Uninformed reporting on off-label medication use

Slow and misleading reporting.

NPR, the Boston Herald, the Philadelphia Inquirer and other news agencies reported on the government's fine of Pfizer, Inc. for actively promoting the off-label use of Bextra.

Most (but not all) of the reporting ignored a similar report from 2003 (http://www.npr.org/templates/story/story.php?storyId=920362) and 2004 (http://www.npr.org/templates/story/story.php?storyId=1895708) regarding Neurontin.

AP reported on 09/02/09 about Pfizer $2.3 billion fine for off-label marketing, but rumors back in January 2009 (Pharmawire) at the time of the Wyeth takeover quoted this exact figure.

While this highlights the need for pharmaceutical companies, the FDA has separately discussed the idea of allowing pharmaceutical representatives to hand out peer reviewed scientific articles concerning the off-label use of their products. This would encourage sales forces to also promote those same off-label uses.

There are comments in the media reporting of this story that are concerning:

1. Off-label uses of medicines are crucial to the health of all Americans. Most people are on important life-saving (and those that improve quality of life) medications on an off-label manner. Off-label simply means that we are using medications for reasons other than are written in the package insert. It would be unreasonable for sponsors to conduct larger (expensive) trials for every indication that drugs work for (and it would further drive up the costs of, already expensive, medications).

Please see out story concerning the off-label use of Genzyme's chemotherapeutic agent, Alemtuzumab (Campath) at http://www.news8austin.com/content/headlines/?ArID=249454&SecID=2 and on our website (www.neurologique.org) under the the About Us --> Media section.

2. The reporting implies that physicians are complicit in the inappropriate (and illegal) promotion of these medications off-label. The stories refer to advisory board meetings where doctor supposedly help Pfizer by planning how best to fraud the system.

Let' remember that physicians want the best for their patients and by necessity this means the use of medications off-label (which is completely legal) since without this many orphan and under-studied diseases would go untreated.

This is completely different from a corporate entity illegally promoting the use of their drug off-label by a non-medical sales force.

Uninformed reporting does not serve the public good and may make doctors hesitant to initiate medications that have the power to alter the course of their patient's lives.

- Dr. Daniel Kantor, MD BSE
Medical Director
Neurologique

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