CliniGene - NoE

Adeno-OTC-case

Scientific Papers

Gene Therapy : As G. case ends, gene therapy suffers another blow

Couzin J, Kaiser J. Science 2005 Feb 18;307(5712):1028

Gene Therapy : Blood test flags agent in death of Penn subject

Bostanci A, Science. 2002 Jan 25;295(5555):604-5.

Complement activation by recombinant adenoviruses

Cichon G, Boeckh-Herwig S, Schmidt HH, Wehnes E, Muller T, Pring-Akerblom P, Burger R. Gene Ther. 2001 Dec;8(23):1794-800.

Gene therapy in the post-G. era

Smith L, Byers JF. JONAS Healthc Law Ethics Regul. 2002 Dec;4(4):104-10

Re.:"A Death in the Laboratory"

Hurwitz RL Mol Ther. 2001 Jul;4(1):4.

A death in the laboratory: the politics of the G. aftermath

Carmen IH Mol Ther. 2001 Apr;3(4):425-8.

US gene therapy in crisis

Teichler Zallen D Trends Genet. 2000 Jun;16(6):272-5.

Failure to inform public is undermining confidence in clinical trials

Marwick C BMJ. 2002 Aug 17;325(7360):356.

Gene therapy experiments put on "clinical hold"

Ciment J BMJ. 2000 Feb 5;320(7231):336

 

Official positions from European and US-scientific committees acting as advisory bodies to competent authorities:

 

Institut Scientifique de la Santé Publique (Belgium Competent Authority)

Report: First Gene Therapy Related Death Dumon JC, Sneyers M, Moens W. Jun 27, 2000

 

US Department of Health & Human Services.

FDA Letter to IND Sponsors/Principal Investigators of Gene Transfer Clinical Trials Regarding Protocol Submission and Adverse Event Requirements. November 5th, 1999

Statement by Dr. Amy Patterson to the Subcommittee on Public Health, U.S. Senate. February 2, 2000

Letter to Sponsor of an IND or master file using or producing a gene therapy product: FDA-CBER. Office of Therapeutics Research & review, March 6th, 2000 Siegel J.

FDA-CBER Federal Notice on the release of safety data related to gene therapy and xenotransplantation clinical trials. Jan 18, 2001

 

NIH

Report from the ACD Working Group – Enhancing the Protection of Human Subjects in Gene Transfer Research at the NIH, July 12, 2000

Letter from OBA – Requirements for Reporting Serious Adverse Events : Request for Institutional Review. November 22, 1999

Assessment of Adenoviral Vector Safety and Toxicity : Report of the NIH Recombinant DNA Advisory Committee. January 1, 2002

 

Information and Reports from European and US-scientific societies:

Policy statement of the American Society of Gene Therapy on reporting of patients adverse events in gene therapy trials.

Woo SL. Mol Ther, 2000 ; 1 : 7

 

Information and Reports from Others:

Four years later, G. case still has lasting implications

Julia Zhou The Daily Pennsylvanian November 6, 2003

Teacher Guide: The Bioethics of Gene Therapy

Molly Malone and Harmony Starr, Genetic Science Learning Center