Alexander: Failing Electronic Health Records Program May Stand in Way of Precision Medicine

“Dr. Francis Collins, director of the National institutes of Health, has told us that a properly functioning records system is essential both to help assemble the genomes of one million individuals and for doctors to be able to use a patient’s genetic information when they write a prescription for individual patients.” –Lamar Alexander

WASHINGTON, D.C., May 5 – U.S. Senator Lamar Alexander (R-Tenn.) today said that the “failed promise” of the $28 billion electronic health records program may stand in the way of a precision medicine initiative until physicians are able to use systems that communicate with one another.

“We’ve got to get these records to a place where the systems can talk to one another – that’s called interoperability – and also where more doctors, particularly the smaller physicians’ offices, want to adopt these systems, can afford the cost, and can be confident that their investment will be of value,” Alexander said.

He added, “Dr. Francis Collins, director of the National Institutes of Health, has told us that a properly functioning records system is essential both to help assemble the genomes of one million individuals and for doctors to be able to use a patient’s genetic information when they write a prescription for individual patients.”

Today’s hearing was the fourth hearing on the committee’s innovation initiative to examine how we get safe drugs, devices, and treatments from the discovery process through the regulatory process into the medicine cabinets and doctors’ offices more quickly and cheaply.

The hearing was on the promise of precision medicine, which is one part of the innovation effort.

The senator’s full remarks are below:

We’re here today to discuss an exciting new direction in our health care called “precision medicine.” What does that mean?

Well, if those of us in this room were a good representation of the United States population, the Centers for Disease Control and Prevention estimates that nearly one in 10 of us would have diabetes.

If doctors could use precision medicine—that is, if they could look at our individual DNA and the genetic and molecular makeup of our disease—then they could potentially tailor treatments to each individual, rather than to the more general category of diabetes.

This is already happening today with cancer treatment. Doctors can look at the mutations of the cancer cell and assess how to treat it. Newsweek reports that “genetic testing on tumors is already starting to become the norm. In the big cancer hospitals like Sloan-Kettering, Dana-Farber and MD Anderson, all incoming patients automatically have their tumors sequenced.”

This is all possible because of the extraordinary achievement of sequencing the human genome, which Dr. Collins—who is here with us testifying today—announced had been completed for the first time along with Dr. Craig Venter and the Human Genome Project in 2000.

So today we’re here to discuss what the National Institutes of Health and private industry are doing in precision medicine, how the Food and Drug Administration will regulate these innovations, how electronic health records can affect our ability to innovate, and what this means for the American patient and for our health care system.

Precision medicine is one of the most exciting new frontiers in medicine.

Senator Murray and I are working on an initiative to ensure that our federal agencies are equipped to review the medical products and processes produced by this kind of cutting edge medicine, so that American patients aren’t waiting on the sidelines because regulatory science can’t keep up.

Our innovation initiative is not just about precision medicine. Precision medicine is a part of this.

President Obama announced a Precision Medicine Initiative in the State of the Union this year. He detailed his plans in an event at the White House that I attended.

The president has proposed, as part of his plan, mapping the genomes of 1 million people and making that information available to medical researchers across the country. I look forward to hearing from our witnesses what sort of benefits would come from this effort.

I also know there are similar private efforts underway and am interested in hearing how you might collaborate. 

I look forward to hearing more about the potential costs and benefits of precision medicine.  We know that costs to sequence the human genome have been reduced significantly in the last two decades.

Dr. Collins, who heads the National Institutes of Health and is testifying this morning, has said that 15 years ago it cost $400 million to sequence the first human genome, whereas today it costs about $1,000.

Very often in health care, innovation initially increases our costs. That does not mean we should not innovate – in this industry, innovation means lives saved, diseases cured, or mobility restored. Innovative new products can increase initial health care costs, but in the long-term could actually decrease health care costs as we make strides in medicine. 

Also, if you look at a disease like Alzheimer’s, which according to the Alzheimer’s Association will cost us $226 billion dollars this year along with other dementias, and if we could use precision medicine to delay onset or cure that disease, we could save precious dollars in our health care system while preventing or alleviating some of the grief and pain associated with this awful disease for patients and their families.

But it is an important thing to be mindful of.

This committee has also been spending time looking at how to improve electronic health records.

The federal government has spent $28 billion to drive the adoption of these records systems, and the result is that doctors don’t like the systems, they say they disrupt workflow, interrupt the doctor-patient relationship, and haven’t been worth the effort.

So, Senator Murray and I have begun a working group to identify the five or six things we can do to help make the failed promise of electronic health records something that physicians and providers look forward to instead of something they endure.

We’ve got to get these records to a place where the systems can talk to one another – that’s called interoperability – and also where more doctors, particularly the smaller physicians’ offices, want to adopt these systems, can afford the cost, and can be confident that their investment will be of value.

Dr. Collins has told us that a properly functioning records system is essential both to help assemble the genomes of one million individuals and for doctors to be able to use a patient’s genetic information when they write a prescription for individual patients.

I look forward to hearing whether our witnesses have to say about that, and about the promise of precision medicine today.    

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For access to this release and Chairman Alexander’s other statements, click here.