National Alliance on Mental Illness
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Statement of Kenneth Duckworth, M.D. On Behalf of NAMI  (The National Alliance on Mental Illness) Before the Food and Drug Administration Pediatric Advisory Committee

March 22, 2006


NAMI (The National Alliance on Mental Illness) greatly appreciates this opportunity to submit a statement on the critically important issue of the safety of medications used to treat attention deficit/hyperactivity disorder (ADHD) in both children and adults.  NAMI applauds the FDA for closely reviewing reports of rare and serious adverse events in children and adults who were taking medications to treat ADHD.

NAMI was founded as a grassroots family advocacy movement 26 years ago in Madison, Wisconsin.  Today, NAMI is the nation's largest grassroots organization of consumer and family members, with approximately 1100 state and local affiliates, dedicated to improving the lives of children and adults living with mental illnesses.

I am the Medical Director for NAMI and am board certified in child and adolescent, adult and forensic psychiatry.  I am also an Assistant Professor of Psychiatry at Harvard Medical School.  I have held many clinical positions and from 2000 to 2003 served as the state medical director and Acting Commissioner for the Massachusetts Department of Mental Health.  I maintain an active clinical practice in Massachusetts, in which I treat children, adolescents and adults with a number of different psychiatric disorders, including ADHD.

The Public Health Crisis in Mental Health

Any discussion about the use of psychotropic medications to treat mental illnesses in children and adults must be framed within the broader systemic context.

We have seen report after report document the public health crisis in this country for children and adults living with mental illnesses.  These reports include President Bush's New Freedom Commission Report on Mental Health issued in 2003 and former Surgeon General David Satcher's comprehensive report on mental health issued in 1999, followed by a report on children's mental health in 2000.

There are enormous barriers that prevent children and adults living with mental illnesses from being treated: stigma, a crisis in the shortage of children's mental health providers, discriminatory caps on mental health coverage, consumer and family "unfriendly" systems that are fragmented and lack accountability, a flawed health care delivery system that forces medical professionals to rush through patient visits, and overall, as the President's New Freedom Commission has noted, a mental health system in "shambles."  As mental health consumers and families from across the country know, the consequences for this broken system are often dire.

Clearly, there is a great urgency for federal, state and local leaders to help end these crises. NAMI will continue our work in providing recommendations on the essential reforms that should immediately be undertaken.

The FDA's review of the safe and appropriate use of ADHD medications must take place in the context of this broader systemic crisis. 

Is a Black Box Warning Appropriate?

The FDA Drug Safety & Risk Management Advisory Committee's recommendation that a black box warning be added to labeling of ADHD medications is premature, given the apparent lack of clear evidence of a link between ADHD medications and serious adverse cardiac events and sudden death.  It raises more questions than it answers.  NAMI calls for an immediate transparent review of data showing the risks of serious and rare adverse cardiac events and sudden death conferred by youth and adults with ADHD taking these medications versus the risks associated with not taking the medications.  Adults with ADHD and families of children living with this serious disorder need to better understand the risk ratio to make informed decisions, in consultation with their treating provider, about the appropriate use of medications to treat ADHD. 

If the data shows that a link exists between these serious and rare side effects and ADHD medications, then a black box warning should be required.  However, if a conclusive link does not exist, then it is certainly premature to warrant such a drastic step.  NAMI calls on the FDA to clarify the existence of data that would support a requirement for a black box warning.

The appropriateness of a "black box" warning is complicated.  On the one hand, it is vitally important for consumers, families and providers to receive heightened warnings and more complete information to understand serious adverse risks. 

However, there are also grave concerns that requiring a black box warning without data showing a link to serious adverse events would discourage many consumers, families and healthcare providers from using ADHD medications when these medications are necessary to treat this serious disorder.  These medications have been extensively studied and found to be highly effective to treat ADHD in children and adults. 

One thing that we know for sure, for children and adults living with ADHD and other mental illnesses, the imposition of unnecessary barriers to needed treatment may pose the greatest risk of all.  For many, the use of psychotropic medications, including those used to treat ADHD, is effective and has dramatically improved the quality of their lives.  In some cases, it has saved lives.  Untreated or inappropriately treated ADHD often has dire consequences, interfering with school and job performance, peer and family relationships, increased risk of substance use and abuse and more.

Rather than prematurely imposing a black box warning, NAMI believes that increased research to better understand whether a clear link exists between the use of ADHD medication in children and adults and serious adverse cardiac health events and sudden death is critically important.

Evidence-based Interventions are Needed!

Children and adults receiving treatment for ADHD, including those prescribed medications, should be closely assessed and carefully monitored as part of sound clinical practice.  This includes an assessment and close monitoring for all adverse events regardless of the type of treatment that an individual receives, however this is especially true when a person is prescribed medication. 

The mental health treatment and service system must adopt evidence-based assessment and intervention approaches that call for clinicians to continually improve care by using the most current evidence and research to make decisions about the most appropriate care for individuals with ADHD and other mental illnesses.  Medical professionals should use this evidence-based intervention approach, in close consultation with consumers and families, especially when determining whether psychotropic medications are safe and appropriate to treat ADHD.

Ultimately, treatment providers, consumers and families (in the case of children) must weigh the risks and benefits associated with providing treatment and determine the most appropriate treatment course.  The current uncertainties reflect a system that is far from perfect, addressing risks in a world in which there are few certain outcomes.

A big part of the problem relates to an overall lack of qualified child and adolescent psychiatrists and others with the expertise to diagnose and properly treat children and adolescents with ADHD and other mental illnesses.  NAMI supports efforts to protect children from inaccurate diagnoses by ensuring that primary care and mental health providers are better informed and educated on the proper diagnosis and the most safe and effective treatment for all mental illnesses.

In the end, the debate on the use of psychotropic medications must also address the critical need to ensure that all those living with mental illnesses have access to safe and effective treatment – with quality clinical care as an integral part of all aspects of the service delivery system.


Although the FDA is under great pressure to act quickly to decide the appropriateness of requiring a black box warning for ADHD medications, deliberations on appropriate regulatory action must balance the need to provide consumers, families and providers with adequate warnings and information about the medications while not limiting treatment options in cases in which medications are clinically indicated and may prove effective or lifesaving.

This oversight and regulatory process warrants a reminder of the Hippocratic Oath "First, do no harm."