Patenting genes and gene sequences: Analysis of public health implications and the law

At issue is whether or not isolated DNA is patent eligible under the U.S. Patent Law and the implications of that determination on public health. The U.S. Patent and Trademark Office has issued patents on DNA since the 1980s, and scientists and researchers have proceeded under that milieu since that time. Today, genetic research and testing related to the human breast cancer genes BRCA1 and BRCA2 is conducted within the framework of seven patents that were issued to Myriad Genetics and the University of Utah Research Foundation between 1997 and 2000. In 2009, suit was filed on behalf of multiple researchers, professional associations and others to invalidate fifteen of the claims underlying those patents. The Court of Appeals for the Federal Circuit, which hears patent cases, has invalidated claims for analyzing and comparing isolated DNA but has upheld claims to isolated DNA. The specific issue of whether isolated DNA is patent eligible is now before the Supreme Court, which is expected to decide the case by year's end. In this work, a systematic review was performed to determine the effects of DNA patents on various stakeholders and, ultimately, on public health; and to provide a legal analysis of the patent eligibility of isolated DNA and the likely outcome of the Supreme Court's decision. ^ A literature review was conducted to: first, identify principle stakeholders with an interest in patent eligibility of the isolated DNA sequences BRCA1 and BRCA2; and second, determine the effect of the case on those stakeholders. Published reports that addressed gene patents, the Myriad litigation, and implications of gene patents on stakeholders were included. Next, an in-depth legal analysis of the patent eligibility of isolated DNA and methods for analyzing it was performed pursuant to accepted methods of legal research and analysis based on legal briefs, federal law and jurisprudence, scholarly works and standard practice legal analysis. ^ Biotechnology, biomedical and clinical research, access to health care, and personalized medicine were identified as the principle stakeholders and interests herein. Many experts believe that the patent eligibility of isolated DNA will not greatly affect the biotechnology industry insofar as genetic testing is concerned; unlike for therapeutics, genetic testing does not require tremendous resources or lead time. The actual impact on biomedical researchers is uncertain, with greater impact expected for researchers whose work is intended for commercial purposes (versus basic science). The impact on access to health care has been surprisingly difficult to assess; while invalidating gene patents might be expected to decrease the cost of genetic testing and improve access to more laboratories and physicians' offices that provide the test, a 2010 study on the actual impact was inconclusive. As for personalized medicine, many experts believe that the availability of personalized medicine is ultimately a public policy issue for Congress, not the courts. ^ Based on the legal analysis performed in this work, this writer believes the Supreme Court is likely to invalidate patents on isolated DNA whose sequences are found in nature, because these gene sequences are a basic tool of scientific and technologic work and patents on isolated DNA would unduly inhibit their future use. Patents on complementary DNA (cDNA) are expected to stand, however, based on the human intervention required to craft cDNA and the product's distinction from the DNA found in nature. ^ In the end, the solution as to how to address gene patents may lie not in jurisprudence but in a fundamental change in business practices to provide expanded licenses to better address the interests of the several stakeholders. ^

Occupational health and safety among commercial sex workers in Ghana

The topic of occupational health and safety (OHS) has been investigated for many years and continues to be a concept often researched today. Generally speaking OHS research has been centered around food safety, construction safety, transportation safety, fire safety, drug and alcohol testing, health and medical management, and industrial hygiene to name a few. However, the concept of OHS concerning female commercial sex workers (FCSWs) has rarely been investigated, often neglected, seldom discussed and is lacking in sound research. Although regarded as the "oldest profession", commercial sex work (CSW) has consistently been ignored, disregarded and under-researched due to the illegality and stigmatization of prostitution. This paper reviews occupational safety and health issues faced by FCSWs in Tema and Accra, Ghana, through in-depth interviews, visits to women's homes, field work, informal conversations and participant observations with FCSWs over a period of two months. Facets of OHS that emerged among FCSWs included sexually transmissible infections, risks associated with harassment and violence from police and clients, alcohol and drug use, irregular hospital visits and/or lack of hospital visits, immigration issues, legal and policing risks. We argue that CSW be viewed as an occupation in great need of interventions to reduce workplace risks and improve the health and safety of FCSWs^

Exploring parental factors and their influence on early adolescent sexual health

Black and Hispanic youth experience the largest burden of sexually transmitted infections, teen pregnancy, and childbirth (Hamilton, Martin, & Ventura, 2011). Minority youth are disporportionately more likely to sexually debut at every age and debut before the age of 13 compared to whites (Centers for Disease Control and Prevention, 2011). However, there is little known about pre-coital sexual activity or protective parental factors in early adolscent minority youth. Parental factors such as parent-child communication and parental monitoring influence adolescent sexual behaviors and pre-coital sexual behaviors in early adolescence. Three distinct methods were used in this dissertation. Study one used qualitative methods, semi-structured, in-depth, individual interviews, to explore parent-child communication in African American mother-early adolescent son dyads. Study two used quantitative methods, secondary data analysis of a cross sectional study, to conduct a moderation analysis. For study three, I conducted a systematic review of parent-based adolescent sexual health interventions. Study one found that mothers feel comfortable talking about sex with adolescents, provide a two-prong sexual health message, and want their sons to tell their when they are thinking of having sex. Study found that parental monitoring moderates the relation between parent-child communication and pre-coital sexual behaviors. Study three found that interventions use a variety of theory, methods, and strategies and that no parent-based programs target faith-based organizations, mother-son or father-daughter dyads, or parents of LGBTQ youth. Adolescent sexual health interventions should consider addressing youth-to-parent disclosure of sexual activity or intentions to debut, addressing both parent-child sexual health communication and parental monitoring, and using a theoretical framework.^

Development and evaluation of a video-based modeling strategy for the dissemination phase of a school health tobacco -use prevention program

Even the best school health education programs will be unsuccessful if they are not disseminated effectively in a manner that encourages classroom adoption and implementation. This study involved two components: (1) the development of a videotape intervention to be used in the dissemination phase of a 4-year, NCI-funded diffusion study and (2) the evaluation of that videotape intervention strategy in comparison with a print (information transfer) strategy. Conceptualization has been guided by Social Learning Theory, Diffusion Theory, and communication theory. Additionally, the PRECEDE Framework has been used. Seventh and 8th grade classroom teachers from Spring Branch Independent School District in west Houston participated in the evaluation of the videotape and print interventions using a 57-item preadoption survey instrument developed by the UT Center for Health Promotion Research and Development. Two-way ANOVA was used to study individual score differences for five outcome variables: Total Scale Score (comprised of 57 predisposing, enabling, and reinforcing items), Adoption Characteristics Subscale, Attitude Toward Innovation Subscale, Receptivity Toward Innovation, and Reinforcement Subscale. The aim of the study is to compare the effect upon score differences of video and print interventions alone and in combination. Seventy-three 7th and 8th grade classroom teachers completed the study providing baseline and post-intervention measures on factors related to the adoption and implementation of tobacco-use prevention programs. Two-way ANOVA, in relation to the study questions, found significant scoring differences for those exposed to the videotape intervention alone for both the Attitude Toward Innovation Subscale and the Receptivity to Adopt Subscale. No significant results were found to suggest that print alone influences favorable scoring differences between baseline and post-intervention testing. One interaction effect was found suggesting video and print combined are more effective for influencing favorable scoring differences for the Reinforcement for the Adoption Subscale.^ This research is unique in that it represents a newly emerging field in health promotion communications research with implications for Social Learning Theory, Diffusion Theory, and communication science that are applicable to the development of improved school health interventions. ^

Comparison of health behaviors of Mexican American and non -Hispanic White females: Implications for health promotion programs

Hispanics form the second-largest minority group in the United States totaling 22 million people. Health data on this population are sparse and inconsistent. This study seeks to determine use of preventative services and risk factor behaviors of Mexican American and non-Hispanic White females residing in South Texas.^ Baseline data from female respondents in household surveys in six South Texas counties (Ramirez and McAlister, 1988; McAlister et al., 1992) were analyzed to test the following hypotheses: (1) Mexican American and Non-Hispanic White females exhibit different patterns of health behaviors; (2) Mexican American females will exhibit different health behaviors regardless of age; and (3) the differences between Mexican American women and non-Hispanic White females are due to education and acculturation factors.^ Over the past decade, the traditional behaviors of Mexican American females have begun to change due to education, acculturation, and their participation in the labor force. The results from this study identify some of the changes that will require immediate attention from health care providers. Results revealed that regardless of ethnicity, age, education, and language preference, non-Hispanic White females were significantly more likely to participate in preventive screening practices than were Mexican American females. Risk factor analysis revealed a different pattern with Mexican American females significantly more likely to be non-smokers, non-alcoholic drinkers, and to have good fat avoidance practices compared to non-Hispanic White females. However, compared to those who are less-educated or Spanish-speaking, Mexican American females with higher levels of education and preference for speaking English only showed positive and negative health behaviors that were more similar to the non-Hispanic White females. The positive health behaviors that come with acculturation, e.g., more participation in preventive care and more physical activity, are welcome changes. But this study has implications for global health development and reinforces a need for "primordial" prevention strategies to deter the unwanted concomitants of economic development and acculturation. Smoking and drinking behaviors among Mexican American females need to be kept at low levels to prevent increased morbidity and premature deaths in this population. ^

Social integration, health behaviors and health status among Mexican-American women in the *southwestern United States

Using the Hispanic Health and Nutrition Examination Survey (HHANES), this research examined several health behaviors and the health status of Mexican American women. This study focused on determining the relative impact of social contextual factors: age, socioeconomic status, quality of life indicators, and urban/rural residence on (a) health behaviors (smoking, obesity and alcohol use) and (b) health status (physician's assessment of health status, subject's assessment of health status and blood pressure levels). In addition, social integration was analyzed. The social integration indicators relate to an individual's degree of integration within his/her social group: marital status, level of acculturation (a continuum of traditional Mexican ways to dominant U.S. cultural ways), status congruency, and employment status. Lastly, the social contextual factors and social integration indicators were examined to identify those factors that contribute most to understanding health behaviors and health status among Mexican American women.^ The study found that the social contextual factors and social integration indicators proved to be important concepts in understanding the health behaviors. Social integration, however, did not predict health status except in the case of the subject's assessment of health status. Age and obesity were the strongest predictors of blood pressure. The social contextual factors and obesity were significant predictors of the physician's assessment of health status while acculturation, education, alcohol use and obesity were significant predictors of the subject's assessment of health status. ^

A comparison of health behaviors of African -American male and female illicit drug users: Implications for community health practice

Prevalence of drug use, HIV, syphilis, and other STDs is particularly high in African-American populations. Although some studies have documented protective changes in health behaviors relevant to these outcomes, other research indicates that risky health behaviors are still widespread. Moreover, little is known about how African-American men and women have differed in their responses to calls to adopt protective behaviors. The study reported in this dissertation investigates gender differences in health risk behavior in a sample of 482 African American chronic, frequent injection drug and crack cocaine users residing in Houston, Texas. It uses baseline and 9 month follow-up data collected on this sample. Four major research questions are addressed. These questions are: Research question 1. What was the overall pattern of reduction in drug use for subjects in the sample? In particular, did subjects who reported a recent (30 day) reduction in drug use and needle sharing risk at baseline also report a reduction at follow-up? Research question 2. Is gender significantly associated with the overall pattern of risk reduction in drug injection observed in the two waves of the study? Research question 3. Is gender significantly associated with the overall pattern of reduction in the number of sexual partners observed in the two waves of the study? Research question 4. Is gender significantly associated with the overall pattern of increase in the use of barrier contraceptives in the two waves of the study? ^

Prevalence and risk factors of asthma and work -related asthma among U.S. adults: Data from the Third National Health and Nutrition Examination Survey, 1988--1994

This cross-sectional analysis of the data from the Third National Health and Nutrition Examination Survey was conducted to determine the prevalence and determinants of asthma and wheezing among US adults, and to identify the occupations and industries at high risk of developing work-related asthma and work-related wheezing. Separate logistic models were developed for physician-diagnosed asthma (MD asthma), wheezing in the previous 12 months (wheezing), work-related asthma and work-related wheezing. Major risk factors including demographic, socioeconomic, indoor air quality, allergy, and other characteristics were analyzed. The prevalence of lifetime MD asthma was 7.7% and the prevalence of wheezing was 17.2%. Mexican-Americans exhibited the lowest prevalence of MD asthma (4.8%; 95% confidence interval (CI): 4.2, 5.4) when compared to other race-ethnic groups. The prevalence of MD asthma or wheezing did not vary by gender. Multiple logistic regression analysis showed that Mexican-Americans were less likely to develop MD asthma (adjusted odds ratio (ORa) = 0.64, 95%CI: 0.45, 0.90) and wheezing (ORa = 0.55, 95%CI: 0.44, 0.69) when compared to non-Hispanic whites. Low education level, current and past smoking status, pet ownership, lifetime diagnosis of physician-diagnosed hay fever and obesity were all significantly associated with MD asthma and wheezing. No significant effect of indoor air pollutants on asthma and wheezing was observed in this study. The prevalence of work-related asthma was 3.70% (95%CI: 2.88, 4.52) and the prevalence of work-related wheezing was 11.46% (95%CI: 9.87, 13.05). The major occupations identified at risk of developing work-related asthma and wheezing were cleaners; farm and agriculture related occupations; entertainment related occupations; protective service occupations; construction; mechanics and repairers; textile; fabricators and assemblers; other transportation and material moving occupations; freight, stock and material movers; motor vehicle operators; and equipment cleaners. The population attributable risk for work-related asthma and wheeze were 26% and 27% respectively. The major industries identified at risk of work-related asthma and wheeze include entertainment related industry; agriculture, forestry and fishing; construction; electrical machinery; repair services; and lodging places. The population attributable risk for work-related asthma was 36.5% and work-related wheezing was 28.5% for industries. Asthma remains an important public health issue in the US and in the other regions of the world. ^

The association between academic achievement and health status among eighth -grade Hispanic students in Houston

This cross-sectional study examines the association between health and academic achievement among Hispanic eighth-grade students in the Houston Independent School District. As part of the district's 3 year Safe Schools/Healthy Students Initiative to enhance comprehensive educational programs, a brief anonymous questionnaire was administered in the classroom to 359 students in two schools during a one-month period in the early part of the 2001 school year. ^ The primary study questions are: Among this sample of Hispanic adolescents, is there a significant association between academic achievement and health status? and in this same population, is there a significant association between health risk behavior and health status? The specific aims of this research are: (1) to describe the association between academic achievement and health status; (2) to describe the association between health risk behaviors and health status; and (3) to describe the relative contribution of health risk behaviors and academic achievement to adolescent health status among this sample of Hispanic adolescents. ^ The survey instrument was a 32-item questionnaire that incorporated: several academic achievement questions measuring usual grades, school-related performance, attendance, student and perceived parental satisfaction with academic achievement, and educational aspirations; two health and quality of life scales measuring adolescent self-reported health; and specific measures of health risk behavior, e.g., frequency of tobacco cigarette smoking, alcohol and other drug use, aggression, and suicidal ideation and behavior that were incorporated from the national Youth Risk Behavior Survey. Questions pertaining to sexual behavior and pregnancy were omitted to comply with school district guidelines. ^ Analysis revealed that strong associations between academic achievement and health status and between health risk behaviors and health status were observed after controlling for the covariates. Eight factors were found to be significantly associated with poor health status: usual grades (low), academic performance (low), academic achievement beliefs (low), classroom and homework performance satisfaction (low), ever drinking alcohol (6 or more times), suicidality (ever thought about, planned for, or sought medical help after attempting suicide), gender (female), and age (15 years and older). (Abstract shortened by UMI.) ^

Attitudes of health-care workers toward pregnant, HIV -positive women

The management of HIV infection with antiretroviral drugs has succeeded in increasing survival rates, but the subject of pregnancy in HIV-positive women continues to garner debate. Discrimination and stigma have been identified as barriers to health care, suggesting that women with HIV may be disinclined to seek prenatal care if health-care workers exhibit negative attitudes toward the women's pregnancies. To optimize prenatal and medical care for women with HIV infection, it is important to understand the general social conditions and cultural context in which these women have children. Goffman's treatise on stigma, Foucault's discussion of the knowledge/power matrix, and Bandura's Social Cognitive Theory offer theoretical perspectives by which we can evaluate the gender, race, and class issues that are inherent in pregnancy decision-making for women with HIV infection. It is also necessary to evaluate prevailing attitudes on childbearing toward HIV-positive women and to review the historical background of prejudice in which HIV-positive women make decisions regarding childbearing. ^ This qualitative study used a survey instrument and one-on-one interviews with HIV-infected women to elicit their perceptions of how they were treated by care providers when they became pregnant. It also included interviews with health-care workers to determine what their feelings are about pregnancy within the context of HIV infection. Results of the ethnographic inquiry reveal that most of the women had negative experiences at some point during a pregnancy, but that the situation improved when they sought care from a provider who was familiar with HIV infection. The health-care providers interviewed were firm in their belief that HIV-positive women deserved optimal care and treated the women with respect, but these are individuals who are also experts in providing care to HIV-positive patients. The question remains as to what kind of care HIV-positive women are receiving generally and what types of attitudes they are being subjected to if they see less experienced providers. Further research is also needed to determine whether HIV-positive women from a broader ethnic representation and higher socioeconomic status experience similar negative attitudes. ^