Info on safety, efficacy unavailable online for top-prescribed drugs

  ·  Health Policy Hub

A review by the Sunlight Foundation found that important safety and other clinical data on more than one-third of the top-prescribed drugs in the U.S. is  not readily available to prescribers, researchers and patients. The transparency watchdog group found that nine of the 25 top-prescribed drugs, including Lipitor, Effexor, and Plavix, lack this online information--meaning most prescribers have an incomplete picture of safety and efficacy on commonly-written scrips.

The data, required by the FDA for approval but often left unpublished in medical journals and other venues, is only online for drugs approved after 1998. Even then, Sunlight reports, the online info may be heavily redacted and is published in manually-created PDFs that "are not hyper-linked or text searchable, and therefore are hard to navigate." Information on drugs approved before 1998 has to be obtained by the characteristically slow and cumbersome Freedom of Information Act request, a process most physicians don't use to inform prescribing decisions.

The Foundation says its unclear whether such data will be included as part of the Obama administration's Open Government Directive, a plan to have each government agency publish previously undisclosed data sets to the public, but drug safety advocates like Dr. Steven Nissen of the Cleveland Clinic say that such drug info should "absolutely" be included.

For more on the review, including a list of the top-prescribed drugs and which data remains inaccessible, read the story here.

--Kate Petersen, PostScript blogger