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!