Programs preview mainstreaming of personalized medicine

Researchers say a data-driven approach is less than a few years away for specialists and less than a decade away for primary care physicians.

By Pamela Lewis Dolan — Posted Nov. 26, 2012

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As health information technology adoption inches closer to a saturation point, it is expected to help accelerate the use of what is known as personalized medicine.

Some large health care organizations recently launched large, multimillion-dollar personalized medicine initiatives that will allow physicians and researchers to combine patient data — including genomic, claims and financial data as well as clinical data collected by physicians — with other sources of data and to apply intensive analytics to develop treatment plans tailored to each patient. The goal is to improve outcomes and control costs by reducing overdiagnosis and ineffective treatments.

Personalized medicine allows physicians to prescribe treatments based on a patient’s genetic makeup and disease profile and the effectiveness of therapies for other patients with similar characteristics. Projects are using this approach to better match patients with complex diseases to the best therapies, eliminating the trial-and-error process that often has resulted in ineffective treatments, particularly in the use of pharmaceuticals.

A paper published in Trends in Molecular Medicine in 2001 found, on average, that prescription drugs are effective for 50% to 75% of patients who take them. This percentage is 25% for cancer patients and 30% of those on Alzheimer’s drugs.

Performing the level of analysis needed to make the best evidence-based decisions would involve access to a lot of data and machines with the computing power to process and analyze the data. Many health care systems now have those capabilities, said Jon Duke, MD, investigator and innovation officer for the Regenstrief Institute, a health research and education organization in Indianapolis that is closely associated with the Indiana University School of Medicine. In November, Regenstrief announced a five-year partnership with Merck to develop personalized, evidence-based care models for chronic conditions such as diabetes, cardiovascular disease and osteoporosis.

Also driving this move toward personalized medicine, Dr. Duke said, is a shift in care models that include accountable care organizations and changes in pay structures that focus on the delivery of value-based care.

Another project, announced in October, was launched at the University of Pittsburgh Medical Center. The five-year, $100 million project is aimed at bringing several data sets into one large data warehouse for purposes of personalized medicine.

Steven Shapiro, MD, chief medical and scientific officer at UPMC, said the most immediate impact from his organization’s and other projects will be felt among specialists, particularly oncologists. “They are the ones that are pushing this a little bit further, because they have access to a lot of tissue when they remove it,” he said.

Some specialists already are using a personalized approach. Physicians at Vanderbilt University Medical Center became aware that a large percentage of organ transplant patients on tacrolimus to prevent organ rejection were experiencing dangerous side effects, according to a commentary by former U.S. Sen. William H. Frist, MD (R, Tenn.), published in October by the Institute of Medicine. Dr. Frist is now an adjunct professor of surgery at Vanderbilt. Researchers discovered a genetic variant associated with tacrolimus blood level variation. Doctors now test patients for the variation before starting treatment, reducing severe side effects for some patients, Dr. Frist wrote.

Darrell West, vice president and director of governance studies and director of the Center for Technology Innovation at the Brookings Institution, argues that changes are needed in the way payers look at genomics testing and interpretation for personalized medicine to reach its fullest potential. For example, few pay for routine collection of this type of data for purposes of predictive modeling.

Although payers are not covering this research, “the one bright sign is that the costs of genetic testing is coming down,” said West, who published a paper in January 2011 that examined the barriers to enabling personalized medicine. “Soon it will be within the price range of ordinary folks. This will spark much greater usage, and the consumer market will push policymakers to make greater use of genomic data.”

Once this data collection becomes routine and new data warehouses are created, such as those at UPMC and Regenstrief, the ability for more primary care physicians to fully incorporate a personalized approach to medicine will become a reality, Dr. Shapiro said. He predicted that personalized medicine will become standard for all doctors within a decade.

Primary care physicians will play a central role in personalized medicine in terms of collecting and incorporating the information in their routine care decisions, Dr. Duke said.

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The high rate of drug ineffectiveness

Researchers have found, on average, that prescription drugs are ineffective for about half of the people who take it. Effectiveness can be influenced by the patient’s genetic makeup or the specific variety of a disease. The percentage of people for whom certain kinds of drugs are ineffective:

75%: cancer drugs

70%: Alzheimer’s drugs

60%: incontinence drugs

53%: hepatitis C drugs

52%: osteoporosis drugs

50%: rheumatoid arthritis drugs

50%: migraine prophylaxis drugs

48%: acute migraine drugs

43%: diabetes drugs

40%: asthma drugs

40%: cardiac arrhythmia drugs

40%: schizophrenia drugs

38%: antidepressants

Source: “Clinical Application of Pharmacogenetics,” Trends in Molecular Medicine, May 2001 (link)

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External links

“Enabling Personalized Medicine through Health Information Technology: Advancing the Integration of Information,” Brookings Institution, Jan. 28, 2011 (link)

“Clinical Application of Pharmacogenetics,” Trends in Molecular Medicine, May 2001 (link)

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