Weekly Roundup – 12/14/07

J0403673The Midwest and Northeast have been pounded by ice storms and Nor’easters.  Here in the Mid-Atlantic, there has been much gloom, both figuratively and literally.  The last of the debates among the candidates before the Iowa Caucuses were held this week.  And I am nearing the end of the marathon review of candidates – on Monday you will see Ron Paul. 

In the meantime, here is a little of what happened this week of interest:

  • Dog Bites Man – Proton Pump Inhibitors off the Heart Attack Hook – It seems we are looking everywhere for cardiac signals these days.  This week the news was that Prilosec (one of the most prescribed drugs in the world up until the time it switched to OTC) and Nexium do not appear to cause heart attacks.  The FDA announced that its safety review showed no evidence of increased risk of heart attacks among these proton pump inhibitors. 
  • Merck Gets Thumbs Down on OTC Mevacor from AC Panel – No surprises here, the FDA’s advisory committee panels voted against a switch for cholesterol-lowering Mevacor.  It was not the first time that Merck made this switch attempt and during that first attempt, the problems with an OTC switch were pretty clear.  In reviewing the questions that the FDA posed to the panel, it was curious to note what was not there as much as what was there.  What was not there was a question about the potential for the drug to be a Behind-the-Counter (BTC) drug should such a category emerge.  In the wake of the FDA’s recent public meeting on that topic, it might have been an insightful question if the FDA seemed tempted to direct Mevacor to that end.  The anticipated action date by the FDA is Jan. 26, 2008.
  • Pharmaceutical Executive Magazine Publishes the Pipeline Report – A very in-depth overview of the current pipeline is published in the December issue of Pharmaceutical Executive and is well-worth a look.

Short entry, but I’m off today and it is the first sunny day we’ve had in several days.  Have a good weekend everyone.

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