June 2010
In the May 6 issue of NEJM there are two articles about public health – a telling use of space in the world’s #1 medical journal. The first article (http://bit.ly/btlPP9) gives an early glimpse of progress achieved in the Healthy People 2010 initiative of DHHS. While interesting, more intriguing was the emphasis in the next such DHHS initiative, Healthy People 2020, on the expanded use of Web-based tools to improve data accessibility and promote global health. The second article (http://bit.ly/b3efxs) describes the use of an automated, 24 hour data collection and processing system (HealthMap) to aggregate reports of diseases of interest (in this case, H1N1) by geographic location. The H1N1 data derived from Internet news sources, but will also soon include information from blogs, Twitter, Facebook and direct reports by users. Eventually, real-time data from electronic medical records will be monitored in the same way for disease surveillance. These are leading-edge examples of how user-driven healthcare can have global impact. Implicit in both articles is the recognition of the rapid emergence of Web 2.0 capabilities that will transform healthcare as we know it.
May 2010
Each year in the U.S., 3 billion prescriptions are written, and there are 1.5 million preventable adverse drug events. In order to take a more proactive stance on drug safety, in November 2009 the FDA announced a Safe Use Initiative, a program to reduce the likelihood of preventable harm from medication use. See FDA web site http://bit.ly/ajW3f7, with many useful links. (The IOM offers another useful resource, a timeline of IOM & FDA actions to improve drug & device safety. http://bit.ly/an5DHC). One of the key activities in the FDA’s Safe Use Initiative is to use existing information better (one of my favorite refrains). Multiple stakeholders (e.g. AHRQ, CDC, drug companies, providers and consumers) will identify drugs liable to preventable harm; 2) those harms will be listed; 3) interventions will be identified; and 4) metrics to measure success of interventions will be identified. An early target appears to be long acting beta agonists (LABAs). Per NEJM April 1 2010 commentary by FDA staffers, in February 2010, the FDA implemented updated recommendations re: LABA labeling, and now intends to take several actions to ensure that prescribers and patients are aware of the labeling changes. The FDA will also assess whether prescribing patterns now change. Stay tuned, as the FDA plans to hold public meetings re: this initiative.
April 2010
Call for Papers! The new International Journal of User Driven Healthcare is seeking original submissions for a Special Issue. focusing on the following questions: Is the recent emergence of User Driven Healthcare really a new, post-EBM paradigm for healthcare, or just an overdue consideration of the other two legs of the original EBM stool? How might this trend affect all stakeholders? Topic examples include: developing valid patient-level evidence using the Web; clinical research strategies using social media and mobile technologies; information management for patients in an EBM world; narrative medicine and EBM; use of collective intelligence to solve healthcare problems for individuals and communities. Submissions from all stakeholders: patients, providers, payers, Health IT, researchers, regulators, and policy wonks are welcomed! All submissions and inquiries should be emailed to me, as Guest Editor for this Special Issue. All submissions will undergo peer-review, and must comply with journal submission guidelines. For more info, see: http://bit.ly/cOpwHv
Submissions Due: July 1, 2010.
March 2010
Wonder-ful. Today, the N. Y. Times reported yet another pivotal study (this one in Alzheimer’s) that has crashed and burned (http://nyti.ms/clZvjh). “What a surprise!” everyone says, for in a smaller trial (performed in Russia – enough said), the study drug seemed really superior to everything else. Makes me wonder whether the sponsors, or the investigators, had ever done a systematic review of the Alzheimer’s efficacy of their compound, similar compounds, and ‘everything else’ prior to designing their pivotal study. I have seen this mistake all too often. What was knowable was not known during study design, for want of a proper assessment of the existing literature. To be fair, I will also state that I don’t know if the company in question ever did this homework or not. Perhaps they did, so the pivotal study result was indeed a surprise. If so, my regrets to all concerned. But like I said, I’ve seen ‘surprise’ results in clinical trials all too often, and when I do, I wonder. In fact, I wonder if those doing due diligence on this company ever performed a systematic review, given the company’s market valuation is reportedly $1.3 billion, based largely on the prospects of this particular drug. Makes me wonder.
February 2010
Will User-driven Healthcare using collaborative multidisciplinary information networks on the Web move us into a post-EBM world? (or better yet, a fully-realized EBM world?) See Handbook of Research on Electronic Collaboration and Organizational Synergy. Vol II. Salmons J & Wilson L, editors. 2009. IGI Global. Chapter by Professor Rakesh Biswas, who is now editing an entire, first-of-its-kind textbook on User-driven Healthcare, to which I am a contributor. Stay tuned.
January 2010
Happy New Year! Let's start 2010 with a question: since when does EBM = death panels? Recent public anger and confusion over the results of the USPSTF review of the evidence re: mammography reveals a profound and widespread ignorance of EBM (not helped by really clumsy explanations and abysmal public relations by the Task Force itself). Any issue is susceptible to politicization in direct relation to the depth of ignorance about it. Here is a prime example. Can’t we do a better job of educating people about EBM? Now that's a worthy resolution for the new year!
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