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The Scoop – FDA Guidance on Reprints | Harvard Emerging Issues in Healthcare | Twitter to Identify HIV Outbreaks March 4, 2014

Filed under: Corporate — CMI/Compas @ 5:30 pm

News flash, this just in: “The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled “Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended Practices.” This draft guidance revises the final guidance titled “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices” published in January 2009. The revised draft guidance provides guidance on FDA’s current thinking on recommended practices for drug or medical device manufacturers and their representatives to follow when distributing to health care professionals or health care entities scientific or medical journal articles, scientific or medical reference texts, or clinical practice guidelines ((CPGs); all three collectively referred to as “scientific and medical publications”) that discuss unapproved new uses for approved drugs or approved or cleared medical devices marketed in the United States.”

Calvin Butts, VP Strategic Services, is attending this week’s Emerging Issues in Healthcare workshop at Harvard, and has shared the following takeaways: No question, DNA testing is one of the most fascinating topics being presented, in particular the case about 23andMe. The expectation is that within 10 years your genetic code will guide your health care treatment. This leads to more questions than answers, including:
• What will people do with that data, will relationships and careers be decided based on your genetic make-up?
• Should the consumer/patient have access to that data?
• Listening to physicians in the room debate the effect of patients obtaining these result with no clinical support or understanding. Consumers want to know and empower themselves, HCPs are scared patients don’t know want to do with test results. Will it cause self-diagnosis and panic? Could that lead to inappropriate actions; which will lead to higher health care cost?
• What would you do if you knew your entire genetic make-up? As a consumers we want to know more about our genetics, but do we really know how to translate the data?
• Will DNA testing lead to consumer to questions like who should I marry? Asking for DNA profile on a first date?
• Physicians are practicing to not order any test if you are not clear what you are with the results. If result are this then that, if that then this.
Another presentation of interest was titled “Community Health Workers- Incentive Design and Management.” It explored the “Health Worker Crisis” – looking at where disease burden is greatest and where human resources and health care providers are. Key takeaways:
• The Advertised mission of the job affects who is attracted to apply
• Compensation affects both recruitment and motivation
• Recognition and social incentives can be highly motivating, but have the potential to backfire among low performers if they promote social comparison
• The why people work is important, people need to be connected to the mission

This week in out-of-the-box thinking: researchers are using Twitter to identify HIV outbreaks in the US. Med students are teaming up with Alzheimer’s patients in a buddy system enabling them to learn more about the disease. Malcolm Gladwell declares the end of deep-thinking, in favor of interoperability using tools we already have.

Venture Beat reports that while a single tool for TV and online ads might make sense in the consumer media realm, “Nielsen’s report, Video Convergence: Buying, Selling and Trusting Across Platforms, estimates that that two separate buying structures are not going to merge until the end of this decade.” The report blames several factors, many of which lead back to the vast differences between how the two media are bought, both in process and volume.

-Carly Kuper, VP, Strategic Marketing & Corporate Communications
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