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by Phyllis Schlafly
All children must be injected with dozens of vaccines
before entering school or daycare, and some of these injections are given
to infants within the first weeks or even hours of birth.
Parents are led to believe
that these injections are required.
Who mandated these vaccines
and what is the decision-making process?
Parents are excluded from the process of deciding
what drugs are injected into their children's bodies. Most states allow
a limited medical exemption and a religious exemption, and a few states
allow a philosophical (or conscientiously held belief) exemption. But
often great pressure is exerted on parents who try to use these exemptions,
and about 98% of
all children are vaccinated.
Since more vaccines are coming on the market every
year and more are being mandated, it's time to ask and answer several
questions about forced medical care of healthy children.
(1) Do
we want government to have the power to force medical treatment on children
against their parents wishes?
(2) Is the process
that produces these mandates honest -- scientifically, bureaucratically,
legislatively, politically -- and open to public scrutiny and peer review?
It's important to recognize that the government is
using popular support for vaccines to subsidize states to set up vaccine
registries to tag all children at birth and track their medical records
all their lives, and the CDC is working to merge these registries into
a national medical database.
When completed, this will achieve one of the principal
goals of the discredited Clinton health care plan: computerizing the health
records of all Americans with unique personal identifiers (Social Security
numbers, if possible).
Vaccine mandates go into effect in America in an intricate
three-step procedure that evades
accountability.
First, the Food and Drug Administration
(FDA) and its Vaccines and Related Biological Products Advisory
Committee (VRBPAC) decide whether a vaccine can be licensed.
Second, the Centers for Disease
Control (CDC) and its Advisory Committee on Immunization Practices
(ACIP) decide whether to include the vaccine on the Child Immunization
Schedule, i.e., put on the list of vaccines that are recommended to be
given to all children.
Third, state legislatures
specify which vaccines and how many doses are required (or authorize a
state health agency to put new vaccines on the compulsory list). State
legislatures or agencies usually follow ACIP's recommendations.
It is obvious that the FDA/ACIP/state decisions make
the approved vaccines immensely profitable by providing a guaranteed market.
Federal laws are supposed to prohibit conflicts of interest, but commercial
conflicts have emerged as a major concern.
Conflicts of Interest
about Vaccines
When a rotavirus (infant diarrhea) vaccine was suddenly
withdrawn from the market in 1999, the public was led to believe that
it was because new information about harmful side effects had been discovered.
At a June 15, 2000 hearing conducted by Rep. Dan Burton's (R-IN) House
Committee on Government Reform, we learned that other factors influenced
the 1998 FDA licensing and CDC recommendation.
Most of the work of the CDC advisory committee is
done in "working groups" behind closed doors without public
scrutiny. Six of the ten working groups had financial ties to pharmaceuticals
that make rotavirus vaccines.
It turns out that half
of those on the two key committees voting for the rotavirus vaccine had
financial ties to vaccine manufacturers, such as being paid
as consultants or lobbyists or owning vaccine patents or owning stock
in pharmaceuticals.
In pre-licensure trials for the rotavirus vaccine,
some babies suffered obstructed bowels a week later, some requiring surgery
to remove a portion of the intestine, a painful condition called intussusception.
Nevertheless, the committees approved the vaccine
for universal use, calling these reports statistically insignificant.
The study data were concealed, and the public did not learn of the problem
until more than 100 cases of
intussusception were reported, including one death.
The vaccine was not even considered to be all that
effective in preventing diarrhea in infants. In one U.S. multicenter trial,
the rotavirus vaccine only had a 49%
efficacy rate in preventing the rotavirus disease.
Within months after government approval, 1.5 million
vaccine doses were given to infants. The Department of Health and Human
Services, in its announcement, stated that "the most common adverse
vaccine reactions included moderate fever, increased irritability, and
decreased appetite and activity," with no mention of side effects
requiring hospitalization or surgery.
The Burton hearings provided some answers to help
explain this disaster. When the rotavirus vaccine was approved by the
FDA committee, 8 members were absent, 2 were excluded, and 4 of the remaining
5 had conflicts of interest that necessitated waivers. This was not a
quorum so they were joined by 5 temporary members, and then all voted
to approve the vaccine. The committee's own charter states that temporary
members are normally not to exceed 4.
The CDC routinely grants conflict-of-interest waivers
to every member of its advisory committee a year at a time, and allows
full participation in the discussions by all members even if they have
a financial stake in the decision.
One member who cast three
votes to recommend the rotavirus vaccine owned a patent for another rotavirus
vaccine and admitted that he was paid by the pharmaceutical industry to
travel around the country and teach doctors that vaccines are safe.
The public still has no access to the actual data
concerning side effects of the rotavirus vaccine or of the controversial
chicken pox or hepatitis B vaccines. If these new vaccines are safe, there
should be no objection to releasing the actual data that demonstrate this.
The obvious incentive
to conceal such data is to hide facts that discredit the public recommendations.
At Burton's June 15 hearing, officials from the FDA
and CDC defended the various conflicts of interest because waivers were
granted. One CDC official went so far as to suggest that it is good to
use vaccine industry insiders on official advisory committees because
they are able to vote based on secret drug-company information! That is
tantamount to letting vaccine industry lobbyists write their own profitable
government mandates, i.e., simply own the process.
It is a great mistake to base vaccine policy on confidential
or trade-secret data. Scientific claims are most reliable when all data
and analyses are subject to public scrutiny.
Our political system demands
that government decisions be subject to democratic checks and balances.
The whole concept of the government forcing experimental
treatment on healthy individuals is disturbing to those who value freedom.
Mandatory vaccine policies depend on overwhelming public acceptance, but
public confidence is eroded by conflicts of interest and secrecy of deliberations
and data.
Government should put all the data, analyses and meeting
minutes on a public website, and this should include a risk-benefit analysis,
cost-benefit analysis, and a comparison against alternate policies. Only
public data and arguments should be considered. The CDC should appoint
advisory committee members with diverse points of view. Scientists from
other fields, consumer advocates, and even vaccine critics would greatly
improve the quality of the recommendations because more policy implications
would be considered.
Who Imposes the Vaccine
Mandates?
The December 27, 2000 issue of JAMA (Journal of the
American Medical Association) contains a very important caveat about who
is responsible for the decisions to mandate vaccines, even though the
article supports the widespread policy of forcing all children to be vaccinated
in order to enter daycare or school.
The JAMA article reports on a Centers for Disease
Control (CDC) study that makes the unsurprising claim that unvaccinated
children are more likely to get measles and pertussis than those who are
vaccinated. The study used Colorado data because that is one of 15 states
that allow parents a philosophical (conscientiously held belief) exemption
in addition to the religious and medical exemptions. Only 1.4 percent
claimed this exemption and more than 98% of Colorado children were vaccinated
in the year cited by the study.
Vaccination is not effective in
about 5 percent of children, so
when there is a measles outbreak, most of the cases
are among vaccinated children.
The CDC has declared that the United States has been
free from indigenous measles since 1998 and the only cases come in with
immigrants.
For the Colorado study, the researchers had to go
back more than ten years to find sufficient cases and include a measles
epidemic. If the researchers wanted to discuss current risks accurately,
they should have focused on immigrants and ineffective vaccinations rather
than on children whom they disdainfully call "exemptors."
It appears that the "experts" and the "authorities"
won't be happy until there is 100% compliance with vaccine mandates. The
real purpose of the JAMA report seems to be to shame or scare the 1 to
2 percent of parents into not using a philosophical exemption and to induce
states to repeal this exemption.
The same issue of JAMA includes an editorial commenting
on this study. It, too, is based on the premise that vaccine mandates
are desirable, and it deplores criticisms of vaccines by parents, implying
that their objections must be based on ignorance or misinformation.
But buried in the JAMA editorial are some startling
comments and revelations. JAMA absolves ACIP, CDC and FDA from any accountability
for the mandating of vaccines in the three-step process described above.
The editorial says, "It is not the responsibility of these advisory
bodies to determine which vaccines are mandated; that decision resides
with the state."
The JAMA editorial issues a warning to state legislators.
They should not mandate a vaccine
just because FDA licenses it or ACIP recommends it;
state legislators are responsible to make their own decisions and cannot
pass the buck to FDA, ACIP or CDC, which only have power to recommend,
but not mandate, the vaccines.
Then comes the question, why do ACIP and FDA so gratuitously
put so many vaccines on the "recommended" list for all children?
JAMA's editorial reveals the answer:
these recommendations
are monetary decisions masquerading as medical decisions.
Here are JAMA's words: "Since federal funding
for vaccines is determined by the ACIP through the Vaccines for Children
(VFC) program, whenever possible the ACIP should endorse funding for vaccines
that physicians and parents wish to administer."
In other words, the real purpose of ACIP and FDA recommendations
is to release federal funds to buy the vaccines from the manufacturers.
Remember that Rep. Dan Burton's investigation in June 2000 revealed many
conflicts of interest among those who sit on federal panels where they
can approve the recommendations that trigger the federal funds.
JAMA issues a stern caveat to the states: "All
vaccines that are licensed and recommended for use in children should
not necessarily be legally mandated for day care or school entry. Each
state needs to assess each vaccine individually. . . . States should determine
whether the disease to be prevented by the vaccines is highly contagious,
results in significant morbidity and mortality, and poses a major health
problem to both the individual and the community."
It's obvious that those are not the criteria used
by the ACIP and FDA in their pronouncements. Many states are now amending
their compulsory vaccination laws to add hepatitis B and chicken pox.
An independent assessment of these vaccines by a state is unlikely to
conclude that they meet the criteria set forth by JAMA.
Rep. Burton should hold more hearings to expose the
government's vaccine licensing/recommendation/ mandate process. Meanwhile,
since the government's decision-making procedure is not only defective
but suspect, we need a philosophical exemption in every
state so that decisions can be made by parents whose motive
is the health of their children, not promoting government purchases of
vaccines.
Independent judgments by states and consumers might
have helped to avoid past blunders like the rotavirus vaccine embarrassment
last year that caused injuries to so many babies. At a minimum, a philosophical
exemption in every state would create a market demand for improvement
of vaccines.
Recall Defective Tires,
But Not Vaccines?
A July 18, 2000 hearing of the House Committee on
Government Reform produced evidence about the health dangers from vaccines
containing thimerosal (mercury). Babies who are injected with the vaccines
specified on the Universal Childhood Immunization Schedule, which are
typically delivered in four to six shots during one doctor's visit, may
receive 40 times the amount of mercury that is considered safe under Environmental
Protection Agency (EPA) guidelines.
An independent evaluation conducted by the National
Research Council confirmed the EPA guidelines as accurate, and the FDA's
own website states that "lead, cadmium, and mercury are examples
of elements that are toxic when present at relatively low levels."
Credible testimony was also given regarding the possible relationship
between symptoms of mercury poisoning and the skyrocketing rate of autism,
now occurring in 1 in 500 children nationwide.
Committee Chairman Dan Burton sent letters to HHS
Secretary Donna Shalala and the Food and Drug Administration (FDA) asking
for the recall of all thimerosal-containing vaccines. His requests and
those of parents of vaccine-injured children have been ignored. This is
despite the fact that the FDA admits that the vaccines on the Childhood
Immunization Schedule are all available in a thimerosal-free version.
Apparently, the FDA is not planning to recall any
of the 50 thimerosal-containing vaccines but only suggests a "phase
out" over time, thus allowing the pharmaceuticals to unload their
defective merchandise on unsuspecting children. For years to come, these
toxic vaccines will continue to be injected in babies in public health
clinics, doctor's offices, and managed care facilities.
It is unconscionable to
continue to put thousands of babies every day at risk from mercury poisoning,
especially when the government is recommending use of these vaccines and
the schools are making them mandatory, and when safe alternatives are
easily available.
Leaving dangerous vaccines on the market so that the
pharmaceuticals can continue to receive revenue from current inventories
(instead of ordering a recall, as happened with tires) seems to be the
pattern.
Even after it was known that oral polio and whole-cell
pertussis vaccines caused a higher rate of adverse reactions, clinics
and doctors continued to use their supplies for years rather than pitch
them in favor of safer vaccines. If there is any reason for HHS and FDA
to continue to put thousands of babies at risk from dangerous vaccines
other than to protect the profits of the powerful pharmaceuticals, we'd
like to know what that might be.
Should Schools Force Medical
Treatment?
In Utica, NY, parents of 77 middle schoolers were
warned in October 2000 that their children would be taken and turned over
to Child Protective Services for neglect unless they were vaccinated against
hepatitis B within two weeks. There was no emergency, no epidemic of hepatitis
B against which children need to be protected, and no evidence that hepatitis
B is being transmitted at school.
The "emergency" was that the school district
would lose a substantial amount of state funding if students did not comply
with the vaccine mandate. So school district physician Dr. Mark Zongrone,
giving his financial (not medical) diagnosis,
said, "We refuse to let that happen."
How did we get to a circumstance in America where
a school, for its own financial self-interest, imposes medical treatment
on children in opposition to their parents' wishes? Is this America or
Nazi Germany? Hepatitis B is primarily an adult disease spread by multiple
sex partners, drug abusers, and those in occupations where they are exposed
to blood. Unless the child is born to an infected mother, children under
the age of 14 are three times
more likely to die or suffer adverse reactions
from the hepatitis B vaccine
than from the disease itself.
Parents of two students in separate schools filed
suit on January 24 against the New York City Board of Education, claiming
that it violated state and federal law by refusing to grant religious
exemptions to forced inoculations. New York law requires schoolchildren
to be injected with a long list of various vaccines, but allows both medical
and religious exemptions.
Seventh grader Catherine Rotella refused the hepatitis
B vaccination, asserting a religious exemption. She was sent to the administrative
office and her parents were called to take her home. After she missed
several days, the school demanded an affidavit from the family's clergy,
which Catherine's father obtained. After she returned to school, two security
guards barged into the middle of a class and physically escorted Catherine
to the principal's office where she was denied the religious exemption
and not allowed to return to school without the vaccination.
Second grader Maja Leibovitz was evicted from school
last November 16 because she had not been vaccinated, even though her
parents, Christian Scientists, claimed a religious exemption. The principal
said he would hold Maja back a grade because she was not attending school,
and then called Child Protective Services, claiming that the mother was
guilty of educational neglect for not placing her child in school.
On January 26, a federal court ordered the New York
City Board of Education to allow these two students to return to school.
They were represented by Liberty Counsel of Orlando. Why did it take a
lawsuit to get the school to obey the law?
Can a Court Order Kids
to Take Drugs?
Can a judge constitutionally order a controversial
drug to be given to a child over the opposition of his parents? Such action
by a Family Court Judge in Albany, NY has touched off a national debate
pitting public schools and the courts against parental rights.
Seven-year-old Kyle Carroll of Berne, NY, was diagnosed
by a psychologist as having ADHD (Attention Deficit/Hyperactivity Disorder)
and a physician prescribed the psychotropic drug Ritalin. The boy soon
exhibited two of the drug's common side effects, sleeplessness and appetite
loss.
When Kyle's parents told school officials they wanted
to temporarily discontinue the medication, they got a visit from the Albany
County Child Protective Services and a petition to appear in court. The
school district accused the Carrolls of "educational neglect"
and they received what amounted to an order from Judge Gerard E. Maney
to start using Ritalin again.
Under what was described as "at least the theoretical
threat of having their child removed from their custody," the Carrolls
agreed to "an adjournment in contemplation of dismissal (ACOD)."
There was no fact-finding hearing before Judge Maney, no testimony taken,
and no written decision rendered. According to law guardian Pamela J.
Joern of Albany, who supported the school's position, "The consent
ACOD directed the parents to comply with the doctor's treatment regimen,
which was a prescription for Ritalin. They could get a second opinion,
but they couldn't ignore the problem."
In order to avoid a prolonged court battle, the Carrolls
compromised, which is usually what happens when parents are subjected
to intimidation by state child protection agencies. The injustice of Judge
Maney's decision will go unreviewed by higher courts, but the Kyle Carroll
case has kicked up a storm of protest on the internet.
This case underscores the need for better medical
privacy protection in order to safeguard against government intervention
in personal medical decisions.
A family's decision whether
or not to use Ritalin is not the government's business.
This judicial activism would never be known outside
of the local community if it were not for the flow of information on the
Internet
Ritalin does not treat an objective physical illness
as, for example, insulin treats diabetes. Ritalin is a serious drug used
to control behavior problems and is very attractive to the schools because
it makes the child more likely to shut up, sit down, and do what he's
told. There are some 3.8 million schoolchildren, mostly boys, who are
said to have ADHD, according to the American Academy of Pediatrics. Estimates
are that most of them are on Ritalin or similar psychotropic drugs.
The number of children labeled ADHD and taking Ritalin
has greatly increased since 1991 when ADHD was covered under the Individuals
with Disabilities Education Act (IDEA), a federal program that brings
more funding to public schools in order to provide extra services. Under
IDEA, the school is required to craft an Individualized Education Plan
(IEP) to accommodate each child, which may include drugs prescribed by
a medical doctor, and that's how Kyle happened to be given Ritalin.
Eagle
Forum February 2001
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