The first Core Outcome Measures in Effectiveness Trials (COMET) workshop in Japan took place, in April 2013, at Kyoto University, stimulating debate about how the Japanese research and practice community might engage with this international initiative and make use of core outcome sets. Toshiaki Furukawa (Professor and Chair, Department of Health Promotion and Human Behaviour Professor, Department of Clinical Epidemiology, Kyoto University) and Rintaro Mori (Head, Department of Health Policy National Centre for Child Health and Development, Tokyo), worked with three of the COMET team (Paula Williamson, Liz Gargon, and Mike Clarke) to deliver the workshop. I attended, along with 80 others from across Japan, including researchers, trialists, systematic reviewers, statisticians, healthcare providers, and clinicians. There were small group activities to discuss the problems with outcomes and the need for a more scientific approach to outcomes, how core outcome sets could help, and how we might develop and use core outcome sets in Japan. These discussions were informed by an introduction to the COMET Initiative and their activities. more…

Doctors first started to speak out about the health impact of nuclear weapons way back in 1980; the BMA published The Medical Effects of Nuclear weapons in 1983 and it was in 1985 that International Physicians for the Prevention of Nuclear War (IPPNW) was awarded the Nobel Peace Prize for its work in publicising what nuclear weapons do to people. Now here we are 30 years later with more countries possessing these “aweful” weapons than ever before – nine at least, including Israel, and several more on the want-to-be list. more…

Low standards of evidence for medical device regulation in Europe have led to clinical concerns about the potential dangers posed by the highest risk (class III) devices, especially implantable devices [1, 2]. In the wake of hip and breast implant scandals [3, 4] and in the midst of growing concerns about the widespread acceptance of the inferior vena cava filter without any evidence of efficacy [5], the MHRA (Medicines and Healthcare products Regulatory Agency) have just published an analysis of responses to their public consultation on draft new European legislation on medical devices [6]. Concerns about patient safety are in the balance against concerns about market access, because from the medical device technology industry point of view, existing quick-to-market European regulations encourage innovation through speedier regulatory approval and faster revenues [7, 8].   more…

My second day in South Sudan, the start of a nine month posting with MSF in this war torn, dustbowl of a town called Nasir, and I’m standing here in the medical ward, utterly lost. In every sense of the word.

How did previous doctors manage the workload out here? I’ve got no idea. In the past hour I’ve been called from the ward a handful of times. First was to the tuberculosis (TB) village, the group of mud huts behind the hospital, where forty TB patients live for the six month duration of their therapy, to talk with a man who is unhappy with the quantity of food he is being given and to try to persuade him not to leave. Next was to our living compound, where our logistician, Paul, is suffering from his second case of gastro this week (it won’t be long until I join the ranks, he assures me), followed by a visit to the re-feeding centre, where the health worker wanted me to please assist with the feeding of a malnourished, but surprisingly feisty young girl. The patch of high energy milk on the front of my T-shirt proves that I tried. And more recently there was the call to outpatients, where dozens of patients are waiting to be seen, crowding under the awning in a vain attempt to avoid this diabolical heat. Fifty degree afternoons are not unheard of here, I’m told. The local word for February, the month just passed, is simply “Fire.” more…

It is 11.59 pm and there is an eerie silence. All afternoon, sirens were wailing relentlessly outside my window, pushing through Red Sox traffic to reach Boylston Street ten minutes round the corner where, at around three o’clock, two explosions hit the city.

Today (15th April 2013) is Patriot’s Day, a commemoration of the opening battles of the American Revolutionary War and the day of the annual Boston marathon. Today I had planned to watch a friend run, but my conscience got the better of me and I went to class instead. As I worked through multivariate regression, thousands of runners were stopped in their tracks by an event that nobody could have anticipated. more…

 My early years at the BMJ were very bound up with Margaret Thatcher. I started as an assistant editor a month before she became prime minister in 1979 and was appointed editor just before she was dethroned as prime minister in 1990. Whatever I write about her will evoke fury in some quarter, and despite our present prime minister saying that she saved the country it’s probably still too early to make a confident judgement on her performance. But I have my memories. more…

 “Email is not work. It’s a distraction.” So said a fierce, bearded lecturer at a talk I attended recently. Is he right?

I have every reason to think him wrong because I tend to start every day by answering my emails—after looking at the BBC News website, Twitter, and Facebook, always in that order. I look forward to the moment when I open up my email and see which fascinating and sometimes much loved people have emailed me. more…

 An item in The Lancet last week (Godecharle et al. Lancet 2013;381:10097-8) bemoans the lack of a regulatory framework for research integrity in Europe. The confusion is neatly illustrated by a map categorising countries by how they handle misconduct. The UK falls into the second best category, along with Germany and Sweden, of countries that have a “national framework.” Only Denmark and Norway are in the top category of countries that have a framework established by law. more…

It is not every day that the Department of Health produces a formal response to two of my dry (and I accept potentially fairly boring) legal opinions.  23 March was a red letter day because it was the first time it has happened.  The department produced a formal response to material I and my fellow barrister, Ligia Osepciu, produced for the campaigning organisation 38 degrees about the NHS (Procurement, Patient Choice and Competition) (No. 2) Regulations 2013, which I have referred to (neutrally) as “the privatisation regulations” since the full name is a bit of a mouthful.

Should I have felt honoured or did it mean that the Department of Health has “marked my card” and I will never be asked to give legal advice to them or any NHS body ever again?  Only time will tell.  However overall I was more than a little disappointed at the quality of the response.  It does, however, show how sensitive ministers are about others commenting on how the privatisation regulations will change the NHS but overall it ducked the main issues and pretended that the regulations brought in little change, which is simply not correct. more…

 Last month the UK government released its amended regulations on NHS procurement after considerable outrage from health organisations, trade unions, and parliamentarians, over what appeared to be clear breaches of agreements. Is it a merely  a cosmetic re-write of regulation 75 again that seeks merely to better disguise the true privatising aim of these regulations, or does it help to address the concerns that many had – this is the million dollar question? The legal situation is highly complex and health commentators gave different interpretations of what the  revised regulations would translate to in practice. more…