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Organization

University of Pennsylvania

Private research university in Philadelphia, Pennsylvania.

5 links, 3 backed by primary records

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Also known as
Penn
Wikidata
Q49117
Legal records

Federal False Claims Act settlement over the University of Pennsylvania gene therapy study

  1. 9 Feb 2005 Settled with U.S. Department of Justice: $517,496, does not admit the government's allegations 1

Connections 5

people who worked here

settled with

owns a stake in

  • Genovo Scholarship & press 45

    A scholarly article says that in 1995 Penn waived part of its conflict-of-interest guidelines, which had given Genovo exclusive rights to license patents from Wilson's lab. A Harvard course case study says Penn's conflict committee reviewed his ties in 1994 and did not seek to end them. Penn denied that money played any part in the trial.

funded by

  • Genovo Scholarship & press 456

    Sources differ on the money: more than $4 million over five years (Daily Pennsylvanian, 2000), more than $4 million a year (a Harvard course case study), nearly a quarter of the institute's budget (a scholarly article).

involved in

Timeline 1 date
  1. 9 Feb 2005 University of Pennsylvania settled with U.S. Department of Justice
Proof 7 sources
  1. U.S. Settles Case of Gene Therapy Study That Ended With Teen's Death (U.S. Attorney's release of 9 February 2005, reprinted in Almanac), University of Pennsylvania Almanac, 15 Feb 2005. Primary record
    In this case, the University of Pennsylvania (Penn) has agreed to pay $517,496 and Children’s National Medical Center (CNMC) has agreed to pay $514,622 to the government to resolve the government’s allegations.
    As set forth in the Agreements, Penn, CNMC, and Drs. Wilson, Batshaw and Raper do not admit to the government’s allegations and contend that their conduct was at all times lawful and appropriate.
    stemming from a University of Pennsylvania gene therapy study that ended with the death of a participant, Arizona teenager Jesse Gelsinger.
  2. Death but one unintended consequence of gene-therapy trial, CMAJ, 2001. Scholarship & press
    Wilson, director of the Penn institute where Gelsinger was treated
  3. Statement from Penn, 9 February 2005 (Almanac, vol. 51, no. 21), University of Pennsylvania Almanac, 15 Feb 2005. Primary record
    Penn faculty members Dr. James M. Wilson and Dr. Steven Raper may continue to make ongoing contributions to medical research.
  4. Penn hit by gene therapy lawsuit, The Daily Pennsylvanian, 19 Sep 2000. Scholarship & press
    The University was given shares of the company
    By 1999, Genovo had agreed to fund the IHGT’s research, giving them more than $4 million over five years to conduct genetic research.
  5. Ethical Considerations in Phase I studies: Gelsinger Case, HarvardX (Harvard T.H. Chan School of Public Health), course case study. Scholarship & press
    UPenn had a 3.2% equity stake
    By 1999, Genovo had provided more than $4 million a year to the Institute.
  6. Legislative Issues in Disclosing Financial Conflicts of Interest to Participants in Biomedical Research: Effectiveness and Methodology, Journal of Korean Medical Science, 2017. Scholarship & press
    Genovo “provide(d) nearly a quarter of the budget” to the IHGT
  7. Institute for Human Gene Therapy Responds to FDA (Almanac Between Issues, 14 February 2000), University of Pennsylvania Almanac, 14 Feb 2000. Primary record
    The record demonstrates that each and every patient who participated in the OTCD trial gave informed consent to participate.
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