Weekly Roundup 5.9.14

Spring lasted about 20 minutes. It was very cool and rainy. Then it was sunny and temperate. Now, temperatures in the 90s are predicted for early next week.  Spring was sort of short, but it was lovely. The azaleas are going wild, the hydrangeas don’t look to excited, but my peonies are standing tall and boasting a lot of buds ready to blossom, which is a vast improvement over last year when I had only a handful of blooms – it was embarrassing really.

We do not have a wealth of blossoms out of FDA this week, but there was a little news worth reporting and here it is:

  • FDA, Aspirin and Heart Health – The agency issued advice this week on the daily use of aspirin as a means of preventing a first heart attack stating that after a review of available evidence and data, the agency does not believe that the evidence supports the general use of aspirin to prevent a first heart attack – which will be news to my physician.  In any case, they state that there is a favorable benefit-risk ratio for secondary prevention for a heart attack.  It does not say how the agency arrived at this decision, but they did note that there are clinical trials currently underway that would provide new information which could change the recommendation in the future.  That may be in keeping with a purely scientific approach, but won’t do much from a communications approach for patients and consumers.
  • New Drug Approved to Help Reduce Risk of Heart Attacks and Strokes – But on the other side of the coin – This week the agency announced approval for Merck’s Zontivity (vorapaxar) – a first-in-class called a protease-activated receptor-1 to reduce risk of heart attack, stroke or cardiovascular death and to resstore blood flow to the heart in patients with a previous heart attack or blockage.  The drug is an anti-platelet agent which decreases the formation of blood clots thereby decreasing the risk of a heart attack or stroke.  The drug label will include a Boxed Warning about the issue of increased risk for bleeding.
  • Exciting Prosthetic Arm Gets FDA Marketing Allowance – A bit late with the Weekly Roundup this week, but glad so that this story could be included.  FDA announced it would allow the marketing of the first prosthetic arm that can translate signals from a person’s muscles to perform complex tasks.  Electrodes in the artificial arm are able to detect electrical activity close to where the arm is attached.  The electrodes convey the signals to a built in computer processor that then translates them into specific movement.  It is the same shape and weight as an adult arm.  In addition, the system can accommodate people who have suffered limb loss at the shoulder, mid-upper arm or mid-lower arm, though not at the elbow or wrist joint.

That’s it for me this week.  I hope you all have a wonderful weekend and that you enjoyed Spring.

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