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Physicians' perceptions on the ethics of free drug samples
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Content
PHYSICIANS’ PERCEPTIONS ON THE ETHICS OF FREE DRUG SAMPLES
by
Lauren Paule Franklin
A Thesis Presented to the
FACULTY OF THE GRADUATE SCHOOL
UNIVERSITY OF SOUTHERN CALIFORNIA
In Partial Fulfillment of the
Requirements for the Degree
MASTER OF ARTS
(STRATEGIC PUBLIC RELATIONS)
May 2008
Copyright 2008 Lauren Paule Franklin
ii
ACKNOWLEDGMENTS
I would like to thank the physicians that participated in my preliminary research
questionnaire and their candid responses, without which this study would not have been
possible. Thank you to my friends and family for their encouragement throughout the
year that brought this paper to its fruition. Thanks to my thesis committee, especially
Jennifer Floto, for your guidance and direction. Lastly, thank you to my parents Peter and
Dana for their undying love and support.
iii
TABLE OF CONTENTS
Acknowledgments ii
Abbreviations v
Abstract vi
Chapter One: Introduction/ Background 1
Background 1
Current Affairs 2
Chapter One Endnotes 7
Chapter Two: Business Goal 9
Chapter Three: Statement of Problem/Opportunity 10
Chapter Three Endnotes 12
Chapter Four: Research Methodology 13
Literature Review/ Secondary Research 13
DTCA Research 13
Medical Ethics 19
Drug Sample Research 21
Public Relations Health Care Ethics 25
Research Goals 26
Research Methods 26
Chapter Four Endnotes 29
Chapter Five: Objective 33
Table 1: Benefits vs. Unfavorable Outcomes of Free Prescription Drug Samples 35
Chapter Five Endnotes 37
Chapter Six: Method 38
Chapter Seven: Results 43
Chapter Eight: Situation Analysis 55
Strengths 55
Weaknesses 56
Opportunities 56
Threats 57
Strategic Implications 57
Chapter Eight Endnotes 59
iv
Chapter Nine: Communication Goals 60
Chapter Ten: Key Stakeholders 61
Chapter Eleven: Key Messages 62
Chapter Eleven Endnotes 65
Chapter Twelve: Strategies and Tactics 66
Chapter Twelve Endnotes 69
Chapter Thirteen: Conclusions 70
Chapter Thirteen Endnotes 73
Chapter Fourteen: Cautionary Note 74
Chapter Fifteen: Recommendations 75
Chapter Fifteen Endnotes 77
Glossary 78
Glossary Endnotes 79
Bibliography 80
v
ABBREVIATIONS
AMA American Medical Association
ARB Angiotensin receptor blocker
DTCA Direct-to-consumer advertising
FDA Food and Drug Administration
HCTZ Hyrdrochlorothiazide
JAMA Journal of the American Medical Association
NYSE New York Stock Exchange
PFE Pfizer, Inc.
ROI Return on investment
vi
ABSTRACT
American physicians are constantly bombarded with offers of free equipment
trial, drug samples, patient materials and scores of other incentives. This practice has
come under scrutiny by consumer advocacy groups in recent years. Of particular concern
is the widely accepted practice of providing drug samples for physicians to then offer to
patients.
This study seeks to discover physicians’ perceptions on the ethics of drug
samples. Direct-to-consumer advertising promotional tactics such as the provision of free
prescription drug samples have been extremely effective in influencing patient brand
loyalty and physician prescribing behavior. However, while drug samples are effective,
the ethics behind them are in question. The author investigates physicians’ perceptions
and opinions of the sampling tactic to better understand if free prescription drug samples
are beneficial to the medical community and the patients that receive such medications.
1
CHAPTER ONE: INTRODUCTION/ BACKGROUND
BACKGROUND
The United States is home to 22 of the 50 largest pharmaceutical and biotech
companies ranked by healthcare revenue. Of those, Johnson & Johnson, Pfizer, Merck &
Co., Abbott Laboratories and Wyeth are among the top 10. We will use Pfizer as the
model to devise a strategic plan for prescription drug samples. Pfizer, Inc. (NYSE: PFE),
the world's largest research-based pharmaceutical company, discovers, develops,
manufactures and markets leading prescription medicines for humans and animals, and
many of the world's best-known consumer brands. For fiscal year 2006 it reported $48.4
billion in revenues as compared with the prior year’s revenues of $47.4 billion, up 2
percent.
i
It employs 105,809 people globally.
ii
Since 2003 Pfizer has invested more than
$7.1 billion in research and development. Also in 2003, Pfizer Inc and Pharmacia
Corporation combined operations, bringing together two of the world’s fastest-growing
companies. Pfizer Inc was selected in 2004 by Dow Jones and Co. to be included in the
Dow Jones Industrial Average, which is the best-known stock market barometer in the
world. That same year, Pfizer Helpful Answers, the pharmaceutical industry's most
comprehensive prescription medicines access initiative was launched, enabling America's
45 million uninsured to obtain Pfizer medicines free or at significant savings.
iii
In the past four years, Pfizer has launched multiple new medications, including:
Relpax, a medication developed specifically for the treatment of migraines; Caduet the
first single pill that treats both high blood pressure and high cholesterol, Lyrica, the first
treatment approved by the U.S. Food and Drug Administration to treat two distinct forms
of neuropathic pain associated with diabetic peripheral neuropathy; and, postherpetic
2
neuralgia and adjunctive treatment of partial onset seizures in adults with epilepsy.
Pfizer’s product portfolio grew in 2006 with the launch of Sutent, a new, oral multikinase
inhibitor to treat patients with metastatic renal cell carcinoma (advanced kidney cancer),
and gastrointestinal stromal tumors. It also makes and markets Chantix, a prescription
medicine to help adults stop smoking.
iv
Supplying patients who need these and other
drugs has become a complex marketing and ethical balancing act.
CURRENT AFFAIRS
Traditional doctor/patient relationships have changed, and one of the most
dramatic shifts in the past 20 years has been the trend of patients coming to the doctor’s
office with drug background information in hand, often as a result of pharmaceutical
advertising. The newest trend that will be debated throughout this paper is direct-to-
consumer advertising. Direct-to-consumer advertising (DTCA) is the promotion of
prescription drugs through newspaper, magazine, television and Internet marketing.
v
DTCA advertising is just one of many marketing and public relations strategies used by
drug companies to promote brand-name prescription drugs. Pharmaceutical companies
employ the promotional tactic of free prescription drug samples to be distributed to
patients as a part of this DTCA strategy. DTCA includes the visits of sales
representatives to doctors, the provision of free samples/gifts for doctors and the
sponsorship of educational conferences. Drug companies also produce a range of other
materials, including brochures, pamphlets and videos, which are available in doctors’
offices or designed to be given to patients during an exam.
3
Reflecting the views of the American Medical Association, the Congress and the
Food and Drug Administration (FDA), current discussions are questioning the value and
efficacy of direct-to-consumer advertising for prescription drugs. The pharmaceutical
industry’s business practices are causing as much debate as are their outlandish, still
burgeoning profits. Consumer advocates and federal regulators are up in arms about the
ethicality of DTCA with primary concern that it compromises public safety. The
pharmaceutical industry has been criticized for its aggressive approaches to product
approval, medication promotion, blocking competition and thwarting regulation. Drug
companies defend themselves by pointing out strong industry competition, the threat of
generic prescriptions, and the high research costs to develop new, groundbreaking drugs.
The United States has the most innovative pharmaceutical industry in the world.
Eighty-five of the 95 new biotechnology medicines approved by the FDA since 1982
have been researched, developed and produced by American companies.
vi
It’s also no
coincidence that Americans spent $140.6 billion on prescription drugs in 2001, and in
2002 the drug makers had the highest profits of any industry.
vii
viii
In addition, the United
States is one of the few countries that allows mass advertising for prescription
pharmaceuticals.
Several important stakeholder groups play key roles in the pharmaceutical
industry: consumers as users and decision makers; physicians as advisors and decision
makers; and insurers as payers. In such a complicated industry that has such a large
impact upon American society, it is no wonder that many topics pertaining to the field are
top of mind and hotly debated.
4
Prescription drug prices are rising faster than inflation.
ix
Unfortunately for
American consumers, prices for the exact same drugs made by the same companies, are
significantly lower in other countries. This has spurred a movement of seniors and other
patients buying prescriptions online or in other countries, which some critics call a risky
practice. However, the industry argues that price and/or profit controls would stifle their
innovation by reducing motivation to invest in costly research to create new
medications.
x
Nonetheless, it is reasonable to wonder if drug companies are only raising
prices to increase their promotion and advertising budgets, in the expectation of increased
profits. Eight of nine major pharmaceutical companies reviewed by Families USA in
2002 spent twice as much on DTCA than they spent on research and development.
xi
Generic-drug companies offer cheaper medications and drive down the prices of
existing brand names. On average, generics are about one-third to two-thirds as costly as
their non-generic equivalents and have captured almost half of the pharmaceutical
market.
xii
In these ways, lawmakers and consumer advocates alike appreciate generics,
but generic drugs alone are not the entire solution. While they offer competition at lower
prices, some have been accused of conspiring with non-generic drug makers to keep
lower priced products off the market, thus keeping prices high.
Drug companies are often hit with huge class action lawsuits and fines. They have
been accused of holding themselves above the law as they market their drugs by any
means necessary. Said companies have created patent ploys to ensure profits, meaning
that as their drug patents are about to expire, drug companies often create medication
successors protected under patents that are virtually identical to their original product.
xiii
Parke-Davis, a former division of Warner-Lambert, was taken to court for allegedly
5
hiring ghostwriters to write scientific articles praising the off-label uses of their drug,
Neurontin, in addition to paying physicians to feature their names in the articles. Clearly,
these tactics are not public relation strategies, but illegal misrepresentations.
xiv
In
addition, a study by the Government Accountability Office found that the FDA is issuing
fewer citations to drug companies for false or misleading ads and are taking longer to do
so.
xv
The report also concludes that the FDA lacks an effective way to screen, review and
track the 10,000 ads that are brought to its attention each year.
Pharmaceutical advertising is under scrutiny: does the ad glut prompt consumers
to seek drugs they do not need? Are the costs of advertising contributing to the increasing
prices of prescription drugs? In a 2003 “CBS Evening News” broadcast, which has strong
viewership of Americans over 50 years of age, almost 25% of the ads were for
prescription drugs.
xvi
In consumer surveys, the share of people reporting that they have
seen an advertisement on television or radio for a prescription drug has more than
doubled between 1993 and 2000, and reached 81% in 2002.
xvii
The money spent on such
advertising appears to be a good investment, in that the best-selling medications are those
that are the most heavily advertised.
xviii
Does DTCA promote price competition? Is it educational and does it empower
Americans to talk to their doctors about their ailments? And do these ads give a balanced
view of risks and benefits or offer any alternatives to drug therapy? Critics argue that
DCTA drives up the overall health care costs by spurring sales of newer, more expensive
products and that they lead to unnecessary treatment for benign conditions.
xix
Some
members of Congress have introduced various measures to regulate DTCA. They attempt
to reduce or eliminate the tax deductions that drug companies take for their marketing
6
expenditures. Despite these efforts, the drug-industry lobbyists are as numerous and as
strong in Washington as ever. Indeed, in 2003 more drug-industry lobbyists walked the
halls of Capitol Hill than lawmakers—at least 600 lobbyists versus 535 senators and
representatives.
xx
DTCA is only one strategy of many utilized in the typical, large-scale
pharmaceutical promotional campaign. The industry spends even more on marketing
prescription drugs directly to doctors.
xxi
This approach includes reciprocal gifting
strategies where doctors are showered with free meals, exotic trips and prescription
samples. In 2001, of the $19.1 billion spent on promotions, $15 billion was specifically
spent on marketing to doctors.
xxii
In response to this, doctors adopted a voluntary code of
conduct that sets boundaries to limit what gifts are acceptable. Doctors should not accept
rewards in exchange for administering certain drugs. Does this mean that the United
States needs to be tougher on the pharmaceutical industry or can the ethics in question be
combated on an individual-practice level?
7
CHAPTER ONE ENDNOTES
i
Pollack, A. Pfizer to lay off 10,000 workers. The New York Times. January 22, 2007.
http://www.nytimes.com/2007/01/22/business/22cnd-
pfizer.html?ex=1327122000&en=b8ce628b49ce0fd4&ei=5088&partner=rssnyt&emc=rs
s
ii
http://www.indeed.com/cmp/Pfizer
iii
http://www.pfizer.com/about/history/2000_present.jsp
iv
http://www.pfizer.com/about/history/2000_present.jsp
v
http://www.sourcewatch.org/index.php?title=Direct-to-consumer_advertising
vi
Gluck, M. Federal policies affecting the cost and availability of new pharmaceuticals.
Kaiser Family Foundation. July 2002; 8.
vii
Fortune 500: How the industries stack up. Fortune. April 14, 2003; 24.
viii
Prescription drug trends. Fact Sheet 3057-02. Kaiser Family Foundation. March
2003.
ix
Hatch, D. Drug company ethics. CQ Researcher Online. Vol 13, No 22. June 2003.
x
Hatch, D. Drug company ethics. CQ Researcher Online. Vol 13, No 22. June 2003.
xi
Profiting from the pain: Where prescription drug dollars go. Families USA. July 2002;
4-5.
xii
Hatch, D. Drug company ethics. CQ Researcher Online. Vol 13, No 22. June 2003.
xiii
Hatch, D. Drug company ethics. CQ Researcher Online. Vol 13, No 22. June 2003.
xiv
Hatch, D. Drug company ethics. CQ Researcher Online. Vol 13, No 22. June 2003.
xv
Wall Street Journal Staff. Drug ads are getting lax scrutiny, GAO says. The Wall Street
Journal. December 14, 2006. B2.
xvi
Hatch, D. Drug company ethics. CQ Researcher Online. Vol 13, No 22. June 2003.
xvii
Rosenthal, M., Berndt, E., Donohue, J., Eptein, A., & Frank, r. Demand effects of
recent changes in prescription drug promotion. Forum for Health Economics & Policy.
2003. Vol 6.
8
xviii
Prescription drugs: FDA oversight of direct-to-consumer advertising has limitations.
GAO. October 2002.
xix
Griffith, D. Drug study questions advertising UC Davis research looks at how
prescriptions matched patients’ request for specific brand. Sacramento Bee. April 27,
2005 Metro Final Edition. B1.
xx
Hatch, D. Drug company ethics. CQ Researcher Online. Vol 13, No 22. June 2003.
xxi
Hatch, D. Drug company ethics. CQ Researcher Online. Vol 13, No 22. June 2003.
xxii
Hatch, D. Drug company ethics. CQ Researcher Online. Vol 13, No 22. June 2003.
9
CHAPTER TWO: BUSINESS GOAL
As a publicly traded company, Pfizer’s primary business goal is to optimize
profits and return on investment (ROI) for its shareholders. To optimize ROI, Pfizer’s
sub-goals are geared toward becoming the preferred choice among pharmaceuticals for
consumers, researchers and physicians. Pfizer is committed to improving its standing in
the health industry by:
1. Being a global leader in health care by providing access to safe, effective and
affordable medicines
2. Creating a leading portfolio of medicines that prevent, treat and cure diseases
across a broad range of therapeutic areas
3. Becoming an industry-leader with innovative products in areas such as oncology,
cardiovascular disease and diabetes
4. Maximizing quality health care through working in partnership with patients to
health care providers, managed care organizations to world governments and non-
governmental organizations
The company attempts to meet the needs of its shareholders and consumers by
placing an emphasis research and development, making and marketing quality products,
and consistent financial performance. In providing this, Pfizer is designed to assure
exceptional pharmaceuticals.
10
CHAPTER THREE: STATEMENT OF PROBLEM/OPPORTUNITY
Recent research has more than proven the effectiveness of free prescription drug
sampling not only in affecting the prescribing behavior of physicians, but also the brand
loyalty among patients. Therefore, because prescription drug samples are so effective, it
is important for pharmaceutical companies such as Pfizer to gauge the perceptions
associated with this practice. It is wise to discover whether physicians are amenable to
accepting and distributing free samples to determine if it is a prudent promotional tactic.
If physicians are not open to the idea and, therefore, are not engaging in handouts, then
the effectiveness is moot.
Considering the intense competition within the pharmaceutical industry,
companies like Pfizer need to be extremely prudent in their actions with physicians,
patients, governmental agencies, patient advocacy groups, etc. Each audience has such
power over the company’s success or failure, that the company must constantly gauge the
effectiveness of its business practices. Prescription drug samples are one of the many
“direct-to-consumer” strategies to increase market share. Recent marketing and
advertising trends in this nation permit for Pfizer to reach out not only to consumers, but
also to doctors who are found to be the real decision makers in the pharmaceutical
industry.
Pharmaceutical companies invest a significant amount of their annual revenues in
supplying physicians with prescription samples. However, research done by Wolf in his
1998 study has also shown that such samples can be wasteful and may not be reaching
the patients intended.
xxiii
It is important to discover physicians’ opinions of prescription
samples to determine if the promotional tactic is worthwhile. This paper will examine the
11
extent to which samples are a wise marketing investment or if there is a more favorable
way to reach and influence physicians.
Pfizer and other pharmaceutical companies have the opportunity to take the lead
and increase their respective shares of the overall pharmaceutical market by influencing
the way doctors prescribe medications, and patients’ brand allegiance to those
medications. As Hall, Tett, and Nissen outline in their report, samples are an effective
tool in increasing prescribing and sales.
xxiv
The provision of free prescription drugs is a
marketing strategy used to influence physician-prescribing behavior. The effectiveness
already known, if doctors welcome prescription drug samples, Pfizer can take advantage
of this tactic and subsequently take control of the market share. Having a hold on
prescribing behavior and brand loyalty will help achieve Pfizer’s business goals. If
prescription drug samples prove to be an amenable promotional tactic, Pfizer can
optimize profits and return on investment from its shareholders, become a global leader
in health care, and create a leading medicine portfolio.
12
CHAPTER THREE ENDNOTES
xxiii
Wolf, B. Drug samples: Benefit or bait. JAMA. 1998;279: 1698-1699.
xxiv
Hall, K., Tett, S. & Nissen, L. Perceptions of the influence of prescription medicine
samples on prescribing by family physicians. Medical Care. Vol. 44. 2006 Lippincott
Williams & Wilkins. 383-387.
13
CHAPTER FOUR: RESEARCH METHODOLOGY
LITERATURE REVIEW/ SECONDARY RESEARCH
DTCA RESEARCH
The effectiveness of direct-to-consumer pharmaceutical advertising (DTCA) and
the relationship between patient exposure and clinicians responses are not well
understood. Spending on DTCA for prescription drugs in the United States has
dramatically risen in recent years, especially since the Food and Drug Administration
(FDA) lifted the ban in 1985. Before the 1980s, the idea of marketing medicines directly
to consumers was widely considered unethical. The big change came as advertising grew
even more prolific in 1997 when the FDA allowed the industry to advertise heavily on
television. The percentage spent on print ads declined significantly during this period
while the percentage spent on TV correspondingly increased.
xxv
In the 1990s, direct-to-
consumer advertising increased at a compounded-annual rate of 30 percent, according to
Ian Morrison's book, Health Care in the New Millennium.
xxvi
This allowance made the
United States the only country other than New Zealand to allow companies to advertise
prescription medicines directly to consumers.
xxvii
This led to a series of groundbreaking
campaigns that sent drug sales through the roof, starting with Schering-Plough’s Claritin
commercials in the late 1990s.
Attempting to reach and influence the buying behavior of patients, pharmaceutical
companies spent about $2.47 billion in 2000. DTCA has been primarily effective through
increasing the market size of an entire medical class. Rosenthal, Berndt, Donohue,
Epstein and Frank estimated in 2003 that 13 to 22% of growth in prescription drug
14
spending is due to DTCA.
xxviii
Wosinska also found that DTCA positively affects total
therapeutic class sales, but only if that brand has preferred status in the market.
xxix
DTCA’s potential for influencing patient perceptions about pharmaceutical drugs
is established in the literature. Morris and Millstein conducted studies in 1984 that
showed that the presentation as well as the amount of information for a prescription could
sway the viewers’ perception of the drug advertised.
xxx
The potential is that the patients
will seek additional information, seek the specific medication and even switch health care
providers if their requests are not addressed. J. Patrick Kelly, Pfizer’s United States
pharmaceutical president has said, “Our advertising is mean to do two things: We want
people to be aware of serious medical conditions and our medicines that treat those
conditions, and we want to motivate them to talk to their doctors. It is our responsibility
to communicate this information effectively so patients work with their health care
providers.”
xxxi
A Prevention Magazine survey discovered that 32% of people who viewed DTC
advertising spoke with their doctor about the advertised drug and 26% of that group
specifically asked for the drug.
xxxii
In addition, 24% of participants said they were likely
to see another doctor if their first request was denied. Consumers who have an ongoing
need for health care and those with children value prescription drug advertising more
highly while older consumers, those who have been sick recently and more educated
consumers are more likely to trust their doctor instead.
xxxiii
However, Morris and
Millstein’s conclusions also showed that up to 14% of the participants took away
mistaken impressions from the ad. This begs the question, while DTCA is influential, is it
effective?
15
The goal of DTCA is to increase new patient flow through customer acquisition
and customer retention. Pharmaceutical companies engage in DTCA because of its
effectiveness as a pull strategy. The intention is that print and television advertisements
will prompt consumers to contemplate their own health prescription drug choices.
Questions are constructed to have the audience consider their own symptoms or ailments.
For example, “Tell your doctor if you have headaches, a history of heart disease or
nausea.” Then the encouragement is given: “Ask your doctor about prescription X and
find out if prescription X is right for you!” This pull strategy then sends the patient into
his/her medical exam prepared, ready with questions, and demanding prescriptions. But
not just any medication: the specific brand they saw advertised.
DTC advertising and marketing strategies allow the pharmaceutical manufacturer
to receive valuable feedback on sales. It is a widespread belief within the pharmaceutical
industry that patients should have a role in the choice of prescriptions drugs. Although
patients are more involved in their treatment decisions as a result of DTCA, the benefits
of such participation are not clearly demonstrated.
The dominance of DTCA is worrisome to many in the medical community. Dr.
Gregg D. Jacobs, a psychologist and assistant professor at Harvard has been quoted as
saying, “You’ve got the patient population being bombarded with advertising on TV.
You’ve got increased advertising to physicians. You’ve got a formula for sales going up
dramatically.”
xxxiv
Is DTCA more persuasive than it is “informative?” Several studies
have alluded to clinicians’ concerns about the quality and content of information
presented in pharmaceutical ads. Patients are becoming increasingly informed and
conscientious thanks to DTCA, but some doctors believe that these ads convince patients
16
that they need a medication they do not. A 1997 survey of physicians by Intercontinental
Marketing Services found that 39% believed that DTCA caused consumers to come to
the wrong conclusions about medications, yet some clinicians feel that advertisements
educate as well.
xxxv
The survey also showed that 35% were in favor of eliminating DTCA
completely.
In 2000, Bell, Kravitz & Wilkes conducted a content analysis of DTC ads and
found that 40% of ads made claims about novelty without commenting on the benefits
and risks compared to traditional therapies.
xxxvi
This may cause unrealistic expectations
of the medication and put pressure on the doctors as administrators of the drug. Although
television and other DTC ads can foster appropriately prescribed drugs, they can lean to
use of drugs for conditions that may not benefit them or pose unnecessary risks.
On the other hand, physicians are to some extent, receptive to DTCA because it
acts as an information source and makes patients aware of the possible drug therapies
available to them. They may be resigned to the presence of DTCA, as there is no sign of
the phenomenon diminishing any time in the near future. If pharmaceutical spending
continues as it has—drug companies spent about $2.5 billion on advertising in 2000,
nearly 10 times more than in 1994—DTCA is here to stay.
xxxvii
With the rise of DTCA, the medical field has, to some degree, shifted to a
consumerism model. As the field stands now, patients are buyers of services and
physicians are now the sellers that are obligated to satisfy the customer. As a result,
doctors may feel undue pressure to act as salesmen, rather than independent authorities.
Service marketing theory says customers should be involved in the decision-
making process in order to enhance customer satisfaction.
xxxviii
Physicians are one of the
17
most critical types of service providers because they have to communicate complex
information to their patients. Some would argue that doctors should value DTCA because
it provides some level of awareness to patients. Gonul, Carter and Wind argue that
advertising of prescription drugs can enhance the physician-patient relationship if the
patients value the information enough to discuss it with their doctors and the doctors are
not predisposed against the drug information.
xxxix
They also find that consumers’ overall
evaluation of DTCA is moderately positive but they prefer the information to be
distributed in the doctor’s office as they receive advice on their condition.
The discussion of influence brings up physicians’ responses to the behaviors that
DTCA spurs. Research has shown that the doctor’s remedial recommendations are
significantly associated with the patient’s expectation of receiving a prescription.
xl
Any
kind of request for a drug has a major influence on physician prescribing. A study by UC
Davis found that doctors are more apt to prescribe drugs for patients who ask for
medication than for those who have the same symptoms but don’t request a drug.
xli
Doctors admit that patient demand affects their prescribing behavior- specifically if they
believe that the patient expected a prescription.
So how do physicians feel about DTCA and the impact that DTCA has had upon
their field of work? Gonul, Carter and Wind show in their study that 84% of physicians
allow and distribute brochures citing prescriptions and 90% distribute material about a
disease state.
xlii
Doctors’ overall opinions about DTCA are becoming more positive, but
they are less enthusiastic about such strategies than consumers. They also prove that more
experienced physicians and those who see a large number of patients a week, value DTC
pharmaceutical advertising more than other doctors and are less threatened by the ads.
18
More exposure to the DTC ads that patients bring in increases physician valuation,
however the more prescriptions a clinician writes, negatively affects their opinion.
xliii
Zachry, Dalen & Jackson found in their study that doctors are willing and likely
to answer patient’s questions about a medication and provide information beyond the
original query.
xliv
Doctors said they do not become frustrated or annoyed with such
requests, and instead are comfortable when a patient asks for a medication. Significantly,
92.5% of physicians said in those cases, they would not prescribe a medication other that
what the patient asked for. However, this study pointed out that clinicians are more likely
to be frustrated or annoyed if the patient is requesting a drug because they saw an
advertisement than if they read about the medication in a drug reference.
These findings are interesting because they show the perceptions doctors have
about DTCA without directly asking for their opinion on the subject matter. It is
important to note here though, that although doctors may have concerns about the stresses
and dangers of voluminous pharmaceutical ads, these concerns do not describe how
doctors react to patients exposed to such DTCA. While they are annoyed, they are not
prejudiced in their actions and relationships with the patients.
It is worth mentioning that physician and patient preferences play an important
role in the prescription decision- preferences shaped to some degree by DTCA.
Hellerstien in 1998 found evidence that habit exists in the prescription behavior of
physicians.
xlv
Also, Gorecki shows that the pioneering brand for any prescription will
dominate the market unless price competition is introduced.
xlvi
Coscelli’s study
discovered that while doctors prescribe heavily across brands and do not specialize in
particular drugs, their choice for prescriptions is driven by a complicated set of
19
factors.
xlvii
Doctors take into account the patients’ preferences and tend to prescribe
brands used in the past, therby further reinforcing brand preference.
Coscelli also showed that patients exhibit strong brand-loyalty and strong state
dependence. When a patient has been on a certain brand for an extended period of time,
they are unlikely and less willing to switch. In addition, consumers will pay a premium to
stay with the pioneer instead of switching to the generic, due to a perceived quality
difference.
xlviii
These habits on behalf of doctors and patients led to the command of
market shares.
MEDICAL ETHICS
Pharmaceutical companies currently employ several promotional strategies for
prescription drugs intended to target physicians and consumers. Because doctors have
been the primary decision makers when it comes to selecting and choosing a prescription
drug, drug companies usually concentrate most of their public relation efforts on
physicians. These PR tactics include visits by the pharmaceutical representatives to the
doctor’s office, phone calls by sales representatives, free prescription samples, print
brochures, and sponsorship of medical events, among others. For instance, the drug
representative makes it a regular practice to stop by the doctor’s office, drop off
materials, and even bring lunch for the office staff, with the intention of establishing
relationships with the doctor and the staff. It is important to note the role of the office
manager in this equation. Since doctors are oftentimes busy, the office manager assumes
the role of the gatekeeper. Pharmaceutical representatives must win the favor of these
individuals to gain face-time with the physicians. Is it a proper allocation of power and
20
regulation to put so much responsibility and authority in the hands of an office
administrator?
There are many potential conflicts of interest in relationships within the medical
industry. While there are no easy answers to ethical questions, the American Medical
Association (AMA) offers guidance and recommendations to individual physicians and
pharmaceutical companies regarding direct-to-consumer advertising and marketing
(DTCA) strategies in their Code of Medical Ethics. Pharmaceutical companies allocate
large resources to promote their products to clinicians. Doctors meet industry
representatives at the office, professional conferences, and research projects. These
encounters offer opportunities to advance medical knowledge, but they also create the
possibility of undue bias.
The medical profession is based on the principle of responsibility: acting in the
best interest of the patient, protecting the patient, allowing the patient informed choice,
and assuring equity in health care.
xlix
The primary purpose of fostering relationships with
the pharmaceutical industry should be enhancing patient care. The acceptance of
individual gifts, trips and the like from the industry is frowned upon in the medical
community because it might diminish the objectivity of professional judgment.
According to the American Medical Association’s Code of Medical Ethics: A
Practical Guide to Physicians, “Any gift accepted by a physician should primarily entail a
benefit to patients and should not be of substantial value. Individual gifts of minimal
value are permissible as long as they relate to the physician’s work.”
l
Doctors should
strive to minimize their biases and strive for objective evaluation of medical information.
21
Research, however shows a strong correlation between receiving industry benefits and
favoring their products.
li
If a perception exists that a physician is dispensing medical advice based on
commercial influence, this undermines a patient’s trust in the doctor’s competence and
raises doubt about whether he/she will put the patient’s interests first. To combat the
potential for bias, the American Medical Association said in 2006 that it would press for
a waiting period before pharmaceutical companies can promote new prescription drugs to
doctors so that physicians can have more time to study the products.
lii
In addition, the
establishment of a gift relationship creates an implicit sense of obligation and reciprocity.
Many physicians are comfortable with limiting their acceptance of gifts to only
those that enhance their medical practice. One must note though that difference of
opinion exist because of the nature of the ethical question and must be gauged regularly
for appropriateness. The AMA asserts that it is unethical for physicians to accept any gift
that is contingent on recommending a particular product. Stricter guidelines directed to
thwart the gifting phenomenon are in place. Yet, the drug companies still utilize this
technique to gain substantial influence. In 2001, the AMA launched a $1 million
campaign to increase awareness of ethics, but pharmaceutical companies such as Bayer,
Merck and Pfizer paid $675,000 of that figure.
liii
DRUG SAMPLE RESEARCH
This paper focuses on one specific direct-to-consumer pharmaceutical marketing
and advertising (DTCA) tactic: free drug samples. The provision of free prescription
medicine samples is a common marketing strategy used by pharmaceutical companies. In
22
one recent study of 391 brands, 95% of those brands sent pharmaceutical representatives
to visit doctor’s offices.
liv
Physician-oriented promotion is a traditional public relations
tactic that remains important today and continues to command a larger share of marketing
budgets than DTCA. In 2001, the value of prescription samples dispersed in the United
States was about $10.5 billion, over 50% of the expense of promotion.
lv
Billy Tauzin, CEO of the Pharmaceutical Research and Manufacturers of
America, issued a statement about the benefits of their promotional tactics: “[It]
empowers patients to learn about diseases and the medicines that treat them; helps us
fight the fact that millions of Americans suffer from diseases that go undetected and
untreated; and still leaves the prescribing of lifesaving to doctors that know their patients
best.”
lvi
Machanda, Chintagunta and Gertzis found that physician relationship outreach
has a significant positive impact on the number of prescriptions written for a particular
drug by a doctor.
lvii
They also found that the number of prescriptions written for a
particular drug by a physician increases when free product samples are provided to that
physician. Gonul on the other hand reports diminishing returns from doctor relationships,
but proves that free samples increase price sensitivity.
lviii
The influence this offer has on
doctor prescribing behavior is still in question, as is its safety to the patient.
Several issues raise concerns about the use of samples. There are some problems
with the practice of unregulated drug distribution including incorrect labeling,
insufficient record keeping, personal use by doctors and staff, as well as expired stock.
lix
In addition, drug samples are often not used for their intended purpose. In fact, 96% of
medical staff surveyed admitted taking samples for private use and wastage is often
23
reported
.
lx
Improper labeling and recording of samples impairs the patient’s ability to
comply with the drug regimen, reduces awareness of drug interactions, and impairs the
pharmaceutical company’s ability to adequately track and manage product recalls.
Most applicable to this paper, Zachry, Dalen, and Jackson found that 77.5% of
clinicians are generally receptive to providing samples.
lxi
However, in accordance with
their other findings, clinicians are less likely to provide samples if the patients saw the
medication in an advertisement than if they were using a drug reference. In addition, the
majority of general practitioners do not think they are influenced in their prescribing by
free samples and do not believe samples play an important role in their practice.
lxii
Alternatively, surveys suggest that physicians are evenly divided between never using
drug vouchers and preferring such vouchers to handing out physical samples.
lxiii
If doctors are amenable to using samples, how are they most commonly utilized?
Further studies have shown that many physicians state they use samples so that their
patients can immediately begin treatment and then they wrote an ongoing prescription for
the brand.
lxiv
Hall, Tett and Nissen assert, “many [doctors state] that they used samples to
commence medicines and then wrote a continuing, brand name prescription.”
lxv
Pharmaceutical companies will be most interested to know that if their product is not in
the doctor’s cabinet, it most likely will not be used in this manner. Significant numbers of
doctors also reported that they did start patients on drugs other than their first choice if
another brand was in their sample cupboards, and that use of those samples led to a
continued prescribing of that product. The availability of drug samples does lead
physicians to dispense and prescribe drugs other than their preference.
lxvi
24
The ethicality of free prescription samples is also a topic of concern for the
medical community. Samples can be considered essentially a gift from the
pharmaceutical industry if doctors and staff use the drugs for personal use, which is a
breech of ethical guidelines defined by the American Medical Association (AMA). This
misuse has been documented, and individuals who use sample medication without doctor
consultation endanger their own health. The availability of these drug samples creates
potential for illegal behavior- using prescription drugs recreationally. On the other hand,
prescription samples can be issued to those patients in economic need who cannot
financially afford expensive medical costs and the high prices required by “normal”
channels.
Drug samples can be characterized as gifts because doctors can then distribute
such medications to patients at no apparent cost. While this practice promotes the medical
principle of equity and justice in health care and allows patients to try a drug without
incurring any expense, it mainly serves to encourage physicians to prescribe the new
product. Once the sample has run out, the probability that the physician will write a
prescription for the same brand is high.
lxvii
When doctors, their families and their staff use
samples for themselves, this only extends the gift relationship.
So from a strictly communications standpoint, as a proven gifting public relations
tactic, effectiveness aside, are free prescription samples an ethical practice? Or does the
reciprocal nature of providing medication on hand undermine the physician’s profession
in itself? Do the social and financial benefits of free drugs outweigh the unintended
negative side effects these prescriptions have yielded? This paper seeks to understand
physicians’ perceptions and opinions on the topic.
25
PUBLIC RELATIONS HEALTH CARE ETHICS
Any examination of medical ethics begs the question, “what is the responsibility
of the Public Relations practitioner?” As prescription drug samples cross from the hands
of the physician to the patient, are PR practitioners held accountable? Today, it is not
unusual for some types of medical specialists, in some markets, to retain publicists to
increase patient flow and attract new customers. Especially in elective medical
professions such as cosmetic surgery and dermatology, doctors are increasingly finding
that they, too, have to engage such marketing techniques like media outreach to obtain
the clientele they want.
This paper considers the role PR practitioners play in the pharmaceutical industry.
These professionals are tasked with crafting and creating the materials that accompany
new prescription drugs. For example, people in the public relations field create all the
educational brochures designed for patients that are found in doctors’ offices, the
informational pamphlets that accompany the medication itself, and other written
resources. By creating these materials, are these PR professionals then held legally
responsible for the content? In most cases no because they rely on input from experts
who presumably review the materials before they are published. . However, do these
professionals then have an ethical responsibility for how they represent the
pharmaceutical company and the medication? Most definitely yes.
26
RESEARCH GOALS
The goal of this thesis is to assess the attitudes and perceptions of a key
stakeholder in the pharmaceutical industry: physicians. The pharmaceutical industry is
adroit at marketing-related analysis and therefore has clearly identified its key audiences
and audience segments. It has been determined that doctors are the key influencers and
key decision makers when it comes to prescription trends. Because they are the ones who
select which drugs will be prescribed, doctors also select which drugs patients will take
and use. Therefore, doctors determine which medications will have the corner on each
diagnostic market segment (i.e. cardiovascular, digestive, respiratory, etc.). The
medication they favor and prescribe more often will undoubtedly have a larger share of
its respective market than its competitors. This paper will aim to identify the attitudes of
physicians toward prescription drug samples.
RESEARCH METHODS
This paper utilizes both primary and secondary research to address the research
goals. In my thesis, I examine the opinions and perceptions of physicians regarding the
use of free prescription drug samples as a public relations promotional strategy because
physicians are the deciders and have the most influence upon the prescription writing
practice. Primary research consisted of in-depth survey questionnaire that was completed
by physicians from various medical specialties. Doctors were sent the questionnaire
through e-mail and were asked to respond via the Internet as well. The six physicians
took 7-10 days to answer the 21 open-ended questions. They were assured that all
27
responses would be kept anonymous as they were for research purposes only. Topics
covered by the questionnaire included:
1. Willingness to administer and distribute prescription drugs samples
2. If they think the distribution to patients is an acceptable practice
3. Reasons prescription drug samples are beneficial or harmful to the medical
community
4. The possible benefits to their own practice
5. If prescription drug samples are useful to the public
6. The benefits of offering and distributing prescription drug samples to patients
7. Unfortunate consequences and disadvantages including which are the most
damaging to the medical community/the public
8. Convenience
9. Trialing purposes for the individual patient
10. Financial need of patients and the percentage of samples they distribute to those
11. If prescription drug samples promote equity in healthcare
12. Permitting immediate drug therapy treatment
13. Price competition
14. Incorrect labeling
15. Misunderstanding of medication instructions when patients receive prescription
drug samples
16. Record keeping of prescription drug samples
17. If drug samples should be considered essentially a gift from pharmaceutical
companies to the physician
28
18. Staff using drug samples for personal use
19. Expired Stock/ waste
20. The benefits of having a pharmacist administer prescriptions
21. Illegal and recreationally use
The doctors could answer freely and openly with any opinions and additional
comments. The data and their responses are covered in the results section of this paper.
29
CHAPTER FOUR ENDNOTES
xxv
Hatch, D. Drug company ethics. CQ Researcher Online. Vol 13, No 22. June 2003.
xxvi
Veracity, D. The great direct-to-consumer prescription drug advertising con: How
patients and doctors alike are easily influenced to demand dangerous drugs.
http://www.naturalnews.com/010315.html July 31, 2005.
xxvii
Jordan, G. Drug makers try new approach in ads; Hard sell provided bitter pill to
swallow for many consumers. The Times-Picayune. March 12, 2006. Living 8.
xxviii
Rosenthal, M., Berndt, E., Donohue, J., Eptein, A., & Frank, r. Demand effects of
recent changes in prescription drug promotion. Forum for Health Economics & Policy.
2003. Vol 6.
xxix
Wosinska, M. 2001. Promoting to multiple agents: The case of direct-to-consumer
drug advertising. Chapter 1 in unpublished Ph. D. dissertation. University of California-
Berkeley, Department of Economics. Berkeley, Calif. Downloaded from
wosinska@econ.berkeley.edu.
xxx
Morris, L. & Millstein, L. Drug advertising to consumers: effects of formats for
magazine and television advertisements. Food Drug Cosmetic Law J. 1984; 39: 497-503.
xxxi
Bloomberg News. Pfizer to detail drugs’ risks and consult doctors earlier. The New
York Times. August 12, 2005. Final Late Edition. C5.
xxxii
Prevention’s International Survey on Wellness and Consumer Reaction to DTC
Advertising on Rx Drugs. Emmanus, Pa: Rodale Press; 2001.
xxxiii
Gonül, F., Carter, F., & Wind, J. What kind of patients and physicians value direct-
to-consumer advertising of prescription drugs. Health Care Management Science. 2000.
Baltzer Science Publishers BV.
xxxiv
Saul, S. Record sales of sleep pills cause worry. The New York Times. February 7,
2006. Final Late Edition. A1.
xxxv
Zachry, W., Dalen, J., & Jackson, T. Clinicians’ responses to direct-to-consumer
advertising of prescription medications. Arch Intern Medicine. Vol. 163. 2003;163:1808-
1812.
xxxvi
Bell, R., Kravitz, R., & Wilkes, M. Direct-to-consumer prescription drug advertising,
1989-1998; a content analysis of conditions, targets, inducements, and appeals. J Fam
Pract. 2000;49:329-335.
30
xxxvii
Hatch, D. Drug company ethics. CQ Researcher Online. Vol 13, No 22. June 2003.
xxxviii
Jayanti, R. The impact of affective responses on physician evaluation: An
exploratory study. Health Marketing Quarterly 12(3). 1995: 49-62.
xxxix
Gonül, F., Carter, F., & Wind, J. What kind of patients and physicians value direct-
to-consumer advertising of prescription drugs. Health Care Management Science. 2000.
Baltzer Science Publishers BV.
xl
Britten N. & Ukoumunne O. The influence of patients’ hopes of receiving a
prescription on doctor’s perceptions and the decision to prescribe: a questionnaire survey.
BMJ. 1997;315:1506-1510.
xli
Griffith, D. Drug study questions advertising UC Davis research looks at how
prescriptions matched patients’ request for specific brand. Sacramento Bee. April 27,
2005 Metro Final Edition. B1.
xlii
Gonül, F., Carter, F., & Wind, J. What kind of patients and physicians value direct-to-
consumer advertising of prescription drugs. Health Care Management Science. 2000.
Baltzer Science Publishers BV.
xliii
Gonul, F., Carter, F., & Wind, J. What kind of patients and physicians value direct-to-
consumer advertising of prescription drugs. Health Care Management Science. 2000.
Baltzer Science Publishers BV.
xliv
Zachry, W., Dalen, J., & Jackson, T. Clinicians’ responses to direct-to-consumer
advertising of prescription medications. Arch Intern Medicine. Vol. 163. 2003;163:1808-
1812.
xlv
Hellerstien, J. 1998, The importance of the physician in the generic versus trade-name
prescription decision. Rand Journal of Economics. 29, 108-137.
xlvi
Gorecki, P. 1986. The importance of being first. The case of prescription drugs in
Canada. International Journal of Industrial Organization. 4, 371-395.
xlvii
Coscelli, A. 2000. The importance of doctors’ and patients’ preferences in the
prescription decision. The Journal of Industrial Economics. Vol 48, No 3. Blackwell
Publishing. September. 349-369.
xlviii
Caves, R. & Hurwitx, M. 1988. Persuasion or information? Promotion and the shares
of brand name and generic pharmaceuticals. Journal of Law and Economics. 31, 299-320.
xlix
Coyle, S. Physician-industry relations. Part 1: Individual physicians. American
College of Physicians-American Society of Internal Medicine. 2002;396-402.
31
l
American Medical Association’s Code of Medical Ethics: A Practical Guide to
Physicians. professionalismppt.ppt from http://ama-assn.org.
li
Chren, M. & Landefeld, C. Physicians’ behavior and their interactions with drug
companies. A controlled study of physicians who requested additions to a hospital drug
formulary. JAMA. 1994;271:684-689.
lii
Wall Street Journal Staff. Drug-ad waiting period urged. The Wall Street Journal. June
15, 2006. D6.
liii
Okie, S. AMA criticized for letting drug firms pay for ethics campaign. The
Washington Post. September 8, 2001. A3.
liv
Rosenthal, M., Berndt, E., Donohue, J., Eptein, A., & Frank, r. Demand effects of
recent changes in prescription drug promotion. Forum for Health Economics & Policy.
2003. Vol 6.
lv
Groves, K., Sketris, I. & Tett, S. Prescription drug samples-does this marketing strategy
counteract policies for quality use of medicines? J Clin Pharm Ther. 2003;28:259-271.
lvi
Griffith, D. Drug study questions advertising UC Davis research looks at how
prescriptions matched patients’ request for specific brand. Sacramento Bee. April 27,
2005 Metro Final Edition. B1.
lvii
Manchanda, P., Chintagunta, P., & Gertzis, S. 2000. Responsiveness of physician
prescription behavior to salesforce effort: An individual level analysis. University of
Chicago, Graduate School of Business. Chicago, Ill. Unpublished manuscript.
Downloaded from puneet.manchanda@gsb.uchicago.edu.
lviii
Gonul, F., Carter, F., Petrova, E., & Srinivasan, K. 2001. Promotion of prescription
drugs and its impact on physician choice behavior. Journal of Marketing. 65(3):79-90.
lix
Hall, K., Tett, S. & Nissen, L. Perceptions of the influence of prescription medicine
samples on prescribing by family physicians. Medical Care. Vol. 44. 2006 Lippincott
Williams & Wilkins. 383-387.
lx
Westfall, J., McCabe, J., & Nicholas, R. Personal used of drug samples by physicians
and office staff. JAMA. 1997;278:141-143.
lxi
Zachry, W., Dalen, J., & Jackson, T. Clinicians’ responses to direct-to-consumer
advertising of prescription medications. Arch Intern Medicine. Vol. 163. 2003;163:1808-
1812.
32
lxii
Hall, K., Tett, S. & Nissen, L. Perceptions of the influence of prescription medicine
samples on prescribing by family physicians. Medical Care. Vol. 44. 2006 Lippincott
Williams & Wilkins. 383-387.
lxiii
Gebhart, F. Pharmacists welcome vouchers of drug samples. Drub Topics. Health
Module. 2002;146,2:25-26.
lxiv
Hall, K., Tett, S. & Nissen, L. Perceptions of the influence of prescription medicine
samples on prescribing by family physicians. Medical Care. Vol. 44. 2006 Lippincott
Williams & Wilkins. 383-387.
lxv
Hall, K., Tett, S. & Nissen, L. Perceptions of the influence of prescription medicine
samples on prescribing by family physicians. Medical Care. Vol. 44. 2006 Lippincott
Williams & Wilkins. 383-387.
lxvi
Chew, L., O’Young, T., Hazlet, T., et al. A physician survey on the effect of drug
sample availability on physician’s behavior. J Gen Intern Med. 2000;15:478-483.
lxvii
Chew, L., O’Young, T., Hazlet, T., et al. A physician survey on the effect of drug
sample availability on physician’s behavior. J Gen Intern Med. 2000;15:478-483.
33
CHAPTER FIVE: OBJECTIVE
This paper seeks to examine the ethicality of providing prescription samples to
physicians as a direct-to-consumer public relations strategy. It investigates the
knowledge, attitudes and behaviors of American physicians regarding the distribution of
sample prescription medications. It is also the intent of this paper to explore the extent to
which physicians believe that gifts designed for patient care such as drug samples are
beneficial to the health care field. Free prescription samples are designed to allow the
pharmaceutical industry and physicians to evaluate initial response to drugs and permit
immediate therapy for patients.
Sampling has its benefits such as trialing for harmful effects, assessing
adaptability with new medication, and patient convenience. Prescription samples allow
patients to begin drug therapy treatment immediately after the doctor has diagnosed the
patient. The patient can walk out of the doctor’s office with a few days’, weeks’, or
months’ supply of the medication, in addition to the written prescription to be filled. Free
samples allow doctors to provide medication to those patients that are in financial need.
Individuals without healthcare insurance can visit clinics or clinicians and receive the
medications they need without the personal expense of costly prescription drugs. In this
way, some would argue that free prescription drug samples promote equity in the health
care field. With samples, drugs are available to all (at least for limited periods), not just
those that can afford them.
In addition, because sampling allows multiple brands to be ready and available to
patients, it theoretically promotes price competition. With the physician having more
options to choose from for any specified drug, pharmaceutical companies must compete
34
on price levels in order to command the market. Lastly, prescription samples have proven
to be an effective sales strategy and help the pharmaceutical company to track how their
product is doing.
Free prescription samples have unfortunate, unintended consequences that may
outweigh the benefits and undermine the promotional practice as a whole. Often times,
these prescription samples have incorrect labeling: they may lack directions, side effects,
purposes, or dangers. This can lead to improper use or misuse, of the product. Also, when
the drug is provided to the patient without pharmacist instruction or counseling, patients
may come to misunderstandings about the medication or may forget the summaries
physicians provide in the diagnosis. There is insufficient record keeping in some offices.
Some doctors do not keep track of which drug samples have been provided to which
patients or in what quantities. Because physicians do not distribute all the prescription
samples they have on hand, there is the inevitable expired stock that begins to pile up and
many of these prescription samples go to waste.
Studies have proven that the doctors themselves and their staffs use a large
proportion of drug samples. 96% of staff surveyed by Westfall, McCabe, and Nicholas in
1997 reported taking samples for personal use, at an estimated cost to pharmaceutical
companies and the government of US $10,000 per annum.
lxviii
Sometimes, the drugs are
taken illegally or for recreational use. Because the doctors and their families take these
samples as “freebies” and perks of the practice, prescription drugs can be considered gifts
from the pharmaceutical companies. There is the ongoing debate on the gift nature of the
free prescription drug samples and the social obligations they create. As previously
discussed, the intent of such a gift is to establish an obligation, or need for reciprocity in
35
the recipients mind. The physician may feel an obligation to the drug company for the
gift of sample drugs and write prescriptions in favor of that company in the future,
irrespective of the relative efficacy of the product.
Table 1: Benefits vs. Unfavorable Outcomes of Free Prescription Drug Samples
Benefits Consequences
Trialing for harmful effects Incorrect labeling
Adaptation with new medication Misunderstanding of medication instruction
Patient convenience Insufficient record keeping
Allows patients in financial need to take
medication without the expense
Personal use by doctors and staff
Immediate drug therapy treatment Waste
Promotes equity in healthcare- drugs
available to all
Expired Stock
Price competition Reciprocal gift nature and social obligation
to pharmaceutical company
Absence of pharmacist for administering
Illegal, recreational use
36
However, there is surprisingly little research on prescription samples. Ergo, as
previously stated, one of the goals of this thesis is to assess physician responses to
pharmaceutical campaigns directed at the public via the tactic of free prescription drug
samples.
37
CHAPTER FIVE ENDNOTES
lxviii
Westfall, J., McCabe, J., & Nicholas RA. Personal use of drug samples by physicians
and office staff. JAMA. 1997;278:141-143.
38
CHAPTER SIX: METHOD
As an effective promotional strategy, prescription drug samples have grown in
practice and are now prevalent in most areas of medical practice. Therefore, I expect that
the majority of physicians sampled in this study will report that pharmaceutical
companies have offered them free drug samples and that the physicians have also
administered and distributed prescription drug samples, at least at one time. In terms of
being open and amenable to the practice, I believe that physicians will be split in their
decision but will have quarrels with prescription drug samples on a whole. They will be
willing to partake, but not necessarily believe that it is a sound or beneficial practice.
Several questions in the in-depth questionnaire ask physicians about the utility of
prescription drug samples. Since these questions will serve to construct the value of
sample prescriptions, I denote the questions by PVi= 1, 2, …
PV1: How often pharmaceutical companies offered prescription drug
samples.
PV2: How frequent prescription drug samples are administered and
distributed from the office.
PV3: How amenable one is to the practice of prescription drug samples.
PV4: The pharmaceutical company offering free prescription drugs is an
ethical practice.
PV5: Distributing prescription drugs is beneficial for my office and
practice.
PV6: Distributing prescription drugs are just a way of doing business in
the medical field.
39
PV7: Prescription drug samples are beneficial to the medical community.
PV8: Prescription drug samples are harmful to the medical community.
PV9: Prescription drug samples are useful to the public.
PV10: Prescription drug samples are worthless to the public.
I expect that physicians view prescription drugs samples as a nuisance and think
that they are more harmful to the medical community than beneficial, yet they have
surrendered to samples, because they have become the norm in today’s medical world.
However, I think that doctors will see prescription drug samples as more beneficial to the
public and their patients than to their profession. Perhaps because of the positives such as
convenience, immediate treatment, finances, and so on.
Several questions in the in-depth interviews will ask physicians about the
consequences of prescription drug samples. Since these questions will serve to construct
the physicians’ perceptions of sample prescriptions, I denote the questions by PPi= 1, 2,
…
PP1: The ability to begin medicinal therapy with free prescription drugs is
convenient and useful for consumers.
PP2: Prescription drug samples allow the medical community to trial for
harmful effects.
PP3: Prescription drug samples allow patients in financial need to take
medication without the personal expense.
PP4: Prescription drug samples permit immediate drug therapy treatment.
PP5: Prescription drug samples promote equity in healthcare.
PP6: Prescription drug samples facilitate price competition.
40
The doctors will agree and confirm all of the listed unfortunate consequences
earlier identified, and will find the absence of pharmacists and other potential dangers to
the patient as the most damaging side effects. However, the doctors will not be able to
easily and readily provide benefits in their summarizations, as the benefits listed are not
as obvious and evident. In addition, the benefits do not outweigh the potential dangers
that are associated with prescription samples, i.e., convenience does not outweigh drug
abuse.
PP7: There is incorrect labeling of prescription drug samples.
PP8: There is often a misunderstanding of medication instructions when
patients receive prescription drug samples.
PP9: There is insufficient record keeping of prescription drug samples.
PP10: There is a large amount of expired stock with prescription drug
samples.
PP11: Prescription drug samples are wasteful.
The research will likely find financial reasons to be the main motivator for
physicians to distribute prescription samples. Doctors will indicate sparing their patient
from the expense of medication as the main reason they hand out prescription drug
samples. For this reason, physicians will favor samples as promoting equity in healthcare.
Equally motivating, doctors will attest to immediate drug therapy as a significant
argument for the distribution of drug samples.
I do not expect physicians to have strong feeling about the price competition
argument as a benefit of prescription samples. Very few will have had experience with
incorrect labeling or will admit that their office has insufficient record keeping of
41
prescription drug samples. Physicians may report that their patients often misunderstand
the medication they receive in their office. If this is so, evidence will point to the need for
pharmacists in the prescribing equation.
I anticipate that the physicians sampled in this study will be evenly split over the
discussion of prescription samples as a gift from the pharmaceutical companies. Equally
split will be the ethical debate of doctors and staff taking samples for personal use. Some
may find it acceptable while others will stand hard on the issue. Waste issue will be
insignificant, as responses will really depend on the office, the medication to be
distributed and other variables.
PP12: Providing physicians with free prescription drug samples is a gift
from pharmaceutical companies.
PP13: Prescription drug samples can be considered a gift from
pharmaceutical companies to the physician.
PP14: Personal use of prescription drug samples by doctors and their staff
is unethical.
Most significantly, I think most physicians will report that they would prefer
pharmacists take over the practice of accepting and distributing free prescription drug
samples than have to deal with the distribution themselves. They will identify the dangers
of medications mixing, proper medical instructions and warnings, and the hope that it
would cut down on recreational use as the rationale a pharmacist should be involved
wherever prescription drugs are concerned.
PP15: Distributing prescription drug samples to patients from a
physician’s office should be allowed.
42
PP16: It is better to have a pharmacist administer prescriptions than have
them handed out at a doctor’s office.
PP17: Prescription samples are often illegal and recreationally used.
PP18: The negative consequences of prescription drugs are significant
enough to outweigh their benefits.
PP19: The importance or value of the following benefits of prescription
drug samples.
Trialing for harmful effects, adaptation with new medication, patient
convenience, financial need basis, immediate treatment, and price
competition.
PP20: The importance of the following negative consequences of
prescription drug samples.
Incorrect labeling, misunderstanding of instructions, poor record keeping,
personal use, waste, expired stock, social obligation tied to gift, absence of
pharmacist, and illegal or recreational use.
On the whole, I expect that the participants will confirm my hypothesis that the
implied reciprocal nature of sample prescription drugs is the bane of the modern
physicians existence. I hypothesize that prescription drug samples are a practice that
physicians do not welcome, but begrudgingly accept as an unavoidable aspect of their
job.
43
CHAPTER SEVEN: RESULTS
Six doctors were interviewed, all from different areas of medical expertise. They
included a cardiologist, an optometrist, a dentist, a general surgeon, and others.
Four out of six doctors are offered prescription drug samples on a consistent
basis—anywhere between two or three times a month to once a week. One doctor
commented that in his or her previous practice, a visit from a pharmaceutical
representative was a daily issue. Of those, the physicians reported that they administer or
distribute prescription drug samples frequently: 5-10 times a week or at least every other
day. Only one doctor reported that he or she does not meet with drug representatives
because he or she does not accept samples or other gifts. “The only thing they are
allowed to leave for me is a peer-reviewed journal article describing their drug, so long as
it is a double blind, randomized, controlled trial.”
In the survey, I attempted to gauge how open the physicians are to the idea of
prescription samples. Overall, the responses were positive in response to physicians
(themselves and their peers) partaking in the practice. Five out of six doctors said they
were very open to prescription drug samples, but said it is up to each individual doctor to
decide if they will administer or not. “I think drug samples are great,” said one
respondent. Another doctor said, “I am open to the idea of samples, but prefer receiving
them in the mail instead of interruptions in my office from sales reps, though sometimes
they have good information and are helpful.” This doctor continues with, “My opinion is
based on the interruption from sales reps—I don’t think many doctors are against
sampling to patients, just the way samples are availed to doctors.”
44
Only one doctor of the six was opposed to the ethicality of prescription drug
samples. He/she said, “Other physicians can do what they want. But the data I have seen
expressly found that the gifts from drug reps REDUCES the rationality of the doctor’s
prescribing behavior – they write for the drug more and for the wrong reasons.” He/she
even went so far as to recommend an article for my review, “Physicians and the
Pharmaceutical Industry - Is a Gift Ever Just a Gift?”
Journal of the American Medical Association (JAMA), January 19, 2000.
Again, five out of six doctors said that prescription drug samples are beneficial to
the medical community. It is beneficial for patients who have no prescription benefits to
help defray personal costs and beneficial as the samples provide an introduction to a
medicine which then promotes familiarity with the medication. Also, it is beneficial
because pharmaceutical representatives support doctors with research information and are
a ready resource of information. The most common response from the respondents was
that prescription drug samples “allows the doctor to trial medications especially in
patients with economic need.”
One said, “I like samples for a very focused reason: in our clinic we use them for
new onset diabetics who require insulin therapy and need to be taught how to use insulin
in our office that day; or for uninsured or underinsured patients. I think it is acceptable
for other physicians to use samples at their discretion. One of the problems with newer
drugs is that they are more expensive than older drugs, so if they are given to patients free
for a month or two they may cost more in the long run when there are better and cheaper,
older drugs available. An example of this is new blood pressure medications such as the
ARB (Angiotensin receptor blocker) drugs for mild hypertension- these drugs are very
45
expensive to consumers and insurance companies. If a new hypertensive patient is given
a prescription for HCTZ (hyrdrochlorothiazide) which is a diuretic and a fraction of the
cost.”
On the negative side of the discussion, it was argued that “I think [prescription
samples] are beneficial as a means of a trial period for a medic to ensure it will work
okay, but I believe they can be harmful if improperly dispensed or if patients get many
samples from many different providers.” Another pointed out that prescription drug
samples are harmful because it leads the doctor to prescribe the wrong drug. “They
prescribe the most expensive drugs even when they have no marginal benefit over
existing drugs.”
Physicians pointed to two key reasons that their practice benefits from
prescription samples. One: economic need of patients, and, two: trying a drug to ensure it
works before purchasing. “I don’t know that there is a benefit in terms of referrals to my
practice. But it often gives me a way to get people onto medications when they may not
be able to afford them.” Another said, “Patients are introduced to medication and the
doctor becomes more familiar with medication.”
Physicians also reported that samples are indeed “a way of doing business” which
is appropriate. “They are a way of doing business just like food vendors give samples, to
try, but many industries don’t have samples, so maybe this industry should or shouldn’t
have samples, but I think it’s helpful.” One doctor had a very good grasp on the strategy
behind samples: “Samples are a “way of doing business” because it is the pharmaceutical
companies out marketing their medication and trying to command more of the market
46
and reap the most money before the drug goes off patent and the company no longer
makes money off their drug.”
The counter argument was also made: “Patients love to get free drugs, and to get
the ones that they see on TV, so [if I offer samples] they like me more and I attract
patients. The patients come to my office to get the free drugs, when they probably would
not have otherwise, and I take the opportunity to check their blood pressure, maybe get
an update on problems that turn out to be unchanging and stable, but still it turns into a
visit or which I can charge their insurance company for a visit that might appear to be
fairly complex and lucrative, if actually unnecessary. The pharmaceutical company is
happy, the doctor’s balance sheet is happy, the patient is happy…. But apart from that,
the clear pattern is that the patient is often taking the wrong drug for the wrong problem
when a cheap, established, boring drug would have done better.”
Hence, the majority of doctors found that prescription drug samples are beneficial
not only to the medical community, but also to their own practice and to their patients.
Therefore, they believe prescription sampling is a worthy practice. The term that came up
over and over again was “trial.” One doctor said that prescription samples allowed her to
teach the patient more effectively about their treatment. He or she could “demonstrate
how to inject and use insulin or glucose meters in our office which increases compliance
in our patients. If I give a prescription for insulin or a meter and don’t teach the patient
how to use it, then they likely will not use the insulin or their meter.”
They also cited convenience as another reason to administer. “[Prescription
samples] save them a trip to the pharmacy which often takes 30-45 minutes from the time
you walk in - and they’re free.” The samples are ready to use in the office. They get the
47
patient started on medication without the delay of getting to the pharmacy. Immediate
access to the medication increases compliance. “If a patient has medication in [his/her]
hand, they are more liable to start the treatment immediately. The doctor, by giving a
sample emphasized the urgency of prompt therapy and thereby probably increases
compliance.” In one interview, the physician contended that these and other examples are
enough to warrant the practice.
One doctor said that ultimately, sampling of prescription drugs is not useful.
“There is a short- term gain that is offset by a much larger long-term problem of getting
patients started on the wrong, more expensive drugs. They take the samples, they think it
works, then in one month they call for me to ‘call in a refill to their pharmacy’ and we do
that in perpetuity. [At first] they think I am a great doctor. They are excited about
‘getting something for free’—of course when the samples run out and they have to pay at
the pharmacy they are appalled at the cost, demand the insurance company pay, and often
the insurance company eventually caves in, causing insurance premiums to rise…. So in
the end the patients pay more, not less.”
As for the adverse consequences of prescription drug sampling, doctors admitted
to improper distribution and the tracking of distribution: the prescriptions may not always
get in the patient’s hands. They also pointed to the time wasted with drug company
representatives, the storage of samples, inappropriate uses of certain medications because
they are “free,” and the opportunity for patients to obtain large quantities of medication
by seeing multiple providers. One said that the “money spent for drug samples will
increase the price of the medicines.” In addition, “Doctors and their staff may consume
all the samples so they aren't being used by the public.”
48
One said, “In the long term, prescription samples cost more money to the
healthcare system as many of the newer ‘sampled’ drugs consume more healthcare
dollars. The cost to the healthcare system is the greatest- if a patient can have great blood
pressure control on an older, cheaper medication this is the best for the system so that
other dollars are available for other patients and recourses. Another consequence is that
the newer drugs have not been out as long, so we may not known the harmful effects of
the drug and now we are exposing more patients to a potentially harmful medications.”
However, the physicians agreed that none of these consequences are damaging to
the patient and that the benefits outweigh the risk if handled properly. “None of these are
damaging but they do consume time and energy that doctors can use to treat patients.”
Only one doctor said he/she doesn’t find samples disadvantageous.
When asked about trialing for harmful effects, if the physician did not report
“unknown,” they commented that prescription samples don’t allow for the medical
community to trial because that is what drug studies are for. Instead they allow for patient
trials. Two of the six doctors said they had witnessed patients with allergic or other
negative reactions to medicines in the first few doses. “This saves the patients or their
insurance from buying one month of a medicine that might get thrown away after three
days if an adverse outcome occurs.” If the patient tries the drug and has an adverse
reaction, the patient won't have filled the prescription. Hopefully the drug profile has
been well established prior to public release. Occasional side effects can be noted and
accommodated on a case-by-case basis.
On the subject of financial need, almost all the doctors agreed that prescription
samples are beneficial because the allow patients in financial need to take medication
49
without the personal expenses and that physicians should provide samples to patients in
need. They reported that they try to give more samples to those in need than those that are
financially stable. One said that about 75% of his or her samples go to those in need,
another approximated 40-50% and one admitted that his or her practice is in an affluent
area where only 5-10% are in need.
The results revealed that prescription drug samples promote equity in healthcare
because they allow for non-formulary dispensing. However, only the larger drug
companies sample the most, so it really isn’t equitable. “Doctor may give a patient a
medication that he or she feels is the most effective therapy without having an insurance
company or not having insurance or lack of money dictate the medication a patient is
given.”
The debate over price competition is still up in the air. Some physicians admitted
that they don’t know much about marketing and the impact on competition. Four of the
six stated that prescription drug samples do not facilitate price competition. In fact, one
pointed out that the opposite results: “they raise prices considerably. By over-using the
more expensive drug for no marginal benefit, we get at best, the same outcome at a
higher price. And since it is often the wrong drug, we get worse outcomes at a higher
price.”
None of the doctors had experienced incorrect labeling of prescription drug
samples. They also agreed that if a misunderstanding of medication instructions exists, it
is the fault of the provider dispensing the medication. It is the responsibility of the
physician to effectively communicate the proper doses and procedures for taking the
samples. Written instructions should be provided with every sample given out. “We write
50
on the box or on paper the instructions for samples.” One commented that
miscommunication and misunderstanding “could easily happen since doctors can just
hand them the package and tell the patient what to do and not actually write the
directions.” One physician said that this miscommunication is rare, but it depends on the
doctor and the staff giving proper instructions. And while they all try to record all the
samples they distribute, none of the doctors could say how significant insufficient record
keeping was. “We try to record all samples given but if a patient is walking to check out
and decides that she wants an optional medication we discussed, that sample occasionally
may not be recorded.”
On the sensitive subject of samples as gifts, the doctors concluded that drug
samples could essentially be considered a gift from pharmaceutical companies only if the
physician, or his/her staff, used them. One commented, “I don’t think it is the
medications, I think it is the lunch and the other materials that they bring that directly
benefits the physician.” Likewise, “The doctors get other perks like dinners at educational
meetings, etc. not drug samples.”
The interesting point was made that pharmaceutical companies are wise to
provide samples because “their drug will probably be less prescribed without the doctor
seeing the results first hand.” Yet some did not think it was unethical for doctors and their
staff to take prescription samples for personal use. Some said doctors should not use
samples, while other said they didn’t think it was “that big of a deal.” “It depends if they
are sampling or using the sample closet as their own personal pharmacy.” “I don’t believe
it is unethical as long as there is clinical documentation of the event.” Another said, “If
51
the staff has the condition the drug is prescribed for, they should take the same amount
we would sample a patient.”
One doctor offered this troubling testimonial: “When I worked in a clinic that did
distribute samples, at least half of all the drugs in the samples closet were consumed by
the staff themselves and never saw the patients at all – especially antibiotics, which were
taken totally inappropriately, for viruses such as colds, or were given to their children at
dangerously high adult doses, were always given with no regard for potential drug
interactions…. Birth control pills and Viagra also disappear very rapidly and with no
apparent correlation to any patient visits. In this sense, the free samples are a gift to the
staff just like tickets to a baseball game… it creates goodwill between the drug
representative and the office, reinforces the brand name of the drug with the staff, and
gets product recognition rolling.
“But the physician enjoys the drugs him or herself with personal consumption,
keeps staff happy – especially when the drug representative brings bobbles and
sandwiches for the staff… the staff really enjoys the free drugs of all types for themselves
and their families. The doctor that sees the drug rep is a hero; the doctor that refuses to
see them is an uncooperative stick-in-the-mud. I have been reprimanded by
administration for not seeing the drug reps and being ‘mean to the poor people and mean
to the staff’…. And they asked me with incredulity ‘then how in the world do you know
what is going on with the new drugs?’—i.e., they have no clue that a whole literature
exists of publications about new drugs, presented as double blind randomized controlled
trials, designed and executed by third parties who have no financial interest in the
outcome of the studies or in which ones are presented to the public…. The drug reps
52
have their audience believing that they are actually a source – THE source of education
for doctors, rather than self-interested mal-educators.”
The physicians were split on whether prescription drugs are wasteful. Four out of
six reported that in their office, they rarely encounter expired stock. “It is incumbent upon
the practice to manage the samples.” Another, “Our representatives stock a set amount of
samples and resample only if we are low. The representatives and my tech keep an eye
on expiration dates. If we are alerted the drug will expire soon, we hand out more
samples to use them before they expire.” On the other hand, one reported that in his/her
prior practice, he/she witnessed first hand how wasteful samples can be. Another
physician said, “It is wasteful even before it expires because it is being used incorrectly
most of the time.”
They all agreed upon the benefits of having a pharmacist administer prescriptions
as opposed to handing them out in their office. There are varying types of medical issues,
so a pharmacist may be better at providing drug interaction material and discussing
adverse reactions than one of the many doctors a single patient sees. It frees the doctor to
worry only about prescribing rather than dispensing. In addition, pharmacists are good at
record keeping and less doctor office administration time would be required.
“Pharmacists can compare all medications taken, looking specifically for drug
interactions if the patient wasn't a good historian to the doctor. In addition, there is less
potential fraud for pain medications.” “Separating the financial incentive to prescribe a
drug from the financial incentive of selling it is a good idea. Doctors have a tendency to
prescribe that which they have in stock and can make a profit on rather than just
prescribing the better drug.”
53
Respondents indicated that prescription samples are rarely used for illegal and
recreational purposes. They pointed out that narcotics are not available for samples, and
that there is not much a high from acid reflux medications, cholesterol medication,
antibiotics etc. And it was noted that pain medications are not liberally sampled.
The main reasons cited by physicians for why they distribute prescription drug
samples in their own practice centered on patient benefit: convenience, defraying costs,
and patient education. One doctor concluded, “I like sampling. Having the samples
reminds me of new therapies to my patients, because I see it on a regular basis in my
cabinet. Having samples of some generic medications, that are on patients formularies
would be nice to have but I am sure this is not cost effective.”
Another said, “I think samples provide a useful service. Representatives could be
more responsive to small volume users of the product. I think an alternative could be to
use coupons, which the patient can take to the pharmacy to be filled with the cost born by
the drug company. However, this does require an additional trip by the patient. I think
the ancillary marketing paraphernalia, e.g. brochures, pens, pamphlets, coffee mugs,
letter openers and the like are more annoying and serve to increase cost than providing
samples does.”
One physician was adamant that prescription drug samples “should be abolished.
If we want to make drugs available for free to the poor then pharmaceutical companies
should produce “drug stamps” like the government produces food stamps. The drug
companies give the stamps to the doctors who can give them to patients in need, along
with the prescription for the drug. The stamps are equivalent to cash at the pharmacy; the
pharmacy turns them into the drug company for cash. But the stamps are good for ANY
54
drug, not just the super expensive ones they are hawking. If their new drug is so much
better than the established cheap and effective one, then give the doctor a double-blind-
randomized, controlled trial produced by a non-interested third party. Let the drug sell
itself based on its superiority, not on manipulative and fraudulent practices.”
55
CHAPTER EIGHT: SITUATION ANALYSIS
For this paper’s purposes, I will again use Pfizer, Inc. as an example to represent
the pharmaceutical industry.
STRENGTHS
1. The single most powerful strength that Pfizer and other pharmaceutical companies
have to rely on is that this promotional tactic is voluntary. Therefore, they have
control over which drugs to provide samples of, what quantities, which doctors to
supply and what information to distribute with the medication.
2. Since the distribution of prescription drug samples is voluntary, Pfizer will be the
essential source of information.
3. Patients appreciate that Pfizer supplies doctors with free medication for patient
use. They appreciate that they can try a new medication at no cost to themselves.
Pfizer is seen as a benevolent company that cares about the convenience of its
customers. It also refutes any assumptions about pharmaceutical companies being
money-hungry and self-serving.
4. Financial resources: Pfizer has $48.4 billion in revenues and ranks number two in
sales.
lxix
5. Successful products: It produces the top selling drug Lipitor, the oral antifungal
medication Diflucan, the long-acting antibiotic Zithromax, the well-known
erectile dysfunction drug Viagra, the anti inflammatory Celebrexm, and Ritalin
which is used for kids with ADD and ADHD.
56
6. With 2005 actual spending of $7.4 billion in research & development, Pfizer
boasts the industry's largest pharmaceutical R&D organization: Pfizer Global
Research and Development.
lxx
WEAKNESSES
1. Pfizer’s internal marketing tactics are under fire for an aggressive direct-to-
customer campaign to sell its prescription drugs like other pharmaceutical
companies.
2. Reputation: As it is with other pharmaceutical companies, the public is skeptical
of Pfizer’s business practices because of their outlandish profits.
3. Awareness: Patients have a limited awareness of Pfizer’s relationships with
physicians and the interactions that could be considered bribery.
4. Wide spectrum: Pfizer’s key stakeholders’ wants and needs are so broad that key
messages must be very specific.
OPPORTUNITIES
1. There is the potential to increase Pfizer’s stock price.
2. Putting prescription drug samples in doctor’s offices for distribution and trial
increases the likelihood that those doctors will prescribe Pfizer products to permit
immediate treatment.
3. Pfizer prescription drug samples increase brand loyalty for patients.
4. Prescription drug samples are an effective way to introduce a new product.
57
5. Industry Leader: Pfizer has the opportunity to be the leader in market share
among members of the pharmaceutical industry.
THREATS
1. If there is malpractice with the prescription drug samples, there is the threat of
lawsuits, corresponding financial concerns and extended bad press.
2. Intense competition from other pharmaceutical companies.
3. Liabilities of prescription drugs: if one of Pfizer’s products proved to be
dangerous to patients’ health.
4. Problems with prescription drug samples would cause concern about how the
FDA regulates the industry.
5. Media Messages: Negative portrayal of pharmaceutical policies and executives
influence members’ behaviors and perceptions of the industry.
6. Competitors: Among the leaders in the pharmaceutical industry, Pfizer is the
leader, but others could adopt the same practices and tactics.
7. Widespread publicity about doctors and their staffs using samples recreationally
or for themselves.
STRATEGIC IMPLICATIONS
1. By providing prescription drug samples to physicians, Pfizer can influence
prescribing behavior and increase brand loyalty.
58
2. Pfizer needs to establish a healthy, consistent, “gift-reciprocal” relationship
between their pharmaceutical representatives and physicians in all medical
practices, around the nation.
3. Build on the existing reputation of Pfizer as a leader in medical research and
excellent, innovative, well-tested pharmaceutical products.
4. For success with prescription samples, use Pfizer’s well-established financial
resources. The initial investment will have great returns in the long run.
5. Be mindful of intense competition and attempt to be the first of all other
pharmaceutical companies in its tactics.
6. Communication with internal personnel and representatives to have a unified
goal.
59
CHAPTER EIGHT ENDNOTES
lxix
http://en.wikipedia.org/wiki/Pfizer#_note-0
lxx
http://en.wikipedia.org/wiki/Pfizer#_note-0
60
CHAPTER NINE: COMMUNICATION GOALS
1. Increase awareness among doctors of the benefits and detriment of blindly
distributing prescription drug samples without checks and balances.
a. Put policies in place on behalf of the doctor
b. Prescription drug samples are effective, however recommending
the newer product as opposed to existing medications for the same
ailments in the long term will prove to be more expensive to the
patient.
c. Stress the responsibility of the doctor in the triangular relationship
between pharmaceutical companies, patients and the doctors. The
weight must be equally shared among all parties in the medical
profession.
2. Increase awareness among consumers that they need to continue their role as
educated patients if direct-to-consumer advertising and prescription drug
sampling is to persist.
a. This is important particularly with older population, people of ages
65 and older.
2. Protect market share of Pfizer’s drugs so that the focus does not come off those
that are not being sampled.
3. Neutralize the negative stigma attached to the notion of bringing the
recommended pharmacist back into the drug sample distribution.
61
CHAPTER TEN: KEY STAKEHOLDERS
1. Shareholders of Pfizer (PFE)
2. Patients who take prescription drug products created by Pfizer
3. Patients who take medication created by the competing pharmaceutical companies
4. FDA which will investigate the promotional tactic
5. Potential customers
6. Physicians
7. Researchers who write for and manage scientific journals, websites and blogs and
influence policy and perception regarding drugs
8. Insurance companies with drug plans
9. Governmental agencies that influence health care legislation
10. American Medical Association
62
CHAPTER ELEVEN: KEY MESSAGES
1. Stockholders:
a. Pfizer is committed to maximizing financial gain and the stock
price.
b. Pfizer has many drugs in development, which will help to boost
their financial situation.
3. Patients who take prescription drug products created by Pfizer
a. Pfizer is inspired by a single goal: your health. That's why we're
dedicated to developing new, safe medicines to prevent and treat
the world's most serious diseases. And with prescription drug
samples, we are making them available to the people who need
them most.
lxxi
4. Patients who take medication created by the competing pharmaceutical
companies
a. Prescription drug sampling is designed for their convenience and
allows patients in financial need to take medication without the
expense.
5. FDA which will investigate the promotional tactic
a. Pfizer can defend itself by pointing out strong industry
competition, the threat of generic prescriptions and the high
research costs to develop new, innovative drugs.
6. Potential customers
63
a. Today, as patients look to play an increasingly active role in their
health, Pfizer offers information and support to help you better
understand the medicines your doctor may prescribe and the
conditions these medicines treat.
lxxii
Our free prescription drug
samples help people without prescription drug coverage get the
medicines they need. You can get important information about
Pfizer prescription medicines from your doctor or our website.
4. Physicians
a. As your partner in providing health care solutions to patients, with
prescription drug samples Pfizer is optimizing your patient care
and manage your practice.
b. Prescription drug sampling allows for trialing, adaptation with new
medication, and immediate drug therapy treatment.
5. Researchers who write for and manage scientific journals, websites and blogs and
influence policy and perception regarding drugs
a. Pfizer researchers and scientists are working to discover and
develop new ways to treat and prevent life-threatening and
debilitating illnesses like Alzheimer's disease and cancer, as well
as to improve wellness and quality of life across a range of
therapeutic areas.
b. Prescription drug sampling permits for drug trialing.
6. Insurance companies with drug plans
64
a. Pfizer is committed to sharing openly with those who affect and
are affected by our business. With you as one of our health care
providers, we work to bring you the information you need to make
decisions about our company and our products.
lxxiii
7. Governmental agencies that influence health care legislation
a. Prescription drug sampling promotes equity in healthcare because
this way drugs are available to all.
b. Drug sampling facilitates price competition.
8. American Medical Association
a. Prescription drug sampling is not intended to influence doctors but
instead directly benefit patients. There is no need for regulation of
this practice because it is in no way considered a gift or bribery.
65
CHAPTER ELEVEN ENDNOTES
lxxi
http://www.pfizer.com/home/
lxxii
http://www.pfizer.com/home/
lxxiii
http://www.pfizer.com/home/
66
CHAPTER TWELVE: STRATEGIES AND TACTICS
The strategies and tactics of this campaign are both communicational and
operational in nature. The following strategies and tactics will occur across the United
States.
1. The main strategy behind providing and supplying physicians with prescription
drug samples is front-of-mind. Pfizer as a pharmaceutical company wants doctors
around the nation to think of Pfizer’s innovative products and medications first
when they write prescriptions. If each physician is stocked with samples of
Pfizer’s medications, it is a constant reminder that these products are available
and effective for the disease or aliment their patient faces.
2. With each new product launch, aggressively “pitch” the new medication to
physicians.
i. Supply physicians with educational information, prescription samples and
promotional pieces such as brochures and pamphlets for their offices.
3. Emphasize Pfizer’s superior medical products in all aspects of communication
and marketing with physicians and patients.
i. It is the responsibility and job of the pharmaceutical representatives to
communicate the benefits and uses of the samples to the physicians. The
goal is for the physicians to distribute as many prescription drug samples
as possible. The more samples in the hands of patients, the more
opportunity for trial, the more brand loyalty exists.
ii. Tactical: Consistent messaging.
iii. Thematic: Emphasize new products as first in the field and innovative.
67
iv. Timing: Pre-launch, launch and post-launch. Widespread in United States.
v. Tonality: Proactive, informative, leadership.
vi. Targets: All key stakeholders.
4. Emphasize the scientific research conducted by Pfizer and FDA in the launch of
each new medication.
i. With 2005 actual spending of $7.4 billion in research & development,
Pfizer boasts the industry's largest pharmaceutical R&D organization:
Pfizer Global Research and Development.
lxxiv
ii. Tactical: Consistent messaging.
iii. Thematic: Emphasize new products as first in the field and innovative.
iv. Timing: Pre-launch, launch and post-launch. Widespread in United States.
v. Tonality: Proactive, informative, leadership.
vi. Targets: All key stakeholders.
5. Convince stockholders that such promotional tactics such as prescription drug
samples will increase stock prices, and be beneficial for their investments.
6. Explain that Pfizer will guard against and try to prevent any mishaps that may
result from prescription samples such as correct labeling, proper stocking, misuse
of the medication, etc.
7. Promote the viability of Pfizer as a public company with the successful products.
8. Try to validate the safety and usefulness of Pfizer’s products to customers and
doctors.
9. Talk about the benefits that prescription drug samples offer not only to patients,
but also to physicians as well such as convenience, immediate therapy, etc.
68
10. Media relations not necessary.
i. Instead, as the physicians are the gatekeepers, it is better to focus our
efforts on doctor relationships. We want a positive perception associated
with Pfizer and our products.
11. Change the language used in communicating with consumers.
i. Simplify language used in applications, brochures, or in any other form of
communication for purposes of clarification. Simplifying the language, as
approved by the legal, operational, and marketing departments, will help
the patients understand their medication.
69
CHAPTER TWELVE ENDNOTES
lxxiv
http://en.wikipedia.org/wiki/Pfizer
70
CHAPTER THIRTEEN: CONCLUSIONS
There has been clear momentum with the pharmaceutical industry’s massive
spending on marketing to doctors. Spending is up 275 % between1996 to 2004, and $18
billion was spent on free drug samples for doctors in 2005 according to the Prescription
Project.
lxxv
Some would argue that many doctors have been prescribing according to
industry profits rather than the patient’s needs. Sales reps aggressively promoted the
painkiller Vioxx, minimizing unfavorable findings on the drug and doctors wrote millions
of prescriptions for the medication- right up until the drug was pulled in 2004 because of
its risk for heart attack and stroke.
lxxvi
“Each day more than 101,000 drug company
representatives -- one for every five office-based physicians -- call on the nation’s
doctors.”
lxxvii
And yet, the research findings in this paper show that the majority of
doctors are open and amenable to accepting and distributing prescription drug samples. In
fact, they testify that they think samples are beneficial to their patients and to their
practice. Providing samples to their patients is convenient for the consumer and increases
favor in the physician-patient relationship. All those involved appreciate the act of
sampling, so is it perhaps a blind eye that is being turned to the admitted unfortunate
consequences?
From a marketing public relations perspective, this paper supports the view that
the promotional tactic of free prescription drug samples is an effective strategy. Previous
research shows that samples are extremely useful not only in influencing prescribing
behavior, but in increasing brand loyalty. And now, this paper shows that physicians are
happy to be apart of the process. So what is the problem? Some members of the medical
community would argue that there seems to be a disconnect because the consequences
71
are so quickly brushed over. They advocate that we cannot disregard the possible damage
samples are causing in our health community. We still have an obligation to avoid the
negative effects of prescription samples on a social and moral level.
For years, with increasingly sophisticated techniques and enormous financial
resources, pharmaceutical companies such as Pfizer have courted physicians. The billions
of dollars in gifts and dinners and seminars and free prescription samples are all intended
to persuade doctors to prescribe their products. But now even lawmakers agree that these
relationships cause physicians to loose sight of the patient’s best interest. Congress is
considering a bill that would require companies like Pfizer to report gifts over $25 so that
patients could learn about their doctor’s actions online.
lxxviii
Some states such as
California have drug company gift disclosure laws. However, the effort to curb industry
influence is moving very slowly. While bills are being drawn up, they are not getting
through Senate to become law.
To discourage the trend toward consumerism in the medical field, doctors must
practice patient-focused care without sacrificing evidence-based care. Doctors must strike
a balance between satisfying the patients’ wants with their needs. DTCA has the potential
to convince patients of the need for a specific medication- it is the duty of the clinician to
rationalize these persuasions. This requires that doctors be effective communicators with
prescription drugs and can verbalize the treatment options.
DTCA and drug samples are opportunities to engage patients and promote
positive health behaviors. Doctors should encourage patients to invest in themselves at
the same time manage patient expectations.
72
The paper delves into public relation issues such as physician’s needs for
reputation management with the practice of sample prescription drugs. Do physicians
base their decision of distribution on patient expectations and norms within the medical
community? I sought to understand whether their perceptions of free prescription drugs
are based on the practice of handing out samples, or merely the samples themselves.
What benefit does this practice hold for physician? It seems that the sampling strategy
has become a widely accepted norm within the medical community: a fact that physicians
have become accustomed to. Are prescription samples just a way of doing business in the
medical field? For those physicians that are opposed to free prescription drug samples,
the paper took their verbatim and for those that are in favor, the paper drew correlations.
This paper highlights the need for more concern about the influence of free
samples on prescribing practice and the resulting effects on health care. Different
methods of medicine distribution such as vouchers need to be developed so that samples
can achieve their intended purposes with out compromising patient safety and medical
ethicality. To some extent, the medical community needs to restore a sense of medical
ethics back to the profession: to serve the needs of the patient first.
73
CHAPTER THIRTEEN ENDNOTES
lxxv
Basler, B. Ties that bind. AARP Bulletin. January-February 2008. 20-26.
lxxvi
Basler, B. Ties that bind. AARP Bulletin. January-February 2008. 20-26.
lxxvii
Basler, B. Ties that bind. AARP Bulletin. January-February 2008. 20-26.
lxxviii
Basler, B. Ties that bind. AARP Bulletin. January-February 2008. 20-26.
74
CHAPTER FOURTEEN: CAUTIONARY NOTE
The findings of this paper must be considered in the context of the limited
population that was surveyed. The characteristics of this population may differ
significantly from providers in other parts of the country. It is also important to
emphasize that these findings represent behavioral intentions rather than actual actions. I
must also note that participants may give socially desirable responses. This bias was
partially addressed by anonymous completion of the interview and questionnaire the
confidential nature of the interviews. More detailed data sets are needed in order to
measure the impact of prescription samples. I do not have sufficiently rich data on the
demographics of my participants nor do I go into detail regarding specific drugs. Perhaps
the study could have measured the ethicality of prescription drug samples on a more
micro-level, for each type of practice, for each drug and each sample campaign. This
would better take into account the role of multiple players in the direct-to-consumer
phenomenon.
75
CHAPTER FIFTEEN: RECOMMENDATIONS
In response to the ethical debate over the reciprocal nature and the negative
consequences of prescription samples, there are an increasing number of physicians who
choose to give patients vouchers for prescriptions instead of handing out medication
samples in their office. Since 81% of pharmacists surveyed by the Kansas Pharmacists
Association said they are seeing an increase in sample coupons, I believe it would be
beneficial to incorporate coupons into the prescription sample process.
lxxix
In this DTCA
tactic, the patient takes a coupon with an accompanying prescription to a pharmacy where
it is filled for free. Some voucher programs allow patients to download vouchers online,
see a physician for a prescription, and then take both to a pharmacy for a free trial. As of
recent, physician sampling has come under increasing scrutiny because of the lack of
regulations for drug sampling.
The voucher tactic has its benefits, the most attractive of which is that giving
vouchers instead of samples brings pharmacists back into the loop. Voucher programs let
doctors stock coupons instead of drugs. The tactic has health benefits as patients who get
the samples from a physician usually get the drug without pharmacy consultation.
Voucher patients get a pharmacist’s screening for things like allergies, contradicting
medications and medical records. Companies that promote vouchers have an advantage
because they can track the vouchers that are issued and redeemed for every major
pharmaceutical manufacturer in the United States. Health plan sponsors appreciate that
the program allows them to not pay for the initial course of therapy.
However, the most visible voucher companies, MedManage Systems and
AdvancePCS, admit that vouchers are an alternative to sampling but will not replace
76
sample programs. They are simply part of a broader DTC marketing campaign. Vouchers
are increasing as a practice because doctors are less inclined to meet with sales
representatives. Physicians are also turning to vouchers because their office setting does
not allow for sampling.
77
CHAPTER FIFTEEN ENDNOTES
lxxix
Gebhart, F. Pharmacists welcome vouchers of drug samples. Drub Topics. Health
Module. 2002;146,2:25-26.
78
GLOSSARY
Food and Drug Administration (FDA): is responsible for protecting the public
health by assuring the safety, efficacy, and security of human and veterinary
drugs, biological products, medical devices, our nation’s food supply, cosmetics,
and products that emit radiation. The FDA is also responsible for advancing the
public health by helping to speed innovations that make medicines and foods
more effective, safer, and more affordable; and helping the public get the
accurate, science-based information they need to use medicines and foods to
improve their health.
lxxx
Prescription Drug Samples: a small amount of prescription medication used as an
example of the larger general product including its character, features, or quality.
A small part or quantity of prescription drugs for medial examination or trial.
Product samples are provided by product manufacturers in the hopes that they
instigate future sales.
lxxxi
American Medical Association (AMA): a not for profit organization that seeks to
promote the art and science of medicine and the betterment of public health. The
American Medical Association helps doctors help patients by uniting physicians
nationwide to work on the most important professional and public health
issues.
lxxxii
Efficacy: the ability to produce the necessary or desired results.
lxxxiii
Drug Interaction: when taken together, prescription drugs can interact with one
another and produce desirable or undesirable results.
Drug Trials: a test or experiment to determine the quality, safety, performance,
usefulness, or public acceptance of something.
lxxxiv
Direct-to-Consumer Advertising (DTCA): presenting information about a product
or business directly to consumers. Direct delivery of advertising to potential
customers.
lxxxv
The Journal of the American Medical Association (JAMA): an international peer-
reviewed general medical journal published continuously since 1883, 48 times per
year. JAMA is the most widely circulated medical journal in the world and is
published in multiple international editions and languages. JAMA's impact factor
is 23.2 and the acceptance rate is approximately 8% of the nearly 6000 solicited
and unsolicited manuscripts it receives annually. The average time from
submission to publication is 124 days and average time from receipt to rejection is
9 days.
lxxxvi
79
GLOSSARY ENDNOTES
lxxx
http://www.fda.gov/opacom/morechoices/mission.html
lxxxi
http://encarta.msn.com/encyclopedia_761586223/Sample.html
lxxxii
http://www.ama-assn.org/ama/pub/category/1815.html
lxxxiii
Encarta World English Dictionary
lxxxiv
Encarta World English Dictionary
lxxxv
http://encarta.msn.com/encyclopedia_761586099/Direct_Advertising.html
lxxxvi
http://jama.ama-assn.org/misc/aboutjama.dtl
80
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Abstract (if available)
Abstract
American physicians are constantly bombarded with offers of free equipment trial, drug samples, patient materials and scores of other incentives. This practice has come under scrutiny by consumer advocacy groups in recent years. Of particular concern is the widely accepted practice of providing drug samples for physicians to then offer to patients.
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University of Southern California Dissertations and Theses
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Franklin, Lauren Paule
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Core Title
Physicians' perceptions on the ethics of free drug samples
School
Annenberg School for Communication
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Master of Arts
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Strategic Public Relations
Publication Date
04/28/2010
Defense Date
04/01/2008
Publisher
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Tag
direct to consumer advertising,Doctors,Drugs,ethics,Marketing,OAI-PMH Harvest,pharmaceutical,physicians,prescription,promotions,Public Relations,samples
Language
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Advisor
Floto, Jennifer D. (
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