Laws

Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (P. L. 108-173)
In addition to establishing a voluntary prescription drug benefit under the Medicare program and requiring Medicare to cover a “preventive physical examination” for beneficiaries, the Act requires the NIH to expand its support for the evaluation of medical technologies to improve the foundation for evidence-based practice.

Pediatric Research Equity Act of 2003 (P.L. 108-155)
The Act authorizes the Food and Drug Administration to require research into pediatric uses for drugs and biological products.

Bills

Hepatitis C Epidemic Control and Prevention Act (H.R. 3539)
Sponsor: Representative Heather Wilson (R-NM)
Latest action: November 19, 2003 - Referred to House Committee on Energy and Commerce.
Highlights: If passed, the bill would direct the Secretary of Health and Human Services (HHS), in consultation with the Directors of the Centers for Disease Control and Prevention (CDC) and the NIH, to develop a plan to prevent, control, and manage hepatitis C infection. It also would require the NIH Director to create a Liver Disease Research Advisory Board.

Improved Nutrition and Physical Activity (IMPACT) Act (S. 1172)
Latest action: December 9, 2003 - Passed by the Senate.
Highlights: If signed into law, this version of IMPACT would establish grants to provide services that would improve nutrition, increase physical activity, and prevent obesity. Earlier in 2003, Representative Mary Bono (R-CA) introduced H.R. 716, a slightly different measure that also is called the IMPACT Act.

National Bone Marrow Donor Registry Reauthorization Act (H.R. 3034)
Latest action: October 2, 2003 - Referred to the Senate Committee on Health, Education, Labor, and Pensions (HELP) after passage by the House.

National Cord Blood Stem Cell Bank Network (S. 1717)
Sponsor: Senator Orrin G. Hatch (R-UT)
Latest action: October 3, 2003 - Referred to Senate HELP Committee.
Highlights: If passed, the bill would establish a network responsible for preparing, storing, and distributing human umbilical cord blood stem cells for patients needing transplants and to support peer-reviewed research using such cells.

Organ Donation and Recovery Improvement (S. 573)
Latest action: December 8, 2003 - Received in the House after passage by the Senate.

Protection for Participants in Research Act of 2003 (H.R. 3594)
Sponsor: Representative Diana DeGette (D-CO)
Latest action: November 21, 2003 - Referred to House Committee on Energy and Commerce.
Highlights: A main provision of the bill is the extension of protections to all participants in human subjects research, regardless of funding source.

Stroke Treatment and Ongoing Prevention Act (H.R. 3658 and S. 1909)
Sponsors: Representative Lois Capps (D-CA) and Senator Thad Cochran (R-MS)
Latest actions: H.R. 3658 - December 8, 2003 - Referred to House Committee on Energy and Commerce.
S. 1909 - November 20, 2003 - Referred to the Senate HELP Committee.

Recent Advances from the NHLBI

PAD by Trained Community Volunteers Increases Survival

The number of survivors of sudden cardiac arrest markedly increased when the victims were helped by community volunteers trained not only to perform CPR but also to use an automated external defibrillator (AED), a device that shocks an ineffectively beating heart back into normal rhythm, according to the results of a large multi-center study funded by the NHLBI in collaboration with the American Heart Association.

The Public Access Defibrillation (PAD) Trial compared survival of cardiac arrest victims in areas where community volunteers were trained in CPR only, to areas where volunteers were trained in both CPR and the use of an AED. The PAD Trial trained approximately 20,000 volunteer rescuers at 24 sites in the U.S. and Canada. “Sudden cardiac arrest is a major cause of death of Americans. This important study shows that lives can be saved by training community volunteers to use external defibrillators,” said Acting NHLBI Director Barbara Alving, M.D.

An important next step in research on the use of AEDs, is to test the safety and effectiveness of home use of these devices. The NHLBI is currently funding a multi-center 7,000 patient study designed to evaluate whether providing the devices to families of heart attack patients will improve survival if a cardiac arrest occurs while the patient is at home.

Moderate Physical Activity Promotes Weight Loss As Well As Intense Exercise

Women trying to lose weight can benefit as much from a moderate physical activity as from an intense workout, according to a study supported by the NHLBI. The “Effect of Exercise Duration and Intensity on Weight Loss in Overweight, Sedentary Women: A Randomized Trial” involved 201 overweight but otherwise healthy women ages 21-45.

Participants were provided with meal plans and instructed to limit their food calories to 1,200 to 1,500 kcal per day. Additionally, participants were randomly assigned to one of four physical activity regimens, which varied by intensity and duration. The regimens consisted of either a moderate- or vigorous-intensity physical activity performed for either a shorter (2 ½ to 3 ½ hours per week) or longer (3 ½ to 5 hours per week) duration. The physical activity consisted primarily of brisk walking, and the regimens used about 1,000 or 2,000 kcal per week.

Women in all four groups lost a significant amount of weight–about 13 to 20 pounds–and maintained their weight loss for a year. They also improved their cardiorespiratory fitness. However, the amount of weight loss or fitness improvement did not differ among the four physical activity regimens.

Hostility and Impatience Increase Long-term Risk of Developing Hypertension

Hostility and impatience (two features of the so-called Type A personality) increased young adults’ long-term risk of developing hypertension (high blood pressure) based on findings from the NHLBI funded Coronary Artery Risk Development in Young Adults (CARDIA) study. Although hostility and impatience increased risk, the other psychological and social factors examined, such as competitiveness (another Type A feature), depression, and anxiety, did not increase risk.

These findings will help researchers to identify behavioral characteristics that require further study. They also highlight the need for people to be able to recognize, modify, and manage harmful psychosocial behaviors so that they can thrive in the fast-paced U.S. society without compromising their cardiovascular health.