Chips and Chocolate: Competing Interests on Cornell’s Campus

Students and staff in the Division of Nutritional Sciences at Cornell University worked with Cornell Dining and the vending company to improve the nutritional quality of foods in the Division’s vending machine. The paper below outlines the background leading up to these changes, the process undergone to implement these changes, selected results and findings, as well as lessons and challenges learned along the way. The project is still ongoing and Cornell University is now looking to roll out healthier vending items throughout the rest of Cornell’s campus.

Background

The vending machine in Savage Hall, Cornell University’s home to the Division of Nutritional Sciences, has traditionally stocked common vending foods – highly processed candy bars, chips, chocolate, gum and other products of poor nutritional quality.

Next to the snack food vending machine is a beverage machine selling the typical array of soda and juice. It is from these two – the food machine and the beverage machine – that one can buy a quick snack. Students, staff and faculty can bring food and leave it in the refrigerator in the adjacent room but if one wants to purchase something on the spot, they are left with a set of unhealthy food choices. This easily accessible, cheap, unhealthy food created an unhealthy food environment in the Division of Nutritional Sciences.

Actions and Outcomes Prior to Changes in the Vending Machine

Graduate students in the Division of Nutritional Sciences decided to take on improving the healthfulness of this food vending machine. It was, more than anything, embarrassing to host visitors, only for them to see this machine as the center piece of our dining area. We began this endeavor, working with Cornell Dining and the vending company, to improve the offerings in this machine.

A vending team consisting of two graduate students and a Senior Extension Associate was formed to spearhead this effort. Once the team was formed, a few crucial events and information gathering sessions occurred. Selected events and outcomes below.

– The vending team conducted research to learn about the vending contract between the Division, Cornell Dining and the vending company. The Division of Nutritional Sciences has a contract with Cornell Dining and Cornell Dining has a contract with a specific vending company.
– The vending team approached Cornell Dining to see whether or not it would be possible to include healthier offerings in the vending machine. Cornell Dining and the vending company agreed that Savage Hall could serve as a pilot program for healthier offerings in vending machines throughout campus.
– Cornell Dining asked the vending team for a set of food standards that could guide the healthier options. The vending team used standards already in place in multiple school districts (and similar to those in the not yet published by the Institute of Medicine’s Nutrition Standards for Food in Schools Report).
– The vending team met to assess products brought forth by the vending company, as possibilities for the updated machine. Cornell Dining and the vending company decided that the entire machine would be healthier options, removing all traditional vending options (with the exception of gum and mints). In addition to healthier options, nutrition facts for each product were posted on the outside of the vending machine.
– The vending team emailed the Division of Nutritional Sciences (faculty, staff and graduate students) soliciting feedback about preferred foods and to increase awareness of project.
– The vending team met with Cornell Dining and the vending company to go over email responses, list of foods presented to the vending team and to determine a timeline for the implementation of healthier foods.
– The vending team provided Cornell Dining and the vending company with a prioritized list of foods (from the initial list they provided to the vending team). Cornell Dining asked the vending team to provide a “wish list” of healthy foods and their respective brands.
– Phase 1 of the project, the healthier food line-up, began at the beginning of the fall semester and lasted until mid-October.

Results: The Product Line-Up for Phase 1 and 2

Phase 1 (August 2007-January 2008)

Foods included: Sun Chips, Smart Food popcorn, baked chips, crackers, pretzels, rice snacks, Oreo Thin Crisps, trail mix, Nutter Butter Bites, peanuts, tuna, fruity snacks, Snackwell’s sandwich cookies, Fig Newtons, granola bars, Nutrigrain bars, sunflower seeds, oatmeal, sugar-free wafers, graham crackers and animal crackers.

These food options remained in place until mid-January, at which time Cornell Dining and the vending company reevaluated the offerings.

Phase 2 (January 2008-March 2008)

Selected products were changed based on availability. The vending company adds “Balanced Choice” labeling.

“Balanced Choice” label affixed to specific foods based on vending company’s supplier. A “green leaf” sticker on a slot in the vending machine indicates a “Balanced Choice” and meets the following nutritional criteria:

  • 7 net grams of fat, or less
  • 260 calories, or less
  • 250 mg of sodium, or less

Phase 2 sales results: For the periods 1/22/07 – 2/15/07 vs. 1/21/08 – 2/15/08, sales transactions were down by 17%, and dollar value of sales were down by 9%. According to Cornell Dining, the machine could not sustain itself with phase 2 sales and product line-up.

Phase 2 sales were compared to vending sales throughout the rest of Cornell and it was determined that the drop in sales might not be due solely to healthier options. Sales also declined for traditional vending machines.

Results: The Survey

The vending team conducted a survey during Phase 2. Thirty individuals completed the survey; 100% of respondents were from within the Division of Nutritional Sciences, 58.6% were graduate students, 6.9% were faculty and 37.9% were staff. The information below represents selected survey responses.

69% of respondents noticed changes in the vending machine. In response to an open- ended question, some changes noticed included:

– Healthier and more hunger-satisfying options – I can now count on finding something I want to eat, at least when it is stocked (which it often isn’t).
– Changes disguised as healthier options but still same old companies with same old corn syrup and allergens.
– Healthier better foods!!
– The tuna fish caught my eye–love it.
– The selection has narrowed somewhat — mostly chips and crisps, mostly high sugar low fat. The high-end entrees are nice though (oatmeal, tuna).
– Nutritional info on the vending machine, 100-cal packs.

29/30 respondents noted additional food or beverage items he/she you would like to see offered in the vending machine. In response to an open-ended question, some desired foods included:

– A trail mix with something sinful in it, ideally bits of chocolate. whole grain crackers (maybe there are some and I just haven’t caught them stocked?). chocolate covered coffee beans (beans are vegetables, right?). reduced fat/salt chex mix. snyder’s honey wheat prezels.
– Organic chocolate.
– More types of nuts and dried fruit varieties.
– CHOCOLATE! Not a lot, nothing crazy — peanut m&m’s or hershey bars…plain good old chocolate.
– Fruit leather.
– Stacys brand pita chips. annies brand cheddar bunnies. fruit leather. small packs of chocolate covered raisins or some other kind of lower fat candy options. any kind of kashi tlc cereal bar or snack chip.
– More chocolate the choices are very bad. Here’s what I think I’m an adult and don’t need someone tell me what I should and shouldn’t eat, I can make the decision myself. I like having healthy choices but bring back the candy. If I’m going to eat bad make it dark chocolate not poptarts.

There were many suggestions for fresh fruit, yogurt, bagels, and other refrigerated items we were unable to stock. There were also suggestions for beverage changes. Our intervention did not alter the beverage selection in any way.

Respondents where then asked the importance of 1) brand, 2) personal preference, 3) health, and 4) price in making purchasing decisions on a scale of 1 to 5, with 1 being least important and 5 being most important.

34.5% of respondents ranked brand as the least important in making a purchasing decision. Personal preference was ranked highest by 51.7% of respondents. Somewhere in between these two variables were health and price.

Respondents answered an open-ended question that asked about their top three most frequently purchased items. Selected answers are listed below.

 

Most Frequently Purchased Items Why Purchased Most Frequently
Nut/fruit mix, crackers, granola bars. Satisfy hunger and, in the case of granola bars, also a sweet tooth. not too awful health wise.
Water, baked chips, nuts. Those are the only things I would eat from the vending machine. I don’t like chocolate bars or regular chips.
M&Ms. Need chocolate at work.
Nutrigrain bars, low fat microwave popcorn (when it was available). I don’t really eat potato chips or packages of cookies, so low fat versions of those items aren’t appealing to me. If fruit/veggies/yogurt, etc were available, I’d be buying that instead.
I would buy candy if it was there. Chips. No other choices. Extra comment. I am an adult I don’t need Cornell Dining telling me I can’t have something by not providing it. Currenty I have to walk to another building to get what I want. Takes away from my job and is inconvenient. Please make the vending machines for EVERYONE not just what you THINK I should eat. I can do that myself. Also parents send their kids to us because they are smart and ready to make their own choices. I don’t think we should police what they eat, after all we aren’t their parents.

Choices yes but no choices no.

Dairy sandwich (or closest alternative). Because I need energy (and food) to be able to study at school, with least time spent in going to and coming back from home.
Pretzels (any kind); granola bar (crunchy); popcorn. Low in fat, sustaining, nice snacks.
Nuts, popcorn, trail mix. They are the least processed and the ones that will not compromise me in terms of allergies.
Trail mix. Only recognizable ‘whole’ food available.
Natural nut mix, baked Lays. They make me feel better rather than worse after I eat them. They do not have trans fats or too much sugar.
Fruit chips fruit and nut trail mix. They are cheap and healthy.
Water, diet soda. No cal.
Strawberry yogurt bars. I love the taste. Cheap.
Mixed nuts, popcorn, pretzels. I like them.
Popcorn (much prefer the low fat version when it is in the machine), Coke, Baked Lays Potato Chips. Popcorn can be shared. Coke tastes yummy.
Peanuts, wheat thins, tuna and crackers. They taste good and are reasonably healthy.
Tuna, chips (baked lays), granola bars (crunchy quaker– not gooey kind). Dessert for lunch late afternoon snack; chocolate needs no explanation.
Popcorn; pretzels; granola bars. Volume of food; fat content; satiety.

Results: Product Line-Up for Phase 3

Phase 3, March-May 2008

The vending company reinstated some of the traditional snack items, and included more chocolate and fruit (dried or as chips). More chocolate and fruit were a reflection of the survey results.

More specifically, Phase 3 eliminated the 10 or so worst-selling items from the Phase 2 healthier food line-up. 10 or so high-selling traditional snack items were reintroduced into the machine. 2/3 of the items, then, were healthier items and approximately 1/3 were traditional snack products.

Phase 4, May 2008-Present

Cornell Dining and the vending company are meeting to review the current food line-up in Savage Hall and to implement selected high-selling healthier options in other vending machines around Cornell’s campus.

Challenges, Concerns and Lessons Learned

Defining “Healthy”

Establishing a definition for “healthy” is complex and can take many forms, making it difficult to determine a set of food standards. The vending team confronted tradeoffs and unknowns beyond nutritional quality such as feasibility, taste, and likability. Some of the questions asked included:

– What may be realistic guidelines?
– What guidelines would align with consumer preferences?
– Is it necessary to cater to consumer preferences, or should improved health and well-being be maintained as the ultimate goal?

The vending company decided that the new machine was to include only healthier foods that met a minimum standard. Previous experience with pilot projects have showed that altering only selected foods is not an accurate indication of the potential for healthier food sales. If the entire machine is overhauled, consumers may be more apt to buy these healthier items.

Contractual Obligations

Contractual obligations between the Division of Nutritional Sciences, Cornell Dining and the vending company constrained the vending team’s ability to source from other healthy vending (see www.yonaturals.com, for example) companies.

Consumer Demand

Because the vending machine is located in a nutrition building it may not be indicative of potential healthier food sales throughout the rest of campus.

Baseline demographic data of those that bought and did not buy food from the vending machine was unknown. This made it difficult to know whether or not the same individuals used the vending machine before and after the implementation of healthier options.

The vending team also confronted internal challenges. After sending an initial email to the entire Division of Nutritional Sciences soliciting feedback about preferred healthy options, staff, faculty and graduate students responded.

Below are selected responses, highlighting the spectrum of consumer demands:

- Thanks for doing this. How about (1) bagels, (2) milk (including skim), (3) yogurt, and (4) fruit (if the quality is good).
– What a wonderful initiative. However, some of us still want need our occasional Snickers/Twix, etc.! Don’t obliterate junk food completely – please.
– Best wishes with the negotiation with vendors.

These responses, ranging from a desire to keep the status quo to encouragement and demand for healthier options, raise a number of questions.

– Should nutritionists, or those working in a nutrition department, eat (or be expected to eat) differently than people in other departments?
– Should selected nutritionists impose these changes on other nutrition and non-nutrition staff working in the building?
– Is it our job to be a role model for other departments? Given the great amount of support for these healthier changes, we may wonder whether there is a stigma attached to eating junk food in the nutrition department.
– Perhaps individuals want the current food offerings but fear being shunned by fellow nutritionists?
– Do nutritionists eat differently elsewhere, in the privacy of their office or home?

Transparency and Availability

The entire list of in-stock and special order foods was never made available to the vending team. Instead, Cornell Dining and the vending company reviewed the vending team’s food standard and product suggestions and approached the vending team with a range of choices, pre-selected from an unidentified master list. The process of selecting foods from this master list of in-stock foods remains unknown.

Although it was clear that Cornell Dining and the vending company were invested in this project, the updated vending machine was severely constrained by the healthier options available. From the food lists the vending team was privy to it was clear that the healthier foods were healthier than traditional vending foods but would still be considered junk food by many health professionals.

This raised additional questions:

– Were there items that were healthier that they had in stock but hadn’t been reviewed by the vending company?
– Does the vending company have a contract with certain brands that limits our ability to get a greater array of healthier foods in the machine?
– If we did have to special order foods, how would it impact the price of products in the vending machine

In order to have even healthier foods, such as whole fruit or milk, the vending company would have to special order them, the machine would require refrigeration and/or the Division would have to work with a different company.

Truck drivers stocking the machine may also influence the availability of healthier options in the machine. Because the vending machine in Savage Hall is different from the rest of Cornell’s campus, the truckers have an added step to ensure what they stock in Savage Hall is indeed what the vending company, Cornell Dining and the vending team has agreed on. This required the truck drivers to set apart Savage Hall foods from the rest of the vending foods. The vending company told us that the drivers may try to “cheat” – that if there was a food that didn’t belong in the machine to notify Cornell Dining. It is easier for the truckers to stock the machine with the same traditional snack foods they use to stock the other machines on campus.

As noted previously, Phase 3 plans do allow these drivers increased flexibility.

A Financial Bottom Line

The vending company is open to stocking healthier items but this is largely because sales may decrease with increased consumer demand for healthier options. Additionally, school wellness policies require healthier options in grade school, forcing companies to make significant changes to their product line-up. The distinct school wellness policies between districts results in a series of fragmented policies and a food industry that can no longer use one standard to determine the specific products available in vending machines. They don’t know what sells, they don’t know which foods may be considered healthier, and importantly, they don’t know how to market themselves. The healthier vending machine in Savage Hall provided an opportunity for this vending company to pilot healthier foods and to ultimately improve their current and future bottom line. The implementation of these school wellness policies, although unfunded, has had a positive impact on vending company buy-in.

Final Thoughts

We all know we are supposed to eat healthfully and exercise regularly. But translating theory into practice involves a deeper and more nuanced understanding of the values at play, the politics of the situation, consumer demand and perhaps most of all, the distinct group of stakeholders involved in the decision-making process.

Mainstream thinking is that nutritionists tend to frame policy decisions around science. We view experts as credible, our science as facts and improving public health as the ultimate goal. If we base our decisions around what science tells us are good and bad foods, we’d likely remove the vending machine altogether. There’s nothing in the machine that even resembles a “health food.” Science tells us, generally, that minimally processed foods are better than processed foods, and that low-salt, low-sugar foods are better than high-salt, high-sugar foods. But beyond this general notion of what’s good and what’s bad, there is much ambiguity and controversy over labeling specific foods as healthy or unhealthy. If we want a healthy machine, should it be filled only with milk? Should it be stocked only with fruit? Or is a mixed fruit and nut granola bar healthy?

One might also expect nutritionists to rebel against traditional snack foods but for years this vending machine has been profitable for the vending company. Although it’s the norm for vending machines to contain high fat, high sodium and highly processed products, we debate whether or not this is acceptable for nutritionists. One questions whether or not, as nutritionists, we should behave differently, desire different foods, and serve as role models for the standards we teach.

We again ask ourselves what it means to be part of the Division of Nutritional Sciences. Do we have a responsibility to be healthy? How do we, and should we, be responsible for changing the set of choices available to individuals? If we create a healthier vending machine, will the consumer base change? Will those who want junk food walk over the next building to buy the traditional unhealthy food offerings? There are no simple answers and no one opinion, even within the Division of Nutritional Sciences. Perhaps most of all, we ask ourselves, is “better-for-you” good enough?

At the end of the day it comes down to who determines our set of choices. The vending team is not trying to taking away choice, but is instead implementing a new set of choices. We are trained to believe choice is set by food companies. If the vending team’s bottom line is public health, and the vending company’s bottom line is dollar signs, who should have the final say? Someone has to set the choices – it’s just a matter of who, and how.

This research was conducted as part of Alexandra Lewin’s doctoral research. The author would like to thank Jennifer Wilkins (Senior Extension Associate, Cornell University), Marion Nestle (Professor, New York University) and Sue Wernimont (graduate student in the Division of Nutritional Sciences) for their contributions and help with this project.

*This research was exempt from human subjects.

 

Photo Credits:
1. trp0
2. programwitch

The Snack Food Association: Washington’s Voice for Sugar, Fat and Salt

A recent study at Brown University Medical School published in the journal Appetite found that reducing the number of snack foods available to consumers could lead to reductions in consumption and therefore lower rates of obesity. However, the trend is in the opposite direction: each year hundreds of new snack foods are introduced to the market, advertised heavily, and retailed in more places. Snack foods represent an important growth opportunity for the food industry both in the U.S. and globally.

In 2005, sales of snack foods exceeded $61 billion in the U.S.3 Snack foods, which tend to be high in calories, sugar, and sodium, have become daily staples for millions of Americans, and, increasingly, for consumers in other parts of the world. Snack foods are among the most heavily advertised products on television, and the U.S. corporations that manufacture them are among the largest and most influential global companies. Retailers like snack foods because they are convenient to sell and have a high profit margin. Remarkably, candy and confectionary products are the third largest food category sold in the U.S., behind carbonated beverages and milk.2 The fourth largest category is salty snacks, and cookies rank seventh.2

Why are products consistently implicated in the growing rates of obesity continuing to expand their market share?

One reason is that makers of snack foods have a far more powerful voice in Washington, where the rules governing food and health are set, than do ordinary eaters or those concerned about obesity. According to its website, the Snack Food Association (SFA) is “the international trade association of the snack food industry.” 2 Founded in 1937, the SFA represents more than 800 manufacturers and suppliers of snack foods worldwide. Members include “manufacturers of potato chips, tortilla chips, cereal snacks, pretzels, popcorn, cheese snacks, snack crackers, meat snacks, pork rinds, snack nuts, party mix, corn snacks, pellet snacks, fruit snacks, snack bars, granola, snack cakes, cookies and various other snacks.”

What does the Snack Food Association do?

Its mission is “to provide value for SFA members by offering services and relationship building forums that strengthen the performance of member companies and support industry growth.” Its activities include serving as the voice for the snack food industry before government; researching and compiling annual snack industry sales and consumer data; promoting increased snack consumption by sponsoring National Snack Food Month in February; providing a positive industry voice to the national, local and trade media; educating manufacturers on technological advances in equipment and raw ingredients, and on consumer trends pertaining to the snack industry; sponsoring the largest convention and trade show in the world devoted exclusively to snacks (to sign up for the 72nd Annual Snaxpo in Orlando, Florida in 2009, visit http://www.snaxpo.com/); and providing technical support to its members through direct assistance, videos, seminars and publications.

In 2007, for example, the Snack Food Association held its annual Spring Summit in Washington, D.C.4 Some 40 snack food executives met with members of the House and Senate, heard a presentation from a top Defense Department official, who encouraged snack food companies to contribute products for troops who visit United Service Organization locations at America’s airports, and were treated to a VIP tour of the U.S. Supreme Court by Chief Justice John Roberts, who answered members questions about corporate law. In a luncheon address, Republican Senator Pat Roberts told the snack execs, “I don’t think the founding fathers felt that the federal government should get into what food we eat. Obesity is a big problem, but it is not the proper role of the federal government to tell people what to eat.” Instead, the Senator stated, consumers should use “moderation” in their diets and he called for legislation requiring schools to include physical education programs in their curriculum. The SFA also supports such legislation.

Other legislative priorities of the SFA include:

  • Opposition to limiting choice for Food Stamp Program participants
  • Opposition to redefining Foods of Minimal Nutritional Value
  • Opposition to the Country of Origin Labeling provision for Processed Peanuts
  • Opposition to union card check legislation, the Employee Free (Forced) Choice Act
  • Support for the Fair Labor Standards Act–Motor Carrier Exemption (Overtime Rules for Drivers of Vehicles Under 10,001 lbs.)
  • Support limited liability for food manufacturers (Commonsense Consumption Act)
  • Support for National Uniformity for Food
  • Support for requiring physical education in schools
  • Support for reform of the U.S. Sugar Program

The SFA has also sponsored research on the effects of sodium on blood pressure and health, and presents health information to the government panels that determine the Dietary Guidelines for Americans.2 The SFA is a sponsor of Best Food Nation , a public relations effort launched by the food industry respond to any criticism of the U.S. food system and to represent the industry’s views on the scientific evidence on obesity. Box 1 shows the members of Best Food Nation.

Box 1. Members of Best Food Nation

American Farm Bureau Federation
American Meat Institute
Cattlemen’s Beef Board
Corn Refiners Association
Food Products Association
International Franchise Association
National Cattlemen’s Beef Association
National Chicken Council
National Council of Chain Restaurants
National Milk Producers Federation
National Pork Board
National Pork Producers Council
National Potato Council
National Restaurant Association
National Retail Federation
National Turkey Federation
Produce Marketing Association
Snack Food Association
U.S. Potato Board
United Egg Producers

Recently, the SFA went before Congress to seek financial assistance from the U.S. government to alleviate the increasing commodities prices of corn, wheat, and other products that are affecting snack foods manufacturers. In fact, the growing price of snack food staples represents a significant threat to the industry’s continued profitability.

The SFA actively opposes any restrictions on the right of corporations to advertise unhealthy products. As required by the Lobbying Disclosure Act of 1995, the SFA is registered as a lobby organization with the Clerk of the U.S. House of Representatives and the Secretary of the U.S. Senate. Among other measures, the SFA has joined with the Alliance for American Advertising.6 According to The Wall Street Journal, at the time of its formation, the Alliance for American Advertising was the most ambitious effort yet to oppose government regulation in food advertising aimed at children; funders include industry giants General Mills, Kellogg and Kraft.7 The SFA has also joined with the lobby organization known as the American Council for Fitness and Nutrition in opposing restrictions on vending machines in schools; funders include PepsiCo, Coca Cola, Kraft Foods, and the National Soft Drink Association.7 These relationships illustrate the complex web of trade associations that work to protect industry interests in Washington and elsewhere.

The SFA also seeks to provide the media with positive messages on the snack food industry. For example, in an April 2007 press release, the SFA announced its support of voluntary school nutrition standards, stating, “The Snack Food Association is delighted to be part of a growing coalition of companies and trade associations that are doing their part to help parents, educators, and health professionals teach kids about healthier lifestyles.”9

Motivated by threats of tighter regulation and costly lawsuits, several multi-billion dollar corporations have agreed to voluntary measures to limit junk food advertising to children over the past two years. In August 2007, the Federal Trade Commission issued subpoenas to 44 food and beverage companies, including Coca Cola, McDonald’s, Kraft, General Mills, and Procter & Gamble, to request information on how they market their products to children.5 Products such as Trix cereal, Oreo cookies, and Pringles potato chips, are some of the products that contribute to childhood obesity. In an effort to convince skeptics that the snack and junk food industries can regulate themselves, some major corporations have implemented voluntary measures. Proposed measures include having at least half of junk food advertising directed at children under the age of 12 include the promotion of “healthier food options” or physical activity.10, 11

Critics of the Snack Food Industry

Critics question the value of these voluntary guidelines. According to Michael Jacobson of the Center for Science in the Public Interest, under these guidelines, so-called healthy ads could include advertisements for sugary cereal because they meet the FDA’s definition of “healthy” which does not speak to sugar content.10 He said the healthy lifestyle message could include Ronald McDonald pedaling a bicycle while eating fast food. 10 He stated, “That message still does more harm than good. It’s a joke.” 10

In recent years, many legislators have become concerned with the role of the food industry in contributing to the high rates of obesity in the U.S. In late 2006, Sen. Tom Harkin, an Iowa Democrat, ordered the Federal Trade Commission to look into the issue of junk-food advertisements targeting children. Commenting on the obesity epidemic, he stated, “We must take steps to protect our children’s health. Parents are being undermined by the junk-food culture that is increasingly promoted to our kids on TV.”5

The bottom Line

In sum, the SFA uses a variety of mechanisms to advance industry interests. The SFA claims to be a positive voice for snack food manufacturers, and it says it supports initiatives aimed at curbing the childhood obesity epidemic. But with most nutritionists agreeing that the central nutrition message today should be to eat less highly processed food, the Snack Food Association remains a powerful force for the opposite message, Eat more of the products our members make. Thus, the SFA serves as a powerful accelerator of the trends that that are making so many Americans overweight, sick and dying prematurely.

References

1. Raynor HA, Wing RR. Effect of limiting snack food variety across days on hedonics and consumption. Appetite. 2006;46(2):168-76.
2. Food Association website. Accessed April 22, 2008 at http://www.sfa.org
3. “Snack Food Trends in the U.S.: Sweet, Salty, Healthy and Kids Snacks.” July 1, 2006 Report published by Packaged Facts. 308 pages — Pub ID: LA1119533. Available for purchase at

http://www.marketresearch.com/map/prod/1119533.html

4. Gatty B. “Hitting ‘the hill’: Snack Food Association members lobbied congress about key issues.” June 1, 2007, Snack Food & Wholesale Bakery. Accessed June 1, 2008 at http://www.allbusiness.com/retail-trade/food-beverage-stores-
specialty-food/4510508-1.html
5. Lopes, G. “FTC not sweet on junk-food ads targeting children.” The Washington Times. November 7, 2006.
6. Institute of Medicine, Committee on Food Marketing and the Diets of Children and Youth, J. Michael McGinnis, Jennifer Appleton Gootman, Vivica I. Kraak, Editors. Food Marketing to Children and Youth: Threat or Opportunity.  2006. Washington, D.C.: The National Academies Press.  Available online at http://www.nap.edu/catalog.php?record_id=11514#toc
7. Ellison S. “Divided, companies fight for the right to plug kids’ food.” January 26, 2005. The Wall Street Journal.
8. Source Watch: A project of the Center for Media and Democracy. Article on the American Council for Fitness and Nutrition. Accessed June 1, 2008 at http://www.sourcewatch.org/index.php?title=American_Council_for_
Fitness_and_Nutrition
9. Snack Food Association press release dated April 26, 2007. “Snack Food Association Supports Voluntary School Nutrition Standards.” Accessed April 22, 2008 at: http://www.sfa.org/pressreleaseclinton.aspx
10. Martin, A. “Leading makers agree to put limits on junk food advertising directed at children.” The New York Times. November 15, 2006.
11. Brooks Barnes. “Limiting ads of junk food for children.” The New York Times. July 18, 2007.

Photo Credits:
1. bmcfee

Fixing the FDA: Options for the Next President

The last several years have not been kind to the Food and Drug Administration (FDA). Critics have accused the agency of being inefficient, failing to meet its mandates and of complicity with the pharmaceutical industry. The FDA has come under attack by Congress, health and medical professionals and the pharmaceutical, tobacco and food industries. One director was forced to quit and the current director has repeatedly been summoned by Congressional committees to respond to criticisms.

With the 2008 presidential election quickly approaching, the topic of health care, including the safety of pharmaceuticals, has gained increasing attention. The next United States President will face great pressure to reform the FDA and will need to simultaneously attend to issues of efficiency, drug and food safety, tobacco and funding. How the President and Congress choose to respond to industry calls to make the FDA even more business friendly and advocates calls for restoring the FDA’s public health mandates will shape how a key federal agency will regulate corporate practices that influence health in the next four years.

This Corporations and Health Watch story begins a series examining recent conflicts about the FDA, the positions of the presidential candidates on the agency and options for 2009 and beyond. This report’s focus is on the FDA and the pharmaceutical industry. Future reports will examine the role of the FDA in regulating food and tobacco.

Drug Safety

Vioxx

The FDA’s recent troubles with Vioxx, Avandia and Heparin illustrate the range of problems the agency faces in premarket testing, oversight of foreign industries and on limiting industry influence on its decisions. In Fall of 2004, pharmaceutical giant Merck began the largest and most expensive drug recall in history by pulling its drug Vioxx off the market after studies showed that chronic use was associated with an increased risk of heart attacks and strokes. Approved in 1999 based on data submitted to the FDA but not reviewed through the standard scientific peer review, Vioxx is reported to have caused as many as 139,000 heart attacks.1

Although Merck was initially praised for its voluntary withdrawal of the product, critics later charged that Merck had known about the risks involved with long-term use far earlier than it had gone public with them.1 Merck was eventually shown to have ignored research published three years earlier, which found that long-term Vioxx use increased risk of cardiovascular events, and to have planted studies in medical journals that were attributed to independent researchers.2 Whistleblower and 20 year employee of the FDA David Graham later testified that the agency’s role in the Vioxx scandal was far from innocent, stating: “What happened with Vioxx is really a symptom of something far more dangerous to the safety of the American people. Simply put, the FDA and its Center for Drug Evaluation and Research are broken.”1

Avandia

In June 2007, the New England Journal of Medicine published a meta analysis of 42 clinical trials for Avandia that showed that the drug was associated with increased risk of myocardial ischemic events.3 It wasn’t until five months later that the FDA announced additional warnings on the Avandia product label. In addition, an advisory committee voted to keep the product on the market despite a later study published in the Journal of the American Medical Association which concluded that Avandia was associated with increased risk of acute myocardial infarction, congestive heart failures and mortality in older patients undergoing diabetes treatment.4

Heparin

Earlier this year, the FDA was criticized for failing to protect Americans against a contaminated supply of the blood thinner Heparin. At least 19 people died and hundreds became sick after consuming the contaminated product that had been imported from China. The Heparin case raised questions about the agency’s ability to regulate and inspect a growing flow of imported drugs and drug ingredients.

Compounding the problem of limited resources for plant inspections, FDA policies do not extend to the foreign study sites that produce more than 20% of clinical trial data submitted to the FDA.5 Moreover, at present, 80% of all active drug ingredients are imported.6 Finally, the FDA has reported an 800% increase in the number of cases of counterfeited pharmaceutical ingredients between 2000-2006.7 Exacerbating the already flawed foreign inspection process is the fact that the FDA does not bring its own translators or hire independent ones but rather relies on English-speaking representatives of the plants it visits to translate during the inspection process.

The Government Accountability Office stated that in order for the FDA to complete full inspections of foreign plants, it would require more than $56 million in additional funds with $15 million required to inspect Chinese plants every two years.8 The New York Times reported that at the current inspection pace, the FDA would need “at least 27 years to inspect every foreign medical device plant that exports to the United States, 13 years to check every foreign drug plant and 1,900 years to examine every foreign food plant.”8 Though the Bush Administration stated there were plans to improve the FDA’s ability to conduct foreign inspections, no funds were allocated for this purpose in President Bush’s yearly budget.

In order to apply for approval, drug companies must conduct clinical trials of products under development. However, the FDA does not require that these clinical trials be published and are therefore not subject to peer review. Mandated by the 1997 Food and Drug Administration Modernization Act (FDAMA), in 2000 the FDA created a national clinical trial registry for pharmaceutical corporations to submit clinical trial data. FDAMA required manufacturers to register their clinical trials at clinicaltrials.gov and to give a detailed account of both their experiments and eligibility requirements for research subjects. However, the FDA neither enforced compliance nor encouraged use of the clinical trial registry. While some manufacturers, such as Merck, did register their clinical trials, they only reported results that favored their products as they are not required to submit raw data. This led to suppression of full information about the efficacy and safety of new products under development.1

The FDA seems to be increasingly entangled with industry in ways that affect the process of review and regulation. For example, the Agency has frequently delayed the release of information about potential health effects of approved medical products. In the case of the Ortho Evra birth control patch manufactured by Johnson & Johnson that was linked to increased risk of blood clots and strokes and resulted in 50 deaths, the FDA did not make public these risks until six years after Johnson & Johnson’s own study showed such an association.9 After numerous lawsuits were filed against the manufacturer, Johnson & Johnson utilized the legal argument of pre-emption, claiming it could not be sued because the FDA had approved the patch and warning label. Testifying at a trial over the schizophrenia drug Zyprexa, former FDA scientist Dr. John Gueriguian who worked at the agency for two decades stated that the FDA did not always pursue strong warnings on products considered potentially dangerous, in part, because the pharmaceutical industry objects to warnings: “We at the FDA know what we can obtain and what we cannot obtain – and what we can’t obtain we will not ask.”9 By withholding negative findings, then using the FDA approval based on this limited information to preempt litigation from those harmed, the drug industry has made the FDA its ally in avoiding liability.

Under-funded, Understaffed and Overtaxed

Responsible for the safety of the nation’s food and drug supply, it might strike the American public as odd that the FDA budget is less than that of the school board of Montgomery County—the county in which the FDA is located.10 The FDA, particularly under the Bush Administration, has been chronically underfunded while at the same time it has been saddled with increasing responsibility.

The Prescription Drug User Fee Act (PDUFA) has been the source of both funding and controversy for the FDA. Adopted in 1992, the act requires pharmaceutical and biological products makers to pay fees for product applications and supplements. These fees are used to hire staff to assist in reviewing product applications, thus accelerating the process of drug approval. Though some have argued that user fees provide a vital source of revenue for an already underfunded agency and have suggested their application to overseas producers, a widely cited New England Journal of Medicine study suggested that PDUFA deadlines affect the safety of approved drugs with those approved right before a deadline being less safe than drugs approved at other times.11 By rushing through product applications, the FDA opens itself to the potential for an increase in recalls. PDUFA must be renewed every five years and over time has become more controversial. Public health critics of the PDUFA argue that it makes the FDA increasingly susceptible to industry pressure. Industry officials have critiqued user fees as unfair as the government is responsible for safety reviews.

Given these uncertainties about both the ability of the FDA to regulate the drug industry and the influence of Big Pharma on the agency through the use of such fees, the agency lost funding for a direct-to-consumer advertising fee provided by the FDA Amendments Act (FDAAA). Legislators also axed $1 million in funding for the new Reagan-Udall Foundation, a foundation created by Congress to work independently from the FDA to enhance product safety and innovation.

With a woefully inadequate budget and what many FDA staff characterize as a demoralizing work environment, the agency faces staff shortages that limit its ability to carry out inspection and regulation tasks properly. In 1997, Congress gave the FDA funding to support more than 9,000 scientists; today the number actually employed is less than 1,000.10 Further, the FDA is not able to match salaries in the private sector making it difficult for the agency to attract top candidates. Under the Bush Administration, the FDA has faced reduced funding and has lacked consistent leadership, often operating without a confirmed commissioner. Drug scandals and low morale have also lead to increased resignations, with many former employees citing pressure to express status quo scientific opinions and a belief that their work supported marketability more than health as reasons for leaving.12 A 2006 Union of Concerned Scientists survey of 5,918 FDA scientists found 1 in 5 reported that they experienced pressure from top-level FDA employees to gear their work according to political and corporate interests.13 Understaffing is also linked to slowdowns in drug approval rates with 19 new drugs being approved in 2007 compared to 53 approved in 1996.14

During this same period, Congress and the President gave the FDA more responsibility. For example, in the fall of 2007, Congress gave the agency increased power to regulate drug safety and data disclosure. However, the ability of the FDA to take on additional responsibilities is hindered not just from lack of adequate funding and high rates of turnover but also by an inefficient organizational climate. As a case in point, the FDA currently uses more than 300 non-compatible databases and has not created a centralized system which would allow researchers, medical professionals and the general public to access clinical trial information efficiently.1 The Office of the Inspector General (OIG) in the Department of Health and Human Services (HHS) has stated that the lack of an efficient FDA information system has hampered its ability to properly oversee research. Because of this, the FDA inspects less than 1% of clinical trials and less than 300 Institutional Review Boards (IRB) each year.14

Challenges from Across the Political Spectrum

The FDA has been a frequent target on Capitol Hill, in the press and from public health advocates. Democratic lawmakers have called for increases in user fees in order to improve surveillance and inspections. Earlier this year Representative Bart Stupak (D-MI), the chairman of the House Energy and Oversight and Investigations subcommittee, called for acting FDA commissioner Andrew von Eschenbach and other FDA officials to resign due to their “total lack of leadership.”14 Referring to scandals over Sanofi-Aventis’ antibiotic Ketek which caused liver damage and other serious side effects, Senator Charles Grassley (R-IA) stated, “There were sirens, red flags, and bullhorns, but it looks like the company and the FDA kept ear plugs and blinders on.”7

Public health advocates commonly critique FDA review and regulatory procedures as serving industry at the expense of public health. Consumers Union, Consumer Federation of America, US PIRG and others have repeatedly argued that the FDA has not adequately protected the American public from dangerous medical and food products and has charged the Bush Administration as crippling an already weak system. In a March 2005 joint letter to the committee charged with reviewing Dr. Lester Crawford to be the Commissioner of the FDA, the three agencies noted that the FDA suffers from a lack of adequate authority to regulate the pharmaceutical industry, from conflicts of interest which prohibited the public release of important research findings, and from the data reporting procedures which favor industry at the expense of peer review and open information.15 Similarly, in April 2008, the Prescription Project, Community Catalyst, National Physicians Alliance, Prescription Access Litigation, Community Catalyst and US PIRG gave comments urging the FDA not to adopt the draft guidance that would have allowed pharmaceutical representatives to distribute single studies to medical providers on the benefits of off-label drug use.16 The coalition called for hearings on what circumstances, if any, should allow for such practices but noted that as the draft guidance was currently constituted, it would benefit industry at the expense of good science and public health and safety. Also in April, Consumers Union Policy Counsel Ami Gadhi testified before the US House of Representatives Subcommittee on Health, Energy & Commerce Committee that “the call for a major overhaul of the FDA has now become a roar.”17

In March of 2005 the Center for Medical Consumers, Center for Science and the Public Interest, Command Trust Network, National Research Center for Women & Families, National Women’s Health Network and US PIRG launched a media campaign including a now defunct website www.FixTheFDA.org, television and print ads detailing the flaws in the FDA regulation system. On one campaign flyer, the groups argued, “Unfortunately, the FDA is broken. The public’s health is being compromised to the point of negligence. The current Vioxx controversy is just the latest symptom of a system in crisis. It’s not all the agency’s fault. Congress has reduced the FDA’s authority, slashed enforcement budgets, and weakened its legal powers.” The groups then called for Congress to close loopholes and fix the FDA before further scandals occurred.

Conservatives arguing from a free-market perspective have suggested that the FDA cannot be reformed and should be abolished. Libertarian new source The Freeman, a publication of the Foundation for Economic Education, has argued that the FDA operates as a legally protected monopoly and that increasing the powers of and funding for the FDA will only exacerbate problems with the fledgling agency. In July of 2005 Freeman author Arthur E. Foulkes claimed that overcautious regulatory and review practices at the FDA kept important medications from market and from helping those who might be benefited by them: “How free is a land in which bureaucrats and politicians decide which health-care options are legal and which is not? No one is made better off by having peaceful options in life denied him. The FDA is beyond being reformed. It should be abolished.”18 In a later Freeman piece, author Larry van Heerden echoed the critiques of public health advocacy groups, noting the impact of user fees and corporate influence on the ability of the FDA to operate efficiently and objectively. However, rather than calling for increased reform and stricter standards to reduce corporate influence, van Heerden argued for abolishing the FDA in support of a free-market system and the responsibility of consumers to be self-informed: “In a system without such gate keeping, where drugs were available along with all the information on risks and benefits, the market would sort out the wheat from the chaff, dramatically lowering the financial stake in any single drug and reducing the tendency for drug companies to engage in fraud and deception.”19

Conservative critiques of the FDA are not new. In the early 1990s a coalition of conservative organizations raised concerns over the FDA regulatory process, particularly questioning agency restrictions on off-label use of medication and the slow rate of new drug approval. Industry leaders and conservative commentators continue to point to the slow down in approval rates as signs of ineffectiveness and an overly-cautious regulatory environment caused, in part, by a bevy of recent scandal over approved pharmaceuticals such as Vioxx. Though the FDA argues that new drugs will have to show marked safety or efficacy advantage over existing drugs in order to gain approval, industry officials claim that slowdowns increase development costs and inhibit competition by blocking new drugs from entering the market and taking market share away from established drugs. Despite overall arguments defending current approval procedures for new drugs, even the FDA’s own Science Board acknowledges that slowdowns in approval for new medical technologies and pharmaceuticals has a negative impact and “means that American lives are at risk.” 20

The FDA responds to its critics

The FDA has both defended itself against its critics and acknowledged deep structural issues that prohibit it from functioning properly. Facing increasing criticism, in 2005 the FDA asked the Institute of Medicine (IOM) to assess the safety of the U.S. drug system. The IOM released its report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public” in September 2006 noting that the “perception of crisis” has compromised the credibility of the FDA and of the pharmaceutical industry;” that there is widespread agreement amongst stakeholders to improve the drug safety system; that the current system is currently hindered by “serious resource constraints that weaken the quality and quantity of the science that is brought to bear on drug safety” as well as a less than optimal organizational climate and insufficient and unclear regulatory authority; and a lack of transparency on the part of both the FDA and the drug industry to communicate safety concerns in a timely and appropriate manner.21 In response to the report, the FDA stated it would take steps to improve the integrity of the science behind the entire process of medical product safety; to improve risk communication policies and procedures; and to strengthen management and operations in order to ensure an effective U.S. drug safety system.22

The 2008 Presidential Election and the Chance for Reform

In their review of the history of the FDA, Borchers et al (2007) note that the “evolution of the FDA can be described as a series of ‘crisis-legislation-adaptation’ cycles: a public health crisis promoted the passage of congressional legislation, which was then followed by implementation of the law by the FDA.”23 Though this pattern reflects the history of the FDA at large, the authors note that current crises and challenges facing the FDA are so severe that only “strong and permanent leadership willing to redefine the role and procedures of the FDA” will be successful in getting the agency back on track. With the 2008 presidential campaign approaching and the state of the FDA in near permanent crisis, neither Democratic candidate Barack Obama nor Republican challenger John McCain have staked out strong positions on the FDA.

Senator Obama’s website offers some information about his stance on prescription drugs. His primary focus is on reducing the cost of prescription drugs by increasing the amount of safe pharmaceuticals imported from the developing world and increasing the amount of generic medications available on the market. While Obama notes the importance of breaking up insurance monopolies that drive up premiums, he does not call for similar moves in the pharmaceutical industry. Further, Obama takes no official stance on the FDA at large, plans to increase the safety of imported drugs or prescription drug marketing.

By comparison, in her campaign, former Democratic challenger Hillary Clinton, commented at more length on FDA issues. On the need for FDA reform, Clinton stated on her website: “Recently, concerns have been raised about the ability of the FDA to ensure the safety of drugs marketed to American consumers. I believe there is a clear need for post-marketing monitoring.”24 Like Obama, Clinton proposed to lower prescription drugs through the promotion of generic medicines and the importing of safe drugs from developing countries. To reduce prescription drug prices, Clinton argued for breaking up pharmaceutical monopolies to create generic competition. On the safety of drug imports, Clinton critiqued the Bush Administration for its failure to protect the American people from unsafe pharmaceutical imports:

If George Bush won’t start that process now, I will when I am President. As I laid out in my import safety agenda, I will require that foreign drug makers produce a certification that they have met American safety standards as a condition of import into the United States, confirmed by independent testing and inspection. I will open permanent FDA oversight offices in at-risk countries like China so that episodes like this one are not repeated. I will require foreign drug makers to accept random, surprise inspections, rather than notifying them in advance – and giving them a chance to clean up their act — as we do now. And I will stiffen civil and criminal penalties for violators. It is a basic obligation of government to protect its citizens. Americans can count on me as President to protect the food we eat, the toys our children play with and the drugs we take to make us healthy, not sick.25

Finally, Clinton noted that for every direct-to-consumer marketing dollar spent, pharmaceutical sales increased by $4.20. To address this issue, she suggested limiting such advertising, instituting a reporting requirement for financial arrangements between providers and industry, and protecting information about the prescribing practices of medical providers from being sold to drug manufacturers.

Senator McCain offers little information about his views on the FDA and the need for its reform on his presidential website. Like the Democratic challengers, McCain calls for increased imports of pharmaceuticals and faster genetic drug approvals. On McCain’s Senate website, transcripts of statements given to the Senate provide more information. In July 2002, McCain urged the Senate to pass the “Greater Access to Affordable Pharmaceuticals Act.” In his testimony, McCain argued against current pharmaceutical monopolies and for increased generic competition. In order to effect such a change, McCain argued: “This should not be done by imposing price controls or creating a universal, government-run health care system. Rather, a balance must be found that protects consumers with market-based, competitive solutions without allowing those protections to be manipulated at the consumers’ expense, particularly senior citizens and working families without health care insurance.”26 In support of the “Pharmaceutical Market Access and Drug Safety Act of 2004,” McCain specifically addressed the safety of drug imports noting, “To ensure the safety of this new system, the FDA would be required to regularly inspect Canadian exporters as well as domestic importers. The legislation also would require all importers and exporters to maintain a full chain of custody, or pedigree, for the drugs imported into the U.S.”27 Finally, in February 2005, McCain supported the “The Pharmacy Market Access and Drug Safety Act of 2005,” which would lower the cost of imported prescription drugs. He stated: “None of us have any illusions that enacting drug importation legislation will easy. Powerful special interests will continue to try to block us every step of the way. However, this is a battle worth fighting and winning for American consumers.”28

In a February 2008 blog entry from EyeOnFDA.com, Mark Senak of marketing and communications giant Fleishman-Hillard, briefly compared the positions of presidential candidates at that time on the FDA. He noted,

All of the candidates also tend to agree that they want to bring in new technology and devices to manage information, cultivate more prevention programs and to improve the quality of healthcare. But what was perhaps most surprising was the fact that as much as the candidates differ on the details of these reforms, they were nearly all in favor of two changes that would have a hefty impact on the pharmaceutical market place – Medicare Part D reform and the importation of prescription drugs. In other words, change with this election cycle is of course, inevitable, but it is also highly possible, if not probable, that candidates from both political parties will embrace these two reforms. To me, that was news. 29

Certainly it seems then that regardless of the winner of the next US presidential election, Americans can expect increased attention to the lowering the price of pharmaceutical products by increasing imports and access to generic medicines. However, neither Obama nor McCain have articulated their positions on the necessity for deep structural reform within the FDA and the need for creative solutions for both a source and level of funding that would allow the agency to properly review and inspect domestic and foreign food and drug applications, data and manufacturing plants.

In the coming months, health advocates may want to press the candidates to explain in more detail their positions on the FDA. More generally, the presidential candidates and those running for Congress will need to articulate how they propose to change the cozy relationship between the pharmaceutical industry and the FDA in order to allow the agency to fulfill its original mandate. Unless the next US President and Congress take a strong stand on the need for FDA reform and a transformation of the relationship between the FDA and the industries it regulates, it is likely that the trends of the past, crisis—legalization—adaptation, will continue at the expense of American health and public safety.

References

1. Dohrman, AJ. Rethinking and Restructuring the FDA Drug Approval Process in Light of the Vioxx Recall. Journal of Corporation Law. 2005;31(1):203-223.
2. Mukherjee, D; Nissen, SE; Topol, EJ. Risk of Cardiovascular Events Associated With Selective COX-2 Inhibitors. JAMA. 2001;286(8):954-959.
3. Nissen, SE; Wolski, K. Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes. New England Journal of Medicine. 2007; 356(24):2457-2471.
4. Lipscombe, LL; Gomes, T; Lvesque, LE; Hux, JE, MSc; Juurlink, DN; Alter, DA. Thiazolidinediones and Cardiovascular Outcomes in Older Patients With Diabetes. JAMA. 2007;298(22):2634-2643. Wechsler, J. FDA Hit for Poor Clinical Oversight. Applied Clinical Trials. 2007;16(11):30-35.
5. Wechsler, J. FDA Hit for Poor Clinical Oversight. Applied Clinical Trials. 2007;16(11):30-35.
6. Washington Post. Fixing the FDA: Lack of funding inhibits crucial drug inspections abroad. Friday, March 7, 2008; A16.
7. Loewenberg, S. US FDA Feels the Heat from Congressional Hearings. The Lancet. 2008; 371:1565-1566.
8. Gardiner, H. U.S. Identifies Tainted Heparin in 11 Countries. New York Times. April 22, 2008.
9. Harris, G; Berenson, A. Drug Makers Near Old Goal: A Legal Shield. The New York Times. April 6, 2008.
10. Hubbard, W. The Overwhelmed FDA. The Boston Globe. June 3, 2007.
11. Carpenter, D; Zucker, EJ; Avorn, J. Drug-Review Deadlines and Safety Problems. New England Journal of Medicine. 2008;358(13):1354-1361.
12. Ross, W. What’s Up with the FDA? Medical Marketing & Media. 2008. Accessed at: http://www.mmm-online.com/Whats-Up-with-the-FDA/article/104861/
13. Union of Concerned Scientists. FDA Scientists Pressured to Exclude, Alter Findings; Scientists Fear Retaliation for Voicing Safety Concerns Public Health and Safety Will Suffer without Leadership from FDA and Congress. 2006. Accessed at: http://www.ucsusa.org/news/press_release/fda-scientists-pressured.
html
14. Wechsler, J. Attacks on FDA Escalate. Pharmaceutical Technology. May 2, 2008. Accessed at: http://pharmtech.findpharma.com/pharmtech/Washington+Report/
Attacks-on-FDA-Escalate/ArticleStandard/Article/detail/515161?context
CategoryId=484
15. Consumers Union; Consumer Federation of America; US Public Interest Group. March 15, 2005. Accessed at: http://www.pirg.org/consumer/pdfs/crawfordfda.pdf
16. Prescription Project; Community Catalyst; National Physicians Alliance; Prescription Access Litigation; Community Catalyst; US PIRG. Comments Concerning the United States Food and Drug Administration Draft Guidance for Industry “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.” Docket No. FDA-2008.D.0053. April 21, 2008.
17. Consumers Union. Statement of Ami Gadhia Concerning Discussion Draft of “FDA Globalization Act” Subcommittee on Health, Energy & Commerce Committee U.S. House of Representatives. May 1, 2008. Accessed at: http://www.consumersunion.org/pub/core_product_safety/005598.html
18. Foulkes, AE. The FDA Cannot be Reformed. The Freeman. July 1, 2005.
19. van Heerden, L. Abolishing the FDA. The Freeman. March 1, 2007.
20. Harris, G. Advisers Say F.D.A.’s Flaws Put Lives at Risk. The New York Times. December 1, 2007.
21. Institute of Medicine. The Future of Drug Safety: Promoting and Protecting the Health of the Public. September 22, 2006. Accessed at: http://www.iom.edu/?id=37339
22. Food and Drug Administration. The Future of Drug Safety: Promoting and Protecting the Health of the Public. FDA’s Response to the Institute of Medicine’s 2006 Report. Accessed at: http://www.fda.gov/oc/reports/iom013007.pdf
23. Borchers, AT; Hagie, F; Keen, CL; Gershwin, ME. The History and Contemporary Challenges of the US Food and Drug Administration. Clinical Therapeutics. 2007; 29(1):1-16.
24. Clinton, H. Accessed at: http://clinton.senate.gov/issues/health/
25. Clinton, H. Clinton Responds to FDA Tripling Its Estimates For Heparin-Related Deaths. April 9, 2008. Accessed at: http://www.hillaryclinton.com/news/release/view/?id=6989
26. McCain, J. McCain Urges Senate to Pass Generic Drug Bill Quickly. July 17, 2002 Accessed at: http://mccain.senate.gov/public/index.cfm?FuseAction=PressOffice.
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27. McCain, J. Pharmaceutical Market Access and Drug Safety Act of 2004. April 21, 2004. Accessed at: http://mccain.senate.gov/public/index.cfm?FuseAction=PressOffice.
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28. McCain, J. McCain Continues to Fight for Lower Prescription Drug Costs. February 9, 2005. Accessed at: http://mccain.senate.gov/public/index.cfm?FuseAction=PressOffice.
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29. Senak, M. Where the Candidates Stand – A Side by Side Comparison and Conclusion. January 02, 2008. Accessed at: http://www.eyeonfda.com/eye_on_fda/2008/01/where-the-candi.html

Photo Credits:

1. MooN
2. goodmosconi
View CHW’s coverage on Corporations, Health and the 2008 Presidential Race:

Part 1: Following the Money
Part 2: Clinton, Obama and McCain on the Role of Corporations
Part 3: Clinton, McCain, Obama and the Food Industry

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

1. Rose N. 2006. The Politics of Life Itself: Biomedicine, Power, and Subjectivity in the Twenty-First Century. Princeton, New Jersey: Princeton University Press. 2006, p. 181.
2. Schwartz R.S. Racial Profiling in Medical Research. New England Journal of Medicine 2001; 344:1392-1393. 
3. Kahn J. Race in a Bottle. Scientific American. 2007; 297(2): 40-45. 
4. A-HeFT. 2007. A-HeFT.org: The Web site of the African American Heart Failure Trial (A-HeFT.) Available at: http://www.aheft.org/. Retrieved October 30, 2007.
5. Kramer J, Vice President of Corporate Communications, NitroMed, personal communication, October 6, 2007.
6. . Heart Failure Backgrounder. Available at: http://www.nitromed.com/pdf/Heart%20Failure%20backgrounder.pdf, retrieved October 8, 2007.
7. NitroMed. 2007. African Americans and Heart Failure. Available at: http://www.nitromed.com/ pipeline/aaheart.asp, retrieved December 8, 2007.
8. Duster T. Race and Reification in Science. Science 2005; 307: 1050-1051. 
9. Haldeman, G.A. et al. 1998. Changes in Mortality from Heart Failure – United States, 1980-1995. Morbidity and Mortality Weekly Report. 47(30): 633-7. Available at: http://www.cdc.gov/MMWR/preview/mmwrhtml/00054249.htm, retrieved March 19, 2008.
10. NitroMed. 2007. Common Questions. Available at: http://www.bidil.com/pnt/questions.php#18, retrieved December 13, 2007.
11. Dressler WW, Oths KS, Gravlee CG.Race and Ethnicity in Public Health Research: Models to Explain Health Disparities. Annual Review of Anthropology 2005; 34: 231-252.
12. Dreifus C. 2005. A Sociologist Confronts ‘The Messy Stuff.’ New York Times, October 18. 2005. Available at :http://www.nytimes.com/2005/10/18/science/18conv.html 
13. Neil J. (BiDil Product Manager, personal email, 11/28/2007)
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.

 

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Tracking the Effects of Corporate Practices on Health