Subject:   Neglect of Reporting Adverse Events
Date:   2004-07-15

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:

1. Pre-Drug Approval: Clinical trials by drug companies which result in negative findings are not published or put in any data base, and are only reported to the FDA. Recently this subject has gained national headlines with the American Medical Association supporting the publication of negative trials. If such trials remained unpublished subsequent trials with the same drug do not have the knowledge and benefit or the previous trials. This seriously compromises informed consent by the public who is asked to participate in research trials or to later use a drug that has been approved.
2. Approved Research for drug marketing: There is no national, uniform and clearly defined mandatory reporting requirements of adverse events by researchers. Currently, there is a hodgepodge of regulations which are subject to diverse interpretations by each institution and so cannot be collated into one uniform data base. Each set of trials for a given drug has to be accessed individually from the raw data/study submitted by the drug company. There is no statistical collation by the FDA for adverse events.
3. Post-marketing surveillance of adverse events: Currently reporting of adverse events for a new drug is voluntary. Doctors fill out a Med-Watch form and submit it to the FDA. The percentage of adverse events which are actually reported is unknown, but it is low and suspected to be as low as 3%. Of the events which are reported, there are private companies who do consolidate this data. This data, however, is only made available at a cost, making the information beyond the reach of the general public.
4. Private Research: Research which does not use federal money or need a requirement for a drug license,  nearly 40% of all research, has no reporting requirements whatsoever – excepting three states, of which Maryland has the best law.

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
(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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