Tuesday, August 03, 2004 By Annette Fuentes,
for E/The Environmental Magazine
http://www.enn.com/news/2004-08-03/s_25228.asp
No one could accuse Lyn Redwood of being anti-vaccination or suspicious
of the medical establishment. After all, the Atlanta, Georgia resident
was a nurse practitioner and member of her county's board of health,
which promoted childhood vaccination. But in 1999, when her happy,
healthy toddler, Will, began to regress developmentally at 15 months-he
lost speech, he avoided eye contact and seemed miserable-Redwood set
out to learn why. And her quest led to thimerosal, a preservative used
in some vaccines that is 49.6 percent ethylmercury, a known neurotoxin.
Redwood had received two
thimerosal-containing injections of RhoGam while pregnant because
her blood was Rh negative. Will got all the
recommended vaccines for infants, including multiple shots of Hepatitis
B, Haemophilus influenzae B (HiB) and diphtheria-tetanus-pertussis
(DTaP)-all containing thimerosal. By her calculations, Redwood's son
has been exposed to mercury in quantities far exceeding safe levels.
To Redwood, the cause of Will's illness was clear: mercury poisoning. "If
someone had told me prior to 1999 that vaccines were responsible for
my son's disabilities, I would have thought they were crazy," she
says.
Thousands of parents like Lyn Redwood have watched their normal children
suddenly become ill, exhibiting symptoms called autism spectrum disorders.
From Attention Deficit Disorder (ADD), Attention Deficit Hyperactivity
Disorder (ADHD) and Asperger's Syndrome on one end of the spectrum,
to severe forms of autism on the other, these illnesses have seemingly
exploded into what many consider an epidemic in just the last decade.
Autism was rare, diagnosed in one in 10,000 children, before 1980.
But in 2002, the National Institutes of Health estimated that one in
250 U.S. children were affected. The Autism Society of America projects
that autism disorders are increasing by 10 percent every year. Boys
are four times more likely than girls to be diagnosed with autism spectrum
disorders, a disparity some scientists attribute to hormonal differences.
Genetics may also play a role in susceptibility. Some critics counter
that rises in autism rates may be better attributed to increasing awareness
among parents and doctors of autism than to any environmental toxin.
But for Redwood and a growing number of activists and scientific researchers,
the key to autism disorders is thimerosal. Can it be mere coincidence,
they ask, that the rise in autism began during the same period when
the number of vaccines was tripled? In the early 1990s, the federal
Food and Drug Administration (FDA) approved for use Hepatitis B and
HiB vaccines for infants and children, and the Centers for Disease
Control and Prevention (CDC) added them to its list of recommended
childhood vaccines.
The total number of vaccines containing mercury increased to 11, containing
a cumulative total 237.5 micrograms of ethylmercury injected into children
during the first year and a half of their lives. There are no standards
on acceptable exposure to ethylmercury, unlike its chemical (and more
toxic) cousin methylmercury, which is found in fish in polluted oceans.
Lax Safety Tests
Although thimerosal, invented
by the Eli Lilly company, has been used to preserve vaccines since
the 1930s (and was used in over-the-counter
products, such as eye drops, nasal sprays and topical antiseptics)
the FDA has never required testing of its safety or of safe levels
of exposure in newborns and children. And the CDC never considered
the consequences of increasing infants' exposure to mercury as it multiplied
the number of suggested vaccines. CDC immunization expert Roger Bernier
explains, "Vaccines tend to be evaluated on an individual basis,
and a holistic view of safety was not part of the review."
Through her research, Redwood
found allies in a group of parents of autistic children who were
also seeking answers. They founded Safe
Minds, an advocacy group that has also conducted studies, including "Autism:
A Novel Form of Mercury Poisoning," published in 2001 in the journal
Medical Hypotheses. The study shows the symptoms of mercury poisoning
were virtually the same as those in autism disorders. Safe Minds took
their findings to government agencies. Redwood says, "We petitioned
the FDA unsuccessfully on three occasions to take thimerosal off the
market."
Congress had requested the
FDA in 1997 to review mercury in products, and in 1998, the agency
had banned all over-the-counter products containing
thimerosal. A year later, the FDA, CDC and National Institutes of Health
issued a joint statement with the American Academy of Pediatrics that
urged vaccine manufacturers to stop using thimerosal because of a "theoretical
potential for neurotoxicity."
In February 2000, scientist Thomas Verstraeten presented the first
of several analyses of the CDC's Vaccine Safety Datalink, a patient
record database that includes information on children vaccinated who
developed neurological disorders. Verstraeten's earliest findings showed
a risk of autism 2.48 times greater for infants who received the highest
amounts of mercury in vaccines. A June 2000 analysis showed a connection
between thimerosal exposure and language, speech and developmental
delays for infants up to six months old.
A Blizzard of Suits
In the years since, the thimerosal-autism connection has become a
hotly contested issue, and one with tremendous political and economic
implications. Hundreds of parents have filed lawsuits against Eli Lilly,
GlaxoSmithKline and other companies that used thimerosal. In November
2002, Congress sought to protect the drug giants from such legal action
by inserting a liability waiver in the Homeland Security Act. Three
months later, public outcry forced its repeal. Although the FDA and
CDC requested that thimerosal be removed from vaccines, no direct ban
was ever issued, and the agencies' scientists have steadfastly defended
thimerosal.
In November 2003 a study published in Pediatrics, and co-authored
by Verstraeten, presented the final analysis of the CDC's database.
All of the positive findings of neurological delays and autism have
disappeared. Safe Minds and other critics argue this is a product of
questionable methodology and selective data use. Verstraeten's current
status as an employee of GlaxoSmithKline was excluded from the article.
WebMD reports that the federally
funded study published in The Lancet the same month by lead researcher
Michael E. Pichichero "offers
reassurance to those who are concerned about the health risks of vaccines
containing the preservative thimerosal." WebMD concludes, "Researchers
found that blood mercury levels in vaccinated infants were well below
those considered safe and that mercury was eliminated from the body
much faster than expected." [1]
But Boyd Haley, a toxicology
researcher at the University of Kentucky and expert on mercury issues,
says he questions the validity of the
study. In February of this year, the California Environmental Protection
Agency issued a report in response to a petition made by the Bayer
Corporation, which was asking the state not to classify thimerosal
as a reproductive and developmental toxin under clean water rules.
The California agency reviewed the scientific literature and concluded
that thimerosal should be considered toxic. Says vaccine researcher
Mark Geier, "This is another powerful piece of evidence showing
that thimerosal has no place in vaccines."
Today, thimerosal is still
used in some vaccines given to children, including Fluzone by Aventis
Pasteur, which is provided in multi-dose
vials. Thimerosal is also present in what are called "trace" amounts,
defined as less than half a microgram of mercury per dose, in several
pediatric vaccines, including a Hepatitis B shot from GlaxoSmithKline.
Infants and children, with their less-developed immune systems and
still-growing neurological systems, are more vulnerable to mercury's
toxicity, but everyone may want to read vaccine labels before being
stuck with a needle. FluMist from MedImmune is an example of a thimerosal-free
vaccine.
Annette Fuentes lives in upstate New York and writes frequently on
health topics.
[Comment and abstract: The Pichichero et al study reported thimerosal
levels in infants and concluded, not enough ethylmercury to do harm.
Subsequently, Waly et al found that at the ethylmercury levels described
by Pichichero et al, ethylmercury inhibited enzymes important for neuronal
development.]
1: Mol Psychiatry. 2004 Apr;9(4):358-70.
Activation of methionine synthase by insulin-like growth factor-1
and dopamine: a target for neurodevelopmental toxins and thimerosal.
Waly M, Olteanu H, Banerjee R, Choi SW, Mason JB, Parker BS, Sukumar
S, Shim S, Sharma A, Benzecry JM, Power-Charnitsky VA, Deth RC.
Department of Pharmaceutical Sciences, Northeastern University, Boston,
MA 02115, USA.
Methylation events play a critical role in the ability of growth factors
to promote normal development. Neurodevelopmental toxins, such as ethanol
and heavy metals, interrupt growth factor signaling, raising the possibility
that they might exert adverse effects on methylation. We found that
insulin-like growth factor-1 (IGF-1)- and dopamine-stimulated methionine
synthase (MS) activity and folate-dependent methylation of phospholipids
in SH-SY5Y human neuroblastoma cells, via a PI3-kinase- and MAP-kinase-dependent
mechanism. The stimulation of this pathway increased DNA methylation,
while its inhibition increased methylation-sensitive gene expression.
Ethanol potently interfered with IGF-1 activation of MS and blocked
its effect on DNA methylation, whereas it did not inhibit the effects
of dopamine. Metal ions potently affected IGF-1 and dopamine-stimulated
MS activity, as well as folate-dependent phospholipids methylation:
Cu(2+) promoted enzyme activity and methylation, while Cu(+), Pb(2+),
Hg(2+) and Al(3+) were inhibitory. The ethylmercury-containing preservative
thimerosal inhibited both IGF-1- and dopamine-stimulated methylation
with an IC(50) of 1 nM and eliminated MS activity. Our findings outline
a novel growth factor signaling pathway that regulates MS activity
and thereby modulates methylation reactions, including DNA methylation.
The potent inhibition of this pathway by ethanol, lead, mercury, aluminum
and thimerosal suggests that it may be an important target of neurodevelopmental
toxins.
PMID: 14745455 [PubMed - in process]
Parents say mercury in shots caused their
children's autism, and they want drug firms to pay. The industry calls
its defense rock-solid.
By Myron Levin LA Times Staff Writer August 7, 2004
http://www.latimes.com/business/la-fi-vaccine7aug07,1,2478873.story

As parents of two severely autistic boys, Kevin and Cheryl Dass
of Kansas City, Mo., face a world of heartache and worry.
Last year Kevin, a FedEx driver, and Cheryl, a part-time hairdresser,
spent $27,000 on therapy for their sons. Financially exhausted, they
are gnawed by these questions:
How will they continue the special help that Dillon and Kyle, their
4 1/2 -year-old twins, so desperately need? Will the boys — who barely
speak, are not toilet-trained and go bonkers when taken out in public
— ever be able to live on their own? If not, what will become of
them when Kevin and Cheryl are gone?
"It's torn our life apart, it really has," Kevin
Dass says.
And, he insists,
it didn't have to happen. The boys were born prematurely and alarmingly
small.
Yet at 3½ months, Dass says, they were
given four shots in a single day, including three containing small
amounts of mercury, a neurotoxin.
"They were still in the hospital on oxygen, staying alive,
and they put this poison in them," Dass says. "They were
fried. They were totally fried."
Like many anguished parents of autistic kids, the Dasses blame the
condition on thimerosal, a mercury-based preservative that until
recently was added to many routine children's shots.
Thimerosal was used to keep bacteria out of vaccines sold in multi-dose
vials. But there were no studies beforehand of its possible effects
on the developing brains of infants. And health officials, who aggressively
expanded immunizations during the 1990s, did not consider that mercury
exposure for millions of children would exceed federal guidelines.
Now, in a dispute
overflowing with bitterness and rancor, more than 4,200 families,
including
the Dasses, are demanding compensation
to help pay for their kids' special needs. Their claims have inundated
an obscure branch of the U.S. Court of Federal Claims in Washington,
sometimes called the "vaccine court."
The parents are pushing a disturbing theory: that their children
were casualties of the war on disease, suffering brain damage from
thimerosal by itself or in combination with measles virus in the
measles-mumps-rubella vaccine. They blame mercury from vaccines and
other sources for an epidemic rise in autism and related neurological
disorders.
They theorize that their children were devastated because they were
less able than most kids to clear mercury from their bodies.
Vaccine makers and health officials strenuously dispute the claims.
While voicing compassion for the children and their families, they
say there is no proof that tiny exposures — typically 1 part mercury
per 10,000 parts of vaccine — can cause brain damage.
"There's simply no reliable scientific evidence" that
thimerosal causes autism, said Loren Cooper, assistant general counsel
for GlaxoSmithKline, the global pharmaceutical giant.
Dr. Stephen Cochi,
head of the national immunization program at the U.S. Centers for
Disease
Control and Prevention, argues that
only "junk scientists and charlatans" support the thimerosal-autism
link.
In May, a committee
of the national Institute of Medicine declared that evidence "favors rejection" of the thimerosal-autism
link. Opposing studies, the panel said, were riddled with "serious
methodological flaws."
In response, parent activists point out that some studies have indicated
a link. They also charge that data were manipulated in one key study
cited by the Institute of Medicine, and that authors of other studies
had ties to vaccine makers.
At stake are not only vast sums of money but reputations and careers.
Vaccine makers face a potential litigation nightmare. And the allegations
confront two agencies: the Food and Drug Administration, which licenses
vaccines, and the CDC, which is in charge of seeing that children
are immunized against everything from polio to whooping cough.
The immunization program has been hailed as a spectacular success,
responsible for saving countless children from illness and death.
But if the parents are right, thousands of their children have become
collateral damage.
For now, the main battleground is a tiny tribunal most people have
never heard of.
The vaccine court was created in 1986 as Congress' response to a
liability crisis. In rare cases, vaccines were being blamed for catastrophic
injuries and even death. Makers were threatening to quit the business,
which in turn threatened the vaccine supply.
The National Vaccine Injury Compensation Act shielded the industry
from civil litigation by instituting a system of no-fault compensation.
Under the law, aggrieved families file petitions, which are heard
by special masters in the vaccine court. Successful claims are paid
from a trust fund fed by a 75-cent surcharge per vaccine dose. The
Department of Health and Human Services oversees the fund, with the
Justice Department acting as its lawyer.
The autism case is approaching a crucial stage: a hearing within
the next few months in which experts will joust over whether mercury
causes autism.
If the verdict is no, the case ends there. If the special master
finds for the parents, individual claims will be heard. A flood of
successful claims could exhaust the $2-billion fund.
Big vaccine makers such as Merck, Wyeth and Aventis-Pasteur, along
with Glaxo, are watching with trepidation. Though safe from liability
in the vaccine court, they are anxious because claims have begun
to leak into the civil courts.
Under the law, petitioners who have gone more than 240 days without
a ruling in the vaccine court can opt out and file a civil suit.
More than three dozen families who've waited long enough have opted
out, and more are sure to follow. A handful of suits are set for
trials next year in Texas, Pennsylvania, Maryland and Georgia.
A legal Catch-22 could doom many claims in both the vaccine court
and civil courts. The compensation law requires that petitions be
filed within three years of the first sign of injury. In many cases,
by the time children were diagnosed with autism and parents learned
of their mercury exposure, the deadline had passed. This technicality
could cause as many as 60% of the petitions to be discarded in the
vaccine court, lawyers for the parents say. And some civil courts
have decreed that people who did not file on time in the vaccine
court can't pursue civil litigation.
"The parents are going through hell. The children are going
through hell," said Richard Saville, a lawyer for some of the
parents. "What we're trying to avoid … is a situation in which
no court ever hears their complaint."
Even so, families who reach the civil courts may gain some advantages
there. They will have access to internal industry documents that
are not available in the vaccine court. Moreover, whereas the vaccine
court pays medical and living costs and up to $250,000 for pain and
suffering, civil juries can award punitive damages as well.
Vaccine makers insist that their defense is rock-solid.
The evidence "is so overwhelmingly one-sided that we are confident
that juries will overcome their natural sympathy for plaintiffs and
decide these cases as science dictates," said Daniel J. Thomasch,
lead outside counsel for Wyeth.
Privately, however, some industry figures conceded that when it
comes to sick children and brokenhearted parents, science doesn't
always win the day.
The companies "are terrified" of huge jury awards because "the
injuries are so grave," said Kevin Conway, a lawyer for parents. "It's
not just the kids, it's the parents, it's the siblings. These people
just live emotionally exhausted and financially devastated lives."
Even if the companies are exonerated, victory will not come cheap.
An industry representative, who predicted vaccine makers will win
every case, said it could cost them hundreds of millions of dollars
to do so.
Autism is the most severe of a range of neurological conditions called
autism spectrum disorders. It limits the ability to communicate,
form relationships and respond appropriately to the environment.
Symptoms can include loss of language and eye contact, extreme withdrawal,
violent or repetitive behavior, and extreme sensitivity to light
and sound.
One in every 166 U.S. children suffers from an autism spectrum disorder,
according to an estimate by the CDC and American Academy of Pediatrics.
In California, the number of cases rose 273% from 1987 to 1998, according
to the state Department of Developmental Services.
It's been suggested that broader definitions and better reporting
are behind the apparent spike. But a study in 2002 by the MIND Institute
at UC Davis found that these are at most minor factors, and that
the increase is real.
In the search for a cause, thimerosal only recently became a suspect.
The compound is 49.6% ethyl mercury, not the methyl mercury found
in fish and power plant emissions. Both forms are toxic, though some
research suggests ethyl mercury is more quickly purged from the body.
Developed 75
years ago by Eli Lilly & Co., thimerosal has been
used in vaccines since the 1930s and was the main ingredient in Merthiolate,
an antiseptic daubed on millions of skinned knees before it was taken
off the market 20 years ago.
Medical literature includes reports of thimerosal poisoning at a
sufficient dose — along with advice to curb its use. Perhaps most
alarming was a 1977 report on the thimerosal-linked deaths of 10
babies in Canada.
According to
the article in Archives of Disease in Childhood, the antiseptic
had been used
to treat exomphalos, a type of umbilical
hernia. Tissue and blood tests revealed high mercury levels in the
dead infants. Moreover, the authors said, it "is extremely unlikely" that
babies who survive the treatment "escape neurological damage,
which may be subtle."
Mercurial antiseptics
should be tightly restricted or banned from hospitals, they wrote, "as
the fact that mercury readily penetrates intact membranes and is
highly toxic seems to have been forgotten."
However, thimerosal remained the most popular of several preservatives
used by vaccine makers to avoid the risk of bacteria from repeated
needle insertions into multi-dose vials. Vaccines also come in single-dose
vials or disposable syringes that do not require preservative. But
doctors and clinics traditionally preferred multi-dose vials because
they were cheaper and easier to store.
No one would have cared but for this confluence of trends: autism
rates were rising, while more mercury was being injected into kids.
The CDC sets the country's immunization schedule, which, in effect,
has the force of law, since in many places children can't enter day
care or school or qualify for public assistance unless their shots
are up to date.
Mercury exposure increased markedly in 1991, when the CDC added
hepatitis B and Haemophilus influenza type b, or Hib, vaccines to
the schedule.
Because these were mostly sold in multi-dose vials, children whose
dutiful parents stayed current with their shots received as many
as nine injections with as much as 187.5 micrograms of mercury in
their first six months of life — exposures well above Environmental
Protection Agency guidelines.
This was disclosed in 1999 in a federal review, which showed that
health authorities had ignored the rising exposures as they added
shots.
In e-mails to
colleagues at the time, Dr. Peter Patriarca, a senior FDA official,
acknowledged
that the agencies were open to attack.
The FDA could be charged with "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," he said in a June 29, 1999, e-mail later
disclosed at a congressional hearing.
It didn't take "rocket science" to track the rising exposures,
Patriarca wrote. Critics may wonder "what took the FDA so long
to do the calculations? Why didn't CDC and the advisory bodies do
these calculations when they rapidly expanded" childhood immunizations?
In July 1999, the CDC and American Academy of Pediatrics called
on vaccine makers to remove thimerosal as a precaution. Manufacturers
began switching to single-dose containers. By 2002, thimerosal was
present only in trace amounts in routine vaccines.
Now it is making something of a comeback. This year, the CDC added
flu shots to the vaccine schedule for children 6 months and older.
Aventis, the only producer of flu vaccine for infants and toddlers,
makes it both in single-dose and mercury-containing multi-dose vials.
The CDC has spurned appeals to recommend thimerosal-free shots for
all children and pregnant women — fearing parents might refuse a
shot for their kids if they couldn't get it mercury-free.
Exasperated by the agency's stance, lawmakers have filed bills in
Congress and several states, including California, to ban thimerosal
from pediatric vaccines.
Cochi of the
CDC says such bills are ill conceived. He says children die of
the flu,
including more than 140 last year, while the risks
of thimerosal are at most theoretical. He blames the uproar on those
eager "to capitalize on the tragedy of parents with children
who have autism, because they see a huge pot of gold at the end of
the rainbow."
"That's the other side of this story," Cochi said, "that
it has the potential to be a gigantic scam on the American taxpayer."
Of all the resentments of the parents, the idea that they are out
for a buck seems to gall them the most.
And when they talk about their lives — the social isolation, financial
distress and bleak prospects of their children — many can't help
but weep. At such times, it's easy to see why vaccine makers would
rather not face them in court.
Kyle and Dillon Dass arrived three months early in January 2000
— weighing 1 pound, 7 ounces and 2 pounds, 15 ounces, respectively.
That was six months after the appeal to remove thimerosal from vaccines.
Kevin, their
father, keeps a copy of an advisory sent to doctors by the Academy
of Pediatrics
shortly before his sons were born. "If
there are limited supplies of thimerosal-free products available,
priority should be given to use in premature infants," it says.
At 3 1/2 months, the boys got four shots in one day. Three contained
thimerosal, according to medical records the Dasses later obtained.
At the time,
the couple had never heard of thimerosal, but Cheryl Dass said
she questioned
giving several shots to her tiny babies.
She did not put up a fight, however, deciding, "Oh well, you
know what you're doing because you save lives everyday."
Lyn Redwood, who lives near Atlanta, says her son Will began receiving
doses while still in the womb.
Redwood, a former nurse, had amniocentesis during pregnancy. Because
her blood was Rh negative, after the procedure she was given shots
of gamma globulin to protect her fetus from an illness called Rh
incompatibility disease.
Years later, Redwood said, she was amazed to learn that the two
gamma globulin shots during pregnancy, and a third when she was breast-feeding,
contained thimerosal.
Will, who has pervasive development disorder, a milder form of autism,
had received an additional 237.5 micrograms of mercury in vaccines
by the time he was 1 1/2 , Redwood said.
Even so, he seemed
to progress nicely until his first birthday. Redwood recalled that
he started to walk, talk and generally do things
on time — before suddenly regressing and slipping away. "He
stopped looking at us. He stopped playing…. It was like 'Invasion
of the Body Snatchers,' " she said. "Somebody had taken
away my baby's soul and just left a shell of him in there."
The bizarre and disruptive behavior of many autistic children can
make their families virtual prisoners in their homes.
Going out in
public "is a train wreck," said Cheryl Dass.
It's impossible to do the family things others take for granted,
like going to a movie or church or "even to pick out a pumpkin."
Kelly Kerns of
Lenexa, Kan., who has an autistic daughter and twin sons, said, "We're
not the families that are doing baseball and birthday parties.
"I'm a mother that lives in a tunnel," she said. "I
haven't been to a family reunion in four years. My family doesn't
understand. They wouldn't understand.
"I used to be a decent person, and I just have acid rolling
from my lips every time I open my mouth," Kerns said. "I
ask God every day what did I do to deserve this. What did these kids
do to deserve what they got?"
Some parents are hopeful, though not holding their breath, for help
from the vaccine court. Others say they'd just as soon get a chance
to bloody the industry in a civil trial.
Said Georgia
Mueller of Kansas City, who has an autistic son: "I
want it to hurt" the manufacturers, because they "never
did the research to make sure this was safe."