Subject: Neglect of Reporting Adverse Events
CIRCARE has strong concerns that considerable scientific data on human research is not being provided to the public, creating unnecessary harm and deaths.
There are currently four major gaps in research reporting:
In sum, each of these four areas constitutes a large gap in the reporting of adverse events. Taken together, the public clearly only has access to a minority of data regarding adverse events, which seriously compromises their ability to give informed consent.
CIRCARE has for 10 years been recommending the reporting and collation of adverse events. Recently, the mandatory reporting and a centralized uniform collection of adverse events in the field of gene transfer research has been adopted by the federal government. We believe that this new mandate serves as a ready model for what is possible and can be extended to other fields of research.
We propose that legislation be enacted to fill such gaps. Both scientific accuracy and human rights demand that data regarding potential harm of treatments become available to other researchers and to the public for whose benefit medical drugs or new devices are being developed and used. As long as such steps are delayed, many serious adverse events and deaths will result.
CIRCARE recommends immediate action to correct the loopholes in each of these four areas and that responsible government agencies take the appropriate steps.
Michael A. Susko MS, CIRCARE President
Adil Shamoo Ph.D., CIRCARE Co-Founder
Link: To create an HTML link to this InfoMail cut and paste the following:
<a href="http://www.circare.org/im/im15July2004.htm">Neglect of Reporting Adverse Events</a>. CIRCARE InfoMail (2004-07-15)
Last Updated: 2006-04-25
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