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September 27, 2010

Research: Other Research

Question from Winnetka, Illinois, USA:

My 17-year-old son was diagnosed with type 1 diabetes on July 5, 2010 during a routine physical. He was not exhibiting any obvious symptoms. His A1c was 7.5 when diagnosed. Currently, it is at 5.9%. He was screened for the Diamyd vaccine and was approved to be a candidate for the trial study. My son is not sure he wants to be a part of the study because of possible unknown long term side effects of the vaccine. Additionally, he fears possible neurological damage because of the GAD antibody injection. GAD is located in the pancreas and the brain and is related to Stiffman syndrome. Currently, children with a neurological disorder cannot be in the study because of the GAD and Stiffman syndrome. My son thinks he is at risk for neurological damage if he receives the vaccine because he has ADHD and a learning disability. The study coordinator said he passed the neurological exam that they gave him and he should not be concerned. From what the study coordinators have been telling me, there have been no side effects reported from the vaccine. However, I was wondering have there been any autistic children in the study? Do you think ADHD and LD are considered neurological disorders?

Answer:

ADHD and LD are clearly disorders involving the nervous system. Your son, you and others of the family are the only ones who can decide if the risks you have been told about in this or any other study are worth taking compared to the potential benefits. In general, we advise our patients similarly but they are the ones who must make the final decision with incomplete information. Most of us who provide informed consent for similar studies believe that if there is enough doubt, then the decision should usually be not to participate.

SB