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(Circulation. 2001;103:e9001.)
© 2001 American Heart Association, Inc.
Cardiovascular News
Gene Therapists Promise Renewed Vigor in Monitoring as Field Progresses
The immediate past president of the American Society of Gene Therapy promised to seek "equitable solutions" to issues of reporting and conflict of interest "so that gene therapy is effective, safe, and as common as immunization is today." Savio Woo, PhD, director of the Institute for Gene Therapy at Mount Sinai School of Medicine in New York City noted, "Patients deserve new and better treatments that are effective and safe."
Dr Woo and other prominent figures in the nation’s gene therapy field spoke at the American Heart Association’s Scientific Sessions 2000 from November 12 through 15, 2000, in New Orleans. Nearly a month later, the federal government published proposed rules that would resolve conflicts over which adverse reactions from gene therapy should be published and in what detail, according to the Washington Post (December 13, 2000). Those who advocate for patients want all adverse events reported and made public. Companies are loath to do so because such reports can adversely affect their profits, and researchers feel hampered by regulations that impede their ability to do research.
The federal government sought a compromise among the factions. Since gene therapy began more than a decade ago, the advisory committee to the National Institutes of Health (NIH) has required that all serious adverse events be reported to it immediately. However, that conflicted with the US Food and Drug Administration’s (FDA) requirement that only serious adverse events believed to be associated with the treatment itself be reported immediately.
Under the proposed rule, the federal