Is the Food Industry Playing with our Brains? New book by former FDA commissioner David Kessler examines neuroscience of overeating

In his new best-selling book titled The End of Overeating: Taking Control of the Insatiable American Appetite, David Kessler, M.D., former U.S. Food and Drug Administration Commissioner, presents research on the newest discoveries of neuroscience related to appetite and eating, as well as the insights he learned from top food industry executives that resulted in his theory on overeating.

It’s no longer news to point out that Americans are gaining weight and most public health folks have heard the alarming projection that if current trends continue, by 2015, 75% of American adults will be overweight and 41% will be obese1 And it’s also no news that many Americans are trying to lose weight. We  spend nearly $60 billion annually on weight loss products and diets 2. This year Weight Watchers stands to earn a $1.58 billion in revenue (excluding sales of food products), and Jenny Craig will earn nearly $610 million 2. Unfortunately, most dieters return to their initial weight within three to five years 3, suggesting that more dieting isn’t going to solve America’s obesity problem.

In his new book The End of Overeating: Taking Control of the Insatiable American Appetite David A. Kessler, M.D., a physician and lawyer who served as Commissioner of the U.S. Food and Drug Administration (FDA) from November 1990 until March 1997, brings a fresh perspective to the obesity problem.  He argues that it is not faulty metabolism or lack of will power that causes people to eat too much or fail at dieting but rather complex brain functions that lead to “conditioned hypereating.” Acording to Kessler, environmental cues trigger biological drives for foods high in fat, sugar and salt  and eventually overwhelm the mechanisms that controlled overeating in earlier eras when unhealthy food was less promoted and less available.

Having spent many years at the FDA synthesizing research on the addictive powers of tobacco, Kessler turned his attention to high fat, salt and sugar foods, which,  after tobacco, are the second leading killer of Americans.   His new book is the result of seven years of research, and last month it emerged on the top-ten bestsellers list for non-fiction in the New York Times Book Review. In his book, Dr. Kessler presents research on the newest discoveries of neuroscience related to appetite and eating, as well as the insights he learned from his interviews with food industry executives.

Hyperpalatable foods engineered by industrial chefs and conditioned overeating

In essence, Dr. Kessler maintains that foods high in fat, salt and sugar alter brain chemistry in a way that compels people to overeat.  While these foods have always been “salient” to humans, the modern food industry has taken advantage of this phenomenon.  Kessler describes how industrial chefs have engineered “hyperpalatable” foods that are layered in fat, sugar and salt to trigger a release of the neurotransmitter dopamine, resulting in “conditioned hypereating.” He profiles engineered foods from some of the most popular brand manufacturers, chain restaurants, and fast food restaurants, including the Cinnamon Crunch Bagel at Panera (430 calories, 8g fat, 430mg sodium), and the Sowthwestern Eggrolls (910 calories, 57g fat, 1960mg sodium) and Boneless Shanghai Wings (1260 calories, 71g fat, 3030mg sodium) from the nation’s second-largest restaurant chain Chili’s Grill and Bar. Dr. Kessler said he estimates that approximately 70 million Americans are affected by hypereating4, and he maintains that  what “the food the industry is selling is much more powerful than we realized.” 5

Advertising: “The emotional gloss”

When  hyperpalatable foods are combined with modern-day marketing and advertising (“the emotional gloss,” as Dr. Kessler puts it), the result is changed social norms that make it acceptable for Americans to eat foods daily that used to be considered occasional treats.  According to Dr. Kessler, “We took down all these barriers; now you can eat anytime, anywhere.  It’s socially acceptable.  We have this constant stimulation, and we’re no longer eating for nutrition.  We took fat, sugar, and salt, made it very appealing, put it on every corner, and made it socially acceptable.” 6 While some have argued that advertising serves an important function in informing consumers about products, Dr. Kessler’s research reveals that food advertisements in fact serve as cues to induce people to eat these engineered, unhealthy foods4. Constant bombarding by advertisements that link these foods to fun and good times makes it more difficult for people to address their overeating.5

Dr. Kessler’s inspiration for the book

In interviews, Dr. Kessler describes his inspiration for the book as well as his own struggles with overeating.  Before he wrote the book, he said that he didn’t know the causes of overeating, but that he knew it “wasn’t just a matter of diet and exercise.” 6 Kessler says his inspiration came seven years ago when he was watching a woman on The Oprah Winfrey Show 5, 6 who in tears, described how she could not control her eating.  He said, “I was sitting there trying to listen as a doctor, but I could also relate to what she was talking about from my own experience.  I needed to understand what was driving her behavior.6

Solutions to the overeating epidemic

This book promises to be highly influential in changing the way that Americans view the practices of the food industry as well as the epidemic of overeating. In an interview with a Huffington Post reporter, Kessler summarized the basic premise of his theory, “Now, we know that highly palatable foods – sugar, fat, salt – are highly reinforcing and can activate the reward center of the brain.  For many people that activation is sustained when they’re cued.  They have such a hard time controlling their eating because they’re constantly being bombarded …For decades the food industry was able to argue, ‘We’re just giving consumers what they want.’ Now we know that giving them highly salient stimuli is activating their brains.” 4

Dr. Kessler says that his book is not meant to be a policy prescription.  Instead, he wants to explain why people  have such a difficult time with overeating. 6 Based on his tobacco experience at the FDA, Dr. Kessler has noted that there are many parallels between problems associated with food and tobacco  industry practices. Both industries manipulate consumer behavior to sell products that are harmful to health.5 He maintains that while government has a role to play, many of the great public health successes have come from changes in the way people perceive the product.4 He states, “We did this with cigarettes. It used to be sexy and glamorous but now people look at it and say, ‘That’s not my friend, that’s not something I want.’ We need to make a cognitive shift as a country and change the way we look at food.” 5

References

1 Wang Y, Beydoun MA. The obesity epidemic in the United States – gender, age, socioeconomic, racial/ethnic, and geographic characteristics: a systematic review and meta-regression analysis. Epidemiologic Reviews. 2007;29:6-28. Available at: http://epirev.oxfordjournals.org/cgi/content/abstract/29/1/6

2 Miley M. New Year, new round of diet programs. Advertising Age. January 12, 2009.

3 Wadden TA, Phelan S. Behavioral assessment of the obese patient.  In: Wadden Ta, Stunkard AJ, eds.  Handbook of Obesity Treatment. New York: Guilford Press, 2002:186-226.

4 McCready L. Interview with Dr. David Kessler, author of The End of Overeating, on why we can’t stop eating. The Huffington Post. May 6, 2009. Available at: http://www.huffingtonpost.com/louise-mccready/d-kessler-author-of-emthe_b_195676.html.

5 Layton L. Crave man: David Kessler know that some foods are hard to resist; now he knows why. The Washington Post. April 27, 2009. Available at: http://www.washingtonpost.com/wp-dyn/content/article/2009/04/26/AR2009042602711.html.

6 Hobson K. David Kessler on why we’re prone to eating too much. U.S. News & World Report. May 4, 2009. http://health.usnews.com/blogs/on-fitness/2009/05/04/david-kessler-on-why-were-prone-to-eating-too-much.html.

 

Photo Credits:
1. publiccitizen

Researching for Advocacy: The Industry Trade Press as a Resource for Activists

A recent report put out by the Berkeley Media Group, entitled, Navigating the Trade Press: What are the food and beverage industries discussing?, recommends public health advocates concerned with obesity regularly monitor various publications, including trade journals and magazines, to stay on top of the latest developments in the food and beverage industries. This review of the report features links to the report and key trade publications recommended for tracking.

To plan effective advocacy campaigns to change health-damaging corporate practices, activists need to understand what company managers are thinking and what business and political strategies they are planning.  Unlike big corporations and trade associations, few advocacy groups or independent researchers have the resources to hire investigators to gather this intelligence.  One practical and inexpensive alternative is to monitor business and trade press coverage of the industry in question.

A few years ago, the Berkely Media Stduies Group released a useful guide called Navigating the Trade Press: What are the food and beverage industries discussing? [pdf] It provides a starting point not only for activists seeking to change the food industry but also for other corporate campaigners who need an overview of the world of trade presses, business publications geared towards industry insiders.  In the report, author Lori Dorfman and Elena Lingas argue that “reading these sources makes it easier to articulate the divergent goals of public health and the food, beverage, and advertising industries,” enabling advocates, who often go up against companies with many times more resources, to more effectively and efficiently contest the practices of these industries that harm heath.

A web link to a 200-item annotated bibliography of key sources for tracking activities of these industries is a main highlight of Navigating the Trade Press. Separating the sources into business and science- focused categories, and then into tiers according to their direct proximity to issues of interest to most obesity prevention advocates, the report highlights the most relevant sources (including websites) for all public health advocates whose work is affected by these industries.  In addition to these sources, the report recommends that advocates choose specialty journals from the bibliography, in addition to the more general sources listed below, in order to stay on top of  industry practices that affect the issues they work on.   Dorfman and Lingas note that most sources offer an opportunity to sign up for periodic newsletters and news alerts via email, making it easy to monitor issues of interest.

Key sources for tracking food and beverage industry activities:

New York Times Business section (see especially the Advertising column)
Wall Street Journal Marketplace section
LA Times
Washington Post
Ad Age
Ad Week
Grocery Manufacturers of America
Food Institute
Food Chemical News
Obesity Policy Report

Some of these publications may require a subscription for viewing full contents on line. Most large public or university libraries have such electronic subscriptions, making these institutions a useful resource for activist researchers.

Future Corporations and Health Watch postings will examine how policy advocates can use the trade press of other industries (e.g., pharmaceutical, firearms, alcohol, tobacco, etc.) in their work. We invite readers to send suggestions to responses@corporationsandhealth.org

To read the full Navigating the Trade Press report and download the excel spreadsheet of food industry sources, please visit:

Mapping the Debate on Food

Marin Institute Releases New Alcohol Tax Calculator Tool

Read about and link to the new tool developed by the Marin Institute designed to assist states in raising revenue through alcohol taxation.

Online Feature Helps States Charge for Harm to Raise Revenue

Marin Institute has released the country’s first online alcohol tax and fee calculator to assist lawmakers looking for new revenue. The user-friendly tool is available at www.MarinInstitute.org.

The powerful program works for every state, as well as nationally and the District of Columbia. You just enter the amount of new tax (nickel or dime a drink, for example) for beer, wine or spirits (or any combination). Then the program instantly estimates additional annual revenues, based on a variety of factors specific to that particular jurisdiction.

Marin Institute developed the tool in response to inquiries from states looking for new revenues sources while holding Big Alcohol accountable for the enormous harm its products cause. Many states have not raised alcohol taxes or fees in decades. States with pending legislation to raise alcohol taxes or fees include: California, Illinois, Massachusetts, Minnesota, New York, Oregon, South Carolina, Tennessee, Wisconsin, Arizona, and Hawaii.

Visit the Tax / Fee Revenue Calculator on Marin Institute’s website to quickly estimate how much your state can raise in new alcohol taxes and fees.

The Impact of Corporate Practices on Health Inequities in the United States

This month, Corporations and Health Watch focuses on the role of corporate practices in producing or maintaining socioeconomic, racial/ethnic or other inequities in health. In our interview, Stephen Thomas [pdf], the director of the Center for Minority Health at the University of Pittsburgh Graduate School of Public Health and founding co-chair of the new Academy for Health Equity, describes the ways corporate decisions contribute to health disparities and assesses various strategies for putting this issue on the agenda in Black, Latino and other low income communities. In the second feature,Martha Lincoln, a PhD student in anthropology at the CUNY Graduate Center, tells the story of Bidil, a prescription drug approved by the US Food and Drug Agency in 2005 for treatment of congestive heart failure. Bidil is the first “race-specific” pharmaceutical to be awarded federal approval. Lincoln describes the ethical, health and financial issues raised by “racial targeting” of a specific population with a specific drug. The third contribution is a selected bibliography and abstracts of recent scientific publications on the role of corporate practices on health disparities. Finally, Alexandra Lewin examines the impact of rising food prices on the school lunch program, suggesting that these price hikes may further reduce access to healthy food for vulnerable populations.

In this commentary, I review some of the pathways by which corporate practices may contribute to health inequities, describe some of the strategies advocates have used to reduce harmful corporate practices or policies and suggest some directions for research and advocacy.

Pathways: How corporate practices contribute to health inequities

How do corporate practices influence the differential burden of disease on different population groups? In previous work, my colleagues and I have identified four business practices that influence health: product design, marketing, retail distribution and pricing. 1, 2 Let’s examine how each contributes to disparities in health.

Product design

By designing products to appeal to specific groups, producers hope to increase sales to these markets. When the product harms health or the targeted population has other vulnerabilities that can magnify its adverse impact, this practice can lead to differential disease profiles. For example, the tobacco industry added menthol to tobacco products in the belief that African-Americans preferred mentholated cigarettes.3 Some research suggests that menthol cigarettes increase the risk of dependence and tobacco-related illnesses.4, 5, 6 As a result, concludes one researcher, menthol “may be partly responsible for the disproportionately high tobacco-related disease and mortality among African Americans generally and African American males particularly.”3 Similarly, the production of malt liquor, characterized by high alcohol content, a sweet taste and often sold in 40 ounce containers, is designed to appeal to male African-Americans, where it has been associated with higher rates of binge drinking and alcohol-related health and safety problems.7 In both the case of menthol cigarettes and malt liquor the problems associated with a product designed to appeal to a specific population were aggravated by heavy marketing to that group.

Targeted marketing

Tobacco, alcohol, and food companies target advertising at Blacks, Hispanics and low-income communities, leading to greater exposure to health-damaging messages.8, 9, 10 In some cases, differential media exposure further exacerbates the adverse impact. Since African-Americans watch more television than whites, they are more exposed to unhealthy food or alcohol advertisements. One study found that 52% of food and beverage advertisements in magazines for Hispanic women were for unhealthy foods and drinks compared to only 29% in this category in mainstream women’s magazines aimed mostly at white women.11 Other forms of marketing such as product promotions and corporate sponsorships also often target vulnerable groups,12, 13 contributing to the health burden these groups experience.

Retail distribution

Corporations play a role in deciding where to locate retail outlets for their products. The density of such outlets results in differential access by socioeconomic status and race/ethnicity to unhealthy products such as tobacco, alcohol, and high fat foods and less access to healthy products such as fresh fruits and vegetables.14, 15 For example, a study in Detroit found that the nearest supermarket was, on average, 1.1 miles further away from neighborhoods in which African Americans resided than from White neighborhoods.16 Decisions to preferentially locate retail outlets selling unhealthy products in Black, Latino or low income communities and those selling healthy products in better off areas may result solely from an assessment of where opportunities for profit are highest or also from implicit or explicit racial prejudice. The motivation, however, does not change the impact of these decisions on health.

Corporate decisions on retail distribution are also a consequence of patterns of racial segregation. Kwate argues that housing segregation drives out supermarkets, which often sell healthier foods, and attracts fast food outlets, which sell calorie dense but nutrient low foods at an affordable price.17 In this case, housing and real estate policies and corporate decisions intersect to create food environments that contribute to obesity, now increasingly concentrated in low income and Black and Latino neighborhoods.

Pricing

By developing pricing policies that make unhealthy products more accessible or healthy products less available to low income, Black, Latino or other ethnic populations, corporations contribute to health disparities. In some cases, this differential pricing is the result of impersonal market forces, e.g., super markets cannot offer volume discounts on products for which a strong demand already exists, making some healthy foods more expensive in poor neighborhood than better off ones. In other cases, big companies choose not to confront pricing practices in the informal or black market economy because they are ultimately profitable. The easy availability of unregulated inexpensive handguns (“Saturday night specials”) in poor communities served as a profit center for many gun manufacturers, even though it also contributed to higher rates of homicides and gun injuries.18, 19 Similarly, the ubiquity of “loosies”, single cigarettes, and untaxed black market cigarettes, helps the tobacco industry to attract and keep young and poor customers and also serves to concentrate tobacco-related diseases on the lower end of the socioeconomic spectrum.20

Corporations make decisions that can contribute to maintaining or increasing disparities through these four business practices, but also through their opposition to stronger government regulation. Weak public health regulation adversely effects all populations but especially those with fewer resources to escape or protect themselves from harm. For example, the automobile industry’s success in avoiding more stringent air pollution standards may have a more detrimental effect on low income and Black and Latino populations since these communities are less able to block or move away from highways or other high traffic areas.21 The tobacco industry’s global success in delaying enforcement of laws against illegal sales of cigarettes contributes to the differential impact of the illicit tobacco market by income and race/ethnicity. For example, one California study found that underage Black and Latino youth were 2.5 times more likely to be sold cigarettes than their white counterparts.22 Finally, vulnerable populations may have less access to public health campaigns that provide the knowledge and skills to reduce the impact of health-damaging industry practices.23 When corporations and their allies advocate privatization of public health services, oppose increased taxes to improve public services or sponsor media campaigns that emphasize individual responsibility for health, they may further undermine the capacity of poor Black or Latino communities to protect themselves from harmful corporate practices.

In sum, the pathways by which corporate decisions may create, maintain or widen socioeconomic or racial/ethnic inequities in health suggest that these business practices can be viewed as a significant determinant of health disparities. In the next section, I describe some of the advocacy strategies that have been used to reduce these disparities.

Strategies 24

In recent years, many organizations and individuals have mobilized to change the practices of the industries that contribute to ill health.25 In some cases, these campaigns have targeted industry practices that contribute directly to health inequities. For example, in Philadelphia, a coalition of African American, community, church, and health organizations led a campaign to force R.J. Reynolds Tobacco Company to drop plans for test marketing Uptown cigarettes, a brand aimed at African Americans. 26

Similarly, a coalition of Chicago Black and Latino groups and the attorneys general of several states worked together to force R.J. Reynolds to modify its Kool Mixx, a tobacco promotional campaign that used hip hop music to appeal to young Blacks and Latinos.27 A neighborhood coalition and a university in Chicago joined forces to advocate bans on alcohol and tobacco billboards in low-income communities of color.28 Many communities have used land-zoning regulations to reduce the density of alcohol, tobacco, and fast food establishments.29

In other cases, community or health advocacy organizations have launched counter-advertising campaigns using African American or Latino images and themes designed to counteract industry’s use of similar elements. In schools across the country, including many in big cities with high proportions of low-income students, parents and advocacy organizations are working to force food companies to end marketing of high-calorie low-nutrient foods within schools.30

In sum, public health campaigns to modify health damaging industry practices are a promising strategy for the primary prevention of health inequity. Using social justice and health equity as themes for community mobilization and policy change may help to bring new constituencies into the effort to reduce disparities.25

A Research and Policy Agenda

For researchers, considering corporate practices as a social determinant of health inequity raises many challenging questions:

  • What is the differential impact of business practices such as product design, marketing, retail distribution and pricing on health disparities?
  • How does the relative impact vary by health condition, industry and population characteristics?
  • What is the attributable risk for business practices in producing health disparities? How do business practices compare to (and interact with) other determinants such as poverty, social hierarchy, and social stress?
  • What policy and programmatic interventions are most effective in reducing the harmful impact of business practices?
  • How do strategies for reducing harmful business practices compare in the preferential benefits they bring to disadvantaged groups?
  • How do the business practices that contribute to health inequities in the United States and other developed nation compare to those operating in the global south?

By focusing attention on these and related questions, conducting systematic studies of the efficacy of various intervention strategies, and better documenting the many existing efforts to change industry practices, researchers and health professionals can bring evidence-based lessons to policymakers that would assist them in selecting policies to maximize the potential for the reduction of disparities.31

For policy makers and policy advocates, framing corporate practices that harm health as a cause of health inequity opens the door for new alliances among those working across industries, e.g., food, tobacco, and guns; across political levels, e.g., local, national and global; and across issues, e.g. corporate reform and responsibility, human rights, and consumer protection. Recent calls for the development of social movements to reduce disparities32 create opportunities for dialogue on these issues. To date, however, more attention ahs focused on public rather than corporate policies that contribute to disparities. By expanding our understanding of the causes and solutions to health inequities, public health advocates can help to move from description of disparities to action to end them.

 

Nicholas Freudenberg is fonder and Director of Corporations and Health Watch and Distinguished Professor of Public Heath at Hunter College, City University of New York.

 

References

1. Freudenberg N. Public health advocacy to change corporate practices: implications for health education practice and research. Health Educ Behav. 2005;32(3):298-319.
2. Freudenberg N, Galea S. The impact of corporate practices on health: implications for health policy. J Public Health Policy. 2008;29(1):86-104. 
3. Gardiner PS. The African Americanization of menthol cigarette use in the United States. Nicotine Tob Res. 2004; 6 Suppl 1:S55-65.
4. Garten S, Falkner RV. Continual smoking of mentholated cigarettes may mask the early warning symptoms of respiratory disease. Prev Med. 2003;37(4):291-6. 
5. Richardson TL. African-American smokers and cancers of the lung and of the upper respiratory and digestive tracts. Is menthol part of the puzzle? West J Med. 1997;166(3):189-94.
6. Wackowski O, Delnevo CD. Menthol cigarettes and indicators of tobacco dependence among adolescents. Addict Behav. 2007;32(9):1964-9. 
7. Time to reclassify malt liquor and flavored malt beverages as a distilled spirit? Available athttp://www.corporationsandhealth.org/malt_liquor_product_profile.php
8. Moore DJ, Williams JD, Qualls WJ. Target marketing of tobacco and alcohol-related products to ethnic minority groups in the United States. Ethn Dis. 1996; 6(1-2):83-98.
9. Alaniz ML. Alcohol availability and targeted advertising in racial/ethnic minority communities. Alcohol Health Res World. 1998;22(4):286-9. 
10. Balbach ED, Gasior RJ, Barbeau, EM. R. J. Reynolds’ targeting of African Americans: 1988-2000. Am J Public Health. 2003; 93:822-827.
11. Duerksen SC, Mikail A, Tom L, Patton A, Lopez J, Amador X, Vargas R, Victorio M, Kustin B, Sadler GR. Health disparities and advertising content of women’s magazines: a cross-sectional study. BMC Public Health. 2005;18;5:85. 
12. Rosenberg NJ, Siegel M. Use of corporate sponsorship as a tobacco marketing tool: a review of tobacco industry sponsorship in the U.S.A, 1995-99. Tob Control. 2001;10(3):239-46.
13. Kuo M, Wechsler H, Greenberg P, et al. The marketing of alcohol to college students: the role of low prices and special promotions. Am J Prev Med. 2003;25(3):204-11. 
14. Schneider JE, Reid RJ, Peterson NA, et al. Tobacco Outlet Density and Demographics at the Tract Level of Analysis in Iowa: Implications for Environmentally Based Prevention Initiatives. Prev Sci. 2005; 15;1-7.
15. Harwood EM, Erickson DJ, Fabian LE, et al. Effects of communities, neighborhoods and stores on retail pricing and promotion of beer. J Stud Alcohol. 2003; 64(5):720-6.
16. Zenk SN, Schulz AJ, Israel BA, et al. Neighborhood racial composition, neighborhood poverty, and the spatial accessibility of supermarkets in metropolitan Detroit. Am J Public Health. 2005 Apr;95(4):660-7. 
17. 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. 
18. Wintemute GJ. Ring of Fire: The Handgun Makers of Southern California, 1994. Violence Prevention Research Program. 19. Wintemute GJ. The relationship between firearm design and firearm violence. Handguns in the 1990s. JAMA. 1996 275(22):1749-53. 
20. Smith KC, Stillman F, Bone L, Yancey N, Price E, Belin P, Kromm EE. Buying and selling loosies in Baltimore: the informal exchange of cigarettes in the community context. J Urban Health. 2007;84(4):494-507. 
21. American Lung Association. Urban air pollution and health inequities: a workshop report. Environ Health Perspect. 2001; 109 Suppl 3:357-74. 
22. Landrine H, Klonoff EA, Campbell R, et al. Sociocultural variables in youth access to tobacco: replication 5 years later.Prev Med. 2000 May;30(5):433-7. 
23. LaVeist, TA. Disentangling Race and Socioeconomic Status: A Key to Understanding Health Inequalities. Journal of Urban Health. 2005;82:iii26-iii34(1). 
24. An earlier version of this section appeared in: Freudenberg N, Galea S, Fahs M. Changing corporate practices to reduce cancer disparities. J Health Care Poor Underserved. 2008;19(1):26-40.
25. Freudenberg N, Bradley SP, Serrano M. Public Health Campaigns to Change Industry Practices That Damage Health: An Analysis of 12 Case Studies. Health Educ Behav. 2007 Dec 12. [Epub ahead of print] 
26. Robinson RG, Sutton C. The coalition against uptown cigarettes. In: Jernigan D, Wright PA, eds. Making news, changing policy: case studies of media advocacy on alcohol and tobacco issues Washington, DC: U.S. Department of Health and Human Services, 1994; 89-108. 
27. National African American Tobacco Prevention Network (NAATPN). National African American Tobacco Network demands that Kool’s stop targeting the hip-hop generation. Press Release. Summerville, NC: NAATPN, 2004 Apr 8. 
28. Hackbarth DP, Schnopp-Wyatt D, Katz D, et al. Collaborative research and action to control the geographic placement of outdoor advertising of alcohol and tobacco products in Chicago. Public Health Rep. 2001;116(6):558-67. 
29. Ashe, M., Jernigan, D., Kline, R, et al.. Land use planning and the control of alcohol, tobacco, firearms, and fast food restaurants. Am J Public Health. 2003; 93: 1404-1408. 
30. Peterson KE, Fox MK. Addressing the epidemic of childhood obesity through school-based interventions: what has been done and where do we go from here? J Law Med Ethics. 2007;35:113-30. 
31. Gibbs BK, Nsiah-Jefferson L, McHugh MD, Trivedi AN, Prothrow-Stith D. Reducing racial and ethnic health disparities: exploring an outcome-oriented agenda for research and policy. J Health Polit Policy Law. 2006; 31(1):185-218.
32. Prevention Institute. Laying the Groundwork for a Movement to Reduce Health Disparities Report II. Prevention Institute, Oakland, CA, April 2007.


Baby Carrots: Model Product for a New Economy?

Under what circumstances can the interests of companies and consumer health coincide? Can food companies make a profit promoting healthier food? To find answers to these questions, this month CHW examines a single product—baby carrots. An analysis of the industry and consumer practices contributing to the rise in popularity of baby carrots offer an opportunity to examine how healthy food can mean big profits for food companies.

 Under what circumstances can the interests of companies and consumer health coincide? Can food companies make a profit promoting healthier food? To find answers to these questions, this month Corporations and Health Watch examines a single product—baby carrots. In his classic The Wealth of Nations, Adam Smith analyzed a pin factory to understand the workings of the newly emerging capitalism. He claimed that by understanding this “trifling manufacture” his readers could appreciate deeper economic dynamics. Here, our more modest goal is to gain insights into the connections between profitability and population health.

Baby carrots are in fact not babies at all. They are specially grown carrot varieties that are cut and peeled into a standard size, so they can be packed and eaten without peeling or any other preparation. Baby carrots were introduced in the late 1980s and a decade later, per capita carrot consumption had more than doubled, with nearly all the growth coming from fresh carrots. According to Ken Hodge, communications director for the International Fresh-Cut Produce Association, the rise in carrot consumption is “one of the biggest success stories in produce.”


Health benefits of carrots

Why is increased carrot consumption important? First, carrots are an important source of Vitamin A and the beta-carotene in carrots is available for synthesis into A with little waste or health risk. According to the U.S Department of Agriculture, Americans get 30% of their Vitamin A from carrots. Second, most nutritionists believe that increasing fruit and vegetable consumption brings a plethora of health benefits: reduced rates of heart disease, cancer, diabetes and other conditions and reductions in obesity, an important contributor to the socioeconomic and racial/ethnic health disparities that characterize the United States. Most Americans fail to eat the suggested 5-10 daily servings of fresh fruits and vegetables so finding products that can lead to increases in consumption is an important priority. Baby carrots are convenient and versatile. They can be part of school lunches, snacks, party food or airline fare; sold in bodegas and grocery stores as well as super markets; or served in day care and after school programs. Carrots can be stored in refrigerators for several days, making them attractive to institutional food programs, small stores and ordinary eaters. Easy to serve and store, baby carrots, sticks, and other types of peeled and cut carrots accounted for 69 percent of U.S. households’ expenditures for fresh carrots in 2003.

Baby carrots: a new profit center?

For producers, baby carrots also have attractions. Baby carrots sell for more than regular carrots and many chains now market their own brands of baby carrots. Baby carrots sell for two or more times the price of their full-sized cousins, making them a profitable value-added product. Overall, according to the United States Department of Agriculture, in 2004, the average wholesale price for fresh carrots (in 2000 dollars) was $18.76 per hundred pounds, down from the 20-year high of $21.28 in 1984. Thus, for consumers prices went down while the shift to baby carrots allowed producers to earn more. Since the late 1990s, however, per capita consumption of carrots began to decline, perhaps revealing the fickle tastes of the American consumer or the very modest investments in carrot advertising. (Have you ever seen a television ad for baby carrots?)


Designer carrots

Like so much of the produce we now eat, baby carrots are designer products, literally shaped by growers to make them more marketable. Not only did growers change the shape and texture of the carrot varieties used for baby carrots—they are longer and narrower so they can be cut into four rather than three segments and peeled more easily, resulting in less waste. Growers also selected for taste and texture. Baby carrots are sweeter than other varieties, part of their appeal for children. Some food activists prefer the taste of other carrot varieties such as the purple carrot or less sweet varieties.

Big Carrot Industry dominates baby carrot market

Baby carrots are not a Mom-and-Pop product from the local family farm. According to the USDA, carrot production is highly mechanized and highly concentrated. Carrots used for processing and fresh carrots use mechanical harvesting techniques and two major California firms account for the majority of all carrot products sold. Grimmway, the largest company, planted about 35,000 acres of carrots a few years ago and grows carrots around the year in Southern California. Grimmway markets more than 40 brands of carrots, segmenting its market into multiple slices. Bolthouse Farms, the other big carrot producer, also sells health drinks. Together these two companies produce 90% of the carrots sold in California.

Lessons for health

So what can we learn from the story of baby carrots? First, baby carrots suggest that there are products than can improve health and make money for the food industry. Selling more baby carrots is good for public health and for the bottom line of some companies. Identifying other similar products and developing strategies to promote their use is an important priority for the nutrition and public health communities. Baby carrots also show that consumers will choose healthy, convenient products when they are readily available and that consumption of healthy products can increase rapidly in certain circumstances.

However, baby carrots also illustrate the some of the dilemmas our current food system faces. Promoting baby carrots, arguably good for health, now supports big growers, encourages energy-consuming food transportation patterns, and discourages locally grown produce. Several characteristics of baby carrots make them an ideal mass market product—dependent on mechanized agriculture, convenient packaging, efficiencies of scale for processing, and highly concentrated production that allows a few growers to make money promoting and expanding baby carrot production. These characteristics give baby carrots the potential to get into enough stores, kitchens and mouths to actually change national patterns of vegetable consumption—an important health priority. Yet these same characteristics may undermine other important goals such as sustainability, wider taste variability, a less concentrated food system and more locally grown food.

In addition, although baby carrots are more profitable than uncut carrots, they still constitute a tiny portion of the food market. No one advertises baby carrots, no websites or Internet games encourage children to use them (please contradict me, readers, if you can), and the profit margins on baby carrots or similar products are unlikely to change the dynamics of California agribusiness. Only a publicly subsidized promotion campaign could change this. The experience of the federal Five a Day Fruit and Vegetable Campaign provides a sobering example of the challenges. Its total budget was one third what Lays and Doritos alone spent marketing their chips.

Finally, baby carrots present both a risk and an opportunity for reducing disparities in access to healthy food and improved health for the socioeconomic and racial/ethnic groups disproportionately burdened by our current food system and economy. On the one hand, like so many other upscale products that promote health, baby carrots could become yet another yuppie food—more available to better off communities and more educated individuals and thus exacerbating the already large differences in fruit and vegetable consumption among the poor and the better off. On the other hand, baby carrots are a product that could be part of every school lunch program, served in child care programs, senior citizens centers, jails and homeless shelters, providing healthier, fresher and tastier options to disadvantaged populations. Already many food programs have introduced baby carrots.

For such an approach to yield public health benefits, however, might require subsidies to keep the market growing and prices affordable. Activists working on the Farm Bill have proposed decreasing public subsidies for unhealthy crops like corn, soy and tobacco and increasing them for healthier foods. Baby carrots might make a good test case for the potential of this strategy to yield sustainable changes in the American diet.

In sum, baby carrots help us to understand the potential and limits of the market forces that currently shape our food system. As food and nutrition advocates chart a healthier future food system, it will help to analyze other products and to consider the micro and macro educational, political and economic strategies that can better align market forces with public health. More broadly, concrete empirical analyses of other products that influence health will help public health professionals and advocates to develop new approaches to health promotion and disease prevention. To advance this consideration,Corporation and Health Watch invites its readers to submit ideas or reports on other products in other sectors.

Nicholas Freudenberg is Distinguished Professor of Public Health at Hunter College and Founder and Director ofCorporations and Health Watch.

Sources

Bonne J. Convenient carrot charms consumers. MSNBC.com July 23,2003. Available at:http://www.msnbc.msn.com/id/3072775/

Brunke H. Commodity Profile: Carrots. Agricultural Marketing Resource Center. Updated and Revised January 2006. Available at: http://aic.ucdavis.edu/profiles/Carrots-2006.pdf

Kuchler F, Stewart H. Price Trends Are Similar for Fruits, Vegetables, and Snack Foods / ERR-55Economic Research Service/USDA, 2008. Available at: http://www.ers.usda.gov/Publications/ERR55/ERR55c.pdf

Nunez J. Off-Colored Vegetables Are Good For You – No Joke. Bakersfield.com, October 10, 2007. Available at:http://people.bakersfield.com/home/ViewPost/33464

Photo Credits:
1. unsureshot
2. amanky

The Depression Epidemic: The “Medication-alization” of Sadness

Is there really an epidemic of depression or is it, as some have suggested, forces of medicalization at work? This article looks at pharma’s direct-to-consumer advertising practices of marketing antidepressants and the health insurance industry’s influence on the perception of depression prevalence.

Surviving America’s Depression Epidemic, “Depression: Epidemic for a Postmodern Age,” “Depression: The Hidden Epidemic.” These kinds of titles lamenting or questioning the popular lay and professional conception of depression as increasingly widespread have become more and more common in recent years. It is true that depression is understood by many as a major public health problem of epidemic proportions. The United States Surgeon General’s 1999 report, “Mental Health: A Report of the Surgeon General,” stresses the widespread nature of mental illness, with one in five Americans affected by mental illness each year. The World Health Organization describes depression as an epidemic that will, within the next 20 years, be second only to cardiovascular disease in terms of disease burden worldwide.1

But what is an epidemic? And for that matter, what exactly do we mean when we say “depression?” The U.S. Centers for Disease Control defines an epidemic as: “the occurrence of disease within a specific geographical area or population that is in excess of what is normally expected.” The term depression is used regularly in our everyday lexicon to refer to a variety of concepts relating to weather patterns to the state of our economy. We also use the word depression to describe a fleeting mood state—the disappointment after failing a test or a feeling resulting from a particularly sad or “depressing” movie. However, increasingly over the last few decades, the general public uses depression as physicians and mental health researchers do—to refer to a mental illness called “major depressive disorder (MDD),” which, as described above, seems to be affecting more and more of us each year.

If depression is an epidemic then, according to the CDC definition, depression is a disease. It also means that depression is occurring “in excess of what is normally expected.” But what is a “normal” amount of depression? Is the number of people found to be depressed in U.S. higher than what should be expected? Are those diagnosed in epidemiologic studies as depressed experiencing disease or just plain old sadness resulting from the normal ups and downs of life?

There is no doubt that depression is a serious, debilitating condition for sufferers, who can be helped immensely by professional interventions, including medication. But it remains the case that there is no definitive test—no blood test or x-ray—to confirm or deny someone has MDD. This uncertainty about cause and the widespread nature of depression “symptoms” makes depression diagnosis malleable and suggestible—offering opportunity to the pharmaceutical industry to expand sales by expanding what is considered treatable “illness.”

Medications work on our biology and therefore pharmaceutical companies depend on biological definition of depression to sell their products. Because of the difficulty in identifying clear cut biological mechanisms for the diagnosis of various mental disorders, the degree to which the mental is medical remains contested.

Medicationalization—DTCA

The medicalization of “sadness,” as it is called by critics of the depression as epidemic perspective, points to direct to consumer (DTC) advertising of antidepressants by pharmaceutical companies as a major vehicle in the expansion of depression diagnoses.2,3 “Medication-alization” seems more like it. In 1997, The Food and Drug Administration approved the use of DTC drug advertisements in broadcast media (TV and radio); before that, advertising was relegated to publications targeted at physicians.4 By 2000, the pharmaceutical industry was spending more than $2 billion on DTC advertisements.

DTC ads for antidepressants typically feature the DSM defined symptoms of major depressive disorder in conjunction with explicit reference to biological etiology, defining depression as a “chemical imbalance” or lack of normal levels of the neurotransmitter serotonin in the brain. While this was once a promising theory, science has not borne out the truth of the “chemical imbalance” theory.5 Today’s science increasingly depicts depression as resulting from a highly complex interaction of human biology, genetics, psychology, and social and physical environments. But even though psychiatry shies away from direct claims about cause, the pharmaceutical industry is sticking with what works—and the result is continued sales. SSRIs have come to be some of the best selling drugs of all time, and the success of these drugs has lead to a proliferation of new antidepressants on the market for depression and a variety of other mental health problems.

Managed care and mental health treatment

Around the time that SSRI antidepressants came on the market in the late 1980’s to early 1990’s, managed care was expanding. Managed care prefers the quickest, least expensive treatment alternatives. In the case of depression treatment that means medication over psychotherapy. The result—patients seeking care for depressive symptoms were more than four times more likely to receive medication for depression in 1997 than in 1987.6

What doctors can diagnose and prescribe as treatment is subject to the approval of a patient’s health insurance companies and what it defines as acceptable diagnosis and treatment. To the degree that patients are unable or unwilling to pay for service out of pocket, they must seek the services covered by their health insurance carrier, all of whom employ at least some managed care practices these days. With recent mental health parity legislation, insurance companies being forced to provide increased psychotherapy benefits, but most still have strict limits on coverage, ironically requiring a mental health problem to be deemed “biologically-based” by the provider to get reimbursed for psychotherapy treatment services.

Protecting the healthy

The number of people experiencing the “symptoms” of Major Depressive Disorder may be plenty. No doubt, the symptoms of depression are common and widespread human experiences. We may have a lot of depression going on, but that there’s “disease” in excess of what’s normally expected in this case is less certain.

Contrary to popular sentiment, while lots of people may be experiencing symptoms of depression, it’s not clear that this is occurring at higher rates than in the past, nor is it the case that everybody who goes to their doctor is clamoring for medication. But with Pharma, physicians and health insurance industries telling us that yes, our experience is very common, but no, it is not normal, and that medication is our best option for feeling better, it’s no wonder that we’ve got a society ripe for viewing depression as an epidemic.

No question society needs to make the protection of the rights and interests of persons with mental illness a priority since they have in the past often been ignored and trampled on. But convincing people who are sad or live in difficult circumstances that the only way they can get better is to take a powerful drug carries its own dangers. Only by critically analyzing the social forces that have created the “epidemic” of depression can we chart effective policies to recues its burdens.

 

References

1 Summerfield D. Depression: epidemic or pseudo-epidemic? Journal of the Royal Society of Medicine. 2005: 99: 161-1.

2 Horwitz A, Wakefield J. The loss of sadness: How psychiatry transformed normal sorrow into depressive disorder. Oxford: Oxford University Press; 2007.

3 Conrad P. The shifting engines of medicalization. Journal of Health and Social Behavior. 2005: 46(1): 3-14.

4 Conrad P, Leiter V. From Lydia Pinkham to Queen Levitra: DTCA and medicalization. Sociology of Health and Illness. 2008: 30: 825-838.

5 Lacasse JR, Leo J. Serotonin and depression: A disconnect between the advertisements and the scientific literature. PLoS Medicine. 2005: 2(12): 1211-1216.

6 Olfson M, Marcus SC, Druss B, Elinson L, Tanielian T, Pincus HA. National trends in the outpatient treatment of depression. JAMA. 2002;287:203-209.

 

Photo Credits:
1. angelinawb 

Sara Kuppin, DrPH, is a postodoctoral fellow in Urban Public Health at Hunter College.

Off-label marketing: Good for business, bad for health

Off-label marketing has been illegal since 1938 but continues despite major lawsuits because expanding market share leads to hefty industry profits. And now, a last minute Bush administration policy push inside the FDA may be giving this practice of off-label marketing the official thumbs up.

Pharmaceutical companies are spending big bucks to settle suits for illegally promoting drugs for off-label uses and harming customers in the process. The practice, called off-label marketing, has been illegal since 1938 but continues because expanding market share leads to hefty industry profits. And now, a last minute Bush administration policy push inside the FDA may be giving this practice of off-label marketing the official thumbs up.

Most recently, Eli Lilly, the maker of Zyprexa, pled guilty to off-label marketing in a federal suit settled in January and has been ordered to pay a $1.4 billion settlement—the largest in Department of Justice history.1 The FDA approved the use of Zyprexa (olanzapine), for treatment for schizophrenia and bipolar illnesses in 1996 but the drug has been used off-label for generalized anxiety disorder, panic disorder, post-traumatic stress disorder, conduct disorders in children and dementia among elderly patients.

After the ruling, Laurie Magid, the Department of Justice acting attorney in the case, severely criticized the industry for endangering consumer health and ignoring federal law by marketing drugs for off-label uses. In a Philadelphia Inquirer op-ed Magid said, “These cases should send a clear message to the entire pharmaceutical industry: This conduct must stop.”2

Industry profits eclipse potential fines?

In the past five years, almost all major pharmaceutical companies have been involved in lawsuits for off-label marketing offenses, resulting in over $6 billion in settlements.3 Industry documents disclosed in these cases show companies knowingly promoted off-label uses for drugs that had unknown or undisclosed health effects for the express purpose of increasing market share and boosting sales.

Neurontin (gabapentin), an adjunctive antiepileptic made by Warner-Lambert (now part of Pfizer), was marketed off-label for epilepsy monotherapy (for use by itself), as a treatment for migraines, bipolar disorder, restless leg syndrome and attention-deficit/hyperactivity disorder (ADHD). That case settled for $430 million.4 Actiq (fentanyl), a painkiller 80 times more potent than morphine made by Cephalon, was approved by the FDA to treat cancer-related pain but was marketed off-label as a general pain reliever.5 Zyprexa, an antipsychotic approved to treat schizophrenia and some events related to bipolar I mania, was illegally marked. In each example, companies marketed their products for more common conditions than those approved by the FDA. And in each case, patients taking these medications for off-label uses experienced significantly more adverse health events, including death, than those taking the drugs for approved uses. All three companies have pleaded guilty to their charges, and the settlement monies are headed to consumer and state restitution funds and whistleblower compensation.

Unfortunately, however, settlement fines seem scarcely enough to successfully curb the practice of off-label marketing when compared to industry profitability. In 2007, the pharmaceutical industry was the nation’s third most profitable industry out of all Fortune 500 firms, with drug sales over $286.5 billion.6 When Lilly’s Zyprexa was leading company sales, the drug brought in over $1 billion per quarter,7 vastly exceeding the recent settlement fine ($1.4B). Today, the company’s total annual revenue is more than $20 billion.

Why off-label marketing is off limits

Much like direct-to-consumer (DTC) advertising, off-label marketing influences prescribing habits which, in turn, drives drug utilization and sales. DTC ads on TV or in magazines are only allowed to promote on-label uses of drugs and are subject to FDA penalties if guidelines are not met. However, off-label marketing, which targets doctors, is illegal because use of a drug for any indication other than the one on the (FDA approved) label carries unknown risks.

Historically, the FDA has served to protect consumers against those risks. Banning the marketing of drugs for unapproved uses was an issue of consumer protection when first addressed as a federal concern. Since 1938, when the Food Drug and Cosmetics Act established new rules for drug makers, off-label marketing was recognized as a serious threat to consumer health. Sulphanilamide, an elixir marketed for the treatment of infection, was the catalyst for this Act. Having never been tested, and containing what is now recognizable as anti-freeze, the “elixir” killed more than 100 people, most of them children, before being taken off the market. Public outrage led to the establishment of what was to become the defining feature of drug regulation: safety and effectiveness as determined by the independent, peer-reviewed clinical trial.8 Theoretically, FDA approval of a medication is granted for specific use(s) and it is for those uses only that the drug can be marketed.

Side effects

Ten years after being on the market, Zyprexa was given a black box warning that states, “Not approved for the treatment of patients with dementia-related psychosis.” Independent studies revealed these patients have almost two times the risk of death compared to those taking a placebo (non-theraputic control drug).9 But the company had already made a global marketing blitz, advertising the drug as a good treatment for dementia-related symptoms. Their “five at five” campaign championed 5 milligrams at 5 PM to subdue disruptive elderly patients with dementia.

Zyprexa also causes weight gain and diabetes, side effects that are particularly pronounced in children and youth. According to the drug’s label, more than half of people taking Zyprexa as a long-tem treatment gain 12 or more pounds. Additionally, “safety and effectiveness in pediatric patients have not been established.” Despite the warnings, the dramatic increase in the number of antipsychotic prescriptions written between 1996 and 2005 was due, one study found, to a “remarkable increase in the rates of use for off-label conditions and use among youth.”10 The authors singled out “drug company marketing effects” and the “dominance of industry-funded trials” as two potential sources for the profusion of antipsychotic prescriptions.

Beyond drug safety; health spending and ‘manufactured’ evidence

To be clear, off-label prescribing is both legal and common—it is off-label marketing that is illegal. Doctors can prescribe any medication they believe will be helpful as long as that drug is FDA approved. Radley et al. reported in the Archives of Internal Medicine that according to a large nationwide sample of prescriber reports collected in 2001, 21% of all prescriptions were for off-label uses.11

Many argue off-label drug prescription is necessary in situations where clinical trials have not included vulnerable populations, for example children and elderly adults, due to ethical guidelines. So off-label prescribing is not necessarily a bad idea, but it does carry extra known and unknown health risks and costs to health care.

There are other concerns about off-label marketing. First, blockbuster drug sales driven by marketing campaigns contribute to skyrocketing health care spending. Prescription drug costs account for $1 out of every $10 spent on health care in the U.S. and that number is expected to increase rapidly over the next 10 years, in part due to rising drug utilization rates.6 In 2007, 3.8 billion prescriptions were filled, up 72% since 1997.6 The U.S. spends $792 per capita on pharmaceuticals, more than all other OECD countries, and nearly twice the OECD median.12 One might expect this kind of spending to translate in to real health benefits, but U.S. health status, as measured by WHO indicators, only slipped further behind developed nations since 1997 with the highest mortality from causes considered amenable to health care.12

Second, conflicts of interest between drug researchers, the pharmaceutical industry and the FDA, leave consumers vulnerable to untested, scientifically unsound medical practices, the health care system to pay for the billions of dollars spent on medications used for off label purposes, and treatments for their untoward side effects. In an interview with McClatchy Newspapers, Arthur Caplan, Professor of Bioethics, University of Pennsylvania called it a “fox in the hen house situation.”13 The research available to doctors regarding off-label drug treatments is heavily biased by pharmaceutical industry interests—one recent study found 73% of medications prescribed for off-label use had “little or no scientific support.”11 Additionally, FDA drug advisory panels that make recommendations about which drugs should be approved are populated with drug company consultants who have financial ties to the drugs reviewed. In a report published in JAMA in 2006, Public Citizen’s Health Research Group found conflicts of interest occurred in 73% of advisory meetings in 2001-2004.14

As Marcia Angell, former editor of The New England Journal of Medicine and author of The Truth About Drug Companies, recently wrote, “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines.”15

Marketing matters—expanding the target audience

When a drug’s specific indication is narrow and therefore appropriate for a relatively small group of patients, pharmaceutical companies can expand potential user groups and boost sales legally by adding new indicators that have been demonstrated to respond favorably to this medication, using scientifically valid testing procedures. This approach, however, requires FDA approval. As the recent court cases reveal, many drug companies chose to sidestep regulatory authorities and expand their drug’s market share by off-label marketing to doctors.

src=”uploads/images/old_archives/img/Cocktailofdrugs.png” alt=”Cocktailofdrugs” hspace=”10″ vspace=”5″ width=”250″ height=”167″ align=”right” />Blockbuster sales of a product approved for a very limited audience is less likely a measure of drug efficacy than the outcome of powerful marketing campaigns directed at doctors. Whether a medication’s use is expanded legally with FDA approval (as GlaxoSmithKline did with Paxil when its use was extended from treatment of depression to social anxiety disorder), or illegally with off-label marketing (as was the case with Neurontin, Actic, Zyprexa and many others), the result is more people receiving a prescription and consequently sales soar. In the words of Barry Brand, Paxil’s product director at GlaxoSmithKline, “Every marketer’s dream is to find an unidentified or unknown market and develop it.”16

For example, in the case of Zyprexa, indicated uses (for schizophrenia and some bipolar symptoms) occur relatively rarely—between 1-3% of the general population. But when the company began marketing the drug as a treatment for other off-label symptoms, the potential market share was greatly expanded. Documents used as evidence in a Zyprexa court case indicate this was the result of a targeted off-label marketing agenda. In a company meeting, Zyprexa brand manager Mike Bandick said the company “intends, quite simply, to redefine the way [primary care physicians] treat mood, thought, and behavioral disturbances.”17 Eli Lilly’s efforts to convince prescribers that Zyprexa was a good treatment for dementia (and several other disorders) launched the drug into a top selling position—with a total of $39 billion in sales since it hit the market.18

FDA industry ‘Guidance Doc,’ new cause for worry

Before a solution to the above concerns can take shape, there is a new monkey wrench in the off-label drug promotion conflict. In January, during the last days of the Bush administration, policy makers at the FDA issued a ‘Guidance Document’ for the pharmaceutical industry.19 Despite recent court rulings, the document appears to give pharmaceutical companies the thumbs-up to market “unapproved new uses” for FDA approved drugs to doctors. In other words, drug sales reps have the legal ‘ok’ to send prescribers medical articles their company has funded, directly benefiting from the evidence they have produced.

Several health and consumer groups strongly criticized an earlier draft of this FDA guidance. In a 2008 statement,20 the Patient and Consumer Coalition, comprising such organizations as Center for Science in the Public Interest, Consumers Union, National Physician’s Alliance, Our Bodies Ourselves, the Prescription Project and others, asserted that it “strongly opposes this draft guidance, which would allow the promotion of off-label use of prescription drugs and medical devices by giving manufacturers the right to distribute reprints of poorly regulated journal articles with minimal federal oversight.” In the Coalition’s view, “the draft guidance is much too lenient, has no enforcement tools, undermines the Food and Drug Administration’s prohibition on off-label marketing, and lowers incentives for drug and device makers to complete clinical trials or seek FDA approval for new uses.”

Proposed solutions

As the FDA comes under new leadership, several solutions to the problem of off-label marketing warrant consideration.

  1. Enforce existing federal laws and drop the exceptionalism in the new ‘Guidance Document.’ As U.S. Attorney Magid from the Zyprexa case wrote, “Off-label marketing is a sales strategy that ignores the basic purpose of the federal drug-regulatory program, which is to protect the consumer… Off-label-marketing cases are not easy to bring. They can take years and involve the review of millions of documents by an alphabet soup of federal agencies, state regulators, and law-enforcement officers. But we will keep bringing them until this practice stops.”2
  2. Pass new laws that require full disclosure of all drug company payments to physicians. Senators Grassley (R-IA) and Kohl (D-WI) have introduced “The Physician Payments Sunshine Act” that would require pharmaceutical companies to report all marketing and payments to doctors to the Department of Health and Human Services. With increased attention to the need for corporate transparency under the Obama administration and a Democrat led Senate, the bill may have a chance to pass this year.
  3. Provide new incentives and penalties to encourage physicians to report off-label promotional campaigns. Fugh-Berman and Melnick suggest increasing fines, increased marketing regulations and more culpability for physicians. “Perhaps financial incentives could be provided to reward physicians and others who report off-label promotions,” the authors suggest.

 

References

1 Pharmaceutical company Eli Lilly to pay record $1.415 billion for off-label drug marketing. U.S. Department of Justice. Jan 15, 2009. Available at: http://www.usdoj.gov/usao/pae/News/Pr/2009/jan/lillyrelease.pdf

2 Magid L. Keeping us safe from drug reps. The Philadelphia Inquirer. Jan. 27, 2009. Available at:http://www.philly.com/inquirer/opinion/20090127_
Keeping_us_safe_from_drug_reps.html

3 Adams C. Bush admin opened door to controversial off-label marketing of drugs. McClatchy-Tribune News. Feb 1, 2009. Available at: http://bulletin.aarp.org/yourhealth/policy/articles/bush_administration
_opened_door_to_controversial_offlabel_marketing_of_drugs.html

4 Warner-Lambert to pay $430 million to resolve criminal and civil health care liability relating to off-label promotion. U.S. Department of Justice. May 13, 2004. Available at: http://www.usdoj.gov/opa/pr/2004/May/04_civ_322.htm

5 Attorney General Announces $6.15 Million Settlement For Illegal Drug Marketing. Connecticut Attorney General’s Office. September 29, 2008. Available at: http://www.ct.gov/ag/cwp/view.asp?a=2795&q=423868

6 Prescription Drug Trends – Fact Sheet. Kaiser Family Foundation. Sept 2008.

7 Ackerman R. Eli Lilly’s Zyprexa sales are depressing. Forbes. April 21, 2008. Available at:http://www.forbes.com/2008/04/21/elililly-pharma-diabetes-markets-equity-cx_ra_0421markets10.html

8 Goozner M. The $800 Million Pill: The Truth behind the Cost of New Drugs. University of California Press; 2004.

9 Patient information sheet: Olanzapine (marketed at Zyprexa). FDA Center for Drug Evaluation and Research. Sept 2006. Available at: http://www.fda.gov/cder/drug/InfoSheets/patient/olanzapinePIS.htm

10 Domino ME, Swartz MS. Who Are the New Users of Antipsychotic Medications? Psychiatric Services. 2008;59(5):507–14.

11 Radley DC, Finkelstein SN, Stafford RS. Off-label Prescribing Among Office-Based Physicians. Arch Intern Med. 2006;166:1021-1026.

12 Towards a High Performing Health Care System: An International Perspective. The Commonwealth Fund. Presentation by Robin Osborn. October 20, 2008.

13 Adams C. Late move on drugs by Bush FDA could be dangerous. McClatchy-Tribune News. Feb 1, 2009. Available at:http://www.mcclatchydc.com/244/story/61113.html

14 Lurie P, Almeida C, Stine N, Stine A, Wolfe S. Financial Conflict of Interest Disclosure and Voting Patterns at Food and Drug Administration Drug Advisory Committee Meetings. JAMA. 2006;295:1921-1928.

15 Mossakowski KN. Is the duration of poverty and unemployment a risk factor for heavy drinking? Soc Sci Med. 2008;67(6):947-55.

16 Vedantam S. Drug Ads Hyping Anxiety Make Some Uneasy. Washington Post. July 16, 2001; Page A01. Available at:http://vedantam.com/socialanxiety07-2001.html

17 Zyprexa Primary Care Presentation. Eli Lilly National Sales Meeting. Mar 13, 2001. Available at:http://www.furiousseasons.com/zyprexa%20documents/
ZY100041630.pdf

18 Levine B. The Case for Giving Eli Lilly the Corporate Death Penalty. AlterNet. March 3, 2009. Available at:http://www.alternet.org/workplace/129709/eli_lilly_and_the
_case_for_a_corporate_death_penalty/

19 Good reprint practices for the distribution of medical journal articles or medical scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices. Department of Health and Human Services. Food and Drug Administration. Office of the Commissioner. Jan 2009. Available at:http://www.fda.gov/oc/op/goodreprint.html

20 Comments of the Patient and Consumer Coalition to the U.S. Food and Drug Administration “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices DRAFT GUIDANCE Docket No. FDA-2008-D-0053.” April 18, 2008. Available at: www.cspinet.org/new/pdf/20080421_group_comments_on_fda_off-label_draft_guidelines.doc

21 Fugh-Berman A, Melnick D. Off-label promotion, on-target sales. PLoS Med. 2008;5(10):e210.

 

Photo Credits:
1. hughelectronic 
2. dust
3. hippie

Tracking the Effects of Corporate Practices on Health