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  • 1.  The Regulatory Watchcat's Comments on KHN Article

    Posted 02-Apr-2019 00:19
    Edited by Julie Omohundro 10-May-2019 22:47
    ​Here is my response to the KHN article on "hidden" FDA reports.

    I'm guessing my response is not what a lot of people might expect. I have a deep, long-standing animosity toward this type of article, and the news tabloids that publish them. I don't try to resolve the question of the hidden reports. Instead, I go after the article's main premise, that it matters whether or not the reports are hidden, and I go after Kaiser Health News for publishing the article.

    The article has been out for over three weeks now. If I could send this response to everyone who has read the original article, I would, but I can't. Nonetheless, I'm going to do my level best to get it out as far and wide as I can.

    If you would like to help me break the internet with it, please send it out to all of your LinkedIn Connections.  Please also consider emailing it directly to colleagues, friends, and family. It's a national news story that was first brought to my attention by a friend who is not in the industry.

    If your local news outlets carried the original story and you can find a reasonably useful email address on their website, send it to them, too.  If you happen to have email addresses for any of your congressional representatives, by all means, email it to them.

    And then, for some real fun, email it to these people:

    Daltman@kff.org; ddarlin@kff.org; erosenthal@kff.org; khayden@kff.org; jhillkirk@kff.org; MLBlanton@kff.org

    The first email address belongs to Drew Altman, President of the Kaiser Family Foundation; the rest are editors at Kaiser Health News.



    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
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  • 2.  RE: The Regulatory Watchcat's Comments on KHN Article

    Posted 02-Apr-2019 00:20
    Here is a link to the original Kaiser Health Network article on "Hidden" FDA Reports, if you want to include it with my response:

    https://khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/



    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------