Patients Demand The ‘Right To Try’ Experimental Drugs, But Costs Can Be Steep

NPR, 3 March 2017
Author: Carrie Feibel
“In the last three years, 33 U.S. states have passed laws aimed at helping dying people get easier access to experimental treatments that are still in the early stages of human testing. Supporters say these patients are just looking for the right to try these treatments. Such laws sound compassionate, but medical ethicists warn they pose worrisome risks to the health and finances of vulnerable patients.”
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Annals for Hospitalists Inpatient Notes – Legislating Quality to Prevent Infection—A Primer for Hospitalists

Ann Intern Med. 2017;166(4):HO2-HO3.
Authors: Jennifer Meddings, MD, MSc; Laurence F. McMahon, Jr.,
“Three major Medicare policies now target rates of catheter-associated urinary tract infection (CAUTI) and central line–associated bloodstream infection (CLABSI) as performance measures in hospitals. These Medicare value-based purchasing programs are designed to levy financial penalties to hospitals, based on infection rates. Mandated by federal law, the goal of these programs is to motivate hospitals to improve safety while guaranteeing Medicare savings. Like many federal laws, these programs are complex, quickly implemented without prior validation, and poorly understood by the people who are directly affected—patients and clinicians.”
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Variation in the costs of surgery: seeking value

Med J Aust 2017; 206 (4): 153-154.
Authors: David J Hillis, David AK Watters, et al
“To ensure high value, the procedures performed must be appropriately indicated, avoiding overservicing or selecting a particular treatment when its likelihood of success, compared with the alternatives, is limited. Health professionals have an ethical responsibility to avoid waste in health care — not only by better targeting resources, but also because “useless tests and treatments cause harm”.
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NHS accused of covering up huge data loss that put thousands at risk

The Guardian, 27 February 2017
Authors: Denis Campbell, Pamela Duncan
“Thousands of patients are feared to have been harmed after the NHS lost more than half a million pieces of confidential medical correspondence, including test results and treatment plans. In one of the biggest losses of sensitive clinical information in the NHS’s 69-year history, more than 500,000 pieces of patient data sent between GPs and hospitals went undelivered over the five years from 2011 to 2016.”
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Betraying the oath: the rot in India’s medical education system

The Hindu, 25 February 2017
Author: Vidya Krishnan
“The Medical Council of India recently barred 32 colleges across the country. Vidya Krishnan reconstructs how one of those, a Bhopal institute, marshalled doctors on hire, fake patients and life-saving equipment on rent for inspection day.”
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How to Keep HIV Cure-Related Trials Ethical: The Benefit/Risk Ratio Challenge

JME Blog, 20 February 2017
Author: Nir Eyal
“While high or unknown risks are a mainstay of early-phase trials in areas like cancer research, cure study participants typically have a safe and efficacious alternative to those risks: remaining on antiretrovirals. Can we justify asking patients who are doing well on antiretrovirals to accept the risk and uncertainty of many HIV cure-related trials? If we cannot, we might need to give up on the hope of curing HIV, or of achieving controlled remission.”
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A Call For The FDA To Raise The Bar For Clinical Trials Is Flawed

Forbes, 22 February 2017
Author: John LaMattina
“As the new Trump administration begins to take shape, there are concerns that new leadership at the FDA will call for less bureaucracy and red tape, thereby lowering the bar for new drug approvals. The view is that onerous regulations are preventing life-saving medications from getting to those who most need them. Lowering the standards for drug approvals may indeed allow for earlier patient access to drugs but, as has been discussed here in the past, liberalization of current regulations would be a mistake. Such actions will unleash drugs that will ultimately prove to be ineffective and, in some cases, harmful rather than beneficial.”
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Benefit-Risk Assessments at the US Food and Drug Administration

JAMA. 2017; 317(7): 693-694.
Author: Robert M. Califf
“The US Food and Drug Administration’s (FDA’s) independent evaluation of medical products for safety and effectiveness prior to granting approval for marketing or new labeled indications is fundamental to assuring the public and clinicians that marketed products have a positive balance of benefit to risk when used according to labeling. Ever since this foundational protection was established in 1962, a body of evidence has supported the use of a flexible but consistent standard when making decisions about marketing approval: Do the benefits of a product outweigh the risks when used as intended and labeled?”
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