Thirteen years after scientists mapped the human genome, a team of experts is working to sequence genomic law.
As the field of genomic medicine continues to grow, a study that started this month will examine current ethical issues and develop new legal recommendations. The study, named LawSeq, is funded by a $2 million grant from the National Institutes of Health. A team of 25 legal, medical and ethical experts from across the country will lead the three-year project.
“Our project is an effort to answer a crying need to update the law, to make the law genuinely responsive to what’s going on,” said Susan Wolf, the lead principal investigator and University law professor.
Genomic medicine allows for doctors to personalize medicine for patients, relying on genetic information to create individualized treatment for many diseases.
“Genomics is an area of incredibly fast-moving technology and science,” Wolf said. “And so the question of what is the standard of care that physicians and other clinicians and other genetic laboratories should be following at any one point is a really difficult question to ask.”
She said there are many issues — like caregiver liability, genomic information quality and needed regulations, privacy of genomic data and test results, genetic discrimination and the line between genomic research and clinical care — involved in genomic medicine that require careful legal and ethical consideration.
“All of these are what I think of as perfect storm questions. Questions that you need legal expertise, ethical expertise, clinical care expertise and science expertise to answer,” Wolf said.
As experts grapple with complex issues in genomic law, health professionals are still learning to understand how genomic medicine should be used, said Richard Sharp, director of the Mayo Clinic’s Biomedical Ethics Program.
“We just don’t quite understand what it is that we need to be concerned about at this stage and what might be more of a hypothetical concern that is unlikely to materialize,” he said. “And that very well may be the value of the project, to make these issues a little more tangible and clearer so we can begin a public discourse around them.”
Sharp does research that focuses on patients’ and practictioners’ views of genomic medicine. Despite the murkiness surrounding the field, he said patients tend to be very optimistic about the potential for genomic medicine, while health care providers may be more wary.
“Many physicians who trained 10 or 20 years ago got very little exposure to genetics as part of their med school training. And so this seems a little foreign to many physicians,” he said.
Sharp said that LawSeq is addressing “one of the most important issues in individualized medicine” by putting in a legal framework that will support the transition from research settings to clinical settings.
Dr. Geoffrey Ginsburg, the director of Duke University’s Center for Applied Genomics and Precision Medicine, said that genomic medicine is particularly useful in medical fields like oncology.
For more than 15 years, oncologists have looked at the changes in the genomes of cancer cells to find solutions and have found several mutations of cancer in this process, Ginsburg said.
“Companies have been able to develop a number of drugs that essentially target the biology that results in mutations, in a way that has resulted in targeted therapies for cancer,” he said.
In the decades to come, genomic medicine could lead the health field to focus on disease prevention rather than treatment, Ginsburg said.
“Our health care system is not focused on prevention, so I think a future state where [there are] more disease prevention activities will certainly be a product of the precision medicine strategy,” he said said.
Wolf said that another of the study’s goals is to create a publicly accessible “living resource” of genomic law data.
“I think right now the law of genomics for a lot of people is a black box — they don’t understand it at all,” he said. “Really all of this should be much more transparent to people.”
