Healthy Skepticism Library item: 19024

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Shwartz LM, Woloshin S.
Lost in transmission--FDA drug information that never reaches clinicians.
Engl J Med 2009 Oct 29; 361:(18):1717-20
http://www.nejm.org/doi/full/10.1056/NEJMp0907708

Abstract:

The 2009 federal stimulus package included $1.1 billion to support comparative-effectiveness research about medical treatments. No money has been allocated — and relatively little would be needed — to disseminate existing but practically inaccessible information about the benefits and harms of prescription drugs. Much critical information that the Food and Drug Administration (FDA) has at the time of approval may fail to make its way into the drug label and relevant journal articles.
The most direct way that the FDA communicates the prescribing information that clinicians need is through the drug label. Labels, the package inserts that come with medications, are reprinted in the Physicians’ Desk Reference and excerpted in electronic references. To ensure that labels do not exaggerate benefits or play down harms, Congress might have required that the FDA or another disinterested party write them. But it did not. Drug labels are written by drug companies, then negotiated and approved by the FDA.
When companies apply for drug approval, they submit the results of preclinical studies and usually at least two phase 3 studies — randomized clinical trials in patients with a particular condition. FDA reviewers with clinical, epidemiologic, statistical, and pharmacologic expertise spend as long as a year evaluating the evidence. FDA review documents (posted at www.accessdata.fda.gov/scripts/cder/drugsatfda/) record the reasoning behind approval decisions. Unfortunately, review documents are lengthy, inconsistently organized, and weakly summarized. But they can be fascinating, providing a sense of how reviewers struggled to decide whether benefits exceed harms. Yet in many cases, information gets lost between FDA review and the approved label. …