Pharmaceutical Marketing Merck “Merck has gone beyond developing and selling prescription pharmaceuticals. It formed joint ventures in 1989 with Johnson & Johnson to sell over the-counter pharmaceuticals; in 1991 with DuPont to expand basic research, and in 2000 with Scherigng-Plough to develop and market new prescriptions medicines. In 1997, Merck and Rhone-Poulenc S. A. (now Sanofi-Aventis S. A. ) combined animal health and poultry genetics business to form Merial Limited, a fully integrated animal health company.
Finally, Merck purchased Medco, a mail –order pharmaceutical distributor, in 2003, and Sirna Therapeutics in 2006” (Kotler & Keller, 2012, p. 43-44). “For branding strategies to be successful and brand value to be created, consumers must be convinced there are meaningful differences among brands in the product or service category. Brand differences often related to attributes or benefits of the product itself . . Merck has lead (its) product categories for decades, due in part to continual innovation” (Kotler & Keller, 2012, p. 243).
Merck has donated $100 million or more to charities in a year (Kotler & Keller, 2012, p. 632). Mission Statements Ex. Japan Both pharmaceutical and biotech companies are starting to make partnership a core competency (Kotler & Keller, 2012, p. 52). Intro: Michael Dawson, author of “The Consumer Trap,” states that the business of marketing, a trillion-dollar –a-year industry, is a social, economical, environmental, and unfriendly cost on Americans today as it “continues to soak up economic and environmental resources and dominate the personal lives of citizens” (Dawson, 2005, p. ). Dawson argues that corporate America is fueled by a continuous marketing race that manipulates people’s perceptions and actions of goods into thinking the economy is out to serve one’s pleasures and happiness, when in all reality, is only out to serve the demand of business today (Dawson, 2005, p. 1). "It is critical that the U. S. government recognizes that intelligently focused nutrition-related efforts are important in helping lead Americans of all ages to lead healthier lifestyles.
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Marketing Nutrition shows how simple solutions can save lives. "--Congressman Timothy V. Johnson, United States House of Representatives (Wansink, 2007, p. 1). There are enormous economic dividends for health care providers, public health institutions, and commercial food companies if we are successful in doing this. "--Dr. David Mela, Expertise Group Leader, Unilever Health Institute(Wansink, 2007, p. 1). Marketing = A mechanism to help pharmacy develop, communicate, and sell future pharmaceutical services to consumers (Grauer, 1981, p. ). Pharmaceutical marketing is an “element of an information continuum, where research concepts are transformed into practical therapeutic tools and where information is progressively layered and made more useful to the health care system” (Levy, 1994, p. 1). Provides an informed choice of carefully characterized agents (Levy, 1994, p. 1). marketing assists physicians in matching drug therapy to individual patient needs (Levy, 1994, p. 1).
Pharmaceutical marketing is presently the most organized and comprehensive information system for updating physicians about the availability, safety, efficacy, hazards, and techniques of using medicines (Levy, 1994, p. 1). pharmaceutical marketing strategies can negatively affect both- the end consumers or the patients and the health care profession (Need of New Pharmaceutical Marketing Strategies, 2010, p. 1). Also, the advertising strategies included in the marketing plan of any pharmaceutical company is not 'direct to consumer' (Need of New Pharmaceutical Marketing Strategies, 2010, p. ). Any pharmaceutical marketing strategy targets the health care professionals or the Doctors who in turn prescribe the drugs to the patients (end consumers) liable to pay for the products (Need of New Pharmaceutical Marketing Strategies, 2010, p. 1). However, a few countries (till date two countries- New Zealand and United States) allow Direct-to-consumer advertising (DTC advertising) for pharmaceutical products (Need of New Pharmaceutical Marketing Strategies, 2010, p. 1). Pharmaceutical Market Trends 2010. Pharmaceutical & Drug Manufacturer Resources.
Retrieved from: http://www. pharmaceutical-drug-manufacturers. com/articles/pharmaceutical-market-trends-2010. html The global pharmaceutical is forecasted to make a significant growth of about 4 - 6%, exceeding $975 billion, with global pharmaceutical market sales expecting to grow at a 4 - 7% compound annual growth rate (CAGR) through 2013, based upon global macroeconomy as well the “changing combination of innovative and mature products apart from the rising influence of healthcare access and funding on market demand” (Pharmaceutical Market Trends 2010, p. ). pharmaceutical sales are growing at a fast rate in India, China, Malaysia, South Korea and Indonesia due to the rising disposable income, several health insurance schemes (that ensures the sales of branded drugs), and intense competition among top pharmaceutical companies in the region (that has boosted the availability of low cost drugs). India - 3rd Largest Producer of Pharmaceuticals Across the World- is already a US$ 8. 2 Billion pharmaceutical market.
The Indian pharmaceutical industry is further expected to grow by 10% in the year 2010. (Pharmaceutical Market Trends 2010, p. 1). The development of infrastructure and rapidly changing regulations in the Middle East are being seen as the cause of its growth. Presently South Africa, Saudi Arabia and Israel dominate the region's pharmaceutical industry due to their better infrastructure and regulatory environment. However, The Middle East pharma market depends on imported pharmaceutical drugs and therapeutics.
The governments of countries in this region are taking measures to raise their domestic production through heavy investments in the pharmaceutical industry (Pharmaceutical Market Trends 2010, p. 1). Pharmaceutical Drugs Trends of fastest expected growth consist of anti-Diabetic Drugs and those for cardiovascular diseases, due to the changes in demographics and lifestyle with anti-hypertensives drugs will dominate the global cardiovascular market with a market share of nearly 50% (Pharmaceutical Market Trends 2010, p. 1). Strategy:
The pharmaceutical companies traditionally adopt four major marketing strategies for promoting their products: Giving drugs as free samples to doctors/ Gifts that hold the company logo or details of one or multiple drugs, providing details of their products through journal articles or opinion leaders; and Sponsoring continuing medical education (Need of New Pharmaceutical Marketing Strategies, 2010, p. 1). Pharmaceutical representatives, also popularly known as medical representatives, are the major pharma marketing strategy for marketing drugs directly to the physicians.
Typically, the expense of this sales force of any pharmaceutical company comprises anything ranging from 15-20% of annual product revenues (Need of New Pharmaceutical Marketing Strategies, 2010, p. 1). "Marketing Nutrition offers a ‘win-win' proposition for all concerned. Insightful companies, health professionals, and policy makers can lead the way . . . in helping people eat better and enjoy food more. "--Dr. James O. Hill, Director of Human Nutrition, University of Colorado Medical School (Wansink, 2007, p. ). Take advantage of future growth opportunities. These growth opportunities will be realized from unmet health-care needs and changing consumer life style trends and values (Grauer, 1981, p. 1). Dispensing and drug-knowledge-distribution pharmaceutical services are reviewed by a product life cycle analysis of sales profits versus time (Grauer, 1981, p. 1). A marketing mix for new pharmaceutical services is developed consisting of service, price, distribution, and promotion strategies.
Marketing can encompass those key elements necessary to meet the organizational goals of pharmacy and provide a systematic, disciplined approach for presenting a new service to consumers (Grauer, 1981, p. 1). The costs of pharmaceutical marketing are substantial, but they are typical of high-technology industries that must communicate important and complex information to sophisticated users. These costs are offset by savings resulting from proper use of medicines and from lower drug costs owing to price competition (Levy, 1994, p. 1). oint to the Food and Drug Administration (FDA) and find comfort in the fact that this agency is tasked with regulating drug advertising. "only" 8% of advertisements are in violation of regulations. at least one of the 11 advertisements in the April issue of the ARCHIVES is likely to be misleading and, thus, provide potentially harmful information. In fact, the FDA, according to David A. Kessler, MD, commissioner, spends most of its time developing the package insert and not, as asserted by Levy, preapproving advertising. According to Kessler, "Except under very special circumstances, the agency does not eview or approve advertising and promotional materials before their dissemination by a drug firm" Furthermore, Kessler states that an "... enormous potential exists for misleading adver¬ tisements to reach the physician and influence prescribing decisions. " (Shaughnessy, Slawson, ; Bennett, 1994, p. 1). Gifts: Giving drugs as free samples to doctors/ Gifts that hold the company logo or details of one or multiple drugs, A study was done in 1995 to gauge the outcome of a patient’s perception of pharmacy marketing regarding physician’s accepting gifts from the pharmaceutical industry.
The objective of this study was to “examine patient perceptions of professional appropriateness and the potential impact on health care of physician acceptance of gifts from the pharmaceutical industry,” via a random telephone suvey of 649 adjults living in the state of Kentucky. Through the random sampling, the outcome of the survey was that Patient awareness of officeuse gifts (eg, pens, notepads) and personal gifts to physicians from the pharmaceutical industry, patient exposure to office-use gifts, and attitudes toward physician acceptance of both office-use and personal gifts. Mainous, Hueston, ; Rich, 1995, p. 1). Eightytwo percent of the respondents were aware that physicians received office-use gifts, while 32% were aware that physicians received personal gifts. Seventy-five percent reported receiving free samples of medication from their physicians. Compared with office-use gifts, more respondents believed that personal gifts to physicians have a negative effect on both health care cost (42% vs 26%) and quality (23% vs 13%). After controlling for demographic variables, as well as awareness and exposure to physician gifts, individuals with at least a high school education were 2. times as likely to believe that personal gifts have a negative effect on the cost of health care and 2. 3 times as likely to believe that personal gifts would have a negative effect on the quality of health care. (Mainous, Hueston, ; Rich, 1995, p. 1). Conclusions These results suggest that the public is generally uninformed about personal gifts from pharmaceutical companies to physicians. If public perception regarding the objectivity of the medical profession is to serve as a guide, these findings suggest a reevaluation may be in order for guidelines regarding physician acceptance of gifts from the harmaceutical industry (Mainous, Hueston, ; Rich, 1995, p. 1). The World Health Organization, the American Medical Association, the American College of Physicians, and the Pharmaceuticals Manufacturers' Association have also published guidelines on perks to physicians from the drug industry. The bottom line is that all these guidelines are voluntary, and physicians have continued to vote "with their feet. " (Shaughnessy, Slawson, & Bennett, 1994, p. 1). controversial 1962 FDA amendments.
Just before 1962, congress studied and concluded that because of patent protection, heavy promotion by the drug companies, consumer ignorance, and minimal incentives for physicians to be concerned with cost, drugs of dubious quality and unnecessarily high expense were being prescribed by physicians, criticisms that sound remarkably familiar even today. Up to that point, the FDA had only required "proof of safety," which dated back to the origins of the modern drug era and the 1938 Food, Drug, and Cosmetic Act (Shaughnessy, Slawson, & Bennett, 1994, p. 1).
Discussions about the influence of pharmaceutical promotion on physicians often focus on gifts and payments of relatively large economic value. This focus is also evident in ethics guidelines addressing pharmaceutical promotion among many professional medical societies. 1 The underlying assumption is that smaller gifts are unlikely to exert influence on prescribing decisions. (Grande, Frosch, Perkins, & Kahn, 2009, p. 1). In contrast, a substantial body of marketing and psychology literature suggests that even trivial items can exert influence irrespective of economic value.
For example, adding a small gift such as personalized mailing labels to a solicitation for donations has been shown to significantly increase contributions. 2 In pharmaceutical promotion, small gifts are often tethered to branding efforts, as items such as pens and coffee mugs display logos. Aside from the intrinsic value of promotional items, branded materials strengthen brand awareness and build brand equity through a variety of largely unconscious but powerful mechanisms. 3 Nonverbal information about the brand, such as symbols or logos, is often more influential than verbal cues. Stronger brands have a memory encoding and storage advantage over unknown brands,5 which facilitates the formation of strong positive associations with the brand. Strong branded products are more often in a "top-of-mind" set of alternatives for consumers to consider. 6 Strong brand awareness provides a justifiable reason for choosing a particular brand. 7-8 This research suggests that small branded promotional items should increase favorable attitudes for the brand being promoted.
We are unaware of studies that test these effects in a clinical context with health professionals, but many physicians, because they are medical experts, believe they are not susceptible to these influences. 5, 9-10 In one survey, just 8% of physicians believed they were susceptible to influence by marketing items such as branded pens, whereas 31% of patients felt these items could influence physicians. 9 The guidelines of the American Medical Association regarding gifts to physicians from industry reflect this belief of lack of susceptibility by permitting "gifts of minimal value. "1 (Grande, Frosch, Perkins, & Kahn, 2009, p. ). The study used a randomized experimental design. Participants were third- and fourth-year medical students at the University of Pennsylvania School of Medicine (Penn) and the University of Miami Miller School of Medicine (Miami). We selected these institutions because of their differing policies regarding interactions between trainees and pharmaceutical company representatives. The University of Pennsylvania has restrictive policies in place that prohibit most gifts, meals, and samples while Miami continues to permit such marketing practices. (Grande, Frosch, Perkins, & Kahn, 2009, p. 1). 007-2008. Study participants were assigned to a control or primed condition based on their day of enrollment. Participants assigned to the "primed" condition were exposed to Lipitor (atorvastatin) branded promotional items immediately prior to completing a computer-based study instrument. These exposures included Lipitor logos on a clipboard (used when signing in to the study room) and notepaper (used to provide participants with their study identification number). Participants assigned to the control condition completed the same procedures but with a plain (nonbranded) clipboard and notepaper.
Randomization was conducted by day in order to avoid contamination of conditions. (Grande, Frosch, Perkins, & Kahn, 2009, p. 1). Participants were told they were enrolling in a study about clinical decision making under varying conditions (Grande, Frosch, Perkins, & Kahn, 2009, p. 1). Our study was designed to measure the influence of exposure to branded promotional items on relative attitudes toward 2 lipid-lowering statins. We examined differences in attitudes toward Lipitor and Zocor (simvastatin) in our exposed (Lipitor promotional items) and control groups.
Lipitor is among the most promoted brand-name statins in the United States while simvastatin is available generically and considered to be nearly equally effective. The study outcomes included measures of implicit and self-reported (ie, explicit) attitudes. (Grande, Frosch, Perkins, & Kahn, 2009, p. 1). Implicit attitudes were evaluated with the Implicit Association Test,11-15 a widely used tool in marketing and psychology research that is thought to be resistant to social desirability bias among research participants.
Initial applications of the IAT, for example, demonstrated the persistence of racial and gender stereotypes and prejudices, even in the face of strong conscious beliefs that such attitudes do not exist and strong social norms that dictate they should not exist. 16-17 Results from the IAT are a better predictor of intergroup discrimination (eg, biased behavior against people of other races/ethnicities, gender, and sexual orientation based on existing attitudes and stereotypes) compared with ostensibly similar self-report measures. 13 In recent years, the use of the IAT has been expanded to research focused on branding and marketing. 8-19 Further details regarding application and validity of the IAT have been published elsewhere13-15; a demonstration can be found at the Project Implicit Web site (https://implicit. harvard. edu/implicit). (Grande, Frosch, Perkins, & Kahn, 2009, p. 1). Explicit attitudes were assessed by self-report. Following the IAT, participants were asked to compare Lipitor and Zocor in 5 dimensions (superiority, preference, efficacy, safety, and convenience) a follow-up anonymous Internet-based survey that assessed their attitudes toward pharmaceutical marketing.
The purpose was to measure differences in attitudes among students at the 2 schools given the differing institutional policies as a possible explanatory factor(Grande, Frosch, Perkins, & Kahn, 200 Then there is the pharmaceutical industry's holy grail of marketing -- the relationship between their sales representatives and medical doctors. To maintain this relationship, often called "detailing," pharmaceutical companies spend a whopping $8,290 per doctor.
The average family doctor receives 28 visits each week from drug reps, who provide free samples, explain new findings from company-sponsored drug trials, and demonstrate the latest innovation in their company’s medical devices. Some doctors, reporters and public health advocates have long decried the pharmaceutical industry's seemingly endless attempts to buy goodwill among medical professionals. But insidious marketing campaigns seeking to rebrand medical conditions as lifestyle choices, and the patients who suffer from them as consumers, have received little scrutiny. (Ebeling, 2008, p. 1). 9, p. ). providing details of their products through journal articles or opinion leaders; Worse, the trend is seriously undermining the regulatory authority of the FDA. It's not surprising that profit-driven, cutting-edge marketing techniques have outstripped the government agency established to guide them. What is surprising is that public health advocates haven't made pharmaceutical rebranding and off-label promotions of drugs and medical devices major issues. In December, the advocacy group Consumers Union sent a letter (PDF) to the FDA requesting tighter DTC advertising regulations on medical devices. Ebeling, 2008, p. 1). The December 2007 issues of the women’s fashion magazines Allure and Harper's Bazaar both featured multi-page spreads on non-surgical cosmetic procedures, including the array of injectable wrinkle fillers. The articles outlined the pros and cons of each filler, evaluating injection pain, cost per injection (most run between $500 and $800 per shot), and how long each lasts (Ebeling, 2008, p. 1). Dermatologist and anti-aging cream entrepreneur Dr. Patricia Wexler is featured prominently in the Bazaar story.
Her remarks about each injectable reflect the marketing language of the brands themselves. When she is discussing Sculptra®, for instance, she describes how the product acts as "a trellis on which the collagen can grow" -- a line marketers use to describe how the device works. She also repeatedly suggests what are off-label, unregulated product applications, such as using injectable fillers in the eye area, in the temples, in the jawline, on the cheekbones, and in the fine lines surrounding the mouth. Dr. Wexler's injectable filler romotions are especially credible among the target audience. Wexler regularly discusses non-invasive, anti-aging procedures on the "Oprah Winfrey Show," the "Today Show," and "Good Morning America," and in the pages of Vogue and Marie Claire. The big pharma companies that make the injectable fillers likely dream of doctors touting their products and suggesting off-label uses for them in popular women's magazines. As the saying goes, they couldn't buy such good press -- but they probably did. (Ebeling, 2008, p. 1). Dr. David J.
Triggle, a pharmacologist at the State University of New York at Buffalo who has written about drug advertising, says a doctor’s endorsement should be scrupulously honest (Saul, 2008, p. 2). Dr. Robert Jarvik, known for the artificial heart he pioneered more than a quarter-century ago. began appearing in television ads two years ago for the Pfizer cholesterol drug Lipitor (Saul, 2008, p. 1). Skip to next paragraph The ads have depicted him, among other outdoorsy pursuits, rowing a one-man racing shell swiftly across a mountain lake. When diet and exercise aren’t enough, adding Lipitor significantly lowers cholesterol,” Dr. Jarvik says in the ad. Celebrity advertising endorsements are nothing new, of course. But the Lipitor campaign is a rare instance of a well-known doctor’s endorsing a drug in advertising — and it has helped rekindle a smoldering debate over whether it is appropriate to aim ads for prescription drugs directly at consumers. A Congressional committee, concerned that the Lipitor ads could be misleading, has said it wants to interview Dr. Jarvik about his role as the drug’s pitchman.
Some of the questions may involve his credentials. Even though Dr. Jarvik holds a medical degree, for example, he is not a cardiologist and is not licensed to practice medicine. So what, critics ask, qualifies him to recommend Lipitor on television — even if, as he says in some of the ads, he takes the drug himself? (Saul, 2008, p. 1). Skip to next paragraphThe House Committee on Energy and Commerce is looking into when and why Dr. Jarvik began taking Lipitor and whether the advertisements give the public a false impression, according to John D.
Dingell, the Michigan Democrat who is the committee’s chairman. “It seems that Pfizer’s No. 1 priority is to sell lots of Lipitor, by whatever means necessary, including misleading the American people,” Mr. Dingell said. Lipitor, the world’s single best-selling drug, is Pfizer’s biggest product, generating sales of $12. 7 billion last year. But as it has come under competition from cheaper generic alternatives, Pfizer has used the Jarvik campaign, introduced in early 2006, to help protect its Lipitor franchise. Wherever the Congressional inquiry leads, the controversy risks damaging Dr.
Jarvik’s credibility and undermining his real medical mission. The Jarvik campaign was rolled out the same year that Zocor, Lipitor’s chief competitor, became available as a generic drug that is widely considered about as effective as Lipitor but is sold at a fraction of the cost. (Saul, 2008, p. 1). Skip to next paragraph Criticism of consumer advertising of pharmaceuticals flared as an issue back in 2004, when Merck withdrew Vioxx, a heavily advertised painkiller, after a clinical trial showed that it sharply increased the risk of heart attacks and strokes.
The pharmaceutical industry adopted voluntary guidelines the next year suggesting that companies delay advertising new products for an unspecified period after they first reach the market (Saul, 2008, p. 1). In early January, the U. S. House Committee on Energy and Commerce began investigating celebrity endorsements in television ads for brand-name drugs. These direct-to-consumer (DTC) ads have been controversial since the Food and Drug Administration (FDA) loosened the rules governing pharmaceutical marketing in 1997.
Before Lipitor made headlines, there was Viagra. Pfizer's "Viva Viagra! " campaign was criticized by the FDA and organizations including the AIDS Healthcare Foundation, who said the DTC ads encouraged recreational use of the erectile dysfunction drug. One print ad suggested that Viagra be used to "celebrate" events such as the Super Bowl or New Year's Eve. (Ebeling, 2008, p. 1). While troubling, DTC ads represent only 14 percent of pharmaceutical companies' marketing budgets.
By the time a 30-second drug commercial airs, the company has conducted months of segmentation studies, held dozens of meetings to define the "communication target" (typically a woman, usually a mother, and of a certain income), and spent millions of dollars to develop the drug's brand and its market. This strategic marketing, which represents the remaining 86 percent of drug promotion expenses, should receive at least as much attention from regulators and lawmakers as DTC ads. (Ebeling, 2008, p. 1).
While DTC ads seek to change patients' behavior, pharmaceutical companies are more interested in changing doctors' behavior. Drug marketers work hard to persuade doctors to prescribe their branded drug over generics and other competitors, and to change other medical practices that limit company profits. To cultivate medical professionals, drug companies may retain a doctor as a spokesperson, position friendly medical "thought-leaders" in the media, or organize free events at posh resorts and expensive hotels to "educate" doctors about a new disease state (think Restless Leg Syndrome) or their latest drug.
In 2000, the biggest 10 pharmaceutical companies spent $1. 9 billion on promotional events alone (Ebeling, 2008, p. 1). For example, the FDA found that Eli Lilly's television broadcast advertisement for Strattera (atomoxetine) was false or misleading because it inadequately communicated the indication for the drug (attention-deficit–hyperactivity disorder) by means of competing visuals, graphics, and music presented concurrently. Similarly, serious risk disclosures were minimized for Strattera, the FDA said, by the distracting visuals and graphics (e. . , erratic camera movement, quick scene changes, and visual changes in point of view). In another case, the FDA said Pfizer's print advertisement for Zoloft (sertraline) was false or misleading because it omitted important information relating to the risk of suicidality in patients, a risk stated on the product's label at the time the advertisement ran. (Donohue, Cevasco, & Rosenthal, 2007, p. 1). Drugs that are advertised to consumers are predominantly new drugs used to treat chronic conditions.
Ten of the top 20 drugs, as ranked by advertising spending, were introduced in 2000 or later. Advertising campaigns generally begin within a year after the introduction of a pharmaceutical product, which raises questions about the extent to which advertising increases the use of drugs with unknown safety profiles. At least one pharmaceutical manufacturer (Bristol-Myers Squibb) recently announced a voluntary moratorium on direct-to-consumer advertising for drugs in the first year after FDA approval.
And PhRMA, the industry trade group, has recommended that manufacturers delay such campaigns for new drugs until after health professionals have been sufficiently educated, although no details have been provided on how long a period was deemed necessary. 20 Finally, in a recent study of drug safety, the Institute of Medicine recommended that the FDA restrict advertising for newer prescription drugs. 8 Our data show that a mandatory waiting period on advertising for new drugs would represent a dramatic departure from current industry practices.
For example, the FDA found that Eli Lilly's television broadcast advertisement for Strattera (atomoxetine) was false or misleading because it inadequately communicated the indication for the drug (attention-deficit–hyperactivity disorder) by means of competing visuals, graphics, and music presented concurrently. Similarly, serious risk disclosures were minimized for Strattera, the FDA said, by the distracting visuals and graphics (e. g. , erratic camera movement, quick scene changes, and visual changes in point of view).
In another case, the FDA said Pfizer's print advertisement for Zoloft (sertraline) was false or misleading because it omitted important information relating to the risk of suicidality in patients, a risk stated on the product's label at the time the advertisement ran. (Donohue, Cevasco, ; Rosenthal, 2007, p. 1). direct-to-consumer advertising of prescription drugs on television. Such advertising has been criticized for encouraging inappropriate use of medications and driving up drug spending. ,2 Concern that such advertising may lead to increased use of expensive medications was amplified by the introduction of a prescription-drug benefit in Medicare in 2006 (Part D). Studies of the effect of advertising on prescribing practices have shown that such advertising increases classwide sales, helps to avert underuse of medicines to treat chronic conditions, and leads to some overuse of prescription drugs. (Donohue, Cevasco, ; Rosenthal, 2007, p. 1). Direct-to-consumer advertising has also been controversial in light of postmarketing revelations regarding problems with drug safety.
Specifically, clinical trials that are required for drug approval are typically not designed to detect rare but significant adverse effects, and contemporary methods of postmarketing surveillance often fail to connect adverse events that have a high rate of background prevalence with the use of particular drugs. After the market withdrawal of Vioxx (rofecoxib), a drug heavily promoted to consumers,6 critics called for the FDA to place limits on direct-to-consumer advertising, particularly for new drugs,7 a view that was reiterated in a recent report by the Institute of Medicine on the safety of medicines. (Donohue, Cevasco, ; Rosenthal, 2007, p. 1). Sponsoring continuing medical education describes the influence of sponsoring on the results, protocol and quality of drugs studies (Deutsches Aerzteblatt International, 2010, p. 1). The authors conclude that pharmaceutical companies exploit a wide variety of possibilities of manipulating study results. Apart from financing the study, financial links to the authors, such as payments for lectures, may tend to make the results of the study more favourable for the company.
Not only the results themselves, but also their interpretation, are significantly more often in accordance with the wishes of the sponsor. (Deutsches Aerzteblatt International, 2010, p. 1). In some publications, the authors detected evidence that sponsors from the pharmaceutical industry had influenced study protocols. For example, placebos were more frequently used in drug studies than was the case with independently financed studies. On the other hand, some favourable effects were linked to financial support from the pharmaceutical industry.
The methodological quality of studies with industrial support tended to be better than with independent drug studies(Deutsches Aerzteblatt International, 2010, p. 1). Most physicians must complete accredited continuing medical education (CME) programs to maintain their medical licenses, hospital privileges, and specialty board certifications. Data from the Accreditation Council for Continuing Medical Education (ACCME) show that CME is a $2 billion per year business in the United States that earns less than half its revenue from physician learners themselves. CME is increasingly underwritten by commercial sponsors — primarily manufacturers of drugs, biologic therapies, or medical devices — that spend more than $1 billion per year in educational grants and other funding to cover more than half the costs for CME activities (Morris ; Taitsman, 2009, p. 1). In recent years, a number of studies have shown that clinical drug trials financed by pharmaceutical companies yield favorable results for company products more often than independent trials do. Moreover, pharmaceutical companies have been found to influence drug trials in various ways. Schott, Pachl, Limbach, Gundert-Remy, Ludwig, ; Lieb, 2011, p. 1). Published drug trials that were financed by pharmaceutical companies, or whose authors declared a financial conflict of interest, were found to yield favorable results for the drug manufacturer more frequently than independently financed trials whose authors had no such conflicts. The results were also interpreted favorably more often than in independently financed trials. Furthermore, there was evidence that pharmaceutical companies influenced study protocols in a way that was favorable to themselves.
The methodological quality of trials financed by pharmaceutical companies was not found to be any worse than that of trials financed in other ways. Conclusion: Published drug trials that are financed by pharmaceutical companies may present a distorted picture. This cannot be explained by any difference in methodological quality between such trials and trials financed in other ways. (Schott, Pachl, Limbach, Gundert-Remy, Ludwig, ; Lieb, 2011, p. 1). Clinical drug trials funded by pharmaceutical companies yield favorable results for the sponsor’s products more often than independent trials do.
This has been demonstrated by a number of studies in recent years Various ways have been described in which pharmaceutical concerns exert influence on the protocol and conduct of drug trials, as well as on the interpretation and publication of their results. This systematic review showed widespread conflicts of interest in the shape of financial connections between scientists, academic institutions, and the pharmaceutical industry. Around one quarter of academic staff and two thirds of academic institutions had financial relationships with industry.
Analysis of 8 review articles embracing a total of 1140 original articles (including randomized controlled trials [RCT], economic analyses, and retrospective cohort studies) revealed a statistically significant association between funding by biomedical companies and conclusions favorable to the pharmaceutical industry (summarized odds ratio [OR] 3. 6, 95% confidence interval [CI] 2. 6–4. 9). Industry financing was also connected with limitations of publication rights and constraints on access to trial data. Schott, Pachl, Limbach, Gundert-Remy, Ludwig, ; Lieb, 2011, p. 1). In the second review, a systematic analysis of 30 publications, Lexchin et al. showed that drug trials financed by pharmaceutical companies are less likely to be published, but that those published more frequently yield positive results for the sponsors’ products than do independently funded studies (8). The quality of the methods employed (analyzed in 13 publications) in trials financed by pharmaceutical companies was not inferior to that in studies with other sources of funding. Schott, Pachl, Limbach, Gundert-Remy, Ludwig, ; Lieb, 2011, p. 1). The authors of the present systematic review set out to assess whether recently published studies reveal a connection between financing of drug trials by pharmaceutical companies and results favorable to these companies’ products. Part 1 investigates whether and, if so, how the type of funding affects study protocol and quality. Part 2 identifies and depicts the aspects of clinical drug trials that can be influenced by financial support from the pharmaceutical industry. Schott, Pachl, Limbach, Gundert-Remy, Ludwig, ; Lieb, 2011, p. 1). The publications included were primarily studies performed with the expressed goal of comparing clinical trials funded by pharmaceutical companies with clinical trials that had not received financial support from such companies, e. g. , with regard to the results or conclusions. These studies were accompanied by a number of publications that investigated the consequences of financing of a study by pharmaceutical companies.
These included, for example, articles in which information from the files of the US licensing authority (Food and Drug Administration, FDA) was compared with data from publications in medical journals, and case studies on individual substances. (Schott, Pachl, Limbach, Gundert-Remy, Ludwig, ; Lieb, 2011, p. 1). Connection between type of funding and results of drug trials Twenty-six of the 57 publications analyzed sought to ascertain whether the results and/or conclusions of drug trials depended on the type of funding or on financial conflicts of interest on the part of the authors (eTable). Schott, Pachl, Limbach, Gundert-Remy, Ludwig, ; Lieb, 2011, p. 1). Altogether, 23 of these 26 studies came to the conclusion that there was a positive correlation between the financing of a study by pharmaceutical companies and/or conflicts of interest on the part of the authors and results or conclusions that were favorable to the sponsor. The statistical significance of this finding was investigated in 22 cases and confirmed in 20. (Schott, Pachl, Limbach, Gundert-Remy, Ludwig, ; Lieb, 2011, p. ). In 4 cases it was apparent that the findings were interpreted favorably towards the pharmaceutical concern that had funded the study, independent of the results (e5–e8). (Schott, Pachl, Limbach, Gundert-Remy, Ludwig, ; Lieb, 2011, p. 1). Another study investigated the connection between the conclusions and the source of financial support in clinical trials that had appeared in 5 influential medical journals over a period of 20 years (e10).
Most trials yielded positive results for the drug in question regardless of the funding source, but this study also revealed a trend over the course of time towards more positive findings in industrially financed trials than in trials supported by non-profit organizations (e10). The third study compared the results (but not the interpretations or conclusions) of clinical trials of drugs used in pain management, some of them long available as generics (e9). (Schott, Pachl, Limbach, Gundert-Remy, Ludwig, ; Lieb, 2011, p. ). Five of the 57 studies analyzed investigated whether funding by pharmaceutical companies affected the design of the study protocol (Table 1 gif ppt). The use of placebos was shown to be significantly more common in RCTs of drugs for psoriasis that were financed by such companies than in those with funding from other sources (e12). Moreover, several studies of treatment for premature ejaculation that were sponsored by a pharmaceutical company were found to have disregarded the relevant objective endpoint (e13).
In an investigation of inhaled corticosteroids, significant differences in the frequency of adverse drug reactions (ADR) between the probands and the control group occurred only half as often when the study had been funded by the manufacturers (see also Part 2). The differences could be attributed wholly to the study design. For example, studies financed by pharmaceutical companies used lower dosages. (Schott, Pachl, Limbach, Gundert-Remy, Ludwig, ; Lieb, 2011, p. 1).
The pharmaceutical company concerned investigated the marketing effect of the study, finding that participating physicians did indeed prescribe rofecoxib significantly more often than non-participants in its first 6 months on the market. (Schott, Pachl, Limbach, Gundert-Remy, Ludwig, ; Lieb, 2011, p. 1). The results of clinical drug trials that are funded by pharmaceutical companies or whose authors have financial conflicts of interest are favorable to the products of the sponsoring company far more frequently than studies whose funding comes from other sources.
Furthermore, interpretation of the data in the conclusions of industrially financed trials more often favors the sponsor. This was shown by the present systematic review and analysis of investigations, published between 1 November 2002 and 16 December 2009, into various diseases, study types (e. g. , RCTs and observational studies), and drugs. The results confirm the conclusions of 2 systematic reviews, both published in 2003, conducted with similar intent (7, 8).
The principle of equipoise, i. e. , uncertainty which of the alternative approaches benefits the patient most, forms the ethical foundation of clinical studies in which the probands receive various treatments (14). This principle seems to be violated in many studies funded by pharmaceutical companies. (Schott, Pachl, Limbach, Gundert-Remy, Ludwig, ; Lieb, 2011, p. 1). There are numerous reasons why studies financed by pharmaceutical manufacturers more often yield positive results.
Four investigations found evidence that pharmaceutical companies influence the study protocol to their advantage (e12–e14, e19), e. g. , by more frequent use of placebos in control groups than in independently funded studies (e12). Although the responsible authorities sometimes demand placebo-controlled trials as a condition of licensing, they also request active controls (15). Further factors leading to higher frequency of results favorable to the sponsor in trials funded by pharmaceutical companies are described in Part 2 of this review. Schott, Pachl, Limbach, Gundert-Remy, Ludwig, ; Lieb, 2011, p. 1). Trials financed by pharmaceutical concerns displayed no signs of poorer methodological quality. On the contrary, two studies showed superior quality (e16, e17). It must be taken into account, however, that some factors that serve to assess the quality of the instruments used in a study were not determined, among them the clinical relevance of the target parameters. In oncology, for instance, there are currently major defects in the protocols of industrially sponsored clinical trials, e. . , deficiencies in the definition of patient-relevant endpoints and in the selection of suitable substances for the control arm of RCTs (16–19). Moreover, clinical trials in oncology are often discontinued after preliminary analysis (20), with the result that only a short time after the licensing of a drug its additional benefits and the safety of new substances can frequently no longer be evaluated, preventing any benefit/risk analysis (21). (Schott, Pachl, Limbach, Gundert-Remy, Ludwig, ; Lieb, 2011, p. 1). Conclusion:
Wansink argues that the true challenge in marketing nutrition lies in leveraging new tools of consumer psychology (which he specifically demonstrates) and by applying lessons from other products' failures and successes. The same tools and insights that have helped make less nutritious products popular also offer the best opportunity to reintroduce a nutritious lifestyle. The key problem with marketing nutrition remains, after all, marketing. (Wansink, 2007, p. 1). New services must therefore be oriented toward consumers (i. e. , patients, health professionals, and third-party agencies) to gain acceptance (Grauer, 1981, p. ). We encourage family physicians interested in providing the best care for their patients to become educated in the advertising techniques used by the pharmaceutical industry. (Shaughnessy, Slawson, & Bennett, 1994, p. 1). | | | | | | | | | | | new challenges as well as opportunities for increasing profitability. If the pharmaceutical companies want to improve their Return-On-Investment (ROI), they have to adopt new communication technologies (digital media) along with their conventional sales force of medical representatives.
They really need to adopt this multi channel marketing strategies for the following reasons: The concept of blockbuster drugs is dying out for big pharmaceutical companies where 2-3 drugs were good enough to pay back the whole investment for a larger number of manufactured drugs. Now the limited prospective for blockbuster drugs (thanks to low investment on R&D and patent expiry) makes it essential to focus on more specialized drugs sold in lower volumes. And when there is low volume products, sales driven marketing strategy (with high cost of sales force) is not feasible.
As far as small pharma companies are concerned, they already have small sales force. However, with the use of digital media, having a lower investment cost (both for the company and its targeted customer) they can easily get return on investment. Customer behavior (doctors behavior) is rapidly changing. Doctors, who are getting more and more busy with increasing patients, can be hardly seen by the medical representatives. They are more inclined towards Internet for obtaining relevant information.
It is the time for pharmaceutical companies to build their marketing strategies around this digital media. Website marketing, online marketing, blogs, social media, forums, chat rooms and any other such media is an influential means to present the company's products and offers through opinion leaders (Need of New Pharmaceutical Marketing Strategies, 2010, p. 1). The right marketing strategy for any pharmaceutical company would be to build on proven strategic marketing principles, along with a focus on changing customer behavior.
Use of digital media through Internet marketing plan is the best marketing strategy that can provide the basis for a changed business model. However, there should be some planning for using digital media for marketing too. It should be a multi channel marketing strategy but should identify the target audience. Every digital media used for all people can not be called the right marketing strategy. The focus should be on the high value customer segment for pharmaceutical products (Need of New Pharmaceutical Marketing Strategies, 2010, p. 1).
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