SchaferAutismReport: Senate Provision Would Inoculate Vaccine Makers

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SCHAFER AUTISM REPORT " Healing Autism:

No Finer a Cause on the Planet "

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Friday, December 16, 2005 Vol. 9 No. 200

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ADVOCACY

* Senate Provision Would Inoculate Vaccine Makers

* Up To $16 Million In Drug Company Stock Investments Conflict 42

U.S. Senators Out of Vaccine Vote

RESEARCH

* WSJ Front Page: Titan's Millions Stir Up Research Into Autism

* Autism And Metabolic Disorders-A Rational Approach

EVENTS

* Live Webcast on Autism from Brookings Institute

* Custom Motorcycle Offered In Autism Fundraiser

FORENSIC

* Asperger Killer Gets Life

LETTERS

* Ask for the Books

ADVOCACY

Senate Provision Would Inoculate Vaccine Makers

By Stone for USA Today

http://www.usatoday.com/news/washington/2005-12-14-vaccine-protection_x.htm

Flu vaccine makers would be shielded from lawsuits under sweeping

language Senate Republicans hope to slip into a bill before Congress

adjourns for the year, a move that has sparked outrage from Democrats and

consumer advocates.

A vote could come as early as Friday, said Amy Call, a spokeswoman for

Senate Majority Leader Bill Frist, R-Tenn., the plan's chief supporter.

Frist hopes to insert the provision into a must-pass defense bill.

Medical experts fear that a fast-spreading avian flu strain, known as

H5N1, could trigger a pandemic flu outbreak should it develop the ability to

spread easily from person to person. President Bush has requested $7.1

billion to help detect and respond to pandemic flu and help states prepare

response plans.

It is unclear whether Congress will act on the Bush request, which

includes the liability provision, this year. Details of the vaccine

liability plan were still being worked on Wednesday. One version would allow

patients harmed by flu vaccines to sue drug companies and distributors for

damages only if they can prove willful misconduct.

Sen. Kennedy, D-Mass., and watchdog groups such as Public

Citizen say that standard is too high and would effectively bar compensation

to victims. They say the measure is so broad that it could apply to

virtually any drug used to treat " epidemics, " which could include such

conditions as diabetes.

They contend that the federal government already has the power to

protect drug companies and that patients harmed by flu vaccines should be

treated the same as those injured by vaccines for measles, chicken pox and

other childhood diseases. A federal " no-fault " program that went into effect

in 1988 offers compensation for patients injured by childhood vaccines and

is funded by a tax on every dose of the covered vaccines that are purchased.

Jillian Aldebron, a spokeswoman for Public Citizen, said that if the

vaccine liability proposal had been law in 1976, 4,000 people who became ill

after taking the swine flu vaccine would have had no recourse to seek

compensation. Neither would military personnel and first responders who

suffered heart attacks and other problems after taking smallpox vaccine in

2003, she said.

" They are trying to insert this outrageous giveaway to the drug

industry ... without public scrutiny or debate, " Kennedy said. " Congress

should reject any backroom deal that gives a free pass to companies that act

irresponsibly or denies fair compensation to injured patients. "

Call, Frist's spokeswoman, said the proposal offers " very targeted,

very limited liability protection " to drug companies. Supporters such as

Sen. Judd Gregg, R-N.H., say it is essential to spur production of vaccine

before a possible pandemic flu outbreak.

" We have heard in no uncertain terms that this is a show stopper for

the (drug) industry, " said Bruce Gellin, director of the national vaccine

program office at the Department of Health and Human Services. " This is a

new vaccine, and because of that, they feel uncomfortable " producing it

without liability protection.

Gregg cited fear of lawsuits as a reason why only four companies are

producing flu vaccines today compared with 25 two decades ago. " Nobody's

going to take the risk of running into the trial lawyers, " he said.

" We would not produce pandemic vaccine without liability protection, "

said Len Lavenda, a spokesman for Sanofi Pasteur, a U.S. subsidiary of

France's Sanofi-Aventis, the world's No. 3 drug company. Without immunity,

he said, " it could destroy the company " - one of four that has contracts to

produce a vaccine for the H5N1 virus.

The pharmaceutical industry has spent more than $800 million in

lobbying and campaign contributions since 1998, according to the Center for

Public Integrity, a watchdog group.

Though drug companies donate to candidates in both political parties,

several Republican lawmakers pushing the liability measure have received

significant contributions from vaccine manufacturers.

GlaxoKline gave Sen. Burr of North Carolina more than

$31,000 for his Senate campaign last year, according to the Center for

Responsive Politics, which tracks campaign contributions. The company, which

is developing a pandemic flu vaccine, gave more than $10,000 to Sen. Mike

Enzi, R-Wyo., in 2002. Pfizer, Merck and other drug companies gave Gregg

nearly $190,000 for his re-election bid last year, according to the center.

When Frist ran for his second term in 2000, he got more than $260,000

from the pharmaceutical industry. Two years later, he came under fire for

slipping a provision into a homeland security bill that would have protected

Eli Lilly from liability over the vaccine preservative thimerosal, which has

been linked to autism in children by parent and advocacy groups. The measure

was repealed in January 2003 amid a public uproar.

The drug companies " are political players, and this is part of their

agenda, " said Larry Noble, executive director of the Center for Responsive

Politics.

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Up To $16 Million In Drug Company Stock Investments Conflict 42 U.S.

Senators Out of Vaccine Vote, Says Watchdog Group

http://tinyurl.com/76mtd

U.S. Newswire - Forty-two U.S. Senators hold stock in pharmaceutical

companies even as they vote on legislation to benefit the drug industry,

according to an analysis released today by the nonprofit, nonpartisan

Foundation for Taxpayer and Consumer Rights (FTCR). The Senate is expected

to vote this week on an eleventh-hour amendment to immunize vaccine makers

for dangerous drugs. Senators should not participate in votes from which

they will financially benefit, said FTCR.

FTCR's analysis of Senate personal financial disclosures reveals that

42 senators -- 27 Republicans and 15 Democrats -- held pharmaceutical stock

worth between $8.1 and $16 million in 2004. Senators earned an additional

$2.5 to $7.2 million in capital gains and dividends, and two senators'

spouses also earned salaries from pharmaceuticals. View the analysis at:

http://www.consumerwatchdog.org/resources/SenPharma.pdf.

" Senators can't ethically support a giveaway deal for the

pharmaceutical industry when their own financial interests match those of

the drug companies, " said Carmen Balber, consumer advocate with FTCR. " A

financial interest in the outcome of legislation should conflict any

politician out of the vote. "

The GOP-backed amendment would grant immunity to drug companies for

any vaccine or product, classified by the Bush Administration as necessary

to respond to a public health threat, when patients are harmed by dangerous

drugs. The amendment is so broad that any product considered a

" countermeasure, " not just vaccines, could be protected.

Senate Majority Leader Frist aims to make the provision an amendment

to a conference report that cannot be altered. Frist's blind trust included

stock in drug companies Abbott Laboratories and & through

2004, each worth $15,000 to $50,000 when the trust was created.

In July, Rep. F. Sensenbrenner (news, bio, voting record)

(R-Wis.) recused himself from a vote on medical malpractice legislation that

would have benefited the pharmaceutical industry because his millions in

drug company stock create the appearance of a conflict of interest.

" It's time the U.S. Senate met the Sensenbrenner standard, " said

Balber.

The pharmaceutical industry was the largest industry donor to Frist's

National Republican Senatorial Committee, and the industry has given 64

percent to 74 percent of its federal contributions to Republicans every year

for the last decade according to the Center for Responsive Politics.

Congressional leaders tried to provide liability protection for the

makers of the vaccine additive Thimerosal in 2002 with an amendment to

Homeland Security legislation based on legislation Frist carried. Frist

denied involvement, but public backlash forced the Senate to remove the

immunity provision.

FTCR filed an ethics complaint with the Senate Select Ethics Committee

last April charging Frist with a conflict of interest for promoting medical

malpractice liability limits while retaining stock worth millions in the

hospital corporation, HCA. HCA owns the nation's fourth largest malpractice

insurer. Read the complaint at:

http://www.consumerwatchdog.org/malpractice/pr/?postId=1882.

FTCR called for an SEC investigation this summer when Sen. Frist

ordered the well-timed sale of his HCA stock. The Justice Department and SEC

are investigating the Senator's stock sale for insider trading. Read the SEC

letter at: http://www.consumerwatchdog.org/resources/Frist_SEC.pdf.

ACTION ALERT: Contact your congresspersons and let them know that

this legislation is bad.

http://www.a-champ.org/

.. . .

RESEARCH

WSJ Front Page: Titan's Millions Stir Up Research Into Autism

Simons Taps Big Stars From Outside Field to Find A Genetic Explanation

By Regalado for The Wall Street Journal

http://online.wsj.com/public/health?mod=tff_main (subscription.)

When their daughter Audrey was just a few months old, Jim and Marilyn

Simons noticed that she wasn't making eye contact. It wasn't until the girl

was 6 years old that she was diagnosed with autism. Ms. Simons scoured

records from her pregnancy. Had something gone wrong? What caused her

condition?

In their quest for answers, the Simonses aren't just another family

seeking comfort. Audrey's father, world-class mathematician H. Simons,

runs Renaissance Technologies Corp., one of the world's most successful

hedge funds. With little notice, the family's charitable foundation has in

the past two years committed $38 million to find the causes of autism. The

money manager says he and his wife will spend $100 million more in what is

rapidly becoming the largest private investment in the field.

The Simonses' philanthropy is stirring up the small community of

autism researchers and advocates. Using his scientific background, Mr.

Simons, 67, personally reviews grant applications. When the Massachusetts

Institute of Technology asked him for money for brain research, he demanded

that the project focus on autism and include scientists he liked. He has

provided his family's DNA for study, pitched in to help solve research

problems and is pushing scientists to probe a genetically based explanation

for the disease.

Mr. Simons is picking star researchers from other specialties --

" Nobel Prize winners and future Nobel Prize winners, " he says -- often

passing over established autism groups or those with differing theories.

Last month he lured a top Columbia University neurobiologist, Gerald

Fischbach, to work part-time leading the foundation's scientific strategy.

In science, as with certain types of financial data, " past performance

is the best predictor of success, " Mr. Simons says.

For most in the autism field, the money manager remains a question

mark, an idiosyncratic billionaire rarely seen or heard from, whose impact

on the field is still unclear. Like many other wealthy donors these days,

Mr. Simons is acting more like a venture capitalist, exerting extraordinary

control over where and how his money is spent. Many are cheering this influx

of cash, hoping Mr. Simons's riches can buy a breakthrough. Others complain

that Mr. Simons isn't working with existing autism groups and that his focus

on finding a genetic explanation could miss the disease's true cause.

Autism is a developmental disorder that exhibits a range of perplexing

symptoms, including failure to develop language skills and lack of empathy

for others. According to the federal government's Centers for Disease

Control and Prevention, between one and three of every 500 children are

afflicted with some form of the disease.

It's an apparent epidemic for which experts have few explanations. In

the highly charged atmosphere surrounding the subject, some parents insist

childhood vaccines or mercury poisoning is to blame. They cite a startling

rise in the number of children being diagnosed, up tenfold over the past

decade. Many experts say this phenomenon is explained by the expanding use

of the autism label by doctors and schools.

Another challenge: What doctors call autism is likely to be several

related disorders. Some autistic children can't speak and throw violent

tantrums, while others have relatively high IQ's. Some say that

understanding the disease could be as difficult as understanding the brain

itself.

Autism researchers lack a " good solid clue, " says Insel, head

of the mental-health institute at the government's National Institutes of

Health. The doctor adds: " We have no lesion. We don't know what systems in

the brain are involved. So we are at the very early stages. It's like cancer

or diabetes research 25 years ago. "

Mr. Simons thinks there's no compelling evidence for some parents'

contention that autism is caused by vaccines or some other environmental

factor. " People want an answer and people want a villain, the evil drug

companies or whatever, " says Mr. Simons. He says the only thing he believes

for sure is that genes play a big role.

It's a propitious moment to step into the field, observers say.

Scientists have already mapped the complete human genome, the three billion

units of DNA that define humans as a species. Combined with new high-tech

tools, this makes gene searches easier and faster to perform, even for

complex mental illnesses. Moreover, government funding for research into

autism, while growing, still trails that for less-common diseases such as

juvenile diabetes and pediatric AIDS. Dr. Insel predicts that genetic clues

will begin spilling out quickly, giving scientists a beachhead from which

they can begin thinking about tests or drugs.

Mr. Simons is well-known in mathematics circles for co-authoring a

high-level piece of geometry known as Chern-Simons. It has since become

important in string theory, the advanced branch of physics that posits a

" theory of everything. " He started young and earned a doctorate in

mathematics at 23. He also proved to be a precocious investor. While in

college, Mr. Simons persuaded his parents to mortgage their home so he could

invest along with some college friends in a pipe-and-tile company in South

America. Mr. Simons says the venture was " nicely successful. "

Astronomical Returns

By the mid-1970s, Mr. Simons moved from academia to Wall Street, with

spectacular results. His hedge fund employs more than 60 top scientific

specialists, including astronomers, physicists and mathematicians, who scour

market data to uncover statistical relationships that could predict the

price movements of commodities, currencies and stocks. His $5 billion

Medallion Fund has averaged 35% annual returns, after fees, since 1989. That

beats even hedge-fund legends Soros and Tudor , according

to the U.S. Offshore Funds Directory.

Mr. Simons earned $670 million last year, according to Institutional

Investor's Alpha magazine. He declines to confirm the figure, which would

rank him second among hedge-fund managers, behind Lampert of ESL

Investments, according to the Alpha survey. The Simonses live in a sprawling

apartment on New York's Fifth Avenue filled with art by painters such as

Milton Avery and Fairfield Porter.

Renaissance is now launching a fund designed to handle up to $100

billion, which, if successful, could become the industry's largest. Like the

$100 million he says he'll spend on autism, it's an eye-popping figure. " I

like big round numbers. The papers call me the $100 billion guy, " says Mr.

Simons, between puffs of a Parliament cigarette.

As the Simons family's wealth grew, their daughter's condition became

more widely known. Audrey, who is now 19, has a mild form of autism. She

started college classes in Manhattan this year but it isn't easy for her,

her parents say. She has difficulty learning and misses social cues.

One hallmark of autism is having restricted or obsessive interests.

Audrey's are attending synagogue and the rights of minorities and women.

" When she writes an essay for school, I usually just tell her to write

one version all about Judaism and women to get it out of her system, " Ms.

Simons, her mother, says.

In an email, Audrey says of her autism that she does " not have as many

problems because of it as some other people do. " She says she wants to be a

novelist and a painter as well as someone who can contribute to the Jewish

world and work on behalf of Nepalese women and children.

After Ms. Simons gave a donation to a New York school for autistic

children, " people began asking us for money " to pay for research, she says.

With the help of a consultant, the Simonses hosted an autism workshop at New

York's Plaza Hotel in June 2003, lining up a guest list of renowned academic

figures.

Mr. Simons says his " take-away " from the meeting was that scientists

had only one solid lead, and that was from studies on identical twins that

began 20 years ago. Doctors have found that if one twin has autism, the

other has a 90% chance of having some symptoms. For non-twin siblings, the

chance falls to between 5% and 10%. That suggests genes play a key role,

although not necessarily a simple one. Scientists believe dozens of

different genes may be involved.

+ Full story here: http://www.sarnet.org/lib/simons.htm

[Thanks to .]

EVIDENCE OF HARM DISCUSSION LIST HEATS UP

AS MERCURY LINK TO AUTISM QUESTION SPREADS

An Evidence of Harm email discussion list has

been created in response to the growing interest

in the book and the issues it chronicles. Now

1,200 subscribers. Here is how to subscribe

(no cost): EOHarm-subscribe at yahoogroups.com

.. . .

Autism And Metabolic Disorders-A Rational Approach

[Article in German]

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=pubmed & dopt=Ab

stract & list_uids=16294704 & query_hl=1

Hahn A, Neubauer BA.

Abteilung Neuropadiatrie und Sozialpadiatrie, Zentrum Kinderheilkunde,

Justus-Liebig-Universitat, Giessen. s.Hahn@...

The causes of autism are heterogeneous and predominantly genetically

determined.

An exact aetiology is found in less than 10% of affected patients.

The disappointment about low rates of success in identifying a

definite pathology, numerous reports about the association of autism and

" metabolic derangements " , and rumours of " miraculous cures " after

application of various drugs and dietary regimes have resulted in

substantial confusion about meaningful diagnostic procedures and rational

therapies for subjects with autism.

The aim of this report is to give an overview about rare, genetically

determined neurometabolic disorders (inborn errors of metabolism) that are

evidently (e.g. -Lemli-Opitz Syndrome) or allegedly (e.g. succinate

semialdehyde dehydrogenase deficiency) associated with autism-specific

symptoms.

Affected patients usually display additional neurological symptoms.

Procedures required to establish the diagnosis and eventual

therapeutic cons! equences derived from a specific metabolic defect are

presented.

In addition to these well-defined neurometabolic disorders for which

there are rational therapeutic strategies, hypotheses about the association

of autism with " metabolic derangements " that could not be confirmed or were

clearly falsified are discussed.

PMID: 16294704 [PubMed - in process]

.. . .

EVENTS

Live Webcast on Autism from Brookings Institute

Autism and Hope Friday, December 16 2pm - 6pm also: Live Webcast

http://www.brookings.edu

Over the course of the last two decades early intervention regimens

for autism spectrum disorders (ASD) have become more effective. Children

with ASD are not only speaking and going to school in significant numbers,

but some adolescents are no longer exhibiting the types and the severity of

symptoms that led to their initial diagnosis and many are able to enjoy

friendships and hold jobs. Even the more severely challenged are often doing

much better than before. However, the availability of the intensive early

intervention that can lead to these outcomes is highly limited in the United

States.

Most parents cannot afford it, and neither government nor the health

insurance industry covers very much of the treatment costs for ASD. The

Brookings Institution, in conjunction with The Help Group of Los Angeles and

with the additional support of the Karmazin Foundation, Autism Speaks, Cure

Autism Now, and Fux, will hold a conference to examine policy

proposals for expanding the availability and affordability of early

intervention for ASD. Drawing on a variety of expert opinions, the

conference aims to illustrate that autism and hope are no longer mutually

exclusive.

For those unable to attend the conference, a live webcast will be

available at http://www.brookings.edu.

.. . .

Custom Motorcycle Offered In Autism Fundraiser

The bike, created by X-Dream Cycle in a puzzle theme, is the prize in a

$100-a-ticket raffle.

By Tony De for the Journal

http://www.projo.com/westbay/content/projo_20051216_w16bike.1d1d216f.html

To call attention to a mysterious and fast-growing disability and

raise money to help families cope with it, the Autism Project has enlisted

the talents of motorcycle builder Ford.

On March 10, someone with a $100 ticket stub and a grin wide enough to

hurt will ride away on the bike that Ford built.

At his X-Dream Cycle shop, on Post Road, Ford designed and built a

custom motorcycle around the image of a jigsaw puzzle -- the universal

symbol for autism, a disorder that manifests itself at an early age and

leaves children unable to connect with the world around them.

For readers on two wheels, this is the bike: a RevTech big-inch V-twin

with a Baker 6-speed, in a pro-street frame with a 5-inch backbone stretch

and 330 rear tire -- should pull 125 horses on the dyno.

For readers on four wheels, that translates to: " Not a chopper. "

" It's exactly what I wanted it to be, " Ford said yesterday, " a

one-of-a-kind, cool-looking bike that anyone would want, but a bike that has

meaning for anyone who knows about autism. "

Ford became interested in helping raise money for autism research as

most people do: by having a personal connection.

" A friend of mine has a child with autism, " he said, " and autism

doesn't receive as much funding as a lot of other things, so I got

involved. "

With a laugh, he added, " And it gave me another chance to build

something. "

In Rhode Island this year, 19 new cases of autism are being diagnosed

for every new case that was recognized in 1992.

Nearly 1.8 million Americans have been diagnosed, a figure that is

increasing by 24,000 annually.

Meanwhile, advocates say, autism research gets about $1 for every $20

spent on diseases that affect fewer children, including leukemia, muscular

dystrophy and cystic fibrosis.

Ford said the puzzle bike will go on tour in the weeks ahead, to

motorcycle shows in Boston and Hartford, and will go on display locally when

the Providence Convention Center hosts the boat show.

Tickets are available online at www.bittersweetapri.org, and at

X-Dream Cycle, on Post Road, just south of Route 37.

The Autism Project will limit sales to 1,000 tickets, and will

announce the winner on March 10 at Rosecliff Mansion, in Newport, at a

dinner dance marking the project's eighth year of advocating for children

with autism.

Web addresses for the Autism Project and X-Dream Cycle are:

http://www.theautismproject.org and www.xdreamcycle.com

Announcement From the Autism Calendar of Events

The Fine Art of Discrete Trial Training -

Horton M.Ed. BCBA

Jan 12-13 Wichita, Kansas

For more information on this autism event and hundreds

of others, see: http://www.sarnet.org/events

- No registering, no password, no fee.

.. . .

FORENSIC

Asperger Killer Gets Life

By Andy for the Sun, UK.

http://www.thesun.co.uk/article/0,,2-2005580284,00.htm

Jobless loner Kieron faces a life sentence after being convicted

yesterday of murdering a schoolgirl.

A jury found him guilty of battering to death ten-year-old

Pilkington- following a two-week trial.

, 18, befriended her during a game of cricket with other

youngsters. He killed her after taking her for a walk in nearby woods.

The youth, from Leigh, Greater Manchester, suffered from Asperger's

Syndrome, a form of autism. But this was not put forward as a defence by his

lawyers at Liverpool Crown Court.

Mr Justice Mackay adjourned sentencing for reports but said: " There is

only one sentence that can be passed on him and that is a life sentence. "

vanished on the evening of July 7. Her body was found later

that night by her grandfather Ken Pilkington after the family launched a

frantic search. There was no evidence of a sexual attack.

who left school aged 13, admitted playing with but

claimed he then went home.

But other witnesses contradicted his story and droplets of 's

blood were found on his trainers.

His reasons for killing the popular girl may never be known. 's

parents were in court to hear the verdict but were too upset to talk

afterwards.

But 's grandmother, Pat , read out a family statement. She

said: " We have been deprived of seeing grow up into a sensitive,

caring adult.

" 's death has destroyed us. Our lives and our home will never be

the same again. "

Outside court, 's grandfather said: " At least the jury has had

the common sense to put this fellow away for good.

" Hearing what happened in court has been terrible.

" We didn't know the full extent of the injuries. We are devastated. "

.. . .

LETTERS

Ask for the Books

I'm a librarian in a small-town library. One of my patrons started

talking to me about her son and asked me if I could help her find books

about autism. I asked her if she was looking into the biomedical approach

and she asked if I could find her a book.

I tried to get the McCandless book, but there were only two copies in

the state and they were both out (one on inter-library loan), so I ordered a

copy for my library. It has been out to twice now, to the original requestor

and to a grandmother of a recently diagnosed child. The grandma told me that

she looked the book over and then went and bought a copy for her daughter,

pronto.

The point of all this: go to your local public library and ask them if

they can add some books on the biomedical aspects of autism to their

collection. Autism is a big topic now, but the biomedical side hasn't gotten

much publicity in the mainstream press, nor in the journals that librarians

use for collection development. Librarians do listen to their patrons,

however, so if you ask the books could end up in your local library, and

they could make a huge difference for more than one family.

-Deborah

Public Service Announcement to the Reader:

AUTISM IS TREATABLE. Consult these sources:

. Autism Research Institute

http://www.autismwebsite.com/ari/index.htm

. Generation Rescue http://www.generationrescue.org

COPYRIGHT NOTICE: The above items are copyright protected. They are for our

readers' personal education or research purposes only and provided at their

request. Articles may not be further reprinted or used commercially without

consent from the copyright holders. To find the copyright holders, follow

the referenced website link provided at the beginning of each item.

SUBSCRIBE to SAR: http://www.sarnet.org or mailto:subs at doitnow.com

_______________________________________________________________________

Lenny Schafer, Editor edit at doitnow.com Conrick Decelie

Miles

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