 |
Published: Sept. 26, 2006 at 1:58 PM
By DAN OLMSTED
UPI Senior Editor
WASHINGTON, Sept. 26 (UPI) -- A shakeup at the CDC and the shaky performance of
the
FDA raise some serious
questions relevant to the debate over the huge rise in reported cases of autism.
Both federal agencies are key to assuring Americans -- and particularly those
whose children receive an ever-increasing load of vaccines -- that there is no
relationship whatsoever between the shots and autism.
But both agencies have come under fire this month in ways that make you wonder
how much confidence to have in their overall performance.
First, the Food and Drug Administration. The agency responsible for the safety
and efficacy of prescription drugs got walloped by the prestigious, independent
Institute of Medicine, whose "often damning" conclusions portrayed an agency
"rife with internal squabbles and hobbled by underfinancing, poor management and
outdated regulations," according to a lead story in The
New York Times.
To be fair, the study was commissioned by the FDA itself, which said in a
statement that "substantial work" to remedy the problems has already been done.
But consider two of the IOM's four main findings:
-- "There is a perception of crisis that has compromised the credibility of FDA
and of the pharmaceutical industry."
-- "FDA and the pharmaceutical industry do not consistently demonstrate
accountability and transparency to the public by communicating safety concerns
in a timely and effective fashion."
This column has pointed out several examples of that -- including our series
titled "Pox," about concerns that the new, combined
measles-mumps-rubella-chickenpox shot might be triggering autistic regression in
susceptible children.
Two children in small clinical trials of the four vaccines subsequently were
diagnosed with autism. But manufacturer Merck & Co. acknowledged that the cases
from Olympia, Wash., weren't reported to the FDA until after the drug was
approved last year.
The FDA didn't bother to respond to our questions about those cases -- a lack of
"accountability and transparency" of the first order. The FDA seems to have a
siege mentality whereby legitimate questions about drug safety are sometimes
treated as insults that are beneath comment.
Perhaps, with the IOM report on the table, that will start to change.
Now to the CDC. The agency both recommends the childhood immunization schedule
and monitors
vaccine safety.
In July, U.S. Rep. Dave Weldon, R-Fla., introduced legislation to take the
safety function away from the CDC. "There's an enormous conflict of interest
within the CDC and if we fail to move vaccine safety out of the CDC, public
confidence in the safety of vaccines will continue to erode," said Weldon, a
medical doctor.
Now a different kind of conflict is emerging at the CDC -- over a sweeping
reorganization instituted by its director, Dr. Julie Gerberding.
"Exodus, morale shake CDC," said the headline in the Sept. 10 story by Alison
Young in the Atlanta Journal-Constitution.
"An exodus of key leaders and scientists from the (CDC) has raised 'great
concern' among five of the six former directors who led the agency over the past
40 years."
That concern was also raised recently on a CDC message blog. While staffers
railed about the proposed changes and management style, one outsider posted his
own critique. Here is part of it:
"If you want to understand the source of the crisis at CDC, you might want to
look in the mirror. ...
"What is the real performance crisis at CDC? ... CDC is failing in its most
critical public mission. ... Speak to any school administrator, group of
families or front line care providers and ask them what the state of health of
America's children is today. What do you think you'll hear? I submit you would
hear that we have the sickest generation of children that any of us have ever
seen.
"But the sickness is not coming from the roster of infectious diseases that all
of you are programmed to consider the enemy. Rather, they are a long list of
chronic, insidious but devastating conditions that are sapping the services
system and turning schools and summer camps into medical distribution centers.
Asthma, diabetes, ADD, ADHD, autism, PDD, obesity, life threatening
food allergies, and the list
goes on. Children and families are in crisis in large numbers."
It's that crisis the shaky performance of the FDA and CDC may be obscuring. No
amount of reorganization or reform will matter until they address it.
|
|