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Third-party payers and the cost of biomedical research.

Four principal arguments have been offered in support of requiring public and private third-party payers to help fund medical research: (1) many of the costs associated with clinical trial participation are for routine care that would be reimbursed if delivered outside of a trial; (2) there is a need to promote scientific research and medical progress and lack of coverage is an impediment to enrollment; (3) to cover the costs of trials expands health care and treatment options for the sick; and (4) it is beneficial for private insurers to cover the costs associated with cancer clinical trials because doing so makes such companies more attractive to consumers. Although many see third-party-payer coverage as a victory for patients and for the future of research, requiring coverage of services provided in a trial beyond those that would be provided to a comparable patient outside the research context raises a number of concerns.

Biomedical Research↗

Public health law in an age of terrorism: rethinking individual rights and common goods.

The balance between individual interests and common goods needs to be recalibrated in an age of terrorism. Public health agencies should have a robust infrastructure to conduct essential public health services at a level of performance that matches evolving threats to the health of the public. This includes a well-trained workforce, electronic information, surveillance, and laboratory capacity. This paper explains modern efforts at public health law reform: a Model Public Health Statute and the Model State Emergency Health Powers Act (MSEHPA), which has been enacted wholly or in part by nineteen states and the District of Columbia. Next, the paper shows why existing public health laws provide a weak foundation for public health practice. Finally, the paper offers a systematic defense of MSEHPA, which has galvanized the public debate around the appropriate balance between public goods and individual rights.

Bioterrorism↗

Bioterrorism, public health, and human rights.

It is unnecessary and counterproductive to sacrifice basic human rights to respond to bioterrorism. Constructive public health legislation, which must be federal, cannot be carefully drafted under panic conditions. When it is, like the "model act," it will predictably rely on broad, arbitrary state authority exercised without public accountability. Public health should resist reverting to its nineteenth-century practices of forced examination and quarantine, which will simply encourage people to avoid physicians, hospitals, and public health practitioners they now trust and actively seek out in emergencies. Upholding human rights is essential to public trust and is ultimately our best defense against the threat of terrorism in the twenty-first century.

Bioterrorism↗

Bioterrorism, public health, and the law.

The controversy over the Model State Emergency Health Powers Act has underscored the enduring tension in public health between guarding the common welfare and respecting individual liberty. The current version of the act, crafted in response to extensive public commentary, attempts to strike a balance between these values but has failed to allay the concerns of many civil libertarians and privacy advocates. Although the debates over the model act have been triggered by the threat of bioterrorism, they illustrate broader philosophical differences, with profound implications for all realms of public health policy.

Bioterrorism↗

Mandated treatment in the community for people with mental disorders.

Commitment to community-based mental health treatment bears limited resemblance to commitment to treatment in a closed institution. It can be better understood in the context of a broad movement to apply leverage to induce treatment engagement, a movement that includes use of the social welfare and justice systems and psychiatric advance directives. Understanding "mandated community treatment" in all of its forms can be advanced by viewing it within the framework of health care quality as recently outlined by the Institute of Medicine, particularly along the dimension of patient-centeredness.

Coercion↗

Round pegs, square holes.

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Commitment of Persons with Psychiatric Disorders↗

The challenge of mandatory evacuation: providing for and deciding for.

Insufficient attention has been given to the ethical and legal questions surrounding mandatory evacuation in disasters and emergencies. We argue that mandatory evacuation orders entail a governmental duty both to provide for people and to decide for people: Government must trigger the provision of critical resources as well as vigorous and persistent efforts to persuade reluctant citizens to leave. Public health professionals, with their experience in weighing costs and risks in the face of uncertainty and balancing individual liberties with the need to protect the common welfare, offer a unique perspective that should be brought to bear in emergencies and disasters.

Civil Rights↗

Attitudes toward the use of quarantine in a public health emergency in four countries.

Countries worldwide face the threat of emerging infectious diseases. To understand the public's reaction to the use of widespread quarantine should such an outbreak occur, the Harvard School of Public Health, with the U.S. Centers for Disease Control and Prevention, undertook a survey of residents of Hong Kong, Taiwan, Singapore, and the United States. A sizable proportion of the public in each country opposed compulsory quarantine. Respondents were concerned about overcrowding, infection, and inability to communicate with family members while in quarantine. Officials will need specific plans to deal with the public's concerns about compulsory quarantine policies.

Attitude to Health↗

Workers' perspectives on mandated employer health insurance.

There is renewed discussion of using employer mandates as a strategy for decreasing the number of uninsured Americans. California recently passed the Health Insurance Act of 2003, the first state-based "play-or-pay" legislation in nearly a decade. To better understand workers' perceptions, the California HealthCare Foundation commissioned NORC at the University of Chicago to conduct a survey to assess workers' views on mandated employer coverage. We found that the vast majority of workers support such a mandate--regardless of whether they are insured--although there is some variation regarding how extensive the mandate should be.

Adolescent↗

Pediatric residency training in child abuse and neglect in the United States.

BACKGROUND: Child abuse and neglect are leading public health problems with significant morbidity and mortality. Previous studies indicate that physicians often lack knowledge and confidence in addressing child abuse and neglect. OBJECTIVES: Our goal was to assess the child abuse and neglect curricula in pediatric residency programs as reported by chief residents and to identify levels of preparedness of residents to address child abuse and neglect on graduation. We analyzed variables related to preparedness. METHODS: A 28-item survey was sent to chief residents of all 203 Accreditation Council for Graduate Medical Education-accredited pediatric residency programs in the United States from 2004-2005. We performed descriptive, bivariable, and multivariable analyses. RESULTS: The response rate was 71%. Most programs taught didactics on physical and sexual abuse, but only 54% included domestic violence. Ninety-three percent of respondents rated their didactics as useful or very useful. Forty-one percent of programs required mandatory clinical rotations in child abuse and neglect, 57% offered elective rotations, and 25% offered no rotations at all. Respondents rated the levels of preparedness of graduating residents to address child abuse and neglect as: very well (12%), well (54%), somewhat well (28%), or not well (6%). Preparedness was significantly associated with didactic usefulness, number of hours of didactics, total number of inpatient cases of child abuse and neglect seen, percent of residents completing mandatory rotations, number of sexual abuse cases during mandatory rotation, number of physical abuse cases during mandatory rotation, and length of mandatory rotation. CONCLUSIONS: Mandatory clinical experiences in child abuse and neglect improve the preparedness of graduating residents to identify and evaluate patients for child abuse and neglect. Perhaps residency training in child abuse and neglect should be a required subspecialty rotation with more explicit curricular content than in the current mandates.

Child↗

Evaluation of the concomitant use of two different EIA tests for HIV screening in blood banks.

OBJECTIVE: In 1998, the Brazilian Ministry of Health made it mandatory for all blood banks in the country to screen donated blood for human immunodeficiency virus (HIV) concomitantly using two different enzyme immunoassay (EIA) tests. Concerned with the best use of available resources, our objective with this study was to evaluate the usefulness of conducting two EIA screening tests instead of just one. METHODS: We analyzed data from 1999 through 2001 obtained by testing 698 191 units of donated blood using two EIA HIV screening tests concomitantly at the Pro-Blood Foundation/Blood Center of São Paulo (Fundação Pró-Sangue/Hemocentro de São Paulo), which is a major blood center in the city of São Paulo, Brazil. All samples reactive in at least one of the two EIA tests were submitted for confirmation by a Western blot (WB) test, and the persons who had donated those samples were also asked to return and provide a follow-up sample. RESULTS: Out of the 698 191 blood units that were donated, 2 718 of them (0.4%) had to be discarded because they were reactive to at least one of the EIA tests. There were two WB-positive donation samples that were reactive in only one HIV EIA screening test. On their follow-up samples, both donors tested WB-negative. These cases were considered false positive results at screening. Of the 2 718 donors who were asked to return and provide a follow-up sample, 1 576 of them (58%) did so. From these 1 576 persons, we found that there were two individuals who had been reactive to only one of the two EIA screening tests and who had also been negative on the WB at screening but who were fully seroconverted on the follow-up sample. We thus estimated that, in comparison to the use of a single EIA screening test, the use of two EIA screening tests would detect only one extra sample out of 410 700 units of blood. CONCLUSIONS: Our data do not support the use of two different, concomitant EIA screening tests for HIV. The great majority of HIV-positive donors have already seroconverted and will be detected using only a single EIA screening test. Only persons who are going through the process of seroconversion may be missed by using a single EIA test and detected using two EIAs for screening. To screen out these individuals and decrease the residual risk of HIV transmission from the blood donated in our center, the use of other techniques, such as nucleic acid testing (NAT) or a p24 antigen assay, would be more effective.

AIDS Serodiagnosis↗