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?
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.
I left you a voice mail last week and wanted to follow up with this written query. ...
-- 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.
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.