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Richard Lehman’s weekly review of medical journals

Richard Lehman’s journal review—26 September 2016

26 Sep, 16 | by BMJ

richard_lehmanNEJM  22 Sep 2016  Vol 375

Learning to love data parasites

Back in January, the chief editor of the NEJM joined many other leading journal editors in signing a radical proposal for data sharing tabled by the International Committee of Medical Journal Editors. But at the same time he co-authored an editorial saying that the research community was deeply worried about the prospect of data parasites invading its glorious body of work. Since then, the NEJM has published a good number of Viewpoints expressing different degrees of love or loathing for data parasites. My heart sank at the prospect of reading three more this week, so I decided to listen to Jeff Drazen’s podcast instead (which is a first for me). Having heard the negative gossip about the recent meeting of the International Committee of Medical Journal Editors, I had low expectations. But JD’s tone is very positive. In fact his discussion of the issues is quite similar to those we had five years ago when Harlan Krumholz set three of us to work with him on the Yale University Open Data Access project. The NEJM conversion may be coming late, and it may be too little for some, but it really is progress. And they are backing it up by releasing the SPRINT data. more…

Richard Lehman’s journal review—19 September 2016

19 Sep, 16 | by BMJ

richard_lehmanNEJM  15 Sep 2016  Vol 375

Preherpetic vaccines in the old
For most people who get shingles, the rash and discomfort last for a couple of weeks and then gradually remit. The point of a shingles vaccine is to prevent post-herpetic neuralgia, an uncommon, unremitting condition which can blight people’s lives. Age increases both your chances of getting shingles and the risk of it causing postherpetic neuralgia. The title of this paper is “Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older” and “Medical writing was provided by 4Clinics, France, with funding support from GlaxoSmithKline Biologicals.” So let’s see what effect this vaccine had on rates of postherpetic neuralgia. “In the pooled modified vaccinated cohort that included all participants 50 years of age or older, postherpetic neuralgia developed in 4 of 32 HZ/su recipients and in 46 of 477 placebo recipients with herpes zoster, during a mean follow-up period of 3.8 years.” By slipping in the word “pooled,” the writers from 4Clinics, France have merged two trials and are no longer reporting on ZOE-70 alone, as they did up to this point, but adding in the over-70 subset from ZOE-50. And in so doing they also reveal that in the over-50s trial, there were no cases at all of postherpetic neuralgia under the age of 70. By that token, I can’t see any point in giving the GSK vaccine to people under the age of 70, especially as it causes a local reaction and/or fatigue in the majority of recipients. But maybe that is not the message that we are meant to take away. **See note below** more…

Richard Lehman’s journal review—12 September 2016

12 Sep, 16 | by BMJ

richard_lehmanNEJM  8 Sep 2016  Vol 375
CPAP & CV events
I adore CPAP and bless the night when she arrived in my life. I embrace her—or rather she embraces me—for seven or eight hours of sleepy bliss. I will not hear a word said against her. Does she reduce my risk of cardiovascular events? Probably not, but I couldn’t care less. Here is a trial that randomly assigned 2717 eligible adults between 45 and 75 years of age who had moderate to severe obstructive sleep apnoea and coronary or cerebrovascular disease to receive continuous positive airways pressure treatment plus usual care or usual care alone. Over 3.7 years, “No significant effect on any individual or other composite cardiovascular end point was observed. CPAP significantly reduced snoring and daytime sleepiness and improved health-related quality of life and mood.” It’s remarkable that it even did that, because the mean duration of adherence to CPAP therapy was just 3.3 hours per night. In the NHS, you wouldn’t be allowed a machine if you used it so little. more…

Richard Lehman’s journal review—5 September 2016

5 Sep, 16 | by BMJ

richard_lehmanNEJM  1 Sep 2016  Vol 375
Adding LABAs to steroid inhalers
This week’s print NEJM contains two trials of adding inhaled long acting beta-adrenergic agents to inhaled corticosteroids. The first recruited 6208 children with asthma from the ages of 4 to 11, and compared fluticasone alone with fluticasone plus salmeterol. We know that salmeterol alone should never be given to children, as the accompanying editorial makes clear: “Monotherapy with a LABA in a child should be considered medical negligence, and we suggest that single LABA inhalers should carry a warning to that effect, as required in the United States by the FDA in 2010.” But in this large trial over 26 weeks, serious events did not differ between the group where salmeterol was added to fluticasone and fluticasone alone, and there were no deaths in either group. more…

Richard Lehman’s journal review—30 August 2016

30 Aug, 16 | by BMJ

richard_lehmanAfter a month’s break, I’m catching up with articles of interest in the main non-BMJ journals throughout August. Normal service will be resumed next week. 

NEJM  Aug 2016  Vol 375

No parasites for five years

405   Following its famous “data parasites” editorial last January, the NEJM has struggled to find a comfortable position on the issue of opening up trial datasets for independent analysis. In its first print issue for August it hosted four Viewpoint articles offering a range of options, mainly for the sharing of trials conducted by academic centres. Completely open sharing does not get a mention—the idea that researchers should make their de-identified data available without restriction. The NEJM spectrum instead begins with the Yale Open Data Access project, of which I’m a proud founder member. We pioneered the “academic intermediary” model and still run one for those who wish to use it. If researchers want to use more direct methods of sharing data, we’re hardly going to stop them. But alas, the very opposite tends to be true. A piece from a hitherto unknown body called The International Consortium of Investigators for Fairness in Trial Data Sharing argues that researchers should retain sole use of their databases for up to five years. I’m genuinely sad and baffled that people with prosperous careers supported by public funding can argue that the research they have performed through the altruism of unpaid people taking voluntary risks is somehow their private property. more…

Richard Lehman’s journal review—25 July 2016

25 Jul, 16 | by BMJ

richard_lehmanNEJM  21 July 2016  Vol 375

MenB vaccination for students
220    We’ve been waiting for decades to get a vaccine against Neisseria meningitidis serogroup B. But now that it’s arrived, it’s hardly the kind of thing that gets people looking for champagne bottles in the fridge. It’s an expensive way to prevent a rare disease, and it’s actually quite hard to prove that it has saved any lives so far. This report from its use during an outbreak at “University A in New Jersey” illustrates the problem. Although this paper (and another in Pediatrics) has input from Princeton University, neither actually mentions this august institution by name. I guess this coyness is because it would prefer to be linked in the public mind with Albert Einstein rather than the outbreak of meningococcal disease that began there in December 2013. Nine students were affected and one died. Nearly 6000 were then given meningitis B vaccination and none of the vaccinated students got the disease. more…

Richard Lehman’s journal review—18 July 2016

18 Jul, 16 | by BMJ

richard_lehmanNEJM 14 July 2016 Vol 375
Olanzapine stops chemo vomiting
134 For about five thousand years, doctors sought out plants that would make their patients vomit, believing that this would expel noxious humours. In this week’s NEJM there’s a good example of this in an interesting short piece about early clinical trials featuring Adrien Helvétius (1662–1727) who introduced ground ipecacuanha root (ipecac) from Brazil. It was still given to children who had taken accidental overdoses when I was a junior doctor. But the true benefactors of mankind today are those who discover powerful anti-emetics to help people taking cancer chemotherapy. Many anti-emetics have been discovered by chance, and the latest of them is olanzapine. We’re used to seeing it used as an antipsychotic which causes somnolence, weight gain, and type 2 diabetes. But over the last two or three years it’s been increasingly used short-term as an anti-emetic for cancer patients. This trial shows that it is highly effective even at the extreme end of the vomiting spectrum. It was compared with placebo in combination with dexamethasone, aprepitant, or fosaprepitant, and a 5-hydroxytryptamine type 3–receptor antagonist, in patients with no previous chemotherapy who were receiving cisplatin (≥70 mg per square meter of body-surface area) or cyclophosphamide–doxorubicin. I think I shall start taking olanzapine half an hour before switching on the news. It might prevent that strange feeling of nausea and being about to go mad.

Richard Lehman’s journal review—11 July 2016

11 Jul, 16 | by BMJ

richard_lehmanNEJM  7 July 2016  Vol 375

Bayesian cancer trials

I’m glad I haven’t got any cancer that I know of. I’m not unique in that, but I’m of an age when friends start getting cancer, and when they ask for advice it really brings home the current realities of oncology. This is the Wild West, with everything from futile treatments offered purely for the sake of doing something to expensive genomic buccaneering based on the belief that a new treatment might offer some sudden cure. There may be one best option for each individual, but for the time being there is no short cut to finding out what it is. In twenty years we might have cracked it, but what is going to happen to my friends (or perhaps me) in the interval? I guess one option is to get recruited into a trial using adaptive randomization. It may not cure you but it might give you a clue about what to try next and it might help similar patients in the future. That’s the sell. Now what of the reality? more…

Richard Lehman’s journal review—4 July 2016

4 Jul, 16 | by BMJ

richard_lehmanNEJM  30 Jun 2016  Vol 374

Cervical sense

2509   This week’s NEJM is an odd mix of the down-to-earth and the arcane. The down-to-earth comes first, ahead of midostaurin for advanced systemic mastocytosis, PD-1 blockade in Merkel-cell carcinoma and deficiency of sFRP4 as the cause of Pyle’s disease. If these conditions did not exist, it would be necessary for the New England Journal to invent them. Meanwhile, in the great world outside the Massachusetts General Hospital, hundreds of thousands of women die avoidably each year from cancer of the uterine cervix. Here’s a really clear short open-access piece describing why and what we could and should do about it instead of destabilising the world in a series of fantasy games. more…

Richard Lehman’s journal reviews—27 June 2016

27 Jun, 16 | by BMJ

richard_lehmanNEJM  23 Jun 2016  Vol 374

Adolescent BMI: big data, little meaning
2430  “How might adolescent BMI affect adult cardiovascular mortality? In our study, we could not control for important risk factors (e.g., smoking, exercise, and physical fitness) or for adult BMI.” Ah, a slight problem then. This study tells you the exact correlation between adolescent body mass index in 2.3 million Israeli Jewish males and cardiovascular mortality up to 40 years later. Overall, less than a tenth of deaths in these men were cardiovascular. They were more likely to die this way if their BMI was over the 50th centile when they were about 17 years old. However, when you can’t even adjust for obvious confounders, what does this actually mean? more…

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