Another study finds no link with vaccines


CHICAGO — Government researchers say they found little evidence of a link between vaccinations and developmental problems in a study of more than 140,000 U.S. children.

The report didn’t satisfy vaccine critics, who claimed the study’s initial results showed a stronger connection but were watered down. They also noted that the study’s lead author now works for a vaccine maker.

The study, published Monday in the December issue of Pediatrics, is one of the latest attempts to determine whether older vaccines with the mercury-containing preservative thimerosal led to nervous-system problems such as autism, as some vocal critics contend.

In one group of children studied, routine vaccines in infancy appeared to slightly increase the risk for tics. In another group, a slight association was seen with language delays but not tics. A third group showed no associations with any disorder.

In all, more than 140,000 children were studied and no link was found with any other disorders, including autism, said co-researcher Dr. Frank DeStefano of the Centers for Disease Control and Prevention.

Many previous studies of vaccines containing the preservative thimerosal also failed to find strong evidence of any link.

The new results are reassuring, DeStefano said, and more definitive answers are expected from in-person examinations the CDC is giving some of the study participants.

But Dr. Mark Geier, a geneticist who has worked as a consultant on parents’ lawsuits against vaccine makers, said the researchers’ own earlier analysis of the study results found strong links between vaccines and such problems — and that the published results attempt to conceal those findings. He claimed the final analysis “is intentional fraud.”

DeStefano acknowledged that the early results suggested stronger links with some disorders, though not autism, but denied that there had been pressure or a cover-up. He said the final data reflect a more thorough recent analysis.

The study’s lead author, former CDC researcher Dr. Thomas Verstraeten, now works for vaccine maker GlaxoSmithKline in Belgium, and Geier said that connection may have influenced how the research was reported.

Verstraeten, who left the CDC in July 2001, did not respond to an e-mail request seeking a response, and company spokeswoman Nancy Pekarek said he did not wish to discuss the results. She provided a written statement in which Verstraeten indicated that since leaving the CDC he has worked only as an adviser as the study was finalized and prepared for publication.

The researchers analyzed data from three health maintenance organizations on children born between 1992 and 1999 and tracked for several years. Information was gathered on several neurodevelopmental disorders, including autism, attention deficit disorders, stammering and emotional disturbances.

While the researchers were beginning to examine their results, public health officials were beginning to publicly address concerns about the use of thimerosal in childhood vaccines. Mercury in high doses has been linked with neurodevelopmental problems. Parents and others worried about potentially dangerous overexposure to thimerosal because of the increasing number of vaccines recommended in childhood.

Vaccine makers have since phased out use of thimerosal as a preservative in childhood vaccines used in the United States, though trace amounts remain in some vaccines.

It is still used as a preservative elsewhere, especially in developing countries, said Dr. Thomas Saari, a member of the American Academy of Pediatrics’ infections diseases committee and a pediatrics professor at the University of Wisconsin in Madison.

Vaccine expert Dr. Neal Halsey of Johns Hopkins University said the study shows that if there is any association between older vaccines and mild disorders, “it must be relatively small.”

“A major health risk should have shown up in a consistent pattern in all three of the HMOs,” Halsey said.

Still, he said the findings might have been different if the researchers had done a separate analysis by gender, since boys are much more susceptible to mercury exposure than girls.
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Copyright 2003 Los Angeles Times

PEDIATRICS Vol. 112 No. 5 November 2003, pp. 1039-1048

Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Databases

Thomas Verstraeten, MD*,, Robert L. Davis, MD, MPH, Frank DeStefano, MD, MPH, Tracy A. Lieu, MD, MPH||, Philip H. Rhodes, PhD, Steven B. Black, MD, Henry Shinefield, MD and Robert T. Chen, MD for the Vaccine Safety Datalink Team

* Epidemic Intelligence Service Program, Epidemiology Program Office, Centers for Disease Control and Prevention, Atlanta, Georgia
Vaccine Safety and Development Activity, Epidemiology and Surveillance Division, National Immunization Program, Centers for Disease Control and
Prevention, Atlanta, Georgia
University of Washington and Group Health Cooperative of Puget Sound, Seattle, Washington
Center for Child Health Care Studies, Department of Ambulatory Care and Prevention, Harvard Pilgrim Health Care and Harvard Medical School, and Division
of General Pediatrics, Children’s Hospital, Boston, Massachusetts
Kaiser Permanente Vaccine Study Center, Oakland, California

Objective. To assess the possible toxicity of thimerosal-containing vaccines (TCVs) among infants.

Methods. A 2-phased retrospective cohort study was conducted using computerized health maintenance organization (HMO) databases. Phase I screened for associations between neurodevelopmental disorders and thimerosal exposure among 124 170 infants who were born during 1992 to 1999 at 2 HMOs (A and B). In phase II, the most common disorders associated with exposure in phase I were reevaluated among 16 717 children who were born during 1991 to 1997 in another HMO (C). Relative risks for neurodevelopmental disorders were calculated per increase of 12.5 µg of estimated cumulative mercury exposure from TCVs in the first, third, and seventh months of life.

Results. In phase I at HMO A, cumulative exposure at 3 months resulted in a significant positive association with tics (relative risk [RR]: 1.89; 95% confidence interval [CI]: 1.05-3.38). At HMO B, increased risks of language delay were found for cumulative exposure at 3 months (RR: 1.13; 95% CI: 1.01-1.27) and 7 months (RR: 1.07; 95% CI: 1.01-1.13). In phase II at HMO C, no significant associations were found. In no analyses were significant increased risks found for autism or attention-deficit disorder.

Conclusions. No consistent significant associations were found between TCVs and neurodevelopmental outcomes. Conflicting results were found at different HMOs for certain outcomes. For resolving the conflicting findings, studies with uniform neurodevelopmental assessments of children with a range of cumulative thimerosal exposures are needed.

Key Words: cohort study o computerized medical record systems o language development disorders o speech disorders o thimerosal o vaccines

Abbreviations: Hg, mercury o EPA, Environmental Protection Agency o TCV, thimerosal-containing vaccine o HMO, health maintenance organization o VSD, Vaccine Safety Datalink o CDC, Centers for Disease Control and Prevention o LBW, low birth weight o ICD-9-CM, International Classification of Diseases, Ninth Revision, Clinical Modification o ADD, attention-deficit disorder o RR, relative risk o HBV, hepatitis B vaccine

Received for publication Jan 24, 2003; accepted Jul 9, 2003.
Peter Zwack,Ph.D.

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