Leroy Hood’s Personalized Medicine Vision Enters Proving Ground at Ohio State

5/18/10Follow @xconomy

Seven years after biotech pioneer Leroy Hood coined the term “P4 Medicine,” for a transformative new idea in healthcare, he has captured the first significant money and manpower from a major U.S. medical school to carry the idea forward.

Ohio State University, the nation’s second-largest university, said late Friday that its board has approved a partnership with Hood’s Institute for Systems Biology in Seattle. This is a two-year collaboration in which both organizations will put in $1 million each. Ohio State provides a group of 55,000 insured employees and family members who could enroll in clinical trials, plus a group of physicians motivated to be on the front line of personalized medicine. The Institute for Systems Biology will contribute cutting-edge analysis of genes and proteins from samples so the physicians can gather useful information to monitor patients and guide their wellness.

The deal means that Hood’s idea for P4 Medicine—shorthand for predictive, preventive, personalized and participatory medicine—is now officially up and running. The vision is that instead of waiting for clinical symptoms to appear, like a tumor spotted on an X-ray after it’s too late, physicians will eventually be able to see early warning signs of malignancies from a pinprick of blood analyzed by genomic instruments and software. If the genes and proteins are truly predictive, then doctors could take early action, or people could adjust their lifestyles accordingly to prevent disease. This vision could transform the $2.5 trillion U.S. healthcare industry, which currently pours most of its resources into reacting to chronic and preventable conditions, with little upfront investment in wellness.

“We’re near a tipping point, to use Gladwell’s term,” Hood says. “People realize things are changing, they need to change, and the old order isn’t going to solve the problems. A lot of people are willing to listen in ways they weren’t willing to listen before to new opportunities.”

Leroy Hood

Leroy Hood

Much of the heavy lifting for this vision is falling to Frederick Lee, whom Hood brought in almost a year ago as the founding executive director of a new nonprofit entity called the P4 Medicine Institute. Lee, 40, has the sort of unusual background that’s probably required for someone to carry out a task this big and broad. He studied molecular biology as an undergrad at MIT, and has a medical degree and completed surgical residency at Stony Brook University Medical School. Lee also has a master’s in public health from Columbia University, where he specialized in the study of preventive medicine, and has executive experience at health giants like GE Healthcare and McKesson, where he tried to implement his ideas.

Fred Lee

Fred Lee

So he’s young, ambitious, and as Hood says, “has a mutually congruent vision,” which is hard to find. Lee tried to implement some similar ideas back when in the corporate world, but he says “we spent a lot of time banging our heads against the wall.”

“We can perform 21st century medicine now, but we’re trying to do it with 19th century infrastructure,” Lee says. “It’s what the P4 Medicine Institute has been created to solve.”

This idea challenges so much conventional wisdom and institutional complacency that it has taken years for Hood to find the right partner. It requires multiple layers of an organization to fully buy into the vision—from CEO to physician to nurse. Then there are insurers. And there are privacy concerns whenever people start capturing huge amounts of genomic data on patients, which makes it hard to find people who will fully go along with the “participatory” element. Money to support the idea, of course, is always an issue.

Even some fundamental technical problems still need to be worked out, Hood says. One is how best to preserve blood samples to run multiple analyses for genes, proteins, messenger RNA, microRNA, whole cells and more, Hood says. Once that’s settled, researchers need to create information technology that is standardized and can seamlessly integrate all those data points—running into the billions for every individual patient—so researchers can spot patterns in what’s gone awry genetically and what’s wrong symptomatically.

Ohio State was the right choice, Hood says, because it performs the functions of both payer and provider of healthcare services to its 55,000 employees and health plan members. That eliminated that hassles with insurance companies that have stymied previous partnership talks. Importantly, Ohio State’s top medical brass have been on a personalized medicine kick for five years, so the idea isn’t completely foreign. Personal ties helped too. Steven Gabbe, the CEO of the Ohio State University Medical Center, goes way back with Hood—the two of them were department chairs at the University of Washington in the late 1990s. And at one point, Hood personally came to speak to the Ohio State University board of trustees, and met with president Gordon Gee, to clinch the deal.

Many of the details on this partnership have yet to be ironed out. The plan is for Ohio State to create a “demonstration project,” in which OSU community members will enroll in clinical trials and people at both Ohio State and ISB will create unified medical records that connect what’s happening at the genetic level with the information people are recording on their health status (things like their diet, exercise, and stress levels). The goals will be to get these trials up and running, generate published knowledge from them, recruit other medical schools to join the cause, and use the experience to enrich the Ohio State medical school curriculum, Gabbe says.

Steve Gabbe

Steve Gabbe

“We think this will help us recruit and retain terrific people who want to do something exciting,” Gabbe says. “Our president Gordon Gee has said we are in a war for talent, and we think this will distinguish us.”

It will probably be six to nine months before the first clinical trials get going, Lee says. He didn’t have details on what diseases the collaboration will seek to study first. But to offer an example, Gabbe noted that he has Type 1 diabetes, a condition in which the body’s immune system attacks pancreatic beta cells, making people unable to produce enough insulin to control blood sugar. Gabbe, 65, diagnosed himself when he was 25 years old and in medical school. He already has personalized therapy, in form of an insulin pump, a continuous glucose monitor, and an ability to adjust his insulin needs based on his diet, exercise, and stress levels on a daily basis.

But what intrigues him today is what could be learned from his genome. About 60 percent of people with a certain genotype are likely to get Type 1 diabetes as children or young adults. It’s not really known what triggers the immune system to go awry and fight pancreatic beta cells. If people could find out their genetic risk profile for Type 1 diabetes, then they or their parents could adjust their behavior, to say, reduce stress in the hopes that this will keep them healthy for a longer period of time into adulthood, when the symptoms are likely to be less severe, Gabbe says.

So that might be one example of the benefit, but I can imagine there will be plenty of people cautious about the risk side of the equation. Last month, Arizona State University agreed to pay $700,000 to settle a dispute with the Havasupai Indian tribe, which said it didn’t authorize wide-ranging genetic studies that researchers conducted on their blood samples.

That story was certainly on Hood’s mind, but he and Lee said they didn’t think it would create any additional barriers to their ambitious undertaking. The important thing is that consent forms fully inform patients before they enroll, and that researchers learn that they need to do more to educate both physicians and patients about what the personalized medicine work means, Hood says. Researchers should learn from “bumps in the road,” like the one at Arizona State, Lee says.

While privacy concerns could slam the brakes on a serious initiative, undermining that critical fourth “P” of participatory, Lee says he’s confident this movement toward P4 medicine will catch. Although he’s not ready to name names, Lee says that a community-based health system in the Northwest, not affiliated with a major university, is close to signing on as the second major participant in the movement toward P4 medicine after Ohio State.

Lee, as a physician who treated patients not many years ago, seems to bring some fresh thinking to the challenge of engaging average citizens in his cause. He didn’t shy away with a lot of vague platitudes when I asked him how he’s going to get people to buy into this idea.

“We want to make care engaging and enjoyable,” Lee says. “I’m a physician, and I have tried to completely avoid the healthcare system for a great part of my life. I know what’s going to happen as a patient. I know my cholesterol is probably off, and I’m going to start on Lipitor, and they’re probably going to yell at me for this and that. I’ll try to be compliant, but I’ll feel bad about myself.”

“Right now the healthcare system is filled with dread and fear and uncertainty and doubt. We feel you can turn that around, and get engagement, if you can predict and prevent disease and start to create novel metrics and present them to the consumer in fun ways. That is really when we become sticky,” Lee says.P4 logo

The barriers are still real, and Lee didn’t try to downplay them. He just thinks they will go away, and personalized medicine will go mainstream over the next five years.

“By then we’ll have attracted a critical mass of industry, academic partners, and consultants on societal issues,” Lee says. “We’ll make headway on societal, ethical, sociologic components. There will be multiple demonstration projects in U.S. and around the world. We’ll have evangelized and created a vision of P4 medicine that consumers will be demanding. Conservatively, you could look at this from a linear perspective, because it’s difficult to think exponentially. But my deep, dark belief is that this will follow an exponential growth curve.”

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