Advisory committees at FDA: the Hinchey Amendment and "conflict of interest" waivers

In approving the Food and Drug Administration's (FDA) Fiscal Year 2007 budget, the House approved an amendment that would prevent the agency from using appropriated funds to waive certain conflicts of interest identified by members of its advisory committees. The amendment, introduced by Representative Hinchey and known as the Hinchey Amendment, provides that no funds may be used to: waive a conflict of interest under Section 505(n)(4) of the Federal Food, Drug, and Cosmetic Act (FDCA) for any voting member of an FDA advisory committee or panel; or make a certification under Section 208(b)(3) of Title 18 of the U.S. Code for any such voting member. This creates a problem, as ties to industry create the very expertise that FDA values in its outside advisors-under the Hinchey Amendment, these very ties would prevent them from serving as advisors to FDA during the drug approval process. The author opposes this change in the law and argues that the Hinchey Amendment would undermine congressional efforts in 1962 and 1989 to carefully balance the goals of attracting qualified experts and protecting agency decisionmaking. Further, the author argues, this change is unnecessary at FDA, because experts on FDA advisory committees divulge their connections to the industry, because the committees offer only advice and do not make agency decisions, and because the agency is under the watchful eye of Congress, the public, and public interest groups. The Article concludes that although FDA's advisory committee conflict-of-interest process can be improved, congressional action is unnecessary, and a change in the law through amendment to an appropriations bill that does not go through the ordinary legislative process (as an amendment to the FDCA or Title 18 would) is inappropriate. Instead, recommendations from organizations studying FDA practice, such as the OIG, GAO, and IOM, should be used to carefully and reflectively amend the process at the agency level, within the existing statutory framework.     

Violent Sex Offenses: How are They Best Measured from Official Records?

In the United States, sexually violent predator (SVP) commitment statutes generally require assessment of an offender's risk of subsequent sexual violence. Current actuarial methods for predicting sexual reoffending were actually designed to predict something else—charges or convictions for offenses deemed sexual based on information obtained from police “rapsheets” alone. This study examined the referral and past offenses of 177 sex offenders. Results showed that police rapsheets (and data based on them) underestimated the number and severity of sexually motivated violent offenses for which sex offenders were actually apprehended. Rapsheet violent offenses seemed a more accurate index of the conduct addressed by SVP legislation than were rapsheet sex offenses. We suggest that, when evaluating sex offenders for SVP status, actuarial instruments designed to predict violent recidivism (as measured by rapsheet violent reoffenses) might be preferable to those designed to predict sexual recidivism (as measured by rapsheet sexual reoffenses).

Genetic variation of 15 STR autosomal loci in the Maracaibo population from Venezuela

Allele frequencies for 15 short tandem repeats (STRs) autosomal loci (D8S1179, D21S11, D7S820, CSF1PO, D3S1358, TH01, D13S317, D16S539, D2S1338, D19S433, vWA, TPOX, D18S51, D5S818 and FGA, included in the AmpFLSTR Identifiler, Applied Biosystems) were studied in the city of Maracaibo, Venezuela and were compared with other published Latin-American populations for the same loci. Population and forensic parameters were estimated.     

Relinquishing custody as a requisite for receiving services for children with serious emotional disorders

A review of the literature was conducted to assess the extent and nature of the practice of requiring parents to transfer custody in order to receive public funding for intensive services needed by their child/adolescent who had a serious emotional disorder. The review focused on the legal and policy basis of this practice as well as its social and psychological impact on child and family. We conclude that the practice of transfer of custody as a requirement for receiving financial aid occurs in a majority of states, though the actual extent of this practice is not known. The major factor influencing the use of transfer of custody appears to be the absence of an appropriate and adequate system of services for children and adolescents with serious emotional disorders. We recommend that the practice of requiring custody transfer for the sole purpose of receiving services be abolished and offer several suggestions for improving acess to services.Preparation of this article was supported in part by the National Institute of Mental Health (NIMH) under contract no. 89MF761903. The authors are grateful to John Burke and Kelly Kelleher of the Division of Biometry and Applied Sciences, NIMH for their assistance on this project. Laurie Flynn, Executive Director for the National Alliance for the Mentally Ill, was very helpful during the informative stage of the project. Barbara Friesen, Director of the Research and Training Center at Portland State University, gave us useful guidance throughout the project. We thank Stephen Hill, Consultant to the National Governors' Association, for his help. We are grateful to Amy Hewitt and Carol Ishler for their assistance in preparing this report. We also would like to acknowledge several individuals who assisted us with research reported in this article. We are grateful to Governor Richard F. Celeste of Ohio for his letter of support for the state survey of custody transfer practices. We appreciate the efforts on behalf of this survey by staff from the State of Ohio, particularly Jean Ellen Stevens, Administrative Assistant to the Director of the Department of Mental Health. Margraret McNally assisted in the compilation of data for both surveys.     

Implications for Criminal Justice from the 2002 and 2006 Department of Defense Gender Relations and Sexual Harrasment Surveys

Sexual misconduct has emerged as a widespread problem throughout the criminal justice system as indicated by law enforcement officer sexual assault incidents in various cities and the findings of the recent National Prison Rape Elimination Act Research Commission. Through multivariate statistical analysis of data from two Department of Defense-wide surveys (2002 and 2006), this paper examines the indicators and cofounders of sexism, sexual harassment, and sexual assault with attention to change during the study period. Findings inform a suggested anticipatory model for prevention and intervention in military settings that, based on shared characteristics such as male dominance and authoritarian culture, provide an approximate reference context for criminal justice sexual misconduct best practices consideration.     

DEET (N,N‐Diethyl‐meta‐toluamide) Induced Delay of Blowfly Landing and Oviposition Rates on Treated Pig Carrion (Sus scrofa L.)

Abstract: The question of whether the insect repellent N,N‐Diethyl‐meta‐toluamide (DEET) affected fly attraction, oviposition, and larval development was investigated; in part, to determine whether the common habit of wearing DEET as a repellent could affect the rate of human decomposition. Experiments using pig surrogates of human decedents were carried out in a rural environment. Dead piglets were sprayed with DEET, and fly behavior, colonization levels, and maggot development were compared with those in nonsprayed controls. Piglets treated with DEET experienced significant delays in fly visitation and oviposition and delayed appearance of each larval instar, as well as reduced total larval numbers (p < 0.01 for all variables), with subsequently reduced decomposition (p < 0.05). Such changes in fly behavior and larval population development would significantly impact the estimation of the period following the death from entomological evidence in decedents wearing DEET at the time of their death.