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Published: April 20, 2006 at 10:27 PM
By DAN OLMSTED
UPI Senior Editor
Call it the silence of the feds.
This week, The Age of Autism began a series of articles entitled "Pox," laying
out the compelling observations of a group of parents in Olympia, Wash., who are
concerned live-virus vaccines are triggering autism.
These parents spotted a possibly troublesome trio of factors in their children's
cases: Chickenpox and measles-mumps-rubella (MMR) vaccinations clustered
together at the earliest recommended ages; a family history of problematic
reactions to naturally occurring chickenpox and other herpesviruses; and the
onset of autism in their children, often following a brief but notable physical
illness.
Two of the children had been in clinical trials in Olympia of vaccines not yet
approved by the U.S. Food and Drug Administration, vaccines with investigational
chickenpox formulas. The FDA subsequently approved one of those drugs, called
ProQuad, last September.
What does the FDA say to these concerns, and in particular to a case of
regressive full-syndrome autism after a clinical trial of a drug it just
approved?
Nothing.
In Part 1, we reported: "The Food and Drug Administration, 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."
On Monday, March 20 -- a month ago -- I sent an e-mail to FDA spokesman Stephen
King asking about the autistic Olympia children from the clinical trials. King
had already told me that there were no minutes available for an FDA advisory
committee hearing prior to ProQuad's approval, because no meeting had been held.
Such meetings sometimes are called if there are concerns about safety or other
issues surrounding proposed or already-approved medicines.
ProQuad combines the existing MMR and the standalone chickenpox vaccine, Varivax,
but with a major difference: It contains about 10 times more chickenpox vaccine,
apparently in order to overcome immune interference from the other weakened live
viruses in the shot.
My e-mail:
"Hi Stephen,
I left you a voice mail last week and wanted to follow up with this written
query. ...
Questions:
-- Was the FDA aware of these or any other reports of autism following (clinical
trials)? If not, would they have been of concern and are they of concern now?
-- Why was it necessary to put significantly more varicella (chickenpox) virus
in ProQuad than in the standalone Varivax shot? ...
-- Has the FDA ever considered immune status of parents re live virus vaccines
as a possible factor in the child's ability to handle them? The mother of one of
the children had a severe case of chickenpox just three years before her child
was born; the father of the other had shingles as a teenager, which is unusual.
Thanks for considering these questions. I would appreciate hearing from you this
week.
Sincerely,
Dan Olmsted
United Press International"
There was no response.
I also learned that one of the Olympia parents, Jennifer Flinton, last summer
called the federal government's Vaccine Adverse Events Reporting System, jointly
monitored by the FDA and the Centers for Disease Control and Prevention, to
report her son Jimmy's autism. She attributed his regression to cumulative
exposure to vaccinations; the worker who took the report said she would follow
up by collecting all the information about the vaccines he was given.
Jimmy Flinton had been in the ProQuad clinical trial in 2002 and developed
autism four months afterwards. He was one of 33 children in the Olympia arm of
the trial.
Merck & Co., which funded the trials and manufactures the vaccines involved
including ProQuad, said it reported the two autism cases from Olympia to the FDA
this March, which is when Age of Autism first asked about them. Merck said that
is also when the parents made the reports, but the parents said they don't know
what Merck is talking about.
Maybe federal health officials have just plain had it with these concerns, which
they clearly consider preposterous. Study after study, they say, has shown no
evidence that vaccines are linked to autism, and in 2004 the widely respected
Institute of Medicine said the case was closed and it was time to look elsewhere
for the cause or causes of autism. Dr. Marie McCormick, the distinguished
Harvard professor who headed that review, famously derided as "really
terrifying, the scientific illiteracy that supports these suspicions."
A single case several months after a child receives an investigational
chickenpox vaccine in a trial with 33 other children certainly wouldn't threaten
that view.
Nor would another case at the same pediatrician's office in the same city using
the same live viruses in another small clinical trial, this one with 68 kids.
Nor would problematic chickenpox histories in those families, nor would the same
pattern among other families with autistic children in the same neighborhood.
...
Still, at some point, wouldn't you expect someone somewhere in the nation's
public health hierarchy to raise an eyebrow? Yet getting anyone's attention is
just about impossible -- in Washington state no less than Washington, D.C.
Dr. Diana Yu of the Thurston County Health Department in Olympia insisted to me
over a period of several weeks that no clinical trials whatsoever had been
conducted by any pediatricians there. This, despite my faxing her consent forms
signed by the parents.
One seven-page documents begins: "Research Subject Consent Form: Vaccine Study
-- Children. Your child is invited to be in a research study ... The study is
being done for Merck & Co. ... (B)oth investigational drugs ... have not been
licensed by the U.S. Food and Drug Administration."
Yu told me: "None of the practices were in any 'clinical trials' as part of any
vaccine study. Some practices may have been 'trying things out' but have not
made it a policy for their clinic yet. With all due respect, these doctors are
not on trial and should not be painted with such a broad stroke."
Nobody's indicting pediatricians. It's public health officials and drug
companies they're wondering about.
"I worry about pediatricians being vilified," said Denise Rohrbeck, one of the
Olympia parents quoted in Pox -- Part 1. "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.
Meanwhile, another potentially significant issue in Olympia remains unanswered
weeks after I raised it with the health department there. The first thing that
caught the parents' attention was a seeming absence of autism cases at one of
the two big medical practices in town, Pediatric Associates.
The parents, who know each other through a countywide support group, haven't
been able to find a single case of full-syndrome autism among preschoolers who
were vaccinated from birth at PA, as the parents call it.
Anecdotal, yes -- but intriguing: Autism cases are not hard to find at the other
pediatric practices in town, no surprise given a rate of autistic disorders of 1
in 166 American children.
So what's up at PA?
Parents say they learned at least half the doctors there delay the chickenpox
and MMR shots until 18 months, and the other half tend to break them up --
giving one at 12 or 15 months and the other about six months later. Records
parents gathered suggest this trend at PA started sometime after 2000 -- records
collected from 1999 show the two shots given together as early as 12 months.
Interestingly, parents found full-syndrome kids from PA born before 2000.
The CDC recommends that the MMR and chickenpox shots be given as soon as
possible beginning at 12 months and no later than 15 months for the MMR and 18
months for chickenpox. That's when the autistic kids the parents in Olympia are
talking about got them -- sooner rather than later and usually at the same time,
not widely spaced or starting at 18 months as appears to be the case at
Pediatric Associates.
Thus the PA kids and their shot patterns might be an informal "control group"
right in the middle of this state capital of just over 50,000 on the South Puget
Sound.
Pediatric Associates did not respond to questions about its immunization
policies. Neither did the county health department, although Yu acknowledged it
would be "simple" for the department to check its records and determine whether
there really is a difference in immunization schedules.
As this series on the Olympia kids unfolds over the next several weeks, the
parents are hopeful that more information -- maybe even some sort of response
from the nation's drug regulators -- will be forthcoming.
Stay tuned. Don't hold breath.
Next: Ryan reacts at the doctor's office.
E-mail: dolmsted@upi.com
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