SCHAFER AUTISM REPORT "Healing Autism:

No Finer a Cause on the Planet"

________________________________________________________________

July 29, 2002 CALENDAR LISTING: EVENTS@doitnow.com

ADVOCACY / PUBLIC HEALTH

* "Urgent! Urgent! Urgent!" Warns Advocates

* US Decision On Smallpox Shots Seen In Days

* House Passes Bill Extending Orphan Drug Tax Credits

* Drug Development

RESEARCH / TREATMENT

* Zinc Supplements at Pregnancy Found Not Helpful, Maybe Harmful for Baby

* Institute of Medicine to Evaluate Supplements

CARE

* 'Care Track' Purchased by a Missouri County

* Girl Pens Book On Autistic Sibling

ADVOCACY / PUBLIC HEALTH

"Urgent! Urgent! Urgent!"

[From the Autism Research Institute, Bernard Rimland.]

Please give this TOP Priority: Phone, Fax and/or Email your US

Senators *immediately* to state your fervent opposition to Sentate Bill 2053

("The Frist Bill"). This bill may be voted on as early this Wednesday, July

31.

If it passes, it will prevent parents from suing the drug companies for

the harm – including autism – caused by poorly manufactured and poorly

tested vaccines.

Juries, not politicians, should decide whether the families are

entitled to compensations from the drug companies.

See website http://www.stopfristbill.org/

Make sure you send us a copy of your letters, too: edit@doitnow.com

* * *

US Decision On Smallpox Shots Seen In Days

[Wrangling over smallpox vaccine policy and the public's fear of

terrorism may be providing the drug industry an opportunity to push through

industry-favorable reforms potentially at the expense of those who are

damaged by this and other vaccines. "It's only natural for industries to

want to protect their profitability," I explain to my son Izak as he stims

off into space, rocking gently to music only he can hear. Finally he smiles

and sings his answer with a few notes of the E-E-E Song. –Lenny]

www.reutershealth.com/archive/2002/07/26/eline/links/20020726elin021.html

Reuters - US officials are putting the final touches on a strategy to

combat smallpox in case of a biological attack and promised on Thursday to

deliver a plan in a few days or 2 weeks at most.

They are weighing the risks of vaccinating large numbers of people

with a vaccine that is relatively dangerous, versus the theoretical but

serious danger of a biological attack.

They also worry that legal action may result if people develop

complications as a result of smallpox vaccinations.

"The threat of smallpox is small, but it's not zero," said Dr. Donald

Henderson, a chief adviser to the federal government on bioterrorism. "If

indeed smallpox were to be released, it would be very serious...potentially

a global catastrophe."

There is no question of vaccinating the general population. Rather,

health experts are trying to decide whether emergency department workers,

firefighters and others who may have to help in case of an attack or

outbreak should get immunizations.

And if so, the question is how many of them, and where, and whether

family members should also be vaccinated. Then the government is dealing

with the question of what kind of action to take should there be an

outbreak.

"We will have a policy in days, or 2 weeks at the most," Henderson

told a briefing for legislative and other staff sponsored by the Alliance

for Health Reform, a nonprofit group that runs forums on health policy.

Smallpox was declared eradicated worldwide in 1980 and routine

vaccination stopped in the United States in 1972. Most, if not all, of the

population is considered vulnerable.

The former Soviet Union is known to have experimented with smallpox as

a potential biological weapon, and the fear is that extremists or even

governments may be planning to use it.

Smallpox covers its victims with pustules and one third of patients

die. It is a prime candidate for use as a biological weapon.

The Health and Human Services Department and the White House are

considering recommendations made by experts who were studying the issue even

before the September 11 attacks and the anthrax-laced letters in October

that killed five people in the US.

But it takes years to develop a new vaccine and the United States is

stuck with 77 million doses of the old DryVax vaccine and 75 million doses

of vaccine that maker Aventis Pasteur had in its freezers and donated.

By the end of the year, 209 million more doses based on the old

formula but made under cleaner laboratory conditions should be available.

But it may not be any safer.

"Smallpox vaccine is probably the least safe human vaccine," Dr.

Anthony Fauci, head of the National Institute of Allergy and Infectious

Diseases, told the briefing.

Complications include a skin infection called eczema vaccinatum.

People with eczema who touch a recently vaccinated person can develop this

potentially fatal complication.

HIV infections, cancer treatments that can suppress the immune system,

and people with transplanted organs all are more susceptible to

complications from smallpox vaccines.

That raises the question of lawsuits, and Henderson said his team is

thinking seriously about that.

"To me, it looks like this is going to be a great place for a trial

lawyer to go to make a lot of money," Tennessee Republican Senator Bill

Frist, a doctor, told the briefing. Copyright © 2002 Reuters Limited

* * *

House Passes Bill Extending Orphan Drug Tax Credits

www.reutershealth.com/archive/2002/07/26/eline/links/20020726elin012.html

Reuters Health- Lawmakers in the US House on Thursday passed a bill

that includes a plan to extend the tax credits offered to makers of orphan

drugs.

The agency gives orphan drug designation to drugs that provide a

significant therapeutic advantage over existing treatments and target

conditions affecting 200,000 or fewer US patients per year.

The highest-profile aspect of the bill is a proposal to allow

taxpayers to deduct part of the cost of buying long-term healthcare

insurance.

But the bill also expands tax credits for firms developing orphan

drugs. Under the new plan, manufacturers would be able to claim the credits

from the time that they apply for orphan drug status, rather than beginning

when the drug is awarded the status.

Under the orphan drug program, which is designed to encourage

development of treatments for rare diseases, tax credits can be claimed for

up to half of certain clinical testing expenses. Orphan drug designation

carries other benefits as well, most notably 7 years of marketing

exclusivity.

The newly passed bill also expands the 75-cent-per-dose federal

vaccine excise tax to hepatitis A vaccines.

The tax is paid on most common childhood vaccines as a way to finance

the National Vaccine Compensation Fund, which makes payments to patients who

have experienced adverse health effects from vaccines if they drop their

lawsuits against vaccine companies.

The long-term care portion of the legislation would allow taxpayers to

write off 25% of the cost of long-term care insurance premiums next year on

insurance for themselves, a spouse or dependents. The deduction expands to

50% of premium costs by 2012.

The bill's supporters said that the tax write-offs are a good way to

entice consumers to buy the coverage. "If we don't put incentives in for

individuals, our public resources will be depleted," said Rep. J.D. Hayworth

(R-AZ), the bill's chief sponsor.

But opponents said the bill would only serve to subsidize the

insurance industry for products that consumers don't really want. Rep.

Fortney (Pete) Stark (D-CA) said the plan would force the government to

spend $561 million in 2012 subsidizing insurance that only about 100,000

people would buy.

"Why are we wasting the taxpayers' money? This is some insurance

salesman run amok," Stark said.

The House passed the bill 362 to 61.

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* * *

Drug Development

[From Medscape Psychiatry & Mental Health eJournal[TM] by Thomas AM

Kramer, MD.]

http://www.medscape.com/viewarticle/439156

In the course of my teaching, consulting, and just talking about

psychopharmacology, it has become clear to me that most practitioners do not

have the vaguest idea where psychotropic drugs come from. Although these

clinicians may be quite knowledgeable about the positive and negative

attributes, interactions with each other, and relative merits, very few have

any idea about how they came into being in the first place. As such, I

thought it might be helpful for the readership of this column to get a basic

introduction to drug development, in order to learn something about the

origin of the prescriptions that they write daily.

Drug development, until fairly recently, was at best a random, and at

worst a problematic and frustrating, process. Often, medications that were

developed for one thing were discovered quite accidentally to have much more

important therapeutic effects for a completely different disorder. It has

been well described that some of the original antipsychotics were originally

developed to assist in anesthesia, and some of the original antidepressants

were originally intended to be medications for tuberculosis or psychosis.

Drug development was done on a "chemical" basis; that is, guesses were made

as to compounds that would be safe and effective based on chemical

structures of established medications. This was very much a trial-and-error

process, since very little was known about how these drugs worked and very

little could be measured beyond actually giving them to a patient.

Drug development always has been and always will be a partnership

between efficacy (ie, whether the drug is effective) and safety (ie, whether

the drug can be tolerated by a patient). There were very few ways of knowing

the answers to those two questions about any given compound unless you tried

it, a process not without its obvious risks. Clozapine was developed many

years before researchers actually determined in any definitive way that it

was effective in the treatment of schizophrenia. The reason it sat on the

shelf for so long was that it was developed at a time in which the only test

to see if a drug was an effective antipsychotic was to inject it into a rat,

and see what happened to the rat's tail. At the time, all effective

antipsychotics made a rat's tail stiff when you injected the medication.

Clozapine did not make the rat's tail stiff and, thus, was felt to be an

ineffective antipsychotic until it was actually tried in patients at a later

time.

Drug development is somewhat more sophisticated now in that some drugs

can be developed biologically. This means that instead of guessing and

experimenting with various chemical structures, hoping to find something

that works, we can look at what we do know about receptors and transmitters

and try to design drugs around that. For example, since we have discovered

that antipsychotic drugs tend to be more effective when they block both D2

and 5HT2A receptors, we can go to the laboratory and design compounds that

block both of those kinds of receptors. One can only assume that as our

technology improves in this regard, we can be more specific and more

directed in developing new medications. Once an actual mechanism of drug

action is found, multiple drugs can be developed to influence that

mechanism. This can be seen with the drugs that focus their activity on the

serotonin transporter, such as selective serotonin reuptake inhibitors and

the newer generation of drugs in the pipeline now with peptide-based

mechanisms of action, such as substance P and neurokinin inhibitors.

Regardless of how the compound is discovered, compounds are ultimately

identified that have possibilities as good drugs for human beings. The

Office of Research and Development of the Pharmaceutical Manufacturers

Association reports that it takes an average of 12 years for an experimental

drug to travel from laboratory to medicine chest. In 1993, according to a

report by the Congressional Office of Technology Assessment, it took $359

million on average to get one medication from the laboratory to the

pharmacist's shelf. In 2000, the cost has been estimated at $802 million.

Compounds that constitute the best guesses of pharmaceutical developers

start out in preclinical testing. This testing consists of laboratory and

animal studies that test for biological activity of the compound against the

targeted disease and various evaluations for safety. These tests take

approximately 3.5 years to complete.

Approximately 1 compound out of every 1000 that enter preclinical

testing actually makes it to some form of human testing. In order to do

human testing, the pharmaceutical company must file what is called an IND

(investigational new drug application) with the US Food and Drug

Administration (FDA). The IND becomes effective if the FDA does not

disapprove it within 30 days. The IND shows the results of previous

experiments and how, where, and by whom the new studies on humans will be

conducted. It also gives the basic information of the drug as known to date

such as the chemical structure, what the drug company's best guess is as to

how it will work in the body, any toxic effects found in the animal studies,

and how the compound is manufactured. In addition, as is true with all

research on human subjects, the IND must be reviewed and approved by the

Institutional Review Boards where the studies will be conducted. Progress on

the clinical trials must be submitted at least annually to the FDA.

The first set of human clinical trials for a new pharmaceutical are

called phase 1 trials and usually involves 20 to 80 healthy volunteers.

These tests take about a year and study a drug's safety profile, including

the safe dosage range. These studies also determine how a drug is absorbed,

distributed, metabolized, and excreted and its duration of action (ie, its

half-life). At the end of these studies, a decision is made whether to

continue to phase 2. If the compound looks like it might be a viable

pharmaceutical at the end of these studies, phase 2 trials are begun. These

are the first time that patients who actually have the disease the drug is

supposed to treat are given the compound. In phase 2 trials, the drug's

effectiveness is assessed. This usually is done with approximately 100 to

300 volunteer patients and takes about 2 years. This is also the first point

at which side effects are noted and the issue of whether actual patients can

tolerate the drug is first addressed. If, after the phase 2 trials, the drug

still looks viable, the clinical trials go into phase 3 trials, which are

the longest and largest of the clinical trial process. Phase 3 trials

usually last about 3 years and involve somewhere between 1000 and 3000

patients in various clinics and hospitals at various sites. Physicians

monitor patients closely to determine efficacy and identify any adverse

reactions. One of the reasons these trials go on so long is that this is the

first opportunity to see what effect the drug has over a relatively long

period of time. For every 5 compounds that enter clinical trials, only 1

makes it through to the end.

If the drug is that 1 in 5 that actually makes it through clinical

trials, the next step is to file a new drug application (NDA) with the FDA.

The pharmaceutical company will only do this if it analyzes all the data and

feels that the drug does demonstrate both safety and effectiveness well. The

NDA must contain all of the scientific information the company has gathered.

NDAs typically run approximately 100,000 pages or more. Although by law the

FDA is allowed 6 months to review an NDA, in almost all cases, the period

between the first submission of the NDA and final FDA approval exceeds that

limit. The average NDA review time for new pharmaceutical compounds approved

10 years ago in 1992 was 29.9 months. Current data points to 12 years from

the time a new chemical compound is synthesized until it is approved by the

government for marketing in the United States.

+ Article continues at: http://www.medscape.com/viewarticle/439156

* * *

RESEARCH / TREATMENT

Zinc Supplements at Pregnancy Found Not Helpful, Maybe Harmful for Baby

'Zinc supplementation during pregnancy and effects on mental development and

behaviour of infants: a follow-up study'

http://www.thelancet.com/journal/vol360/iss9329/full/llan.360.9329.original_

research.21893.1

Jena D Hamadani, George J Fuchs, Saskia J M Osendarp, Syed N Huda, Sally M

Grantham-McGregor Centre for Health and Population Research, International

Centre for Diarrhoeal Disease Research, Bangladesh (J D Hamadani DCH, G J

Fuchs MD, S J M Osendarp PhD); Department of Pediatrics, University of

Arkansas for Medical Sciences, USA (G J Fuchs); Division of Human Nutrition

and Epidemiology, Wageningen University, Netherlands (S J M Osendarp);

Institute of Nutrition and Food Science, University of Dhaka, Bangladesh (S

N Huda PhD); Centre for International Child Health, Institute of Child

Health, University College London, UK (J D Hamandani, Prof S M

Grantham-McGregor FRCP)Correspondence to: Prof S M Grantham-McGregor, Centre

for International Child Health, Institute of Child Health, London WC1N 1EH,

UK. (e-mail:s.mcgregor@ich.ucl.ac.uk)

Summary

Background

Zinc deficiency is widely prevalent in developing countries. Zinc

supplements given to Bangladeshi pregnant women have been shown to reduce

infants' infectious disease morbidity. We assessed these infants at age 13

months to establish the effect of antenatal zinc supplementation on infant

development and behaviour.

Methods

The study originally consisted of 559 pregnant women who were randomly

allocated to zinc (30 mg daily) or placebo (cellulose) from 4 months'

gestation to delivery. The effect of zinc supplementation on pregnancy

outcome and on infant growth and morbidity in the first 6 months was

assessed. We then randomly selected a subsample of 168 infants from 383 who

completed the study at 6 months. When babies in this subsample reached age

13 months, we assessed mental development with Bayley scales of infant

development-II, rated behaviour on a modified version of Wolke's scales, and

measured weight and height.

Findings

When we controlled for differences between tested and non-tested

participants, infants in the placebo group had higher scores on mental

development index (regression coefficient=3·3, SE 1·6, 95% CI 0·2-6·5,

p=0·04) and psychomotor development index (5·1, 2·4, 0·2-9·9, p=0·04) than

those in the zinc-supplemented group. Zinc supplementation had no

significant effect on behaviour or growth. The children's nutritional status

was poor, and weight-for-age at testing was strongly related to

developmental levels, which accounted for some of the treatment effect.

Interpretation

Prenatal supplementation with zinc alone in poor women from Bangladesh

does not seem to confer benefit on infants' mental development. Such

treatment should be considered with caution.

Lancet 2002; 360: 290-94

* * *

Institute of Medicine to Evaluate Supplements

[It looks like a big step in the move to regulate the industry.

Thanks to Denise Karp.]

http://www.cnn.com/2002/HEALTH/diet.fitness/07/24/evaluating.supplements.ap/

index.html

The Institute of Medicine has picked six controversial dietary

supplements for a new evaluation program it developed for the Food and Drug

Administration.

The six, which may pose health hazards, will serve to test the

framework for determining the safety of supplements, which have become a

major industry in recent years but face only limited government regulation.

The institute, a branch of the National Academy of Sciences, said in a

preliminary report Wednesday that it had selected the supplements chaparral,

chromium picolinate, glucosamine, melatonin, saw palmetto and shark

cartilage for reviews.

The final version of the report is expected to go to the FDA in the

fall, IOM committee chairman Barbara O. Schneeman said.

At that time, the FDA will make the final decision on doing the six

studies, said Schneeman, of the University of California, Davis.

The FDA could do the evaluation internally or contract it out, she

said, adding that it would also be appropriate to ask manufacturers for

data, although it would be voluntary for them to provide it.

The FDA estimates that as many as 29,000 different dietary supplements

are available and that Americans spend an estimated $700 million per year on

supplements.

However, a 1994 law specifically exempted supplement makers from

having to prove their products are safe before selling them. The FDA has to

prove that a supplement is unsafe before it can be removed from the market.

The herb ephedra is a prime example of the agency's problems in

dealing with supplements.

At least 54 deaths and about 1,000 reports of complications have been

linked to the popular supplement since the mid-1990s, according to an

analysis in the New England Journal of Medicine two years ago.

But, after two years of FDA work developing rules seeking to bar

certain ephedra doses, industry protests killed the move. The agency then

began working on warning labels, but last month the Bush administration

ordered a new safety review of the stimulant before any action can be taken.

Supplement makers praised the step.

Schneeman said the committee did not include ephedra in its list

because "there is a lot of activity going on around ephedra and I'm not sure

we would help the process by putting it into a prototype evaluation."

Frustrated in its efforts to regulate supplements, the FDA asked the

Institute to develop a method for evaluating their safety.

In its report, the institute established guiding principles in

reviewing supplements, including a credible report of a serious adverse

event in humans associated with the supplement; evidence of harm in

laboratory animal studies and the presence of constituents similar to known

toxic or harmful compounds.

The supplements chosen for the first safety evaluations cover a

variety of types and uses, the institute noted. The selected supplements and

the reason they were chosen, are:

* Chaparral, because of concerns about liver toxicity. Used in an herbal

tea.

* Chromium picolinate, because of reports of kidney toxicity and effects on

insulin regulation in diabetics. Promoted to reduce body fat.

* Glucosamine, because of concerns about its use by diabetics. Sold as an

arthritis treatment.

* Melatonin, because of reports of complications. Used to treat sleep

disorders and jet lag.

* Saw palmetto, because of reports of heart problems. Sold as a prostate

treatment.

* Shark cartilage, because of a report of hepatitis following ingestion.

Promoted as a treatment for cancer and other health conditions.

* * *

CARE

'Care Track' Purchased by a Missouri County

[By Fred Spriggs in the Webster County Citizen.]

http://www.webstercountycitizen.com/display/inn_news/News13.txt

Two calls from mothers of children "at risk" to wander and become lost

provided the impetus for Webster County Sheriff Ron Worsham's department to

purchase a high-technology tracking device called "Care Track."

Project Lifesaver uses an electronic wrist band that sends out a

constant pulsing tracking signal every second.

The device is worn by people suffering from Alzheimer's, Down Syndrome

and for autistic children and others suffering from impairments that make

them a risk to wander away from caregivers.

Worsham said his department has purchased two Project Lifesaver

receivers to aid during searches.

"Last year their were 312 wanderers in the United States," the sheriff

said. "Using this system, the average time it took to find someone lost

wearing the system was only 22 minutes -- but more importantly, there were

no injuries or deaths."

Worsham said the biggest aid for law-enforcement officers in-volved in

a search is that only two officers are needed when using the Care Track

device.

"The equipment only weighs one ounce but will send a signal over one

mile on the ground, day or night, and up to five miles when the receiver is

located in an aircraft or helicopter," Worsham said.

Start-up cost for equipment and training for the Webster County

Rangers and Reserves is about $5,200.

Worsham said the group will hold fund-raising projects to obtain the

money.

"Any donations would be greatly appreciated," he said. "We want to get

this life-saving project implemented as soon as possible."

Worsham said that two armbands also were purchased with the receivers.

These will be given to people at risk who are unable to pay for the

cost of their own armband.

For more information on Care Track, call the Webster County Sheriff's

Department at (417) 468-2222.

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* * *

Girl Pens Book On Autistic Sibling

[By Erica Noonan in the Boston Globe.]

http://www.boston.com/dailyglobe2/206/northwest/Girl_pens_book_on_autistic_s

ibling+.shtml

Nine-year-old Sarah Peralta is already a wellspring of knowledge about

autism, explaining matter-of-factly that she's already "given the autism

lecture" to her classmates at Hastings Elementary School. What did she tell

them about the neurological disorder that impairs brain development in the

areas of communication and social interaction in more than a half-million

Americans?

"Everything," says Sarah. But she's most interested in how the

disorder affects her 8-year-old brother, Evan.

Sarah is quick to explain to friends why Evan doesn't talk, why he

spends hours seemingly in his own head or playing with sticks he finds

outside, and why, sometimes, he doesn't like to wear clothes. ("It's a

sensory thing," she once quipped to a quizzical playmate.)

Soon Sarah will have a much bigger platform upon which to tell

thousands more youngsters, and their parents, about what it's like to have

an autistic sibling in the family.

Her first book, "All About My Brother," set for publication on Sept.

2, is a hand-drawn picture book examining different aspects of Evan's

world - ranging from his enthusiasm for swimming and Popsicles, to his big

sister's occasional confusion over his solitary nature.

"Evan is hard to play with sometimes because he would rather flick a

stick than play a game. I feel bad that he never has play dates. I could not

live without playing with my friends. It is hard to understand what makes a

stick so interesting. Maybe one day he will tell us," she writes.

Sarah figures that looking at the world though her brother's eyes, and

sharing what she sees, will hopefully enlighten other children who are

afraid of or confused by autism.

"Some kids are afraid of kids who are different from themselves.

Sometimes they are even mean to someone who is different to show they are

tough," she writes.

Sarah began "All About My Brother" when she was 6 years old, outlining

chapters and coloring pictures after her mother suggested she put her

thoughts about Evan into a book for other children to read.

There are few such books for the siblings of autistic children, said

Sarah's mother, Dorothea Iannuzzi, a social worker and mental health

counselor. Despite a close network of autism-impacted families in Lexington,

Bedford, and Concord, parents generally must struggle for many frustrating

years to find treatments for their children's specific and unique form of

the disorder.

"In that way, it is so much more challenging," Iannuzzi said. "With

autism there are no absolutes. ... We are hoping that this book will help

families and could even be used in classrooms."

Keith Myles, president of Autism Asperger Publishing Co., said this

was the first book penned by a child that his Kansas-based publishing house

has ever printed. The company publishes approximately 25 books a year about

autism and related disorders.

AAPC editors were charmed by "All About My Brother," he said, and plan

to sell it for $16.95 on the organization's Web site and at the many

academic conferences held on autism every year.

"It's a delightful book," Myles said. "Often parents are concerned

about what they should do where the siblings are concerned.

"It's often hard for a child to talk about their feeling about an

autistic sibling, and you see here that Sarah loves her brother. She is

looking through Evan's eyes, and doesn't try to make him conform to her

standards."

Sarah said she's looking forward to her first book signing,

tentatively scheduled for 1 p.m. on Sept. 21 at The Story Loft in Lexington

Center.

"I'm excited," she said. "I love to talk to people." Copyright 2002

Globe Newspaper Company.

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