JAMA  3 Apr 2013  Vol 309
1355    With the runaway success of the Alltrials petition, it may seem as if everyone in the world has now agreed on the need to share every bit of data relating to every medical device and product used on millions of patients every day. In reality, this is going to be a very slow process, involving hard work over many years. Nobody is more aware of this than Joe Ross and Harlan Krumholz, whose YODA project is pioneering the methodology needed to do the job properly, in a way that few others have even considered attempting. The imperative to do this work is absolute, and is beautifully set out by them in this Viewpoint article. But the editor of JAMA, Howard Bauchner, announced in Oxford that he is planning to sit on the fence about Alltrials a while longer, consulting his editorial board in a few months’ time. In the meantime we can look forward to a piece on the “unintended consequences” of data disclosure by Robert Califf some time soon. more…

JAMA  27 Mar 2013  Vol 309
1241    Have you ever heard of someone who’s recently had a heart attack going off and having 40 infusions of disodium ethylenediaminetetraacetic acid, ascorbate, B vitamins, electrolytes, procaine and heparin? No, I hadn’t either, until I went to give a talk to some cardiac rehabilitation patients about 12 years ago. more…

JAMA  20 Mar 2013  Vol 309
1125    Is aliskiren a good drug for heart failure? Despite the negative result of this Novartis-funded trial (ASTRONAUT), I think the answer is probably yes. First of all, let me remind you that aliskiren is a direct renin blocker. In other words, it acts right at the start of the renin-angiotensin- aldosterone cascade. But unfortunately for alis and her sister kirens, these renin blockers have come on the scene too late. We already have perfectly good RAAS inhibitors in the form of ACE inhibitors, ARBs, and aldosterone blockers, and between them they do all that it is possible to do via RAAS inhibition in heart failure: which, by the way, is not much, since typical NNTs lie over 30. Now imagine a world where renin blockers were first on the scene, and we selected patients for heart failure trials on the basis of BNP rather than ejection fraction; then this trial would probably have been a resounding success. Because the ASTRONAUT groups were not well matched: the patients put on aliskiren had a mean NT-BNP of 4239 pg/ml compared with 2718 pg/ml in the placebo group: in other words, they were experiencing considerably worse ventricular strain. Yet they still had better outcomes than the less ill controls, albeit not to the point of statistical significance. If you removed all the ACE inhibitors, ARBs, and the amazing amount of mineralocorticoid blockade (57%) from these patients, there would probably have been a very significant benefit in mortality and readmission from aliskiren. But life is unfair, and Novartis may just have to face the fact that Alice has come too late to lead them into Wonderland: though a trial in heart failure with preserved systolic ejection fraction, but without diabetes, might be interesting.
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JAMA  13 Mar 2013  Vol 309
997   Obstructive sleep apnoea is very, very common. In the preamble to this Australian study, a third of the adult population is accused of having symptoms that might be OSA. Previous studies have shown that polysomnography has no significant advantages over a home video, reporting by sleeping partners, or a trial of self-titrated continuous positive airways pressure. So the question arises whether specialist sleep clinics are really needed, or whether a sleep service of equal effectiveness can be provided in primary care. In this randomized non-inferiority study, the results of the two modes of care were equally good. So come on, enterprising commissioning GPs: buy a few CPAP machines and offer a local service. Nobody seems to care about conflicts of interest any more, and I guess if this coalition lasts a year or two more, you’ll be able to charge patients at the door on the grounds that OSA is “just snoring” and not worthy of NHS provision. In fact it is a powerful cardiovascular risk factor and a major prognostic indicator e.g. in heart failure.
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JAMA  6 Mar 2013  Vol 309
887   The Greek for belt is zoster, while the Latin for girdle is cingulum. Add Greek for creeping (or snake) and you get herpes zoster, or break down Latin for girdle and you get “shingles.” Either way, you wish it not to happen, and wonder why it has. Concurrent infection and lowered immunity are often blamed, and so suspicion has fallen on the tumour necrosis factor alpha blockers which are commonly used in rheumatoid arthritis. But this study shows that RA patients taking TNF-α blockers are no more likely to get shingles than those who are taking “non-biological” treatments.
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JAMA  27 Feb 2013  Vol 781
781    Heart failure divides into two broad classes: the first is caused by damage to the myocardium and is associated with reduction in the left ventricular ejection fraction, and we know pretty well how to treat it; the second is associated with stiffening of the ventricles and the main capacitance vessels, and we don’t know how to treat it, or even what to call it. It is often called “diastolic HF” but this term should really be reserved for the subset who have demonstrable reduction in diastolic filling. And as we fuss over these imaging-based definitions we lose sight of the patient as a whole, who is typically elderly and hypertensive with other comorbidities and taking a variety of pre-existing medication. That’s not to say we shouldn’t try to apply some science to improving their treatment, and this German-Austrian trial was inspired by the theoretical possibility that aldosterone blockade would reverse some of the effects of diastolic dysfunction. And it did. But unfortunately the patients could not notice any difference between spironolactone 25mg and placebo, because what little benefit the former had was purely on LV remodelling and BNP levels. Their diastolic filling indices actually dropped and so (non-significantly) did their walking distance.
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JAMA  20 Feb 2013  Vol 309
689    Long back in the last century, I was a hysterectomy robot. This was the lowest form of life in a London teaching hospital obstetrics and gynaecology department. I spent my days clerking patients and feeling gravid abdomens, and my nights (one in two) stitching episiotomies and writing out drug charts in between brief episodes of sweaty sleep. The following day would often be spent assisting at hysterectomies. My main function was to remain upright, with a retractor in one or both hands. Thank God that better robots have now been designed, ones that can actually take an intelligent part in the procedure. They allow the gynaecologists of the twenty first century to sit at a console remote from the patient, fiddling with her insides while they take sips of freshly brewed Starbucks. Does this improve patient outcomes compared with the normal procedure for benign disease, which is laparoscopic hysterectomy? Well no, but it costs more and is worth it for the Starbucks.
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 JAMA  13 Feb 2013  Vol 309
559    Last week I had a go at the editors of the NEJM and The Lancet  for publishing misleadingly reported pharma funded trials, in contradiction to their own idealistically stated views. Now, on p 607, the editor of JAMA maps out the moral high ground which he thinks necessary for restoring confidence in the pharmaceutical industry. Howard Bauchner is no Ben Goldacre, and readers of his book Bad Pharma will find this piece wishy-washy by comparison. Nonetheless he calls for independence in analysis: “the data analysis should be performed by academic investigators who are not employed by the company sponsoring the research.” more…

JAMA  6 Feb 2013  Vol 309
453    Stone the crows, a great little study from Oz that will change your practice at a stroke. They recruited 212 patients with intermittent claudication who had never had invasive treatment—which immediately made me realise the study couldn’t have been done in America, where at the first twinge of calf pain you get a stent or balloon stuck down your femoral artery. No, these were mostly fine specimens of Australian manhood, mean age 65, getting pains below the level of their shorts if they walked too far, despite the fact that one third of them had never smoked and all of them had normal blood pressure. One half of them were randomized to a well-known drug and after six months they found they could walk four minutes longer before they had to stop. The wonder drug? Ramipril 10mg. This is the kind of trial that makes nobody millions of dollars, but which we should all be doing in our fields of interest. It took just three interested hospitals in Southern Australia.
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JAMA Intern Med  28 Jan 2013  Vol 173
93    One of the chief glories of this journal (formerly called the Archives) lies in the articles labelled LESS IS MORE, which can range from editorials to original research papers, and this issue contains no fewer than four such. The US health economy contains massive incentives to do too much, while the tendency of the NHS is often to do too little; but it is interesting to see how even in our system, we might be better off if we did less of certain things. Rita Redberg is a very hands-on editor and contributes to three pieces in this issue: here she joins forces to comment on how much overtreatment has decreased in the USA since 1999. The answer, of course, is that it hasn’t at all.
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