Medical Editors vs. Pharma: Round Two
Read this wire story reporting the details behind the NEJM editorial published online yesterday (subscribers can the download editorial here NEJM Editorial).
The bottom-line? The ICMJE (medical journal editors) have drawn their line in the sand. They want transparency when they publish studies. They want to be sure that what they are publishing is representative of the body of data available for a therapy and not just a snippet of what worked. They want to be sure that companies have not self-selected parts of a study to submit for publication.
Are they being reasonable? You bet your ass they are. Pharma’s reputation when it comes to publishing fairly is deeply tarnished. A brief anecdote. A few years ago, at an advisory board meeting called by my former employer, the issue of biased publication was raised. Speaking on behalf of my employer, I confidently asserted to the hushed group of thirty or so experts that we would never suppress data harmful to a drug we were developing. In my mind, the next few seconds replay like a cartoon reel…a comedic pause followed by uproarious mocking laughter, accusatory pointing, sub-lethal pratfalls, and red-faced gasps for air. Investigators and opinion leaders that I had assumed trusted me personally, had, in reality, no faith that I could control the avarice of my employer when push came to shove. They were sure that my employer would do whatever necessary to put its drugs in the best light.
Well…I still strongly believe that they were mistaken. But it matters not. Pharma now has no choice but to comply with the wishes of medical editors, the U.S. Congress and the lay public when it comes to publication transparency. They must register their trials in advance of their conduct. And they must register them in a way that allows the drugs under study to be tracked easily. Registering all drugs as “investigational drug” is not going to suffice. Companies that try such tactics past the ICMJE deadline this summer are going to be publicly burned at the stake. The writing is now literally on the wall. Pharma better learn to read.
