Prescription Drug Regulation, Promotion, And Advocacy Has Gotten More Vexing In 2017

Health Affairs Blog, 23 March 2017
Author: Jerry Avorn
“Early 2017 has been one of the most interesting and challenging times for anyone concerned with medication regulation and evidence-based prescribing — as well as for the patients and health care professionals who will be so heavily impacted recent policy changes.”
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Scope of practice largely undefined

MJA Insight, 20 March 2017
Author: Sue Ieraci
“Most people working in medicine are familiar with the term “scope of practice”, but many of us may not have thought much about how guidelines are developed or regulated. As more intra- and inter-professional problems occur, however, we may find that the structures for doing so are not as robust as we may hope.”
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Conflict of Interest in Seminal Hepatitis C Virus and Cholesterol Management Guidelines

JAMA Intern Med. 2017;177(3):352-357.
Authors: Akilah A. Jefferson, Steven D. Pearson
“Neither the cholesterol guideline nor the hepatitis C virus guideline fully met the IOM standards for commercial COI management, and discordance between committee leader guideline disclosures and those in contemporaneous articles was common. Adherence to additional IOM standards for guideline development and evidence review was mixed. Adoption of consistent COI frameworks across specialty societies may help ensure that clinical guidelines are developed in a transparent and trustworthy manner.”
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No doubt about it: smokefree laws cut heart attacks in big way

The Conversation, 7 March 2017
Author: Stanton Glantz
“There is strong and consistent evidence that exposure to secondhand smoke causes heart attacks and that smokefree workplace and public place laws cut heart attacks (and other diseases). The most recent evidence comes from a large study in Sao Paolo, Brazil, where heart attack deaths dropped by 12 percent following implementation of its smokefree law.”
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How We Are Manipulated To Believe New Is Better When It Comes To Our Health

Forbes, 2 March 2017
Author: Robert Pearl
“What struck me was that neither medical device story presented convincing evidence that the product would make a real difference in outcomes for patients. Yet both medical devices were backed by investors with billion-dollar expectations. The applications were clever, but the promises made and the media coverage provided far surpassed what the research demonstrated.”
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Guidelines to Limit Added Sugar Intake: Junk Science or Junk Food?

Ann Intern Med. 2017; 166(4): 305-306.
Authors: Dean Schillinger, Cristin Kearns
“When it comes to added sugars, there are clear conflicts between public health interests and the interests of the food and beverage (F&B) industry. Studies are more likely to conclude there is no relationship between sugar consumption and health outcomes when investigators receive financial support from F&B companies. Industry documents show that the F&B industry has manipulated research on sugars for public relations purposes. Erickson and colleagues report a systematic review of the scientific basis of guidelines on sugar intake, providing another occasion for concern about these conflicts.”
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The Scientific Basis of Guideline Recommendations on Sugar Intake: A Systematic Review

Ann Intern Med. 2017;166(4):257-267.
Authors: Jennifer Erickson, Behnam Sadeghirad, Lyubov Lytvyn, Joanne Slavin, Bradley C. Johnston
“Guidelines on dietary sugar do not meet criteria for trustworthy recommendations and are based on low-quality evidence. Public health officials (when promulgating these recommendations) and their public audience (when considering dietary behavior) should be aware of these limitations.”
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Benefit-Risk Assessments at the US Food and Drug Administration

JAMA. 2017; 317(7): 693-694.
Author: Robert M. Califf
“The US Food and Drug Administration’s (FDA’s) independent evaluation of medical products for safety and effectiveness prior to granting approval for marketing or new labeled indications is fundamental to assuring the public and clinicians that marketed products have a positive balance of benefit to risk when used according to labeling. Ever since this foundational protection was established in 1962, a body of evidence has supported the use of a flexible but consistent standard when making decisions about marketing approval: Do the benefits of a product outweigh the risks when used as intended and labeled?”
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Unproven alternative medicines recommended by third of Australian pharmacists

The Guardian, 13 February 2017
Author: Melissa Davey
“Nearly one third of pharmacists are recommending complementary and alternative medicines with little-to-no evidence for their efficacy, including useless homeopathic products and potentially harmful herbal products.”
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The Use of Public Health Evidence in Whole Woman’s Health v Hellerstedt

JAMA Intern Med. 2017;177(2):155-156.
Author: Daniel Grossman
“Enacted in 2013, Texas’s House Bill 2 (HB 2) was one of the most restrictive abortion laws in the country. The law had 4 provisions: (1) physicians providing abortion had to have admitting privileges at nearby hospitals, (2) medication abortion had to be provided according to the protocol described in the US Food and Drug Administration (FDA)-approved labeling of mifepristone, (3) most abortions at 20 weeks postfertilization or later were banned, and (4) facilities providing abortion had to meet the standards of ambulatory surgical centers. The first 3 provisions went into effect by November 2013; the fourth provision, meeting the standards of ambulatory surgical centers, was enforced only briefly in October 2014 before the US Supreme Court issued a stay.”
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