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Archive for June, 2014

first order solution…

There are things one misses by going to medical school and having a medical career. People like me know next to nothing about business or legal matters. Pre-Med was all science. Medical School was all science, A couple of residencies and psychoanalytic training didn’t fill in any legal blank spaces. And frankly, most doctors are […]

interlude…

a missing link…

In the last post [doing the right thing…], I was praising Canadian Bill C-17 to amend their Food and Drug Act to give the government needed powers to deal with Clinical Trial reporting and drug approval, but I was worried that I couldn’t find the details [that place where the devil lives]. I was helpfully […]

doing the right thing…

While Europe’s EMA struggles with PHARMA interference with Data Transparency, the UK fights the good fight against a gradient of opposition and contention, and the southern colonies here remain frozen in the industrial revolution, the northern colonies seem poised to be quietly just doing the right thing: Vanessa’s Law Honours Memory Of Tory MP Terence […]

not going away…

about “All”…

As many of you are aware, the back and forth between David Healy, Ben Goldacre of AllTrials, and Tracey Brown of Sense about Science continues [Sense about Science: Follow the Rhetoric, Sense about Science: First Admit no Harm, Sense about Science: Follow the Lawsuit, and their respective comments]. There are many issues in contention, not […]

requiem for evidence based medicine…

Evidence based medicine: a movement in crisis? by Trisha Greenhalgh, Jeremy Howick, Neal Maskrey, for the Evidence Based Medicine Renaissance Group British Medical Journal. 2014 348:g3725 It is more than 20 years since the evidence based medicine working group announced a “new paradigm” for teaching and practising clinical medicine. Tradition, anecdote, and theoretical reasoning from […]

internecine battles…

"First, we need to speak on behalf of both our patients and the growing body of science as physician experts on mental health. This means helping others understand what we know so well as physicians — that these illnesses are real, disabling, and strongly associated with medical comorbidity, but also amenable to care, treatment, and […]

out of the shadows…

European Ombudsman reaction to EMA’s 12 June 2014 statement issued after its Management Board meeting 13 Jun, 2014 The European Ombudsman, Emily O’Reilly, notes the statement EMA published after its management board meeting on 12 June. As EMA now intends to finalise a revised wording for its proactive clinical trial data policy, the Ombudsman cannot […]

thoughts?…

Yeah, I’m still stuck on the things that lead up to the EMA U Turn, a house that PHARMA built like so many others. I tried sitting down this afternoon and pretending I’m an AbbVie executive, and then detached from that identification and looked at what I was worried about during my moments as a […]