Yesterday’s announcement that the EMA Management Board may have adopted a less obstructive policy to releasing clinical trial data comes hard on the heels of widespread coverage (see here, here, here, and here) and protests (by the EU Ombudsman, us, us again, Trudo Lemmens, the ISDB/AIM/ Nordic Cochrane Centre/ Medicines in Europe Forum, German IQWiG, […]
Category: Open data
Jim Murray: A surprising development in the case of InterMune vs the EMA
InterMune has withdrawn part of its legal challenge to stop the European Medicines Agency from disclosing certain documents, which relate to the medicine Esbriet (Pirfenidone). The company is still looking for a prohibition on disclosure, but has withdrawn its application for an interim order, which would prevent disclosure before the full hearing of the case. (InterMune […]
The BMJ Today: The dangers of anal sex, ensuring service redesign is evidence based, and the EMA taken to task over data disclosure
There are some topics that the British just don’t like to talk about, and bottoms, bowel habits, and anal sex fall firmly into that category—even when the conversation is with their GP. But these conversations are necessary. The latest statistics from Cancer Research UK show that rates of anal cancer in the UK have increased […]
Richard Lehman: The Medical Reformation
The Reformation that we know best began some time after the year 1500, but had its roots in a technological revolution, which took place 50 years earlier—the invention of the printing press. Then (1450-1500): Thanks to the printing press, the Holy Scriptures became widely available in Latin. But ordinary people could not read them, and […]
Jim Murray: Policy making behind closed doors
Campaigning for transparency on clinical trial results at EU level is getting to be like playing snakes and ladders, and I’ve just spotted three snakes. I’ve been trying to “deconstruct” the EMA’s reply by letter to the Ombudsman’s concerns about the agency’s volte-face on transparency. The results worry me—a lot. The EMA says that the […]
Jim Murray: Volte-face by the European Medicines Agency?
The European Medicines Agency (EMA) has recently published to a targeted audience final consultation draft papers on its new “proactive” transparency policy on clinical trial results. As reported, information published under the draft policy would be on a screen-read only basis, would not include commercially confidential information (CCI) as defined by the EMA, would be subject […]
Jim Murray: Abbvie withdraw case against European Medicines Agency
AbbVie have withdrawn their legal challenge against the release of certain company documents on Humira (adalimunab) by the EMA. This followed an offer by the agency to redact parts of the document originally intended for release. Is this good news? There are those who think it is, but we cannot be entirely sure at this […]
Jim Murray: New fronts in the struggle for transparency
The European Court of Justice has struck down and ordered a rehearing of the cases for an interim injunction to stop the European Medicines Agency’s new transparency policy on clinical trial results. The two companies, AbbVie and Intermune, will have to give more specific arguments as to why the relevant data should not be disclosed, […]
Simon Wessely: The lost trial—a Christmas story
A long long time ago, well, 1995 if you are asking, I was part of a team running a randomised controlled trial. I was, and indeed still am, working in a general hospital as a liaison psychiatrist. Back then, and still now, a considerable proportion of those admitted to the general hospital wards had problems […]
Jim Murray: Transparency may help to reduce the misselling of medicines
Greater transparency on clinical trial results would help reduce off-label promotion—the promotion of medicines for uses for which they have not been approved. Looking at the US since 2004, I compiled a table of cases taken by the Department of Justice involving off-label promotion where the fines, penalties, and/or settlements came to more than $300 […]