Successful preimplantation genetic diagnosis (PGD) to avoid creating a child affected by a genetically-based disorder was reported in 1989. Since then PGD has been used to biopsy and analyze embryos created through in viuo fertilization (IVF) to avoid transferring to the mother’s uterus an embryo affected by a mutation or chromosomal abnormality associated with serious illness. PGD to avoid serious and early-onset illness in the child-to-be is widely accepted. PGD prevents gestation of an affected embryo and reduces the chance that the parents will be faced with a difficult decision of whether to terminate the pregnancy. More controversial have been PGD to select the sex of the child-to-be for “family balancing” (rather than to avoid a sex-linked disorder), PGD for mere susceptibility to disease and for late-onset disorders such as Alzheimer diseas, and most controversially, PGD to create a donor child who is Human Leukocyte Antigen (HLA-matched with a preexisting sibling in need of stem cell transplant.

The treatment of pregnant women addicted to drugs provides an especially important and illustrative example of how political and popular demands can successfully challenge professional ethical norms associated with clinical medicine — norms such as confidentiality, patient autonomy, and the right to consent to and to refuse treatment. One increasingly popular policy approach is to limit patient autonomy by coercing women in an attempt to change their behavior, either by involuntary civil commitment or by imprisoning them for drug abuse or child neglect. Thirty-five states have criminally prosecuted women for substance abuse or alcohol use during pregnancy. Other states aggressively use involuntary civil commitment as a means to protect the yet-to-be-born from harm during pregnancy. Medical professionals have been forced to participate in these programs by mandatory reporting requirements.

Policymakers use financial incentives to achieve a wide variety of public objectives, from pollution reduction to the employment of welfare recipients. Combining insights from economic theory with lessons learned from actual implementation, this article analyzes the implications of two such policies: first, subsidizing contraception, and second, offering financial incentives to individuals for sterilization or for using a long-term, semipermanent method of contraception such as the Intra-Uterine Device (IUD), Depo-Provera or Norplant. These subsidy and incentive policies achieve their goals through a myriad of individuals who make their reproductive choices in response to particular costs and benefits. Such programs are ethically and politically controversial. In this paper, I address the question of whether they can be justified either economically or ethically.

The first section of this article presents an economic theory to assess whether a subsidy, tax, or incentive is economically efficient, both generally and in the context of contraception.

The increasing life expectancy of terminally-ill people has raised many public policy concerns about end-of-life care. Due to increased longevity and the lack of cures for illnesses like cancer and heart disease, palliative care, particularly pain management, has become an important mode OF medical therapy. Palliative care providers feel that “[h]ealth care professionals have a moral duty to provide adequate palliative care and pain relief, even if such care shortens the patient’s life.” Practitioners of forensic medicine grapple with determining when to classify the death of a person formerly receiving palliative care as a non-natural death. Such classification may be paramount in the enforcement of new statutes that aim at preventing assisted suicide or monitoring the quality of health care, but it potentially places forensic medicine and palliative medicine in adversarial roles.

The potential power of predictive genetic testing as a risk regulator is impressive. By identifying asymptomatic individuals who are at risk of becoming ill, predictive genetic testing may enable those individuals to take prophylactic measures. As new therapies become available, the usefulness of genetic testing undoubtedly will increase. Further, when a person's family medical history indicates a propensity towards a particular genetic disease, a negative test result may open up otherwise denied opportunities by showing that this person has not inherited suspect genes. In the latter type of case, a negative test result may reassure the individual that pursuing a particular course of action (such as planning a family or training for a job) is worthwhile, or may convince prospective employers that the individual will be a serviceable employee.

Population genomics seeks to better understand genomic diversity and variation at the level of populations. Numerous ethical questions are raised by large studies of human genomic diversity. First, at the level of ethical means, the confidentiality of the genetic data obtained and its handing (data banks, access, involvement of private sector, etc.) are challenging. Second, at the more fundamental level of ethical goals or ends, we find questions concerning the meaning and the interpretation of genetic knowledge. What shall we do with this knowledge? Who will decide research orientation and priorities? Ethical questions raised by population genomics imply those of “classical genomics,” but they have the additional ethical complexity of research done on populations. How should we take this particular aspect into account?

Over the past 5 years, a series of articles in leading American newspapers has revealed the extent to which the conduct of clinical trials may be affected by inducements offered by corporate research sponsors and accepted by some unscrupulous physicians. The cases described were disturbing. They involved physicians engaged in excessive “enrollment activities” in exchange for money. Some of these physicians perpetrated fraud, falsifying their recruitment records in order to increase their profits. Others ignored exclusion criteria designed to ensure the safety of subjects and the validity of research results, referring their patients to research investigating treatments for conditions from which they did not suffer. One of the articles reports that physicians focusing exclusively on commercial research regularly divulge annual incomes upwards of $1,000,000 with profits in excess of $300,000. Two physicians accumulated well over $10,000,000 through clinical trials activities in less than a decade.

The highly publicized deaths of research participants Ellen Roche and Jesse Gelsinger are stark reminders that risk is inherent in medical research and while untoward outcomes are infrequent when compared to individual and societal benefits, injury and even death will happen. Who is responsible for the welfare of research subjects and what are they owed? Why were they put at risk to begin with? Are obligations, if any, to research subjects dependent on the type of study in which they participate, in recognition that there may be personal benefit from participation in some studies?

The issue of injury resulting from participation in research and answers to questions such as those just posed were last considered in depth nearly 20 years ago by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.

In the past ten years, there has been growing interest in and concern about protecting the privacy of personal medical information. Insofar as medical records increasingly are stored electronically, and electronic information can be shared easily and widely, there have been legislative efforts as well as scholarly analyses calling for greater privacy protections to ensure that patients can feel safe disclosing personal information to their health-care providers. At the same time, the volume of biomedical research conducted in this country continues to grow. The budget of the National Institutes of Health, for example, was $20,298 million in 2001, having more than doubled from a budget of $9,218 million 10 years before. This growing body of research includes increased efforts to use stored medical records as a source of data for health services, epidemiologic, and clinical studies.

Because research involving human subjects exposes people to risk not always for their own potential benefit, the question arises as to how best ensure that: (1) research participants are protected and benefited according to the highest ethical standards, while, on the other hand, (2) researchers are protected and free to do research that will produce clinical advances for both research participants and society as a whole.

The balancing of the risk to research participants versus the benefits derived from the research is performed in many counrries by a system for the protection of human research participants that is laid out in national laws and regulations. In the United States, this system is based on principles emanating from the Nuremberg Code, the World Medical Association Declaration of Helsinki,and the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the Belmont Rept).

Intellectual property in biotechnology invention provides important incentives for research and development leading to advances in genetic tests and treatments. However, there have been numerous concerns raised regarding the negative effect patents on gene sequences and their practical applications may have on clinical research and the availability of new medical tests and procedures. One concern is that licensing policies attempting to capture for the benefit of the licensor valuable rights to downstream research results and products may increase the financial risks and cliniinish potential payoffs of — and therefore motivation for — performing downstream research and development. In addition, very broad patent claims allowed by the U.S. Patent and Trademark Office, the sheer growth in patents claiming genetic sequences, and threats of overlapping patents create a veritable minefield for researchers in both academia and industry. The concern is that research may be stifled because of the high cost and hassle of negotiating access.

In financial disputes involving research, the parties are traditionally individual researchers and their institutions, biotech and pharmaceutical companies, and other entities engaged in the commercial development of biomedical research. Occasionally, research subjects claim that researchers have misled them or misappropriated their biological materials to derive financial gain. The best known example is the case of Moore v. Regents of the University of California, decided in 1990.

With new developments in genomics, large-scale repositories of tissue and other biological specimens are increasingly important. Biobanks have been established by various researchers, commercial entities, health-care institutions, and even entire countries. Individuals who contribute specimens almost always retain no commercial interest in any resulting research and language to that effect is now customarily included in informed consent documents signed at the time the specimen is given. Suppose, however, that the research subjects actually collect the specimens themselves, recruit the researcher, and provide financial support for the research.

In Ferguson v. City of Charleston, the Medical University of South Carolina (MUSC) developed a policy in conjunction with police and prosecutors that requires pregnant and post-pregnancy women to be tested for cocaine in their urine if they presented with certain factors. If the patient is still pregnant, her first positive test results in referral to a substance abuse program. After a second positive test, or upon failure to comply with the substance abuse program, the woman would be arrested. If a patient tested positive upon delivery of her baby, she would be arrested “as soon as medically possible.” A Solicitor’s Letter given to and signed by each woman after her first positive test explains these comequences. Concomitantly, a letter given to all patients receiving prenatal care informs them of the effects of drug use and warns of possible referral to the prosecutor’s office.

In State v. McKnight, the Supreme Court of South Carolina decided 3-2 to affirm McKnight’s conviction for homicide by child abuse based on the finding that her cocaine use during pregnancy caused her daughter to be stillborn. Under South Carolina law, a person is guilty of homicide by child abuse if he or she “causes the death of a child under the age of eleven while committing child abuse or neglect, and the death occurs under circumstances manifesting extreme indifference to human life.” During the trial, the pathologist who conducted the autopsy testified that (1) the only way for the infant to have cocaine byproducts present in her system was ifthe mother had ingested cocaine, and (2) the cause of death was intrauterine fetal demise. Another pathologist testified that there was a reasonable degree of medical certainty that the cause of death was intrauterine cocaine exposure.

In February, the Food and Drug Administration announced a rule imposing new manufacturer labeling requirements for antibiotics. The aim of the new standards is to educate physicians and patients about the dangers of improper antibiotic use. Overprescription of antibiotics, as well as patient failure to comply with treatment regimens, has led to the development of drug-resistant bacteria. “Antibacterial resistance is a serious and growing public health problem in the United States and worldwide,” FDA Commissioner Mark McClellan said in a press release accompanying the rule. “Without effective antibiotic drugs, common infections, that were once easily treated, can create a serious health threat to children and adults alike.”

The FDA regulates foods, drugs, and cosmetics introduced into interstate commerce for safety and effectiveness. Currently, the agency requires drug labels to provide “adequate directions for use,” including indications, quantity of dose, frequency, duration, route, and preparation.