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.

Both the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) play a role in regulating pain management technologies, including pharmaceutical products and medical devices indicated for analgesic use. Yet, as things stand, these two key federal entities, with their distinctly different missions and cultures, contribute to the persistent undertreatment of pain through both overregulation and duplicative regulation. The solution lies in refining pain regulation so that a better balance is created between the need to ensure patient access to pain relief and the need to prevent and reduce drug diversion.

Various federal regulatory mechanisms — such as limits on supplies and distribution channels — have created barriers that ultimately affect access to pain management technologies for legitimate users. As the FDA and DEA focus their attention on the misuse of legitimate pain technologies, patients ultimately may be deprived of valuable analgesic agents.

One hundred years ago, most wars occurred between nations; today, large-scale violent conflict consists almost exclusively of civil wars in which civilians constitute 30 percent of casualties.’ According to a recent World Bank study of conflict, the poorest one-sixth of the worlds population suffers four-fifths of the consequences of civil wars. While poverty is the greatest risk factor determining a nation’s likelihood of entering into conflict, it is also one of instability’s most predictable consequencet—thus, war is a vicious cycle, and poor nations may remain at risk for intense violence for years or even decades.

I would like to extend my appreciation to the planning committee of this outstanding conference, the Centers for Disease Control and Prevention (CDC) and the American Society of Law, Medicine & Ethics (ASLME) for allowing me to have this great opportunity to share my experience in teaching and studying medical and public health law and ethics with my U.S. colleagues. This morning, USA Today is reporting that Brundtland, the Director General of the World Health Organization (WHO), finally declared that the aggressive control measures have stopped SARS. I think it is a special achievement on her part as she departs the WHO in less than two weeks. The new Director General of the WHO, JW Lee, is a close friend of mine.

Science provides the most important set of tools for the evaluation of complementary and alternative medicine (CAM). Nonetheless, there are important limits in science that constrain its ability to evaluate CAM effectively. Some are the limits encountered by science in conventional medical research. Others are peculiar to this controversial topic. The most important limits are not those inherent within the basic methods of science, but rather within the culture of science — the particular ways that scientific knowledge, theory, and method are configured and arrayed rhetorically, and in the social context in which science operates. It is the limitations of scientists as a group of human beings more than science as a set of methods that hamper scientific evaluation of CAM.

Thank you so much for the invitation to be here with you. It is always a pleasure to be with people who understand, believe in, and know the importance of public health. Those of us who work in the legislative arena know how infrequent it is to have dialogue and conversation with people who really have a good, tangible, hands-on working knowledge of health care, and particularly of public health.

The notion of public health is an interesting one. It will range—if you talk to people in the legislature or out of the legislature—from just complete ignorance to total unawareness of what we mean by the words “public health.” When you talk to individuals like us in this room, we find a mixture of definitions, a mixture of understandings, and a mixture of appreciation as to what public health really is.

It is generally recognized that China, while attempting to develop modern scientific medicine in carrying out its national policy for modernization, has also made significant efforts to integrate traditional Chinese medicine into its health care system. For instance, the World Health Organization's first global strategy on traditional and alternative medicine (released in May 2002) lists China as one of only four of its member states to have attained an integrative health care system. However, medical integration can take many different forms and involve quite different health care standards. A health care standard is a set of mechanisms by which distinct diagnostic and therapeutic practices and products are validated or accredited for use in health care delivery. Traditional Chinese medicine and modern scientific medicine adopt different sets of such mechanisms and thereby engage different health care standards. Accordingly, in appraising the Chinese integrative health care system, it is important to investigate which health care standard has been appealed to.

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.

A recurring theme in the debate over adequate pain management is the extent to which physicians’ fear of criminal investigation and prosecution has set up barriers to appropriate dispensing of pain relief to patients. While there have been several studies looking at the regulatory environment and its effect on physicians’ prescribing practices and the treatment of pain, there has been scant research on the probability of investigation or prosecution of physicians who aggressively prescribe opioids for pain management.

To understand whether physicians’ fear of investigation or prosecution is based on a realistic assessment of risk, the authors surveyed chief prosecutors in four states (Maryland, Connecticut, Oregon, and Washington), all of which have varying degrees of focus, prosecutorial culture, and regulatory attitudes toward this issue.

The discussion about complementary and alternative medicine (CAM) is sometimes rather heated. “Quackery!” the cry goes. A large proportion “of unconventional practices entail theories that are patently unscientific.” “It is time for the scientific community to stop giving alternative medicine a free ride. There cannot be two kinds of medicine — conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work.” “I submit that if these treatments cannot withstand the test of empirical research, … then we have wasted a lot of time and effort. The time has been wasted on all the people who have spent years learning falsehoods about acupuncture points and the principles of homeopathy. And the patients have wasted their time, money, and efforts receiving treatments that were not what they were represented to be or were harmful.”

A single defining question perennially intrigues scholars and practitioners interested in public heath: To what extent should human rights be limited to protect the community’s health and safety? The question achieved prominence in the aftermath of the attacks on the World Trade Center and Pentagon on September 11, 2001 and with the intentional dispersal of anthrax spores through the U.S. Postal Systein. The conflict between security and public health intensified with the development of the Model State Emergency Health Powers Act (“Model Act”), drafted by the Center for Law and the Public’s Health at the request of the Centers for Disease Control and Prevention. The Model Act grants states consiclernble powers to control persons and property in response to a public health emergency, defined to inclucle bioterrorism or the appearance of novel or previously controlled or eradicated infectious agents or biological toxins.

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?

Nurses are on the front lines of pain management, yet in Alabama and eleven other states they are not legally authorized to prescribe any controlled pain medications. In this survey of certified registered nurse practitioners in Alabama, 83 percent of the nurses responding to a question about the connection between prescriptive authority and pain management said that the lack of prescriptive authority for controlled substances delays pain management treatment, and 88 percent of those proffering an opinion about the importance of prescriptive authority said that expanding their prescriptive authority to include those medications would improve patient outcomes.

At the same time, however, many nurses indicated that they are not adequately prepared to prescribe and manage pain medications. Fifty-five percent of the nurses responding to a question about whether they were prepared to make decisions when working under protocols related to controlled substances answered no. And 44 percent of the respondents to a question about the nurse practitioner educational curricula said that they did not feel their education had adequately prepared them for prescribing controlled pain medications.

The Centers for Disease Control and Prevention’s (CDC) goal is to develop a surveillance system of public health laws that would both support research and analysis among policymakers and legislators, and support the scientific basis for public health law. This session was convened, in part, to discuss the value of creating an electronic system to track public health legal information. Public health surveillance is the “ongoing, systematic collection, analysis, interpretation, and dissemination of data regarding a health-related event for use in public health action to reduce morbidity and mortality and to improve health. Data disseminated by a public health surveillance system can be used for immediate public health action, program planning and evaluation, and formulating research hypotheses.” There is currently no system available that meets the goals of this definition of “surveillance” for public health laws.

There is a fine balance between civil liberties and protection of the public’s health.

Legislators, especially those in the western United States, are concerned about selling the Model State Act (“Act”) because of the loss of civil liberties. State constitutions give governors broad powers, such as declaring martial law and giving public health leaders the authority to act. State laws should consider issues such as property rights; taking of businesses and supplies; quarantine and isolation; due process; coordination among states, counties and cities; communication systems; conscription of doctors and nurses; and compensation. When two mock emergency response drills were held in New Mexico, concerns arose regarding opening records associated with dams, national laboratories, waste repositories, and three air force bases.

Critics of international trade agreements often cast them as threats to human health, and they can point to some sobering warnings from world history. Infectious diseases have swept across political boundaries, carried by traders, colonists, and other agents of globalization. Transnational epidemics have laid economies low, undermining political stability. The spread of viruses and bacteria to peoples previously unexposed and therefore lacking immunity has decimated populations and changed the political course of continents. Trade, exploration, and warfare have repeatedly produced encounters between peoples at different levels of agricultural and technological development. Often, the results have been devastating for the disadvantaged group — economic marginalization, loss of sovereignty and culture, and collapse of public health. Yet the rise of civilization — plant and animal domestication, division of labor, technology, and resulting prosperity — was powered in large part by movement of products and knowledge along routes of trade and migration.

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.

Scholarship has intrinsic value, of course; but when good scholarship can stimulate change for the better in an area as fundamental to human dignity as health care and the relief of suffering, there is a special satisfaction. This has been our experience since 1996, when the first of now four special issues of this journal focused on legal, regulatory, ethical, professional, and financial issues in medical treatment for pain.

With the generous and steadfast support of the Mayday Fund, the American Society of Law, Medicine & Ethics (ASLME) has generated a significant body of scholarship published in the Journal of Law, Medicine & Ethics (JLME). This research has proven absolutely essential in changing public policy to support better care for those who suffer pain.

Over these years, the Mayday Project at ASLME has tackled many of the real and perceived barriers to effective pain relief. In pain management, both real and perceived obstacles can have a powerful negative effect.

Entry into the practice of medicine is heavily regulated through scope of practice and licensing laws that make it illegal for nonlicensed individuals to perform many medical services. As institutions are structured at the beginning of the twenty-first century, most regulation takes place at the state level, through state departments of health that establish criteria for performing different types of medical activities, and that restrict allowable activities for various types of health care professionals. The regulations over the activities of physicians are more uniform across states than for other health care professionals because, although the regulation is done by individual state governments, the standards for physicians are set by the National Board of Medical Examiners, a group controlled by physicians themselves. The justification for this regulation is that it produces higher quality health care. Some would make an even stronger argument that regulation is necessary because patients do not have sufficient knowledge to distinguish effective practitioners from ineffective ones.