The international Good Clinical Practices Code: Time for a Global Approach

The WHO and ICH (International Conference for Harmonization) GCP codes have not been updated since 1995 and 1996 respectively. Currently, a partial revision of the ICH GCP code is ongoing, but the update process does not seem sufficiently inclusive. If GCP codes are meant to set standards pertinent and applicable at global level, then a more comprehensive revision is needed, characterized by more transparency and more inclusiveness together with adequate representation of researchers, sponsors, regulators and ethical reviewers from LMICs

raffaella ravinetto

by Raffaella Ravinetto*

Head of Clinical Trials Unit, Antwerp Institute of Tropical Medicine

The international Good Clinical Practices Code: Time for a Global Approach

 

The Good Clinical Practices (GCP) codes are meant to set globally applicable standards for the conduct of clinical trials on pharmaceutical products on human subjects (1). They are “an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects”. Compliance with GCP “provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible” (2).

There are two international GCP codes: the one of the World Health Organization (WHO) (1) and the one of the International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (2). Despite their similarities, they originate from quite different frameworks. The WHO is an international organization that brings together 194 Member States, and it is mandated to direct and coordinate international health within the United Nations system (http://www.who.int/about/en/). The ICH brings together the regulatory authorities and pharmaceutical industry from the European Union, the United States, Japan, Canada and Switzerland, and it is mandated “to improve, through harmonisation, the efficiency of the process for developing and registering new medicinal products in the form of the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use” (http://www.ich.org/home.html). Despite its limited mandate, the ICH has the ambition to become a global standard, and today most clinical research actors in Low- and Middle-Income Countries (LMICs) refer to the ICH rather than WHO GCP code. Non-ICH countries are involved in ICH through the Global Cooperation Group, but in practice their contribution seems to be quite limited (3),

Early critics of the ICH GCP code contended that it derived from informal consensus (considered as the weakest approach to guidelines development) and that it was written in absence of a systematic up-to-date search for the relevant literature (4). Others argued that the international GCP codes were “created by a small number of regulatory agencies and drug companies from industrialized nations, with little input from developing countries” (5).  Leading academic researchers also contended that the international GCP codes lack consideration for the challenges met by clinical researchers in LMICs (6, 7). The latter is not surprising. While other guidelines and regulations are subject to periodical revisions, the WHO and ICH GCP codes have not been updated since 1995 and 1996 respectively. Thus, they reflect the situation of more than twenty years ago, when multi-centre clinical trials were mainly conducted in Western contexts, and they do not take into account the challenges met today, in the context of “globalization of clinical trials”, with more and more trials carried out in LMICs (8). Since the international GCP codes guide and orient most national legislators and most funding agencies, their failure to address the challenges of researchers in LMICs may result in insufficient protection of research subjects and communities in these contexts.

We are not aware of any update of WHO GCP. Conversely, a partial revision of the ICH GCP code is ongoing, to modernize it “by supplementing with additional recommendations which will facilitate broad and consistent international implementation of new methodologies” (http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Addendum_Step2.pdf). The fact that the revision was accompanied by an open consultation (till 31st January 2016) surely provided a positive opportunity to try to have an impact. But the update process was poorly known and it does not seem sufficiently inclusive. In practice, it is not clear whether significant inputs came from the non-ICH region, and to what extent they will be taken into account.

If GCP codes are meant to set standards pertinent and applicable at global level, then a more comprehensive revision is needed, characterized by more transparency and more inclusiveness. In particular, adequate representation of researchers, sponsors, regulators and ethical reviewers from LMICs should be ensured. The revised guidelines should be strongly rooted in ethics, be sensitive to the different cultural and social perspectives, and take into account trials- and context-related challenges, for being at the same time “global”, “context centered” and “patient centered”.

This paper derives from a doctoral thesis, “Methodological and ethical challenges in non-commercial North-South collaborative clinical trials”, carried out at KU Leuven (Belgium). The manuscript is available at https://lirias.kuleuven.be/handle/123456789/517274.

References 

1) World Health Organization (WHO). Guidelines for Good Clinical Practices for trials on pharmaceutical products. 1995. WHO Technical Report Series No. 850, Annex 3. Geneva, Switzerland. Last accessed on 14/09/2015 at http://apps.who.int/medicinedocs/pdf/whozip13e/whozip13e.pdf

2) International Conference of Harmonization (ICH). ICH Tripartite Guideline for Good Clinical Practices E6 (R1), 10th June 1996. Last accessed on 14/09/2015 at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf

3) Specht S and Klingmann I. ICH: strenghts, weaknesses, and future tasks. Ther Inn & Reg Science 2014; 48(3):357-61

4) Grimes DA, Hubacher D, Nanda K, Schulz KF, Moher D and Altman DG. The Good Clinical Practice guideline: a bronze standard for clinical research. Lancet 2005; 366(9480):172-4

5) Rennie S. The FDA and Helsinki. Hastings Cent Rep 2009: 39(3):49

6) White NJ. Editorial: Clinical trials in tropical diseases: a politically incorrect view. Trop Med Int Health 2006; 11(10):1483-4

7) Lang T, Cheah P Y and White N J. Clinical research: time for sensible global guidelines. Lancet 2011; 377(9777):1553–5

8) Lang T and Siribaddana S. Clinical trials have gone global: is this a good thing? PLoS Med 2012;  9(6):e1001228

 

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*Raffaella Ravinetto holds a Pharmacy Degree from the University of Torino and a Postgraduate Diploma in Tropical Medicine from the Antwerp Institute of Tropical Medicine.   

After a seven-year experience as a Clinical Research Scientist in the private pharmaceutical sector, she worked in emergency and development programs in the Balkans and in Africa. In 2002, she joined Médecins Sans Frontières (MSF), where she followed various dossiers on access to essential medicines and quality of medicines, while performing regular field assessments. She currently works at the Antwerp Institute of Tropical Medicine, as head of the Clinical Trials Unit, coordinator of the Switching the Poles Clinical Research Network and promoter of Quamed (a Network promoting evidence-based strategies for universal access to quality medicines). She was president of the Italian branch of MSF (2007-2011).   

Her main areas of interest include North-South collaborative clinical research, research ethics (particularly in relation to resource-constrained settings) and access to health. 

 

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Streamlining R&D Core Areas for Global Health Reporting

While complex R&D reporting frameworks, including the one suggested by COHRED’s Research Fairness Initiative, are commendable and exhaustive, streamlined models should be looked for in order to enhance confidence, overcome reluctance, and make the reporting practice actually an easy task

MINOLTA DIGITAL CAMERA

by Daniele Dionisio*

Member, European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases

Streamlining R&D Core Areas for Global Health Reporting

 

As recently pointed out, …Partnerships are essential to deliver research and innovation for global health and development. Sustainable Development Goal 17 emphasizes that all the other Sustainable Development Goals rely on partnerships for their achievement. Yet, there is no agreed framework, benchmark, or standard of best practice on which to model governmental, corporate, non-profit, or academic partnerships – particularly not considering ‘fairness’ of international research collaborations to partners in low- and middle-income countries….

To fill these gaps, a reporting system is needed most with a focus on what interested parties really do to increase the fairness of research partnerships they are involved in.

While complex reporting frameworks, including the one suggested by COHRED’s Research Fairness Initiative, are commendable and exhaustive, streamlined models should be looked for in order to enhance confidence, overcome reluctance, and make the reporting practice actually an easy task.

Bearing this in mind, a minimum, not to be given up data collection should arise from essential core questions. In my opinion, they should align with philosophy and the field approach DNDi Charity has been successfully pursuing since the last decade.

As such, essential areas for reporting should entail answering a small set of questions as below:

How has the organisation/partnership managed to break the link between the cost of R&D and the price of products and ensure that the fruits of innovation are accessible at the lowest possible price for patients?

How has the organisation/partnership managed to integrate global health R&D monitoring, coordination and financing?

Based on fully affordable new medicines rolled-out by DNDI over ten years, DNDI’s cost estimates should be taken into account. As the Charity reports: “..DNDi’s cost of development ranges from EUR 6-20 million for an improved treatment, and EUR 30-40 million for a new chemical entity. However, the usual attrition in the field of R&D for infectious diseases, and the inherent risk of failure, should be taken into account, bringing the cost range of an improved treatment to EUR 10-40 million, and EUR 100-150 million for a new chemical entity”.

Report on cost details relevant to service providers and partners

The costs of activities externalized to service providers should be made explicit in full. Partners, as per DNDi words, bring specific value to the projects under different forms:  Free access to their assets (e.g. compound libraries); In-kind contributions (expertise, including from independent/ retired experts; active pharmaceutical ingredient (API) or manufactured products for trials; delivery/funding of R&D process, e.g. pharmacokinetic/pharmacodynamics studies; registration) Operational role in downstream processes (manufacturing, distribution) as ‘implementation partner’.

How has the WHO’s Prequalification Programme been involved as a guide for national regulatory authorities in low –and middle income countries with weak regulatory capacity?

How and to what extent has the organisation/partnership been routed in open models for innovation?

How has the organisation/partnership managed to ensure that the partnership outputs are placed and remain in the public domain?

Do the licensing terms of partnership research outputs explicitly guarantee equitable and affordable access to treatments based on ■Perpetual royalty-free, nonexclusive, sub-licensable licenses in the specific disease areas determined in the contract; ■Worldwide research and manufacturing rights; ■Commitment to make the final product available at cost, plus a minimal margin, in all endemic countries, regardless of their income level; ■Non-exclusivity, enabling technology transfer and local production to multiply sources of production and decrease cost of product?

How has the organisation/partnership assured licensing terms (including access to knowledge and data) whereby the research itself and the outputs of research are considered public goods?

Has the research knowledge been timely published in open access journals and publicly accessed databases?

As a guarantee of patient-centricity in decision-making: how has the organisation/partnership involved patient representatives and field practitioners?

To what extent has the organisation/partnership involved authorities and partners in neglected-disease endemic countries to help define priorities and facilitate implementation of new tools?

How has the organisation/partnership secured alliances with pharma/biotech companies and academia through innovative IP licensing to access sources of knowledge in order to identify potential new compounds and ultimately reduce the cost of development?

How has the organisation/partnership maintained a balance of public and private support to minimize as much as possible earmarked donations and ensure that no one donor contributes more than 25% of the overall budget?

How has the organisation/partnership diversified funding to prevent unhealthy influence by, or dependence upon, any single donor?

 

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*Daniele Dionisio is a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. Dionisio is former director of the Infectious Disease Division at the Pistoia City Hospital (Italy), and Head of the research project PEAH – Policies for Equitable Access to Health.

d.dionisio@tiscali.it  http://www.peah.it/  https://twitter.com/DanieleDionisio

 

HIV Serodiscordant Couples: They Want to Have Children but Can They?

HIV-infected women in serodiscordant partnerships in African countries experience relationship stress due to low socioeconomic status, gender-related power dynamics and pressure to have children with their current partner to ‘bind’ the relationship. These stressors may influence ART adherence. As biomedical interventions (ART, PrEP, VMMC) are scaled up, couple-focused interventions including shared decision making, risk-reduction counseling, mutual adherence support, safer conception and economic empowerment could improve relationship and treatment outcomes in serodiscordant partnerships  

Junior Bazile

by Junior Bazile MD, MPH

Moderator of the HIV Treatment and Prevention Community on Global Health Delivery Online

Global Health Delivery Project at Harvard University

HIV Serodiscordant Couples: They Want to Have Children but Can They?

How to Manage Programs with HIV Serodiscordant Couples

 

It is a fact that in all HIV/AIDS programs there is need for appropriate counseling, psychosocial support and management of the HIV serodiscordant couples.

Biologically and immunologically there have been many explanations on why the partner of an HIV positive patient would not get infected even if the two have sexual intercourses without condoms. There have been explanations offered about the existence of the Natural Killer (NK) cells that would offer a certain immunity to the seronegative partner and more recently it has been discovered that a mutation in the CCR5 receptors, which are the receptors of predilection for HIV, can confer a certain immunity against HIV to the seronegative partner.

Beyond the biological and immunological concepts, one thing remains true: the serodiscordant couples want to have sex (and ideally without condoms), and they want to have children despite the fact that nurses and doctors have been encouraging them to use condoms every time that they are having sex.

There are a few ways that we can help them to have a safe conception.

HIV viral load of the positive partner plays a key role. As long as the HIV viral load is undetectable, the risk of transmission to uninfected partner is greatly reduced. In addition, there is a role of pre-exposure prophylaxis (PreP)

Contrary to common belief, serodiscordant couples often stay together, especially if they have children, with a median duration of partnership of 7 years (range, 3-14) [1] Although there have been concerns that intimate partner violence (IPV) could be prevalent in HIV-1 serodiscordant couples, their frequency of IPV is similar to the general population [1].

Fertility intentions are common in serodiscordant couples – 36% of HIV-1 infected women and 28% of HIV-1 infected men [2]. Not surprisingly, pregnancy rates in Africa are high; pregnancy incidence was 15.3 per 100 person-years in HIV-1 uninfected women and 16.0 per 100 person-years in HIV-1 infected women [3].

Couples with HIV-1 uninfected women can practice non-intercourse insemination. However, sperm washing and intrauterine insemination are not available for the majority of couples with HIV-1 uninfected women. With the advent of ART and PrEP for HIV-1 prevention, options for serodiscordant couples desiring safer conception include:

a) Delay trying to conceive until the HIV-1 infected partner has achieved complete viral suppression.

b) Daily oral Truvada pre-exposure prophylaxis for the HIV-1 uninfected woman until she conceives.

c) Limit sex without condoms to peak fertility periods

d) Treatment for sexually transmitted infections

e) Circumcision for HIV-1 uninfected male partners

The couple should be reminded that the efficacy of antiretroviral-based HIV-1 prevention is dependent on their medication adherence [4].

Although genetic factors may influence HIV-1 transmission risk (32-base pair deletion in chemokine receptor 5, haplotype HLA-DRB1*1301), these appear to occur in a minority of individuals. The main risk factor for sexual transmission is plasma and genital viral load in the HIV-1 infected partner[4].

Cultural factors certainly influence uptake of HIV-1 prevention interventions. For example, use of traditional herbal medicine alongside ART is not uncommon. In addition, scale-up of voluntary medical male circumcision (VMMC) in non-circumcising communities can be challenging. However, high-level community advocacy helped increase uptake of VMMC in Western Kenya. Between 2008 and 2013, 792,931 boys and men were circumcised (92% of the target number). Male circumcision prevalence in Nyanza increased from 45% in 2007 to 66% in 2012 [5].

The issue of serodiscordance can be a complex one for both health professionals and patients. Health providers offering HIV test, nurses, doctors who are interacting with the serodiscordant couples need to be trained in couple counseling. As we all know, talking about HIV to one individual can be complicated let alone talking to two individuals who are either married or living in common law where only one of them is infected. When considering the tons of questions and worries that the negative partner might have it can feel overwhelming.

It seems that social support, health education for patients and the whole community at large are really key to ensure that discordant couples understand their situations, understand each other, support each other and make the best decisions when it comes to conceive a baby.

Even before considering any decision about conception the couples should ensure that viral suppression is completed, circumcision for male seronegative should be emphasized, pre-exposure prophylaxis should be practiced regularly, treatment of any STI and condom use during fertile periods should be encouraged.

Nowadays pre-exposure prophylaxis is more and more available even in the resource-limited settings. However, in the resource-limited settings, patients should be educated and particularly they should be made aware of the existence of such services. In counseling sessions, those points must be clearly explained to the couples and the counselors should ensure that the couples understand each of the points. We need to point out that for some patients issues related to condom, pre-exposure prophylaxis and even circumcision might not be easily digested.

While we typically see patients in individual consultations, ideally HIV care and treatment services should discuss fertility and childbearing jointly with female and male partners. There are several distinct advantages to a couple-based approach. First, because partnerships have an important influence on fertility decisions, consulting with couples can be useful in helping individuals and their partners arrive at appropriate informed decisions about fertility. Second, the health of both partners is important towards safe conception and pregnancy, and delivering care to both partners may therefore be necessary. Third, if a couple is struggling to conceive, there are specific investigations and interventions for both women and men, and investigating and treating one partner only may lead to suboptimal outcomes. However, this entails disclosure of HIV status between partners, which can be a major challenge. At the minimum, the HIV status of both partners must be known and disclosed in order to manage this process safely and effectively.

Despite the importance of a couple-based approach, there are circumstances where an individual desires a child but does not know the serostatus of the partner, or desires a child in the absence of a regular partner or a partner who is willing or able to attend the clinic. These situations present particular challenges.

HIV-infected women in serodiscordant partnerships are at high risk of abandonment, partnership dissolution, and economic hardship. Prior work in Uganda found that partnership dissolution was 3 times as likely in female-positive/male-negative couples than HIV-uninfected couples. Notably, female-negative/male-positive couples were not more likely to divorce or separate than HIV-uninfected couples, suggesting HIV-infection in women was significantly associated with relationship dissolution [6].

In Nairobi, Kenya, 469 serodiscordant couples, 64% of which had HIV-1 infected women partners, were followed between 2007 and 2009. Incidence of partnership dissolution was high – 16.6 per 100 couple-years. Of the 85 subjects who reported separation or divorce, 45 (53%) cited HIV discordance as the main reason [7]. Not having children in the partnership, being unmarried and low socioeconomic status predicted partnership dissolution. Among couples without an income, female-positive/male-negative couples were 5 times as likely to separate as male-positive/female-negative couples.

HIV-infected women in serodiscordant partnerships experience relationship stress due to low socioeconomic status, gender-related power dynamics and pressure to have children with their current partner to ‘bind’ the relationship. These stressors may influence ART adherence. As biomedical interventions (ART, PrEP, VMMC) are scaled up, couple-focused interventions including shared decision making, risk-reduction counseling, mutual adherence support, safer conception and economic empowerment could improve relationship and treatment outcomes in serodiscordant partnerships.

 

References

[1] Mujugira A, Baeten JM, Donnell D, Ndase P, Mugo NR, Barnes L, et al. Characteristics of HIV-1 Serodiscordant Couples Enrolled in a Clinical Trial of Antiretroviral Pre-Exposure Prophylaxis for HIV-1 Prevention. PLoS ONE. 2011   6(10): e25828.

[2] Murnane PM, Celum C, Mugo Nelly et al. Efficacy of pre-exposure prophylaxis for HIV-1 prevention among high-risk heterosexuals: subgroup analyses from a randomized trial. AIDS 2013, 27:2155–2160

[3] Mugo NR, Heffron R, Donnell D et al. Increased Risk of HIV-1 Transmission in Pregnancy: A Prospective Study among African HIV-1 Serodiscordant Couples. AIDS 2011, 25 (15): 1887-1895

[4] Matthews LT, Smit JA, Cu-Uvin S, Cohan D. Antiretroviral and safer conception for HIV serodiscordant couples. Curr Opin HIV AIDS. 2012, 7(6) 569-578

[5] Kenya AIDS Indicator Survey 2015

[6] Porter L, Hao L, Bishai D, et al. HIV status and union dissolution in sub-Saharan Africa: the case of Rakai, Uganda. Demography  2004, 41: 465–482

[7] Mackelprang RD, Bosire R, Guthrie BL et al. High Rates of Relationship Dissolution Among Heterosexual HIV-Serodiscordant Couples in Kenya. AIDS Behav. 2014, 18(1): 189-193

 

 

 

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A Bridge between Human Trafficking and Sex Work

...human trafficking activists want nothing to do with a sex worker’s rights based approach as they believe the existence of prostitution is to blame for the plight of forced labor, and sex worker’s want nothing to do with trafficking activists out of a need to distance themselves from anti-trafficking activists (at times) very punitive movement....these two realities are often dealt with by policy makers and activists alike as being mutually exclusive, when they are in fact, not

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by Laura LeMoon*

Disease Research & Intervention Specialist at King Co. Public Health Seattle USA

A Bridge between Human Trafficking and Sex Work

 

Why are human trafficking activists and sex worker’s rights activists at such odds with each other?  Spend any good amount of time in the United States …watch our news stories…read our newspapers… and it might appear that all prostitution is human trafficking and all human trafficking is prostitution. Therefore human trafficking activists want nothing to do with a sex worker’s rights based approach as they believe the existence of prostitution is to blame for the plight of forced labor, and sex worker’s want nothing to do with trafficking activists out of a need to distance themselves from anti-trafficking activists (at times) very punitive movement.  As a former Sex Worker AND human trafficking survivor, I can tell you that these two realities are often dealt with by policy makers and activists alike as being mutually exclusive, when they are in fact, not.

To give some background on the difference between these two movements, it is important to understand the political movement behind “sex work.” The Sex Workers rights movement began in the 1970’s, inspired by the women’s liberation movement , gay rights movement and the civil rights movement of the 1960’s. The term “Sex Worker” was created at this time as a unifying moniker for individuals engaged in the sex industry, and as a distinct marker of “choice” for ones participation in erotic services. The term “Sex Worker” today, is still a highly politicized term and one used to highlight ones agency and freedom of choice to participate in the sex industry. The sex worker’s rights movement is based on a kind of Marxist worker’s rights approach founded on the concept that sex work is legitimate work and like fishing in the Bering Sea or farming, those harms must be directly addressed and mitigated by tools such as national and local policy making.

Nonprofit organizations in the United States that are rooted in the Sex Worker rights movement have traditionally focused on harm-reduction methods to address issues like sexually transmitted infections, HIV prevention/intervention and primary and gynecological health care. However what these organizations have been woefully behind the eight ball on is the issue of violence in sex work and the management of trauma as a result. Many rights-based nonprofits feel that to focus on the issue of violence (whether professional or personal) is to give unfair air-time to an overpublicized issue in the world of erotic servicer work. Therefore, many pro-rights nonprofits shy away from directly addressing the issues of force, fraud and coercion or overt violence in their programming due to a kind of knee-jerk response to protect the community from further “bad press”. The lack of desire in the Sex Worker community to talk about violence comes from an understandable place; that the community is tired of defending itself against constant attacks from perceived outsiders that seek to blame the problem of forced labor on the existence of prostitution itself. Sex Workers’ rights organizations and activists are also tired of having the focus on them be singular in nature. Of course there are more issues facing people in the sex industry than violence, just as there are more issues facing this community than the need for STI  screening and access to free condoms. However, rights activists are not reacting to this in a way that is helpful to the sex working community at large. By not wanting to directly address the issues of force, fraud and coercion and overt violence from the perspective of a rights-based approach, sex worker rights activists are only acknowledging a partial reality of sex work as well as a partial need for services.

Likewise, the many activists involved in human trafficking awareness- often people or organizations with religious affiliations- are not serving trafficking survivors by placing the blame of all the potential harms/risks of sex work on sex work itself and ignoring the complex continuum of choice that can exist in the sex industry for many. In their narrow view of sex work at large, they are cutting themselves off at the knees in their abilities to truly tap into the full spectrum of violence and coercion that can exist for people in the industry, as well as their ability to connect with community members who may have a more complex relationship to sex work than just good or bad, victim or whore, black or white.

What needs to be done is a bridge built between these two activist communities. In actuality, we are not working at cross purposes. As an activist working within the Sex Worker rights community, I see the first steps as both endogenous and exogenous. Sex Worker’s rights organizations must begin to recalibrate programming according to the direct needs reported by communities being served. Not based on providence, or what is most comfortable for activists to address based on our own fears of misinterpretation by “outsiders.” Additionally, Sex Worker activists need to get comfortable reaching across the table to anti- trafficking activists and abolitionists alike who may not share a similar purview on prostitution.  Agreement certainly will not always happen, however the schism currently existing between these two ideologies has only proved to impede much needed innovative change in approaches to violence and coercion in sexual economies. We must stop fighting against each other and look to the ways that we can build upon common interest and create bridges based on the mutually held ideal of self-determination and bodily integrity for all those who come to the sex industry.

 

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*Laura LeMoon was born in Washington State, USA in 1985. She earned her Bachelor of Arts degree in Women’s studies at Mills College in California and began her career in research authoring a pilot study on violence in the lives of Sex Workers of all genders at a nonprofit peer-based medical clinic for Sex Workers in San Francisco, California. Laura has continued her Sex Worker advocacy in the red-light district of Kolkata, India at the Sex Workers’ union Durbar Mahila Samanwaya Committee, has worked with famous Sex Workers rights pioneer Carol Leigh, assisted in forming human-trafficking focus groups at the International Rescue Committee and has worked as an ethnographer for the National HIV Behavioral Surveillance run nationally in the U.S. via the Centers for Disease Control, which is focused around HIV and high risk populations. Currently she is working as a Disease Research & Intervention Specialist on the National HIV Behavioral Surveillance (NHBS), which this year focuses on HIV risk and women who exchange sex. She is also the co-founder of a Sex Workers’ collective in Seattle that works to provide harm reduction services to street-based Sex Workers on one of Seattle’s last remaining “strolls.” She lives in Washington State, USA.

Why do Some American Citizens not support Universal Health Care?

This paper is an exploration of some possible answers to this confounding question, including some misconceptions and interesting opinions. As such, it will not explore health care as a right or pros and cons of universal health care. Rather, its scope is limited to expressing reasons given by a few people for not supporting universal health care in the United States of America

Corie Leifer2

by Corie Leifer*

Project and Department Assistant at Phillips-Medisize

Why do Some American Citizens not support Universal Health Care?

 

The universal health care debate in America is not a new one. The discussion has already lasted more than 100 years and shows no signs of coming to an end. This is despite the fact that, for more than a century, other democratic countries have had universal health care systems in place. As an American living in the Netherlands I have been asked more than once why all Americans are not in favor of universal health care. As an American also does not understand this viewpoint, I find this a hard question to answer. Additionally, as a nurse and public health specialist, I have a special interest in this topic.

I feel it necessary to state my bias and purpose upfront and clearly express that this article is not scientific. It is an exploration of some possible answers to this confounding question, including some misconceptions and interesting opinions. This paper will not explore health care as a right or pros and cons of universal health care. The scope of this article is limited to expressing reasons given by a few people for not supporting universal health care in the United States of America.

The question of universal health care is clearly much more complex than can be answered with a simple, “yes, we provide it” or “no, we don’t”. The variations are endless. There is a history behind this debate. There are philosophical, moral, ethical, and personal issues that need to be explored and considered. There are many perspectives from which to see this complex subject as well, due to the various stakeholders involved in health care delivery. This paper explores concerns from the perspective of a patient regarding their support of universal health care.

Here are a few of the reasons that American citizens have expressed to me for why they do not support universal health care:

Government is ineffective and inefficient 

This reason was given by more than one respondent. There are regular problems with government-run programs in America, such as Veterans Affairs (VA), social security, and Medicaid/Medicare. It was expressed that there is too much overhead without oversight in current government programs. There is a fear that, even if these systems are funded, there is no guarantee that it is sustainable. One respondent specifically did not like the idea of contributing to a universal healthcare fund, when there was no guarantee that as she aged that fund would still be around to take care of her when she needs it most. There is a common misconception that there are only two options: government provided health care or privatized health care. Furthermore, it was expressed that people value things less when they do not have to pay for them. The assumption is that government provided health care is free to the patient. Americans are often unaware of a third option available in many other countries; government subsidized private health care.

Don’t like being told what to do 

Another reason given for not supporting universal health care is the idea that something is mandatory. When I pointed out that car insurance is also mandatory, the respondent argued that she could choose not to drive. Americans often reference their individual rights and seem to resent being told that they must do something. In addition, the individualistic culture leads people to feel that they are not sick, why should they care if someone else is? The strange thing is that other services are forced on Americans such as schooling, but the same resentment does not seem to apply.

Overburdened system

It was expressed that if everyone were to have access to health care, then the already overburdened system will collapse. Worries included increased wait times due to increased patient load and the ability to receive appropriate, quality, timely care and treatment. One possible solution to this problem is to educate and create more healthcare professionals. Unfortunately, that also includes a financial investment from an industry that is already having to make austere decisions and take cost-cutting measures. Rising costs were also a major concern for all parties. However, that is a subject about which entire books are written, and, thus, will not be addressed in this brief opinion editorial.

 

What I am able to conclude from my brief research, if it can be called that, is that this topic is as extensive as it is complicated. The intricacies and considerations involved health care services are limitless. The scope of a discussion is very hard to limit because each topic is closely linked to multiple other issues. Each question leads to another question, rather than an answer. That is why it is easy to put on the back burner. I think the true answer to why universal health care is not an idea supported by all Americans is because there is not enough comprehendible information available. There are nuances and details that confuse even those who are knowledgeable and informed. In order to persuade everyone to support universal health care, clear and concise messages about the program need to be developed based on addressing public concerns.

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*Corie Leifer was born in 1981 in Connecticut, USA. After earning a bachelor degree in communications and another in nursing in the United States, she moved to the Netherlands in 2011 to earn a Master of Health Science degree with a focus on International Public Health from Vrije Universiteit in Amsterdam. During this study, Corie completed her internship at AFEW and subsequently joined AFEW as Office Manager. As a research intern, she investigated the use of SMS campaigns to reduce the spread of HIV/AIDS. Corie has international marketing and communications experience, having worked at Operation Smile, Inc. and Trader Publishing Company prior to returning to school. Corie is also a Registered Nurse licensed in the Commonwealth of Virginia, USA. Since April 2016 Corie serves as Project and Department Assistant at Phillips-Medisize.

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