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Archive for the 'OPINION' Category

In lieu of flowers

( OPINION )

In lieu of flowers, Mickey’s family would appreciate it if you would donate to these groups:   Foundation for Integrity and Responsibility in Medicine – 16 Cutler St, Suite 104, Warren RI 02885 All Trials Lown Institute Thank you so much.  

Help Remember My Old Man

( OPINION )

You are all invited to share your memories of my father and his work. I have created a site for such purposes.

Goodnight, Mickey

( OPINION )

Dad died just before midnight last night. Every end-of-life choice made was his, and knowing that gives Mom, Caitlin, and I a lot of peace. The only sadness (not really a regret, since we did all we could to make this happen), was that Dad could not make it back home to die. He was […]

A Post from Someone Who isn’t Mickey

( OPINION )

Abby here. I’m Mickey’s daughter and luckily, I am Dad’s admin, so I’m able to log in and post. My husband and I traveled to Georgia Wednesday afternoon because my father has been admitted to the ICU. He has severe pneumonia, COPD, and renal failure. Yesterday he was intubated and sedated and he remains in […]

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 […]