December 2, 2005

Cicely Reese

Center for Drug Evaluation & Research (HFD 21)

Food & Drug Administration

5630 Fishers Lane , Room 1093

Rockville , MD 20857

SUBJECT:  Psychopharmacologic Drugs Advisory Committee Meeting – re Methylphenidate Transdermal System – Methypatch, December 2, 2005

To the members of the Executive Committee:

In the interest of safeguarding the lives and the health of America ’s children  Ablechild, calls upon your committee to deny approval of the Methylphenidate Transdermal System known as Methypatch currently being presented before your committee for approval. 

Our experience in working with parents and children who have been subjected to methylphenidate in pill form has educated us to the degree that we are fully committed to opposing the long term application of this class 2 drug in patch form. We have repeatedly noted the disastrous effect on the health, behavior and lives of children who have been prescribed this very dangerous chemical drug.  We have noted continuing and long lasting negative effects from the use of this drug to include insomnia, anxiety, suicidality, heart abnormalities, hostility, and confusion, to name just a few effects.  Now research reports from The University of Texas M.D. Anderson Cancer Center in Houston and the University of Texas Medical Branch at Galveston have reported detection of chromosomal abnormalities in children who have been subjected to methylphenidate.  These abnormalities have occurred in children who are being given this drug in pill form.  This should lead anyone to logically conclude that to subject children to long lasting applied patches saturated with this chemical forebodes great dangers, including an increased risk of cancer in the future lives of these children, a clear risk factor clearly supported by these research reports.  Virtually all of the children in the research program experienced chromosomal changes!

It is not uncommon for our children to experiment, share, test, or sell drugs of this nature!  There is little doubt that this very dangerous drug would, should your committee approve it in patch form, be abused in many ways.  It is well known that methylphenidate is the most commonly abused drug among our youth.  To present it in the form of an applied patch would make that abuse, along with experimentation, more accessible and tempting to any youth.  Experimentation by sharing a patch or crimes involving this kind of highly addictive drug would become a common occurrence and is preventable.

As advocates for the life and health of America ’s children and for the elimination of chemically endangering their lives Ablechild takes a firm stand in opposition to the Methypatch submitted to your committee for approval by Britain’s Shire Pharmaceuticals Group Plc and  U.S. Noven Pharmaceuticals, Inc.  Ablechild requests your committee disapprove this application for approval and by so doing you will be working with us to help safeguard the lives and health of America ’s children.

Sincerely,

Patricia Weathers             Sheila Matthews                  Gloria Wright

President                         National Vice President        Vice President

Ablechild.org                    Ablechild.org                        Ablechild.org

www.ablechild.org

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