Evidence Briefs: Public Health Topics
Federal
New drugs extend life and improve its quality. Drug patents provide an incentive to develop new drugs, but patented drugs are often expensive and they block the sale of inexpensive generic copies. Generic firms have grown active in challenging the validity of drug patents over the past two decades, in an effort to enter the market prior to expiration of the patent. This project examines these legal challenges and their effects on the entry of generic drugs and access to medicines. These analyses will help inform current policy debates about how well pharmaceutical patent laws and regulations balance innovation and access, and their effect on public health.
Grant Number: 68399
Funding Date: Mon, 11/15/2010
Researching Institution: Columbia University
Researcher: Bhaven Sampat, Ph.D.; C. Scott Hemphill, J.D., Ph.D.
Regulatory agencies established to protect the public all face a fundamental challenge: there are many more firms to inspect than there are government personnel to inspect them. For example, more than 50,000 Americans die each year from health and safety hazards at work, but the U.S. Occupational Safety and Health Administration (OSHA) can only visit about 1 percent of the nation's potentially dangerous workplaces each year. Improving OSHA's and other agencies' techniques for selecting workplaces for inspection could help prevent numerous unnecessary injuries and fatalities. A multidisciplinary team of experts in science, law, and statistics from the University of Pennsylvania will use cutting edge analytical techniques to develop and test alternative strategies for deploying regulatory inspection resources based on risk levels and on financial and other characteristics of individual companies.
Grant Number: 68398
Funding Date: Mon, 11/15/2010
Researching Institution: University of Pennsylvania
Researcher: Adam Finkel, M.P.P., Sc.D.; Cary Coglianese, Ph.D., M.P.P.,J.D.,A.B.
The United States Environmental Protection Agency (EPA) is considering revisions to the Lead and Copper Rule (LCR). The revisions will help reduce the public health problems caused by unsafe or toxic levels of lead in drinking water. This study will help identify gaps in existing policies on water sampling to measure lead levels, replacement of water lines that contain lead, and public education aimed at reducing exposure to lead. The responsibility for avoiding harmful exposures to lead in drinking water is shared between water utilities, consumers, regulatory agencies and manufacturers. Findings from this study may help the EPA in revising the LCR. The findings may also help policy makers shape future laws and regulations, especially when multiple groups share responsibility for preventing toxic exposures to lead.
Funding Date: Mon, 11/15/2010
Researching Institution: Virginia Polytechnic Institute and State University
Researcher: Marc Edwards, Ph.D.; Stephanie Pollack, J.D.
To maintain their tax-exempt status, federal and state governments require non-profit hospitals to provide benefits to the communities in which they reside. The Internal Revenue Service (IRS) is developing regulations that require these hospitals to provide more extensive information than previously required about the benefits they are providing to the community. Using data from hospital responses to the new preliminary IRS reporting requirements, this study aims to document which community benefit activities are undertaken and which of these are considered public health activities. The study will also identify those activities that are collaborative efforts between hospitals and public health entities.
Grant Number: 68393
Funding Date: Mon, 11/15/2010
Researching Institution: Saint Louis University
Researcher: Connie Evashwick, Sc.D.; Jesse Goldner, M.A., J.D., Jason S. Turner, Ph.D., M.A.E
This project will use (1) a mapping study to assess the status of accreditation laws, policies and regulations in 20 states that have been identified as having or making progress towards accreditation, followed by (2) a mechanism study involving process tracing in six case study states to examine how and why states developed, adopted, and implemented a particular legal structure. The mechanism study will also utilize the conceptual framework of public health system and services research (PHSSR) to explore the impact that legal structure has on the organizational capacity, functions, and outputs of resulting accreditation programs. Deliverables for this project include a "legal supplement" to The Accreditation Road Map, a tool aimed at assisting states in the creation of a successful accreditation program. The legal supplement will be disseminated electronically to all study participants, states participating in the Multistate Learning Collaborative, and others to guide agency accreditation activities.
Grant Number: 67142
Funding Date: Tue, 12/01/2009
Researching Institution: University of North Carolina, North Carolina Institute for Public Health
Researcher: Edward L. Baker, M.D., M.P.H., Gene W. Matthews, J.D.
Publication Date: 12/07/2009
The Problem:
Youth violence is an enormous public health problem in the United States, standing as the second leading cause of death for people between the ages of 10 and 24. CDC, National Center for Injury Prevention and Control. WISQRS. Juvenile court systems have often been criticized for inadequately deterring and poorly preventing recidivism among violent youthful offenders. Steiner B, Hemmens C, Bell V. Legislative Waiver Reconsidered: General Deterrent Effects of Statutory Exclusion Laws Enacted Post-1979. Justice Quarterly. 2006;23(1):34-59.
The Law:
All states have adopted laws that allow judicial waiver of jurisdiction by the juvenile court system, which sends young offenders to adult criminal systems. Some states use a discretionary approach, giving deference to the juvenile court judge. Other states employ an automatic approach: jurisdiction is waived for specific violent offenses or when the offender has prior violent arrests. For examples of juvenile waiver laws, see RCW 13.40.110 (Washington), Fla Stat § 985.556 (Florida), and MN Stats 260B.101 (Minnesota).
The Evidence:
In a systematic review, a Community Guide expert panel reviewed seven studies evaluating the impact of six laws allowing juvenile transfer. McGowan A, Hahn R, Liberman A, et al. Effects on violence of laws and policies facilitating the transfer of juveniles from the juvenile justice system to the adult justice system: a systematic review. Am J Prev Med 2007;32(4S):S7–S28. Across the studies, the reviewers observed an overall negative effect. Notably, there was a 34 percent median increase in recidivism among youths processed though adult systems compared to those retained in the juvenile courts. In addition, transfer of youths led to an increase in pretrial violence, victimization and violence in adult facilities, and elevated suicide rates among the incarcerated youths. According to the expert panel, there was not enough evidence to determine the true effect of waiver as a deterrent.
The Bottom Line:
In the judgment of a Community Guide expert panel, there is sufficient evidence to conclude that processing youths through adult systems has a negative impact on public health.
Additional Resources: Heilbrun, et al. A National Survey of US Statutes on juvenile transfer: implications for policy and practice. Behavioral Sciences and the Law. 1998;15(2):125-149.
Publication Date: 12/07/2009
The Problem:
Firearms are the second leading cause of injury and deaths in the United States accounting for 30,896 deaths and 71,417 injuries in 2006. Over 80 percent of teen homicides and almost half of teen suicides in involved a gun in 2005. CDC: WISQUARS. Overall, more than half of all homicides involve a gun. US Department of Justice: Crime Statistics.
The Law:
The federal government, through the Interim Brady Handgun Violence Prevention Act, in place from 1993 to 1998, established a five-day waiting period for the purchase of a firearm. In 1998, the Brady Handgun Violence Prevention Act (18 U.S.C. §921-922) updated the Interim Brady Law, replacing the five day waiting period and the mandatory background check conducted by law enforcement officials with an instant computerized background check that typically takes a few seconds (but may take up to three days). Some states have implemented longer waiting periods; for example, California’s waiting period is 10 days (Cal. Penal Code §§ 12071(b)(3)(A), 12072(c)(1)) and New York’s waiting period can be up to six months (NY PEN § 400.00(4-a)). The aim of waiting periods is to allow time to complete background checks on the purchaser and to provide time for individuals with impulsive violent intentions to “cool off.”
The Evidence:
Hahn et al. reviewed seven studies that measured the effects of waiting periods on murder, aggravated assault, robbery, rape, firearm-related suicide, and unintentional firearm injury. Hahn, et al. Firearms laws and the reduction of violence: a systemic review. Am J Prev Med. 2005;28(2S1):40-71. The reviewers found the underlying studies to have a number of methodological limitations. The findings of the underlying studies were inconsistent and or statistically insignificant. For there reasons, the reviewers were unable to determine the effectiveness of waiting periods laws as interventions aimed at reducing gun-related harms.
The Bottom Line:
In the judgment of a Community Guide expert panel, there is insufficient evidence to determine the effectiveness of waiting period laws as public health interventions aimed at preventing gun-related violence and suicide.
Additional Information:
For more information on the Brady Act National Instantaneous Criminal Background Check System (NICS), see the FBI’s NICS factsheet.
A new firearms research database launched by the Harvard School of Public Health makes scholarly articles more accessible to reporters, law enforcement, public health officials, policymakers, and the general public. The Firearms Research Digest provides summaries of articles gathered from social science, criminology, medical and public health journals and is written in clear, accessible language for use by those outside academia.
The website currently covers six years of research published between 2003 and 2008. The digest will be expanded over time to include articles from 1988 to the present.
Additional Resources: Brady Act National Instantaneous Criminal Background Check System , The Firearms Research Digest
Publication Date: 12/07/2009
The Problem:
Firearms are the second leading cause of injury and deaths in the United States accounting for 30,896 deaths and 71,417 injuries in 2006. Over 80 percent of teen homicides and almost half of teen suicides involved a gun in 2005. CDC: WISQUARS. Overall, more than half of all homicides involve a gun. US Department of Justice: Crime Statistics.
The Law:
Federal, state, and local laws prohibit specific firearms and ammunition. These bans often apply to firearms and ammunition viewed as exceedingly dangerous and not regularly used for hunting (e.g., hollow point bullets in New Jersey, N.J.S. 2C:39-3(f)). In 1994 Congress passed the Violent Crime Control and Law Enforcement Act (VCCLEA), which proscribed the manufacture, transfer, and possession of semiautomatic assault weapons and large capacity magazines. VCCLEA expired in 2004. State laws have also targeted guns disproportionately involved in crimes, such as inexpensive, small-caliber handguns (e.g., “Saturday night specials,” in Massachusetts, 140 MGL 123, 501 CMR 7.00) and assault pistols (e.g., MD Crim Code §4-303 (Maryland)). In 1976, Washington D.C. banned the transfer and possession of all handguns (DC ST §§7–2502.01(a), 7–2502.02(a)(4)). Provisions of this law were found unconstitutional in District of Columbia v. Heller, 128 S.Ct. 2783 (2008).
The Evidence:
Hahn et al. reviewed nine studies that measured the impact of state or local bans on specific firearms and ammunition. Hahn, et al. Firearms laws and the reduction of violence: a systemic review. Am J Prev Med. 2005;28(2S1):40-71. Five of the studies examined the impact of the Washington D.C. handgun ban; one study examined the impact of the VCCLEA provisions banning assault weapons and large capacity ammunition; and one measured the impact of a ban on Saturday night specials. Outcomes measured included intentional firearm injury, gun-related suicide, and unintentional firearm injury. The remaining studies measured the proportion of banned firearms (Saturday Night Specials and assault pistols) in Maryland among all firearms involved in crimes. Although there was some positive evidence suggesting a link between VCCLEA and reductions in homicides and between the banning of Saturday Night Specials in Maryland and reduction of such guns in Maryland crime, the studies also found inconsistent results. Based on the findings and the limited number of primary studies, the reviewers concluded that there is currently not enough evidence to validate the effectiveness of bans on specific firearms and ammunition as a public health measure.
The Bottom Line:
In the judgment of a Community Guide expert panel, there is insufficient evidence to establish the effectiveness of such bans as public health interventions aimed at reducing gun-related harms.
Additional Information:
A new firearms research database launched by the Harvard School of Public Health makes scholarly articles more accessible to reporters, law enforcement, public health officials, policymakers, and the general public. The Firearms Research Digest provides summaries of articles gathered from social science, criminology, medical and public health journals and is written in clear, accessible language for use by those outside academia.
The website currently covers six years of research published between 2003 and 2008. The digest will be expanded over time to include articles from 1988 to the present.
Additional Resources: Bureau of Alcohol, Tobacco and Firearms, The Firearms Research Digest
Publication Date: 12/07/2009
The Problem:
The operation of motor vehicles while intoxicated is a major public health problem. Each year in the United States roughly 13,400 people die and an additional 255,500 are injured in motor vehicle crashes involving an alcohol-impaired driver. In 2006, these crashes accounted for almost a third of all U.S. traffic-related deaths. Drivers age 16 to 20 who engage in drunk driving pose an especially dangerous risk to themselves and other motorists. CDC: Impaired Driving Factsheet.
The Law:
All U.S. states currently set the minimum legal drinking age at 21 years (MLDA21). Federal legislation withholds federal highway funds from states that do not adopt an MLDA of 21 years (23 U.S.C. § 158). For examples of MLDA21 laws, see TX Alcoholic Beverage Code § 106.04 (Texas), Conn. Gen. Stat. 30-1(12) and Conn. Gen. Stat. §30-89 (Connecticut).
The Evidence:
Two independent systematic reviews of the relevant studies of this intervention have found a robust association between raising the MLDA to 21 and reductions in alcohol-related crashes. In a Community Guide systematic review, Shults et al. reviewed 33 studies that examined the effect of MLDA21 on fatal and nonfatal crashes likely to have involved alcohol. Shults, et al. Reviews of Evidence Regarding Interventions to Reduce Alcohol-Impaired Driving. Am J Prev Med. 2001;21(4S):66-88. Seventeen of the underlying studies evaluated the impact of raising the MLDA to 21, 11 evaluated laws that lowered the MLDA, and remaining 18 used regression analysis to measure changes in both directions. The review found a median reduction in alcohol-related crashes of 17 percent associated with raising the MLDA and a median increase of 8 percent in alcohol-related crashes associated with lowering the MLDA.
Wagenaar and Toomey reviewed 48 studies that measured the impact of MLDA21 on alcohol consumption and reviewed 57 studies that measured the impact of MLDA21 on alcohol-related crashes. Wagenaar, Toomey. Effects of Minimum Drinking age Laws: Review and Analyses of the Literature from 1960 to 2000. Journal of Studies on Alcohol. 2002(14 Suppl):206-25. Across the 48 studies, the authors identified 27 measures finding a statistically significant inverse relationship between MLDA21 and alcohol consumption (8 found a statistically insignificant inverse relationship; 5 found a positive relationship). Some of the measures included, for example, self-reported alcohol consumption and sale of particular alcoholic beverages. Fifty-two measures were indentified finding a statistically significant inverse relation between MLDA21 and crashes (12 found a statistically insignificant inverse relationship; 2 found a positive relationship). These measures included a broad range of types of injuries and crashes outcomes (e.g., nighttime fatal crashes, alcohol-related crashes).
The Bottom Line:
In the judgment of a Community Guide expert panel and the authors of a peer-reviewed systematic study, there is strong evidence to support the effectiveness of MLDA21 as an intervention aimed at reducing alcohol involved motor vehicle crashes.
Additional Information:
The Community Guide provides online access to a table summarizing the results of each study it reviewed.
Additional Resources: The Community Guide
Publication Date: 12/07/2009
The Problem:
The shortage of adequate, affordable housing is a major public health problem, which draws family resources away from other health expenditures, such as nutritious food and healthcare, and exposes children and others to lead and other pathogens. CDC and U.S. Department of Housing and Urban Development. Healthy housing reference manual. The scarcity of affordable housing also creates pockets of concentrated poverty, which deleteriously affects the health of children and their families. The Urban Institute. Research on Record: Housing.
The Law:
One way that governments have attempted to address the shortage of affordably priced housing is through programs that subsidize housing costs. Tenant-based rental assistance programs subsidize the cost of housing for low-income households in the private housing market. One of the more prominent examples is the U.S. Department of Housing and Urban Development (HUD) Section 8 program, which state and local governments administer. This program is authorized by 42 U.S.C. 1437(f) and regulated by 24 C.F.R. 982. Three other well known examples are the Housing Allowance Experiment, the Gautreaux program, and the Moving to Opportunity for Fair Housing program.
The Evidence:
Anderson et al. reviewed 12 studies that assessed the effectiveness of tenant-based rental assistance programs as a public health intervention aimed at improving household safety and reducing exposure to crime. Anderson LM, et al. Providing affordable family housing and reducing residential segregation by income: a systematic review. Am J Prev Med. 2003;24(3S):S47-67. The 12 studies focused specifically on the four federal housing efforts mentioned above. The review found tenant-based rental assistance to be effective in increasing household safety and reducing exposure to crime. According to the reviewers, the underlying studies also provide evidence that these programs improve housing quality, reduce behavioral problems among children at home and in school, and improve the physical and psychological health of parental figures.
The Bottom Line:
In the judgment of a Community Guide expert panel, there is sufficient evidence to suggest that tenant-based rental assistance programs (or affordable housing rental vouchers programs) are effective public health interventions aimed at addressing the shortage of affordable housing and its associated risks to health.
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Public Health Law Research is a national program of the Robert Wood Johnson Foundation. It is housed at the Temple University Beasley School of Law.