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Subject:   Lack of Reporting of Adverse Events Leading to Duplication of Harm
Date:   2003-03-09

CIRCARE has serious concerns that considerable data relating to adverse events and deaths is not being reported. As CIRCARE has maintained, there is a statistical case that thousands of deaths and tens of thousands of adverse events do not become publicized. Aside from the concrete harm done to existing subjects, potential subjects are not aware of these adverse events relevant to their research protocol, leaving the informed consent process seriously flawed. This has happened in two recent highly publicized deaths of volunteers at U.S. research institutions – in the case of Jesse Gelsinger at the University of Pennslvania and Ellen Roche at Johns Hopkins University.

The current patchwork of regulations, which leaves animals more protected than humans, allows major research to be conducted without reporting adverse events. One major loophole is that privately funded research – which is not a part of an application for drug licensing – is not required to report to any federal oversight body. Therefore, failed experiments do not have to be reported.

Consider the recent case of a French company which conducted retrovirus research on children and voluntarily reported two cases of induced cancer or leukemia in a recent study. The public disclosure of these adverse events and the handling by the FDA thus far is a model example of how the system should work. As a result of public pressure, the FDA has also revealed that in 50 other studies which used retroviral vectors as the gene transfer agent, all subjects died. There is no specific reference by the FDA as to whether the deaths were related or unrelated to the gene transfer research. It would seem that parents of children for this prospective type of experimental research would want to know results of all retroviral experiments (even if causation of harm has not been clearly established) before consenting for their children to undergo this therapy.

See the Boston Globe story: Gene Therapy Trials are Restored by FDA Despite Cancer Cases. Raja Mishra. 2003-03-01. The Boston Globe. Available from http://web.archive.org/web/20030306001240/http://www.boston.com/dailyglobe2/060/nation/Gene_therapy_trials_are_restored_by_FDA_despite_cancer_cases+.shtml

It will take federal legislation to alter this situation. Currently, private, for-profit companies have little incentive to report adverse events. This may be due, in part, because companies do not want their competition to know their proprietary results, meaning that yet other companies may well end up replicating deaths and adverse events.

CIRCARE has long advocated mandatory reporting of adverse events and deaths by private or publicly funded research and the maintenance of a national registry. We believe that this would avoid many adverse events and deaths, as well as create more trust in research and in the long run further the gains of science. CIRCARE, additionally, advocates for a no-fault insurance to cover the cost of health care for those volunteers who become injured due as research subjects.

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

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


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<a href="http://www.circare.org/im/im9Mar2003.htm">Lack of Reporting of Adverse Events Leading to Duplication of Harm</a>. CIRCARE InfoMail (2003-03-09)

Last Updated: 2006-04-25

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