In 1848 Dorothea Dix, the famous 19th century advocate for the indigent mentally ill, appealed to the United States Congress to support the setaside of a very large tract of land that was to be used for the “Relief and Support of the Indigent Curable and Incurable Insane.” She stated:

Over the past 20 years, international development assistance for health has increased, albeit for some diseases more than others. However, the triple crises of food, fuel, and finance have raised questions regarding whether aid flows will continue to increase, or even be maintained in the coming future. Health and education are often the first victims of budget cuts in times of limited funding and competing priorities as they are viewed to be in the realm of “low politics” as opposed to security and military spending, which are seen as “high politics.” Cuts in overseas development aid will have a drastic impact on countries where external funding makes up a significant proportion of national health budgets. Although global health aid accounts for only 0.3% of total expenditures on health globally (6.5% in sub-Saharan Africa), in some countries like the Solomon Islands and Mozambique, for example, 82% and 66% of the national health budgets respectively come from external resources. WHO estimates that 23 countries have over 30% of their total health expenditures funded by donors.

Embryonic stem cell (ESC) research has been a source of ethical, legal, and social controversy since the first successful culturing of human ESCs in the laboratory in 1998. The controversy has slowed the pace of stem cell science and shaped many aspects of its subsequent development. This paper assesses the main issues that have bedeviled stem cell progress and identifies the ethical fault lines that are likely to continue.

The time is appropriate for such an assessment because the field is poised for a period of rapid development. President Obama has removed the Bush administration’s restrictions on federal funding. A huge influx of federal research funds is in the offing and presumably a more rapid maturing of the science will take place. Stem cell science is also moving into the clinical realm. In March 2009, the Food and Drug Administration (FDA) approved the first clinical trial with an ESC-derived therapy for spinal cord injuries, an important first step — though by no means a final or a sure one — in moving ESC research out of the laboratory into clinical medicine. Finally, recent work with induced pluripotent stem (IPS) cells suggests that non-embryonic sources of pluripotent stem cells may one day be routinely available. Such a development will lessen the temperature of the ethical debate while raising other issues.

Since the fourth century, B.C.E., the Oath of Hippocrates has been the starting point in analyzing the obligations of physicians to protect the privacy and confidentiality interests of their patients. The pertinent provision of the Oath reads as follows: “What I may see or hear in the course of the treatment or even outside of the treatment in regard to the life of men, which on no account must be spread abroad, I will keep to myself, holding such things shameful to be spoken about.”

This part of the Oath is subject to more than one interpretation, but its commonly accepted meaning provides the ethical foundation for the physician’s duty of confidentiality. The Oath expressly declares that a physician’s obligation of confidentiality applies beyond matters of medical care. At a time when there were no hospitals or physician offices, patients received medical care in their homes or in public places. Physicians treating patients in their homes could be expected to see and hear a wide range of activities that might be considered embarrassing, immoral, or even illegal.

It is useful in an article of this kind to inform the reader of the author’s background, biases, and rationale for the format and content. As a clinically trained psychiatrist and addiction specialist/researcher, my training and experience have led me to best understand the “clinical side” of alcoholism and substance abuse. A large part of my career has been devoted to treating individuals with alcohol use disorders, especially in the context of clinical trials devoted to finding new medications to reduce craving, drinking, and preventing relapse. I also teach professionals about the diagnosis and treatment of alcohol and other substance abuse disorders. While my focus has been mainly on alcohol use disorders, much of what is known about the neuroscience of addiction is applicable to many, if not all, substances of abuse. I have seen the ravages of these diseases, including death, but I more commonly see the milder forms of these diseases that make people’s lives just plain miserable and/or less enjoyable or productive than they would have been without their addiction.

On April 1, 2001, I joined the world of Health Information Technology. I started a solo gynecology practice with no income and only expenses. I hired a medical assistant to be my front desk person and my clinical helper. I rented a smaller space than most physicians could use for this purpose because my plan was to use technology to avoid both chart storage as well as the people needed to maintain a medical record library.

I hired a hospital employee to put together my “network.” He helped me install my software and set up an automatic backup system. I purchased a single robust desktop computer and brought in an older computer from home for the front desk. I bought a scanner and an inexpensive laser printer. The hardware including a router for my “network” of two computers cost me about $6000. The software, a combined practice management system with an associated EMR requiring only single entry of patient demographics, cost me about $7000.

Lost at times in the heat of debate about stem cell research, or any controversial advanced technology, is the need for precision in debate and discussion. The details matter a great deal, ranging from the need to use words that have precise definitions, to accurately quote colleagues and adversaries, and to cite scientific and medical results in a way that reflects the quality, rigor, and reliability of the work at issue. Regrettably, considerable inaccuracy has found its way into the debates about stem cells, on all sides, with consequent fogging of the issues.

A key detail that is often overlooked in the debates about the uses of human embryonic stem cells in research comes from the nature of in vitro fertilization (IVF) treatment for infertility. Specifically, there are many frozen human embryos (more precisely called blastocysts) that are in excess of reproductive needs of the couple who generated them, and that must be either frozen indefinitely, donated to another couple, or destroyed.

On August 28, 2008, Michael Marmot, Chair of the Commission on Social Determinants of Health, formally handed over the Commission’s Final Report to Margaret Chan, the Director-General of the World Health Organization, at the Palais des Nations in Geneva. It was a significant moment. Dr. Chan addressed a hall packed with representatives of the world’s communications media in a speech that was remarkably direct. Dr. Chan reiterated the Commission’s position that to improve health and health equity action needs to be taken not just across the health sector but across all social and economic policy areas, and stated, “Social deprivation is not a matter of fate. It is a marker of policy failure.” This was a bold statement from one of the world’s leading diplomats. Policy failure! The phrase echoes the Commission’s assertion that “a toxic combination of poor social policies, unfair economic arrangements and bad politics is killing people on a grand scale.” The Commission’s messages are far reaching.

The ethical debate on embryo research, particularly on whether to destroy human embryos for stem cell research, is sometimes said to involve a confrontation between religion and science. The claim is misleading at best. Ironically, religious claims have not infrequently been invoked by those who support human embryonic stem cell research, who have said that such research will enable us to “answer the prayers of America’s families” or present us with “the biblical power to cure.” And even religious organizations (as well as scientists and ethicists who share some of their concerns on this issue) have often made the case against the ethical acceptability of this research relying on science, and on general ethical considerations that transcend religious divisions. The Catholic Church, in particular, maintains that the ethical norm against directly taking the life of any innocent human being can be understood and embraced by people of good will, with or without religious faith, and that the application of this norm to the present controversy depends on an understanding of some basic facts about early human development.

As a worldwide economic crisis emerged at the end of 2008, international health agencies were quick to highlight its predictable impact on health in the poorest of communities. The World Health Organization (WHO) underscored the need for a multisectoral approach to the crisis, “seeking health gains through demonstrating the importance of health in all policies” and whether current investments in health addressed the broader social determinants of health. However, despite good intentions and decades of discussion addressing the need for transformative changes globally to reduce poverty and improve health equity, little progress has been made.

A recent report on progress towards the Millennium Development Goals (MDGs) indicates that many targeted goals have not been met, with some goals lagging many years behind schedule (“Four years after the target date, gender parity in education has yet to be achieved”). Although progress towards achieving the MDGs has been made for some specific conditions (e.g., malaria), where targeted interventions have had an immediate impact, limited progress is reported in more complex areas such as maternal child health. Such complex health issues require structural changes, strong political will, long-term funding, and consideration of other health determinants, such as education and exposure to environmental hazards.

A criminal offense requires two elements. First, it requires proof of misconduct that is specifically prohibited by law (actus reus). Second, it requires proof of sufficient intention or recklessness (mens rea) to warrant assignment of moral culpability for the act. For example, a person who kills another person intentionally is typically guilty of murder, while a person who kills recklessly or in the heat of passion in response to provocation may be guilty of manslaughter, and a person who kills accidentally is not guilty of any crime. Even if the elements of the offense have been proven by the prosecution, the actor may not be punishable if the defense proves that his conduct was either justified (e.g., self-defense) or excused (e.g., duress).

The hypothetical case of Mr. Jenkins illustrates innovations in digital health information technology that may profoundly change medical care and the doctorpatient relationship. The Internet contains enormous amounts of health information, and about threequarters of Internet users look online for health information. 1 Sometimes patients bring information they found on the Internet to their physicians. Physicians and patients can also now communicate by e-mail rather than by telephone or office visits, although these e-mail communications may not be integrated into the patient’s medical record. Furthermore, electronic medical records are slowly being adopted, particularly in hospitals and large integrated health systems. Funding to promote the adoption of electronic medical records (EMRs) has been included in the 2009 federal stimulus package under the Obama Administration.

In his accompanying article, Dr. Kinscherff has convincingly demonstrated why a categorical exclusion of personality disorders from the definition of “mental disease” in insanity defense adjudication is arbitrary, both conceptually and clinically. He explains his position in the context of a vignette involving a hypothetical defendant, Wilhelmina Sykes, charged with ramming her car into another car obstructing her path, causing serious injury to its driver. Dr. Kinscherff correctly points out that the determinative issue in applying the insanity defense in any case, including the hypothetical case involving Ms. Sykes, is whether the defendant experienced a legally relevant functional impairment at the time of the offense. In many states — and in the hypothetical jurisdiction in which Ms. Sykes is being prosecuted — the relevant functional impairments are those that could have affected her ability “to appreciate the wrongfulness of her conduct” or “to conform her conduct to the requirements of the law.

Judging by their contribution to the global burden of death and disability, chronic, non-communicable diseases (NCDs) are the most serious health challenge facing the world today. The statistics tell a frightening story. Over 35 million people died from chronic diseases in 2005 — principally cardiovascular disease, cancer, and chronic respiratory disease. Driven by population growth and population ageing, deaths from non-communicable diseases are expected to increase by 17% over the period 2005-2015, accounting for 69% of global deaths by 2030.

Cardiovascular disease (CVD), the leading cause of death in all regions except sub-Saharan Africa, is estimated to rise from 17.1 million deaths (2004) to 23.4 million deaths (2030). Cancer deaths will increase from 7.4 million to 11.8 million over the same period. Due to population growth, mergers and acquisitions, and the marketing of global cigarette brands in developing countries, deaths from tobacco will rise from 5.4 million per year (2005), through 6.4 million (2015), to 8.3 million by 2030. These figures include a doubling in tobacco deaths in low- and middle-income countries from 3.4 million to 6.8 million lives annually. By 2015, smoking will cause 50% more deaths than HIV/AIDS.

As policy makers place great hope in health information technology (HIT) as a means to lower costs and achieve improvements in health care quality, safety, and efficiency, organizations at the forefront of building health information exchange (HIE) networks attempt to weave the concept and function of informed consent into an evolving information-driven health care system. The vast amount of information that will become available to both health professionals and patients in the new HIT-driven environment can reasonably be expected to affect the relationship between them in many ways, particularly in the area of informed consent. During this early stage of HIT adoption, it is critical that we engage in discussions regarding informed consent’s proper role in a heretofore unknown health care environment — one in which electronic information sharing holds primary (and possibly rightful) importance. The central and largely unexamined question of whether and how the legal and ethical underpinnings of informed consent will fit into the context of HITenabled treatment is critical to both public policy and clinical practice.

Although the first human embryonic stem cells (hESCs) were produced in 1998, the direction of U.S. policy on stem cell research was set nearly 20 years earlier when the recommendations of a congressionally established Ethics Advisory Board were ignored by the Reagan administration. Thus began an unprecedented and unparalleled 30-year-long history of political intrusions in an area of scientific and biomedical research that has measurable impacts on the health of Americans. Driving these intrusions were religiously informed public policy positions that have usually escaped critical ethical analysis. Here I record my own encounters with this history of intrusions and the thinking behind them.

My most abrupt encounter with the politics of stem cell research occurred on September 6, 2006, at a hearing of the Senate Subcommittee on Labor, Health and Human Services and Related Agencies, chaired by Senator Arlen Specter. Just a week before, scientists at Advanced Cell Technology (ACT), a small Massachusetts biotech company, had published a paper in the journal Nature in which they described a method for extracting stem cells from early human embryos while leaving the embryos intact and viable. As head of ACT’s Ethics Advisory Board, I had supported this research.