Appendix C A Comment by Frederick R. Anderson

Our society's initial attempt to resolve issues of privacy in biomedical and clinical research is off to a poor start. We are drafting statutes to create many new rights for research subjects and new duties for biomedical institutions. Perhaps it was inevitable that we would focus on defining privacy and property rights for research subjects, because our law already contains a vast arsenal of private rights to protect individuals from community coercion. Democratic government uses the engine of political struggle between competing factions to power law making. We have a rich and evocative language for rights-based public discourse that can be quickly mobilized when the interests of society and the individual appear to be about to collide.

We are justifiably proud of a political heritage that includes federal and state bills of rights, statutes to protect groups within our society from discrimination and to provide them the opportunity to succeed, and, yes, an already-impressive body of law and practice to protect research subjects and patients from institutional abuse. Yet we live in a time when rights-based approaches sometimes overwhelm community interests. We need to restore the balance between individual rights and social responsibility in the policies we adopt, including, as David Korn put it, selecting the right "equipoise" between protecting the privacy and rights of research subjects and patients, on the one hand, and the need for data that will enable biomedical research to advance, on the other.

At present, our lawmakers may be on the verge of a proliferation of rights that may delay striking the optimum balance for years and may impede biomedical research with little gain in the protection of individual research subjects. Worse, the current rights-based political discourse seems to drive stakeholders



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--> Appendix C A Comment by Frederick R. Anderson Our society's initial attempt to resolve issues of privacy in biomedical and clinical research is off to a poor start. We are drafting statutes to create many new rights for research subjects and new duties for biomedical institutions. Perhaps it was inevitable that we would focus on defining privacy and property rights for research subjects, because our law already contains a vast arsenal of private rights to protect individuals from community coercion. Democratic government uses the engine of political struggle between competing factions to power law making. We have a rich and evocative language for rights-based public discourse that can be quickly mobilized when the interests of society and the individual appear to be about to collide. We are justifiably proud of a political heritage that includes federal and state bills of rights, statutes to protect groups within our society from discrimination and to provide them the opportunity to succeed, and, yes, an already-impressive body of law and practice to protect research subjects and patients from institutional abuse. Yet we live in a time when rights-based approaches sometimes overwhelm community interests. We need to restore the balance between individual rights and social responsibility in the policies we adopt, including, as David Korn put it, selecting the right "equipoise" between protecting the privacy and rights of research subjects and patients, on the one hand, and the need for data that will enable biomedical research to advance, on the other. At present, our lawmakers may be on the verge of a proliferation of rights that may delay striking the optimum balance for years and may impede biomedical research with little gain in the protection of individual research subjects. Worse, the current rights-based political discourse seems to drive stakeholders

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--> apart, exaggerating—perhaps even on occasion creating—differences that could be reconciled if we placed somewhat less emphasis on rights to privacy and property and more emphasis on opportunities for shared responsibility in relieving genetically-based human suffering. This perspective has practical implications for current legislative debates about the rights of research subjects. Legislation can be drafted that strikes an appropriate balance and lays the foundation for incentive-based cooperation between research subjects, families and genetically-related groups, researchers, care providers, insurers, employers, and family planning counselors. My plea for balance between rights and responsibilities may perhaps be dismissed as the idealistic musings of a disaffected attorney. I must sound positively disloyal to others of my ilk whose bread-and-butter, like my own, is rights-based statute-drafting, regulatory representation, and litigation. Yet, the case can be made on purely practical grounds that the course on which we have embarked will fail, and that eventually we will want to strike a more publicly minded "equipoise" between individual rights and the overall community interest. Let me elaborate. Some stakeholders, including some researchers, seem intent on erecting a legal wall with genetic information about individuals on one side of the wall, and insurers, employers, researchers, medical caregivers, and even spouses, children, and other family members on the other side.* At the conference, Susan Rose stated that "privacy does not exist," i.e., cannot be guaranteed. I believe that individual genetic information (especially for research purposes) can be kept confidential and that practical measures can be put in place to ensure confidentiality, at least so far as our current genetic database is concerned. However, as time passes, the amount and value of genetic information will assume enormous proportions. At some relatively proximate time in the future, after (1) a substantial number of the estimated 4,000 genetic diseases is mapped, (2) genetic predisposition to disease and injury is better understood, and (3) a significant part of a person's ordinary medical care becomes genetics-based, the pressure to use this wealth of information in health care delivery, family planning, employment decisions, and life and health insurance will be overwhelming. Statutory prohibitions against the use of a large genetic database are unrealistic and will engender abuse, covert markets in information, litigation to vindicate (or abrogate) rights, and an intolerant climate for additional research. We cannot pursue the genetics revolution while simultaneously erecting legal barriers to its practical use. I agree that genotype and phenotype are not deterministically linked by rigid cause-and-effect. A person's genome never will be to a person what a blueprint *   To summarize for emphasis: an individual may refuse genetic testing; may permit it but ask not to be told the results; may receive the results but not have to act on it; may deny or subsequently withdraw access to test results and samples to anyone; and may bargain financially without limit for the use of test results and bodily samples.

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--> is to a house. Still, a major (if not the major) goal of genetic research is to increase the statistical correlation between genotypical and phenotypical attributes. At some point in the future (and where genetics research is concerned, the future always arrives sooner than expected), the practical value of genotypical information will be overwhelming. At that time, it will become morally indefensible not to use that information in making health care, family, and estate planning decisions for oneself and one's family, and accurate use of that information by employers and insurers cannot continue to be called ''misuse'' or "discriminatory." The current state of affairs is revealed in the intensifying debate over what constitutes a patient's "medical record" and what should and should not be included in it. We gave this issue serious attention at the workshop. Two observations seem in order about the genetic medical record. First, medical records seem headed down the same path as legal records. We appear to be moving into an era of formalistic, even adversarial, medical record keeping. We focus more and more on how prejudicial, discriminatory, or injurious to one's privacy interests the contents of the medical record may be, and less on how that record may best serve the patient and society. Hospital staffs, researchers, and legislators are beginning to discuss the "medical record" much the same way we attorneys discuss the "legal record," which in regulatory rule makings, trials, and appeals is the critical repository of information on which a regulatory or judicial decision must be based. Lawyers spend a great deal of time and energy sparring over the contents of the record, because the decision maker cannot "go beyond the record" in deciding important questions about life, liberty, and property. We may be headed into an era when the contents of the patients' medical record are defined by elaborate rules. Second, recently proposed legislation on genetic information may thwart informed decision-making based on the medical record, by keeping some of the most vital data out of the record if the patient so desires. Yet where else but in the medical record should the most valuable information for the most important decisions we can make about treatment be located? A family lockbox? The black market? Word-of-mouth? We may be perversely reversing the incentives we should be creating: complete records shared with family members, care providers, researchers, family planners, insurers, and attorneys. It became clear at the workshop that the impact of legislation drafted primarily to prevent insurers from denying coverage may "spill over" into biomedical research, with researchers swept along with insurers in being denied access to genetic data. Because of its pivotal role in the current debate, insurance deserves special mention here. The current consensus appears to be that an insurer should be denied access to genetic information that could cause it to deny life or health coverage for an individual and/or relative whose genetic profile suggests an uninsurable risk. Commentators, including the leadership of the Human Genome Project, brook

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--> little willingness to consider any possibility other than making denial of insurance in such circumstances strictly illegal. Such a policy makes sense only in the short run. In the long run, the imbalance of knowledge between insureds, who will hold all the cards, and insurers, who will be denied any by law, would likely bankrupt the insurance industry. We were told at the workshop that preliminary studies of carriers of the BRCA1 and 2 genes who are at greater risk of breast cancer indicate that insureds do not purchase coverage that takes their greater risk of cancer into account. Yet assume that I am a married forty-year-old with three children and a genetic profile that suggests a 70 percent likelihood I will die in my fifties after a long and costly illness. Would it be responsible of me to purchase insurance coverage as if I had an average life and health expectancy? I would be more likely to buy the health and life insurance my condition and family needs suggested, and at very favorable rates, because my insurers would be denied genetic information that would assist them in predicting both their higher outlays for my medical care and the shorter time my invested premiums would earn a return. As Cynthia Kenyon suggested at the workshop, perhaps national health insurance will receive support as the way to spread the financial impact of genetic risk. Dr. Kenyon suggested genetic testing could be made a condition of national coverage, thus removing the financial incentive to conceal genetic data—a boon to care providers, researchers, and others, although not necessarily to citizens as employees. Yet Dr. Kenyon's proposal for national health insurance raises numerous societal concerns best reserved for debate another day. Substituting a government program for existing market-based approaches raises questions about efficiency, tax policy, bureaucracy, and flexibility that buck the current trend toward privatizing, not socializing, social services. The nation's experience with the federal vaccination injury compensation scheme, the federal Black Lung compensation program, and other funds that have attributes of Dr. Kenyon's proposal has been expensive and troubled, to say the least. Another possibility exists that is more consonant with the approach advocated in beginning this comment. That is to afford insurers an opportunity to develop entirely new products, in competition with each other, and in collaboration with their customers and their families, health care providers, and a new generation of family financial advisers who are sure to arise as the genetic revolution continues. If insurers can meet the challenge that is currently viewed as the most difficult to resolve, i.e., providing affordable privately financed insurance that takes account of the insured's genetic profile, then issues about access to genetic data for research, and about complete and accessible medical records for treatment and family planning, should be easier to resolve. It remains to be seen if insurers are up to this challenge. But they should be afforded the opportunity before the knowledge imbalance I alluded to earlier overwhelms the industry and non-market schemes such as national health insurance begin to receive serious attention.

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--> At the workshop, David Korn was correct that practical, effective means exist at present to protect research subjects from stigma or penalty, through degrees of "anonymization" (my noun, not his) of medical records. If I correctly read the workshop, his position captured the desire, if not the actual agenda, of most workshop participants. As a lawyer who works in the legislative and regulatory arenas of Washington, it struck me that the various institutions and points of view represented around the table could form an effective coalition, not only to ensure that legislation and regulation do not needlessly impede genetic research, but also to advance a more cooperative, responsibility-based social response to the genetic revolution. Many of the organizations represented have their own efforts under way in support of responsible privacy measures to protect research subjects from harm. Yet the patients' groups, private and public research institutions, professional associations, companies, and agencies present represented a potential coalition whose impact could be greater than the sum of its parts.