The European Medicines Agency (EMA) has issued its long anticipated new policy (policy 0070) on prospective access to clinical trial data, and is now in consultations to figure out the details of its implementation. We were invited to join these ongoing consultations, and have previously reported on the debate here and here. We have been […]
Pamplona 2015—The General Assembly of the International Society of Drug Bulletins (ISDB) At the end of June, the city of Pamplona was getting ready to celebrate the fiestas in honour of San Fermín, the patron saint of Navarra, and the week long challenge of the encierro (running of the bulls). Much ceremony and excitement surrounds […]
NEJM 5 Feb 2015 Vol 372 519 Refractory angina seems to be common in cardiac clinics but not in primary care. When all the drugs have failed, and revascularization is not an option, device makers like to get inventive. The latest gizmo is an hour-glass shaped expandable metal object which sits at the portal of […]
My earlier blog outlined BMJ reader feedback to the two updated Cochrane reviews on the benefits and harms in influenza of the neuraminidase inhibitors oseltamivir (Tamiflu) and zanamivir (Relenza). But the two research articles also attracted a great deal of attention in the blogosphere. […]
NEJM 10 Apr 2014 Vol 370 OL A deadly virus has been conquered. Hepatitis C genotype 1 can be cleared with a simple oral combination treatment, and compared to that, the rest of this week’s medical news seems minor. So I will start by running through the hepatitis C papers which have just appeared on […]
Gathering evidence is clear straightforward science. Right? Not if you believe the speakers at “Evidence Live.” Today’s presentations were a challenge to believers. Fraud, misconduct, non disclosure of data, and conflict of interest were just part of the problem. Peter Wilmshurst (University Hospital of North Staffordshire) whose dedication to the truth in the face of […]
NEJM 1 Nov 2012 Vol 367 1677 Cancer screening campaigns—getting past uninformative persuasion is a topical subject on both sides of the Atlantic. Nobody writes better about it than Steven Woloshin and Lisa Schwarz, and in this Perspective piece they join forces with two colleagues to point the way forward. All past and many present […]
“The same standard of openness should apply to all (drug) trial data, whether sponsored by industry, investigator-initiated, or sponsored by public grant-giving bodies.” That’s the view of representatives from the European Medicines Agency and the regulatory bodies from France, the UK, and the Netherlands writing in PLoS Medicine. Their statement comes as accompaniment to an […]
Healthcare staff are being urged to get flu jabs, but are current management options adequate? […]
Few would disagree that organ donation and transplant surgery is a remarkable achievement. It is a selfless gift that unlocks the potential to cure disease or allay symptoms. But if that “gift” was a bone fixation plate, or an implantable cardiac defibrillator, would the perception be the same? The initial “gift” production responsibility is not […]