Maxwell J. Mehlman

Biogerontology, “Anti‐aging Medicine,” and the Challenges of Human Enhancement

Slowing the aging process would be one of the most dramatic and momentous ways of enhancing human beings. It is also one that mainstream science is on the brink of pursuing. The state of the science, together with its possible impact, make it an important example for how to think about research into all enhancement technologies.

The Shame of Medical Malpractice

Much of the rhetoric surrounding medical malpractice reform claims to address the unfairness of the current system. A 2003 report entitled Resolving the Medical Malpractice Crisis: Fairness Considerations identified factors that would make the system fair or unfair, analyzed the current system in light of these factors, and considered which reforms would make the system fairer. This article shifts the inquiry from objective to subjective fairness, that is, from reality to perception. Many physicians feel that the current system is unfair. Why? What is it about the current system that they feel is unfair?

Genetic Enhancement: Plan Now to Act Later

All three main articles in the issues of the Kennedy Institute of Ethics Journal endorse the view that genetic enhancement should be permitted, including human germ-line genetic enhancement. However, unregulated, wealth-based access to genetic enhancement in general, and germ-line enhancement in particular, would create intolerable risks for society. Although there are a number of practical problems raised by proposals to regulate or restrict access to genetic enhancement, which will make it difficult if not impossible to muster support for any effective restrictions until we begin to experience the societal problems that genetic enhancement will create, it is important to consider now what restrictions would be appropriate, how they would be imposed, and what changes would be needed in existing laws and institutions to facilitate them. Without this type of groundwork, there is no way society will be in a position to act in time.

Making All the Children Above Average: Ethical and Regulatory Concerns for Pediatricians in Pediatric Enhancement Research

Building on the knowledge generated by the long history of disease-oriented research, the next few decades will witness an explosion of biomedical enhancements to make people faster, stronger, smarter, less forgetful, happier, prettier, and live longer. Growing interest in pediatric enhancements is likely to stimulate the conduct of enhancement research involving children. However, guidelines for the protection of human subjects were developed for investigations of therapeutic modalities. To date, virtually no attention has been paid to whether these rules would be appropriate for investigations to establish the safety and efficacy of technologies intended for enhancement rather than therapeutic uses and, if not, whether ethically acceptable rules could be designed. This article discusses whether the current guidelines for pediatric research provide appropriate protections for pediatric subjects in enhancement research and considers what additional protections might be necessary.

When Do Health Care Decisions Discriminate against Persons with Disabilities

Recent interpretations of laws prohibiting discrimination against persons with disabilities indicate that these laws will play a greater role in health care decision making than previously anticipated. This article employs lessons from other areas of antidiscrimination law to examine these developments and to provide a framework for making health care decisions that are consistent with these new legal interpretations. This article addresses decisions in individual cases, treatment policies adopted by health care providers, and coverage programs of third-party payers, both public and private.

Wrongful Birth: Medical, Legal, and Philosophical Issues

“ W ’ rongful birth” is a controversial malpractice action, which has arisen in the past two decades, secondary to an expanding knowledge of human genetics and the constitutionally protected access to abortion. Under the wrongful birth claim, parents of a child with a congenital illness or abnormality may bring suit against a physician who allegedly failed to provide appropriate prenatal counseling or information. Typically, the parents claim that they were inadequately warned of a potential problem in their child, and that this paucity of timely information prevented them from avoiding the pregnancy or from obtaining an abortion. While these cases have arisen in a variety of clinical circumstances,’ a characteristic example is the obstetrician who fails to offer amniocentesis to a woman of advanced maternal age who subsequently gives birth to a child with Down syndrome. Since the parents were prevented from learning of the abnormality and therefore exercising the option to terminate the pregnancy, they may claim damages for themselves for the wrongful birth of the infant. These legal cases are relevant to the practice of medicine since they help define professional standards for what information physicians should know and offer to patients. Defining these standards in areas of medicine that pertain to reproduction is particularly difficult. The pace of discovery in human genetics has led to a rapidly expanding body of knowledge that relates to reproductive risks, making it difficult for physicians to incorporate this new information into clinical practice. Second, the subject of reproductive decisions, particularly abortion, is value-laden and continues to be the subject of divisive controversy. A principal use of prenatal information by prospective parents will be selective abortion. The wrongful birth concept requires that we define what physicians are obligated by law to tell prospective parents when the result might be the termination of the pregnancy. For example, and this goes beyond post-partum illnesses or abnormalities, should parents have a legal right to know if their fetus may suffer from an adult onset disease forty or fifty years in the future? This question takes us beyond the professional issues to the basic philosophical question of how much control parents should have over the genetic nature of their children. The wrongful birth claim raises a set of complex medical, legal, and philosophical issues that will become increasingly important and difficult as our understanding of human genetics improves. This article will provide an analysis of the significant issues raised by this claim, and we will identify key questions that require further research and debate. Wrongful birth suits must be distinguished from “wrongful life” and “wrongful pregnancy” suits. Wrongful life suits are brought on behalf of the impaired child against the physician, often as a companion suit to wrongful birth. These suits claim damages for the child for the negligent provision of information leading to his or her existence in an impaired state. Due to the problematic claim that the child would have preferred nonexistence to life with impairments, the wrongful life claim has met with limited success in the courts.2 Under the wrongful pregnancy claim, parents may allege negligence in the performance of a sterilization or an abortion procedure if, after the procedure, a healthy child is born. Although there are some issues in these claims that overlap with issues in wrongful birth, readers are referred to other reviews for a complete discussion of wrongful life and wrongful pregnancy suits.3

Ethical and Legal Issues in Enhancement Research on Human Subjects

The United States, along with other nations and international organizations, has developed an elaborate system of ethical norms and legal rules to govern biomedical research using human subjects. These policies govern research that might provide direct health benefits to participants and research in which there is no prospect for participant health benefits. There has been little discussion, however, about how well these rules would apply to research designed to improve participants’ capabilities or characteristics beyond the goal of good health. When mentioned at all in the literature, this so-called enhancement research, as opposed to research aimed at diagnosing, preventing, curing, or treating illnesses or medical conditions, is usually dismissed without explanation.

Predictive genetic testing in urology: ethical and social issues

In order to maximize the benefits of predictive genetic testing in urology, the potential ethical and social risks must be identified and minimized. Necessary steps include providing adequate information for patients and families; preparing them to receive test results; maintaining confidentiality to avoid social stigma and discrimination; preserving the principal of solidarity to provide assurances of medical care and social support for persons at risk of genetic illness; and avoiding inappropriate social pressure to prevent the birth of at-risk individuals. Health professionals must play a significant role in helping individuals, families, and society in general to make sound testing decisions and policy.

Assuring the Quality of Medical Care: The Impact of Outcome Measurement and Practice Standards

For the better part of the last decade, the major goal of health care policy has been to reduce health care costs. This has raised fears that the quality of care may suffer, as providers cut corners in response to cost containment pressures from the government and other third-party payers.’ These concerns over quality in turn have increased interest in the complex systems that monitor and regulate health care quality.2 Three main questions have been raised about the ability of the quality assurance systems to assure the quality of care. First, they may not be sufficiently effective, especially given the threat to quality posed by efforts to contain costs. For example, quality assurance has been criticized for focusing on a small number of aberrant physicians and hospitals-a so-called “bad apples” approach3-rather than on improving the overall quality of care and for failing to identify more than a handful of the poor quality providers believed to exist.4 Health care providerss also complain that quality assurance systems treat them unfairly. Physicians object to being evaluated by quality assurance personnel who are not physicians6 or by physicians whom they regard as unqualified to make quality determinations.’ Fairness issues are also raised by Medicare regulations that allow a provider to be sanctioned before receiving an administrative hearing.* Finally, questions have been raised about the costliness of the present quality assurance systems. The major mechanism by which the government assures the quality of care under Medicare-the Utilization and Quality Control Peer Review Organizations (PRO) programcosts approximately

Ethical, legal, social, and policy issues in the use of genomic technology by the U.S. Military

300 million a year.9 Not only are there complaints about the amount that is being spent to assure quality, but when viewed along with the perceived lack of effectiveness mentioned earlier, it is questionable that the current quality assurance mechanisms deliver enough quality bang for the buck.’O Two factors are primarily responsible for the perceived shortcomings of the current quality assurance system. First, it is extremely difficult to determine the impact of a provider’s care on a patient’s health statusthat is, to establish that there is a causal connection between the actions of a provider and the health of the patient, and to measure the effect. If a patient dies in a hospital, for example, the hospital cannot be accused of delivering poor quality care unless it can be shown that the patient died at least in part because of the hospital’s act or omission, rather than because of the patient’s underlying illness or condition or because of something some previous provider did or did not do.” By the same token, if an observed improvement in a patient’s health would have occurred regardless of the provider’s behavior, or was brought about by the behavior of a prior or subsequent provider, then the provider’s behavior did not cause the improvement and the provider cannot be given credit for it.12 Even if a causal link can be shown between the actions of the provider and the health of the patient, it is often difficult to determine to what degree the provider affected the patient’s health status. Much of the ineffectiveness, unfairness and costliness that are attributed to present quality assurance systems stems from the elaborate, expensive and often highly subjective methods that they rely on to establish causation and to measure the effect of provider behavior. The second factor that complicates quality assurance efforts is the difficulty of determining that the care the patient received, assuming that it produced an undesirable result, deviated sufficiently from what should have been provided that the quality assurance system should