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December 06, 2002
U.S. IMMUNIZATION NEWS
"FDA Rules Hinder Cancer Vaccines"
USA Today (www.usatoday.com) (12/05/02) P. 13A; Gottlieb, Scott
In an editorial in USA Today, Dr. Scott Gottlieb says that the development
of cancer vaccines is hurt by the FDA's favoritism for large placebo
trials. The insistence on using placebos dissuades people with early-stage
or treatable cancers from participating in vaccine trials because there is
a chance that the patients will receive no medicine. As a result, not many
products receive approval because they are tested most often on the sickest
patients with severely compromised immune systems. Gottlieb suggests that
the FDA relax some of the stringent guidelines to attack cancer in the same
way it approached AIDS treatments in the early 1990s.
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