JAMA  6 June 2012  Vol 307
2269    As I near my fifteenth year of writing comments on the medical journals every weekend, I sometimes envy columnists who can write their copy ahead of time and take the odd week—or even month—off. I don’t have any prepared store of fine phrases or worked up indignation, but depend for inspiration entirely on the material spread out fresh and steaming before me each week, if you understand the metaphor. I refer to a fine meal, of course. Unfortunately there is little fine food on the menu this week. Negative studies are worthy and must be published: it is important for those who look after small children with cystic fibrosis to know that it makes no difference whether the inhaled saline they are given is isotonic or hypertonic. And this was a well-powered study which measured exacerbations over four years. It deserves to be in JAMA. more…

The regulation and governance of clinical research continues to be a key discussion for the clinical research community. Last year, following increasing pressure the government and regulators began to look at ways to reform the system to support and increase the amount of research taking place in the UK.

The good news is that we’re on course to transform health research in the UK. more…

JAMA  23 May 2012  Vol 307
2161    Daytime sleepiness is one of the main reasons for treating obstructive sleep apnoea, another one being the risk of cardiovascular events and hypertension in untreated OSA. Continuous positive airway pressure is the standard treatment, and observational evidence suggests that as well as keeping people more alert by day, it may also reduce adverse cardiovascular consequences. I hadn’t realized before reading this paper (and the associated editorial) that there is no evidence for this from randomized trials. The Spanish sleep and breathing network considered that it would be unethical to do an RCT in symptomatic OSA: instead they selected people with OSA but without daytime sleepiness and randomised them to a prescription of CPAP versus no prescription. Many of the CPAP group found the fiddle of using it all night long too much, and rarely did, so that on an intention-to-treat basis this trial could prove nothing: in those who were compliant, there was a trend to better outcomes. more…

JAMA  16 May 2012  Vol 307
Do we all live on the same planet? I’m nearing the end of an amazing year at Yale, surrounded by superlatively intelligent people working on the outcomes of US healthcare. I myself occupy a space with brilliant newly qualified young doctors from India, Iran, and Brazil, putting together a book on patient-centred medicine. Most of the ideas we discuss about patient autonomy and shared decision making are quite new to them. All day long we work in cyberspace with people all over the world. When we leave the confines of our artificially lit space with temperamental air-conditioning, we blink in the sunshine and walk past black garbage-sifters begging for money, sallow drug addicts, and drunk disabled people shouting at each other. We share a street with these people, a town, a country, a world. But I cannot say that we really share anything with them, except perhaps for some coins we have in our pockets. more…

JAMA  4 Apr 2012  Vol 307
1394    A special dread settles on me this week as I know I am going to have to write about breast cancer screening. But let’s leave the dread question of whole-population mammography for later, and consider the add-on benefit of annual ultrasound or single-screening MRI in selected high-risk women. While the war over breast screening rages unchecked in the letters and a book review in this week’s Lancet, let’s take refuge in this little corner of the battlefield, where at least the fog of war is not too thick and we can count a few weapons and estimate a few casualties. The volunteer combatants are women with dense breasts and at least one factor that increases their risk of breast cancer. The ultimate proof of victory, as in all screening studies, will be a reduction in total mortality. The casualty list should include every woman undergoing biopsy or surgery, because nobody comes away from these things altogether unscathed, be it mentally or physically. This study gives us a casualty list, including the number of enemy killed (breast cancers detected and operated on), but cannot give us any idea of the extent or the cost of victory, because it was run over a three-year period only. Our brave lasses certainly saw their share of action: 2725 over the age of 25 (!) went through annual mammography and ultrasound, and 612 ended up having MRI. During that time 110 had 111 breast cancer events: 33 detected by mammography only, 32 by ultrasound only, 26 by both, and 9 by MRI after mammography plus ultrasound; 11 were not detected by any imaging screen. Enough. We can tell from these figures that the three imaging modalities will pick up most cancers; but the true cost—mentally, physically, and financially—can only be hinted at in a study like this. Only very long-term follow-up will give us a true estimate of overdiagnosis and the degree to which such screening detects cancers which would never progress. But in just these three years, a total of 1272 biopsies were performed—more than ten for each cancer detected. So this high risk group may well see a small reduction in all-cause mortality over the course of their “screening lives,” but it will be purchased at a high cost in medical procedures and anxiety. In fact any woman undergoing this cycle of procedures would be extremely lucky to get away with a single fine-needle biopsy during her life—two or three would be more likely. more…

JAMA  28 Mar 2012  Vol 307
1257    Medical conferences exist to affirm everything that hinders the progress of medicine as a compassionate and honest enterprise. They are a showcase for authority figures, pharma-funded research, half-completed work in the form of abstracts and late-breaking sessions; they use up prodigious amounts of money and carbon fuels; they reward high-tech flashiness and set no value on basic care and joined-up thinking: they reinforce a career structure and a social hierarchy in medicine which undermines the whole concept of patient-centredness. I’m glad to see all these feelings shared by John Ioannidis in this Viewpoint piece. John is a famous iconoclast who wrote the classic 2005 PLoS Medicine paper, Why Most Published Research Findings Are False. Here he proposes that nobody with any ties to industry over the preceding 3 years should be allowed to organize a conference. Also, that in order to ascertain the educational benefit of conferences, the next one should be randomized. more…

JAMA  22 Feb 2012  Vol 307
813    When an Italian team of physicists reported that they had detected neutrinos travelling faster than light, the televisual physicist Jim Al-Khalili promised to eat his boxer shorts if it proved to be true. It turns out to have been a measurement error due to faulty wiring. Unbelievable results either shatter the laws of the known universe, or else they are wrong. So if a study tells us that 42% of women and 31% of men presenting with myocardial infarction do not have chest pain (or even pain in the arm or jaw), this either overturns clinical medicine as we know it – from experience and from several other large cohort studies – or else it is due to lousy recording. Guess which. This retrospective study is based on a single tick in a box completed by busy physicians looking after over a million patients coming into American hospitals with heart attacks between 1994 and 2006. It could be that they had better things to do than record the obvious. If these figures are true, then I will eat my elegant black Marks & Spencer long johns. These thermal underpants have proved very effective at protecting my lower parts from the ravages of winter on the eastern seaboard of America, and I just wish journal editors were as effective at protecting us against the ravages of bad data.
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JAMA  15 Feb 2012  Vol 306
669    This week’s star Viewpoint piece is about The Unintended Consequences of Conflict of Interest Disclosure. It seems to me that twenty-first century medicine operates on roughly the same principle as the court of the Grand Vizier of the Ottoman Empire – prestige is judged by the number of bribes you are offered. Far from being a source of shame and reluctance to publish, these are routinely flaunted at the end of most interventional trials in the leading medical journals. I once counted 63 for a single individual; and perhaps he would argue that once you enter double figures, they begin to cancel each other out. How did we reach a state where the default setting of our medical culture is conspicuous corruption? As the authors here point out, this cannot go on: “Conflicts of interest, including fee-for-service arrangements, are at the heart of the astronomical increases in healthcare costs in the United States, and transparency is no substitute for more substantive reform.” And just as the US health system thinks of ways to get out of this hole, our British political masters are determined to push us into it.
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JAMA  25 Jan 2012  Vol 307
373   Here’s the kind of study that’s all too rare in the medical literature: an important interventional trial that is not funded by pharma. The question is whether giving a proton pump inhibitor can improve outcomes in poorly controlled childhood asthma: a reasonable hypothesis to test, since a high proportion of such children have been shown to have asymptomatic acid reflux. This double-blind RCT recruited 306 children from 19 US centres, and shows that daily lansoprazole has no benefit and that it may have important harms. The active drug group had more respiratory infections and markedly more fractures (6 vs 1): not to the point of statistical significance, but definitely to the point of warranting an urgent database study of fracture incidence in children taking regular PPIs. more…

JAMA  18 Jan 2012  Vol 307
265     Cangrelor is one of a number of reversible thienopyridine platelet inhibitors competing to replace clopidogrel. This could be an enormous market, but the BRIDGE study, funded by The Medicines Company, begins with a small niche: patients who discontinue antiplatelet treatment before elective coronary artery bypass grafting. The problem that this study is alleged to address is the risk of rebound coronary events in such patients, unless some kind of platelet inhibition is maintained up to near the time of surgery (using IV cangrelor, of course); but in fact a coronary end-point appears nowhere in the trial. Instead, the primary end points are bleeding during surgery and laboratory platelet function tests. These lab tests are the weakest of surrogates, and I am unconvinced that there is a problem here that cannot be addressed in a simpler way. This study really doesn’t belong in a leading medical journal. more…