Canadian Lawyer

Genomic Bubble" where the authors, one of whom was Timothy Caulfield, Canada research chair in health law and policy at the University of Alberta, wrote: "If we fail to evaluate the considerable promise of genomics through a realistic lens, exaggerated expectations will undermine its legitimacy, threaten its sustainability, and result in misallocation of resources [and] . . . fuel unrealistic expectations for predictive genetic testing and uncritical translation of discoveries." The reason for what might be called genetic a genetics has proven to be complication incarnate. Cancers can have one kind of genetic makeup if situated in one place in the body, and quite another if they have metastasized to a different locale. Hundreds of genes have been associated with common diseases, each of which add or decrease by a few percentage points your risk of getting the disease, but are so common — some found in upwards of 50 per cent of people — that they must also be doing something very health positive in the body. The compli- cations are so intrinsic and so knotted that in 2010, Harold Varmus, director of the U.S. National Cancer Institute, dismissively told the New York Times, "Genomics is a way to do science, not medicine. counter-revolution is that hoping for genetically revolutionized medicine, except — and that is the point of this article — if one is looking at the gene-based diagnosis and personalized treatment of certain rare kinds of heart conditions known as arrhythmias. In that arena not only has medicine experienced a tsunami of change, but as you will see the social/legal/ethical quandaries which doomsayers in the past believed would bedevil lawyers and regulators are begin- ning to surge into view. And this potentially legal and ethically All true and all disappointing for those " fraught rare heart genetics revolution is of particular import in Canada. In this country, for a number of reasons — close kin marriages in some areas, active genetics research, and world-class heart institutes — we have become among the planet's leaders in both generating arrhythmia genetic advances and in gen- erating the extremely knotted sociology a genetics' revolution was supposed to bring forth. I will lead you through this but to give context as to what has been occurring you need some medical background. Arrhythmias are the electrical misfir- ings of the heart made famous by athletes trotting off playing fields, keeling over, and suddenly dying — often without any previous signs of illnesses. While physical heart changes are seen in some conditions, often an ECG or other imaging reveals nothing structurally wrong with the heart either before or after an attack. Effectively the heart battery just went dead. While the condition can be very rare agent is a loud noise; in a third it is the restlessness of early morning sleeping pat- terns. Their specific genetic fingerprint says that person A should take beta block- ers to ward off an attack and person B should have a defibrillator installed. Preventative measures can be taken in in the world population as a whole, strik- ing one in 2,000 to one in 10,000 peo- ple, they can be very much more com- mon in certain areas of this country. A Newfoundland variety of arrhythmogenic right ventricular cardiomyopathy (ARVC) has been diagnosed in about one in 500 people. Among the 5,400 Gitxsan aborigi- nals of northern British Columbia, the occurrence of people with the tribe' cial mutation of a long QT syndrome gene is one in 90. Unlike diseases such as Huntington' where a genetic test told carriers they would come down with a condition that medicine could do nothing to either fore- stall or cure, quite the reverse situation has occurred in many arrhythmias. For exam- ple, a heart attack is triggered in a geneti- cally distinct version of long QT syndrome by exercise; in another the heart-stopping s 32 M AY 2012 www. CANADIAN Lawyermag.com s spe- some instances even before the condition manifests itself. Doctors in Newfoundland are so confident they can associate disease appearance with genetics that they now routinely recommend that the boys in their late teens and girls in their late 20s who carry the gene for a local variant of ARVC have heart-restarting defibrillators implanted in their bodies. Even — the rest of the sentence must be written in bold- face — if they have no symptoms of the disease whatsoever. With this as a background let' at what I believe is the only actual judg- ment in the area, a 2006 decision by the Supreme Court of Newfoundland in the case B.D. v. Eastern Regional Health Integrated Authority, a St. John' s look complex. It pitted a 30-year-old ARVC-gene- s Hospital carrying man, who had had a defibrillator implanted in him, against his mother. The man wanted the defibrillator removed because, according to the judgment, "it adversely affects his life in other ways which makes its presence unacceptable to him." His mother panicked at what she saw as her son' to have the removal blocked by the courts. She feared that without the defibrillator s reckless action and sought

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