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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A Federal Ban on Making Lethal Viruses Is Lifted

NYT, 19 December 2017
Author: Donald G McNeil Jr
“Federal officials on Tuesday ended a moratorium imposed three years ago on funding research that alters germs to make them more lethal. Such work can now proceed, said Dr. Francis S. Collins, the head of the National Institutes of Health, but only if a scientific panel decides that the benefits justify the risks.”
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Court orders Trump administration to give immigrant teens abortion access

Reuters, 19 December 2017
Author: Sarah N Lynch
“A U.S. District Court judge ruled on Monday that President Donald Trump’s administration must allow access to abortion for two pregnant teenagers who are in the country illegally, escalating a high-profile legal fight.”
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We must follow California’s example and repeal archaic HIV laws

The BMJ Opinion, 15 December 2017
Author: Sofia Gruskin
“Recently, my home state of California made national headlines when it repealed an HIV criminalisation law and reduced penalties for exposing other people to the virus. It was a landmark decision grounded in science and human rights that will go into effect next month.”
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DOJ Stepping Up Prosecutions Of Medical Providers Who Abuse Prescribing Authority

NPR interview, 11 December 2017
Host: Robert Siegel
“It’s believed that 80 percent of people addicted to heroin today started with prescription painkillers. The over-prescription of opioids in the U.S. has been well documented. NPR’s Robert Siegel speaks with U.S. Deputy Attorney General Rod Rosenstein about how the Department of Justice is ramping up prosecutions of medical providers who abuse their prescribing authority when it comes to opioids.”
Find transcript here.

US neurologist escapes jail for alleged serial sexual assaults but faces more accusers

BMJ 2017; 359: j5474
Author: Owen Dyer
“A neurologist who used his specialized knowledge of rare diseases to trap female patients into abusive doctor-patient relationships has escaped jail in a Pennsylvania court but will never practice again. He also faces live police investigations in two other US states where he previously worked.”
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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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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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