Age of Autism article addresses viral issues

[Guest guest]

Dan Olmsted's latest article is heavy on varicella zoster. I e-

mailed him and said he should contact Stan. He e-mailed back that

one of the families he's talked to has had a pretty amazing recovery

and their child was on Valtrex.

Day 7 on Valtrex here. A few small pimples near the lips, lots more

laughing and smiling.

The article is copied below.

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The Age of Autism: Pox -- Part 1

OLYMPIA, WA, United States (UPI) -- Children in families with

problematic reactions to chickenpox virus may be at risk for

developing autism if they get that live-virus immunization too close

to other live-virus vaccines, a three-month United Press

International investigation of cases in one northwest U.S. city

suggests.

Several such families in the Washington state capital of Olympia

watched their children regress into full-syndrome autism -- losing

language and social skills and adopting repetitive behaviors -- in

the months following the shots. Two children had participated in

small clinical trials in Olympia of investigational Merck & Co.

chickenpox vaccines in combination with the live-virus mumps-measles-

rubella vaccine -- the MMR.

Federal health authorities consistently have rejected concerns about

a link between immunizations and autism. But a family background of

problems coping with viruses used in live-virus vaccines has not

been considered a possible risk factor, experts said.

One of the children in the clinical trials, Jimmy Flinton, now 4,

got about 10 times the standard dose of chickenpox vaccine in a shot

that also contained the MMR.

Called ProQuad, that combined immunization was approved by the U.S.

Food and Drug Administration last September -- the first time

four 'attenuated' or weakened live viruses have been mixed together

in a single shot.

The second child, Baltzley, now 6, got an

investigational 'process upgrade' chickenpox shot and a separate MMR

shot at the same office visit.

Both children have a parent who had unusual reactions to chickenpox

virus.

`s Baltzley`s mother, , had chickenpox three times,

the last at age 16, just three years before he was born. Jimmy

Flinton`s father, , had shingles as a teenager. Shingles is

reactivated chickenpox virus that painfully inflames nerves and

mostly affects older people or those with weakened immune systems.

Both children got the vaccines at 12 months, the age at which

chickenpox and MMR immunizations are first recommended by the

Centers for Disease Control and Prevention. They were among a total

of 101 subjects in the two trials in Olympia, according to the

Western Institutional Review Board, which approved the trial

protocols.

Half-a-dozen other parents of preschool-age autistic children from

the same neighborhood in Olympia recognized a common thread: unusual

chickenpox histories in their families and simultaneous or closely

timed chickenpox and MMR shots in their children.

'It`s the proximity of the chickenpox and MMR vaccinations' and the

family histories that stand out, said Rohrbeck, mother of 3-

year-old Grant.

Rohrbeck has not been able to develop immunity to chickenpox despite

being twice vaccinated as an adult, the last time just two years

before her son was born. A couple of months before he got the

standard chickenpox and MMR shots at the same office visit at age 1,

Grant had a stubborn and severe case of roseola, which like

chickenpox is a herpesvirus.

Four days after the MMR and chickenpox injections he became ill with

a fever and lay limp in his mother`s arms for the first time in his

life.

'He began having chronic diarrhea, and by his 15-month checkup he

had regressed so drastically that his pediatrician suggested he

could be autistic,' Rohrback recalled. The doctor agreed to the

parents` request for an immediate neurodevelopmental evaluation,

which resulted in a diagnosis of full-syndrome autism.

Rohbeck said she began looking for a possible connection between

vaccines and autism among neighborhood children after the Thurston

County Health Department did not follow up on parents` concerns

raised at a meeting last October. With the parents` continued

involvement, she has now compiled vaccination records of 14 Olympia

children diagnosed with autism, as well as 16 who are not.

The admittedly unscientific chickenpox-MMR association continues to

be striking, and the two cases following the clinical trials seemed

to underscore it, she said.

A Merck spokeswoman said the company reported those two cases to the

FDA this March -- the same month UPI asked Merck about them.

'We just received these reports in March 2006, six months after

ProQuad was approved in the U.S., and they were sent to the FDA

after we received them,' Merck`s Fanelle said in a

statement. She said Merck received 'the two reports of autism AEs

from Olympia -- one from the parent of a child in the ProQuad trial

and one from the parent of a child in (the `process upgrade`

chickenpox) study.'

Parents Flinton and Baltzley say they never called

Merck and wouldn`t know who to contact there; last summer,

Flinton reported Jimmy`s autism to the federal government`s Vaccine

Adverse Events Reporting System, attributing it to the cumulative

effects of vaccination. The federal health employee she spoke to on

the phone said she would follow up by gathering lot numbers and

other information on the vaccines.

The parents said their pediatrician, who conducted both of the Merck-

funded trials in Olympia, knew about their children`s autism

diagnoses within months of their participation in January 2001 and

October 2002.

The Olympia trials were part of wider Merck studies conducted at

several sites in the United States and abroad. Fanelle said Merck

would not disclose information about any other reports of autism.

'We have confirmed your original inquiry on whether we received the

two reports out of Olympia,' she said. 'We are not going to comment

on reports beyond this.

'There were more than 7,000 children in our ProQuad trials, 5,800 of

whom received ProQuad vaccine,' she added.

Sparby of the Western Institutional Review Board in Olympia

said it had not received reports of autism from the local ProQuad

study, but she noted the protocol 'was not designed to assess long-

term safety, as it called for follow-up for only 42 days following

vaccine administration.'

The FDA, which approves drugs after determining they are safe and

effective and monitors reports of side effects after they come on

the market, did not respond to repeated inquiries from UPI about the

Olympia cases or parents` concerns about family chickenpox

histories.

Other unusual histories in neighborhood families with autistic

children 6 and under:

-- Another child had roseola 12 weeks before getting his chickenpox

and MMR shots;

-- Another father had shingles as a teenager;

-- Another mother had chickenpox as an adult two years before her

pregnancy;

-- A mother had chronic cold sores, also a herpesvirus, as a child

that were so severe they had to be treated medically;

In addition, another mother had a case of measles as an adult.

Merck, which manufactures the standard MMR shot and the standalone

Varivax chickenpox shot as well as the experimental vaccines used in

the clinical trials, said repeated studies show no relation between

vaccines and autism.

'We don`t see an association,' spokeswoman Fanelle 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

preservative thimerosal. The report also 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.

In the United States, controversy over a possible link has centered

on thimerosal. Beginning in the late 1980s children were exposed to

increasing amounts of thimerosal, which is half ethyl mercury, as

more vaccines were mandated.

Thimerosal was phased out of routine childhood immunizations -- but

not all flu shots given to children and pregnant women -- beginning

in 1999. Although the Olympia children with autism were born after

the phase-out was recommended, their vaccine records show more than

half of them got at least one shot containing thimerosal during the

first year of life. It is possible all of them did, but incomplete

information from manufacturers makes that uncertain.

Chickenpox and MMR immunizations don`t contain thimerosal because

the mercury would inactivate the viruses, but some proponents of a

vaccine-autism link suspect thimerosal exposure from other

immunizations could have a potentiating effect, damaging a child`s

defenses and paving the way for live viruses to wreck havoc.

All live-virus vaccines are attenuated -- significantly weakened

based on the theory that this creates immunity without causing the

actual disease or other adverse health consequences. Other vaccines

on the U.S. childhood immunization schedule, including hepatitis B

and the polio shot, contain killed or so-called inactivated viruses.

Live polio virus was dropped in 2000 after health authorities

determined it was actually causing polio in a small number of cases.

Despite the Olympia parents` concern, none points an accusing finger

at doctors.

'I worry about pediatricians being vilified,' said Rohrbeck. 'We

vaccinated our son because we shared their faith that vaccines were

safe.

'If it turns out that some vaccines are not safe for all children

and that these hazards could have been found with more rigorous

testing -- or worse, that the dangers were already known -- that`s

the fault of the CDC, the FDA and the manufacturers,' she said.

'I`ll defend doctors to the end on this point. They are a convenient

front line for those agencies to hide behind -- it`s just shameful.'

The theory that live virus immunizations could trigger autism first

arose in 1998 in Britain, when gastroenterologist Dr.

Wakefield published a paper suggesting a possible association

between childhood MMR immunization, bowel disease and regressive

autism.

The premise: Interaction between viruses -- scientifically known as

immune interference -- could depress a susceptible child`s immune

system, lead to persistent infection by the measles virus in the GI

tract and possibly the nervous system itself, and trigger autism-

inducing brain damage. While the case has not been proven, it gains

plausibility from the fact that naturally occurring measles

infection is known to cause delayed brain damage in a small

percentage of children, proponents of the theory say.

Wakefield`s study, and his plea in Britain to separate the component

measles, mumps and rubella (German measles) vaccines and administer

them a year apart to reduce possible risk, caused an uproar. Co-

authors subsequently repudiated part of the paper, conflict-of-

interest allegations emerged, and the prestigious Lancet, which

originally published the study, issued a statement calling

it 'fatally flawed.'

Wakefield was asked to leave his medical job in Britain and is now

doing research in Austin, Texas.

After the Olympia cases were described to him by UPI in March,

Wakefield met with several of those parents at an autism conference

in Portland, Ore. He also read studies Merck cites as central to the

FDA approval of ProQuad.

'It`s actually heartbreaking, listening to these parents, because

you`re staring into an abyss,' Wakefield said afterwards. 'You`re

listening to stories which reflect the fundamental misconception of

vaccine manufacturers of what viruses are and what they do. The

whole perception of these people is dangerously naïve.'

In contrast to the United States, British health authorities have

not recommended chickenpox immunization. But an MMR-chickenpox shot

was under discussion there at one point, and Wakefield said he

warned its developers that putting four live viruses in one shot was

a bad idea.

He says the Olympia cases show why.

'As far as I`m concerned, you are further increasing the likelihood

of persistent infection and delayed disease, which they are never

looking for and therefore they will never find if it does occur, as

it did clearly in a relatively short space of time with some of

these children, and it`s never ascribed to an adverse reaction to

the vaccine.'

On its Web site, the CDC says such concerns -- and Wakefield`s

studies in particular -- are not based on good science.

'Current scientific evidence does not support the hypothesis that

MMR vaccine, or any combination of vaccines, causes the development

of autism, including regressive forms of autism,' the CDC says.

'The existing studies that suggest a causal relationship between MMR

vaccine and autism have generated media attention. However, these

studies have significant weaknesses and are far outweighed by

epidemiological studies ... that have consistently failed to show a

causal relationship between MMR vaccine and autism.'

( http://www.cdc.gov/nip/vacsafe/concerns/autism/autism-mmr.htm)

Dr. Jeff Bradstreet, a family practitioner in Florida who treats

3,000 autistic children and has worked with Wakefield, said he

believes the risk of autism rises the earlier and closer together

that live-virus vaccines are administered. He warned the Institute

of Medicine in 2004 that it was ignoring the possibility that

younger children are more vulnerable because their immune and

neurological systems are immature.

'There`s definitely been an association of kids getting MMR at 12

months and crashing (becoming autistic),' Bradstreet said.

He said adding 10 times the standard dose of chickenpox virus,

called varicella-zoster, to the MMR shot and administering it to 1-

year-olds is playing with fire.

'We think putting varicella with MMR is just nuts.'

British researcher Shattock sees another reason to be concerned

with combining the four viruses: He suspects that children who get

wild -- or naturally occurring -- chickenpox too close in time to

the MMR shot face a higher risk for autism. That scenario parallels

the one Olympia parents noticed with the chickenpox vaccination.

Shattock, director of the Autism Research Unit in the School of

Sciences at the University of Sunderland, said he noticed that

autistic British children whose parents blame the MMR for triggering

the disorder had a pattern of 'undisclosed viral illness' around the

time of the shot.

He studied the records of 100 of those children, compared to 100

children whose parents did not cite the MMR as the trigger, to see

if there was a higher incidence of chickenpox cases three months

before or after the MMR immunization.

'Now, there was,' Shattock said in an interview while attending an

autism conference this month in Washington, D.C. 'It wasn`t

statistically significant at the 95 percent level -- but enough to

make you think that if it was a huge study, it might be.'

His concern about adding chickenpox to the MMR shot: 'I`m worried

about it because of the interference of the vaccines, mainly because

it depresses the immune system by yet another mechanism.'

A Merck scientist discussed that issue at a CDC meeting in 2004, the

year before ProQuad was approved, according to agency minutes. Dr.

Florian Schodel 'confirmed the possibility' that the chickenpox

virus component of ProQuad was 'causing a local immune suppression

and an increase in measles virus replication. ...

'The current hypothesis is that the varicella and measles virus are

co-infecting the same or proximate areas of the body and engaging in

a specific interaction, but how that works is as yet unknown.'

He said the interference appeared to involve only the chickenpox and

measles viruses -- 'there is no such effect for the mumps or rubella

vaccines administered locally at the same time.'

At the same meeting, Merck`s Dr. Barbara Keller said the amount of

chickenpox virus in ProQuad is 'about a log' -- or 10 times --

higher than Merck`s standalone chickenpox vaccine, Varivax, in order

to overcome immune interference.

Both Wakefield and Shattock said the Olympia families` unusual

histories with chickenpox are worrisome because their children might

have inherited problems coping with the vaccine.

'There`s no doubt the immune response to viruses is determined by

our genetic constitution,' Wakefield said. 'It may well be there is

a genetically determined predisposition to abnormal handling of

chickenpox virus, at least in children.

'This kind of phenomenon has been shown to (play a role in) measles.

The immune response to measles is determined by your genetic

profile. It`s certainly consistent with what is known about the

immune response to viruses.'

ProQuad is likely to be widely adopted by healthcare professionals

who previously administered separate MMR and Varivax shots.

'Use of licensed combination vaccines, such as (ProQuad), is

preferred to separate injection of their equivalent component

vaccines,' says the new edition of the CDC`s authoritative 'Pink

Book' on vaccine-preventable diseases.

'When used, (the immunization) should be administered on or after

the first birthday, preferably as soon as the child becomes eligible

for vaccination.'

This series of articles, based on reporting in Olympia in February

and March, tells the families` stories, looks at the scientific

controversy and examines implications for the autism-vaccine debate.

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Next: 'He has gone backward mentally ... '

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E-mail: dolmsted@...

Copyright 2006 by United Press International