Indian Journal of Medical Informatics. 2009; 4(1): 4

http://ijmi.org

Article

A Comparison of the Consumer Information in Pharmaceutical Company Web Sites and Reference Articles

Jatin Shah¹, Smitha Mathews², Adam Goode³, Andre Cabral⁴, Chad Cook⁵ and Ricardo Pietrobon⁶

¹Duke NUS Graduate Medical School,

2, Jalan Bukit Merah, Singapore 169547

²Kalpavriksha Healthcare & Research, Maharashtra, 421202 India

³Assistant Professor, Graduate Program, Physical & Occup Therapy, Oxford Physical Therapy Clinic 1005 Slater Road Durham,

NC 27703

⁴Center for Excellence in Surgical Outcomes,

Department of Surgery, Duke University Medical Center,

Box 3094, Durham, NC, 27710 USA

⁵Assistant Professor, Graduate Program, Physical & Occup Therarpy,

Box 3907 Med Ctr Durham, NC 27710

⁶Associate Vice Chair and Associate Professor, Department of Surgery,

Duke University Health System and Assistant Professor Duke Graduate Medical School,

Singapore, Box 3094, Durham, NC, 27710 USA

Abstract:

BACKGROUND

Despite their many benefits to consumers, pharmaceutical direct to consumer (DTC) marketing sites have the potential to misinform. This could have potentially far-reaching negative consequences on the health of consumers, needing stringent quality control to assess the authenticity of the websites' claims. We examined pharmaceutical DTC websites to compare their claims of efficacy and side effect/ limitations against their references. This study is a direct, structured, observational study of pharmaceutical websites. The information of four randomly selected pharmaceutical DTC websites and their five drugs, were compared for the accuracy concerning efficacy, side effects and limitations with cited reference material. Analyses were scored as: Yes, No and Unsatisfactory.

RESULTS

A total of 45 claims of efficacy and 32 claims of drug side effects/limitations were supported from corresponding referenced studies. The websites provided, referenced support of 45 of the 65 claims of efficacy. Side effects and limitations were poorly represented with 32 of the 85 referenced claims being found in the corresponding websites in comparison to supporting articles.

CONCLUSIONS

Majority of pharmaceutical websites provide a greater number and proportion of references regarding claims of efficacy as compared to side effects and limitations.

Keywords:

Drug Industry; Internet; Resource Guides; Drug Information Services

1. Introduction

The consumer revolution, propelled by improved education, growing awareness and institutional policy support, has effectively sanctified the rights of the consumer. Recognizing this trend, and understanding the true power of the consumer, industry has focused carefully on their needs, behaviors and reactions. This is amply reflected in the way medical products and services are promoted to the public by the pharmaceutical industry. Their signal strategy has been the marketing of prescription drugs via "Direct to Consumer" (DTC) advertising [1] which has been phenomenally successful [2,3,4]. Previously, manufacturers directed their marketing at medical professionals, and not at end users [5]. The change is evident from the expenditure of $685 million for ads in newspapers and general interest magazines as compared to $473 million for medical journals in 2000 [6].

The Internet and the information revolution have enhanced the "consumer phenomenon" by bringing information, goods and services to the consumers' fingertips. Recognizing the sheer number of people turning to the Internet for information, pharmaceutical companies have increasingly taken DTC marketing online. General corporate and product-dedicated websites have become mainstays not only for the launch and promotion of new products, but also for product-related information, such as indications, contraindications, doses and side effects. Morris et al. observed that 57% of DTC advertisements provided a Web address in 1998, compared with 14% in 1996 [7]. The number of potential prescription drug consumers (the majority of whom are older adults) who strongly prefer manufacturers' DTC websites to other sources of information is growing [8].

Despite their many benefits to consumers, pharmaceutical DTC marketing sites have the potential to misinform. In view of potentially far-reaching negative consequences on the health of uninformed and misinformed consumers, there needs to be stringent oversight of the information presented. It is thus vital to 1. assess the authenticity of the websites' claims, which should conform to the original references cited, and 2. check the availability and accuracy of various links and Web addresses providing further information [9].

Drug advertisements aimed at consumers comprise three categories viz. health-centered, reminder and product-specific advertisements [10]. Most advertisements fall into the last category [11]. Few studies of online DTC advertisements have been performed to date. Imbalance between risk and benefit information presented on websites was noted earlier with reference to FDA's "Fair Balance" Act [12]. Pharmaceutical ads are aimed to educate both physicians and consumers, and they typically include links to other websites and documents. However, studies indicate that they often make inaccurate or easily misunderstood claims, report invalid scientific data, and provide incorrect interpretations of studies [5]. The question naturally arises, can pharmaceutical advertisements serve the dual purpose of promoting products and providing accurate information to the public?

It has been noted elsewhere that DTC advertisements tend to emphasize a drug's positive features and downplay its side effects (which are frequently hidden in lines of small text) [13]. The FDA plays a major role in reviewing and regulating advertisements, stressing the concept of "fair balance." Risks as well as benefits must be clearly identified, with the risks presented prominently, in a readable fashion, so as not to unfairly emphasize the benefits [1]. In spite of this, an estimated 35% of DTC advertisements are thought to fall short of presenting a "fair balance" of risk and benefits [14].

There have been noteworthy examples of harm done to consumers by improperly conducted DTC campaigns [15]. Lawsuits have been filed and pharmaceutical companies have been charged fines for making groundless claims on their websites. [16,17]. We believe that websites that provide complete and accurate information about a drug's benefits and side effects, along with links to references for further information, serve the interests of physicians as well as consumers.

The purpose of this study was to examine data concerning efficacy, limitations and side effects as reported on selected pharmaceutical DTC drug websites, checking against the sites' references to relevant studies for consistency. We attempted to uncover veiled information and determine whether the information disclosed was bolstered by sound data. We hypothesized that some information on selected websites, when compared to referenced studies, would prove to be inconsistent, perhaps even misleading or disingenuous.

2. Results

In all, five drugs representing four pharmaceutical companies were evaluated for their safety and efficacy information on pharmaceutical DTC drug wesbites. All five drugs are targeted to treat disparate disorders such as rheumatoid arthritis, cholesterol, early stage breast cancer, benign prostatic hyperplasia, and metastatic bone cancer. A total of 25 links were accessed to gather 15 references, efficacy claims, and side effect/limitations from the primary pharmaceutical drug DTC website. To gather the references for drug efficacy, side effects and limitations, it took an average of 5 links (range 1-13) past the homepage, the highest (13) for the drug leflunomide to support 21 claims of efficacy and fewest (1) for the drug zoledronic acid to support 5 claims of drug efficacy (Table 1).

Of the five drug websites, a total of 45 claims of efficacy and 32 claims of drug side effects/limitations were supported by corresponding referenced studies. The websites provided referenced support for 45 of the 65 claims of efficacy (Table 1) mentioned. Rosuvastatin calcium provided least support to the claim of drug efficacy with reference data in 10 of the 26 (38.4%), which was the highest percentage deficit of the group selected. Zoledronic acid (100%), finasteride (75%), and letrozole tablets (83.3%) provided the highest percentage of references to support claims of drug efficacy (Table 1).

Although the majority provided a reference for the efficacy of the drug, many did not provide access to the reference to support claims of efficacy and some provided unsatisfactory information when compared to the referenced study. Leflunomide had eight, while three unsatisfactory responses were observed from letrozole tablets, zoledronic acid, and rosuvastatin calcium websites. These were associated with inaccessible "data on file" errors. Leflunomide had two unsatisfactory differences, which were associated with the website not emphasizing the fact that the majority of patients had no change in joint space narrowing or erosion from baseline at 24 months. Finasteride was the most accurate providing appropriate accessible references for all claims of efficacy (Table 2).

Side effects and limitations were poorly represented with 32 of the 85 referenced side effect/limitations being found in the corresponding websites in comparison to supporting articles (Table 1). Slightly over 53% of the referenced side effects / limitations from the corresponding references were provided on leflunomide website & links and slightly over 51% provided by rosuvastatin calcium. Both of finasteride's websites failed to provide satisfactory side effects/limitations from the supporting articles. Zoledronic acid and letrozole tablets only provided 20% and 13% of the

Side effects and limitations were poorly represented with 32 of the 85 referenced side effect/limitations being found in the corresponding websites in comparison to supporting articles (Table 1).

Slightly over 53% of the referenced side effects / limitations from the corresponding references were provided on leflunomide website & links and slightly over 51% provided by rosuvastatin calcium. Both of finasteride's websites failed to provide satisfactory side effects/limitations from the supporting articles. Zoledronic acid and letrozole tablets only provided 20% and 13% of the referenced side effects/limitations from the corresponding reference on websites/links respectively. Unlike the reference for efficacy, the unsatisfactory trends were associated with failure to outline all side effects/limitations from the reference. When unsatisfactory referenced information was compared with the website information, finasteride's website failed to comprehensively outline the specific sex related side effects such as decreased libido, impotence, breast enlargement and tenderness, and rashes.

Although letrozole tablets only provided references for side effects and limitations in seven of thirty website links, in two situations, the company did not outline problems associated with worsening of tumor-related symptoms nor were hot flashes, nausea, and hair thinning reported. Rosuvastatin calcium failed to outline the side effects/limitations of caution with concurrent use of alcohol or a history of liver disease, the increased risk of uncomplicated myalgia or myopathy, elevations of creatine kinase, and the potential for rhabdomyolysis. Leflunomide failed to outline the side effects of diarrhea, elevated liver enzymes, alopecia, and rash and the limitations in use for patients with severe immunodeficiency, bone marrow dysplasia, or severe uncontrolled infections. Zoledronic acid only provided side effects and limitations on one of five website links but was forthcoming regarding the referenced findings. Although not represented on all drug websites, the side effects and limitations were provided in at least some of them.

3. Discussion

Our study found that, although the four selected companies made an effort to provide references for efficacy claims through their DTC drug websites and links, in many cases the references could not be accessed by the consumer. DTC drug websites also failed to reference information regarding side effects and limitations. The result is that the DTC drug websites emphasize efficacy at the expense of important information related to risk. This effect was seen most clearly in our analysis of the websites' explanations of side effects and limitations, especially for the drug letrozole. The difference in emphasis between claims of efficacy and reported side effects and limitations created an unbalanced picture of risk/benefit, i.e., an absence of "fair balance."

Huh and Cude corroborate our finding that a majority of websites (81.7%) present incomplete risk information [12]. Manufacturers may also place such information at a remote location on their website, requiring more clicks and scrolling to access it [18]. Another study reported that only 8% of websites provided a direct link from the home page to risk information; in comparison, 82% of home pages displayed product benefits directly on the home page [12]. This lack of fair balance may undermine consumer protection. In another study of 44 pharmaceutical websites, only two-third of them mentioned a single highest-incidence side effect or three major side effects, and only half completely reported side effects with rates of 10% or more [18]. There have been a number of reports of pharmaceutical companies making inconsistent claims in promotional material. For example exaggerated assertions on lack of sedative effects for Loratidine [19], contradictory claims of rare association of methotrexate and side effects like bone marrow suppression and acute disturbances of liver function [20, 21, 22,23] and controversial publicity of "winning combination" of glibenclamide and metformin [24, 25].
However, these websites may fall short of "fair balance" while advertising their products. Advertisements can be misleading if they do not present information on both risk and benefit in equal scope, depth and detail [26]. Consumers should be provided with the most up-to-date information available in a user-friendly, balanced and thorough fashion, with ancillary proof of benefits, side effects and limitations [27]. The Federal Trade Commission (FTC) recommends that drug manufacturers should display a brief summary of information among the minimum elements shown on a website [28]. Information on risk should ideally be on the same webpage that displays major benefits, accompanied by a link to a page containing complete risk information.

Presently, information on side effects and limitations are not as well represented on corporate websites as efficacy claims, especially in comparison to cited references. The websites offer unbalanced and incomplete information, sometimes aggravated by unavailable references. Consumers who view incomplete risk statements are more likely to recommend or purchase an advertised drug and to identify the drug as safe [29]. References must be made easily accessible, and their contents must be verified. This will help clinicians practice evidence-based prescribing, and it will prevent consumers from being misled. It is clear that while designing a website location, display and navigation are equally important as the content.

This study may be limited by its small sample size and the fact that websites were accessed in a single day. Due to the dynamic and interactive nature of the Internet, these sites may have been modified or significantly changed since the study was performed. With these limitations in mind, future studies should examine a wider range of drugs, and should continue to measure the variation between the information provided on the website and on the cited references. Another limitation concerns the evaluation of safety: There is no obvious way to find out whether a company has disclosed all relevant safety findings. Ideally, one might evaluate all safety information, from all sources, including anecdotal safety reports, in addition to conducting a thorough review of safety-reporting databases and websites. This would be a massive undertaking. The primary objective of this more limited study was to focus strictly on the information posted on each company's website, so information from other websites was not included in the analysis. The study was conducted over a 30 day period to facilitate the collection of quality data. We also argue that incorrect or incomplete information displayed on a pharmaceutical DTC drug website, even for a short duration is not ethical. The information could have been viewed and noted as true by scores of people visiting the website for information. Even if this information is revised later, the discrepancy could already have put the viewers at risk.

4. Conclusion

In conclusion, our findings suggest that the majority of pharmaceutical websites provide a greater number and proportion of references regarding claims of efficacy compared with side effects and limitations. We confirmed our hypothesis that the information provided by the DTC sites is inconsistent and even misleading. The incomplete/incorrect information might put the consumer at risk. To frame the problem more broadly: Pharmaceutical websites, a source of information, in which an increasing percentage of consumers place their trust, are providing an inconsistent and unbalanced view of the risks and benefits attendant to their medications. A complete and balanced portrayal of efficacy and side effects, supported by references, is needed.

5. Methods

Design

This is a direct, structured and observational study. We analyzed risk/benefit claims by comparing them to supporting articles. Structured criteria were developed to decrease the likelihood of observer error.

Sampling of Drugs

We analyzed risk/benefit claims by comparing them to supporting articles. Structured criteria were developed to decrease the likelihood of observer error.

Selection of Pharmaceutical companies

First, a list of top 10 pharmaceutical companies were selected [36] and each was assigned a unique number. In order to narrow down the list of companies, GNU-R (an open source statistical computing software) generated randomization sequence was used to select the sample of companies. This generated a list of 4 companies, the names of which have been coded/de-identified as Company A, B, C and D for the reader. The primary objective behind this was not to put forth any specific company information that could bias the readers on the basis of these results. The objective of this paper is to make people aware of the discrepancies that do exist. The data collection and analysis team were aware of the names of the companies.

Selection of drugs

A list of drugs manufactured by these four companies was prepared and each drug was assigned a number. A randomization process, as described above was recreated to narrow down the list of drugs. This led to the selection of five drugs, whose trade names have been masked for the reader and are referred to,by their generic names - leflunomide, rosuvastatin calcium, letrozole tablets, finasteride and zoledronic acid. This selection process allowed for the possibility of choosing more than one drug from a single company.

Procedure

Pharmacuetical DTC websites for each drug was accessed on a single date and all contents were saved on a hard disk to analyze it later. This was necessary considering the evolving nature of Internet advertising that continuously leads to change and updation of the website information. However, the analysis of this data collected was done over a period of 30 days (from March 2005 to April 2005). A total of five pharmaceutical DTC drug home pages and related 25 links were accessed to gather 15 references.

We began our investigation on the home page of each pharmaceutical company website. We located and opened the link for related drug DTC website. Each page was carefully examined to note the location, navigation structure (including the number of mouse clicks needed to reach relevant information) and extent of information offered. The study relevant information catered in each pharmaceutical DTC drug website was retrieved.

A spreadsheet was used to compile data, including the name of the drug, efficacy claims along with references, side effects/limitations and respective references, number of mouse clicks required to access references, and referenced claims of efficacy and side effects. We also noted safety claims that were not included in the website itself but were available in references provided by links.

Data collection, review and analysis

We collected data concerning drug efficacy, side effects and supporting scientific references. We classified the information as follows: First, efficacy-related claims were checked against references cited and scored in the following manner: 1) Yes: a reference was cited, and was publicly available; or 2) No: the claim was not supported by a reference, or the reference was not publicly available. If a reference was provided and it was publicly available, it was accessed and reviewed. We then compared the pharmaceutical DTC drug websites' claims against the corresponding references; If they didn't agree, or if the claim was not verified by the reference or the data was not retrievable by the consumer, the claim was scored as 3) Unsatisfactory.

We also evaluated the cited references to assess whether reported side effects and limitations were the same as those on the website. References were scored thus: 1) Yes: the website provided the same information on side effects and limitations as the cited reference; 2) No: the website failed to report the side effects and limitations in the referenced study; or 3) Unsatisfactory: reported side effects and limitations were dissimilar or incomplete when compared with the reference. We accessed many links to gather the total number of efficacy claims, side effects and limitations from the main website and from references.

Primarily, the evaluation procedure consisted of comparing the information catered in pharmaceutical companies' DTC drug website with that of the respective full reference link provided. This comparison helped in scoring the information in terms of whether it matched or was there any discrepancy. The primary data abstraction was carried out by a medical student (AC) and a physical therapist (AG) under the supervision of a qualified epidemiologist (RP), who are authors in this manuscript. The data was reviewed by qualified Physical therapists and discussed with the authors. Any disagreements in the findings of the two reviewers were resolved by mutual agreement.

List of abbreviations

AE - Adverse events

DTC - Direct to Consumer

FDA - Food and Drug Administration

FTC - Federal Trade Commission

Competing Interests

None.

Authors' Contributions

JS and SM drafted the manuscript. AC and AG collected the data. AG and CC carried out the analysis of data. RP conceived the study, and participated in its design and coordination. All authors participated in the design of the study and review of the final manuscript.

Acknowledgement

Ricardo Pietrobon and team "Research on Research", templates for writing introduction and discussion sections of the manuscript, Duke University Health System. (date of retrieval/access - 2 Nov 2009) <http://researchonresearch.org/ >

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Paper received on 04/05/2009; accepted on 02/07/2009

Correspondence:

Ricardo Pietrobon MD, PHD, MBA

Associate Vice Chair and Assistant Professor,

Department of Surgery, Duke University Health System and

Assistant Professor Duke Graduate Medical School, Singapore

DUMC 3094

Durham, NC 27710 USA

Telephone: (919) 919-668-2054

FAX: 919-681-8886

rpietro@duke.edu

This Open Access article is available at: http://ijmi.org/index.php/ijmi/article/view/y09i1a4

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