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Immunization Safety Review:
Measles-Mumps-Rubella Vaccine and Autism
Steve Eidelman, 2001
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 More on Immunization and Autism
 From: Steve Eidelman
 

 Immunization is widely regarded as one of the world's most effective tools
 for protecting public health. In the United States alone,

 child-vaccination programs have resulted in the elimination of smallpox and polio and

 rendered once-common, often debilitating, and potentially life-threatening

 infectious diseases--such as diphtheria, pertussis, and measles--exceedingly uncommon.

 But along with these benefits have come concerns about safety, making some
 immunization policies a subject of public debate. One such issue is

 whether or not the measles-mumps-rubella (MMR) vaccine causes autistic spectrum

 disorders (ASD), frequently referred to simply as autism.

 The MMR vaccine, which comprises three vaccines given in a single shot,
 has been extremely successful in virtually eliminating measles, mumps, and

 rubella in the United States. Measles cases, for example, dropped from

 over 400,000 per year in the pre-vaccine era to only 100 in 1999. However,

 these diseases remain a serious threat in other parts of the world where

 children are not routinely vaccinated. Measles alone resulted in over a million

 deaths in children around the world last year.

 Some parents and researchers are concerned though that the MMR vaccine
might cause ASD. Autistic spectrum disorders are incurable, permanent diseases

 that result in serious developmental problems in children. Although

 scientists generally agree that most cases of ASD result from events that

 occur in the prenatal period or shortly after birth, there is considerable

 concern because autistic symptoms typically do not emerge until the

 child's second year--about the same time the MMR vaccine is first administered. In

 addition, there are concerns that the introduction of wide-scale use of

 MMR coincides with an apparent increase in the incidence of autism.

 Recent research in Britain provides suggestive evidence of such a link. In
 a highly publicized study, published in The Lancet in 1998, researchers

 describe 12 children who developed behavioral problems, including ASD,

 shortly after receiving the MMR vaccine. While the authors note that their

 study did not prove an association between MMR and ASD, it suggests the

 need for further research on this hypothesis. Since then, this group and other

 scientists have further examined this potential relationship.

 The CDC and the National Institutes of Health recognized the need for an
 independent group to carefully examine the hypothesized MMR-autism link

 and address other vaccine-safety issues as well, in order to give some

 guidance to themselves, health care providers, researchers, and a concerned public.

 These agencies engaged the Institute of Medicine (IOM), which in turn

 appointed the Immunization Safety Review Committee, a 15-member body of

 health professionals with wide-ranging expertise in areas relevant to the

 problem. To preclude any real or perceived conflicts of interest,

 candidate members were subject to strict selection criteria that excluded anyone who

 had participated in research on vaccine safety, received funding from

 vaccine manufacturers or their parent companies, or served on vaccine

 advisory committees. The results of the committee's assessment of the

 issue are described in the report titled Immunization Safety Review:

 Measles-Mumps-Rubella Vaccine and Autism.

 The committee has reviewed the numerous research efforts on the MMR-autism
 hypothesis. "The evidence favors rejection of a causal relationship at the

 population level between MMR vaccine and autistic spectrum disorders," the

 committee concludes in its report. "A consistent body of epidemiological

evidence shows no association at a population level between MMR and ASD," the report says.

  Moreover, the committee can find no proven biological mechanisms that
 would explain such a relationship. Scientists have suggested some theories, but

 none have been demonstrated. For example, though it is possible that a

 viral infection caused by the vaccine could invade the central nervous system,

 provoke an autoimmune response and ultimately produce autism, researchers

 have observed no evidence of this kind of injury. Finally, scientists have not

 been able to make inferences by studying the hypothesis in laboratory

 animals because of the difficulty of mimicking these conditions in animals.

 Other leading medical groups--the American Academy of Pediatrics, the
 World Health Organization, and British health authorities--have come to similar

 conclusions for largely the same reasons.

 Though the MMR-autism question might appear to be resolved, science is
 always a work in progress; a conclusion is only as good as the methods of

 the analysis. The epidemiological studies, traditional public health tools

 used to examine the risk factors for a disease on a population level, were

 at a disadvantage here because there is little variation in exposure to

 MMR since children in most developed countries are vaccinated similarly.

 Furthermore, the difficulties in diagnosing and determining the exact

 onset of autism in children make it difficult to design appropriate studies and

 compare the results from those studies.

 The committee acknowledges they could not rule out another
 possibility--that MMR vaccine could contribute to ASD in a small number of children--because

 existing epidemiological tools may not have enough precision to detect the

 occurrence of rare effects like ASD.

 The significance of this set of issues transcends the science alone.
 Infectious diseases like measles, mumps, and rubella, left unchecked,

 could cause considerable sickness and death. Public-health officials fear a

 repetition of the pertussis-vaccine history of the 1970s, when the

 combination of low numbers of pertussis cases and public concerns about

 the vaccine's safety caused immunization rates around the world to plummet,

 with sobering results. In Japan, for instance, pertussis vaccine coverage

 dropped from 80% to 10% in the mid-1970's resulting in epidemic involving 13,000

 reported cases and 41 deaths. "Similar disease outbreaks could easily

 occur, with devastating effects," says the committee, "were immunization rates to

 decline as a result of fears regarding MMR vaccine."

 Still, "the responsibility of the government to ensure the safety of [the
 MMR] vaccine is high, even if the adverse outcome is rare," the committee

 notes. The seriousness of autism - an incurable and serious behavioral

 disorder - requires rigorous consideration of all possible etiologies. And

 in any case, it adds, the level of public concern about MMR vaccine safety

 is high and must be meaningfully addressed.

 This is especially important in that MMR vaccination is required by law in
 all 50 states for entry into school and day care, in part, to protect the

 health of others. These factors, the committee concludes, suggest the need

 for continued attention to this issue.

 At present, however, no change of MMR immunization procedures is warranted.
 The report plainly states that "The committee does not recommend a policy

 review at this time of the licensure of MMR vaccine or of the current

 schedule and recommendations for administration of MMR vaccine."

 The committee does propose targeted research efforts and more rigorous
 data-gathering procedures. These would give scientists a firmer

 understanding of MMR vaccination and any possible side effects. In

 particular, the committee recommends the use of common definitions for

 autism cases; more detail and documentation in their reporting; comparing

 the effects of different immunization exposures; and clinical and

 epidemiological studies to identify risk factors and biological markers of ASD.

 Further, the committee notes that government agencies responsible for
 immunization should recognize that most members of the public currently

 get their information on this and other health issues from the news media and

 the Internet. As a result, agencies such as the CDC and Food and Drug

 Administration must actively work at providing helpful public

 communications, beginning with the improved accessibility of their own Web sites.

 "Attention should be given to how the material is perceived and used by
 those with the right and desire to know--the parents of children about to

 be immunized or those who believe their child has been adversely affected,"

 the committee says. "Direct input from parents and other stakeholders would be

 invaluable in conducting a systematic and effective evaluation of current

 communication tools."



 For More Information...

 Information on the Immunization Safety Review Committee can be found at
 www.iom.edu/ImSafety

 Copies of Immunization Safety Review: Measles-Mumps-Rubella Vaccine and
 Autism are available for sale from the National Academy Press; call (800)

 624-6242 or (202) 334-3313 (in the Washington metropolitan area), or visit

 the NAP home page.

 This study was funded by the Centers for Disease Control and Prevention
 and

 the National Institute of Allergy and Infectious Diseases of the National

 Institutes of Health as part of an National Institute of Health Task Order No. 74.

 The Institute of Medicine is a private, nonprofit organization that
 provides health policy advice under a congressional charter granted to the National

 Academy of Sciences. For more information about the Institute of Medicine,

 visit the IOM home page at ww.iom.edu.

 © 2001 by the National Academy of Sciences. All rights reserved.

 Permission is granted to reproduce this document in its entirety, with no
 additions or alterations.



 IMMUNIZATION SAFETY REVIEW COMMITTEE

 MARIE McCORMICK, M.D., Sc.D., (Chair), Professor and Chair, Department of
 Maternal and Child Health, Harvard School of Public Health

 RONALD BAYER, Ph.D., Professor, Division of Sociomedical Sciences, School

 of  Public Health, Columbia University

 ROSEMARY CASEY, M.D., Associate Professor of Pediatrics, Jefferson Medical

 College and Director, Lankenau Faculty Pediatrics, Wynnewood, Pennsylvania

 JOSHUA COHEN, Ph.D., Senior Research Associate, Harvard Center for Risk

 Analysis, Harvard School of Public Health

 VERNICE DAVIS-ANTHONY, M.P.H., Senior Vice President, Corporate Affairs

 and Community Health, St. John Health System, Detroit, MI

 BETSY FOXMAN, Ph.D., Professor, Department of Epidemiology, School of

 Public Health, University of Michigan

 CONSTANTINE GATSONIS, Ph.D., Professor of Medical Science and Applied Math,

 and Director, Center for Statistical Sciences, Brown University

 STEVEN GOODMAN, M.D., M.H.S., Ph.D., Associate Professor, Department of

 Oncology, Division of Biostatistics, Johns Hopkins School of Medicine

 ELLEN HORAK, M.S.N., Chief of Local Services, Office of Local and Rural

 Health, Kansas Department of Health and Environment

 MICHAEL KABACK, M.D., Professor, Pediatrics and Reproductive Medicine,

 University of California, San Diego

 Gerald Medoff, M.D., Professor, Department of Internal Medicine,

 Washington University School of Medicine

 REBECCA PARKIN, Ph.D., Associate Research Professor, Department of

 Occupational & Environmental Health, School of Public Health and Health

 Services, George Washington University

 BENNETT SHAYWITZ, M.D., Professor of Pediatrics and Neurology,

 Co-Director, Yale Center for the Study of Learning and Attention

 CHRISTOPHER WILSON, M.D., Professor and Chair, Department of Immunology,

 University of Washington

 ALFRED BERG, M.D., M.P.H., Professor and Chair, Department of Family

 Medicine, University of Washington School of Medicine is a member of the

 Immunization Safety Review Committee, but was unable to attend the meeting

 on the topic of this report.

 Health Promotion and Disease Prevention Board Liaison
 RICHARD B. JOHNSTON, Jr., M.D., Professor of Pediatrics, Department of

 Pediatrics, University of Colorado School of Medicine and National Jewish

 Medical & Research Center

 Staff
 KATHLEEN STRATTON, Ph.D., Study Director

 ALICIA GABLE, M.P.H., Program Officer

 PADMA SHETTY, M.D., Program Officer

 DONNA ALMARIO, Research Associate

 KYSA CHRISTIE, Research Assistant

 ANN ST. CLAIRE, Senior Project Assistant

 ROSE MARIE MARTINEZ, Sc.D., Director, Board on Health Promotion and

 Disease Prevention

 Steven M. Eidelman
 Executive Director

 The Arc of the United States

 1010 Wayne Avenue, Suite 650

 Silver Spring, MD 20910

 301-565-5469 - Phone

 301-565-3843 - Fax

 eidelman@thearc.org

 http://www.thearc.org

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