ablechild

Ablechild Testifies Before FDA on February 9, 2006

My name is Clinton Libbey, and I am here today as a volunteer member of Ablechild, a national non-profit organization comprised of parents personally affected by, and greatly concerned with, the issues of psychotropic drugs being prescribed to our children and the erosion of full informed consent.

I have had first hand experience with the label ADHD and the drugs prescribed. As a concerned parent, I investigated the drugs that were being considered for my son, many of which are being reviewed by this panel currently. What I found was misinformation and distortions pertaining to both the subjective psychiatric labels being assigned to our children and the drugs being prescribed to them. As a result, it is almost impossible for parents to receive factual information on labels and drug effects, compromising their ability to make fully educated decisions.

When dealing with drugs that have known side effects, the oath of first do no harm must be transformed to first do no harm without full informed consent. It is full informed consent that provides parents with the information that they need in order to effectively make decisions regarding their children. This is especially the case when the treatment may cause the one side effect that is irreversible – Death. When the diagnosis is less severe than the possible side effects, full informed consent is critical and should not be adulterated in any manner.

I, for instance, was misinformed when several medical doctors told me that no one has died as a result of taking these drugs provided that they are taken in accordance with the dosage guidelines. I was also told that they are not addictive. I asked one doctor about a structural heart defect that my son had since it was contraindicated on the warning label. He told me that it is common and that in a previous case they had a second opinion and prescribed the drug in the end. I was alarmed since it was contraindicated and the doctor no longer considered it an issue.

Upon further investigation I found parents who had lost their children due to these drugs with autopsy reports directly linking ADHD drugs with their children’s deaths. The fact is that children have died even though dosage recommendations on an approved label were strictly adhered to. I found many other parents who have had children harmed by drug effects, which are often marked on their label but downplayed by many in the medical profession. All too frequently risks are not disclosed to parents seeking to make the best possible decision regarding their child.

As a society, we must disclose potential side effects prior to treatment in order to guarantee an individual’s right to full informed consent. Strict adherence to this principal also transfers a significant amount of liability to the individual and is therefore good for all parties involved.

As a result, I am here to argue for action that will allow concerned parents, such as you and me, to make informed decisions regarding the drugs being prescribed to our children. The American Medical Association couldn’t have said it any better when in 1999 they were quoted: "Informed consent can be effectively exercised only if the patient possesses enough information to enable an intelligent choice." Ignorance is not bliss when you are a parent.

While many say that there needs to be more research on these drugs. I, with the parents that make up Ablechild, many of whom are victims of the effects of these drugs, find that stronger warning labels and stiffer guidelines regulating full disclosure would be a more appropriate step. Furthermore, Medwatch filings should be mandatory for adverse reactions within the pediatric population.

The following victims of ADHD drug effects should stand for itself and the realization that if even one more child were to die due to these drugs it would be one too many.

Shaina Dunkle 1991-2001 10 years old. I am submitting written testimony from her parents to the committee.

Stephanie Hall 1984-1996 11 years old

Matthew Smith 1986-2000 14 years old

Samuel Grossman 1973-1986 13 years old

Raymon Perrone 1975-1985 10 years old

Daniel Ehrlich 1970-1984 14 years old

Rylia Wilson 1995- 2001 5 years old

Please don’t allow another child to lose their life without at least warning their parents.

Thank you for your time and consideration.

Clinton Libbey

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