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Schwartz Center Rounds |
Department of Medicine, Division of Hematology-Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA; Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Key Words. Cancer • Support • Psychosocial • Personal • Communication • Connection
Correspondence: Richard T. Penson, M.R.C.P., M.D., Department of Medicine, Division of Hematology-Oncology, Massachusetts General Hospital, 55 Fruit Street, Yawkey 9066, Boston, Massachusetts, 02114-2617, USA. Telephone: 617-726-5867; Fax: 617-724-6898; e-mail: rpenson{at}partners.org
Received December 30, 2005; accepted for publication December 30, 2005.
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ABSTRACT |
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 Top Abstract PresentationDirect-to-Consumer Advertising:...Ethical IssuesA Patient's PerspectiveNegative Effects on the...Empowering PatientsInformation QualityCommercial Free SpeechRegulation and Legal IssuesDiscussionPatient and Provider AttitudesPatient OutcomesProvider OutcomesRecent DevelopmentsConclusionDisclosure of Potential Conflict...References |
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PRESENTATION |
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TopAbstractPresentationDirect-to-Consumer Advertising:...Ethical IssuesA Patient's PerspectiveNegative Effects on the...Empowering PatientsInformation QualityCommercial Free SpeechRegulation and Legal IssuesDiscussionPatient and Provider AttitudesPatient OutcomesProvider OutcomesRecent DevelopmentsConclusionDisclosure of Potential Conflict...References |
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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?
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DIRECT-TO-CONSUMER ADVERTISING: DEFINITION AND OVERVIEW |
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TopAbstractPresentationDirect-to-Consumer Advertising:...Ethical IssuesA Patient's PerspectiveNegative Effects on the...Empowering PatientsInformation QualityCommercial Free SpeechRegulation and Legal IssuesDiscussionPatient and Provider AttitudesPatient OutcomesProvider OutcomesRecent DevelopmentsConclusionDisclosure of Potential Conflict...References |
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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.
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ETHICAL ISSUES |
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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.
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A PATIENT’S PERSPECTIVE |
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TopAbstractPresentationDirect-to-Consumer Advertising:...Ethical IssuesA Patient's PerspectiveNegative Effects on the...Empowering PatientsInformation QualityCommercial Free SpeechRegulation and Legal IssuesDiscussionPatient and Provider AttitudesPatient OutcomesProvider OutcomesRecent DevelopmentsConclusionDisclosure of Potential Conflict...References |
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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 physician–patient 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.
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NEGATIVE EFFECTS ON THE PATIENT –PROVIDER RELATIONSHIP |
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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.
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EMPOWERING PATIENTS |
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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.
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INFORMATION QUALITY |
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TopAbstractPresentationDirect-to-Consumer Advertising:...Ethical IssuesA Patient's PerspectiveNegative Effects on the...Empowering PatientsInformation QualityCommercial Free SpeechRegulation and Legal IssuesDiscussionPatient and Provider AttitudesPatient OutcomesProvider OutcomesRecent DevelopmentsConclusionDisclosure of Potential Conflict...References |
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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.
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COMMERCIAL FREE SPEECH |
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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].
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REGULATION AND LEGAL ISSUES |
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TopAbstractPresentationDirect-to-Consumer Advertising:...Ethical IssuesA Patient's PerspectiveNegative Effects on the...Empowering PatientsInformation QualityCommercial Free SpeechRegulation and Legal IssuesDiscussionPatient and Provider AttitudesPatient OutcomesProvider OutcomesRecent DevelopmentsConclusionDisclosure of Potential Conflict...References |
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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.
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DISCUSSION |
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TopAbstractPresentationDirect-to-Consumer Advertising:...Ethical IssuesA Patient's PerspectiveNegative Effects on the...Empowering PatientsInformation QualityCommercial Free SpeechRegulation and Legal IssuesDiscussionPatient and Provider AttitudesPatient OutcomesProvider OutcomesRecent DevelopmentsConclusionDisclosure of Potential Conflict...References |
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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].
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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 physician–patient 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].
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PATIENT AND PROVIDER ATTITUDES |
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TopAbstractPresentationDirect-to-Consumer Advertising:...Ethical IssuesA Patient's PerspectiveNegative Effects on the...Empowering PatientsInformation QualityCommercial Free SpeechRegulation and Legal IssuesDiscussionPatient and Provider AttitudesPatient OutcomesProvider OutcomesRecent DevelopmentsConclusionDisclosure of Potential Conflict...References |
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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 patient–ONP dialogue. The authors concluded that direct-to-consumer advertising was prevalent in ONP–patient encounters and had the potential to influence prescribing behavior.
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PATIENT OUTCOMES |
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TopAbstractPresentationDirect-to-Consumer Advertising:...Ethical IssuesA Patient's PerspectiveNegative Effects on the...Empowering PatientsInformation QualityCommercial Free SpeechRegulation and Legal IssuesDiscussionPatient and Provider AttitudesPatient OutcomesProvider OutcomesRecent DevelopmentsConclusionDisclosure of Potential Conflict...References |
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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].
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PROVIDER OUTCOMES |
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TopAbstractPresentationDirect-to-Consumer Advertising:...Ethical IssuesA Patient's PerspectiveNegative Effects on the...Empowering PatientsInformation QualityCommercial Free SpeechRegulation and Legal IssuesDiscussionPatient and Provider AttitudesPatient OutcomesProvider OutcomesRecent DevelopmentsConclusionDisclosure of Potential Conflict...References |
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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].
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RECENT DEVELOPMENTS |
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TopAbstractPresentationDirect-to-Consumer Advertising:...Ethical IssuesA Patient's PerspectiveNegative Effects on the...Empowering PatientsInformation QualityCommercial Free SpeechRegulation and Legal IssuesDiscussionPatient and Provider AttitudesPatient OutcomesProvider OutcomesRecent DevelopmentsConclusionDisclosure of Potential Conflict...References |
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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.
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CONCLUSION |
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TopAbstractPresentationDirect-to-Consumer Advertising:...Ethical IssuesA Patient's PerspectiveNegative Effects on the...Empowering PatientsInformation QualityCommercial Free SpeechRegulation and Legal IssuesDiscussionPatient and Provider AttitudesPatient OutcomesProvider OutcomesRecent DevelopmentsConclusionDisclosure of Potential Conflict...References |
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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.
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DISCLOSURE OF POTENTIAL CONFLICT OF INTEREST |
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TopAbstractPresentationDirect-to-Consumer Advertising:...Ethical IssuesA Patient's PerspectiveNegative Effects on the...Empowering PatientsInformation QualityCommercial Free SpeechRegulation and Legal IssuesDiscussionPatient and Provider AttitudesPatient OutcomesProvider OutcomesRecent DevelopmentsConclusionDisclosure of Potential Conflict...References |
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REFERENCES |
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