Will Whole-Genome Sequencing Create New Liability Woes for Physicians?

What's to come?
Nov. 25 2011 12:21 AM

The Doctor Will See Your Genome Now

Will whole-genome sequencing create a new liability tsunami for physicians?

This article arises from Future Tensea collaboration among Arizona State University, the New America Foundation, and Slate. Future Tense explores the ways emerging technologies affect society, policy, and culture. To read more, visit the Future Tense homepage and the Future Tense blog. You can also follow us on Twitter.

111010_FUTURE_docPatient
As genome sequencing becomes more affordable, more patients are going to be asking doctors very difficult questions

Photo by iStockphoto.

Just over 10 years ago, the sequencing of the first human genome was announced at a White House press conference. In the decade since, the practical application of genomic information has been disappointingly slow. That is about to change. We are rapidly—much faster than many anticipated—approaching the widespread clinical use of whole-genome sequencing. WGS involves the complete sequencing of all 6 billion-plus base pairs of DNA in our individual genomes. Just 10 years ago, it cost $100 million to sequence an entire genome. Today, WGS is commercially available for less than $10,000, and several companies are racing to get the cost below $1,000 within the next few years. The $1,000 price tag is the magical flip point at which the National Institutes of Health and many experts in the field believe WGS will be economically feasible for routine use in medical care.

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Though we haven’t reached that $1,000 milestone yet, WGS is already being rapidly adopted across the country. In 2009, fewer than 100 people had ever undergone WGS, but that number jumped to more than 2,000 in 2010 and is expected to reach 30,000 this year. The accelerating adoption of WGS brings with it much promise, but as with any rapid technology change, it will also have disruptive consequences, at least in this transition period. Unfortunately for doctors, they will likely bear much of the brunt of this disruption.

On the positive side, a number of patients have already reaped dramatic benefits from WGS. A 6-year-old Wisconsin boy received a life-saving umbilical-cord-blood transplant after WGS showed that a unique DNA mutation was responsible for his mysterious bowel disease. A pair of 14-year-old San Diego twins suffering from a debilitating movement disorder were successfully treated after WGS revealed they had a rare mutation that could be corrected by a simple amino acid supplement. A family of four in Silicon Valley recently underwent WGS, revealing that a teenage daughter had several mutations putting her at high risk of blood clots. That information will help let her doctors treat her before the blood clots become a problem, instead of only when the damage has been done. More generally, a growing number of cancer patients have benefited from tailored therapies based on new mutations in their tumor discovered by comparing the complete genomes of their healthy cells with those of their tumor cells.

Given these dramatic successes, it seems clear that WGS is going to be good for patients, enabling them to receive treatment tailored to their personal genetic makeup. However, should genomic sequencing become nearly as routine as, say, a colonoscopy or cholesterol check, doctors—most of whom have no formal genetics training—may find themselves in a precarious position. These doctors may be extraordinarily vulnerable to lawsuits regardless of whether they embrace or resist the use of WGS with their own patients. While other players such as the testing labs may also be subject to lawsuits if they negligently conduct or interpret genetic tests, it is doctors who will be required to communicate and explain test results to patients, which is the step that involves the greatest duty to the patient and carries the biggest risk of liability. 

As with any new technology, many doctors will resist adopting WGS, at least initially. As the cost of sequencing continues its precipitous decline, and ever-more doctors and patients use the technology, the performance gap between those who adopt it and those who resist will inevitably grow larger. At the same time, many courts are moving toward a national rather than local standard of care. Essentially, this means that doctors, whether they work in underfunded hospitals or prestigious academic medical centers, are expected to offer the same quality of care. Let’s say that two patients, living across the country from each other, are suffering from the same medical problem. The one in a rich, technology-friendly hospital is offered WGS by her doctor. Her life is saved as a result. But the other patient, either because his hospital doesn’t have the resources or because his doctor is not comfortable with WGS, doesn’t have the test and dies as a result. That doctor may be now be liable for that patient’s death.

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