SCHAFER AUTISM REPORT "Healing Autism:

No Finer a Cause on the Planet"

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October 18, 2002 Promote Your Event - Free! - Send a

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RESEARCH

* UCD M.I.N.D. Institute Study Finds Autism Increase Is Real

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PUBLIC HEALTH

* FDA Seizes 'Autism' Supplements from Kirkman Labs

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* Brain Scans Reveal Clues About Asperger Syndrome

* Families With Two Or More Children With Autism Sought For

$10.2 Million Study

TREATMENT

* Fish Oil May Help Relieve Stubborn Depression

* Morning Dose of Adderall XR Improves ADHD Into Evening

ADVOCACY

* Treat, Says The Court

* Readers' Posts

RESEARCH

UCD M.I.N.D. Institute Study Finds Autism Increase Is Real

Sacramento — The unprecedented increase in autism in California is real and cannot be explained away by artificial factors, such as misclassification and criteria changes, according to the results of a large statewide epidemiological study:

“Speculation about the increase in autism in California has led some to try to explain it away as a statistical issue or with other factors that artificially inflated the numbers,” said UC Davis pediatric epidemiologist Robert S. Byrd, who is the principal investigator on the study. “Instead, we found that autism is on the rise in the state and we still do not know why. The results of this study are, without a doubt, sobering.”

Key findings of the study are that:

• The observed increase in autism cases cannot be explained by a

loosening in the criteria used to make the diagnosis.

• Some children reported with mental retardation and not autism did

meet criteria for autism, but this misclassification does not appear to have changed over time.

• Because more than 90 percent of the children in the survey are

native born, major migration of children into California does not contribute to the increase.

• A diagnosis of mental retardation associated with autism had

declined significantly between the two age groups.

• The percentage of parent-reported regression (loss of developmental

milestones) does not differ between two age groups.

• Gastrointestinal symptoms, including constipation and vomiting, in

the first 15 months are more commonly reported by parents in the younger group

“While this study does not identify the cause of autism, it does verify that autism has not been over-reported in the California Regional Center System and that some children diagnosed with mental retardation are, in fact, autistic,” Byrd said.

Byrd and his research team earlier this year enrolled 684 California children who received services from one of the California Regional Centers to participate in the study. They systematically gathered information for children in two age groups - 7 to 9 years of age and 17 to 19 years of age - from families of 375 children with a diagnosis of full syndrome autism and 309 children with a diagnosis of mental retardation without full syndrome autism. Byrd, a pediatrician with UC Davis Children’s Hospital, and his colleagues, conducted the study for the M.I.N.D. Institute at UC Davis to help explain reasons behind significant increases in the number of autistic children entering the state’s 21 regional centers.

A 1999 report by the California Department of Developmental Services (DDS), which operates the centers, found a 273 percent increase in autism cases between 1987 and 1998. The report was the catalyst for the state Legislature and Gov. Gray Davis to direct DDS and the M.I.N.D. Institute to identify factors responsible for the increase, funding the effort with a $1 million appropriation.

Autism is a complex and severe developmental disorder that affects a person’s ability to communicate, form relationships with others, and respond appropriately to the environment. Those affected may avoid making eye contact and lack the ability to read faces for signs of emotion or other cues. Children typically do not engage in social play or games with their peers. Unusual behaviors such as rocking, hand-flapping or even self- injurious behavior may be present in some cases.

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Commentary

By Rick Rollens

Parent advocate

The take-away message today from the M.LN.D. Institute’s groundbreaking and comprehensive three year $1 million study is that California’s rapidly growing autism epidemic is REAL, and that this epidemic cannot be explained away by increased awareness, better diagnosis or having missed these children in the past, or by confusing autism with other disorders, or by families moving to California for services for their autistic children.

It is clear that a purely genetic basis for autism cannot explain the rapidly increasing numbers of new cases of autism in California; in fact, as we all know, you cannot have a purely genetic disease epidemic. We now know that environmental factors are at play.

As a result of this study, those who have simply refused to believe that we are in the midst of a real autism epidemic no longer can put forth their simplistic explanations and denials that the epidemic exists, indeed those explanations and denials have now been scientifically removed from the debate.

We now know that inure parents then ever are reporting cases of regressive autism and gastrointestinal problems that plague their autistic children. We also know that over one-third of parents of young children with autism believe that vaccines caused their child’s condition.

This study sustains what many in the autism community believe, that is, that the autism epidemic is real and growing and that a major commitment of hundreds of millions of dollars to support research and treatments for this national health emergency is urgently needed. That efforts such as those that are underway at the M.I.N.D. Institute to examine the role of environmental factors such as toxic and viral exposures, as well as autoimmune issues, and childhood vaccinations in the development of autism should be immediately accelerated to the top of the autism research agenda.”

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Commentary

By Bernard Rimland, PhD.

Autism Research Institute

The study released today by the M.I.N.D. Institute wil1 prove to be a landmark, in that it clearly dispels many myths and misconceptions regarding the reality of the widely discussed epidemic of autism.

The report states that:

I. The epidemic is very real. There has been an enormous increase in the prevalence of autism, and the increase cannot be explained by the artifacts of

a. Greater awareness of autism.

b. Looser criteria for the diagnosis of autism.

c. Immigration of families seeking services for autistic children into

California.

II. The cause of the increase cannot be attributed to genetic factors (there is no genetic epidemic). Therefore, the environmental causes wbich have been implicated by numerous researchers in the U.S. and the U.K., especially immune and autoimmune dysfunction due to exposure of the child to the mercury and viruses in childhood vaccines must be given high priority research attention.

111. The recent increase in gastrointestinal symptoms in the first 15 months of life, as reported in the study, is highly consistent with the excessive vaccination theory of causation and underlines the urgency of exploring vaccine-related issues.

While I am in agreement with the major conclusions of the California Study, which support and confirm the findings of studies done elsewhere, I disagree with the statement that “recent estimations put the prevalence at 10 to 12 per 10,000 persons.” In fact, a number of studies in the U.S. and the U.K. have reported figures as high as 45 to 60 cases of autism per 10,000 live births. The epidemic is not only real, but also very serious.

I also observe that while the focus of the new report is on autism, there are similarly unexplained large increases in the last 15 years in a number of other childhood disorders involving immune system dysfunction such as ADHD, asthma allergies, and juvenile diabetes. These, like autism, have increased dramatically since the 1980s while the number of vaccine doses given before age two has increased from 8 to 22.

This new report on the epidemiology of autism in California is a call for action that must not be ignored. Vaccines have never been properly evaluated for safety. The assumption of safety is not warranted. The problem must be confronted with research aimed at rational changes in vaccine policy.

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PUBLIC HEALTH

FDA Seizes 'Autism' Supplements from Kirkman Labs

FDA's Senior Veternarian Lester Crawford Sics US Marshalls on popular supplier

The US Food and Drug Administration said on Thursday it had ordered the seizure of hundreds of bottles of a dietary supplement that the agency said falsely claimed to treat autism.

US marshals raided Humphrey Laboratories of Lake Oswego, Oregon, doing business as Kirkman Laboratories, and took away bottles of Kirkman's HypoAllergenic Taurine Capsules, the agency said.

"FDA seized these products because they violate the Federal Food, Drug and Cosmetic Act," the agency said in a statement. "In accordance with the Act, all dietary supplement products' labeling must be truthful and not misleading and may not make any claims that the product will cure, mitigate, treat, or prevent disease."

The FDA did admit in their statement that "to date no illnesses have been reported in association with consumption of this product." The FDA actions are apparently not in response to consumer complaints.

FDA will continue to identify and take appropriate enforcement actions against fraudulently marketed dietary supplement products that make unsubstantiated medical claims in their labeling.

"Consequently, the claims that the capsules treat autism caused the firm's product to be a misbranded food and an unapproved new drug."

Apparently, the offending assertion comes from a description of Taurine in Kirkman's catalogue that includes the following: "Dr. Jeff Bradstreet, a physician in Palm Bay, Florida who treats autistic patients reports good success in treating autism with Taurine."

The FDA said it tracked down the company from its Internet site.

In a reprint of an article that appeared in this newsletter just last Tuesday, "Stung by Courts, F.D.A. Rethinks Its Rules", the NY Times reported on the FDA's controversial practices like the raid on Kirkman's:

"After losing a series of court decisions that found it in violation of the First Amendment's guarantee of freedom of speech, the Food and Drug Administration has begun a wide-ranging review of regulations that control what the makers of drugs, supplements, food and cosmetics can say about their products.

"At issue is the delicate balance between a company's right to communicate with its customers and the food and drug agency's mandate to protect the public.

"But the court decisions, which included a stinging rebuke from the Supreme Court in April, have prompted the agency to ask whether it may, at times, have gone too far in its insistence that it decides when scientific truth has been established and what companies can say. At issue are regulations governing everything from what a drug company can print on a T-shirt to what a sales representative can say in the privacy of a doctor's office.

"No one is advocating that false or inaccurate claims be permitted. But agency officials are asking questions like whether they can continue to prevent food companies from making health claims for their products and whether they can continue to insist that drug advertising include a full accounting of side effects and conditions that may make the drug inadvisable.

[Contact the FDA at:]

FDA Deputy Commissioner Lester M. Crawford email: deputy.commissioner@fda.gov or 5600 Fisher Lane, Rockville, MD 20857, Phone: 301-827-2410, Fax: 301-443-3100

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Commentary on

FDA Seizure of Taurine,

'A Perfectly Safe and Very Useful Supplement for Autism'

By Bernard Rimland Ph.D.

Autism Research Institute

The FDA seizure of "hundreds of bottles" of taurine from Kirkman Laboratories is doubly outrageous.

First, a study commissioned by the FDA itself in the 90's reported that no serious side effects were seen in any of 442 research STUDIES in which human subjects were given single amino acids such as taurine. Why deprive autistic children of a nutrient often found helpful to them, when there is no evidence whatever of possible harm?

Second, when there are well over 100,000 deaths per year in the US from FDA approved prescription drugs, an immense damage done to children given FDA approved vaccines, why is the FDA expending precious resources seizing safe, nutritional supplements intended to help the very children harmed by these vaccines?

I hope every family that reads this commentary will write or phone their congressmen and Senators to urge that the FDA's ongoing relentless war against nutritional supplements be stopped immediately, and that the FDA be required to address the truly harmful products: prescription drugs and vaccines.

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RESEARCH

Brain Scans Reveal Clues About Asperger Syndrome

Reuters Health - For the first time, brain scans of people with a type of autism called Asperger syndrome are helping scientists to zero in on abnormalities in brain function that may explain their behavior.

Autism, which affects about 1 in every 500 children, impairs a person's ability to communicate and form relationships with other people. People with Asperger syndrome are relatively high functioning and are not learning-disabled, according to Dr. Declan G. M. Murphy and colleagues at St. George's Hospital Medical School in London. Instead, these individuals tend to have impaired social skills, and also to exhibit obsessive-compulsive type behaviors.

While people with autism are known to have abnormalities in the frontal lobe and other parts of the brain, there has not been any research into whether people with Asperger syndrome have such abnormalities. To investigate, and to find out if abnormalities might be linked to behavior, the UK team performed MRI scans of the brains of 14 people with Asperger syndrome and compared them with scans from 18 healthy people.

Their findings are published in the October issue of the Archives of General Psychiatry.

"We found significant differences in the amount, and connectivity, of nerve cells in the brains of people with Asperger syndrome," Murphy told Reuters Health. "These differences occurred in brain regions which are crucial to understanding human emotions, and in repetitive 'checking' behaviors.

"In addition, degree of biological abnormality was related to severity of symptoms," the researcher added.

These findings demonstrate that people with Asperger syndrome have biological differences in their brains that explain their behavior, noted Murphy, who added, "they aren't simply 'weird.' "They were born with these differences and they weren't caused by the way they were brought up, but they are caused--most likely--by differences in cell development," Murphy explained.

Murphy notes that the new findings fill a major gap in understanding why people with Asperger syndrome are the way they are.

"Further studies are needed of brain development and aging across the spectrum of people with autistic disorder," the authors conclude.

SOURCE: Archives of General Psychiatry 2002;59:885-891.

Copyright © 2002 Reuters Limited.

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Families With Two Or More Children With Autism Sought For $10.2 Million Study

Researchers have launched a hunt in Washington and 15 other states for 250 families with two or more autistic children to participate in a $10.2 million University of Washington study to uncover the genetic and neurobiological causes of autism. The National Institute of Child Health and Human Development, one of the National Institutes of Health, is funding the study, which is also designed to develop intervention programs to assist children with the development disorder. Geraldine Dawson, director of the UW's Autism Center and a psychology professor, heads the interdisciplinary team of researchers.

Dawson said children selected for the genetic study will receive free diagnostic evaluations, and their families' travel and hotel expenses associated with the study also will be covered. The genetic testing and diagnostic evaluations will be conducted at cooperating universities and clinics in Alaska, Arizona, California, Colorado, Florida, Georgia, Idaho, Montana, New Jersey, New York, North Carolina, Oregon, Pennsylvania, Tennessee and Texas, as well as at the University of Washington.

Research by Dawson and others indicates that autism appears to be a spectrum of developmental disorders, rather than a single one. The condition interferes with a child's ability to communicate or relate socially with other people. Those afflicted with autism have a restricted range of activities and interests, and about 75 percent of children with autism also have some form of mental retardation. "We are interested in what accounts for the tremendous variability in people with autism," said Dawson. "Some go on to the regular classroom in school while 25 percent never develop any kind of spoken language. There may well be many subtypes of autism, just as it appears there are different types of Alzheimer's disease.

"In our genetics research we are trying to locate between five and 20 genes that are possibly related to autism. We are expanding our genetics studies because our earlier work indicates that traits of autism can be seen in family members related to children with autism. In some cases, these relatives may only exhibit one or two traits of autism."

The neurobiological portion of the UW research study will include continuation of a long-term study of the brain and behavioral development involving 75 children with autism, 40 developmentally delayed children and 40 normally developing ones. This study, begun when the children were toddlers, has shown that 3-year-olds with autism have larger than normal brains and that these children also have difficulty recognizing and distinguishing emotions from facial expressions.

Among the goals of the UW Autism Center and this study are finding the genetic markers for autism and improving detection of the disorder during infancy so children and their families can be helped as soon as possible.

Parents who want more information about the study or want to enroll their families as participants may call 800-994-9701.

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TREATMENT

Fish Oil May Help Relieve Stubborn Depression

Reuters Health - Daily supplements of an omega-3 fatty acid--found in fish and fish oil--may help alleviate the symptoms of depression in patients who do not respond to standard antidepressant medications, new research findings suggest.

Dr. Malcolm Peet of the Swallownest Court Hospital in Sheffield, England and his colleague found that depressed patients who received a daily dose of 1 gram of an omega-3 fatty acid for 12 weeks experienced a decrease in their symptoms, such as sadness, anxiety and sleeping problems.

The only side effect of the treatment appeared to be gastrointestinal problems, which Peet and his co-author Dr. David F. Horrobin of Laxdale Research, Ltd. in Stirling, Scotland, deemed "mild."

All of the patients had tried other medications before enrolling in the current study, including selective serotonin reuptake inhibitors (SSRIs) such as Prozac and medications from an older family of drugs called tricyclic antidepressants. Both types of drug are considered standard treatments for depression.

This is not the first study to suggest that omega-3 fatty acids, such as the form of eicosapenaenoic acid (EPA) used in this report, may help patients with psychiatric disorders. Previous researchers have suggested that the balance of omega-3 fatty acids in the brain may become skewed in people with depression, and earlier studies have shown that fish oil supplements can help alleviate the symptoms of schizophrenia and bipolar disorder, or manic depression.

In addition, researchers have found that people who are depressed, as well as those diagnosed with cardiovascular diseases and other conditions associated with depression, have relatively low levels of omega-3 fatty acids in their blood.

In the current study, reported in the October issue of the Archives of General Psychiatry, Peet and Horrobin asked 70 depressed patients who had not benefited from previous treatments to take a daily dose of either 1 gram, 2 grams or 4 grams of EPA, or an inactive drug. The treatment lasted 12 weeks.

The investigators found that people given the 1 gram daily EPA dose experienced improvements--relative to those given the inactive drug--in all of the measured aspects of depression, including sadness, anxiety, low libido and suicidal tendencies. In fact, 69% of the patients treated with the 1-gram daily dose achieved a 50% reduction in their symptoms of depression, a result seen in only 25% of the patients given an inactive drug.

"The effect of ethyl-eicosapentaenoate (the form of EPA used) applies to all major components of the depressive syndrome and is seen equally in the patient and physician assessments," the authors write.

Peet and Horrobin did not note any improvements in the patients given higher doses of the fatty acid relative to the placebo group, which they suggested may be due to the small number of people who were given either 2 grams or 4 grams per day.

"Although there appeared to be a trend toward significant efficacy at the 4-gram per day dosage, larger studies would be required to elucidate possible beneficial effects of the higher dosages," they write.

SOURCE: Archives of General Psychiatry 2002;59:913-919.

Copyright © 2002 Reuters Limited.

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Morning Dose of Adderall XR Improves ADHD Into Evening

Effect increased with higher doses

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Adderall XR improves the symptoms of attention-deficit hyperactivity disorder in children throughout a school day and into the evening with one morning dose, reported Dr. Joseph Biederman of Massachusetts General Hospital, Boston, and his colleagues.

The response of children to Adderall XR (SLI381) improves with increasingly higher doses without significantly increasing the rate of most adverse events, the investigators said.

Teachers and parents rated the improvement of 563 children aged 6-12 years with attention-deficit hyperactivity disorder (ADHD) who were randomized to either Adderall XR or placebo.

The children in the Adderall XR group were split into those who received 10 mg per day for 3 weeks; 10 mg per day for 1 week and 20 mg per day for 2 weeks; and 10, 20, and 30 mg per day, increasing by 10 mg each week for 3 weeks.

The study was funded by Shire Pharmaceutical Development Inc. of Rockville, Md., manufacturer of Adderall XR.

At school, the Adderall XR group had an improvement in ADHD behavior that was roughly five times larger than in those who received placebo, according to Dr. Biederman. Teachers assessed the students at 10 a.m. and 2 p.m. three times per week using the Conners Global Index Scale for Teachers (Pediatrics 110[2]:258-66, 2002).

Adderall XR improved ADHD behavior at school significantly more than placebo at all doses, but the smallest improvements were associated with the 10-mg group and largest improvements with the 30-mg group.

The 128 children in the 10-mg group had significantly greater improvement than the placebo group beginning in week 1, but this improvement remained basically unchanged during the following 2 weeks.

The 112 children in the 20-mg group continued to improve through week 2, but their improvement stopped in week 3. However, the 120 children in the 30-mg group improved during all 3 weeks of treatment.

Parents of the children who received Adderall XR rated the children as having a 1.5-fold relative improvement in ADHD behavior at home over their behavior off of treatment.

At home, parents evaluated their children's ADHD behavior on either Saturday or Sunday—at 10 a.m., 1 p.m., and after 4 p.m.—with the Conners Global Index Scale for Parents, the investigators said.

At each dose level, Adderall XR improved ADHD behavior in the early and late afternoon as effectively as it did in the morning.

“Such results indicate that the duration of action of SLI381 should allow for [pharmacologic] support of homework activities, after-school athletic and social activities, as well as family life—critical components of the child's life,” Dr. Biederman and his associates said.

Children who had been treated previously with stimulants or were naive to ADHD treatment responded equally well to treatment.

The adverse events of anorexia, insomnia, abdominal pain, emotional lability, vomiting, and nervousness occurred significantly more often in the Adderall XR groups, but 69% of all adverse events were mild.

With the exception of anorexia, which had an incidence of 22% in the Adderall XR groups, the investigators found no clear evidence for a dose-relationship in the incidence of adverse events in any of the Adderall XR groups.

A posthoc analysis found that 34% of the treatment-naive children reported anorexia, significantly more than 16% of children who had prior experience with ADHD medications.

“It can not be determined from these data whether the reported incidence of [anorexia] would abate over time,” the investigators said.

Adderall XR contains a 50:50 ratio of immediate- and a delayed-release Microtrol beads, in which the delayed-release beads activate 4-6 hours after oral administration.

In each bead is a mixture of the neutral salts of dextroamphetamine sulfate, amphetamine sulfate, D,L-amphetamine aspartate, and the dextro isomer of amphetamine saccharate, according to investigators.

This study gives physicians “another arrow in the quiver” for treating ADHD in children, especially when “the standard of care is becoming a once-a-day medication,” said Dr. Daniel B. Kessler, director the Arizona Child Study Center in Phoenix.

However, this study gives data on children with relatively simple ADHD—only those with a primary diagnosis of the hyperactive-compulsive subtype of ADHD or its combined subtypes—when “we're beginning to realize that half or more have comorbid conditions,” Dr. Kessler commented.

“For example, on which medications do children with ADHD and anxiety or ADHD and tic do best?” he added in an interview.

Dr. Kessler, who is a developmental and behavioral pediatrician, is on the speakers bureaus for—but does not receive research support from—many of the manufacturers of medications used to treat ADHD. Copyright © 2002 by International Medical News Group.

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ADVOCACY

Treat, Says The Court

lines/headdex/headdexEditorials_temp/2/2/3/ <- - address ends here.

Universality is at the heart of Canada's publicly funded health-care system. No one is denied the care he or she needs because of inability to pay. Regrettably, in the case of autistic children in British Columbia, what should have been a political matter became a legal one. The B.C. Court of Appeal insisted unanimously this week that the province pay for a specialized treatment for these children.

But the fault rests with the government. It failed to grasp the situation of children whose autism is characterized by profound withdrawal. Without the treatment, they are condemned to a life of isolation. With it, they have a chance to live meaningfully among their peers. What could be more necessary than that? As a general principle, the courts should leave funding issues to elected officials. Those officials are accountable to the electorate; the judges are not. Legislators also have a greater ability to hold public consultations before making their decisions. In particular, given the need for fiscal responsibility, the court was unwise in this case to order the government to pay CAN$20,000 in symbolic damages.

The funding for the autism treatment is not cheap. The intensive program ordered by the court -- the only treatment known to be effective -- involves 40 hours a week of one-on-one behavioural therapy, and costs $45,000 to $60,000 a year for each child, for two to three years. Since roughly one child in 1,000 suffers from autism, that could mean about 200 B.C. preschoolers at a time could benefit -- a total cost of as much as $12-million.

On the other hand, more than 90 per cent of untreated children are placed in group homes or other institutions, at a cost that may exceed $100,000 a year. Only one in 64 children will improve without treatment.

The savings in denying treatment are therefore illusory. Of the four children whose parents brought the B.C. legal challenge, after struggling to pay for the treatment themselves, three were able to enter mainstream school classrooms.

There is a strong argument to be made that, when the courts step in to order services, they open the floodgates. Today it may be autistic children. Tomorrow it might be, say, fertility treatments for individuals or couples who are unable to conceive on their own.

But British Columbia raised the floodgates argument in 1997, when, in a precedent-setting case, the Supreme Court of Canada ordered hospitals to provide sign-language interpreters for deaf patients. B.C. argued that virtually everyone with an unmet medical need would be seeking a court order for the treatment. It didn't happen.

In the end, the B.C. court case shows how difficult it will be to control health-care costs by trying to limit insured services at the margins (or to the marginalized). To deny one group of children a necessary treatment in a universal system is to deny their worth as human beings. That is what makes it a constitutional matter. Universality does not mean everything -- but it does mean everyone.

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Readers' Posts

I have read a report that Parents with autistic children are saying that a natural compound in a person's body called carnosine have helped their kids. I am very interested in trying it with my six year old autistic son, But I am not sure which brand of carnosine is good, where did you get it and how much dose he should take? Are there any parents who used carnosine can give me some advice, I can be reached at yzhao12@yahoo.com.

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I have a daugher who has autism. She is almost nine, and starting puberty. I need some information on how to help her through this process. Debbie Townley dbit1@msn.com

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Any ideas for indoor activities for 3 low functioning young autistics. They have almost no play interests and they are tired of videos. Winter's coming. Cindy cynjo@earthlink.net

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Commentary on "Psychopathology of 'Non-Male' [what a designation!]' Parents of Children with Autism": Have the researchers asked whether the "non-male" parents had the same psychopathology before and after their children were diagnosed? Has it occurred to them that living with a child with autism may have increased the likelihood of depression, etc.? Laurie Murdock

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