REMARKS BY LINDA GOLODNER, PRESIDENT & CEO
NATIONAL CONSUMERS LEAGUE
RESPONSIBLE RX PRESS CONFERENCE, NATIONAL PRESS CLUB WASHINGTON, DC
MARCH 20, 2006

Good morning and welcome. My name is Linda Golodner; I’m president and CEO of the National Consumers League. I will make a presentation and will be followed by Dr. David Goodman, Assistant Professor of Psychiatry and Behavioral Sciences at Johns Hopkins University School of Medicine. He is a clinician and a internationally renown ADHD researcher. He will then introduce Ronald Furman, father of a child with ADHD, who sees the daily impact of this condition through his daughter’s eyes and through his own first-hand experience with ADHD. Following our presentations we would welcome questions.

One of the most important goals of the National Consumers League is to provide clear comprehensive information to consumers about their healthcare and the healthcare of their families. Consumers are more and more responsible for making their own healthcare decisions these days. They need information to make smart, informed choices. We also advocate for reforms that keep consumer needs and concerns at the top of the national agenda.

Today, we are here to talk about a medical condition that has certainly had its share of controversy – attention deficit hyperactivity disorder – ADHD. Much as been written, discussed and debated about ADHD – some of it responsible, grounded in science and medicine and in the best interest of patients and families. Some of it, unfortunately, has been medically inaccurate, politically charged, socially divisive and directed at advancing a particular agenda more than providing parents and patients with meaningful help.

To us, the ADHD issue is quite clear. ADHD is one of the most common neurobehavioral disorders among children. According to the National Institutes of Health, it affects about 2 million children in the United States. While there isn’t a cure for ADHD, decades of science and clinical experience have shown that, through the use of behavioral therapy and, if appropriate, the right medication, the symptoms of ADHD – impulsivity, hyperactivity, inattention – can be successfully treated and their intensity and frequency significantly reduced. Most of the medications currently available to treat ADHD symptoms have been used safely and effectively for decades.

Over the past few years, regulatory authorities and some medical professionals have raised concerns about the safety of ADHD medications. Last month, an FDA Advisory Committee evaluated the potential for cardiovascular risk among some patients taking these medications. Later this week, another advisory committee will convene to continue a discussion they began last year around the risk of adverse events such as agitation, depression, and suicidal ideation.

Many ADHD experts, and indeed several members of these advisory committees, have debated whether there is evidence to warrant stronger language in materials consumers receive on risks, benefits, and how to take the medications. We know whatever the advisory committee recommends to the FDA and the resulting decisions by the Agency will result in media coverage that will create confusion and concern among parents of children with ADHD.

NCL supports the work of the FDA, the patient advocates, and the medical community in making these decisions, but we feel it important that clear information be available for parents as they talk to their doctors about the best treatment for their child.

Parents must be able to weigh the evidence, appropriately assess risks and benefits and take an active role partnering with their physicians to make the best treatment decisions for their children.

When parents are faced with the need to manage a child’s medical condition, we believe there are a number of absolutes.

#1 access to clear, comprehensive, and authoritative information on diagnosis, treatment and ongoing management.

#2 a true partnership must exist between parents and their children’s healthcare professionals – physicians, nurse, pharmacists, who must be able to communicate and listen to their patients. We believe that parents who assume this partnership role in their child’s healthcare are far more likely to see better outcomes.

Today, the National Consumers League is announcing a new initiative that we believe will help make significant progress toward that goal.

Responsible Rx will help parents make successful and appropriate treatment choices for their child with ADHD. They will be able to access tools to improve communication with their healthcare professionals and to understand the risks and benefits of medications.

NCL will establish an independent advisory committee to develop the content of the Web site and other materials for parents. It is for parents who want an active role with their physicians, who are concerned about medication safety but have found it difficult to assess how safety concerns may or may not apply to their own child – and parents who are looking for clarity and reassurance in an environment of uncertainty.

We are grateful to Dr. Goodman and Mr. Furman for their insights and their participation in this initiative, and we will look to them for their continued help as we finalize all the components of this initiative. NCL would also like to thank Specialty Pharmaceuticals Division of McNeil for its role as the founding sponsor of Responsible Rx.

Our approach will be clear, simple and consumer-friendly. By going to our Web site ResponsibleRx.Org parents will be able to access a toolkit with multiple components:

#1 Assessing risks and benefits of ADHD medications – how to read the label and information that has been provided about the medication. How to take the medicine and what to expect when taking it.

#2 a Journal to monitor their child’s progress and share with health professionals at the next visit

#3 Tools to recognize any signs and symptoms that may signal concern and warrant the attention of their physician.

#4 to help parents ask the right questions when talking to health professionals about treatment.

And finally.

#5 Frequently asked questions and answers – that we hope to develop with parents of children with ADHD and patients so we aren't assuming we know the most important concerns of parents and their children.

The Web site is operational today with basic information about AHDH for parents, teachers, employers, and health professionals. As the FDA makes decisions in the next month, we will then use that information to develop the specific content about medications.

The National Consumers League believes Responsible Rx will make a difference in the lives of parents of children with ADHD. The program responds to an unmet need, and we are committed to giving parents the tools to take greater control and ensure optimal, appropriate treatment for their children.