Barack Obama became the first sitting U.S. president to publish an academic paper last week, much to the chagrin of grad students who ‘just have too much going on this month to publish.’ The article, published in the Journal of American Medical Association, analyzes the effects the Affordable Care Act has had on Americans. He lays out some recommendations for improving health care under the ACA, and offers some lessons for future policy makers. In one of those lessons, he criticizes special interests like the pharmaceutical industry for being reluctant towards change, citing pharma lobbying against drug pricing legislation. Seems to us like that callout could be the source of some Obama JAMA drama.
That’s not really the question. The Electronic Medical Record (EMR) train has left the station. The next question is, how accurate and complete are EMRs? Well, there are two different answers to that question. A recent study published in the Journal of the American Medical Informatics Association looked at physician notes from Beaumont Hospital in Royal Oak, Michigan, as they transitioned from a paper-based record system to an EMR system. The net-net: inaccurate documentation was significantly higher in the EMR by a rate of more than 5 to 1 (24.4% error rate with the EMR, 4.4% with paper), but omissions were far more likely with paper notes compared with EMR notes (41.2% vs. 17.6%). Have fun conducting your next RWE project and at your next doctor visit.
The FDA’s advisory committee had a busy week last week recommending approval for two separate biosimilar products, both of which received unanimous support. Amgen’s proposed biosimilar for AbbVie’s Humira, ABP 501, received a nod from the committee while Sandoz’ etanercept got a thumbs up as a biosimilar to Amgen’s Enbrel. With consumers demanding lower drug prices and pharma fighting for longer exclusivity, marketing these biosimilars is another discussion…at least in the US. These reference products are still under patent in the US, but the EMA has already accepted Sandoz’ Marketing Authorization Application and Amgen just struck a deal with Daiichi Sankyo to begin commercializing ABP 501 and eight other biosimilars in Japan.
And there’s no reason to be sad about it. We probably shouldn’t count our drugs before they hatch, but Sage Therapeutics has finished a preliminary study addressing postpartum depression that saw the easing of symptoms in 7 of 10 patients, compared to 1 of 11 in a placebo group. The study, which used the intravenously administered SAGE-547, has helped Sage’s stock price surge 37% with the knowledge that upwards of half a million postpartum depression patients annually could be treated if the drug develops beyond its current trial stage into a finished product. While the goal is to transform SAGE-547 into an equally effective orally taken drug, many hurdles remain between here and the finish line.
People smarter than most have developed a new kind of bio-ink. No, you can’t get it at Staples. But don’t let that stop you from getting excited about this stem cell-containing ink that can be used to engineer bone and cartilage via 3D printing. The team developed a formulation that contains two different polymer based components—one extracted from seaweed, the other a synthetic polymer used in the medical industry—and a retrofitted benchtop 3D printer to generate a full-size tracheal cartilage ring in just 5 weeks. Sounds slow for the person who could really use a tracheal cartilage ring right about now. Potential uses include joints for hip and knee replacement surgeries as well as nose reconstruction. Lord Voldemort would be pleased.