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The death of 36-year-old Jolee Mohr in a gene transfer experiment sponsored by Targeted Genetics Corporation of Seattle raises important concerns about other participants in the 20 study locations across the country, and about participants in clinical trials of gene therapy and biomedical research more generally.
- How did the shortcomings of the informed-consent document and process affect Jolee Mohr's understanding of the risks involved? What role did they play in her decision to participate in the arthritis study? Are there similar flaws in other study locations?
- Did Jolee Mohr's doctor inform her about the payment made by Targeted Genetics for enrolling her in the study? Are similar payments being made in other study locations? If so, are other participants informed?
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Did the delay in reporting Jolee Mohr's illness by the doctors involved in the Targeted Genetics experiment put other participants at risk?
- What was the process used to approve changes in the study protocol that allowed participation by people already taking arthritis drugs, and changes that allowed two injections of the experimental treatment instead of one?
In a press statement on August 2, the Center for Genetics and Society raised concerns about changes in FDA and NIH procedures on gene transfer experimentation, and called for greater transparency and accountability in this field. CGS also called for limiting gene transfer experimentation to people who suffer from serious conditions for which there are no acceptable alternative treatments, because of the field's record of several deaths, hundreds of serious adverse events, and very little benefit after 17 years.
Arizona: Glendale and TucsonCalifornia: Palm Desert and UplandColorado: DenverFlorida: Boca Raton, Ocala, StuartIdaho: Coeur d'AleneIllinois: Chicago, SpringfieldMaryland: Frederick
Nevada: RenoNew York: Johnson CityOklahoma: Oklahoma CityPennsylvania: Duncansville, Willow GroveTexas: Austin, Dallas (2 sites), San AntonioWashington: Seattle
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Contact:
Osagie Obasogie
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