The Age of Autism: Rattled regulators

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conclusions portrayed an agency "rife with internal squabbles and hobbled by underfinancing, poor management and outdated regulations," according to a lead story in The New York Times.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.