It comes as no surprise that, for the first time in nearly 15 years, a serious debate has emerged about the need to ensure quality, affordable coverage for all Americans. The statistics and stories about cost, coverage, and quality shortcomings abound and are indisputable. Setting the human consequences aside, the economic, budgetary competitiveness and demographic challenges facing the nation demand pragmatic and comprehensive reform. As health care costs (and cost-shifting from the uninsured) weigh down businesses and workers alike as well as federal, state, and local governments, stakeholders and forward-looking policymakers have started the drum-beat of reform — to the relief of most Americans.

This symposium explores the boldest recommendation of the Institute of Medicine’s (IOM) Committee on Increasing Rates of Organ Donation (hereafter Committee), namely, the recommendation that the U.S. consider a new population of potential donors. In its 2006 report, Organ Donation: Opportunities for Action, the committee recommended pilot programs in socalled “uncontrolled” donation after a circulatory determination of death (uDCD). Potential uDCD donors have died from an unexpected loss of circulation, either due to sudden cardiac arrest or excessive blood loss following traumatic injury. Because circulation is lost before death is determined and long before organ procurement could begin, potentially transplantable organs will die from oxygen starvation (warm ischemia) unless they are quickly preserved by cooling or other means.

Technology has outpaced the capacity of researchers performing research on human participants to interpret all data generated and handle those data responsibly. This poses a critical challenge to existing rules governing human subjects research. The technologies used in research to generate images, scans, and data can now produce so much information that there is significant potential for incidental findings (IFs), findings generated in the course of research but beyond the aims of the study. Neuroimaging scans may visualize the entire brain and even the entire head; computed tomography (CT) colonography research may visualize the entire torso, from the base of the lungs to the pubis; genetics studies may reveal “extra” and sometimes unwanted information about the family, such as misattributed paternity and undisclosed adoption; and genomic microarray research increasingly involves whole-genome analysis (WGA) revealing an individual’s complete genotype, with enormous potential for uncovering unexpected information about an individual’s genetics and risks of developing future conditions.

In May of 2006, the Abigail Alliance for Better Access to Development Drugs (Abigail) appeared to have won a victory when a divided panel of the Court of Appeals for the District of Columbia Circuit (D.C. Circuit) ruled that “terminally ill, mentally competent adult patients” had a constitutionally protected right to access investigational medications. This victory was short lived, however. On August 7, 2007, the D.C. Circuit sitting en banc reversed this earlier decision, marking a setback in Abigail's campaign for removal of the regulatory barriers that currently prevent terminally ill patients from gaining early access to investigational drugs (i.e., experimental drugs). This loss represents a big blow for Abigail's cause, because there is no guarantee that they will have another day in court, and attaining their goal through other branches of the government remains uncertain.

Many activities concerning the unknown involve the potential for risk, and clinical research is no exception. Some research participants experience correlative benefit; others do not. When the participants are adults, as in Phase I trials with healthy volunteers, we rely on a highly individualistic decision-making process based on autonomous choice. This assumes that the ability to make voluntary, competent, informed choices, evaluating the risks and benefits from a personal perspective, offers the best protection for research participants. Rightly or wrongly, we depend heavily on informed consent for protection. We have further refined our post-Nuremberg ethical principles by requiring that safety and toxicity of drugs and devices be first assessed on the least vulnerable. In addition, we assume Institutional Review Boards (IRBs) will screen out protocols involving an inappropriate level of risk.

Twenty-four U.S. states have enacted HIV exposure laws that prohibit HIV-positive persons from engaging in sexual activities with partners to whom they have not disclosed their HIV-status. From a public health perspective, HIV serostatus exposure laws can be viewed as structural interventions that seek to limit the spread of HIV by acting at the policy level. A central premise of these laws is that informed partners are more likely to protect themselves by declining sex, by substituting less risky activities for higher-risk ones, or by using condoms, than are uninformed partners. However, the effectiveness of these laws at preventing HIV transmission is not known.

There is little standardization among existing HIV exposure laws, which vary substantially with respect to the sexual activities that are prohibited without prior serostatus disclosure. Among the strictest laws are those in Arkansas, Michigan, New Jersey, and Ohio which mandate disclosure prior to almost any type of sexual contact.

The New Jersey Supreme Court has continually avoided making moral judgments about the value of life and emphasized that such decision making should be the province of the potential parents. Recently, in Acuna v. Turkish, the court elaborated on the limitations of the decision-making right of the potential parents, and its decision demonstrated that New Jersey courts were only willing to require physicians to disclose all relevant medical information, and not moral statements that had not been agreed upon by the state's medical community, people, or legislature. Acuna might be read as a departure from the trend displayed by New Jersey courts in “wrongful birth” and “wrongful life” actions toward empowering potential parents to decide if they want to bring the pregnancy to term. However, the decision actually fits squarely within this trend in that the reluctance to expand the information to which potential parents are entitled from their physicians can be directly tied to the reluctance of the New Jersey Supreme Court to weigh in on the value of life in wrongful birth and wrongful life suits.

The human papillomavirus (HPV) is the most common sexually transmitted infection worldwide. In the United States, more than six million people are infected each year. Although most HPV infections are benign, two strains of HPV cause 70 percent of cervical cancer cases. Two other strains of HPV are associated with 90 percent of genital warts cases.

In June 2006, the Food and Drug Administration (FDA) approved the first vaccine against HPV. Sold as Gardasil, the quadrivalent vaccine is intended to prevent four strains of HPV associated with cervical cancer, precancerous genital lesions, and genital warts. Following FDA approval, the national Advisory Committee on Immunization Practices (ACIP) recommended routine vaccination for girls ages 11-12 with three doses of quadrivalent HPV vaccine. Thereafter, state legislatures around the country engaged in an intense effort to pass laws mandating vaccination of young girls against HPV. This activity was spurred in part by an intense lobbying campaign by Merck, the manufacturer of the vaccine.

As of January 1, 2008, over 98,000 people are waiting for organ transplants in the United States of America. Of those, nearly 75,000 are waiting for a kidney. In this calendar year, fewer than 15,000 will receive a kidney transplant from a deceased donor. The average waiting time for a deceased donor kidney now exceeds five years in virtually all metropolitan areas. Sadly, nearly as many people die waiting as there are deceased donors each year, despite monumental efforts by the entire transplant community to increase both the number of organ donors and the number of organs recovered from each donor. The imbalance between demand and supply has led to considerable efforts to expand the criteria for what is considered an acceptable organ donor by the Organ Procurement and Transplant Network (OPTN), thereby hoping somewhat to assuage the shortfall of donor organs. So-called Expanded Criteria Donors (ECDs) may be older than 50, have history of hypertension, or have died from intracerebral hemorrhage and/or have impaired renal function. ECDs now make up nearly 40% of the donor population.

The recent withdrawals of Vioxx, Celebrex, and other drugs from the market have spurred high-profile hearings in Congress and increased concern over the state of drug regulation in consumer protection and academic circles. This renewed focus on national drug safety has translated ineluctably into new legislation designed to mitigate that outcry. The most notable example, the passage of the Food and Drug Administration Amendments Act (FDAAA) this past September, is at least partly intended as a response to an apparent lack of public confidence in existing drug safety practices.

Of the many provisions in the FDAAA, perhaps none carries greater implications for drug safety than the reauthorized Prescription Drug User Fee Act (PDUFA). Now in its fourth iteration, the newest PDUFA differs in important respects from the statute it supersedes.

In this paper, we assume that organ donation policy in the United States will continue to be based on an opt-in model, requiring express consent to donate, and that families will continue to have the prerogative to make donation decisions whenever the deceased person has not recorded his or her own preferences in advance. The limited question addressed here is what should be done when a potential donor dies unexpectedly, without any recorded expression of his or her wishes at hand, while a family decision is being sought.

Screening for prostate cancer with the prostate-specific antigen (PSA) blood test is controversial, as evidence to date has not demonstrated such screening does more good than harm. While the potential benefit of PSA screening on reducing prostate cancer mortality has not been documented in randomized trials, many risks of PSA screening have been well documented. These risks include a substantially higher risk of a prostate cancer diagnosis over a screenee’s lifetime, false-positive and false-negative test results, possible complications from biopsies done in response to suspicious test results, and substantial risks of side effects from subsequent prostate cancer treatments. Nevertheless, PSA screening is widespread in the United States, and many physicians in a national survey reported supporting routine PSA screening as well as getting PSA tests themselves, despite the lack of evidence.

Despite governmental and private antismoking initiatives, tobacco smoking remains a significant public health and economic challenge. The Centers for Disease Control and Prevention (CDC) estimates that for each year between 1997 and 2001, cigarette smoking and exposure to secondhand smoke caused approximately 438,000 U.S. residents to die prematurely, resulting in 5.5 million years of potential life lost, and in $92 billion dollars of lost productivity. Also, despite convincing scientific data that laws against indoor smoking protect people from the negative health effects of cigarette smoke, not all states have afforded their residents this protection. As of July 2007, 16 states neither restricted nor banned indoor smoking in restaurants, private worksites, or government worksites, and many state statutes only required separate rooms for smokers rather than eliminating all smoking inside buildings. In several states, local governments have attempted to fill this gap by adopting their own antismoking measures.

In the early days of organ transplantation from deceased donors (mid-1950s), the surgical team would bring the donor into the operating room with the recipient, the respirator would be stopped, and the team would wait for the donor’s heart to cease beating. This type of organ donation has been defined as donation after cardiac death (DCD), also referred to as non-heart-beating donation (NHBD). These donors were not declared dead using neurological criteria, but rather using conventional cardiorespiratory criteria. In 1959, Mollaret and Goulon coined the term “coma dépassé” (beyond coma) for the patients with an irreversible state of coma and apnea. Jean Morelle and Guy Alexandre of the Catholic University of Louvain, Belgium, were the first to introduce a set of brain death criteria based on the description of coma dépassé, and carried out, in 1963, the first transplants from a brain dead donor in their country and in the world.

“I think there’s a big strong belief in [...] the community … and maybe it’s in the world at large that somehow the doctors are more concerned about harvesting the organs than what’s best for the patient.”1 In the past 45 years, organ and tissue recovery and transplantation have moved from the occasional and experimental to a standard of care for end-stage organ failure; receiving an organ transplant is for many the only opportunity for increased quantity and/or quality of life. The increasing prevalence of diseases such as viral hepatitis, diabetes, and hypertension has significantly increased the incidence of end-organ failure. Additionally, surgical advances have permitted less stringent qualification criteria, so that people of advanced age or patients who may be in a physiologically fragile state are now eligible to be organ recipients. These changes have created a significant demand for organs.