Pharmas Market with Mike Huckman

Embargo-gate at the ACC


Embargo-gate at the ACC
Scientific journals and medical groups employ media embargoes on studies that are to be published or presented. The common practice gives reporters like me a chance to read and digest the information in advance, interview researchers and experts, maybe talk to patients so that when the embargo lifts full and accurate stories will air, run in the papers or cross the wires. It also gives the journals and medical groups a way to manage the news cycle and get more media bang for their publication or conference. Such was supposed to be the case at this week's American College of Cardiology conference in New Orleans. Monday was the day when the embargo would lift on the data from Pfizer's failed torcetrapib for cholesterol. That happened on schedule and without incident. And Tuesday was scheduled to be the day when the embargo lifted on the highly-anticipated COURAGE (an acronym) clinical trial comparing stents to drugs. Occasionally embargoes are broken by a reporter or a media outlet--sometimes inadvertantly, sometimes on purpose--but this break, according to several sources, takes the cake. Monday morning there were at least two stories on the web or in print quoting one or two doctors who spoke at events sponsored the night before by two separate medical devicemakers. At those symposiums the doctors who had been privvy to the COURAGE study results reportedly spilled the beans on at least some of the data. Reporters happened to be in the audience and justifiably, in my opinion, ran with the information. This was stock-moving, headline-grabbing news about how older heart medicines may work just as well as newer, expensive stents on patients who have "stable" angina or chest pain. After the doctor or doctors broke the embargo and the stories appeared other reporters who were not at the company-sponsored events urged the ACC to take action. The ACC leadership quickly decided to lift the embargo on the detailed data at 2 p.m. ET Monday instead of the previously planned 9:30 a.m. Tuesday. That sent reporters--including me--scrambling in between all of the other things we had to cover that day to get our ducks in a row and our stories ready for air or publication much sooner than expected. Deadline met. Not a problem. That's my job. But the ACC was not and still is not happy. Here's an excerpt from the statement it issued on Monday morning:

"We are extremely disappointed that this individual or individuals released this information, betraying the confidentiality of the scholarly process and the professional integrity of the scientific community. The American College of Cardiology will be considering strong sanctions against the individual or individuals involved."

The next morning a senior ACC official told me the doctor or doctors would have hell to pay and that there will be severe, far-reaching repercussions over what happened. This person called it a flagrant violation not only of the embargo policies of the "New England Journal of Medicine" and the ACC, but also of long-accepted physician-researcher ethics and codes of conduct. We'll see what, if anything, happens in the fallout.

And finally a clarification. In my posting last week regarding Dendreon when I referred to the Sanofi-Aventis drug Taxotere I should have written that it is also known by the generic name docetaxel. I did not mean to imply it is available as a generic.

Questions? Comments?