E SSAYS

Is Marketing the motion schemes.3 All of these problems can be traced

back to marketing-inspired ruses.
The second, less apparent trend is a decline in new
Enemy of drug applications marking breakthrough discoveries. In
the words of a 2006 Government Accountability Office
report to Congress, “Innovation in the pharmaceutical
Pharmaceutical industry has become stagnant.”4 Merrill Goozner, head of
the Center for Science in the Public Interest, explains,

Innovation? “Three out of every four drug applications involve drugs

that either replicated the action of medicines already on
the market or were new formulations that at best added
minor conveniences for patients and doctors.”5
Some have had the intuition that these two trends are
connected, but the dots have not been empirically or
even notionally linked in a way that would light a path to
reform. The two appear to be effects of a different order.
I will argue that they are joined because they reflect the
ascendancy of marketing throughout the pharmaceutical
BY KALMAN APPLBAUM industry and in particular because they result from the in-
tegration of pharmaceutical firms’ marketing efforts with
their formerly semiautonomous research and develop-
Clinical trials are the most credible and powerful form of ment (R&D) divisions.
marketing in the prelaunch period. My goal in this essay is to connect some of the dots—
—Francoise Simon and Philip Kotler1 to show that the decline of innovation is also linked to
the rise of marketing. Discovery of medical cures relies on

T
wo alarming trends have surfaced in the pharma- honestly pursued scientific outcomes and a clear separa-
ceutical industry these past two decades. The first tion of influence over scientific practices and goals. I
is a surge in ethics violations. Despite journalists, specify the rise in the early 1990s of blockbuster drugs—
researchers, bloggers, and lately lawmakers who have the handful of brands that account for nearly half the in-
been working to shame the industry into self-reform, the dustry’s profit—as the catalyst for yoking R&D to mar-
pace at which new scandals are born appears, if anything, keting, a development that would have been unfamiliar
to be accelerating.2 There is wrongdoing in every stage of and unnatural to most pharmaceutical executives of prior
drug development and promotion. The list includes cam- generations. I draw on industry sources to depict man-
paigns to “ghost manage” the conduct of basic science, to agerial principles at work in defining the relationship, the
rig clinical trials, to run trials in poor countries where most telling of which is referred to as “precommercial
ethical oversight is weak, to market medical conditions planning and marketing.”
far beyond their natural incidence (“condition branding,” Precommercial planning and marketing demonstrates
as the marketers term it), to sway public health criteria how the marketing-driven outlook in pharmaceutical
for the threshold of disease risk, and to lure some of the companies today pushes these enterprises toward an esca-
nation’s most respected doctors into risky off-label pro- lation in the adoption of marketing rationales at the ex-
pense of public health. What emerges is a system in
Kalman Applbaum, “Is Marketing the Enemy of Pharmaceutical Innova- which the scientific search for cures and the marketing-
tion?” Hastings Center Report 39, no. 4 (2009): 13-17. led pursuit of meeting unmet medical needs stand not in

July-August 2009 HASTINGS CENTER REPORT 13

cooperative tandem, one with the other, but in direct compe- This model was apparently accurate for many historical
tition. Precommercial planning and marketing, in short, is a cures, and it remains the image the pharmaceutical industry
legal but unethical practice when applied to humanly vital in- projects to the public about how it operates. But this model
dustries such as the pursuit of medical cures. has in fact ceased to apply. Given the time crunch for gener-
ating profits from a drug, this model, too, is not sustainable.
Marketing and R&D Precommercial planning and marketing is the attempt to
compress the sequence by involving scientists and incorporat-

W hat is precommercial planning and marketing? A re-

cent podcast at Pharmavoice, “a Website for life-sci-
ences executives and other healthcare-service related profes-
ing their research capacities directly into the marketing
process. This is the integration of marketing and R&D.
Beginning in the 1990s, pharmaceutical marketing execu-
sionals,” was entitled “Pharmaceutical Marketing and Plan- tives began speaking obsessively about the integration of mar-
ning: Securing Future Success through Meaningful Differen- keting and R&D. The first to do this may have been William
tiation.” The guest speaker was Laurie Lucas, founder of L3 Steere, Jr., who was promoted from the marketing depart-
Healthcare Marketing, LLC, which explains its objective this ment to CEO at Pfizer in 1991. In his book Generation Rx,
way: “The pharmaceutical market is evolving rapidly, growing Greg Critser describes Steere’s priorities for the company
in complexity, and there is less time to maximize a product’s upon assuming command. There were three. “The first one
potential. Medical communications are critical to under- was get marketing and research closer together. The second
standing the target therapeutic area, and to communicating a one was get marketing and research closer together. And then
product’s unique attributes.”6 The “less time” here refers to he said the third one was get marketing and research closer to-
the length of time under patent during which a firm can sell gether.”7
and accrue profits for a drug. Since a patent is taken out upon The procedural details of this transformation—and a
the formulation of a molecule and several years elapse before transformation clearly was what was entailed—would have to
the drug is developed, approved, and brought to market, be worked out by field officers such as Laurie Lucas. A white
companies are always seeking to shorten the time between paper produced by her firm, L3 Healthcare Marketing, de-
patent registration and product launch. The clinical research clares that “Pre-commercial marketing requires the collabora-
phase and the approval process can hardly be made shorter tion of multiple brand stakeholders, including clinical affairs,
than it has been already. Lucas wishes to teach her clients that pre-clinical, regulatory, legal, medical affairs, and marketing.
by starting the marketing prior to the launch itself, the period Everyone involved should have an understanding of the broad
of time before the drug can be sold can nevertheless be lever- commercial issues that will or are likely to affect the product
aged to improve profitability during the commercial phase of when it reaches the market, as well as the elements that create
the drug. She refers to this, using the general parlance, as “pre- value for a product.”8 In 2002, at a roundtable entitled
commercial planning and marketing.” “When Worlds Collide: The Unleashed Power of Market-
Many people assume that a drug goes through a three-step ing/R&D Collaboration,” one executive observed, “At Takeda
pipeline: we believe that the opportunity is integrating early and
through target product development profiles, making sure
Research  Development  Marketing that everyone is going in the same direction.”9 He described
the drug Trovan as an ideal example of such integration.10 An-
This model, if it was ever accurate, is certainly not sustain- other executive said, “At AstraZeneca R&D people started to
able now. If you start just with discovery and development of embrace more of the entrepreneurial mindset and understand
a product and only subsequently think about marketing it, customer needs better”—in other words, the institutional re-
you risk bringing to market a product that may have had only organization under the direction of marketing. “We struggled
modest potential for commercial success to begin with. Logi- initially, but it eased once the R&D folks truly understood
cally, you would want to have a little market research mixed in what we were all working toward, which is value enhancement.
with the drug R&D: you would have market researchers gath- We were all trying to figure out how to have an impact on the
er data at clinics and hospitals, and you would use this data to bottom line.” And an executive from Wyeth concluded, “You
select among research proposals for drugs with the greatest can’t have a blockbuster without [integration].”
market potential. Or, executives might go to the laboratory In these and many more comments we hear that integra-
and solicit research into known diseases. In this case, the lab- tion of marketing and R&D is the first important step toward
oratory personnel need not be bothered with marketing con- what marketers in many consumer goods industries call value
siderations per se. They might take their orders from those creation. Since the internally created value has to mirror what
who have the market’s needs clearly in mind, but their scien- external stakeholders will value also, its counterpart is value
tific work would not otherwise be affected. A flow chart of demonstration. Value creation and demonstration therefore
this sequence might be: mirror the distinction between internal and external stake-
holders. If creating value is the focus of the pharmaceutical
Market Research Research DevelopmentMarketing company team, with implications for how therapies are iden-

14 H A S T I N G S C E N T E R R E P O R T July-August 2009
tified and researched, the complementary task is demonstrat- in development—clinical trials can be altered accordingly.
ing that value to the world outside the company. Thought leader participation in successive trial phases is itself
This distinction is more analytical than practical. The or- part of the procedure aimed to ensure awareness and adoption
ganizational approach to creating value internally in fact bears at the time of launch. “Opinion leaders drive the second-most
a strong resemblance to demonstrating value to external crucial premarketing component, that is, publications. There
stakeholders—regulators, physicians, and insurers who must is a close correlation between successful launches and aggres-
be brought “on board” in the drug marketing process. In the- sive publication programs.”14 Laurie Lucas calls this “value
ory and practice, value creation and demonstration work best through data.”
when they are absolutely simultaneous and perceptually coin- Simon and Kotler are not speaking the language of coop-
cident in the minds of all stakeholders, internal and external. eration between marketing and science but of the strategic in-
Lucas speaks of the “collabora- tegration of the two at every
tion of internal team members step under the direction of mar-
and external experts.” Since the keting. Marketing must own the
internal team—which includes pipeline, not just react to its
sales reps, “regulatory,” “publi- Given the time crunch for outcomes. As one of the execu-
cation planners,” and in-house tives from the “When Worlds
physicians employed as market-
ing personnel—and the external
generating profits, drug Collide” roundtable said, “The
companies that do it right don’t
actors—which include physi- talk about R&D and market-
cians and the public—both companies try to integrate ing. If you can get the key peo-
need to be convinced of the new ple to all be brand managers—
product’s value in order to max- marketing and R&D by to look for brands rather than
imize its commercial potential, just compounds . . . Branding is
the responsibility of marketing
also extends across this divide.
incorporating scientists’ about the ownership of ideas.
The Cox-2 inhibitors are the
The practical implication of most recent examples of owning
this is that even from the outset research capacities directly the science from day one.” The
the entire team, including lab Cox-2 inhibitors, of course, are
researchers, is devoted to into the marketing process. Vioxx, Celebrex, and Bextra, a
demonstrating the efficacy and class of drugs associated with
safety of the product yet to be the most florid marketing
born. The new flow chart be- malfeasance in recent history.
comes:
Contradictory Notions of Value
Value Creation/Demonstration (Marketing Research)R&D
Marketing Control

A fuller schematic that temporally juxtaposes clinical and

W hat is meaningful to marketers may be meaningless to
science and vice versa. Medical, scientific value consists
in a discovery’s capacity to explain phenomena verifiably and
commercial strategies is produced as a prelaunch strategy map then be applied to reduce human suffering from disease. Mar-
used by the SDC Group consulting company. The map keting value, by contrast, is fluid, relative, and contingent on
should be read not as a static set of procedures associated with perceived utility. Marketing value is measured in accordance
each prelaunch stage, but as an emergent set of strategic con- with its ability to achieve product differentiation, which refers
siderations. Even before phase I trials, “thought leaders”— to the process of making one’s product offering appear unique
meaning influential doctors—are “developed.”11 Publications in the marketplace and superior to those of one’s competitors.
are brought out to begin the awareness campaign and to ini- Product differentiation is in many ways the prime directive of
tiate a paper trail for future citations. Françoise Simon (presi- all marketing.
dent of the SDC Group) and Philip Kotler estimated in 2003 In the integration of marketing and R&D across contem-
that thought leader development accounted for 20 percent of porary medicine, we find fewer and fewer expressions of sci-
marketing costs and was rising.12 By comparison, direct-to- entific value—an outright cure for Dread Disease X, or a
consumer advertising in 2004 accounted for only 14 percent frank evaluation of the many-sided approaches to delaying or
of pharmaceutical spending.13 In the preclinical stage, managing diseases we cannot yet cure. Instead, we find in in-
thought leaders can “communicate unmet medical needs and creasing abundance the promotion of marketing values and
shape the design and endpoints of Phase I and II clinical tri- the gargantuan effort to demonstrate these to the different
als.” Thus, depending on what thought leaders learn from stakeholders whose cooperation is required for the successful
doctors and patients—and what selling points they are able to launching of the product. Marketing and scientific concepts
“communicate” to them regarding the promise of a drug still of value can but need not overlap. What is valuable to mar-

July-August 2009 HASTINGS CENTER REPORT 15

keters can be meaningless, dangerous, and costly to everyone Publicly Funded Research?
else.
For pharmaceutical marketers, as we have seen to especial-
ly great effect in the heyday of the industry’s quest for block-
busters since the early 1990s, pharmaceutical value has often
A ny discussion aimed at realigning existing arrangements,
much less granting oversight responsibility to govern-
ment, is likely to arouse fears about meddling in the private
been a marketing proposition, not a scientific one. The num- sector. Nevertheless, the point has been reached where neither
ber of “me too” drugs that have been proposed since then is a the interests of public health nor the private patient are being
predictable outcome of the integration of marketing and served by an industry that has, officially or otherwise, been
R&D. The very expression “me too” is telling: the develop- entrusted to deliver a significant portion of our health prod-
ment of these drugs creates marketing value through the sub- ucts.
segmentation of existing markets.15 The ethical violations I propose sequestering pharmaceutical R&D as a strategic
stem from the same source as the drag on innovation—name- and humanitarian industry, in the same sense as one speaks of
ly, the uncontrolled pursuit of national defense-related indus-
marketing values and the com- tries such as aerospace or, for-
pany philosophy this reflects merly, telecommunications and
and produces. semiconductors. No one would
When we look at pharma-
ceutical companies’ ethical vio-
Pharmaceutical value has argue that these industries have
not generated scientific break-
lations, we tend to conclude
that greed (as reflected in exces-
increasingly become a throughs, or that the eventual
commercialization of these tech-
sive marketing) and individual nologies has been unprofitable.
unethical decisions are to marketing proposition, not Only the dogged faith of free-
blame. To some degree, they market devotees that break-
are, but we should not lose sight
of the nonprosecutable organi-
a scientific one. What is throughs spring not from pater-
nalistic expert systems but from
zational norms that lie behind
these abuses and that both fuel
valuable to marketers can industrial competition stands as
an obstacle to accepting this
ethical breaches and dampen framework.
the impetus to develop innova- be meaningless, dangerous, Merrill Goozner argues that
tive products. By organizational there has been a huge misper-
norms, I mean the marketing
practices that have at their back
and costly to everyone else. ception about the sources of sci-
entific creativity in the pharma-
sound managerial principles, ceutical and biotech industries.
marketing’s peculiar but accept- He shows “that the inception of
ed form of apprehending mar- drugs which have truly made a
ket needs, and the unrelenting requirement to adapt to a difference in recent years and which will make a difference in
patent-driven competitive commercial environment. the twenty-first century can almost always be found in the
What should strike us most in the marketing practices that vast biomedical research enterprise funded by the federal gov-
have come to light in various court trials is how routine they ernment.”16 If he is correct, then an appropriation of the re-
appear to be. The spectacle of the trials is in this sense a dis- search function of the pharmaceutical industry to federal re-
traction, since it focuses our attention on violations. But the sponsibility, with the aim of separating marketing and R&D,
violations stem from marketing practices that are not at all will disable the vast machinery of tendentious, marketing-dri-
covert—in fact, they are positively embraced. ven science without making useful invention less likely. The
As the system is now organized, patents encourage drug corruption described at the beginning of this essay will be
firms to sideline the uncertain and difficult search for pio- mitigated, and rare diseases and those suffered mainly by poor
neering cures to serious diseases in favor of what they call people would get the research and development attention
“meaningful product differentiation strategies.” In that they deserve. There would be tremendous health care savings
scheme, meaningfulness is defined relative to an image of nov- from the dismantling of the vast marketing expenditures de-
elty, efficacy, and safety that firms endeavor to influence voted to marketing-adjunct R&D, to the production of drugs
through myriad forms of propaganda. The vast resources ex- showing no advantage over their predecessors, and to the
pended on defending and promoting what Alastair Matheson competitive carpet bombing of doctor’s offices with sales reps.
aptly calls “corporate science” are bleeding us of health care re- The public has much at stake in how pharmaceutical re-
sources and muddying the scientific and clinical waters in search is conducted; its participation in the industry’s gover-
which bona fide researchers must also swim. nance should reflect that investment. At present, the public’s
participation in pharmaceutical governance is restricted be-
cause pharmaceutical companies, as private enterprises, are

16 HASTINGS CENTER REPORT July-August 2009

 estimate of nonbreakthrough applications to 92 percent; P. Shetty,
legally entitled to keep most of their practices, strategies, and “More Creative Thinking Needed On Drug R&D,” YaleGlobal Online,
data (market and scientific) secret. The privilege that has been http://yaleglobal.yale.edu/display.article?id=5678.
afforded the private sector to determine what our health care 6. L3 Healthcare Marketing, LLC, home page, http://www.l3hm.
priorities should be derives from the incongruous belief that, com/index.php, accessed June 29, 2008.
as Richard Henry Tawney put it nearly a century ago, “The 7. G. Critser, Generation Rx (New York: Houghton Mifflin, 2005),
enjoyment of property and the direction of industry are con- 91.
sidered to require no justification, because they are regarded 8. L3 Healthcare Marketing, “Pharmaceutical Marketing and Plan-
as rights which stand by their own virtue, not functions to be ning: Securing Future Success through Meaningful Differentiation,”
http://www.l3hm.com/documents/L3_Pre-CommercialWhitepa-
judged by the success with which they contribute to a social per0508.pdf, p. 1, accessed June 30, 2008.
purpose.”17 9. W. Koberstein, “When Worlds Collide: The Unleashed Power of
In an age in which treatment of the sick is increasingly de- Marketing/R&D Collaboration,” Pharmaceutical Executive, September
pendent on pharmacological intervention, there is work also 1, 2002, http://pharmexec.findpharma.com/pharmexec/Current+Issue/
for salesmen and market researchers. Encouraging pharma- When-Worlds-Collide/ArticleLong/Article/detail/29963.
ceutical industry marketers to concentrate on their expertise 10. Trovan later became infamous for the ethical research abuses as-
of commercialization and distribution can also yield many sociated with its testing practices in Nigeria.
goods. We can seek their help in assessing clinicians’ needs 11. Thought leaders are also known as “key opinion leaders” or
KOLs. An excellent description of how KOLs are recruited and the pur-
and treatment outcomes, in devising inventive schemes for poses they serve can be found in A. Matheson, “Corporate Science and
treatment adherence, and for helping in the logistical man- the Husbandry of Scientific and Medical Knowledge by the Pharma-
agement of the delivery of medicines to patients who so des- ceutical Industry,” BioSocieties 3 (2008): 355-82.
perately need them, both at home and in other parts of the 12. Simon and Kotler, Building Global Biobrands, 147.
world. 13. J.M. Donohue, M. Cavasco, and M.B. Rosenthal, “A Decade of
Direct-to-Consumer Advertising of Prescription Drugs,” New England
1. F. Simon and P. Kotler, Building Global Biobrands (New York: Free Journal of Medicine 357 (2007): 673-81.
Press, 2003), 147. 14. Simon and Kotler, Building Global Biobrands, 147.
2. As I was revising this essay, the following appeared in my home- 15. Arguments have been offered in favor of the utility of “me too”
town newspaper: “The conclusions were clear: Women who took hor- drugs, the most robust of which is that drugs in the same therapeutic
mone therapy drugs were at increased risk for breast cancer, heart dis- class might offer differential efficacy and side-effect profiles for different
ease, stroke and blood clots. The findings were so strong that researchers patients. This is true and offers some qualification to the criticism of
stopped a clinical trial in 2002, five years early, because it would have these drugs. Factually, however, the number of “me too” drugs among a
been unethical to continue giving the drugs to women. But that same narrow range of profitable therapeutic classes is disproportionate, and
year, the University of Wisconsin-Madison’s School of Medicine and the distinguishing profiles among these tend to be narrower than adver-
Public Health began a medical education program for doctors that pro- tised. My argument here is that drug companies do not pursue the pro-
moted hormone therapy, touted its benefits and downplayed its risks. duction of “me too” drugs with the aim of offering medically meaning-
For the next six years, thousands of doctors from around the country ful differences, but rather to win easy market share in markets where de-
took the online course that was funded entirely by a $12 million grant velopment of these drugs contributes to their absolute growth.
from Wyeth Pharmaceuticals, which makes the hormone therapy drugs 16. M. Goozner, The $800 Million Pill: The Truth Behind the Cost of
used in the study, Prempro and Premarin.” J. Fauber and S. Rust, “Are New Drugs (Berkeley: University of California Press, 2004), 8.
Doctors’ Loyalties Divided? UW Course for Doctors Pushed Risky
17. R.H. Tawney, The Acquisitive Society (New York: Harcourt, Brace
Therapy,” Milwaukee Journal Sentinel, January 25, 2009.
and Company, 1920), 24.
3. See D. Healy, “The Engineers of Human Souls and Academia,”
Epidemiologia e Psichiatria Sociale 16, no. 3 (2007): 205-11; S. Sismon-
do, “Ghost Management: How Much of the Medical Literature Is
Shaped Behind the Scenes by the Pharmaceutical Industry?” PLoS Med-
icine 4, no. 9 (2007): e286; S. Sismondo, ed., “Special Issue on Inter-
sections of Pharmaceutical Research and Marketing,” Social Studies of
Science 34, no. 2 (2004); A. Petryna, “Ethical Variability: Drug Devel-
opment and Globalizing Clinical Trials,” American Ethnologist 32, no. 2
(2005): 183-97; R. Moynihan and D. Henry, “The Fight against Dis-
ease Mongering: Generating Knowledge for Action,” PLoS Medicine 3,
no. 4 (2006): e191; K. Applbaum, “Pharmaceutical Marketing and the
Invention of the Medical Consumer,” PLoS Medicine 3, no. 4 (2006); K.
Applbaum, “Getting to Yes: Corporate Power and the Creation of a Psy-
chopharmaceutical Blockbuster,” Culture, Medicine and Psychiatry 33,
no. 2 (2009): 185-215.
4. Government Accountability Office, “New Drug Development:
Science, Business, Regulatory, and Intellectual Property Issues Cited as
Hampering Drug Development Efforts,” 2006, http://www.gao.gov/
new.items/d0749.pdf.
5. M. Goozner, “GAO: Drug Innovation Lags Despite High Drug
Prices,” Gooznews on Health, December 19, 2006; http://209.
85.229.132/search?q=cache:akdAKwFemfUJ:www.gooznews.com/archi
ves/2006_12.html, accessed June 18, 2009. Another study revises the

July-August 2009 HASTINGS CENTER REPORT 17