Wednesday, October 12, 2011

Do not be afraid...

...to really want what you desire.

I pledge to really want: pneumococcal conjugate vaccine for the indigenous and poor in rural Guatemala.

Description of the problem:
In rural Guatemala, Maya children are theoretically at increased risk of invasive infection with encapsulated organisms, not only for socioeconomic reasons, but also via possible genetic or hereditary mechanisms. This theoretical risk is based on data from populations served by US Indian Health Service (primarily Apache, Alaskan native and Navajo nation) and Canadian Inuit and First Nations populations.

Evidence for multiple etiologies for this elevated risk has been presented (increased nasal carriage, inadequate vaccine coverage, dysfunctional maternal-to-infant transmission of passive immunity to encapsulated organisms, increased host and community susceptibility, i.e. genetic polymorphisms that decrease immunogenic response to encapsulated pathogens and/or vaccine components vs. underlying malnutrition vs. poor living conditions and crowding vs. inaccessibility of healthcare services), and the importance of timely and universal immunization against lethal encapsulated organisms of among indigenous populations in North America is well established, and some have even advocated "enhanced" vaccines and vaccination schedules for this at-risk population. (See: Lancet 1996;347(9000):517-20; Pediatrics 1999,104(3 Pt 1):564-7; Lancet 1996 Feb 24;347(9000):517-20; Am J Dis Child 1986, 140(9):943-6.)

Unfortunately, because of limited health services in rural areas of Guatemala and the long-standing marginalization of Maya communities, little to no research has been done on the elevated risk that encapsulated organisms may pose to indigenous Guatemalans. The single epidemiologic research study from Guatemala (Pubmed search terms, July 8, 2010: ("Haemophilus influenzae"[Mesh] OR "Streptococcus pneumoniae"[Mesh]) AND ("Guatemala"[Mesh] OR "Indians, Central American"[Mesh])) is based on cases presenting to large biomedical centers in Guatemala City--centers that are accessible to few impoverished, rural Maya communities; these studies, thus, suffer from distortions due to selection and severity biases (Int J Infect Dis. 2008 May;12(3):289-97). Moreover, besides one study on shifting antimicrobial sensitivity of nasopharyngeal S. pneumo isolates in Guatemalan children (Int J Infect Dis 2008, 12(3):289-97), and another on passive immunity via breastfeeding (Adv Exp Med Biol 1991;310:1-15), the only published study on prevention of invasive infection with encapsulated organisms in Guatemalan children is based on 103 Guatemala-to-US adoptees from Guatemalan orphanages and foster homes between 1988-2004 (Pediatrics 2005; 115(6):e710-7).

The latter data showed that 46% of the 103 adoptees had any (i.e., adequate and inadequate) documented vaccination against Hib, and only 26% of the 103 adoptees had adequate, documented vaccination against Hib. That is, about one-quarter of this cohort of Guatemalan children met the recommended standards for immunoprophylaxis against Hib. Of course, this data also suffers from selection bias, as protection and healthcare in orphanages and foster homes, most of which will be in larger urban centers, may be quite dissimilar from the experience of the general population of rural Maya children. This cohort of children should not be taken as a representative sample of pediatric preventative care in Guatemala, as they were being actively optimized, from legal, biomedical and moral standpoints, for adoption by concerned and sympathetic families in the US. Moreover, while the sample size (n = 103) lends an added measure of biostatistical robustness to the analysis, the cohort was accumulated over the course of sixteen tumultuous years in recent Guatemalan history. Even from a limited biomedical perspective, this cohort is neither homogeneous, spanning the years when Hib vaccination would have been introduced in Guatemala (late 1980's to early 1990's), nor representative, polysaccharide pneumococcal vaccination having been introduced briefly in the mid-2000's (indeed, no mention is made of pneumococcal vaccination status in this paper). More broadly, in sociological and historical terms, the years between 1988-2004--to say nothing of the years since--saw huge upheavals in the organization of the Guatemalan government and health systems (e.g., the transition to democracy in the 1990's, and the neoliberalization of rural healthcare in the 2000's).

In short, there is insufficient data on the risk of and rates of vaccination against invasive pneumococcal and H. influenzae, type B disease in Guatemalan children, particularly in rural areas where majority Maya communities may have both a higher incidence and severity of infection due to encapsulated organisms. According to official sources, national coverage with 3 doses of Hib is 92%, thanks in large part to a combined Hep B/Hib/DTaP (i.e. Pediarix) that was introduced in 2005. No similar data is available, however, for pneumococcal vaccination. Children do not routinely receive this vaccine, even though many government-issue vaccination cards actually include a blank space for PCV7 (and, on some newer cards, even PCV13). The Guatemalan Association of Infectious Diseases, the Guatemalan Pediatric Association and the Guatemalan Internal Medicine Association justify the absence of PCV7 in governmental community outreach programs in rural areas by citing WHO guidelines that "countries should consider implementing pneumococcal vaccination, especially countries with under-5 mortality > 50/1000 live births"--the official national rate in Guatemala being 35/1000, which hides the same regional and ethnic disparities that I have alluded to above--"and countries with total under-5 deaths >50,000"--the official national rate being 15,000. This line of argumentation assumes that we cannot truly want what is only humane to desire: it assumes that it is impossible to make morally and statistically significant improvements on the rate of infant and child mortality.

My task, then, is to have the courage to really want a world where indigenous Guatemalan children are protected against unnecessary death due to invasive pneumococcal disease. In pragmatic terms, it will be necessary to mount direct assaults on intellectual property rights by establishing strategic alliances that re-establish and protect the domain of the biomedical commons.

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Citations:
Clin Infect Dis 2000, 31(1):34-41; Clin Infect Dis 2010, 50(9):1238-46; Pediatr Infect Dis 2009, 28(8):711-6; Clin Infect Dis 2008, 47(4):476-84; J Infect Dis 2007 Oct 15;196(8):1211-20; J Infect Dis 2007 Jul 1;196(1):104-14; JAMA 2007, 297(16):1784-92; Clin Infect Dis 2007, 44(9):1173-9; Vaccine 2007, 25(19):3816-26; Am J Epidemiol 2004,160(3):270-8; Lancet 2003,362(9381):355-61; J Infect Dis 2003 Jul 1;188(1):81-9; Pediatrics 1999,104(3 Pt 1):564-7; J Infect Dis 1994, 170(2):461-4; J Infect Dis 1994,170(2):368-76; J Infect Dis 1994, 170(2):368-76; Arch Intern Med 1992, 152(8):1641-5; J Infect Dis 1974,130(1):67-9; Am Rev Respir Dis 1974;109(5):577-8.