Scientists have envisioned a time in medicine when patients no longer have to undergo trial and error to determine which drugs will help treat or cure them when they are sick – and that era may be coming soon, as hospitals and medical centers are gathering information on patients and sequencing their genes.
“In the past these have been research experiments geared at trying to better understand disease,” Jonathan Sheldon, global vice president for Oracle Health Sciences, said in an interview with U.S. News. “We still need to do that, but we are in a position now in which some academic medical centers are using that information to drive clinical decision making.”
He explained that some of the changes in the way patients are involved in their care, as well as changing the way medical records are shared and protected, would allow for more health care providers to do the same, and would maximize how effective providers could be. These recommendations were outlined in a white paper, “From Evolution to Revolution: Building the 21st Century Genomic Infrastructure,” released Thursday, and followed by a panel discussion about policy changes. The event, in which Sheldon was a panelist, was held at the Capitol Visitor Center in Washington.
Individual hospitals and medical centers are beginning some of these studies. Brian Wells, associate vice president of health technology and academic computing at Penn Medicine, shared at the panel that researchers are examining how some patients metabolize drugs so doctors can prescribe the one that would work best. One of the studies underway will show how quickly smokers metabolize nicotine, and will help guide doctors in determining whether to prescribe a smoking cessation patch or Chantix, a pill.
In health care circles, precision medicine has been one of the most-talked about topics of the year since President Barack Obama mentioned it in his State of the Union address. The human genome has been sequenced since 2003, but for years the data have sat mostly stagnant, other than in a handful of academic medical centers or genetic testing facilities.
“It will be feasible in the coming decade that genomic data will play into health care decisions made,” said Josh New, a policy analyst at the Center for Data Innovation and one of the moderators of Thursday’s panel.
Efforts to prepare for an age of precision medicine, however, have been underway for some time. In 2009, the federal government through the economic stimulus package funnelled $19 billion to hospitals and individual doctors who adopted electronic medical records. The move largely worked: Before the passage of the stimulus bill, 9.4 percent of hospitals had adopted the technology. By 2014, the participation rate reached 75.5 percent, according to a data brief compiled by the government’s Office of the National Coordinator for Health information Technology.
The initiative was supposed to lay the groundwork for eventually keeping not only a patient’s clinical history, but also his or her genetic code. These records, however, largely exist in a vacuum. For the most part, one hospital or provider cannot send data to another, leaving patients with the same cumbersome process that existed when their records were kept in paper files.
“Unless we can deal with the interoperability of the clinical data, then that genetic data won’t mean anything,” Sheldon says.
Modernizing laws that guard patient privacy and security, experts say, would greatly improve health providers and hospitals’ ability to track patient information and to exchange it with others. Much has changed since the time these laws were created: Patients can keep their records on their cell phones, iPads or laptops – devices that simply didn’t exist or weren’t widespread when the laws were passed.
“How are we going to get access to the data if we are under all these regulatory requirements?” Annerose Berndt, vice president of analytics and information at the University of Pittsburgh Medical Center, asked in Thursday’s panel.
Toby Bloom, deputy scientific director of informatics of the New York Genome Center, said at the panel that one way to restructure medical records would be to give patients more control. Patients, she said, should be able to make their records available to medical research if that is something they want. “I don’t believe in getting rid of all regulations,” she said. “I just want the right regulations for patients.”
Though precision medicine holds promise in finding treatments for individual diseases, Dr. Sandro Galea, dean of Boston University’s School of Public Health, is concerned that other major issues in public health will take a back seat.
“The big challenge is that the genomic medicine agenda is for the development of highly specialized, highly specific drugs instead of the approach of making population healthier,” he said in an interview with U.S. News.
For instance, genetics won’t solve the socioeconomic and racial disparities that exist in the U.S. in terms of solving problems that affect certain populations – including obesity, teen pregnancy or Type 2 diabetes. None of these, Galea points out, can be influenced by precision medicine, but by living conditions and environmental factors that can be tackled through public health initiatives.
“We need a careful, judicious recalibration of our enthusiasm with personalized medicine to balance it out with population health,” he says.