March 2009

Obama Administration Chooses New FDA Leadership

On March 14th, President Obama announced the nomination of Dr. Margaret Hamburg to serve as the Commissioner of the U.S. Food and Drug Administration (FDA). Prior to this nomination Dr.Hamburg was the founding Vice President of the Nuclear Threat Initiative’s Biological Program. Previously, Dr.Hamburg also served as the Assistant Secretary for Planning and Evaluation at the U.S. Department of Health and Human Services and New York City Health Commissioner. Obama also named Dr. Joshua Sharfstein to the Principal Deputy Commissioner post this month.

ACT-AD looks forward to working with Drs. Hamburg and Sharfstein to address regulatory issues that could impact patient access to emerging AD treatments. In particular, the coalition and its members hope to constructively engage the new leaders on ways to enhance the capacity of the neurology program at FDA.

To read more about the FDA appointments, click here.

Progress Reported in Biomarker Tests for Alzheimer’s Disease

Scientists studying Alzheimer’s disease as part of the Alzheimer’s Disease Neuroimaging Initiative (ADNI) have reported a major step forward in developing a test to improve the diagnosis of AD. Two biomarker proteins in cerebrospinal fluid, tau and beta-amyloid, were isolated and measured in cerebrospinal fluid of AD patients.  Through analysis of these samples, investigators were able to confirm earlier findings and to develop biomarker profiles that they believe may signal the onset of AD.

The ACT-AD coalition is encouraged by the progress of this research. The discovery and validation of biomarkers will assist in identifying individuals who are at risk for the disease and also one day help assess how patients respond to new AD treatments.  In September of 2008, the coalition worked with prominent Alzheimer’s researchers to alert FDA officials of growing consensus in the research community that the inclusion of biomarkers as pathological indicators for AD could improve clinical trials for new therapies.  Among other measures, the letter stressed the importance of testing levels of beta-amyloid and tau in cerebrospinal fluid.

To learn more about the ADNI research findings, click here.

To read the biomarkers letter to the FDA, click here.

National Alzheimer’s Plan is Unveiled to Congress

On March 25th, former House Speaker Newt Gingrich (R-GA) and former Sen. Bob Kerrey (D-NE), co-chairs of the Alzheimer’s Study Group (ASG), released their National Strategic Plan for addressing the looming Alzheimer’s epidemic.  During their testimony before the Senate Special Committee on Aging, Gingrich and Kerrey laid out the need for a project approach to creating a path for Alzheimer’s prevention and care improvement solutions. They proposed the establishment of an outcomes-oriented office within the federal government tasked with advancing the capability to prevent Alzheimer’s disease.  This office would also be charged with implementing a reimbursement system centered on value-based payment for dementia services California First Lady Maria Shriver and former Supreme Court Justice Sandra Day O’Connor, who have personally been affected by this disease through loved ones, also testified at the hearing.

For 10 months, the Alzheimer’s Study Group engaged key AD stakeholders to uncover leading obstacles impeding meaningful progress to combat Alzheimer’s. ACT-AD provided input to the ASG during this lengthy recommendation gathering process. We support recommendations in the report that aim to streamline research and encourage the development of consensus around tools such as biomarkers.  We hope that Congress will carefully consider this plan and move to enact policies that would allow for more robust support of science and speed discovery of more effective AD interventions.

Chairman Published in Alzheimer’s and Dementia Journal

The March 2009 issue of Alzheimer’s and Dementia: The Journal of the Alzheimer’s Association includes a policy paper authored by Dan Perry, Chairman of ACT-AD.  The paper titled “Advancing Alzheimer’s Drug Review as a National Priority” highlights the urgent need for policymakers and regulators to re-examine the way in which novel therapies for Alzheimer’s disease are evaluated by the U.S. Food and Drug Administration.  It also underscores the increasing demand for better Alzheimer’s treatments and the limited treatment options currently available to patients. By drawing on the coalition’s progress to date, Perry details how ACT-AD is working collaboratively with the FDA to ensure more rapid review of promising new Alzheimer’s therapies.

To access the article, click here.