Framingham Study

When I was Governor of Utah I became fascinated by the potential of personalized medicine. Researchers years before had begun developing the Utah Population Database (UPD) which is genealogy records accumulated by the Church of Jesus Christ of Latter Day Saints, combined with medical records, disease registries and other publicly available documents. When combined with genetic information on certain families, the UPD was a powerful tool in finding the genes linked to specific forms of cancer and other diseases.

I wanted to enhance the Utah database by creating capacity to track directly more families. Our strategy was to identify families that had settled in Utah in the mid-19th century and track their descendents. Incidentally, my family fit into that category.

Periodically, I would invite some of the most respected members of those families to the Governor’s residence for dinner with me and a genetic scientist. Our conversation would lead to an invitation for their family to participate in the project. Accepting meant they would organize what I called a “poke and probe” family reunion. Family members would fill out questionnaires about their history and behavior. Each would be physically examined. Each participant committed to repeat the effort in subsequent years.

One night, after sitting quietly through dinner and the conversation, an older man indicated to me that he had something he wanted to say.

“I don’t understand all the science here, but I do believe there is something to this genetics stuff.” He continued, “This week I was diagnosed with macular degeneration and I’m 70 years old. When my father was 70 years old, he had the same symptoms. When my grandfather was 70 years old, he had them too. If there is something my family can do to prevent a grandson or granddaughter from having to go through this—we’re in.”

A couple of years later, I found myself Secretary of Health and Human Services. I attended a meeting launching another project to pioneer future genetics research. At that meeting it was announced that the gene causing macular degeneration had been isolated.

I doubt my friend from Utah had anything directly to do with the discovery. However, his family’s participation in that project will undoubtedly result in future announcements.

This week I was in Framingham, Massachusetts, a community about 45 minutes out of Boston. It’s a quiet little town and one wouldn’t naturally think of it as a capital of medical research. However, if you use the words Framingham Study to most medical researchers it evokes a responsive recognition.

In 1948, the Public Health Service, working with some local physicians and researchers, persuaded the entire community to be part of a long term study on a wide range of health related behavioral studies. They have been at it now nearly 60 years. More than 14,000 people have participated. The benefits to the average American just keep piling up. (Read op-ed article)

Having detailed medical histories on all these people and their families, when combined with new genetic information and electronic medical record technology, will be profoundly important.

I traveled to Framingham to thank the participants in that study and to encourage them to pass the ethic of consistent involvement to their children. It was a reminder to me of how important it is that ordinary people understand the impact they can have on the health and well-being of future generations.

Comments

Secretary Leavitt,

Respectfully Sir, I say to you that information can be used sometimes against us as well as for us. There is a danger in someone having too much information about us. Identity is the heart of an individual. Nakedness is pretty uncomfortable. I am not sure who I should give my heart to at times....it's opening Pandora's box.

I would say to you to give me the tools so that I may keep this information for myself and so that I may divulge it when I trust the entity desiring it. Information has a tendency to change hands too easily. Even sophisticated security measures are not reliable. Personally, I can always think of a way around them and I can think of some pretty stringent security measures! (not that I have tried to avoid things...I just chew on issues sometimes and think too much)

I also understand the benefits that you mention.

What makes me uncomfortable is that I can think of many ways this information gathering could be used to our detriment.

I can speak from my own heart and my own experience. I was handed a set of tools that I used to go beyond any condition or illness that I had to face in my life and that of my recorded family history. That and my own personal faith has been what has kept me going. No database can contain what I believe so what is the point of all the other information...who we are is not just in our genes, it's in our heart too.

I appreciate the database that the Church of Latter Day Saints has created. We, personally, have looked into our family roots in depth. The Framingham Study was/is a good idea. Allow people to volunteer for studies and information gathering but what you suggest could easily be compelled from us...i don't like that Sir.

Again from my personal experience and point of view, perhaps too much information just serves to either blind us to our possibilities OR keep us bogged down in excuses for not getting the job done.

I was adopted and used information from databases to track down the story of my birth-mother. The search was healing. Having the information that I needed to have helped me to move beyond the hurts that adoption causes. This is a good use for familial information. Knowing how she was limited or not would have given me preconceived ideas. There is a benefit to adoption too, sometimes self-less mothers do right by their children. My mother made a self-less decision. I wish I had known her... I was better off without her story until my identity was formed.

I am just revealing all of this to illuminate the fine line that I walk when chewing on the idea of information gathering.

I am mostly concerned about times down the road where we may be facing a different set of difficulties. Once information is gathered it tends not to be ungathered. I would just urge caution and patience with what information we gather on each other going forward. It's a marathon, not a sprint....who said that first???

...and I don't mean my criticism of your idea as a criticism of you personally :) Just wearing my heart on the outside.

Best Regards,
Jackie-standingfirm

Posted by: standingfirm | November 30, 2007 at 02:28 PM

I don't think there is too much information. I need to know thing, sometimes I here something and I chose to ignore it.

Posted by: baby boy | December 24, 2007 at 07:44 AM

Sec'y Leavitt,

Have you been briefed on the Johns Hopkins studies by Peter Pronovost? He examined the use of checklists in emergency room care. He showed, in situations ranging from the heavily resourced (at Hopkins) to the fiscally stretched (Michigan ICUs in Detroit) that checklists assured that providers give the "standard of care" for the studied procedures no matter what distractions would otherwise lead to missing steps that cost dollars, suffering and lives.

Using the checklists based on THE EXISTING STANDARD OF CARE, Michigan ICUs reduced bloodstream infections 67%, saved an estimated $175,000,000 and over 1500 lives.

What would have been an expansion of this program to ASSURE THE CURRENT STANDARD OF CARE is followed has been stopped by the Office for Human Research Protections. Have you spoken to acting director Ivor Pritchard about this decision? How does OHRP's protection of "research subjects" trump HHS's duty to protect the health of all Americans. Wouldn't duty that include not preventing efforts to assure they receive the agreed upon STANDARD OF CARE, each step of it?

This OHRP decision has a faulty basis and I request that you review and reverse it.

Thanks for blogging, and thank you for this access.

Posted by: Kris Singleton | December 31, 2007 at 01:29 PM

Clinical research studies help to keep our nation viable in today's society. As more and more countries are expanding their intellectual capacity as well as educational infrastructure, it is on us to stay ahead or at least keep up in terms of health research.

Posted by: Pam | July 28, 2008 at 01:18 PM