By Kevin Davies and Steven Withrow
Dec 2005 / Jan 2006 | Industry leaders at a recent conference were unanimous in their conviction that personalized medicine will change the practice of medicine and drug development but expressed grave concern at the lack of appropriate medical education currently available to bring that paradigm shift to fruition. That was one of the central themes to emerge during a two-day conference on personalized medicine hosted by Harvard Partners Center for Genetics and Genomics*.
|INDIVIDUALIZED MEDICINE: Speakers at Harvard included |
David Brailer, Mara Aspinall, and Reed Tuckson.
Reed Tuckson, senior VP of consumer health and medical care advancement at UnitedHealthcare
(UHC), wasted no time in declaring the warning signs of a healthcare system in crisis — General Motors’ $1.1 billion first-quarter loss, flagging patient care in American hospitals, the overuse of antibiotics, the fatal overprescription of COX-2 inhibitors, and the alarming rise of chronic disease in an aging population.
Aggregating medical data can be used to predict disease risk. Next year, UHC will take a first step down this road by rolling out a healthcare information card. But Tuckson warned that healthcare providers are wholly unprepared for the revolution in genetics and face an enormous challenge helping patients in the future. “I am terrified of the American educational system,” he said.
The data warehouses of companies such as UHC could be turned into knowledge and wisdom, said Pfizer senior vice president for global development, Declan Doogan. Tomorrow’s physical exam, he said, would measure a variety of lifestyle and environmental factors — serum proteomics for early detection, gene expression to herald clinical disease, and molecular profiles of tumors to guide therapy. This requires a mindshift in viewing such expenses as a positive investment in healthcare rather than a cost.
Ralph Synderman, emeritus chancellor for health affairs and president and CEO of Duke University Health System, said we are on the cusp of a second transformation in healthcare — the first being the introduction of science into medicine more than a century ago. Contemporary medicine is characterized by a “find it, fix it” approach, “reactive, sporadic, disease-oriented, physician-directed.” The result is that 75 percent of healthcare system expenditure is spent on treating acute, late-stage disease.
The goal is to shift detection of disease earlier in the cycle, at a much lower cost. Genomics, proteomics, metabolomics, medical technologies, and informatics will propel the wave of the second medical revolution.
According to Mara Aspinall, president of Genzyme Genetics, the future of personalized medicine is all about “overcoming fear.” Pharmas have a “fundamental and rational fear” over decreased market size, although as in the cases of Gleevec and Herceptin, it is better to have some share of market versus none. The payor industry sees another layer of cost but no change in physician practice. And patients are concerned that drugs only work 20 percent of the time, and not falling in that minority.
But there is an additional fear — a fear among physicians of understanding new genetic diagnostic tests that much be overcome with “a broad educational effort, starting at medical schools.”
Bruce Korf of the University of Alabama at Birmingham drummed home the medical education crisis. Fewer than 40 percent of medical schools run a genetics course, he said, and according to a recent survey, only one-third of physicians polled feel trained or competent to discuss genetic information. Medical informatics is a disruptive technology akin to a Tower of Babel. “Why can’t [Google] crawl through medical records?” Korf posed. “Is Wal-Mart-Google the future of medicine?”
IBM and HP
“Around the world, healthcare is becoming an ecosystem...increasingly interdependent,” said Michael Svinte, vice president, information-based medicine, IBM Healthcare and Life Sciences. Not surprisingly, IT plays a “critical enabling role” in IBM’s vision of individualized, optimized medicine, and Svinte pointed out collaborations with the Cleveland Clinic to construct a platform to integrate imaging data and with LineaGen to incorporate genealogical and high-throughput data, along with electronic medical records, in autoimmune research. (See “LineaGen and IBM to Collaborate,” July 2005 Bio•IT World, page 14.)
Recent IBM initiatives include spearheading The Genographic Project (see “Taking a World Genography Test,” June 2005 Bio•IT World, page 20); addressing employee privacy and security issues relating to genetic discrimination; forming an interoperability consortium with Microsoft and Hewlett-Packard; and investing in biobanking, which Svinte called “the fuel for personalized medicine.”
Jeffrey Miller, Hewlett-Packard’s VP, health industry, worldwide public sector, health and education, sees a need for more robust documentation systems and a trend of moving away from the process level toward a model that is “much more object-oriented...from structural programming toward object programming.”
The main challenges in acquiring information, Miller said, include the industry’s growing “paper problem” but also the boom in data generated by digital pathology and mobile technology. He also spoke about information lifecycle management and what he called “contextual access” to information, where context is based on location. “If I’m a clinician, showing me a genomic model probably isn’t very helpful,” he said.
“We’re still in the foothills of personalized medicine today,” said David Brailer, national coordinator for health-IT, U.S. Department of Health & Human Services, noting the “incredible synergy” in risk prediction, pharmacotherapy, and targeted therapies — change vectors acting across the entire healthcare continuum. There are still many “impracticable questions,” he said, “[but] we have created a space to have a dialogue about healthcare.”
*Personalized Medicine: Promises and Prospects. Harvard Partners Center for Genetics and Genomics, Nov. 3-4, 2005.