Can We—and Should We—Ensure Genetic Privacy?

Faced with the specter of people unable to get insurance or jobs because of their genes, state legislatures around the country have begun passing laws to prevent this sort of genetic discrimination. Such efforts are admirable, the workshop members agreed, but they can unwittingly go too far. In particular, when legislators move beyond banning genetic discrimination to trying to establish some sort of genetic privacy, their efforts are likely to run into complications.

The idea itself is beguiling: set up a wall around a person's genetic information so that no one can access or exploit that information without the person's express consent. But ensuring genetic privacy is not as simple—or as desirable—as it sounds. The workshop participants described several dilemmas.

One practical difficulty is that it is nearly impossible to say where "genetic" information stops and other medical information begins. "There is no feasible operational way that you can carve genetic information out of the medical record for purposes of rational legislative or regulatory oversight," said David Korn of the American Association of Medical Colleges. "You just cannot do it. And yet so much of the public debate has been focused on these terms as though they were in fact discrete and unambiguous elements that could be grabbed, bounded and managed. I think the more we continue to go that route, the more confused and impassioned this debate is going to be."

Vicky Whittemore of the National Tuberous Sclerosis Association offered a concrete example of what Korn was talking about. "You cannot walk into a doctor's office and get a genetic test for tuberous sclerosis," she said, noting that one of the genes that causes tuberous sclerosis was identified only last August. So it is not possible for a person's medical file to contain "genetic" information about the presence of the disease, at least in the sense of a genetic test that



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--> Can We—and Should We—Ensure Genetic Privacy? Faced with the specter of people unable to get insurance or jobs because of their genes, state legislatures around the country have begun passing laws to prevent this sort of genetic discrimination. Such efforts are admirable, the workshop members agreed, but they can unwittingly go too far. In particular, when legislators move beyond banning genetic discrimination to trying to establish some sort of genetic privacy, their efforts are likely to run into complications. The idea itself is beguiling: set up a wall around a person's genetic information so that no one can access or exploit that information without the person's express consent. But ensuring genetic privacy is not as simple—or as desirable—as it sounds. The workshop participants described several dilemmas. One practical difficulty is that it is nearly impossible to say where "genetic" information stops and other medical information begins. "There is no feasible operational way that you can carve genetic information out of the medical record for purposes of rational legislative or regulatory oversight," said David Korn of the American Association of Medical Colleges. "You just cannot do it. And yet so much of the public debate has been focused on these terms as though they were in fact discrete and unambiguous elements that could be grabbed, bounded and managed. I think the more we continue to go that route, the more confused and impassioned this debate is going to be." Vicky Whittemore of the National Tuberous Sclerosis Association offered a concrete example of what Korn was talking about. "You cannot walk into a doctor's office and get a genetic test for tuberous sclerosis," she said, noting that one of the genes that causes tuberous sclerosis was identified only last August. So it is not possible for a person's medical file to contain "genetic" information about the presence of the disease, at least in the sense of a genetic test that

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--> pinpointed the faulty gene. "However," she continued, "if I am diagnosed with tuberous sclerosis clinically because I have had an MRI of my brain, an echocardiogram of my heart, and I have had a skin exam, then that information is in my medical record. And the words 'tuberous sclerosis' written in my medical record are genetic information. So, with respect to laws being proposed to separate genetic information from medical information, in many cases that is impossible, without going back and erasing the words 'tuberous sclerosis' out of my medical record wherever they appear." In short, much of the standard information in medical records is actually genetic in nature, although little of it today actually derives from genetic testing. At first glance, it might seem possible to guarantee privacy for only that information which comes directly from testing a person's DNA and leave other medical details, even those with genetic implications, alone. But that too is impractical, for a different reason. As researchers learn more and more about the genetic contributions to disease, that knowledge will become an increasingly important part of treating disease. For example, Edward Penhoet of the Chiron Corporation in Emeryville, California, spoke of "the progress which is being made in identifying tumors very carefully from a genetic point of view so that when we treat the tumors we will have the maximum amount of knowledge available to us for that treatment." A doctor might know, for instance, that breast tumors in women with one particular genetic mutation would shrink rapidly when exposed to Drug X, while tumors in women with a second mutation would shrug off Drug X but respond well to Drug Y. Thus the results of the genetic test would need to be an integral part of the medical record. "The more information the better if you are trying to treat an individual patient," Penhoet said, "but it seems to me that we are spending a lot of time creating barriers to the truly valuable aspects of this which will come in the near term when we are able to describe each person in much greater detail and therefore customize treatment to individual people in a way that makes treatment much more effective for a variety of different diseases." Regulations that wall off a certain amount of information in the name of genetic privacy would "compromise our ability to address the truly more important issue, which is how you use all this information to develop medical treatments which are much more specific, much more targeted, and therefore much more effective." More generally, Korn said, the urge to create a right to genetic privacy betrays a lack of understanding of how the American system of health care and biomedical research operates. "I think of the system as one in which there is a set of overlapping, interlocking activities among which there has got to be a very low impedance flow of information in order for the system to work." Anything that blocks that flow of information, such as strict regulations regarding the use of human genetic data, will inevitably hurt the effectiveness of both research and medical care, he said. "I think people don't understand the degree to which both

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--> The Dark Side of Genetic Privacy Frederick Anderson, an attorney with Cadwalader, Wickersham & Taft in Washington, D.C., offered a perspective on the problems of genetic privacy quite different from those of the biomedical researchers at the workshop. As genetic information becomes more plentiful and more precise, he said, it will become much more valuable and much more coveted. Passing laws that give an individual total control over his genetic information would create enormous tensions between the individual and the people and groups that would like to—or might even need to—get access to that information. "I predict black markets in information," Anderson said. "I predict squabbles between spouses because the husband or wife never reveals the condition that they by law are entitled as an individual in a rights-based culture to keep secret. They haven't shared with their family. They haven't shared even with their own physician, with whom they are thrust into an adversarial posture because of the kinds of laws we are drafting. And they certainly haven't shared that information with their insurers or their employers." "The fact is, though, we as human beings in a society need to have that information available to precisely that list of role players with whom we are not willing to share the information." Spouses will want to know before they decide to have children if their partner has a genetic disease. Doctors will need as much genetic information as possible to perform the best treatments. And that information will inevitably go into the medical record, which insurance companies and employers will demand to see. ''So," Anderson said, "we are going to end up coming back to some kind of socially acceptable way to have the information shared, including with insurers.'' Simply creating a right to genetic privacy is a recipe for decades of legal wrangling, which would keep lawyers like Anderson busy but would not be in the best interests of anyone else. the American health care delivery system and the vast array of medical research have to have access to records and samples and other archival patient materials. So, with the best of intentions, some of these state initiatives begin with a call for preventing discrimination in the health insurance market specifically and then move on to large statements about disclosure of information that simply would tie everything up in knots. It would be like throwing sand in the gears if such language were applied as articulated. It just won't work, and I think the problem is that the people trying to do these things don't understand how the system works." Creating a right to genetic privacy will come at a price, Korn concluded, and that price will be to hamper the nation's system of medical care and research. "The issue then is where you draw the line between a low impedance free flow of information and a very high threshold barrier to inappropriate leakage, and that point has not been well defined in the public discourse." Up to now, he said, the debate has generally been presented as a choice between two extreme positions.

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--> "Either you don't want any barriers, which I don't think is politically viable, or you want barriers thrown in all over the place, which will bring the whole system to a halt." Ultimately, he said, finding the best solution will depend upon understanding the system and the various tradeoffs involved, debating those tradeoffs, and finding a balance between the desire for genetic privacy and the desire for continued improvement in the nation's health care system.