Editorial note: a slight variation of this appeared last week on The Conversation. In 2010, the European Ombudsman ruled that the European Medicines Agency should open access to clinical trials data when companies applied to get their drugs on the market. The ombudsman decided public health was more important than considerations of commercial confidentiality. In February … [Read more...] about Trade Wars we have known and loved: Brand EFPIA v Korea
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Health Action International: Access to Trial Data
Editorial Note: Leah Cowan and Ancel-la Santos from Health Action International wrote this post covering the release of a HAI position paper on Access to Clinical Trial Data. HAI have been to the forefront of the move to patient reporting of Adverse Events. It has a position as a partner with the European Consumer Organization (BEUC) in support of EMA in the current legal … [Read more...] about Health Action International: Access to Trial Data
GSK’s Transparency and Access Journey
Editorial Note: This post has been put together by Peter Goetzsche and David Healy Dear Dr Goetzsche ... "At GSK we firmly believe that making more information available, including clinical study reports and anonymised patient-level data, will enable researchers to study the science behind today’s medicines more closely, to learn more about them and how they can best be … [Read more...] about GSK’s Transparency and Access Journey
SHIT Happens – 2
SHIT stands for Secret Health Ingredient in Treatment - see SHIT Happens. In the early twentieth century SHIT was some supposedly secret magic chemical. In the early twenty-first century SHIT is important information about adverse effects of a drug that has been kept hidden. In SHIT Happens, we reported that RxISK has adverse event data on a range of GSK, Pfizer, Lilly and … [Read more...] about SHIT Happens – 2
SHIT Happens
A century ago, a distinction was drawn between the ethical pharmaceutical industry and the patent medicines industry. Ethical companies specified what was in their medicines, whereas the patent industry kept the details hidden. The birth of pharma The patent medicines industry flourished on the back of a promise that some Secret Health Ingredient in their Treatment (SHIT) … [Read more...] about SHIT Happens
The Attitude of Chicks to Trojans & Horses
Editorial Note: This is a cross post from 1boringoldman's Wisdom of the Dixie Chicks. It raises questions about a Lancet editorial jointly written by GSK and AllTrials it would seem. It calls on Iain and Ben to tell us what they are up to. So far there appears to be no clear response from AllTrials. There is an ambiguous message here. This repost omits the image of a Trojan … [Read more...] about The Attitude of Chicks to Trojans & Horses
A Black Box Warning for Clinical Trials?
Controlled trials are universally touted as providing gold standard information on drugs. Doctors are routinely taught to disbelieve the evidence of their own eyes and trust in controlled trials instead. Governments in North America and Europe are forcing patients to participate in controlled trials — saying that you get better care in a controlled trial — and claiming that … [Read more...] about A Black Box Warning for Clinical Trials?
GSK’s Manifesto: Voyeurs of the World Unite!
Editorial Note: There is a widespread impression that the pharmaceutical industry are split on the issue of access to clinical trial data with the bad guys like AbbVie taking legal actions to block access and the good guys like GSK in favor of transparency. An editorial like this one from GSK's James Shannon in the Huffington Post on September 3rd might support such … [Read more...] about GSK’s Manifesto: Voyeurs of the World Unite!
AbbVie: Sharing The Yellow Stuff
Editorial Note: This is the second part of our effort to "translate" Neal Parker's recent presentation in Bruxelles. The first half is here Neal Parker Avoiding Adverse Events. Reading the first half and Neal Parker's original transcript - available here - will give lots more material for the Caption Competition below. The least dramatic moment in Mr Parker's talk laying … [Read more...] about AbbVie: Sharing The Yellow Stuff
Neal Parker Avoiding Adverse Events
Editorial Note: Neal Parker, Section Head Legal, Biologics Strategic Development at AbbVie, was an industry representative on a panel organized by EFPIA - The European Federation of Pharmaceutical Industries and Associates on August 27th in Bruxelles. In two posts AbbVie's Mission to Discover New Diseases and AbbVie's Mission to Discover New Patients, we gave a transcript of … [Read more...] about Neal Parker Avoiding Adverse Events