What a Week!
From the Pfizer shocker about Torcetrapib, to new guidance from Merck and Lilly, to the FDA Advisory Committee meeting on the safety of drug-coated stents -- it was an incredibly busy week.
Some final thoughts on the stent meeting. Besides the inadequate size of the venue (see previous post) I also think the FDA could have improved the structure of the meeting. I don't know who makes such decisions, but this 19-member panel (19!) was charged with trying to reach a consensus. In other words, there were no straight up or down, yes or no votes on the various questions put to them as is typically the case at such advisory meetings. This was not only a challenge for the committee members and especially the committee chair, but also for the hundreds of analysts, doctors and reporters who were in the audience and listening to the webcast trying to make heads or tails of what, if anything, the panel had "decided" to recommend to the FDA. At times there was clear disagreement among the panel members, but then the chair would simply make a pronouncement about the "consensus" and move onto the next question.
In the end, the committee "agreed" that drug-coated stents, when used as directed on the label, appear to be safe. But when they're used on unapproved patients -- a practice called, "off-label" -- the risk of heart attack, blood clots and death is greater. Those patients include diabetics, people in the throes of a heart attack, people with big blockages or blockages that turn corners -- i.e. requiring stents at 90-degree angles. The chair said the FDA could add a warning to the label about those risks. The committee also said that off-label patients should take the bloodthinner Plavix for at least a year after the procedure and if they can't or won't do that then they shouldn't get a drug-coated stent. And there was talk about requiring companies to do bigger, longer clinical trials specifically looking at the risk of blood clots and death. Many panel members expressed a great deal of frustration with the lack of available data about the issue. Toward the end of the meeting, the committee was under pressure to hurry up and get through the rest of the questions and get out of the room by 4:30ish because the hotel had a wedding in the same ballroom that evening. The FDA usually, but not always, follows the advice of its advisory committees. So, watch for something out of the FDA in the not-too-distant future.
Tomorrow, Merck holds its annual analyst meeting at its New Jersey headquarters. Since the company gave guidance last week tomorrow's meeting will mostly be about its drug pipeline. We'll be reporting live from there starting on "Squawk Box".
And then this Friday we'll be airing our installment of "7 for '07" -- seven questions for the sector that could be answered or dealt with next year.
Questions? Comments? PharmasMarket@cnbc.com