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Published: April 29, 2006 at 8:16 PM
By DAN OLMSTED
UPI Senior Editor
When 12-month-old Jimmy Flinton joined a clinical trial of a new immunization
for chickenpox, measles, mumps and rubella, no one told his family it contained
about 10 times the usual dose of live-virus chickenpox vaccine.
And no one considered whether his family's unusual chickenpox history --
including adolescent shingles and herpesvirus in the eyes -- might raise the
risk of adverse reactions to the vaccine.
Now that Jimmy has been diagnosed with regressive autism, they wish someone had
done so.
In 2002 Jimmy's mom, Jennifer Flinton, signed a seven-page "Research Subject
Consent Form -- Vaccine Study (Children)" at the office of her pediatrician in
Olympia, Wash.
"Your child is invited to be in a research study," reads the form, which lists
Merck & Co. of Whitehouse Station, N.J., as the sponsor. "You need to decide
whether or not you want your child to be in this study. Please take your time to
make your decision."
The purpose was "to test the safety of the study vaccine, ProQuad refrigerated
and to show that this vaccine provides a similar level of protection as compared
to another study vaccine, ProQuad frozen." Both versions contained attenuated --
substantially weakened -- live viruses designed to trick the body into
developing immunity to real-live measles, mumps, rubella (German measles) and
chickenpox.
Previously, those first three vaccines were combined into one shot called the
MMR, made by Merck; the chickenpox vaccine came in a separate shot called
Varivax, also by Merck.
ProQuad was Merck's investigational vaccine designed to put all four in one
shot.
Tests already had determined ProQuad required more chickenpox virus than Varivax
to produce the same level of immunity. A phenomenon called immune interference,
in which viruses interact and interfere with each other in the human body,
rendered the dose from the standalone vaccine insufficient.
The consent form Jennifer Flinton signed did not say anything about more
chickenpox virus. It simply said ProQuad was "a combination of two licensed
vaccines," the MMR and Varivax.
Merck wouldn't confirm exactly how much more chickenpox virus is in ProQuad,
characterizing it only as "higher." But in 2004, a Merck scientist said the
amount in ProQuad was "about a log" -- 10 times -- higher, according to minutes
of a meeting at the Centers for Disease Control and Prevention.
As already reported in this series, Jimmy Flinton's family is one of several in
the same Olympia neighborhood who spotted a common thread: They had unusual
histories of chickenpox and other herpesviruses in their families; their child
got the chickenpox and MMR shots in close temporal proximity, often at the same
12-month office visit when both are first recommended; and the child
subsequently was diagnosed with regressive autism.
Jimmy is one of two children who were in small trials at age 12 months of
chickenpox and MMR vaccines. Jimmy's group had 33 participants, according to the
Western Institutional Review Board in Olympia, which approved the protocol.
The second child was among 68 trialing Merck "process upgrade" chickenpox shots
given with the standard MMR.
The local trials were part of Merck studies of the vaccines in the United States
and abroad. Spokeswoman Christine Fanelle would not address whether any other
cases of autism had been reported in the broader trials, but she emphasized that
neither Merck not independent experts have found a relation between vaccines and
autism.
"We don't see an association," she said, citing as confirmation a 2004 report by
the widely respected Institute of Medicine, part of the National Academies. That
report rejected a link between autism and either the MMR vaccine or the
mercury-based vaccine preservative thimerosal, and it urged that research
dollars be spent on "more promising" autism research.
"There will always be some people who say vaccines cause autism despite the lack
of scientific evidence," Fanelle said.
Based on their admittedly anecdotal observations, however, the Olympia parents
are concerned that inherited problems handling vaccine viruses may be an
overlooked risk factor for autism in some children.
Jimmy Flinton's paternal grandmother, Mary Southon, had a routine case of
chickenpox in kindergarten. Fifteen years later, in 1970, she developed shingles
on her right leg -- painful, blister-like pustules at nerve endings caused by
reactivated chickenpox virus.
That is decidedly not routine. Shingles usually occur in older people or those
with immune suppression, such as cancer patients undergoing chemotherapy.
"I was a healthy 20-year-old woman," Southon said, recalling her surprise at the
outbreak. The infection lasted several weeks and left her with permanent mild
circulatory weakness in her leg and edema just above the ankle.
"I remember how painful it was and how it seemed to go on for the longest time,"
said Southon, who lives in Olympia. She was going through a divorce at the time
and suspects stress might have triggered the outbreak. She also suffered from
lifelong recurrent cold sores, another herpesvirus.
Twenty years later, in 1990, Southon made a painful mistake that reminded her of
that vulnerability.
"What happened was, I stuck a hard contact (lens) in my mouth, not knowing I was
getting a cold sore. I put it into my eye and did it with the other contact,
too.
"I developed cold sores on both corneas. That was very painful and went on for
several weeks before the doctors finally figured out what it was," she said. The
doctor put her on medication for shingles and the problem cleared up, though not
before doing damage she says will one day require cornea transplants.
Coincidentally or not, Southon said she has not had any cold sores since she
took the shingles medicine.
Her son, Paul Flinton, also had chickenpox as a child. At age 15, Paul got
shingles, too -- also remarkable, doubly so given his mother's similar history.
The shingles spread along his neck, primarily on the right side, up to his jaw
line; he even had a spot on his forehead.
"The doctor did diagnose it as shingles and was just amazed someone that young
had developed it," Southon recalled. It was also a stressful period in Paul
life's, she said, but the ongoing family pattern suggests unusual, inherited
susceptibility to the virus.
"It just seems there is a genetic weakness towards it, a tendency to pick up the
herpesvirus and run with it," Mary Southon said. Given that, they might not have
enrolled Paul son's Jimmy in the ProQuad trial if they knew it had 10 times the
standard dose of chickenpox virus.
She questioned why Merck would allow a child with Jimmy's family background to
test any chickenpox vaccine.
"It's heartbreaking to think this could have been prevented if they (Merck) had
done a little more research or had been a little more imaginative in
(considering) what could have happened," she said.
"I just think the rush to develop the vaccine is criminal. Why would they want
to give babies 10 times the amount of the virus? Where is the thinking on that?"
Several vaccine researchers who remain concerned abut a possible autism link
told this column they find the Olympia cluster, and Jimmy's case in particular,
deeply disturbing. The children's histories fit one of the major vaccine-autism
hypotheses like a surgical glove: the idea that interference among live viruses
in vaccines could warp the body's natural immune response, leading to persistent
infection and delayed neurological problems.
After Age of Autism outlined the cases to him last month, British
gastroenterologist Dr. Andrew Wakefield -- the chief proponent of that
controversial theory -- met with several of the Olympia parents. He called their
stories heartbreaking and likened the experience to "staring into an abyss" of
unintended vaccination consequences that he fears are not confined to Olympia.
"The key to many of the problems you see with viral vaccines is interference,"
he said afterward.
"The host control of a viral infection is fundamentally mediated through an
adequate immune response, and that immune response has been conditioned by tens
of thousands of years of evolution," said Wakefield. "And the outcome of an
infection is dependent on the pattern of exposure.
"So measles is innocuous when encountered under normal circumstances of dose and
age of exposure. But when it's encountered under atypical circumstances early in
life, particularly at high dose, then the outcome is very different. And the
problem for these viruses is persistence and delayed disease," he said.
"So if they can establish persistent infection, elude the host immune response,
then they can all come back and cause delayed disease later in life."
"And herpesviruses do exactly the same thing," he added.
"What alarms me about the cavalier approach of the industry and everybody else,
the regulators, to these viruses is they presume the wild infection to be nasty
and the vaccines to be innocuous -- that they can manipulate something that is
biologically highly intelligent and exploit it to their advantage.
"And they can't. The viruses don't behave like that and they never will. They
merely come back to haunt you as something different."
Wakefield, who left Britain in the wake of the controversy generated by his
theories and now is conducting research in the United States, said it is
well-established that problems coping with viruses can be inherited. His
theories are based on research into the MMR vaccine; Britain does not give
routine chickenpox immunizations.
The Institute of Medicine's 2004 report dismissed Wakefield's concerns as
speculation untethered to any scientific foundation. It said "the body of
epidemiological evidence favors rejection of a causal relationship between the
MMR vaccine and autism. ... The committee further finds that potential
biological mechanisms for vaccine-induced autism that have been generated to
date are theoretical only."
"The overwhelming evidence from several well-designed studies indicates that
childhood vaccines are not associated with autism," said Dr. Marie McCormick of
the Harvard School of Public Health, who chaired the IOM's immunization review
committee.
"We strongly support ongoing research to discover the cause or causes of this
devastating disorder. Resources would be used most effectively if they were
directed toward those avenues of inquiry that offer the greatest promise for
answers. Without supporting evidence, the vaccine hypothesis does not hold such
promise."
The CDC, whose Advisory Committee on Immunization Practices recommends the
childhood vaccination schedule that states adopt, funded the Institute of
Medicine study along with the National Institutes of Health.
"Groups of experts, including the American Academy of Pediatrics, agree that MMR
vaccine is not responsible for recent increases in the number of children with
autism," the CDC noted.
"The existing studies that suggest a causal relationship between MMR vaccine and
autism have generated media attention," the CDC said. "However, these studies
have significant weaknesses and are far outweighed by the epidemiologic studies
that have consistently failed to show a causal relationship between MMR vaccine
and autism."
On Oct. 30, 2002, James George Flinton had his blood drawn as a baseline for the
clinical trial in Olympia. At the same office visit, he got the ProQuad shot --
the refrigerated version, as it turned out.
For his participation, Jimmy's family got a $50 gift certificate, with another
to come at the end of a 42-day safety follow-up period when his blood would be
drawn again to see if ProQuad worked.
Last September, the Food and Drug Administration approved frozen ProQuad for
children 12 months to 12 years old. Merck said it is still working on the
refrigerated version.
Next: Downward spiral
This ongoing series of columns on the roots and rise of autism welcomes reader
response. Links to all the columns are available at theageofautism.com. E-mail:
dolmsted@upi.com
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