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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.
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 associati
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