Testing Treatments in a Tube: Induced Pluripotent Stem Cell Research (IPSC) is a recently developed method of changing ordinary white blood cells from individual blood samples so that they behave in the laboratory like cells from other organs. The first step reduces the specific functionality of the white cells, resulting in cells called IPSC's. The second step transforms the IPSC to imitate the function of another specific cell type such as liver, kidney or nerve cells. Since the IPSC testing is conducted in a laboratory after blood samples are drawn, the donor is not personally exposed to any tests or treatments.

Researchers at FHS expect to learn more about how cells in various tissues and organs work to maintain health or cause diseases by using IPSC methods with blood samples collected at the exams that start in April 2011 . For example, cells that are made to imitate liver cell function can be used in the laboratory to measure cholesterol production and how drug treatment changes cholesterol levels. Because cells from various people may behave differently, and because FHS has so much information already on the health of its participants, IPSC research at the FHS may lead to important discoveries about treatment of diseases. In the Framingham Heart Study research, white cells will never be altered to behave as reproductive cells. Participants at the Framingham Heart Study can use the consent form check boxes to choose to be included in or excluded from IPSC research.

For decades, Framingham Heart Study (FHS) participants have generously donated blood samples for research. Hundreds of articles have been published based on analyses of these samples. We store remaining specimens in freezers for future projects. Meanwhile, laboratory techniques have improved, so very small amounts of specimen are enough for a large variety of measurements. In his letter to you, FHS Director, Dr. Daniel Levy, describes the SABRe CVD Initiative. Projects in this program will support highly worthwhile research using FHS specimens and data to discover factors affecting health and disease. We are taking care to protect the confidentiality of participants' information. At least one of the projects will include a partnership called a CRADA (Cooperative Research And Development Agreement) between the National Institutes of Health (NIH), Boston University, and BG Medicine, a private company that has expertise in cutting-edge laboratory measurements. For this project, we will use stored samples according to the preferences of each participant as recorded on consent forms. CRADAs provide opportunities for government biomedical investigators to join with colleagues from industry and academia in the pursuit of common research goals and, relevant to the mission of the NIH, to facilitate the development and commercialization of healthcare-related products and services. CRADAs are authorized by NIH only with collaborators who will make significant intellectual contributions to specific research projects or will contribute essential research materials or technical resources not otherwise readily available to NIH. In some cases, successful commercialization of the fruits of the collaboration may lead to a financial return to one or more of the CRADA partners. We want to ensure that you are informed about FHS research activities. Some questions about the SABRe CVD Initiative are answered below. If you have additional questions, please contact your FHS Coordinator. Phone numbers are provided in this newsletter. We thank you again for your ongoing support of FHS research.

What is a biomarker?
It is any characteristic of living things that can be measured and studied, including blood tests. The SABRe CVD Initiative is especially interested in studying FHS biomarkers from blood related to CVD and its risk factors.

Where are specimens from? Where do they go?
Blood samples from past and present FHS exams are processed and stored in various ways. Some tests are performed in the FHS laboratory; other procedures are conducted in off-site labs that have special equipment and expertise. For SABRe CVD, most of the lab tests will be performed at specialized labs.

What is the outcome of the lab measurements?
The results of lab measurements are biomarker levels, scores, percentages, or classifications. These numbers (data) are compared to other FHS information to find new patterns that suggest how disease and health occur in populations.

Who has access to the specimens and data?
Investigators wishing to use specimens or resulting data for analysis must get approval from a review committee that judges the merits of the research.

President Obama visited NIH today (September 30, 2009) and announced an additional 5 billion dollars in research funding. In the same speech, he highlighted the work of the Framingham Heart Study:

"Through these investments in research, we will also have the opportunity to make strides in the treatment and prevention of heart disease, the leading cause of death in the United States. Since 1948, for example, researchers have been following generations of residents in the town of Framingham, Massachusetts, to better understand the cause of cardiovascular illness. Now, we have a chance to study the DNA of these participants and connect what we know after decades of observation to what we'll soon know about their genetic makeup. And perhaps we can identify those who are likely get high blood pressure or high cholesterol and find ways to intervene before heart disease even develops."