Fundamental differences exist between the objectives of “health message design” as used in the public health environment, and

Introduction: Jack E. Angel
Part One: Lewis Pringle, Ph.D.
Part Two: Harry Sweeney

Before the

U.S. Food and Drug Administration

Rockville, MD

____________________________________

)

In the Matter of: )

) Docket No. 2003N-0344

Consumer-Directed )

Promotion )

____________________________________)

COMMENTS OF THE

COALITION FOR HEALTHCARE COMMUNICATION

Submitted by:

Jack E. Angel

Executive Director

Coalition for Healthcare Communication

January 14, 2004

EXECUTIVE SUMMARY & RECOMMENDATIONS*

The Coalition for Healthcare Communication (CHC or the Coalition) strongly supports efforts on the part of the Food and Drug Administration (FDA) to improve the development and dissemination of important and truthful risk information about prescription drugs to all affected audiences, including the public at large, through all media. In response to FDA’s request for comments about the role of DTC advertising in such endeavors, we are pleased to provide several recommendations based on the record, and a two-part commentary on direct-to-consumer advertising. Part 1 is an expert review of the effective use of audience modeling in consumer advertising with comments on the limitations of mass media by Lewis G. Pringle, PhD;

Part 2 is a review of pertinent recent initiatives and developments in the field of health risk communications that we believe are of specific relevance to the current discussions of DTCA regulatory policy.

Over the past several years, FDA has developed significant resources and efforts to ensure that its regulatory policy on DTCA is based on the best available data and research. Implicit in the FDA efforts is the maxim that the American public is best served by fact and data based regulation.

Through FDA’s participation as an active member of the Agency for Healthcare Research and Quality’s (AHRQ) Centers for Education & Research on Therapeutics (CERTs) program, the CERTs five-part, Risk Communication Workshop series, the development of the CERTs Partnerships to Advance Therapeutics (PATHs) program, its request for public comments concerning experience with DTCA communications, open hearings on the topic, and continued commitment to the development of an appropriate research and education agenda, FDA has established a new standard of public/private cooperation in the conduct of its policy-making affairs.

The FDA, however, cannot adequately assess the success or failure of DTC advertising without a clear specification of the objectives of this advertising. As Dr. Pringle notes, there are fundamental differences between the objectives of “health message design” as used in the public health environment, and the objectives of product-oriented, commercial messages such as DTC advertising.

The primary goal of all DTC advertising is and should be to convince a consumer to discuss a medical condition with his or her doctor. DTC ads are not intended to provide highly detailed information to a consumer about all of a drug product’s benefits and risks. DTC ads are not intended, nor should they attempt, to take the place of a thorough conversation between a patient and doctor about a specific medical condition and the potential benefits and risks of drug treatment or other treatment options. As Dr. Pringle concludes, mass media advertising cannot do these jobs and should not be asked to do so.

There is substantial evidence that DTC advertising presently is successfully meeting its most basic goal – to convince consumers to talk to their doctor about a specific medical condition. In the FDA’s own recent survey of 500 doctors, 80% of those surveyed felt that the ads made patients aware of health problems, while 85% percent felt their patients were more likely to use their prescriptions properly because of the ads. Furthermore, 78% thought these ads led patients to seek treatment for potentially serious conditions. (Direct-to-Consumer Advertising of Prescription Drugs: Physician Survey Preliminary Results; Washington, DC; Division of Drug Marketing, Advertising and Communication, Food and Drug Administration, January 2003)

A study by Prevention Magazine found that DTC advertising led an estimated 24.7 million Americans to ask their doctors about a medical condition that they had not previously discussed. (Prevention Magazine; National Survey of Consumer Reactions to Direct-to-Consumer Advertising; Emmaus, PA; Rodale Press, 2001)

In a recent survey of African American physicians conducted by the National Medical Association (NMA), 72% of those responding believed that prescription drug advertising promotes increased communication between doctors and patients. (“To Do No Harm,” Journal of the National Medical Association; April 2002)

A major consumer group, the National Consumers League (NCL), also released a highly favorable survey concerning DTC advertising. As Linda Golodner, the NCL President, forcefully stated, the NCL survey demonstrates that: “With DTC ads, large numbers of consumers are made aware of medical conditions and treatments that they may otherwise not know exist.” (Effectiveness of and Attitudes Towards Medication Advertising: Summary of Survey Findings; Washington, DC; Prepared for NCL by ORC International, October 2002)

In fact, almost two-thirds of the NCL survey respondents disagreed with the statement that ads for medications should only be in medical magazines for doctors. Golodner also noted that these types of ads often “help destigmatize conditions that may have otherwise gone untreated due to patient embarrassment and limited medical knowledge.” Ibid.

While the FDA has made tremendous progress since revising the rules for broadcast DTC advertising in 1997, the Coalition believes that the current rules for print ads, particularly the “brief summary” requirement, deserve careful further consideration.

Advertising is not intended to be an encyclopedia of information about a product. Dr. Pringle cites numerous studies that conclude that all commercial messages have a finite and limited capacity to convey information. Information overload is a real and serious challenge in advertising for any product or service, including DTC advertising. While print advertising may be able to contain more information than a broadcast ad, even print advertising is subject to information overload. Under the current FDA rules, DTC print ads must contain extremely voluminous, detailed and highly technical information that is generally written for healthcare professionals, not consumers.

Dr. Pringle concludes that vast arrays of information are not necessarily better for the consumer and may actually lead consumers to “tune out” of the entire message.

Current standards for the provision of risk information about prescription drugs are inadequate. As noted by Hoek et al¹, “It is clear from US studies that excessive detail serves only to confuse consumers and inhibits rather than develops their understanding of the promoted brand.”

The work of Schommer et al^2,3 on the ordering of cognitive effort and information overload that results from the processing of prescription drug information also suggests the need for a flexible approach to the provision of risk information. “[I]nformation processing sequence is important to consider when providing prescription drug information to individuals,” the authors note.

As suggested by the Coalition previously⁴, acknowledged by Schommer et al² and augmented by the comments of Day⁵ at the recent public hearings on DTC, a policy calling for the development of a general warning statement about the seriousness of prescription drug medication suitable for use in all media, coupled with a detailed outline that can be elaborated upon in newspaper, magazine and online media of the most serious potential side effects to discuss with one’s physician, is likely to be the most practical way of solving the regulatory mandate and risk information overload dilemma.

As reported by Day⁵, in her studies, the grade level of readability for side effects information in some cases is six to eight grades higher than for benefits information. Use of the physicians’ prescribing information language in newspaper and magazine “brief summaries” therefore, while perhaps satisfying the regulatory mandate for fair balance, is demonstrably inadequate to the task of practically informing patients of the risks of medication in a manner that will not frighten them away from taking valuable medications, or that will enable them to make a reasonably considered judgment about their physician’s recommendations.

As Schommer et al concluded³, “More work is needed to understand the delicate balance between individuals’ need for information at a level sufficient for decision-making and their need for information at a level that will not overload them as they cognitively process and utilize it.”

While the past few years have resulted in the generation of impressive data supporting the value of DTCA, we recognize that as suggested in much of the professional literature and in discussions at the FDA’s open meeting of September 2003, significant gaps in evidence still exist. Such evidence is a prerequisite before any fundamental changes in FDA regulatory policy be proposed. Accordingly, the Coalition for Healthcare Communication respectfully requests that:

1) FDA maintain its current DTCA policy without the adoption of any major changes, unless such changes are supported by an evidence-based record of need, including data on the likelihood of effectiveness of any specific mandate to achieve its proposed objective, and research on the possibly counter-productive effects of any such mandate and the opportunity for comment by industry and other interested parties before any proposed changes are instituted.

2) The FDA carry out a thorough evaluation of the current rules for DTC advertising in print media to determine how those ads can be more effective. As part of such a review of the current print rules, the FDA should request longitudinal studies to examine the impact of alternative risk warnings in all DTC ads, including a general risk warning, an expanded drug class risk warning and a specific product risk warning – all to include evaluation of each communication for specific “information overload” and actual health outcome data (i.e., prescription fulfillment). Again, no changes should be made in this area without sufficient opportunity for industry comment and input.

3) FDA recognize that DTCA is consistent both with First Amendment protections of commercial speech and the advancement of the public health. In the former instance, there is a record that communication mandates have clear limits and possibly counterproductive effects; moreover, no record yet exists on the effectiveness of any specific additional mandate. In the latter instance, special care is needed to develop policies that are likely to actually achieve the intended results – a better informed and motivated patient population; such policies require careful study, continuous monitoring and frequent re-examination and/or revision to achieve optimum effectiveness.

4) The FDA should encourage commercial sponsors of DTCA to experiment with alternative methods for disseminating prescription drug risk and benefit information using integrated media plans to optimize such communications for a selected range of U.S. population segments, providing waivers or suspending enforcement of regulations that might otherwise impede such experimentation, and

5) FDA initiate its own grants program for appropriate communications research projects providing grants and involving collaboration with the communications industries to help establish standards for effective prescription drug risk communications.

In addition to these specific recommendations, the Coalition also suggests that FDA carefully consider convening a Consensus Conference on Pharmaceutical Communications to examine the current state of the art and to identify areas of potentially fruitful research and collaboration between the public and private sectors, including representatives from appropriate government agencies, the pharmaceutical industry, the communications industries, professional associations, consumer advocates and the public at large. Such an initiative is a next logical step as a result of the extensive presentations and discussion at the September 2003 open meeting. CHC notes that several academic research institutions^1,2 are involved in the study of issues that are closely related to the policy issues before FDA. In addition to the inclusion of such academic researchers, Coalition members and affiliated organizations such as the Advertising Research Foundation, the Advertising Council, the Association of National Advertisers, Association of Medical Publishers, and the Medical Advertising Council of the AAAAs would add a significant measure of current, expert, communications industry perspective to the process.

Lewis G. Pringle, PhD

2858 North Stout Road, Liberty, IN 47353
Tel: 1-765-458-6006, Fax: 1-765-458-6032

EMAIL: lewpring@ruraltek.com or lewpringle@direcway.com

Yorktown University, Yorktown, Virginia, Professor of Marketing, August, 2002 to Present

Dr. Pringle is a Founding Member of the Faculty at Yorktown University and teaches its Core Courses in Marketing. In addition, Dr. Pringle is Chairman of the Department of Managerial Economics and a Member of the University’s Board of Directors.

Miami University, Oxford, Ohio, The Joseph C. Seibert Professor of Marketing, August, 1995 to August, 2001

In 1995, Dr. Pringle accepted a Chaired Professorship at Miami University in Oxford, Ohio. In that capacity, he taught, several times, the Capstone Course in Marketing Strategy as well as several courses in Market Research.. In addition to his work in renewing the scholarship role associated with the academic life, Lew served as Chairman of the Marketing Strategy Committee of INFORMS (Institute for Operations Research and the Management Sciences), Chairman of the Search Committee for a new Chaired Professorship at Miami, Chairman of the School's Marketing Strategy Committee, an active member of the Faculty Evaluation Committee and was a member of the Board of the Miami University Performing Arts Association. Dr. Pringle also served six years as member of the Visiting Committee of MIT's Sloan School of Management, as Associate Editor of Marketing Science for 15 years and has published in that journal as well as in such journals as the Journal of Marketing Research and the Harvard Business Review. Even in his retirement from the Seibert Chair at Miami, forced upon him by health considerations, Lew has remained active. In addition to his work on behalf of Yorktown University, he lectures occasionally elsewhere in the U.S., has served as Member of the Board of the INFORMS Marketing College and has recently been named to the Editorial Board of the Journal of Advertising Research. Dr. Pringle is also a Fellow of the Royal Statistical Society and has served as Co-Chair of the Public Information Committee of INFORMS.

L. G. Pringle & Associates and P & W Information Systems, Partner, January, 1992 to August, 1995

In January of 1992, Lew retired from BBDO Worldwide, after twenty three years of service, to form, together with his partners, L. G. Pringle and Associates, Inc. as well as P & W Information Systems, SA., both companies devoted to developing trade, business and investment between Russia and the other new Commonwealth Republics, on the one hand, and Western business organizations, on the other. Fundamental to the business intent of each of these two firms was the establishment of mutually profitable, friendly and lasting business relationships between those involved. The primary objective was to help clients evolve a long term business program, uniting them with suitable Russian interests and capacities, helping them to solve problems and eliminate obstacles in order to achieve mutually profitable, formalized, lasting relationships. To facilitate these efforts, the two firms offered clients consulting advice and services in the areas of trade, investment, joint ventures, participation in current privatization efforts, co-manufacturing, licensing and technology (intellectual property) acquisition. In terms of financial services, direct payment mechanisms, financing, debt exchange, barter and counter-trade transactions were utilized.

BBDO Worldwide, Executive Vice President, Chairman and CEO of BBDO Europe (from April 1986 to August 1990)

In April of 1986, Dr. Pringle assumed responsibility for BBDO's interests in Europe, Africa and the Middle East. At the time, the agency's Capitalized Sales were $550,000,000. During his four years tenure in this position, those sales tripled to over $1,600,000,000, while profit grew at about the same rate.

During this period, Pringle served on the Boards of most of BBDO's larger agencies in Europe and completed BBDO's coverage of Western Europe, acquiring agencies in Portugal, Finland, Norway and Ireland, in addition to many additional agencies in those countries in which the company already had representation. He also led the process through which BBDO formed its agency network in the business-to-business area of communications, creating the BBDO Business Communications Network, principally in Europe but also in the US and in Australia. That Network alone, by 1990, contributed about $300,000,000 in sales to BBDO Worldwide. In addition, Pringle brought BBDO to the Soviet Union, where it became a pioneer in the integration of modern Russia with the rest of the developed world. In the process, Lew developed a number of friendships and professional relationships with very senior Soviet officials, both in the government as well as in the Ministerial system. Pringle regarded his biggest challenge in Europe as the integration of BBDO agencies, market by market, into an organization culturally and professionally committed to serving multinational clients in cross-border marketing and advertising efforts. The experience he gained in this effort, traveling approximately 70% of the time within Europe from his U.K. base, dealing with senior client personnel, typically responsible in their own organizations for their company's interests in Europe

and organizing BBDO's response to better serve the needs of these people, is perhaps the single most important and differentiating aspect of his international career experience.

Executive Vice President, Executive Director, Marketing and Strategy (1984 - 1986)

In 1984, after six years as BBDO Worldwide's Director of Research Services, Dr. Pringle left that position to work with the Chairman/CEO and COO of BBDO Worldwide, to help them formulate a plan for the global future of the company. The task was a highly practical one; to answer the question of what organizational, structural and professional changes were needed in BBDO Worldwide to permit it to optimally address the rapidly evolving needs of its clients on a global scale? The results of his work on this question were presented to a Worldwide Management meeting in September 1985 and those directions were accepted, in all respects.

Senior Vice President, Director of Research Services (1978 - 1984)

Dr. Pringle was Director of Research Services for BBDO Worldwide from 1978 to 1984. During that time, he was elected Senior Vice President and member of the BBDO Worldwide Board of Directors (1978) and Executive Vice President (1981). He managed a department of from 80 to 100 people, with an overall budget approximating $10,000,000. In terms of professional accomplishments, he thinks of his greatest satisfaction as coming from setting the standards of commitment to BBDO's clients as well as excellence in the work produced; and, in nourishing the culture without which neither can be sustained. Even as Director, he was able to participate personally in the improvement of the company's techniques as well as in the creation of marketing and advertising strategy. BBDO, during this period, had documented credentials as the very best in research and strategy formulation.

Director of Management Information Services and International Research (1976 - 1978)

During this two-year period, Dr. Pringle re-entered the research function at BBDO and was responsible for all research conducted by the agency, on behalf of clients and otherwise, outside the New York Company. In addition, he was responsible for the Marketing Department, Information Center as well as the training of young account executives within the agency.

Management Supervisor and Assistant to the President, International (1974 - 1976)

The President of BBDO’s International Company hired Pringle back to BBDO in 1974. During the subsequent two years, he worked as assistant to that man as well as Management Supervisor on the Citibank account. Particularly in the former role, he learned much about international business, in general, as well as about the conduct of business per se.

Assistant Professor, Graduate School of Industrial Administration, Carnegie Mellon University (1973 - 1974)

Because of his prior academic background, Dr. Pringle was long motivated to "test market" Academe and did so for one year at Carnegie Mellon, teaching marketing to Masters Degree candidates and econometrics to PhD's.

Vice President, Director of Management Science (1968 - 1973)

Pringle joined BBDO as an Associate Research Director in 1968, was appointed a Senior Associate Research Director in 1969 and elected a Vice President that same year. In 1971, he was appointed Director of the Management Science Department, a group that he created, numbering about 25 people, of operations research, systems and other analytically oriented people. His academic background, at the time he was originally hired by BBDO, was somewhat unusual for the advertising business. Pringle had an undergraduate degree in Chemistry from Harvard, a Masters in Business from MIT's Sloan School as well as spending another four years at MIT earning a doctorate with specialization in statistics and operations research. At the time he was approached by an executive recruitment firm in 1968, representing BBDO, Pringle was within days of accepting an appointment as Assistant Professor of Finance at UCLA.

Education: AB, Harvard College, 1959 - 1963

MS, Sloan School of Management, Massachusetts Institute of Technology, 1963 - 1965

PhD, Sloan School of Management, Massachusetts Institute of Technology, 1965-1969

Personal: Born 13 February, 1941, three sons, 2 granddaughters, 2 grandsons

Direct-To-Consumer {DTC} Advertising: A Practical Communications Model and Commentary on Risk Communications

In 1759, Dr. Samuel Johnson said[2]: “The trade of advertising is now so near to perfection that it is not easy to propose any improvement”. Confirming his endorsement of that view, a century and a half later in 1923, Claude Hopkins, generally regarded as one of the greatest of advertising’s pioneers, said[3] “The time has come when advertising, in some hands, has reached the status of science.”

Not wishing to argue with authorities as respected as these and while acknowledging that the views just cited may somewhat overstate the capacity of today’s advertising practitioner to deliver precisely what a Marketing Plan calls for, it is nevertheless fair to state that enough is known about how advertising works to have a high degree of confidence that, in good and faithful hands, advertising will ordinarily accomplish that which can reasonably be expected of it.

Note that I used the phrase “good and faithful hands”. Perhaps more so than in other fields of endeavor, in which the standards of excellence and ability are more uniformly distributed and where calipers appropriate to the task are more readily available to measure the results of the effort expended, this phrase represents a necessary equivocation. The fields of advertising and even marketing are littered with ersatz ‘experts’, each of whom has uncommon confidence in his or her own respective opinions. With respect to most fields of professional activity, the ordinary onlooker will easily and openly concede a lack of expertise. But, when it comes to advertising, everyone’s an expert. As Leo Burnett expressed it, “I’ve learned that any fool can write a bad ad, but it takes a real genius to keep his hands off a good one”. It is, in general, not recognized by the public, nor often even by less able members of the profession, that excellence in advertising really is not a chance event, or a fortuitously aligned series of lucky breaks. No, good advertising is learned…………. And it is earned.

Claude Hopkins on advertising again[4]: “Thousands of men claim ability to do it. And there is still a wide impression that many men can. As a result, much advertising goes by favor. But the men who know realize that the problems are as many and as important as the problems in building a skyscraper. And many of them lie in the foundations.” It may not be a science yet, but good advertising people generally know what they’re doing. They know what can be done. And, of greater relevance to this commentary, they know what can’t!

Throughout the course of this document, I shall assume that genuine, able and worthy advertising professionals are involved in the advertising to be discussed here.

One of the implications of this restriction is that real professionals in the field of advertising can be expected to insist on particular standards in the execution of their responsibilities. One of these standards, also relevant to the intent of this paper, is the advertising creator’s need for certain information prior to beginning the actual creative effort. While it is true that ad professionals and agencies may vary somewhat in the types of information they want, in the ways in which they describe that information and how they articulate the role of each of those elements in their evolving grasp of any marketing challenge which confronts them, nevertheless the basic elements of information they require are virtually identical – from person to person, from agency to agency, from product category to product category. Why? Because, ordinarily, really knowing what the advertising should be doing is the highest calling of all. As David Ogilvy put it, “What you say in advertising is more important than how you say it.” And this, of course, is true of all types of advertising and, I believe, particularly true in the field of public health communication.

An advertising professional wants to know: (a) who he’s going to be talking to/with and (b) what, precisely, is the intended advertising supposed to accomplish. Now, as stated, these two data won’t appear to be very much out of the ordinary. In fact, they may seem rather obvious. But, as in much of advertising, appearances can be deceiving. This is one of advertising’s most singular points of contrast with other professions. There is an infinity of possible approaches to almost any aspect of its creation. Different approaches to a given objective often appear indistinguishable; the choice between them a matter of near indifference The putative differences in perceived value among those millions of alternatives may seem, to the casual observer, quite modest[5]. That, however, is a snare and a delusion.

The truth often is that those seemingly modest differences ultimately will have compelling motivational consequences, especially when strung together in series. Take (a) ‘who he’s going to be talking to/with’, for example. Just the apparently straightforward task of responding to that question alone has millions of alternative executions. The choice of target audience is critically important. If a mistake is made at this point in one’s analysis, everything is lost. There is no way to repair the damage.

Let me suggest as examples just a few of the issues: (i) first, on what basis SHOULD a target population be selected? (ii) their number? (iii) their age or other demographic characteristics, (iv) because they already hold certain opinions, (v) because they have prior attitudes we find attractive, (vi) or prior attitudes we wish to change, (vii) because of their behavior in the past, (viii) because they are likely to become ill, (ix) because they buy other pharmaceutical products in great quantity, (x) because they like our brand, (xi) because they don’t like our brand. And…………. many, many more! Each of these viewpoints can be translated into a statement that describes the intended target of our advertising. Which is the right one; the best one?

Next, comes the choice of (b) what, precisely, is the intended advertising supposed to accomplish? Note first, an inversion of sorts. This objective isn’t stated in terms of what the advertising should say, or look like or even what the copy points should be or in what media should it be placed, etc. etc. Instead, its focus is on what the advertising is expected to accomplish. It is the obligation of Advertising Strategy, then, to (i) define the precise individuals we expect to address with our advertising and (ii) state with explicit and appropriate detail what it is we want to have left in the mind of each and every member of that target audience after the advertising has completed its act of communication.

Now, of what relevance is this discussion to Direct-to-Consumer pharmaceutical advertising? In fact, it is this identification of the purpose of advertising that controls one’s view of such issues as:

(1) what kind of ‘advertising content’ is needed to accomplish the objectives delineated in (b) above.

(2) to the extent that this desired content (1) is compromised by the need to serve purposes external/additional to those identified in the statement of Advertising Strategy, what will result from such a change in focus? What are the costs of adherence to legislation and/or regulatory mandates that require ‘compliance’ but don’t speak to the need for effective communication of the content in (1) above?

Stated more directly, if the objective for DTC advertising is to accomplish the following:

(i) sensitize and otherwise make members of a defined target population aware that certain physical symptoms may indicate the presence of a particular disease or other condition inconsistent with a state of good health and……….

(ii) simultaneously, together with achieving the awareness described in (i), give that same target population the clear understanding that medical advances, in particular, medication, may now be available that have the potential to somehow cure or remediate the condition under discussion and……..

(iii) that a timely visit with his or her doctor is the only way forward both to determine a) whether the treatment described is appropriate and likely to be medically effective for that particular patient as well as b) whether (or not) there may exist significant offsetting risks that the treatment could cause some harm to the patient.

Direct-to-Consumer pharmaceutical advertising then, in this context, has as among its most important charges, alerting potential patients that, for the reasons stated in (i), (ii) and (iii) above, they should go see their doctor. Period.

If that is a correct statement of fact (and I believe it to be so), then any execution of that message should be judged effective predominantly based upon its success in prompting those who should see their doctor to actually go do so. That, then, should be the statistic of central public health interest, while the commercial matter of increased prescriptions for the advertised drug becomes a secondary consideration.

Clearly implied by this argument is that the advertising thereby created should not be evaluated in terms of the number of words it contains…………. or the number of copy points it attempts to communicate. It should also not be evaluated by its ability to communicate a long list of the various types of risk that may or may not be possible sequelae of the treatment at issue. It is well known and will be discussed further shortly, that an advertisement is a fragile thing. It’s effectiveness is easily lost by forcing it to attempt too much; by placing upon it excessive and unwise burdens. An ad with too many words will choke the intended target consumer. An ad that attempts to communicate much more than one single copy point is likely to fail in the effort. An ad that fritters away its clearly finite ability to do the worthy job already assigned to it as described above, by forcing upon it the accomplishment of duties alien to its fundamental nature, and to do so prior to having a physician determine that the medication is appropriate at all…………….. is a loss to all involved.

This paper, in summary, intends to make the case that DTC advertising has a truly special, perhaps even noble, life-saving role to play. It can do so best, as long as its real purpose and real capacity is kept foremost in mind.

Prescription drug DTC advertising is not the first to have been asked to do more than it is capable of doing. Nor has this mistake been confined to the realm of pharmaceutical advertising, in general. In fact, it’s a common error, ranging far and wide over the advertising landscape. Most advertising professionals know these mistakes for what they are. As a result, they are easily recognized. The truth is:

(1) there are some things that advertising cannot do well,

(2) those things ordinarily need to be done by other means to be effective

(3) ignoring the truth of (1) and (2) can only damage or destroy all the good of which the advertising, in its unencumbered form, is capable – while achieving little or nothing in return.

YES, garbling-up a message with too many words and (more importantly) concepts will destroy the communication.

YES, describing in excruciating detail the multitude of possible side effects of any given drug therapy will destroy the communication.

All of that is well known and long since established, well beyond any serious discussion to the contrary.

But these facts aren't even the most important ones.

The most important fact is that doing these things is not the proper responsibility of advertising, in the first place. Assigning such objectives to advertising inappropriately removes the pressure to have these worthy goals properly handled in an environment and by the means most appropriate to these tasks. And, in the case at hand, I reference: (i) does the patient actually suffer from the indicated disease, (ii) if yes, is the medication appropriate to the identified task, (iii) is the patient susceptible to certain side effects, (iv) does the patient currently use medication which poses interaction risk of any material sort and (v) having thus deduced answers to (i), (ii), (iii) and (iv), how can those answers best be communicated to the patient? Answer: only by a healthcare professional whose training, experience, intellect and personal contact with the patient allows him or her to draw those conclusions. The role for DTC advertising in these five instances is de minimis.