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Tom Jefferson and Peter Doshi: EMA’s double U-turn on its Peeping Tom policy for data release

13 Jun, 14 | by BMJ

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, and AllTrials). All this, plus a Twitter #screenonly campaign, reveals enormous discontent with the agency’s last minute announcement of “view on screen only” access to clinical study reports (CSRs), new “redaction principles,” and new legal “terms of use.”

In two responses, EMA executive director Guido Rasi defended the agency’s draft policy, explaining that the EMA’s latest draft policy represented “absolutely no change in direction.” more…

James Partridge: The face of a warrior for the human spirit

13 Jun, 14 | by BMJ

James PartridgeTo be chosen as the subject of the first People’s Portrait was, as Simon Weston put it, a very humbling experience. But as he showed consistently throughout the beautifully crafted BBC film about the making of the portrait, he is a delightfully humble man.

But not in the way you might imagine I mean. Not passive or unctuous as in the mode of Dickens’ Uriah Heap. No. A strong humble. A servant with such a great commitment to helping people, inspiring people by his remarkable courage and frankness. He is not the classical hero figure rising up and charging towards a huge goal of his own imagining. more…

Zoe Smith: Changing the story for neglected tropical diseases

11 Jun, 14 | by BMJ

zoe_smithWhile it’s been challenging to make neglected tropical diseases (NTDs) a priority on the global health agenda, until recently, the struggle to raise the conversation beyond niche circles has been even harder.

The illnesses are prevalent in places that many would struggle to find on a map, let alone pronounce (echinococcosis and onchocerciasis, for example). Factors like these make NTDs a challenging story to sell, especially as they mainly affect the world’s poorest (around 1.4 billion people).

Despite this challenge, at Development Progress, an Overseas Development Institute project, we have been working to highlight the drivers of progress in tackling NTDs, as these diseases have wide cross-sectoral links and effects, as well as an impact on almost all of the Millennium Development Goals (MDGs). more…

Chris Hopson: You get what you pay for—a different approach to the 2015/16 NHS tariff is crucial

10 Jun, 14 | by BMJ

chris_hopsonIf you get what you pay for, then 2015/16 risks being a very difficult year for the NHS, as the system affordability challenge, according to Monitor, jumps from 3.1% to 6.6%. This is driven by increasing demand and costs, a flat NHS budget, changes to NHS pension arrangements, and the *Better Care Fund.

NHS providers are also contending with pressure on NHS England’s specialist commissioning budget, which was overspent by more than £800 million last year (of which over £400 million was covered by the use of non recurrent and contingency reserves), but which is a key source of income for many trusts. And, on top of this, NHS providers are also faced with unfunded demands for mandatory service improvements, such as seven day services and increased staffing ratios. more…

Ahmed Rashid: Can we ever be “just friends” with big pharma?

6 Jun, 14 | by BMJ

ahmed_rashidIt’s been less than a decade since I started medical school and even in my short career the relationship between doctors and the drug industry has undergone drastic change. During undergraduate clinical placements, I spent many lunchtimes making polite conversation about a drug I had no interest in to justify scoffing the indulgent Waitrose sandwiches and chocolate brownies that the smiley rep had shrewdly chosen. My neatly ironed white coat was never without a pen, tourniquet, or tendon hammer stamped with a drug brand. Others went further and wore drug branded lanyards and stethoscopes around their necks. It was part of the look of the trendy junior doctors we emulated and nobody thought anything of it. I’m not sure people in their twenties are ever venerable enough to say “Oh, how things have changed!” but they really have. This is all but a distant memory now and rightly so. more…

Kevin Watkins: Universal health coverage—back on the global agenda

5 Jun, 14 | by BMJ

kevin_watkinsA few years ago, I was at a rural hospital in Eastern Province, Zambia. Doctors were trying frantically, and in the end unsuccessfully, to save the life of a five year old boy. He died from acute respiratory tract infection. But what really killed him, as one of the doctors told me afterwards, was poverty: his parents had been unable to afford the antibiotics that might have saved him.

Sometimes we lose sight of what’s at stake in the great debates on development—and nowhere more so than in health. Over the past few years, universal health coverage (UHC) has returned to the international agenda with a vengeance. Governments are making stirring commitments to deliver healthcare for all their citizens. Aid donors are promising to support their efforts. UHC has even made it to the shortlist for inclusion in the post 2015 Millennium Development Goals. more…

Gwyn Samuel Williams: “Les Miserables” examiners

5 Jun, 14 | by BMJ

gwyn_williamsI recently had the single pleasure of undergoing exit exams run by the Royal College of Ophthalmologists and could not help but wonder at how examiners could on the whole be easily categorised into certain subtypes which readers may find fascinating. This phenomenon has certainly has not been observed before in published world literature.

First, and certainly foremost, is the kindly empathetic Jean Valjean examiner. Shown kindness by others and helped along the way they are keen to repay their debt and help the younger generation by teaching and by lenient examination. “Who am I?” they ask themselves “to condemn this man to misery, pretend I do not feel his agony. This innocent who bears my face and goes to judgement in my place? When kindness was shown to me who am I to harass? What will I do? I will let him pass.” Unless serious errors are made then progress is assured and the debt of kindness is then perhaps passed on. more…

Simon Poole: NICE, statins, data, and doctors

4 Jun, 14 | by BMJ

simon_pooleIn June 2009, the World Health Organization declared the swine flu outbreak to be a pandemic. Most of us will recall the grave concerns expressed by politicians and the media about this potentially fatal illness. I remember at this time being called out late on a Friday evening to a patient suspected to have contracted the virus. With gown, gloves, and a mask on, I assessed the child, referred to the guidance based on previous recommendations from the National Institute for Health and Care Excellence (NICE), and wrote the first prescription for the precious antivirals that we believed were potentially lifesaving. So valuable were these medications perceived to be, that there was even talk of the possibility of their storage facilities requiring military security.

In April of this year, the Cochrane Collaboration published what many believe to be a damning review of the efficacy of these antivirals, claiming that a lack of access to available trial data had hampered the ability to verify the safety and effectiveness of these medications in 2009. The previous absence of this data was a gross betrayal of trust, and exposed physicians and patients to all the risks associated with prescribing a medication whose true value now appears to have been exaggerated. more…

David Berger: Stoushes, rorts, and cuts in Australian healthcare

3 Jun, 14 | by BMJ

david_bergerTo Europeans, Australia resembles the kind of alien planet so beloved of 1950s American science fiction writers. Strange, bounding animals hop across an arid, unfamiliar landscape, dotted with queer trees and even queerer, multi-coloured birds. The indigenous inhabitants of this planet called these birds “kookaburra,” although their meaning was allegedly misinterpreted when the colonists thought they also called the hopping animals “kangaroo.” The colonists speak a quaint form of English, and over time they have developed their own slightly drawling accent. They even have their own unique words to describe phenomena that seem to happen very frequently on this planet—words such as “stoush” (a bunfight or a punch-up) and “rort” (a swindle that involves gaming the system).

At the moment, there’s a major stoush about healthcare cuts going on between the prime minister, Tony Abbott, along with his Liberal National Coalition government, and, well, almost everyone else. The nature of this healthcare stoush is not entirely unlike any of the many stoushes that British doctors have been embroiled in over the years, as they have fought to defend publicly funded healthcare. more…

Florence Smith: NCDs and HIV—where’s the intersection?

30 May, 14 | by BMJ

florence_smithAt first glance, NCDs (non-communicable diseases) and HIV/AIDS seem to have little in common. However, a recent symposium, organised by the London School of Hygiene and Tropical Medicine and FHI360, showed that there is great scope for those working on these two big issues in global health to learn from each other.

HIV/AIDS has caused around 36 million deaths worldwide over the last three decades, but with new treatments mortality rates have dropped dramatically, and it now accounts for around 1.6 million deaths a year. NCDs kill just over 36 million people annually, with 80% of those deaths occurring in low and middle income countries. The World Health Organization has set a target to reduce deaths from NCDs, in those aged under 70, by 25% by 2025. more…

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