F.D.A. Speeds Review of Gene Therapies, Vowing to Target Rogue Clinics

NYT, 17 November 2017
Authors: Sheila Kaplan, Denise Grady
“The Food and Drug Administration on Thursday issued new guidelines to speed the introduction of treatments involving human cells and tissues, including gene therapy. But the agency also said it would crack down on rogue clinics offering dangerous or unproven versions of those treatments.”
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Ethics of fertility preservation for prepubertal children: should clinicians offer procedures where efficacy is largely unproven?

JME Blog, 15 November 2017
Authors: Rosalind J McDougall, Lynn Gillam, Clare Delany, Yasmin Jayasinghe
“These were the kinds of questions that doctors brought to our clinical ethics service. They wanted ethical advice about offering surgical procedures for young children with cancer, aimed at preserving fertility. This is an area of rapidly developing science, but there is currently little evidence that the fertility preservation process works for very young patients.”
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Designing Ethical Trials of Germline Gene Editing

N Engl J Med 2017; 377:1911-1913
Author: Bryan Cwik
“Much of the biomedical ethics literature on gene editing has focused on broad social issues related to how it should be done, such as questions about using it for enhancing human cognitive abilities. Comparatively little has dealt with more ground-floor ethical issues about the design of clinical trials and use of gene editing in reproductive medicine. The time for that discussion has now come: foreseeable use of gene editing in reproductive medicine is no longer science fiction, and it’s important to consider seriously what would be required for the conduct of ethically sound clinical trials of this new technology.”
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Attacks against health care in Syria, 2015–16: results from a real-time reporting tool

The Lancet, 390(10109), p2278–2286
Authors: Mohamed Elamein, Hilary Bower, Camilo Valderrama, et al.
“The data system used in this study addressed double-counting, reduced the effect of potentially biased self-reports, and produced credible data from anonymous information. The MVH tool could be feasibly deployed in many conflict areas. Reliable data are essential to show how far warring parties have strayed from international law protecting health care in conflict and to effectively harness legal mechanisms to discourage future perpetrators.”
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Johnson & Johnson wins California lawsuit claiming asbestos in talc caused cancer

Reuters, 17 November 2017
Author: Nate Raymond
“A California jury on Thursday ruled in favor of Johnson & Johnson in a lawsuit by a woman who said she developed the cancer mesothelioma after being exposed to asbestos in the company’s talc-based products including J&J’s Baby Powder.”
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Emergency Legal Authority and the Opioid Crisis

NEJM Perspective, 15 November 2017
Authors: Lainie Rutkow, Jon S. Vernick
“Recently, six states have taken the unusual step of using their legal authority to declare their opioid-overdose situation an emergency. When a government issues an emergency declaration, it can temporarily act to mitigate the emergency using powers and resources that might not otherwise be available to it. Typically, emergency declarations pertain to natural disasters or infectious disease outbreaks. The severity of the opioid-overdose crisis has led to some of the first emergency declarations for a noncommunicable health condition, though their impact remains unclear.”
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Australia urged to sue Big Tobacco for past healthcare costs

SMH, 20 November 2017
Authors: Steve Lillebuen, Neelima Choahan
“Australia should consider suing Big Tobacco to recover the tens of billions spent each year on smoking-related illnesses, health researchers say. More than $30 billion is estimated to be spent each year on the health, social and economic costs related to smoking as one of the country’s preventable causes of death.”
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Woman who rejected breast cancer diagnosis may undergo surgery without her consent

BMJ 2017; 359: j5358
Author: Clare Dyer
“A 66 year old woman with paranoid schizophrenia may be put under general anaesthetic and have surgery for breast cancer without her consent, a High Court judge has ruled. Mr Justice Keehan declared that the woman, referred to as JT, who denied that she had cancer, lacked the capacity to decide for herself whether to have the treatment.”
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