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Executive Summary

PERTUSSIS VACCINE ENCEPHALOPATHY RISK IS "VASTLY OVERRATED" by physicians and the public, Edward Mortimer, MD, American Academy of Pediatrics, asserted at a meeting of the Institute of Medicine's Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines Jan. 10. The results of a large British epidemiologic study, the National Childhood Encephalopathy Study, and circumstantial evidence suggests that "the vast majority, if not all, cases of alleged pertussis vaccine encephalopathy are not caused by the vaccine," Mortimer told the panel. The IoM study of childhood vaccine adverse reactions was commissioned by HHS under the National Childhood Vaccine Injury Compensation Act, which required a study within three years of the law's enactment. IoM organized the 12-member committee to begin a 20-month study of the scientific evidence on the adverse health consequences of pertussis and rubella vaccines. Chaired by Harvey Fineberg, MD, Harvard School of Public Health, the IoM committee plans to hold an interim public workshop to gather additional evidence from experts once the study is completed. A final report, to be issued in May 1991, will be sent to the House Energy and Commerce Committee, the Senate Labor & Human Resources Committee and HHS. "For many years most physicians, including me, accepted acute pertussis vaccine encephalopathy, sometimes with permanent disability or death, as an unfortunate but necessary evil -- as a price to pay -- for the control of pertussis, especially in infants," Mortimer said. Only since the 1981 publication and continuing analysis of the British National Childhood Encephalopathy Study, and further analysis of alleged pertussis vaccine encephalopathy, Mortimer said, "has this concept come under serious question." Mortimer concluded that the "syndrome either does not occur at all, or, if it does, the rate (attributable risk) is far too low to be measurable." Currently, the AAP Red Book states that the rate of encephalopathy within seven days is 1:140,000; and, for permanent neurologic deficits, 1:330,000. He also dismissed the possibility of a link between diphtheria-tetanus-pertussis vaccine and Sudden Infant Death Syndrome, autism and learning disorders. "It is approximately as absurd to implicate DTP as it is to blame AIDS or Alzheimer's disease on the vaccine," he said. Among those testifying to the adverse effects of DTP vaccines, Mark Thoman, MD, a former president of the American Academy of Clinical Toxicology, said he has evaluated 233 patients since 1978 who were referred to him as possible DTP-related cases by defense and plaintiff attorneys, malpractice insurance carriers and families. Of those cases, at least 141, and possibly 187 "are due to the pertussis vaccine," Thoman said. Among adverse short-term reactions, he reported, are sleep pattern alteration, vomiting, weak head support, "unconsolable" crying and "febrile or afebrile" seizures. Longer-term health consequences can include diminished head circumference in developing infants. Jeffrey Schwartz, from the Advisory Commission on Childhood Vaccines and Dissatisfied Parents Together, asserted that "the U.S. Claims Court's vaccine injury compensation program has begun to acknowledge publicly what has been published repeatedly, but buried in the medical literature, for more than 65 years: that pertussis vaccine can and does cause or contribute to permanent brain damage in some children; and that pertussis vaccine can and does cause death in an unknown number of children by anaphylactic reaction, shock-collapse, and/or status epilepticus, and that such deaths often are improperly classified as SIDS cases."

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