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Archives Of Neurology • November 2007<br />

Optic Neuritis and Vaccination Investigation:<br />

Failure to Consider Significant Sex Differences<br />

and Multiple Vaccine Combinations<br />

Renata J. M. Engler, MD; Mary Klote, MD;<br />

Michael R. Nelson, MD, PhD<br />

Abstract<br />

In follow-up to recent correspondence related to the study of vaccinations and subsequent<br />

optic neuritis by the Centers for Disease Control and Prevention (CDC),1,2<br />

we are deeply concerned regarding the lack of consideration of sex differences in<br />

incidence of disease for the ICD-9 code 377.3, a common finding for autoimmune<br />

disorders, particularly in young adults aged 18 to 39 years. The Defense Medical<br />

Surveillance System (DMSS) demonstrates that in the population of service<br />

members of greatest concern, there is a consistent pattern, regardless of year for<br />

review, of increased disease incidence by first visit in women compared with men.<br />

This sex difference is also independent of race. The Figure was extracted from the<br />

remote access program to data contained within the DMSS offered by the Army<br />

Medical Surveillance Activity.3 Similar sex differences were identified for ICD-9<br />

codes for optic neuritis, unspecified (377.30); optic papillitis (377.31); retrobulbar<br />

neuritis, acute (377.32); and optic neuritis, other (377.39) during the period between<br />

January 1, 1998, and December 31, 2003. It is of increasing concern in the<br />

context of medical evidence and research that sex differences are not adequately<br />

considered in both research design and data analysis. Given the mandatory nature<br />

of immunizations in the military health system and the fact that most visits involve<br />

complex and sometimes new mixtures, concern for sex-based risk differences is<br />

not a minor question and merits far more attention on the agenda of vaccine safety<br />

surveillance.<br />

“we are deeply concerned<br />

regarding the lack of consideration<br />

of sex differences in incidence of disease ...<br />

there is a consistent pattern, regardless of year<br />

for review, of increased disease incidence<br />

by first visit in women compared with men ...”<br />

http://archneur.jamanetwork.com/article.aspx?articleid=794738&resultClick=3

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