Autism in a Needle?
The toxic tale of vaccinations and mercury poisoning
By
Annette Fuentes | 11.11.03
Lyn Redwood’s son Will was a healthy, happy baby who met all the normal
developmental standard. He was walking and talking by one year. About three
months later, however, he began to regress, losing speech, avoiding eye contact
and appearing miserable. He didn’t seem happy anymore, Redwood said in a
recent interview. He just wanted to sit in his infant seat and watch
videos over and over again.
Doctors initially blamed hearing problems for Will’s decline. Neurologists told
the parents that their son had global and receptive speech delay. At age 5, the
boy was diagnosed as autistic by his school.
Seeking answers to her son’s condition, Redwood turned to the Internet in 1999
and began a search that led to startling discoveries about thimerosal. This
vaccine preservative is composed of nearly 50 percent mercury, which is a known
neurotoxin especially harmful to fetuses, infants and children. What’s more, it
has been linked to a range of symptoms collectively known as Autism Spectrum
Disorders. At one end is severe autism, in which children are socially
withdrawn, do not speak and exhibit bizarre, repetitive, sometimes aggressive
behaviors. At the other end are Asperger’s Syndrome, a high-functioning form of
autism, Pervasive Developmental Disorder (PDD), Attention Deficit Disorder
(ADD) and Attention Deficit Hyperactivity Disorder (ADHD).
Thimerosal was widely used since the ‘40s in over-the-counter medicines until
that use was banned in 1998. It’s still found in some vaccines for adults and
infants. Its medical, political, economic and international implications
represent a chilling chapter in the history of public health, in which
regulatory agencies were negligent, if not guilty, in covering up health
hazards, by failing to act quickly to protect millions of children. Said
Redwood, a nurse practitioner and a board of health member in her Georgia
county, where vaccination is a major public health program: If someone had told
me prior to 1999 that vaccines were responsible for my son’s disabilities, I
would have thought they were crazy.
Regulators asleep at the switch
Before 1980, autism was diagnosed in 1 in 10,000 children; in 2002, the
National Institutes of Health raised that figure to 1 in 250 children. The
Autism Society of America now estimates that autism disorders are growing by 10
percent or more annually. Some scientists believe boys are afflicted by the
neurological disorders of autism at a rate three to six times that of girls
because the female hormone estrogen protects against mercury toxicity.
In a sad twist, scientists increasingly believe that the mercury-laced vaccines
meant to protect children from illness are at the root of this spike. In 1985,
four of the shots recommended for infants in their first 18 months contained
thimerosal. By 1991, the Centers for Disease Control and Prevention (CDC) added
three Hepatitis B shots (each containing 12.5 micrograms of thimerosal) and four
Hib shots (each with 25 micrograms of mercury). As a result, the number of
vaccines containing thimerosal jumped to 11, and the amount of mercury exposure
mushroomed to 237.5 micrograms, an amount that exceeded all federal limits.
Neither the Food and Drug Administration (FDA) nor the CDC, the nation’s chief
regulatory agencies for pharmaceutical products and the watchdogs of public
health, added up the micrograms. The regulatory spotlight was finally fixed on
thimerosal in 1997 when Congress passed the FDA Modernization Act. Part of the
act required the FDA to investigate all drugs that contained mercury and
determine their effects on humans. Within a year, the FDA had called for the
removal of all thimerosal-containing products from over-the-counter products.
Thimerosal remained in more than 50 vaccines, however, until the Public Health
Service (which includes the FDA, the CDC and the National Institutes of Health)
and the American Academy of Pediatrics issued a statement in July 1999 “urging”
vaccine makers to reduce or eliminate thimerosal because of “theoretical
potential for neurotoxicity.”
Last year, the staff for Rep. Dan Burton (R-Ill.) obtained an internal e-mail
written June 29, 1999, by former FDA scientist Peter Patriarca. In that e-mail
Patriarca offered his colleagues a pros and cons assessment of the thimerosal
statement shortly before its release:
Will raise questions about FDA being “asleep at the switch” for
decades, by allowing a potentially hazardous compound to remain in many
childhood vaccines, and not forcing manufacturers to exclude it from new
products. Will also raise questions about various advisory bodies about
aggressive recommendations for use. We must keep in mind that the dose of
ethyl mercury was not generated by “rocket science”: conversion of the % of
thimerosal to actual ug [micrograms] of mercury involves 9th grade algebra.
What took the FDA so long to do the calculations? Why didn’t CDC and the
advisory bodies do these calculations while rapidly expanding the childhood
immunization schedule?
Roger Bernier, of the CDC’s national immunization program, received the
e-mail. In a recent interview he explained why the cumulative amount of mercury
was never figured. “Vaccines tend to be evaluated on an individual basis, the
requirements for safety and efficacy on an individual basis,” Bernier said.
“This holistic view of safety was not part of the review.” Bernier said the
health agencies did not order vaccine makers to stop using thimerosal and to
recall existing vaccines containing it because “this was a theoretical concern,
it was conceived as precautionary measure, not because evidence showed a risk.
There wasn’t a sense of urgency. It was viewed as something to be done”not
because we had to, but because it should be done.”
Toxicity and plausibility
While the FDA and CDC moved glacially slow on mercury, the EPA had been
since the early ‘70s aggressively educating the public about ingesting mercury
in food, especially fish, and setting standards for exposure. The inconsistent
approach to mercury is reflected in the standards agencies set for maximum daily
consumption. Set in micrograms per kilogram of body weight, the EPA’s standard
is lowest, at .1 micrograms, the FDA’s is .4 micrograms. Those guidelines are
for methylmercury, the toxic cousin of ethylmercury, which is in thimerosal.
While some government scientists defending the use of thimerosal have argued
that ethyl is less toxic than methyl, both forms will harm living tissue,
according to Boyd Haley, chair of the department of chemistry at the University
of Kentucky and an expert on toxic metals. “Some parents of autistic children
called me and asked me to look at thimerosal. We did some experiments with
human brain tissue and it was dramatic,” Haley said. “It penetrates the
proteins in the brain. It is toxic to neurons and enzymes.” Haley co-authored
an August 2003 study that showed autistic children retained more mercury in
their bodies than normal children, evidenced by higher levels of the toxin in
their hair. That means the ethylmercury from thimerosal had been absorbed into
their brain and other body tissue, likely causing neurological damage.
The July 1999 statement on thimerosal hardly put the issue to rest. For Redwood,
it was the catalyst that led to the creation of SAFE MINDS, a parents’ group
that has conducted research on the thimerosal-autism disorders link. With
several other parents of autistic children, in 2001 Redwood published Autism: A
Novel Form of Mercury Poisoning in the journal Medical Hypotheses. Their
study showed that the symptoms of mercury poisoning mirrored those of autism and
concluded that early exposure to mercury from thimerosal had caused many cases
of autism, while genetic and environmental factors made some children more
vulnerable than others. “Once we got the paper together, we contacted the NIH,
CDC and FDA,” Redwood said. “We got mixed responses. We petitioned the FDA on
three occasions to take thimerosal off the market. They turned us down.”
The CDC launched its own study of thimerosal safety in vaccines in fall 1999,
tasking Dr. Thomas Verstraeten to analyze the agency’s Vaccine Safety Datalink,
which gathers information on vaccine safety from several health maintenance
organizations. Verstraetenâ’s first report in February 2000 found a
statistically significant risk for neurological developmental disorders at age 3
months as the amount of thimerosal that babies received increased. And he found
a risk of autism 2.48 times greater for infants getting higher amounts of
thimerosal in vaccines, compared to infants who received thimerosal-free
vaccines. A June 2000 analysis by Verstraeten found a link between thimerosal
and language, speech and developmental delays during the child’s first 6 months.
Verstraeten’s initial findings were never publicly released, and SAFE MINDS
obtained copies of his reports only through Freedom of Information Act filings
in 2001. For Robert Krakow, whose son is autistic, Verstraeten’s findings were
a bittersweet discovery. “If the Verstraeten report had been publicized, my
wife would have read about it because she was up on these things and our son
wouldn’t have had thimerosal-containing vaccines,” he said. “Why is the public
not told? To protect the vaccine makers.” Verstraeten left the CDC shortly
after his presentation to work for vaccine maker GlaxoSmithKline in Belgium. He
declined to comment for this article, citing “ongoing litigation in the U.S.
regarding thimerosal.”
The thimerosal issue continues to reverberate in the scientific and public
health community. The Institute of Medicine (IOM), an advisory body created by
the National Academies of Science, convened in fall 2001 to assess thimerosal’s
potential to cause autism and other neurological problems in children. The IOM’s
statement, after assessing Verstraeten’s research and hearing testimony of
scientists such as Haley and others linking autism and thimerosal, walked a fine
line. It said in part: “Although the hypothesis that exposure to
thimerosal-containing vaccines could be associated with neurodevelopmental
disorders is not established¦ the hypothesis is biologically plausible.”
In the past year, further studies of thimerosal’s connection to autism have been
churned out in scientific journals, primarily denying any link. A December 2002
study funded by the National Institutes of Health and published in The Lancet
claimed thimerosal was safe for babies. An October 2003 study from Denmark also
purported to disprove the thimerosal-autism link. The most recent study,
published November 1 in Pediatrics by Thomas Verstraeten and a CDC colleague,
uses the same CDC database but this time erases any connection between
thimerosal and neurological damage to children.
If the CDC and FDA seemed to acknowledge the risks of thimerosal four years ago
and the need to get mercury out of medical products, today the official stance
is to circle the wagons against mounting public and scientific criticism about
its handling of the thimerosal issue.”Rational people can think differently,
but to resolve this issue they must be honest to the American people,” Haley
said of the regulators. “They could come out and say we’ve cleaned it up, we’ll
keep it out. But what they do is come up with cockamamie articles and fight
back.”
The stakes are high for the pharmaceutical industry. Eli Lilly, inventor of
thimerosal, was granted protection from lawsuits by parents of autistic
children under a short-lived provision slipped into the Homeland Security Act
in November 2002 (see sidebar). But hundreds of lawsuits now have been filed
against it and other companies, including Merck, GlaxoSmithKline, Aventis
Pasteur and American Home Products, which have used thimerosal in children’s
vaccines. An additional 4,000 claims are pending in the federal Vaccine Injury
Compensation Program. “These kids are not going to die. They are going to live
50, 60 years and the cost will be monumental,” said Krakow, a New York attorney
who filed a case with the vaccine compensation program on behalf of his son.
”The political hurdles are the bigger problem. This is so big and gets to the
heart of lots of issues, like what I call the government-pharmaceutical
complex.”
Thimerosal is global
Today, vaccine makers have removed thimerosal from almost all childhood
vaccines or created thimerosal-free alternatives. But some still have trace
amounts, such as GlaxoSmithKline”s Pediatrix, and its DTaP-Hepatitis B vaccine.
Aventis Pasteur manufactures six vaccines for adults using thimerosal,
including tetanus and flu, each with 25 micrograms of ethylmercury. Merck’s
Hepatitis B for adults contains 25 micrograms of ethylmercury. While the health
effects of that amount of mercury for adults are unknown, limiting exposure in
all forms”in foods and environmentally”should be a priority of the FDA and CDC,
according to Kentucky researcher Haley. “They should be working on getting all
the mercury out. Thimerosal suppresses the immune system, and if you have some
elderly person who has a compromised immune system, a flu shot with thimerosal
can pose a risk,” Haley said. “They are saying its OK to give to Third World
countries where children have compromised immune systems to begin with.
(Representatives for Aventis and Merck did not respond to requests for comment
on their companies’ policies on thimerosal use.) But to date, neither the FDA
nor the CDC has issued a clear preference for thimerosal-free vaccines. Many
critics believe that is a politically defensive, not a scientifically sound
one.
The Third World is the next frontier in the thimerosal debate. Eli Lilly has
licensing agreements with drug companies in 40 countries that make thimerosal
and market it under the trade name Merthiolate. In countries where sanitary
conditions are questionable, vaccine preservatives become crucial. Single-dose
vials rather than multi-dose containers have provided one solution in the United
States, but in the developing world that strategy poses challenges and costs.
The World Health Organization (WHO), which has a vast vaccination program,
assessed the thimerosal issue in 1999, prompted by the U.S. health agencies’
review. The agency echoed the U.S. position and declared in its weekly
newsletter: “With the weight of public opinion against the use of mercury of any
sort, WHO and other agencies has begun the process of reducing and removing
[thimerosal] from vaccines.” The WHO outlined a three-year plan for creating
alternative preservatives and new vaccine delivery technologies with the goal of
eventually eliminating mercury.
Yet in 2003, WHO abandoned this aggressive plan and issued a revised policy on
thimerosal, citing its own vaccine advisory committee’s decision that
ethylmercury is less harmful than methylmercury, and that “there is no reason on
grounds of safety to change immunization practices with [thimerosal]-containing
vaccines since the benefit outweighs any risks.”
What happened over four years, according to Dr. Philippe Duclos, coordinator
of WHO’s Immunization Safety Project, was a dose of reality. “Taking thimerosol
away was more tricky than originally thought,” he said. “Taking it away might
have created a vaccine with a lower safety profile. And the use of monodose
vaccines in many places is difficult because of production capacity. Changing
the capacity is a major investment, and you can’t just assume things will be
done correctly. It takes time.
Duclos insisted that recent research has shown risks associated with thimerosal
are more theoretical than real”and so far alternatives are elusive. “Vaccine
distribution in developing countries is a tricky thing. If you use monodose,
products will overload the cold chain [the process by which vaccines are
maintained at between 2 and 8 degrees Celsius]. Expanding that capacity would
take a tremendous amount of time and money and it becomes a matter of
priorities.”
For U.S. pharmaceuticals, though, the global market for vaccines containing
thimerosal is a goldmine. UNICEF, the WHO’s parent body, purchases 40 percent
of all vaccines used in developing countries and Merck is its sole supplier.
Merck makes Recombivax HB, a Hepatitis B vaccine that contains thimerosal.
Beyond the issue of thimerosal’s link to autism and developmental disorders
lies the larger question of public trust in national vaccination programs in the
United States and the developing world, where global agencies like the WHO and
its health programs can be viewed as politically suspect. The thimerosal
debacle at the FDA and CDC, with its taint of conflicts of interest with big
drug companies and compromised research, does more harm than good, given that
the medical community’s primary directive is “First, do no harm.”
“I am a farm boy. I own a farm today. I am a person who knows the value of
vaccinations,” [Haley] said. “But if the American people realize how the CDC
and the vaccine boards work, they are going to lose faith, and that isn’t my
doing. Its their own doing.”
Annette Fuentes is a New York-based journalist who writes frequently on
health and social policy issues. A contributing editor of In These Times,
she is co-author with Barbara Ehrenreich of Women in the Global Factory.
http://inthesetimes.com/members/profile_view_ind.php?id=31
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