The above head line originates from the September 10, 2007 LA Times. The research information originated from the Adverse Event Reporting System, which has been operational since 1998. This system collects all voluntary accounts of negative drug incidents submitted directly to the US Food and Drug Administration (FDA) or via drug producers.

The results of this investigation indicated severe negative drug incidents increased 2.6-times from 34,966 to 89,842. Additionally, deadly negative drug incidents increased 2.7-fold from 5519 to 15,107.This increase was during 1998 thru 2005. The study observed that documented severe incidents increased 4 times greater than the total number of outpatient prescriptions throughout the exact same time period.

Thomas J. Moore, the study's lead author stated, "This is a strong range of data that demonstrates the system is failing and it is getting even worse. We have been in denial regarding drug safety." Moore continued, "The obvious finding is that we're losing ground when it comes to drug safety, which really should be of deep concern."

Dr. Gerald Dal Pan, director of the FDA's office of surveillance and epidemiology made attempts to justify the finding in a response in the LA Times stating, "There are obviously additional factors to blame for this increase, such as the rise in media focus on drug safety along with the use of the Internet making it easier for the general public to document negative incidents to the FDA."

Back to Articles List