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Archive for October, 2012

no fault retraction…

On July 2, 2012, the DOJ announced a $3 B settlement with GSK involving Civil and Criminal penalties: Criminal Plea Agreement Under the provisions of the Food, Drug and Cosmetic Act, a company in its application to the FDA must specify each intended use of a drug.   After the FDA approves the product as […]

crisis of confidence…

New England Journal of Medicine September 20, 2012: A Randomized Study of How Physicians Interpret Research Funding Disclosures September 20, 2012: Believe the Data Hooked: Ethics, Medicine, and Pharma September 27, 2012: NEJM: Overly Defensive, or Just Naive? October 12, 2012: More on Sponsorship of Studies in Medical Journals Like many of us, Dr. Brodie […]

sola“…

“In the below video, Forbes contributor, former sell-side analyst, and Manhattan Institute fellow Avik Roy discuss our reasons for being skeptical about sola“… [reference article]

fly fishing…

New psychiatric drugs low priority for pharmaceutical firms Huge unmet need for better drugs for people with depression CBC News Oct 14, 2012 The pharmaceutical industry has largely abandoned drug development for mental illnesses even though depression is a leading cause of disability, experts say. Authors of papers published in this week’s issue of the […]

already?…

Lilly, Roche drugs chosen for Alzheimer’s prevention trial Press Release: Eli Lilly & Co 12 Oct 12 Eli Lilly & Co.’s solanezumab and Roche Holding AG’s gantenerumab were selected for a long-term Alzheimer’s trial run by Washington University at St. Louis scientists seeking to block the disease’s symptoms. The experimental medicines will be tested in […]

the only enduring contract…

One can only imagine the motives of GSK in having their counsel write this letter to the editor of the Chronicle of Higher Education, a letter so contrary to the plea agreement they signed in the recent DOJ case. The editor’s response [in italics below] adequately refutes Mr. Lee’s assertions, but why bother to write […]

new open-ness?…

GSK pledges transparency on drugs research data GlaxoSmithKline has set out a new transparency policy that includes sharing information from its studies, as it moves to distance itself from recent multi-billion dollar US fines. The Telegraph By Jessica Winch 12 Oct 2012 Three months after GSK was fined $3bn [£1.9bn] for fraud related to concealing […]

déjà vu…

I was scanning through older posts looking for something. I stopped on the one about Solanezumab for Alzheimer’s [SHOW ME THE DATA!…] and my eyes lingered on the titles of the two articles I’d listed: Eli Lilly surges on conflicting data for Alzheimer’s drug solanezumab Experimental Lilly drug may help slow mental decline in people […]

something else…

Something new on the GlaxoSmithKline web site, something just added: Data Transparency James Shannon is a member of the Royal College of Physicians and has been our chief medical officer since May 2012. Here he talks about our commitment to share our research data, a policy we hope will improve confidence in our products and […]

take a look…

The age of Alchemy was much more pervasive than we realize from our modern view of charlatans or magicians wearing robes and pointed hats in the contemporary medieval fantasy literature and films. It was a predominant tradition on four continents for three plus centuries, sometimes dichotomous with and at other times intermingled with religion as […]