Friday, September 25, 2015

This week in ePharma: Martin Shkreli - the new Most Hated Man in Pharma | NHS is under controversy over data security

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Medical data security glitch: The NHS Choices Health Apps remove many apps for their poor encription practices.
Another glitch in the security system could've caused damage by leaking users' data into the hands of perpetrators. After a study conducted by researchers in London, it was revealed that many health apps previously approved by the National Health Services (NHS), a publicly funded healthcare system in England, have, in fact, lacked the security measures to prevent the data from leaking. The health apps were included in the NHS England's Health Apps Library, the public resource of health information. The NHS Choices Health Apps website states as their mission "Safe and trusted apps to help you manage your health" and promises that "reviewed by the NHS" means "to ensure they are clinically safe." As the aftermath of the study, the health apps that were found exercising poor online encryption practices were removed from the library.

Martin Shkreli, the CEO of Turing Pharmaceutics, whom AdAge calls the new Most Hated Man in America, has made the headlines overnight by jacking up the price for the drug Pyrimethamine (trade name Daraprim) from $13.5 to $750 per pill just a little over a month after acquiring exclusive rights for the drug.

According to Wikipedia, Daraprim is commonly used as an antimalarial drug as well as in treatment of food-borne infections, (when combined with the sulfonamide antibiotic sulfadiazine) affecting people with weakened immune system (HIV-positive in particularly.) Daraprim is on the World Health Organization's List of Essential Medicines, the most important medications needed in a basic health system.

FDA establishes the Patient Engagement Advisory Committee
FDA creates the first-ever Patient Engagement Advisory Committee. The purpose, as stated on the FDA website is to "provide advice to the Commissioner or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients." The committee will consist of nine board members who will be advising on establishing better communications and cooperation between drug and med device makers, patients, consumers' interests, and the FDA policy.
Some of the duties of the committee will include: benefits and risks, patient preference study design, medical device labeling, unmet clinical needs, available alternatives, and patient reported outcomes.


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About the author: Ksenia Newton, a Digital Marketing Assistant at IIR USA, Pharma Division, who works on various aspects of the industry including social media, marketing analysis and media. She can be reached at knewton@iirusa.com
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