In the Kingdom of the Sick: A Social History of Chronic Illness in America

by Laurie Edwards

  Barber observes that the commodification of pharmaceuticals, right alongside cars, household goods, and other products, is “a very American thing,” something a whole generation has grown accustomed to seeing.24 In fact, America is the only country other than New Zealand that allows DTC advertising. There is an entire generation of potential patients who have grown up seeing drug ads and don’t remember things any other way. I know this firsthand, because I meet members of this generation every semester when I greet my new health sciences students. This self-selected group is more aware of the ads than other majors might be, particularly the pharmacy students, but for people their age, drug ads are simply a part of daily life. It is hard to flip through a magazine or sit through a television program without seeing an ad for a new prescription drug. From the “purple pill” campaign (Nexium) to the fluttering nighttime Luna moth (Lunesta) to the ubiquitous buzzing bees, insects, and wind-tousled flowers that dominate commercials for allergy medications, the DTC marketing of pharmaceutical drugs has dramatically altered the way patients and physician interact and has challenged the basic notion of what constitutes an illness. With celebrities endorsing drugs to grow longer eyelashes or relieve restless leg syndrome now firmly entrenched in the popular consumer health lexicon, critics of DTC advertising charge that drug companies are “creating” diseases so patients will see themselves in the ads and ask their physicians for a prescription.

  One such critic is Jennifer Shaw. For over eight years, Shaw was a top-ranking sales representative for Big Pharma, until she left the industry to write her memoir, Big Pharma’s Sexy Little Secret, detailing the behind-the-scenes machinations of the pharmaceutical sales industry.

  “Many patients are walking into their doctor’s office demanding specific medications that they saw on TV … Once the patient feels they need to be on that specific medication, there is little a doctor can do to persuade them otherwise. Anything else the doctor puts the patient on will now ‘not work.’ The patient is basically brainwashed from the DTC [advertising],” Shaw says.

  Brainwashed, possibly—unless, of course, that patient approaches his or her doctor with questions about the medication, about the symptoms he or she is experiencing that resonate with the ad, and they have a conversation about it. That’s the ideal situation worth striving for, but the issue is, how do we ensure that happens?

  In the fifteen years it has been legal, skeptics have had concerns over the safety of the drugs that are featured in DTC advertising, mainly through television ads. Also at issue is the Food and Drug Administration’s ability to enforce regulations that ads must accurately reflect the balance of a drug’s benefits and risks. Research published in the New England Journal of Medicine found that while we know spending on DTC advertising increased 330 percent between 1996 and 2005, the number of letters sent to companies from the FDA indicating violations of these regulations dropped from 142 in 1997 to 21 in 2006.25 It turns out that drug companies fare dismally when it comes to properly advertising prescriptions to health care professionals (the one writing the scripts), too: a study published in 2011 found that of 192 pharmaceutical ads published in biomedical journals, a mere 18 percent were fully compliant with FDA guidelines. More than half (58 percent) of the ads failed to quantify serious risks, while 48 percent lacked verifiable references.26 Researchers attribute this lack of oversight and compliance to inadequate resources at the FDA, and hope that updating FDA guidelines to include more transparency, particularly with safety and efficacy information, will improve the quality of information given to physicians.27

  Pharmaceutical companies and other proponents of DTC advertising contend that it exists to give patients and physicians educational information about various conditions and treatment options. It is a form of patient education, and readily available patient education is a positive development and a tool for collaboration. However, a major complaint about DTC ads is that TV commercials fail to adequately portray the serious risks of prescription drugs. Factors such as the speed at which side effects are mentioned, the rapid pace at which images flicker on the screen, and the feel-good quality of those images (fields of flowers and butterflies, families cavorting on the beach or in a park) can distort the impact of a drug’s serious risks. It is unclear whether patients are well enough versed to weed through the distractions—or, more pertinently, whether they are even given ample opportunity to do so. FDA laws require a “fair balance” of information, meaning that the content and delivery of a drug’s primary risks must be presented in a similar way to its primary benefits.28 This does not mean benefits and risks warrant equal time or space, but the concept of fair balance certainly leaves a lot of leeway for interpretation.

  For her part, Shaw sees this fair-balance requirement as one favorable aspect of DTC advertising because it means mentioning side effects or other considerations patients might not hear in a physician’s office at all.

  “I can tell you from experience [that] when a pharmaceutical sales rep pitches to a doctor, we state many benefits and rarely state more than one possible side effect. We make sure that we say whatever is necessary to convince the doctor that we are carrying the best medication out there,” she says. While doctors may leave out certain facts when discussing drugs and their side effects with patients, patients can potentially find this information after seeing a drug in a commercial if they do some research and view package inserts online.

  “My point is that if DTC helps the patients realize that there are options, there are side effects associated with prescription meds and they need to get informed and ask doctors questions, that is a good thing. But, if a patient sees a commercial on TV and marches into a doctor’s office and specifically requests that medication for no other reason than the commercial, they may be receiving a prescription that is not in their best interest,” says Shaw, who is now a passionate advocate for informed choices for patients. DTC advertising may be an iteration of the consumer culture we are immersed in, but prescription drugs will never be simply another commodity to brand and market—not when people’s lives are at stake.

  For Duncan Cross, DTC ads represent a diversion of resources that should be earmarked for patient care. “There is no therapeutic benefit to these ads, and yet every sick person in the country winds up subsidizing them one way or another,” he says. To his point, DTC advertising of “blockbuster” drugs, those name-brand top sellers we can all spot the jingles for, has another effect: contributing indirectly and directly to the increasing costs of medical care. In fact, the money spent promoting and marketing big-name drugs is one of the biggest criticisms of DTC advertising. Experts call these lucrative, heavily marketed brand-name drugs “me-too” drugs because they are minor variations of older drugs, ones that are often produced to extend patents on drugs that are about to expire. This way, pharmaceutical companies get exclusive marketing rights for what is essentially the same drug.29 In a 2004 interview, Dr. Marcia Angell, former editor-in-chief of the New England Journal of Medicine and author of The Truth About the Drug Companies, explained that me-too drugs don’t just cost money in promotions and marketing; they siphon away from the type of true innovation that many patients need.

  “If you look at the new drugs marketed over the last six years, 78 percent weren’t even new chemical compounds. They were just new combinations or different formulations of old drugs. And 68 percent were classified by the FDA as unlikely to be improvements over drugs already on pharmacy shelves,” Dr. Angell said, adding that drug shortages exist in other disease categories because making them is not as profitable as churning out more me-too drugs.

  Lack of innovation is especially worrying for patients with rare diseases, who are at an obvious disadvantage since their small populations (two hundred thousand patients or fewer) make them unattractive to drug developers. If all patients are vulnerable in the consumer-Pharma relationship, then patients with rare diseases have the most perilous position. We rely on the Orphan Drug Act, first enacted in 1983, legislatio
n that gives pharmaceutical companies incentives to research and develop medications for rare diseases, which obviously aren’t the cash cows that diseases that affect millions more patients are. We risk losing out on true innovation in favor of promotion.

  Still, if we hold the idea that culture change happens when people start having conversations, then there is value in this scenario. We are talking about illness more, and potentially embarrassing or stigmatizing chronic health conditions are a regular part of our syntax. What DTC advertising exposes—and social media and patient groups should combat—is that people are not as informed as they need to be if they are getting their information from a thirty-second commercial. When a consumer decides to request a medication based on seeing a TV ad, the self-diagnosis and selection of treatment are placed before the clinical and laboratory assessments that would support the diagnosis and choice of treatment. Ideally, the physician would correct the sequence of events, and a comprehensive conversation and appropriate observations and tests would occur based on differential diagnoses.

  Since pharmaceutical companies are naturally looking to expand their consumer reach, it is no surprise that they have followed patients and patient organizations into the virtual world. Some do it better (that is, more transparently) than others, and their growing social media presence translates into even more discernment for patients. In an effort to get their products visible, pharmaceutical companies and their PR reps have gone “new school,” where the patients are: they are on Twitter, they are on Facebook, they maintain blogs, YouTube channels, and more.

  “I believe social networking is a great avenue to explore for health care innovation and product marketing. Since next-generation health and health care is largely about driving behavior change through getting trusted information, where better than Facebook and other similar sites to get the word out virally about new solutions and products and to utilize ‘positive peer pressure’ for better living? Patients will be able to benefit from higher-value-added products and services and experience real life change,” says Tony Chen of FDAzilla, a company that helps professionals work smarter with the FDA by making data usable and actionable.30 “While old-school companies are still negotiating with their ad firm on a marketing theme for their product launch, new-school companies already have thousands of people using it and giving them feedback for the next version of their product,” he says. Some companies have started interacting with patients and thought-leaders in the world of health care social media directly, sponsoring summits and conferences to hear from patients and explore how best to engage with them through social media platforms.

  Patient advocacy groups, such an integral part of modern-day patient-hood and culture change when it comes to health care and chronic disease, are caught up in this transparency dynamic, too. When they are legitimate and not biased by funding sources, Barbara Kivowitz calls them “the first oasis for a desperate, thirsty, wandering sick person.” Over time, the connections and support patients receive from patient advocacy can help them become advocates themselves and give insight and action back into the system itself.

  According to Dr. Adriane Fugh-Berman, an associate professor at Georgetown University and director of Pharmedout, a project at the university’s medical center that helps physicians identify and respond to inappropriate drug promotions, there are only about six national consumer advocacy groups that do not take any money from pharmaceutical companies, a conflict of interest that patients shouldn’t ignore. It can be difficult to locate sponsorship on some of the sites that do receive funding. Since drug companies have co-opted existing groups without indicating the real sponsor in the past, Fugh-Berman sees as dangerous the potential for this to happen on social networking sites. A 2011 study in the American Journal of Public Health found that most advocacy groups that have the appearance of being grassroots organizations fail to disclose the grants they get from pharmaceutical companies. At the same time, these groups have agendas that often overlap with the marketing efforts of their financial supporters. For example, increasing public awareness about a disease or increasing physicians’ recognition of it could lead to more sales of treatments and devices designed for that disease.31 Regulations that require disclosure of gifts to physicians do not extend to patient advocacy groups, something researchers hope will change in the future.

  Do the benefits of access to health innovation and communities of patients outweigh the risks of potential conflicts of interest or inappropriate marketing? If patients are aware of any financial relationships between companies and advocacy groups, perhaps yes.

  “I’m fine with it, as long as there is transparency,” says Rosalind Joffe, the chronic illness life coach from Newton, Massachusetts. Both of her websites, keepworkinggirlfriend.com and cicoach.com, contain ads for services that are relevant to her clients. “In many ways, advertising, blogs, and networking sites are terrific ways for the medical consumer to know what is available,” she says. An ad for a product that helps people lift things, which can be a daily struggle with the debilitating effects of multiple sclerosis, is a prime example of the type of ad Joffee would green-light. A patient with multiple sclerosis herself, Joffe was once a spokesperson for Biogen Idec (producer of the multiple sclerosis drug Avonex) at patient education seminars. Avonex was never promoted by any of the speakers, although there were tables that had information about the product.

  “Again, I think it’s all about transparency,” Joffe says. “My website sells my services as a chronic illness coach and the products that help them but it also has lots of free and valuable information … folks with chronic illness, in particular, feel susceptible to being ‘duped’ by false promises or false advertising. I use the Web to promote my services and it’s how people have found me and how my business has grown the way it has. There’s always a fine line between ‘advertising’ and ‘information.’ “

  We do indeed live in a culture of consumption, and as patients with chronic illness, we are magnets for health information. We need patient advocacy groups to keep fighting for research and resources, just as we need pharmaceutical companies to strive for drug innovation and authentic dialogue. Collaboration is what makes e-Patient Dave deBronkart’s success story possible, what makes participatory medicine a goal for twenty-first-century patients and physicians alike.

  “One great challenge we face is the cultural barrier in which some people—providers and patients alike—have built a belief system where clinicians have an almost shamanistic magic to them. In that belief system it’s sacrilege or travesty for a patient to have any power. We address this by sharing stories that prove patients truly can bring value to the table, and by refining the point: I helped in my case, but I’m no oncologist, I’m no kidney surgeon, I’m no orthopedic surgeon, I’m no nurse. The point isn’t to overthrow doctors; it’s that patients can help,” says deBronkart. His comments shed perspective on the future of health care in the digital age, but they are also reminiscent of the same type of power balance patients and advocates have sought for decades: not to dismantle the figure of the physician altogether, but to legitimize the patient voice and legitimize the knowledge both parties brings to the relationship.

  Chapter 9

  What Future, at What Cost?

  When chef and health columnist Wendell Fowler penned an article lambasting the irresponsibility of an ice cream fundraiser for children with type 1 diabetes in the summer of 2011, he raised the ire of much of the type 1 diabetes community. In assuming the foods they chose were a main cause of their diabetes, Fowler made an entirely too common mistake: he failed to differentiate between type 1 diabetes, an autoimmune disease formerly known as juvenile diabetes, and the much more prevalent type 2 diabetes. Only about 5 percent of patients with diabetes have type 1, which occurs when an autoimmune response attacks the pancreas and it stops producing insulin altogether, meaning patients are insulin-dependent for life.1 For the millions of Americans who have type 2 diabetes, which is often associated with obesity,
they can sometimes manage their condition through changes in diet and lifestyle before they require medication or insulin. The insinuation that type 1 children should not have ice cream or that their lifestyle choices caused their disease angered patients and advocates, who felt that a health columnist and chef should know better than to contribute to the pervasive myth about type 1 diabetes. A viral response played out in social media circles, with type 1 diabetics posting pictures of themselves eating ice cream on Facebook and bloggers indignantly calling Fowler to task for his misinformation.

  This incident is just one small example of the uneasiness that surrounds questions of individual responsibility for behavior and illness. Type 1 diabetics don’t like being judged for doing something to cause their illness. They don’t want to inherit the stereotypes and associations that come with type 2 diabetes, or live with the burden of expectation that if they just ate differently or exercised more, they could “cure” their incurable disease. At the same time, type 2 diabetics don’t want to be cast off as lazy or gluttonous and subject to the snap judgments people make about their lifestyle, decisions, and character.

  When cookbook author and television chef and personality Paula Deen disclosed she had type 2 diabetes in 2012, news articles, blog posts, and commenters were quick to criticize; after all, Deen’s Southern-style cooking is known for its generous amounts of butter, cream, sugar, and other rich, indulgent ingredients. Deen’s decision to wait several years to disclose her condition while publicly espousing her high-fat recipes, and her endorsement deal with Novo Nordisk, the pharmaceutical company that manufactures her diabetes medication, added to the maelstrom. Many saw Deen as a hypocrite.