SCHAFER AUTISM REPORT "Healing Autism:
No Finer a Cause on the Planet"
Tuesday, November 1, 2005 Vol. 9 No. 172
THE AUTISM CALENDAR OF EVENTS IS OUT!
* MMR: The Unanswered Questions
* Scientists Tie Two Additional Genes to Dyslexia
* ADHD Drugs Might Become Available As Patch
* Congress Weakens Organic Labeling
* Minnesota Attorney General To Scrutinize Autism Center
* Autism One Radio Special Nov 2 Senate Bill 1873
* TV: Supernanny Teams With Acclaimed Autism Expert To Help Child
* Asperger Boy Can Not Attend Indiana Catholic School
* Forced Inoculations Beginning Of Bush's Bad Bird Flu Plan
MMR: The Unanswered Questions
Daily Mail, UK
Since Dr Andrew Wakefield first triggered the furore over a possible
link between autism, bowel disease and the measles, mumps and rubella triple
jab in 1998, the controversy has never died away. Now a study by the
respected Cochrane Library has said, on the basis of 31 pieces of research
into the possible side effects of MMR, that it found no association between
MMR and autism.
Cue a frenzy of gloating by Wakefield's enemies, ripe denunciations of
those like this newspaper who took his concerns seriously and demands that
we apologise for creating a scare that left children unvaccinated and at
risk of measles, mumps and rubella. The Cochrane Library study, they
shrieked, had found MMR to be 'safe', given it the 'all clear' and declared
all such fears to be 'unfounded'.
This is a load of old baloney. These people should start by reading
the actual study rather than lazily recycling the press release. For the
study didn't say anything like this at all.
Certainly the lead Cochrane reviewer Vittorio Demicheli said in that
press release: 'We conclude that all the major unintended events, such as
triggering Crohn's disease or autism, were suspected on the basis of
But Wakefield never suggested a link between MMR and Crohn's disease,
a disorder of the bowel. Wakefield reported instead the discovery of an
entirely new syndrome, autistic enterocolitis, which produced distressing
bowel symptoms along with a number of developmental problems resembling
autism - but which the Cochrane report did not even mention.
Moreover, it did not conclude that Wakefield's evidence was
unreliable. On the contrary, it said that no fewer than nine of the most
celebrated studies that have been used against him were unreliable in the
way they were constructed. As a result, it said, their conclusions that MMR
was 'safe' or 'well-tolerated' need to be 'interpreted with caution'.
Next, the press release said: 'There was no credible evidence behind
claims of harm from the MMR vaccination.' But the study did not say that. It
did not even examine those claims of harm, which arose not from the
epidemiological studies of patterns of disease which Cochrane investigated,
but from clinical investigations of actual children.
What the report did say but was not mentioned in that extremely odd
press notice was this: 'The design and reporting of safety outcomes in MMR
vaccine studies, both pre-and post-marketing, are largely inadequate'. And
just as significant, this: 'We found only limited evidence of the safety of
MMR compared to its single component vaccines.'
In other words, far from saying MMR was safe the study said explicitly
that the evidence for its safety was not good enough. Yes, it also said the
evidence it looked at did not support any association between MMR and
autism. But that does not mean it said the vaccine was safe. It was rather
that it didn't find anything to suggest that it was not.
And that was because the epidemiological studies that it examined are
intrinsically unlikely to reveal the truth about the effects of MMR. For a
start, they rely on medical records. But the parents complained that their
children's doctors dismissed all their concerns about autistic symptoms or
bowel disease. So they never entered anything out of the ordinary on their
Furthermore, for the vast majority of children, the vaccine poses no
problem at all. Only a very small proportion are said to have been badly
affected, possibly through a combination of environmental or genetic
factors. But population-wide studies are considered too large and
insensitive to pick up small numbers like this.
It is the evidence that Cochrane did not examine that is the only
material worth studying. This is the clinical evidence obtained not just by
Wakefield and his associates but by others, which has posed alarming
questions that have never been answered.
Wakefield's discovery of autistic enterocolitis as a completely new
syndrome has now been replicated in studies around the world as a new and so
far unexplained disease in patients with autism.
It has also been discovered that autistic symptoms have got far worse
in a number of children after they received booster jabs - and such booster
jab evidence has been accepted by the American Institute of Medicine, at
least, as an indication of cause and effect.
Most explosively of all, vaccine-strain measles virus has been found
in the cerebro-spinal fluid of some autistic children - which suggests that
in those cases the vaccine may have had a catastrophic effect on the brain.
None of this proves that MMR has caused autism in some children. But
it does raise questions which need to be resolved as a matter of urgency.
The only way to do so is to conduct large-scale clinical trials, which the
government has consistently refused to do.
Hopes of examining the existing clinical evidence were pinned on the
legal case being brought by parents claiming compensation on behalf of
children said to have been damaged by the vaccine. But this case foundered
when the parents' legal aid was abruptly withdrawn.
Now Wakefield himself is being arraigned before the General Medical
Council on eleven counts of serious professional misconduct, including an
alleged conflict of interest over receiving funding from the parents'
lawyers, which he has strenuously denied.
Compare this with the Cochrane paper, where under the rubric
'potential conflict of interest' Dr Tom Jefferson, who is listed as the
study's second author, acknowledges that in 1999 he acted as a consultant
for a legal team advising the MMR vaccine manufacturers.
Another researcher who helped with the Cochrane paper was one of the
authors of a prominent study which rubbished Wakefield's research -- a study
which the Cochrane report itself then investigated.
And a number of epidemiological studies which the government has used
to state that MMR is safe have been written by researchers with links to
drug companies or to governmental bodies with an interest in disproving
Are these not real conflicts of interest which should be investigated,
rather than hounding the doctor whose discoveries have raised concerns over
public health which have never been addressed?
One of Cochrane's findings should give even those jeering from the
sidelines pause. This was that the 'Urabe' strain of the mumps component of
the triple vaccine causes aseptic meningitis.
Although the current vaccine does not contain this Urabe strain, the
first batch of MMR vaccine introduced in 1989 did - even though the Health
Department knew at the time that Canada had already withdrawn it because it
The British vaccine was only replaced years later, after researchers
discovered to their horror an association with aseptic meningitis in
Britain. So the idea that MMR was always safe is demonstrable nonsense.
The MMR scandal is getting worse. Urgent questions about the vaccine's
safety remain unanswered. The doctor who raised those questions is being
subjected to what appears to be a witch-hunt. The parents' recourse through
the courts has been blocked. Now they have to put up with being told yet
again that the evidence of their own eyes is fraudulent.
Every responsible person wants to see children vaccinated against
dangerous diseases. But public anxiety could have been allayed overnight had
the government permitted single vaccine jabs. Instead, we have clouds of
obfuscation, an ignorant cacophony of catcalls - and an unresolved public
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Scientists Tie Two Additional Genes to Dyslexia
Note: We have already reprinted another story on this subject. This
one is by Sandra Blakeslee for the NY Times.
One year after scientists discovered a gene whose flaw contributes to
dyslexia, two more such genes have now been identified.
The findings, described yesterday in Salt Lake City at a meeting of
the American Society of Human Genetics, support the idea that many people
deemed simply lazy or stupid because of their severe reading problems may
instead have a genetic disorder that interfered with the wiring of their
brains before birth.
"I am ecstatic about this research," said Dr. Albert M. Galaburda of
Harvard Medical School, a leading authority on developmental disorders who
was not involved in the latest discoveries.
The findings, added to last year's, mean that for the first time, "we
have a link between genes, brain development and a complex behavioral
syndrome," Dr. Galaburda said.
As many as a dozen genes are probably involved in the disorder, he
said, with each playing a role in the necessary migration of neurons as the
brain's circuitry develops.
Researchers said a genetic test for dyslexia should be available
within a year or less. Children in families that have a history of the
disorder could then be tested, with a cheek swab, before they are exposed to
reading instruction. If children carry a genetic risk, they could be placed
in early intervention programs.
"Reading ability is a proxy for intelligence in American culture,"
said Dr. Sally E. Shaywitz of Yale University School of Medicine, a
pediatrician who is an expert on dyslexia. The findings should help overcome
stereotypes and get children the assistance they need, she said.
One of the genes newly linked to dyslexia is called DCDC2. It is
active in reading centers in the human brain, said Dr. Jeffrey R. Gruen, a
Yale geneticist who described the discovery at a news conference yesterday.
Large deletions in a regulatory region of the gene were found in one of
every five dyslexics tested, making it less active.
Fluent readers and dyslexics alike have the protein made by this gene,
Dr. Gruen said, but it is less abundant in dyslexic brains. The function of
the protein is not known, he said.
Rats also have the DCDC2 gene, so it should not be misconstrued as a
spelling or reading gene, Dr. Gruen said. Rather, the gene supports the
circuitry that underlies reading. When it was perturbed in unborn rats, he
said, neurons migrated shorter distances, undercutting early brain
The second gene, called Robo1, was discovered by Dr. Juha Kere, a
professor of molecular genetics at the Karolinska Institute in Stockholm. It
is a developmental gene that guides connections, called axons, between the
brain's two hemispheres, Dr. Kere said in an interview.
When the gene's activity is reduced, the number of finer connections,
called dendrites, is reduced in brain areas involved in reading.
"You get the right signals going, but they do less well in terms of
rapid processing," Dr. Kere said.
Many dyslexia experts believe that reading problems stem from an
inability to process the fast sounds of spoken words.
. . .
ADHD Drugs Might Become Available As Patch
Children who are prescribed ADHD drugs may soon have a choice: the
patch or the pill.
A new patch system delivers methylpnenidate, the main ingredient in
Ritalin, Concerta, and Methyln throughout the day. The patch is made by
Noven and Shire pharmaceuticals. It is the first ADHD drug that does not
have to be taken orally.
Studies have shown the patch works at least as well as the pills. It
does have similar side effects one of the benefits is the affects appear to
last longer than the usual 10 to 12 hours.
The company is now awaiting FDA approval.
. . .
Congress Weakens Organic Labeling
If you have been shopping carefully, reading all the labels and
otherwise attempting to ensure that only "organic" substances enter your
body in the food you eat, your task just got a little tougher. According to
a release from the Organic Consumers Association, a rider in a bill passed
by Congress last week has "weakened" the laws defining food, to allow
"synthetic substances" to be included in foods labeled as "organic." The
opposition group, the Organic Trade Association, in conjunction with major
food processing corporations like Smucker's, Dean Foods, and Kraft, have
lobbied Congress to amend the Organic Foods Production Act to allow for this
leeway in "organic dairy standards."
The OCA cites a recent court decision, ruling that the OFPA does not
allow these "non-natural" ingredients in foods labeled "organic." The
Congressional action was thus required to bypass this decision, and the OCA
is not pleased.
"Congress voted last night to weaken the national organic standards
that consumers count on to preserve the integrity of the organic label,"
Ronnie Cummins, OCA National Director is quoted as saying. "The process was
profoundly undemocratic and the end result is a serious setback for the
multi billion dollar alternative food and farming system that the organic
community has so painstakingly built up over the past 35 years. . Industry's
stealth attack has unnecessarily damaged the standards that helped organic
foods become the fastest growing sector in the food industry."
. . .
Minnesota Attorney General To Scrutinize Autism Center
By Dan Browning and Pat Doyl for the Star Tribune
Minnesota Attorney General Mike Hatch said Thursday he would try to
determine if one of the state's largest programs for autistic children has
misspent Medicaid money and whether the board of the nonprofit organization
is formed properly.
Hatch said he would have Medicaid specialists in his office review
billings from the tax-exempt Minnesota Autism Center to the state Department
of Human Services. The center relies on public money for most of its budget.
"It's very clear that there's been enough controversy involving the
billing matters ... that it does merit review by the state," Hatch said.
Staff psychologists at the center have complained of being pressured
to approve treatment services that may not have been medically necessary for
the autistic sons of two board members, Ron Carey and Kathryn Marshall.
Carey and Marshall defended the therapy for their children, saying it
was proper and necessary and approved by DHS. They deny seeking special
treatment or overstepping their authority as board members. Carey is
chairman of the Republic Party of Minnesota; Marshall is a retired lawyer.
Hatch, a DFLer running for governor, said he was reacting in part to a
story about the dispute published Thursday in the Star Tribune.
He said he also was responding to complaints from some employees of
the center and to conversations in the past week with DHS about the matter.
The dispute resulted in a lawsuit earlier this year by board members
Tim Wilkin and Larry Colson against Carey, Marshall and two other board
members with children in the program. Wilkin, a Republican, is assistant
House majority leader. Colson is a Republican activist.
In a settlement of the suit, Wilkin and Colson agreed to resign from
the board and to say their claims were not factual. The center agreed to
develop a conflict-of-interest policy.
A Hennepin County judge overseeing the case asked earlier this year
that Hatch look into the matter, and the attorney general said he had
referred complaints about the Autism Center to DHS. "We're unclear whether
DHS is reviewing it or not," Hatch said in reference to the earlier inquiry.
DHS said state law bars it from publicly confirming investigations
unless they are closed.
However, DHS Commissioner Kevin Goodno said Thursday that the agency's
"Surveillance and Integrity Review Section routinely works closely with the
Attorney General's Office Medicaid Fraud Unit and supports its efforts to
investigate any activity it suspects may be fraudulent."
The Autism Center provides intensive behavior intervention therapy,
which involves a team of therapists who work with an autistic child for 40
or more hours a week. It typically lasts about three years and can cost
$100,000 a year or more at its most intense periods. The center has 88
clients and a waiting list of more than 100.
Glen Sallows, director of the Wisconsin Early Autism Project in
Madison, said that such therapy generally should start before age 3 and that
most gains occur in the first year. Results are believed to diminish for
Legislators Weigh In
"If there is a question in terms of its effectiveness, and you're
spending that kind of quantity of money, then what about the other kind of
therapies that may not be as expensive but have ... pretty good results as
well?" asked Rep. Fran Bradley, R-Rochester, who chairs the House Health
Policy and Finance Committee. "You're not going to have as much money left
Bradley said that questions about the therapy's effectiveness and the
growing expense of Medicaid to the state will probably reduce support for
funding a 2001 law that would dedicate money for such therapy in the future.
Sen. Linda Berglin, DFL-Minneapolis, chairwoman of the Health and
Human Services budget division of the Finance Committee, said that the
therapy may help some younger children but that she has concerns about the
cost and overall effectiveness.
Berglin said that she might ask the Legislative Audit Commission to
review the matter.
[Thanks to Rick Rollens.]
. . .
Autism One Radio Special Nov 2 Senate Bill 1873 A Worldwide, Web-Based Radio
Station for the Care, Treatment, and Recovery of Children with Autism
Wednesday, November 2nd:
Special: Senate Bill 1873 & the President's Tuesday avian flu
12:45 pm - 2:15 ET Why is S.1873: the "Biodefense and Pandemic
Vaccine and Drug Development Act of 2005," one of the most unfriendly pieces
of legislation yet to you, your children, your neighbors? What positive
steps can you take right away? Join Autism One Radio and guests, including
Barbara Loe Fisher of the National Vaccine Information Center, Jim Moody,
Esq. of Advocates for a Competitive Economy and SafeMinds, and Laura Bono of
the National Autism Association for these questions and commentary on the
President's avian flu briefing of Tuesday, November 1st.
Note: For more information on this subject see commentary below:
Forced Inoculations Beginning Of Bush's Bad Bird Flu Plan
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 over
1,100 subscribers. Here is how to subscribe
(no cost): EOHarmfirstname.lastname@example.org
. . .
TV: Supernanny Teams With An Acclaimed Autism Expert To Help A Child Who Is
An Outsider In His Own Home On "Supernanny," November 4, ABC
Supernanny Jo Frost teams with world-renowned autism expert Dr. Lynn
Koegel to tackle the parenting issues faced by a family whose three-year-old
son is an outsider in his own home. This episode of "Supernanny" airs on
Friday, November 4 (8:00-9:00 p.m. ET) on the ABC Television Network.
Deirdre and Trae Facente don't know how to integrate their autistic
son Tristin into their daily life with their twins, Kayla and Marlana (4).
Tristin is completely non-verbal, caught up in his own world of
spinning, jumping, swinging and, often, taking off his clothes. The only
time he spends with his family is sitting at the dinner table. The twins,
who demand much of their stay-at-home mom's attention, can't figure out how
to play with their little brother.
The parents are at a loss as to how to help Tristin come out of his
zone and join the family.
Enter Dr. Koegel and Supernanny. Together they refine the classic
Supernanny methods and teach all the Facentes Dr. Koegel's inclusion and
communication techniques to help engage Tristin. For example, when they
introduce the new daily schedule to everyone, Dr. Koegel uses a picture
board with Tristin to help him understand in a concrete way.
In just a week, silent Tristin goes from zero words to speaking
hundreds of times using over 20 new words. He is bursting with requests to
play a favorite game, be tickled or eat a treat. Step-by-step, Jo and Dr.
Koegel help the parents keep Tristin from his disruptive behaviors by
including him in family chores and activities. These efforts culminate in
the boy helping his dad set the table, a seemingly mundane task that is so
miraculous for Tristin, it brings tears to Trae's eyes.
Lynn Kern Koegel, Ph.D is one of the world's foremost experts on the
treatment of autism. She and her husband, Robert L. Koegel, Ph.D., founded
the renowned Koegel Autism Center at the Graduate School of Education at the
University of California, Santa Barbara. She co-wrote the bestselling book
on autism, Overcoming Autism: Finding the Answers, Strategies, and Hope that
can Transform a Child's Life, which was recently released in paperback, and
also co-authored, with Robert Koegel, the new book, Pivotal Response
Treatments for Autism.
. . .
Asperger Boy May Not Attend Indiana Catholic School
By Olivia Clarke for the NW Times, Indiana.
Munster resident Nancy Wojcik is upset her son can no longer attend
St. Thomas More Catholic School.
Wojcik said her son, Joshua, has Asperger Syndrome, a disorder that
falls under the autism umbrella. She said her son is very intelligent, but
lacks the social skills many children his age have.
She said she was told about a week before school started that her son
could no longer attend St. Thomas More School because it did not have the
financial resources to properly educate him. She believes the school handled
the situation poorly and has the money to help him. He now attends Wilbur
Wright Middle School in Munster.
"We go to church every week and hear of how racism and discrimination
are wrong," Wojcik said. "I feel like we are a bunch of hypocrites. You have
an opportunity to practice what you preach. ... I just think that it's too
easy for them to pick and choose who to admit."
Stacey Atwood, principal at St. Thomas More School, said the school
shares Wojcik's frustrations.
The school believed Joshua needed to have an instructional assistant
with him at all times because of previous incidents, but it could not afford
it, Atwood said. The school decided his needs would be best served in a
public school, she said.
Atwood said Catholic schools have limited resources that prevent them
from offering the same type of special education services as public schools.
Public schools receive federal dollars for special education students, but
nonpublic schools do not receive that financial help.
"We are really focused on trying to meet the needs of these kids,"
Atwood said. "It is very frustrating to have a lack of funding to support
what we want to do. It is a very generous church. But what I am looking for
isn't a quick fix. I would like something in place that would be long-term
that provides for the needs of children with special needs."
Private school students are not legally entitled to the same level of
services as public school students, said Bob Marra, associate superintendent
of the Indiana Department of Education's Division of Exceptional Learners.
The public school district where the private school is located is
required to provide some assistance to special education students in that
private school, Marra said. Public school districts receive money to provide
this help, but it isn't always enough to help all students equally, he said.
+ Full article here: http://tinyurl.com/9v3sa
. . .
Forced Inoculations Beginning Of Bush's Bad Bird Flu Plan
By John Hanchette.
Last week's column warned of imminent federal legislation that would
toss powerful pharmaceutical companies billions of dollars and complete
protection from liability suits in case untested and experimental bird flu
vaccines damage American recipients. It drew heavy response.
The bill (S. 1873) -- a big congressional wet kiss to the drug
industry -- is dressed up in a noble-sounding title: "Biodefense and
Pandemic Vaccine and Drug Development Act."
In essence, however, it would force Americans to receive inoculations
against a disease that has yet to kill one of them, while removing their
constitutional right to seek redress in our courts in case of injury or
death from the shots because of company negligence. The proposal, now moving
its way through the Senate, would also ban citizens from using the Freedom
of Information Act and other popular informational laws to discover whether
the new vaccine (when it is finally produced) was effective and safe, and
even whether anyone had suffered adverse reactions to it.
Some of the e-mails and letters were laudatory, but sadly and
predictably, many readers missed the point.
One wrote that I could only have reached my conclusions if I started
from the position that the pharmaceutical companies were "evil" and that the
World Health Organization, the Centers for Disease Control, and "practically
every virologist and epidemiologist in the world is part of a conspiracy."
Or was I saying that I have "some sort of privileged information that H5N1
influenza will never mutate and begin to infect humans and even if it does,
it won't reach the USA?"
He ended by quoting some venerable Chinese philosopher's advice to
"plan for what is difficult while it is easy, do what is great while it is
Well, yes, point taken on the aphorism -- but that's exactly the
philosophical tack I'm following here: identifying a cancerous piece of
federal business and dissecting it while it is still an undivided cell. If
this bill -- which is absolutely laden with hidden agendas -- metastasizes
into actual law, Senate 1873 could further ruin an already devastated
national health care system.
Sure, the bird influenza that has killed 62 Asians may mutate into
easily contractible flu for humans. I acknowledge that. It may soon reach
the United States. I acknowledge that. But my beef is the thematic hidden
agenda in this dangerous Senate bill that is designed to protect wealthy
corporate contributors from any consequences of money-motivated,
irresponsible scientific research and development. The legal precedent would
be ruinous and take decades to set right.
One thing the bill-backer friends of Big Pharma are trying to slip
through with this legislation is a market exclusivity provision that would
extend patents on hugely profitable drugs that are about to evolve into the
category of cheaper generic medicines.
Further, it would prohibit federal drug buyers from contracting with
generic medicine makers to save taxpayers billions of dollars -- a current
Further, it would allow federal health officials to purchase
medicines, vaccines and other palliatives by simple fiat without taking
Further, and most onerously, the bill would vastly broaden the
definition of products eligible to be characterized as "countermeasures" to
terrorism -- in other words, potentially classifying commonly purchased
substances like ibuprofen and aspirin as terrorist-fighting devices.
I'm not the only one who's noticed the exclusivity aspect of this
The Coalition for a Competitive Pharmaceutical Market (CCPM) is an
unusually broad-based national coalition of organizations powerful on
Capitol Hill in representing employers, health insurers, chain drugstores,
generic drug makers and pharmacy benefit managers.
Last week, this huge group urged the Senate to revise the "biodefense"
bill to remove the broadened definition of terrorism "countermeasures"
because the proposal allows it to be done "in a way that could grant
existing everyday medicines -- rather than novel products related to
(defense) against bioterrorism -- multiple years of additional market
This, contends CCPM chairman Annette Guarisco, "would unnecessarily
drive up prescription drug costs for private and public payers without
advancing our nation's bioterrorism preparedness."
Even the big health insurance companies and pharmaceutical management
lobbyists were startled by the brazen provisions at the expense of common
citizens Senate 1873 portends.
Mark J. Rubino, chief pharmacy officer for Aetna Inc., states, "For
private and public purchasers seeking to provide consumers with
therapeutically equivalent, but more cost-efficient generic drugs, the
market exclusivity provision included in the Biodefense bill takes us in
exactly the wrong direction."
Mark Merritt, president of the Pharmaceutical Care Management
Association, said, "This drug monopoly extension proposal is a sweeping and
unprecedented measure that would rewrite drug-patenting and force working
families, the disabled, and seniors to pay more for their prescription
drugs. Perhaps most troubling of all, this measure has moved forward without
any regard to the cost (effects) it would have on on Medicare, Medicaid, and
private payers. America's working families, seniors, and small businesses
Some who read the column accused me of overstating the liability
protections for Big Pharma contained in the bill. Surely, they wrote, I was
guilty of hyperbole or making things up. Surely, federal legislators
wouldn't remove the cherished American right to redress wrongs or seek
compensation for uninvited injury.
Oh, yeah? The language seems pretty clear to me. It provides
incredibly broad and iron-clad protection from any American seeking legal
remedy from Big Pharma and just about everyone else involved in protecting
against bird flu. Look up the draft bill's Section 319F-3 (a) if you don't
"Authority -- As provided in subsection (b), and subject to subsection
(b) (1) C, a manufacturer, distributor, or administrator of a security
countermeasure, or a qualified pandemic and epidemic product, or a health
care provider shall be immune from suit or liability caused by or arising
out of the design, development, clinical testing and investigation,
manufacture, labeling, distribution, sale, purchase, donation, dispensing,
prescribing, administration, or use of a countermeasure, or a qualified
pandemic and epidemic product, described in subsection (b) (1) (a)."
That just about covers the waterfront, as they say. The only avenue of
relief an injured vaccine or medicine recipient or survivor could follow is
requesting an investigation of their allegation by the Secretary of Health
and Human Services -- who would have to find "clear and convincing evidence"
of "willful misconduct" that "caused the product to present a significant or
unreasonable risk to human health and proximately caused the injury alleged
by the party."
There are at least seven tough legal tests contained in that one
paragraph. And if the HHS Secretary refuses to even investigate the
complaint of injury or death, such decision is completely "within the
Secretary's discretion and shall not be subject to judicial review."
If the secretary does find for the complaining injured party -- which
is extremely unlikely -- the drugmaker or distributor or health care
provider named in the determination can petition the federal court in the
District of Columbia for "judicial review" of the HHS ruling. But no
subpoenas shall be issued, "nor shall other compulsory process apply," and
no third parties can intervene. The drug company appeal "shall automatically
stay the Secretary's determination for the duration of the judicial
There are six more pages of legal gobbledygook backing this up, one of
them defining the scope of protection from lawsuit as extending to
allegations "relating to, or resulting from the design, development,
clinical testing and investigation, manufacture, labeling, distribution,
sale, purchase, donation, dispensing, prescribing, administration, or use of
product" defined as measures against pandemics or terrorism. There, is that
specific enough for you? Is that an imaginative figment?
Interpretation of this congressional language: Pigs will fly backwards
and upside down before the common citizen gets any redress or compensation
for injury or death resulting from a bird flu vaccine or medicine.
Why are vaccine safety advocates so adamant that John Q. Public might
get screwed by all this protect-Big Pharma bird flu legislation? Because it
has happened before.
In the 1970s, the panic over swine flu led to an ill-advised vaccine
push that crippled many recipients and cost the drug makers millions.
In the 1980s, a dangerously reactive vaccine against whooping cough
injured and killed thousands when a safer foreign alternative was already
available but stubbornly unapproved by the FDA.
In the 1990s, the federal health establishment insisted -- and still
insists -- there is no connection between toxic mercury preservatives in
mandated childhood vaccines and the astounding increase in autism (from 1 in
10,000 births to 1 in 166 births), despite ample scientific evidence to the
Experimental anthrax vaccine is still being tested on troops without
informed consent, and was almost tested on infants until a big public fuss
The yearly hoohah over getting your flu shots to protect against
contractible human flu results in less than desired protection because the
scientists are always fighting the previous year's struggle that has already
mutated or died out.
+ Commentary continues here:
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Teresa Conrick Edward Decelie