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AUTISM FIRST STEPS
AUTISM DAILY NEWSLETTER
Wednesday January 9, 2002
INDEX:
* Merck hit for plant
problems
* LAW SUIT UPDATES - MERCURY
* BUSH PUSHES METHODOLOGY!
* 60 MINUTES II, Wednesday on CBS/TV (8 pm ET, 1-9-02)
* Paxil Poised to Battle
* Deptford case shows special-ed woes
* Study: Supplement Mix Eases Bipolar Symptoms
* Golf for Autism
* Autism
Intervention San Diego Meeting
******************************
Merck hit for plant problems
FDA
cites the drug maker after Pa. plant inspections
BY ED SILVERMAN
STAR-LEDGER STAFF
Merck
& Co. has been cited by federal regulators for numerous quality-control
problems at a manufacturing plant where several important vaccines are made.
The Food and Drug Administration issued two enforcement reports -- extensive
reviews of manufacturing practices -- following inspections of a Merck plant in
Pennsylvania this past summer and fall, according to documents obtained by The
Star-Ledger. After the second report was compiled in November, the Merck
executive in charge of vaccine operations at the West Point, Pa., plant took
early retirement, according to a company memo. The FDA found Merck improperly
performed procedures for sterility, testing and documentation, among other
things. They were noticed by regulators at the same time Merck bid on -- and
lost -- a $428 million contract to make smallpox vaccine for the federal
government. Such inspections are routine in the pharmaceutical industry, but
lengthy enforcement reports aren't -- the second report was 22 pages.
Ultimately, Merck could face stiff fines if enough serious violations are found
over a prolonged period. Meanwhile, people familiar with the situation say
production at the plant has been halted while new supervisors are trained.
Between 300 and 400 people work there. This is only the latest reversal of
fortunes for the Whitehouse Station drug maker, which makes some of the
best-known medicines. Recently, patents expired on some big-selling drugs, its
Vioxx painkiller missed sales targets and was linked to cardiovascular
problems, and company officials scaled back their earnings outlook. "Merck's
had a particularly tough year. And they've got a way to go to get back on
track," said Mark Ravera, an analyst at Mehta Partners, a health-care
investment firm. "Something like this would not be a welcome addition to
their burdens. They certainly don't need any more bad press. But the FDA has
been really cracking down on everybody." Indeed, the FDA review is another
example of how regulators, who have been widely criticized for the way they
approve new drugs, have become stricter about enforcing manufacturing problems.
In 2000, the FDA levied a large fine on American Home Products Corp. and has
recently cited plants run by Schering-Plough Corp. and Eli Lilly & Co. A
Merck spokesman, Greg Reaves, declined to comment on dealings with the FDA or
the departure of the vaccines executive, James Laser. Reached at home, Laser,
55, declined to comment. "I don't think there are a whole lot of dots to
connect." Reaves also insisted any supply shortages are due to
"voluntary" interruptions in production, which he attributed to
maintenance upgrades and changes in manufacturing practices. But he stressed
that shipments are proceeding. Among the problems the FDA found at Merck:
Timely inspections weren't performed after noticing sterility failures.
Discrepancies in the number of rejected batches weren't documented.
Spreadsheets used to determine questionable results weren't verified.
Sufficient air pressure in the building wasn't maintained properly. The FDA
typically doesn't comment on inspections that haven't yet been resolved, but an
FDA source said the Merck case remains open. Products made at Merck's Building
29, part of a huge research and manufacturing facility in West Point, include
Varivax, a chicken pox vaccine; a vaccine for MMR, or measles, mumps and rubella;
and vaccines for Hepatitis A and B, the spokesman confirmed. Vaccines generated
only about $1 billion in sales for Merck last year out of total revenue of $21
billion. But Merck has repeatedly identified vaccines as a growth engine. For
instance, the company is working on an AIDS vaccine. "Vaccines aren't as
big as Zocor," the cholesterol medication, said Hemant Shah, an
independent analyst who tracks drug makers. "But it's still an important
business." Ed Silverman can be reached at esilverman@starledger.com or at
(973) 392-1542.
http://www.nj.com/business/ledger/index.ssf?/business/ledger/1580e88.html
******************************
LAW
SUIT UPDATES - MERCURY
Two new
on-line questionnaires have recently been added to http://www.talkinternational.com
Now those wishing to participate in lawsuits pertaining
to mercury dental amalgam as well as Thimerosal can visit our
Free Legal Registry and download, and print questionnaires from our site.
Completed questionnaires may be faxed or returned by regular mail. The Canadian
Class Action Lawsuit filed in March 1998 is still alive and well. A meeting is
currently being arranged with the new lawyers handling this case and we will
advise as to updates on this matter as soon as possible thereafter, but it is
our intention to push for certification prior to June of this year.. We
will keep all interested parties and stakeholders in touch through our
TALKNEWS, TALKHEALTH & CFMR Broadcast Lists. Currently we have
lawyers actively working on both mercury amalgam and Thimerosal Lawsuits . More
lawyers are expected to become involved in both Canada and the U.S. over the
next several months as we continue to review strategies and potential cases
with them. It is important during this time that a true indication of just how
many people potentially qualify and are interested in participating in these
cases are represented. The simplest and most cost efficient way for the law
firms and us to compile this information is through Talk International.com’s
Legal Registry. If you have not already done so, complete and submit your
questionnaire as soon as possible and encourage your patients, friends and
others to do the same. Please note that your joining the legal registry in
no way precludes you from proceeding in any other action in which you may be
involved. It simply enhances your opportunity for success substantially. Law
firms looking to become involved in these very important issues and requiring
access to experts, representative plaintiffs, strategies and issues of
commonality are invited to contact us directly.Sincerely
Wayne Obie
Media
& Public Relations
Talk
International.com
communications@talkinternational.com
******************************
BUSH PUSHES METHODOLOGY!
In his speech celebrating his signing
of the ESEA education bill reauthorization, this very day, President George W.
Bush said the following:
[on why mandated standardized testing is necessary and required by the new law]
" . We need to know whether the methodologies the teachers are using
are working! "
Therefore,
1. Methodology is no longer a dirty word. When you use
it, cite President Bush as your source.
2. From now on in IEP meetings and discussions with
speducrats and sped. teachers and service providers, repeat the following, over
and over: "Since the President has said 'we need to know whether the
methodologies the teachers are using are working,' I am entitled to, and need
to know what methodologies are being used with my child so that I can determine
whether they are working, and if not, which other methodology(ies) might
work."
3. And, of course, since the President says it is a topic for
discussion and informed decision (otherwise why would he insist on testing and
looking at methodologies' results?), your child's IEP meeting may now include
discussions of methodology, and so should your child's IEP.
See, Republicans can be wonderful!
Dee Alpert, ex-Republican District Co-Leader, 69th Assembly District
(Manhattan, Upper West Side
******************************
60 MINUTES II, Wednesday on CBS/TV (8 pm ET,
1-9-02)
A woman named Miriam Weintraub has produced an intriguing story
about a strange neurological condition called synesthesia -- where sounds are
not just heard, they're seen and felt ... where numbers can have a smell and
the word Friday actually tastes like Spam. Tune in, if you can.
******************************
Paxil Poised to Battle
PTSD's Big Three
By Michael
Smith , MD
WebMD Medical News
Reviewed By Dr. Gary
Vogin
Posttraumatic stress disorder can be emotionally crippling, and some have
predicted an epidemic following the events of Sept. 11. But a new study shows
that one well-known drug may be the first medication approved to treat all
aspects of the illness. PTSD can follow a traumatic experience, such as
surviving or witnessing a violent physical attack or injury. Other distressing
circumstances that can trigger PTSD include being in a serious accident, seeing
someone killed, and surviving a terrorist bomb blast or war. In PTSD, memories
of the traumatic event intrude into daily life and even into dreams. The person
with PTSD "relives" what happened, over and over again --
experiencing great anxiety and distress in the process. People with PTSD are
usually extremely self-protective, or hypervigilant; they startle easily; and
have trouble concentrating. They may also be depressed and/or have phobias,
such as intense fear of leaving the house. Recurring PTSD episodes can be so
upsetting that the person with PTSD actively avoids people or environments that
may trigger them. Researchers at the New York State Psychiatric Institute at
Columbia University say that the antidepressant Paxil is the first drug shown
to treat all three major symptoms of PTSD. Paxil is a cousin drug of other
antidepressants, including Prozac, Zoloft, and Celexa. In the study, more than
550 people with PTSD received either Paxil or a placebo for 12 weeks. The
researchers looked closely at each person's symptoms, including re-experiencing
the traumatic event, avoiding social situations, and being hypervigilant. The
study was partially funded by GlaxoSmithKline, Paxil's manufacturer. People
taking Paxil had significant improvement compared with those taking placebo.
This was true for both men and women, and regardless of what type of trauma
triggered their PTSD. In addition, Paxil improved depression, which is often
seen in people with PTSD. Those taking the drug were able to function better
socially, with family, and at work. Paxil is reportedly in the final stages of
approval for the treatment of PTSD. Should it get the OK, the researchers say
it would be the first drug for fighting the three evils of this long-term
disease. With reporting by Daniel DeNoon
WebMD
with AOL Health - Paxil Poised to Battle PTSD's
******************************
The Philadelphia Inquirer
Tuesday, November 13, 2001
Deptford case shows special-ed woes
The district has to repay the family of an autistic child. Other schools
face similar problems
By Jake Wagman
Inquirer Suburban Staff
A federal judge this month ordered the Deptford Township School District to
pay almost $140,000 for the education of an autistic child.
The case is among an increasing number in New Jersey in which
a judge is
asked to decide whether a school has met the requirements of federal
special-education legislation.
Few public schools are equipped to teach children with autism
and other
severe conditions. In order to meet Congress' mandate of a "free and
appropriate education," students are often sent to out-of-district public
or
private schools, with their home district picking up the cost.
Collingswood, Medford, Pemberton Township and Voorhees are
among the
hundreds of New Jersey school districts that have sought relief in state
courts from making these expensive accommodations since Congress amended the
Individuals With Disabilities Education Act in 1997.
An administrative law judge in Trenton ruled against Deptford
in a case
heard in December and ordered the district to create a full-day learning
program for the student, identified in court documents as H.B. The judge
also ordered Deptford to reimburse the student's parents for therapy,
evaluation and transportation costs.
Autism is a mental disorder characterized by self-absorption,
inability
to interact socially, repetitive behavior, and language dysfunction.
Deptford took the rare step of appealing the case to U.S.
District Court
in Camden. On Nov.2, Judge Jerome B. Simandle issued his ruling in favor of
H.B.'s parents, saying Deptford's appeal rested mostly on a
"paperwork"
technicality.
Between September 1999 and February 2000, the Mount Holly therapy center
where H.B. was enrolled was unapproved by the state while criminal
background checks of the staff--a requirement enforced for the first time
last year-- were pending. Deptford argued that the center's temporary
lack
of state recognition excluded the school district from having to pay for the
enrollment.
The district has been ordered to pay $139,165 to reimburse
the student's
parents, who have moved out of the district, for two years' worth of
services: $2,231 for transportation, $4,625 for doctor's evaluations, $41,900
for speech therapy, $73,456 for behavioral therapy, $7575 for occupational
therapy and $9,378 for other educational costs.
The average per-student cost in the Deptford district is
$7,500.
Deptford Superintendent David H. Moyer said the district
would have to
cut funding for academic or extracurricular programs to satisfy the court
order.
"We empathize with the parents, but we just can't afford
it, so we have
to litigate," he said.
Moyer said the problem with special education is not in the
schools but
in the funding system. The 1997 version of the Individuals With Disabilities
in Education Act stated that the government would pay 40 percent of a state's
special-education costs. To date, the most Congress has authorized in a
year
is 11 percent, Moyer said.
"The administrative law judges are removed from local
districts. They
are judging stuff strictly from the ivory-tower perspective. They render
a
decision, and you have to live with it," Moyer said. "Try
telling the
average senior citizen on the corner you spent $200,000 on a kid. They
won't
understand."
Because of the expense of instructing students with autism
--which
emphasizes long hours of one-on-one instruction-- parents have no choice but
to go to court, said Jamie Epstein, a Camden County lawyer who specializes in
special-education cases and represented H.B.'s parents.
"There is no way that, except for the wealthiest ones,
parents can
provide an appropriate education for a child with autism," Epstein said.
Jake Wagman's e-mail address is jwagman@phillynews.com
******************************
Study: Supplement Mix Eases Bipolar Symptoms
By
Liza Jane Maltin
WebMD Medical News
(Dec. 20) -- There's new evidence from a small-scale study that dietary
supplements may alleviate the radical, often incapacitating mood shifts of
bipolar disorder in some patients. When researchers tested their
multi-ingredient mixture on 14 patients, nearly half were able to decrease or
even discontinue their regular medication.
The report and an accompanying editorial appear in the December issue of Journal
of Clinical Psychiatry.
The Canadian researchers, led by Bonnie J. Kaplan, PhD, of the University of
Calgary, based their approach on the well-established notion that abnormal
levels of vitamins, minerals, and other nutrients have been associated with a
host of mental and physical ailments.
In fact, bipolar disorder is typically treated with the mineral lithium, brain
levels of which are off-kilter in people with the illness.
"We spent the last five years developing and testing a nutritional supplement
that will help alleviate mental illness," the researchers write in a news
release.
In the six-month trial, 14 patients, aged 19-46, continued on their regular
medications, but also took the specially-formulated, 36-ingredient supplement
mixture of vitamins, minerals, amino acids, and antioxidants. Prior to the
study, the patients had used an average of 10 different drugs to help control
their symptoms, and each had been hospitalized at least once.
At regular intervals during the trial, patients took several standardized tests
to measure their depression and mania symptoms. Within two weeks, most of the
patients showed 50%-66% improvements in all symptoms. "In some
cases," the researchers write, "the supplement replaced psychotropic
medications and the patients remained well."
The only side effect complained of was nausea, which went away if patients took
the supplement with food or at a lower dose.
"In view of the 50 years of experience with lithium, the notion that
minerals can treat bipolar disorder is unsurprising," writes editorialist
Charles W. Popper, PhD, from the department of psychiatry at Harvard Medical
School. "However, the nutrient supplement studied by Kaplan and colleagues
contains no lithium."
Besides being an exciting new approach to treating mental illness, the findings
could have significant monetary implications, writes Popper. Even if patients
were only able to reduce their standard medication by half, it would make a
huge difference, given the cost of traditional psychiatric drugs compared with
nutritional supplements.
Granted, the whole approach is still "in a very early stage of scientific
investigation," Popper writes, and much larger, more rigorous trials are
needed. But "depending on how this line of research develops, [we] may
need to rethink the traditional bias against nutritional supplementation as a
potential treatment for major psychiatric disorders."
Reviewed By Charlotte Grayson
© 1996-2001 WebMD Corporation. All rights reserved.
AOL News: Study Says
Supplement Mix Eases Bipolar Symptoms
******************************
Golf for Autism
GOLFERS NEEDED!!!!
The North County Chapter ASA will be the official charity
for the golf tournament associated with the San Diego Marathon. It will be
held at Twin Oaks Course in San Marcos on THURSDAY, JANUARY 17th, 2002. A
silent auction and lunch will follow the golf. This event promises to be a
lot of fun and it gives the opportunity to everyone to support the NCCASA
and the work the Chapter accomplishes in North County.
There are still a few player spots available, and even a couple of hole
sponsorships. So, check your calendars!! Contact Merryn Affleck at
760-479-1420 for information.
******************************
Autism Intervention San Diego Meeting
Monthly
Support Group & Training for Parents & Professionals
"Why
Challenging Behaviors Happen,
What
You Can Do About It,
and
What Usually Goes Wrong"
Presented
by Paul Dores, Ph.D.
Dr. Paul Dores is a psychologist in private practice in San Diego with
30 years experience working with individuals with autism, starting with
the UCLA Autism Project, under Ivar Lovaas, Ph.D., in the early 1970's.
He is a member of the Board of Directors of the San Diego Chapter of the
Autism Society of America, a Clinical Advisor to Blue Cross, and an
independent consultant to a number of school districts in San Diego and
Orange County.
This is an exciting opportunity to hear a local expert address
behavioral issues prior to an upcoming conference. Dr. Dores and TERI,
Inc. are sponsors of the 4th Annual Autism Through The Lifespan
Conference: A Focus on Middle School to AdultYears. This February 2002
conference focuses on issues of interest to families, teachers and other
professionals working with individuals with autism during adolescence
and adulthood. Hear what he has to say about working with younger
children:
Date: Sunday, January 20, 2002
Time: 2:30 – 4:30pm
Location: Mira Mesa Catholic Charities, 9535 Kearny Villa Rd. #101, San
Diego [Directions below]
Childcare is not being provided for this meeting.
Autism Intervention San Diego is a parent training and support group
addressing the issues of younger children on the autistic spectrum. We
maintain a parents-only, moderated email list through the Internet. To
join the moderated parents-only group, email Lisa Rose at
LCRose@ispwest.com. A non-moderated list for parents and professionals
to exchange local information, and post meetings and conferences is
located at AutismIntervention_SanDiego@yahoo.groups.
Directions to Catholic Charities: 9535 Kearny Villa Rd. #101, San
Diego, CA 92126. From I-15 exit Miramar Road and travel west about 2
blocks to Kearny Villa Road. Turn right (north) at the stoplight. You
will see a storage facility immediately around the corner on your right
and then a small one-story office/light industry strip mall at 9535
Kearny Villa Rd. (on the right hand side/east). There is a small parking
lot in front, lots of parking on the street and more parking behind the
building. There is a sign for Catholic Charities in front of suite 101.
Since we are not affiliated directly with Catholic Charities, please do
not call them for information.
******************************
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