Untitled Document
"People often wonder why regulatory officials would protect drug
makers. In large part, because the CDC and FDA policy decisions are made through
advisory panels whose members have financial relationships with the same companies
they are charged to regulate."
A growing number of professionals in the health care field are reporting
that a relationship exists between the epidemic in neurodevelopmental disorders
of autism, attention deficit hyperactive disorder, and speech or language delay
all across the country, and the use of thimerosal, the mercury-based preservative
used in childhood vaccines.
Vaccines are the only medicines that Americans are mandated to receive
as a condition for attendance in school and day care, and for some types of
employment. Parents who receive federal assistance are also required to show
proof that their children have been vaccinated.
While the mandate for which vaccines must be included on the vaccine schedule
is a state mandate, it is the Centers for Disease Control and Prevention (CDC)
and its Advisory Committee that make the recommendations to which the majority
of states adhere when determining mandates. The current epidemic actually began
in the late 1980s when a large number of new vaccines were added to the schedule.
The blame is at least partially attributable to the failure of government officials
to keep track of the cumulative amounts of mercury as they added triple-dose-vaccines
to the schedule and the amount of thimerosal was multiplied by three.
Each new vaccine contained 25 micrograms of mercury and according to Professor
Lynn Adams, of Radford University, who specializes in autism, by 1999, a study
determined that the average child received 33 doses of 10 different vaccines
by the age 5.
Elected lawmakers first became aware of the problem in 1999, when the House
Committee on Government Reform initiated an investigation into the dangers of
mercury exposure. An alarm rang early about the exposure of children to thimerosal.
By October 25, 2000, Committee Chairman, Dan Burton (R-IN), was trying to get
the substance out of vaccines as quickly as possible and sent a letter to the
Department of Health and Human Services, asking the director to get the FDA
to recall all vaccines with thimerosal.
“We all know and accept that mercury is a neurotoxin, and yet the FDA
has failed to recall the 50 vaccines that contain Thimerosal,” Burton
wrote. “Every day that mercury-containing vaccines remain on the market
is another day HHS is putting 8,000 children at risk,” he said.
“I implore you to conduct a full recall of these products,” he
wrote. “If the only action ... is a gradual phase out, children will continue
to be put at risk every day,” Burton warned. “These vaccines will
continue to be injected in children for years to come - putting our nation's
most vulnerable population ... at risk for mercury poisoning," he added.
The Reform Committee soon discovered that regulatory agencies were still allowing
thimerosal to be used decades after the recognition that it was harmful. The
Committee was told that the Food and Drug Administration, (FDA), uses a subjective
barometer in determining when a product that has known risks can remain on the
market. According to the agency:
"at the heart of all FDA’s product evaluation decisions is a judgment
about whether a new product’s benefits to users will outweigh its risks.
No regulated product is totally risk-free, so these judgments are important.
The FDA will allow a product to present more of a risk when its potential benefit
is great—especially for products used to treat serious, life-threatening
conditions."
The argument that the known risks of infectious diseases outweighs any potential
risk of neurological damage is one that has continuously been used by officials.
The FDA claims that any risk from thimerosal is theoretical because no proof
of harm exists.
However, after its review of scientific literature and listening to the testimony
of witnesses, the Committee found plenty of evidence to support the fact that
thimerosal posed a grave risk. "The possible risk for harm from either
low dose chronic or one time high level (bolus dose) exposure to thimerosal
is not "theoretical," but very real and documented in the medical
literature," the Committee said.
The Committee also discovered that regulatory agencies have never required
drug companies to conduct studies on the use of thimerosal. During a June 20,
2002, hearing, Burton questioned officials from the FDA and CDC and said, "You
mean to tell me that since 1929, we've been using Thimerosal and the only test
that you know of is from 1929, and every one of those people had mennigitis,
and they all died?"
In his opening statement at a July 18, 2000, hearing, Burton said:
"We assume that the FDA would protect our children from exposure to any
level of mercury through drugs. But that hasn’t been the case. Thimerosal
was first marketed in 1930 and has become the most widely used preservative
in vaccines. It is present in over 50 licensed vaccines."
"The FDA recently acknowledged that in the first six months of life, children
get more mercury than is considered safe by the EPA," Burton noted. "The
truth is that sometimes kids go to their doctor’s office and get four
or five vaccines at the same time," he added.
"My grandson received vaccines for nine different diseases in one day,"
Burton said. "He may have been exposed to 62.5 micrograms of mercury in
one day through his vaccines."
"According to his weight, the maximum safe level of mercury he should
be exposed to in one day is 1.51 micrograms," Burton advised. "This
is forty-one times the amount at which harm can be caused," he added.
In his opening remarks at a June 19, 2002, hearing, Burton described the devastation
of witnessing the correlation between vaccines and autism.
"My only grandson became autistic right before my eyes – shortly
after receiving his federally recommended and state-mandated vaccines. Without
a full explanation of what was in the shots being given, my talkative, playful,
outgoing, healthy, grandson Christian was subjected to very high levels of mercury
through his vaccines. He also received the MMR vaccine. Within a few days he
was showing signs of autism."
People often wonder why regulatory officials would protect drug makers. In
large part, because the CDC and FDA policy decisions are made through advisory
panels whose members have financial relationships with the same companies they
are charged to regulate.
The decisions of the 300 experts who sit on the FDA's 18 advisory committees
affect billions of dollars in sales. The panel members play a crucial role in
determining what drugs will be approved and participate in just about every
major decision related to industry regulation.
When it comes to vaccines, the large population in the USA transforms into
a lucrative customer base when our government makes vaccines mandatory and keeps
adding more and more to the list. Between 2003 and 2006, it was predicted that
the annual global market for vaccines would rise from $6 billion to $10 billion,
by Mark Benjamin for United Press International on July 21, 2003.
Investors follow the decisions made by the advisory panels closely. A favorable
vote by a committee can add hundreds of millions of dollars to a company's stock
value which also means the potential for corruption in the panels is enormous.
In a July 18, 2000 hearing, Burton mentioned the problem. "We have a lot
of doctors who serve on Federal advisory committees who have serious conflicts-of-interest
problems. They’re allowed to vote on vaccines made by companies that they
get money from."
An analysis conducted by USA Today, of 159 FDA advisory committee meetings
that took place between January 1, 1998, and June 30, 2000, revealed conflicts
of interest were wide-spread:
At 92% of the meetings, at least one member had a financial conflict of interest.
At least one committee member had a financial stake in the topic under review
at 146 of 159 advisory committee meetings.
At 55% of meetings, half or more of the FDA advisers had conflicts of interest.
At the 102 meetings dealing with the fate of a specific drug, 33% of the experts
had a financial conflict.
Many parents are now refusing to vaccinate their children because they believe
there is an on-going conspiracy by government officials and the pharmaceutical
industry to boost profits by mandating unnecessary vaccines, while at the same
time, denying their potential for harm. Congressman Burton addressed this issue
in a June 19, 2002 hearing:
"Parents are increasingly concerned that the Department may be inherently
conflicted in its multiple roles of promoting immunization, regulating manufacturers,
looking for adverse events, managing the vaccine injury compensation program,
and developing new vaccines. Families share my concern that vaccine manufacturers
have too much influence as well."
Burton also noted the need to get honest about the current epidemic. "As
representatives of the people, we have a responsibility to ensure that our public
health officials are adequately and honestly addressing this epidemic and its
possible links to vaccine injury," he said.
In May 2003, the Reform Committee, released a report that said the "FDA
and the CDC failed in their duty to be vigilant as new vaccines containing thimerosal
were approved and added to the immunization schedule."
As an example the report cited the Hepatitis B vaccine. "When the Hepatitis
B and Haemophilus Influenzae Type b vaccines were added to the recommended schedule
of childhood immunizations, the cumulative amount of ethylmercury to which children
were exposed nearly tripled." The report identified thimerosal as the cause
of the autism and chastised the FDA:
“Thimerosal used as a preservative in vaccines is directly related to
the autism epidemic. 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 and the sharper eyes of infant exposure to
this known neurotoxin. The public health agencies failure to act is indicative
of institutional malfeasance for self protection and misplaced protectionism
of the pharmaceutical industry.”
Many people have not yet recognized the seriousness of the epidemic, largely
because the majority of people have not seen many autistic children due to the
fact that parents seldom take their affected children out in public because
of the difficulty in trying to control them in a strange environment.
However, the rising numbers in special education classes in the nation's public
school system provides a clear measurement of how wide-spread the epidemic has
become. State by state statistics for students with autism from the Department
of Education for the 12-year period between 1992-93 and 2003-04, are almost
unbelievable. For instance, in Ohio in 1992-93, there were only 22 cases of
autism, by 2003-04 there were 5,146. In Illinois, there were only 5 cases twelve
years ago and 6,005 in 2003-04. Wisconsin had 18 cases of autism in 1992-93
and the numbers rose to 3,259 in 2003-04.
The true reality of these statistics will register in the not too distant future.
"With eighty percent of autistic Americans under the age of 18, the dramatic
impact of this crisis will be felt by taxpayers in the coming years when these
autistic children become adults," says Anne McElroy Dachel, Media Relations
Coordinator for the National Autism Association.
Most vaccines on the immunization schedule now are said to be thimerosal-free
but some still do contain trace amounts. "An exception is the flu shot,
which the Centers for Disease Control and Prevention recommends for pregnant
women and for infants 6 to 23 months old,” advises Don Olmsted in United
Press International on November 19, 2005.
For 6 to 23-month-old infants, the schedule calls for two flu shots that contain
12.5 micrograms of thimerosal each to be given a month apart. “That total
of is the same amount that was in vaccines some parents believe triggered their
child's autism," Olmsted advises. "And some of them believe in utero
exposure to mercury via the pregnant mother might be the most dangerous exposure
of all,” he said.
When deciding whether mercury-laced flu vaccines are safe for children, parents
had better think long and hard before rolling the dice.