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The Huffington Post David Kirby
Government Concedes Vaccine-Autism Case in Federal Court - Now What?
After years of insisting there is no evidence to link vaccines with the onset of autism spectrum disorder (ASD),
the US government has quietly conceded a vaccine-autism case in the Court of Federal Claims.
The unprecedented concession was filed on November 9, and sealed to protect the plaintiff's identify. It was
obtained through individuals unrelated to the case.
The claim, one of 4,900 autism cases currently pending in Federal "Vaccine Court," was conceded by US Assistant
Attorney General Peter Keisler and other Justice Department officials, on behalf of the Department of Health and Human Services,
the "defendant" in all Vaccine Court cases.
The child's claim against the government -- that mercury-containing vaccines were the cause of her autism --
was supposed to be one of three "test cases" for the thimerosal-autism theory currently under consideration by a three-member
panel of Special Masters, the presiding justices in Federal Claims Court.
Keisler wrote that medical personnel at the HHS Division of Vaccine Injury Compensation (DVIC) had reviewed the
case and "concluded that compensation is appropriate."
The doctors conceded that the child was healthy and developing normally until her 18-month well-baby visit, when
she received vaccinations against nine different diseases all at once (two contained thimerosal).
Days later, the girl began spiraling downward into a cascade of illnesses and setbacks that, within months, presented
as symptoms of autism, including: No response to verbal direction; loss of language skills; no eye contact; loss of "relatedness;"
insomnia; incessant screaming; arching; and "watching the florescent lights repeatedly during examination."
Seven months after vaccination, the patient was diagnosed by Dr. Andrew Zimmerman, a leading neurologist at the
Kennedy Krieger Children's Hospital Neurology Clinic, with "regressive encephalopathy (brain disease) with features consistent
with autistic spectrum disorder, following normal development." The girl also met the Diagnostic and Statistical Manual for
Mental Disorders (DSM-IV) official criteria for autism.
In its written concession, the government said the child had a pre-existing mitochondrial disorder that was "aggravated"
by her shots, and which ultimately resulted in an ASD diagnosis.
"The vaccinations received on July 19, 2000, significantly aggravated an underlying mitochondrial disorder,"
the concession says, "which predisposed her to deficits in cellular energy metabolism, and manifested as a regressive encephalopathy
with features of ASD."
This statement is good news for the girl and her family, who will now be compensated for the lifetime of care
she will require. But its implications for the larger vaccine-autism debate, and for public health policy in general, are
not as certain.
In fact, the government's concession seems to raise more questions than it answers.
1) Is there a connection between vaccines, mitochondrial disorders and a diagnosis of autism, at least in some
cases?
Mitochondria, you may recall from biology class, are the little powerhouses within cells that convert food into
electrical energy, partly through a complex process called "oxidative phosphorylation." If this process is impaired, mitochondrial
disorder will ensue.
The child in this case had several markers for Mt disease, which was confirmed by muscle biopsy. Mt disease is
often marked by lethargy, poor muscle tone, poor food digestion and bowel problems, something found in many children diagnosed
with autism.
But mitochondrial disorders are rare in the general population, affecting some 2-per-10,000 people (or just 0.2%).
So with 4,900 cases filed in Vaccine Court, this case should be the one and only, extremely rare instance of Mt disease in
all the autism proceedings.
But it is not.
Mitochondrial disorders are now thought to be the most common disease associated with ASD. Some journal articles
and other analyses have estimated that 10% to 20% of all autism cases may involve mitochondrial disorders, which would make
them one thousand times more common among people with ASD than the general population.
Another article, published in the Journal of Child Neurology and co-authored by Dr. Zimmerman, showed that 38%
of Kennedy Krieger Institute autism patients studied had one marker for impaired oxidative phosphorylation, and 47% had a
second marker.
The authors -- who reported on a case-study of the same autism claim conceded in Vaccine Court -- noted that
"children who have (mitochondrial-related) dysfunctional cellular energy metabolism might be more prone to undergo autistic
regression between 18 and 30 months of age if they also have infections or immunizations at the same time."
An interesting aspect of Mt disease in autism is that, with ASD, the mitochondrial disease seems to be milder
than in "classic" cases of Mt disorder. In fact, classic Mt disease is almost always inherited, either passed down by the
mother through mitochondrial DNA, or by both parents through nuclear DNA.
In autism-related Mt disease, however, the disorder is not typically found in other family members, and instead
appears to be largely of the sporadic variety, which may now account for 75% of all mitochondrial disorders.
Meanwhile, an informal survey of seven families of children with cases currently pending in Vaccine Court revealed
that all seven showed markers for mitochondrial dysfunction, dating back to their earliest medical tests. The facts in all
seven claims mirror the case just conceded by the government: Normal development followed by vaccination, immediate illness,
and rapid decline culminating in an autism diagnosis.
2) With 4,900 cases pending, and more coming, will the government concede those with underlying Mt disease --
and if it not, will the Court award compensation?
The Court will soon begin processing the 4900 cases pending before it. What if 10% to 20% of them can demonstrate
the same Mt disease and same set of facts as those in the conceded case? Would the government be obliged to concede 500, or
even 1,000 cases? What impact would that have on public opinion? And is there enough money currently in the vaccine injury
fund to cover so many settlements?
When asked for a comment last week about the court settlement, a spokesman for HHS furnished the following written
statement:
"DVIC has reviewed the scientific information concerning the allegation that vaccines
cause autism and has found no credible evidence to support the claim. Accordingly, in every case under the Vaccine Act, DVIC
has maintained the position that vaccines do not cause autism, and has never concluded in any case that autism was caused
by vaccination."
3) If the government is claiming that vaccines did not "cause" autism, but instead aggravated a condition to
"manifest" as autism, isn't that a very fine distinction?
For most affected families, such linguistic gymnastics is not so important. And even if a vaccine injury "manifested"
as autism in only one case, isn't that still a significant development worthy of informing the public?
On the other hand, perhaps what the government is claiming is that vaccination resulted in the symptoms of autism,
but not in an actual, factually correct diagnosis of autism itself.
4) If the government is claiming that this child does NOT have autism, then how many other children might also
have something else that merely "mimics" autism?
Is it possible that 10%-20% of the cases that we now label as "autism," are not autism at all, but rather some
previously undefined "look-alike" syndrome that merely presents as "features" of autism?
This question gets to the heart of what autism actually is. The disorder is defined solely as a collection of
features, nothing more. If you have the features (and the diagnosis), you have the disorder. The underlying biology is the
great unknown.
But let's say the government does determine that these kids don't have actual "autism" (something I speculated
on HuffPost a year ago). Then shouldn't the Feds go back and test all people with ASD for impaired oxidative phosphorylation,
perhaps reclassifying many of them?
If so, will we then see "autism" cases drop by tens, if not hundreds of thousands of people? Will there be a
corresponding ascension of a newly described disorder, perhaps something like "Vaccine Aggravated Mitochondrial Disease with
Features of ASD?"
And if this child was technically "misdiagnosed" with DSM-IV autism by Dr Zimmerman, how does he feel about HHS
doctors issuing a second opinion re-diagnosis of his patient, whom they presumably had neither met nor examined? (Zimmerman
declined an interview).
And along those lines, aren't Bush administration officials somewhat wary of making long-distance, retroactive
diagnoses from Washington, given that the Terry Schiavo incident has not yet faded from national memory?
5) Was this child's Mt disease caused by a genetic mutation, as the government implies, and wouldn't that have
manifested as "ASD features" anyway?
In the concession, the government notes that the patient had a "single nucleotide change" in the mitochondrial
DNA gene T2387C, implying that this was the underlying cause of her manifested "features" of autism.
While it's true that some inherited forms of Mt disease can manifest as developmental delays, (and even ASD in
the form of Rhett Syndrome) these forms are linked to identified genetic mutations, of which T2387C is not involved. In fact
little, if anything, is known about the function of this particular gene.
What's more, there is no evidence that this girl, prior to vaccination, suffered from any kind of "disorder"
at all- genetic, mitochondrial or otherwise. Some forms of Mt disease are so mild that the person is unaware of being affected.
This perfectly developing girl may have had Mt disorder at the time of vaccination, but nobody detected, or even suspected
it.
And, there is no evidence to suggest that this girl would have regressed into symptoms consistent with a DSM-IV
autism diagnosis without her vaccinations. If there was such evidence, then why on earth would these extremely well-funded
government attorneys compensate this alleged injury in Vaccine Court? Why wouldn't they move to dismiss, or at least fight
the case at trial?
6) What are the implications for research?
The concession raises at least two critical research questions: What are the causes of Mt dysfunction; and how
could vaccines aggravate that dysfunction to the point of "autistic features?"
While some Mt disorders are clearly inherited, the "sporadic" form is thought to account for 75% of all cases,
according to the United Mitochondrial Disease Foundation. So what causes sporadic Mt disease? "Medicines or other toxins,"
says the Cleveland Clinic, a leading authority on the subject.
Use of the AIDS drug AZT, for example, can cause Mt disorders by deleting large segments of mitochondrial DNA.
If that is the case, might other exposures to drugs or toxins (i.e., thimerosal, mercury in fish, air pollution, pesticides,
live viruses) also cause sporadic Mt disease in certain subsets of children, through similar genotoxic mechanisms?
Among the prime cellular targets of mercury are mitochondria, and thimerosal-induced cell death has been associated
with the depolarization of mitochondrial membrane, according to the International Journal of Molecular Medicine among several
others. (Coincidently, the first case of Mt disease was diagnosed in 1959, just 15 years after the first autism case was named,
and two decades after thimerosal's introduction as a vaccine preservative.)
Regardless of its cause, shouldn't HHS sponsor research into Mt disease and the biological mechanisms by which
vaccines could aggravate the disorder? We still do not know what it was, exactly, about this girl's vaccines that aggravated
her condition. Was it the thimerosal? The three live viruses? The two attenuated viruses? Other ingredients like aluminum?
A combination of the above?
And of course, if vaccine injuries can aggravate Mt disease to the point of manifesting as autism features, then
what other underlying disorders or conditions (genetic, autoimmune, allergic, etc.) might also be aggravated to the same extent?
7) What are the implications for medicine and public health?
Should the government develop and approve new treatments for "aggravated mitochondrial disease with ASD features?"
Interestingly, many of the treatments currently deployed in Mt disease (i.e., coenzyme Q10, vitamin B-12, lipoic acid, biotin,
dietary changes, etc.) are part of the alternative treatment regimen that many parents use on their children with ASD.
And, if a significant minority of autism cases can be linked to Mt disease and vaccines, shouldn't these products
one day carry an FDA Black Box warning label, and shouldn't children with Mt disorders be exempt from mandatory immunization?
8) What are the implications for the vaccine-autism debate?
It's too early to tell. But this concession could conceivably make it more difficult for some officials to continue
insisting there is "absolutely no link" between vaccines and autism.
It also puts the Federal Government's Vaccine Court defense strategy somewhat into jeopardy. DOJ lawyers and
witnesses have argued that autism is genetic, with no evidence to support an environmental component. And, they insist, it's
simply impossible to construct a chain of events linking immunizations to the disorder.
Government officials may need to rethink their legal strategy, as well as their public relations campaigns, given
their own slightly contradictory concession in this case.
9) What is the bottom line here?
The public, (including world leaders) will demand to know what is going on inside the US Federal health establishment.
Yes, as of now, n=1, a solitary vaccine-autism concession. But what if n=10% or 20%? Who will pay to clean up that mess?
The significance of this concession will unfortunately be fought over in the usual, vitriolic way -- and I fully
expect to be slammed for even raising these questions. Despite that, the language of this concession cannot be changed, or
swept away.
Its key words are "aggravated" and "manifested." Without the aggravation of the vaccines, it is uncertain that
the manifestation would have occurred at all.
When a kid with peanut allergy eats a peanut and dies, we don't say "his underlying metabolic condition was significantly
aggravated to the extent of manifesting as an anaphylactic shock with features of death."
No, we say the peanut killed the poor boy. Remove the peanut from the equation, and he would still be with us
today.
Many people look forward to hearing more from HHS officials about why they are settling this claim. But whatever
their explanation, they cannot change the fundamental facts of this extraordinary case:
The United State government is compensating at least one child for vaccine injuries that resulted in a diagnosis
of autism.
And that is big news, no matter how you want to say it.
NOTE: Full text of the government's statement is posted down below.
David Kirby is the author of "Evidence of Harm - Mercury in Vaccines and the Autism Epidemic, A Medical Controversy"
(St. Martins Press 2005.
********************
FIRST AUTISM-VACCINE
LINK: HOW HANNAH MADE HISTORY
By Alison Young The Atlanta Journal-Constitution Published on: 03/06/08
In a move autism family advocates call unprecedented, federal health
officials have concluded that childhood vaccines contributed to symptoms of the disorder in a 9-year-old Georgia girl.
While government officials continue to maintain that vaccines don't
cause autism, advocates say the recent settlement of the girl's injury case in a secretive federal vaccine court shows otherwise.
The U.S. Department of Health and Human Services has concluded the
family of Hannah Poling of Athens is entitled to compensation from a federal vaccine injury fund, according to the text of
a court document in the case. The amount of the family's award is still being determined.
The language in the document does not establish a clear-cut vaccine-autism
link. But it does say the government concluded that vaccines aggravated a rare underlying metabolic condition that resulted
in a brain disorder "with features of autism spectrum disorder."
In an interview Wednesday with The Atlanta Journal-Constitution,
Hannah's parents, Jon and Terry Poling, said the government's concession in the case will help pay for the numerous therapists
and other medical experts their autistic child needs —- now and for the rest of her life.
"At least we have some commitment from the government to take care
of Hannah when we're gone," said Dr. Jon Poling, a neurologist.
But the case also thrusts the family into a national spotlight in
the controversial public debate over whether vaccines have played some role in the growing number of U.S. children diagnosed
with autism. Of particular concern to some families is the mercury-based preservative thimerosal, not used in child vaccines
(except for some flu shots) since 2001.
Hannah's case was one of three vaccine-court test cases alleging
that thimerosal caused the children's autism. The other cases go to trial in May.
Suspicion of vaccines is fueled in part by vocal advocates —-
including radio shock jock Don Imus and actress Jenny McCarthy —- speaking out on radio and TV shows such as "Oprah"
and "Larry King Live."
Even Republican presidential candidate Sen. John McCain said on the
campaign trail that "there's strong evidence" that a preservative in vaccines is fueling the dramatic rise in autism cases
across the country.
As many as 1 in 150 children in some communities have autism disorders,
says the Centers for Disease Control and Prevention.
"We need to recognize this is a national crisis," Jon Poling said.
Autism is a lifelong neurological disorder that causes problems with
communication and the ability to have normal social interactions. Autism and related autism spectrum disorders cover a range
of symptoms that can vary from mild to severe. The cause is unknown, but scientists believe genes may play a role.
Pediatricians and public health officials worry that this case may
cause fear among some parents and prompt them to refuse to vaccinate their children, and put them in real danger from measles,
whooping cough and other diseases.
"The risks of diseases are real risks," said Dr. Melinda Wharton,
deputy director of CDC's National Center for Immunization and Respiratory Diseases. Numerous large studies don't support a
relationship between vaccines and autism, according to the CDC and the Institutes of Medicine.
The Georgia girl's case —- and its implications in the vaccine-autism
debate —- raise more questions than it answers, experts say.
Some medical experts say it's difficult to fully assess the case
because the federal vaccine-court documents are sealed from public view.
"It raised a lot of questions for us," said Dr. David Tayloe Jr.,
president-elect of the American Academy of Pediatrics. The national medical group's leadership has been seeking more information
about Hannah's vaccine-court case since last week when a sealed vaccine-court document detailing the government's settlement
was posted on the Internet by an autism book author, then circulated widely among autism groups.
The pediatrics association has been trying to get access to official
documents in the case so medical experts can delve into the science, assess whether there are implications for other children
and answer questions from doctors and families.
"Our responsibility is to make sure the public is given good information
and make sure the hype doesn't distract from public health," Tayloe said. "I still would not think that we're going to have
evidence showing a role of vaccines actually causing autism."
According to the leaked document posted online, the government's
Division of Vaccine Injury Compensation concluded that five shots Hannah received in July 2000, when she was 19 months old,
"significantly aggravated an underlying mitochondrial disorder" and resulted in a brain disorder "with features of autism
spectrum disorder."
Sallie Bernard, executive director of the national autism advocacy
group SafeMinds, called the case "unprecedented" in that a link between vaccines and autism is being made public. Federal
health officials "have insisted there is no link at all between vaccines and vaccine components and autism. And apparently
that is not true," she said.
The case also is significant because other autistic children have
mitochondrial disorders, Bernard said. "The question is: What is the proportion?"
Robert Krakow, a New York attorney representing other autistic children
in vaccine court, said the significance of the case is "potentially explosive." He said he has several clients with similar
histories.
Hannah requires one-on-one care at all times, said her mother, Terry
Poling, a nurse and lawyer. The Polings described how Hannah was a normal, verbal toddler until she received several vaccines
during a well-baby visit. Within 48 hours of the shots, she developed a high fever and inconsolable crying and refused to
walk. She stopped sleeping through the night. At 3 months of age, she began showing signs of autism, including spinning and
staring at lights and fans. For a while, she lost her ability to speak.
When Hannah was 6 months old, as the family came to grips with the
likelihood that she was autistic, they turned to leading experts in neurology. "I had to know. My daughter didn't just suddenly
develop autism for no reason," Terry Poling said.
Hannah's father co-authored an article about her case, which was
published in the Journal of Child Neurology in 2006.
Hannah, who has two older brothers, continues to have mild to moderate
symptoms of autism. The family says early and ongoing intensive therapy has been critical for her.
"The biggest question right now for the public is: How unique is
Hannah's case?" said Jon Poling. Poling said he suspects there are other children like Hannah.
Cliff Shoemaker, the Polings' attorney, said the family has filed
a petition with the vaccine court to unseal all of Hannah's records and allow both the family and the government to fully
discuss the case.
Despite this, a spokesman for the U.S. Department of Justice, which
reprersents the government in court cases, would not grant interviews or explain to the AJC why it isn't releasing the records.
HHS officials, who administer the vaccine compensation fund, also declined to be interviewed, citing the court's confidentiality
requirements.
Shoemaker said the government's November concession in the case is
public, but the government's reasons aren't. "I'm not aware of any other conceded autism cases," he said.
Congress created the National Vaccine Injury Compensation Program
in 1988 after widespread lawsuits against manufacturers and health-care providers stemming from reports of side-effects of
a version of the diphtheria-tetanus-pertussis vaccine used in the 1980s.
With companies getting out of the vaccine business for liability
reasons, Congress established the program and a trust fund to serve as a no-fault alternative for resolving certain vaccine
injury claims.
The average injury compensation to an individual in vaccine court
has been about $1 million. In fiscal year 2007, more than $91 million was awarded to people harmed by vaccines.
Q&A
What does the case mean for the safety of vaccines? Medical experts
said parents should continue vaccinating their children because it protects them from diseases known to be deadly. If they're
concerned, they should talk with their pediatrician.
Q: What is autism?
A: Autism spectrum disorders are a range of developmental disabilities
—- from mild to severe —- characterized by communication problems, an inability to have normal social interactions
and unusual behaviors.
Q: What causes autism?
A: Scientists don't know but are exploring what role genetics may
play, as well as possible environmental factors.
Q: Why is this Georgia child's case drawing so much attention?
A: A leaked federal vaccine court document, posted on the Internet
and widely circulated among advocates, shows the government has agreed to compensate her. Federal health officials have conceded
that the five shots she received in July 2000 "significantly aggravated an underlying mitochondrial disorder," which manifested
as a brain disease with features of autism. Autism family advocates say this shows the government is conceding —- after
years of blanket denials —- that vaccines play a role in at least some autism cases.
Q: What do federal health officials say about the case?
A: The U.S. Department of Health and Human Services branch that administers
the vaccine injury program says the government "continues to maintain the position that vaccines do not cause autism and has
never concluded in any case that autism was caused by vaccination."
Q: What are mitochondrial disorders?
A: Mitochondria are tiny rod-like structures that serve as the energy-making
machines inside cells. When mitochondria don't work properly, they produce less energy and can cause various body systems
to fail.
Q: What causes the disorders?
A: For the most part, genes. Sometimes a person's mitochondria —-
if their genes make them susceptible —- can be affected by environmental factors such as medications. The Georgia girl's
family suspects her mitochondria were damaged by a mercury-based preservative in the vaccines she received. Tests didn't find
a genetical link in her case, the family said.
Q: What's the relationship between mitochondrial disorders and autism?
A: While some children with mitochondrial disorders have autistic
symptoms, the vast majority do not, said Dr. Bruce Cohen, a pediatric neurologist at the Cleveland Clinic and past-president
of the Mitochondrial Medicine Society. Most autistic children do not have mitochondrial disease, he said.
Q: How can a mitochondrial disorder be aggravated by vaccinations?
A: Vaccination —- like illnesses, starvation, extreme heat
or any other stress on the body —- may unmask a mitochondrial disorder, experts said. When a vaccine is injected, it
causes the body to mount an immune response. This requires increased energy the body may not have if there is an underlying
mitochondrial disorder. Still, Cohen said he recommends vaccination, even for most patients with diagnosed mitochondrial disorders.
That's because of the greater danger posed by vaccine-preventable diseases.
Q: How common is this?
A: According to the United Mitochondrial Disease Foundation, at least
one in every 4,000 children born in the U.S. each year will develop a mitochondrial disease by age 10. Many children are misdiagnosed
with such things as atypical cerebral palsy, seizure disorders and other diseases. Adults also can be diagnosed with adult-onset
mitochondrial disease.
ELIZABETH LANDT / Staff
MITOCHONDRIAL DISORDERS
Energy for our bodies is created within our cells. This massive job is handled by the mitochondria. When these tiny guys can't
do their job, our whole body suffers.
Normal mitochondrion
1. Mitochondria are tiny power plants inside human cells that convert food into energy.
2. If the mitochondria are not working properly, the cell does not get the energy it needs to do its work within the body.
Diagram includes a cell containing normal and dysfunctional mitochondrion; the inside of a normal mitochondrian; its Energy-producing
particles; DNA.
Organ systems:
3. The brain, heart and lungs require the most energy to function properly. If they don't have adequate energy, these organs
begin to fail. Symptoms vary depending on the part of the body involved.
—-
Possible symptoms
Mitochondrial disorders are rare. Not everyone who has these symptoms has dysfunctional mitochondria.
Brain: Developmental delays, seizures, autistic features, migraines, atypical cerebral palsy
Eyes and ears: Visual or hearing loss, degeneration of retina cells
Heart: Heart blocks, Cardiomyopathy
Muscles: Weakness, cramping, gastrointestinal problems, muscle pain
Liver: Low blood sugar, liver failure
Kidneys: Failure to excrete acid or wasting
Pancreas and other glands: Diabetes and inability to make digestive enzymes, low calcium
Nerves: Weakness (may be intermittent), fainting, Chronic nerve pain
Systemic: Failure to gain weight, fatigue, unexplained vomiting, short stature, respiratory problems
Mitochondrian disorders generally involve three or more organ systems and in some cases produces symptoms similar to autism.
Sources: United Mitochondrial Disease Foundation
Source url: http://www.ajc.com/metro/content/printedition/2008/03/06/autism0306b.html ********************
The Huffington Post David Kirby The Vaccine-Autism Court Document Every American Should Read
Posted February 26, 2008 | 02:38 PM (EST)
Below is a verbatim copy of the US Government concession filed last November in a vaccine-autism case in
the Court of Federal Claims, with the names of the family redacted. It is the subject of my post yesterday.
Every American should read this document, and interpret for themselves what they think their government is trying
to say about the relationship, if any, between immunizations and a diagnosis of autism spectrum disorder.
If you feel this document suggests that some kind of link may be possible, you might consider forwarding it to
your elected representatives for further investigation.
But, of course, if you feel that this document in no way implicates vaccines, then let's just keep going about
our business as usual and not pay any attention to all those sick kids behind the curtain.
IN THE UNITED STATES COURT OF FEDERAL CLAIMS OFFICE OF SPECIAL MASTERS
CHILD, a minor,
by her Parents and Natural Guardians,
Petitioners,
v.
SECRETARY OF HEALTH AND HUMAN SERVICES,
Respondent.
RESPONDENT'S RULE 4(c) REPORT
In accordance with RCFC, Appendix B, Vaccine Rule 4(c), the Secretary of Health and Human
Services submits the following response to the petition for compensation filed in this case.
FACTS
CHILD ("CHILD") was born on December --, 1998, and weighed eight pounds, ten ounces. Petitioners'
Exhibit ("Pet. Ex.") 54 at 13. The pregnancy was complicated by gestational diabetes. Id. at 13. CHILD received her first
Hepatitis B immunization on December 27, 1998. Pet. Ex. 31 at 2.
From January 26, 1999 through June 28, 1999, CHILD visited the Pediatric Center, in Catonsville,
Maryland, for well-child examinations and minor complaints, including fever and eczema. Pet. Ex. 31 at 5-10, 19. During this
time period, she received the following pediatric vaccinations, without incident:
Vaccine Dates Administered
Hep B 12/27/98; 1/26/99
IPV 3/12/99; 4/27/99
Hib 3/12/99; 4/27/99; 6/28/99
DTaP 3/12/99; 4/27/99; 6/28/99
Id. at 2.
At seven months of age, CHILD was diagnosed with bilateral otitis media. Pet. Ex. 31 at 20.
In the subsequent months between July 1999 and January 2000, she had frequent bouts of otitis media, which doctors treated
with multiple antibiotics. Pet. Ex. 2 at 4. On December 3,1999, CHILD was seen by Karl Diehn, M.D., at Ear, Nose, and Throat
Associates of the Greater Baltimore Medical Center ("ENT Associates"). Pet. Ex. 31 at 44. Dr. Diehn recommend that CHILD receive
PE tubes for her "recurrent otitis media and serious otitis." Id. CHILD received PE tubes in January 2000. Pet. Ex. 24 at
7. Due to CHILD's otitis media, her mother did not allow CHILD to receive the standard 12 and 15 month childhood immunizations.
Pet. Ex. 2 at 4.
According to the medical records, CHILD consistently met her developmental milestones during
the first eighteen months of her life. The record of an October 5, 1999 visit to the Pediatric Center notes that CHILD was
mimicking sounds, crawling, and sitting. Pet. Ex. 31 at 9. The record of her 12-month pediatric examination notes that she
was using the words "Mom" and "Dad," pulling herself up, and cruising. Id. at 10.
At a July 19, 2000 pediatric visit, the pediatrician observed that CHILD "spoke well" and
was "alert and active." Pet. Ex. 31 at 11. CHILD's mother reported that CHILD had regular bowel movements and slept through
the night. Id. At the July 19, 2000 examination, CHILD received five vaccinations - DTaP, Hib, MMR, Varivax, and IPV. Id.
at 2, 11.
According to her mother's affidavit, CHILD developed a fever of 102.3 degrees two days after
her immunizations and was lethargic, irritable, and cried for long periods of time. Pet. Ex. 2 at 6. She exhibited intermittent,
high-pitched screaming and a decreased response to stimuli. Id. MOM spoke with the pediatrician, who told her that CHILD was
having a normal reaction to her immunizations. Id. According to CHILD's mother, this behavior continued over the next ten
days, and CHILD also began to arch her back when she cried. Id.
On July 31, 2000, CHILD presented to the Pediatric Center with a 101-102 degree temperature,
a diminished appetite, and small red dots on her chest. Pet. Ex. 31 at 28. The nurse practitioner recorded that CHILD was
extremely irritable and inconsolable. Id. She was diagnosed with a post-varicella vaccination rash. Id. at 29.
Two months later, on September 26, 2000, CHILD returned to the Pediatric Center with a temperature
of 102 degrees, diarrhea, nasal discharge, a reduced appetite, and pulling at her left ear. Id. at 29. Two days later, on
September 28, 2000, CHILD was again seen at the Pediatric Center because her diarrhea continued, she was congested, and her
mother reported that CHILD was crying during urination. Id. at 32. On November 1, 2000, CHILD received bilateral PE tubes.
Id. at 38. On November 13, 2000, a physician at ENT Associates noted that CHILD was "obviously hearing better" and her audiogram
was normal. Id. at 38. On November 27, 2000, CHILD was seen at the Pediatric Center with complaints of diarrhea, vomiting,
diminished energy, fever, and a rash on her cheek. Id. at 33. At a follow-up visit, on December 14, 2000, the doctor noted
that CHILD had a possible speech delay. Id.
CHILD was evaluated at the Howard County Infants and Toddlers Program, on November 17, 2000,
and November 28, 2000, due to concerns about her language development. Pet. Ex. 19 at 2, 7. The assessment team observed deficits
in CHILD's communication and social development. Id. at 6. CHILD's mother reported that CHILD had become less responsive to
verbal direction in the previous four months and had lost some language skills. Id. At 2.
On December 21, 2000, CHILD returned to ENT Associates because of an obstruction in her right
ear and fussiness. Pet. Ex. 31 at 39. Dr. Grace Matesic identified a middle ear effusion and recorded that CHILD was having
some balance issues and not progressing with her speech. Id. On December 27, 2000, CHILD visited ENT Associates, where Dr.
Grace Matesic observed that CHILD's left PE tube was obstructed with crust. Pet. Ex. 14 at 6. The tube was replaced on January
17, 2001. Id.
Dr. Andrew Zimmerman, a pediatric neurologist, evaluated CHILD at the Kennedy Krieger Children's
Hospital Neurology Clinic ("Krieger Institute"), on February 8, 2001. Pet. Ex. 25 at 1. Dr. Zimmerman reported that after
CHILD's immunizations of July 19, 2000, an "encephalopathy progressed to persistent loss of previously acquired language,
eye contact, and relatedness." Id. He noted a disruption in CHILD's sleep patterns, persistent screaming and arching, the
development of pica to foreign objects, and loose stools. Id. Dr. Zimmerman observed that CHILD watched the fluorescent lights
repeatedly during the examination and would not make eye contact. Id. He diagnosed CHILD with "regressive
encephalopathy with features consistent with an autistic spectrum disorder, following normal development." Id. At 2. Dr. Zimmerman
ordered genetic testing, a magnetic resonance imaging test ("MRI"), and an electroencephalogram ("EEG"). Id.
Dr. Zimmerman referred CHILD to the Krieger Institute's Occupational Therapy Clinic and the
Center for Autism and Related Disorders ("CARDS"). Pet. Ex. 25 at 40. She was evaluated at the Occupational Therapy Clinic
by Stacey Merenstein, OTR/L, on February 23, 2001. Id. The evaluation report summarized that CHILD had deficits in "many areas
of sensory processing which decrease[d] her ability to interpret sensory input and influence[d] her motor performance as a
result." Id. at 45. CHILD was evaluated by Alice Kau and Kelley Duff, on May 16, 2001, at CARDS. Pet. Ex. 25 at 17. The clinicians
concluded that CHILD was developmentally delayed and demonstrated features of autistic disorder. Id. at 22.
CHILD returned to Dr. Zimmerman, on May 17, 2001, for a follow-up consultation. Pet. Ex. 25
at 4. An overnight EEG, performed on April 6, 2001, showed no seizure discharges. Id. at 16. An MRI, performed on March 14,
2001, was normal. Pet. Ex. 24 at 16. A G-band test revealed a normal karyotype. Pet. Ex. 25 at 16. Laboratory studies, however,
strongly indicated an underlying mitochondrial disorder. Id. at 4.
Dr. Zimmerman referred CHILD for a neurogenetics consultation to evaluate her abnormal metabolic
test results. Pet. Ex. 25 at 8. CHILD met with Dr. Richard Kelley, a specialist in neurogenetics, on May 22, 2001, at the
Krieger Institute. Id. In his assessment, Dr. Kelley affirmed that CHILD's history and lab results were consistent with "an
etiologically unexplained metabolic disorder that appear[ed] to be a common cause of developmental regression." Id. at 7.
He continued to note that children with biochemical profiles similar to CHILD's develop normally until sometime between the
first and second year of life when their metabolic pattern becomes apparent, at which time they developmentally regress. Id.
Dr. Kelley described this condition as "mitochondrial PPD." Id.
On October 4, 2001, Dr. John Schoffner, at Horizon Molecular Medicine in Norcross, Georgia,
examined CHILD to assess whether her clinical manifestations were related to a defect in cellular energetics. Pet. Ex. 16
at 26. After reviewing her history, Dr. Schoffner agreed that the previous metabolic testing was "suggestive of a defect in
cellular energetics." Id. Dr. Schoffner recommended a muscle biopsy, genetic testing, metabolic testing, and cell culture
based testing. Id. at 36. A CSF organic acids test, on January 8, 2002, displayed an increased lactate to pyruvate ratio of
28,1 which can be seen in disorders of mitochondrial oxidative phosphorylation. Id. at 22. A muscle biopsy test for oxidative
phosphorylation disease revealed abnormal results for Type One and Three. Id. at 3. The most prominent findings were scattered
atrophic myofibers that were mostly type one oxidative phosphorylation dependent myofibers, mild increase in lipid in selected
myofibers, and occasional myofiber with reduced cytochrome c oxidase activity. Id. at 7. After reviewing these laboratory
results, Dr. Schoffner diagnosed CHILD with oxidative phosphorylation disease. Id. at 3. In February 2004, a mitochondrial
DNA ("mtDNA") point mutation analysis revealed a single nucleotide change in the 16S ribosomal RNA gene (T2387C). Id. at 11.
CHILD returned to the Krieger Institute, on July 7, 2004, for a follow-up evaluation with
Dr. Zimmerman. Pet. Ex. 57 at 9. He reported CHILD "had done very well" with treatment for a mitochondrial dysfunction. Dr.
Zimmerman concluded that CHILD would continue to require services in speech, occupational, physical, and behavioral therapy.
Id.
On April 14, 2006, CHILD was brought by ambulance to Athens Regional Hospital and developed
a tonic seizure en route. Pet. Ex. 10 at 38. An EEG showed diffuse slowing. Id. At 40. She was diagnosed with having experienced
a prolonged complex partial seizure and transferred to Scottish Rite Hospital. Id. at 39, 44. She experienced no more seizures
while at Scottish Rite Hospital and was discharged on the medications Trileptal and Diastal. Id. at 44. A follow-up MRI of
the brain, on June 16, 2006, was normal with evidence of a left mastoiditis manifested by distortion of the air cells. Id.
at 36. An EEG, performed on August 15, 2006,
showed "rhythmic epileptiform discharges in the right temporal region and then focal slowing during a witnessed
clinical seizure." Id. At 37. CHILD continues to suffer from a seizure disorder.
ANALYSIS
Medical personnel at the Division of Vaccine Injury Compensation, Department of Health and
Human Services (DVIC) have reviewed the facts of this case, as presented by the petition, medical records, and affidavits.
After a thorough review, DVIC has concluded that compensation is appropriate in this case.
In sum, DVIC has concluded that the facts of this case meet the statutory criteria for demonstrating
that the vaccinations CHILD received on July 19, 2000, significantly aggravated an underlying mitochondrial disorder, which
predisposed her to deficits in cellular energy metabolism, and manifested as a regressive encephalopathy with features of
autism spectrum disorder. Therefore, respondent recommends that compensation be awarded to petitioners in accordance with
42 U.S.C. § 300aa-11(c)(1)(C)(ii).
DVIC has concluded that CHILD's complex partial seizure disorder, with an onset of almost
six years after her July 19, 2000 vaccinations, is not related to a vaccine-injury.
Respectfully submitted,
PETER D. KEISLER Assistant Attorney General
TIMOTHY P. GARREN Director Torts Branch, Civil
Division
MARK W. ROGERS Deputy Director Torts Branch, Civil
Division
VINCENT J. MATANOSKI Assistant Director Torts
Branch, Civil Division
s/ Linda S. Renzi by s/ Lynn E. Ricciardella LINDA S. RENZI
Senior Trial Counsel Torts Branch, Civil Division U.S. Department of Justice
P.O. Box 146 Benjamin Franklin Station Washington, D.C. 20044
(202) 616-4133
DATE: November 9, 2007
PS: On Friday, February 22, HHS conceded that this child's complex partial seizure disorder was also caused by
her vaccines. Now we the taxpayers will award this family compensation to finance her seizure medication. Surely ALL decent
people can agree that is a good thing.
Deadly Immunity
Robert F. Kennedy Jr. investigates the government cover-up of a mercury/autism scandal
By ROBERT F. KENNEDY JR.
In June 2000, a group of top government scientists and health officials gathered for a meeting at the isolated Simpsonwood
conference center in Norcross, Georgia. Convened by the Centers for Disease Control and Prevention, the meeting was held at
this Methodist retreat center, nestled in wooded farmland next to the Chattahoochee River, to ensure complete secrecy. The
agency had issued no public announcement of the session -- only private invitations to fifty-two attendees. There were high-level
officials from the CDC and the Food and Drug Administration, the top vaccine specialist from the World Health Organization
in Geneva and representatives of every major vaccine manufacturer, including GlaxoSmithKline, Merck, Wyeth and Aventis Pasteur.
All of the scientific data under discussion, CDC officials repeatedly reminded the participants, was strictly "embargoed."
There would be no making photocopies of documents, no taking papers with them when they left.
The federal officials and industry representatives had assembled to discuss a disturbing new study that raised alarming questions
about the safety of a host of common childhood vaccines administered to infants and young children. According to a CDC epidemiologist
named Tom Verstraeten, who had analyzed the agency's massive database containing the medical records of 100,000 children,
a mercury-based preservative in the vaccines -- thimerosal -- appeared to be responsible for a dramatic increase in autism
and a host of other neurological disorders among children. "I was actually stunned by what I saw," Verstraeten told those
assembled at Simpsonwood, citing the staggering number of earlier studies that indicate a link between thimerosal and speech
delays, attention-deficit disorder, hyperactivity and autism. Since 1991, when the CDC and the FDA had recommended that three
additional vaccines laced with the preservative be given to extremely young infants -- in one case, within hours of birth
-- the estimated number of cases of autism had increased fifteenfold, from one in every 2,500 children to one in 166 children.
Even for scientists and doctors accustomed to confronting issues of life and death, the findings were frightening. "You can
play with this all you want," Dr. Bill Weil, a consultant for the American Academy of Pediatrics, told the group. The results
"are statistically significant." Dr. Richard Johnston, an immunologist and pediatrician from the University of Colorado whose
grandson had been born early on the morning of the meeting's first day, was even more alarmed. "My gut feeling?" he said.
"Forgive this personal comment -- I do not want my grandson to get a thimerosal-containing vaccine until we know better what
is going on."
But instead of taking immediate steps to alert the public and rid the vaccine supply of thimerosal, the officials and executives
at Simpsonwood spent most of the next two days discussing how to cover up the damaging data. According to transcripts obtained
under the Freedom of Information Act, many at the meeting were concerned about how the damaging revelations about thimerosal
would affect the vaccine industry's bottom line. "We are in a bad position from the standpoint of defending any lawsuits,"
said Dr. Robert Brent, a pediatrician at the Alfred I. duPont Hospital for Children in Delaware. "This will be a resource
to our very busy plaintiff attorneys in this country." Dr. Bob Chen, head of vaccine safety for the CDC, expressed relief
that "given the sensitivity of the information, we have been able to keep it out of the hands of, let's say, less responsible
hands." Dr. John Clements, vaccines advisor at the World Health Organization, declared that "perhaps this study should not
have been done at all." He added that "the research results have to be handled," warning that the study "will be taken by
others and will be used in other ways beyond the control of this group."
In fact, the government has proved to be far more adept at handling the damage than at protecting children's health. The CDC
paid the Institute of Medicine to conduct a new study to whitewash the risks of thimerosal, ordering researchers to "rule
out" the chemical's link to autism. It withheld Verstraeten's findings, even though they had been slated for immediate publication,
and told other scientists that his original data had been "lost" and could not be replicated. And to thwart the Freedom of
Information Act, it handed its giant database of vaccine records over to a private company, declaring it off-limits to researchers.
By the time Verstraeten finally published his study in 2003, he had gone to work for GlaxoSmithKline and reworked his data
to bury the link between thimerosal and autism.
Vaccine manufacturers had already begun to phase thimerosal out of injections given to American infants -- but they continued
to sell off their mercury-based supplies of vaccines until last year. The CDC and FDA gave them a hand, buying up the tainted
vaccines for export to developing countries and allowing drug companies to continue using the preservative in some American
vaccines -- including several pediatric flu shots as well as tetanus boosters routinely given to eleven-year-olds.
The drug companies are also getting help from powerful lawmakers in Washington. Senate Majority Leader Bill Frist, who has
received $873,000 in contributions from the pharmaceutical industry, has been working to immunize vaccine makers from liability
in 4,200 lawsuits that have been filed by the parents of injured children. On five separate occasions, Frist has tried to
seal all of the government's vaccine-related documents -- including the Simpsonwood transcripts -- and shield Eli Lilly, the
developer of thimerosal, from subpoenas. In 2002, the day after Frist quietly slipped a rider known as the "Eli Lilly Protection
Act" into a homeland security bill, the company contributed $10,000 to his campaign and bought 5,000 copies of his book on
bioterrorism. The measure was repealed by Congress in 2003 -- but earlier this year, Frist slipped another provision into
an anti-terrorism bill that would deny compensation to children suffering from vaccine-related brain disorders. "The lawsuits
are of such magnitude that they could put vaccine producers out of business and limit our capacity to deal with a biological
attack by terrorists," says Dean Rosen, health policy adviser to Frist.
Even many conservatives are shocked by the government's effort to cover up the dangers of thimerosal. Rep. Dan Burton, a Republican
from Indiana, oversaw a three-year investigation of thimerosal after his grandson was diagnosed with autism. "Thimerosal used
as a preservative in vaccines is directly related to the autism epidemic," his House Government Reform Committee concluded
in its final report. "This epidemic in all probability may have been prevented or curtailed had the FDA not been asleep at
the switch regarding a lack of safety data regarding injected thimerosal, a known neurotoxin." The FDA and other public-health
agencies failed to act, the committee added, out of "institutional malfeasance for self protection" and "misplaced protectionism
of the pharmaceutical industry."
The story of how government health agencies colluded with Big Pharma to hide the risks of thimerosal from the public is a
chilling case study of institutional arrogance, power and greed. I was drawn into the controversy only reluctantly. As an
attorney and environmentalist who has spent years working on issues of mercury toxicity, I frequently met mothers of autistic
children who were absolutely convinced that their kids had been injured by vaccines. Privately, I was skeptical.
I doubted that autism could be blamed on a single source, and I certainly understood the government's need to reassure parents
that vaccinations are safe; the eradication of deadly childhood diseases depends on it. I tended to agree with skeptics like
Rep. Henry Waxman, a Democrat from California, who criticized his colleagues on the House Government Reform Committee for
leaping to conclusions about autism and vaccinations. "Why should we scare people about immunization," Waxman pointed out
at one hearing, "until we know the facts?"
It was only after reading the Simpsonwood transcripts, studying the leading scientific research and talking with many of the
nation's pre-eminent authorities on mercury that I became convinced that the link between thimerosal and the epidemic of childhood
neurological disorders is real. Five of my own children are members of the Thimerosal Generation -- those born between 1989
and 2003 -- who received heavy doses of mercury from vaccines. "The elementary grades are overwhelmed with children who have
symptoms of neurological or immune-system damage," Patti White, a school nurse, told the House Government Reform Committee
in 1999. "Vaccines are supposed to be making us healthier; however, in twenty-five years of nursing I have never seen so many
damaged, sick kids. Something very, very wrong is happening to our children."
More than 500,000 kids currently suffer from autism, and pediatricians diagnose more than 40,000 new cases every year. The
disease was unknown until 1943, when it was identified and diagnosed among eleven children born in the months after thimerosal
was first added to baby vaccines in 1931.
Some skeptics dispute that the rise in autism is caused by thimerosal-tainted vaccinations. They argue that the increase is
a result of better diagnosis -- a theory that seems questionable at best, given that most of the new cases of autism are clustered
within a single generation of children. "If the epidemic is truly an artifact of poor diagnosis," scoffs Dr. Boyd Haley, one
of the world's authorities on mercury toxicity, "then where are all the twenty-year-old autistics?" Other researchers point
out that Americans are exposed to a greater cumulative "load" of mercury than ever before, from contaminated fish to dental
fillings, and suggest that thimerosal in vaccines may be only part of a much larger problem. It's a concern that certainly
deserves far more attention than it has received -- but it overlooks the fact that the mercury concentrations in vaccines
dwarf other sources of exposure to our children.
What is most striking is the lengths to which many of the leading detectives have gone to ignore -- and cover up -- the evidence
against thimerosal. From the very beginning, the scientific case against the mercury additive has been overwhelming. The preservative,
which is used to stem fungi and bacterial growth in vaccines, contains ethylmercury, a potent neurotoxin. Truckloads of studies
have shown that mercury tends to accumulate in the brains of primates and other animals after they are injected with vaccines
-- and that the developing brains of infants are particularly susceptible. In 1977, a Russian study found that adults exposed
to much lower concentrations of ethylmercury than those given to American children still suffered brain damage years later.
Russia banned thimerosal from children's vaccines twenty years ago, and Denmark, Austria, Japan, Great Britain and all the
Scandinavian countries have since followed suit.
"You couldn't even construct a study that shows thimerosal is safe," says Haley, who heads the chemistry department at the
University of Kentucky. "It's just too darn toxic. If you inject thimerosal into an animal, its brain will sicken. If you
apply it to living tissue, the cells die. If you put it in a petri dish, the culture dies. Knowing these things, it would
be shocking if one could inject it into an infant without causing damage."
Internal documents reveal that Eli Lilly, which first developed thimerosal, knew from the start that its product could cause
damage -- and even death -- in both animals and humans. In 1930, the company tested thimerosal by administering it to twenty-two
patients with terminal meningitis, all of whom died within weeks of being injected -- a fact Lilly didn't bother to report
in its study declaring thimerosal safe. In 1935, researchers at another vaccine manufacturer, Pittman-Moore, warned Lilly
that its claims about thimerosal's safety "did not check with ours." Half the dogs Pittman injected with thimerosal-based
vaccines became sick, leading researchers there to declare the preservative "unsatisfactory as a serum intended for use on
dogs."
In the decades that followed, the evidence against thimerosal continued to mount. During the Second World War, when the Department
of Defense used the preservative in vaccines on soldiers, it required Lilly to label it "poison." In 1967, a study in Applied
Microbiology found that thimerosal killed mice when added to injected vaccines. Four years later, Lilly's own studies discerned
that thimerosal was "toxic to tissue cells" in concentrations as low as one part per million -- 100 times weaker than the
concentration in a typical vaccine. Even so, the company continued to promote thimerosal as "nontoxic" and also incorporated
it into topical disinfectants. In 1977, ten babies at a Toronto hospital died when an antiseptic preserved with thimerosal
was dabbed onto their umbilical cords.
In 1982, the FDA proposed a ban on over-the-counter products that contained thimerosal, and in 1991 the agency considered
banning it from animal vaccines. But tragically, that same year, the CDC recommended that infants be injected with a series
of mercury-laced vaccines. Newborns would be vaccinated for hepatitis B within twenty-four hours of birth, and two-month-old
infants would be immunized for haemophilus influenzae B and diphtheria-tetanus-pertussis.
The drug industry knew the additional vaccines posed a danger. The same year that the CDC approved the new vaccines, Dr. Maurice
Hilleman, one of the fathers of Merck's vaccine programs, warned the company that six-month-olds who were administered the
shots would suffer dangerous exposure to mercury. He recommended that thimerosal be discontinued, "especially when used on
infants and children," noting that the industry knew of nontoxic alternatives. "The best way to go," he added, "is to switch
to dispensing the actual vaccines without adding preservatives."
For Merck and other drug companies, however, the obstacle was money. Thimerosal enables the pharmaceutical industry to package
vaccines in vials that contain multiple doses, which require additional protection because they are more easily contaminated
by multiple needle entries. The larger vials cost half as much to produce as smaller, single-dose vials, making it cheaper
for international agencies to distribute them to impoverished regions at risk of epidemics. Faced with this "cost consideration,"
Merck ignored Hilleman's warnings, and government officials continued to push more and more thimerosal-based vaccines for
children. Before 1989, American preschoolers received eleven vaccinations -- for polio, diphtheria-tetanus-pertussis and measles-mumps-rubella.
A decade later, thanks to federal recommendations, children were receiving a total of twenty-two immunizations by the time
they reached first grade.
As the number of vaccines increased, the rate of autism among children exploded. During the 1990s, 40 million children were
injected with thimerosal-based vaccines, receiving unprecedented levels of mercury during a period critical for brain development.
Despite the well-documented dangers of thimerosal, it appears that no one bothered to add up the cumulative dose of mercury
that children would receive from the mandated vaccines. "What took the FDA so long to do the calculations?" Peter Patriarca,
director of viral products for the agency, asked in an e-mail to the CDC in 1999. "Why didn't CDC and the advisory bodies
do these calculations when they rapidly expanded the childhood immunization schedule?"
But by that time, the damage was done. At two months, when the infant brain is still at a critical stage of development, infants
routinely received three inoculations that contained a total of 62.5 micrograms of ethylmercury -- a level 99 times greater
than the EPA's limit for daily exposure to methylmercury, a related neurotoxin. Although the vaccine industry insists that
ethylmercury poses little danger because it breaks down rapidly and is removed by the body, several studies -- including one
published in April by the National Institutes of Health -- suggest that ethylmercury is actually more toxic to developing
brains and stays in the brain longer than methylmercury.
Officials responsible for childhood immunizations insist that the additional vaccines were necessary to protect infants from
disease and that thimerosal is still essential in developing nations, which, they often claim, cannot afford the single-dose
vials that don't require a preservative. Dr. Paul Offit, one of CDC's top vaccine advisers, told me, "I think if we really
have an influenza pandemic -- and certainly we will in the next twenty years, because we always do -- there's no way on God's
earth that we immunize 280 million people with single-dose vials. There has to be multidose vials."
But while public-health officials may have been well-intentioned, many of those on the CDC advisory committee who backed the
additional vaccines had close ties to the industry. Dr. Sam Katz, the committee's chair, was a paid consultant for most of
the major vaccine makers and was part of a team that developed the measles vaccine and brought it to licensure in 1963. Dr.
Neal Halsey, another committee member, worked as a researcher for the vaccine companies and received honoraria from Abbott
Labs for his research on the hepatitis B vaccine.
Indeed, in the tight circle of scientists who work on vaccines, such conflicts of interest are common. Rep. Burton says that
the CDC "routinely allows scientists with blatant conflicts of interest to serve on intellectual advisory committees that
make recommendations on new vaccines," even though they have "interests in the products and companies for which they are supposed
to be providing unbiased oversight." The House Government Reform Committee discovered that four of the eight CDC advisers
who approved guidelines for a rotavirus vaccine "had financial ties to the pharmaceutical companies that were developing different
versions of the vaccine."
Offit, who shares a patent on one of the vaccines, acknowledged to me that he "would make money" if his vote eventually leads
to a marketable product. But he dismissed my suggestion that a scientist's direct financial stake in CDC approval might bias
his judgment. "It provides no conflict for me," he insists. "I have simply been informed by the process, not corrupted by
it. When I sat around that table, my sole intent was trying to make recommendations that best benefited the children in this
country. It's offensive to say that physicians and public-health people are in the pocket of industry and thus are making
decisions that they know are unsafe for children. It's just not the way it works."
Other vaccine scientists and regulators gave me similar assurances. Like Offit, they view themselves as enlightened guardians
of children's health, proud of their "partnerships" with pharmaceutical companies, immune to the seductions of personal profit,
besieged by irrational activists whose anti-vaccine campaigns are endangering children's health. They are often resentful
of questioning. "Science," says Offit, "is best left to scientists."
Still, some government officials were alarmed by the apparent conflicts of interest. In his e-mail to CDC administrators in
1999, Paul Patriarca of the FDA blasted federal regulators for failing to adequately scrutinize the danger posed by the added
baby vaccines. "I'm not sure there will be an easy way out of the potential perception that the FDA, CDC and immunization-policy
bodies may have been asleep at the switch re: thimerosal until now," Patriarca wrote. The close ties between regulatory officials
and the pharmaceutical industry, he added, "will also raise questions about various advisory bodies regarding aggressive recommendations
for use" of thimerosal in child vaccines.
If federal regulators and government scientists failed to grasp the potential risks of thimerosal over the years, no one could
claim ignorance after the secret meeting at Simpsonwood. But rather than conduct more studies to test the link to autism and
other forms of brain damage, the CDC placed politics over science. The agency turned its database on childhood vaccines --
which had been developed largely at taxpayer expense -- over to a private agency, America's Health Insurance Plans, ensuring
that it could not be used for additional research. It also instructed the Institute of Medicine, an advisory organization
that is part of the National Academy of Sciences, to produce a study debunking the link between thimerosal and brain disorders.
The CDC "wants us to declare, well, that these things are pretty safe," Dr. Marie McCormick, who chaired the IOM's Immunization
Safety Review Committee, told her fellow researchers when they first met in January 2001. "We are not ever going to come down
that [autism] is a true side effect" of thimerosal exposure. According to transcripts of the meeting, the committee's chief
staffer, Kathleen Stratton, predicted that the IOM would conclude that the evidence was "inadequate to accept or reject a
causal relation" between thimerosal and autism. That, she added, was the result "Walt wants" -- a reference to Dr. Walter
Orenstein, director of the National Immunization Program for the CDC.
For those who had devoted their lives to promoting vaccination, the revelations about thimerosal threatened to undermine everything
they had worked for. "We've got a dragon by the tail here," said Dr. Michael Kaback, another committee member. "The more negative
that [our] presentation is, the less likely people are to use vaccination, immunization -- and we know what the results of
that will be. We are kind of caught in a trap. How we work our way out of the trap, I think is the charge."
Even in public, federal officials made it clear that their primary goal in studying thimerosal was to dispel doubts about
vaccines. "Four current studies are taking place to rule out the proposed link between autism and thimerosal," Dr. Gordon
Douglas, then-director of strategic planning for vaccine research at the National Institutes of Health, assured a Princeton
University gathering in May 2001. "In order to undo the harmful effects of research claiming to link the [measles] vaccine
to an elevated risk of autism, we need to conduct and publicize additional studies to assure parents of safety." Douglas formerly
served as president of vaccinations for Merck, where he ignored warnings about thimerosal's risks.
In May of last year, the Institute of Medicine issued its final report. Its conclusion: There is no proven link between autism
and thimerosal in vaccines. Rather than reviewing the large body of literature describing the toxicity of thimerosal, the
report relied on four disastrously flawed epidemiological studies examining European countries, where children received much
smaller doses of thimerosal than American kids. It also cited a new version of the Verstraeten study, published in the journal
Pediatrics, that had been reworked to reduce the link between thimerosal and autism. The new study included children too young
to have been diagnosed with autism and overlooked others who showed signs of the disease. The IOM declared the case closed
and -- in a startling position for a scientific body -- recommended that no further research be conducted.
The report may have satisfied the CDC, but it convinced no one. Rep. David Weldon, a Republican physician from Florida who
serves on the House Government Reform Committee, attacked the Institute of Medicine, saying it relied on a handful of studies
that were "fatally flawed" by "poor design" and failed to represent "all the available scientific and medical research." CDC
officials are not interested in an honest search for the truth, Weldon told me, because "an association between vaccines and
autism would force them to admit that their policies irreparably damaged thousands of children. Who would want to make that
conclusion about themselves?"
Under pressure from Congress and parents, the Institute of Medicine convened another panel to address continuing concerns
about the Vaccine Safety Datalink Data Sharing program. In February, the new panel, composed of different scientists, criticized
the way the VSD had been used in the Verstraeten study, and urged the CDC to make its vaccine database available to the public.
So far, though, only two scientists have managed to gain access. Dr. Mark Geier, president of the Genetics Center of America,
and his son, David, spent a year battling to obtain the medical records from the CDC. Since August 2002, when members of Congress
pressured the agency to turn over the data, the Geiers have completed six studies that demonstrate a powerful correlation
between thimerosal and neurological damage in children. One study, which compares the cumulative dose of mercury received
by children born between 1981 and 1985 with those born between 1990 and 1996, found a "very significant relationship" between
autism and vaccines. Another study of educational performance found that kids who received higher doses of thimerosal in vaccines
were nearly three times as likely to be diagnosed with autism and more than three times as likely to suffer from speech disorders
and mental retardation. Another soon-to-be published study shows that autism rates are in decline following the recent elimination
of thimerosal from most vaccines.
As the federal government worked to prevent scientists from studying vaccines, others have stepped in to study the link to
autism. In April, reporter Dan Olmsted of UPI undertook one of the more interesting studies himself. Searching for children
who had not been exposed to mercury in vaccines -- the kind of population that scientists typically use as a "control" in
experiments -- Olmsted scoured the Amish of Lancaster County, Pennsylvania, who refuse to immunize their infants. Given the
national rate of autism, Olmsted calculated that there should be 130 autistics among the Amish. He found only four. One had
been exposed to high levels of mercury from a power plant. The other three -- including one child adopted from outside the
Amish community -- had received their vaccines.
At the state level, many officials have also conducted in-depth reviews of thimerosal. While the Institute of Medicine was
busy whitewashing the risks, the Iowa legislature was carefully combing through all of the available scientific and biological
data. "After three years of review, I became convinced there was sufficient credible research to show a link between mercury
and the increased incidences in autism," says state Sen. Ken Veenstra, a Republican who oversaw the investigation. "The fact
that Iowa's 700 percent increase in autism began in the 1990s, right after more and more vaccines were added to the children's
vaccine schedules, is solid evidence alone." Last year, Iowa became the first state to ban mercury in vaccines, followed by
California. Similar bans are now under consideration in thirty-two other states.
But instead of following suit, the FDA continues to allow manufacturers to include thimerosal in scores of over-the-counter
medications as well as steroids and injected collagen. Even more alarming, the government continues to ship vaccines preserved
with thimerosal to developing countries -- some of which are now experiencing a sudden explosion in autism rates. In China,
where the disease was virtually unknown prior to the introduction of thimerosal by U.S. drug manufacturers in 1999, news reports
indicate that there are now more than 1.8 million autistics. Although reliable numbers are hard to come by, autistic disorders
also appear to be soaring in India, Argentina, Nicaragua and other developing countries that are now using thimerosal-laced
vaccines. The World Health Organization continues to insist thimerosal is safe, but it promises to keep the possibility that
it is linked to neurological disorders "under review."
I devoted time to study this issue because I believe that this is a moral crisis that must be addressed. If, as the evidence
suggests, our public-health authorities knowingly allowed the pharmaceutical industry to poison an entire generation of American
children, their actions arguably constitute one of the biggest scandals in the annals of American medicine. "The CDC is guilty
of incompetence and gross negligence," says Mark Blaxill, vice president of Safe Minds, a nonprofit organization concerned
about the role of mercury in medicines. "The damage caused by vaccine exposure is massive. It's bigger than asbestos, bigger
than tobacco, bigger than anything you've ever seen."
It's hard to calculate the damage to our country -- and to the international efforts to eradicate epidemic diseases -- if
Third World nations come to believe that America's most heralded foreign-aid initiative is poisoning their children. It's
not difficult to predict how this scenario will be interpreted by America's enemies abroad. The scientists and researchers
-- many of them sincere, even idealistic -- who are participating in efforts to hide the science on thimerosal claim that
they are trying to advance the lofty goal of protecting children in developing nations from disease pandemics. They are badly
misguided. Their failure to come clean on thimerosal will come back horribly to haunt our country and the world's poorest
populations.
NOTE: This story has been updated to correct several inaccuracies in the original, published version. As originally reported,
American preschoolers received only three vaccinations before 1989, but the article failed to note that they were innoculated
a total of eleven times with those vaccines, including boosters. The article also misstated the level of ethylmercury received
by infants injected with all their shots by the age of six months. It was 187 micrograms - an amount forty percent, not 187
times, greater than the EPA's limit for daily exposure to methylmercury. Finally, because of an editing error, the article
misstated the contents of the rotavirus vaccine approved by the CDC. It did not contain thimerosal. Salon and Rolling Stone
regret the errors.
An earlier version of this story stated that the Institute of Medicine convened a second panel to review the work of the Immunization
Safety Review Committee that had found no evidence of a link between thimerosal and autism. In fact, the IOM convened the
second panel to address continuing concerns about the Vaccine Safety Datalink Data Sharing program, including those raised
by critics of the IOM's earlier work. But the panel was not charged with reviewing the committee's findings. The story also
inadvertently omitted a word and transposed two sentences in a quote by Dr. John Clements, and incorrectly stated that Dr.
Sam Katz held a patent with Merck on the measles vaccine. In fact, Dr. Katz was part of a team that developed the vaccine
and brought it to licensure, but he never held the patent. Salon and Rolling Stone regret the errors.
CLARIFICATION: After publication of this story, Salon and Rolling Stone corrected an error that misstated the level of ethylmercury
received by infants injected with all their shots by the age of six months. It was 187 micrograms ? an amount forty percent,
not 187 times, greater than the EPA's limit for daily exposure to methylmercury. At the time of the correction, we were aware
that the comparison itself was flawed, but as journalists we considered it more appropriate to state the correct figure rather
than replace it with another number entirely.
Since that earlier correction, however, it has become clear from responses to the article that the forty-percent number, while
accurate, is misleading. It measures the total mercury load an infant received from vaccines during the first six months,
calculates the daily average received based on average body weight, and then compares that number to the EPA daily limit.
But infants did not receive the vaccines as a ?daily average? ? they received massive doses on a single day, through multiple
shots. As the story states, these single-day doses exceeded the EPA limit by as much as 99 times. Based on the misunderstanding,
and to avoid further confusion, we have amended the story to eliminate the forty-percent figure.
Correction: The story misattributed a quote to Andy Olson, former legislative counsel to Senator Bill Frist. The comment was
made by Dean Rosen, health policy adviser to the senator. Rolling Stone and Salon.com regret the error.
Source:
http://www.rollingstone.com/politics/story/_/id/7395411?pageid=rs.Politics&pageregion=single1&rnd=1122143108250&has-player=false
Vaccinations: The Overlooked Factors
Bernard Rimland, Ph.D. Autism Research Institute 4182 Adams
Avenue San Diego, CA 92116
Vaccinations, like motherhood and apple pie, have long been regarded
as taboo topics, beyond criticism. No more. The publication in The Lancet of the article by Andrew Wakefield and associates,
providing a well-documented mechanism for the long suspected role of MMR vaccines in causing autism, has raised an international
furor.
I began to suspect a link between the DPT vaccination and autism as
early as in the mid 1960s, based on letters from and interviews with many parents. Our Form E-3 parent questionnaire, dating
from 1967, asked parents about their children's reaction to the DPT shot. H. L. Coulter and B. L. Fisher state, in their excellent
book, DPT: Shot in the Dark (1985), "The phenomenon of early infantile autism was first observed and discussed by physicians
in the early 1940s, a few years after the pertussis vaccine became more widely used in the United States .... The parallel
to certain areas of pertussis vaccine damage is striking" (p. 123).
Readers of the Autism Research Review International (ARRI)
are well aware of the autism-vaccine controversy (see ARRI 10/4, 10/1, 9/3, 9/2, 9/1, 6/3), but until now the mass
media have been kept largely in the dark. In Britain, where there has been an epidemic of autism, with hundreds of families
registering for projected class-action law suits, some newspapers have been devoting half-page or larger articles to the controversy.
Dr. Wakefield and his courageous collaborators have endured a torrent
of criticism and abuse from those dedicated to silencing anyone challenging the sacred-cow status of vaccines. The fact is,
vaccines are not nearly as safe, nor anywhere near as effective, as vaccination proponents claim.
Dr. Wakefield's opponents argue, quite speciously, that he is confusing
association with causation, and that the autism link may be merely "coincidental."
I find it doubly ironic that the vaccine advocates accuse Wakefield
of this elementary error in logic. That very argument was used just as wrongly--against vaccinations--by the opponents
of Edward Jenner when he introduced vaccination to Europe. (It was used earlier in Asia.) Jenner's observation that milkmaids
exposed to pox-infected cows developed a resistance to smallpox was attributed to coincidence. Fortunately for today's vaccine
proponents, Jenner's critics did not succeed in dismissing his observations as merely "coincidence."
The second irony is that the critics who accuse Dr. Wakefield
of confusing association with causation are guilty of doing that very thing--deliberately, not mistakenly--while trying to
influence public policy, by claiming that vaccines cause steep declines in the incidence of disease when there is good evidence
that the decline was often due to other factors -- that is, to coincidence.
In their reply to Wakefield's article, "Vaccine adverse effects: causal
or coincidental?," R.T. Chen and F. DeStephano (Lancet 2/28/98) present a table implying that the incidence of a number
of diseases was enormously reduced by vaccinations. In fact, judging from data presented by Neil Z. Miller in his book Vaccines,
are They Safe and Effective?, the reductions Chen and DeStephano cite are often coincidental rather than causal. In the
case of measles, the death rate did drop precipitously over a period of four decades, but the death rate fell 95% before
the measles vaccine was introduced! In the case of polio, the death rate had dropped 60% from its peak in the 1920s and '30s
before the vaccines arrived in the 1950s. There is considerable evidence that the claims of benefit for other vaccines
(e.g., pertussis, tetanus) are also greatly inflated.
There is an enormous amount of credible evidence that vaccines can
and do cause harm. In response to what was seen as a cause-and-effect relationship with sudden infant death syndrome (SIDS),
the Japanese government, in 1979, ordered the postponement of routine DPT shots until after the age of two. "SIDS has virtually
disappeared from Japan (Neil Z. Miller, Immunization,, Theory vs. Reality (1996).) In an article titled, "The Dark
Side of Immunizations?," Science News (November 22, 1997) reported findings by scientists implicating the rise in diabetes
and asthma to vaccines, and these allegations are just the tip of a very large iceberg. (The medical establishment's ferocious
defense of vaccines as irrefutably safe and beneficial somehow reminds me of the Titanic.)
I am not saying that vaccinations are without value. I am saying that
their benefits have been overstated, and their dangers dismissed much too carelessly.
QUESTIONS. The Black Death is estimated to have killed one third of
the population of Europe before it subsided. Why did it subside? Largely because the immune system is a marvelously adaptable
instrument which learned, naturally, how to cope with the plague.
Interesting though it is that one out of three died of the plague,
it is even more interesting that two out of three lived. Why?
Although the headlines alarmed us all when some people died as a result
of the swine flu vaccine and some people died when exposed to Legionnaire's disease, it is even more interesting that most
people survived. Why? Why are some children injured by MMR shots and others not?
The answer is that people are very different, in many ways. Part of
the difference is genetic. Another part is environmental.
We can't do much about the genetic part right now, but we can do a
lot about each person's susceptibility to disease, including vaccine-induced disease, by dealing intelligently with the environment.
TOXIC EXPOSURE. It is no secret that our environment is loaded with
toxins, many of which greatly impair not only the brain but also the immune system. Lead, mercury, pesticides, and solvents
all can create havoc with the immune system. There is of course a huge literature on this topic. Two excellent recent books
are: Our Toxic World: Who is Looking After our Kids by H. E. Buttram, M.D., and Richard Piccolo (1996), and Is This
Your Child's World? by Doris Rapp, M.D. (1997).
NUTRITION. In my view, the most important, and by far the most feasible,
approach to preventing damage by toxins of all kinds, including the toxins in vaccines (vaccines contain mercury, aluminum
and formaldehyde, in addition to germs) is to help the child's developing, immature immune system by providing generous amounts
of the nutrients the body needs if it is going to be able to protect itself from a dangerous, toxin-laden world.
In his book Every Second Child (1981), Archie Kalokerinos,
an Australian physician, tells us that the death rate among the aborigine children he was assigned to help was an astounding
50%! His investigation showed these deaths to be associated with vaccinations, and he found the children's diets to be severely
deficient in vitamin C. By merely administering vitamin C (100 mg per month of age), he dropped the death rate to nearly zero.
In my view, and in the view of many others who have studied these
problems, every mother-to-be, starting well before conception, should be taking significant (several grams a day, at least)
amounts of vitamin C, and every child should also be given supplements--especially in view of the stress on the immune system
imposed by vaccines.
But vitamin C is by no means the only nutrient that should be supplemented
if the immune system is to develop and function effectively. Nutrients known to be effective in autism, vitamin B6 and DMG,
have been shown in laboratory studies to enhance immune function. The minerals zinc and selenium, both implicated in many
cases of autism, are critical in immune function.
Nutrition is the single most important determinant of immune function,
according to world authority R. K. Chandra, who specifically mentions zinc, selenium, iron, copper, vitamins A, C, E, B6,
and folic acid.
The message is very clear: mothers should take a high quality, broad-spectrum
vitamin and mineral supplement before conception, and during pregnancy and lactation. And every child should also be getting
extra nutrients through mother's milk or along with food, if the immune system is to develop properly. The cost of not doing
so may be very high.
* * * * * * * * * * * * * * *
March 14, 2003
http://www.chron.com/cs/CDA/story.hts/health/1819125
Autism numbers surge, prompting call for research By LINDSEY TANNER Associated Press
CHICAGO -- Mention autism to parents, doctors and scientists
these days, and among an earful of different theories will emerge a common nod of agreement: The perplexing condition is not
nearly as rare as once was thought.
As recently as a decade ago it was estimated that only about
4 in 10,000 children were affected. Research now suggests the rate may be at least 10 times higher.
The numbers have fueled debates over whether there has been
a true surge of cases and whether environment or genetics could be the cause. Some parents and research advocates blame vaccines
despite evidence to the contrary.
But many mainstream scientists point to two much less worrisome
explanations: The definition for autism has changed and schools now offer more educational services to autistic kids.
In 1991, the U.S. Department of Education made autism a new,
separate category for special education services offered at public schools. Those services tend to be broader and more intensive
than for other disorders, including mental retardation. There's evidence that the 1991 change prompted "diagnostic substitution,"
said Dr. Fred Volkmar, a Yale University researcher.
"Everybody's interested in getting better services," he said.
Statistics seem to back up the theory. Department of Education
figures show that the number of children getting services for mental retardation fell from 553,262 in 1991-92 to 532,362 in
1992-93. During those years, the number of children getting services for autism swelled from 5,415 to 15,580.
The change in school services and the definition, along with
research showing that early intervention could help, raised awareness of the condition.
Autism used to be thought of as "the kid who sits in a corner
watching the record player go around and around. Everybody said that's what autistic is and anything else is not," said pediatrician
Joel Schwab.
Like many doctors, Schwab said, he may have inadvertently
diagnosed autistic youngsters a decade ago as being mentally retarded, or with nondescript behavior problems.
Now, autism increasingly is recognized as "being more than
just the classic picture," he said.
Molecular biologist Andy Shih, director of research and programs
for the National Alliance for Autism Research, says that whether there has been a surge in cases, "what is clear is that autism
is a serious public health issue.
"With potentially 1 million Americans afflicted with this
disorder," Shih said, "it is no longer something that is rare or seldom seen."
The impact has reached far outside the medical realm.
Many schools are struggling to provide enough services to
affected children, funding for research into causes has grown, and lawsuits blaming vaccines are proliferating.
"There's just so many kids who have been affected, it's hard
to find somebody who doesn't know somebody who has a kid with autism," said Liz Birt of Wilmette, Ill., whose 9-year-old son,
Matthew, is autistic.
Matthew developed normally until he was 15 months old. He
developed autism symptoms gradually after receiving two childhood vaccinations on the same day, Birt said. He stopped talking,
acted as if he was deaf, spun in circles, stared at lights and shunned his family.
Within seven blocks of their suburban Chicago home, five other
children also are afflicted. "It's just rampant," Birt said.
Autism even ended up in a debate over a last-minute provision
attached to Homeland Security legislation enacted last fall. The provision, aimed at protecting drug makers from lawsuits
over vaccine-related injuries, prompted protests in Washington in January by parents who think childhood vaccines cause autism.
Much has been learned about autism in the past half century.
The once prevailing "refrigerator mother" theory suggesting cold, aloof mothers caused autism was long ago thrown out as scientific
advances favored a biological cause.
But many key questions remain. Researchers don't know if a
single gene or many are involved, or possibly different ones in different cases.
Some think environmental factors might trigger the disease
in genetically susceptible people. Potentially plausible but unproven triggers range from illness during pregnancy to soil
toxins, electromagnetic waves and even vaccines, though strong evidence so far suggests the shots are safe.
"There's so many things that it could be," said Dr. Robert
Byrd of the University of California at Davis. A recent study suggested autism cases in California surged nearly 300 percent
over 10 years, and Davis researchers are trying to pinpoint why.
Autism has raised deep questions ever since psychiatrist Leo
Kanner first described it as a distinct developmental disorder in the early 1940s, after observing several curiously afflicted
children in Baltimore.
* * * * * * * * * * * * * * * * * * * * * * ** * * * * * * * * * * * *
Here is the latest research article [Spring 2003] on
the link between Thimerosal in Childhood Vaccines and neurodevelopmental Disorders & Heart Disease. It is the Geier &
Geier article in the Spring 2003 Journal of American Physicians and Surgeons. The study clearly shows evidence between mercury
in childhood vaccines and the epidemic of Autism in recent years.
http://www.jpands.org/vol8no1/geier.pdf
* * * * * * * * * * * * * * * * * * * * * * ** * * * * * * * * * * * *
Over 60 years ago FDA approved a little known
product, thimerosal, to be used as a preservative. Now today, many parents question if this product is responsible for the
current epidemic of children diagnosed with learning disabilities and autism.
Lyn Redwood RN, MSN, CRNP
Thimerosal
Current thinking suggests that exposure to mercury is primarily from environmental and dietary sources, dental amalgams
and rare catastrophic events. Recently, however, another common and pervasive source of mercury exposure has been identified,
thimerosal. Thimerosal was first approved as an additive by FDA in the 1930's. It has been utilized as a preservative to prevent
bacterial contamination in a number blood and biological products including vaccines and immune globulin's and over the counter
eye and nose drops. The danger that thimerosal presents is that it contains 49.5% ethyl mercury by weight. Mercury is a potent
human toxicant, which has long been the source of many serious health problems. It is especially toxic to the rapidly developing
fetal and infant brain. While acceptable levels for exposure are published by Federal Agencies, mercury is a poison at any
level.
Chemically, thimerosal is a water soluble-cream colored crystalline powder. In the human body thimerosal is
metabolized to ethylmercury and thiosalicylate. The literature on thimerosal metabolism and excretion is old and toxicological
information is limited. Therefore, it has been assumed that the toxicity of ethylmercury is equivalent to methylmercury until
further information is available. In the past there have been case reports of toxicity and death following inadvertent massive
exposures.
FDA's Discovery
In 1997 when the FDA Modernization Act was signed into law there was an attached
amendment which required the FDA to compile a list of drugs and food that contain intentionally introduced mercury compounds
and to provide a quantitative and qualitative analysis of the mercury compounds on the list. One may ask why FDA did not
routinely perform this task. FDA's mission is to ensure purity, safety, potency and efficacy of individual products, and such
analysis have never been a required part of the permitting process. In it's review, which took two years to complete, the
FDA discovered that infants who receive thimerosal-containing vaccines at several visits may be exposed to more mercury than
recommended by Federal guidelines for total mercury exposure.
Infant vaccines that routinely contained thimerosal
were DPT, Hep.B and HiB. (Table 1) Following the CDC recommended vaccine schedule infants were exposed anywhere from 0 to
187.5 mcg of ethyl mercury, depending on the vaccine manufacturer and total exposure through 18 months could be as high as
237.5 mcg. (Table 2) The dose thought to be allowable by EPA is 0.1 mcg per kilogram per day. If an average 5 kg infant received
all thimerosal containing vaccines at his 2 month visit the exposure that day would be 62.5 mcg ethyl mercury, an exposure
that is 125 times above the EPA's guideline.
In its analysis, the FDA multiplied EPA's daily exposure levels of 0.1mcg
per kilogram by 180 days, even though the exposures had occurred on only 4 days during this time period. It is perplexing
that FDA chose to average an infant's total exposure to mercury over the first six months of life as though children were
being exposed on a daily basis, and reported that amounts were only slightly above one of the Federal guidelines. According
to toxicologist, because of the inherent pharmokinetics of mercury and its long half-life in the body, you can not legitimately
calculate the effect of a large injected bolus dose as thought it were ingested in small amount over a longer period of time.
This method of analysis inaccurately minimizes the levels of exposure. If one were to look at the mercury in thimerosal from
a daily dose perspective, no one vaccine containing thimerosal would be able to meet EPA's guidelines for safe exposure. A
simple analogy can be made that one may safely consume 4 Tylenol a day in 6-hour intervals for a month but consuming 120 Tylenol
in one day would be equivalent dosing. This dose not only defies logic, but sound medical practice.
At the same time
the FDA findings were released, The American Academy of Pediatrics published An Interim Report to Physicians on Thimerosal
in Vaccine. In this document the AAP and Public Health Service agreed that the use of thimerosal containing vaccines should
be reduced or eliminated,stating that any potential risk was of concern. While the document discussed much of the uncertainty
regarding the potential effect of mercury exposure in vaccines, it clearly stated that there was no evidence of harm having
occurred from this exposure. The Academy also recommended "Infants and children who have received thimerosal-containing vaccines
do not need to have blood, urine, or hair tested for mercury since the concentrations would be quite low and would not require
treatment." If no testing for mercury was recommended, then how could one know for a fact that there is was no "evidence of
harm"? (AAP, 1999).
Historical Perspective
It is interesting to note that thimerosal was introduced only a
few short years before Dr. Leo Kanner described a new mental disorder which differed "markedly and uniquely from anything
reported" before. In its early history autism was diagnosed more frequently in affluent families, but became more evenly distributed
socioeconomically by the 1970's. This apparent widening in demographics paralleled the increasing availability of vaccines
to all children through federally sponsored programs. It has been during this same time period, the 1980's and especially
the 1990's, that we have witnessed a tremendous increase in the occurrence of autism spectrum disorders.
(Table 3)
In the late 1980's and early 1990's the vaccine schedule was amended to include both Hepatitis B and HiB vaccines.
Each of these vaccines are administered to infants 3 times during the first six-months of life. Their addition to the vaccine
schedule potentially tripled an infant's exposure to mercury, should they receive all thimerosal-containing vaccines. An additional
concern is that these vaccine exposures are occurring on top of prenatal exposures from immune globulin preparations administered
during pregnancy to RH- mothers, dietary, dental and environmental exposures.
Current Investigations
Information
from large epidemiological studies conducted in mercury exposed populations suggests that intermittent large exposures may
pose more risk than small daily exposures. In one study, lower scores on memory, attention, language and motor function tests
were found years later in children who had been exposed prenatally to intermittent bolus doses of methyl mercury from dietary
exposure at levels that had been previously thought to be safe. (Grandjean, 1998)
In a recent investigation, mercury
levels were obtained before and after exposure to 12.5 mcg of ethyl mercury in hepatatis B vaccine in 15 preterm and 5 term
infants.(Stajich, 2000) There were no differences between the preterm and term infants with respect to mean pre-vaccination
levels although post immunization mercury levels were significantly increased in both groups of infants. Post vaccination
levels in preterm infants were 3 times higher than those of term infants, a difference that was statistically significant.
Of interest, one preterm infant developed a post vaccinal mercury level of 23.6 mcg/L, which falls within the range known
to result in neurodevelopmental dysfunction. (Grandjean, 1994)
At the June 21, 2000 Advisory Committee for Immunization
Practices meeting held in Atlanta, Georgia, Dr. Thomas Verstraeten of the National Immunization Program presented a review
of vaccine safety datalink information on thimerosal containing vaccines. Over 400,000 children participate in the vaccine
safety datalink program. From this database 100,000 eligible children charts were reviewed to determine exposure to thimerosal
containing vaccines and specific neurodevelopmental outcomes. Key findings were statistically significant associations between
cumulative exposure to thimerosal containing vaccines at 2 months of age and unspecified developmental delay; 3 months of
age and tics; 6 months of age and attention deficit disorder; 1,3,and 6 moths of age and speech and language delay and neurodevelopmental
delays in general.
According to a recent report in the Weekly Epidemiology Record, January 2000, which reviewed the
use of Thimerosal as a vaccine preservative stated that "this safety assessment cannot currently exclude the possibility of
subtle neurodevelopmental abnormalities in infants from a cumulative exposure to thimerosal in vaccines." (Wkly Epi Rec, 2000)
What Next
There are many unknowns with respect to thimerosal. These include; a paucity of data on the metabolism,
excretion and toxicity of ethyl mercury, the levels of risk to the fetus from maternal exposures and to the infant from exposure
occurring during critical windows of neurological development and the effect of large intermittent bolus exposures to ethyl
mercury verses daily low dose oral exposures to methyl mercury. Current investigations are underway from both governmental
and private agencies in an effort to address these concerns.
Not only are they're many unanswered questions concerning
mercury exposure from thimerosal in vaccines, but there appears to be no general consensus as to how best proceed to diagnose,
or effectively treat elevated mercury levels in children. The effectiveness of chelating agents in crossing the blood brain
barrier has become a topic of scrutiny, as well as the ability to treat a long-standing exposure which occurred during a critical
time in development.
At a recent conference, a number of physicians who specialize in the treatment of children with
autism and developmental disorders reported finding many children with elevated mercury levels who had remarkable improvement
in behaviors, speech and cognition when treated with a program to reduce oxidative stress and metal body burden. (DAN, 2000).
What to do
Despite this information, the FDA has only "encouraged" vaccine manufacturers to reduce or eliminate
thimerosal. According to the FDA, there are currently enough vaccine products that are thimerosal free to meet the immunization
needs in the U.S. the first 6 months of life. Therefore, until there is more research available assuring its safe use in infants,
it would only be prudent to give preference to all thimerosal-free vaccines. Dr. Neal Halsey, at the Institute for Vaccine
Safety, Johns Hopkins, summed up this issue best in a recent article on thimerosal published in the Hepatitis Control Report,
Summer 1999 issue. "We can say there is no evidence of harm (from thimerosal), but the truth is no one has looked." Hepatitis
Control Report, 1999).
Currently there are still 30 vaccine products on the market that contain thimerosal. The general
public, as well as health care providers, needs to be aware that there are many different vaccine products available, both
with and without thimerosal. Parents research the safest car seats and toys for their children, but do not realize that they
also need to research vaccines as well. Thimerosal has been eliminated from latex paints, merthiolate and many other over
the counter products because of serious toxic effects in infants from these products. Although FDA has only focused on thimerosal
in infant vaccines at this time, all vaccines that contain this product should come under scrutiny in the near future.
Is
there "Cause for Concern"
Although there are many unanswered questions about excessive mercury exposure in infants
who received multiple thimerosal containing vaccines, there are many well-documented facts that support concerns that mercury
is playing a role in the recent epidemic of learning disabilities and autism spectrum disorders. These include the facts that:
Mercury toxicity is cumulative and occurs when the rate of exposure exceeds the rate of elimination. This results
in a delayed neurotoxicity, which can manifest months after the exposure. Many children diagnosed with autism experience normal
development and then regress.
The major toxicity of mercury compounds is expressed in the central nervous system,
although immune and gastrointestinal systems are also commonly affected. The same abnormalities in these systems have been
found in children with autism.
Mercury causes a pervasive disruption in the body by binding to sulfur which causes
widespread dysfunction of enzymes, transport mechanisms and structural proteins. Therefore, clinical manifestations involve
multiple organ systems with variable features and intensities. The same is true for autism.
Susceptibility to mercury
appears to have a genetic component and boys are documented to be more affected than girls approximately 4 to 1. Autism and
ADD/ADHD also occurs more frequently in boys than girls.
Mercury toxicity is known to cause speech and hearing deficits,
including difficulty speaking and understanding speech. One of the primary features of autism is receptive and expressive
language delay.
Sensory disturbances, including numbness in the mouth, hands and feet, sensitivity to loud noises,
aversion to touch and over or under response to pain, are common manifestations of mercury toxicity. These same sensory disturbances
are also common in children with autism.
Mercury exposure is known to cause cognitive impairment and difficulty with
abstract ideas and complex commands, social withdrawal, anxiety and obsessive-compulsive behaviors. These same symptoms are
also well documented in children with autism.
Mercury disrupts serotonin, dopamine, glutamate and acetylcholine neurotransmitters.
These same abnormalities have been found in children with autism.
Mercury in the brain targets the Purkinje cells
and granule layer of the cerebellum as well as the amygdala and hippocampus, while other areas are spared. This same pattern
of pathology has been found in autistic brains.
Mercury toxicity causes damage to the immune system and triggers autoimmune
processes, including shifts in the Th2 lymphocytes. These same autoimmune processes are known to occur in autism.
Mercury
exposure can increase susceptibility to certain virus strains, which may be related to a decrease in NK cell function. A subset
of autistic children have been found to have evidence of chronic viral infections, including measles virus.
Mercury
poisoning can cause gastrointestinal disturbances and inhibit digestive enzymes and peptides. Many children with autism develop
gastrointestinal problems and have difficulty digesting dairy and wheat products.
If you would like additional information
on mercury and autism go to: http://www.autism-mercury.com or to http://www.safeminds.org
To view a comparison paper on Autism and Mercury paper go to
http://www.canfoundation.org
For information on vaccines go to http://www.909shot.com
References
American Academy of Pediatrics. Thimerosal in vaccines-An interim report to clinicians. Available
at http://www.aap.org/new/thimpublic.htm.
Accessed October 18, 1999.
Grandjean P, Weihe P, White, RF, Debes F.
Cognitive performance of children prenatally exposed to "safe" levels of methylmercury. Environ Res. 1998; 77: 165-172.
Stajich,
G, Loez, G, Harry W, Sexson W. Iatrogenic exposure to mercury after hepatitis B vaccination in preterm infants. The J. of
Peds. 2000; 136 (5); 679-681.
Grandjean P. Weihe P, Nielse, J. Methylmercury: Significance of interuterine and postnatal
exposures. Clin. Chem. 1994: 40 (7) 1395-1400.
Thimerosal as a vaccine preservative. Wkly Epi Rec. 2000; Jan 14; 75
(2): 12-16.
Hep. Control Rep. Summer, 1999. Uproar over a little-known preservative, thimerosal, jostles U.S. hepatitis
B vaccination policy. Vol. 4, No.2.
************************************************************
THE AUTISM-VACCINE DISASTER
Bernard Rimland, Ph.D. Autism Research Institute 4182
Adams Avenue San Diego, CA 92116
Her voice cracked. She fought back tears, but went
on with her story. I had to phone you, she said. Ted [not his real name] came back from speaking at a small autism conference
last night. He was obviously disturbed. Agitated. After a time I asked what was wrong. He broke down and cried. Ive never
seen my husband cry before. As a laboratory scientist, he has studied blood and urine samples from autistic children for many
years, but has had almost no direct contact with any of the kids. But he had to wait several hours at the airport after the
conference. The parents of an autistic child, also returning from the conference, sat near him at the airport so he had his
first direct experience of what life is like for these families. It really upset him emotionally, and me too. It is terrible.
Like Ted, society in the U.S., and in almost all
the other so-called developed countries, is finally beginning to experience autism for the first time, up close and personal.
The experience is not pleasant, or easily forgotten.
In our 1995 editorial, Is there an autism epidemic?
(ARRI 9/3), we asserted that the numbers of autistic children were increasing alarmingly, and that vaccine damage was
a likely cause of the increase. That was seven years ago, and our views were rejected and reviled by the supposed authorities.
No epidemic, they all said, just greater awareness. And vaccines are perfectly safe.
Now the stark reality of the epidemic is all too
well documented, and has become front-page news. The lame excuses have been swept aside by the California study, which systematically
showed that increased awareness, changing diagnostic criteria, and immigration by families seeking services could not account
for the huge increase in numbers.
Experts puzzled by autism increase, the headlines
say, in response to the tap-dancing by medical and public health authorities who continue to ignore the mounting evidence
that over-vaccination, particularly with mercury-containing vaccines, is by far the most probable cause of the epidemic.
Do vaccines cause autism? For the past several
years in the U.S., and for longer in the U.K., the debate has been raging. The number of vaccine doses given before age two
has risen from three in 1940, when autism occurred in perhaps one case per 10,000 births, to 22 vaccine doses before age two
in the year 2000. The best current estimates are that autism occurs in 45 to 65 children per 10,000 live births. And most
vaccines have contained toxic levels of the mercury-based preservative thimerosal, to which many children are exquisitely
sensitive.
It is by no means unusual for a scientific controversy
to have significant social, political and economic implications. The current controversy over the safety of childhood vaccines,
however, has implications of truly enormous and long-enduring proportions. There is so much at stake that science has been
forced into the back seat. Both sides realize that winning is the crucial issue, and each side feels its future is at stake.
And it is.
The medical establishment has sponsored a series
of irrelevant and misleading epidemiological studies, such as the recent badly flawed Denmark study, in its attempt to exonerate
vaccine injury as the major cause of the epidemic. Thus far, laboratory medicine has played only a minor role in the controversy.
The U.S. Congressional hearings and Institute of Medicine reports make little more than passing reference to the laboratory
studies, but that will change as the vaccine injury lawsuits reach the courts. Past issues of the ARRI have featured many
of these studies (see ARRI 16/2, 16/1, 15/4, 15/3, 15/1, 14/4, 14/3, 13/3, 12/1), and more are forthcoming.
On the one side are the parents who feel their
children were injured by the vaccines. They assert that their children were normal until an adverse vaccine reactions was
observed. They often have home videos, school records and other documentation to bolster their claims. They note the lack
of long-term studies of vaccine safety and the admission by a former FDA commissioner that as few as one percent of adverse
reactions have been reported under the purely voluntary U.S. Vaccine Adverse Event Reporting System (VAERS). They are supported
by a small cadre of professionals who risk derision and censure from their peers by producing data and citing studies which
would seem to support these parents claims.
They face enormously powerful and influential opposition:
the very wealthy drug companies with their legions of researchers and attorneys, the prestigious and affluent medical societies
such as the American Academy of Pediatrics, and of course the virtually unlimited resources of such agencies as the Centers
for Disease Control and the Food and Drug Administration. The medical establishment argues that by casting doubt on vaccine
safety, the parents and their supporters will lower the vaccination rate and cause the return of deadly epidemics which, they
say-and it is contested-have been banished by vaccinating close to 100 percent of the children.
A class action lawsuit has been in the U.K. court
system for several years, and at least seven vaccine injury court cases have been filed in the U.S. in recent months, with
many more in the pre-filing stage as this is written.
Billions of dollars in compensation
are at stake. Estimates for the lifetime care of each autistic child are in the two-million-dollar range, and if recent studies
in the U.K. and the U.S. are to be believed (the results are contested), the prevalence of autism has increased in the past
decade by 1,000 percent or more-from 4.5 per 10,000 births to 45 or more per 10,000.
A trial lawyer active in the tobacco industry injury-compensation
litigation recently said, If you think the cigarette companies were hit hard, wait till these vaccine cases get to the juries.
The jurors, who awarded millions of dollars to the plaintiffs, had limited sympathy for them, since the risks of emphysema
and lung cancer were well known, and the plaintiffs had only a few years left in any case. But the children didnt choose to
be vaccinated-and their whole lives, and their families lives, have been ruined.
But it is not just money-drug company money-that
is at stake. Credibility is a major issue. The entire medical establishment-the drug companies, the medical schools, the medical
societies, and the government agencies-have all staked their reputations on the safety of vaccines. The public has already
indicated its growing distrust of conventional medicine by moving its money toward alternative approaches. If the court cases
come down in favor of the families, the high esteem which conventional medicine has enjoyed is likely to erode rapidly. Rebuilding
public confidence would not be easy.
* * * * * * * * * * * * * * * * * * * * * * * *
* * * * * * * * * * * *
Mercury Connection to Autism
Immune Reactive
Conditions: The mercury connection to Autism, schizophrenia,ADD, eczema, lupus, asthma, and allergies (snipped from larger
study) by: Bernard Windham - Chemical Engineer
The incidence of neurotoxic, allergic, and immune reactive conditions
such as autism, scizophrenia, ADD, dyslexia, allergies, asthma, eczema, lupus,psoriasis, childhood diabetes, etc. have been
increasing rapidly in recent years(1,2,3,5,23). A recent report by the National Research Council found that 50% of all pregnancies
in the U.S. are now resulting in prenatal or postnatal mortality, significant birth defects, or otherwise chronically unhealthy
babies(3). Exposure to toxic chemcials or environmental factors appear to be a factor in as much as 28 percent of the 4 million
children born each year(3), with 1 in 6 having one of the neurological conditions previously listed.. According to the U.S.
FDA, at least 26 million have allergies and at least 17 million have asthma. The largest increase has been in infants(1,2,,5-7,23),
with an increase in autism cases to over 500,000 (1,2,23,22), an over 500% increase to a level of almost 1 per 250 infants
in the last decade(2), making it the 3rd most common childhood condition, along with similar increases in ADD, and over 10
% of infants- approximately 15 million in the U.S. with such conditions or systemic eczema(1). Studies researching the reason
for these rapid increases in infant reactive conditions seem to implicate earlier and higher usage of vaccines containing
mercury(thimerosal) as a likely connection(2,2b,23,30,40). A recent study comparing pre- and post-vaccination mercury levels,
found a significant increase in both preterm and term infants after vaccination(42), with post-vaccination mercury levels
approximately 3 times higher in the preterm infants as compared with term infants. The study found mercury blood levels up
to 23.6 ug/L and recieved an average dose of 16.7 ug/kg. Just this one vaccination gave an exposure to mercury that is many
times the U.S. ATSDR adult minimum risk level(MRL) for mercury of .3/ug/kg body weight per day(41).
It has been estimated
that if all of the vaccines recommended by the American Assoc. of Pediatrics are given and contain thimerosal, then by age
6 months an infant would have received 187 micrograms of ethyl mercury which is more than the EPA/ATSDR health standard for
organic mercury(33,41) and by age 3 the typical child has received over 235 micrograms of mercury thimerosal from vaccinations
which is considerably more than Federal mercury safety guidelines(41), in addition to significant levels from other sources
for many(23). Infants during this period have undeveloped blood brain barriers and much of the mercury goes to the brain,
resulting in significant adverse neurological effects in those that are most susceptible(43,3).
Because of the evidence
the FDA has completed a study and written a letter to vaccine manufacturers asking that mercury be removed from vaccines.
The updated letter stated, "The Center for Biologics Evaluation and Research (CBER) has completed its evaluation of the use
of thimerosal in vaccines...Our review concluded that reducing or eliminating thimerosal from vaccines is merited(44). The
letter pointed to a joint statement by the American Academy of Pediatrics and the United States Public Health Service in
1999, which "called for the removal of thimerosal from vaccines as soon as possible."
Many thousands of parents have
reported that their child got such conditions after vaccination, and tests have confirmed high levels of mercury in many of
those tested, along with other toxic exposures. An additional source of thimerosal to the fetus of women who are RH negative
is the 30 micrograms in the RhoGAM shot they receive. Underweight infants that get the same dose of thimerosal as other infants
have also been found to be at special risk. Many of those diagnosed with high mercury levels have also been found to have
significant improvement after mercury detoxification(23,30,40,11,35).
Thimerosal had been previously removed from
similar preservative uses in eye drops and eye medications after evidence of a connection to chronic degenerative eye conditions.
After over 15,000 law suits were filed in France over adverse effects of the Hepatitis B vaccine, the French Minister of Health
ended the mandatory hepatitis B vaccination program for all school children. Adverse effects included neurological disorders
and autoimmune disorders such as multiple sclerosis and lupus. Some hospitals in the U.S. also quit recommending certain vaccinations.
Although vaccinations appear to be the largest source of mercury in infants, mercury has been found to be transmitted
from the mother to the fetus through the placenta and accumulate in the fetus to higher levels than in the mother's blood(22).
Breast milk of women who have amalgam fillings or eat a lot of fish has also been found to be a significant source of mercury
in infants and young children(22,45).
A direct mechanism involving mercury's inhibition of cellular enzymatic processes
by binding with the hydroxyl radical(SH) in amino acids appears to be a major part of the connection to these allergic/immune
reactive conditions(15-23,36,46). For example mercury has been found to strongly inhibit the activity of xanthine oxidase
and dipeptyl peptidase (DPP IV) which are required in the digestion of the milk protein casein(15,16,17,19,20,22), and the
same protein that is cluster differentiation antigen 26 (CD26) which helps T lymphocyte activation. CD26 or DPPIV is a cell
surfact glycoprotein that is very susceptible to inactivation by mercury binding to its cysteinyl domain. Mercury and other
toxic metals also inhibit binding of opioid receptor agonists to opioid receptors, while magnesium stimulates binding to opioid
receptors(15).
Studies involving a large sample of patients with autism, scizophrenia, or mania found that over 90
% of those tested had high levels of the milk protein beta-casomorphin-7 in their blood and urine and defective enzymatic
processes for digesting milk protein(24,25,27), and similarly for the corresponding enzyme needed to digest wheat gluten 24,26).The
studies found high levels of Ig A antigen specific antibodies for casein, lactalbumin and beta-lactoglovulin and IgG and IgM
for casein. Beta-casomorphine-7 is a morphine like compound that results in neural disfunction (24,25), as well as being a
direct histamine releaser in humans and inducing skin reactions (14,21,25c).
Similarly many also had a corresponding
form of gluten protein(26). Elimination of milk and wheat products and sulfur foods from the diet has been found to improve
the condition. A double blind study using a potent opiate antagonist, naltrexone(NAL), produced significant reduction in autistic
symptomology among the 56% most responsive to opioid effects(28). The behavioral improvements was accompanied by alterations
in the distribution of the major lymphocyte subsets, with a significant increase in the T-helper-inducers and a significant
reduction of the T-cytotoxic-suppressors and a normalization of the CD4/CD8 ratio. Studies have found mercury causes increased
levels of the CD8 T-cytotoxic-suppressors(29). As noted previously, such populations of patients have also been found to have
high levels of mercury and to recover after mercury detox(23,11,22,30,40). As mercury levels are reduced the protein binding
is reduced and improvement in the enzymatic process occurs(22,11).
Additional cellular level enzymatic effects of
mercury's binding with proteins include blockage of sulfur oxidation processes and neurotransmitter amino acids which have
been found to be significant factors in many autistics 18,36,46,17), plus enzymatic processes involving vitamins B6 and B12,
with effects on the cytochrome-C energy processes as well. Epson salts(magnesium sulfate)baths, supplementation with the p5p
form of Vit B6 and vit B12 shots are methods of dealing with these enzymatic blockages that have been found effective by those
treating such conditions. Mercury has also been found to have adverse effects on cellular mineral levels of calcium, magnesium,
zinc, and lithium(39,22,46). Supplementing with these minerals has also been found to be effective in the majority of cases(39)
Another of the results of these toxic exposures and enzymatic blockages is the effect on the liver and disfunction
of the liver detoxification processes which autistic children have been found to have(30,36,22). All of the autistic cases
tested were found to have high toxic exposures/effects and liver detoxification profiles outside of normal(30).
Along
with these blockages of cellular enzymatic processes, mercury has been found to cause additional neurological and immune system
effects in many through immune/autoimmune reactions(11,12,35). Mercury(22) as well as thimerosal(31,32) also have direct neurotoxic
effects on brain nucleotid binding proteins through their effect on Ca2+ATPase and Na+/K+ATPase activity. But the effects
on the neurological and immune systems of exposure to various toxic substances such as toxic metals and environmental pollutants
has also been found to have additive or synergistic effects and to be a factor in increasing eczema, allergies, asthma, delayed
food allergies, and sensitivity to other lesser allergens(14-22,35). Most of the children tested for toxic exposures have
found high or reactive levels of other toxic metals, and organochlorine compounds(30,40,11,12,35,4).
Other than the
organochlorines or toxic metals which are discussed later, three common pollutants that have been documented to have effects
on such conditions are traffic and industrial pollutants nitrogen oxide, power plant residual oil fly ash, and organochlorine
pollutants(4).
Another effect of mercury and toxic metals is a reduction in B- lymphocytes (37,38,22). One of these
studies(37) dealing with autistic patients and further work with such patients has found this causes a tendency to be more
seriously affected by viruses and to develop intestinal disorders including leaky gut, lymphoid modular hyperplasia, and a
high incidence of parasites.
Allergic contact eczema is the most frequent occupational disease(1,22), and the most
common cause of contact eczema is exposure to toxic metals(1,6-12,22). The metals most commonly causing allergic immune reactivity
are nickel, mercury, chromium, cobalt, and palladium(1,6-14,22). The highest level of sensitization is to Infants, who are
most reactive to thimerosal, a form of mercury that has been used as a preservative in vaccines and eye drops(6,7). There
is strong suggestive and clinical evidence for a connection between toxic metals and autism(2b,15-40).
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July 20, 2001
IOM reviews evidence on thimerosal link to autism
Persistent concern about the safety of vaccinations prompted
the US National Academy of Sciences Institute of Medicine to convene an open public meeting in Cambridge, Massachusetts, on
July 16, to review the evidence for an association between thimerosal, a mercury-containing preservative found in multidose
vaccine preparations,and neurodevelopmental outcomes, particularly autism, the prevalence of which has apparently increased
over the past decade.
Thimerosal, also known as ethylmercury, has been used as a preservative since 1930, and is now
hypothesised to carry similar risks as methylmercury, a chemical that is known to be toxic in animals and human beings. In
June, 1999, the American Academy of Pediatrics and the US Public Health Service, acknowledging that mercury exposure from
vaccinations given in the first 6 months of life exceeded maximum acceptable levels established in federal guidelines, called
for a halt to the manufacture of thimerosal-containing vaccines. Although no longer routinely given in the USA (European and
UK regulators have also recommended phasing out their use), they are still the norm in many other parts of the world, especially
in developing countries. Neal Halsey (Johns Hopkins University, Baltimore, Maryland, USA) said that all countries need to
stop using these vaccines now, but single-use vaccines, carrying added costs for storage, production, alternative preservatives,
and quality control measures, are prohibitively expensive for developing countries.
The meeting was the third in a
series of gatherings hosted by the IOM's Immunization Safety Review Committee, an independent expert group established by
joint request of the Centers for Disease Control and Prevention and the National Institutes of Health. In its report, to be
issued within 90 days of the meeting, the committee will recommend public health responses for surveillance, research, and
policy. It will consider, in addition to the evidence for causality, the biological plausibility of adverse events, and will
explore the social and cultural context of the issue. Faith McLellan
Source url:
Source:
http://www.lef.org/magazine/mag2001/may2001_report_mercury_1.html
Toxicity - Your next visit to the dentist may not be as innocent as you think by Jim O'Brien
The pervasive lack of
public awareness about this very serious issue is an obstacle to progress. Even scientists and physicians tend to be relatively
uninformed. Jordan Davis, M.D.
In case anyone still wants to defend the safety record of mercury dentists and dental
personnel who work with amalgam are chronically exposed to mercury vapor. Mercury levels in urine of dental personnal average
about two times that of controls. Jordan Davis, M.D.
When they go to dental hygienists, mercury amalgams should not
be polished. We also recommend against dental appliances such as braces. Charles Williamson, M.D.
The list of problems
mercury vapor can cause is endless. Charles Williamson, M.D.
* * * * * * * * Charles Williamson, M.D., co-director
of the Toxic Studies Institute in Boca Raton, Florida and colleague, Jordan Davis, M.D., sat down with Life Extension magazine
for an in-depth interview on the problem of mercury toxicity caused by dental fillings. Unlike past treatments of this subject,
the two physicians spoke from a clinical, medical and scientific not a dental perspective.
The issue of mercury toxicity
is a delicate one. For decades, most people have seen a visit to the dentist and subsequent cavity filling as a necessary
and regular procedure. Side effects have not routinely been brought to light, so few have challenged the status quo. Evidence
suggests, however, that such an apparently harmless procedure can have detrimental effects.
I envision something along
the lines of the backlash against tobacco, or drunk driving. Imagine a mercury amalgam protest group patterned after M.A.D.D.Mothers
Against Drunk Driving. When that organization came about, we saw results. Thats what we desperately need now. Charles Williamson,
M.D.
Charles Williamson, M.D., co-director of the Toxic Studies Institute in Boca Raton, Florida, takes the matter
very seriously. Once mothers realize the fillings in their teeth damage the development of their babies brains while theyre
in the womb, and once these women understand this damage can result in low IQ, learning and behavioral problems after birth,
then we'll see a public outcry against the use of mercury amalgam.
I envision something along the lines of the backlash
against tobacco, or drunk driving. Imagine a mercury amalgam protest group patterned after M.A.D.D.Mothers Against Drunk Driving.
When that organization came about, we saw results. Thats what we desperately need now. Perhaps we could call it M.A.M.A.Mothers
Against Mercury Amalgams.
Dr. Williamson continues: One of these days, theres going to be a mammoth lawsuit about
mercury fillings, similar to one thats already been filed in Canada. Its going to be bigger than what weve seen over tobacco.
Its going to hit people like a Mack truck that putting mercury amalgam in their teeth amounts to putting poison in their mouths.
Once they realize that in no uncertain terms, theyre going to be angry. Part of our job is to educate, inform and disturb
them so theyll do something about it.
Mercury vapor is toxic, period, Dr. Williamson goes on. The fetus is especially
vulnerable to that toxicity, which can cause brain damage. Specifically, mercury vapor can cause learning disabilities, autism
and attention deficit disorder in unborn children. How will parents feel when they grasp that?
Dr. Williamson and
his colleague, Jordan Davis, M.D., say toxicity due to mercury amalgams is pandemic in our societyyet hardly anybody understands
or appreciates that fact. As it turns out, mercury toxicity could provide a significant explanation for the explosion in learning
and behavioral problems, autism and a whole host of other conditions since World War IIthat 55-year period corresponds to
the introduction and widespread use of mercury amalgam.
Its an enormous problem, explains Dr. Davis.
There
are the medical consequences, the symptoms. Mercury is toxic and it harms people. We'll get into the science behind that statement
latertheres a ton of evidence to substantiate it. Dr. Williamson says that the toxicity results in disorders primarily of
the central nervous system; the head, neck and oral cavity; the gastrointestinal tract; the cardiovascular, renal and immune
systems. Exposure to mercury fillings results in a chronic toxicity, not acute poisoning, he noted as an aside.
According
to Dr. Williamson, the toxicity can manifest in irritability and anxiety, restlessness and emotional instability, loss of
memory, inability to concentrate, mental confusion, depression, anti-social behavior, suicidal tendencies, muscle weakness
and loss of coordination; bleeding gums and loosening of teeth; abdominal cramps, chronic diarrhea and/or constipation; abnormal
heart rhythms and blood pressure (high or low) and unexplained elevations of cholesterol and triglycerides; repeated infections
or cancer; and generalized complaints such as chronic headaches, allergies, dermatitis, cold and clammy skin or excessive
perspiration, ringing in the ears, joint and muscle pain, unsteady gait, wheezing, heart palpitations, sinus congestion, allergies,
loss of appetite or chronic obesity.
Dr. Davis explains that these symptoms have inexplicably been on the rise in
the past 50 years, without any unifying explanation. But findings in the past 10 years indicate that mercury toxicity may
be the common link between these seemingly unrelated symptoms.
There are specific treatment protocols to detoxify
individuals and rid them of their mercury burden. Removing mercury fillings is an obvious step in that process, but surprisingly,
its not the first one. It must be preceeded and followed by systemic detoxification. We'll detail the clinical treatment process
later, said Dr. Davis.
The Mercury amalgam problem also works on the level of society as a public health probleman
unrecognized one, at that. The pervasive lack of public awareness about this very serious issue is an obstacle to progress.
Even scientists and physicians tend to be relatively uninformed, says Dr. Davis.
And there is even organized resistance
on the part of dentists who use mercury amalgams. There has been for a very long time because they have a lot to lose. Dentists
have pride, reputation, money and liability on the line. To admit that they have mistakenly been using a harmful substance
to treat tooth decay for many years is a very difficult confession to makeand its fraught with extremely serious consequences.
Dr. Williamson is most outspoken about the scientific and ethical issues of the mercury question. When will dentists
reach the point where theyll say, Were not going to put poison in peoples mouths any longer? The science is blatantly overwhelming
that mercury amalgams leak toxic vapors. The irony is that dentists who place the compound in peoples mouths do not treat
it like a toxic substance. In fact, leftover amalgam must be disposed of according to strict EPA guidelines.
More
importantly, says Dr. Williamson, there are studies from world renowned institutions that categorically show a cause-and-effect
relationship between mercury and disease; this is particularly true of Alzheimers disease. Mercury is a cytotoxini.e. it poisons
cells. Why wouldn't it make you sick?
Many researchers have reasoned as much over the years but they never had the
scientific ammunition to overcome the arguments of organized dentistry in favor of mercury amalgam. But in 1991, Boyd Haley,
Ph.D., a research toxicologist at the University of Kentucky in Lexington discovered some hard evidence that changed the mercury
debate for good.
It was almost accidental, Dr. Haley told Life Extension. I found out how damaging mercury amalgam
is to the brain while studying tissue affected by Alzheimers disease.
The basic research I conducted shows the difference
between normal and diseased tissue. My own examination of Alzheimers affected cells told me there had to be a toxicanta toxic
substance that causes it. So I went searching for one. I identified two environmental sources that could be responsible: Cadmium,
mainly found in cigarette smoke, and mercury. Dr. Haley published his results. Then, the anti-amalgam lobby got in touch with
him and told him that dentists were putting stuff in peoples mouths that leaks mercury.
Frankly, I thought they were
nuts, says Dr. Haley. No way would anybody, let alone responsible health care professionals, put people at serious risk by
putting a toxic substance in their bodies, I reasoned.
But I did an experiment. I put mercury amalgam in water. Then,
I placed a sample of brain tissue in that water and checked on it over time. After a period of several weeks, I noticed that
the exposure to mercury had suppressed the secretion from the brain tissue of tubulina major enzyme that performs critical
functions in the brain. This finding was consistent both with mercury toxicity and with brain tissue as affected by Alzheimers
disease.
Dr. Haley continues: From that, I concluded that theres clearly leakage from mercury amalgamand that theres
a strong probability that people who have such fillings in their teeth are being exposed to chronic, low-dose mercury leakage.
According to Dr. Haley, having a mouthful of mercury from age 14 until age 65 and beyond would greatly increase risk in anyone
susceptible to Alzheimers disease.
Needless to say, dentists do not welcome Dr. Haleys views. They insist mercury
amalgam is safe, non-toxic and that it doesnt leak. [But the fact of the matter is that] mercury is a neurotoxin. It leeches
out of dental fillings, of that there is no doubt. Anybody can measure it. It heightens the risk of Alzheimers and Parkinsons
disease as well as other neurolgical disorders. Dentists defend their use of mercury amalgam, but its unjustifiable. I feel
like I've been arguing with the town drunk for eight or nine years. My conclusion is simple and direct: mercury is the toxicant
behind Alzheimers disease. It may not be the only one, but mercurys role in the development of Alzheimers disease is clear.
Dr. Williamson applauds Prof. Haleys impeccable science and says his findings establish a straight cause-and-effect
relationship. But from his perspective as a clinician, he believes the Alzheimers disease connection is only the tip of the
iceberg.
The list of problems mercury vapor can cause is endless. There is an extremely high incidence of depression,
memory loss and behavioral problems including violent outbursts that can be explained by exposure to mercury vapor, Dr. Williamson
told Life Extension.
He says that mercury toxicity also produces systemic effects, from foul breath and ringing in
the ears to general fatigue or unexplained numbness or burning sensations that may be related. Most disturbingly, Dr. Williamson
points out, is the evidence linking mercury vapor exposure to the development of chronic kidney disease and autoimmune disorders
such as arthritis, lupus erythematosus (LE), multiple sclerosis (MS), scleroderma, amyotropic lateral sclerosis (ALS) and
hypothyroidism.
The real point is this: mercury is toxic. And that statement is now beyond debate. According
to Dr. Williamson, The World Health Organization (WHO) states that there is no safe level of mercury in humans that does not
kills cells and harm body processes. Floridas environmental regulatory agency notes that one mercury filling from one tooth
thrown into a lake is enough to contaminate that lake for fishing and swimming. Dentists have consistently denied that mercury
amalgam is dangerous, but, says Dr. Williamson, that position is simply wrong. We wont spend a lot of time analyzing why dentists
have maintained this mistaken position, but mistaken it is.
The American Dental Association, which for so long has
promoted the use of mercury amalgams, has recently divested itself of any culpability with regard to mercury. In a case before
the Superior Court of the State of California, lawyers for The ADA and others stated: The ADA owes no legal duty of care to
protect the public from allegedly dangerous products used by dentists. The ADA did not manufacture, design, supply or install
the mercury-containing amalgams. The ADA does not control those who do. The ADAs only alleged involvement in the product was
to provide information regarding its use. Dissemination of information relating to the practice of dentistry does not create
a duty of care to protect the public from potential injury.
Dr. Williamson goes on to make an observation: Now, an
obvious question arises: if mercury were safe, as the dental profession has insisted for years, why would the American Dental
Association feel obligated to claim nobody can hold it responsible for the harm it has caused? Their statement is just a way
of saying, the stuff's dangerous, but don't blame us if it hurts you.
In their practice at the Toxic Studies Institute,
Drs. Williamson and Davis see every day the ways in which mercury makes people sick. And responsible individuals and
organizations are catching on to this fact.
The American Academy of Pediatrics has called for a moratorium on the
use of mercury (Thimerosal) in vaccines, says Dr. Williamson. The Academys action is laudable. One local gynecologist is counseling
her patients about eating fish during pregnancy. She is rightly concerned about mercury intake from fish, which goes directly
to the fetus, and we applaud her for recognizing the hazards mercury poses to the developing fetus. However, mercury-contaminated
fish and Thimerosal in vaccinations barely scratch the surface of the overall problem. The great majority of the body-burden
of mercury 87% comes from dental amalgams, which continuously give off mercury vapor.
According to Dr. Williamson,
themercury accumulates in the tissue and leads to increased oxidative damage, mitochondrial dysfunction and cell death. This
is toxic to anyone, he says, but especially to mothers-to-be and most of all to the developing fetus via rapid placental transfer.
The fetal pituitary glandwhich affects development of the endocrine, immune and reproductive systemsconcentrates mercury.
Dr. Williamson says that, most notably, mercury decreases transport to the fetus of oxygen and essential nutrients,
including amino acids, glucose, magnesium, zinc and vitamin B12. It also depresses the enzyme Isocitric Dehydrogenase in the
fetus. This suppression in turn causes reduced iodine uptake and hypothyroidism, learning disabilities and impairment and
reduction in IQ. Mercury is also strongly associated with behavioral disorders, autism and autistic spectrum disorders, including
attention deficit disorder. Further, mercury exposure affects levels of nerve growth factor in the brain, impairs astrocyte
function and causes brain developmental imbalances.
All of these problems and events can be compounded 10-fold, he
says, if a pregnant woman should have mercury amalgam placed in her teeth or removed from them during the first trimester
of pregnancy. And dental work of any kind is worse in the first trimester than in the second or third. The level of mercury
in the tissue of the fetus, newborn and young children is directly proportional to the number of amalgam surfaces in the mothers
mouth. Inorganic mercury methylated in the mouth by microorganisms to organic mercury is the most acutely neurotoxic form.
Dr. Williamson adds that mercury from dental amalgams is often stored in breast milk in much greater concentrations
than in the mothers tissuesand the amount of mercury in breast milk is likewise directly proportional to the number of amalgams
the mother has in her mouth. Heavy metal toxicity in general, and mercury toxicity in particular, can have a very damaging
effect on fertility. Mercury amalgams in teeth have been associated with a host of female complaints, but especially difficulty
conceiving, outright sterility and spontaneous abortions (miscarriages). Likewise, sperm count and motility in males can be
greatly lowered.
Again, Dr. Williamson: Think of it like this: mercury amalgams are a mere two centimeters away from
the pituitary gland. Vapor from these amalgams has an affinity for this gland in high concentrations. The effect of these
vapors on this gland can bring about hormonal disruptions and menstrual cycle disorders. When mercury burdens are decreased
or eliminated, menstrual cycles normalize and spontaneous pregnancies notably increase.
Dr. Williamson suggests that
people who already have mercury amalgams should avoid hot beverages and chewing gumboth of which stimulate the release of
mercury vapor. Anybody who has mercury fillings and suffers from bruxismgrinding their teeth in their sleepshould be evaluated
for treatment.
When they go to dental hygienists, mercury amalgams should not be polished. We also recommend against
dental appliances such as braces when patients have mercury amalgams in their teeth.
In addition to intensive detoxification
and mercury amalgam removal, there is another protective step people can take, Dr. Williamson noted. Since we know that mercury
is an extremely potent oxidant and serves to damage and kill cells, we recommend individuals make it a point to have high
levels of natural mercury chelators or detoxifiers in their bodies. Two very important substances are vitamin C and glutathione:
we give these to our patients in very high doses to assist with mercury detoxification. And we also use mercury-free, organic
Chlorella.
On a preventive basis, they strongly urge parents not to have mercury amalgams placed in their childrens
teeth. Many safe, bio-compatible materials are available to use for filling cavities in place of mercury amalgams.
In
case anyone still wants to defend the safety record of mercury, lets consider the harmful effects in has on dentists, dental
office personnel and their familiesits overwhelming, said Dr. Davis.
Dentists and dental personnel who work with amalgam
are chronically exposed to mercury vapor. Mercury levels in urine of dental personnal average about two times that of controls.
Walking into the average dental office can result in a mercury exposure thats approximately equivalent to having 19 amalgam
fillings.
Dr. Davis points out that mercurys burden on the body increases with age, and older dentists have median
mercury urine levels about four times those of controls, as well as higher brain burdens. Dentists and dental personnel experience
significantly higher levels of neurological, memory, mood and behavioral problems, which increase with years of exposure.
Female dental technicians who work with amalgam have significantly reduced fertility and lowered probability of conceptionand
their children have significantly lower average IQ compared to the general population.
Further, the homes of many
dentists have been found to have high levels of mercury contamination, probably caused by the dentists bringing it home on
shoes and clothes. Autopsies of former dental staff have found levels of mercury in the pituitary gland that averaged more
than 10 times greater than that of controlsand also found higher levels in the occipital cortex, renal cortex and thyroid.
And it gets even more grim. Dentists have the highest rate of suicide of any profession. They also suffer a high incidence
of depression and memory disorders. According to Dr. Davis, A large number of dentists wind up being placed on permanent disabilityand
frequently carry a nebulous diagnosis of non-specific neurological disorder, which we believe is mercury toxicity, plain and
simple.
The scientific truth is beginning to register with governments around the world and in the United States.
In Sweden, it is against the law to use mercury amalgams. In Canada, Health Canadathe national health insurance systemhas
urged the nations dentists to stop giving mercury amalgam to children, pregnant woman and people with kidney disorders.
In
late 1999, the California Dental Boardthe largest in the country termed the mercury in amalgam hazardous, and advised dentists
to issue warnings about the reproductive toxicity of mercury and other adverse reactions. And in the summer of 2000, a judge
in Maryland ruled that the state agency that regulates dentistry violated the law by prohibiting dentists from discussing
the risks of amalgam with their patients.
Finally, if you have mercury fillings and are worried about mercury poisoning,
what should you do? The first thing you have to recognize is that you have a medical problem. Says Dr. Davis: You may carry
a traditional diagnosis for your health problem(s) but the diganosis or diagnoses may have a strong non-traditional link to
the mercury in your mouth.
The bottom line is that multiple signs and symptoms may be present in multiple organs,
the manifestations of which can be overt or occult. This is why a trained medical doctor with special knowledge in heavy metals
toxicity should be consulted to thoroughly evaluate your history and each of your bodys organ systems.
Eventually,
you will need a dentist to remove your fillings, but first, you need a medical evaluation to see how much mercury is stored
in your tissues, and how much toxicity youre suffering. You will need to know how well your kidneys are functioning before
any treatments or mercury removal may safely take place.
Dr. Davis points to some of the tests medical doctors use
in cases like this, which include The DMPS challenge, which stimulates the binding and elimination of a portion of stored
mercury, which is then measured by a urinary excretion count; the creatinine clearance test, to measure kidney function (which
mercury can severely compromise). This test can help determine which substances can be safely used for mercury detoxification,
or even to tell if the kidneys can safely tolerate mercury detoxification. Other tests commonly employed are the H-Scan, which
measures visual reaction time, vibrotactile sensitivity, muscle movement time, decision-making ability and memory function.
Dr. Davis states, After those tests, you may require a medical detoxification of heavy metals generally, and mercury
specifically, both before and after having your mercury amalgams removed. Medical doctors, not dentists, administer medicinal
compounds that bind heavy metals and cause them to be eliminated from the body via the renal or fecal routes, separately or
together. We use DMPS intravenously and oral DMSA.
Finding a dentist to perform the procedure can be trying. Chances
are your family dentist will volunteer, but odds are he or she will not be suited for the job. Removing amalgams has become
a speciality unto itself. Dentists who perform this work often bear the qualifiers, Mercury-Free, or Biologic Dentist. They
have had special formal training in mercury amalgam removal and have special equipment on hand in their offices to reduce
dangerous mercury vapor exposure during the removal process for patients, themselves and other dental personnel. Simply yanking
out fillings can release extremely high levels of mercury vapor, which goes directly into tissue, and is stored, or sequestered.
During the removal process, a certain amount of vapor contamination is going to take place. But a properly trained
biologic dentist can keep this hazard to a minimum.
MERCURY DETOXIFICATION PROTOCOL
To treat patients for
mercury overload, doctors prescribe a variety of nutrients and drugs to chelate mercury out of the body and protect cells
from the effects of the large amounts of free mercury being released into the bloodstream for urinary excretion. It is especially
important to initiate this protocol at least two weeks before mercury dental fillings (amalgams) are to be removed.
What
follows is a 33-day mercury detoxification protocol used by many alternative medicine doctors.
For weeks one and two, the following nutrients
should be taken:
NUTRIENT DOSE N-Acetyl-Cysteine (NAC) 600 mg twice a day Alpha Lipoic Acid 250 mg two times
a day Glutathione 250 mg twice a day Glycine 500 mg twice a day Vitamin C 5,000 to 10,000 mg a day Vitamin
E 400 to 800 IU a day MSM (methylsulphonyl methane) 1000 mg twice a day Garlic (high-allicin form such as Pure Gar)
Avoid if offensive odor becomes a social problem. 900 mg a day Cilantro (Chinese parsley)Stop using Cilantro after two
weeks or on the day that mercury chelation therapy begins during the third week. 1 drop, rubbed on to the wrist two times
a day Chlorella - may cause diarrhea, so starting off at the lower dose is important. 1500 to 3000 mg a day for the first
14 days. On days 13-33 increase to 7000 to 8000 mg a day. Selenium - Avoid selenium for the 19 days of Chemet therapy
that begins in the third week. 200 mcg Multi-vitamin - If Life Extension Mix were used, it would provide some of the individual
nutrients recommended above. Note: Health conscious people are already taking many of these natural mercury chelating
and glutathione-enhancing nutrients.
Starting at week three, continue taking all of the above nutrients except selenium
and cilantro and initiate treatment with the drug Chemet using the following dose:
First five days Days six through
nineteen Chemet (DMSA)(meso-2,3-dimercaptosuccinic acid)100 mg every eight hours 100 mg every twelve hours
Chemet
(DMSA) is a sulfhydryl-containing, water-soluble, non-toxic, orally-administered metal chelator which has been in use as an
antidote to heavy metal toxicity since the 1950s. More recent clinical use and research substantiates this compounds efficacy
and safety, and establishes it as the premier metal chelation compound, based on oral dosing, urinary excretion, and its safety
characteristics compared to other chelating substances. Chemet is a prescription drug.
In lieu of oral Chemet therapy,
some doctors prefer to use intravenous mercury chelation therapy which is described later in the protocol.
Blood and
urine testing
Before initiating this 33-day mercury detoxification protocol, doctors suggest that a CBC-Chemistry
blood test be performed that includes kidney-liver-thyroid function, lipids and magnesium. Of greatest concern is potential
kidney toxicity that can occur when the body releases its mercury stores for excretion through the kidneys. Those with underlying
kidney disease may not be able to undergo aggressive mercury detoxification therapy.
The only proven method of diagnosing
mercury overload in the body is a 24 hour urine collection. This involves a laboratory sending you a urine collection bag
for you to urinate in over a 24 hour period. If urine mercury levels are elevated, the 33-day protocol is advised. At the
end of the 33-days, another 24-hour urine collection is recommended to verify that sufficient mercury detoxification has really
occurred.
Intravenous mercury chelation therapy
Some doctors aggressively treat mercury overload with intravenous
therapy designed to specifically chelate mercury from the body. The chelating agent used to remove mercury from the body is
called DMPS (dimercapto-propanyl-sulfate). In addition to DMPS, doctors often add ten grams of vitamin C and other nutrients
to further help detoxify the body and protect cells during this mercury removal process.
It is important to note that
while standard chelation therapy using EDTA (ethylene diamine tetra acidic acid) removes calcium and lead, it does not adequately
bind to and remove mercury.
Intravenous therapy using DMPS may involve six monthly visits to the doctors office until
a urine test shows that mercury levels have dropped to the safest possible level.
Drug and supplement availability
Intravenous therapies are available from physicians who specialize in mercury detoxification therapy. Chemet is a
prescription drug sold at most pharmacies. Nutrients such as cilantro, chlorella, alpha lipoic acid, etc. are available from
The Life Extension Buyers Club.
The need for professional expertise
When undergoing mercury detoxification
therapy, using a doctor with particular expertise in this field provides the greatest assurance of a safe and effective outcome.
At the end of this article, we have provided contact information for Dr. Williamsons clinic in Boca Raton, Florida. Dr. Williamson
expects to practice at the new Life Extension Medical Center (Institute of Anti-Aging Medicine) in Ft. Lauderdale, FL. (1-888-710-5433).
For a list of alternative physicians in your area that may be knowledgeable about mercury detoxification, refer to
the Innovative Physician section on The Foundation's Home Page at www.lef.org. It is important to note that not all of these
doctors have expertise in mercury detoxification.
Undergoing complete mercury detoxification requires strict adherence
to an individualized regimen of diet modification, supplements, drugs, multiple physician visits, blood-urine tests, etc.
For more detailed information about what is involved in mercury detoxification, refer to the Life Extension Abstracts section.
************************************************************ Mercury Connected to Neuro Problems Source:
http://www.medscape.com/reuters/prof/2000/07/07.12/20000712plcy002.html By Steve Mitchell WASHINGTON,
Jul 12 (Reuters Health) - Although the US environmental Protection Agency's threshold level of exposure for methylmercury
appears to be protective for most people, the level may not be low enough to reduce the risk of neurologic damage during
prenatal development, according to a report issued Tuesday by the National Academy of Sciences' National Research Council.
The report suggests that children born to women who consumed large amounts of fish and seafood during pregnancy
may be at an increased risk of neurologic problems. "Although we believe EPA's guideline on methylmercury
is generally adequate to protect most people....we need to better understand how this chemical affects brain development
in fetuses and children," Dr. Robert A. Goyer, from Chapel Hill, North Carolina, chair of the committee that wrote the
report, said in a press release. The committee's report estimates that 60,000 children may be born in the US each
year with neurologic problems due to exposure to methylmercury in utero. An EPA spokesperson told Reuters Health that this
"is unacceptable." However, the agency representative maintained that the report "strongly confirms the protective
level that EPA uses," which is a threshold of 0.1 micrograms per kilogram of body weight per day. There
is evidence to suggest that methylmercury also may affect the cardiovascular and immune systems, the report notes. The possibility
of damage to these systems during prenatal exposure "is of some concern," committee member Dr. David C. Bellinger
of Harvard Medical School told Reuters Health. "The committee would like to see additional research focused on this,"
he said. Dr. Bellinger noted that the committee's findings support the level set by the EPA. As for whether the
report could result in a lowering of the exposure threshold level for pregnant women, he said that that "is really a
policy call." The report calls for additional research in several areas in relation to methylmercury exposure.
Dr. Goyer suggested that "trends in methylmercury exposure including regional differences should be analyzed, as should
subpopulations whose diets are high in fish and seafood." The committee's report requests further investigation
into the carcinogenic, reproductive and immunologic effects of life-long exposure to low-dose methylmercury. It also calls
for more research on individual variance, such as genetic makeup, age, sex, health and nutrition, that may affect response
to exposure. Dental fillings are a source of mercury that "needs to be looked at more closely," Dr.
Bellinger said. There is a "fair bit of evidence that the level of mercury in fillings could be substantial for some
people," he added. In conjunction with the mercury exposure obtained by consuming fish, dental fillings may be associated
with adverse events, he said. In regard to how the report will affect the EPA's decision to control mercury emission
from the largest source of mercury air pollution in the US, coal-fired power plants, as it is required to do under the Clean
Air Act, the agency spokesperson would only say that it will make that decision by the end of the year. The EPA
representative noted that "the Clinton-Gore administration already has taken several major actions to significantly reduce
mercury releases into the environment, including controls on municipal waste combustors and hazardous waste and medical waste
incinerators."
************************************************************ Mercury Fact Sheet Source: http://www.atsdr.cdc.gov/tfacts46.html
Agency for Toxic Substances and Disease Registry This fact sheet answers the most frequently asked health
questions about mercury. For more information, you may call the ATSDR Information Center at 1-888-422-8737. This fact sheet
is one in a series of summaries about hazardous substances and their health effects. This information is important because
this substance may harm you. The effects of exposure to any hazardous substance depend on the dose, the duration, how you
are exposed, personal traits and habits, and whether other chemicals are present. HIGHLIGHTS: Exposure to mercury
occurs from breathing contaminated air, ingesting contaminated water and food, and having dental and medical treatments. Mercury,
at high levels, may damage the brain, kidneys, and developing fetus. This chemical has been found in at least 714 of 1,467
National Priorities List sites identified by the Environmental Protection Agency. What is mercury? Mercury
is a naturally occurring metal which has several forms. The metallic mercury is a shiny, silver-white, odorless liquid. If
heated, it is a colorless, odorless gas. Mercury combines with other elements, such as chlorine, sulfur, or
oxygen, to form inorganic mercury compounds or "salts," which are usually white powders or crystals. Mercury also
combines with carbon to make organic mercury compounds. The most common one, methylmercury, is produced mainly by small organisms
in the water and soil. More mercury in the environment can increase the levels of methylmercury that these small organisms
make. Metallic mercury is used to produce chlorine gas and caustic soda and also used in thermometers, dental
fillings, and batteries. Mercury salts are used in skin-lightening creams and as antiseptic creams and ointments.
What happens to mercury when it enters the environment? Inorganic mercury (metallic mercury and inorganic
mercury compounds) enters the air from mining ore deposits, burning coal and waste, and from manufacturing plants. It enters
the water or soil from natural deposits, disposal of wastes, and volcanic activity. Methylmercury may be formed in water and
soil by small organisms called bacteria. Methylmercury builds up in the tissues of fish. Larger and older fish tend to have
the highest levels of mercury. How might I be exposed to mercury? Eating fish or shellfish contaminated
with methylmercury. Breathing vapors in air from spills, incinerators, and industries that burn mercury-containing fuels.
Release of mercury from dental work and medical treatments. Breathing contaminated workplace air or skin contact during use
in the workplace (dental, health services, chemical, and other industries that use mercury). Practicing rituals
that include mercury. How can mercury affect my health? The nervous system is very sensitive to
all forms of mercury.Methylmercury and metal vapors are more harmful than other forms, because more mercury in these forms
reaches the brain. Exposure to high levels of metallic, inorganic, or organic mercury can permanently damage the brain, kidneys,and
developing fetus. Effects on brain functioning may result in irritability, shyness, tremors, changes in vision or hearing,
and memory problems. Short-term exposure to high levels of metallic mercury vapors may cause effects including
lung damage, nausea, vomiting, diarrhea, increases in blood pressure or heart rate, skin rashes, and eye irritation.
How likely is mercury to cause cancer? There are inadequate human cancer data available for all forms of
mercury. Mercuric chloride has caused increases in several types of tumors in rats and mice, while methylmercury increased
kidney tumors in male mice. The EPA has determined that mercuric chloride and methyl mercury are possible human carcinogens.
How can mercury affect children? Very young children are more sensitive to mercury than adults.
Mercury in the mother's body passes to the fetus and can pass to a nursing infant through breast milk. However, the benefits
of breast feeding may be greater than the possible adverse effects of mercury in breast milk. Mercury's harmful
effects that may be passed from the mother to the developing fetus include brain damage, mental retardation, and incoordination,
blindness, seizures, and an inability to speak. Children poisoned by mercury may develop problems of their nervous and digestive
systems and kidney damage. How can families reduce the risk of exposure to mercury? Carefully handle
and dispose of products that contain mercury, such as thermometers or fluorescent light bulbs. Do not vacuum up spilled mercury,
because it will vaporize and increase exposure. If a large amount of mercury has been spilled, contact your health department.
Teach children not to play with shiny, silver liquids. Properly dispose of older medicines that contain mercury.
Keep all mercury-containing medicines away from children. Pregnant women and children should keep away from rooms
where liquid mercury has been used. Learn about wildlife and fish advisories in your area from your public health
or natural resources department. Is there a medical test to show whether I've been exposed to mercury?
Tests are available to measure mercury levels in the body. Blood or urine samples are used to test for exposure to metallic
mercury and to inorganic forms of mercury. Mercury in whole blood or in scalp hair is measured to determine exposure to methylmercury.
Your doctor can take samples and send them to a testing laboratory. Has the federal government made recommendations
to protect human health? The EPA has set a limit of 2 parts of mercury per billion parts of drinking water (2
ppb). The Food and Drug Administration (FDA) has set a maximum permissible level of 1 part of methylmercury in
a million parts of seafood (1 ppm). The Occupational Safety and Health Administration (OSHA) has set limits of
0.1 milligram of organic mercury per cubic meter of workplace air (0.1 mg/m³) and 0.05 mg/m³ of metallic mercury vapor for
8-hour shifts and 40-hour work weeks. Source of Information Agency for Toxic Substances and Disease Registry
(ATSDR). 1999. Toxicological profile for mercury. Atlanta, GA: U.S. Department of Health and Human Services, Public Health
Service. Animal testing is sometimes necessary to find out how toxic substances might harm people and how to
treat people who have been exposed. Laws today protect the welfare of research animals and scientists must follow strict guidelines.
Where can I get more information? ATSDR can tell you where to find occupational and environmental health
clinics. Their specialists can recognize, evaluate, and treat illnesses resulting from exposure to hazardous substances. You
can also contact your community or state health or environmental quality department if you have any more questions or concerns.
For more information, contact: Agency for Toxic Substances and Disease Registry Division of
Toxicology 1600 Clifton Road NE, Mailstop E-29 Atlanta, GA 30333 Phone: 1-888-422-8737 FAX: 404-639-6359
U.S. Department of Health and Human Services Public Health Service Agency for Toxic Substances and
Disease Registry
Autism-Mercury support/discussion list at Yahoo Groups. A great support list that discusses current issues related to the
increasing incidence of autism and the potential link between excessive mercury exposure via thimerosal in infant vaccines.
Click anywhere on this text to send an e-mail to the moderator to request subscription.
EXEMPTIONS FROM CHILDHOOD IMMUNIZATION REQUIREMENTS |
|
By: John Kasprak, Senior Attorney |
You
asked for information on state laws exempting children from immunization requirements for medical, religious, and philosophical
reasons. You are interested in any available information concerning the number of individuals taking such exemptions, including
any trends.
SUMMARY
Although
exemptions vary from state to state, all school immunization laws grant exemptions to children for medical reasons, according
to the National Conference of State Legislatures (NCSL). Every state, except Mississippi and West Virginia, exempts individuals
who have religious beliefs against immunization. Such exemptions are intended for those whose religious beliefs would be infringed
if the state forced them to have their children vaccinated.
With
the recent passage of laws in Texas and Arkansas, 20 states now allow exemption to vaccinations based on philosophical, personal,
or conscientiously held beliefs. In many of these states, individuals must object to all vaccines, not just a particular vaccine
in order to use the philosophical or personal belief exemption.
STATES
WITH RELIGIOUS AND PHILOSOPHICAL EXEMPTIONS FROM CHILDHOOD IMMUNIZATION REQUIREMENTS
Every
state, except Mississippi and West Virginia, grant religious exemptions to individuals for religious beliefs. A "religious
exemption" generally means that a provision in state statute allows parents to exempt their children from immunization if
it contradicts their sincere religious beliefs. Twenty states now provide a philosophical exemption in their law, with Texas
and Arkansas the most recent additions to this list with passage of legislation in 2003. A "philosophical exemption" suggests
that the statutory language does not restrict the exemption to purely religious or spiritual beliefs, but for example, allows
it based on "moral, philosophical or other personal beliefs" (Maine) or in some cases, based simply on the individual's (parents')
beliefs (California).
Table
1 summarizes each state's status concerning these exemptions.
Table 1: States with Religious and Philosophical Exemptions from Childhood Immunization Requirements
State |
Religious
Exemptions |
Philosophical
Exemptions |
Alabama |
Yes |
No |
Alaska |
Yes |
No |
Arizona |
Yes |
Yes |
Arkansas |
Yes |
Yes |
California |
Yes |
Yes |
Colorado |
Yes |
Yes |
Connecticut |
Yes |
No |
Delaware |
Yes |
No |
Florida |
Yes |
No |
Georgia |
Yes |
No |
Hawaii |
Yes |
No |
Idaho |
Yes |
Yes |
Illinois |
Yes |
No |
Indiana |
Yes |
No |
Iowa |
Yes |
No |
Kansas |
Yes |
No |
Kentucky |
Yes |
No |
Louisiana |
Yes |
Yes |
Maine |
Yes |
Yes |
Maryland |
Yes |
No |
Massachusetts |
Yes |
No |
Michigan |
Yes |
Yes |
Minnesota |
Yes |
Yes |
Mississippi |
No |
No |
Missouri |
Yes |
Yes |
Montana |
Yes |
No |
Nebraska |
Yes |
Yes |
Nevada |
Yes |
No |
New Hampshire |
Yes |
No |
New Jersey |
Yes |
No |
New Mexico |
Yes |
Yes |
New York |
Yes |
No |
North Carolina |
Yes |
No |
North Dakota |
Yes |
Yes |
Ohio |
Yes |
Yes |
Oklahoma |
Yes |
Yes |
Oregon |
Yes |
No |
Pennsylvania |
Yes |
No |
Rhode Island |
Yes |
No |
South Carolina |
Yes |
No |
South Dakota |
Yes |
No |
Tennessee |
Yes |
No |
Texas |
Yes |
Yes |
Utah |
Yes |
Yes |
Vermont |
Yes |
Yes |
Virginia |
Yes |
No |
Washington |
Yes |
Yes |
West Virginia |
No |
No |
Wisconsin |
Yes |
Yes |
Wyoming |
Yes |
No |
District of Columbia |
Yes |
No |
Source:
NCSL State Legislative Report, August 2002, updated 2004; chart taken from "School Vaccination Requirements, Legal and Social
Perspectives," James G. Hodge, Jr.
INDIVIDUAL
STATE LAWS
Following
is more detail on selected states' exemption policy.
California
In
California, a parent must submit a letter or affidavit to the governing authority stating that the immunization is contrary
to his or her beliefs (Calif. Health and Safety Code, § 120365). "Governing authority" refers to the governing board of each
school district or the authority of each public or private institution responsible for the operation and control of the institution.
But under state law, whenever there is good cause to believe that the person has been exposed to a communicable disease, that
person may be temporarily excluded from the institution until the local health officer is satisfied that the person is no
longer at risk of developing the disease.
Maine
Under
Maine law, in order to claim a religious or philosophical exemption the parent must "state in writing a sincere religious
belief which is contrary to the immunization requirement... or an opposition to the immunization for philosophical reasons"
(Maine Revised Statutes, § 6359).
Michigan
A
child is exempt from Michigan's immunization requirements "if a parent, guardian, or person in loco parentis of the child
presents a written statement to the administrator of the child's school or operator of the group program to the effect that
the requirements of this part cannot be met because of religious convictions or other objection to immunization" (Michigan
Code, § 333. 9215).
Minnesota
A
child is exempt from vaccinations in Minnesota if a notarized statement signed by the minor child's parent is submitted to
the person supervising the school or child care facility stating "that the person has not been immunized as prescribed...because
of the conscientiously held beliefs of the parent or guardian of the minor child .... (Minn. Stats. § 121A. 15).
Texas
A
new Texas law took effect September 1, 2003 that allows an exemption to immunization requirements for reasons of conscience,
including religious beliefs (HB 2292). School officials may grant such exemptions provided the parent or guardian submits
an official Texas Department of Health affidavit to the school.
Vermont
A
person can be exempt from Vermont's immunization requirements "if the person, or in the case of a minor the person's parent
or guardian states in writing that the person, parent or guardian has religious beliefs or moral convictions opposed to immunization"
(Vermont stats. § 1122).
Wisconsin
Under
Wisconsin law, the immunization requirement is waived "if the student, if an adult, or the student's parent, guardian or legal
custodian submits a written statement to the school, day care center, or nursery school objecting to the immunization for
reasons of health, religion or personal conviction. At the time any school, day care center, or nursery school notifies a
student, parent, guardian or legal custodian of the immunization requirements, it shall inform the person in writing of the
person's right to a waiver" (Wisc. Stat. § 252. 94).
NUMBERS,
TRENDS CONCERNING EXEMPTIONS TO IMMUNIZATION
According
to the federal Centers for Disease Control (CDC), almost 38,000 children were exempted from receiving the usual round of childhood
immunizations in the most recently reported year (see Mitchell, "Parents Opting Out of Vaccines for Kids, UPI, November 13,
2003). Nearly half of that total was exempted for religious reasons. States experiencing a dramatic increase in exemptions
include Colorado, Oregon, Washington, and Michigan (Oregon is the only one of these four without a philosophical exemption
but it does have a religious exemption). Colorado, which has the lowest vaccination coverage rate in the country, has seen
a significant increase in exemption rates, from 0. 3% of kindergartners to 3% over a 10-year period. Michigan's exemption
rate is almost 6%, or more than 7,500 kindergarten-aged children. Washington's exemption rate has increased from 3. 4% of
kindergarten-aged children five years ago to a current level of 4. 1% (about 2,400 children).
Oregon's
number of exemptions has doubled since 1999, with the bulk of this due to an increase in religious exemptions. In particular,
Ashland, a small city in Jackson County, Oregon, has a high rate of religious exemptions. In school year 2000-2001, 11% of
school children in Ashland had a religious exemption to vaccination, compared to 3% for all of Jackson County and 2. 7% for
the state.
According
to the article cited above, exemption rates range from 1% to 2. 8% for several other states, including Arizona, California,
Idaho, Indiana, Maine, Minnesota, Montana, Pennsylvania, Rhode Island, Utah, Vermont, and Wyoming.
Source: http://www.cga.state.ct.us/2004/olrdata/ph/rpt/2004-R-0263.htm
*********************************
Vaccine Injury Claims Face Grueling
Fight
Victims increasingly view U.S. compensation program as adversarial and
tightfisted.
By Myron Levin Times Staff Writer
November 29, 2004
Like good moms everywhere, Janet Zuhlke made sure
her kids got their shots.
This proved disastrous for her daughter, Rachel. She was a healthy 5-year-old until a brain
injury triggered by a routine vaccination left her mentally retarded, physically handicapped and legally blind.
A single
mother raising three daughters in Satellite Beach, Fla., Zuhlke needed help with the enormous costs of Rachel's lifetime care.
So she brought a case in a federal tribunal set up to handle vaccine injury claims.
There, opposing lawyers hired expert
witnesses to prove that Rachel's injuries weren't vaccine-related. When that failed, they balked at paying for costly medicines
her doctors said she badly needed.
The Zuhlkes finally won — but it took more than 10 years.
"I thought
it was very cruel," Zuhlke said. "People were very aware of the fact that my family was suffering."
The lawyers who
opposed the Zuhlkes were not working for a vaccine company but the Justice Department. Government attorneys fought relentlessly
to defeat a mother who thought she was doing the right thing by getting her daughter a government-mandated vaccine.
It
wasn't supposed to happen that way in the Vaccine Injury Compensation Program, informally known as the vaccine court. Created
by Congress and jointly run by the Department of Health and Human Services, the Justice Department and the U.S. Court of Federal
Claims, it was designed to shield vaccine makers from damage awards that were threatening to drive them from the business.
It also was supposed to compensate victims in rare cases of injury under a flexible, no-fault system that would avoid
the rancor and delay of traditional litigation. Claims were to be handled "quickly, easily and with certainty and generosity,"
said a House report accompanying the legislation in 1986.
Instead, say advocates for families with injury claims, federal
officials often fight them with such zeal that many who deserve help are denied it, and even successful cases get bogged down
for years.
The program "was supposed to be non-adversarial and it's become very adversarial," said Rep. Dan Burton
(R-Ind.), whose House Subcommittee on Human Rights and Wellness has held hearings on the matter. Many have "had legitimate
claims and they went on for eight, nine, 10 years."
Vaccine compensation officials refused to be interviewed, but in
written statements they said the program had "an excellent record of promptly and appropriately compensating" valid claims.
Over
the years, about $1.5 billion has been paid out in compensation and legal fees for more than 1,800 families, most of which
would have had little chance of winning a civil trial, the officials said. They insisted that the vaccine court was less adversarial
than civil courts, but said they were obliged to fight claims that weren't based on good science.
This was "never intended
to serve as compensation source for … conditions that are not vaccine-related," said Joyce Somsak, the program's acting
director.
But in trying to weed out undeserving claims, critics say, the government has insisted on a level of proof
of injury that is almost impossible to meet.
And a Times analysis of claims data shows that the court has become more
unyielding over time: Officials are much less likely than in earlier years to concede that a vaccine was responsible for an
injury or death. The percentage of people getting awards also has declined.
Even when families do win compensation, officials have sometimes battled them over just a few dollars.
In
one case, government representatives argued that $150 a year was too much to spend on wheelchair maintenance. They have haggled
over how much to allow for replacement shoes and braces for people with polio. Another time, they recommended rubber sheets
for the bed of an incontinent person because they were cheaper, although less comfortable, than disposables costing $135 a
year.
"We never anticipated the extent [they] would go to deny these kids compensation," said Barbara Loe Fisher of
the National Vaccine Information Center, who lobbied for the bill that created the program.
Viewed another way, by
being tightfisted, officials have been good stewards of the vaccine injury trust fund, the self-insurance pool that pays awards
to the injured. In fact, the fund — fed by a surcharge of 75 cents per vaccine dose — has ballooned to more than
$2 billion, while earning about as much in annual interest as it pays in awards.
But the fund was not meant to be a
moneymaker. The idea was that it was better to "err on the side of compensating the victim," said Rep. Henry Waxman (D-Los
Angeles), sponsor of the legislation.
Roots
of the Program
Along with clean water and sanitation, mass immunization ranks among the great milestones in public
health. Among its glittering achievements: Measles cases in the U.S. dropped from about half a million in 1960 to 42 last
year, according to the Centers for Disease Control and Prevention, or CDC.
But although millions benefit, even the
safest vaccines aren't safe for everyone.
Because of genetic differences, some people are harmed by vaccines "that
almost everybody else responds to just fine," said Dr. Robert W. Block, former chairman of a federal advisory panel on childhood
vaccines.
And some have paid a terrible price. For example, until 2000, when the U.S. switched from the oral live
polio vaccine to inactivated polio shots, the vaccine itself caused a few polio cases each year.
Gordon Pierson, a
12-year-old in Jackson, Tenn., contracted polio as an infant this way and is paralyzed and unable to speak.
"We were
doing what we thought was best for our son, and the exact opposite happened," said his father, Randy Pierson. "We were just
heartbroken, and we are every day."
Fear of legal fallout inspired the National Vaccine Injury Compensation Act. At
the time, vaccine makers were facing a surge in claims, mainly from adverse reactions to the diphtheria-pertussis-tetanus,
or DPT, vaccine. An exodus from the market and shortages seemed possible. In response, Congress decreed that instead of suing
vaccine makers, people would first have to seek compensation from the new vaccine court.
Health and Human Services
officials would administer the trust fund and screen petitions, deciding whether to concede or oppose each claim. Justice
Department lawyers would appear in court on their behalf.
Petitioners could not seek awards for punitive damages or
losses to family members as they could in civil court. But they were to benefit from greater speed and flexibility, and a
lower burden of proof. Moreover, the program typically would pay petitioners' legal costs once the case was over, win or lose.
However, what was meant to be a win-win proposition instead has been mostly "a stupendous success in protecting the
industry," said George Washington University law professor Peter H. Meyers, who directs a group of law students who represent
petitioners. As for helping victims, he said, the record is "much more spotty."
Some see this as a natural result of
federal health officials' fierce devotion to the immunization program — and their fear that if enough injuries were
acknowledged, people would be afraid to get their shots.
Universal immunization is a fundamental mission of Health
and Human Services. One of its branches, the Food and Drug Administration, licenses vaccines, and another, the CDC, promotes
their use with such slogans as "Vaccination: An Act of Love."
From the start, agency officials worried that the program
might create an exaggerated public impression of the risks of vaccines. At a congressional hearing before passage of the bill,
Assistant Secretary for Health Edward N. Brandt Jr. warned that despite the program's laudable goal, it could "provide a significant
disincentive to childhood vaccination programs."
Burden
of Proof Shifts
In 1995, the government changed the rules of the vaccine court in a way that made cases more contentious,
protracted and harder for petitioners to win.
Officials amended the vaccine injury table, a set of guidelines that
had tilted many cases in petitioners' favor. According to the table, if certain symptoms appeared within a specified time
after a shot, the vaccine was deemed the culprit unless the government could prove another cause. Many "table injuries" were
simply conceded by the government, leaving only the amount of compensation to be determined.
A few amendments changed
all that. In one major shift, "seizure disorder" was scratched from the table as a telltale sign of injury from a DPT shot.
And a new, more restrictive definition of encephalopathy — or brain dysfunction — meant that many conditions that
had been table injuries suddenly were not.
Somsak said the table was changed for one reason only: to better "conform
with the scientific evidence."
But the upshot was that in many cases the burden shifted from the government to prove
the shot didn't cause injury to the petitioner to show that it did. Because it's usually hard to prove with certainty that
a vaccine caused harm, the effect of the change was profound.
The Times analyzed a vaccine court database of 10,741
claims filed over 16 years. The analysis showed that in the three years before the changes, the government conceded one-third
of all claims. Of cases filed in that period, compensation was awarded in just over half.
But since the changes took
effect March 10, 1995, the government has conceded just one claim in seven. About 35% of petitioners have received compensation.
And
cases dragging beyond five years have become increasingly common.
Even the court's top judicial officer, Chief Special
Master Gary J. Golkiewicz, has lamented the drift toward "full-blown litigation."
"Clearly," he said in one of his
rulings, "that is not what Congress intended when it designed the program as an alternative to tort litigation."
Clifford
J. Shoemaker, a lawyer for petitioners, said if the government softened its stance, the worst that would happen is that a
"family that needs some money to deal with their profoundly injured child is going to get it."
"Is that such a terrible
thing?" he asked.
Some observers have warned that the government's uncompromising attitude could backfire.
Although
the law directs all claims to vaccine court, it allows those who disagree with a ruling — or have waited more than 240
days — to sue vaccine makers in civil court. So far, few have.
But by their tough stance, officials may be inviting
more civil suits, Rep. Waxman said. "The whole idea of the compensation system is to be generous so they [petitioners] won't
want to go to court."
Lost on a Technicality
Vaccine
court officials were none too generous with Veronica Spohn.
Her parents claimed that a DPT shot caused their infant
daughter to suffer brain damage. But they lost on a technicality: Their petition was filed a few hours late.
Although
the vaccine compensation program was billed as more flexible, its three-year statute of limitations is draconian compared
with rules of civil courts in all 50 states, which place no deadlines on the filing of injury claims for minors.
In
the Spohn case, the doctor's records were a mess, alternately giving July 17 and July 19, 1992, as the date of the fateful
shot. The family's lawyer filed the petition July 18, 1995, thinking he had made the deadline with a day to spare. In fact,
he was a day late.
Seizing on the error, the Justice Department moved for dismissal. Special Master Elizabeth Wright
concurred, citing the Spohns' "failure to use due diligence in pursuing the claim."
It was "very much an injustice,"
said Veronica's mother, Karen Spohn, a nurse in Butler, Pa. "I had a normal child, and all of a sudden in one day, within
hours of the vaccine … she became a child with a disability" who is "going to need assistance for the rest of her life."
"They
didn't rule that she didn't have damage. All they did was say, you filed 12 hours too late — too bad on you."
Spohn
said she was too heartsick at that point to look into filing a civil lawsuit.
"Emotionally I couldn't deal with" continuing
the fight, said Spohn, who preferred to "accept what you're dealt with and go through life."
Lengthy Legal Battle
In the case of Dustin Barton, the government
fought so long that the Albuquerque boy did not live to see the resolution of his claim.
As an infant, he had suffered
seizures and brain damage after a DPT shot. But Dustin had a congenital neurological condition, known as periventricular leukomalacia,
that the government blamed for his injuries.
His mother, Lori Barton, filed the claim in November 1991. The case dragged
on for years. Barton told friends and family that she suspected the government was waiting for Dustin to die — noting
that it would be cheaper for the program to pay the death benefit of $250,000 than to buy an annuity to cover lifetime care.
Dustin
eventually did die of a seizure, nearly six years into the case, but the government continued to fight. Finally in May 2000,
8 1/2 years after the petition was filed, the family won a ruling that Dustin's injuries were vaccine-related.
Not
ready to give up, Justice Department lawyers considered an appeal. Then they offered a deal: They would drop the challenge
if the Bartons agreed the decision would remain unpublished. This meant it would not be sent to legal databases, such as Westlaw,
where attorneys for other petitioners could see it.
Lori Barton, who has since died, described her reaction at a congressional
hearing in December 2001: "To me, it was extortion." But Barton, who then was seriously ill and had borrowed thousands of
dollars to pay expert witnesses, took the deal.
In a statement to The Times, the Justice Department said it had made
similar deals "on very rare occasions." It happens when the government "disagrees with a decision but believes that settlement
is fair and in both parties' interests."
Family
Finances Ruined
Rachel Zuhlke's claim was filed in September 1992. The government blamed her brain injuries on complications
from a strep infection she had about the same time she got her DPT shot.
Janet Zuhlke said Rachel's illness contributed
to the breakup of her marriage. She also lost her job as a dental assistant because of frequent absences to deal with Rachel's
medical emergencies. Even with health insurance, the family's finances were wrecked.
"We had a lot of hot dogs," Zuhlke
said. "We had two other children that went without many, many, many things … because I couldn't afford them."
Her
case moved at a crawl, getting repeatedly reassigned to different special masters, and from one Justice Department lawyer
to another, who repeatedly got extensions to complete filings in the case.
Nearly eight years into the case, Golkiewicz,
the chief special master, brought in a mediator for settlement talks. Zuhlke recalled her despair — and the special
master's shock — when the Justice Department refused to make a settlement offer. "You should have seen Golkiewicz's
face fall on the table," she said.
Golkiewicz said recently that he was disappointed that the case didn't settle,
but that didn't mean "that one side or the other was at fault."
Still, he said, the case took far too long, and the
Zuhlkes "had every reason to feel frustrated."
As it turned out, the government lost its all-or-nothing gamble. In
July 2001, Special Master George Hastings ruled that Rachel was entitled to compensation. Fifteen months later, he granted
a multimillion-dollar award, including $925,000 for her pain and suffering, future lost earnings and past medical bills, and
at least $90,000 a year for living and healthcare costs.
Although relieved that the case is finally over, Zuhlke still
struggles with grief over what happened to her child, now a young woman. Rachel's life, she said, "is so different from what
it should be at 20."
And she still finds it "unfathomable" that the government fought her claim for so long, Zuhlke
said. "My little girl hadn't done anything wrong."
*********************************
Curbside
Consultation
A
Mother Who Refuses to Vaccinate Her Child
Case
Scenario
Some
of my young patients have parents who, despite being well educated have, in my opinion, some irrational beliefs. An example
of this is a young mother who recently refused to vaccinate her baby. This mother said that she had heard of adverse reactions
to vaccines, and she did not want to risk her baby's health. She had heard that some vaccines have dangerous additives, that
the measles vaccine is associated with autism, and that the varicella vaccine could cause her child to have chickenpox in
adulthood when it would be more dangerous. Vaccines, she had read, weaken the immune system.
I tried to explain that many of her
concerns have been addressed or repudiated, but she would have none of it. "Doctors are uninformed about the risks of vaccines,"
she said. "Vaccines actually cause diseases instead of preventing them." This seemed like too much of an argument for me to
tackle during an office visit.
I concluded that this mother is taking
advantage of the fact that other children are immunized and relies on the immunization of others to protect her child from
diseases. I suggested that she think about the benefits of immunizations and remain open to changing her mind.
Commentary
Physicians
may find it incredible that some parents are reluctant to immunize their children despite the tremendous successes of vaccines
in decreasing the morbidity and mortality of childhood diseases. Unfortunately, this particular scenario is likely to become
more common because parents no longer see these diseases; they focus instead on the rare but often sensationalized adverse
effects of vaccines. The accompanying table summarizes a variety of factors that may affect a person's perception of
vaccine risks. In particular, parents may overestimate the frequency of serious vaccine risks or avoid doing anything that
might put their child at risk, even if the risk is much less than the child could encounter from the disease itself.1
Parents also may have the idea that their child is protected because other children have been immunized.
|
Factors
Affecting Vaccine Risk Perception
|
Factor |
Comment |
Voluntary controllable risks |
More acceptable than involuntary risks |
Natural risks |
More acceptable than man-made risks |
Frightening or memorable risks |
Less acceptable than less frightening or less memorable risks |
Risks due to commission (action) bias |
Less acceptable than risks due to omission (i.e., not vaccinating) |
Ambiguity aversion |
Known risks may be more acceptable than unknown risks of lesser magnitude (e.g., risks of disease vs. new vaccine)
|
Freeloading |
Rely on high vaccination rate and herd immunity to protect unvaccinated |
Bandwagoning |
Vaccinate because everyone else is |
Altruism |
Accept personal risk to benefit community or society |
|
Information
from Ball LK, Evans G, Bostrom A. Risky business: challenges in vaccine risk communication. Pediatrics 1998;101:453-8. |
|
|
Physicians should acknowledge that vaccines
are not always 100 percent effective and, in rare instances, can have serious adverse effects. However, it also should be
pointed out that the benefits of immunization almost always exceed the potential risks. For example, measles kills almost
1 million children worldwide each year, especially in developing countries. From 1989 to 1991, more than 55,000 children in
the United States contracted measles, and more than 120 of them died.2 After a campaign to improve immunization
rates with the measles, mumps, and rubella (MMR) vaccine, the annual number of reported measles cases in the United States
is now less than 100. A significant percentage of U.S. measles cases, however, are imported from other countries.
In 1999, the U.S. Food and Drug Administration
determined that the use of the mercury-containing preservative thimerosal in vaccines might, theoretically, expose infants
to more mercury than is recommended. Except for local hypersensitivity reactions, thimerosal has not been found to cause any
harm.3 Even so, the preservative has been removed from all routine childhood vaccines that previously contained
it.
Allegations also have been made of a
link between autism and the MMR vaccine. In 1998, Wakefield and colleagues4 reviewed 12 children with ileal-lymphoid-nodular
hyperplasia, nonspecific colitis, and pervasive developmental disorder. Although parents associated the onset of behavior
symptoms with MMR vaccination in eight of the 12 children (who did not have preceding bowel symptoms), the investigators noted
that "We did not prove an association between measles, mumps, and rubella vaccine and the syndrome described."4
A much larger study5 of 498
autistic children in the United Kingdom did not confirm a causal association between MMR vaccine and autism. The U.S. Institute
of Medicine concluded that current evidence favored rejection of a causal relationship at the population level between MMR
vaccine and autism.6 They noted, however, that they could not exclude the possibility that MMR vaccine could contribute
to autism in a small number of children.6
Varicella vaccine has been licensed
for use in the United States since 1995, but it has been used for more than 20 years in Japan.7 The vaccine has
been found to be 85 percent effective overall and 97 percent effective in preventing moderate to severe disease.7
As the number of varicella-immunized children increases, the incidence of wild-type varicella decreases. Unvaccinated children
consequently have less chance of catching natural disease in childhood, but they are at greater risk for becoming infected
in adolescence or adulthood, when complications and death from the disease are more likely. Although a small percentage of
vaccinated children contract varicella each year, these illnesses are much less severe than those occurring in unvaccinated
children or adults.
Almost one quarter of parents believe
that too many immunizations could weaken their child's immune system.8 However, newer vaccines contain fewer antigens
than older vaccines and have not been demonstrated to increase susceptibility to infection.9 In fact, failure to
immunize exposes the child to developing not only the disease but also potential secondary complications, such as post-varicella
group A beta-hemolytic streptococcal infection.9 In one study,10 unvaccinated children in Colorado were
22 times more likely to develop measles and almost six times more likely to develop pertussis than were vaccinated children.
Even immunized children had a greater relative risk of developing disease because of the increased risk of disease posed by
the unvaccinated children.10
Factual information may or may not change
the minds of parents who express concerns or actively refuse to immunize their children. Physicians may wish to probe the
underlying reasons for a parent's decision and allow the parent the opportunity to change the decision at a later date. However,
family physicians should be knowledgeable about immunization indications, contraindications, and controversies.
Physicians must provide parents with
a current Vaccine Information Statement (VIS) each time a vaccine covered under the National Vaccine Injury Compensation Program
is administered. Copies of each VIS can be obtained from the Centers for Disease Control and Prevention (www.cdc.gov/nip/
publications) or the Immunization Action Coalition (www.immunize.org). Other immunization resources include the National Network
for Immunization Information (www.immunizationinfo.org); the Vaccine Education Center at the Children's Hospital of Philadelphia
(www.vaccine.chop.edu); and the Society of Teachers of Family Medicine Group on Immunization Education (www. immunizationed.org).
The latter site has a Palm-based personal digital assistant (PDA) program called "Shots 2003" that can be downloaded at no
charge.
Should parents continue to refuse immunization
for their child, the physician may wish to have them sign a Refusal to Vaccinate form that is available from the American
Academy of Pediatrics at www.cispimmunize.org.
SANFORD
R. KIMMEL, M.D. Department of Clinical Family Medicine Medical College of Ohio Toledo, Ohio
Supported
by funding from the Centers for Disease Control and Prevention, National Immunization Program, through Cooperative Agreement
U66/ CCU719217-01 to the Society of Teachers of Family Medicine Foundation.
Source: http://www.aafp.org/afp/20030201/curbside.html
*******************************************
Comparison symptoms autism and mercury poisoning
Table A: Summary
Comparison of Characteristics of Autism & Mercury Poisoning
Mercury
Poisoning |
Autism
|
Psychiatric Disturbances |
|
Social deficits, shyness, social withdrawal
|
Social deficits, social withdrawal,
shyness |
Depression, mood swings; mask face |
Depressive traits, mood swings; flat
affect |
Anxiety |
Anxiety |
Schizoid tendencies, OCD traits |
Schizophrenic & OCD traits; repetitiveness
|
Lacks eye contact, hesitant to engage
others |
Lack of eye contact, avoids conversation
|
Irrational fears |
Irrational fears |
Irritability, aggression, temper tantrums
|
Irritability, aggression, temper tantrums
|
Impaired face recognition |
Impaired face recognition |
Speech, Language & Hearing Deficits |
|
Loss of speech, failure to develop speech
|
Delayed language, failure to develop
speech |
Dysarthria; articulation problems |
Dysarthria; articulation problems |
Speech comprehension deficits |
Speech comprehension deficits |
Verbalizing & word retrieval problems
|
Echolalia; word use & pragmatic
errors |
Sound sensitivity |
Sound sensitivity |
Hearing loss; deafness in very high
doses |
Mild to profound hearing loss |
Poor performance on language IQ tests
|
Poor performance on verbal IQ tests
|
Sensory Abnormalities</TD<
tr> |
|
Abnormal sensation in mouth & extremities
|
Abnormal sensation in mouth & extremities
|
Sound sensitivity |
Sound sensitivity |
Abnormal touch sensations; touch aversion
|
Abnormal touch sensations; touch aversion
|
Vestibular abnormalities |
Vestibular abnormalities |
Motor Disorders |
|
Involuntary jerking movements - arm
flapping, ankle jerks, myoclonal jerks, choreiform movements, circling, rocking |
Stereotyped movements - arm flapping,
jumping, circling, spinning, rocking; myoclonal jerks; choreiform movements |
Deficits in eye-hand coordination; limb
apraxia; intention tremors |
Poor eye-hand coordination; limb apraxia;
problems with intentional movements |
Gait impairment; ataxia - from incoordination
& clumsiness to inability to walk, stand, or sit; loss of motor control |
Abnormal gait and posture, clumsiness
and incoordination; difficulties sitting, lying, crawling, and walking |
Difficulty in chewing or swallowing
|
Difficulty chewing or swallowing |
Unusual postures; toe walking |
Unusual postures; toe walking |
Cognitive Impairments |
|
Borderline intelligence, mental retardation
- some cases reversible |
Borderline intelligence, mental retardation
- sometimes "recovered" |
Poor concentration, attention, response
inhibition |
Poor concentration, attention, shifting
attention |
Uneven performance on IQ subtests |
Uneven performance on IQ subtests |
Verbal IQ higher than performance IQ
|
Verbal IQ higher than performance IQ
|
Poor short term, verbal, & auditory
memory |
Poor short term, auditory & verbal
memory |
Poor visual and perceptual motor skills,
impairment in simple reaction time |
Poor visual and perceptual motor skills,
lower performance on timed tests |
Difficulty carrying out complex commands
|
Difficulty carrying out multiple commands
|
Word-comprehension difficulties |
Word-comprehension difficulties |
Deficits in understanding abstract ideas
& symbolism; degeneration of higher mental powers |
Deficits in abstract thinking &
symbolism, understanding other’s mental states, sequencing, planning & organizing |
Unusual Behaviors |
|
Stereotyped sniffing (rats) |
Stereotyped, repetitive behaviors |
ADHD traits |
ADHD traits |
Agitation, unprovoked crying, grimacing,
staring spells |
Agitation, unprovoked crying, grimacing,
staring spells |
Sleep difficulties |
Sleep difficulties |
Eating disorders, feeding problems |
Eating disorders, feeding problems |
Self injurious behavior, e.g. head banging
|
Self injurious behavior, e.g. head banging
|
Visual Impairments |
|
Poor eye contact, impaired visual fixation
|
Poor eye contact, problems in joint
attention |
“Visual impairments,” blindness,
near-sightedness, decreased visual acuity |
“Visual impairments”; inaccurate/slow
saccades; decreased rod functioning |
Light sensitivity, photophobia |
Over-sensitivity to light |
Blurred or hazy vision |
Blurred vision |
Constricted visual fields |
Not described |
Physical Disturbances |
|
|
|
Increase in cerebral palsy; hyper- or
hypo-tonia; abnormal reflexes; decreased muscle strength, especially upper body; incontinence; problems chewing, swallowing,
salivating |
Increase in cerebral palsy; hyper- or
hypotonia; decreased muscle strength, especially upper body; incontinence; problems chewing and swallowing |
Rashes, dermatitis/dry skin, itching;
burning |
Rashes, dermatitis, eczema, itching
|
Autonomic disturbance: excessive sweating,
poor circulation, elevated heart rate |
Autonomic disturbance: unusual sweating,
poor circulation, elevated heart rate |
Gastro-intestinal Disturbances</TD<
tr> |
|
Gastroenteritis, diarrhea; abdominal
pain, constipation, “colitis” |
Diarrhea, constipation, gaseousness,
abdominal discomfort, colitis |
Anorexia, weight loss, nausea, poor
appetite |
Anorexia; feeding problems/vomiting
|
Lesions of ileum & colon; increased
gut permeability |
Leaky gut syndrome |
Inhibits dipeptidyl peptidase IV, which
cleaves casomorphin |
Inadequate endopeptidase enzymes needed
for breakdown of casein & gluten |
Abnormal Biochemistry |
|
Binds -SH groups; blocks sulfate transporter
in intestines, kidneys |
Low sulfate levels |
Has special affinity for purines &
pyrimidines |
Purine & pyrimidine metabolism errors
lead to autistic features |
Reduces availability of glutathione,
needed in neurons, cells & liver to detoxify heavy metals |
Low levels of glutathione; decreased
ability of liver to detoxify heavy metals |
Causes significant reduction in glutathione
peroxidase and glutathione reductase |
Abnormal glutathione peroxidase activities
in erythrocytes |
Disrupts mitochondrial activities, especially
in brain |
Mitochondrial dysfunction, especially
in brain |
Immune Dysfunction |
|
Sensitivity due to allergic or autoimmune
reactions; sensitive individuals more likely to have allergies, asthma, autoimmune-like symptoms, especially rheumatoid-like
ones |
More likely to have allergies and asthma;
familial presence of autoimmune diseases, especially rheumatoid arthritis; IgA deficiencies |
Can produce an immune response in CNS
|
On-going immune response in CNS |
Causes brain/MBP autoantibodies |
Brain/MBP autoantibodies present |
Causes overproduction of Th2 subset;
kills/inhibits lymphocytes, T-cells, and monocytes; decreases NK T-cell activity; induces or suppresses IFNg & IL-2 |
Skewed immune-cell subset in the Th2
direction; decreased responses to T-cell mitogens; reduced NK T-cell function; increased IFNg & IL-12 |
CNS Structural Pathology |
|
Selectively targets brain areas unable
to detoxify or reduce Hg-induced oxidative stress |
Specific areas of brain pathology; many
functions spared |
Damage to Purkinje and granular cells
|
Damage to Purkinje and granular cells
|
Accummulates in amygdala and hippocampus
|
Pathology in amygdala and hippocampus
|
Causes abnormal neuronal cytoarchitecture;
disrupts neuronal migration & cell division; reduces NCAMs |
Neuronal disorganization; increased
neuronal cell replication, increased glial cells; depressed expression of NCAMs |
Progressive microcephaly |
Progressive microcephaly and macrocephaly
|
Brain stem defects in some cases |
Brain stem defects in some cases |
Abnormalities in Neuro-chemistry |
|
Prevents presynaptic serotonin release
& inhibits serotonin transport; causes calcium disruptions |
Decreased serotonin synthesis in children;
abnormal calcium metabolism |
Alters dopamine systems; peroxidine
deficiency in rats resembles mercurialism in humans |
Possibly high or low dopamine levels;
positive response to peroxidine (lowers dopamine levels) |
Elevates epinephrine & norepinephrine
levels by blocking enzyme that degrades epinephrine |
Elevated norepinephrine and epinephrine
|
Elevates glutamate |
Elevated glutamate and aspartate |
Leads to cortical acetylcholine deficiency;
increases muscarinic receptor density in hippocampus & cerebellum |
Cortical acetylcholine deficiency; reduced
muscarinic receptor binding in hippocampus |
Causes demyelinating neuropathy |
Demyelination in brain |
EEG Abnormalities / Epilepsy |
|
Causes abnormal EEGs, epileptiform activity
|
Abnormal EEGs, epileptiform activity
|
Causes seizures, convulsions |
Seizures; epilepsy |
Causes subtle, low amplitude seizure
activity |
Subtle, low amplitude seizure activities
|
Population Characteristics |
|
Effects more males than females |
Male:female ratio estimated at 4:1 |
At low doses, only affects those geneticially
susceptible |
High heritability - concordance for
MZ twins is 90% |
First added to childhood vaccines in
1930s |
First "discovered" among children born
in 1930s |
Exposure levels steadily increased since
1930s with rate of vaccination, number of vaccines |
Prevalence of autism has steadily increased
from 1 in 2000 (pre1970) to 1 in 500 (early 1990s), higher in 2000. |
Exposure occurs at 0 - 15 months; clinical
silent stage means symptom emergence delayed; symptoms emerge gradually, starting with movement & sensation |
Symptoms emerge from 4 months to 2 years
old; symptoms emerge gradually, starting with movement & sensation |
Source: http://www.vaccinationnews.com/Scandals/Feb_15_02/comparison_symptoms.htm
|