Ashley事件から生命倫理を考える（ミラー）

(June 8, 2009)―As advocates for people living with mental illnesses, we strongly urge the FDA to carefully consider the importance of viable treatment options for bipolar disorder and schizophrenia in pediatric and adolescent populations. Access to safe and effective treatments, including more information about all treatment options, is crucial to treating these serious and complex conditions in children and adolescents.

Bipolar disorder and schizophrenia are very real, life-threatening diseases which can appear in childhood and adolescence. For example, federally funded research (STEP-BD) found that, of 3,658 adult patients studied, 68% reported bipolar disease onset in childhood or adolescence. Patients with child onset had, on average, fewer days of euthymia (or neutral mood), greater impairment in functioning and poorer quality of life. Those with adolescent onset have better outcomes than those with child onset, but were still worse off than those who did not suffer from bipolar disorder until adulthood. These alarming statistics highlight the need for early recognition and treatment, which offers children and adolescents their best chance to achieve and maintain wellness.

We encourage an open and transparent scientific discourse about all pharmacologic treatments that come before the Advisory Committee and urge the Committee to carefully weigh the available evidence regarding safety and efficacy. No one treatment option works for all children. In order for physicians and families to make informed treatment decisions they need access to a full range of medications and treatment options and to the research regarding the risks and benefits of these treatments. More long-term clinical research in children and adolescents is also needed to better understand the risks and benefits of these medications when used over an extended period.

As we know, these medications can also have serious side effects, which is why it is crucial that parents and physicians have as much information as possible in order to make informed decisions and weigh the risk of side effects and adverse reactions against the risk of not treating these very serious diseases. Other treatments for grave childhood illnesses such as cancer can cause hair loss, nausea, compromised immune systems and even death. However, few people question the necessity of these aggressive forms of treatment. Like cancer, aggressive treatment may be needed for some patients with bipolar disorder and schizophrenia, diseases with a higher risk of death than some forms of cancer.

The best way to protect the health of our nation’s children and adolescents is to increase access to treatment options and communicate accurate, scientific information that helps parents and physicians cope with and properly treat these devastating illnesses.