Health News Review
  • Jan 24 2014

    JAMA papers raise questions about FDA drug and device approval

    An important series of papers was published in the Journal of the American Medical Association this week. “Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012,” by Dr. Joseph Ross and colleagues, concluded that the quality of clinical trial evidence used by the FDA as the basis of approving new drugs varies widely.  [...]

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  • Jul 19 2013

    FDA warning letter to robotic surgery manufacturer, which complains of “negative press”

    Bloomberg News reports: “Intuitive Surgical Inc. (ISRG), the maker of robotic surgical devices, fell in extended trading after it disclosed a Food and Drug Administration warning letter and reduced its sales forecast. The company received the warning letter July 17, Chief Executive Officer Gary Guthart said during a conference call with analysts to discuss quarterly [...]

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  • Apr 17 2013

    How “groundbreaking” are skin cholesterol tests?

    In a week in which we already wrote about US drug stores giving out free statin drugs, we thought readers might be interested in how a new (new-ish) skin cholesterol test is being marketed, and how some Canadian drug stores are getting in on the act. Someone in Canada sent me the following news release: [...]

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  • Apr 9 2013

    Urology journal publishes papers with questions about robots and proton beam therapy

    Probably the two most frequent subjects on this blog regarding the proliferation of new medical technologies are proton beam radiation therapy and robotic surgery.  Since this blog focuses on media messages about health care interventions, we generally focus on the marketing claims made for these technologies. The latest edition of the journal Current Urology Reports [...]

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  • Nov 20 2012

    RxISK.org — A Megaphone For Patients and Their Doctors

    Noteworthy new website launch – RxISK.org: “Making medicines safer for all of us.” It’s founded by Dr. David Healy, internationally renowned psychiatrist and author from Wales; Dr. Dee Mangin of New Zealand, Dr. Kalman Applbaum of the University of Wisconsin, Dr. Nancy Olivieri and others you can read about here. The project’s own description: “RxISK [...]

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  • Oct 18 2012

    Medical devices and shared decision-making: Daisy chains of decades of device approval without rigorous assessment

    The journal Arthritis Care & Research has accepted for future publication – and posted online (for subscribers) – an unedited paper, “Preceding the Procedure:  Medical Devices and Shared Decision-Making.”  The paper builds on a hypothetical example of a man in his 50s with hip arthritis who is facing a decision about total hip replacement.  Excerpts: [...]

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  • Mar 8 2012

    New survey shows FDA employees’ medical device approval concerns

    The NPR “Shots” blog and the Star Tribune were the only mainstream news organizations I saw that reported on a new survey by the Union of Concerned Scientists (opens as pdf file). Under the headline, “FDA Survey uncovers concerns over influence,” the Strib reported: Some workers in the medical device approval section of the Food [...]

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  • Dec 14 2011

    Lap-Band Billboards Finally Catch FDA’s Attention

    The following is a cross-post from the Reporting on Health website, written by one of our HealthNewsReview.org story reviewers, William Heisel, who publishes the excellent blog, William Heisel’s Antidote: Investigating Untold Health Stories. ——————————————————————————————————————————————————– For doctors selling risky cosmetic surgery procedures, using billboards to lure patients is just one more roll of the dice. This [...]

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  • Oct 13 2011

    The limitations of progression-free survival as an endpoint – NPR addresses

    On the NPR Shots blog, Scott Hensley addresses, “Avastin For Breast Cancer: Hope Versus False Hope.” Excerpt: Any day now FDA Commissioner Margaret Hamburg is expected to make a final decision on Avastin’s fate. Women who said Avastin helped their breast cancer were out in force at a June hearing of an appeal of FDA’s [...]

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  • Aug 16 2011

    FDA publishes “Communicating Risks & Benefits: An Evidence-Based User’s Guide”

    The FDA’s Risk Communication Advisory Committee, of which I’m a member, today published a book written by committee members, “Communicating Risks and Benefits: An Evidence-Based User’s Guide.” The book is available online as a pdf file. My chapter was on the tendency for journalists, when reporting on health care interventions, to exaggerate benefits and minimize [...]

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