FDA Reconsidering Drug Safety Reporting Methods

Probably the weakest link in the conventional health care paradigm that's pushed many people to consider alternative treatments, especially over the past year: The FDA's means of monitoring drug safety, with the saga of controversial anti-inflammatories Vioxx, Celebrex and Bextra still fresh on the minds of many patients and legislators.

Acknowledging flaws in its Adverse Event Reporting System (AERS), the FDA begins a two-day hearing this morning to discuss improvements. Although top officials believe AERS is effective in detecting problems, the head of the FDA's statistical science office found deep flaws in the system, acknowledging reports aren't systematically collected nor complete with important clinical information.

And side effects can be tough evaluate based on a patient's individual drug regimen and reports of deadly drug interactions that attract attention from media outlets and Web sites like mine.

By the numbers:

  • The FDA received some 400,000 reports last year, with some 75 percent pertaining to drugs. That represents a huge 62 percent increase of 2003 numbers.
  • Experts estimate less than 10 percent of potential side effects are reported.
  • Only 40 percent of these reports are submitted online. Almost all of the rest are either mailed or faxed. To that end, the FDA is working on a Web-based system upgrade that would make it easier for doctors and consumers to send reports directly to its database.

Will an improved data collection system create meaningful change overnight in how the FDA operates? Probably not, as long as they continue to put drugs on a fast track to approval, and to punish some of its critics for their hard work and honesty.

Reuters.com May 16, 2005

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