Gene Therapy Death Raises Troubling Questions

By Center for Genetics and Society | 08.08.2007
Press Statement
Troubling new revelations have emerged this week in the death of an Illinois woman in a gene therapy trial for arthritis, prompting the Center for Genetics and Society to call on the federal government to consider firmer regulatory action.

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.

Based on these concerns, the Center for Genetics and Society is urging the Food and Drug Administration (FDA) to make public complete information about the Targeted Genetics arthritis study. This information should include full details about the informed-consent process in all study locations, about payments to doctors who enrolled their patients in the study, and about changes to the inclusion criteria for the study since it was reviewed by the National Institutes of Health (NIH) committee in 2003.
 
Among the questions raised by the death in the Targeted Genetics arthritis study:
  • 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?
  • 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.

The Targeted Genetics arthritis study, which has been suspended by the FDA, was being conducted in the following locations, according to the NIH web site that tracks clinical trials:
Arizona: Glendale and Tucson
California: Palm Desert and Upland
Colorado: Denver
Florida: Boca Raton, Ocala, Stuart
Idaho: Coeur d'Alene
Illinois: Chicago, Springfield
Maryland: Frederick
Nevada: Reno
New York: Johnson City
Oklahoma: Oklahoma City
Pennsylvania: Duncansville, Willow Grove
Texas: Austin, Dallas (2 sites), San Antonio
Washington: Seattle
 
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The Center for Genetics and Society is a nonprofit information and public affairs organization working to encourage responsible uses and effective societal governance of the new human genetic and reproductive technologies. It supports women's health and reproductive rights, including the right to terminate an unwanted pregnancy. For more information, see http://www.genetics-and-society.rsvp1.com/s18cb01U7wp

Contact:
Osagie Obasogie
510-625-0819 x310

 

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