AHA Comment to Fed Reg Notice

Chairman of the Board
Gary L. Ellis
President
Daniel W . Jones, MD, FAHA
Chairman-Elect
David A. Josserand
President-Elect
Timothy J. Gardner, MD, FAHA
Immediate Past
Chairman of the Board
Andrew B. Buroker, Esq.
Immediate Past President
Raymond J. Gibbons, MD, FAHA
Secretary-Treasurer
Debra W . Lockwood, CPA
Directors
Donna Arnett, PhD, FAHA
Roberto Bolli, MD, FAHA
Shonta Chambers, MSW
Mark A. Creager, MD, FAHA
Shawn A. Dennis
Ray Durazo
Debra Geihsler
Max Gomez, PhD
Thomas A. MacLean, PhD
Neil M. Meltzer, MPH
Judith F. Olson, Esq.
William H. Roach Jr., Esq.
Ralph L. Sacco, MD, FAHA
David A. Spina
Samuel H. Turner Sr.
Chief Executive Officer
M. Cass W heeler

January 4, 2008

Paul Sorlie
Division of Prevention and Population Sciences
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, MSC # 7936
Bethesda, MD 20892
RE: The Framingham Study

Chief Operating Officer
National Center
Nancy A. Brown

Dear Dr. Sorlie:

Chief Operating Officer
Field Operations
Gordon L. McCullough

On behalf of the American Heart Association (AHA), including the American
Stroke Association (ASA) and over 22.5 million AHA and ASA volunteers and
supporters, we appreciate the opportunity to submit our comments in response to
the National Institutes of Health’s (NIH) proposed data collection as part of the
Framingham Study.

Chief Science Officer
Rose Marie Robertson, MD,
FAHA
Executive Vice President
Healthcare Markets
Meighan Girgus
Executive Vice President
Corporate Operations & CFO
Sunder D. Joshi
Executive Vice President
Communications and
Health Outreach
Robyn Lee Landry, APR
Executive Vice President
Corporate Secretary &
General Counsel
David W m. Livingston, Esq.
Executive Vice President
Advocacy
Mark A. Schoeberl
Executive Vice President
Development
Suzie Upton
Executive Vice President
Technology & Customer Strategies
Michael Wilson

“ Buil di ng he al thi er lives,
free of cardiovascular
di se as es a nd st r ok e.”

Since 1924, the American Heart Association has dedicated itself to reducing death
and disability from heart disease and stroke – the #1 and #3 leading causes of
death in the United States – through research, education, community-based
programs, and advocacy. AHA and ASA are committed to achieving a reduction
in coronary heart disease, stroke and associated risk by 25% by 2010.
AHA offers the following thoughts and comments on the data collection for the
Framingham Study. Our comments focus on two areas: 1) the significance of the
Framingham Study and 2) the practical utility of the information collection.
Significance of the Framingham Study
Funded in 1948, the Framingham Study – under the direction of the National
Heart Institute (now known as the National Heart, Lung, and Blood Institute,
NHLBI) – embarked on an ambitious project in health research. At the time, little
was known about the general causes of heart disease and stroke, but the death
rates for cardiovascular disease (CVD) had been increasing steadily since the
beginning of the century and had become an American epidemic.

American Heart Association . Advocacy Department
1150 Connecticut Ave., NW, Suite 300, Washington, DC 20036
202-785-7900 . Fax 202-785-7950 . www.americanheart.org/yourethecure

American Heart Association
January 4, 2008

The Framingham Study
Page 2

Over the past 60 years, careful monitoring of the Framingham Study population has led to a
number of milestone discoveries including the identification of the major CVD modifiable risk
factors – high blood pressure, high blood cholesterol, cigarette smoking, obesity, diabetes, and
physical inactivity – as well as a great deal of valuable information on the effects of related
factors such as blood triglycerides and HDL cholesterol, age, gender, and psychosocial measures.
Since its inception, the study has produced over 1,200 articles in leading medical journals. The
concept of CVD risk factors has become an integral part of the modern medical curriculum and
has led to the development of effective treatment and preventive strategies in clinical and public
health practice because of the Framingham Study.
Of particular importance are the Risk Assessment Tool for estimating 10-year risk of developing
hard coronary heart disease (CHD) and the Stroke Risk Profiles that were developed from the
Framingham Study. Both are widely used by cardiologists and general practitioners to predict an
individual’s likelihood of developing CHD and stroke in the next 10 years. The CHD risk
prediction tool has been adopted by the National Cholesterol Education Program, Adult
Treatment Panel for detection, evaluation, and treatment of high blood cholesterol in adults.
Because of the Framingham Study and its role in identifying risk factors for CVD, we have
observed a marked decline in CHD and stroke mortality over the past few decades.
Practical Utility of the Information Collection
The Framingham Study continues to make important scientific contributions by enhancing
research capabilities and capitalizing on its inherent resources. The study investigators are
expanding their research into other areas such as the role of genetic factors in CVD and genomewide association studies for cardiovascular outcomes. The Framingham Study investigators also
collaborate with leading researchers from around the country and the world on projects in stroke
and dementia, osteoporosis and arthritis, nutrition, diabetes, eye diseases, hearing disorders, lung
diseases, and genetics of common disease.
AHA uses a huge amount of information that is generated by the Framingham Study for our
research, education, and community-based programs and activities. The above-mentioned CHD
risk prediction tool and the Stroke Risk Profiles are disseminated to healthcare providers,
patients, and the general public alike through our website and other print materials. Findings
from the Framingham Study are repeatedly citied in AHA/American College of Cardiology joint
practice guidelines, as well as in a number of AHA scientific statements and evidence-based
practice guidelines.
The ongoing research activities and the additional data collection requested by the National
Heart, Blood, and Lung Institute will generate new scientific information, which will enhance
and improve our capabilities to serve the public who are at risk of developing heart disease and
stroke. We believe that it is important and useful to collect the data.
In conclusion, AHA supports the proposed National Institutes of Health data collection in the
Framingham Study.

American Heart Association
January 4, 2008

The Framingham Study
Page 3

If you have any questions or need any additional information, please do not hesitate to contact
Susan Bishop, MA, Regulatory Relations Manager, at 202-785-7908 or via email at
susan.k.bishop@heart.org.
Sincerely,

Daniel W. Jones, MD
President, AHA