OPEN 8 ACCESS Freely available onllne
`
`PLOS MEDICINE
`
`The Cost of Pushing Pills: A New Estimate of
`Pharmaceutical Promotion Expenditures in
`the United States
`Marc-Andre Gagnon'. Joel Lexchin
`
`o the late 19505, the late
`
`IDemocratic Senator Estes
`
`Kefauver. Chairman of the
`United States Senate’s Anti-Trust
`
`and Monopoly Subcommittee. put
`together the first extensive indictment
`against the business workings of the
`pharmaceutical industry. He laid three
`charges at the door of the industry.
`(1} Patents sustained predatory prices
`and excessive margins; (2) Costs and
`prices were extravagantly increased by
`large expenditures in marketing; and
`(3) Most of the industry's new products
`were no more effective than established
`
`drugs on the market [1]. Kefauver’s
`indictment against a marketing-driven
`industry created a representation of the
`pharmaceutical industry far different
`than the one offered by the industry
`itself. As Freud and colleagues put it,
`the image of life-saving “researchers in
`white coats” was now contested by the
`one of greedy “reps in cars“ [‘2]. The
`outcome of the struggle over the image
`of the industry is crucial because of its
`potential to influence the regulatory
`environment in which the industry
`operates.
`Fifty years later, the debate still
`continues between these two depictions
`of the industry. The absence of reliable
`data on the industry‘s cost structures
`allows partisans on both sides of the
`debate to cite figures favorable to their
`own positions. The amount of money
`spent by pharmaceutical companies on
`promotion compared to the amount
`spent on research and development is
`at the heart of the debate, especially in
`the United States. A reliable estimate
`
`of the former is needed to bridge the
`divide between the industry‘s vision
`of researchdriven, innovative, and
`life-saving pharmaceutical companies
`
`The Policy Forum allcvws health policy makers around
`the world to discuss challenges and opportunities for
`improving health care in their societies.
`
`and the critics' portrayal of an
`industry based on marketing-driven
`profiteering.
`IMS, a firm specializing in
`pharmaceutical market intelligence.
`is usually considered to be the
`authority For assessing pharmaceutical
`promotion expenditures. The US
`General Accounting Office, for
`example, refers to IMS numbers in
`concluding that “pharmaceutical
`companies spend more on research
`and development initiatives than on
`all drug promotional activities” [3].
`Based on the data provided by IMS
`[4], the Pharmaceutical Research and
`Manufacturers of America (PhRMA),
`an American industrial lobby group
`for research-based pharmaceutical
`companies, also contends that
`pharmaceutical firms spend more on
`research and development [R&D) than
`on marketing: US$296 billion on RScl')
`in 2004 in the US [5] as compared to
`US$217 billion for all promotional
`activities. [4]
`In this paper, we make the case
`for the need for a new estimate of
`
`promotional expenditures. We then
`explain how we used proprietary
`databases to construct a revised
`
`estimate and finally, we compare our
`results with those from other data
`
`sources to argue in favor of changing
`the priorities of the industry.
`
`The Case for a New Estimate of
`Pharmaceutical Promotion
`
`There are many concerns about
`the acouracy of the [MS data. First.
`IMS compiles its information
`through surveys of firms, creating
`the possibility that companies may
`systematically underestimate some of
`their promotional costs to enhance
`their public image. Second. [MS does
`not include the cost of meetings and
`talks sponsored by pharmaceutical
`companies featuring either doctors
`or sales representatives as speakers.
`
`The number of promotional meetings
`has increased dramatically in recent
`years, going from 120,000 in 1998 to
`371,000 in 2004 [6]. In 2000. the top
`ten pharmaceutical companies were
`spendingjust under US$19 billion on
`314,000 such events [7]. Third, IMS
`does not include the amount spent
`on phase IV “seeding“ trials, trials
`designed to promote the prescription
`of new drugs rather than to generate
`scientific data. In 2004, 13.2% (US$43
`billion) of R&D expenditures by
`American pharmaceutical firms was
`spent on phase IV trials [5]. Almost
`75% of these trials are managed solely
`by the commercial. as opposed to the
`clinical, division of biopharmaceutical
`companies. strongly suggesting that the
`vast majority of these trials are done
`just for their promotional value [8].
`Finally, IMS data seem inconsistent
`with estimates based on the
`
`information in the annual reports
`of pharmaceutical companies. For
`example. in an accounting study based
`
`FundingtThe authors received no specific funding
`for this article.
`
`Competing IntereststThe authors have declared
`that no competing interests exist.
`
`citation: Gag non MA, Lexchin J {2003} The cost of
`pushing pills: A new estimate of pharmaceutical
`promotion expenditures in the united states. PLoS
`Med Si‘l): e‘l. doi:10.13?lfjoumal.pmed.0050m‘l
`
`Copyright: © 2008 Gagnon and Leuhin. This is an
`open-access article distributed under the terms
`of the Creative Commons Attribution License,
`which permits unrestricted use. distribution.
`and reprtxiuction in any medium. provided the
`original authot and source are credited.
`
`Abbreviations: AWP. average wholesale price:
`PhRMA. Pharmaceutical Research and Manufacturers
`of America: REID. research and development
`
`Marc-Andre Gagnon is with the Departement
`de Sociologie.Universite du Quebec a Montreal,
`Montreal. Quebec. Canada. Joel Lexcliin is with the
`School of Health Policy and Management. York
`University. Toronto. Ontario, Canada
`
`“ To whom correspondence should be addressed.
`E-mail: magagnon©umontreatca
`
`@' PLoS Medicine | www.plosmedicine.org
`
`0029
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`January 2008 | Volumes | Issuei
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`Table 1. Pharmaceutical Marketing Expenditures in the United States in 2004:
`Data from IMS, CAM, and Our New Estimate
`
`
`
` Type of Promotion IMS {USS CAM (USS New Estimate Percent of Total
`
`Billions!
`Billions)
`(USS Billions}
`of New Estimate
`
`Samples
`Detailing
`DTCA (Data provided by CMR)
`Meetings
`E-promotion. mailing. clinical trials
`Journal advertising
`Unmonitored promotion [estimated
`Total
`
`I 5.9
`13
`4
`
`nd
`mi
`05
`nd
`217
`
`6.3
`20,4
`4
`2
`0.3
`0.5
`14.4
`47.9
`
`15.9 {IMS}
`20.4 [CAM]
`4 tCMFt}
`2 (CAM)
`0.3 {CAM}
`0.5 {CAWIMS}
`14.4 {CAM}
`57.5
`
`27.?
`35.5
`7
`3.5
`0.5
`0.9
`25
`100
`
`'lncludes incomplete disclosure and omissions by surveyed physicians promotion to unaudited physician categories.
`promotion in un monitored joumals, and could possiny include unethical forms of promotion funded out ofthe firms’
`marketing budget. See text for details about this category.
`DTCA. direct-townsumer advertising: nd, no data
`doi:10.1371!j0umal.pmed.00’50001.1001
`
`on the annual reports of ten of the
`largest global pharmaceutical firms,
`Lauzon and Hasbani showed that
`between 1996 and 2005, these firms
`globally spent a total of US$739 billion
`on “marketing and administration.”
`In comparison, these same firms spent
`US$699 billion in manufacturing costs,
`US$288 billion in R&l), and had a net
`investment in property and equipment
`of US$43 billion, while receiving
`US$558 billion in profits [9].
`Annual reports, however, have their
`(M11 limitations. First, pharmaceutical
`firms are multinational and diversified;
`their annual reports provide no
`information on how much they spend
`on pharmaceutical marketing, as
`Compared to the marketing of their
`nt:n-pharnutceutical products, and they
`do not provide information about how
`much is spent on marketing specifically
`in the US. Second, annual reports
`merge the categories of “marketing”
`and “admin istration,” without
`delineating the relative importance
`of each. Finally, “marketing” is a
`category that includes more than just
`promotion; it also includes the costs of
`packaging and distribution. In terms
`of olfering a more precise estimate of
`overall expenditures on pharmaceutical
`promotion in the US, annual reports
`are thus far from satisfactory.
`In the absence of any collection
`of information on promotional
`spending by government or any
`other noncommercial source, the
`market research Company IMS
`has long been the only source of
`such information, which it gains by
`surveying pharmaceutical firms. Since
`2003, however, the market research
`Company CAM has been providing
`Comprehensive information on
`
`promotion expenditures by surveying
`doctors instead of firms. (In July 2005,
`CAM was merged into the Cegedim
`Group, another market research
`company.) We chose to compare
`IMS data to those produced by (2AM
`in order to provide a more accurate
`estimate of promotional spending in
`the US. Other proprietary sources of
`data do not break down promotional
`expenditures into different categories
`and therefore were not used in our
`
`comparison.
`
`Methods
`
`According to its Web site (http://
`tnijmshcalthcom/L [MS
`provides business intelligence and
`strategic consulting services for the
`pharmaceutical and health care
`industries. It is a global Company
`established in more than 100 Countries.
`
`IMS gathers data from 29,000 data
`suppliers at 225,000 supplier sites
`worldwide. It monitors 75% of
`prescription drug sales in over 100
`countries, and 90% of US presCription
`drug sales. It tracks more than 1 million
`products from more than 3,000 active
`drug manufacturers. [MS data for 2004
`were obtained from its Web site for
`
`the amount spent on: visits by sales
`representatives (detailing), samples,
`direct-to-consumer advertising, and
`journal advertising.
`The Cegedim Web site (http://www.
`cegedim-crm.com/index.php?id=l 2)
`describes CAM as a global company
`dedicated to auditing promotional
`activities of the pharmaceutical
`industry, established in 35 Countries
`worldwide. (2AM annually surveys
`a representative sample of 2,000
`primary care physicians and 4,800
`specialists in a variety of specialties
`
`in selected locations in the US. From
`
`(IAM's newsletter [10], we obtained
`access to data from CAM for the same
`
`promotion categories as from IMS. In
`addition, CAM provided figures for
`the amount of spending 011 company
`sponsored meetings, e-promotion,
`mailings, and clinical trials.
`We used 2004 as the comparison
`year because it. was the latest year For
`which information was available ii'om
`
`both organizations. We focused on the
`US because it is the only Country for
`which information is available for all
`
`important promotional categories. The
`US is also, by far, the largest market
`for pharmaceuticals in the world,
`representing around 43% of global
`sales [1 1,12] and global promotion
`Expenditures [ l0, I3].
`We asked both CAM and IMS
`
`about the procedures that they used
`to collect information on different
`
`aspects of promotion. Based on the
`answers we received, we determined
`the relevant figures for expenditures
`for samples and detailing. Each
`author independently decided on
`which values should be used, based
`on an understanding of the methods
`that the companies used to collect
`the information and the limitations
`of those methods. Differences were
`
`resolved by consensus.
`We queried (1AM and IMS about
`the estimated value of unmonitored
`
`promotional expenditures. IMS did
`not provide an answer to this question.
`In order to validate its estimates, CAM
`relies on a validation Committee that
`
`includes representatives from various
`pharmaceutical firms, including
`Merck, Pfizer, Bristol-Myers Squibb,
`Eli Lilly, Aventis, Sanofi-Synthelabo,
`AstraZeneca, and Wyeth. Under
`a confidentiality agreement, the
`firms supply CAM with internal data
`related to their detailing activity and
`promotional costs in the US. Through
`the validation committee, (1AM
`can thus compare totals obtained
`through its own audits with the firms‘
`internal data about their promotional
`budgets in order to evaluate if all
`promotion has been properly audited
`through its physician surveys. As a
`result of this Comparison, CAM‘s
`validation committee considers that
`
`about 30% of promotional spending
`is not accounted for in its figures.
`(1AM is unable to provide an exact
`breakdown of unmonitored promotion,
`
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`but it believes that around 10% is
`
`dtte to incomplete disclosure and
`omissions by Surveyed physicians and
`the remaining 20% comes from a
`combination of promotion directed
`at categories of physicians that are
`not surveyed, unmonitored journals
`in which pharmaceutical promotion
`appears, and possibly unethical
`forms of promotion. We adjusted
`total expenditures to account for this
`ttn reported 30%.
`
`Results
`
`For 2004, CAM reported total
`promotional spending in the US of
`US$335 billion [10], while IMS gave
`the figure of US$277 billion for the
`same year [4]. Both (JAM and IMS
`cited the media intelligence company
`(JMR as the source for the amount
`
`spent on direct-to-consumer advertising
`(US$4 billion), and they also gave the
`same figure forjournal advertising
`(US$0.53 billion).
`There were two major differences
`between the two sets of figures: the
`amounts spent on detailing and
`the amounts spent on samples.
`IMS estimated the amount spent
`on detailing at US$13 billion [4]
`versus US$204 billion for (1AM [10],
`and while IMS gave a retail value of
`US$153 billion for samples [14] , CAM
`estimated a wholesale value of US$6.53
`billion [10].
`Using the IMS figure of US$159
`billion for the retail value of samples,
`and adding the CAM figures for
`detailing and other marketing expenses
`after correcting for the 30% estimate
`of unaccminted promotion, we arrived
`at US$57.53 billion for the total amount
`spent in the US in 2004, more than
`twice what IMS reported (see Table 1).
`
`Discussion
`
`Our revised estimate for promotional
`spending in the US is more than twice
`that from IMS. This number compares
`to US$31.15 billion for domestic
`industrial pharmaceutical RScD
`(including public funds for industrial
`R&D) in 2004 as reported by the
`National Science Foundation [15].
`However, even our revised figure
`is likely to be incomplete. There are
`other avenues for promotion that
`would not be captured by either IMS
`or (JAM, such as ghostwriting [16]
`and illegal off-label promotion [l7].
`Furthermore, items with promotional
`
`potential such as "seeding trials" or
`educational grants might be included
`in other budgets and would not be seen
`in the confidential material provided to
`CAM‘s validation committee.
`IMS and (JAM data were used for
`
`comparison purposes for a number of
`reasons: data from both were publicly
`available, both operate on a global
`scale and are well regarded by the
`pharmaceutical industry, both break
`down their information by different
`categories of promotion, and, most
`importantly, they use different methods
`for gathering their data, thereby
`allowing us to triangulate on a more
`accurate ligure for each category.
`Methodological differences between
`the ways that IMS and (JAM collect data
`will affect the values for promotional
`spending depending on the category
`being considered. Because of the
`problematic nature of some data from
`each firm, we believe that the most
`precise picture ofindustiy spending
`can be obtained by selectively using
`both sets of figures.
`(JAM compiles its data on the value
`of detailing and samples through
`systematic surveys of primary care
`providers and specialists and by
`estimating an average cost for each
`visit by a sales representative according
`to the type of physician. By contrast,
`IMS compiles its data on the value
`of detailing through surveys of firms,
`while its data on samples are obtained
`by monitoring products directly from
`manufacturers.
`
`types of detailing, for example. the
`use of sales representatives for illegal
`off-label promotion, whereas doctors
`are not likely to distinguish between
`on- and off-label promotion and
`would report all encounters with sales
`representatives.
`In the case of samples, there is
`also a large difference between the
`IMS (US$150 billion) and (JAM
`(US$63 billion) estimates. (JAM
`estimates the amount spent 011
`samples by multiplying the number
`of samples declared by physicians
`with their wholesale value. The latter
`
`is determined by using the average
`wholesale price (AWP), which is the
`amount set by manufacturers and used
`by Medicare in the US to determine
`reimbursement. (JAM then divides that
`amount in half to account for the fact
`
`that samples are frequently given ottt
`in small dosage forms. CAM admits,
`however, that the amount for samples is
`understated because, when physicians
`lill ottt their survey, any quantity of
`samples of the saute product left
`during a call is considered to be only
`one sample ttnit. (JAM's calculations
`also rely on the AWP, which has been
`criticized for not taking into account
`the various discounts and rebates that
`
`are negotiated between manufacturers
`and purchasers [l8].
`IMS provides exact figures for the
`retail value for samples by monitoring
`90% of all pharmaceutical transactions
`and by tracking products directly
`from manufacturers. This method
`
`There is a significant discrepancy
`between the two sets of data in the cost
`
`for calculating the value of samples
`is much more direct than (JAM’s and
`
`of detailing: US$73 billion for IMS
`and US$204 billion for (JAM. This
`difference can be explained by the fact
`that CAM offers a more complete data
`set since it includes in the average cost
`of a call (a sales representative's visit to
`a physician) not only the “cost to field
`the rep" (salary and benefits of the
`representative and the transportation
`cost} but also the costs for the area
`and regional managers, the cost of the
`training, and the cost of detail aids such
`as brochures and advertising material.
`By contrast, in reporting the cost of
`detailing IMS only considers the “cost
`to field the rep." Furthermore, relying
`on physician~generated data to estimate
`the amount spent on detailing is likely
`to give a more accurate figure than
`using ligttres generated by surveying
`firms. Companies may not report some
`
`therefore is likely to be subject to less
`error.
`
`Using the wholesale value for
`samples, the CAM figure would be
`appropriate if we were arguing that
`the money spent on samples should
`go to another activity such as RScD.
`However, we have used the retail value
`of samples because this is consistent
`with companies' reporting ofdrttgs
`they donate [19]. As these are both
`categories of products that are being
`distributed without a charge to the
`user, it is inconsistent for donations to
`be reported in terms of retail value and
`samples in terms of wholesale value.
`We believe that it is appropriate to
`correct for ttnmonitored promotion
`and that the figure we used is a reliable
`estimate. The 30% correction factor
`
`is based on a direct comparison that
`
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`CAM is able to make between the data
`
`it collects through its surveys and the
`amount reported by companies.
`There are other ways of combining
`the data that we have presented,
`but with the exception of choosing
`the lower amounts for detailing
`and samples and ignoring the 30%
`for unmonitored promotion, all of
`them yield a higher figure than the
`one from IMS. Some examples of
`alternative estimates follow: using the
`CAM estimate for the wholesale value
`
`of samples and the 30% adjustment,
`the total amount would be US$473
`billion; without the 30% adjustment
`(JAM’s estimate is US$335 billion.
`Adding the figures for the categories
`that IMS does not cover (meetings,
`e-promotion, mailing, clinical trials)
`boosts its estimate to US$31 billion;
`using the lower figures for detailing
`and samples plus the CAM amounts for
`the other categories and applying the
`30% adjustment gives an amount of
`US$201 billion. Therefore, the actual
`amount could range from a low of
`US$217 billion to a high of US$575
`billion. Our analysis shows, however,
`that the figure of US$575 billion is the
`most appropriate one when using the
`most relevant figures for each category
`of promotional spending.
`Excluding direct-ttrconsumer
`advertising, CAM considers that around
`80% of the remaining promotion is
`directed towards physicians, with 20%
`of this figure going to pharmacists.
`(IMS does not provide any comparable
`values.) With about 700,000 practicing
`physicians in the US in 2004 [20], we
`estimate that with a total expenditure
`of US$575 billion, the industry spent
`around US$61.000 in promotion
`per physician. As a percentage of US
`domestic sales of US$235.4 billion [21],
`promotion consumes 24.4% of the sales
`dollar versus 13.4% for R&D.
`Our new estimate of total promotion
`costs and promotion as a percentage
`of sales is broadly in line with estimates
`of promotional or marketing spending
`from other sources. The annual reports
`of Novartis distinguish “marketing”
`from “administration.” Marcia Angeli
`extrapolates from this annual report
`to the entire industry and calculates
`a figure of US$54 billion spent on
`pharmaceutical promotion in the
`US in 2001 [22] . As a proportion of
`sales, she estimates 33% is spent on
`marketing. Using similar methodology,
`
`the Office of Technology Assessment
`derived an estimate for marketing costs
`in the US by extrapolating from the
`cost structure of Eli Lilly. The Office
`of Technology Assessmen t considers
`that firms spend around 22.5% of their
`sales on marketing [23]. Based on
`United Nations Industrial Development
`Olganization estimates, a report
`from the Organ nation for Economic
`Cooperation and Development
`estimated that, in 1989, pharmaceutical
`firms globally spent 24% of their sales
`on marketing [24], bttt few details of
`the methodology used were provided,
`making it impossible to verify the
`accuracy of the estimate. Finally, in
`2005 Consumers International surveyed
`20 European pharmaceutical firms to
`obtain more information about their
`
`exact expenditures on drug promotion.
`Among the 20 [inns contacted, only
`five agreed to provide separate Iigttres
`for marketing, which ranged from 31%
`to 50% of sales depending on the firm
`[25].
`The results are also consistent with
`data on the share of revenue allocated
`
`to “marketing and administration“
`according to annual reports of large
`pharmaceutical companies, if we
`consider that the largest part of
`“marketing and administration” is
`devoted to promotion. Lauzon and
`I-Iasbani found that 33.1% of revenues
`
`was allocated to “marketing and
`administration” [9], similar to the 31%
`reported by the Centers for Medicare
`and Medicaid Services [26] and the
`27% from Families USA [27].
`The value of our estimate over
`these others is that it is not based on
`
`extrapolating from annual reports
`of firms that are both diversified and
`multinational. Our estimate is driven
`
`by quantifiable data from highly
`reliable sources and concerns only the
`promotion of pharmaceutical products
`in the US. The derivation of our figure
`is thus transparent and can form the
`basis for a vigorous debate.
`
`Conclusion
`
`From this new estimate, it appears
`that pharmaceutical companies
`spend almost twice as much on
`promotion as they do on R&D. These
`numbers clearly show how promotion
`predominates over R8cD in the
`pharmaceutical industry, contrary to
`the industry's claim. While the amount
`Spent on promotion is not in itselfa
`
`confirmation of Kefauver‘s depiction
`of the pharmaceutical industry,
`it confirms the public image of a
`marketing-driven industry and provides
`an important argument to petition in
`favor of transforming the workings of
`the industry in the direction of more
`research and less promotion. I
`
`Supporting Information
`Abstract 51. English abstract
`Found at doi:10.13’Fl/joumal.
`pmed.0050001.stl001 (20 KB DOC).
`Alternative language Abstract 51.
`Translation of the abstract into French by
`MAG
`
`Found at doi:10.13’Fl/joumal.
`pmed.0050001.stl002 (20 KB DOC).
`Appendix 51 .
`Tile Web links displayed ill the footnotes
`4,?,l[l.13,l4. and 21 are now defunct. In
`order to make accessible all data we used
`for this article, this appendix provides
`supporting information or alternative
`sources for the defunct Web links.
`
`Found at doi:10.1371/joumal.
`plncdllllfiflfllll ,sdllilfi (994 KB l‘DF).
`
`Acknowledgments
`The authors would like to thank_[ean—
`Francois Duplain from (1AM Group
`(Canada), Syh'ic (laumond and Sue
`Cavallucci front IMS Health Canada, Lesley
`Shulenbnrg at Thomson Centchatch,
`and Eric PineaultJean F. Gerbiui. Marc
`Hasbani, and Marie (larpentier ['or their
`help and comments.
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