September 10th, 2012

Selections from Richard Lehman’s Literature Review: September 10th

CardioExchange is pleased to reprint selections from Dr. Richard Lehman’s weekly journal review blog at Selected summaries are relevant to our audience, but we encourage members to engage with the entire blog.

JAMA  5 Sep 2012  Vol 308

The FDA and the Safety Risks of Innovation (pg. 869): Cancer, multiple sclerosis, stroke: do you want your patients to get the benefit of new drugs for these conditions as soon as possible? It’s pretty hard to say no to a question like that, but if you follow the flow of this rhetoric you can easily ignore poor evidence of benefit, and absence of evidence of safety. That’s what the authors of this short piece demonstrate in relation to vandetanib for medullary thyroid cancer, fingolimod for MS, and dabigatran for stroke prevention in AF. For all these drugs, the US Food and Drug Administration used its expedited approval program, as it did for 46% of the new drugs which came before it in 2011. All of them are expensive and in each of these three cases there are clear signals of harm: but they have been let loose on patients simply on condition that there will be post-marketing studies. The same happens in the UK, and we are about to lose what small protection NICE once offered, since now any manufacturer will be able to appeal against rejection and have a NICE decision overturned by an “independent” assessor picked by the Department of Health. This ridiculous travesty of proper regulation shows that nothing has been learnt from the lessons of Vioxx or Avandia. Pre-order your copy of Ben Goldacre’s Bad Pharma now.

Aortic Stiffness in the Elderly (pg. 875):  Framingham is a town which is getting swallowed in the urban sprawl to the west of Boston, Massachusetts, and if you are very clever at negotiating its northern outskirts you will find yourself in wonderful woodland garden containing many gems of the spring season, especially trilliums. Oops, I digress. This is meant to be about the latest from the Framingham Heart Study, not Plant of the Week. Start again: if you want the best source of knowledge about the wild flowers of New England, or about the natural history of cardiovascular disease in a mainly white population since 1948, turn to Framingham. The Framingham Heart Study has generated about 2,400 papers since 1950, and if you piece them all together… well, you may be dead before you’re finished, like most of the original cohort. This latest paper explores the important question of aortic stiffness in the elderly: important because it is a predictor of total mortality and especially of heart failure without systolic dysfunction. The surprise for me here was that previous hypertension was not associated with late arterial stiffening. So it just seems to happen.

CMR to Detect MI in Older Adults (pg. 890):  It’s one thing to recruit several thousand people in a Massachusetts town with a large Italian population, but just imagine if you had a few hundred thousand people inhabiting an island which few of them want to leave, descended mostly from the same few 1,000-year-old families. You could capture the entire population genome (this happened years ago) and do all the epidemiology you liked. ICELAND-MI does what it says on the side of the trawler: it looked for cardiac MRI (CMR) evidence of myocardial infarction in 936 participants aged 67 to 93 years, including 670 who were randomly selected and 266 with diabetes. Previously undetected MI showing up on CMR is about 60% commoner than recognized MI, and carries about the same prognosis. These sons and dottirs should all be on the standard post-MI drug cocktail.

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