Direct-to-Consumer Advertising in Oncology
作者：Gregory A. Abel, Richard T. Penson, Steven Joffe, Lidia Schapira, Bruce A. Chabner, Thomas J. Lynch, Jr.
【关键词】 Cancer,•,Support,•,Psychosocial,•,Personal,•,Communication,•,Connection
ABSTRACT
Shortly before his death in 1995, Kenneth B. Schwartz, a cancer patient at Massachusetts General Hospital (MGH), founded The Kenneth B. Schwartz Center at MGH. The Schwartz Center is a nonprofit organization dedicated to supporting and advancing compassionate health care delivery, which provides hope to patients and support to caregivers while encouraging the healing process. The center sponsors the Schwartz Center Rounds, a monthly multidisciplinary forum in which caregivers reflect on important psychosocial issues faced by patients, their families, and their caregivers, and gain insight and support from fellow staff members. Increasingly, cancer patients are subjected to advertisements related to oncologic therapies and other cancer-related products in the popular media. Such direct-to-consumer advertising is controversial: while it may inform, educate, and perhaps even empower patients, it also has the ability to misinform patients, and strain their relationships with oncology providers. The U.S. Food and Drug Administration requires that direct-to-consumer advertising provide a balanced presentation of a product’s benefits, risks, and side effects, but this can be difficult to achieve. Through a discussion of this topic by an oncology fellow, ethicist, cancer survivor, and senior oncologist, the role of direct-to-consumer advertising and its often subtle effects on clinical practice in oncology are explored. Although sparse, the medical literature on this increasingly prevalent type of medical communication is also reviewed.
PRESENTATION
Four speakers present different perspectives on direct-to-consumer advertising in oncology: an oncology fellow, an ethicist, a cancer survivor, and a senior oncologist. They highlight both the positive and negative aspects of direct-to-consumer advertising in oncology. Staff and patients’ personal and clinical details have been changed to protect their identity.
Moderator:
One of the things the Rounds focuses on is any issue that becomes an obstacle between caregivers and patients. Direct-to-consumer advertising has exploded in health care over the past several years. For example, many people in this room have heard radio commercials regarding the care that is available at different hospitals in Boston. In addition, many of us have seen everyday ads for pharmaceuticals, both in print and in other media, and patients increasingly bring us not just literature from the internet, but rather a message that they have received through advertising. The difference between this and other types of information is that direct-to-consumer advertising is often molded to meet a select niche, that of the potential consumer. The question is: how might this change the way we interact with patients?
DIRECT-TO-CONSUMER ADVERTISING: DEFINITION AND OVERVIEW
Oncology Fellow:
For this discussion, direct-to-consumer advertising may be defined as any unsolicited promotional endeavor by a pharmaceutical company or other provider of medical services to present information about medicine or medical services to the public in the popular media [1]. It includes television and radio advertisements, newspaper and magazine advertisements, billboards, and direct mailings. Another class of materials that is sometimes considered to be direct-to-consumer advertising is the brochures that drug companies supply for physicians to give to patients. Although these brochures are provided to patients "indirectly" through physicians, they may have a marketing component and sometimes make claims about drug benefits and risks.
Direct-to-consumer advertising does not include advertising in medical journals, for which the target audience is providers and not consumers. Strictly speaking, it also does not include internet advertising on pharmaceutical websites, as such information is solicited by consumers. Finally, one definition excludes medication "fulfillment materials" that consumers can obtain by mail after calling a number or sending in a postcard from an advertisement, as these are then considered solicited.
The most common item advertised directly to consumers is medication, but there are many other products that are also promoted this way. Examples are medical devices, the services of hospitals and cancer centers, genetic testing, imaging services, home health services, and even supportive and hospice care. Chemotherapy, targeted therapies, and hormonal therapies for cancer have also come to be advertised directly to patients.
One question I have been pondering, in terms of direct-to-consumer advertising, is whether it manifests differently in oncology than in other areas of medicine. Perhaps oncology patients and their families are especially vulnerable to direct-to-consumer advertising because they are desperate to learn about any therapy that might possibly work to treat cancer. It seems that, despite advances in oncology, there is still no other diagnosis that is met with such trepidation and desperation. How do we ensure that direct-to-consumer advertising does not inappropriately tap into these fears for marketing purposes?
There are other important questions. For example, we need to consider the idea of "fair balance." In regulating direct-to-consumer advertising, the U.S. Food and Drug Administration (FDA) requires that direct-to-consumer advertisements present benefits, risks, and side effects evenhandedly. This may not be possible in an advertisement for chemotherapeutics, given how complicated such agents are in terms of their comparative benefits and the many untoward effects that are possible in seriously ill people. Should there be a line drawn for oncology products to allow direct-to-consumer advertising only for supportive medications such as antiemetics and analgesics?
Finally, would a delay in new-product direct-to-consumer advertising, like Senate Majority Leader William Frist proposed last summer [2, p. 225], be worthwhile for chemotherapeutics? Indeed, a 2-year delay in knowing about a new cancer medication might be counterproductive in oncology, as it is longer than the natural history of many of our diseases.
ETHICAL ISSUES
Ethicist:
The first thing I would say is that whatever the source of the information, from pharmaceutical companies or medical providers, the provision of unbiased and useful information to patients and to the public is a good thing. In contrast, the provision of biased information is obviously problematic.
Could information that comes from pharmaceutical companies through the lay media to patients be made unbiased, objective, and useful? If we think that with increased oversight, we could have unbiased information coming from pharmaceutical companies, then the answer is to put that oversight in place and develop systems for making sure the information provided is unbiased and reasonable. Alternatively, there may be an irreconcilable conflict of interest with respect to the pharmaceutical companies’ aims in sponsoring direct-to-consumer advertising, such that this sort of unbiased advertising fundamentally cannot happen. Reconciling the competing issues would be impossible because the parties are too conflicted, and the answer then would be to not allow direct-to-consumer advertising at all.
Direct-to-consumer advertising certainly has the ability to change the nature of the relationships that caregivers have with their patients, and vice versa. That is true of medical information that comes from any source, such as information available on the internet, from advocacy groups, and from professional organizations. Any of this information could potentially change the quality of that relationship and strengthen the position of patients and families.
From what I have seen of direct-to-consumer advertising, a lot of the drugs that are promoted seem to be lifestyle drugs, or so-called "me-too" drugs. I have not seen a lot of advertising for chemotherapy, although we are starting to see more advertising for supportive drugs that are relevant to oncology. I have a hypothesis about which types of oncology drugs are most likely to be advertised directly to the consumer. I think they are less likely to be those drugs that have been proven to have benefits, have no competitors, or are known to be cost-effective. There would be no reason to promote them, as they are going to be used anyway. In contrast, it’s those drugs in competitive markets, at the margins of evidence-based medicine, where pressure from patients resulting from direct-to-consumer advertising might lead to more prescribing. I suspect that these marginal drugs will be the very ones that are advertised most, which is worrisome.
A PATIENT’S PERSPECTIVE
Cancer survivor:
I speak today from the perspective of an ovarian cancer survivor and a person who has been in treatment for many years with autoimmune disease, so some of the blandishments from direct-to-consumer advertising are aimed directly at me. My starting position is that it is good for patients to be armed with good information. I am not sure, however, that direct-to-consumer advertising is the place to get that information. It can often be a good place to start.
With some ads, I cannot figure out what in the world they are pitching. A man and a woman in their 40s, both fit, with fabulous cheek bones, staring into each other’s eyes while a thousand violins saw away... is it treatment for erectile dysfunction? Rheumatoid arthritis? Life insurance? Diamonds? Perhaps they are deliberately vague, or maybe I still suffer the vestiges of "chemo brain," because a lot of times I just don’t get it.
The ads pitched to cancer patients or patients with rheumatoid arthritis are clearer, but what strikes me is that the bad news is airbrushed away. It is left to the physician to deliver the bad news that the ads carefully omit, such as "your insurance may pay for Zofran® (ondansetron; GlaxoSmithKline), for Remicade® (infliximab; Centocor, Inc.), for Enbrel® (Etanercept; Amgen Inc. and Wyeth), but only after other drugs fail." That makes the physician the agent of the insurance carrier, whether he wants to be or not. Similarly, Enbrel® ads don’t tell you it isn’t a pill; you have to stick a needle into yourself. I’m on Remicade® because I’d rather have someone else stick a needle into me than do it myself. I know from my treatment with Neupogen® (filgrastim; Amgen Inc.) that "...find a fleshy part of your stomach or thigh..." is the easiest part of the protocol.
So what can a patient do? I can only tell you my own experience. You can be threatened and defensive. You can pretend that you know more―that you are the wise, all-knowing doctor. That’s what happened to me in 1997 when I asked my mother’s doctor why she didn’t prescribe Fosamax® (alendronate; Merck & Co., Inc.) to control the osteoporosis that was crumbling my mother’s spine. "It’s an experimental drug," she told me. She also told me she couldn’t talk to me because Medicare didn’t pay her to communicate with family. The reaction of patients to this response will probably be the same as mine: rage and frustration that questions are trivialized and the response equivocal, or just plain wrong.
On the other hand, I remember my oncologist’s response when I came to his office with my sheaf of information copied from the internet. "You must get sick of patients with their internet questions," I said. His response, "Oh, no, it keeps me on my toes." He could have been inwardly grinding his teeth, but his answer relieved me, empowered me, and averted any physicianpatient tension.
What’s the attraction for patients in direct-to-consumer advertising? Mostly, it’s an effort, I think, to right the balance of power in a situation in which we feel powerless. The medical profession has the information and knowledge, but it’s my body: my lumpy, highly imperfect body, but one with which I’ve grown familiar over the years. And now weird, scary things are going on, that you know much more about than I do. I may not know about what’s happening inside my body, but I do know how chemotherapy affected me, and that’s where direct-to-consumer advertising can also find a home. Zofran® and Neupogen®, for example, allowed me to get out of the house and lead a seminormal life (if a bald, sweating, anorectic woman can be said to have a normal life).
Righting the imbalance of power in the relationship between physician and patient is the first reason these ads are attractive. Second, and this was not my issue, but I know it’s true for others, is whether we already have a relationship with our caregivers. I knew a long time ago that I would never get sick (we never do), but if I were, I wanted to get my care at the same hospital where I had worked for many years. I also had a longstanding relationship with my primary care physician. This is not true for many folks, and it’s particularly hard for patients referred in from the community. Direct-to-consumer advertising allows that patient to test the doctor ("Does this guy know what he’s talking about?"), another teeth-grinding experience for physicians.
Almost every phase of our lives is being medicalized, a process in which consumers and providers are co-conspirators. Something wrong? Take a pill. See an expert. Go to the doctor. We are all complicit in this unfortunate evolution. Direct-to-consumer advertising finds a home in this phenomenon. Linked to this is that we live in a culture of blame, a culture of victims. We don’t want to acknowledge that actions have consequences. If I eat too much, I get fat. But rather than eating less and getting exercise, wouldn’t it be great to take a pill so I can eat all I want?
What I want from my doctors, and which, thank God, I received, is the sense that I am a partner in my own care. I want to talk to my ophthalmologist about Restasis® (cyclosporine ophthalmic emulsion; Allergan Inc.), my rheumatologist about Remicade®, and my oncologist about Zofran® and Neupogen®, and have my ideas and questions treated with respect and dignity rather than trivialized. Don’t treat me like a blithering idiot, even if I am. Take me as I am, with my limitations and my terror, and understand that I want knowledge about my own disease, whether I get it from you or from the pharmaceutical industry. I’d rather it be you.
NEGATIVE EFFECTS ON THE PATIENT PROVIDER RELATIONSHIP
Senior Oncologist:
I will start by saying that I remember practicing medicine before 1997 (the year when the FDA expanded the role of broadcast direct-to-consumer advertising), and there really has been a change. I can give you some observations from the field to support the idea that it has impacted the patientprovider relationship, and in my view, in a bad way. In some instances, it has merely accentuated or exacerbated communication difficulties. Some doctors are exasperated by demanding or inquisitive patients, and many feel they are unfairly cast as villains in sorry confrontations between advertisers and payers.
It’s not about withholding information. I believe in solid partnerships through education and information. I have volunteered my time and effort to make information available to patients through the American Society of Clinical Oncology (ASCO)’s website People Living with Cancer. It is a website for patients and laypeople that has up-to-date information on every kind of cancer, every kind of treatment, and a section on how to cope and where to find help. We have struggled at ASCO, and I have personally struggled, with just how much assistance we should accept from the pharmaceutical industry when seeking their sponsorship for such educational campaigns and initiatives.
I think that if the pharmaceutical companies were really interested in empowering and educating the public, they could form a consortium. For example, all of the companies that make H2-blockers could put out an informational advertisement together regarding the use and potential benefits of this class of drugs and on the bottom of the advertisement put everybody’s logo and say "you choose." If the point is to educate, there are far better ways to do it. The purpose of direct-to-consumer advertising is to sell products, not to educate in its broadest sense. The mission is to make money. The billions of dollars spent on advertising clearly inflate the prices of the drugs. We need to acknowledge the exciting partnerships between academia and industry to develop new drugs. That’s fantastic and worthy of our support. But we are not currently discussing the benefits of drug development and medical advances; today’s topic deals only with advertising existing and expensive new drugs. Flooding us with advertisements for Neulasta® (pegfilgrastim; Amgen Inc.) during the SuperBowl serves only one purpose: to make sure that every person receiving chemotherapy with access to a television will ask his or her physician about the drug the next day.
My opinion is that the mission of the pharmaceutical companies with direct-to-consumer advertising is to make a profit, artfully disguised as providing a service and educating. We need to think about the financial cost to the general public as well as to consider safety issues. The Vioxx® (rofecoxib; Merck & Co., Inc.) story is a perfect example of how people really felt they needed to advocate for themselves and ask for a drug they thought was better, when in reality it lead to regrettable complications.
EMPOWERING PATIENTS
Moderator:
I am struck by what we saw happen with Procrit® (epoetin alpha; Ortho Biotech Products, L.P.). Before it was advertised directly to consumers, nobody was using it, partially because patients did not tell their doctors they were fatigued. It is a classic example of empowering patients, telling them, ", if you are tired, tell your doctor you are tired and they can give you something for it." This led to a dramatic increase in use of Procrit®. For many patients, that led to a better outcome: better hemoglobin and better tolerance of chemotherapy. Obviously, I am disturbed by the excesses. I think Bill Frist’s idea of 2 years before allowing direct-to-consumer advertising is reasonable for new drugs, but I wonder if we run the risk of missing an opportunity, like with Procrit®, to help patients communicate better with their doctors.
Senior Oncologist:
I am absolutely with you on that, the idea of partnership, sharing information, and training our nurses and doctors to elicit symptoms. This way, we can ensure that we find out what is troubling a patient, and that we don’t block their concerns with "your counts are fine, here are the orders for chemotherapy," as if that’s our only job. One of the things we can do is train ourselves to communicate clearly and provide the "right" amount of information to each patient. Obviously, we are dependent on the pharmaceutical companies for much of the information on new drugs. At some point, however, there has to be a compromise that falls short of allowing an unchecked stream of advertising into patients’ living rooms.
INFORMATION QUALITY
Oncology Nurse:
One of the things that really bothers me is the lack of important information and the misinformation. We have mentioned Procrit®. I am not sure if the advertisements mention the fact that the drug works by increasing hemoglobin and that there are many other reasons for fatigue in patients with cancer. They make it sound as if it works for any kind of fatigue. It’s that kind of potential misinformation that makes direct-to-consumer advertising difficult.
Physician:
That’s true. Some direct-to-consumer advertising may be for drugs that do not have clear utility, and that’s why the companies are pushing them. Others are for more valuable medications, like Procrit® or others that actually have to do with quality of life.
Oncology Nurse:
It is also interesting that direct-to-consumer advertising for medications seldom includes the cost. Patients don’t know when they go into the physician’s office if a new drug they saw advertised is not on the formulary because it costs ten times what the old drug cost. That’s unfair. It is a blind form of advertising when that information is not shared with the consumer.
COMMERCIAL FREE SPEECH
Moderator:
I think direct-to-consumer advertising has probably gone too far. I do think that there should be some more stringent safeguards and controls, yet I am provoked by the free speech question. I am persuaded by the fact that licensed products deserve to be marketed.
Oncology Fellow:
The issue of commercial free speech is a difficult one, but it does seem that the FDA is committed to protecting the right of pharmaceutical companies to provide information about their products. Interestingly, we are the only country that currently protects this particular aspect of free speech, as we are unique among nations in allowing direct-to-consumer advertising without discussion of a ban. New Zealand has allowed it freely in the past, but there is currently a moratorium on the practice there; as part of a new combined drug regulation scheme with Australia, it is likely to be completely banned [3].
REGULATION AND LEGAL ISSUES
Physician:
I think that sometimes we are obliged to resort to a legal route to try to get pharmaceutical companies to tow the line.
Oncology Fellow:
Again, the FDA does regulate direct-to-consumer advertising and also takes enforcement actions against companies who do not abide by their rules. Some drug companies submit their ads to the FDA before they appear in print or on television, but all are supposed to do so at least simultaneously with the advertisement’s appearance. In 2004, the FDA reviewed 52,800 promotional pieces [4]. The mechanism of legal action against ads that do not provide fair balance is to send a warning letter that results in the termination of a campaign. The FDA can also ask that the drug companies undertake a corrective campaign. This happened with an advertisement for Taxotere® (docetaxel; Aventis Pharmaceuticals Inc.) that was found to be misleading. Still, some feel that the FDA’s oversight is not rigorous enough. Beyond the FDA, I wonder if oncology providers need to get more involved in regulating cancer-related direct-to-consumer advertising.
Social worker:
It is a public health issue, no question about it. I think of the International Physicians for Prevention of Nuclear War. They came out and spoke against weapons being produced and how it affected physicians, taking the position that "we are the healers and we are telling you that you are hurting, not healing." It is hard to do that directly with drug companies, but it might be necessary.
DISCUSSION
Background of Direct-to-Consumer Advertising in the U.S.
Direct-to-consumer advertising is an increasingly prevalent phenomenon in the U.S. In 1990, $47 million was spent on print and broadcast advertisements aimed directly at medical consumers; by 2000, this had risen to $2.5 billion, with more than $100 million spent for some individual drugs [5]. While more recent data are less readily available, it is likely that billions more are now spent, with at least $4 billion per year as a recent estimate [6]. Indeed, the money spent on this type of advertising can be substantial when compared with revenue: in 2004, GlaxoSmithKline spent $157 million on advertising for its erectile dysfunction medication Levitra® (vardenafil; GlaxoSmithKline), which that year had only about $250 million in sales [7].
The pharmaceutical companies are the fifth largest buyer of television time. Commercials such as Amgen’s "I’m ready" television campaign for Neulasta® are not inexpensive: Adweek estimates that, pharmaceutical companies spent over $6.5 billion in 2004 [2]. While perhaps experiencing a more cautious rise, cancer-related direct-to-consumer advertising now seems to be becoming more widespread. Table 1 provides a list, by class, of cancer medications that have appeared in the past 2 years of the magazine CURE. Initiated in 2002, CURE is a publication that is directed at cancer patients, survivors, and caregivers. In their media kit for potential advertisers, CURE claims a quarterly circulation of 425,000 readers (e.g., 195,000 women with current or former breast cancer) [8].
Historically, the timeline for direct-to-consumer advertising began in the early 1700s, when "patent" medications were first advertised in U.S. newspapers. Over the next 200 years, advertisements for such medications formed the largest part of newspaper revenues. Cures for ailments from dandruff to rheumatism were peddled, but claims were not regulated [1]. The next important year with respect to regulation of direct-to-consumer advertising was 1938, when the Food, Drug, and Cosmetic Act was passed. The newly-created FDA was given authority over the labeling of drugs, but the Federal Trade Commission was charged to "regulate" drug promotion and advertising [9]. In 1962, The Kefauver-Harris Act was passed, requiring that all drugs be proven to be both safe and effective. This act also transferred the authority for oversight of prescription drug promotional material to the FDA. This era saw the birth of the concept of "fair balance," the idea that an advertisement for a medication should include both a discussion of benefits as well as risks and side effects. Most advertisements were still directed solely at providers [1, 9].
In 1981, the first modern direct-to-consumer advertisement appeared in Reader’s Digest for the pneumonia vaccine Pneumovax® (Merck & Co., Inc.) [9]. That same year, the pharmaceutical lobbyists proposed that consumers should be allowed to reap what they saw as the educational benefits of direct-to-consumer advertising. Attitudes toward the physicianpatient partnership were also changing, and the political climate became more favorable to the pharmaceutical industry. In 1985, after a brief moratorium on the practice of direct-to-consumer advertising in order to survey consumers and encourage public debate, the FDA published a notice in the Federal Register stating that the 1962 regulations were sufficient to protect consumers from misleading material [1]. That notice opened the door to widespread print direct-to-consumer advertisements. "Fair balance" continued to be the rule, and most print ads included the entire package insert to cover all possible drug risks and complications.
In 1997, after several years of discussion with the pharmaceutical industry and following a public hearing, the FDA issued a new Guidance for Industry in the Federal Register [10]. That document specified that it was not necessary to provide detailed summaries of potential risks and side effects in broadcast media. For the first time, advertisers could provide the name of a drug and condition in a television advertisement without having to disclose all the product’s risks, only what the FDA deemed a "major statement" of those risks. Advertisers also had to have "adequate provision" for access to a "brief summary" of these risks somewhere else (e.g., toll-free numbers, fax, the internet, print advertising). Three types of broadcast advertisements evolved:"health-seeking"(educational about medical issue, no access to brief summary required), "reminder" (just the name of a drug, no access to brief summary required), and "product-specific" (mentions product and use, brief summary or adequate provision required) [4]. Many believe that the 1997 clarification of the rules for broadcast advertising was responsible for the deluge of such advertisements seen in recent years, although there is some evidence that it began to increase a few years earlier [11].
PATIENT AND PROVIDER ATTITUDES
In 1999, the FDA conducted a survey of 1,081 consumers to determine their attitudes about direct-to-consumer advertising. They repeated the survey with another 960 consumers in 2002 and surveyed 500 physicians as well [12]. In the consumer surveys, of interest were changes in the respondents’ responses over time. For example, in 1999, 52% of those surveyed said they "like" seeing direct-to-consumer advertisements, but by 2002 this number had declined to 32%. In 1999, 52% of the respondents said that an ad prompted them to search for further information, compared with only 43% in 2002. Regarding which sources the respondents consulted for further information after seeing an advertisement, in 1999, 83% consulted their own doctor, compared with 89% in 2002; 18% turned to the internet in 1999, compared with 38% in 2002.
The results of the FDA’s physician survey are often cited as evidence that providers do not, on the whole, feel that direct-to-consumer advertising should be eliminated. This is because, of the 500 physicians polled, only 32% felt direct-to-consumer advertising was negative, whereas 40% believed that it was positive, and 28% thought it had no overall effect. Interestingly, general practitioners reported a more negative overall impact of direct-to-consumer advertisements than specialists, perhaps reflecting the ability of the more focused specialist to resist requests for specialized medications. As a subspecialist, this might also be true of the oncology provider.
Subsequent independent surveys have shown both positive and negative attitudes toward direct-to-consumer advertising [13, 14]. A large national study published in Health Affairs in 2003 by Weissman and colleagues [15] showed that, of 3,000 adult consumers, 86% had seen or heard an ad, and 35% of these consumers were prompted by an ad to discuss a medication with their doctor. For those who did discuss a medication, 25% received a new diagnosis, 43% of which were deemed "high priority" according to predetermined criteria. The authors concluded that direct-to-consumer advertising could have beneficial effects. They later surveyed a national sample of 643 physicians [16] and found that 70% felt that direct-to-consumer advertising helped to educate patients. The physicians reported prescribing a requested drug 39% of the time. While not without their critics [17, 18], these two studies appear to be the most comprehensive yet on the topic of direct-to-consumer advertising.
Finally, while studies specific to oncology are rare, Viale and Sanchez Yamamoto [19] surveyed 221 American oncology nurse practitioners (ONPs). Ninety-four percent reported having had a request for medication by a patient who had seen an advertisement, with 40% experiencing one to five requests per week. Fifty-two percent of the ONPs "never" felt pressured to prescribe, but 43% "sometimes" felt pressured to prescribe. Alarmingly, 74% said patients asked for inappropriate medications. Interestingly, 63% felt that direct-to-consumer advertising fostered patientONP dialogue. The authors concluded that direct-to-consumer advertising was prevalent in ONPpatient encounters and had the potential to influence prescribing behavior.
PATIENT OUTCOMES
How do patients’ attitudes about direct-to-consumer advertising affect their behavior? In a survey of 329 respondents from Sacramento, CA, Bell and associates showed that awareness of advertisements and respondents’ subsequent medication requests were both associated with prescription drug use in general, media exposure, positive attitudes toward direct-to-consumer advertising, poorer health, and better insurance coverage [20]. Respondents were more likely to be aware of ads for treatments for the diseases they had; for example, asthmatics were twice as likely to be aware of advertisements for an asthma drug than those without asthma (p = .002). This result argues that cancer patients should have high attention to cancer-related ads. An earlier study suggested that a combination of baseline media exposure, attitudinal factors, and medication experience were likely to influence whether or not patients would ask for a medication after having seen an ad [21], and Sumpradit and colleagues reported that patients who had talked to their doctors about an ad were about twice as likely to have a chronic medical condition [22].
A study conducted by the Centers for Disease Control examined whether exposure to direct-to-consumer advertising increased the number of patients undergoing genetic testing for breast and ovarian cancer [23]. By comparing patient outcomes in two cities (Atlanta and Denver) where campaigns for genetic testing had appeared with those in two cities where such advertisements had not (Raleigh-Durham and Seattle), they were able to show that potential cancer patients are affected by direct-to-consumer advertising. They surveyed 1,635 women and 1,054 providers. Despite a low consumer response rate (45%), the study demonstrated that consumer respondents were about twice as likely to have heard of the genetic test if they lived in a city where it was advertised (p < .05), and providers in the advertising cities were about twice as likely to say that, comparing the past 6 months with the same period in the prior year, requests for the test had increased (p < .05). Direct-to-consumer advertising for genetic testing for cancer susceptibility has since become an intensely controversial area [24].
PROVIDER OUTCOMES
Another major question in the nascent literature on direct-to-consumer advertising concerns how advertising affects provider prescribing behavior [25]. Zachry and associates [26] performed a postal survey of Arizona primary care physicians (n = 1,080) and physician assistants (n = 704) with questionnaires containing several hypothetical patient scenarios. Clinicians who responded to a patient’s questions supposedly prompted by direct-to-consumer advertising, relative to those who responded to the same questions apparently prompted by a patient’s having read the Physicians’ Desk Reference, were more likely to become annoyed with the patient (p =.003), less likely to answer the patient’s questions (p =.03), and less likely to provide a prescription (p < .001) for a requested medication. The authors thus posited that clinicians may be less receptive to medication questions and requests when they arise from direct-to-consumer advertising.
This observation is further strengthened by a recent randomized clinical trial using standardized patient actors. Kravitz and colleagues [27] developed six roles for the actors by "crossing" two conditions (major depression and adjustment disorder) with three medication request types (brand-specific, general, or none). These six types of standardized patients were then sent into the offices of 150 primary care physicians who had agreed to see a few standardized patients over a 1-year period. On different visits, they either asked for the antidepressant Paxil® (paroxetine; GlaxoSmithKline), asked for a nonspecific antidepressant after supposedly having seen a television program about depression, or did not ask for medication at all. Importantly, the authors assumed that most doctors feel that an antide-pressant is a reasonable choice for major depression but more questionable for adjustment disorder.
For major depression, rates of all antidepressant prescribing were 53%, 76%, and 31% for standardized patients making brand-specific, general medication, and no requests (p < .001 for differences among rates). Thus, general requests were more effective even than brand-specific requests. In adjustment disorder, all antidepressant prescribing rates were 55%, 39%, and 10% (p < .001). For this more questionable indication, it seems that general requests were less effective than with major depression, but brand-specific requests were more powerful. This hints at more influence for direct-to-consumer marketing when drugs are of questionable use, as are antidepressants in adjustment disorder [28].
RECENT DEVELOPMENTS
In February of 2004, the FDA issued a draft Guidance for Industry regarding the information included in the brief summary portion of direct-to-consumer advertisements [29]. Several pharmaceutical advertisers have responded by changing their practice of reprinting their approved package insert and now include more patient-friendly explanations of possible side effects. The FDA also recently issued Draft Guidances for industry comment purposes on consumer-directed broadcast advertising of restricted medical devices [30], as well as help-seeking and other disease awareness communications by or on behalf of drug and device firms [31]. Such developments, especially the possibility of clearer language for the brief summary, were cautiously applauded, notably in a January 2005 perspective piece in The New England Journal of Medicine [32].
In July of 2005, Senator Frist, a former practicing physician, called for a 2-year ban on direct-to-consumer advertising and asked for the Government Accounting Office to study the issue. [2] Dr. Frist’s suggestion was not taken lightly by the Pharmaceutical Researchers and Manufacturers of America (PhRMA). In August of 2005, the Association, lead by CEO William Tauzin, a former congressman, adopted voluntary "guiding principles" to go into effect in January of 2006 [33]. Highlights include the requirement that participating companies should submit all new direct-to-consumer television advertisements to the FDA before releasing them for broadcast and that direct-to-consumer television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved (the end of "reminder ads"). The principles also assert that companies should spend an "appropriate" amount of time to educate health professionals about new medicines before beginning their first direct-to-consumer advertising campaigns. This appropriate amount of time is left to be determined by the companies themselves, but is ostensibly somewhat short of Dr. Frist’s 2-year suggestion.
The FDA held a public hearing on direct-to-consumer promotion of medical products in November of 2005. Thirty-eight speakers presented their views on the topic, including the president of Pfizer, patients who had had prior experience with the medium, lobbyists both for and against direct-to-consumer advertising, and several academic researchers [34]. Other topics included a review of the new Draft Guidance for the brief summary, the use of celebrities in direct-to-consumer advertising, internet advertising, and the ethics of direct-to-consumer advertising of genetic testing.
CONCLUSION
Direct-to-consumer advertising as it has developed over the past several decades has many potential benefits and perils. Benefits include that it might strengthen the providerpatient relationship through empowering and educating patients and that it may help address patient underdiagnosis and undertreatment. It is also possibly part of a guaranteed right to commercial free speech under the first amendment. Perils are that it can be misleading, does not seem to be rigorously regulated, and can also undermine the providerpatient relationship. Worse, it may lead to inappropriate provider prescribing behavior and increased health care costs, especially in cases in which the best course of medical therapy is not clear.
Issues in direct-to-consumer advertising specific to oncology include the special vulnerability of cancer patients to marketing manipulation, the problem of achieving fair balance in advertisements for complicated chemotherapeutics, and the possibly harmful nature of a proposed delay in direct-to-consumer advertising in the case of certain new oncology medications. The year 2006 promises to be a pivotal time for this topic, as the new PhRMA principles go into effect and the FDA considers the data presented at the November 2005 public hearings. Finally, new research is needed to highlight both the special effects that this powerful mode of communication may have in oncology and to devise methods to protect cancer patients from any unseemly consequences.
DISCLOSURE OF POTENTIAL CONFLICT OF INTEREST
The authors indicate no potential conflicts of interest.
REFERENCES
Wilkes MS, Bell RA, Kravitz RL. Direct-to-consumer prescription drug advertising: trends, impact, and implications. Health Aff (Millwood) 2000;19:110128.
Melillo W. Drug companies work to stave off legislation. Adweek, July 11, 2005.
Lenzer J. FDA investigates direct to consumer adverts. BMJ 2005;331:1102.
Behrman RE. The Impact of Direct-to-Consumer Drug Advertising on Seniors’ Health and Health Care Costs. Testimony Before the Senate Special Committee on Aging. United States Senate, September 29, 2005.
Fintor L. Direct-to-consumer marketing: how has it fared? J Natl Cancer Inst 2002;94:329331.
Saul S. Drug makers to police consumer campaigns. The New York Times, August 3, 2005:7.
Macilwain C. Drug firms back-pedal on direct advertising. Nature 2005;436:910911.
CURE Magazine Media Kit.
Lyles A. Direct marketing of pharmaceuticals to consumers. Annu Rev Public Health 2002;23:7391.
U.S. Department of Health and Human Services. Guidance for Industry. Consumer-Directed Broadcast Advertisements. August 1999.
Rosenthal MB, Berndt ER, Donohue JM et al. Promotion of prescription drugs to consumers. N Engl J Med 2002;346:498505.
Aiken K, Swassy J, Braman A. Patient and Physician Attitudes and Behaviors Associated With DTC Promotion of Prescription Drugs―Summary of FDA Survey Research Results. Appendix B.3. 2002 Physician Survey.
Murray E, Lo B, Pollack L et al. Direct-to-consumer advertising: public perceptions of its effects on health behaviors, health care, and the doctor-patient relationship. J Am Board Fam Pract 2004;17:618.
Robinson AR, Hohmann KB, Rifkin JI et al. Direct-to-consumer pharmaceutical advertising: physician and public opinion and potential effects on the physician-patient relationship. Arch Intern Med 2004;164:427432.
Weissman JS, Blumenthal D, Silk AJ et al. Consumers’ reports on the health effects of direct-to-consumer drug advertising. Health Aff (Millwood) 2003;(suppl web exclusives): W3-82W3-95.
Weissman JS, Blumenthal D, Silk AJ et al. Physician reports on patient encounters involving direct-to-consumer drug advertising. Health Aff (Millwood) 2004;(suppl web exclusives): W4-219W4-233.
Avorn J. Advertising and prescription drugs: promotion, education, and the public’s health. Health Aff (Millwood) 2003;(suppl web exclusives): W3-104W3-108.
Dubois RW. Pharmaceutical promotion: don’t throw the baby out with the bathwater. Health Aff (Millwood) 2003;(suppl web exclusives):W3-96W3-103.
Viale PH, Sanchez Yamamoto D. The attitudes and beliefs of oncology nurse practitioners regarding direct-to-consumer advertising of prescription medications. Oncol Nurs Forum 2004;31:777783.
Bell RA, Kravitz RL, Wilkes MS. Direct-to-consumer prescription drug advertising and the public. J Gen Intern Med 1999;14:651657.
Peyrot M, Alperstein NM, Van Doren D et al. Direct-to-consumer ads can influence behavior. Advertising increases consumer knowledge and prescription drug requests. Mark Health Serv 1998;18:2632.
Sumpradit N, Fors SW, McCormick L. Consumers’ attitudes and behavior toward prescription drug advertising. Am J Health Behav 2002;26:6875.
Centers for Disease Control and Prevention (CDC). Genetic testing for breast and ovarian cancer susceptibility: evaluating direct-to-consumer marketing--Atlanta, Denver, Raleigh-Durham, and Seattle, 2003. MMWR Morb Mortal Wkly Rep 2004;53:603606.
Gray S, Olopade OI. Direct-to-consumer marketing of genetic tests for cancer: buyer beware. J Clin Oncol 2003;21:31913193.
Mintzes B, Barer ML, Kravitz RL et al. How does direct-to-consumer advertising (DTCA) affect prescribing? A survey in primary care environments with and without legal DTCA. CMAJ 2003;169:405412.
Zachry WM 3rd, Dalen JE, Jackson TR. Clinicians’ responses to direct-to-consumer advertising of prescription medications. Arch Intern Med 2003;163:18081812.
Kravitz RL, Epstein RM, Feldman MD et al. Influence of patient’s requests for direct-to-consumer advertised antidepressants: a randomized controlled trial. JAMA 2005;293:19952002.
Hollon MF. Direct-to-consumer advertising: a haphazard approach to health promotion. JAMA 2005;293:20302033.
U.S. Department of Health and Human Services. Guidance for Industry. Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements. Draft Guidance, January, 2004.
U.S. Department of Health and Human Services. Draft Guidance for Industry and FDA. Consumer-Directed Broadcast Advertising on Restricted Devices. Draft Guidance - Issued 2/10/04.
U.S. Department of Health and Human Services. Guidance for Industry. "Help-Seeking" and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms. Draft Guidance, January 2004.
Berndt ER. To inform or persuade? Direct-to-consumer advertising of prescription drugs. N Engl J Med 2005;352:325328.
PhRMA Guiding Principles: Direct to Consumer Advertisements About Prescription Medicines.
Vastag B. FDA considers tightening regulations for direct-to-consumer advertising. J Natl Cancer Inst 2005;97:18061807.
