Tag Archives: scientific

Pharma Petitions FDA for Binding Off-Label Rules


Eliminating illegal off-label promotion while engaging in legal scientific discourse around unapproved uses to ensure patient safety is a difficult line to walk for medical device and pharmaceutical companies. Today, the current broadly-written laws are open to expensive and retrospective interpretation delivered by the FDA, DOJ  and HHS via detailed warning letters, untitled letters, CIAs and DPAs. This is unproductive.

Seven pharmaceutical companies filed a Citizen Petition to FDA for Off-Label Guidance on July 5th Continue reading

Why GPP? for Doctors and Sales Reps

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Jonathan Sackier, MD, is a Visiting Professor of Surgery at the University of Virginia. He discusses the regulatory environment in medicine in the US, as well as the Good Promotional Practices Alliance.

Video reproduced with permission from The Doctor’s Channel–a time-saving site of short one- to two-minute streaming video clips with insights and opinions from experts in 35 different specialties, as well as community and lifestyle features that help doctors stay on top of the latest news, ideas and information.

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Sex, Lies, and Vaccinations

Author: Jonathan Sackier
The sex in the title is included (a) to get your attention and (b) because without it one does not have children. And they are the focus of this rant. The lies and vaccination parts will become apparent.

Much of the writing on this site focuses on life science corporate wrongdoing, whether by acts of omission or commission. But what of my colleagues? What happens when a doctor does wrong? Medical practice is an imperfect canvas, a collage of patchy data and artistically applied practical, real life experiences. We get it wrong on occasion, but such errors are not the result of ill-intention. I am not referring to what is deemed wrong by those staunch soldiers of virtue, the malpractice attorneys.  Very often good doctors – and their malpractice carriers – are persecuted for a bad outcome that is the result of nature of the disease or just plum bad luck. And neither am I referring to downright incompetence – amputating the wrong limb or administering the incorrect dose. I am talking about cold-blooded deception driven by greed, personal pride or political belief. The enzyme that has prompted this tirade is the recent exposure of Dr. Andrew Wakefield’s fraudulent publication that drove mothers and fathers to believe that vaccinating their offspring against measles, mumps or rubella (MMR) might cause autism. Continue reading

Medical Product Promotion is a Team Sport!

Author: Jonathan Sackier

Despite living in the USA for over 20 years and having grown up in Britain, I still do not get most American team sports. The fans are so civil to one another, the preoccupation with math in baseball, TV time-outs in football and the ease of scoring in basketball leave me confused. Ice hockey I get; fast, violent, passionate fans – all very like the football I know. And in English football, okay, soccer, we actually use our feet! Focusing on team sports is a good starting place for my weekly rant – bringing a medical product to market is – or should be – a team sport, but how often is that the case? Continue reading