State Sepsis Mandates — A New Era for Regulation of Hospital Quality

NEJM, 21 May 2017
Authors: Tina B. Hershey, Jeremy M. Kahn
“Sepsis is a major cause of illness and death in the United States, affecting more than 1.5 million Americans each year at an annual cost of over $20 billion. To improve outcomes of sepsis, policymakers are increasingly using regulatory mechanisms intended to provide incentives to clinicians and hospitals to improve the quality of sepsis care. One such initiative is an unprecedented set of New York State regulations implemented in 2013 and collectively known as “Rory’s Regulations.” Named after Rory Staunton, who died at 12 years of age from sepsis resulting from a soft-tissue infection, Rory’s Regulations mandate that all hospitals in the state use evidence-based protocols for sepsis identification and management and that they report to the state government data on their sepsis-protocol adherence and clinical outcomes.”
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Abbott, Novartis and Sanofi Targeted in NPPA Clampdown on Drugs Sold Without Price Approval

RAPS, 23 May 2017
Author: Nick Paul Taylor
“The National Pharmaceutical Pricing Authority (NPPA) of India is taking action against drugmakers including Abbott, GlaxoSmithKline, Novartis and Sanofi. These top pharmaceutical firms allegedly introduced drugs without seeking price approval and may have to pay back what they overcharged. In a letter to the companies the director of enforcement at NPPA, accused the businesses of altering scheduled formulations, either by changing the dose or combining the drug with a non-scheduled medicine. To NPPA, such changes represent the introduction of new drugs. As such, the companies should have obtained approval from NPPA for the prices of their new products before introducing them to the market.”
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Many patients with early-stage breast cancer receive costly, inappropriate testing

EurekAlert, 24 May 2017
Author: Fred Hutchinson Cancer Research Center
“A study from Fred Hutchinson Cancer Research Center shows that asymptomatic women who have been treated for early-stage breast cancer often undergo advanced imaging and other tests that provide little if any medical benefit, could have harmful effects and may increase their financial burden.”
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French drugmaker Servier to face trial over weight-loss Mediator

Reuters, 24 May 2017
Authors: Simond Carraud, Matthias Blamont, Emmanuel Jarry and Leigh Thomas
“The Paris prosecutor’s office said on Wednesday that drugmaker Servier as well as the French drug regulator should face trial over weight-loss pill Mediator, believed to have caused at least 500 deaths in one of France’s worst health scandals. Once licensed as a diabetes treatment, the drug was widely prescribed as an appetite suppressant to help people lose weight. The prosecutor’s indictment covers charges of misleading claims as well as manslaughter and targets 14 people as well as 11 institutions including Servier and the French drug regulator ANSM.”
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Deadly brain infection in German MS patient prompts Roche investigation

Reuters, 24 May 2017
Authors: John Miller, Bill Berkrot, Greg Mahlich and Lisa Shumaker
“A person in Germany treated with Roche Holding AG’s new multiple sclerosis drug Ocrevus has been diagnosed with an often-deadly brain infection after switching from another medication earlier this year. Roche said it was investigating a case of Progressive Multifocal Leukoencephalopathy (PML) in a patient previously being treated for three years with Biogen Inc’s Tysabri and who had received a single dose of Ocrevus in February. Ocrevus was approved in the United States in March.”
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Man XXX Herbal capsules pose a serious risk

TGA, 12 May 2017
Source: TGA
“Man XXX Herbal capsules pose a serious risk to your health and should not be taken. The Therapeutic Goods Administration (TGA) has tested a product labelled Man XXX Herbal capsules and found that: the capsules contain the undeclared substance levodopa and consumers are advised that levodopa is a prescription-only substance in Australia. Man XXX Herbal capsules have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA. The investigations have shown that a number of people in Australia may have bought the product online.”
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How to rein in the widening disease definitions that label more healthy people as sick

The Conversation, 16 May 2017
Authors: Ray Moynihan, Rita Horvath
“Medical panels are constantly changing diagnostic cut-offs and lowering thresholds to classify many conditions and diseases. Those changes determine whether we or our loved ones receive a diagnosis that might help us – by, for example, giving us access to a life-saving treatment – or harm us – by bringing the anxiety, cost and danger of an unneeded medical label.”
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Toward Responsible Human Genome Editing

JAMA 2017; 317(18):1829-1830
Authors: Richard O. Hynes; Barry S. Coller; Matthew Porteus
“The speed at which the science is advancing raises important questions about human genome editing, such as how to balance potential benefits against risks of unintended harms, how to regulate the use of genome editing and incorporate societal values into policy decisions, and how to respect the diverse perspectives of individuals, nations, and cultures that will influence whether and how to use these technologies. A new report from the US National Academies of Sciences and Medicine addresses these questions and makes recommendations for the application and oversight of human genome editing in 3 major settings.”
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A Third of Drugs Have Safety Issues After Approval

WebMD, 10 May 2017
Author: Robert Preidt
“Safety problems emerge with nearly one in three prescription drugs after they’ve been approved by the U.S. Food and Drug Administration, a new study reveals. Researchers examined data on drugs approved by the FDA between 2001 and 2010, with follow-up through 2017. The investigators found that 32 percent of the drugs had safety issues after approval.”
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Billions saved because FDA didn’t rush approval of Alzheimer’s drug

Reuters, 10 May 2017
Author: Gene Emery
“The U.S. Food and Drug Administration’s decision not to rush approval for Eli Lilly’s experimental Alzheimer’s treatment solanezumab – a drug that turned out to be ineffective – may have saved American taxpayers as much as $100 billion over the past four years, an analysis concludes. The analysis comes amid pressure on FDA to use less-strict standards in deciding whether a drug should be approved. Some agency critics have called on the government to approve all drugs that are not toxic and let market forces determine which are best.”
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