism, USA Today

Court rules autism not connected to vaccines, USA Today

Court Says Vaccine Not the Cause of Autism, U.S. News & World Report

Vaccines Not to Blame for Autism, Court Rules, U.S. News & World Report

No MMR and autism link - US court, The Press Association

Ruling Won't End Autism Debate, Groups Pledge, ABC News

The Original Vaccine/Autism Study Debunked, Washington Post

Court experts: No link between vaccines, autism, Newsday, NY

Should court ruling end autism debate? Atlanta Journal Constitution

If you recall, last fall federal health officials agreed that vaccines contributed to an autistic Georgia girl's symptoms.

Court Says Vaccine Not to Blame for Autism, New York Times

In contrast, J. B. Handley, the founder of Generation Rescue, which blames vaccines for autism, said the decision not to compensate the Cedillos was "an incomprehensible injustice."

Autism Speaks, which finances research and has sharp divisions among founding members on the vaccine question, said the rulings "do not mitigate the need for further scientific investigation."

Last March, in a settlement reached in the compensation court, the federal government did concede that a young girl with autism had been damaged by vaccines. But the government and other experts said the case was not a precedent because the girl, Hannah Poling, had a number of unusual conditions that might have contributed to her disorder.

Vaccines Exonerated on Autism, New York Times

No evidence of autism-vaccine link, court rules, Los Angeles Times, CA

"I'm sure the decision was based on some of the current science that is out there and the scientific community hasn't invested in the types of independent research necessary to get to the bottom of the issue," said Rick Rollens of Sacramento, who has an autistic son and co-founded the UC Davis MIND Institute.

Rollens and others said these verdicts wouldn't make parents stop questioning the safety of vaccines, especially when the parents see changes in their children right after vaccination.

"There's no denying what happens to your child when you see it firsthand," said Rollens. "Maybe we haven't asked all the right questions yet."

The parent-advocates held out hope that the government might still acknowledge connections between vaccines and autism through other mechanisms. Last year, they pointed out, the Department of Health and Human Services concluded that vaccines aggravated an underlying metabolic disorder in Hannah Poling, a young girl from Georgia who developed a brain disorder with features of autism.

By Robert F. Kennedy, Jr.

On February 12, the federal "Vaccine Court" in Washington issued a sweeping ruling in three highly touted "test cases" against families who claimed that their childrens' autism had been caused by vaccines. The Special Masters in those three cases found that Petitioners failed to establish causation between MMR vaccines, the mercury-laced vaccine preservative thimerosal, and autism (the court decision, which is under appeal, deferred any finding on a thimerosal-only theory of causation). The rulings could have a significant precedential impact on some 5,000 families who opted to bring their cases in the Omnibus Autism Proceedings (OAP) hoping that the vaccine court would officially hold that the MMR vaccine or thimerosal had caused autism in their children.

The New York Times joined the government Health Agency (HRSA) and its big pharma allies hailing the decisions as proof that the scientific doubts about vaccine safety had finally been "demolished." The US Department of Health and Human services said the rulings should "help reassure parents that vaccines do not cause autism." The Times, which has made itself a blind mouthpiece for HRSA and a leading defender of vaccine safety, joined crowing government and vaccine industry flacks applauding the decisions like giddy cheerleaders, rooting for the same court that many of these same voices viscously derided just one year ago, after Hannah Poling won compensation for her vaccine induced autism.

But last week, the parents of yet another child with autism spectrum disorder (ASD) were awarded a lump sum of more than $810,000 (plus an estimated $30-40,000 per year for autism services and care) in compensation by the Court, which ruled that the measels-mumps-rubella (MMR) vaccine had caused acute brain damage that led to his autism spectrum disorder.

The family of 10-year-old Bailey Banks won their case quietly and without fanfare in June of 2007, but the ruling has only now come to public attention. In the remarkably clear and eloquent decision, Special Master Richard Abell ruled that the Banks had successfully demonstrated that "the MMR vaccine at issue actually caused the conditions from which Bailey suffered and continues to suffer."

Bailey's diagnosis is Pervasive Developmental Disorder -- Not Otherwise Specified (PDD-NOS) which has been recognized as an autism spectrum disorder by CDC, HRSA and the other federal health agencies since at least the 1990s.

In his conclusion, Special Master Abell ruled that Petitioners had proven that the MMR had directly caused a brain inflammation illness called acute disseminated encephalomyelitis (ADEM) which, in turn, had caused the autism spectrum disorder PDD-NOS in the child:

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 [an autism spectrum disorder]. 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... a proximate sequence of cause and effect leading inexorably from vaccination to Pervasive Developmental Delay.
The Bailey decision is not an isolated ruling. We now know of at least two other successful ADEM cases argued in Vaccine Court. More significantly, an explosive investigation by CBS News has found that since 1988, the vaccine court has awarded money judgments, often in the millions of dollars, to thirteen hundred and twenty two families whose children suffered brain damage from vaccines. In many of these cases, the government paid out awards following a judicial finding that vaccine injury lead to the child's autism spectrum disorder. In each of these cases, the plaintiffs' attorneys made the same tactical decision made by Bailey Bank's lawyer, electing to opt out of the highly charged Omnibus Autism Proceedings and argue their autism cases in the regular vaccine court. In many other successful cases, attorneys elected to steer clear of the hot button autism issue altogether and seek recovery instead for the underlying brain damage that caused their client's autism.

Medical records associated with these proceedings clearly tell the tale. In perhaps hundreds of these cases, the children have all the classic symptoms of regressive autism; following vaccination a perfectly healthy child experiences high fever, seizures, and other illnesses, then gradually, over about three months, loses language, the ability to make eye contact, becomes "over-focused" and engages in stereotypical head banging and screaming and then suffers developmental delays characteristic of autism. Many of these children had received the autism diagnosis. Yet the radioactive word "autism" appears nowhere in the decision.

Instead the vaccine court Special Masters rest their judgments on their finding that the vaccines caused some generalized brain injury, mainly Encephalopathy/encephalitis (brain inflammation) or "seizure disorders" -- conditions known to cause autism-like symptoms. A large number of the children who have won these judgments have been separately diagnosed with autism. HRSA acknowledged this fact in a recent letter, but told us it does not keep data on how many of these children were autistic.

The Vaccine Court, in other words, seems quite willing to award millions of dollars in taxpayer funded compensation to vaccine-injured autistic children, so long as they don't have to call the injury by the loaded term "autism." That hazard is particularly acute for vaccine victims who appear before the Omnibus Autism Proceedings (OAP). Since that body's decisions are closely watched, published and accorded the weight of precedent, many lawyers consider the burden of proof for petitioners to be impossibly high before the OAP Panel. It was for this reason that Bailey's attorney, Mark McLaren, elected to opt out of the OAP and try his case separately, even though Bailey has been receiving autism-related services in his home state and was eligible to file a case in the Court's Omnibus Autism Proceedings (OAP).

McLaren told us he wanted to avoid the added burden facing petitioners under the media glare and precedential weight attending OAP panel trials. "We considered [the OAP route] because [Bailey] is on the autistic spectrum of disorders, but we thought we could try it separately and apart from the Omnibus, and not as a test case," explained McLaren. "We thought we'd have a better chance if we tried to on its own merit, away from the spotlights and the precedent setting pressures that attend these OAP test cases - and it worked."

Bob Krakow, a leading attorney for vaccine damaged children told that many lawyers are now convinced that filing a claim in the OAP is a losing proposition. "There's a growing conviction that if you have a autistic client who has also been diagnosed with encephalopathy/encephalitis or seizure disorder, you are better off not mentioning the word "autism" if you want to win the case." He recommended instead filing a non autism claim like "mental retardation with seizure disorder" for an autistic client.

Although the vaccine court is mandated to fairly serve the victims of vaccine injuries, their primary purpose and raison d'etre is to protect the vaccine program and vaccine makers. Damages are doled out from a 75-cent tax on every vaccine sold and not from the vaccine makers. "You can understand why special masters, burdened with their duty to protect vaccine programs, might be unwilling to make the direct causal link between autism and vaccines," Krakow observed. "If you ask the big question and answer it in the affirmative, there is a sense that it will damage the vaccine program irreparably."

Vaccine Court judges are equipped with a draconian armory of weapons deployable against plaintiffs intent on proving the causal connection between vaccines and autism. Jury trials are prohibited. Damages are capped; awards for pain and suffering are strictly limited and punitive damages banned altogether. Vaccine defenders have an army of Department of Justice attorneys with virtually unlimited resources for expert witnesses and other litigation costs. Plaintiffs, in contrast, must fund the up front costs for experts on their own. In a cultural choice that clearly favors defendants, vaccine court gives overwhelming weight to written medical records which are often inaccurate -- over all other forms of testimony and evidence. Observations by parents and other caretakers are given little weight.

Worst of all -- plaintiffs have no right to discovery either against the pharmaceutical industry or the government. Since autism is a behavioral affliction rather than a precisely defined biological injury -- epidemiological studies are critical to establishing its causation. But the greatest source of epidemiological data is the Vaccine Safety Datalink (VSD) -- the government maintained medical records of hundreds of thousands of vaccinated children -- which HHS has gone to great lengths to keep out of the hands of plaintiffs' attorneys and independent scientists. Unfortunately the vaccine court has judicially anointed this corrupt concealment by consistently denying every motion by petitioners to view the VSD. The raw data collected in the VSD would undoubtedly provide the epidemiological evidence needed to understand the relationship between vaccines and autism. The absence of such studies makes it easy for judges to say to plaintiffs they have not met their burden of proving causation.

Meanwhile, CDC has actively, openly and systematically suppressed and defunded epidemiological studies that might establish a causal link. CDC has ignored repeated pleadings that it fund peer reviewed studies of unvaccinated American cohorts like the Amish and home-schooled children. At the same time the agency has worked overtime ginning up a series of fatally-flawed European studies purporting to dispute the link. Even a cursory critical examination reveals that the oft-cited Danish, English, and Italian studies are rank tobacco science. Many of them were funded by CDC, a badly compromised agency, performed by vaccine industry scientists, and published in miserably conflicted journals.

Needless to say, the existence of these phony studies, combined with the deliberate dearth of epidemiological evidence makes it easy for the special masters to dodge a politically explosive finding by holding that there is "insufficient evidence."

And, speaking of tobacco, it's worth recalling that for sixty years the tobacco industry successfully defended a product that was killing one out of every five of its customers against thousands of legal actions brought by its victims and their families. Tobacco lawyers protected the cigarette companies by arguing that there was no proven link between tobacco and lung cancer. Bob Krakow sees many parallels. Big tobacco uses the same tactic of manufacturing research that seems to dispute the connection to exploit the burdens on plaintiffs to prove causation. Big tobacco prevailed for six decades even without the help of supportive government agencies deliberately suppressing real science and research. In that sense vaccine victims must leap a much higher hurdle.

Despite the perilous odds stacked against them in vaccine court, the evidence of a vaccine/autism link is so strong that vaccine court judges and government agencies have now recognized at least two theories of how vaccines cause autism: the Vaccine-to-ADEM-to-ASD link in Bailey Banks' case, and vaccine-induced aggravation of an underlying mitochondrial dysfunction that caused full-blown autism in the Hannah Poling case. Both theories are different from those rejected in the three cases last week.

Perhaps, these new disclosures will prompt The Times, with all its influence, to actually make prudent journalistic inquiries into the phony science CDC uses to defend its claims of "vaccine safety." If it does, the paper will realize it has once again been ill used by government agencies in a tragic campaign of public deceit. The Times should make the reasonable demand that the government health agencies finally release the Vaccine Safety Datalink for independent scientific research and that CDC and HRSA lift their opposition to genuine epidemiological studies that might finally provide real scientific answers to this debate.

The Huffington Post

By David Kirby

A ruling from Federal Vaccine Court -- that MMR vaccine caused an autism spectrum disorder in a young boy named Bailey Banks -- flies directly in the face of the triple-play decision against a vaccine-autism link issued by the Court on February 12.

The Special Masters in those three cases inferred that the vaccine-autism theory was the stuff of Alice in Wonderland fantasy, and virtually accused the childrens' physicians of medical malpractice. (CNN's Dr. Sanjay Gupta called the Court's language "snide," and we agree).

Meanwhile, the US Department of Health and Human services said the rulings should "help reassure parents that vaccines do not cause autism." But why should parents feel reassured when two out of five autism cases (40%) - that we know of - have won taxpayer-funded compensation in Vaccine Court?

The Ruling

In his decision, Special Master Abell ruled that the MMR vaccine produced a side effect in Bailey called acute disseminated encephalomyelitis (ADEM). ADEM is a neurological disorder characterized by inflammation of the brain and spinal cord. The disorder results in damage to the myelin sheath, a fatty coating that insulates nerve fibers in the brain. ADEM can be caused by natural infections, especially from the measles virus. But it also is a recognized post-vaccination injury, especially from vaccines for rabies, pertussis, influenza, and MMR.

Evidence presented to support an MMR-ADEM link was compelling. It included a 1994 report from the Institute of Medicine that said it was biologically plausible for a vaccine to "induce... an autoimmune response... by nonspecific activation of the T cells directed against myelin proteins."

In fact, both parties in the Banks case agreed "that the IOM has cited demonstrative evidence of a biologically plausible relation between the measles vaccine and demyelinating diseases such as ADEM," the Court wrote.

Most cases of ADEM (80%) are in children. Symptoms usually appear within a few days to a couple of weeks. They include: headache, delirium, lethargy, seizures, stiff neck, fever, ataxia (incoordination), optic nerve damage, nausea, vomiting, weight loss, irritability and changes in mental status.

I know of thousands of parents who witnessed many of these same symptoms afflict their children shortly after vaccination, most typically the MMR. Did these children with autism also suffer initially from ADEM or some subclinical version of the disorder? We may never know (physical signs like myelin damage are transitory).

Bailey Banks was given an MRI when his parents brought him to the hospital 16 days after his MMR vaccine, and that helped confirm his diagnosis. The children I know who were brought in with similar symptoms were instead given Tylenol and told to go home.

(Interestingly, Tylenol can affect production of glutathione, an essential antioxidant and detoxifier. A preliminary study from UC San Diego showed that children who were given Tylenol after their MMR vaccine were several times more likely to develop autism than other children. "Tylenol and MMR was significantly associated with autistic disorder," the authors wrote. "More research needs to be completed to confirm the results of this preliminary study.")

Is vaccine-induced ADEM (and similar disorders) a neurological gateway for a subset of children to go on and develop an ASD? That question will now become subject to debate. Thousands of parents have reported similar reactions and symptoms following vaccination, yet they lack radiological proof of ADEM or related disorders in the form of an MRI. Meanwhile, most children with autism do not present with myelin damage, but many do test positive for antibodies to myelin basic protein (MBP).

Also worth noting is that ADEM causes an inflammatory response in the brain, primarily in the microglial cells. It is also associated with abnormal cytokine levels in the brain, and with autoimmunity. Autism, meanwhile, has been linked to brain inflammation, microglial cell activation, cytokine imbalances, and autoimmunity.

In most cases, symptoms of ADEM disappear within a few weeks or so, and the disorder may be treated with IV cortisone to help reduce inflammation. But none of the children with autism that I know were ever examined or treated for a possible case of ADEM or other acute cases of encephalitis/demyelinating disorder. By now, their myelin damage may have repaired itself, yet the damaging agents, (MBP antibodies), persist.

ADEM is said to be rare, but the disorder may be grossly under-diagnosed (or misdiagnosed). Even the government's chief witness against Bailey's case testified that he sees patients with ADEM "on a fairly regular basis." What's more, Bailey's was the third successful vaccine-ADEM case argued in Vaccine Court (that we know of) so far.

Can ADEM Cause PDD/ASD?

Special Master Abell had no trouble linking MMR to ADEM in Bailey Banks' case. But linking his ADEM to PDD/ASD was more difficult.

There is no medical literature to support an ADEM-PDD link. The government's expert witness, Dr. John MacDonald, testified that "all the medical literature is negative in that regard." Instead, he proposed an alternative hypothesis for Bailey's PDD (he suggested it was caused by glucose transporter 1 deficiency).

But Special Master Abell berated the government's witness in much the same way that Hastings et al. had criticized witnesses for the families in their three cases.

"This (glucose) hypothesis, which (MacDonald) declined to incorporate as a plausible, probable theory of explanation, was used by Respondent to blunt Petitioner's theory of ADEM," Abell wrote. "This hypothesis was not given to a reasonable degree of medical probability or certainty, and Respondent's expert admitted that it was merely 'a possible, not necessarily a probable diagnosis.'"

Abell also chided MacDonald for his assertion that "all the medical literature is negative" in regards to an ADEM-PDD link. "However, soon thereafter, he corrected this statement by clarifying, 'I can find no literature relating ADEM to autism or [PDD],'" Abell wrote. "It may be that Respondent's research reveals a dearth of evidence linking ADEM to PDD, but that is not the same as positive proof that the two are unrelated, something Respondent was unable to produce. Therefore, the statement that 'all the medical literature is negative' is incorrect."

The Court also took MacDonald to task for insisting that Bailey's initial symptoms were not 100% consistent with the signs of ADEM. "His distinction seems one of degree, not of type, and strikes as a trifle semantic," Abell sniffed. He also noted that McDonald was having a hard time determining Bailey's current diagnosis. "He ultimately concluded that 'Bailey falls into the large group of children with autism/PDD in which by our current evidence-based medicine we rarely can make a specific diagnosis.'"

Special Master Abell seemed to lend more credence to witnesses for the Banks family.

Chief among them was Dr. Ivan Lopez, a neurologist and psychiatrist. Dr. Lopez testified that "the majority of patients with ADEM improve significantly," but added that "the exception to this rule is when patients have been exposed to measles, just like in the case of MMR vaccine," in which case subsequent brain damage "may occur in up to 50 percent of patients." He said such events include "mental syndromes such as PDD and others," and opined that "up to 50 percent of patients...who have had ADEM will show (PDD) as a consequence."

Dr. Lopez, a member of the US Military, gave his testimony by phone from Mobile, AL where, the next day, he was to ship out for a tour of duty in Iraq.

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.

Does Bailey Banks Have Autism?

Bailey Banks does not have "classic" or full-blown autism. But he has been diagnosed with PDD-NOS, which is squarely on the autism spectrum of disorders. There was quite a bit of back-and-forth on Bailey's diagnosis in the ruling, whose heading included the term "Non-autistic developmental delay." At several points in the proceedings, witnesses took great pains to say that Bailey does not have "autism" which, technical speaking, is true.

On the other hand, Special Master Abell included notations declaring that "Pervasive Developmental Delay describes a class of conditions, and it is apparent from the record that the parties and the medical records are referring to Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)."

Even so, some will argue that Bailey does not have an ASD. They are simply wrong. The diagnosis of PDD-NOS was added to the list of autism spectrum disorders in the 1980s. It was precisely from the inclusion of these "milder" cases into the total number, that the CDC came up with the estimate of 1-in-150 US children with some form of "autism/ASD."

So, if Bailey does not have ASD, then the number of "autism" cases is well below the 1-in-150 mark and needs to be revised downward (the CDC once estimated that 40% of ASD cases were "non-autistic" in the classic sense).

What's more, Bailey does not have a "mild" form of ASD -- he struggles every day with endless challenges. He receives autism services in his home state and attends a special school for children with autism. Bailey was also completely eligible to file a case in the Court's Omnibus Autism Proceedings (OAP), along with 5,000 other claims.

And besides, if the government chooses after-the-fact to argue that Banks simply has another form of brain damage but not, specifically "autism," is that really any comfort?

This particular theory of causation -- Vaccine-to-ADEM-to-ASD -- is different from the three cases that lost, and different than the theory in the Hannah Poling case (vaccine-induced aggravation of an underlying mitochondrial dysfunction caused full-blown autism).

So we now have two novel theories of how vaccines might contribute to ASD -- both ADEM and mitochondrial dysfunction are recognized by the Court as contributing factors.

And yet the government insists it has never made an award for vaccine induced ASD, just vaccine related ASD.

"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," said David Bowman, a spokesman for HHS's Health Resources and Services Administration. "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," he added, "or may ultimately end up with autism or autistic symptoms, but we do not track cases on this basis.

Unfortunately, the track record on vaccines is cloudy in this particular Court: Three out of four ADEM cases have been successful; and (at least) two out of five ASD cases have also won.

People will argue that ADEM is rare; that vaccines "only" caused PDD in Bailey; and that this was a legal and not scientific decision. The problem is we don't know how prevalent ADEM is because we never looked; while "PDD" is interchangeable with "ASD" in the language of public health. And, the three cases that lost were also "legal" decisions.

Robert Kennedy, Jr. and I would love nothing more than to reassure parents that the nation's current vaccine program is 100% safe for all kids, and that zero credible evidence has been presented to link vaccines with autism. But that simply isn't true -- as at least two court cases have found.

Why the Obama administration needs to restore public faith in the safety of childhood vaccines.

Related links:

• Autism: How Childhood Vaccines Became Villains
• Autism Timeline: Tracking a vexing and mysterious disorder

By Dr. Louis Z. Cooper, Heidi Larson and Dr. Samuel L. Katz

The mainstream media applauded the U.S. federal "vaccine court"'s decision Feb. 12 that the MMR vaccine and vaccines containing ethyl mercury as a preservative did not cause autism in three children chosen as test cases. But that's not enough to repair the damage already done to the U.S. vaccine program.

It's hard for a single court decision to compete with ongoing allegations from grieving parents and celebrities that vaccines created an epidemic of autism. Those allegations have generated confusion and fear in the minds of many young parents, reduced public trust in the remarkable benefits and safety of U.S. immunization programs and put both vaccinated and unvaccinated children at increased risk from preventable diseases. Furthermore, significant unanswered questions about the safety of vaccines have been documented by the Institute of Medicine and the National Institutes of Health. For example, are some few individuals genetically more susceptible to adverse reactions from certain vaccines? A more common worry among parents is "Are too many vaccines given too soon?"

Parents of newborn infants can't take two years of study, as did the vaccine court, to sort out sound science from junk, innuendo and unsubstantiated allegation. As a result, rates of vaccine refusal have climbed to levels allowing clustered outbreaks of vaccine-preventable diseases such as measles, pertussis and meningitis, posing a threat to those unvaccinated because of medical contraindications, age and parental choice. For example, in Washington, statewide refusal rates now exceed 5 percent, including rates exceeding 15 percent in some counties. Other states show doubling rates. Also worrisome is the disproportionate amount of time pediatricians must now spend to assure fearful parents that vaccination is the best choice for their child. At what level will the growing refusal rates put us at risk of major epidemics?

What has been missing in order to give parents confidence that immunization is one of the best ways to protect the health of their children? Our national failure falls into two categories. First, we've had inadequate ongoing, credible education of the public and health professions from trusted public-health officials concerning the known and unknown benefits and risks of vaccines. Today's parents have little fear of diseases they mistakenly think have been eliminated by vaccines. Second, there's been grossly insufficient investment in research on the safety of immunization. Together, these failures contributed to undermining of public confidence.

This is not the first time parental concern has threatened to deprive our children of the benefits of immunization. In the early 1980s, a spate of lawsuits threatened to drive vaccinemakers and doctors out of the immunization business. Then three highly polarized groups—parents who believed vaccines injured their children, vaccine companies and pediatricians—collaborated to create the National Childhood Vaccine Injury Act of 1986 (NCVIA). That law, a pragmatic, compromise solution, saved a then-fragile U.S. immunization effort. It offered financial relief to vaccine-injured children, prevented the demise of a vaccine industry that had dwindled rapidly from 26 to four companies and protected pediatricians whose careers then were being jeopardized by malpractice suits, even though they were properly administering vaccines. Over the past two decades, that law has distributed $1.8 billion with financial compensation to more than 2,200 families and individuals, encouraged dramatic expansion of the vaccine industry and allowed pediatricians to remain the mainstay of our successful immunization program.

The vaccine injury act put the secretary of the Department of Health and Human Services (HHS) in charge of planning and monitoring the effectiveness and safety of our national immunization program. There's plenty of financial incentive for industry, venture capitalists, government agencies, clinicians and the academic community to develop and distribute vaccines. In contrast, without federal government investment, no such incentives are available to support research on vaccine safety.

The responsibility for development, licensing, purchase, distribution and monitoring of vaccines is divided among a handful of federal agencies. Because of the wide range of scientific skills needed to study the safety of vaccines, we need a coordinated plan with funds to match. But no such plan has ever been put in effect. (In the last few months of his tenure under President George W. Bush, HHS Secretary Michael Leavitt did make some progress, but the effort was unfunded, incomplete and hampered by his short, lame-duck status.)

What remains to be done? The incoming secretary of HHS, with the backing of the White House, must carry out aggressively the duties assigned by the 1986 law: development and implementation of a national vaccine plan that includes adequate funds for communication and vaccine-safety research. Given the current distrust of government, development and accountability for the plan deserves serious, transparent input, not just by scientists but also by more than token participation of the public. It is that public whose trust has been eroded.

As parents, grandparents and health professionals, we know how immunization has revolutionized child health. But to maintain that progress, we must restore public trust in vaccinations. Ignoring public anxiety about childhood vaccines—and the increase in parents who skip or stretch out immunizations—risks even more serious outbreaks of vaccine-preventable diseases. We need visible leadership from the incoming secretary of HHS, supported by President Obama. The new public-health team must describe clearly the known benefits and risks of vaccines—and take into account safety issues as perceived by the public and scientific community. We know the new administration has a long list of problems to confront, but there are few issues more urgent than the health of our children. We hope they act quickly.

Dr. Louis Z. Cooper is professor emeritus of pediatrics at Columbia University and a former president of the American Academy of Pediatrics (AAP). Heidi Larson is an associate research professor at Clark University and a research associate at the Harvard Center for Population and Development Studies. Dr. Samuel L. Katz is the W. C. Davison Professor & chair emeritus of the department of pediatrics at Duke University School of Medicine and a former chair of the Advisory Committee on Immunization Practice at the CDC and former chair of the AAP's Committee on Infectious Diseases.

AFP/MERCK/File – Gardasil's human papillomavirus vaccine (HPV). Spanish health authorities have withdrawn tens of …

MADRID (AFP) – Spanish health authorities have withdrawn tens of thousands of doses of a vaccine against cervical cancer after two teenagers who received the shots were hospitalised, regional authorities said on Tuesday.

A batch of nearly 76,000 doses of the human papillomavirus vaccine (HPV) was withdrawn from market, a government statement said, after two girls in the eastern Valencia region fell seriously ill hours after receiving them.

"One of the girls got out of intensive care this weekend and the other is still there. Both are in stable condition," a Valencia health department spokeswoman told AFP.

The two girls were vaccinated last week as part of a vast government vaccination programme targeting adolescents.

The vaccine prevents the most common types of HPV, a common virus spread through sexual contact that can cause cervical cancer.

Some 500,000 cases of cervical cancer are discovered each year, according to United Nations estimates, many in developing countries. If left untreated, invasive cervical cancer is almost always fatal.

Spanish health authorities said in a statement the batch of the Gardasil brand of vaccines was distributed country-wide, with some earmarked for regional vaccination programs and the rest sold at pharmacies.

The vaccine has been available for girls since 2006, ideally before their first sexual encounter.

Sweden recently announced it would offer the vaccines to all primary school girls free of charge as of 2010.