Mister S. Goes To Washington

Let’s just assume that Mr. Martin Shkrely had provided full testimony at the Congressional hearing, this is what it might have said: Read my lips: NO MORE REBATES ! Link to this post!

Moving Towards Greater Transparency – One Step At A Time, Inexorably

Sharing trial data has been a controversial topic for quite a while. Recently the editors of major medical journals decided to take a stand. They will make access to trial source data a requirement, as a condition of publication, arguing that Continue reading Moving Towards Greater Transparency – One Step At A Time, Inexorably

Artie’s Law: Avoid Bad Advice and Don’t Follow ‘Mission Impossible’ Advice

In this day and age, few truly broad spectrum antibiotics are in development, although this does not hold true for narrow-spectrums.  Just think of all the MRSA drugs (quinolones, FabI inhibitors), the pseudomonas drugs (NCEs and monoclonals) or some narrow Continue reading Artie’s Law: Avoid Bad Advice and Don’t Follow ‘Mission Impossible’ Advice

Why Some Did Not Make It

There are numerous reasons why drugs get stuck in development.  Certainly, problems with efficacy or problems with safety are main reasons but there are many other ‘derailers’ as well.  For instance regulatory issues or manufacturing, difficulties can stop a program.  Continue reading Why Some Did Not Make It

Why Did PK/PD Modeling Fail Doripenem in VAP?

When imipenem is dosed at 1 g q8h for serious infections, it is infused over 40-60 min. Its label states that it is indicated for “lower RTI”, an old-fashioned term from the days when bronchitis and pneumonias were still lumped Continue reading Why Did PK/PD Modeling Fail Doripenem in VAP?