Annual Press Audit: Front Page Pharma

For many in the industry, it felt like pharma was hardly ever out of the news this year—and the news was mostly bad. That feeling wasn't all in your head, as this year's Audit of Media Coverage of Ethical Issues in the Pharmaceutical Industry confirms. Coverage of legal and ethical issues related to pharma increased sharply; the newspapers in the study pool published more than twice as many front-page and editorial-page stories on these topics than they did in last year's study.

Some key findings:

• The majority of the articles about the industry continue to be negative, but there was a substantial increase in the number of stories that took a neutral position, and a corresponding decrease in the number that took a negative point of view.

• Several new topics took center stage this year—especially safety, which was a key concern in more than half of all articles studied.

• Following the pattern we noted last year, there were some serious disconnects between the issues that dominated the press and those identified as important by PhRMA.

Processing the News

The audit was sponsored by the Arrupe Center for Business Ethics at Saint Joseph's University and is the second of its type. (For last year's results, see "Good News, Bad News" in the April 2005 issue of Pharmaceutical Executive.) The purpose of the audit was to shed light on the following questions:

• What ethical and legal controversies face pharma—and what kinds of coverage do they attract?

• How do the issues reported by top newspapers compare to the list of important topics developed by PhRMA?

• Do the articles support or oppose the positions taken by the 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 these findings for the industry?

The audit looked at the five US newspapers with the highest circulations: USA Today, the Wall Street Journal, the New York Times, the Los Angeles Times, and the Washington Post.

Under the Microscope

We focused on daily newspapers rather than the broadcast media or weekly magazines for a number of reasons. Newspapers can cover a broader range of issues and in more depth than the sound bites reported on radio and TV. Business and news magazines are also constrained by their weekly or monthly formats. Furthermore, with their editorial and op-ed pages newspapers have a substantial amount of content that takes a specific, unambiguous position—pro or con—toward the controversies in question. Finally, the five papers we selected are a particularly important group that both reflect a broad range of public opinion and play an important role in shaping US media coverage.

Which Side Are You On?

The audit covers the period October 1, 2004, through September 30, 2005. To be included in the study, an article had to (a) focus on an ethical or legal issue facing the pharma industry and (b) appear either on the front page or on the editorial or op-ed pages—an indication of major news and public sentiment. (Letters to the editor were not counted as editorial-page articles.) Clearly, media scrutiny of the industry has increased since last year. We selected and analyzed a total of 271 articles, more than double last year's total of 105.

The top ethical issues covered by the press included safety, drug prices, and the issues surrounding clinical trials (right). The issues flagged as important on PhRMA´s Web site anticipated many of the most-covered issues, but not all. The biggest omission: the topic of the year, safety.

Once the pool of articles was established, the team examined four factors:

Issues discussed For each article, we identified and categorized the relevant legal and ethical issues discussed. Fifty articles covered two or more issues and were counted under all relevant categories. [REFER]

Headline We categorized each headline as positive, negative, or neutral toward the industry. For example, "Despite Vow, Drug Makers Still Withhold Data" (New York Times, May 31, 2005, page A1) was clearly classified as a negative headline, while "Drug Ads Let Patients Participate in Care" (USA Today, June 15, 2005, page 10A) was labeled positive.

Story body We also analyzed each complete article 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 DTC advertising—a position that the industry opposes—was deemed negative. In contrast, an article claiming that DTC advertising resulted in more informed patients was designated as positive, given the industry's stance on the issue.

Balance Regardless of the dominant position taken by the article, we also looked to see if the articles 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—we concluded that the article covered both sides. When no mention of the opposing view was presented, the article was labeled as one-sided.

Hot Button Issues

The chart on page 58, "Frequency Analysis of Ethical Issues," shows which topics the articles covered, and how many articles were devoted to each topic. The results are striking in that 114 articles focused on drug safety, an issue that hardly registered on the radar screen last year. This finding reflects the Vioxx (rofecoxib) and related stories that dominated the headlines and newspaper coverage in 2005. (The word "Vioxx" appeared in 25 headlines.) High drug prices and concerns about differential pricing, the runaway number-one issue last year, was a distant second this year with 54 articles. Disclosure of clinical-trial data and manufacturing processes was a hot topic this year and last, ranking second in frequency last year and fourth this year. Importation/reimportation of drugs from Canada and other countries dropped from third on the list last year to sixth this year. Clinical study design and sponsorship concerns and marketing and sales incentives to healthcare providers moved into the top five list this year, coming in third and fifth place, respectively.

As for the slant of the articles, several important points emerged as we compared this year's results with last year's:

Headlines were more likely to be neutral. Last year only about one-quarter of headlines were neutral, while 57 percent were negative and 18 percent were positive. This year, there were fewer positive headlines (9 percent) and fewer negative (44 percent), while the neutral headlines nearly doubled to 47 percent. (See "Which Side Are You On?" above.)

The articles were more negative (and positive) than the headlines. This was the case last year, as well. Compared with the headline analysis, the full-text articles yielded more positives, more negatives, and fewer neutrals. The headlines were more neutral toward the industry—mostly because they were more general. Although the percentage of favorable articles was greater than the percentage of favorable headlines (19.2 percent compared with 9.2 percent), the same relationship held true with articles critical of the industry (where 43.9 percent of the headlines were negative and 60.1 percent of the articles).

The front page was just as negative as the editorial page. It might be reasonable to expect that the editorial page would have a higher percentage of both positive and negative articles, because that's the part of the newspaper devoted to opinions. In fact, though, the percentage of negative stories was the same on the front page and the editorial page: 60 percent. There were more positive stories on the editorial page (23 percent compared with 15 on the front page) and more neutral articles on the front page (25 percent compared with 17 percent on the editorial page).

Does that show that news stories are biased? Possibly, but it also reflects a reality of the news business and the way reporters regard "news hooks": When a story like Vioxx breaks, additional sources will emerge to add their accusations—in the case of Vioxx, that the company knew about the problems with the product, that it covered up its knowledge, that it had concealed data, that it had falsified a journal article, and so forth. Each new accusation tends to be treated as a separate, newsworthy event. And each of those stories will tend to register as negative.

The coverage was more balanced this year than last. Although most headlines and articles did not support the positions of the industry, the coverage did acknowledge pharma's point of view in 83 percent of the articles. This figure increased from last year when 78 percent of the articles mentioned both sides of the disputed issue.

PhRMA Issues

The other chart on page 58, "Consolidation of Issues on PhRMA Web site," shows how this year's audit compared with the issues highlighted on the PhRMA site in December 2005. Similar to last year, several of the issues identified by the audit were not included in PhRMA's list. 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 (for example, efforts to provide access to patients in developing countries), new drug treatment/research, and issues related to vaccines (for example, bird flu and shortages of vaccines).

On the positive side of the ledger, PhRMA's list included drug prices, issues related to clinical study design (under R&D), reimportation, and DTC advertising. These four issues were discussed in 39 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 more than 42 percent of the articles. Other issues identified by PhRMA—such as Medicare, Medicaid, and the courts—were covered by the newspapers, but in most cases, the articles mentioning them were categorized by our researchers in other areas, such as drug pricing.

Implications for Pharma and PhRMA

Again this year, findings of this study have several key implications for the pharmaceutical industry and for PhRMA. Press coverage both follows and leads public sentiment. It identifies issues that have emerged in the recent past—but it also helps shape how people think about issues moving forward. With that in mind, here are some areas for pharmaceutical companies to consider, based on this year's coverage:

Drug safety and data disclosure Articles on drug safety dominated the nation's top newspapers, undoubtedly tied to allegations and court proceedings about Vioxx, Bextra (valdecoxib), and related drugs. These allegations represent additional examples of the risk of product liability for the pharmaceutical industry. The "calculated" risk of developing a new drug from a large number of development compounds is a known risk, which companies choose to accept (10 to 15 years and an average of $800 million to bring a new medicine to market). At this time, however, product liability can be considered an "uncalculated" risk with profit-consuming and stock-devaluing implications. To cite just one example, Wyeth's involvement in the diet drug cocktail known as fen-phen (fenfluramine, phentermine, dexfenfluramine) cost the company and its stakeholders billions of dollars.

If ever there was a time to introduce an impeccable standard, such as Six Sigma, to clinical data collection and post-approval monitoring, it is now. Pharma can consider this an opportunity and work with FDA for more efficient ways to achieve data reporting. This has the potential to not only help prevent future drug liability crises in our litigious climate, but also improve healthcare delivery consistent with the goals of PhRMA's chairman—better access, affordability, information, and education

Drug prices/Medicare Although it was a distant second to drug safety, there is still sensitivity about the cost of prescription medicines. As mentioned earlier, the new Medicare Drug Benefit received very little coverage as an ethical issue, primarily because it is seen as a vehicle to alleviate a financial problem for many seniors. The complexity of the new program, however, presents an opportunity for pharma to provide patient assistance and understanding of the potential benefits and use of the program. Information on PhRMA's Web site, and programs such as the Partnership for Prescription Assistance, provide an excellent starting point.

Negotiations with Medicare, Medicaid and other payers/providers Pharma companies need to be prepared for a new level of price negotiations with the federal government, because Medicare can become their largest customer, depending on the company's product line. Even more competitive negotiations among all companies with drugs on state Medicaid formularies may be the result. Hopefully, these negotiations will not require resolution in the courts by PhRMA as it has had to intervene on behalf of the millions of patients trying to gain access to pharma drugs.

Finally, it is also interesting to see issues become more prominent and merit enough attention to be monitored as a potential impact on business in 2006. These are issues related to vaccines (for those companies with vaccine-production capability), NIH Ethics Rule (for all companies working with NIH) and Right to Life/Contraception (for negotiations with pharmacy providers and certain pharmacy buying organizations).

We recognize the tangible commitment made to healthcare by pharma companies—including R&D expenditures of $33.2 billion by PhRMA member companies, which represents almost 18 percent of domestic sales and is more than the amount sent by NIH and the international pharmaceutical industry combined (based on 2003 financials). That's an important commitment—and one that makes it essential that the industry address the ethical issues and achieve more favorable media coverage.

The authors wish to thank research assistants Meghan Kelly, Sarah Poole, and Camille Siochi, and business librarian Cynthia Slater for their contributions to this article.

Stephen J. Porth, PhD, is a fellow of the Arrupe Center for Business Ethics and professor at Saint Joseph's University in Philadelphia. He can be reached at sporth@mailhost.sju.eduGeorge P. Sillup, PhD, is an Arrupe Fellow and assistant professor at Saint Joseph's University. He can be reached at sillup@sju.edu