Biomedical Engineering Reference
In-Depth Information
•
Did they see patterns of serious adverse events in trials involving
adenoviral vectors?
The follow-up to the death of Gelsinger was arduous for his family,
the federal government, and the research community. In December 1999,
the RAC meeting was devoted to reviewing what had caused Gelsinger's
death and how the oversight system could be modified to prevent similar
tragedies in the future. In January 2000, the FDA sent the Penn research
group a series of inspectional observations and placed a clinical hold on
the OTC deficiency trial. One month later, Senator Bill Frist convened a
hearing on the oversight of human gene transfer research at which
Gelsinger's father, Paul, and I testified. The FDA sent a formal warning
letter in March to Wilson and the IHGT at Penn. Two months later, an
external review committee chaired by former senator John Danforth
reported its findings to University of Pennsylvania president Judith
Rodin, who in response, decided to discontinue all clinical research at
the institute.
12
During the summer of 2000, the University of Pennsylvania decided
not to renew its agreement with Genovo. According to published reports
in the
Wall Street Journal
and the
Philadelphia Inquirer
, Genovo was
sold to Targeted Genetics for newly issued shares of stock valued at $89.9
million. The newspapers also disclosed that Penn had owned a 3.2
percent equity stake in Genovo, for which it received Targeted Genetics
stock valued at $1.4 million, and that Wilson had owned a 30 percent
nonvoting equity stake, for which he received Targeted Genetics stock
valued at $13.5 million. Biogen was to receive $50 million worth of
Targeted Genetics stock in exchange for its stake in Genovo.
13
In September 2000, the Gelsinger family sued the University of Penn-
sylvania for the wrongful death of Jesse Gelsinger. After six weeks of
negotiation between the parties, the case was settled without going to
trial. The terms of the settlement were not disclosed.
14
The tragic death of Gelsinger in 1999 has had a decisive impact on
the public oversight of human gene transfer research in the United States.
Since October 2000, there have been several promising developments at
the NIH and the FDA. One of the most encouraging developments of
late 2000, 2001, and early 2002 has been the step-by-step restoration of
RAC's traditional role. An October 2000
Federal Register
notice stipu-
lated that RAC review and subsequent local institutional approval must
