Category

Archive for the 'OPINION' Category

call me, maybe…

( OPINION )

Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated REGULATORY AFFAIRS PROFESSIONALS SOCIETY By Zachary Brennan 31 January 2017 In a sign of what’s to come for the US Food and Drug Administration [FDA], President Donald Trump told pharmaceutical company CEOs Tuesday that his administration will be “cutting regulations at a […]

24 hours…

( OPINION )

what we need to know?…

( OPINION )

I don’t much like questionnaires. But if required, I prefer yes/no or one word answer questions. And I’ve never designed a questionnaire [before today]. But as I was thinking about post-approval monitoring, I decided I’d give it a shot. I was thinking about what information you might gather post approval in help seeking patients taking […]

basic efficacy table – it’s what’s missing that matters…

( OPINION )

I’ll be the first to admit that I’ve been pretty muddled these last several months – since, oh say, around 10:00 PM on November 8th, 2016 to be more precise. I’ve tried out any number of defense mechanisms to tell myself that I’m doing just fine. But to be honest, this election sort of took […]

the basic efficacy table II…

( OPINION )

When Dr. Bernard Carroll comments here, he often uses the term "hand waving" when describing some of the tricky maneuvers used in the clinical trial reports to smooth over shaky logic or rationalize absurdities. It’s a great term, I think originating in the world of stage magicians who use exaggerated gesticulations to distract your attention. […]

the basic efficacy table I…

( OPINION )

I don’t know if my musings about the Linux story worked, but what I was trying to talk about was the computer community’s struggles with the secrecy of the commercial developers – a problem similar to ours with Clinical Trials and their sponsors. Watching those computer code struggles happen from the sidelines, things took of […]

the commercial strangle-hold…

( OPINION )

Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study by Rosa Ahn, Alexandra Woodbridge, Ann Abraham, Susan Saba, Deborah Korenstein, Erin Madden, W John Boscardin, and Salomeh Keyhani. BMJ 2017 356:i6770 [full text on-line] Objective: To examine the association between the presence of individual principal investigators’ financial ties to the manufacturer […]

places and spaces…

( OPINION )

Cartograms of the 2016 presidential election [with the country scaled by population rather than area]. On the left, colored by who won the county. On the right, color gradient by percentage vote in county. Can you say Urban versus Rural?

show me the damn  code  numbers!…

( OPINION )

The background image is an iPhone photo of a spreadsheet opened on that little Linux computer in the last post, and the midground is a spreadsheet from my Windows computer. They’re both Open Source versions of OpenOffice, the free Office Suite that I use instead of Microsoft Excel [foreground]. The point of the graphic is […]

here’s Linus…

( OPINION )

Sometimes it’s the things right under your nose that are the hardest things to see. This is my desktop at home [uncharacteristically uncluttered]. Pretty much standard fare with a couple of 27" monitors connected to a big Windows 10 computer under the desk. But there are some anomalies. Why the two keyboards? and the two […]