The promotion of olanzapine in primary care: an examination of internal industry documents

Social Science & Medicine 69 (2009) 14–20 The promotion of olanzapine in primary care: An examination of internal industrydocuments Department of Psychology, Metropolitan State University, 1450 Energy Park Drive, St. Paul, MN 55108, United States Media reports have discussed how olanzapine was marketed off-label for dementia and subsyndromal bipolar disorder. Much of this marketing occurred in primary care settings. However, these reports haveprovided few details. In legal proceedings, Lilly disclosed internal documents that detail the strategies utilized to market olanzapine. The current paper addresses the marketing of olanzapine in detail based upon a review of these documents. All 358 documents released by Lilly are publicly available online.
Documents were utilized for this review if they were relevant to the marketing of olanzapine in primary care settings in the United States. It was found that olanzapine was marketed off-label in primary care settings for relatively mild symptoms that were framed as bipolar disorder and schizophrenia. A key strategy in this campaign was the use of hypothetical patient profiles in detailing visits, most of which clearly failed to meet diagnostic criteria for any recognized mental disorder. Evidence emerged that olanzapine was also marketed off-label as a treatment for dementia.
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Olanzapine (ZyprexaÒ) is an atypical antipsychotic agent including a criminal fine of $515 million, subject to the guilty that is currently Federal Drug Administration (FDA)-approved for plea being accepted by the U.S. District Court. This is the the acute and long-term treatment of bipolar I disorder and largest individual corporate criminal fine in US history schizophrenia as well as agitation associated with these condi- tions. A media report alleged that olanzapine was promoted off- tive officer of Lilly, said in a press release that ‘‘we deeply regret label as a treatment for dementia and that sales representatives the past actions covered by this misdemeanor plea’’ were instructed to market olanzapine as a treatment for symptoms In October 2008, Lilly also settled olanzapine marketing- of schizophrenia and bipolar disorder, even if patients did not related claims brought by 33 states for $62 million ( necessarily meet the full diagnostic criteria for either condition (). Likewise, there has been further discussion of Olanzapine use has been linked to significant weight gain the off-label marketing of olanzapine for dementia ).
Reports have suggested that off-label marketing of olanzapine occurred in primary care settings ). Lilly originally denied allegations of off-label marketing ( but in January 2009, as part of a global settlement with the United States to resolve criminal and civil allegations that have led to serious health consequences. It is certainly possible it promoted Zyprexa for uses not approved by the FDA, Lilly agreed that some patients taking olanzapine for an off-label condition to plead guilty to a misdemeanor criminal charge of misbranding received some symptomatic relief. However, a meta-analysis indi- cated that olanzapine showed no benefit versus placebo in treating specifically admitted that between September 1999 and 31 March 2001 it promoted Zyprexa in elderly populations as treatment for At present, there is no evidence from controlled clinical trials dementia, including Alzheimer’s dementia. Furthermore, the available regarding the efficacy of olanzapine in treating relatively company has agreed to a monetary settlement of $1.415 billion, mild nervous symptoms such as those for which olanzapine wasmarketed.
While reports have described various details of marketing * Tel.: þ1 651 999 5826; fax: þ1 651 999 5822.
in-depth analysis of the topic has not appeared in the media and no 0277-9536/$ – see front matter Ó 2009 Elsevier Ltd. All rights reserved.
doi:10.1016/j.socscimed.2009.05.001 G.I. Spielmans / Social Science & Medicine 69 (2009) 14–20 peer-reviewed article has addressed the latest revelations surrounding olanzapine’s marketing. This paper presents findingsfrom internal Lilly documents which were disclosed by Lilly in legal proceedings but which are now publicly available online. The paperwill describe Lilly’s high expectations for olanzapine and how Lilly clearly had high sales expectations for olanzapine.
olanzapine was marketed in primary care using broadened defini- According to a 1997 document, olanzapine ‘‘is a profound corporate tions of bipolar disorder and schizophrenia. In addition, evidence opportunity’’ and was intended to be ‘‘the world’s number one will be discussed regarding the marketing of olanzapine as neuroscience pharmaceutical in history’’ In 2001, a treatment for both dementia and ‘‘schizophrenia lite,’’ as will a document describing a Zyprexa Product Team meeting stated, details of the main methods used to market the drug, primarily ‘‘The company is betting the farm on Zyprexa.the ability of Eli Lilly focusing on the promotion of olanzapine to primary care to remain independent.depends solely on our ability to achieve world class commercialization of Zyprexa [emphases in original].’’The same document stated, ‘‘If we succeed, Zyprexa will be themost successful pharmaceutical product ever.we will have made history’’ (Olanzapine sales were expected to reach$6 billion by 2006 and nearly $8 billion by 2010 ).
Indeed, sales have been robust, with global olanzapine salesranking among the top eight drugs in sales each year from 2000to Documents pertaining to Lilly’s marketing of olanzapine as 2007, ranking fourth among all drugs in 2002 (, pg. 9) well as side effects of the medication were obtained via subpoena, at about $4 billion, and leveling off at about $4.7–$5.0 billion and were expected to remain under seal. However, the documents were leaked to a New York Times reporter (Alex Berenson), who ). In order to help reach these impressive sales wrote several pieces based upon the documents ( goals, olanzapine was marketed not only toward psychiatrists but there has been controversy surrounding the disclosure of the ), an effort that met with some success. Though constituting documents outside the litigation (), the US District a relatively small fraction of overall sales, it was estimated in 2002 Court refused to grant injunctions to prevent five named websites that olanzapine sales in primary care would total about $368 from publishing the documents. Furthermore, the judge in the million in 2003 (pg. 6). Further sales figures for case stated that ‘‘no website is enjoined from disseminating olanzapine in primary care were unavailable from the documents.
As early as 1995 (, pg. 43), Lilly discussed seeking approval for olanzapine as a treatment for bipolar disorder. Shortlyafter its March 2000 FDA approval as a short-term treatment for The entire set of documents was reviewed by the present bipolar disorder, Lilly began a promotional initiative, dubbed Viva author. The majority of the documents were related to health Zyprexa later retitled Zyprexa Limitless ( concerns, particularly hyperglycemia and/or diabetes. Of the 358 ) that aimed to increase the use of olanzapine in primary care documents, 67 were relevant to the present focus on marketing in settings. About 59,000 primary care physicians (PCPs) in the US primary care and these are the focus of this paper (of the remainder, were labeled as ‘‘key targets’’ of this program, which launched in 50 related to marketing, but focused on health concerns rather than approximately October 2000 pg. 1). According to primary care, and the remaining 241 documents were unrelated to the brand manager for Zyprexa, Mike Bandick, ‘‘[olanzapine’s] marketing). Documents ranged in dates from 1995 to 2004 and potential in this arena is virtually untapped’’ (pg. 1). In multiple included a variety of memoranda, reports, email messages, and documents, the marketing message for olanzapine in primary care was stated clearly: ‘‘Zyprexa: The safe, proven solution in mood,thought, and behavior disorders’’ , pg. 1; , pg. 6). Additionally, the marketing strategy was designed to ‘‘fit within the brand vision of broad spectrum efficacy’’ pg. 1), though olanzapine was only FDA-approved for the The documents were reviewed using the principles of grounded treatment of bipolar manic and mixed episodes and for schizo- theory in which no a priori hypothesis was tested; rather, obser- phrenia when the primary care marketing campaign began. Ban- vations were made and theory generated from the obtained dick further stated that the intention of Viva Zyprexa was to ‘‘redefine the way PCPs treat mood, thought, and behavioral consistent in their portrayal of tactics used to market olanzapine in disturbances’’ (pg. 12) and another document primary care settings. As each document relevant to marketing in stated that a main component of the primary care marketing primary care was reviewed, the author compiled notes about the message was to ‘‘focus on symptoms and behaviors found in mood, key points contained within the document. These notes were thought, and behavioral disturbances’’ , pg. 9, grouped into several different categories (primary care, marketing, emphasis in original). In a similar vein, olanzapine was rebranded dementia, bipolar, etc.). After review of the initial set of notes, the as a ‘‘broad spectrum psychotropic’’ in the primary care campaign author compiled a more abbreviated set of notes and checked the original documents to ensure they were cited accurately. From both The promotion of olanzapine in primary care was associated sets of notes and the set of accompanying documents, the current with some concerns at Lilly, including that ‘‘Zyprexa’s primary paper was compiled. The author maintains full responsibility for indications – schizophrenia and bipolar – are not viewed as PCP- the data extraction and interpretation of the referenced internal treated conditions, so there’s not a specific indication for Lilly reps to promote in the PCP segment’’ and that most PCPs write very few G.I. Spielmans / Social Science & Medicine 69 (2009) 14–20 antipsychotic and mood stabilizer prescriptions ( pg. 1). The promotion of Zyprexa in the primary care settingincluded the use of hypothetical patient profiles as well as posi- Olanzapine was marketed in the primary care setting based tioning olanzapine ‘‘as the next incremental step in the PCP’s largely upon the presentation of scripted patient profiles expanding clinical orbit: e.g., SSRI’s /2nd generation [antide- ). A total of 10 different profiles were discussed in the pressants] / safe gentle psychotropics’’ (, pg. 1).
obtained documents. The majority of these patients fall into the Using a similar analogy, it was stated: ‘‘just as Prozac revolutionized bipolar spectrum, defined quite loosely.
the treatment of depression in the late 80s and throughout the 90s, A hypothetical patient named Donna was featured in a handful so too will Zyprexa forever change the way primary care physicians view and treat bipolar disorder’’ pg. 3).
). The ‘‘goal and focus [was] on creating a market [for It was clear that olanzapine was not to be marketed in primary olanzapine]’’ with her case pg. 2). She was care as a treatment for severe bipolar disorder (bipolar I), as these described as ‘‘a single mom in her mid-30s, appearing in your office patients are generally referred to psychiatrists by primary care in drab clothing and appearing somewhat ill at ease. Her chief physicians. In the June 2002 Primary Care Sales Force Resource complaint is, ‘I feel so anxious and irritable lately.’ Today, she says Guide (), the prevalence of bipolar disorder is esti- she’s been sleeping more than usual and has trouble concentrating mated to be as high as 6%, an estimate much higher than epide- at work and at home. However, several appointments earlier, she miological lifetime prevalence estimates for bipolar I, which range was talkative, elated, and reported little need for sleep.’’ from about 1% to 3%; only estimates that include ‘‘subthreshold’’ Under the heading ‘‘Create Action’’, a script read, ‘‘I would like cases of bipolar disorder have found a 6% lifetime prevalence rate you to get a patient like Donna started today. I will be back in a week to follow up’’ (pg. 8). In another document, Rather than limiting representatives to discussing clear-cut cases of a more detailed description of Donna is provided. She was bipolar I (for which olanzapine was FDA-indicated) olanzapine was described as exhibiting the four ‘‘core symptoms [of complicated instead marketed as a treatment for ‘‘complicated mood,’’ a cluster mood, including] mood swings, irritability, sleep disturbances and of symptoms that seems related to a notably less severe variety of anxiety, as well as other symptoms including a lack of concentra- bipolar disorder. For example, a script in the 2002 Primary Care tion, mood lability and increased energy, depressed mood, loss of Sales Force Resource Guide, stated: ‘‘Doctor, you treat patients who interest, and agitation.’’ The symptoms were described as occurring present with complicated mood symptoms. Many of these patients simultaneously, ‘‘hence her mixed [i.e., mixed episode] presenta- are struggling to gain control of symptoms like anxiety, irritability, disruptive sleep, and mood swings.’’ , pg. 5). In The hypothetical patient named Mark ‘‘is a middle-aged male addition, a visual aid to be used by representatives’ lists anxiety, brought in by his wife. He appears agitated and disheveled. His wife irritability, disturbed sleep, and mood swings as the core compo- says that he is irritable and causing problems at home but he nents of complicated mood pg. 6). According to the believes he is fine.’’ It is further mentioned that he has had DSM-IV, anxiety is not a symptom of bipolar disorder and it is ‘‘periods’’ where he needed little sleep and had ‘‘significantly unclear to what extent disturbed sleep maps onto the DSM-IV increased energy.’’ Further, his ‘‘anger and mood swings are causing criterion of decreased need for sleep for bipolar disorder. The use of trouble at work’’ (, pg. 9). In another document, his mood swings as a descriptor is likewise unclear, and it is likely that symptoms were said to be indicative of a manic episode many more people would endorse having ‘‘mood swings’’ than would actually meet the DSM-IV criteria for shifting between An undated document titled ‘‘PCP Discussion Guide,’’ focused on clinically significant episodes of mania and depression.
‘‘using olanzapine for patients with complicated mood symptoms.’’ The ‘‘complicated mood patient’’ was said to relate to ‘‘untapped Three patients (Ashley, Andrea, and Cindy) were described. Ashley growth potential’’ for the use of olanzapine in primary care settings was described as having insomnia, irritability, distractibility, , pg. 3). As touched on related above, under the ‘‘PCP and racing thoughts. She also ‘‘has a tendency to be over-talkative.’’ Vision’’ of olanzapine, it was stated that the plan was to ‘‘expand our , pg. 4). DSM-IV criteria for bipolar I disorder market by redefining how primary care physicians identify, diagnose, require significant impairment in social or occupational func- and treat complicated mood disorders (i.e., bipolar disorder) tioning, psychotic features, or hospitalization to prevent harm to pg. 2).’’ In June 2002, it was written, regarding complicated self or others; no such impairment is noted in Ashley’s case.
mood, ‘‘we’ve only scratched the surface of a market with tremendous Andrea, another hypothetical case, was described as suffering upside’’ (pg. 5). Sales representatives were instructed from a variety of depressive symptoms. After taking an antide- to handle primary care physician concerns that they do not treat pressant for 10 days, her behavior became ‘‘increasingly irritable, bipolar or schizophrenia as follows: ‘‘Make sure the PCP recognizes the restless, anxious, hyperverbal, and [she] experiences great difficulty type of patient we are talking about today, not the psychotic or sleeping (pg. 7).’’ She was then labeled as manic and treated severely ill patient, but the complicated mood patient who has symptoms of irritability, anxiety, poor sleep and mood swings’’ The case named Cindy suffered from a variety of depressive pg. 1). Such symptoms do not appear to meet DSM-IV symptoms as well as distractibility, irritability, inability to sit still, and racing thoughts. After taking an antidepressant, she became A Lilly market researcher suggested that bipolar disorder tends ‘‘very anxious, agitated and hyperactive, with pressured speech and to lead primary care physicians to think of acutely manic patients, racing thoughts (pg. 12).’’ After taking olanzapine, she ‘‘reports ‘‘less so the hypomanic or less severely ill patient, which tend to be significant improvement’’ within one week (pg. 12).
the patients presenting most often in their offices ( The scenarios of Cindy, Andrea, and Ashley were not discussed pg. 3).’’ The same market researcher suggested that sales repre- directly in further documents, though one document ( sentatives ‘‘help [primary care physicians] recognize the ‘mushy ) referred to ‘‘three good complicated mood case summa- middle’ patients they are already treating. pg. 7).’’ It ries’’, (pg. 2). It may well be that this is a reference to the afore- was also suggested that patients on ‘‘the low to middle end’’ of mentioned three cases as it also mentioned an email attachment bipolar severity, who were ‘‘higher functioning’’ receive olanzapine partially titled ‘‘PCP DiscGd’’, which coincides with the document treatment via their primary care physicians , pg. 11).
titled ‘‘PCP Discussion Guide’’ (that described G.I. Spielmans / Social Science & Medicine 69 (2009) 14–20 the three cases. The ‘‘PCP Discussion Guide’’ further stated that ‘‘I disturbances without impairing her cognitive functioning ( would highly suggest we direct reps to utilize’’ the three cases in marketing (pg. 1). However, it is unclear to what extent these cases The script went on to ask, ‘‘Do you see patients like Martha? were utilized to promote olanzapine in the primary care setting.
What medication(s) do you prescribe in treating her behavioral Another mood-related patient profile, Michael, was included in a document titled ‘‘Olanzapine Primary Care Q3 Implementation According to a media report a Lilly spokes- Guide’’, dated June 2001 (). Michael was described as person indicated that the Martha profile was utilized to reference ‘‘highly functional’’ but ‘‘prone to mood swings’’ and as having a patient with untreated schizophrenia; however, Martha’s case switched from ‘‘down, unmotivated, detached’’ to ‘‘wired, irritable, seems more consistent with mild dementia rather than schizo- and anxious.hasn’t been sleeping much.’’ His wife was concerned phrenia that has remained undetected for decades. Olanzapine is about his ‘‘recent spending habits and erratic behavior’’ (pg. 12).
typically utilized in doses of at least 10–15 mg daily for schizo- In addition, one other patient profile, David, was described very briefly in one document. Though it appears that David represented a patient with bipolar disorder, he was later replaced by Michael, suggested that patients like Martha receive doses in the 2.5 mg– perhaps because market research ) labeled David as 5 mg range (a range typical of what was utilized in a ‘‘strike out’’ pg. 8). Based upon the description of their symptoms, the cases described above do not appear to reference clear-cut cases of bipolar I disorder.
although Lilly claimed that they intended Martha’s profile torepresent a patient with schizophrenia, an internal email stated that the diagnosis of Martha was ‘‘dementia’’ (pg. 1),followed by a comment that ‘‘we are getting a little grief from some As early as 1996, Lilly sought to collect data for an FDA indication of our docs about promoting Zyprexa for dementia’’ (pg. 1). Several for ‘‘psychosis in Alzheimer’s’’ pg. 43) and, in psychiatrists have disagreed with the assessment of Martha’s case a Zyprexa Product Team document from 1997, ‘‘dementia with as one of schizophrenia, noting that schizophrenia ‘‘could not be psychosis’’ was listed in the highest priority group for olanzapine confused with mild dementia’’ ).
under ‘‘disease state prioritization’’ (pg. 18). In 1999,a document that focused on primary care physicians stated that ‘‘Dementia should be first message’’ , pg. 1); the samedocument added that some physicians ‘‘might prescribe outside of It is likely that few primary care physicians treat schizophrenia label’’ (pg. 2). Further, in 2001, the Integrated Product Plan for on a regular basis. However, the primary care marketing campaign olanzapine stated that the drug would remain the ‘‘bestselling placed significant emphasis on symptoms of ‘‘thought distur- psychotropic drug in history’’ by treating people suffering from bances,’’ including discussion of disorganized thinking, as well as ‘‘schizophrenia, bipolar disorder, and dementia’’ poor attention, poor judgment and lack of insight pg. 5). Documents provided various timelines for expected FDA Olanzapine was specifically marketed for ‘‘mood, approval in dementia, though olanzapine never received FDA thought, and behavior disorders’’ in an ‘‘intentionally broad and approval for the population with dementia ( vague’’ manner, ‘‘providing latitude to frame the discussion around ). Lilly appears to have stopped pursuing FDA approval symptoms and behaviors rather than specific indications’’ pg. 1). While schizophrenia is not treated frequently by zapine carries a label warning (along with other atypical antipsy- PCPs, one document mentioned the idea of treating schizophrenia chotics) that the drug is related to an increased risk of death when or ‘‘schizophrenia lite’’ in primary care (pg. 7).
taken by elderly patients with dementia-related psychoses.
Zyprexa brand manager, Mike Bandick stated that donepezil (a cholinesterase inhibitor popularly used in dementia) belongs toa ‘‘companion’’ class of medication, a drug ‘‘we augment rather The profile named Kelly was purportedly designed to represent than replace’’ pg. 23). Further, it is mentioned a patient with some form of psychotic disorder. Kelly was described that the marketing of olanzapine in long-term care settings as becoming more ‘‘socially isolated and fearful. Her personal (where dementia is quite common) may have adversely impacted hygiene is starting to decline and she is difficult to draw out.[her olanzapine sales in bipolar and schizophrenia markets ( family says] ‘she thinks people are talking about her behind her back’’’. The description of Kelly does not appear to place her intoany recognized DSM-IV disorder category. She is described earlier in the document as struggling with ‘‘mild to moderate psychosis.’’ In a manner similar to bipolar disorder/complicated mood, Kelly replaced a profile named Christine (that was documents detailed the marketing of dementia to primary care listed as a patient with ‘‘schizophrenia lite’’ (A physicians through the use of a hypothetical patient profile, detailed description of Christine was not located in the archive.
Kelly’s case replaced that of Christine because Kelly seemed ‘‘more Martha is a widow who lives independently and has been your treatable’’ in a primary care setting, while Christine seemed patient for some time. She is becoming more complicated to manage, and you note increasing agitation. Her sleep isdisturbed; she dozes during the day and is up most of the night. Her family has shared their concerns with you, saying‘‘She thinks we’re trying to take advantage of her.’’ Martha’s Starting in 2000, a sizable campaign was launched to increase family doesn’t want to send her to a nursing home, but her olanzapine prescriptions in primary care. Materials utilized by sales agitation and confusion must be addressed. Your goals of representatives in primary care contained a high prevalence esti- treatment for Martha may include reducing her behavioral mate for bipolar I disorder, as one document suggested that the G.I. Spielmans / Social Science & Medicine 69 (2009) 14–20 prevalence of bipolar disorder was 6% (), yet the It appears that olanzapine’s marketing in primary care can be prevalence for bipolar I disorder has been estimated as much less viewed as a similar attempt to market a drug for a new niche – ‘‘Just as Prozac revolutionized the treatment of depression in the late 80s In addition, as suggested above, hypothetical cases used and throughout the 90s, so too will Zyprexa forever change the way various diagnostic criteria that were overly inclusive, and presented primary care physicians view and treat bipolar disorder’’ scenarios of several patients who did not seem to meet criteria for , pg. 3). Carving out new niches and expanding a drug’s uses to bipolar I disorder or schizophrenia. Based upon review of several a wide range of medical conditions (defined loosely) is a common documents, it appears that sales representatives were instructed to tactic. In a pharmaceutical trade publication, it was written that market olanzapine as a treatment for patients well outside of its ‘‘indication expansion is also tried and tested in the psychotropic field, where diagnostic distinctions can be blurred.(, In addition, there is evidence that Lilly para. 22).’’ The expansion of somewhat fuzzy boundaries of mental promoted olanzapine off-label for dementia illness makes perfect sense in a highly competitive market in which ), and marketed olanzapine as a long-term various pharmaceutical companies are attempting to maximize treatment for bipolar disorder in advance of its FDA approval for the sales. Such expanded definitions open the gates to more people qualifying as mentally ill, for which they might receive treatment The relatively mild symptoms marketed by Lilly as components of with ‘‘broad spectrum psychotropics’’ that purportedly work to ‘‘complicated mood’’ (anxiety, irritability, disturbed sleep, and mood alleviate a wide variety of symptoms. Part of such market expansion swings) are ill-defined and, to some extent, are likely to be experi- occurs by marketing to primary care physicians, who have access to enced by a large number of people. Labeling this constellation of ill- a wide base of patients. Indeed, it is interesting to note that Lilly’s defined and likely common symptoms as indicative of a mental most famous product, fluoxetine (Prozac), was successful largely condition is suggestive of ‘disease mongering’ a term referencing the because it vastly expanded the depression treatment market into effort of pharmaceutical companies to broaden the market by convincing patients (and physicians) that a large number of people As described in the paper and elsewhere (e.g., are suffering from a (usually relatively mild) illness which would benefit from pharmaceutical intervention ( companies utilize many methods to market their products. It is not In trade journals, pharmaceutical industry insiders have entirely clear why patient profiles were seemingly utilized quite plainly stated that expanding the market for their products via frequently in the marketing of olanzapine in primary care, though ‘‘condition branding’’ (an industry term analogous to ‘disease one document pointed out that the profiles would aid physicians in mongering’) is a highly useful tool in the marketing arsenal recognizing symptoms and in ‘‘early identification of relevant ). Indeed, the current corpus of internal documents hints that, in addition to marketing olanzapine, sales Given that olanzapine was estimated to hit over $350 million in representatives were also marketing the expanded boundaries of primary care sales in 2003, it appears that a reasonably large bipolar disorder. No longer was bipolar disorder a relatively number of patients in primary care received olanzapine prescrip- uncommon condition relegated to treatment by psychiatrists, it was tions. As the primary care marketing campaign seemed focused to be marketed as a common illness with a broad spectrum of severity primarily on cases suffering from relatively mild mental distress that warranted treatment in primary care. Despite an expanded (e.g., ‘‘complicated mood’’), many patients who were prescribed treatment market, there is a paucity of controlled clinical trial data olanzapine via primary care may have been prescribed treatment regarding the benefits and risks of treating adults with mild symp- that lacked a supporting evidence base. Several studies have linked toms of bipolar disorder/complicated mood with ‘mood stabilizers’ or atypical antipsychotics such as olanzapine One document stated that Lilly was committed to position olanzapine as a ‘‘broad spectrum psychotropic to differentiate it from other antipsychotics.’’ (). Such a focus on may increase risk for cardiovascular disease product differentiation is sensible in a crowded marketplace of Indeed, the olanzapine label was updated in October 2007 to atypical antipsychotic medications. Indeed, product differentiation reflect an increased risk of hyperglycemia, hyperlipidemia, and is a key component of modern-day marketing, with products from weight gain. Thus, it is quite possible that some patients received cola to toilet cleaners to antidepressants marketed on the basis of a treatment of questionable efficacy that resulted in adverse health their ostensible uniqueness, often in spite of their high degree of effects, though the current documents do not clarify to what extent similarity to competing products (Lilly also such health consequences may have occurred.
emphasized product differentiation when marketing its antide- This study has a number of limitations, the most obvious of pressant duloxetine as a treatment for patients with depression which is the reliance on the present set of documents. Though their who also suffer from physical pain, as research indicated that authenticity has not been challenged, it is certainly possible that entering this niche market would differentiate duloxetine from its the documents may have been taken out of context and that further competition As part of the marketing strategy for internal documents related to olanzapine’s promotion would paint duloxetine, hypothetical patient profiles tailored to the perceived a different picture of how the drug was marketed. However, this market were created, though it is unclear to what extent the patient seems unlikely given that the documents obtained were quite profiles were used in detailing visits (This niche consistent in their descriptions of the marketing of the compound.
strategy appears to have been successful, as duloxetine sales The documents were reviewed by one author, so it is possible that exceeded $2 billion in 2007. Indeed, Lilly expects duloxetine sales to different reviewers may come to different conclusions. As all the overtake those of its current bestseller, olanzapine, in 2008 internal documents are accessible by the public online (Despite the successful marketing of duloxetine, they can be easily examined by anyone who a recent meta-analysis concluded that the drug yielded little to no wishes to check the veracity of the current author’s claims. The source benefit over placebo in treating pain symptoms in depression material was also somewhat dated, in that documents reviewed (though Lilly claims duloxetine is indeed effec- dated from 1995 to 2004. Practices regarding the marketing of olan- zapine that have occurred since 2004 are thus unknown.
G.I. Spielmans / Social Science & Medicine 69 (2009) 14–20 Given that regulations surrounding off-label marketing are De Deyn, P. P., Carrasco, M. M., Deberdt, W., Jeandel, C., Hay, D. P., Feldman, P. D., et al. (2004). Olanzapine versus placebo in the treatment of psychosis with orwithout associated behavioral disturbances in patients with Alzheimer’s disease. International Journal of Geriatric Psychiatry, 19, 115–126.
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