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Talk About Curing Autism (TACA) provides general information of interest to the autism community. The information comes from a variety of sources and TACA does not independently verify any of it. The views expressed herein are not necessarily TACA’s. TACA does not engage in lobbying or other political activities.

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August 2009 #2

Here is your update on TACA (Talk About Curing Autism). If you are new to our site... WELCOME! This newsletter is produced two to four times each month.

We are an autism education and support group. We want to make this e-newsletter informative for you. As always, contact us your thoughts and/or questions so we can improve it.

We focus on parent information and support, parent mentoring, dietary intervention, the latest in medical research, special education law, reviews of the latest treatments, and many other topics relating to autism. Our main goal is to build our community so we can connect, share and support each other.

Talk About Curing Autism (TACA) provides general information of interest to the autism community. The information comes from a variety of sources and TACA does not independently verify any of it. The views expressed herein are not necessarily TACA’s.

1. Find a TACA Meeting

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.

2. Real Help Now Conference

Listen, Learn & Take Action for Your Child at the Real Help Now Conference

Saturday, October 3, 2009 • 8:30 a.m.-5 p.m.

Searching for and finding the right information to help your child can be overwhelming for families affected by autism. The Real Help Now Conference was developed to bring the latest information on medical, dietary and legal issues for children with autism, and most importantly, help parents through the often daunting process of determining how to organize and prioritize their intervention efforts.

The Real Help Now Conference will provide two important tools for translating the information gained from the speakers into action for your child:

1. Real Help Now Workbook with step-by-step processes to help you to determine appropriate interventions and timelines for taking action in the realms of medical and dietary intervention, education, finances and home life. (Sorry, this Workbook is only available at the conference.)

2. TACA parent mentors who have been there, done that. Our experienced mentors will be on hand to to work with you one-on-one to answer your questions and share what has worked for their child.

Whether you are just starting out on the autism journey or are an experienced parent, you will learn from nationally known experts about how you can help your child at the Real Help Now Conference. Our speakers include:

• Lisa Ackerman, TACA Founder & Executive Director
• Timothy A. Adams, Esq., special education attorney
• Lynne Arnold, TACA mom
• Koren Barett, ND, naturopath and DAN! doctor
• Michael Giammatteo, TACA dad
• Moira Giammatteo, TACA mom
• Jerry Kartzinel, MD, internationally known author, lecturer, and clinician
• Doris Rapp, MD, author of "Is This Your Child?"
• Cindy Schneider, MD, DAN! doctor

Register now online and save on early registration!

• Parent Registration: Individual, Couple with One Guide, Couple with Two Guides
• Professional Registration
• Exhibitor/Sponsor Opportunities

Complete conference information

3. Join Us for Coffee Talk!

Come and receive some extra support or to chat all topics related to autism and meet other TACA families at these informal, monthly get-togethers.

› Fultdondale, AL
› Huntsville, AL
› Bakersfield, CA
› Inland Empire, CA
› Orange County, CA
› Visalia, CA
› Indianapolis, IN
› Glen Burnie, MD
› Gaithersburg, MD
› Hamilton, NJ
› Las Vegas, NV
› Fitchburg, WI

4. Daily Autism Updates for Families

All news related to autism:  

For daily updates to all autism legislative issues: ChangeforAutism.org

AgeofAutism.com

5. Friend for Andrea: Autistic teen's quest to fit in

MSNBC

14-week friendship boot camp aims to helps kids master social cues

By Alicia Chang

updated 5:17 a.m. PT, Fri., Aug 21, 2009

LOS ANGELES - Thirteen-year-old Andrea Levy ticked off a mental list of rules to follow when her guest arrived: Greet her at the door. Introduce her to the family. Offer a cold drink.

Above all, make her feel welcome by letting her choose what to do.

"Do you want to make pizza now or do you want to make it later?" the lanky, raven-haired teen rehearsed in the kitchen, as her mother spread out dough and toppings.

This was a pivotal moment for Andrea, a girl who invited just one acquaintance to her bat mitzvah.

Andrea has autism, and socializing doesn't come naturally. For the past several weeks, she's gone to classes that teach the delicate ins and outs of making friends — an Emily Post rules of etiquette for autistic teens.

For Andrea, this pizza date is the ultimate test.

The bell rings. The door opens. Can she remember what she needs to do?

More important, will she make a friend?

Even for socially adept kids, the teen years, full of angst and peer pressure, can be a challenge. It's an especially difficult time for kids with autism spectrum disorders, a catchall term for a range of poorly understood brain conditions — from the milder Asperger's syndrome to more severe autism marked by lack of eye contact, poor communication and repetitive behavior such as head-banging.

An estimated 1 in 150 American children has some form of autism. There's no known cure. Some research suggests autistic kids who get help early can overcome some of their deficits. But the social skills they learn as a toddler may not be so useful to a teen.

"A lot of our kids need a tune-up. They need new skills to help them survive in their new social world," said clinical psychologist Elizabeth Laugeson of the University of California, Los Angeles, who runs a 3 1/2-month friendship program for high-functioning autistic teens like Andrea.

Growing up, Andrea hardly had friends at all. They either moved away or grew tired by her inability to emotionally connect.

Some doctors said not to worry; others thought she had a speech impairment.

'Always a step behind her peers'
None of the answers made sense to Andrea's parents until two medical experts, including a pediatrician who specialized in developmental disorders, diagnosed her as autistic.

The family soon enrolled Andrea in special play therapy.

"We try and help her make friends, but she's always a step behind her peers," said her mother, Gina Levy.

In some respects, Andrea is a typical teenage girl who is crazed about celebrity gossip magazines, romance novels, drama and chorus. But she can be withdrawn and doesn't always get the subtleties of body language and other nonverbal signs.

a received after completing the PEERS program at the University of California, Los Angeles in Los Angeles.
Whenever she gets stuck in a conversation, she tends to stare, making people around her uncomfortable. She doesn't mean to be impolite — it's just her way of watching and learning.

"I know I'm weird and I know I'm not normal," said Andrea, who looks like a young Anne Hathaway with braces. "I've always known I'm not normal."

Andrea found company from nine other high-functioning autistic teens who enrolled in a 14-week friendship boot camp earlier this year. More than 100 teens have graduated from the UCLA Program for the Education and Enrichment of Relational Skills, or PEERS for short, which costs $100 a session and is covered by many insurers.

Social coaches
Unlike other autism interventions, parents also must participate. They learn to become social coaches for their children so that their new skills can be retained when the program is over.

Every week, Laugeson, a peppy clinical psychologist known as "Dr. Liz," leads the students through a maze of social survival skills: how to have a two-way conversation, how to trade information to find common interests, how to gracefully enter a conversation and how to be a good host. In class, the teens role-play with one another and also must practice what they've learned outside of class in weekly homework assignments.

Laugeson peppers the lessons with friendly reminders about proper etiquette:

"Don't be a conversation hog."

"Give a cover story for why you are calling."

"Don't be an interviewer."

"Say you're sorry when you make someone angry, sad or upset."

"You need to trade information at least 50 percent of the time during the get-togethers."

Earlier this year, Laugeson published a study in the Journal of Autism and Developmental Disorders on how the parent-involved training has worked so far. In a study of 33 autistic teens, those who went through the program had more friends come to their houses than those who did not.

"There isn't much research on social group training that incorporates parents. That's a key factor for success," said Barbara Becker-Cottrill, who heads the West Virginia Autism Training Center at Marshall University. She has no connection with PEERS, but has reviewed Laugeson's research. "Parents are children's first and probably best teachers."

Despite the gains, Laugeson said the program is not a cure-all. Parents know this and don't expect their children to blossom into social butterflies overnight.

Andrea's mother has two goals: "I hope she becomes a better conversationalist and feels more comfortable around her peers."

Autism treatments
While there's no cure, there are a variety of treatments that have been shown to help.
msnbc.com

Andrea's journey through an unfamiliar social world has been filled with some stumbles.

During a role-playing exercise, she was paired with a classmate to talk about their favorite book. Andrea was so eager to share her love of "Gone with the Wind" that she lapsed into a two-minute monologue about the plot. A counselor stepped in and reminded her not to be a "conversation hog."

One of Andrea's early attempts to inject herself into an existing conversation revealed some awkwardness. As a group of classmates chatted away about an animated movie, Andrea stood aloof, avoiding eye contact and unsure of what to do. Laugeson pulled her aside, advised her to listen and find a pause.

By the time Andrea rejoined the group, the discussion had switched to macadamia nuts. Andrea saw an opening and chimed in: "Well, I've tried macadamia nuts and they're pretty good. When I was little, I would eat a lot."

As time went on, Andrea's confidence improved. Through practice, she has let go of her tendency to be an interviewer during phone calls. On her own, she came up with the idea of asking the kids who were signing her yearbook to jot down their phone numbers too, a ploy that won her praise from the counselors and gave her a pool of potential friends to call.

Other teens in the class also progressed, but at a slower pace.
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A fellow 13-year-old, Elias Cazares Jr., was diagnosed with autism two years ago. He displays more outward signs of the disorder — rocking back and forth, constantly blinking, fidgeting with his face. Elias is obsessed with video games and talks of nothing else.

Unlike Andrea who got therapy growing up, this is the first time Elias has had professional help.

At times the pressure is too much. One day after class, Elias had a meltdown and refused to do the following week's homework — calling someone outside of the group. Elias confided to Laugeson that he was teased at school and did not want to befriend the bullies. She calmed him down and said he could dial a cousin instead.

Small steps
Despite the struggles, Elias' father is proud of the small steps he's taken: He recently called his neighbor to schedule a get-together. He also started making small talk with a younger kid in his hip-hop class, but he's been too afraid to ask for his phone number.

"What I want for him is a more normal life, to have at least one or two friends," said Elias Cazares Sr.

As the teens hone their bonding skills, parents gather separately for their own lesson.

UCLA postdoctoral fellow Alex Gantman, "Dr. Alex," runs the parent session. It is a chance for them to talk about their kids' problems and progress and for Gantman to give pointers on helping the teens navigate their social surroundings.

50-50 chance child will be rejected by peers
One hard truth to face: There's a 50-50 chance that a kid will be rejected by peers, Gantman said, and it's OK to let them know that.

He points out that follow-up phone calls are critical in a budding friendship.

"Teens move on really quickly. Somebody else gets their attention and boom, they're gone unless you really develop a strong friendship bond," he said.

Gantman is working to expand the training to young autistic adults. They often struggle with dating skills as portrayed in the summer romance movie, "Adam," about a young man with Asperger's who falls in love with his neighbor.

The PEERS program deals only with friendships, and teens must use the skills they learn in class in the real world. As part of their homework during the last month of the training, they had to play host to potential friends outside of the group.

Andrea invited over a fellow drama classmate with something in common. Both had a digestive problem that meant they couldn't eat foods containing wheat. So the two girls were going to make a gluten-free pizza.

Before the guest arrived, Andrea, dressed in a denim skirt and blouse, went over the steps of being a good host. The door bell buzzed. Her ponytailed guest was five minutes early and wearing a shy smile.

After exchanging pleasantries, the two gathered in the kitchen. Andrea got off to a slow start, standing at times with her arms crossed in front while her mother chatted away.

Then, she remembered her hosting duties and asked if the classmate wanted to add the pizza toppings first.

The guest deferred. "You can go first."

Andrea demonstrated: "So you put a little bit of sauce ... and sprinkle on the cheese."

"Perfect," the classmate replied.

After pizza, Andrea, with some prompting from her mother, asked what to do next.

The guest was indifferent so the two migrated to Andrea's room to watch a movie. After they got bored, they headed to the living room to play video games where Andrea got a chance to practice good sportsmanship.

Despite beating her guest in almost every round, Andrea threw out words of praise: "Good job" and "Come on. You can do this."

"You did well," Andrea said after winning the last round.

The two haven't hung out since the culinary experience. It's been an up-and-down time. But Andrea managed to have four get-togethers with a girl she met in chorus. And she's felt those familiar teen pangs of loss when she was stood up by another girl.

The older, wiser Andrea shook it off. She focused on a new set of possible friends she met while awaiting her turn to dive at the local swimming pool.

After overhearing that her schoolmates were on Facebook, she persuaded her mother to let her create a profile. She sent out "a gazillion friend requests" hoping a few will bite.

She has 33 friends and counting.

6. Special Education Law Update: Recent Supreme Court Decision

Parents Entitled to Reimbursement for Private School Tuition when school doesn’t not provide a Free and Appropriate Public Education (FAPE)

The United States Supreme Court ruled recently in the FOREST GROVE SCHOOL DISTRICT v. T. A. case that parents could be reimbursed for private school tuition from their public school district, even if the child never received special education or related services from the public school district. 

Facts of the case

The student in this case attended public school from first grade through a portion of his junior year of high school.  Teachers frequently observed his difficulties in school completing homework and concentrating but these difficulties increased when he entered high school.

During his freshman year, his mother contacted the school to discuss his academic problems.  At the end of that year he was evaluated by a school psychologist.  The psychologist “after interviewing him,  examining his school records and administering cognitive ability tests concluded that he did not need further testing for learning disabilities or other health impairments including ADHD.”  As a result of these findings the school did not qualify him for Special Education. During his junior year of high school his problems increased, his parents sought a private assessment, and he was diagnosed with ADHD and a number of disabilities related to learning and memory.

Advised by a private specialist that he would do better in a different environment, his parents pulled him out of the public school and enrolled him in a private facility. Shortly thereafter, the parents hired an attorney and requested an administrative due process hearing to determine eligibility for special education services.

After filing for due process, the school asked for a second attempt at evaluating the student.  However, after retesting, the district again determined that the child would not qualify for special education because his disability did not significantly interfere with his education.

In the Due process hearing, the hearing officer found that the initial evaluation conducted by the school psychologist was “legally inadequate because it failed to address all areas of suspected disability” as required by the Individuals with Disability Education Act (IDEA).  The hearing officer also found that the “ADHD adversely affected his educational performance and that the public school district failed to meet it’s obligations under IDEA” and that the district was obligated to provide a Free and Appropriate Public Education (FAPE) and failed to do so. As a result, the private school placement was deemed appropriate the public school district was ordered to reimburse the parents for the cost of private school tuition.

Federal District Court

The School District appealed the case to Federal District Court and the court set aside the reimbursement award and concluded the amendments that congress made to the Individuals with Disabilities Education Act in 1997 created a bar against tuition reimbursements unless a child already had been receiving education or related services by the public  school district.

Court of Appeals for the 9th Circuit

The case was then appealed to the Ninth Circuit Court of Appeals who rejected the District Court’s analysis, ruling that the amendments made to IDEA did not “diminish” a courts authority to award reimbursement when necessary and appropriate.

Supreme Court Decision

The Supreme Court rejected the school’s argument that the child had to first receive services in special education from the public school before the parent could receive reimbursement. The Supreme Court noted that the school’s interpretation would conflict with the requirements that States must “identify, locate, and evaluate … all children with disabilities” to ensure they received needed special education services.  Furthermore, the school’s conclusion would have meant students who had not received any prior services would have had fewer rights than those to whom the school had provided prior services to. Additionally, restricting the reimbursements to only children who had previously been served by public school systems would immunize the systems for never providing the help a disabled child needed. 

Impact on Parents-

In this case, the school failed to evaluate the child properly, and based on an inadequate evaluation refused to provide services to address his needs, leaving the parent with no choice but to place the child in a private school. The court held that where the school allowed a child to fail and refused to provide FAPE it would require the school district to reimburse parents for private school tuition, even if the child never received special education or related services from the public school district. However, a court must consider all relevant factors to determine whether reimbursement for some or all of the cost of the child's private school education is warranted including “the notice provided by parents and the school district's opportunities for evaluating the child."

Parents who place their children during the pendency of review proceedings, without the consent of state or local school officials, do so at their own financial risk.  Before removing a child from public school and unilaterally placing the child into a private school, parents should seek the advice of an attorney on the likelihood of success in seeking reimbursement as getting reimbursement is often difficult.  If you enroll your child in a private school without district consent, this finding states that the court could require the school district to reimburse you if it can be proven by you that: 1) The school district did not provide FAPE, and 2) Private school is an appropriate placement.

As stated above, the court will consider relevant factors when deciding whether to reimburse parents and how much they will grant in the reimbursement.  Hearing officers and courts will often look whether or not the parents gave the school the chance to provide FAPE, and will consider many other factors such as whether the parents made the child available for an evaluation, the notice given to the IEP team of changing the child’s placement, whether parents notified the school district of their intent to reject the IEP and others. If you believe that your child needs a private placement you should look into this option but remember that even after this decision receiving reimbursement for private tuition is still an uphill battle.

To read the decision follow this link  http://www.supremecourtus.gov/opinions/08pdf/08-305.pdf

7. When Vaccine Development is Family Business:
Thomas Insel's Conflicted Role on Vaccines and Autism

Age of Autism

By Dan Olmsted and Mark Blaxill

(Four Insel Brothers, Four MDs (left to right) Jonathan, Richard, Thomas, and Paul)

Thomas R. Insel, the psychiatrist in charge of autism research at the National Institutes of Health (NIH), has a family connection to one of the vaccines potentially implicated in the sharp rise in autism rates since 1990. His brother, Richard A. Insel, was part of both the research team that developed the vaccine for Haemophilus influenza B (Hib) and the company that profited from the introduction of the first commercial Hib vaccine formulation. Richard Insel was a co-founder and director of Praxis Biologics--a vaccine development company in Rochester, New York--that together with a research team at the University of Rochester developed and then sold HibTITER®, a vaccine for Hib first licensed for children in December 1988 and for infants in October 1990. Largely based on the momentum of its successful Hib vaccine, Praxis Biologics was sold in 1989 to American Cyanamid in a deal valued at $190 million. As co-founder and director, Richard Insel held shares that gave him a 2% interest in the company, making his personal share of the transaction worth close to $4 million.

Despite his family connection to the Hib vaccine, there is neither evidence nor suggestion of undisclosed financial conflict on Thomas Insel’s part; all the Praxis Biologics transactions and development activity associated with HibTITER® occurred at least twenty years ago and involved his brother, Richard Insel. Nor has Richard Insel been involved in autism research in any way. But HibTITER® contained the ethyl mercury-based preservative thimerosal, a vaccine component that has been at the center of an ongoing controversy in autism. Many organizations concerned over vaccine safety, including many autism groups, have been asking for increased NIH funding for vaccine safety research, including research into the effects of thimerosal. In that context, Age of Autism’s investigation of Thomas Insel’s familial link to a thimerosal-containing vaccine developed by his brother raises important questions, and advocates for more research on a possible link reacted strongly to the connection.
Put simply, Thomas Insel presides over the NIH research into the causes of autism. In his dual capacity as autism planner and brother (see HERE), responding to these concerns would require him to address a personally difficult question: Did his brother help develop a product that increased the risk of autism in children?

“With a topic as sensitive and combustible as vaccines and autism, Insel needs to move on and hand the reigns over to someone with no conflicts, real or perceived," said J.B. Handley of Generation Rescue. Age of Autism outlined this article and the reaction of some autism advocates to a spokeswoman for the National Institute of Mental Health, of which Insel is director. She said Insel is on vacation "this week and next week at least" and could not be reached for comment. In a brief conversation, she said that in general "he falls back on the science, not some personal view of anything" in making policy decisions.

Richard Insel, Praxis Biologics and the Hib Vaccine

Richard Insel was named in 2003 as the Executive Vice President for Research of the Juvenile Diabetes Research Foundation (JDRF). Before that, he spent 26 years in and around the University of Rochester Medical Center, working in pediatrics, immunology and infectious diseases. Early in his career at Rochester, he began researching the Hib bacterium, a major cause of bacterial meningitis in young children. He subsequently published numerous articles on Hib together with Porter Anderson and David Smith, both of the University of Rochester. Their team at Rochester is widely credited with creating the first licensed infant vaccine for Hib.

Although all of these men were active scientific participants in the development of HibTITER®, there was an apparent division of responsibilities. Anderson took on the leading scientific role while Smith led the business side. Richard Insel played a subordinate role on both the scientific and commercial sides. Anderson was the top named scientist, according to the standard textbook Vaccines, which reported that “Haemophilus B oligosaccharide conjugate B (HbOC) vaccine was developed by Porter Anderson at the University of Rochester.” David Smith, by comparison, moved on from his role as Chairman of Pediatrics at the University of Rochester (he worked closely there with Anderson) in 1983 when he founded Praxis Biologics and served as chairman and Chief Executive Officer until its sale in 1989. Textbook summaries aside, both leaders received a degree of shared scientific acclamation for their work, as Anderson and Smith shared (along with two NIH researchers who worked on a different Hib vaccine formulation) the Albert Lasker Clinical Medical Research Award in 1996 for their work on the HibTITER® vaccine.

The Praxis Biologics HibTITER® vaccine marked a major shift in childhood vaccine development and ushered in a new age of vaccine administration for infants under six months of age. In a tribute Richard Insel wrote for Smith upon his death in 1999, he noted that “licensing in 1990 of the conjugate vaccine represented the first FDA license for any vaccine for young infants since the trivalent oral poliovirus vaccine was introduced in 1962.”

If Richard Insel was not first in line for the major awards that went to the HibTITER®/HbOC developers (there were three other major variants of Hib vaccine developed around the same time, but HbOC was the first licensed for infants), he was certainly a member of the inner circle. He describes himself in his JDRF biography as “scientific co-founder” of Praxis Biologics and he served there as a member of the Board of Directors, appointed in 1988 when Smith regained his CEO position after a brief boardroom struggle. Both Anderson and Smith valued his contribution highly. In their 1996 essay marking their acceptance of the Lasker award, they wrote, “All our many colleagues in laboratories and in the academic and medical communities who contributed to this work cannot, unfortunately, be acknowledged in the references, [but]... David H. Smith and Porter Anderson thank… their colleagues at…the University of Rochester (NY) for help and collaboration, especially Drs Fred S. Rosen, Richard A. Insel, and Michael E. Pichichero, and they acknowledge the expertise and industry of the staff of Praxis Biologics.”

Insel was well recognized and rewarded for his work at Rochester and Praxis Biologics. In terms of scientific recognition, he was a co-author on over 30 papers on Hib and the related immunology issues. He was also a co-inventor on a vaccine patent for Hib conjugate vaccines. In terms of commercial reward, by 1989, he had received nearly 280,000 common shares of Praxis Biologics. When American Cyanamid purchased the company that year for an estimated $14 per share, Insel’s holdings were worth nearly $4 million. [Note: there is also a possibility that Insel received additional income through royalties paid to the University of Rochester on the patented conjugate technology used in both HibTITER® and Prevnar® vaccines. Age of Autism estimates that Rochester received over $200 million in royalties on Porter Anderson’s patents; 50% of these royalties were distributed to the inventors. But we cannot confirm that anyone other than the named inventors on Anderson’s “Immunogenic conjugates” patents received payments. Richard Insel, although often acknowledged as part of the inventor team, was not a named inventor on the licensed patents.]

By most accounts, the Hib vaccine has been highly successful in reducing cases of childhood bacterial meningitis. But the first versions of the commercial infant Hib vaccines--including products developed by Praxis (then Lederle-Praxis, now Wyeth), Merck and Connaught/Merieux (now Sanofi Pasteur)—were all preserved with thimerosal.

Mercury in all its forms is uniquely toxic to infants, but ethyl mercury stands apart among the most toxic manmade forms of mercury. And starting in 1991, two new mercury containing childhood vaccines—the Hib and the hepatitis B vaccines—were introduced to the childhood immunization schedule. Combined with the DPT vaccine already in use, the licensure of the Praxis Biologics’ Hib vaccine contributed to a sharp increase in infant mercury exposure. As part of the core team that developed and commercialized this new product, Richard Insel was therefore intimately connected to the growing concerns over possible causes of exploding autism rates. And this was an issue his brother Thomas would later face in his role as the head NIH strategic planner for autism.

Thomas Insel, the Autism Strategic Plan and Vaccine Safety Research

In his role as chair of the Interagency Autism Coordinating Committee (IACC), Thomas Insel was instructed by the Combating Autism Act (CAA) of 2006 to develop a strategic plan for autism research. According to the CAA, the IACC must “develop and annually update a strategic plan for the conduct of, and support for, autism spectrum disorder research, including proposed budgetary requirements.”

This was no idle provision. The idea of requiring NIH to develop a strategic plan for autism research came out of months of intense discussion and negotiation among autism advocates as different versions of the CAA were making their way through Congress. In their normal course of business, NIH approves grant applications as they are submitted by scientists on a one-by-one basis. Although this approach ostensibly rewards high-quality applications, it also has well-recognized drawbacks. The collective bias of the review panels and the natural inertia of consensus-based science can make it difficult to attack new problems aggressively and sponsor controversial research. When a new disease problem requires more urgent action with funding directed strategically to priority areas for the disease rather than popular problems for science, the passive review approach can break down completely. Scientists are a cautious lot and typically apply for grants in areas that have broad scientific appeal, such as genomics, rather than those that may be most valuable in the case of a specific disease condition.

Because of this problem, autism community advocates, long dissatisfied with the slow response of the broader scientific community to the autism crisis, inserted the strategic plan provision into CAA. In order to make sure the new money was well-spent, these advocates proposed the strategic planning mechanism to hold NIH leaders accountable for their decision making. The autism strategic plan would set priorities and allocate resources for the entire body of autism research and force NIH to truly “combat autism” rather than simply process grants.

So in order to comply with these clear instructions from Congress, and starting in 2007,
Thomas Insel orchestrated a lengthy, complex and increasingly contentious planning process for autism research. After many hours of meetings, much debate and a controversial round of votes on the vaccine issue, the IACC released its first plan on January 26, 2009.

By all accounts, Insel ‘s initial approach to the planning process was made with energy and broad outreach. Nevertheless, many autism advocates were concerned with his managerial decisions from the beginning. At the outset of the process, he appointed another psychiatrist and autism parent, Joyce Chung, as project manager. But Chung’s objectivity was immediately called into question when advocates learned she was married to the anthropologist Roy Grinker. Grinker released a book on autism in 2007 called Unstrange Minds, in which he took the controversial view that rising autism rates are an illusion and the rising recognition of autism is merely a social phenomenon. The idea that his wife, Joyce Chung, would be project manager for the autism strategic plan mandated by an act of Congress inspired by the rising rate of autism sparked suspicion from the start.

Initial concerns among autism groups over the objectivity of the process first raised by Chung’s appointment increased over time. Given the instruction from Congress to develop a strategic plan but with no clear blueprint for how to do so, Insel chose to make up the process as he went along. And despite his active outreach, Insel chose to keep decision-making power close to the vest. Authority for writing the plan was first delegated to a hand-picked working group, one selected with no input from the IACC. Confronted with community concerns over the obvious potential for bias under such an approach, Insel disbanded this initial group and set up a second working group, one selected based on nominations by IACC members [full disclosure: one of us (MB) served on this second working group]. This group met once in person and once on the phone, was subsequently disbanded and replaced with a third hand-picked group.

The concerns over Insel’s management of the planning process escalated after that. During the IACC strategic plan reviews, there were numerous areas of debate. These included, but were not limited to, questions of vaccine safety. On December 12, 2008, the IACC debated the vaccine safety issue and voted (narrowly) to recommend research into the study of the link between autism and vaccines. Specifically, the draft plan recommended that NIH undertake to study of “vaccines, vaccine components and multiple vaccine administration in autism causation and severity through a variety of approaches including cell and animal studies and understanding whether and how certain subpopulations in humans may be more susceptible to adverse effects of vaccines.
Estimated budget $6,000,000."

In the context of the $900 million budget for autism research authorized under CAA, this was not a large amount, but for the autism community, it was a substantial step forward. IACC member Lyn Redwood of SafeMinds remarked at the time, “Although I would have rather had a colonoscopy than attend another IACC meeting, we surprisingly made some headway!”

But Insel moved swiftly to reverse this vote. In a surprise move during the next IACC meeting on January 14, 2009, Insel singled out this vaccine safety research provision and put it back up for a revote. According to the meeting transcript, Insel made a remarkable admission, “Let me introduce another issue, and I'm sensitive to Lyn's concern about reopening things we voted on…[but] this is perhaps the only issue that we've dealt with that is now part of litigation that involves the department; that it's a HRSA issue, and I'm concerned about the optics.”

In layman’s terms, the “optics” Insel was referring to was the simple issue of conflict of interest. He was asking how NIH, as part of the Department of Human Health and Services (HHS), could investigate issues relating to the programs of one its agencies (CDC) as it was adjudicating vaccine injury claims under another one of its agencies (HRSA). (The proceedings of the so-called “vaccine court”, including the Omnibus Autism Proceedings into the link between autism and some vaccine injuries, are managed by HRSA under the Vaccine Injury Compensation Act).

Insel claimed not to like how this looked. “So the optics of having HRSA vote on issues related to autism and vaccines, when they have a large court case, the optics of having people who could be perceived to have or to represent those who have a financial investment in this issue. It takes it out of the realm of a scientific question, a research question, and it raises the possibility that some could see whatever comments we make as being biased by non-scientific issues.”

So just two weeks before releasing the final strategic plan, Insel singled out the prior vote on vaccine research, and asked for a new vote. With full support from the HHS members on the panel (HHS holds a solid majority of the votes), the vaccine research was voted out of the plan.

NIH has not been so reticent to fund vaccine safety investigations when the charter and investigator team has been friendlier to vaccine manufacturers. In addition to Richard Insel, one of the three Rochester researchers credited by Porter Anderson and David Smith was Michael Pichichero. Pichichero describes himself on his web-site as “a member of the discovery team at the University of Rochester that invented, tested and licensed a Haemophilus influenza b (Hib) conjugate vaccine (HibTITER®) now universally given to children in the U.S.” But unlike Richard Insel, Michael Pichichero has conducted research into the toxicity of thimerosal. In two NIH funded publications, Pichichero gave thimerosal a clean bill of health. Nowhere in either publication did he mention his personal connection to HibTITER®.

Autism Community Concerns over Thomas Insel’s Leadership

In his remarkable admission, Insel worried aloud about the “optics” of NIH investigating the vaccine programs managed by its sister agency, the CDC, while claims of vaccine injury were being adjudicated by another sister agency, HRSA. His concern appears well-founded. Within the HHS family, there are no clear checks and balances on the power of the department to suppress one public interest (vaccine safety) in favor of another (vaccine promotion) when the department leadership chooses to retain potentially conflicting activities within the family.

But what about his brother’s vaccine? Interestingly, Thomas Insel has never matched his expressed concern over the “optics” of investigations within the HHS family with similar sensitivity to the optics problem within his own family. It’s a fair question. Could Thomas Insel be using his position as IACC chair to prevent funding of research that risks tarnishing his brother’s accomplishments?

Although Insel’s public posture on the connection on autism and vaccines has shifted over time, he has appeared consistently eager to reject any connection to the Hib vaccine. Himself a vaccine developer (he conducted an HIV vaccine research earlier in his career), he told one of us (DO) in an 2007 interview that while vaccines might be involved, the thimerosal theory had been “disproven.” When asked by a parent at the 2007 NAA conference for his views on the vaccine-autism link, he gave a noncommittal response. But then he went on to make an unsolicited remark. Out of either a desire to be provocative or insensitivity (or both), he told the audience that perhaps scientists would invent “a vaccine for autism” some day.

More recently, Insel’s position has hardened. In testimony in front of a Senate committee this month, he told Senator Tom Harkin that funding more research into the effects of the dramatic increase in childhood vaccines would be “a waste of money.”

When asked whether this information affected their trust in Insel’s capacity to direct autism research resources, autism advocates had more to say. IACC member Lyn Redwood of SafeMinds commented, “That certainly explains his bias with regard to vaccine research, it’s an obvious conflict of interest”, but preferred not to elaborate further.
Redwood’s organization, SafeMinds, issued an official statement, however, calling for institutional changes in the oversight of autism research. “"These revelations on conflicts of interest held by Insel are disturbing and help explain why he has abandoned scientific inquiry in favor of blocking any research relating to vaccines as a cause of autism. His claim during the Harkin hearing earlier this month that the vaccine-autism science is ‘done’ is in direct conflict with the recommendations of the National Vaccine Advisory Committee (NVAC) and others calling for baseline data on the health of unvaccinated children. A policy of deliberate ignorance is not an acceptable substitute for sound science. Our community would be better served by the leadership of an agency such as The National Institute of Child Health and Human Development (NICHD) whose mission is clearly aligned with biomedical research for children who are sick or the National Institute for Environmental Health Sciences (NIEHS) whose mission focuses on finding individual susceptibilities and environmental triggers to disease."

Others were more focused on Insel’s personal leadership and argued that he should resign from his post as head of IACC. "How can any autism organization or parent believe Insel will give vaccines a thorough look with his brother, at the very least, whispering in his ear?” asked JB Handley of Generation Rescue. “With a topic as sensitive and combustible as vaccines and autism, Insel needs to move on and hand the reigns over to someone with no conflicts, real or perceived."

Wendy Fournier from the National Autism Association was also critical of Insel’s IACC performance. “Tom Insel has lost the confidence of the autism community in his role as chairman of the IACC. He has wasted precious years for our children with his poor leadership and blatant bias. Our country is facing the biggest health crisis of our time. We need answers now, and that means following the science wherever it leads – even if it implicates the vaccine program.” Ms. Fournier also called for Insel to resign as IACC chair, saying, “This community desperately needs and deserves leadership that puts our children first. Tom Insel is clearly not the man for the job. How many more children will we allow to be lost under his watch?”

Although he now researches another chronic childhood onset illness at JDRF, Richard Insel has stayed away from autism research, but between his Rochester colleague Michael Pichichero’s research exonerating thimerosal and his brother Thomas’ efforts blocking research into vaccines in the autism strategic plan, his Hib vaccine has had ample defense. This is scant comfort for parents of autistic children, many of whom believe their children are vaccine injured and are losing faith in the integrity of the vaccine safety system as currently managed within the HHS family of agencies. Revelations like this go further than concerns over “optics”, and only serve to reinforce their perception that the system is rigged against them.

This is true for both weak and powerful autism parents. Katie Wright is the daughter of the founders of Autism Speaks, the world’s largest autism research organization. Her son Christian was the inspiration for her parents to start Autism Speaks and she has been a harsh critic of Insel’s leadership over the few years.

We asked Ms. Wright what she thought about Insel’s family conflict. She made the following statement. “The reason why parents do not trust the medical establishment regarding vaccine safety is because they see the pervasive conflicts of interest throughout the CDC and the NIH. The very same people who have long standing biases or financial interests in our vaccination program are the ones who work so hard to block any vaccine safety research. We need transparent and objective leadership at IACC, and Insel will never be able to provide that. It is time for Insel to go.”

Rebecca Estepp, of Talk About Curing Autism (TACA) concurred, arguing that Insel’s family conflict is only part of this greater concern over a rigged system of vaccine safety and wonders how HHS can defend its oversight of that system. "There’s an ancient dilemma about the problem of checks and balances on the powerful,” Estepp points out. “It goes in the form of a question. ‘Who is guarding the guards?’” She suggests that Insel’s personal connection to the vaccine business is part of this larger problem. “How can we expect impartiality from a regulator who himself has developed vaccines? How can we expect objectivity from a man whose own brother developed one of the vaccines in question?"
--
Dan Olmsted is Editor and Mark Blaxill Editor at Large of Age of Autism. Blaxill is also a director of Safe Minds.

8. Immunity for Swine Flu Vaccine Makers... not necessarily you

by Lindsayvalley

Thu Aug 20, 2009 at 08:33:07 AM PDT

Legal Immunity Set for Swine Flu Vaccine Makers is already in place before the new experimental swine flu vaccine comes rolling out.

Department of Health and Human Services Secretary Kathleen Sibelius has not only given immunity to the makers of Tamiflu and Relenza for injuries stemming from their use against swine flu, she has granted immunity to future swine flu vaccines and “any associated adjuvants”.

The last time the government embarked on a major vaccine campaign against a new swine flu, thousands filed claims contending they suffered side effects from the shots. This time around, they will have no recourse.

Lindsayvalley's diary :: ::
The 2006 Public Readiness and Emergency Preparedness Act (the PREP Act) allows the DHHS Secretary to invoke almost complete immunity from liability for manufacturers of vaccines and drugs used to combat a declared public health emergency. It also removes the right to a trial jury unless a plaintiff can provide clear evidence of willful misconduct that resulted in death or serious physical injury -- and gets permission to sue from the DHHS Secretary.

But once the PREP Act is invoked to shield manufacturers from liability, the pharmaceutical firms have no financial incentive to make the safest product, and have a negative incentive to test it for safety. As long as they do not deliberately harm consumers of the product, they will not be liable for damages.

As 120 million doses of H1N1 swine flu virus vaccine are being rushed out before flu season this fall, some are raising concerns over what they believe is an effort to rush the drug through safety trials.

One concern is the probability that the mercury-containing preservative thimerosal will be an ingredient in some of the doses of the new vaccine. Another concern is also the new adjuvant Squalene, which has devastating side effects when injected into the bloodstream. Oil-based vaccination adjuvants like squalene have been proved to generate concentrated, unremitting immune responses over long periods of time. Gulf War Syndrome (GWS) veterans received anthrax vaccines containing squalene. MF59 (the Novartis squalene adjuvant) was an unapproved ingredient in experimental anthrax vaccines and has since been linked to the devastating autoimmune diseases suffered by countless Gulf War vets. It is still not approved by the FDA.

A 2000 study published in the American Journal of Pathology demonstrated a single injection of the adjuvant squalene into rats triggered “chronic, immune-mediated joint-specific inflammation,” also known as rheumatoid arthritis.

The swine flu is officially being called a pandemic. However, the word 'pandemic' only means that a new virus is spreading across the world. It says nothing about its level of physical danger. That level of severity, according to The World Health Organization, is only “moderate.” And they go on to say:

“On present evidence, the overwhelming majority of patients experience mild symptoms and make a rapid and full recovery, often in the absence of any form of medical treatment.

Worldwide, the number of deaths is small. Each and every one of these deaths is tragic, and we have to brace ourselves to see more. However, we do not expect to see a sudden and dramatic jump in the number of severe or fatal infections.”

The fact is that the swine flu has claimed a mere 429 lives WORLDWIDE (as of July 15), while the regular flu (not the swine flu) has allegedly killed 13,000 in the United States since January (although there is strong support that even these types of figures are grossly exaggerated to increase vaccine sales).

As it stands, the run-of-the-mill flu is FAR more dangerous than the swine flu, and you were likely not worried about the regular flu before the media started hyping up this exotic new "killer flu." They sure know how to push our buttons.

Just like in 1976, today there is clearly a lot of fear-mongering going on that has a noticeable subplot -- preparing you for possible draconian measures by forcing you to accept the idea of mandatory vaccinations.

This is not the time to fall for hype. These public scare-tactics are designed to make money, not protect your health. Do your research. Evaluate your individual risk. Think for yourselves. Ask to read the vaccine insert. And remember, these vaccines also come with toxins, including ethylene glycol, formaldehyde, phenol (carbolic acid) and even antibiotics like Neomycin and streptomycin. Right into your bloodstream.

As long as this vaccine is not made mandatory, you have a choice. Make sure you inform yourself.

9. Gardasil Researcher Speaks Out

www.cbsnews.com

WASHINGTON, August 19, 2009
By Sharyl Attkisson

(CBS) Amid questions about the safety of the HPV vaccine Gardasil one of the lead researchers for the Merck drug is speaking out about its risks, benefits and aggressive marketing.

Dr. Diane Harper says young girls and their parents should receive more complete warnings before receiving the vaccine to prevent cervical cancer. Dr. Harper helped design and carry out the Phase II and Phase III safety and effectiveness studies to get Gardasil approved, and authored many of the published, scholarly papers about it. She has been a paid speaker and consultant to Merck. It’s highly unusual for a researcher to publicly criticize a medicine or vaccine she helped get approved.

Dr. Harper joins a number of consumer watchdogs, vaccine safety advocates, and parents who question the vaccine’s risk-versus-benefit profile. She says data available for Gardasil shows that it lasts five years; there is no data showing that it remains effective beyond five years.

This raises questions about the CDC’s recommendation that the series of shots be given to girls as young as 11-years ol. “If we vaccinate 11 year olds and the protection doesn’t last... we’ve put them at harm from side effects, small but real, for no benefit,” says Dr. Harper. “The benefit to public health is nothing, there is no reduction in cervical cancers, they are just postponed, unless the protection lasts for at least 15 years, and over 70% of all sexually active females of all ages are vaccinated.” She also says that enough serious side effects have been reported after Gardasil use that the vaccine could prove riskier than the cervical cancer it purports to prevent. Cervical cancer is usually entirely curable when detected early through normal Pap screenings.

Dr. Scott Ratner and his wife, who’s also a physician, expressed similar concerns as Dr. Harper in an interview with CBS News last year. One of their teenage daughters became severely ill after her first dose of Gardasil. Dr. Ratner says she’d have been better off getting cervical cancer than the vaccination. “My daughter went from a varsity lacrosse player at Choate to a chronically ill, steroid-dependent patient with autoimmune myofasciitis. I’ve had to ask myself why I let my eldest of three daughters get an unproven vaccine against a few strains of a nonlethal virus that can be dealt with in more effective ways.”

Merck and the Centers for Disease Control and Prevention maintain Gardasil is safe and effective, and that adequate warnings are provided, cautioning about soreness at the injection site and risk of fainting after vaccination. A new study in the Journal of the American Medical Association found while the overall risk of side effects appears to be comparable to other vaccines, Gardasil has a higher incidence of blood clots reported. Merck says it continues to have confidence in Gardasil’s safety profile. Merck also says it’s looking into cases of ALS, commonly known as Lou Gehrig’s Disease, reported after vaccination. ALS is a progressive neurodegenerative disease that attacks motor neurons in the brain and spinal cord. Merck and the CDC say there is currently no evidence that Gardasil caused ALS in the cases reported. Merck is also monitoring the number of deaths reported after Gardasil: at least 32. Merck and CDC says it’s unclear whether the deaths were related to the vaccine, and that just because patients died after the shots doesn’t mean the shots were necessarily to blame.

According to Dr. Harper, assessing the true adverse event risk of Gardasil, and comparing it to the risk of cervical cancer can be tricky and complex. "The number of women who die from cervical cancer in the US every year is small but real. It is small because of the success of the Pap screening program."

The risks of serious adverse events including death reported after Gardasil use in (the JAMA article by CDC’s Dr. Barbara Slade) were 3.4/100,000 doses distributed. The rate of serious adverse events on par with the death rate of cervical cancer. Gardasil has been associated with at least as many serious adverse events as there are deaths from cervical cancer developing each year. Indeed, the risks of vaccination are underreported in Slade's article, as they are based on a denominator of doses distributed from Merck's warehouse. Up to a third of those doses may be in refrigerators waiting to be dispensed as the autumn onslaught of vaccine messages is sent home to parents the first day of school. Should the denominator in Dr. Slade's work be adjusted to account for this, and then divided by three for the number of women who would receive all three doses, the incidence rate of serious adverse events increases up to five fold. How does a parent value that information?

Dr. Harper agrees with Merck and the CDC that Gardasil is safe for most girls and women. But she says the side effects reported so far call for more complete disclosure to patients. She says they should be told that protection from the vaccination might not last long enough to provide a cancer protection benefit, and that its risks - “small but real” - could occur more often than the cervical cancer itself would.

"Parents and women must know that deaths occurred. Not all deaths that have been reported were represented in Dr. Slade's work, one-third of the death reports were unavailable to the CDC, leaving the parents of the deceased teenagers in despair that the CDC is ignoring the very rare but real occurrences that need not have happened if parents were given information stating that there are real, but small risks of death surrounding the administration of Gardasil."

She also worries that Merck’s aggressive marketing of the vaccine may have given women a false sense of security. "The future expectations women hold because they have received free doses of Gardasil purchased by philanthropic foundations, by public health agencies or covered by insurance is the true threat to cervical cancer in the future. Should women stop Pap screening after vaccination, the cervical cancer rate will actually increase per year. Should women believe this is preventive for all cancers - something never stated, but often inferred by many in the population-- a reduction in all health care will compound our current health crisis. Should Gardasil not be effective for more than 15 years, the most costly public health experiment in cancer control will have failed miserably."

CDC continues to recommend Gardasil for girls and young women. The agency says the vaccine’s benefits outweigh its risks and that it is an important tool in fighting a serious cancer.

Dr. Harper says the risk-benefit analysis for Gardasil in other countries may shape up differently than what she believes is true in the US. “Of course, in developing countries where there is no safety Pap screening for women repeatedly over their lifetimes, the risks of serious adverse events may be acceptable as the incidence rate of cervical cancer is five to 12 times higher than in the US, dwarfing the risk of death reported after Gardasil.”

10. Dateline NBC: A Dose of Controversy

Links, web-exclusive videos, and more related to "A Dose of Controversy," Dateline NBC's unprecedented look at the emotional debate surrounding vaccines and the suggested link to autism.

Watch Online

Thoughtful House Statement

11. Dr. Bernadine Healy Implies Hubris on Part of Docs Who Deny Vaccine Autism Possibility