Paul wrote about Jesse's death and explained why his son volunteered to partipate in the Ornithine Transcarbamylase Deficiency Clinical Trial at The Institute for Human Gene Therapy.
Gelsinger P. Jesse's Intent.© 2001. Available from http://www.circare.org/submit/jintent.pdf
On 2005-02-09, more than five years after Jesse died, the U.S. Department of Justice announced civil settlement agreements with James Wilson M.D., Steven Raper M.D., The Institute for Human Gene Therapy at The University of Pennsylvania, Mark Batshaw M.D., and Children's National Medical Center. Paul responded to the settlements on 2005-02-14.
CIRCARE InfoMail 2005-02-14: Lack of Effective Accountability in Research Deaths
Follow this link to find the civil settlement agreements, information on NIH grants awarded to Drs. Wilson, Raper, and Batshaw, links to transcripts of meetings of the National Institutes of Health Recombinant DNA Advisory Committee, and related documents.
This page has news coverage, public statements from The Institute for Human Gene Therapy, FDA warning letters, and Office for Human Research Protections determination letters. It ends with an update on what Paul is doing today.
The Gelsinger Case. The Washington Post. (Multi-article collection.)
URL: http://www.washingtonpost.com/wp-dyn/health/specials/genetherapy/gelsingercase/
Patient Dies While Undergoing Gene Therapy. Nicholas Wade. The New York Times. 1999-09-29.
URL: http://partners.nytimes.com/library/national/science/092999sci-gene-therapy.html
Patient's Death Stops Gene Therapy Studies. Associated Press. 1999-10-12.
URL: http://partners.nytimes.com/library/national/science/101299sci-gene-therapy.html
U.S. Moves to Require Disclosure of Gene Tests. Sheryl Gay Stolberg. The New York Times. 1999-10-30.
URL: http://partners.nytimes.com/library/national/science/health/103099gene-therapy.html
A Death Puts Gene Therapy Under Increasing Scrutiny. 1999-11-04.
URL: http://partners.nytimes.com/library/national/science/health/110499hth-gene-therapy.html
F.D.A. Officials Fault Penn Team in Gene Therapy Death. Sheryl Gay Stolberg. The New York Times. 1999-12-09.
URL: http://partners.nytimes.com/library/national/science/health/120999hth-gene-therapy.html
Tribute and Apologies in Gene Therapy Death. Sheryl Gay Stolberg. The New York Times. 1999-12-10.
URL: http://partners.nytimes.com/library/national/science/health/121099hth-gene-therapy.html
Youth's Death Shakes New Field of Gene Experiments on Humans. Sheryl Gay Stolberg. The New York Times. 2000-01-27.
URL: http://partners.nytimes.com/library/national/science/012700sci-gene-therapy.html
Scientists Defend Suspended Gene Therapy. Sheryl Gay Stolberg. The New York Times. 2000-02-15.
URL: http://partners.nytimes.com/library/national/science/health/021500hth-gene-therapy.html
Ornithine Transcarbamylase Deficiency Clinical Trial. The Institute for Human Gene Therapy, The University of Pennsylvania. 1997-2000.
Statement on the Death of Jesse Gelsinger. The Institute for for Human Gene Therapy, The University of Pennsylvania. 1999-09.
Preliminary Findings Reported on the Death of Jesse Gelsinger. The Institute for Gene Therapy, The University of Pennsylvania. 1999-12-02.
Institute for Human Gene Therapy Responds to FDA. The University of Pennsylvania, The Institute for Human Gene Therapy. 2000-02-14.
Response to FDA. The University of Pennsylvania, The Institute for Human Gene Therapy. 2000-02-22.
The University of Pennsylvania Announces Actions. The Institute for Human Gene Therapy, The University of Pennsylvania. 2000-05-24.
The Institute for Human Gene Therapy: More Information the Ornithine Transcarbamylase Deficiency Clinical Trial. The Institute for Human Gene Therapy, The University of Pennsylvania. 2000-06-16. (Many links to news stories are available on this page.)
Report of Independent Panel Reviewing the University of Pennsylvania's Institute for Human Gene Therapy. 2000-04-27. Penn Almanac. Vol. 46, No. 34, May 30, 2000.
Action by the University of Pennsylvania in Response to the Report of the Independent Panel Reviewing the Institute for Human Gene Therapy.
Penn Almanac. Vol. 46, No. 34, May 30, 2000.
Masiello SA. FDA Warning Letter to James Wilson M.D., Ph.D. 2000-03-03. (Sponsor obligations.) Available from http://www.fda.gov/foi/warning_letters/m3435n.pdf
Masiello SA. FDA Warning Letter to James Wilson M.D., Ph.D. 2000-07-03. (Good Laboratory Practices.) Available from http://www.fda.gov/foi/warning_letters/m3897n.pdf
Masiello SA. FDA Warning Letter to Steven E. Raper M.D. 2000-11-30. Available from http://www.fda.gov/foi/warning_letters/m4912n.pdf
Masiello SA. FDA Notice of Initiation of Disqualification Proceedings and Opportunity to Explain to Mark L. Batshaw M.D. 2000-11-30. Available from http://www.fda.gov/foi/nidpoe/n14l.pdf
Masiello SA. FDA Notice of Initiation of Disqualification Proceedings and Opportunity to Explain to James Wilson M.D., Ph.D. 2000-11-30. Available from http://www.fda.gov/foi/nidpoe/n12l.pdf
Baker DE. FDA Notice of Opportunity for Hearing to James Wilson M.D., Ph.D. The Institute for Human Gene Therapy, The University of Pennsylvania. 2002-02-08. Available from http://www.fda.gov/foi/nooh/Wilson.pdf
FDA Center for Biologic Evaluation and Research Biological Response Modifiers Advisory Committee Meeting Documents. 2000. Available from http://www.fda.gov/ohrms/dockets/ac/cber00.htm#Biological%20Response%20Modifiers%20Advisory%20Committee
Borror KC. Office for Human Research Protections Determination Letter to The University of Pennsylvania. 2001-05-07. Available from http://www.hhs.gov/ohrp/detrm_letrs/may01a.pdf
Borror KC. Office for Human Research Protections Determination Letter to The University of Pennsylvania. 2001-09-26. Available from http://www.hhs.gov/ohrp/detrm_letrs/sept01b.pdf
In their determination letter of 2001-09-26 to The University of Pennsylvania the Office for Human Research Protections wrote:
Based upon its review, OHRP makes the following determinations.
A. Findings Regarding Research Project:
Recombinant Adenovirus Gene Transfer in Adults with Partial Ornithine Transcarbamylase Deficiency(1) OHRP finds that when reviewing protocol applications, the Institutional Review Board (IRB) often lacked sufficient information to make the determinations required for approval of research under Department of Health and Human Services (HHS) regulations at 45 CFR 46.111.
Corrective Action: OHRP acknowledges that U Penn has established Sponsor-Investigator Standard Operating Procedures (SOP) which require that any protocol amendment be prepared using a strike-out function to highlight changes and that each change must be outlined in a cover memo. OHRP also acknowledges that the U Penn IRB now has a written requirement that recruitment materials must be submitted to the IRB for review and approval. In addition, investigators will be provided with additional guidance on protocol drafting. OHRP also acknowledges that the Institute for Human Gene Therapy will no longer sponsor clinical trials, and all trials have stopped further enrollment.
(2) OHRP finds that the informed consent documents reviewed and approved by the IRB for the OTCD study failed to adequately address the following element required by HHS regulations at 45 CFR 46.116(a)(1): A complete description of the procedures to be followed, and identification of any procedures which are experimental.
Corrective Action: OHRP acknowledges that U Penn is instituting new SOPs detailing instructions to Sponsor-Investigators regarding informed consent documents, and specific IRB SOPs regarding general requirements and documentation of informed consent and assent. In addition, U Penn is currently training investigators, IRB members and IRB staff on these issues.
(3) HHS regulations at 45 CFR 46.109(a) require that the IRB review and approve all non-exempt human subject research. An article that appeared October 25, 1996 in the
Page 3 of 5
Neal Nathanson, M.D. – University of Pennsylvania
September 26, 2001Philadelphia Inquirer noted that Drs. Wilson and Batshaw attended the national meeting of the National Urea Cycle Foundation, in which they described their study and asked for volunteers. The article stated that they drew blood at that meeting
to identify carriers and possible test subjects.OHRP finds that this screening for prospective subjects involved human subjects research and occurred prior to IRB approval for this activity.Corrective Action: OHRP acknowledges that the U Penn IRB reviewed information regarding the recruitment activities two months after the screening activity and that the IRB subsequently approved the informed consent document for this activity approximately one year later. OHRP also acknowledges that the IRB currently requires that new protocol submissions clearly identify the need for IRB review and approval of all information to be given to subjects as part of the recruiting process and that recruiting strategies themselves must be approved.
In March, 2003 Paul was asked to serve on the advisory board of Partnership for Research Protection Inc., a JCAHO/NCQA Collaboration providing an accreditation program for institutional review boards. As of 2005-11-15, Partnership for Research Protection Inc. ceased providing IRB accreditation because they found there was not sufficient demand for this service.
Partnership for Human Research Protection to Dissolve Due to Lack of Demand. BNA Medical Research Law & Policy Report®. 2005-09-21.
URL: http://healthcenter.bna.com/pic2/hc.nsf/id/BNAP-6GFS2J?OpenDocument
Angell M. HHS Conference on Financial Conflicts of Interest. 2000-08-16. Available from http://aspe.hhs.gov/sp/coi/angell.htm
Last Updated: 2007-04-01
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