Campaign Profile: The Prescription Project

Posted on by Corporations and Health Watch

The problem of conflicts of interest between the pharmaceutical industry and prescribing physicians

The Prescription Project seeks to ensure that “industry-physician relationships are free of conflicts of interest and that physicians base their prescribing decisions on accurate and unbiased information.” Recent events such as Merck’s withdrawal of Vioxx after aggressively promoting its use to physicians and consumers and an FDA warning on GlaxoKlineSmith’s heavily promoted diabetes drug Avandia have focused public attention on the ways that the drug industry promotes its products.

The Prescription Project was founded in 2007 to encourage new approaches to ending conflicts of interest. In combination with a team of academic researchers, two of the project’s directors published an article on the problem of conflicts of interests between industry and physicians in the Journal of American Medical Association [1]. Community Catalyst, a national non-profit health care advocacy organization, founded the Prescription Project in partnership with the Institute on Medicine as a Profession, a research center at Columbia University with funding from the Pew Charitable Trust. Jim O’Hara, the managing director of policy initiatives at Pew, explained the rationale for the Project,  “If you’ve been in the waiting room when these Chinese lunches are taken into the back office, it may raise the question whether the decisions are based on the best scientific evidence about medication or whether or not those Sichuan shrimp have something to do with the prescribing patterns” [2]. The pharmaceutical industry spends $7 billion dollars per year marketing to doctors and another $18 billion on samples for physicians and patients [3].

Research and Policy Guidance for Academic Medical Centers and Government

By conducting research on the influence of pharmaceutical marketing on physician prescribing behavior, The Prescription Project provides evidence to guide policy recommendations for medical institutions. The group also conducts case study investigations of Academic Medical Centers (AMCs), seeking to understand the impact of its suggested guidelines. For example, if such studies show that the pharmaceutical industries continue to support drug research in institutions that impose guidelines, other institutions may overcome their resistance to change. Already several medical centers, including those at Yale, the University of Pennsylvania, Stanford and the University of Michigan have implemented or announced restrictions on drug industry marketing to their physicians.

The Project also seeks to influence national policy on conflict of interest rules such as the Physician Payments Sunshine Act recently introduced to the Senate [4]. Charles Grassley (R-IA), co-author of the Sunshine Act, recently told the New York Times ”Right now, the public has no way to know whether a doctor’s been given money that might affect prescribing habits” [5]. Media coverage of these proposals offers the Prescription Project an opportunity to influence the national debate [6].

The Prescription Project also advocates at the state level, urging legislatures to follow the precedent set by states like Maine, Vermont and New Hampshire that have passed prescription confidentiality legislation [7]. Though the law has been overturned and is now being fought in appeals court, New Hampshire’s 2006 Prescription Confidentiality Act was the first of its kind [8].

Prescription Project Critics

The Project has attracted criticism both from the pharmaceutical industry and physicians. Critics within medical institutions argue the Prescription Project’s guidelines to reduce conflicts of interest are unnecessary because physicians do not make decisions based on “pizza and pens,” as Harvard Medical School hematologist Thomas Stossel is quoted saying in a recent Lancet article [9]. Stossel is concerned that restrictions on interactions between the drug industry and physicians could obstruct the biomedical advances that have come out of collaborative research partnerships [9].

The drug industry insists that the guidelines the Prescription Project proposes are unnecessary. Ken Johnson, senior vice president at the Pharmaceutical Research and Manufacturers of America, said, “A new law is not necessary when pharmaceutical marketing is already heavily regulated by the Food and Drug Administration [5].” In addition, the American Medical Association, which received more than  $46 million for its 2005 sale of data on physician prescribing practices [7], has yet to take a position on the federal proposal [10]. (See box below).

Despite those who feel that guidelines on industry-physician relationships are not needed, studies show that free samples and meals, gifts, funding for travel and lodging, continuing medical education, research funding, and honoraria funded by pharmaceutical companies do influence physician prescribing and professional behavior [11]. Social and psychological studies indicate gift-giving can bias decisions about patient care and create an unspoken reciprocity agreement wherein physicians are obligated to prescribe the products most heavily marketed to them [12, 13]. This situation not only creates real or perceived conflicts-of-interest, but may also increase overall drug spending [14].

Beyond voluntary guidelines

Based on this evidence [15] and its own research [13] on the psychological dynamics of industry marketing, the Prescription Project believes that voluntary guidelines will not prevent conflict-of-interest [13]. They recommend instead the prohibition of industry-physician interactions [13]. The Prescription Project’s Executive Director, Robert Restuccia, commends AMCs, such as Boston Medical Center and Boston University School of Medicine, which have taken up the groups recommendations because they “recognize the harmful impact of pharmaceutical marketing—it undermines better patient care, increases our nation’s health care costs and ultimately decreases confidence in physician independence” [16]. For The Prescription Project, AMCs serve as model institutions for strict mandates because of their ability to adopt change quickly and instill medical ethics in coming generations of medical providers.

Data Mining

For more than 65 years, the American Medical Association has been selling pharmaceutical companies the Physician Masterfile, a database that contains information on the prescribing practices and other characteristics of 900,000 practitioners, most of whom are not AMA members [17]. Most physicians are unaware of this practice. The drug companies then use data mining techniques to understand the profiles of prescribers of their products and provide pharmaceutical sales representatives, “drug detailers”, with the guidance needed on how best to approach individual doctors.  The Prescription Project has collaborated with the National Physicians Alliance and American Medical Student Association to demand an end to the sale of this information to pharmaceutical companies and better protection of physician privacy.

Data mining is a big business for data collection companies such as IMS Health Inc., Plymouth Meeting, Verispan L.L.C., Wolters Kluwer Health. These businesses combine physician data with pharmaceutical prescribing data from pharmacy chains and other prescription sources to form complex physician profiles. The data mining groups then sell the hybrid information to drug companies, which in turn, create specialized marketing efforts directed at individual providers. The AMA insists the sale of the Masterfile is strictly for “licensure,” the legitimate process of verifying credentials and maintaining continuing medical education efforts [17], but the hefty profit its sale turns each year and the failure of the society to inform practitioners of the practice, has led many to call for policy change.

At the annual AMA meeting in Chicago this past summer, physicians engaged in the conflict-of-interest problem spoke out against the AMA’s relationship with Pharma interest groups. A member of the National Physicians Alliance, Dr. Ben Schaefer said he understands the necessity of physician prescribing data for research and continuing education, but states, “As a physician, I want my prescription information to be protected from commercial exploitation” [18]. Three states have passed legislation that either prohibits data mining or allows physicians to make their own privacy decisions, but in each case, data mining companies have sued.

Drug companies argue the data mining restrictions violate commercial free speech and threaten public health research. Chief Executive Director of Wolters Kluwer Health, Jeff McCaulley, admits “It’s true that the pharmaceutical sales reps were using these lists to target high-prescribing doctors,” but he says the pharmaceutical industry has changed its practices and is now more “responsible” with physician data [19]. Despite these claims, pharma interests have vowed to take legal action against any similar measures.

The Prescription Project has taken on a role as watchdog on the data mining issue. Legal council, Sean Flynn, noted that “the incorporation of prescribers into the commission structure of pharmaceutical sales incentives debases the medical profession, and, the more the practice becomes public, (the more it) breaks the chain of trust between doctor and client” [18].

McDonald’s and Children’s Health: The Production of New Customers

Posted on by Corporations and Health Watch

In a recent study published in the Archives of Pediatrics and Adolescent Medicine, 1 researchers found that low income 3 to 5 year old children preferred the taste of hamburgers, chicken, French fries, carrots or low fat milk if they thought the products were from McDonald’s, whether or not they actually were. Thus, in their first years of life, children had come to associate McDonald’s branding with desirable foods, creating a lifetime potential for obesity and over consumption of the high fat, low nutrient products that McDonald’s features. To understand its success in imprinting even the youngest children, Corporations and Health Watch investigated the range of McDonald’s activities geared towards children. By focusing on the specific ways that one company goes about reaching children, we hope to gain insights that can guide public health strategies to reduce childhood obesity.

According to its 2006 Annual Report, McDonald’s is the leading global foodservice retailer with more than 30,000 local restaurants serving 52 million people in more than 100 countries each day. Its 2006 revenues were $ 21.6 billion, up 16% from 2004.

 

McDonald’s leads in food advertising to children

Marketing directly to children began in the 1960s. McDonald’s founder Ray Kroc, along with Walt Disney, has been credited with recognizing that children constitute a valuable and distinct market segment. Kroc observed that, “A child who loves our TV commercials and brings her grandparents to a McDonald’s gives us two more customers.” 2(p. 41) Developing brand loyalty in children influences both later purchases and the buying patterns of parents. At the forefront of marketing to children, McDonald’s spends more on advertising in general than any other brand. 2(p. 4) In 2006, McDonald’s spent almost $2.5 million a day on traditional advertising in the United States. About 40% of McDonald’s total advertising budget is directed at children. 3(p.102)

The use of cartoon characters and icons

Ronald McDonald, the face of McDonald’s, is a symbol of the corporation’s dedication to reaching young customers. The only fictional character with a higher degree of name recognition by children is Santa Claus. 2(p.4) A study of 9-10 year old Australian youth demonstrated that more than half believed that Ronald McDonald knew what was best for them to eat. 3(p.100) To reinforce the association of fun and entertainment with its fast food, McDonald’s offers a line of videos featuring Ronald McDonald and the McDonaldland characters. McDonald’s use of cartoons to market to children extends to the Internet as well. An earlier version of the McDonald’s children’s website told young visitors Ronald was the “ultimate authority on everything” and they were encouraged to send Ronald an email telling him their favorite food items, their favorite sports team, favorite book and their name. 2(p. 45) Directly soliciting children for personal information is now prohibited without parental approval thanks to the Children’s Online Privacy Protection Act of 2000. One of the McDonald’s current websites aimed at children, Ronald.com, tells children they can “learn, play and create while having fun.” On the site, children interact with “adver-games” which are designed to engage children with both the game and an advertisement. The site’s games all feature Ronald McDonald somewhere in the game. Happymeal.com, a site designed to encourage children toward physical activity, also prominently features the “Happy Meals” logo each time a new game is opened.

Restaurant design

The atmosphere of McDonald’s itself is designed to be “family friendly.” McDonald’s operates more than 8.000 playgrounds around the United States, more than any other private American corporation and far more than any municipality. Originally modeled on Disney World, the playgrounds provide an environment that is designed to appeal to children through bright colors, toys and clowns, and also to parents by providing a safe place for children to play. For children who live in low-income neighborhoods without safe or adequately maintained public parks and playgrounds, McDonald’s may offer one of the few opportunities for such forms of play and sociality. Birthday and other parties can be held at many McDonald’s which provides, on a cost per child basis, the food, invitations, paper and plastic wear, party entertainers, party favors and clean-up afterward. These design elements contribute to associating McDonald’s with fun and socialibility.

Toys and entertainment

In 1979, McDonald’s launched its first “Happy Meal,” which included numerous toys such as a “McDoodler stencil,” a puzzle book, and McDonaldland character eraser in a cardboard box with a circus theme. By 2003, 20% of McDonald’s meals sold were Happy Meals and they accounted for $3.5 billion in revenues. The fast food giant stands as one the United State’s largest distributors of toys. 2(p. 4) In addition to toys, McDonald’s appeals directly to children through cartoon characters, catchy jingles, and food shaped and colored to appeal to children. In addition, McDonald’s develops strategic partnerships, sponsorships, character licensing agreements and endorsements with celebrities and corporations such as NBA stars, Disney, the Fox Kids Network, DreamWorks and the Olympics. 2 Among the celebrities who have done product endorsements for McDonald’s are Venus and Serena Williams, Cedric the Entertainer, Kobe Bryant and Michael Jordan. Through such alliances, McDonald’s aims to have children associate the good feelings they have about celebrities, characters and companies with McDonald’s itself. That fit and celebrated athletes promote its products further associates McDonald’s with health and fitness.

In addition to television commercials featuring celebrities and promoting cartoon character toy give-a-ways, McDonald’s targets children through product placement and sponsorship. The fast food company has paid to have its food products featured in such children’s films as “George of the Jungle,” “The Flintstones,” and “Richie Rich.” 3(p.113) McDonald’s also sponsored the children’s show “The Teletubbies” and distributed toys representing the four characters. As with the Teletubbies, the company produces multiple versions of toys associated with movies and television. 4(p. 181) Children are encouraged to collect them all to obtain the full set, thus encouraging return visits—and more Happy Meals. In 1999 alone, McDonald’s released eighty different versions of Furby. 2(p.47)

McDonald’s marketing to children extends beyond television commercials, kid-friendly websites, toys and playgrounds. In 1987 McDonald’s launched their “McKids” line of clothing that was initially sold at Sears, Roebuck & Co. It was later picked up by Wal-Mart which dropped the line in 2003. Now McKids is offering a line of branded toys such as bikes, skateboards and scooters designed to encourage children to be more active between their visits to the Golden Arches.

McEducation

In their 2005 study of the clustering of fast food restaurants around public schools, Bryn et al reported that “Fast-food restaurants are concentrated within a short walking distance from schools, exposing children to poor-quality food environments in their school neighborhoods.” In the early years of McDonald’s, founder Ray Kroc actually flew in a Cessna scouting for new sites near schools. 2(p. 66) Like other fast food companies, McDonald’s does more than just place itself close to schools; in recent years it has opened outlets within high school cafeterias. According to a recent CDC survey, in 2006, 24% of the nation’s high schools and 19% of its middle schools offered on-site brand name fast foods.

McDonald’s also sponsors Channel One programming, provides educational curricula that feature information about working at McDonald’s and offers incentive programs, like “McSpellit Club,” whereby students can earn meals at the restaurant for spelling, reading and good attendance. 4,5 In addition, McDonald’s is a client of Cover Concepts, a company which provides branded textbook covers free to students and schools. 5 Finally, in 2005, with 31,000 elementary schools around the country, McDonald’s launched its “Passport to Play” program, aimed at encouraging physical fitness for third through fifth graders. Each time children play a game from around the country, they receive a golden arches stamp on a pretend passport. The website states, “Passport to Play is a fun way to keep kids’ minds engaged and bodies active. Teach your students how kids from around the world play, snack and grow [emphasis added].” Bryn Austin, assistant professor of pediatrics at the Boston Children’s Hospital suggested the program might be a “Trojan Horse” created to keep McDonald’s name in schools.

But McDonald’s doesn’t just take money from students; it raises money for them. In New Haven, CT, a group of teachers and staff from the New Haven Middle School participated in a McDonald’s educational program working a 4 hour shift at the counters and the drive-up window. By doing so, their school received 20% of the profits during the time they staffed the establishment. While the teachers worked, students decorated the walls of the restaurant with pictures of the golden arches. 3(p. 130) On October 13 of this year, 450 McDonald’s establishments in Tennessee participated in a similar “McTeachers Night” program. In addition, the corporation sponsors young people’s sports teams such as the McDonald’s All American High School Basketball Team.

Strategic Locations and Charity 

To keep its name in front of young people, McDonald’s develops partnerships with institutions where children are likely to be found. In August 2001, the fast food corporation began a 10 year, $16 million contract with the Smithsonian Institution’s Air and Space Museum. The museum features McDonald’s food as well as food from two other companies owned by McDonald’s, Boston Market and Donatos Pizzeria.3(p. 300) The Philadelphia Children’s Hospital and other children’s hospitals around the country feature a McDonald’s in their facilities. Finally, The Ronald McDonald House Charities has provided housing and meals to families with more than two million seriously ill children, further reinforcing the idea that Ronald McDonald and the McDonald’s corporation care about children’s health.

Influencing parents to reach children

Children are believed to influence approximately $500 billion of spending each year. 3(p. 101) Thus, while McDonald’s focuses much of its marketing on children, the fast food giant also seeks to influence parents’ purchasing decisions. Corporate memos discuss the company’s desire for adults to feel like “good parents” by taking their children to McDonald’s in order to make them happy. 2(p. 50). To counter criticism that fast and junk foods contribute to obesity and other health problems, McDonald’s recently launched a contest to recruit mothers for three day paid field trips where they will be given access to the farms “where our fresh ingredients are grown, to our world-class suppliers and to our restaurants.”

McWorld

As McDonald’s saturates US markets and succeeds in attracting young Americans as lifetime customers, growth increasingly depends on expanding its consumer base through overseas marketing. McDonald’s opens about four new restaurants every day overseas. 2(p.229) The table below shows the growth in McDonald’s outlets in various parts of the world between 1991 and 2001. 3(p.58)

Growth in McDonald’s Outlets by World Region, 1991-2001

In preparation for the 2008 Beijing Olympics, McDonald’s is promoting aninternational contest for 300 children, 100 from China, to win trips to the games.

The increased visibility and availability of McDonald’s around the world has succeeded in reaching greater numbers of children. At one primary school in Beijing, all of the children recognized and liked Ronald McDonald, and believed that “Uncle McDonald was funny, gentle, kind and…understood children’s hearts.” 2(p. 231) In Japan, 98% of children recognized Ronald McDonald; In England the figure was 93%. 3(p. 99) Ronald McDonald speaks to children in twenty-five languages including Russian, Portuguese, Tagalog, Hindi, Cantonese and Papiamento. 3(p. 13) A 1996 survey of children’s television programming in Australia, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Netherlands, Norway, Sweden, UK and the United States found that McDonald’s was the most prolific advertiser overall.

But does it work?

Commenting on the results of the previously mentioned study of children’s preference for food with a McDonald’s packaging, company spokesman Walt Riker stated that McDonald’s had been “actively addressing” the issue of children and nutrition and that McDonald’s was “providing solutions.” However, Dr. Victor Stasbuger, an author of American Academy of Pediatrics policy calling for limits on marketing to children argued that the study illustrated the success of fast food marketing to children: “Advertisers have tried to do exactly what this study is talking about–to brand younger and younger children, to instill in them an almost obsessional desire for a particular brand-name product.”

Impact on health

In 1998, 89% of children in the United States eight years of age or younger had visited a McDonald’s at least once a month. In response to this information, R.J. Milano, a McDonald’s Vice President stated that their goal for the following year was to reach 100%. He boasted “I’m going to own every kid transaction out there.” 3(p. 291). The health impact for both youth and adults of increased intake of salt, fat and sugar associated with the consumption of fast and junk foods has become clear as rates childhood obesity and type 2 diabetes have escalated. At least 30% of calories in the average child’s diet are currently derived from fast food, salty snacks, sweets and soft drinks. In response to increased media attention and legal action, fast food companies such as McDonald’s claim to be offering healthier alternatives. In addition, McDonald’s was one of 11 major food companies that recently agreed to limit voluntarily its food advertising to children . Recently McDonald’s began offering Happy Meals with slices of apples and milk. However, while the new Happy Meals did reduce overall fat and calorie content, the “Apple Dippers” included in the meal increased the sugar content. Additionally, while McDonald’s has done away with its “supersize” option for adults, in 2001 it introduced “Mighty Kids Meals” which offer more food for only slightly more money.

Regulations around the world

More than 50 other countries currently regulate marketing directed at children. Twenty-five European states prohibit advertising during children’s programming of a duration of 30 minutes or less. In 1992, Sweden banned all television marketing directed at children twelve and under. Similarly, advertising in children’s programming have been banned in Ireland, Norway, Belgium and Holland.1 Since 2001 Broadcasting Commission of Ireland has prohibited the use of celebrities and cartoon characters to advertise food. Regulations disallowing advertising to children 13 years or younger have been in effect since 1980 in the Canadian province of Quebec. In the United States, the Federal Trade Commission lacks the authority to restrict television advertising. Given the previous failure of voluntary guidelines to reduce growing rates of obesity, numerous advocacy and public health groups have called for government regulations.

Recommendations

Many public health organizations in the United States and elsewhere have made specific recommendations. In December 2005, the Institute of Medicine (IOM) released a comprehensive report on the impact of food marketing to children in the United States. The report found that American children are not achieving basic nutritional goals both in terms of underconsumption of important nutrients and overconsumption of fat, salt and sugar. While the dietary patterns of children are a complex in origin and include cultural values, economic status, social environments and media environments, the IOM concluded that food and beverage marketing “influences the preferences and purchase requests of children, influences consumption at least in the short term, is a likely contributor to less healthy diets, and may contribute to negative diet-related health outcomes and risks among children and youth.”

Strategic Alliance, a coalition of nutrition and physical activity advocates in California, recommends that all marketing and advertising of junk and fast foods be eliminated for children and youth. Amongst other measures, International Association of Consumer Food Organizations (IACFO)—an international association of non-governmental organizations representing consumer interests in the areas of nutrition, food safety, and food policy—urges governments to restrict or ban all food advertisements to children and prohibit the marketing of soda, junk and fast foods in schools. The IACFO also points to the importance of global action on this issue, noting that restrictions in the developed world often send multinational corporations overseas to the global south where they market unhealthy products with greater ease. Given escalating global rates of diet related chronic disease, public health and advocacy calls for more stringent and federally and globally enforceable standards seem warranted. In the words of Gro Harlem Brundtland , former Director General of the World Health Organization: “Marketing approaches matter for public health. They influence our own–and in particular our children’s–patterns of behavior. Given that they are designed to succeed, they have serious consequences for those at whom they are targeted.”

Zoe Meleo-Erwin, MA is graduate student in sociology at The Graduate Center, City University of New York.

 

References

1. Robinson, TN; Borzekowski, DLG; Matheson, DM & Kraemer, HC. Effects of Fast Food Branding on Young Children’s Taste Preferences. Archives of Pediatrics and Adolescent Medicine. 2007. 161(8):792-797.
2. Schlosser, E. Fast Food Nation: The Dark Side of the All-American Meal. 2001. Boston: Houghton Mifflin.
3. Brownell, K. & Horgen, KB. Food Fight: The Inside Story of the Food Industry, America’s Obesity Crisis & What We Can Do About It. 2004. New York: McGraw Hill.
4. Nestle, M. Food Politics: How the Food Industry Influences Nutrition and Health. 2002. Berkeley: University of California Press.
5. Story, M. & French, S. Food Advertising and Marketing Directed at Children and Adolescents in the US. International Journal of Behavioral Nutrition and Physical Activity. 2004;1:3. Available at: http://www.ijbnpa.org/content/1/1/3. Accessed October 21, 2007.

Photo credits:

1. La Fotodama 
2. Sama Sama – Massa
3. Petite-Tomo