Personalized drug therapies based on genetic profiling can help avert hospitalizations and boost compliance, but the economic impact on drug makers has yet to be determined.
One of the largest health systems in Illinois is aiming to become a leader in precision medicine.
Evanston, IL-based NorthShore University HealthSystem formally launched a pharmacogenomics clinic last week and is set to unveil the not-for-profit organization's multifaceted Center for Personalized Medicine by early April, health system officials say.
Henry "Mark" Dunnenberger, PharmD |
In addition to the pharmacogenomics clinic, NorthShore's Center for Personalized Medicine is slated to have several core components, such as personalized medicine consult clinics, where genomic specialists will help diagnose and treat patients based on genetic information.
Other elements of the Center for Personalized Medicine include cancer care based on genetic profiling as well as a research initiative to collect and analyze DNA samples from 100,000 people in the Chicago metropolitan area.
Henry "Mark" Dunnenberger, PharmD, a senior clinical specialist at NorthShore who is leading the new pharmacogenomics clinic, said this week that his facility has the potential to benefit a wide swath of patients "across the spectrum of disease care."
He describes pharmacogenomics as being revolutionary on two medication fronts: dose adjustment and medication selection. "It could be your body doesn't clear a drug very well. It could be that a drug doesn't do you any good. We can pre-emptively modify your therapy."
"It limits trial and error. It alleviates time to improve symptoms. We're providing safer medication, which avoids hospitalization," he says, noting the application of pharmacogenomics in prescriptions of medication helps boost patient compliance. "There are [fewer] side effects… If you can tell patients, 'we tailored this therapy for you,' then they are more likely to take it."
Personal Impact
The molecular biologist leading NorthShore's effort to collect 100,000 DNA samples from Chicagoland residents has experienced the value of pharmacogenomics firsthand.
Kathy Mangold, PhD, had a family history of a serious clotting disorder, deep vein thrombosis, and decided to have her blood analyzed to see whether she had a genetic predisposition for the condition. Testing revealed Mangold had a mutation that increased her risk for blood clots as much as 20 times. And she started taking preventative medication – one aspirin per day.
Mangold, who started working for NorthShore in 1999, also underwent drug metabolism testing for Warfarin, the frontline medication for deep vein thrombosis, and found that her body breaks down the drug more slowly than most patients. "That information sat in my medical record for a long time," she said.
Then in January 2014, Mangold underwent surgery to remove a benign brain tumor. "I didn't have a blood clot when I was in the hospital, but I wasn't as active as I should have been when I got home," she said.
She developed a blood clot in one of her legs and because of information gleaned from the testing years earlier, was prescribed to take Warfarin at a dosage level 40% lower than the standard therapy, but safer for her.
The molecular biologist's personal experience with personalized medicine has benefited several members of her family, as well. "Taking an aspirin a day is a simple fix. I shared [this information] with my family, and they also were tested. They could have a discussion with their physicians to decide the best thing to do."
There are millions of Americans who do not have pharmacogenomics facilities in their communities, but they still can benefit from the technology, Mangold says.
Three of her brothers live in Montana towns with populations as low as 100 people, 30 miles from the nearest hospital. "They could get blood taken and sent off for testing. Then their doctors could consult with us at NorthShore. It's not [a level of care] as grand and complete as we have at NorthShore, but they still had access. They could get this care even in a rural area of Montana."
Mangold said she also shared her pharmacogenomics information with some of her cousins, in part because genetic mutations associated with deep vein thrombosis have been linked to pregnancy complications. "It has had a far-reaching impact on my family."
Pharmacogenomics' Impact on Bottom Lines
In addition to the potential for pharmacogenomics to have a broad impact on patients, the technology is likely to have a significant financial impact on the healthcare industry, Dunnenberger says.
Prescribing the right drug, at the right dosage, at the right time has obvious financial benefits for healthcare providers, including avoidance of costlier interventions such as surgical procedures. "There's a little more cost upfront, but we're pushing to a preventive model of care."
The impact of pharmacogenomics on drug makers, however, "is yet to be determined," Dunnenberger says.
For decades, pharmaceutical companies have banked on a volume-based business model: The more drugs they sell to more people at the highest possible dose, the more profits they have generated. While pharmacogenomics is likely to cut into sales volume for many medications, there is a silver lining for drug makers, he says.
"There are some drugs that never make it to market because of their toxicity profile. Pharmacogenomics could be a method to rescue some drugs: 5 to 10% of patients may be able to tolerate a drug," he said. "In those cases, you have to have a very specific mutation for the drug to work."
The pharmacogenomics clinic at NorthShore is the first of its kind in the Chicago metropolitan area, according to Dunnenberger. Several other large healthcare providers across the country have launched pharmacogenomics clinics and research facilities, including Mayo Clinic's Center for Individualized Medicine in Rochester, MN, and the Center for Experimental Drugs and Diagnostics at Boston-based Massachusetts General Hospital.
Christopher Cheney is the CMO editor at HealthLeaders.