Our descriptive data show that disparities in Black-White mortality increased after the introduction of 3 lifesaving innovations, each of which affected a different segment of the population and was mandated by US federal legislation. Our data indicate that federal laws may have contributed to the increased disparities in Black-White mortality observed. Specifically, the failure of key laws to account for recognized social determinants may have inadvertently favored Whites with respect to access to those lifesaving innovations. Existing societal efforts to equalize medical innovations across race, gender, and age through law may therefore do little to deliver equal access to lifesaving treatments.
Although research has linked many social determinants to increased racial disparities in mortality,21,22
these determinants have not generally been disease specific. By contrast, our data show disease-specific, asynchronous increases that are temporally linked to federally mandated lifesaving innovations. To our knowledge, there was no corresponding general increase in such disparities. At least 2 plausible hypotheses are consistent with our descriptive results. One hypothesis is that federal legislation inadvertently promoted the observed racial disparities, and the other is that federal legislation impeded the identification of these problems.
Laws that are relevant to HAART and surfactants include the Food, Drug, and Cosmetic Act (52 Stat 1040) and the Public Health Service Act (42 USC ×× 241 and 247, chapter 6a, subchapter 2). Laws related to reimbursement for screening mammography include the 2 aforementioned laws along with the Social Security Act (42 USC 7) and the Civil Rights Act (78 Stat 241).41–43
Laws relevant to postinnovation surveillance and control include Food and Drug Administration (FDA) legislation and the Anti-Lobbying Act (Pub L No. 80–772).44
The 1971 Kefauver-Harris amendments to the Food, Drug, and Cosmetic Act called for the FDA to be the gatekeeper for new medications. The Public Health Service Act acknowledges this gatekeeper role, and the FDA requires efficacy studies for licensure. FDA requirements are embedded in Title 18 of the Social Security Act, so Medicare may pay only for FDA-approved innovations. The Civil Rights Act of 1964 (42 USC × 2000d et seq) stipulates that federal funds cannot be allocated to racially segregated health care services. Collectively, these laws aim to guarantee safe and equal access to lifesaving health care innovations across race and gender. Medicare and the Civil Rights Act are credited with ending segregated health care in the southern United States.45,46
Unfortunately, the narrow definitions of drug efficacy and medical assistance in those laws may be biased against equitable diffusion of innovations. Medicare law defines medical assistance only in terms of payments to health care providers, whereas FDA law addresses only biological safety, efficacy, and effectiveness. By contrast, current theory suggests that the causes of racial disparities in health are fundamentally social, with health care and the biological characteristics of medications and procedures provided through the health care system being of secondary importance.21,47
Related evidence shows that lifesaving innovations may have adverse social effects.1–5
Medicare coverage of mammography was a positive step that benefited many women (both White and Black), but inequalities may have been exacerbated because the benefit was so narrowly focused on providing a payment for services that were already unequally distributed. The intent of the law is for both Black and White women to benefit from Medicare-funded mammograms, but White women may have been in a better position to do so, in part because they face fewer nonmonetary barriers. There is evidence that cost remains a barrier to predominantly Black low-income populations, even those with Medicare benefits.48,49
Moreover, Blacks more often identify noncash social barriers as deterrents to cancer screening.50,51
As noted by Clark et al.,50
Blacks are more likely than were Whites to face logistical barriers such as poor transportation and competing time demands, both of which may be augmented by fear, perceptions of risk, and interactions between such factors and negative attributes of providers and health systems (e.g., provider time pressures and fragmented care).50–56
If cash inadequacy and noncash barriers exert greater force among Blacks than among Whites, then Medicare’s definitions of assistance could bias acquisition of screening mammography in favor of Whites even if health care delivery is not racially segregated. If our hypothesis is correct, future expansions of health care coverage will need to acknowledge this unintended consequence and create structural support for more equitable diffusion, distribution, and benefit.
The Food, Drug, and Cosmetic Act may exert bias by focusing exclusively on biological effects and excluding socially adverse effects from efficacy and effectiveness requirements. In previous research, FDA efficacy restrictions based on comorbidity have been associated with Black disparities in clinical trial participation,57,58
at least in part because comorbidity may be more likely to occur among sociodemographically disadvantaged groups. Our data may reflect this situation with respect to HAART (among men) and respiratory distress syndrome. The absence of this finding for HAART among women is also supportive given that women’s clinical trial participation was low (although the clinical trial protocol did not specifically exclude women57
). Exclusion of socially adverse effects from postinnovation surveillance may lead to bias in effectiveness assessments.
Our data also raise the alarming specter that 22421 premature deaths from HIV, breast cancer, and respiratory distress syndrome among Blacks may have occurred from 1990 through 2006 as a result of unequal diffusion of lifesaving innovations. If the average number of premature deaths in each age group between 2002 and 2006 (the most recent year for which data are available) continued through 2009, an additional 6252 deaths may have occurred (28673 deaths in all).
The US Public Health Service (PHS) identified the phenomenon of increased racial disparities following the introduction of a health care innovation1,2
and recognized that social factors may lead to variable population effects from the same biological agent.3
This phenomenon may have suggested a similar outcome when new innovations such as HAART, surfactants, and screening mammography were introduced. Specifically, as noted in the introduction, the PHS showed that introduction of Sabin vaccine led to increased racial disparities in poliomyelitis1,2
and that social factors influenced the effectiveness of the measles vaccine.3
By contrast, published PHS surveillance reports showing increased Black-White disparities after the introduction of HAART have included only general comments (e.g., “mortality rates vary by region and race”59[p3]
and “mortality rates varied by region and race … and age group and race”60[p5]
In addition, a National Cancer Institute report using PHS data on breast cancer mortality disparities between Black and White women did not specifically address women aged 65 years or older (women’s age categories were 60–69 years, 70–79 years, and 80–89 years).61
A later report focused on overall age-adjusted rates.62
Many federally supported studies (e.g., Smith-Bindman et al.63
) have noted Medicare’s inability to prevent disparities in breast cancer mortality; however, to our knowledge, none of these studies have hypothesized that Medicare may promote disparities.
Regarding surfactants, a 10% deficit (not statistically significant) in the administration of surfactant therapy was observed among Black infants in 1 midwestern city even after potential confounders had been taken into account. This finding was reported in a leading scientific journal with the caveat that the results needed to be interpreted with caution.64
However, we have been unable to find the systematic national surveillance and control that might have indicated whether the cautious optimism about surfactant therapy was justified. We hypothesize that the paradoxical contrasts between PHS investigations of the Sabin1,2
vaccines and PHS investigations into the public health impact of HAART, surfactants, and reimbursement for screening mammography reflect, in part, inadvertent impediments to public health surveillance that may appear in the Anti-Lobbying Act.
According to the Anti-Lobbying Act and associated code, it is a felony to use federal funds directly or indirectly to pay for any personal service, advertisement, printed matter, or other device intended to influence a member of Congress, a jurisdiction, or an official of any government to favor or oppose (by vote or otherwise) any legislation, ratification, policy, or appropriation unless Congress specifically requests such advice. To our knowledge, Congress has not authorized such funding and, despite its 1948 origin, there is evidence that the Anti-Lobbying Act retains considerable force at the PHS (I. Arias, Centers for Disease Control and Prevention, written communication, May 2008). By contrast, the present report was authorized through congressional approval for scientific peer-reviewed research on the scientific basis for US racial disparities.
Several limitations should be mentioned. Because our data are descriptive, they contribute relevant information to the formulation of but not the testing of hypotheses.65
Also, our data were based on death certificate information and thus are subject to the usual limitations associated with such information.66
However, death certificates have been found to provide valid estimates of HIV mortality.4
Reports as to breast cancer validity are mixed, and concern has been expressed regarding validity of estimates among the elderly.67,68
Our multivariable analyses were limited by the relatively small number of counties with reliable mortality rate data, particularly for respiratory distress syndrome, and the results of our analyses should be interpreted with caution. The results may suggest, however, that factors associated with communities’ success in diffusion of innovations are not the simple opposite of those factors associated with postinnovation mortality.
Moreover, although our ecological data show associations between such factors as county-level SES and Black mortality, the data cannot address the question of whether the same is true at the individual level. Finally, the results have other plausible alternative explanations, including the possibility that the disparities observed depend on biological differences such as the earlier maturation of surfactants among Blacks64
and the possibility that environmental factors are associated with greater comorbidity among Blacks independent of SES. Therefore, although confirmation of the hypotheses proposed in this article might lead to calls for fundamental change, the present data are not a suitable basis for policy.
Analytic epidemiological studies comparing racial differences indiffusion of innovations and individual mortality would provide important and timely data to test hypotheses concerning inadvertent promotion of racial disparities in mortality by both Medicare (e.g., because the narrow definition of medical assistance as cash may favor acquisition of services by those for whom cash alone is the major barrier) and the Food, Drug, and Cosmetic Act (e.g., because failure to consider that the introduction of an innovation may have adverse social effects, as well as biological effects, may promote the persistence of social effects).
Such research would also provide a means for the following: (1) distinguishing the relative effects of cash and noncash barriers to diffusion of innovations among Blacks and Whites and delineating causal pathways for such barriers (should they exist); (2) estimating confounding attributable to social or biological factors; (3) explaining the extensive geographical variation observed in our data (including results consistent with Landrigan’s finding that the same biological agent may produce significantly different health outcomes in biologically comparable communities3
); and (4) explaining differences in factors predicting Black mortality and those predicting postinnovation reductions in both Black mortality and Black-White MRRs. Evaluation of our hypothesis concerning the anti-lobbying law would require more qualitative approaches, including surveys, focus groups, and interviews with key informants.
In our analyses, we used different measures of association to estimate Black-White disparities because each confers importantly relevant and complementary information. In the past, the risk difference measure has been preferred by some for policy decisions, partly because that measure does not reflect baseline values.68
It is not clear, however, whether risk difference would be appropriate for tracking disparities. For example, if mortality rates declined from 4 to 3 per 1000 population among Blacks and from 2 to 1 per 1000 population among Whites, this measure would show no difference, even though the percentage of decline among Blacks (25%) was only half that among Whites. The MRR, with an increase of 50% in this example, does reflect such inequities and also enables estimation of excess mortality. Although risk differences were less consistent than MRRs in our data, the specific ways in which such values relate to unequal diffusion of innovations will remain unknown until appropriate analytic studies are done.
In general, our data contribute to a growing body of evidence that US disparities in mortality are most strongly associated with diseases that are preventable or treatable.69
In other words, lifesaving breakthroughs in screening, diagnosis, and treatment may predictably intensify structural inequities in delivery or diffusion. Elimination of poverty would be a long-term solution.21
In the interim, however, our data are compatible with the possibility that conscious, targeted efforts, including possible modifications of federal law, may be needed to ensure more equitable distribution of innovations.
If our primary hypothesis is valid, then strategies designed to achieve equality in health care delivery, real-world effectiveness, and population-level health outcomes should become an explicit goal of all publicly funded programs at each stage, including approval, licensure, payment, and delivery. Going forward, public health may need to take a more assertive role in surveillance of and structural support for equitable diffusion and benefit of new innovations to ensure equity in health outcome improvements across all segments of the population. Further research is necessary to test this hypothesis, including analytic epidemiological studies designed a priori to do so.