Monthly Archives: October 2008
Eliminate Waste (Whatever That Is)
There’s a fascinating editorial in this week’s New England Journal of Medicine by Henry J. Aaron, a healthcare economist at the Brookings Institution. Aaron argues that on average healtchare spending is not wasteful, since its benefits exceed its costs. But that doesn’t mean there isn’t waste. The trick, though, is to identify it, and as [...]
Posted in Uncategorized Tagged Brookings Institution, healthcare, Henry J. Aarons, waste Leave a comment
Pfizer Responds to Adverse Events Report
A report released last week by the The Institute for Safe Medication Practices (and covered yesterday on PharmExec.com), listed Pfizer’s smoking cessation drug Chantix as the number one most reported drug for adverse reactions in the first quarter of 2008.
The report states that FDA received 1,001 reports of serious side effects for varenicline (the generic [...]
Posted in Safety Tagged adverse reactions, Chantix, ISMP, Pfizer, Safety, Side Effects, smoking 2 Comments
Heat From FDAAA: Time For New GPP
Good Publication Practice, or GPP, is often the first port-of-call for companies publishing in the biomedical sector.
But consider this. The first ideas for GPP were formed a decade ago, and now the time is right for GPP2: the new, revised Good Publication Practice.
Why now? Pharma publication practice is a hot potato. Purported cases of publication-related [...]
Posted in Regulatory Tagged Chris Graf, clinicaltrials.gov, FDAAA, GPP, ICMJE, ISMPP, Publication Planning, Steering Committee Leave a comment

Distractions Abound – DTC Perspectives Day 2