Subject:   The Creation of a Database For Recording Adverse Events in Genetic Studies
Date:   2004-04-12

The NIH and the FDA have finalized a 3 year effort to create a web database designed to make the reporting and monitoring of adverse reactions mandatory in gene transfer research. In 1995 the initial effort to create this database, then known as the Gene Therapy Information Network (GTIN), was dropped by the FDA and the NIH. The effort was halted at the time due to a combination of inadequate expertise, insufficient funding, and industry lobbying. Research companies were concerned that releasing adverse event information would endanger patent rights and so exercised their right – created by laws which they had lobbied for – not to have adverse event information disseminated. That right of non-dissemination endangers research participants by not giving research participants, other researchers, and government agencies the information they need to insure the safety of clinical trials. Researchers have always been required to report adverse events in all research. Gene transfer, because of its special nature dealing with the human genome, has had the requirement from its inception that adverse reaction information be reported to the FDA and the NIH and so remain in the public eye. That mandate was not working and it took a tragedy to bring the problems to light.

The entirely preventable death of Jesse Gelsinger in a flawed gene transfer experiment at the University of Pennsylvania in September 1999 exposed the weakness of the government's effort to manage gene transfer. Had this Genetic Modification Clinical Research Information System (GeMCRIS) been in place, the 18 year-old's death would have been prevented. Paul Gelsinger, Jesse's father, is now Vice-President of CIRCARE. Once an adversary of the FDA and the NIH for their failed oversight efforts, he is now grateful for their efforts to recreate this web based information system.

CIRCARE'S concern now is that this practice only applies to gene therapy, only a small fraction of medical research. We believe that a similar system should be adopted for all of clinical research to insure the safety of those willing to place their lives at the forefront of medical research.

See the link below for further information:
URL: http://www.nih.gov/news/pr/mar2004/od-26.htm

Paul Gelsinger, Vice President, CIRCARE

Michael A. Susko MS, CIRCARE President
(410) 499-4895

Adil Shamoo Ph.D., CIRCARE Co-Founder
(410) 706-3327

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Last Updated: 2006-04-25

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