A small but groundbreaking study of infants who received vaccines
containing a mercury-based preservative has found that the levels of
mercury in their blood were well within the federal safety limits.
The study, reported last week in the Lancet, medical journal
based in London, also found that infants excrete the mercury much
faster than expected, suggesting that it does not build up from one
vaccination to the next.
The preservative, thimerosal, is no longer used in U.S. vaccines
for infants younger than 6 months old, but the issue is important to
parents of children who did receive thimerosal-containing vaccines
as infants and are now autistic. Thousands of those parents have
filed hundreds of damage claims or lawsuits against thimerosal's
maker. A clause protecting Eli Lilly & Co., the manufacturer, from
lawsuits was mysteriously slipped into the domestic security law
signed by President Bush on Nov. 25.
The director of the Institute for Vaccine Safety at Johns Hopkins
University, Dr. Neal Halsey, praised the study as "much needed and
done quite well," although more work needs to be done, he said,
especially on underweight babies and long-term follow-up.
FINDINGS 'VERY MUCH OFF-BASE'
But Sallie Bernard, director of Safe Minds, a parents group suing
the vaccine industry, vehemently attacked it, calling its optimistic
conclusions "very much off-base."
Mercury is unquestionably poisonous. At extreme doses, it causes
tremors and madness. Children who accidentally get high doses tend
to speak and walk later and have tics and lower intelligence, but
not autism, medical experts say.
Small amounts, however, are common in soil and plants, in power
plant fumes and in dental fillings. Fish are the largest source for
humans, and a tuna sandwich may contain more mercury than a vaccine
shot.
No scientific study has proved that thimerosal causes any ill
effects, but at the urging of federal health officials, vaccine
makers began eliminating it in mid-1999. The study began with that
recommendation.
Thimerosal, which kills fungi and bacteria, is still used to
preserve vaccines sent to the Third World, and the World Health
Organization defends it.
The vaccines prevent common diseases there, so the benefits far
exceed potential side effects. Also, vaccines there must survive
dirtier storage conditions and are shipped in bottles containing a
number of doses to save money.
HOW STUDY WAS CONDUCTED
The Lancet study, led by Dr. Michael Pichichero of the University
of Rochester, tested the blood, urine and stool of 33 infants ages 2
months to 6 months, all of them seen by Rochester pediatricians
injecting thimerosal- containing vaccines. They were compared with
15 infants seen at a clinic in Bethesda, Md., that used mercury-free
vaccines.
In their first six months, children typically receive three doses
of diphtheria-tetanus-pertussis vaccine, one or two for hepatitis B,
and sometimes up to three for haemophilus influenza. Other vaccines,
such as polio,
may not contain thimerosal.
The Environmental Protection Agency's safe level for mercury in
children's blood is 5.9 parts per billion. That, Pichichero
explained, is based on a study of children in the Faeroe Islands,
southeast of Iceland, whose mothers ate whale blubber polluted with
mercury and PCBs. When the mothers had 59 or more parts per billion
of mercury in their blood while pregnant, their children scored
lower on intelligence tests several years later. The EPA took
one-tenth of that -- 5.9 parts -- as a safe level.
All but one of the infants in the group exposed to thimerosal had
blood levels of 1 to 3 parts per billion; the one exception went to
4.1. In the mercury-free control group, only one baby had even a
measurable level of mercury.
The babies had high concentrations of ethyl mercury in their
stools, indicating it was being rapidly excreted. Its half-life in
the blood appeared to be seven days, which surprised the
investigators, Pichichero said, since methyl mercury, the kind found
in fish, has a half-life of 45 days.
Quick excretion suggests that the thimerosal mercury would not
build up in the brain from a child's two-month shots to the
four-month and six-month shots,
causing cumulative damage, said Halsey of the vaccine safety
institute. That conclusion was reassuring, he said.
"I give the investigators lots of credit for acting quickly and
doing a study that a lot of people didn't want to do," he added.
"Who wants to sit down and say to parents, 'We're giving your babies
vaccines containing mercury'?"
But Bernard of Safe Minds called the study "small and mediocre"
and said it was alarming that The Lancet had given it such
prominence.
She complained that Pichichero had done studies for Eli Lilly and
other vaccine makers, that 33 children were too few to be conclusive
and that blood had been drawn several days after immunizations, so
peak levels might have been missed.
Bernard also pointed out that the child with the 4.1 mercury
level was of high-normal weight and had received only about 60
percent of the thimerosal that children received under typical
immunization regimens of the 1990s.
That the child approached the EPA's safe level suggested, she
said, that a smaller child receiving all thimerosal-containing shots
might exceed it.
Pichichero acknowledged that he had done antibiotic studies for
Lilly and vaccine studies for other companies, but he said that this
one was paid for by the National Institutes of Health.
He agreed that the size of the sample was relatively small and
said a follow-up study of 200 children was under way in Argentina,
where thimerosal is still used. Some children as small as four
pounds would be included in that study, he said, and blood would be
drawn within hours of vaccination.
He did not disagree that, theoretically, an underweight child
might exceed the EPA safe level.
"We recognize those shortcomings," Pichichero said, but he argued
that they did not invalidate his conclusions. Mercury levels in the
body take days to stabilize, he said, adding that damage to fetuses
is greater than to infants and that neurological damage is thought
to result from long-term high mercury levels, not brief peaks.