Ensuring Respect for Human Research Participants: Institutional Review Boards and Sharing Results From Research

JAMA. 2016;316(11):1149-1150
Authors: Samuel N. Doernberg, David Wendler
“The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that investigators report summary results of eligible clinical trials to ClinicalTrials.gov within 1 year of trial completion. This requirement is in part intended to promote medical innovation by enabling meta-analyses and further research based on the results of clinical trials. Sharing trial results helps to counteract a publication bias favoring positive trials that can “distort the evidence base” of clinical guidelines and patient care. In addition, sharing the results of clinical trials is important for ethical reasons: it helps to justify exposing participants to the risks of clinical trials and shows respect for those who assume these risks.”
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How Kenyan and Tanzanian medicine producers deserve a shot in the arm

The Conversation, 28 September 2016
Authors: Samuel Wangwe, Maureen Mackintosh
“Despite major improvement in access to HIV/Aids and TB treatment most people living in Africa still lack access to reliable and appropriate medicines. They continue to struggle with the worst health status in the world. Why is this happening? What can be done? Unexpectedly, part of the explanation can be found in the state of Africa’s own pharmaceutical industry. Far too little is heard about the industry in debates about access to medicines. And it’s often said that Africa has no pharmaceutical industry. But this simply isn’t true.”
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The Proposed Federal ‘Right-To-Try’ Law Is Not The Answer For Critically Ill Patients

Health Affairs Blog, 27 September 2016
Author: Jonathan Friedlaender
“Currently, patients have two main options to access experimental therapies that may treat their conditions but that have not yet been approved by the Food and Drug Administration (FDA): enrolling in a clinical trial or applying to FDA’s expanded access (also known as compassionate use) program. But because FDA’s expanded access program has been viewed as cumbersome and overly restrictive, 31 states have passed “Right-To-Try” laws in the past two years. Based on model legislation created by the Goldwater Institute, a public policy think tank, right-to-try laws are intended to authorize use of experimental, not-yet-approved treatments for patients with advanced illness; prohibit sanctions of health care providers for providing experimental treatment; and clarify health insurers’ roles.”
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UVLrx Therapy Lights Up Charlatans Dealing In Medical Devices

Forbes, 26 September 2016
Author: Britt Marie Hermes
“Without approval by the U.S. Food and Drug Administration, a new medical device called UVLrx has hit alternative medicine practices across the country. The device delivers an illuminated cocktail of red, green and ultraviolet wavelengths directly into the bloodstream that is claimed to improve circulation and oxygen saturation, reduce pain, modulate the immune system and lessen inflammation.”
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Belgian euthanasia model splits Aussie experts

MJA Insight, Issue 37, 26 September 2016
Author: Sarah Colyer
“GPs in Belgium are becoming increasingly confident about referring patients for euthanasia, new research suggests, as in September 2016 the country approved the first death of a child under its laws. The latest study has divided Australian experts amid renewed clamour for a national vote on the issue. Opponents claim that the findings provide fresh evidence of a slippery slope of widening justification for euthanasia, and of the ineffectiveness of safeguards to avoid abuse of the legislation. Supporters, by contrast, emphasise that the overall rate of deaths is still very low, and say that euthanasia is finding a natural place in palliative care.”
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Should non-disclosures be considered as morally equivalent to lies within the doctor–patient relationship?

J Med Ethics 2016;42:632-635 doi:10.1136/medethics-2015-103014
Authors: Caitriona l Cox, Zoe Fritz
“In modern practice, doctors who outright lie to their patients are often condemned, yet those who employ non-lying deceptions tend to be judged less critically. Some areas of non-disclosure have recently been challenged: not telling patients about resuscitation decisions; inadequately informing patients about risks of alternative procedures and withholding information about medical errors. Despite this, there remain many areas of clinical practice where non-disclosures of information are accepted, where lies about such information would not be.”
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How big pharma spent $650k on Australian nurses in six months

SMH, 24 September 2016
Authors: Rania Spooner, Craig Butt
“Researchers are concerned the support is aimed at increasing prescriptions and will drive up the costs of medication. “These companies currently market some of the highest-cost drugs on the market for diseases such as cancer and hepatitis C,” said Dr Quinn Grundy, a nurse and researcher at the University of Sydney.”
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