Corporate Practices as a Determinant of Health Disparities: An Interview with Stephen Thomas

Stephen Thomas, Ph.D. is the director of the Center for Minority Health (CMH) and the Philip Hallen Professor of Community Health and Social Justice in the University of Pittsburgh Graduate School of Public Health. He has written widely about racebased disparities and is founding cochair, with Thomas LaVeist from Johns Hopkins University, of the new Academy for Health Equity, an organization whose mission is to “utilize rigorous scientific research, policy development, and community advocacy to eliminate health disparities and create a social movement designed to ensure equal opportunity for health.” Recently Corporations and Health Watch director Nick Freudenberg interviewed Dr. Thomas about his views on corporate practices as a social determinant of health and as a creator of disparities in health, an interview excerpted here.

CHW: In your view, what role do the practices of food, alcohol, and tobacco industries play in explaining differences in black and white health status?

ST: I think this question about fast food, alcohol, and tobacco marketing is an underrecognized burden driving racial and ethnic health disparities simply because of the artificial tension between market forces and issues of personal judgment. I don’t think they’re all artificial but they are sometimes set up as if they are mutually exclusive. In a free society we assume that people have the right to choose and therefore if they choose to make bad choice it’s their fault, not the fault of the broader society or the environment in which they live and operate. And that gives a false choice that has resulted in many African American communities suffering disproportionately from very sophisticated targeted marketing in black neighborhoods when it comes to legal commercial products that are known risk factors associated with poor health outcomes. For a long time, the tobacco industry put a lot of money into cultivating publications and organizations serving African Americans including, but not limited to, Jet and Ebony magazines. Additionally, they’ve sponsored conferences with civil rights organizations like the Urban League and NAACP as well as demonstrate their commitment to “diversity” by hiring black executives to get them into the African American community and establish market share and brand loyalty. The industry’s successful use of “cultural tailoring” resulted in a positive dynamic with black leaders and those spheres of influence in which they operate. In this way tobacco and alcohol industry executives have more “bottom line credibility” than those of us in public health.

CHW: Do you see differences between tobacco and food and alcohol, other industries which play an important role in health, both in the way they’ve acted in black communities and in the way they’re perceived in the black community?

ST: Yes. First of all the alcohol and tobacco industries market products that are not required to sustain life, and yet the food industry does. And both the alcohol and tobacco industries have used sophisticated marketing techniques to penetrate the black community with products that are known to be associated with negative health outcomes. Tobacco is the most egregious because there’s no healthy way to use their products, but the alcohol industry has also been very sophisticated in their penetration. For the food industry, it was only recently that we had enough scientific evidence to show that these poor food choices, (empty calories, fat, supersizing), and the marketing of fast food in black neighborhoods is directly related to poor health outcomes.

Billboard for Uptown Cigarettes, a product developed by RJ Reynolds to market to African Americans but withdrawn after community protests.

CHW: Given these differences, how would you suggest that public health researchers and those concerned about health disparities address the food industry?

ST: I don’t think we’ll be able to fight that battle in the food industry the way we did with tobacco because you do have to eat to live, and so it requires a partnership. We cannot demonize fast food like we demonized tobacco. It’s not likely that we’ll have the equivalent of a tobacco settlement with fast food companies. We might consider following the path of the Robert Wood Johnson Foundation, which is partnering with the food industry as a way of trying to address the national problem of childhood obesity. So it is a Faustian bargain when McDonald’s starts distributing pedometers and positioning themselves to be the promoters of physical activity and good health.

CHW: As food companies look to partner, particularly with African American communities, what should communities do in order to ensure fair partnerships?

ST: I don’t think you can have a fair partnership on an unfair playing field. So I can think of no equal partner when you talk about the industry. I think therefore that vulnerable neighborhoods, be they Black, Hispanic, or poor of any color are always at a disadvantage. So they’d end up trading jobs and economic benefits that do not reduce the risk of the products that’s being marketed in the community. I don’t think it could be done fairly, in other words I think that there is a role for the federal government and for regulation in those kinds of interactions.

CHW: The federal government has said eliminating disparities in health is one of its goals. Do you think Federal, state and local government can make real differences in health disparities by targeting the disparity producing activities of the industries that we’re discussing?

ST: Well the goal to eliminate racial and ethnic health disparities outlined in Healthy People 2010 was really set in motion before the current administration was in place. But the current administration has actually supported decreased regulation and an increase in letting the market decide policy. Their focus has been on personal responsibility and as a result, poor food choices and exposure to alcohol and tobacco advertisements have been seen more as individual choices and moral failings rather than actual business practices, business policies, and federal policies that make urban city communities in particular vulnerable. It’s my hope that in Healthy People 2020 we do not lose the focus on eliminating racial and ethnic health disparities. The sevenpart Public Broadcasting documentary “Unnatural Causes” will hopefully raise awareness about the role that policy and poverty and social determinates of health play in population health. However, if you don’t watch public TV you may not even know that the documentary exists. It’s really up to us as a community to use the documentary to mobilize at the local level as a grassroots movement for health equity. I think grassroots movements can affect change at these broader levels where social determinants of health operate. But it cannot be done unless the community is educated.

CHW: As you’ve probably seen, there’s a lot of discussion in public health about how public health advocates frame issues in order to successfully mobilize communities. I wonder if you think there’s potential for using the disparities in health and the racial targeting frames as a way of approaching industry and personal responsibility for health.

ST: I think that the health disparity and health equity frame has created a space to move beyond the biomedical model, organ systems model and the diseasespecific model, so that we really can address these broader issues. The problem is that the language really doesn’t capture headlines. One need only look at the national news to see literally a story every day focused on a new medical breakthrough for some rare and odd disease and seldom do we have that kind of focus on racial and ethnic health disparities. So we need to do work in how to frame our issues also in a very aggressive media market. Currently, there is no national organization currently focused on health disparity. However, this summer will be the founding meeting of the Academy for Health Equity in Denver and I think that’s the nascent beginnings of a national organization to provide leadership in this area. But, like any new nonprofit organization, it is vulnerable to changes in funding cycles and other startup issues. And because they’ve staked out their moral and scientific ground in “health equity”, the organization may not be able to morally take money from pharmaceuticals and other [such] businesses because it would be a contradiction … inconsistent with their philosophical foundation.

CHW: As you know, advertisers, including alcohol, tobacco and food corporations, use cultural and racial ethnic images and themes to sell products that are health damaging. How do you think this targeting is viewed in the black community and does it raise ethical issues for you?

ST: I think the targeting is viewed positively, even if the product is negative, because the images are so compelling. In other words, the industry has trumped public health in understanding how to shape behavior. They have powerful imagery and we have no equivalent in terms of matching this level of sophistication. So when you see a McDonald’s or any fast food product ad that takes place in a black church or has the gospel theme music, automatically black people resonate with that even though the product may be a well known “killer” of black people. Someone inside the public relations firm has tapped into the cultural understanding of black people. And I have yet to see public health counter with our version of this understanding. And even if we did, we’d never get the market share or broadcast time. So here again we are on an unequal playing field: ethnic targeting works. Our aim should not be to criticize it because they’re being successful with promoting negative behaviors, but to somehow harness it to do just the opposite.

CHW: Do you think that there’s room within ethnic targeting to contest how the food, alcohol and tobacco corporations do that? For instance, the “Truth” Campaign around tobacco targeted youth around a specific set of values.

ST: I think that we can attack it but there are several things I’ve seen that diminish my enthusiasm for how effective it can be. For example, we have tobacco companies now doing primetime TV spots, very highly produced, supposedly promoting antismoking among teens. But if you talk to anyone in the professional health communication industry, they will very clearly tell you that the methods being used don’t work. So what you’re seeing is that the industry is using their market share to promote antismoking messages that they already know don’t work. In the environmental area, we have oil companies promoting environmental friendliness. We will soon see alcohol companies promoting “don’t drink”. I don’t think that we can count on them to actually do things that are not in their selfinterest. And so on the surface it looks like they’re promoting health messages and in reality they’re actually using techniques that have already proven to be unsuccessful in health behavior change. We have no equivalent counter point to this type of PR insurgency. . The Truth campaign was excellent, but fragile in the sense that it is vulnerable to funding cuts and it is vulnerable to only being able to be used on one area like tobacco. We need the equivalent of that across the full range of products being marketed that are known to cause disease.

CHW: Let’s say some grouping of public health professionals and advocates working in African American and Latino communities asks for your advice about how to create such a broadbased mobilization. What advice could you give them? What strategy could they take to counter multiple industries and multiple products to compete effectively with these industries in the middletolong term?

ST: I believe we have to think completely outside of the box. I’m going to be radical here for a moment and say that there should be a tax on companies with products that are known to be associated with premature illness and death. These funds would go into a national endowment to support the media campaign, a campaign that is not under industry control and that would use people like Chris Rock and other entertainers to produce the health education message as part of their public service contribution. I don’t think the reach of the entertainment industry can be underestimated in terms of getting the word out. But there has to be a sustainable funding base that’s not so vulnerable to a downturn in grants and those kinds of things.

CHW: What piece of that do you think can happen on the neighborhood level?

ST: I’ll give you an example around the issue of tobacco: in Philadelphia people literally went out and whitewashed billboards where there were tobacco ads. That was front page news; it was highly visible. It definitely mobilized people, but the problem is that it also destroyed property. And when it was all over, after the media cycle, was what next? The billboards were back up. I think that at the local level, we need to have a billboard audit and to have a policy where some percentage of billboards is controlled by the community to promote health and prevent disease.

CHW: Earlier you talked about the role of tobacco philanthropy in the black community. Do you have any suggestions or thoughts about how to raise that as an issue for dialogue and debate within African American or for that matter other communities?

ST: I think it has to be raised by black people. When white public health professionals raise the issue, they never come up with a way of replacing the revenue that’s lost. As a result, a black magazine or a black organization can’t have its national meeting because the revenue’s lost. So it looks like well wishing white liberals not understanding the dynamics of what it takes to sustain black publications or black organizations. It’s like a false choice, a trap. So there have to be credible African Americans leading this charge.

CHW: Perhaps the tax fund that you talked about could offer a real alternative for supporting arts and cultural and other organizations that would address race and class based health disparities.

ST: Absolutely. Unfortunately, black advocacy groups in Washington that could take on this issue have lost their credibility because they’ve taken money from the tobacco and alcohol industries in order to support their lobbying efforts on behalf of the black community. We shouldn’t underestimate the power of the marketplace. If we get African Americans and other minorities to change their habits then we don’t have to rely solely on the practices of advertisers. There is probably some history of how industries have changed simply because the consumer has changed and I think we need to look back and find examples, especially coming out of the civil rights movement, and see if we can replicate it. I also think that we need enforcement. Finally, I would say that we have to look in the mirror as public health officials and harness the new technology of YouTube, the web and Wikipedia to really break out beyond the traditional channels. Right now as you can see with what’s happened with digital music; the whole industry’s business model is upsidedown. That has opened up space for us in public health to use digital media as a way of creating a new space where the playing field is more equal to create innovative messaging that can promote health and prevent disease. I don’t think we’ve done enough in that arena. And we cannot simply complain; we also have to produce. Now is the time for less talk and more action!

Selected recent peer-reviewed articles on corporate targeting and the impact of corporate practices on socioeconomic, racial/ethnic, gender and age inequities in health

A small but growing number of studies examine how corporate practices influence health inequities. Studies have described and analyzed how corporations target selected populations for marketing of unhealthy products, assessed the impact of these practices on differences in health behavior and health, and explored other ways that corporate decisions maintain or exacerbate health disparities. Here Corporations and Health Watch summarizes a few of these recent reports and invites readers to submit additions to the list for subsequent posting.

Baker EA, Schootman M, Barnidge E, Kelly C. The role of race and poverty in access to foods that enable individuals to adhere to dietary guidelines. Prev Chronic Dis. 2006; 3(3):A76.

Analyzes the results of an audit of community supermarkets and fast food restaurants to assess the location and availability of food choices that enable individuals to meet the dietary guidelines established by the U.S. Department of Agriculture. The researchers used supermarket and fast food restaurant audit tools to assess the availability of healthy food choices in the urban area of St. Louis, Missouri. The researchers found that two factors (race and income) are associated with the location of food outlets and the selection of foods available. Individuals living in mixed or white high-poverty areas and in primarily African American areas are less likely to have access to foods that would enable them to make healthy food choices. The researchers recommend collaborations with the business community and political structures to make it economically viable to provide equal access to healthy food choices.

Brody H, Hunt LM. BiDil: assessing a race-based pharmaceutical. Ann Fam Med. 2006; 4(6): 556-60.

Analyzes scientific evidence on BiDil, the first drug approved by the Food and Drug Administration to be marketed to a single racial-ethnic group, African Americans, for the treatment of congestive heart failure. The authors discuss the problems that can arise when race is viewed as a biological-medical construct, leading to an overly simplistic assumption of a racial and hence presumed genetic difference while obscuring the “economic, social, cultural, and ethical issues lurking in the background.” The authors predict that the manufacturer will launch a publicity campaign targeting African Americans, and that family medicine doctors will be asked by their patients for the new “for blacks only” medication.

Freudenberg N, Galea S, Fahs M. Changing corporate practices to reduce cancer disparities. J Health Care Poor Underserved.2008; 19(1):26-40.

Reviews data on disparities in cancer morbidity and mortality in the United States, and reviews evidence on corporate practices contribute to cancer risk behavior, incidence, and cancer disparities. The authors propose that the practices of the tobacco, alcohol and food industries be considered as modifiable social determinants of health. The authors conclude with recommendations for research, practice, and policy that would lead to what they term “less carcinogenic” corporate practices.

Kwate N O A. Fried chicken and fresh apples: Racial segregation as a fundamental cause of fast food density in black neighborhoods. Health and Place 2008;14:32-44.

Analyzes pathways by which racial segregation contributes to higher density of fast food outlets in Black neighborhoods in US. The author proposes that population characteristics, economic characteristics, physical infrastructure and social processes of Black neighborhoods each contribute to creation of “localized geographic areas for targeting by fast food corporations and operators.”

Kwate NO, Lee TH. Ghettoizing outdoor advertising: disadvantage and ad panel density in black neighborhoods. J Urban Health. 2007;84(1):21-31.

Investigates correlates of density of outdoor advertising in predominantly African American neighborhoods in New York City. Authors found that that black neighborhoods have more outdoor advertising space than white neighborhoods, and these spaces disproportionately market alcohol and tobacco advertisements. By linking census data with property data at the census block group level, investigators found that two neighborhood-level determinants of ad density were income level and physical decay.

Macdonald L, Cummins S, Macintyre S. Neighbourhood fast food environment and area deprivation-substitution or concentration? Appetite. 2007l;49(1):251-4.

Investigates associations between area deprivation and the location of the four largest fast-food chains in Scotland and England. The authors report statistically significant increases in density of outlets from more affluent to more deprived areas for each individual fast-food chain and all chains combined. They conclude that these findings support a “concentration” effect whereby environmental risk factors for obesity appear to be ‘concentrated’ in more deprived areas.

Monsivais P, Drewnowski A. The rising cost of low-energy-density foods. J Am Diet Assoc. 2007; 107(12): 2071-6.

Discusses the results of a study on the energy density and retail prices of 372 foods and beverages in major supermarket chains in the Seattle, WA metropolitan area in 2004 and 2006 (energy density and prices were calculated in terms of $/100g and $/1,000 kcal). The researchers discuss the role of lower energy-density foods as a strategy for managing overweight and obesity. The two-year price change for the least energy-dense foods was +19.5% whereas the price change for the most energy-dense foods was -1.8%. The researchers suggest that the lower price of energy-dense foods and the resistance of energy-dense foods to price inflation may help explain why the highest rates of obesity in the United States are observed among those with limited economic means.

Morrison MA, Krugman DM, Pumsoon P. Under the radar: smokeless tobacco advertising in magazines with substantial youth readership. Am J Public Health. 2008; 98(3): 543-48.

Reviews the level of advertising of smokeless tobacco products before and after the Smokeless Tobacco Master Settlement Agreement (STMSA). The researchers determined that the STMSA appears to have had a limited effect on adolescents’ exposure to the advertising of smokeless tobacco in magazines with high youth readership. The researchers determined that adolescent boys (aged 12-17) are at greatest risk for exposure to smokeless tobacco advertisements.

Primack BA, Bost JE, Land SR, Fine MJ. Volume of tobacco advertising in African American markets: systematic review and meta-analyses. Public Health Rep. 2007; 122(5): 607-15.

Reviews the peer-reviewed literature on the density of pro-tobacco media messages. Of the studies identified for inclusion, 11 met the eligibility criteria for the current review. The researchers pooled the results of these studies in a meta-analysis and conclude that African Americans are exposed to a higher volume of pro-tobacco advertising. The researchers also cite evidence demonstrating that African Americans bear the greatest morbidity and mortality burdens due to smoking, and that exposure to pro-tobacco media messages predicts cigarette smoking.

Schor JB, Ford M. From Tastes Great to Cool: Children’s Food Marketing and the Rise of the Symbolic. Journal of Law, Medicine & Ethics. 2007; Spring issue on Childhood Obesity: 10-21.

Discusses the increasing participation of children in the consumer markets, their heavy media use and exposure to high levels of advertising. The researchers discuss deteriorating diets and rising obesity, as well as the shift in children’s food advertisements from product attributes to symbolic messages. The researchers cite studies that demonstrate that exposure to junk food marketing is much higher for low-income children as well as racial and ethnic minority children, groups that also have higher rates of obesity.

Thompson DA, Flores G, Ebel BE, Christakis DA. Comida en venta: after-school advertising on Spanish-language television in the United States. J Pediatr. 2008; 152(4): 576-81.

Analyzes the content of food and drink commercials aired during after-school hours (3 to 9 p.m.) on two Spanish-language television stations in the United States. The researchers found that children viewing Spanish-language television in the United States after school are exposed to food and drink commercials, mostly advertising unhealthy foods, including fast foods and sugared drinks. The researchers propose that food and beverage advertising to children via Spanish-language television may contribute to the high rates of obesity among Latino children.

Yerger VB, Przewoznik J, Malone RE. Racialized geography, corporate activity, and health disparities: tobacco industry targeting of inner cities. J Health Care Poor Underserved. 2007; 18(4 Suppl): 10-38

Reviews more than 400 internal documents from the tobacco industry to explore the ways in which the tobacco industry targeted inner cities populated predominately by low-income African American residents in the 1970s-1990s. The authors cite studies demonstrating that smoking rates remain higher among the poor, the less educated and other underserved populations, despite significant reductions in the overall smoking rate in the United States. This archival analysis demonstrates how the tobacco industry’s promotion activities and the “menthol wars” fought by tobacco companies in America’s inner-cities have contributed to the tobacco-related health disparities that we observe today.

“Because You Want More Life to Live:” BiDil, a Heart Failure Prescription for “Self-Identified Blacks”

In June 2005, the US Food and Drug Administration made history by approving the patented pharmaceutical BiDil to treat African American patients suffering from congestive heart failure. BiDil, whose generic name is isosorbide dinitrate/hydralazine hydrochloride, is not the first race-specific pharmaceutical (that distinction may belong to Travatan, a brand of eye drops marketed to black patients1) — but it is the first race-specific pharmaceutical to be awarded federal approval.

Its appearance sparked controversy in the medical and bioethics communities, as some lauded the drug’s development and others deemed it a designer drug that sanctioned racial profiling in medicine2 and loaned credibility to the concept of race as biology. This flurry of excitement was matched in the market: anticipation of the drug’s release caused the value of shares in NitroMed, the company that owned the patent to BiDil, to more than triple in the months leading up to the FDA’s announcement.

Citing the medical establishment’s historic neglect of African American patients, NitroMed has promoted BiDil as a bold step by the pharmaceutical industry and a path-breaking effort to reverse long-standing racial health disparities in heart failure. The drug’s development was also hailed by the NAACP and the Association of Black Cardiologists. But in an article written forScientific American, Jonathan Kahn, expert on race and bioethics, lambasted BiDil’s passage to market as a tangled tale of inconclusive studies, regulatory hurdles and commercial motives.3 Kahn pointed out that BiDil is not a new drug, nor was it initially designed for use in black patients. It is a combination of two generic vasodilators, hydralazine and isosorbide dinitrate (ISDN), which increase the bioavailability of nitric oxide, relax blood vessels, and relieve stress on the pumping heart. H/I was patented as BiDil after a series of pharmaceutical trials appeared to confirm its worth as an improved therapy to treat congestive heart failure in self-identified black patients. This claim rests on three assumptions, each to be examined here. First, the claim asserts that the drug is more effective in black patients than in other patients; second, it posits that heart failure is overrepresented among black patients; and finally, it assumes that black is a meaningful category in medicine. The critique of Bidil challenges these assumptions and argues that they promote structural inequalities in health care and misrepresent sociological determinants as biological facts.

1. Shown to Save the Lives of Black Heart Failure Patients

BiDil’s designation as a race-specific drug results from an attempt to justify the patenting of generic drugs, and in order for this to be accomplished, its innovator was required to manipulate the research design of the pharmaceutical trials that appeared to prove H/I’s efficacy in only certain patients. Jay Cohn, a University of Minnesota cardiologist who began using hydralazine and ISDN in combination to treat heart failure, was unable to secure a patent on the two generics, and also failed in an early attempt to secure FDA approval of the H/I combination. Retrospectively reviewing data from earlier trials, Cohn sought to prove that a sub-population had shown strong response to treatment. Leveraging the results of a prior trial which had enrolled just 49 African Americans, Cohn applied for a patent on the use of H/I to treat heart failure in black patients. Approved in 2000, the patent will last until 2020.3

Subsequently, Cohn organized the African American Heart Failure Trial (A-HeFT) in 2004 with a study population of 1,080self-identified black heart failure patients4 at 150 different study sites, including Morehouse Medical School and other historically black institutions.5 The study’s early results were remarkable: the active arm of the study experienced a 43% reduction in mortality, and the data and safety monitoring board of the study determined that it would be unethical to deny the drug to participants who were receiving only standard contemporary modern care. The trial was halted at the 8-month mark to provide H/I to all participants.5

At the conclusion of the African-American Heart Failure Trial, the investigators filed a new application for the therapy’s approval with the FDA. In just months, the FDA decided to approve BiDil, satisfied the drug had been shown to decrease mortality, to reduce hospitalization, and to improve patients’ functional status, and to slow the progression of heart failure in self-identified blacks.5 But because the A-HeFT included only self-identified black patients, it could not confirm whether BiDil is more effective in black patients than in any other population. The frequently cited hypothesis that H/I would yield similar results in patients of other racial groups remains untested.

2. African Americans: At High Risk for Heart Failure?

A fact sheet from NitroMed’s public relations office states that an estimated 750,000 African Americans are currently diagnosed with heart failure, with the number expected to increase to nearly 900,000 by 2010.6 Elsewhere, NitroMed claims that African-American heart failure patients are disproportionately over-represented in the North American heart failure population and that African Americans aged 45-64 face a mortality risk more than twice that of white heart failure patients.7

While these statistics appear to confirm the popularly held belief that African Americans are prone to suffer cardiac conditions more than other racial groups, NYU sociologist Troy Duster argues that NitroMed’s use of these data is misleading. The age group 45 to 64 only accounts for about 6% of heart failure mortality, and for those over 65, the statistical differences between ‘African Americans and Caucasians’ nearly completely disappear.8 This statement is backed up by CDC data showing that heart-failure-related mortality among African Americans has actually declined since 1988, and that this rate of decline outpaces the decreasing level of heart-failure-related death rates in the Caucasian population.9 Apparently, NitroMed is culling data to create the impression that all African Americans are at high risk for heart failure and premature death.

In the Common Questions portion of its website, NitroMed answers the question Why are African Americans at greater risk for heart failure? in two sentences:

Two well-known contributors to the increased risk are much higher rates of high blood pressure and diabetes in the African American community. Other potential risk factors being explored are African Americans’ lower access to and use of health care services, greater exposure to environmental pollutants, and greater tendencies to be overweight and to get less exercise.10

Interestingly, this statement does not mention genetic risk factors, although NitroMed is currently supporting research to isolate gene sequences related to heart failure. However, heart failure is not a genetic disease. As NitroMed correctly states in its own FAQ, the etiology of heart failure is shaped by multiple inputs. As anthropologists W.W. Dressler and colleagues propose, attempts to link hypertension rates in African Americans to single variables (genetic factors, higher rates of obesity and smoking, and socioeconomic status) have failed to explain race-bound health disparities completely.11 And as Troy Duster has argued, the role of racism in the heart health of African Americans may represent the most meaningful link between race and disease prevalence.12 In short, the marketing of BiDil is a misguided – or cynical – attempt to medicalize the stress of racism, and to convert a social problem into profit.

3. Target Markets and Self-Identified Blackness

Finally, the FDA’s approval of BiDil raises a practical problem: How are doctors to determine who is black? Though BiDil’s legally approved patient population consists of self-identified blacks, Bidil.com uses the term African-Americaninterchangeably with black, and company personnel are slippery on the issue of who is eligible for the prescription. In response to a query, a NitroMed representative wrote:

If a multiracial or a dark skinned individual decides that they are a self identified black and a physician believes that BiDil is an appropriate option for their heart failure, then they would be an appropriate candidate for BiDil.13

Self-identified black is a catch-all category that could include patients whose origins are African American, Melanesian, or South African, but the A-HeFT’s study design recognized no distinctions between such populations: a patient might have joined the A-HeFT on the basis of ancestral, regional, genetic, phenotypic, or even cultural blackness. Sidestepping responsibility for racing its participants, the study design of the A-HeFT did not require researchers to confirm that a study participant conformed to any given definition of blackness: though subjects were meant to be screened in on the basis of diagnosis and race, the trial was administered colorblind.14 This point was pressed home at an FDA advisory committee meeting, when a woman of apparent Asian ancestry asked whether she would have been admitted to the study if she’d self-identified as black. The study investigators responded ‘Yes.’14 By refusing to define who may be reasonably considered blackin clinical trials, NitroMed also maximized its market of potential patient-consumers.

Despite early enthusiasm about BiDil, its high public profile, and its strategic efforts to appeal to as many patients as possible, the drug ultimately faced a challenging capital marketing environment. In BiDil’s first year on the market, physicians only wrote 84,000 prescriptions, due partly to insurers’ reluctance to reimburse.14 NitroMed was criticized for the drug’s high cost, which at $1.80 a pill (or $5.40 a day) equaled 4 to 7 times the price of generic isosorbide plus hydralazine. Some physicians prescribed patients to the two generics, despite the difficulty of establishing the correct ratio in a dose.15

In its first year, BiDil turned profits of only $11M, far short of the $100M that analysts anticipated. By January 2008, NitroMed had ceased corporate expenditure for the sales and marketing of BiDil, cut staff from 90 to 20, and retained an investment bank to explore strategic alternatives.16 Roughly translated, NitroMed is for sale.

Though BiDil’s disappointing performance might come as a relief to its critics, its probable disappearance from the market represents a setback for the 5 million Americans who face an incapacitating and potentially fatal disease, and for whom the value of this therapy has barely been realized. The development of race-based therapies or, beyond that threshold,personalized medicine may allow pharmaceutical corporations to create and corner target markets that provide more effective therapies for people with specific conditions, creating an opportunity for improved health for some and higher profits for drug companies. Though pharmaceutical companies often cite these advantages to justify the development of designer therapies, such endeavors siphon resources from research that will address the needs of the greatest number of patients, produce more expensive drugs that may not be affordable to those most in need, and encourage the confusion of sociological factors with biological facts. BiDil’s short-lived moment on the market illustrates the perils of leaving decisions about drug development in the hands of corporate managers whose bottom line is their balance sheet, not public health.

 

Martha Lincoln is a doctoral student in the PhD Program in Anthropology ay the CUNY Graduate Center, New York, New York.

 

References

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14. Kreimer S. 2007. BiDil not Widely Prescribed. DOC News 4(7): 23. 
15. Brody H, Hunt L. BiDil: Assessing a Race-Based Pharmaceutical. Annals of Family Medicine 2006; 4:556-560.
16. NitroMed Reports on BiDil XR(TM) Progress Following FDA Meeting, Announces Restructuring and Suspension of BiDil(R) Sales Force, and Retains Investment Bank to Advise on Strategic Options. 2008. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c= 130535&p=irol-newsArticle&ID=1096799&highlight= retrieved January 21, 2008.

No Such Thing As A Free Lunch: The impact of food price increases on school food and food inequities

If you are feeling a pinch from increased dairy prices, imagine the impact of a program serving 30 million school meals a day—with each meal including 8 oz of milk on the tray.
— Jennifer Weber, Manager of National Nutrition Policy, Journal of the American Dietetic Association, April 2008

Gas prices are exorbitant and the price of wheat and milk is through the roof. Consumers may make lifestyle adjustments—drive a bit less, opt out of a cappuccino or attend fewer movies, but there are also large institutional changes occurring. And it’s shaping our kids, literally. In the face of rising obesity rates, especially in low-income communities where obesity rates are disproportionately high, schools are having an even tougher time battling the bulge. In the long run, these changes could reduce access to healthy food for children in low-income communities, further exacerbating inequities in health between these and better off children.

Both the National School Lunch Program (NSLP) and competitive foods, those foods sold a la carte outside the NSLP, are affected by rising food and gas prices. As documented by the Economic Research Service, in 2007 milk prices increased by 17%, cheese by 15%, bread by 12% and rice and pasta by 13%.

Kids in poorer communities will suffer most – these already cash-strapped schools are looking for ways to cut costs, undermining many efforts districts have made to implement the mandated, but unfunded, school wellness policies.

School wellness policies, mandated through the Child Nutrition and WIC Reauthorization Act of 2004, required that all school districts participating in the NSLP established wellness policies by July, 2006 and adopted these policies by the start of the 2006 school year. This law requires, among other actions, that schools define their goals for nutrition education, physical activity and nutrition guidelines selected by the local educational agency for all foods available on each school campus.1

But this was more easily said than done and under-resourced school districts are facing major challenges. Schools with good intentions are finding they can’t keep up with the nutritional guidelines set through the program. Many times the healthier items that meet the standards aren’t available, and more recently, to increase revenues , some schools are looking for ways to bring back hot ticket items—highly processed junk sold outside the NSLP by private food and beverage companies.

For the past two decades, school districts have traditionally relied heavily on sales from both vending machine pouring rights contracts and a la carte items to increase school funding. Restricting these foods is clearly beneficial for kids’ health in both the short and long term, and may prove to be financially beneficial in the long run. At least for now, however, schools are feeling the pinch from this lost revenue. And disparities among districts cause certain areas to feel the brunt of this more than others – for example, compared to mostly white school districts, districts with proportionally more Latinos have earned more revenue from pouring rights contracts.2, 3 At the same time, these are frequently the communities in dire need of obesity prevention programs. Low-income, urban, African-American and Latino communities have rates of overweight or obesity that can exceed 40% of elementary school kids.4

But that’s only part one of the double whammy. The NSLP, which serves more than 30 million children, over half of whom receive either free or reduced price lunch, is also suffering from rising food costs. Increasingly expensive meals are causing schools to grapple with how to keep healthier, quality items on the menu. Districts throughout the country are cutting back on fruits and vegetables as costs continue to soar.

Below is a breakdown, as compiled by the School Nutrition Association (SNA), detailing school food prices, reimbursement and total revenue, excluding labor and other costs:

Cost of School Lunch

  Average Meal Prices for Students Reimbursement Rates Total Revenue per Lunch
Full Paid Lunches Elementary: $1.66
Middle School: $1.85
High School: $1.90
$0.23 Elementary: $1.89
Middle School: $2.08
High School: $2.13
Reduced Price Lunch* $0.38-$0.40 $2 $2.38-$2.40
Free Lunch** $0 $2.40 $2.40
*Students with household incomes between 130%-185% of the poverty level receive meals at a reduced price rates
**Students with household incomes below 130% of the poverty level receive meals for free.


Compiled by the School Nutrition Association (SNA)
Sources: School Nutrition Operations Report: The State of School Nutrition 2007 and United States Department of Agriculture (USDA)

SNA researchers found that based on an estimated average cost to prepare a school lunch (including labor, food and other inputs) of about $2.70 to $3.10, and revenue of anywhere from $2.00 to $2.60 to offset that cost (from federal reimbursements, commodity entitlement and the average price paid for a school lunch) school nutrition programs are experiencing a potential loss of $5 to $8 million per school day based on 30 million school lunches provided.5

Their research also indicates that more than 60% of school nutrition directors had meal costs that exceeded the NSLP reimbursement6 and more than 78% of school nutrition programs have increased costs, largely from the cost of healthier items as a result of implementing district’s nutrition standards,7 coupled with rising food costs. At the same time, about half the school nutrition directors ranked both funding and cost of food/food preparation as the biggest obstacle within their programs.8

Some school administrators are lobbying schools to use general funds for school foods – clearly easier in high-resource areas with a larger revenue stream. For many low-income districts, schools either lack these funds altogether or end up cutting other valuable programs instead, risking widening gaps in educational achievement as well as health.

Food prices show no sign of decreasing and with the lack of necessary funding for school food programs, districts are forced to pass along this increased cost to kids’ parents. According to the School Nutrition Association, about one-third of school districts raised the cost of full-price lunch by about 9% during the 2006-2007 school year. Errors in verifying eligibility can magnify the adverse impact of price rises. A 2004 USDA study found that under current verification procedures, children in more than one of every three families selected for verification in metropolitan areas lost their free or reduced-price meal benefits despite being eligible for such meals.9, 10

Recently some food analysts have argued that rapidly rising prices for unhealthy foods (e.g., wheat and corn) will encourage people to eat more fruits and vegetables, whose prices are increasing more slowly. But schools in these resource-poor districts have never been able to afford lots of fruits and vegetables. Now they are merely adding to the growing list of increasingly expensive and out of reach foods.

If there is one glimmer of something positive to come from this, perhaps it’s that schools are learning to conserve, cook from scratch, be creative. A recent article in the Birmingham News said the following about one school district in Alabama:

In Hoover schools, nutrition program personnel are controlling costs by monitoring food purchases and keeping an eye on inventory to prevent waste, Wood [coordinator of the school system’s child nutrition program] said. They’ve also substituted food items as prices fluctuate. They’ve eliminated maraschino cherries as a garnish, for example, and opted for apples and bananas instead of pricier grapes. They are using more mandarin oranges and less fruit cocktail, and they’ve started making their own steak and gravy instead of buying pre-made product.

But these are modest changes and bigger, threats to affordable and healthy school food loom ahead. As food prices increase and federal support remains flat or declines, schools will find it ever more difficult to say no to an easy source of revenue: soda, cookies, and other junk food. Here we go again.

Alexandra Lewin is a staff person at Corporations and Health Watch and is finishing her PhD in nutrition at Cornell University.

 

References1. School Nutrition Association and School Nutrition Foundation. From Cupcakes to Carrots: Local Wellness Policies One Year Later. September 2007.
2. Johnston LD, Delva J, O’Malley PM. Sports participation and physical education in American secondary schools: current levels and racial/ethnic and socioeconomic disparities. Am J Prev Med 2007;33(4S):S195-S208.
3. Johnston LD, Delva J, O’Malley PM. Soft drink availability, contracts, and revenues in American schools. Am J Prev Med 2007;33(4S):S209-S225.
4. Slusser WM, Neumann CG, Cumberland WG, Browdy BL. Overweight in urban, low-income, African-American and Hispanic children attending Los Angeles elementary schools: research stimulating action. Public Health Nutr 2005;8:141- 8.
5. School Nutrition Association. SNA Statement on USDA Meal Cost Study. 11 April 2008.
6. School Nutrition Association. SNA 2007 Trends Report. Alexandria, VA: School Nutrition Association; 2007.
7. School Nutrition Association. From Cupcakes to Carrots: Local School Wellness Policies One Year Later; September 2007.
8. School Nutrition Association. School Nutrition Operations Report: The State of School Nutrition 2007; August 2007.
9. Neuberger, Z. Reducing Paperwork and Connective with Low-Income Children with School Meals: Opportunities under the New Child Nutrition Reauthorization Law. Center on Budget and Policy Priorities. 22 November 2004.
10. Neuberger article references: Case Study of National School Lunch Program Verification Outcomes in Large Metropolitan School Districts, prepared by Mathematica Policy Research, Inc. under a research contract with the Food and Nutrition Service, USDA, Report CN-04-AV3, April 2004, available at http://www.fns.usda.gov/oane/MENU/Published/CNP/CNP.HTM and What Have We Learned from FNS New Research Findings about Overcertification in the School Meals Programs?.
11. Osburn, L. Rising food prices forcing schools to get creative at lunchtime. The Birmingham News. 21 April 2008.

 

Image Credit:

1. freefoto.com

Corporate Targeting and the Impact of Corporate Practices on Socioeconomic, Racial/ethnic, Gender and Age Inequities in Health

Selected Peer-reviewed Articles

A small but growing number of studies examine how corporate practices influence health inequities. Studies have described and analyzed how corporations target selected populations for marketing of unhealthy products, assessed the impact of these practices on differences in health behavior and health, and explored other ways that corporate decisions maintain or exacerbate health disparities.

Here Corporations and Health Watch summarizes a few of these recent reports and invites readers to submit additions to the list for subsequent posting.

 

Baker EA, Schootman M, Barnidge E, Kelly C. The role of race and poverty in access to foods that enable individuals to adhere to dietary guidelines. Prev Chronic Dis.2006; 3(3):A76.

Analyzes the results of an audit of community supermarkets and fast food restaurants to assess the location and availability of food choices that enable individuals to meet the dietary guidelines established by the U.S. Department of Agriculture. The researchers used supermarket and fast food restaurant audit tools to assess the availability of healthy food choices in the urban area of St. Louis, Missouri. The researchers found that two factors (race and income) are associated with the location of food outlets and the selection of foods available. Individuals living in mixed or white high-poverty areas and in primarily African American areas are less likely to have access to foods that would enable them to make healthy food choices. The researchers recommend collaborations with the business community and political structures to make it economically viable to provide equal access to healthy food choices.

 

Brody H, Hunt LM. BiDil: assessing a race-based pharmaceutical. Ann Fam Med. 2006; 4(6): 556-60.

Analyzes scientific evidence on BiDil, the first drug approved by the Food and Drug Administration to be marketed to a single racial-ethnic group, African Americans, for the treatment of congestive heart failure. The authors discuss the problems that can arise when race is viewed as a biological-medical construct, leading to an overly simplistic assumption of a racial and hence presumed genetic difference while obscuring the “economic, social, cultural, and ethical issues lurking in the background.” The authors predict that the manufacturer will launch a publicity campaign targeting African Americans, and that family medicine doctors will be asked by their patients for the new “for blacks only” medication.

 

Freudenberg N, Galea S, Fahs M. Changing corporate practices to reduce cancer disparities. J Health Care Poor Underserved. 2008; 19(1):26-40.

Reviews data on disparities in cancer morbidity and mortality in the United States, and reviews evidence on corporate practices contribute to cancer risk behavior, incidence, and cancer disparities. The authors propose that the practices of the tobacco, alcohol and food industries be considered as modifiable social determinants of health. The authors conclude with recommendations for research, practice, and policy that would lead to what they term “less carcinogenic” corporate practices.

 

Kwate N O A. Fried chicken and fresh apples: Racial segregation as a fundamental cause of fast food density in black neighborhoods. Health and Place 2008;14:32-44.

Analyzes pathways by which racial segregation contributes to higher density of fast food outlets in Black neighborhoods in US. The author proposes that population characteristics, economic characteristics, physical infrastructure and social processes of Black neighborhoods each contribute to creation of “localized geographic areas for targeting by fast food corporations and operators.”

 

Kwate NO, Lee TH. Ghettoizing outdoor advertising: disadvantage and ad panel density in black neighborhoods. J Urban Health. 2007;84(1):21-31.

 

Investigates correlates of density of outdoor advertising in predominantly African American neighborhoods in New York City. Authors found that that black neighborhoods have more outdoor advertising space than white neighborhoods, and these spaces disproportionately market alcohol and tobacco advertisements. By linking census data with property data at the census block group level, investigators found that two neighborhood-level determinants of ad density were income level and physical decay.

 

Macdonald L, Cummins S, Macintyre S. Neighbourhood fast food environment and area deprivation-substitution or concentration? Appetite. 2007l;49(1):251-4.

Investigates associations between area deprivation and the location of the four largest fast-food chains in Scotland and England. The authors report statistically significant increases in density of outlets from more affluent to more deprived areas for each individual fast-food chain and all chains combined. They conclude that these findings support a “concentration” effect whereby environmental risk factors for obesity appear to be ‘concentrated’ in more deprived areas.

 

Monsivais P, Drewnowski A. The rising cost of low-energy-density foods. J Am Diet Assoc. 2007; 107(12): 2071-6.

Discusses the results of a study on the energy density and retail prices of 372 foods and beverages in major supermarket chains in the Seattle, WA metropolitan area in 2004 and 2006 (energy density and prices were calculated in terms of $/100g and $/1,000 kcal). The researchers discuss the role of lower energy-density foods as a strategy for managing overweight and obesity. The two-year price change for the least energy-dense foods was +19.5% whereas the price change for the most energy-dense foods was -1.8%. The researchers suggest that the lower price of energy-dense foods and the resistance of energy-dense foods to price inflation may help explain why the highest rates of obesity in the United States are observed among those with limited economic means.

 

Morrison MA, Krugman DM, Pumsoon P. Under the radar: smokeless tobacco advertising in magazines with substantial youth readership. Am J Public Health. 2008; 98(3): 543-48.

Reviews the level of advertising of smokeless tobacco products before and after the Smokeless Tobacco Master Settlement Agreement (STMSA). The researchers determined that the STMSA appears to have had a limited effect on adolescents’ exposure to the advertising of smokeless tobacco in magazines with high youth readership. The researchers determined that adolescent boys (aged 12-17) are at greatest risk for exposure to smokeless tobacco advertisements.

 

Primack BA, Bost JE, Land SR, Fine MJ. Volume of tobacco advertising in African American markets: systematic review and meta-analyses. Public Health Rep. 2007; 122(5): 607-15.

Reviews the peer-reviewed literature on the density of pro-tobacco media messages. Of the studies identified for inclusion, 11 met the eligibility criteria for the current review. The researchers pooled the results of these studies in a meta-analysis and conclude that African Americans are exposed to a higher volume of pro-tobacco advertising. The researchers also cite evidence demonstrating that African Americans bear the greatest morbidity and mortality burdens due to smoking, and that exposure to pro-tobacco media messages predicts cigarette smoking.

 

Schor JB, Ford M. From Tastes Great to Cool: Children’s Food Marketing and the Rise of the Symbolic. Journal of Law, Medicine & Ethics. 2007; Spring issue on Childhood Obesity: 10-21.

Discusses the increasing participation of children in the consumer markets, their heavy media use and exposure to high levels of advertising. The researchers discuss deteriorating diets and rising obesity, as well as the shift in children’s food advertisements from product attributes to symbolic messages. The researchers cite studies that demonstrate that exposure to junk food marketing is much higher for low-income children as well as racial and ethnic minority children, groups that also have higher rates of obesity.

 

Thompson DA, Flores G, Ebel BE, Christakis DA. Comida en venta: after-school advertising on Spanish-language television in the United States. J Pediatr. 2008; 152(4): 576-81.

Analyzes the content of food and drink commercials aired during after-school hours (3 to 9 p.m.) on two Spanish-language television stations in the United States. The researchers found that children viewing Spanish-language television in the United States after school are exposed to food and drink commercials, mostly advertising unhealthy foods, including fast foods and sugared drinks. The researchers propose that food and beverage advertising to children via Spanish-language television may contribute to the high rates of obesity among Latino children.

 

Yerger VB, Przewoznik J, Malone RE. Racialized geography, corporate activity, and health disparities: tobacco industry targeting of inner cities. J Health Care Poor Underserved. 2007; 18(4 Suppl): 10-38

Reviews more than 400 internal documents from the tobacco industry to explore the ways in which the tobacco industry targeted inner cities populated predominately by low-income African American residents in the 1970s-1990s. The authors cite studies demonstrating that smoking rates remain higher among the poor, the less educated and other underserved populations, despite significant reductions in the overall smoking rate in the United States. This archival analysis demonstrates how the tobacco industry’s promotion activities and the “menthol wars” fought by tobacco companies in America’s inner-cities have contributed to the tobacco-related health disparities that we observe today.

Corporations and Campus Research: How private industry dollars influence scientific discovery and threaten public health

On March 26, 2008, the New York Times published a front page story revealing that the Liggett Group, a major tobacco company, had supported research at Weill Cornell Medical College showing the benefits of early screening for lung cancer. The article, published by the New England Journal of Medicine in 2006 did not disclose the source of funding. The Journal’s editor, Dr. Jeffrey M. Drazen, told the Times“In the seven years that I’ve been here, we have never knowingly published anything supported by a cigarette maker.” The authors of the report and officials at Weill Medical College denied any effort to cover up the source of the funding. However, former New England Journal editor Dr. Jerome Kassirer, author of a book about medical conflicts of interest, expressed skepticism about this denial. He told the Times that he believed that Weill Cornell had created the foundation to hide its receipt of money from a cigarette company. You have to ask yourself the question, ‘Why did the tobacco company want to support her research?’ They want to show that lung cancer is not so bad as everybody thinks because screening can save people; and that’s outrageous.

Last November, the University of California at Berkeley and BP, the global energy company formerly known as British Petroleum, signed a $500 million, 10-year deal to create the Energy Biosciences Institute to conduct research on energy and environmental issues. BP will appoint four of the Institute’s eight directors and, according to the Daily Cal, the Berkeley student newspaper, at least 50 BP scientists will be able to conduct proprietaryresearch at UC Berkeley and the University of Illinois. These researchers work under the sole control and discretion of BP, and their work can remain secret and thus free from scrutiny. Critics expressed concerns about the academic integrity of the Institute and also questioned a partnership with a company that has been indicted in numerous environmental violations and illegal business practices. Only a few months prior to signing the contract with Berkeley, BP and its subsidiaries paid $373 million to settle dozens of legal cases, including one that involved the leaking of crude oil from pipelines in Alaska.

To prove that UC doesn’t limit sponsorship to industries under attack by public health and environmental advocates, University of California at Davis recently accepted an endowed chair in chocolate science from the Mars Corporation in order to study the antioxidant properties of cacao.In fiscal year 2006-7, UC received more than $16.6 million from Philip Morris for tobacco research, and in September 2007, the Board of Regents voted 14 to 4 to continue accepting tobacco money for faculty research. According to the San Francisco Chronicle, nearly all the regents expressed disdain for the tobacco industry’s criminal behavior and distortion of research, but several of those who voted to continue to accept funding said they were deferring to faculty concerns about academic freedom. Intended to shield researchers from tobacco industry influences, the resolution adds new administrative procedures. Under this new measure, research proposals seeking tobacco industry funding are now required to pass through a scholarly review and receive approval from the campus chancellor. In addition, the UC president must present annual reports to the Regents on the number of proposals submitted, approved and funded, along with a description of each.

Moving east, the University of Virginia’s School of Medicine decided in 2006 to accept $25 million from Philip Morris to fund research on youth and tobacco. When challenged on the decision, Dean Arthur Garson insisted the answer was simple, a company has offered us $20 million to develop better ways so kids don’t smoke. Period.

These and many similar accounts highlight a growing trend in academia to accept industry money to pay for research, new laboratories, and high-powered professors. In 2005, industry provided universities with $2.3 billion for research and development. While the dollar amount has been growing, according to Daniel Greenberg, author of Science for Sale The Perils, Rewards and Delusions of Campus Capitalism,1 industry actually contributes only a tiny fraction of the overall university research budget—far more comes form government sources such as the National Institutes of Health (NIH) and the National Science Foundation (NSF). In New York State, for example, total university spending on research and development in 2004 was $3.4 billion, of which only $146 million—just over 4%—came from industry.

Why the new push for corporate funding for university research?

If industry pays for only a small part of academic research, why are universities now so eager to pull in industry dollars? Why are they willing to cede control of their own research, a prerogative often jealously guarded in the past? And what are the consequences of this growing source of support for academic institutions and for public health research? In this reportCorporations and Health Watch examines industry influence on academic research; assesses its impact on universities, science and public health; and describes critics’ efforts to counter this trend and pose other policy options.

As in any intimate relationship, changes reflect the concerns of both partners. For universities, the most obvious starting point is dollars. Between 1970 and 2003, federal funding for research increased dramatically, making it easy for many universities and researchers to steadily increase their research revenues. Just between 1999 and 2003, the NIH budget more than doubled from $13 billion to $27 billion.2 But since then, the Bush Administration has cut funding for scientific research at both NIH and NSF, forcing universities to turn elsewhere to support their habit.

On the business side, the quest for a stronger and more direct presence in university research reflects the downturn in federal funding but also a recognition that direct funding offers some advantages. These include the right to conduct research that benefits companies directly; to withhold information that could jeopardize profits; and to send university scientists to appear in public forums to advance the company’s agenda, perhaps with greater credibility than their own staff. In the longer run, these trends can help business to privatize university research, allowing market forces and the search for profits—rather than academic traditions—to dictate the rules of research. As Robert Reich notes in his new book Supercapitalism,3 increased competition among global companies forces them to seek every competitive edge they can find. Increasingly, bought scientists are one such edge.Rather than discontinue research projects altogether, universities and health institutions are taking up partnerships with corporations, exchanging rights to intellectual property for financial support. While this practice is not uncommon to university engineering and technology programs, its increasing presence in the biomedical and other health sectors is of particular concern to the health of the public.

The BP deal with Berkeley illustrates these benefits of direct funding, allowing dozens of scientists to pursue a research agenda shaped by the company on university property, where scientists benefit from the publicly supported (through California tax support and prior NIH funding) research infrastructure but escape the usual obligation to share their findings with the public and the wider scientific community.

The tobacco industry has long hired scientists to ‘debunk,’ or increase doubt about accepted scientific findings that show that tobacco causes cancer and other health conditions. Research studies show that several industries often withhold research findings that could cause a problem for their products or choose to require scientists to pose their research questions in a way that minimizes the possibility for finding harm.

In 2005, the British newspaper The Observer reported that a respected osteoporosis researcher at Sheffield University had questioned American pharmaceutical giant Procter and Gamble’s (P&G), decision to publish drug research in his name even though he had not been given full access to the data that the paper reported, and that the report was written by a ‘ghost writer’ paid for by P&G before being given to him.When researchers change findings at the behest of the sponsoring company to or fail to disclose industry sponsorship of their work, companies exploit the credibility of apparently independent scientists. In the case of Vioxx, the painkiller withdrawn from the market by Merck after it was linked to serious cardiovascular side effects, it appears that university scientists changed their findings at the behest of the company. The editor of the New England Journal of Medicine, which originally published the study, charged that an internal company memo showed that the researchers knowingly suppressed data on three additional heart attacks among Vioxx users that was available months before the paper was published.4 Had that data been included, Vioxx would have looked much riskier.

If universities and companies benefit from new partnerships, what’s the problem?

While growing corporate academic research partnerships may bring benefits to both universities and companies, they raise serious problems for academic integrity, scientific credibility and public health.

First, the imperative to produce findings that benefit the bottom line encourages biased, even dangerous science. For example, on his blog (BrodyHooked) and in his new book Hooked: How Medicine’s Dependence on the Pharmaceutical Industry Undermines Professional Ethics,5 Howard Brody, Director of the Institute for the Medical Humanities University of Texas Medical Branch notes that commercially sponsored studies paid for by the pharmaceutical industry are roughly four times more likely than neutral studies to favor the company’s drug. So commercial bias has been shown to be real and substantial.Similarly, researchers found that studies sponsored by the food industry to evaluate the health benefits of their product were 7.6 times more likely to find such benefits than were studies wholly funded by independent sources.6

Closer corporate ties may also jeopardize traditional academic values of freedom of inquiry, an obligation to share and disseminate research findings freely, and to criticize other researchers’ work without fear of reprisal. In exchange for their dollars, companies often ask universities to sign agreements that restrict publication rights, assign patents or other intellectual property to the company rather than the scientist or the public, and compromise protections for human volunteers.This biased evidence base can skew public policy deliberations—if negative findings have been suppressed, policy makers may falsely assume a product has been demonstrated to be safe. Moreover, increased media focus on industry manipulation of scientific research to benefit its bottom line, whether by suppressing negative findings, ghost writing articles, or preventing authors from sharing proprietary discoveries that could benefit the sponsoring company, can tarnish all scientists. This increased distrust of scientists can make it harder for researchers to participate in public debate as independent voices. For example, when it turned out that much of the research evidence—and advocacy—on behalf of the Human Papilloma Virus vaccine was sponsored by Merck & Co., the maker of the vaccine Gardasil, many citizen groups opposed mandatory vaccinations, even though most public health officials believe the vaccine is a public health advance.7

Since companies support research that they believe will bring in new revenues, they are more likely to fund projects that yield intellectual property that can be patented and sold, such as alternative fuel sources, new processed foods, or medical drugs and devices. Some of these products may promote population health but others do not. Significantly, research that benefits the public but does not generate profits is avoided, thus skewing the research enterprise. As corporate funding increases and government funding declines, this trend may accelerate.

Companies often attach many strings to their gifts, ensuring they can maintain control of the research. For example, in the partnership between BP and UC Berkeley, BP requires that it appoint company representatives for 4 out of 8 board of director seats. Corporate ties to university leaders are especially prevalent in medical schools. In a national survey of department chairs at 140 medical schools and teaching hospitals, Eric Campbell, Senior Scientist at the Institute for Health Policy at Massachusetts General Hospital, found that 60% of department chairs and 67% of departments as administrative units had relationships with industry—as a consultant, member of an advisory board, paid speaker, officer, founder, or member of the board of directors.8 When such ties are normative, resisting undue corporate influence may be especially difficult.

Developing guidelines for reducing corporate influence on university research

In summary, closer ties with corporations may represent a threat to universities because they can undermine academic freedom, divert university resources from other more pressing scientific questions and social needs, and make universities accessories to corporate interests rather than free-standing critical institutions.

In recent years, several research organizations and researchers have proposed guidelines to reduce corporate influences on university research. Many professional organizations, university administrators and researchers are resisting the corporate takeover and seeking to establish professional guidelines and standards that limit corporate influence on the university.

Public Citizen’s Health Research Group, for example, lays out a framework in which one can begin to think about solutions to or prevention of potential conflicts. In a 2007 report to the Institute of Medicine’s Committee on Conflict of Interest in Medical Research, Education, and Practice, the Health Research Group described three basic approaches that can be taken up by institutions—legal restrictions, policy restrictions, and disclosure.9

As an example of a policy decision, the University of Texas’ McCombs School of Business recently turned down an offer of money from Altria Group, the former parent company to Philip Morris. For UT McCombs, the decision was an ethical one. Dean George stated the leadership of the school felt that in some sense it was tainted money, that it is money gotten from a product that is significantly harming people. Associate Dean Paula Murray called the decision to turn down Altria’s money a no-brainer. 10

Professional associations like the International Epidemiology Association, the Institute on Medicine as a Profession, and the Union of Concerned Scientists, as well as advocacy campaigns such as the Restoring Scientific Integrity Network, the Prescription Project, theCenter for Tobacco Control Research and Education, and the Center for Science in the Public Interest work to educate researchers about corporate influences on university research and advocate for the adoption of policies that will remove industry interests from academic research endeavors.

Both the Center for Science in the Public Interest (CSPI) and the Union of Concerned Scientists offer explicit policy options for universities and individual researchers.

 

How to get corporate interests out of academic research

1. Universities can adopt corporate funding policies to protect their autonomy and preserve researchers’ academic freedoms.

2. Universities can prohibit representatives of corporate donors from sitting on research programs’ governing boards.

3. Universities can prohibit industry donors from controlling the content and direction of research programs.

4. Universities can eliminate ‘first rights’ intellectual property clauses from donor agreements.

5. Universities can ensure that company representatives cannot make substantive editorial changes in manuscripts or delay their publication.

Source: The Center for Science in the Public Interest. Strings Tied to Industry-Academic Collaborations at ‘Big Oil U.’ Press Release. Jan 22, 2008.

And the Union of Concerned Scientists called on the scientific community to hold Congress accountable to upholding the pursuit of scientific integrity with the following suggestions:

Scientists employed by government institutions commit themselves to serve the public good free from undisclosed conflicts of interest and to carry out science that is reliable and useful, while respecting statutory limitations such as national security laws. Therefore, government scientists should, without fear of reprisal or retaliation, have the freedom to:

  • Conduct their work without political or private-sector interference;
  • Communicate candidly their findings to Congress, the public, and their scientific peers;
  • Publish their work and to participate fully in the scientific community;
  • Disclose misrepresentation, censorship, and other abuses of science; and
  • Have their technical work evaluated by scientific peers.

A third set of guidelines, shown below, has been proposed by the Royal Netherlands Academy of Sciences.11 These provide detailed suggestions for how to negotiate university industry agreements that do not compromise academic integrity or bias results. By using these various guidelines, academic institutions and university researchers can begin to reassert their rights and responsibilities to set the terms for their scientific inquiries.

Declaration of scientific independence*

1. The structure of the research shall not be geared towards producing the desired outcome for the client.

2. The assignment and its objective shall preferably be formulated jointly by the client and the researcher.

3. Remuneration and other tokens of appreciation shall never depend on the outcomes or interpretation of the research.

4. The results of the scientific research shall be published irrespective of whether they are favourable to the client.

5. The scientist shall always be free to publish the findings of the research within a specified reasonable period of time. In this context two months can be regarded as a reasonable period, with six months generally the maximum (this period being calculated from the moment that the final results are submitted to the client). An exception should be made where there are issues of intellectual property in which case a period of no longer than 12 month would be acceptable.

6. The methods of publication shall be stipulated in the contract. Publication in a scientific journal shall take place in consultation with the client, but the researcher shall have the final say on the contents, the authors, the form of publication and where the research will be published.

7. External financiers of research assignments and/or other sponsors shall be mentioned by name in publications and other forms of disclosure.

8. Relevant interests and/or advisory relations of the researcher(s) shall be cited in publications and other forms of disclosure.

9. The text of the contract shall be available for inspection in confidence by the National Council on Research Integrity (LOWI).

 

*This Declaration forms the heart of the code of conduct proposed by the Royal Netherlands Academy of Sciences.

Source: Van der Meer J et al, 2007.11

References

1. Greenberg DS. Science for Sale The Perils, Rewards and Delusions of Campus Capitalism.ChicagoILUniversity of Chicago Press; 2007.
2. Mervis J. NIH Shrinks, NSF Crawls as Congress Finishes Spending Bills. Science. 2006:311(5757):28–9. 
3. Reich RB. Supercapitalism: The Transformation of Business, Democracy, and Everyday Life. New York: Kopf; 2007. 
4. Curfman GD, Morrissey S, Drazen JM. Expression of concern: Bombardier et al., Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med. 2000;343:1520-8. 
5. Brody H. Hooked: How Medicine’s Dependence on the Pharmaceutical Industry Undermines Professional Ethics. Rowman & Littlefield Publishers, Inc.: Lanham, MD; 2008.
6. Lesser LI, Ebbeling CB, Goozner M, Wypij D, Ludwig DS. Relationship between funding source and conclusion among nutrition-related scientific articles. PLoS Med. 2007 Jan;4(1):e5. 
7. Allen TJ. Merck’s Murky Dealings: HPV Vaccine Lobby Backfires. Special to CorpWatch, March 7th, 2007. Available at:http://www.corpwatch.org/article.php?id=14401. Accessed March 24, 2008. 
8. Campbell EG. Institutional academic industry relationships. JAMA. 2007;298(15):1779-86.
9. Lurie P. Presentation before the Institute of Medicine’s Committee on Conflict of Interest in Medical Research, Education, and Practice (HRG publication #1830). November 5, 2007. Washington, DC. Available at:http://www.citizen.org/publications/release.cfm?ID=7553
&secID=1656&catID=126
. Accessed on March 24, 2008. 
10. Finder A. Some Campuses Decide Tobacco Company Money Is ‘Tainted.’ The New York Times. Feb 4, 2008. Available at:http://www.nytimes.com/2008/02/04/education/04tobacco.html. Accessed on March 24, 2008. 
11. van der Meer JW, de Gier AM, van Swaaij WP, Katan MB. Independent medical research. Neth J Med. 2007;65(4):124-6.

Do pharmaceutical marketing and pricing practices reduce compliance with cardiovascular medications?

Cardiovascular disease (CVD) is the most prevalent condition treated in primary care practice and contributes to the socioeconomic and racial/ethnic inequities in health that characterize the U.S. Treating hypertension and hyperlipidemia, CVD’s major risk factors, can significantly reduce the risk of severe cardiovascular outcomes. Although safe and effective medications are available for this purpose, maintaining healthy blood pressure and cholesterol is difficult, particularly for people from disadvantaged populations. Conventional wisdom says that providing free pharmaceutical samples should help patients to take their medicine but a recent study in Medical Care found that “individuals receiving samples have higher prescription expenditures than their counterparts.” The authors concluded that “these findings suggest that sample recipients remain disproportionately burdened by prescription costs even after sample receipt.”1 While there are many factors that contribute to this problem, here we examine the role of prescription medication marketing practices and costs on patient adherence to prescribed medications.

Adherence to prescribed medications for the control of chronic conditions may be particularly difficult for many disadvantaged populations for multiple reasons, including sociocultural influences that inhibit productive patient-physician communication, low health literacy, and difficulty adjustinglifestyle and health behaviors, among others. These factors have been described in the medical literature and are often the target of patient-level interventions. However another significant but less-studied influence on adherence is the inability of patients to consistently fill prescriptions because of cost of medications. Numerous studies have shown that lower income and/or uninsured patients frequently forgo needed medical care because of cost2,3,4,5,6 delay filling and refilling prescriptions because of cost,7 or share prescriptions with friends and family members because of cost.8 Given these data, we wonder why cost has been given so little attention, and propose that pharmaceutical industry marketing practices might be a factor in compliance.

The pharmaceutical industry continues to develop and market new classes of medications to treat hypertension and hyperlipidemia, even though effective medications to treat these conditions have been available for many years. While the new medications are typically considerably more expensive, they are heavily advertised for any improvement in effectiveness, specificity in their action, and reduced side effects than the earlier drugs. However, there are convincing data showing that in many cases established therapies can be about as effective as the newer medications for many patients.9,10 For example, the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial showed that thiazide-type diuretics are as effective as newer antihypertensive medications, such as an angiotensin converting enzyme (ACE) inhibitor, in reducing blood pressure and cardiovascular complications.9 We acknowledge that contradictory evidence also exists.11 Appropriate decisions about which of the available medication therapies should be prescribed to individual patients include clinical considerations, tolerance of side effects, and other patient-level factors. To date, cost seems to have been of less immediate concern for many prescribing physicians.

To understand why cost might not be routinely considered as a primary factor in clinical decision making, we must take a look at the way medications are marketed. The largest domain of pharmaceutical marketing is the direct promotion of medications to physicians by pharmaceutical representatives, termed “detailing.” Such interactions with pharmaceutical representatives are frequent, occur in multiple clinical settings, and begin as early as medical school. Pharmaceutical representatives have a well-established role in the clinical setting that may extend beyond educating physicians about new medications. Data indicate that this marketing behavior is likely to have had an impact on CVD treatment patterns in particular as the medications to treat its major risk factors are among the most marketed medications, and marketed medications tend to overwhelm the market share of all medications for a particular condition. For example, those medications that are marketed for hyperlipidemia account for about two-thirds of the market share of medications to treat this condition.12

A recent anthropological assessment argues that pharmaceutical representatives create a”culture of gift exchanges” in hospitals and clinics.13 Gifts can include early data on “cutting edge” treatments, supplies for both home and office, opportunities to attend professional conferences, staff lunches, and so on. Some analysts argue that this gift culture creates a conflict of interest for physicians, influencing them to make inappropriate clinical decisions. In this view, pharmaceutical representatives may negatively influence clinical practice not by encouraging physicians to ignore good clinical practice when prescribing medications (that is, accounting for clinical considerations, tolerance of side effects, and other patient-level factors). Rather, sales people may lead physicians to make questionable medication choices when factors other than these clinical benefits are the primary factors at stake. Specifically, interactions with pharmaceutical representatives may lead physicians to prescribe the newest and/or most costly medications to some patients for whom less expensive, cost-effective treatment alternatives are also available. (See Peay and Peay,14 for a discussion of this issue.) This practice would not only increase medical costs, but could also lead to poor medication access and adherence, and ultimately lead to poorer patient outcomes – particularly for the most disadvantaged patients.

So exactly how might pharmaceutical marketing practices mask real cost considerations? One way is the distribution of free product samples. Free samples of medication (“sampling”) are given to physicians to pass along to their patients, a key part of the gift culture previously described. The stated intent of sampling is to allow patients to have access to a free short-term trial of a new medication to determine drug tolerance, side effects, and clinical response, before making a commitment to purchase a longer term supply of the medication. However, physicians frequently report that they give samples in order to provide free or low-cost medications to their uninsured/underinsured patients.15,16

Studies suggest that most physicians recognize that medication cost may be a substantial barrier to patients’ ability to adhere to prescribed medication regimens, and believe that cost should be a consideration when making treatment choices for patients. (See Alexander et al.17,18,19 for discussions of this issue.) However few physicians actually take the necessary steps to adequately monitor either cost or cost-related adherence, by, for example, initiating conversations about medication-taking behaviors, the out-of-pocket costs of medications, and the potential for cost to be a barrier to filling or refilling prescriptions and medication adherence.17,20,21 For physicians who are made aware of cost concerns, the sample closet is frequently thought to be their only resource. Surprisingly few physicians are aware of strategies other than pharmaceutical sponsored medication samples to help patients reduce their financial burdens due to the cost of multiple medications.17,22 Alternatives can include suggesting behavior modification, prescribing generic medications, using pharmaceutical sponsored Medication Assistance Programs, and referring patients to 340B Drug Pricing Programs (federal programs that entitle health centers to purchase/distribute medications at Medicaid prices or lower). Thus, despite the concern about the problems associated with pharmaceutical marketing in general, many physicians strongly support “sampling.”

What is the harm of “sampling?” While potential harms have not yet been described fully, the availability of samples may influence medication choices when there are many medication options available to the physician. For example, while it is possible that use of samples encourages adherence to prescribed medications, it is also possible that the use of samples reduces adherence because patients who are used to receiving free samples only take these expensive medications when samples are available. Additionally, because the large number of uninsured/underinsured patients, the ongoing availability of samples cannot be assured. Thus, reliance on samples alone for uninsured/underinsured patients is an inadequate long-term strategy to provide access to pharmaceuticals. Additionally, the distribution of samples presents a great potential for medical errors due to inadequate labeling and record keeping, in addition to the previously discussed concerns about inappropriate treatment choices. Beginning in 2004, the Joint Commission on Accreditation of Healthcare Organizations requires that accredited health care organizations follow specific guidelines for managing medications that includes processes for ordering and prescribing, preparing and dispensing, administering, monitoring, selecting and procuring, and storing medications, including samples. Because the nature of relationships with pharmaceutical representatives was intentionally informal (as part of a “gift culture” described above), shifting the system of documenting the receipt/distribution of samples received from pharmaceutical representatives from an informal to a formal system has been difficult for many safety net settings.

We believe rigorously designed observational and experimental studies are warranted to determine whether the potential cost saving benefit of having samples available equals the potential harm that this practice might cause for the treatment of cardiovascular disease and its major risk factors in primary care settings. Such studies will also help to address the larger question about whether pharmaceutical marketing practices in general make it more or less difficult for physicians to address medication cost concerns of their patients, and, ultimately to improve adherence to necessary treatments for the major risk factors for cardiovascular disease and reduce health disparities.

Nancy Sohler, Ph.D., MPH, is an assistant medical professor of health policy at the Sophie Davis Medical School of the City University of New York.

Jonathan N. Tobin, Ph.D., is the President/CEO of Clinical Directors Network, a primary care practice-based research network and clinician training organization that works with medically underserved communities. He is also Professor and Director of Education and Training at the Institute for Public Health Sciences of Yeshiva University.

Andrea Cassells, MPH, is the Director of Clinical Affairs at Clinical Directors Network in New York City.

For More Information

Organizations working to change health harming practices of the pharmaceutical industry:

The Prescription Project 
Prescription Access Litigation 
Consumers Union Prescription for Change 
Marketing Overdose (Consumers International) 
Pushing Prescriptions (Center for Public Integrity) 
Center for Medical Consumers

 

References

1. Jackson JE, Doescher MP, Saver BG, Fishman P. Prescription drug coverage, health, and medication acquisition among seniors with one or more chronic conditions. Med Care. 2004;42(11):1056-65.
2. Wilson IB, Rogers WH, Chang H, Safran DG. Cost-related Skipping of Medications and Other Treatments Among Medicare Beneficiaries Between 1998 and 2000: Results of a National Study. J Gen Intern Med. 2005;20:715-20. 
3. Heisler M, Wagner TH, Piette JD. Patient Strategies to Cope with High Prescription Medication Costs: Who is Cutting Back on Necessities, Increasing Debt, or Underusing Medications? J Behav Med. 2005;28(1):43-51.
4. Klein D, Turvey C; Wallace R. Elders Who Delay Medication Because of Cost: Health Insurance, Demographic, Health and Financial Correlates. Gerontologist. 2004;44(6):779-87.
5. Kennedy J, Coyne J, Sclar D. Drug affordability and prescription noncompliance in the United States: 1997-2002. Clin Ther. 2004;26(4):607-14.
6. Piette JD, Heisler M, Krein S, Kerr EA. The Role of Patient-Physician Trust in Moderating Medication Nonadherence Due to Cost Pressures. Arch Intern Med. 2005;165(15):1749-55.
7. Jackson JE, Doescher MP, Saver BG, Fishman P. Prescription drug coverage, health, and medication acquisition among seniors with one or more chronic conditions. Med Care. 2004; 42(11):1056-65.
8. Bonuck KA, Memmott MM, Arno PS. Cost-Related Prescription Drug Misuse Among Older Persons. Health Aff.2001;20(5):241-51.
9. Davis BR, Piller LB, Cutler JA, Furberg C, Dunn K, Franklin S, Goff D, Leenen F, Mohiuddin S, Papademetriou V, Proschan M, Ellsworth A, Golden J, Colon P, Crow R, for the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) Collaborative Research Group. Role of Diuretics in the Prevention of Heart Failure: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Circulation. 2006;113:2201-10.
10. Cheetham TC, Chan J, Benson V, Richmond C, Levin E, Campen D. Successful conversion of patients with hypercholesterolemia from a brand name to a generic cholesterol-lowering drug. Am J Manag Care. 2005;11(9):546-52.
11. Litchenberg FR. Are the benefits of newer drugs worth their cost? Evidence from the 1996 MEPS. Health Aff.2001;20(5):241-251.
12. National Institute for Health Care Management Foundation, Prescription Drugs and Mass Media advertising 2000(November 2001). 
13. Oldani MJ. Thick Prescriptions: Toward an interpretation of pharmaceutical sales practices. Med Anthropol Q.2004;18(3):325-56.
14. Peay MY, Peay ER. The role of commercial sources in the adoption of a new drug. Soc Sci Med. 1988;26:1183-99.
15. Spiller LD, Wymer WW. Physicians’ perceptions and uses of commercial drug information sources: an examination of pharmaceutical marketing to physicians. Health Mark Q. 2001;19:91-106.
16. Chew LD, O’Young TS, Hazlet TK, Bradley KA, Maynard C, Lessler DS. A Physician Survey of the Effect of Drug Sample Availability on Physicians’ Behavior. J Gen Intern Med. 2000;15(7):478-83.
17. Alexander GC, Casalino LP, Meltzer DO. Physician strategies to reduce patients’ out-of-pocket prescription costs. Arch Intern Med. 2005;165(6):633-36.
18. Alexander GC, Casalino LP, Tseng CW, McFadden D, Meltzer DO. Barriers to patient-physician communication about out-of-pocket costs. J Gen Intern Med. 2004;19(8):856-60.
19. Alexander GC, Casalino LP, Meltzer DO. Patient-physician communication about out-of-pocket costs. JAMA,2003;290:953-58.
20. Shrank WH, Fox SA, Kirk A, Ettner SL, Cantrell CH, Glassman P, Asch SM. The effect of pharmacy benefit design on patient-physician communication about costs. J Gen Intern Med. 2006;21(4):334-39.
21. Bokhour BG, Berlowitz DR, Long JA, Kressin NR. How do providers assess antihypertensive medication adherence in medical encounters? J Gen Intern Med. 2006;21:577-83.
22. Shrank WH, Hoang T, Ettner SL, Glassman PA, Nair K, DeLapp D, Dirstine J, Avorn J, Asch SM. The implications of choice: prescribing generic or preferred pharmaceuticals improves medication adherence for chronic conditions. Arch Intern Med. 2006;166(3):332-37.

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1. betsythedevine
2. fortinbras

Tracking the Effects of Corporate Practices on Health