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TREATMENT

* Parents Push For 'Gold Standard' In Therapy

ADVOCACY

* Hope for Autism Comes At A Price

* Class Action by Children with Autism to Halt

Quebec Government Discrimination

* Teens Organize Autism Workshop

AWARENESS

* Is There A 'Geek' Syndrome?

PUBLIC HEALTH

* FDA Halts Use Of Old Anthrax Vaccine

* Readers' Posts

 

TREATMENT

Parents Push For 'Gold Standard' In Therapy

[By Kim Honey in the Toronto Globe and Mail.] http://click.topica.com/maaaATKaaT4cyaaaaaab/

They're just three little letters, but the dollar signs attached to them are about to make a profound impression on governments and taxpayers.

ABA, which stands for applied behavioural analysis, has been around since the seventies, but is only now entering the Canadian vernacular.

Parent advocates of autistic children are suing provincial governments and school boards, who in turn are loath to provide the therapy because it can cost between $40,000 and $60,000 per child per year.

UCLA psychologist Ivar Lovaas is considered the granddaddy of ABA, a system of behavioural modification that uses basic principles of psychology -- positive reinforcement, where children "work" for rewards such as candy or toys -- to gradually teach autistic children language skills and how to play appropriately.

Prof. Lovaas's 15-year study, published in 1987, showed 47 per cent of autistic children who received intensive early intervention before age 4 achieved "normal functioning."

He says autistic children need about 40 hours a week of the one-on-one treatment, which should focus first on language and speech deficits, then on integration with peers.

Intensive behavioural intervention, of IBI, is an umbrella term that includes Lovaas therapy, but provincial governments use it to refer to a wide range of intensive early-intervention programs, particularly those that are offered fewer than 40 hours a week.

Because of its claims to "normalize" autistic children, ABA has become the gold standard for parent advocates who are demanding it from health departments and schools.

"Everybody wants their kid to be cured, and they're being told that this is the only way to cure your kid," said Bryna Siegel, a psychologist at the University of California in San Francisco.

"So they'd be crazy not to want this."

There are organizations such as Families for Early Autism Treatment

(FEAT) that promote only Lovaas treatment.

Sabrina Freeman, a member of the B.C. chapter of FEAT, was one of the four people who successfully sued the provincial government.

The B.C. Court of Appeal recently ordered the province to provide ABA to four children, one of them Ms. Freeman's daughter.

Prof. Siegel said that although there's no question ABA works, it's not clear whether it works significantly better than other treatments.

In her own research, she found children who do well with ABA are self-learners who started out with fewer symptoms of autism: normal nonverbal IQs, some language, and a sense of curiosity.

Students in school-based intervention programs did very well, too, if their parents put a lot of effort into integrating them into the community.

"Typically these were intact families, at least one of the parents quit whatever they were doing full time to do this full time, and they really had a sense of keeping the child meaningfully engaged every moment of the day," she said.

Some of the other treatments and therapy that have shown results include TEACCH, a developmental program that uses structured teaching, and the Picture Exchange Communication System, or PECS, which employs pictures on cards to teach children to construct simple sentences.

 

 

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ADVOCACY

Hope for Autism Comes At A Price

Parents of children with disorder think costly new therapy can help offspring, but who will pay? Kim Honey reports

[By Kim Honey in the Toronto Globe and Mail.] http://click.topica.com/maaaATKaaT4claaaaaab/

The sun is already glinting off Bedford Basin when Jo-Lynn Fenton climbs the stairs in her neat, two-storey house in a new subdivision near Halifax.

She unlocks the door to the stark bedroom where her youngest son, Rhys, is crouched under the comforter muttering, "Cold, cold." His pajamas are in a heap on the floor.

Five-year-old Rhys has been known to wake up, ready to start the day, at 3:30 a.m., and spend the first few hours careering around his room, slamming his body into the walls. His parents took down his blinds after they found him chewing on them, and removed the dresser and change table so he couldn't use them as a launch pad for his particular brand of indoor gymnastics. Even the grate that covers the heating duct is screwed into the floor.

On this warm fall day, Mrs. Fenton, a slim, 39-year-old with a Bluenoser's lilt and self-deprecating sense of humour, has been up since 6:00 a.m., and there are three backpacks and two lunch bags lined up by the front door to prove it. Her husband, Bruce, a lieutenant in the navy, was up and out of the house before 7.

It's Monday, a school day, and that means Mrs. Fenton has about an hour to get Rhys and his nine-year-old brother, Liam, who has a milder form of autism called Asperger's syndrome, to their classrooms at Bedford South School, a few blocks away.

It's not an easy task. She has to dress Rhys, who refuses to allow her to do up the snaps on his red-and-navy striped rugby shirt or turn up the cuffs on his pants. Then there's Liam, who finds his brother's uncontrollable behaviour incredibly irritating. "He makes him nuts," Mrs. Fenton explained. "They get along like oil and vinegar."

The two boys have so many food issues it's hard to keep track: Liam will eat only about 10 foods, and Rhys, who is fatally allergic to eggs and nuts, absolutely refuses to eat the plain pasta he likes for lunch unless it's been cooked that morning. Both of them eat a bowl of dry Froot Loops and a glass of chocolate milk -- the only kind of milk they'll drink -- for breakfast.

Liam is egocentric, insists on controlling his environment, and has a very literal interpretation of language. When he gets frustrated, he can erupt in a tantrum, although not nearly as often or for as long as his brother.

Rhys, who is classified as extremely hyperactive, displays impulsive behaviour, never sits still, avoids eye contact, and talks in repetitive chunks, mainly lines of dialogue he's memorized from his vast collection of videos.

"The last psychologist's report for Rhys said I should not be alone with my children" because they are so difficult for one person to manage, Mrs. Fenton said, laughing at the well-meaning, but impractical, advice. "Really, to watch Rhys, am I really watching Liam? No."

There was a time not too long ago when children like Rhys would have been institutionalized and Liam's prospects for living an independent life would have been severely limited.

Now they go to school, where they are taught in special-education classes or, in many cases, integrated into the regular classroom. The transformation occurred as a range of therapies, most created by behavioural psychologists, made vast improvements in the lives of children once thought to be severely handicapped by their inability to talk, lack of social skills, sensory sensitivities and ritualistic behaviour.

"Research is showing us these kids can live independent lives; they can actually be employable if you do it [treatment] right," said Toronto school-board trustee Shelley Carroll, whose 12-year-old daughter has Asperger's syndrome. "If you get it right, you can save society from one more burden, and I think there are so many [autistic children] we've got to figure that out."

Like many parents of children with autism, Mrs. Fenton -- who has three university degrees -- is bright, well-educated, and an expert in the vagaries of the condition, not to mention the only reliable source of information about the idiosyncrasies of her children.

Advocates like her have been transformed into activists for the therapies that will allow their children to connect with a world that, for many, is nothing more than a disconnected jumble, a sensory overload.

That means teachers, principals, and school-board specialists are increasingly faced with parents who often know more about the subject than they do, and who are demanding what they see as the gold standard in treatments and therapies, even if that costs more than tuition at a private school.

The treatment they are pinning their hopes on -- mainly because a 1987 study showed almost half the children who received it for 40 hours a week achieved normal behaviour -- is called applied behavioural analysis or ABA.

Now that the B.C. Court of Appeal has ordered the provincial government to provide one-on-one therapy to four autistic children, at an estimated cost per child of between $40,000 and $60,000 a year, the stage is set for a showdown that will have vast repercussions for departments of health and education.

Although some provinces already pay for a version of ABA for preschool children, treatment is usually cut off once they reach school age.

Now parents such as Joyce Dassonville, a Dartmouth, N.S., lawyer, are setting their sights on school boards.

Her youngest daughter, Dominique, couldn't speak when she went off to kindergarten in 2000.

+ Article continues at: http://click.topica.com/maaaATKaaT4claaaaaab/

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Class Action by Children with Autism to Halt Quebec Government Discrimination Support Statement By Quebec Human Rights Commission

[Thanks to R. Miles.] http://www.newswire.ca/releases/October2002/21/c3079.html

CNW - A group representing hundreds of families of children with autism spectrum disorders announced today at a press conference that the Quebec Commission des droits de la personne et des droits de la jeunesse (Quebec's Human Rights Commission) has informed them of its intention to intervene on their behalf in their class action suit against the Quebec Government. The families have undertaken this legal action to put a halt to the Quebec Government's systematic discrimination which has been denying their children a medically necessary treatment, intensive behavioral early intervention. Only last week, a British Columbia Court of Appeal ruling against the BC Government established a clear precedent that it is discrimination under the Canadian Charter of Rights and Freedoms for a provincial government to not provide medically necessary fully funded intensive behavior intervention for children with Autism Spectrum Disorders of all ages as long as deemed beneficial by the child's physician.

By rejecting the Government of British Colombia's appeal of the BC Supreme Court's Auton decision, the BC Court of Appeal's ruling on October 9 has provided additional support to the Quebec parents' class action suit. The unanimous decision upheld the Auton decision which requires the BC Government to provide intensive early behavioral intervention, as a medical necessary treatment, for children with an Autism Spectrum Disorder (ASD). It has also opened the door for legal action on behalf of many thousands of children with autism conditions in various provinces in Canada who currently are being denied treatment. The Court of Appeal also extended the decision so that even school age children with Autism Spectrum Disorders, through court intervention if necessary, will be able to access such intervention if requested by the family physician (with the written support of a neurologist or psychologist), with non-compliant civil servants facing possible contempt charges. This decision will go a long way to compel provinces and territories, such as Quebec, that have been unwilling to finally provide effective autism treatment to provide it regardless of severity, specific diagnosis or age.

The court decision is all the more important given the rapid increase in the number of children diagnosed with autism conditions (63% increase from 1999 to 2001 in Canada). It is widely recognized that early intensive behavioral intervention can significantly improve the functioning of children with autism, which the BC Court of Appeal noted in its decision, and is critical to avoiding an otherwise bleak institutionalized future. Effective treatment provision will help to reduce lifelong costs to governments (cost- effectiveness research indicates by 50%), and will reduce the human suffering of people with autism conditions and their families. Because appropriate services are generally not available, human suffering associated with autism conditions in Canada is profound.

Two Canadian courts have now spoken: not providing effective treatment in the form of intensive behavioral intervention to people with Autism Spectrum Disorders is discrimination under the Canadian Charter of Rights and Freedoms. Autism Society Canada, therefore, throws its full support behind the legal action undertaken by the Quebec Autism Class Action Committee.

Autism Society Canada www.autismsocietycanada.ca

Quebec Class Action Committee http://beaudincom.com/autisme/

Fédération québécoise de l'autisme et des autres troubles envahissants

de développement http://www.autisme.qc.ca/

BC Court of Appeal decision http://www.courts.gov.bc.ca/jdb-txt/ca/02/05/2002BCCA0538.htm

* * *

Teens Organize Autism Workshop

Brebeuf students hope event will enable more parents to get aid for disabled children.

By Rob Schneider rob.schneider@indystar.com http://www.indystar.com/article.php?autism21.html

At Brebeuf Jesuit Preparatory School, students are expected to serve the community. But when a school government class took on autism as an issue, even state officials took notice.

What started last year as an invitation to state legislators to learn more about the neurological disorder has evolved this year into an effort to help parents of autistic children get the financial support and services they need.

Linda Smoot's government class has sent fliers to every school within a 75-mile radius of Indianapolis, inviting parents of autistic children to attend Operation Autism Connection, an open house scheduled for Tuesday from 2 p.m. to 7 p.m.

Experts will be on hand to help those parents sign up for support service waivers that can provide up to $13,500 to pay for services ranging from speech therapy to respite care so parents get a break from their child-rearing duties.

"I want them to walk out the door ready for it (the waiver) to be processed," said Susan Hansen, Brebeuf's chief financial officer and mother of a 16-year-old son with autism.

The waivers can make a big difference in quality of life for those dealing with an autistic child, experts say.

In Indiana, the number of children with autism registered in schools has grown from 116 in 1989 to 3,832 last year, according to the state Department of Education.

The disability can manifest itself in different ways, ranging from social and verbal impairment to self-destructive behavior and outbursts.

In April, the state made available 7,000 support service waivers for people with developmental disabilities, including autism. About 5,000 of the waivers are left.

But Hansen worries that not enough families know about them. "Families are confused because they think, 'I'm already on the waiting list,' " she said. But that's usually for an autism waiver -- not a support services waiver, she noted.

The autism waiver provides a higher level of financial support -- $20,000 to $40,000. But the state will have only 400 of the autism waivers by the end of this fiscal year in June, and there are about 2,000 families on a waiting list.

Hansen, a member of the Indiana General Assembly's Autism Commission, said she hopes Tuesday's event will help parents find some relief.

"We want to get the word out to people on the waiting list that, 'Hey, while you are waiting, you may be eligible for the support services waiver, that there are some other things out there you can take advantage of,' " said Alison Becker, director of the state's Bureau of Developmental Disabilities.

Becker said students have done their homework for the open house, even attending a meeting of the Autism Commission a month ago.

"It was really neat to see this class take this on as a project," she said. "You don't see high school kids take an interest in this population."

Senior Erin Greer, 18, is one of those students.

In addition to working on the open house, she has spent the past year as a "big buddy" to a 13-year-old boy with autism. They visit The Children's Museum and go on other outings.

"It was really a neat, eye-opening experience," she said of learning to communicate with the youth and watching how other people reacted to him.

Teacher Smoot said the project has another lesson -- that though government can be frustrating to navigate, it's not impossible.

"That's what I want kids to see -- it can be done."

Call Rob Schneider at 1-317-444-6278.

* * *

AWARENESS

Is There A 'Geek' Syndrome?

Observers are mystified by an explosion in autism cases, especially in California, where the increase has been more than 200 per cent. In Ottawa and Silicon Valley, Carolyn Abraham explores one controversial theory: That people with superior technical ability but poor social skills are meeting and mixing genes in high-tech centres, and having offspring susceptible to a disorder whose traits hold up an eerie mirror to our computerized culture.

[When does a phenotype become a stereotype? When the lay media gets ahold of it. By Carolyn Abraham in the Toronto Globe and Mail. -LS] http://click.topica.com/maaaATKaaT4cmaaaaaab/

At the basement computer in a bungalow just outside Ottawa, Sean McRae is designing a town. Eyes glued to the screen, hand to the mouse, he is holding forth on the cost-benefit ratios of various municipal

infrastructures: "Light residential versus commercial, hospitals at $500, stadiums at $5,000. All developments must be connected to a power grid or people can't see. Put it here and it's just that simple."

Sean is eight years old. Before his fascination with civic planning, it was clocks, right down to their pinion springs. Before that, it was world calendars, then National Hockey League arenas -- he can name the seating capacity of every one. Sean could read by the age of 3, and recite numbers in five different languages.

But even now he can't brush his teeth, or play with other kids at birthday parties.

Sean was 4 when doctors told Rob and Elizabeth McRae that their son had high-functioning autism. He had the classic social deficits, the screaming tantrums at the beeping of a microwave or the misplacement of a toy, the frustrated hand-flapping, the rocking and running in circles to calm himself, and the fixation on routines and arcane facts (his favourite book is the Nokia cellphone manual).

The McRaes have no idea how their son came by this baffling neuro-developmental disorder. But what they do see is a mysterious genetic

connection: Rob McRae is a computer programmer who recognizes his own traits in Sean, the visual memory, technical proficiency and intense concentration. He even rocks in meetings, he says, and so do other colleagues in Ottawa's high-tech field.

In fact, doctors have noted that parents in fields such as engineering and computer science, with their particular talents and quirks, seem to run a greater risk of having children with autism or its high-intellect variant, Asperger's Syndrome. Now, this link is becoming a matter of public debate, pinging through the tech corridors of Ottawa and the on- and off-line networks of Cambridge, Dublin and Boston's Route 128. Some call it "Geek Syndrome."

When the McRaes met parents of other children with Autistic Spectrum Disorders through the Royal Ottawa Hospital, they noticed that most of the families had at least one parent in computers, engineering or math. Elizabeth McRae, who is now president of the Ottawa chapter of the Autism Society, can name 10 off the top of her head.

"If you look at the parents," says Jeanette Holden, a geneticist and professor at Queen's University, "you can think of autism as a 'super them.' "

Anita Acheson calls it the "too-much-of-a-good-thing theory." Mrs. Acheson, who has a 12-year-old son with autism, is an Ottawa computer programmer, married to another computer programmer. As she puts it, 30 years ago, she might have been a math teacher and her husband an engineer. Then they never would have met, as they did at Carleton University's school of computer science.

The Achesons are among the participants in Dr. Holden's project, backed by the Canadian Institutes of Health Research, to collect the DNA of affected families. "Wherever you have a high density of people in computer programming . . . clustering in a certain place," Dr. Holden says, "my sense is you're going to see this trend."

Bill Gates, don of the Microsoft monopoly and the world's richest man, is thought to be the best-known public face of Asperger's, prone to rocking, monotones and temper tantrums. Microsoft has taken the extraordinary step of paying for its employees' autistic children to undergo costly behavioural-analysis therapy.

It may be that human ingenuity has always owed a debt to traits on the autistic spectrum, that from somewhere along this dimension genius springs, giving us the wheel, the steam engine and the rocket as well as the microchip. But in our ever-more-wired world, where toddlers can learn the alphabet on the Internet, it's reasonable to ask whether our technical fluency is slowly enriching the species with a genetic vulnerability to social-deficit disorders.

Hans Asperger himself, who identified the syndrome that bears his name in 1943, likened the affected children to "automatons." One of the leading experts has said computers were invented by and for people with Asperger's. It all leads to an eerie image of the tools remaking their makers.

And nowhere more hauntingly than in the high-tech mecca of Silicon Valley, California. There, nestled in the apron of the Santa Cruz mountains, where Hewlett met Packard and the digital age flickered to life in a Palo Alto garage, residents fear they are in the midst of an autism epidemic.

On a brilliant Saturday morning three weeks ago, 300 anxious parents, teachers and therapists filed into the darkness of the Lewis B. Meyer auditorium at Santa Clara University. They bore notepads, name tags and the most troubling of questions: Why are our children sick? Santa Clara is one of those blink-and-you-miss-it northern California towns, one of more than a dozen in Santa Clara County, better known by its proud nickname of Silicon Valley. The valley is only 80 kilometres long, but in its brief stretch from San Francisco to San Jose are the low-slung office parks of more than 12,000 electronics and software companies, giants like Intel, Netscape, Sun Microsystems, 3Com and Cisco.

More high-tech professionals live among the valley's 1.8 million people than anywhere else on the planet, and those that have turned up this morning are hearing too much to process: Autism appears to be exploding all over the industrialized world. But here in California, the numbers are staggering.

From 1987 to 1998, the state Department of Developmental Services recorded a 273-per-cent jump in demand to treat autistic disorders, while the state population grew only 19 per cent. And that figure doesn't include cases of high-functioning autism or Asperger's.

Once considered rare, autism is now the No. 1 disability entering California state social services. Greater awareness may partly account for it. But a two-year, state-wide investigation released this week concluded the trend cannot be explained by artificial factors, such as changes to diagnostic practices or immigration.

State officials report an average of eight new cases a day, meaning that a child in California is diagnosed with autism every few hours.

"These kids are coming out of the woodwork," says conference speaker Rick Rollens, a former secretary of the California Senate whose son has autism. "Anyone who doesn't call this an epidemic is in denial. They say these kids were missed before, but that would be like missing a train wreck."

His point is clear on a trip to the nearby Morgan Center, a day school for children and adults with autistic disorders. There's Mattie, 8, who has pulled his Tupperware container of macaroni from his lunchbox and insists on eating it -- right now, though it's only midmorning.

But Mattie can't speak, so he squeals at a deafening pitch, his hands flapping ceaselessly as a teacher tries to distract him with a detailed drawing of an apple tree. Mattie takes a swing at her, but then accepts a magic marker.

And then there comes a glimmer of the mind within: Despite his continued screaming and flapping, he manages to trace that fruit tree with remarkable precision.

Inside, hunched over a piece of foolscap, is Jeff, 35, who has been at the Morgan for 27 years. When he learns there is a visitor from Canada, he looks up: "My mother was born in Canada. In Victoria, British Columbia. My Aunt Helen lives in Victoria, in British Columbia, that's a province in Canada," he says, his pencil hardly pausing as it covers the page in columns of long division and multiplication with nine- and 10-digit numbers.

One in 10 people with autism is a savant. "You can give Jeff almost any number to multiply. He can do it about as quick as a calculator," says Jennifer Sullivan, the school's executive director. Calculators, computers, Gameboys, any gadget with buttons, levers or knobs are the most treasured toys at the Morgan Center. Educators use computer time to reward lessons well done, and exploit them as one of their most powerful teaching tools.

"With computers," Ms. Sullivan says, her students "can't fail, or be judged. They push a button, they make something happen."

Referrals to the Morgan Center have ballooned, as have autism programs at all the local schools, some hiring student aides straight out of Starbucks to cope with the caseload. It was Ms. Sullivan and her staff who organized the Santa Clara conference, officially entitled, "Autism: Is there an epidemic in Silicon Valley?"

In the discussions there, all the usual suspects were trotted out as possible causes: childhood vaccines, despite studies and reassurances from mainstream medicine; environmental toxins; autoimmune triggers; infections; or genes -- their genes.

The morning session was dominated by the similarities between autism and the traits associated with the valley's high-tech heroes, who can devote endless hours to writing code and design silicon chips the size of quarters, but are often more comfortable with computers than with people.

The Massachusetts Institute of Technology, a premier training ground of the techcentric, actually provides a one-day seminar to school its students in basic social skills. It teaches table manners, deciphering body language and how to dress, make small talk, listen attentively, make eye contact -- and ask for a date, in a session called "Nerdy Love."

It was Wired magazine, the high-tech bible, that coined the term Geek Syndrome for the Silicon Valley autism explosion. Not long ago it would have come off as a school-yard slur. But the computer revolution made geek chic -- not to mention wealthy, powerful and proud.

The first Geek Pride Festival took place in Boston two years ago, attracting more than 3,000 attendants, who rallied to the cry of "Be There and Be Square." Silicon Valley has celebrated its idiosyncrasies with similar exuberance, in offices where employees can ride between cubicles on pink bicycles, or descend floors on slides instead elevators.

So it's with little fear of a spam attack that Steve Silberman, who wrote the Geek Syndrome article, took to the stage to discuss Silicon Valley's oddities. He talked about how much children with autism reminded him of the software executives he interviews. One man, with an autistic daughter, so hated the ring of his telephone that he replaced the bell with a light, and disabled the buzz of the clothes dryer in favour of a pop-up icon on his computer to tell him when it's time to unload.

"I think we're all living somewhere on the spectrum," Mr. Silberman told the audience, who laughed as they might at a comedian whose jokes cut close to home.

In the crowd was Sandy McInnis, a slight computer engineer in a blue shirt and dockers. Mr. McInnis and his wife, also a software engineer, have a young daughter with autism. He can see parallels, but he worries the tech-autism link trivializes the disorder's devastating impact: "Autistic disorder is much more severe than Asperger's or being a geek. We are talking here about children who cannot talk, who cannot understand much of anything, scream frequently for no apparent reason."

Certainly many feel insulted by the notion that they carry "geek genes," that the very discussion adds medical stigma to stereotype. Autism, after all, strikes all ethnicities and social classes; one of the highest known rates of the disorder is in Brick, N.J., a town known for fishing and tourism, where residents fear that an unknown toxin is causing autism in four out of every 500 children.

But Ms. Sullivan says the link to tech professionals is tough to ignore. "We all notice that there are more parents who are engineers who have these kinds of kids. Usually there's just something, I don't know, odd about them," she says. "At cocktail parties, they're talking about something you're not remotely interested in, but they don't have a clue, they can't read your body language or see your boredom. Once we had an event at the school and we couldn't get these particular parents to leave. Everyone else had gone, we had our keys in our hand and we were turning out the lights.

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* * *

PUBLIC HEALTH

FDA Halts Use Of Old Anthrax Vaccine

[This begs the question: Is this situation analogous to the purported "dirty vaccines" - Autism connection? By Thomas D. Williams, Courant, Connecticut, CTNet.com. -LS] http://click.topica.com/maaaATKaaT4czaaaaaab/

As the U.S. gears up for a potential confrontation with Iraq, the U.S. Food and Drug Administration has halted use of older lots of the military's anthrax vaccine, and officials acknowledge that the vaccine is riskier than once thought.

In August, the FDA acknowledged that the vaccine manufacturer's license needed to be updated. That was seven months after the agency ordered that new warnings for consumers be included in the vaccine's insert package. It said the vaccine could harm people with immunity disorders, could cause a host of serious long-term adverse reactions and could already be responsible for six deaths and a number of birth defects.

The warnings, developed from complaints by military vaccine users since 1998, state that adverse reactions are expected in 5 percent to 35 percent of people who take the injection. That compares with the previous expected rate of 0.2 percent, established many years ago.

But the label represents more than a simple warning. It is tantamount to an FDA admission of a licensing problem that began in 1985 and remains unresolved today.

The Department of Defense has said it is developing a new anthrax vaccine to respond to the concerns connected to the one in use now, but it asserts that the vaccine is both safe and effective.

In 1985, the FDA began reviewing the anthrax vaccine's manufacturing process to ensure it complied with federal rules for drugs. Recently, the FDA conceded to two Connecticut Air Force Reserve pilots that the review was never completed. The FDA told Maj. Russell Dingle and Maj. Thomas Rempfer that it would accomplish this, but didn't set a deadline to do so.

Dingle, of East Hartford, and Rempfer, of Suffield, who jointly filed a citizen petition with the FDA and a federal lawsuit against the manufacturer challenging the vaccine, said they don't truly expect the FDA to review the process again. That is because if the agency does, they said, it will have to stop licensing the drug. The central problem is that the drug was never properly tested, said the two pilots, who have been researching the drug since they were ordered to take it while in the Air National Guard in 1998.

Manufacturers apply for drug licenses with the FDA after testing their products on volunteers. The FDA reviews the tests, the vaccine's safety and effectiveness and the manufacturing process before approving the license to manufacture the vaccine.

In 1970, Merck, a pharmaceutical company, obtained the initial federal license to produce the anthrax vaccine. It eventually stopped manufacturing the drug.

In the 1970s and 1980s, the Pentagon began sponsoring the manufacturing of the vaccine through the state of Michigan's health department. It used the old Merck testing data, collected from volunteers working in sheep wool mills, to justify the safety and effectiveness of the Michigan-manufactured vaccine.

Because the FDA never properly scrutinized this testing, and because the manufacturing process was changed in 1990, said Dingle and Rempfer, the drug simply is not properly licensed.

And its latest adverse reaction rate, they said, shows the vaccine is indeed different from the one tested by Merck.

In 1998, BioPort Corp. of Lansing, Mich., purchased the state of Michigan's manufacturing operation and all of its vaccine, then used it to inoculate the first 500,000 of the 2.4 million service members ordered to take it. In the meantime, BioPort sought approval to produce its own new batches of the vaccine.

In January, the FDA approved BioPort's facilities and its vaccine manufacturing processes after four years of failed federal inspections and infusion of millions of more taxpayer dollars for plant improvements.

As a result of Dingle's and Rempfer's challenge to the vaccine, the FDA said only the new BioPort batches can be used. In June, the Pentagon had ordered both the old and BioPort's newer vaccine to be used, in high threat areas only.

Because of the FDA's concession that the old vaccine, manufactured by the state of Michigan and sold by BioPort, was not properly tested for safety and effectiveness, Rempfer and Dingle said, the Defense Department should now promptly pardon hundreds of service members punished for refusing to be inoculated with that vaccine. They insist the department should also properly care for the hundreds who became ill from adverse effects of the vaccine.

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Readers' Posts

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Does anyone have any info and/or any experience with Carnosine, Carn-Aware, or Dr. Michael Chez? I have ordered for my HFA 7 year old son. Please respond to ikeyoung@paducah.com

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Is your life touched by Autism, ADD/ADHD, Chronic Fatigue? Are you working to give your child or family member a future? The NeuroImmune Dysfunction Research Institute and Parent Coalition are excited to bring to you 'The NIDS Network', a newsletter dedicated to bringing you information on Neuro-Immune Dysfunction Syndromes - from bloodwork to research to immune modulators. The inaugural issue of The NIDS Network is ready to hit the streets. To obtain a newsletter, call the NIDS number 1-888-540-4999 or 1-818-951-8579 or email to info@healnids.org and leave your name and complete address.

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The Institute of Medicine's Immunization Safety Review Committee will publicly release its report, "SV40 Contamination and Polio Vaccine and Cancer" on Tuesday, October 22, 2002 at 10:00 AM EDT. Upon release, the report and the news release will be available on the Web at http://National-Academies.org.

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Scottsdale, AZ. Interested in finding speech delayed classes for 4-5 yr. old verbal girl. Group classes and local school district information on sites that offer speech emphasis, OT, PT, classes appreciated. DAWCFP@aol.com

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Seeking teacher/ therapist to work with communication in Dallas Moisuk1@airmail.net

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Talk About Curing Autism (TACA)- San Diego (formerly Autism Intervention San

Diego) Monthly Support Group & Training for Parents & Professionals Meeting Tuesday evening, Oct. 22 6:30-8:00 Catholic Charities, Mira Mesa 9535 Kearny Villa Rd. #101, San Diego, CA 92126 Topic: Relationship Development Intervention (RDI) Lisa Rose at LCRose@ispwest.com.

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Hiring caring and experienced therapists, Senior Therapists, and consultants (M.A. degree required for consultants). Growing agency with exceptional reputation in the South Bay (Southern California). Send resume by email. sabrinam@autismed.com

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New manual on teaching social skills to children with autism. A user-friendly Hands-on tool, aimed at assessment and teaching strategies using the Module System. www.kellymckinnon.com, Kelly McKinnon, M.A., Janis Krempa, M.Ed

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My autistic daughter doesn't seem to fit any standard autism profile, ie.; vaccinated (no), antibiotics (no), dairy in first year of life (no), regression (no). I'm at a loss as to a 'why' my child is autistic. Are there any other parents who have a similar story? I have a theory, but no one to bounce ideas off of. Thank you all in advance for any contribution. Teri Baker teribaker97436@yahoo.com

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We are parents of a 6 year old ASD boy for whom we are considering risperidone (resperdol). Would greatly appreciate any insights into/experiences with this. chengwajnowski@msn.com

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