Discoveries/Innovations: Google Has an Eye on Health

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Google unveiled a “smart contact lens” that can measure glucose levels in a person’s tears, potentially saving diabetics from the sometimes painful and constantly disruptive task of pricking their fingers to test their blood. This prototype contact lens uses a tiny wireless chip and miniaturized glucose sensor embedded between two layers of soft contact lens material to generate a reading once per second. The project’s co-founders, Brian Otis and Babak Parviz, also announced on Google’s official blog that they plan to explore ways of integrating LED lights into the lens that would indicate when glucose levels have crossed above or below certain thresholds.

While Otis and Parviz have already started discussions with the FDA, officials from Google told the Associated Press that the device is at least five years away from being ready for consumers. The project is currently looking for partners who can help bring this product to market and can develop apps that would make the measurements from the contact lens available to the patient and their doctor. Netherland-based NovioSense BV developed a wireless device that can monitor glucose levels in tears in 2012 and is also attempting to bring a similar kind of contact lens to the market.

DC Dispatch: Obama Proposes Medicare Drug Changes

The Obama administration is proposing changes to Medicare that would eliminate the special protections that antidepressants, antipsychotics and immunosuppressant drugs have enjoyed since the launch of the Medicare prescription benefit in 2006. Currently, “all or substantially all” medications in those three classes must be covered by any private insurance plan that offers prescription benefits to seniors and disabled beneficiaries. This ensured that Medicare participants would have the broadest possible access to drugs in those classes.

The administration’s proposal, which was published in the Federal Register in January, says that the protection is no longer required to guarantee access and it could save taxpayers a total of $720 million by 2019 as well as help control the problem of antipsychotics drugs being improperly prescribed in nursing homes. If the new policy is adopted in the coming months it could take effect by 2015, according to the Associated Press.

Dan Mendelson, CEO of Avalere Health, a market analysis firm, doubts this plan would deliver the savings the proposal promises. “I’m not sure that Medicare saves money from this kind of a change,” he told the Associated Press. “Other elements of the program may have a cost increase if people are not using medications in the right way.”

Med Device: World’s Smallest Pacemaker

At a size comparable to that of a nickel, Medtronic announced the first-in-human implant of the Micra Transcatheter Pacing System (TPS)—the world’s smallest pacemaker. The device was implanted in a patient in Linz, Austria as part of the Medtronic global pivotal clinical trial. The study is a single-arm, multi-center global clinical trial that will enroll up to 780 patients at approximately 50 centers. Medtronic will release initial results from the first 60 patients in the second half of 2014.

“Because of its small size and unique design, the Micra TPS can be introduced directly into the heart via a minimally invasive procedure, without the need for leads,” says Clemens Steinwender, MD, Head of Cardiology at the Linz General Hospital in Linz, Austria. “The combination of this novel technology with a transcatheter procedure can benefit patients by potentially reducing pocket or lead complications and recovery times observed with traditional surgical pacemaker implants.”

TeleMed Text: Physician’s EHR Preferences

As EHR adoption continues to grow it becomes more important to learn how physicians are using these programs and what they want from them. PDR Network has released a new EHR Playbook, which compiles findings and insights gleaned from the more than 160,000 prescribers (providers) and nearly 600,000 users that the company reaches through its established national network of more than 200 EHR partners/vendors. Some of the more interesting findings include:

  • 85% of doctors prefer to view EHRs on their desktop/laptop on a daily basis. In fact, 65% never use a smartphone, 61% never use an iPad/tablet and 88% never use an e-reader to interact with EHRs.
  • 7% of physicians actually spend more than 7 hours interacting with EHRs in the exam room alone. However, 35% spend only less than an hour with an EHR in the exam room, 48% spend between one and three hours with an EHR between patient exams and 46% spend between one and three hours with an EHR at the end of the day.
  • 52% of physicians said it would reduce their reliance on search engines if they could access the drug information they needed within their EHR and 59% said they believe they could save between five and 20 minutes a day if FDA labeling was integrated right into their EHR.

See the chart below to learn how physicians rate the importance of the current offerings available to them through EHRs.

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FDA Update

New Social Media Guidance

The FDA issued a new draft guidance, Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics, that provides marketers with a little more clarity on some aspects of digital marketing and social media. The guidance helps clarify the differences between company-controlled and independently generated content (such as visitor comments), provides recommendations on submitting promotional materials that have a “real-time” dynamic and more. Read the full guidance at bit.ly/FDAGuide3.

Warning Letters

After issuing just 13 warning letters citing medical food issues since 2001, the FDA has sent four since April 2013, according to RAPS. That includes its latest warning letter to NVN Therapeutics, which informs the company that its product Glucorein PCOS is being misbranded as a medical food as the agency can find no evidence that patients with polycystic ovarian syndrome (PCOS) have any medically determined nutrient requirements. The agency also sent similar letters to Metagenics and Accera, Inc. within the last nine months, signaling a crackdown on anything that doesn’t meet the FDA’s definition of medical food.

New Approvals

GlaxoSmithKline’s Tafinlar (dabrafenib) was granted breakthrough therapy status for the treatment of patients with metastatic BRAF V600E mutation-positive non-small-cell lung cancer (NSCLC) who have received at least one prior line of platinum-containing chemotherapy. The FDA also approved GSK’s Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with COPD.

Novo Nordisk’s Tretten (Coagulation Factor XIII A-Subunit [Recombinant]) was approved as the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, known as congenital Factor XIII A-subunit deficiency.

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