The Hydrocephalus Association Provides Commentary to the Food and Drug Administration

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On September 13, 2010, the Hydrocephalus Association had the opportunity to provide commentary at an Open Public Hearing sponsored by the Food and Drug Administration (FDA).  FDA currently funds a project called the “Ask Study,”  which aims to assess, from the perspective of a young person,  the effectiveness of various neurological medical devices they use to combat various conditions.  Among these devices are shunts.

From the perspective of the hydrocephalus community, the study faces a few recruitment challenges.  Participants in the study are required to be children between the ages of 7 and 15, who have received their devices within the preceding 12 months.  We are concerned that the age range is narrow, and that restricting participants to those who have received their shunt within the last 12 months leaves out many thousands of children who received them at birth, or when they were very young.  Additionally, the range of experiences among children who receive shunts is so wide that we want to see that wider variety recognized.

CEO Laurene McKillop provided commentary, which you can read by clicking here.  Our main concern is that government policymakers at every level realize just how ineffective shunting can be; how under-resourced it is from the developmental perspective, especially when compared to other medical devices; and how desperately we need and seek better treatment options.

HA hopes to provide additional input to the ASK Study as it proceeds and has volunteered to help with recruitment efforts.  Contact us if you would like more information, and don’t forget to read our commentary!

2 Comments for : The Hydrocephalus Association Provides Commentary to the Food and Drug Administration
  1. Reply

    I spoke at a Food & Drug Administration (CDRH) Town Hall meeting in Irvine, CA. This event was primarly for industry, however, there were a couple physicians and patient advocates present who spoke on their concerns with FDA approving medical devices too hastily. I spoke briefly on a few of my experiences with CNS shunts and the CDRH’s oversight of these devices. I am very qualified to speak on these topics as I was responsible for the 1999 STAMP conference in Washington, D.C. in 1999, and was author of an earlier petition on anti-siphon devices. Mostly, I elaborated how mHealth, HIT, and Social Media sites can improve patient-user feedback on their experiences with medical devices. But, I couldn’t resist the opportunity to share some of my findings from drum circles (I’m a facilitator & researcher) and my medical intuitive experiences, which I connected to the 15-25% “placebo effect” findings widely seen in drug and medical device clinical trials. This drew a warm response.

    Today, many CNS shunt user patients post and discuss their health & shunt issues on Yahoo, MSN, WebMD, Facebook, and numerous other forums. But, the people we need to read this, namely FDA, shunt manufacturers, and your treating physicians, are for the most part not engaged on these forums and not receiving accurate feedback and data on your status and shunt device. Short of this feedback, I think progress and solutions in addressing key issues with shunts and hydrocephalus today will be slower in coming.

    I also elaborated some of my concerns with patients using Internet sites (like Facebook and Yahoo) and blogs to discuss their medical care. Patients should be forwearned that on Facebook, your name, photos, and other identifying information are available via your profile. Additional safeguards are still needed. Earlier this year, some seedy groups copied content from a blog post (incl. my company name & hydrocephalus URL page) and pasted it into hundreds of web sites used to sell seedy online health items. It redirected traffic away from my hydrocephalus page to these seedy sites, plus hurt my Google and Yahoo page rankings.

    The CDRH’s summary and findings from yesturday’s Town Hall will be available later. All said, I think it was good that I spoke and represented those of us with CNS shunts.

    Stephen Dolle
    Dolle Communications
    Newport Beach, CA

    • Hilary Weiner
    • October 2, 2010
    Reply

    I would like to see some articles on coping with hydrocephalus which started in adulthood. I was diagnosed with NPH at the age of 51, and basically had to start life again after being shunted. I am too scattered to focus on anything for any length of time, and still have short term memory problems after being shunted almost 2 years. Where is the advocacy for people like me?

    Hilary

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