Ethical issues in the pharmaceutical industry: an analysis of US newspapers

The Authors

George P. Sillup, Department of Pharmaceutical Marketing, Saint Joseph's University, Philadelphia, Pennsylvania, USA

Stephen J. Porth, Haub School of Business, Saint Joseph's University, Philadelphia, Pennsylvania, USA

Acknowledgements

The authors wish to thank the Saint Joseph's University's Pedro Arrupe Center for Business Ethics for their support.

Abstract

Purpose – The purpose of this study is to analyze newspaper coverage of ethical issues in the pharmaceutical industry.

Design/methodology/approach – The top five US newspapers were audited over two years and yielded 376 articles, which appeared as front-page stories or editorials. First, headlines were analyzed and categorized as positive, negative, or neutral toward the industry. Next, the full-text of each article was analyzed and ethical issues in each article were categorized. Then, articles were evaluated to determine whether the opposing point of view was included. Finally, comparisons were made between the identified issues and the issues cited by PhRMA, the pharmaceutical industry's trade association.

Findings – Analysis of the ethical issues revealed different results for the two years. In 2004, the most common issues covered were drug pricing, data disclosure and importation/reimportation. In 2005, drug safety was the number one issue, due to Vioxx^® with drug pricing a distant second. Headlines were negative 57.1 percent in 2004 and 43.9 percent in 2005. Full-text articles were negative 69.5 percent in 2004 and 60.1 percent in 2005. The opposing point of view was included 77.7 percent in 2004 and increased to 82.7 percent in 2005. Ethical issues cited by PhRMA, (e.g. drug pricing), received heavy coverage but several identified issues were not on PhRMA's list, notably drug safety.

Practical implications – Pharmaceutical companies need to take action to address the negative impression about them.

Originality/value – This research establishes a practical methodology to evaluate newspaper coverage of ethical issues involving the pharmaceutical industry.

Article Type:

Research paper

Keyword(s):

Ethics; Pharmaceuticals industry; Drug administration; Health and safety; Mass media; Newspapers.

Journal:

International Journal of Pharmaceutical and Healthcare Marketing

Volume:

Number:

Year:

2008

pp:

163-180

Copyright ©

Emerald Group Publishing Limited

ISSN:

1750-6123

Introduction

Hardly a day passes without reports of ethical issues and transgressions in the media. Among the many ways the media communicates to us, newspaper coverage is one of the most common and accessible. Newspaper is a medium that is contemplated long after the sound bites on radio and television are heard because the content of articles remains as a point of reference. This is often true in the case of ethical issues involving pharmaceutical companies, where front-page stories draw attention to an issue, such as drug pricing, and editorials take a specific and unambiguous position – pro or con – about that issue. The purpose of this study is to analyze media coverage of the pharmaceutical industry. Specifically, this study identifies and discusses the results of a two-year audit of newspaper coverage of ethical issues in the pharmaceutical industry.

From one perspective, the pharmaceutical industry is a vital industry not only because of its economic significance but also because of its impact on the health and well-being of people of all ages and economic levels. The ultimate ethical goal in the pharmaceutical industry is to discover and develop safe and efficacious drugs that allow patients to live longer, healthier and more productive lives, while making a profit to reward shareholders and to invest in research for the next generation of medicines. According to the Pharmaceutical Research & Manufacturers Association (PhRMA), the industry's trade association, pharmaceutical companies invested more than $50 billion over the last 30 years to discover and develop new medicines. Furthermore, studies confirm the inherent risk of those investments. It typically takes over $800 million and 10-12 years to develop a new drug from 250 compounds entered into a pharmaceutical company's clinical testing, to establish its safety and efficacy and to gain approval for sale in the US (Dimasi and Paquette, 2004; Bale, 2005).

From another perspective, however, the plight of many patients in the US raises important ethical concerns. For example, many seniors go to the pharmacy to get their prescriptions refilled on the day their pensions arrive each month. Some need a branded product with no generic alternatives, incurring a more expensive second-tier co-pay according to their retirement healthcare benefits. Often with a history of other complications and co-morbidities and on fixed incomes, their purchase of prescription medicines will make it difficult to buy other necessities. Such cases are not uncommon and invite newspaper coverage highlighting ethical concerns in the pharmaceutical industry.

But does this coverage accurately reflect the behavior of the pharmaceutical industry? Executives in the pharmaceutical industry frequently lament the way their industry is portrayed in the media, especially in US newspapers. The perception of many industry insiders is that “pharma-bashing” is a favorite pastime of the press. Likewise, the negative press, according to industry executives, seems to taint the public image of the industry and cast the pharmaceutical companies as the villain in the US healthcare delivery system. The reality is that there is no monolithic healthcare delivery system in the US but rather many entities, such as drug wholesalers, providers (doctors and hospitals), and payers, each with independent profit motives contributing to the price a patient pays for prescription medications. Considering that the ultimate ethical goal of the industry is to discover and develop safe and efficacious medicines that allow patients to live longer, healthier and more productive lives, and that pharmaceutical companies have made remarkable progress toward achieving that goal, is not pharma really one of the “good guys”?

To understand media coverage of the pharmaceutical industry, the top five newspapers in the US as defined by circulation were analyzed over a 24-month period. All front-page articles and editorials pertaining to a set of priority issues in the pharmaceutical industry were identified and content analyzed to answer the following research questions:

According to the leading US newspapers, what are the prominent ethical/legal issues in the pharmaceutical industry and which issues get the most coverage?
How do the issues as reported by the newspapers compare to PhRMA's list of important topics?
How are those issues reported? That is, do the newspaper articles support or oppose the positions taken by the pharmaceutical industry as defined by PhRMA?
How often do reporters include the industry's perspective in the stories that cover the issues of the day?
What are the implications of the audit for researchers, executives and managers in the pharmaceutical industry?

Literature review

The literature is replete with studies of ethical issues in the pharmaceutical industry and documents virtually all the issues reported in newspapers. During the last half century, studies on ethical issues such as the polio vaccine shortage and subsequent law suit against Cutter Pharmaceutical for negligence in 1958 started from that has grown to the present day, addressing issues like marketing practices, clinical study design and pricing of prescription medicines (Offit, 2005). Prior to coverage in the peer-reviewed literature, newspapers carried stories about drugs overstating their therapeutic capabilities as far back as the 1850s when the first sales representatives began to call on physicians (Pepin, 1996). Although much of the literature is about ethical issues in the US, the pharmaceutical industry's involvement in provocative issues is a global phenomenon (Ornellana, 2002).

Sales and marketing practices in the industry are areas of potential ethical transgression and are addressed extensively in the literature. As primary interfaces between pharmaceutical companies and patients, physicians are the target of marketing and sales efforts. For example, gift-giving, even gifts of negligible value, by drug companies can influence physicians' prescribing behavior and be a conflict of interest (Katz et al., 2003; Blumenthal, 2004). Even nurses working in physicians' offices have been influenced by gifts (Edmunds, 2004).

Interestingly, despite the literature coverage and publicity in newspapers, physicians are still prone to the enticement of gifts according to a recent national survey (Brett et al., 2003). But the ethical compromise does not stop there. The literature suggests gift-giving leads to more compromising relationships, such as writing treatment guidelines that will shape the prescribing behavior of other physicians (Studdert et al., 2004; Goozner, 2005). Other instances include prescribing drugs that a patient does not need and switching a patient to a new drug just to increase the sale of that new drug (Kassirer, 2005; Kmietowicz, 2004).

Beyond gift giving, other marketing practices have raised ethical questions. Pharmaceutical companies have “redefined” a disease to treat more patients. For example, depression went from an incidence of 50 per million in 1950 to 100 per million today, far beyond epidemiologic projections. Could this be the result of increased pharmaceutical marketing for new anti-depressants (Healy, 2000)? Another marketing strategy that is recognized as an ethical issue is lowering thresholds for therapy to sell drugs to more patients (Moynihan and Cassels, 2005). These marketing and sales practices are costly and can add up to more than what some companies spent on R&D (Goozner, 2004; Angell, 2004). They are also far-ranging and encompass working with medical students and advertising directly to patients with direct-to-consumer (DTC) marketing (Sierles et al., 2005). DTC advertising is an area of particular concern due to its potential to mislead patients (Chandra and Holt, 1999). Banned until 1980, the use of DTC advertising by pharmaceutical companies has increased, though there are guidelines to advertise on television (Pinkus, 2002).

Another area of attention in the literature concerns clinical data, the link between science and business. Clinical data must support the approval for sale of new drugs (Marsa, 1997). Reports describe practices of questionable ethics such as deliberately miscoding data to minimize a side effect, enrolling healthy children in pediatric studies and aggressively diagnosing medical problems in healthy volunteers to aid in recruiting patients, as was the case in the ketamine trials (Healy, 2003; Koren, 2003; Tishler and Gordon, 1999). The date when the final treatment is given to a patient under a study protocol (time-to-last-treatment) is always a milestone in clinical studies and efforts to achieve it faster have lead to ethical dilemmas. Examples from the literature are treating the homeless in exchange for basic rewards, such as food and medical care (Beauchamp et al., 2002). Other examples include using clinical research organizations (CROs), whose mission is to run clinical studies for pharmaceutical companies, primarily because they have an existing network of clinical trial sites; or using ghostwriters to “hoodwink” medical journals and publish favorable study results faster (Schieppati et al., 2002; Wagena and Knipschild, 2005).

The literature also discusses financial rewards provided to clinical centers by pharmaceutical companies. For example, there is the infamous case of Dr Nancy Olivieri, who was sued by the pharmaceutical company, Apotex, after she informed her patients that the study drug (deferiprone) was ineffective in treating some children. Supported by the Canadian Association of University Teachers, the initial judgment was in her favor (Olivieri, 2003). However, Toronto General Hospital, her employer, was under contract with Apotex, and Apotex pursued it further (Shuchman, 2002). The whole story is now available in a book by Shuchman (2005), The Drug Trial: Nancy Olivieri and the Science Scandal that Rocked the Hospital for Sick Children.

Drug safety is another ethical dilemma that is not only in the peer-reviewed literature but also in the popular press, such as Consumer Reports. A recent and epic case with a dominating presence in the media is Merck's Vioxx^®. Consumer Report (2006) claims that Vioxx's heart risks were de-emphasized despite the drug's “black box” warning, a designation posted on drug package inserts to warn users about dangerous side effects. One peer-reviewed journal editorial praises Merck for taking the drug off the market quickly but questions their lack of thorough investigation of the side effects ( The Lancet, 2004b). Examples of other drug safety concerns include reports of companies that did not fully apprise patients of inherent dangers; and out-of-court settlements in drug injury cases ( The Lancet, 2004a; Davidson, 2004; Herxheimer, 1996, 1999).

Concerns about drug pricing have been covered extensively in the literature and newspapers, dating back over 30 years (Maitland, 2002; Walker, 1971). Another issue is patent exclusivity and the opposition of pharmaceutical companies to any actions that could make additional sources of product available before patent expiration, resulting in restricted patient access to drugs. An example of this is illustrated by Bristol-Myers Squibb's desire to sell their branded anti-immunodeficiency syndrome (AIDS) drug, AZACTAM^® and to oppose the availability of “generic” aztreonam, thereby making it unavailable to patients who cannot afford the branded drug (Gewertz and Amado, 2004). Another issue is regulatory attempts to impede marketing, production or use of drugs, which has led to a doctrine that approves the use of a drug that is life saving but has side effects that can cause injury – a doctrine that is not allowed for other products (Masek, 2000).

The literature also represents the pharmaceutical industry favorably in many cases. Publications note that patients enter clinical studies without coercion and get access to a drug that cures their illness when approved drugs are unable to do so (Pepin, 1997). One of the eight myths about the drug industry's ethics identified by Spilker (1984) is that consumer advocates provide the public with unbiased truths about the drug industry. According to Spilker (1984), in addition to being unfairly represented by consumer advocates, pharmaceutical companies are often the focal point of hostility because they are one of the most well-known components of healthcare delivery.

Other components of health care delivery are payers, policy makers and providers, like doctors and hospitals, who have also been accused in the literature of ethical transgressions. Examples are HMO physicians obligated to cut costs, a physicians' conference refusing to sell space to an anti-pharma group, or the conflict of interest that can result from partnering between medical organizations and pharmaceutical companies (Veatch, 1985; Lenzer, 2005; Kerridge et al., 2005). Pharmaceutical companies also get maligned for the transgressions of clinical trialists who fail to provide appropriate treatment or full safety to patients (Barrett and Jay, 2005).

It is also important to recognize that generic drugs are not always the solution to more expensive branded drugs. Generics are used to fill one in three prescriptions in the USA today and are sometimes priced just below the patented drug. Generic pharmaceutical companies that only manufacture products once they have been approved for sale as a new therapy do not incur the same level of R&D expenditures as pharmaceutical companies with a mission to discover and develop new drugs. Generic manufacturers are aggressive about pricing and have been linked to unethical tactics to get their generic alternative approved sooner. An example of this is the 1989 scandal when several generic companies used bribery and fraud to obtain early FDA approval (Heacock, 1990).

Research literature is more comprehensive than newspapers in representing both the pros and cons of ethical issues facing the pharmaceutical industry. For example, the literature not only explains the potential consequences of using a pharmaceutical product but also talks about the responsibility of healthcare providers and patients taking the drug (Hanekamp, 2005). On the con side, the literature contains a comparable number of unfavorable publications depicting pharmaceutical companies as exploiting patients to pursue profits as in the cases of interferon β and cyclo-oxygenase 2 inhibitor (Vallance, 2005). On the pro side, the literature reports about treatment guidelines for ethical interaction in all facets of medicine. One example is the recent conflict-of-interest statement issued by diabetic medicine practioners (Heller, 2004). There has also been considerable coverage about how the National Institutes of Health (NIH) have implemented their rules in August 2005 that limit stock ownership but prohibit consulting (Kaiser, 2005; Marris, 2005). An encouraging note is the pharmaceutical industry's recognition that general business ethics are critical to its long-term sustainability (Fombrun and Foss, 2004).

Research methodology

The top five US newspapers as defined by circulation – The USA Today, The Wall Street Journal, The New York Times, The Los Angeles Times, and The Washington Post – were audited from October 1, 2003 through September 30, 2005 (HeadlineSpot.com Lists, 2007). To be included in the study, an article had to focus on an ethical/legal issue in the pharmaceutical industry and appear either as a front-page story or on the editorial page – an indication of major news and public sentiment. Letters to the editor were excluded. This approach yielded a grand total of 376 front-page articles and editorials with more than twice the number in 2005 than 2004 (271 vs 105) as shown in Table I. Clearly, scrutiny of the industry in newspapers has increased between the two years.

For each article, the headline was analyzed first and categorized as positive, negative, or neutral toward the industry. These assessments were done independently by the authors and by two research assistants. To ensure inter-rater reliability and validity of assessments, the research assistants were trained to assess the articles according to the methodology described below. In addition, the assessments were cross-checked for consistency, and any differences were examined and discussed by the team of researchers. For example, “Despite Vow, Drug Makers Still Withhold Data” from The New York Times was classified as a negative headline, while “Drug Ads Let Patients Participate in Care” from The USA Today was labeled positive (Berenson, 2005; Brannon, 2005). Next, the ethical issues discussed in each article, such as drug pricing or data disclosure, were identified and categorized. Seventy-three articles (23 in 2004 and 50 in 2005) covered two or more issues and were included in relevant sections. Then, each complete article was analyzed to determine whether it took a positive, negative, or neutral position toward the pharmaceutical industry. For example, any article that called for restrictions or a prohibition on direct-to-consumer (DTC) advertising – a position that the industry opposes – was deemed negative. In contrast, a article claiming that DTC advertising resulted in more informed patients was designated as positive, given the industry's stance on the issue.

Regardless of the dominant position taken by the article, each article was evaluated to see if it included the opposing point of view. When an explicit statement about an opposing view was included in the article – even if the two sides did not receive equal coverage – it was concluded that the article covered both sides. When no mention of the opposing view was presented, the article was labeled as one-sided and was not included in the study. Additionally, articles that had no defensible “opposing view” were not included. For example, one article discussed “one of the biggest health scourges of the developing world: counterfeit pharmaceuticals,” whereby fake, substandard and expired medicines are sold openly in pharmacies and outdoor markets (Naik, 2004).

Then, comparisons were made between the identified issues and the issues cited by PhRMA and posted on their web site in December 2004 and December 2005. Finally, because perceptions may be influenced by headlines, the headlines were evaluated to determine whether they supported, opposed or were neutral toward the pharmaceutical industry and the headline analysis was compared to the assessments of the full-text articles.

Findings

What are the issues?

The analysis of the ethical issues revealed different results for the two years assessed as shown in Table II. In 2004, the most common issues reported were drug pricing (35 articles), data disclosure of clinical trials and/or reporting of adverse events of drugs currently on the market (28 articles), and importing or reimporting drugs from Canada (24 articles). Four other ethical issues received moderate attention, ranging from five articles on the FDA drug approval process to nine on generic drugs and on marketing restrictions. The audit also uncovered an assortment of other ethical/legal issues; including three on the growth of drug counterfeiting (e.g. production of adulterated medications and/or sale of these drugs over the internet). Other issues, each covered twice, included calls for the NIH to ban drug industry payments in the form of consulting fees to NIH scientists, discussions of the merits of experimental trials preceding full-scale clinical study, efforts by pharmaceutical benefit managers (PBMs) and insurers to restrict drugs on the Medicare formulary, and the pros and cons of programs designed to provide AIDS treatments to developing countries. Considering that the articles on generics and drug imports were more broadly about ways to reduce drug prices, “pricing” emerges as the single most dominant issue in the audit, with 68 hits in 105 articles (64.8 percent) in 2004. Articles about data disclosure of research results, especially for clinical trials with adverse events, and/or establishing a mandatory public drug registry were common but a distant second compared to pricing.

The results of the audit for 2005 are striking in that 114 articles focused on the topic of drug safety, an issue that hardly registered on the radar screen in 2004. This finding reflects the Vioxx and related stories which dominated the headlines and newspaper coverage in 2005 (“Vioxx” appeared in 25 headlines). High drug prices and concerns about differential pricing, the run-away number one issue in 2004, was a distant second in 2005 with 54 articles. Data disclosure of clinical trials and manufacturing processes was a prominent topic in both years studied, ranking second in frequency in 2004 and fourth in 2005. Importation/reimportation of drugs from Canada and other countries dropped from third in 2004 to sixth in 2005. Clinical study design and sponsorship concerns, and marketing and sales incentives to providers moved into the top-five list in 2005, coming in third and fifth places, respectively.

When the ethical issues in the two study years were combined, six issues emerge as the most frequently observed. Drug safety was the most frequent issue with 114 observations, all of which occurred in 2005. It was followed by pricing with 89 observations and a 54 percent increase from 2004 to 2005 (35-54 observations) and data disclosure and reporting requirements (programs or attempts to mandate publication of data, particularly from clinical studies with unfavorable results and/or from drugs currently on the market) with 54 observations split almost equally over the two years. Importation/reimportation was fourth with 37 observations with about a 50 percent decrease from 2004 to 2005 (24-13). Not surprisingly due to the relationship with drug safety, clinical study design and sponsorship (issues related to protocol treatment of patients and pharma payments to trial sites) emerged as a new issue in 2005 and was fifth with 30 observations. Market restrictions and sales incentives or anything that impacts marketing/sales efforts was sixth with 23 observations.

Comparison between ethical issues identified and PhRMA issues

PhRMA, the pharmaceutical industry's trade association, identifies a list of issues on its web site with the capability to impact member companies. This list was compared to the ethical issues identified by the audit, which revealed valuable observations. Of the nine issues PhRMA identified on its 2004 list, pricing, data disclosure, and drug reimportation received heavy front-page or editorial-page coverage. Four other PhRMA issues received moderate attention in the newspapers: generics, marketing restrictions, intellectual property, and FDA approvals. Manufacturing restrictions and research restrictions, the remaining PhRMA issues, received no coverage.

Similarly, several of the issues from the newspaper audit were not found on PhRMA's list from December 2005. For example, three of the top five issues in the audit – drug safety, data disclosure, and marketing and sales incentives used by pharma – were not part of the PhRMA list. Other topics that received significant newspaper coverage but did not appear on PhRMA's list were developing countries (e.g. efforts to provide access to patients in developing countries), new drug treatment/research, and issues related to vaccines (e.g. shortages of vaccines and articles about bird flu).

On the positive side of the ledger, PhRMA's 2005 list included drug prices, issues related to clinical study design (under R&D), reimportation, and DTC Advertising. These four issues were discussed in 38.7 percent of the articles in the audit. This represents significant overlap between the issues PhRMA identified and those that were uncovered in the audit. The glaring omission to PhRMA's list is drug safety which was discussed in over 42 percent of the articles. Other issues identified by PhRMA – such as Medicare and Medicaid programs, and in the courts – received modest coverage by the newspapers as shown in Table III.

Headlines vs articles

Headlines are often all that consumers read or remember from their newspaper and can be influential in shaping perceptions. In 2004, the analysis found that the majority of headlines opposed the industry: 57.1 percent were negative, 18.1 percent were positive, and 24.8 percent were neutral. Taken as a whole, the full-text articles were even more negative than the tone of headlines. Interestingly, there were a greater number of positive and negative articles compared with the headline analysis, meaning that the headlines were more neutral toward the industry – mostly because they were more general. Although the percentage of favorable articles in 2004 was only slightly greater than the percentage of headlines (20 percent compared with 18.1 percent), the proportion of articles critical of the industry was much greater, 69.5 percent compared with 57.1 percent.

Although most headlines and articles in 2004 did not support the positions of the industry, 77.7 percent of the articles mentioned both sides of the disputed issue. In 2005 pharma's perspective was included in 82.7 percent of the articles. In contrast to 2004 when most headlines were negative toward the industry (57.1 percent), the analysis of headlines for 2005 found that 46.9 percent were neutral, 43.9 percent were negative and 9.2 percent were positive. This is good news and bad news for pharma companies because headlines were less negative but also less positive toward the industry. These results are shown in Table IV.

As was the case in 2004, the full-text articles in 2005 were even more likely than headlines to be negative. Despite the fact that the percentage of favorable articles in 2005 was greater than the headlines (19.2 percent compared with 9.2 percent), the proportion of articles critical of the industry was also greater (60.1 percent compared with 43.9 percent).

The audit shows that full-text articles were even more likely than headlines to be negative toward the industry. The full-text analysis is interesting in that the percentage of positive and negative articles in 2005 both decreased consistently with the headlines while the percentage of neutral articles increased from 10.5 percent in 2004 to 20.7 percent in 2005. The percentage of favorable articles stayed about the same in 2004 and 2005 (20 percent vs 19.2 percent) but the proportion of articles that were critical of the industry and/or industry positions decreased from 69.5 percent in 2004 to 60.1 percent in 2005. These results are also shown in Table IV.

Discussion

This analysis of leading US newspapers confirms the perception of many pharmaceutical executives that press coverage tends to be critical of industry practices and positions. Almost 70 percent of the articles in 2004 and 60 percent in 2005 were assessed as negative or taking positions contrary to those endorsed by PhRMA and by the pharmaceutical companies. The issues that attracted the most attention were drug safety, pricing, data disclosure, importation/reimportation, clinical study design and sponsorship, and marketing and sales restrictions.

Drug safety

Drug safety emerged as a new and predominant issue in 2005, identified 114 times. This issue includes concerns about the comprehensiveness of reporting of all side effects observed during a clinical study. This is especially true for what the pharmaceutical industry characterizes as serious adverse events (SAEs), which can be life threatening. Not surprisingly, this issue dominated the nation's top newspapers; undoubtedly tied to allegations about Vioxx, Bextra^® and related drugs.

This issue has important ethical consequences because it suggests deception and lack of integrity (with regard to clinical studies and their impact on safety); conflict of interest (with regard to sponsorship); and lack of ethical responsibility to the patient as stakeholder to provide a sound product (with regard to safety).

Drug pricing

The high price of medications is a message resonating across the United States and identified by our analysis 35 times in 2004 and 54 times in 2005. The USA Today reported that “AARP's study of 155 name-brand drugs found an average price increase of 27.6 percent over four years… compared to a 10.4 percent inflation rate” (Welch, 2005). The Washington Post editorial predicted that drug price control legislation is likely – “the key question is how quickly it will come” (Masters, 2004). As part of identifying potential ballot issues, The Los Angeles Times reported efforts by the city to enact a proposal to establish a consortium to buy drugs in bulk from Canada to receive better pricing for residents, employers and hospitals, claiming that “the (federal) ban on negotiating bulk-rate prices benefits only the powerful drug companies, not the taxpayers” (Rau, 2004).

In defense of the industry, The Washington Post published an editorial by Robert Goldberg, Director of the Center for Medical Progress at the Manhattan Institute for Policy Research, arguing that the US produces more new drugs “than any other country because it is largely free of price controls… About 75 percent of all new drugs are discovered and used in the US first” (Goldberg, 2003). “Innovation and patients will get hurt” if the emotional appeal for price controls is heeded (Goldberg, 2003). The pricing issue raises questions about sound management regarding meaningful R&D costs and the public perception of wasteful advertising. Thus, the ethical concern of just prices for drugs is of prime importance.

Data disclosure

Data disclosure was the third most frequently identified issue with virtually the same number in 2004 and 2005; 28 and 26, respectively. Articles that discussed allegations of data suppression by pharmaceutical companies were common in light of the problems with antidepressant use by children. A headline in The Washington Post proclaimed: “Drugmakers Prefer Silence on Test Data; Firms Violate US Law by Not Registering Trials” (Vedantam, 2004). The Washington Post contended that some drug companies were not disclosing data on clinical trials of antidepressants and that “conflicts of interest and company control of data have thrown out the scientific method” (Vedantam, 2004).

Some articles called for enforcement of a mandatory national drug registry of clinical trials. The USA Today published an editorial by Alan Homer of PhRMA, arguing that efforts to expand access to clinical trial data are already underway, and that PhRMA supported the establishment of a central registry and has encouraged its members to participate (Homer, 2004). Similarly, The Washington Post editorial suggested that a requirement to publish all results “might backfire and wind up discouraging companies from conducting any trials at all” (The Washington Post Editorial Board, 2004b). Instead, it encouraged Congress to study the issue and develop a system for disclosing trial results.

Importation/reimportation

Importation/reimportation, an issue identified almost twice as many times in 2004 than in 2005, focuses on importing or reimporting drugs, primarily from Canada. It is one attempt to circumvent the high price of drugs. The articles discussed reimportation as a way to cut the cost of prescription medicines for individual patients, and help states and communities balance their health care budgets.

Efforts to legalize reimportation or circumvent the existing ban were commonly reported. According to the Washington Post, USA:

Customs estimates 10 million US citizens bring in medications across land borders each year. An additional two million arrive annually by mail from Thailand, India, South Africa and other points and still more come from online pharmacies in Canada (Flaherty and Gilbert, 2003).

In 2004, The Washington Post also reported that the “clamor for legislation to permit Americans to buy lower-cost prescription drugs from Canada … will grow” and the Montgomery County Council, where many FDA employees live, voted to begin buying drugs from Canada, defying a federal law, in an effort to “save as much as $20 million per year” (The Washington Post Editorial Board, 2004a). In 2005, however, it seems as though an increased focus on drug safety has muted attention on this issue.

Clinical study design and sponsorship

This describes issues related to protocol treatment of patients, such as placebo-controlled trials or payment to clinical trial sites by pharmaceutical companies. It seems to be related to the drug safety issue and emerged in 2005 with 30 observations. Given the impact of the drug safety issue on the pharmaceutical industry, it is likely that this issue will continue to receive widespread attention in the newspapers.

Marketing restrictions and sales incentives

An issue that was on the radar screen in both years is marketing restrictions and sales incentives. It pertains to any regulations or guidelines that can potentially impact marketing or sales practices, such as providing gifts or incentives to physicians, promotion of drug benefits or off-label use of an approved drug. In 2004 and 2005, it was identified nine and 14 times, respectively.

Implications

Pharmaceutical companies need to take action to address the negative impression about them notwithstanding the tangible commitment they make to healthcare, including R&D expenditures of $33.2 billion by PhRMA member companies (17.7 percent of domestic sales), more than the NIH and the international pharmaceutical industry combined. The findings of this study have implications for researchers interested in better understanding how ethical issues reported in newspapers effect pharma, as well as for pharmaceutical executives and Public relations (PR) managers of pharma companies.

Researchers

This study's findings invite researchers to understand more thoroughly the impact of media coverage on the pharmaceutical industry. Future studies should assess the relationship between media coverage and corporate reputation (Edmunds, 2004). For example, what impact does media coverage of a major positive or negative ethical issue have on stock price performance or measures of corporate reputation? Similarly, researchers could focus on corporate press releases issued in response to major media coverage to determine what impact, if any, they have on ethical issue-corporate reputation relationship. In addition, this study could be extended beyond newspapers to all forms of media coverage. Furthermore, research on frequently occurring issues could be expanded to assess the impact of issues that occur less frequently, such as the NIH Ethics Rule, Right to Life/Contraception or biotechnology. Understanding their potential impact can be an excellent predictor of how media coverage can influence public perceptions of the industry as well as the sale of the pharmaceutical industry's future products.

The study also establishes the basis for researchers to compare these findings with the media coverage of other industries, such as “big oil”. Consider the media attention given to the high price of gas in the US during the spring and summer of 2006. Instead of scrutinizing big pharma, the media focused on big oil. Is media coverage primarily focused on any negative activity that draws our attention regardless of the industry or are other industries portrayed in a more favorable light than pharma? For example, Merck's program to provide treatment for HIV patients in sub-Saharan Africa never merited front-page coverage as the drug safety issues related to Vioxx did. Is the pharmaceutical industry being held to a higher standard, perhaps because its products relate directly to quality of life issues?

Executives

This study also has implications for executives in the pharmaceutical industry. Findings show that newspaper coverage is largely negative and highlight the scrutiny placed on pharmaceutical companies. This scrutiny has intensified from year one to year two of the study as measured by the number of newspaper articles which doubled. For example, as a result of the most frequently reported issue in newspapers last year, drug safety, executives face an unprecedented level of attention in this regard. The study also encourages pharma executives to consider not only the usual stakeholders in healthcare delivery (i.e. the five Ps – patients, providers, payers, policymakers, products) but also be more attuned to a sixth P – publicity.

Public relations managers

PR managers of pharma companies may also want to consider the implications of this study. Because media coverage about the pharmaceutical industry is more negative than positive, it appears to have tainted the public image of the industry. But is the tainted image due to the industry's ineffectiveness in communicating its messages and positions, or because those messages are not compelling to the public, or both? If the problem is ineffective communication, PR managers need to devise ways to work more proactively and cooperatively with the media. One effective way to help the patient/consumer understand the issues the industry faces and reaffirm the industry's contribution to US healthcare delivery is to coordinate individual company activities with those of PhRMA. PhRMA, under the leadership of Billy Tauzin, seems to be headed in the right direction by moving from a “no comment” posture to greater transparency and more willingness to address key issues.

If on the other hand, the message is clear but not convincing, PR can help a pharma company re-examine its positions and priorities and rethink its messages. Perhaps, the public, or at least the media, is not convinced that the patient comes first, as the Johnson & Johnson Credo so famously asserts: “Our first responsibility is to the doctors, nurse and patients… and all who use our products and services” (Johnson & Johnson, 2005). The overriding ethical challenge for the pharmaceutical industry is to serve the well-being of the patient, and then to convince the public that that is precisely what it set out to do.

Conclusion

This study assessed newspaper coverage of ethical issues in the pharmaceutical industry and found the coverage to be predominately negative and increasing in frequency (more than doubling over the two-year study). In addition, a thorough review of the literature found that ethical issues in the pharmaceutical industry, such as drug safety, were reported as far back as the 1850s and have been studied with greater frequency beginning more than a half century ago. Importantly, the research is more comprehensive than the newspapers in addressing both the “pro” and “con” perspectives of the ethical issues. The tone of the articles covering the six most prominent issues reported in newspapers – drug safety, pricing, data disclosure, importation/reimportation, clinical study design and marketing restrictions – is predominantly negative and critical of the positions taken by the industry. Additionally, comparison with issues considered significant by the pharmaceutical industry's trade association revealed a match with many issues but not the most frequently observed issue, drug safety. The implications of these findings for future researchers and for decision-makers in the pharmaceutical industry are identified and discussed.

Table INumber of articles

Table IIFrequency analysis of ethical issues

Table IIIComparison between ethical issues identified and PhRMA issues

Table IVAnalysis of headlines and full-text articles

References

Angell, M. (2004), The Truth about the Drug Companies: How They Deceive Us and What To Do about It, 1st ed., Random House, New York, NY, .