Archive for 'Clinical trials' Category

Children and medicines

By Anthony - Last updated: Thursday, April 10, 2008

The past few weeks have had a few interesting papers published on the subject of medicines and children. Children are often ill-served by medication, partly due to the difficulties associated with medication use in children and running clinical trials, and partly because of pharmaceutical companies lack of interest in obtaining paediatric licences for a small […]

Race based medicine

By Anthony - Last updated: Friday, August 10, 2007

Scientific American has an interesting editorial and article by Jonathan Kahn on drugs licensed for use in particular races. Kahn argues that looking at racial targeting, rather than true individualized medicine, may lead to a “trend that may segregate medicine and fatten the profits of drugmakers without addressing the underlying causes that are killing so […]

Thalidomide

By Anthony - Last updated: Saturday, May 19, 2007

As a counterpoint to the post about the mouse, it is worth remembering that sometimes suspicions of harm can be true. Here are thirteen facts about thalidomide, some of which you might not have known. Chemie Grünenthal, who developed thalidomide (Contergan in Germany, Distaval in the UK), had two drugs pulled from the market prior […]

TGN1412 mentioned in Dispatches

By Anthony - Last updated: Tuesday, September 26, 2006

Brian Deer has been using the Freedom of Information Act to look into TGN1412: Confidential documents obtained by The Sunday Times and Channel 4’s Dispatches programme reveal the drug was administered on average 15 times more quickly to the volunteers than to monkeys in earlier safety studies. The possibility that such a crude error led […]

TGN1412 – long-term consequences

By Anthony - Last updated: Monday, July 31, 2006

The Daily Telegraph reports on long-term consequences in some of the TGN1412 victims: Last week Mr Day passed on a medical assessment by the immunologist Prof Richard Powell to his clients, who include Nav Modi, 24, from Forest Gate, east London, and three other men aged 19, 30 and 29. Prof Powell wrote of patient […]

TGN 1412: Expert Scientific Group Report

By Anthony - Last updated: Tuesday, July 25, 2006

The disastrous TGN 1412 clinical trial led to the publication of a report entitled: Expert Scientific Group on phase one clinical trials. It is a 357 page document in ten PDF sections, which I currently haven’t time to wade through. Here’s what the MHRA say about it: Prof. Kent Woods, MHRA Chief Executive, said: “We […]

Clinical trial transparency

By Anthony - Last updated: Sunday, July 2, 2006

Three things the industry should do with clinical trials from Ian Chalmers’ From optimism to disillusion about commitment to transparency in the medico-industrial complex [PDF file]: 1 All pharmaceutical companies should join Aventis, Amgen, LEO Pharma, Otsuka, Serono and 3M Pharmaceuticals in publicly endorsing the Good Publication Practice Guidelines for Pharmaceutical Companies 2 Industry as […]

TGN1412 last man out

By Anthony - Last updated: Wednesday, June 28, 2006

The last man , Ryan Wilson, to suffer the consequences of the TGN1412 trial is out. Although he is recovering to some extent and has a positive outlook, he has been left with permanent disabilities and his chosen career is effectively over at the age of 20.

Clinical trial registration

By Anthony - Last updated: Monday, May 15, 2006

Fiona Godlee on trial registration; the TGN1412 saga seems to have given a big push for openess: The long running campaign for comprehensive registration of clinical trials has taken a turn for the better. Over the past two years discussions have shifted from whether ongoing trials should be registered at all to detailed negotiations with […]