TV DTC Educate Little, Increase Sales Less

[JohnMack]

Drugmaker TV Ads Educate Little, May Be Misleading, Study Says

By Elizabeth Lopatto

Jan. 29 (Bloomberg) -- TV advertising by Pfizer Inc. and other drugmakers has ``limited'' educational value and may oversell the benefits of medicine, researchers said.

While only about one in every four commercials in a study described the risk factors or the prevalence of the diseases discussed, some 95 percent relied on emotional appeals to consumers, researchers said in the January-February issue of Annals of Family Medicine.

While drugmakers portray direct-to-consumer advertising as a tool for making people aware of drugs' benefits, health advocates say it confuses people and puts pressure on doctors to write prescriptions. U.S. viewers, on average, see as much as 16 hours of commercials yearly for prescription drugs, topping time spent with doctors, according to earlier research. The industry in 2005 agreed to voluntary guidelines on ad content.

``Drug companies should not sell be selling drugs by manipulating consumers' emotions,'' the lead author of the study, Dominick Frosch, a professor of medicine at the University of California, Los Angeles, said in a Jan 26 telephone interview.

The industry, led in outlays by London-based GlaxoSmithKline Plc, spent $4.9 billion for consumer ads of all types in the first 11 months of 2006, $86 million more than for all of 2005, according to Nielsen Monitor-Plus data.

The researchers said they reviewed 38 different commercials aired during evening news shows or prime-time programs. While 19 percent of the ads mentioned lifestyle changes as an adjunct to medicine, none of the commercials portrayed such changes as an alternative to medication, according to the study.

Crestor, Nexium

"There are changes in lifestyle that could help people with insomnia,'' Frosch said. "They may not need prescription drugs. It would be helpful and educational to provide alternatives.''

Ads for the Crestor cholesterol drug and Nexium heartburn pill, both made by London-based AstraZeneca Plc, the second- largest U.K. drugmaker, were among those covered by the study.

The Nexium campaign illustrates how drugmakers appeal to emotions, playing on themes such as gaining social approval, according to the study. The researchers said the ads showed a family having dinner.

In one commercial, orange juice turned to acid, while in another, gravy was transformed into thumbtacks, the researchers said. Only after the narrator promoted ``Nexium, the healing purple pill,'' were the characters were able to eat and participate in the dinner-table conversation.

'Constrained' by Time

"TV advertising is constrained by the amount of time you can communicate a message: the awareness of a disease,'' said Manny Rivera, the consumer brand director for Nexium in the U.S., in a telephone interview on Jan. 26. "The goal is to get the patient-physician dialogue going.''

The study appears to be based on "pretty dated information,'' said Jack Cox, a spokesman for New York-based Pfizer, the world's largest drug company, in a telephone interview.

The ads surveyed were from 2004, before new voluntary guidelines for direct-to-consumer drug ads were released by the Pharmaceutical Research and Manufacturers of America, a Washington-based trade group known as PhRMA, Cox said. He also said he questions the methods used by the researchers.

"Their entire interpretation was subjective,'' he said. "They didn't talk to consumers or physicians. It was a bunch of Ph.D.'s sitting around, looking at ads.''

While the researchers' method of examining ads was standard, "it's hard to draw conclusions from a content analysis, as to what consumers are getting,'' Lauren Block, a professor of marketing at the City University of New York's Baruch College, said in a telephone interview today.

Benefits and Risks

PhRMA's guidelines say ads should be designed to ``achieve a balanced presentation of the benefits and risks associated with prescription medicine,'' according to the group's Web site.

The principles also say drugmakers should submit ads to the U.S. Food and Drug Administration for review before airing them. The FDA's practice has been to allow companies to air ads first and only then submit them for review.

In editorial published along with the study, former FDA Commissioner David Kessler and a co-author said the drug companies ``should adhere to the standards and ethics of medicine, not the standards and ethics of selling soap or some other consumer product that presents minimal risks.''

Kessler now is medical dean and vice chancellor for medical affairs at the University of California, San Francisco.

For every 10 percent increase in advertising for a given type of medicine, prescription sales for the category rise 1 percent, according to a 2003 study by the Henry J. Kaiser Family Foundation, based in Menlo Park, California. In 2002, every extra dollar drug companies spent on ads pushed up revenue by $4.20, the research found.

[JohnMack]

This study may or may not be blogworthy, but one statement from a Pfizer spokesperson stands out and deserves scrutiny; namely, "It was a bunch of Ph.D.'s sitting around, looking at ads.''

I guess Pfizer develops its drugs without the help of PhDs. No wonder it's had trouble bringing drugs to market lately.

Or maybe Pfizer is not with the mainstream thinking of pharma-friendly organizations like the Coalition of Healthcare Communication, which urges that FDA fund more studies by PhDs on how to communicate risk in DTC ads.

[JohnMack]

Pharma Advertisers Decry Misleading Study
January 30, 2007

By Jim Edwards

NEW YORK -- Advertisers’ lobbying groups reacted with anger today at a study published in the Annals of Family Medicine that criticized direct-to-consumer prescription drug advertising.

The study was out of date and misconceived, the marketer advocates said.

The study, published Monday, concluded that “only 26%” of drug ads on TV made claims about “risk factors or causes of the condition” in question.

The study also noted that seven of the 38 ads captured in the study were “reminder” ads (promotions which tout the name of the drug but give no other information.) Reminder ads are the subject of a voluntary ban among major drug marketers.

The results are flawed because the study was conducted two years before the reminder ad ban came into effect, said PhRMA, the drug industry lobby group.

“Unfortunately, the study published in the Annals of Family Medicine is based on a sampling of old advertisements broadcast in 2004—long before PhRMA’s Guiding Principles went into effect,” said PhRMA representative Ken Johnson in a statement. “The study does not reflect any of the positive changes in DTC advertisements over the past 12 months and therefore has little relevance to the current policy discussion on direct-to-consumer advertising.”

Click here for the rest...

[JohnMack]

This is from my friend John Kamp< Executive Director of the Coalition for Healthcare Communication:

Coalition Responds to DTC Study, Editorial
In Annals of Family Medicine, January/February 2007

The January/February 2007 edition of the Annals of Family Medicine contains a report on a DTC research study and an accompanying editorial co-authored by former FDA Commissioner David Kessler. Although the FDA needs to ground its DTC policy on the science of consumer behavior, the study and the editorial would lead policy makers in the wrong direction.

Either editorialists Kessler and Levy didn’t read the study carefully or chose to ignore its limits. Nothing in the research supports their opinions and conclusions that more stringent DTC rules are needed. Further, the research authors largely ignore the significant body of studies on the effects of advertising on consumer beliefs and behaviors, including the FDA's own studies, that demonstrate that exposure to advertising leads to more and better doctor-patient conversations.

The authors of the study recognize its limitations, but not their own bias. They note at the end of their Introduction that the study uses "content analysis" which as they say "is a well-established method of inquiry for generating research questions and hypotheses for future experimental and observational studies that examine the effects of adverting on consumers beliefs and behaviors." (Emphasis added) What they don’t appear to recognize is that the study of DTC advertising has largely eclipsed any need for such rudimentary research. Mainline social science researchers have largely abandoned content analysis because it does little to illuminate consumer behavior and can easily mislead lay readers, policy makers, and even academic leaders.

Worse, the authors of the research appear to have designed it to confuse rather than enlighten. The authors’ choice of what to code and how to interpret it, as well as their conclusions in the Discussion section, could easily lead the casual reader to believe that the ads somehow "failed" academic scrutiny and thus need to be more highly regulated. We hope policy makers read the study critically and respect its limits, rather than use it recklessly to support calls for more restrictive DTC policy.

The entire issue of DTC advertising, as well as the regulation of it by the FDA, calls for more and better social science. The Coalition for Healthcare Communication has petitioned the FDA asking the agency to develop a communication advisory committee that could bring better social science to the regulation of consumer advertising. This study would not meet any test of scientific rigor that Dr. Kessler correctly championed during his tenure at FDA. In fact, the scientific studies by the FDA to date have been much more scholarly, granular, precise and useful than this. Clearly, FDA is already well ahead of these researchers in both technique and interpretation.
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Unfortunately, the study denigrates emotional appeals and calls for more fact based advertising. Facts are fine and DTC advertising provides great facts and information, particularly since the industry adopted the PhRMA DTC self-regulation Principles in 2005.

Meanwhile, emotions are a fact of life. Emotions drive much human behavior, including our eagerness to follow our doctors’ instructions. Without emotion, much advertising would be wasted, and great opportunities to advance patient care would be squandered. Good DTC advertising policy demands respect for a clear understanding of consumer behavior, how patients think and act, what drives them to take the medicines that often enable longer and healthier lives. Sophisticated social scientists know this and can help the FDA use this knowledge to inform good public policy choices.

Doctors choose medications for their patients largely based on the science of medicine and the experience of other patients, making it appropriate to focus professional advertising on those facts. Patients respond to different facts and appeals. Good policy requires focus on the information needs of patients, rather than the needs of prescribers.

Today, partially because of exposure to advertising, patients are empowered to have more informed conversations with their doctors about drugs that might be useful for them. Doctors still control the prescribing decision, but look to patients as active participants in decisions and for better adherence to their instructions. DTC advertising plays an increasingly valuable role in this process.

The authors observe that advertising is not a perfect or complete communication tool. No such tool exists, including drug labels, "brief summaries," doctor/patient discussions, extensive continuing education programs and the like. If we had such a magic wand, we all would waive it and our research on DTC could end. In reality, each communication tool has a place, but none can carry the load by itself. So, let's not allow the pursuit of the authors’ implied perfect model for communication impede the beneficial use of advertising.

Although interesting, this study is far from a definitive work and certainly not a basis for more stringent FDA regulation of DTC advertising.

[JohnMack]

Direct-to-Consumer Advertising: Is It Too Late to Manage the Risks?

David A. Kessler, MD and Douglas A. Levy, JD School of Medicine, University of California, San Francisco, San Francisco, Calif
CORRESPONDING AUTHOR: Douglas A. Levy, JD, School of Medicine, Box 0410, University of California, San Francisco, San Francisco, CA 94143-0410 kesslerd@medsch.ucsf.edu


Key Words: Drug industry • prescriptions, drug • public health • health education • primary health care • physician-patient relations • marketing, television, consumer health information


Pharmaceutical spending on television commercials nearly doubled from $654 million in 2001 to a staggering $1.19 billion in 2005. Nearly one third of the 2005 spending was on only 1 category: sleep medicines.1 Yet, sleep disorders, however problematic and serious they may be, are almost inconsequential when compared with the major causes of the death in the United States: cardiovascular disease, cancer, and unintentional injuries.2 No matter how much the industry claims its advertising provides public health benefits, the amount spent promoting drugs for conditions of varying severity begs the question of whether the industry truly is acting for the public benefit.


As Frosch et al show in this issue,3 nearly all pharmaceutical ads are based on emotional appeals, not facts, and few provide necessary details about the causes of a medical condition, risk factors, or lifestyle changes that may be appropriate alternatives to pharmaceutical intervention.

Although none of these findings are surprising, they should be disturbing.

As physicians, we know that even the most effective pharmaceutical may not be right for every patient. Physicians consider everything from individual risk factors and medical history to lifestyle and insurance status before writing a prescription. Yet, when patients walk in the door having just seen a television ad showing a miserable allergy sufferer dancing through a weed-filled field, they expect that a simple stroke of a pen onto a prescription pad will solve whatever their problems may be. Patients learn for the first time about conditions they never worried about before and ask physicians for new medicines by trade name because they saw it on television.


Patients have always expected simple answers to complex questions, but direct-to-consumer (DTC) advertising has elevated this problem to new heights, because patients in some ways now rely on Madison Avenue as a provider of health information. There is nothing wrong with pharmaceutical companies communicating directly with consumers, but they should adhere to the standards and ethics of medicine, not the standards and ethics of selling soap or some other consumer product that presents minimal risks.
Pharmaceutical companies like to say that DTC ads make people aware of medical conditions they did not know they had. Industry spokesman Paul Antony told a Senate hearing in 2005, "DTC advertising can be a powerful tool in educating millions of people and improving health."4


Even if health education is true theoretically, it does not appear to be true in practice. Furthermore, one might question the societal benefit should such communications result in millions more people with conditions being diagnosed that are not major factors in morbidity and mortality. There likely would be strong support for pharmaceutical advertising if it led to millions more conditions diagnosed and people being treated for diabetes or heart disease.


What is equally important is the possibility—the likelihood—that consumers who make health decisions based on what they learn from television commercials ultimately take medicines they may not need, spend money on brand medicines that may be no better than alternatives, or avoid healthy behaviors because they falsely think a medicine is all they need.


In general, the ads that consumers see do not contain the right balance of information to provide any meaningful health education. The facts gleaned from DTC ads are minimal at best, which is an unsurprising consequence of condensing decades of research into a 60-second commercial. Moreover, findings from patients’ and physicians’ surveys show that the messages that patients take from DTC ads and into their physicians’ offices are often wrong.5 The pharmaceutical companies have done a skillful job of portraying complex medicines in the simplest terms—even if doing so creates inaccurate perceptions in the minds of our patients.


One fact is unquestionable: DTC ads do not effectively or consistently convey important information about product risks and benefits. When the Food and Drug Administration surveyed a sampling of primary care and specialty physicians in 2002, 41% of all physicians said they believed their patients were confused about a drug’s efficacy because of DTC ads they saw; 22% of primary care physicians and 13% of specialists said they felt "somewhat" or "very" pressured to prescribe a drug when a patient requested it.6 Even if physicians resist this pressure, the possibility of risk remains.


Under increased scrutiny, major pharmaceutical companies last year announced new advertising guidelines and pledged to portray serious health conditions seriously and to disclose risks, side effects, and warnings adequately.7 Although these efforts may be a step in the right direction, physicians, consumers, and policy makers must take further action so that the facts about medicines are not lost in the advertising fog. As Frosch et al correctly point out, the consequences of poor judgments are quite different for drugs than they are for soap.


FOOTNOTES
Conflict of interest: Dr. Kessler is a member of the International Advisory Board of Fleishman-Hillard public relations. Mr. Levy is a former employee of Fleishman-Hillard public relations and holds stock in its parent company, Omnicom, which is a public relations and advertising agency holding company. Neither Fleishman-Hillard nor Omnicom had any involvement in this editorial.

Received for publication October 20, 2006. Accepted for publication October 23, 2006.


REFERENCES

1. Prescription drugs. Media Week. May 1, 2006;SR30.
2. Health, United States, 2005 With Chartbook on Trends in the Health of Americans. Hyattsville, Md: National Center for Health Statistics; 2005:195.
3. Frosch DL, Krueger PM, Hornik RC, Cronholm PF, Barg FK. Creating demand for prescription drugs: a content analysis of television direct-to-consumer-advertising. Ann Fam Med. 2007;5(1):6–13.[Abstract/Free Full Text]
4. PhRMA Chief Medical Officer Testifies on DTC Advertising. Washington, DC; 2005: News release publishing PhRMA testimony at Senate hearing. Available at: http://www.phrma.org/publications/te...r_advertising/. Accessed: 10 October 2006.
5. Aikin KJ, Braman AC. Patient and Physician Attitudes and Behaviors Associated With DTC Promotion of Prescription Drugs—Summary of FDA Survey Research Results. Washington, DC: US Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research; 2004:63–84.
6. The Impact of Direct-to-Consumer Drug Advertising on Seniors’ Health and Health Care Costs. Senate Special Committee on Aging. First Session ed. Washington, DC: US Government Printing Office; 2005:30.
7. PhRMA guiding principles direct-to-consumer advertisements about prescription medicines. 2005. Available at: http://www.phrma.org/files/DTCGuidingprinciples.pdf. Accessed: 10 October 2006.