HIV Infection Linked to Injection Use of Oxymorphone in Indiana, 2014-2015

BACKGROUND: In January 2015, a total of 11 new diagnoses of human immunodeficiency virus (HIV) infection were reported in a small community in Indiana. We investigated the extent and cause of the outbreak and implemented control measures. METHODS: We identified an outbreak-related case as laboratory-confirmed HIV infection newly diagnosed after October 1, 2014, in a person who either resided in Scott County, Indiana, or was named by another case patient as a syringe-sharing or sexual partner. HIV polymerase (pol) sequences from case patients were phylogenetically analyzed, and potential risk factors associated with HIV infection were ascertained. RESULTS: From November 18, 2014, to November 1, 2015, HIV infection was diagnosed in 181 case patients. Most of these patients (87.8%) reported having injected the extended-release formulation of the prescription opioid oxymorphone, and 92.3% were coinfected with hepatitis C virus. Among 159 case patients who had an HIV type 1 pol gene sequence, 157 (98.7%) had sequences that were highly related, as determined by phylogenetic analyses. Contact tracing investigations led to the identification of 536 persons who were named as contacts of case patients; 468 of these contacts (87.3%) were located, assessed for risk, tested for HIV, and, if infected, linked to care. The number of times a contact was named as a syringe-sharing partner by a case patient was significantly associated with the risk of HIV infection (adjusted risk ratio for each time named, 1.9; P<0.001). In response to this outbreak, a public health emergency was declared on March 26, 2015, and a syringe-service program in Indiana was established for the first time. CONCLUSIONS: Injection-drug use of extended-release oxymorphone within a network of persons who inject drugs in Indiana led to the introduction and rapid transmission of HIV. (Funded by the state government of Indiana and others.)

Take a Label Claim, and Pay Me in the Morning: A Challenge to FDA's Argument that its Final Rule (Jan. 2000) on Structure/Function Claims for Dietary Supplements Does Not Constitute a Compensable Regulatory Taking Under the Fifth Amendment

On January 6, 2000, the Food and Drug Administration ("FDA") published its final rule prescribing the kinds of statements which can be made about the effect of a dietary supplement on the structure or function of the body ("structure/function" claims), in accordance with the Dietary Supplement Health and Education Act of 1994 ("DSHEA"). Under DSHEA, dietary supplements can bear structure/function claims without prior FDA review. But they cannot, without such prior review, bear a claim that they can prevent, treat, cure, mitigate or diagnose disease ("disease claim"). One of the most controversial aspects of the final rule, and the subject of this paper, is FDA's regulation of what the agency chooses to call "implied disease claims": The final rule precludes express disease claims ("prevent[s] osteoporosis") and implied disease claims ("prevents bone fragility in post-menopausal women") without prior FDA review. The final rule clarifies that such express and implied disease claims can be made through the name of a product ("Carpaltum," "CircuCure"), through a statement about the formulation of a product (contains aspirin), or through the use of pictures, vignettes, or symbols (electrocardiogram tracings). The rule permits claims that do not relate to disease. These include health maintenance claims ("maintains a healthy circulatory system"), other non-disease claims ("for muscle enhancement," "helps you relax,"), and claims for common, minor symptoms associated with life stages ("for common symptoms of PMS," "for hot flashes")

A Preliminary Investigation of the Prevalence of Corporal Punishment of Children and Selected Co-occurring Behaviours in Households on New Providence, The Bahamas

The purpose of this study was to examine the link between violence in homes, focusing on corporal punishment of children as a means of discipline, and other behaviours (including sexual abuse, illegal drug use, domestic violence, hitting of pets) which may be a cause for concern. This paper reports the results of a survey of 933 people and 12 case studies. Violence, physical or domestic, occurred in 62% of survey participants’ homes. The survey indicated that in respondents’ homes many children were physically hurt as a means of discipline. Children were spanked in 77% of homes with children, pets were hit in 25% of homes with pets, and domestic violence was found in 23% of homes. These findings suggest that those who use violence in their homes may not understand the wider and longer-term consequences of their actions for both victims and society. Case study participants seemed to view only severe physical violence as abuse. They also appeared reluctant to report abuse to the authorities which can hamper the efforts to curb violence in home