Posted on 02/25/2005 7:42:35 PM PST by neverdem
Responding to growing concerns about its ability to monitor the side effects of vaccines, the Centers for Disease Control and Prevention decided last week to separate its national immunization program, which advocates vaccination, from its vaccine safety branch, which monitors the potential risks of the vaccines.
The action comes at a time of increasing public outcry over the government's handling of drug safety issues. Earlier this month, the Food and Drug Administration announced that it would create a board to advise it on drug complications and to warn patients about unsafe drugs.
Critics of the disease-control agency have argued for some time that the advocacy nature of its immunization program hinders its ability to monitor and investigate any adverse reactions to vaccines.
Much of the pressure has come from lawmakers and parents of autistic children, who are concerned about a possible link between rising rates of autism and a mercury preservative, thimerosal, once widely used in childhood vaccines. They have argued that the agency's dual role in promoting vaccines and overseeing their safety is a serious conflict of interest.
The decision to separate the offices was announced last Friday, a day after a panel of medical experts urged the agency to improve access to a database of patient information that is at the center of a dispute over whether vaccines can cause autism.
Dr. Julie L. Gerberding, the director of the agency, said that shifting the safety branch was intended to improve its "credibility and capability," and that the branch would now be led by Dr. Dixie E. Snider Jr., the agency's chief of science.
"We believe the best practice for the safety monitoring program is to keep it in a separate locus from the large-scale program," Dr. Gerberding said.
Representative Dave Weldon, Republican of Florida and a physician who has a strong interest in autism issues, called the move "a step in the right direction."
"You can't have an organization whose primary charge is getting kids vaccinated also have credibility in looking at side effects," Dr. Weldon said. "Their primary mission is getting lots of kids vaccinated. I don't think they should be the same people looking at safety."
But Dr. Paul Offit, who was a member of a federal advisory panel on immunization practices, said the idea that the agency would be less concerned about whether vaccines were safe than with seeing that every child received a shot was absurd.
"The notion has been that this is the fox guarding the henhouse," said Dr. Offit, who is also a pediatrician at the Children's Hospital of Philadelphia. "That's not true. They care as much about vaccines being safe as they care about them working. They wouldn't recommend them unless they felt the benefits clearly outweighed the risks."
But Dr. Weldon and others say the agency has made it difficult to assess what those risks might be, particularly as they relate to autism.
Their concerns were echoed on Feb. 17 by a panel of medical experts assembled by the Institute of Medicine, an arm of the National Academy of Sciences. The committee recommended that the C.D.C. ease some restrictions on outside scientists who want to use its heavily guarded Vaccine Safety Datalink, which holds more than seven million medical records that the agency uses to monitor adverse reactions to vaccines.
Dr. Thomas Verstraeten, a former researcher at the agency, used the database to carry out a large study that was published in 2003. Many scientists have said the study shows no statistical link between thimerosal and autism.
But Dr. Weldon and the parent groups, through the Freedom of Information Act, later obtained an earlier draft of the study that had not been made public. The early findings did suggest a relationship between exposure to thimerosal and some developmental delays, and Dr. Weldon and the groups say the results were deliberately "watered down."
Two outside researchers, Dr. Mark Geier and his son, David Geier, who were expert witnesses for parents seeking damages from the National Vaccine Injury Compensation Program, have fought for access to the database. The agency has been hesitant, fearing that doing so could violate the privacy of those whose medical histories are in it.
Dr. Stephen E. Fienberg, a professor at Carnegie Mellon University and a member of the committee that weighed in on the dispute, suggested the Geiers be granted further access.
Now, outside researchers who want access must submit a proposal and obtain permission from the more than a half-dozen health maintenance organizations that provide the centers with their medical records. The report determined that the inquiry process should be streamlined, and listed steps the disease-control agency could follow to balance patient privacy with the need to open the database to some outside researchers.
Tom Skinner, a C.D.C. spokesman, said his agency would consider all of the committee's recommendations and work to carry them out.
"We're going to continue to deliberate on them as we strengthen our vaccine program," Mr. Skinner said. "All of this supports our desire to continue to place a high priority on vaccine safety."
The agency has come under fierce criticism for its handling of the preliminary findings from the 2003 Verstraeten study. Dr. Weldon has alleged wrongdoing, pointing to transcripts of a private meeting where agency staff members shared Dr. Verstraeten's findings with representatives of the vaccine industry, government officials and physicians.
The study's authors have argued that later phases of the study were intended to replicate earlier findings, but found no association between thimerosal and developmental delays. Numerous epidemiological studies conducted in Europe have also shown no link between autism and vaccines containing thimerosal.
Anahad O'Connor reported from New York for this article, and Gardiner Harris from Washington.
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