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Examining Gender in Pharmaceutical Rhetoric Through a Cultural Studies Lens: A Case Study on the Gardasil Vaccine
Title
Examining Gender in Pharmaceutical Rhetoric Through a Cultural Studies Lens: A Case Study on the Gardasil Vaccine.
Creator
Fickley, Jennifer, Bowdon, Melody, Scott, John, Bell, Kathleen, Delorme, Denise, University of Central Florida
Abstract / Description
On June 8, 2006, Merck announced the debut of Gardasil, the world's first vaccine found successful in preventing human papillomavirus (HPV) infections, a sexually transmitted infection that is one of the main causes of certain cancers in men and women, including cervical, vulvar, penile and anal cancers. To promote the vaccine's release, Merck launched Gardasil's (")One Less(") advertising campaign that included television commercials, print ads and a consumer-focused website (www.Gardasil...
Show moreOn June 8, 2006, Merck announced the debut of Gardasil, the world's first vaccine found successful in preventing human papillomavirus (HPV) infections, a sexually transmitted infection that is one of the main causes of certain cancers in men and women, including cervical, vulvar, penile and anal cancers. To promote the vaccine's release, Merck launched Gardasil's (")One Less(") advertising campaign that included television commercials, print ads and a consumer-focused website (www.Gardasil.com), each promoting the message that (")you(") could now be (")one less woman(") affected by cervical cancer ((")One Less(") campaign). The vaccine, tested and approved only for females age 9-26, was advertised to this age group, as well as parents or guardians responsible for making medical decisions for female minors. As the campaign launched, commercials depicted females laughing and enjoying hobbies while mentioning the positive decision they made to receive the Gardasil vaccine. Many commercials also included portrayals of mothers talking happily about their decision to get their young daughters vaccinated. Interestingly, male figures were completely left out of Gardasil's (")One Less(") campaign ads, despite the fact that in reality, males administer the vaccine as medical professionals, transmit the infection as sexual partners, and suffer cancers as HPV-infected patients. Males were even left out of the ads as parents, who were always portrayed by women in the ad campaign. Informed consumers may have expected all this to change on Oct. 16, 2009 (-) three years after Gardasil's debut (-) when the Food (&) Drug Administration (FDA) approved the vaccine for use in males age 9-26 to protect against HPV-caused genital warts. Though Merck's vaccine was now accessible to more consumers than ever, the advertising that surrounded this medical breakthrough changed very little. Television commercials for the vaccine still promoted Gardasil primarily to women for the purpose of preventing HPV-related cervical cancer. Again, men were not featured in commercials as medical professionals, parents, guardians, romantic partners, or even as patients able to get the vaccine. Males did begin appearing on the vaccine's official website, however these depictions were limited to showing only young boys, who appeared standing with a mother's protective arm around them. Males that represent the older age range (up to age 26) were never shown. What effect does the lack of male representation have on the verbal and nonverbal message these ads are sending consumers about who fits in the target consumer group, as well as who is at risk for an HPV infection? On a broader level, how does gender representation as a whole affect pharmaceutical advertisements and the adoption of the potentially life-saving products they promote? How does a pharmaceutical technology become (")gendered(")? How do specific gender portrayals impact the educational aspects of pharmaceutical ads, which may shape a consumer's opinion of who is at risk for an illness, and who is responsible for its treatment or prevention? And how do these gender portrayals connect with, reflect or reinforce dominant cultural beliefs about the roles males and females play in protecting themselves and others from disease? In this study, I investigate these questions using a blended cultural studies/social sciences research perspective, first looking at the controversial history of direct-to-consumer pharmaceutical advertising and the gender stereotypes that traditionally exist in this form of rhetoric. I then test the affect Merck's gender portrayals has on its ad message in a blind study done with a small sample population, which provides evidence that Merck's ads are confusing and exclusive of certain populations, particularly men. I then investigate how Merck's existing gender portrayals, and strong focus on women, reflect larger historical beliefs on the roles that males and females play in health care and in the family. I show how, through advertising, Gardasil has become (")gendered(") as a pharmaceutical technology for female children. From here, I will show how pharmaceutical companies, such as Merck, have both reflected and reinforced the belief that women are the primary caregivers to children, how this stereotype is both damaging and statistically incorrect, and how using it targets Gardasil ads to a very narrow population of consumers, miscommunicating the message of who is at risk for illness contraction and perhaps even damaging sales in addition to prevention. I later provide evidence that Merck's current Gardasil ad series and other actions in the marketplace are dangerously misleading certain populations regarding the nature of the HPV virus, the protective abilities of the vaccine, and the populations responsible for accessing Gardasil. I then provide the argument that gendering Gardasil as a (")women's technology(") is done intentionally by Merck, which has a history of making profits a priority over responsibly treating patient health. I conclude by providing detailed suggestions on how Merck can augment their current ad series to de-gender Gardasil to become more medically responsible, and break out of the cycle of portraying men and women using damaging and outdated stereotypes. Instead, my suggestions for changes to Gardasil's advertising approach would make the vaccine's messages appeal to all audiences at risk.
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Date Issued
2012
Identifier
CFE0004304, ucf:49486
Format
Document (PDF)
PURL
http://purl.flvc.org/ucf/fd/CFE0004304
PLANT-MADE ORAL VACCINES: EVALUATION OF CAPSULES
Title
PLANT-MADE ORAL VACCINES: EVALUATION OF CAPSULES.
Creator
New, James, Daniell, Henry, University of Central Florida
Abstract / Description
Antigen expression through the Chloroplast Transformation Technology (CTT) produces bioencapsulated subunit-vaccines, capable of eliciting immune responses when delivered orally. Considerable challenges to effective plant-based vaccines are the normalization of dosage and preservation of accumulated antigen, which is complicated by variable high water content and protease activity. This study critically examines the efficacy of lyophilization in dehydrating plant-tissues and preserving plant...
Show moreAntigen expression through the Chloroplast Transformation Technology (CTT) produces bioencapsulated subunit-vaccines, capable of eliciting immune responses when delivered orally. Considerable challenges to effective plant-based vaccines are the normalization of dosage and preservation of accumulated antigen, which is complicated by variable high water content and protease activity. This study critically examines the efficacy of lyophilization in dehydrating plant-tissues and preserving plant-derived antigens with vaccine potential. Lyophilization was optimized through gravimetric analysis using lettuce expressing Protective Antigen (PA) of Bacillus anthracis (LS-HPAG) and the human autoantigen Proinsulin (Pins) fused to Cholera toxin subunit B (LS-CTB-Pins). Lyophilization for 48-hours was sufficient treatment to reduce lettuce to 4.57% of its original weight, which retained .058% water content in the bound state; these levels corresponded with oven-dried controls while antigen was stabilized for over a year of storage at room temperature. A simulated gastric fluid assay was applied to evaluate stability of plant derived antigens during digestion. It was observed that lettuce plant cells conferred protection through antigen bioencapsulation for up to an hour under enzymatic digestive conditions. LS-HPAG immunogenicity was then demonstrated through the induction of a PA-specific IgG response by through oral boosting of C57/BL6 test mice. Survival during toxin challenge demonstrated a protective immune response if 40% of animal immunized by plant-derived PA. Lastly, the inclusion of excipient and adjuvant additives will be considered and utilized for the development of prototype vaccine capsule formulations.
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Date Issued
2011
Identifier
CFH0003861, ucf:44689
Format
Document (PDF)
PURL
http://purl.flvc.org/ucf/fd/CFH0003861
LOW COST PRODUCTION OF PROINSULIN IN TOBACCO AND LETTUCE CHLOROPLASTS FOR INJECTABLE OR ORAL DELIVERY OF FUNCTIONAL INSULIN AND C-PEPTIDE
Title
LOW COST PRODUCTION OF PROINSULIN IN TOBACCO AND LETTUCE CHLOROPLASTS FOR INJECTABLE OR ORAL DELIVERY OF FUNCTIONAL INSULIN AND C-PEPTIDE.
Creator
Burberry, Diane, Daniell, Henry, University of Central Florida
Abstract / Description
Current treatment for type I diabetes includes delivery of insulin via injection or pump, which is highly invasive and expensive. The production of chloroplast-derived proinsulin should reduce cost and facilitate oral delivery. Therefore, tobacco and lettuce chloroplasts were transformed with the cholera toxin B subunit fused with human proinsulin (A, B, and C peptides) containing three furin cleavage sites (CTB-PFx3). Transplastomic lines were confirmed for site-specific integration of...
Show moreCurrent treatment for type I diabetes includes delivery of insulin via injection or pump, which is highly invasive and expensive. The production of chloroplast-derived proinsulin should reduce cost and facilitate oral delivery. Therefore, tobacco and lettuce chloroplasts were transformed with the cholera toxin B subunit fused with human proinsulin (A, B, and C peptides) containing three furin cleavage sites (CTB-PFx3). Transplastomic lines were confirmed for site-specific integration of transgene and homoplasmy. Old tobacco leaves accumulated proinsulin up to 47% of total leaf protein (TLP). Old lettuce leaves accumulated proinsulin up to 53% TLP. Accumulation was so stable that up to ~40% proinsulin in TLP was observed even in senescent and dried lettuce leaves, facilitating their processing and storage in the field. Based on the yield of only monomers and dimers of proinsulin (3 mg/g leaf, a significant underestimation), with a 50% loss of protein during the purification process, one acre of tobacco could yield up to 20 million daily doses of insulin per year. Proinsulin from tobacco leaves was purified up to 98% using metal affinity chromatography without any His-tag. Furin protease cleaved insulin peptides in vitro. Oral delivery of unprocessed proinsulin bioencapsulated in plant cells or injectable delivery into mice showed reduction in blood glucose levels similar to processed commercial insulin. C-peptide should aid in longterm treatment of diabetic complications including stimulation of nerve and renal functions. Hyper-expression of functional proinsulin and exceptional stability in dehydrated leaves offer a low cost platform for oral and injectable delivery of cleavable proinsulin.
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Date Issued
2010
Identifier
CFE0003257, ucf:48554
Format
Document (PDF)
PURL
http://purl.flvc.org/ucf/fd/CFE0003257
Anthropogenic Organic Chemical Removal from a Surficial Groundwater and Mass Transfer Modeling in a Nanofiltration Membrane Process
Title
Anthropogenic Organic Chemical Removal from a Surficial Groundwater and Mass Transfer Modeling in a Nanofiltration Membrane Process.
Creator
Jeffery, Samantha, Duranceau, Steven, Lee, Woo Hyoung, Sadmani, A H M Anwar, Yestrebsky, Cherie, University of Central Florida
Abstract / Description
This dissertation reports on research related to trace organic compounds (TrOCs) in surficial groundwater supplies and their subsequent removal from nanofiltration (NF) membranes. The research was conducted along coastal South Florida in cooperation with the Town of Jupiter Water Utilities, Jupiter, FL (Town). The focus of the research was to determine the extent of reclaimed water impacts on surficial groundwater supplies and subsequent effects on the Town's NF water treatment plant. Routine...
Show moreThis dissertation reports on research related to trace organic compounds (TrOCs) in surficial groundwater supplies and their subsequent removal from nanofiltration (NF) membranes. The research was conducted along coastal South Florida in cooperation with the Town of Jupiter Water Utilities, Jupiter, FL (Town). The focus of the research was to determine the extent of reclaimed water impacts on surficial groundwater supplies and subsequent effects on the Town's NF water treatment plant. Routine monitoring of fourteen TrOCs in reclaimed water and at the water treatment facility revealed varying degrees of TrOC detection in the environment. Certain TrOCs, including caffeine and DEET, were detected in a majority of the water sampling locations evaluated in this work. However, subsequent dilution with highly-treated reverse osmosis (RO) permeate from alternative supplies resulted in TrOCs below detection limits in potable water at the point-of-entry (POE). Pilot testing was employed to determine the extent of TrOC removal by NF. Prior to evaluating TrOC removal, hydraulic transients within the pilot process were first examined to determine the required length of time the pilot needed to reach steady-state. The transient response of a center-port NF membrane process was evaluated using a step-input dose of a sodium chloride solution. The pilot was configured as a two-stage, split-feed, center-exit, 7:2 pressure vessel array process, where the feed water is fed to both ends of six element pressure vessels, and permeate and concentrate streams are collected after only three membrane elements. The transient response was described as a log-logistic system with a maximum delay time of 285 seconds for an 85% water recovery and 267 gallon per minute feed flowrate.Eleven TrOC pilot unit experiments were conducted with feed concentrations ranging from 0.52 to 4,500 ?g/L. TrOC rejection was well-correlated with compound molecular volume and polarizability, with coefficient of determination (R2) values of 0.94. To enhance this correlation, an extensive literature review was conducted and independent literature sources were correlated with rejection. Literature citations reporting the removal effectiveness of an additional sixty-one TrOCs by loose NF membranes (a total of 95 data points) were found to be well-correlated with molecular volume and polarizability, with R2 values of 0.72 and 0.71, respectively.Of the TrOC's detected during this research, the anthropogenic solute caffeine was selected to be modeled using the homogeneous solution diffusion model (HSDM) and the HSDM with film theory (HSDM-FT). Mass transfer coefficients, K_w (water) K_s (caffeine), and k_b (caffeine back-transport) were determined experimentally, and K_s was also determined using the Sherwood correlation method. Findings indicate that caffeine transport through the NF pilot could be explained using experimentally determined K_s values without incorporating film theory, since the HSDM resulted in a better correlation between predicted and actual caffeine permeate concentrations compared to the HSDM-FT and the HSDM using K_s obtained using Sherwood applications. Predicted versus actual caffeine content was linearly compared, revealing R2 values on the order of 0.99, 0.96, and 0.99 for the HSDM without FT, HSDM-FT, and HSDM using a K_s value obtained using the Sherwood correlation method. However, the use of the HSDM-FT and the Sherwood number resulted in the over-prediction of caffeine concentrations in permeate streams by 27 percent and 104 percent, respectively.
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Date Issued
2016
Identifier
CFE0006331, ucf:51545
Format
Document (PDF)
PURL
http://purl.flvc.org/ucf/fd/CFE0006331
Quality by Design Procedure for Continuous Pharmaceutical Manufacturing: An Integrated Flowsheet Model Approach
Title
Quality by Design Procedure for Continuous Pharmaceutical Manufacturing: An Integrated Flowsheet Model Approach.
Creator
Vezina, Ashley, Elshennawy, Ahmad, Rabelo, Luis, Karwowski, Waldemar, University of Central Florida
Abstract / Description
Pharmaceutical manufacturing is crucial to global healthcare and requires a higher, more consistent level of quality than any other industry. Yet, the traditional pharmaceutical batch manufacturing has remained largely unchanged in the last fifty years due to high R(&)D costs, shorter patent durations, and regulatory uncertainty. This has led regulatory bodies to promote modernization of manufacturing process to continuous pharmaceutical manufacturing (CPM) by introducing new methodologies...
Show morePharmaceutical manufacturing is crucial to global healthcare and requires a higher, more consistent level of quality than any other industry. Yet, the traditional pharmaceutical batch manufacturing has remained largely unchanged in the last fifty years due to high R(&)D costs, shorter patent durations, and regulatory uncertainty. This has led regulatory bodies to promote modernization of manufacturing process to continuous pharmaceutical manufacturing (CPM) by introducing new methodologies including quality by design, design space, and process analytical technology (PAT). This represents a shift away from the traditional pharmaceutical manufacturing way of thinking towards a risk based approach that promotes increased product and process knowledge through a data-rich environment. While both literature and regulatory bodies acknowledge the need for modernization, manufacturers have been slow to modernize due to uncertainty and lack of confidence in the applications of these methodologies. This paper aims to describe the current applications of QbD principles in literature and the current regulatory environment to identify gaps in literature through leveraging regulatory guidelines and CPM literature. To aid in closing the gap between QbD theory and QbD application, a QbD algorithm for CPM using an integrated flowsheet models is also developed and analyzed. This will help to increase manufacturing confidence in CPM by providing answers to questions about the CPM business case, applications of QbD tools, process validation and sensitivity, and process and equipment characteristics. An integrated flowsheet model will aid in the decision-making process and process optimization, breaking away from ex silico methods extensively covered in literature.
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Date Issued
2017
Identifier
CFE0006923, ucf:51683
Format
Document (PDF)
PURL
http://purl.flvc.org/ucf/fd/CFE0006923
AMYLOID-BETA42 TOXICITY REDUCTION IN HUMAN NEUROBLASTOMA CELLS USING CHOLERA TOXIN B SUBUNIT-MYELIN BASIC PROTEIN EXPRESSED IN CHLOROPLASTS
Title
AMYLOID-BETA42 TOXICITY REDUCTION IN HUMAN NEUROBLASTOMA CELLS USING CHOLERA TOXIN B SUBUNIT-MYELIN BASIC PROTEIN EXPRESSED IN CHLOROPLASTS.
Creator
Ayache, Alexandra, Daniell, Henry, University of Central Florida
Abstract / Description
Alzheimer's disease (AD) is an age progressive neurodegenerative brain disorder, affecting 37 million people worldwide. Cleavage of amyloid precursor protein by β- and γ-secretase produces the amyloid-beta (Aβ) protein, which significantly contributes to AD pathogenesis. The Aβ aggregates, formed at the surface of neurons and intracellularly, cause neurotoxicity and decrease synaptic function. Inhibiting or degrading Aβ accumulation is a key goal for development of new AD treatments. Evidence...
Show moreAlzheimer's disease (AD) is an age progressive neurodegenerative brain disorder, affecting 37 million people worldwide. Cleavage of amyloid precursor protein by β- and γ-secretase produces the amyloid-beta (Aβ) protein, which significantly contributes to AD pathogenesis. The Aβ aggregates, formed at the surface of neurons and intracellularly, cause neurotoxicity and decrease synaptic function. Inhibiting or degrading Aβ accumulation is a key goal for development of new AD treatments. Evidence shows that human Myelin Basic Protein (MBP) binds to and degrades Aβ thereby, preventing cytotoxicity. A potential method for oral drug delivery that will allow plant-derived bioencapsulated MBP to pass through intestinal epithelium and bypass denaturing stomach acidity is quite novel. Cholera Toxin B subunit (CTB), when fused with MBP, can serve as a vehicle for oral delivery of this chloroplast expressed therapeutic protein into the systemic circulation. Within chloroplast, CTB forms a pentameric structure that binds to GM1 ganglioside receptors, allowing receptor-mediated endocytosis. In order to investigate protein entry through neuronal GM1 receptors, we first created CTB fused to the green fluorescent protein (GFP). Incubation of this fusion protein with human neuroblastoma cells resulted in GFP entry into these cells whereas GFP alone was unable to enter. Similarly, co-incubation of CTB-MBP, via neuronal GM1 binding, allowed MBP to reduce neurotoxicity of Aβ42 treated cells by 37.1%. Delivery of CTB-MBP through GM1 receptor mediated binding should therefore facilitate oral administration, storage, heat stability and low cost AD treatment.
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Date Issued
2012
Identifier
CFH0004249, ucf:44916
Format
Document (PDF)
PURL
http://purl.flvc.org/ucf/fd/CFH0004249