Undermining Genetic Privacy? Employee Wellness Programs and the Law

NEJM, 24 May 2017
Authors: Kathy L. Hudson, Karen Pollitz
“Genetic information is becoming ubiquitous in research and medicine. The cost of genetic analysis continues to fall, and its medical and personal value continues to grow. Anticipating this age of genetic medicine, policymakers passed laws and regulations years ago to protect Americans’ privacy and prevent misuse of their health-related information. But a bill moving through the House of Representatives, called the Preserving Employee Wellness Programs Act (H.R. 1313), would preempt key protections. Because the bill, which was sent to the full House by the Education and the Workforce Committee in March, would substantially change legal protections related to the collection and treatment of personal health and genetic information by workplace wellness programs, it should be on the radar screens of physicians, researchers, and the public.”
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Written versus verbal consent: a qualitative study of stakeholder views of consent procedures used at the time of recruitment into a peripartum trial conducted in an emergency setting

BMC Medical Ethics 2017 18:36
Authors: J. Lawton, N. Hallowell, C. Snowdon, J. E. Norman, K. Carruthers, F. C. Denison
“Obtaining prospective written consent from women to participate in trials when they are experiencing an obstetric emergency is challenging. Alternative consent pathways, such as gaining verbal consent at enrolment followed, later, by obtaining written consent, have been advocated by some clinicians and bioethicists but have received little empirical attention.”
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State Sepsis Mandates — A New Era for Regulation of Hospital Quality

NEJM, 21 May 2017
Authors: Tina B. Hershey, Jeremy M. Kahn
“Sepsis is a major cause of illness and death in the United States, affecting more than 1.5 million Americans each year at an annual cost of over $20 billion. To improve outcomes of sepsis, policymakers are increasingly using regulatory mechanisms intended to provide incentives to clinicians and hospitals to improve the quality of sepsis care. One such initiative is an unprecedented set of New York State regulations implemented in 2013 and collectively known as “Rory’s Regulations.” Named after Rory Staunton, who died at 12 years of age from sepsis resulting from a soft-tissue infection, Rory’s Regulations mandate that all hospitals in the state use evidence-based protocols for sepsis identification and management and that they report to the state government data on their sepsis-protocol adherence and clinical outcomes.”
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Abbott, Novartis and Sanofi Targeted in NPPA Clampdown on Drugs Sold Without Price Approval

RAPS, 23 May 2017
Author: Nick Paul Taylor
“The National Pharmaceutical Pricing Authority (NPPA) of India is taking action against drugmakers including Abbott, GlaxoSmithKline, Novartis and Sanofi. These top pharmaceutical firms allegedly introduced drugs without seeking price approval and may have to pay back what they overcharged. In a letter to the companies the director of enforcement at NPPA, accused the businesses of altering scheduled formulations, either by changing the dose or combining the drug with a non-scheduled medicine. To NPPA, such changes represent the introduction of new drugs. As such, the companies should have obtained approval from NPPA for the prices of their new products before introducing them to the market.”
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Modi’s generics-only drugs plan worries health experts, Indian pharma sector

Reuters, 25 May 2017
Author: Zeba Siddiqui
“India’s plan to bring in a law to ensure doctors prescribe medicines only by their generic names risks proliferating the sale of substandard drugs in a country where regulation is already lax, doctors and pharmaceutical executives say. Prime Minister said last month that the government was looking at such a law to improve affordability of medicines in the country of 1.2 billion people. Pharmaceutical executives said any law would have to stipulate that the drugs consumers get from pharmacists meet certain quality standards.”
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Alzheimer’s Deaths Jump 55 Percent: CDC

WebMD, 25 May 2017
Author: Steven Reinberg
“As more baby boomers age, deaths from Alzheimer’s disease have jumped 55 percent, and in a quarter of those cases the heavy burden of caregiving has fallen on loved ones, U.S. health officials report. “Alzheimer’s disease is a public health problem that affects not only people with Alzheimer’s disease, but also the people who provide care to them, which is often family members,” said report author Christopher Taylor.”
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Safe space for illegal drug consumption in Baltimore would save $6 million a year

Eurekalert, 25 May 2017
Source: Johns Hopkins University Bloomberg School of Public Health
“A new cost-benefit analysis conducted by the Johns Hopkins Bloomberg School of Public Health and others suggests that $6 million in costs related to the opioid epidemic could be saved each year if a single “safe consumption” space for illicit drug users were opened in Baltimore. It would also reduce overdose deaths, HIV and hepatitis C infections, overdose-related ambulance calls and hospitalizations – and bring scores of people into treatment, they found.”
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Many patients with early-stage breast cancer receive costly, inappropriate testing

EurekAlert, 24 May 2017
Author: Fred Hutchinson Cancer Research Center
“A study from Fred Hutchinson Cancer Research Center shows that asymptomatic women who have been treated for early-stage breast cancer often undergo advanced imaging and other tests that provide little if any medical benefit, could have harmful effects and may increase their financial burden.”
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Ethics Survey: Drug testing remains a clinical tug of war

Behavioural Net, 18 May 2017
Author: Julie Miller
“In recent weeks, the American Society of Addiction Medicine (ASAM) prepared comprehensive guidelines on drug testing within the continuum of care. The goal is to present evidence-based recommendations for the frequency and application of testing, which payers and providers can adopt as best practices. It’s significant because up until now, there was no true consensus. And there’s also no denying that some treatment operators have aimed to maximize their profit streams through the overuse of testing and subsequent billing of insurance companies.”
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