Developing a Hookworm Vaccine; Examining the Complexity of a Human Rights Approach to Development

HookWorm Disease by Country. Image by WHO, courtesy wikimedia commons. Red=60 cases per 100,000, Yellow=less than 10
Primum Non Nocere – Above All, Do No Harm[1]
The disease and the vaccine
Human Rights and development giant, the Bill and Melinda Gates Foundation, supports the fight against many neglected and infectious tropical diseases, including hookworm. They are funding the Human Hookworm Vaccine Initiative led by the non-profit Sabine Vaccine Institute. By examining this project from a human rights based approach, the complexity of development work is evident, raising far more questions than it answers.
Hookworm infection is not necessarily dangerous. Infact, the CDC recommends not treating light infections of hookworm.[2] The effects of more severe infections are anemia, physical and mental developmental impairment.[3] Over 600 million people world-wide, are estimated to suffer from hookworm infection.[4]
The current treatment for hookworm infection is the administration of albendazole or mebendazole manufactured by GlaxoKlineSmith and Johnson & Johnson respectively. As the disease is most commonly transmitted through hookworm larvae in feces, preventative measures include wider access to and proper use of latrines as well as the wearing of shoes. The vaccine has been developed and is undergoing clinical trials.[5]
Human rights issues
Before testing of the vaccine is concluded and administered to the public at large, a human rights based approach to this project requires examination of several issues besides the efficacy questions of clinical trials. The human right to health is not fulfilled by the individual successes of short-term development projects. Peter Uvin reminds us that, “a right is about a long-term guarantee, a set of structural claims, particularly for the most vulnerable and underprivileged or excluded.”[6] So then, we must examine whether the introduction of a hookworm vaccine would be likely contribute to long-term improvements of health accessibility. A step-by-step proposal of such a Human Rights Impact Assessment specific to the needs of public health policy was proposed as early as 1998.[7] The WHO also recently published a working paper addressing impact assessments.[8]
Hookworm research
One critical area of investigation for an impact assessment of the hookworm vaccine would be the wider arena of research related to hookworms. Research institutions are studying the administration of hookworms as treatment for Multiple Sclerosis (MS), asthma, allergies, Chron’s disease, lupus, heart disease and many others.[9] The rationale is a continuation of the hygiene hypothesis. For example, a recent study on the effect of helminth (worm) infection in patients with MS offers the following:
In recent decades, epidemiological evidence has accumulated indicating a steady increase in autoimmune disease incidence in developed countries. Both improvement in sanitary conditions in general and reduction in infectious disease prevalence in particular have been proposed as the cause. Following this premise, we recently demonstrated that helminth-infected MS patients showed significantly lower number of relapses, reduced disability-evaluating test scores, and significantly lower magnetic resonance imaging activity compared with uninfected MS subjects.[10]
These beneficial and therapeutic properties of hookworm infection begin to make evident the difference and importance between the individual treatment of a moderate to severe hookworm infection and vaccination that would prevent infection, from a human rights perspective.
In many public health epidemics access to expensive medical treatments can be the prohibitive factor for successful treatment. This is not the case for hookworm infections. Johnson & Johnson donates 50 million tablets of mebendazole per year and GlaxoSmithKline makes albendazole available for US 2 cents per pill.[11] However, in developed countries, where people would be willing and able to pay much more for such a treatment, hookworm infection is rare. This circumstance negates the problem of profit loss through diversion that Thomas Pogge addresses in his outline for the implementation of a “GBD patent.”[12] But this would certainly not be the case if the requirement for mebendazole and albendazole transformed into the need for the very expensive medications used to treat Multiple Sclerosis in developed countries. The same would apply to the other modern diseases linked to the absence of hookworms and other helminths.
Questions remain
Hookworm infection is interesting from a development perspective because effective treatment and prevention methods are known and widely available. The lack of their successful implementation has spurred the development of a vaccine. A successful vaccination campaign could actually lower the priority of infrastructure development that makes existing treatment and prevention so difficult. The primary question is whether the possible long-term contribution to a more complex health problem constitutes a violation of non-retrogression, the development version of primum non nocere. Step II of the Human Rights Impact Assessment tool requires that we ask “[i]s there a better approach?” and “[i]s a
particular policy as effective as other feasible options?” among others.[13] The authors conclude that “[p]ublic health programs that respect human rights will encourage individuals and communities to trust, and cooperate with, public health authorities. Promotion of human rights, particularly among previously disenfranchised groups, increases their ability to protect their own health.”[14] Human rights based development requires that the developers and supporters of the Hookworm vaccine ask and answer whether their product meets this standard.
[1] A Latin maxim often incorrectly attributed to Hippocrates, but nonetheless, “an
axiom central to clinical pharmacology and to the education of medical and
graduate students.” Cedric Smith, “Origin and Uses of Primum Non Nocere–Above
All, Do No Harm!,” Journal of Clinical Pharmacology 45 (April 2005): 371,
doi:10.1177/0091270004273680.
[2] The diagnostic algorithm which is implemented when diagnosing hookworm infections. http://phil.cdc.gov/phil/details.asp
[3] WHO, Initiative for Vaccine Research, Parasitic Diseases, Hookworm disease, Disease
burden, http://www.who.int/vaccine_research/diseases/soa_parasitic/en/index2.html.
[4] Bill and Melinda Gates Foundation, “Neglected and Other Tropical Diseases, Strategy Overview,” 2009, http://www.gatesfoundation.org/global-health/Documents/noids-strategy.pdf
[5] Sabine Vaccine Institute, Hookworm Disease Overview, http://www.sabin.org/sites/all/modules/sabin/svi_factsheetxml/disease.php?id=10,
accessed April 19, 2011.
[6] Peter Uvin, Human Rights and Development, (Bloomfield, CT: Kumarian, 2004) 53.
[7] Lawrence Gostin, Jonathan M. Mann and Larry Gostin, “Towards the Development of a Human
Rights Impact Assessment for the Formulation and Evaluation of Public Health
Policies,” Health and Human Rights, 1 (Autumn 1994): 58-80, http://www.jstor.org/stable/4065262.
[8] Ilse Worm, World Health Organization, “Human Rights and Gender Equality and Health: Overview
of Impact Assessment Tools,” Health and Human Rights Working Paper Series No 7,
Dresden, April 2010, http://www.who.int/hhr/information/mapping_impact_assessment.pdf.
[9] For examples see: MS: Jorge Correale and Mauricio Farez, “Helminth Antigens
Modulate Immune Responses in Cells from Multiple Sclerosis Patients through
TLR2-Dependent Mechanisms,” The Journal of Immunology, 183
(2009): 5999-6012, doi: 10.4049/jimmunol.0900897.; Asthma: Susanne Lau and
Paolo Maria Matricardi, “Worms, Asthma, and the Hygiene Hypothesis,” The
Lancet, 367 (May 2006): 1556-1558, doi:10.1016/S0140-6736(06)68670-4. Chron’s
disease: Aditya Reddy and Bernard Fried, “The use of Trichuris suis and other
helminth therapies to treat Crohn’s disease,” Parasitology Research, 100
(2007): 921-927, DOI: 10.1007/s00436-006-0416-4.
[10] Jorge Correale and Mauricio Farez, “Helminth Antigens Modulate Immune Responses in
Cells from Multiple Sclerosis Patients through TLR2-Dependent Mechanisms,” The
Journal of Immunology, 183 (2009): 5999, doi: 10.4049/jimmunol.0900897.
[11] Sabine Vaccine Institute, Hookworm Disease Overview, http://www.sabin.org/sites/all/modules/sabin/svi_factsheetxml/disease.php?id=10,
accessed April 19, 2011.
[12] Thomas Pogge, “Must we exclude the poor?” in World Poverty and Human Rights, (Malden,
MA: Polity Press, 2008), 222-261.
[13] Gostin, Mann and Gostin, “Towards the Development of a Human Rights Impact Assessment,”
63.
[14] Ibid., 77.
© 2011, Chivon Blanton. All rights reserved.