Open Medicine EU

Archives for Pharmaceuticals

The recent conference in Cork on conflict of interest was extremely interesting and will provide the basis for a few posts on this blog – the speakers’ presentation can be seen here. In a well received intervention, Noel Wathion of the European Medicines Agency announced that the agency would now publish an electronic declaration of… » read more

Posted by Jim Murray

I’ve been looking more closely at the bribery of doctors and health care officials in Greece. My sources are mainly UK court documents, and documents released by UK Serious Fraud Office and the Securities and Exchange Commission and the Department of Justice in the US. The bribery lasted for about eight years from 1998 onwards.… » read more

Posted by Jim Murray

It’s Hard to be Good

To get approval for a new medicine it is necessary to provide evidence that the medicine works – which usually means showing that it is better than a placebo. It is not usually necessary to provide comparative data showing how the new medicine measures up against an existing medicine or treatment. Good comparative data helps… » read more

Posted by Jim Murray

The European Medicines Agency is in difficulty, perhaps even in crisis. It is time for DG Sanco to take action. The board has been unable to approve either of the two short-listed candidates for Executive Director and the European Parliament has refused to discharge the agency’s accounts for 2009. The Parliament is one element of… » read more

Posted by Jim Murray

Within weeks of his retirement as Executive Director of the European Medicines Agency, Thomas Lonnegren was appointed to the board of NDA a “regulatory and market access business” and has also joined a number of other industry groups CBio, Novo Nordisk, LUNDBECK A/S. The appointments were approved at least by the chairman or the board… » read more

Posted by Jim Murray

In an earlier post I reported that the FDA was to test a drug, sodium thiopental, imported for use in executions. Some weeks later, according to the Wall Street Journal, the agency said that it was “charged by Congress with protecting the public health …… Reviewing substances imported or used for the purpose of state-authorized… » read more

Posted by Jim Murray

ZYPREXA OFF-LABEL

Prescribing “off-label” means prescribing a medicine for a use for which it is not authorised. Pharmaceutical companies may not promote off-label use of their medicines, for good reason. There is not the same tested scientific base for off-label use as there is for authorised use. Qualified doctors may prescribe off-label, on the basis of their… » read more

Posted by Jim Murray

Prequel to Seroquel

How is science made in a pharmaceutical company, when billions of Euros may depend on the outcome of a scientific experiment? A partial, if incomplete, glimpse at the process can be seen in the documents released last year in a court case in the US on the AstraZeneca medicine Seroquel. (Seroquel is a “blockbuster” drug,… » read more

Posted by Jim Murray