Federal Right-to-Try Legislation — Threatening the FDA’s Public Health Mission

NEJM, 10 January 2018
Authors: Steven Joffe, Holly Fernandez Lynch
“Though popular with the public and supported by politicians from both parties, the legislation has been widely criticized by policy experts. In isolation, its impact would probably be limited, since the bill was substantially hollowed out to secure the necessary votes. Nonetheless, the motivation behind the proposed legislation threatens to weaken the FDA’s ability to pursue its public health mission.”
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In Opioid Battle, Cherokee Want Their Day in Tribal Court

NYT, 17 December 2017
Author: Jan Hoffman
“The Cherokee suit argues that the pharmacy chains Walmart, Walgreens and CVS Health, as well as the giant drug distributors McKesson, Cardinal Health and AmerisourceBergen, flouted federal drug-monitoring laws and allowed prescription opioids to pour into the Cherokee territory at some of the highest rates in the country. Such neglect, Mr. Hembree claims, amounts to exploitation of a people.”
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New Zealand bans vaginal mesh implants

The Guardian, 13 December 2017
Author: Hannah Devlin
“New Zealand has become the first major country to effectively ban vaginal mesh implants in response to safety concerns over the surgery. The country’s Ministry of Health announced on Monday that it had written to leading mesh suppliers asking them to stop marketing the products from January – or prove that their products are safe.”
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Rules on reporting trials must be better enforced, say health integrity groups

BMJ 2017; 359: j5786
Author: Deborah Cohen
“Unregulated reporting of clinical trials opens the door to fraud and corruption, undermining medical advances and public health objectives, a report has warned. The report, by a consortium of “health integrity organisations,” urges governments to enforce current rules to ensure that patients, doctors, and scientists can access the full results of all clinical trials.”
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The Real Problem With Human Head Transplantation

JME Blog, 4 December 2017
Author: Michael S. Dauber
“The medical community has resoundingly asserted that the procedure is extraordinarily unethical, given the current state of our medical technology and the unforeseen effects such a procedure might have on the patient, assuming the patient survived at all. While these are certainly serious issues, the real problem with this picture is with international regulations: none of the laws and policies designed to protect patients and human research subjects have been able to stop them Canavero and Ren, nor are they likely to do so.”
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Controversial pelvic mesh devices banned in Australia by medical watchdog

SMH, 30 November 2017
Author: Ebony Bowden
“Vaginal mesh is to be banned in Australia after the medical regulator found the risk posed to patients by the device outweighed any benefits.The Therapeutic Goods Administration announced the ban this week after an investigation which followed widespread complaints from women who said the implants left them in debilitating pain.”
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Why Tobacco Companies Are Paying to Tell You Smoking Kills

NYT, 24 November 2017
Author: Sapna Maheshwari
“The messages stem from a lawsuit brought by the Justice Department in 1999. As part of the 2006 ruling in the suit, which sought to punish cigarette makers for decades of deceiving the public about the dangers of their product, the companies were ordered to disseminate “corrective statements” centered on the health risks and addictive nature of smoking. But until now, they resisted through appeals and by wrangling over wording.”
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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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