The above headline comes from the September 10, 2007 LA Times and is one of many articles reporting on a study published on the same day in the Archives of Internal Medicine. The study data came from the Adverse Event Reporting System, which has been in operation since 1998. This system collects all voluntary reports of adverse drug events submitted directly to the US Food and Drug Administration (FDA) or through drug manufacturers.
The results of this study showed that from 1998 through 2005 reported, serious adverse drug events increased 2.6-times from 34,966 to 89,842. In addition, fatal adverse drug events increased 2.7-fold from 5519 to 15,107. The study noted that reported serious events increased 4 times faster than the total number of outpatient prescriptions during the same period of time.
Thomas J. Moore, the study's lead author and a senior scientist for drug safety and policy at the Institute for Safe Medication Practices of Huntington Valley, Pennsylvania, stated, "This is a direct set of data that shows that the system is failing and it is getting worse. We are in denial about drug safety." Moore continued, "The clear finding is that we are losing ground in terms of drug safety, and that ought to be of great concern."
Dr. Gerald Dal Pan, director of the FDA's office of surveillance and epidemiology tried to explain away the finding in a response in the LA Times when he said, "There are clearly other factors responsible for this increase, such as the increase in public attention to drug safety and use of the Internet to make it easier for the public to report adverse events to the FDA."
This report is bringing more political pressure from legislators for the FDA to take stronger action. Senator Charles Grassley, of Iowa and an outspoken FDA critic said in a statement, "This report is another indication that the FDA's post-market review of drugs must be rigorous and timely. The FDA needs to commit itself to considering and acting on the additional data gathered from more adverse events being reported considering the deaths associated with these adverse drug events."
The conclusion of the researchers in their study serves as a glaring reminder of the risks. They state, "These data show a marked increase in reported deaths and serious injuries associated with drug therapy over the study period. The results highlight the importance of this public health problem and illustrate the need for improved systems to manage the risks of prescription drugs."