The Body Politic

Increasingly, physicians are understanding that there is no such thing as a one-size-fits-all treatment for patients, even if they have the same condition. “Precision medicine,” or personalized medicine, is an approach to disease prevention and treatment that considers individual variability in genes, environment, and lifestyle. A treatment that is successful for one person may not work for another person due to his or her particular biological makeup.

The toolkit of personalized medicine involves rigorous experimentation, genetic testing, and the strategic use of healthcare data sets to better match treatments to patients. Machine-learning algorithms and artificial intelligence are being applied to newly available troves of health data, which include genomic sequences, patients’ medical records, and diagnostic test results, to predict outcomes and recommend treatment plans.

With these new technologies, we can expect medicine in the future to work more like Netflix, serving up individually tailored suggestions based on our precise behavioral patterns. Personalized medicine has huge potential to improve patient care and populationwide health while reducing wasteful medical spending. Yet like any emerging trend, it also carries some risks. What are the implications for health law?

The Revolution in Data Collection

“Our legal and regulatory frameworks may not be perfectly suited for these exciting new developments,” said Professor Radhika Rao, who researches the law of the human body. Many current practices, from genetic testing and screening to assisted reproduction, are so different from traditional approaches to medicine, she said. “We need new tools to understand how these should be developed, regulated, and used. We need to make sure that we are not losing out on the benefits while also making sure that there are appropriate protections for patients and experimental subjects.”

Joshua Marker ’09 is senior director of Legal at Evidation Health, a technology and services startup that built a platform to measure real-world outcomes and help health care companies understand patient behaviors that drive them. Evidation uses data from newer technology, such as wearable devices, sensors, and mobile applications to conduct virtual, “siteless” studies to measure health outcomes outside clinic walls. The company has conducted IRB-approved research using patient-permissioned data in multiple disease states, such as chronic pain, multiple sclerosis, diabetes, hypertension, and mental health.

“The basic doctor’s visit hasn’t changed in 30 years,” Marker said. “You’re in a room with a physician. Maybe now they use tablets and digital records, but the care model is fundamentally the same.” Now, things are poised to change because patients can collect their own data on an ongoing basis. Heart rate, blood pressure, glucose levels, respiration rate, and all sorts of bioindicators can be tracked outside of the doctor’s office, which can give both the physicians and healthcare companies more complete information when designing potential therapeutic options. “When patients consent to the use of their data reflecting real-world behaviors in research, it has the potential to change the delivery of healthcare, making it centered around the individual, rather than the clinic,” he said.

From a legal perspective, Marker said that his job is challenging because he deals with questions that may not have arisen before in a given business context. “When you work at the cutting edge, you often find yourself in gray areas. It can be challenging when technological development outpaces the law,  and the letter of the law may be an imperfect fit to a given business model,” he said.

Most industries want to collect data about individuals so that they can market and advertise to the subjects in a more targeted fashion, he explained. But the Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulates protected health information so that it functionally cannot be used for marketing purposes.  The value of health data is much greater, it can be used to improve health outcomes at a population level.

“Healthcare has access to more data points from populations across time than ever before that can help manufacturers identify relevant patterns and develop treatment pathways that will work for different people,” Marker said. “It allows healthcare to be more precise and improve the lives of humanity.”

The Informed Consent Dilemma

Yet collecting data isn’t by definition benign or beneficial, Rao said. The positive developments hinge on the idea of informed consent, for which there is still no absolute standard that can fully protect a patient. Rao has done research on several cases in which vulnerable populations were effectively deprived of access to the medical technologies that were developed from the insights found in their health data and bio samples. A few cases of indigenous tribes being exploited for their biological information have been heard in court. The 2010 book by Rebecca Skloot, The Immortal Life of Henrietta Lacks, explored these issues.

Lacks was an African-American woman whose cancer cells were taken without her knowledge or consent to create a valuable cell line that ended up in labs across the world. Her cells were essential for developing the polio vaccine, several cancer treatments, in vitro fertilization, and cloning. Yet her contribution was not recognized for decades, while her family members lived in poverty and couldn’t afford healthcare.

In a recent paper published in the Journal of Law, Medicine, & Ethics, Rao wrote that even in cases where informed consent was obtained from the subjects of medical research, the doctrine of informed consent is a collective fiction. It “thinly masks the uncomfortable fact that the subjects of human research are not actually afforded full information regarding the types of research that may be contemplated, nor do they provide meaningful consent,” she wrote.

Rao proposes that since informed consent fails to provide adequate protection to the donors of biological materials, it might be better to assign property rights to those who donate biological materials and data. “The reluctance to invoke property probably stems from fears of resurrecting slavery and the commodification of human beings,” she wrote. But ironically, not allowing property rights for body materials leads to new forms of exploitation, Rao asserted. Human research subjects should be able to “control the course of research, and to share in the resulting benefits or profits,” she wrote.

These concerns are top of mind for Stephanie Alessi Kraft ’13, an acting assistant professor at the University of Washington School of Medicine in the division of bioethics, in the Department of Pediatrics. She regularly consults with practicing physicians about bioethical issues and helps design empirical bioethics research. Kraft understands that ethics can become blurry when clinical institutions are working with corporations to collect data for research purposes.

“We want to make sure that the institutions running the research are trustworthy and that they treat patients in the way they want to be treated,” she said. But avoiding another Henrietta Lacks situation doesn’t mean that vulnerable populations should not be included in clinical studies.

It’s important for medical research to collect data from diverse populations so that variation in disease and treatment across human populations isn’t generalized based on research with only one group. “That affects the quality of the data if we are not representing the full spectrum of subjects,” Kraft said. Yet achieving truly protective informed consent is challenging when working with less-educated subjects, those with low literacy, or non-English speakers.

For a genomics technology research project with the Clinical Sequencing EvidenceGenerating Research (CSER) consortium in Denver, Kraft is creating new study materials that are designed for those who have little science background. “A lot of informed consent documents are written at a high reading level, so we are working on conveying the specifics of genetic research so that it is more accessible and complete,” she said.

Patients in primary care clinics will be given a family history assessment tool to see if there are hereditary cancers among genetic relatives. If patients screen positive for these, their blood will be taken for a targeted gene sequence panel. Then, patients can choose to be informed of some secondary findings and their carrier status. Patients will also be offered genetic counseling to discuss the findings, which may help them enjoy better health in the future. Researchers will use the data from the study to learn more about patterns in cancer genetics. Kraft hopes that if patients know that the institution is trying to be trustworthy, they will feel respected.

Rao applauds this but still thinks that the laws governing medical data need to change. Time and again, the practice of obtaining informed consent has been less than ideal, and those who give biosamples don’t usually profit from them. She points to how Brazil handled the exploitation of its indigenous population when their blood samples were taken by drug company researchers under unethical circumstances. “They’ve completely outlawed any kind of biopiracy unless the company shares 1 percent of the profits from what is developed with the state,” she said.

Brazil’s approach is only one way to handle the dilemma. “There are different ways to propertize that we should explore,” Rao said. “From property in a public trust where citizenry share rights, to startups implementing property rights on biomaterial and genetic info, we have alternatives to informed consent that could provide even more benefits to patients and research subjects helping to develop personalized medicine.”

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