Drug Policy Question of the Week – 6-5-11

As answered by Mary Jane Borden, Editor of Drug War Facts for the Drug Truth Network on 6-5-11. http://www.drugtruth.net/cms/node/3413

Question of the Week: What are adverse drug events?

An article in the Connecticut Law Review defines the U.S. Food and Drug Administration (FDA) as the agency that

“regulates both the safety and effectiveness of prescription pharmaceuticals and certain medical devices. In addition to ensuring that prescription drugs are safe and effective before they are sold in interstate commerce, the FDA approves all information a manufacturer plans to provide physicians on a drug’s recommended use, contraindications, risks, and side-effects.”

The FDA’s Center for Drug Evaluation and Research (CDER) is the regulatory body that oversees over-the-counter and prescription drugs, and biological therapeutics. This agency has produced several trendable reports, including a data briefing covering 1996 to 2006.

This paper overviews the CDER’s Adverse Event Reporting System that compiles

“voluntary adverse drug reaction reports from [healthcare practitioners] and required reports from manufacturers … this system forms “the basis of “signals” that there may be a potential for serious and unrecognized drug-associated events [or reactions].”

Drug reaction numbers from this FDA system are now displayed in two Drug War Facts Tables, one called “Prescription Drug Product Approvals, Recalls and Adverse Event Reports” and the other named “AERS Patient Outcomes by Year,” both sourced directly from the FDA.

Both of these tables reflect troubling statistics. The former table shows that Adverse Drug Event reports to the FDA concerning prescription drugs soared by almost +75% for the six years (2002-2007) compared to the prior six years (1996-2001). Further, and perhaps more disturbing, adverse reaction outcome “deaths” totaling over 370,000 and “serious outcomes” eclipsing 2,300,000 occurred during the ten years from 2000 to 2009 for the prescription drugs tracked by this FDA system.

These facts and others like them can be found in the Regulation of Prescription Drugs section of the United States chapter of Drug War Facts at www.drugwarfacts.org.

Drug Policy Question of the Week – 5-28-11

As answered by Mary Jane Borden, Editor of Drug War Facts for the Drug Truth Network on 5-28-11. http://www.drugtruth.net/cms/node/3403

Question of the Week: What are Clinical Trials?

Wikipedia defines clinical trials as,

“a set of procedures in medical research conducted to allow safety and efficacy data to be collected for health interventions such as drugs, diagnostics, devices, and therapy protocols.”

Clinical trials in the United States begin with the Food and Drug Administration or FDA that

“regulates both the safety and effectiveness of prescription pharmaceuticals and certain medical devices.”

The National Bureau of Economic Research overviews this process that,

“begins when a firm files an Investigational New Drug [IND] application, which requests permission from the FDA to conduct clinical trials on humans … Once the FDA gives its approval, the firm may begin conducting clinical trials for the drug, which proceed in three phases.”

“The goal of Phase I is to evaluate the drug’s safety and to obtain data on its pharmacologic properties. Typically, phase I trials enroll small numbers of healthy volunteers. Phase II trials then enroll slightly larger numbers of sick volunteers. The goal of these trials is to begin investigating a drug’s efficacy and optimal dosage, and to monitor the drug’s safety in diseased patents. Finally, Phase III testing typically involves larger numbers of sick patients and is the most costly stage of the approval process. Phase III testing seeks to establish more definitively the efficacy of a drug, as well as to discover any rare side effects. Upon the completion of Phase III testing, the firm submits a New Drug Application to the FDA, which is accompanied by the results of the clinical trials. The FDA may then reject the application, require further clinical testing, or approve the drug outright.”

These facts and others like them can be found Regulation of Prescription Drugs section of the United States Chapter of Drug War Facts at www.drugwarfacts.org.