Case Study: Merck and the Vioxx Recall

Kelvin Gabel

Benedictine University

Case Study: Merck and the Vioxx Recall

According to Lawrence and Weber (2014), former Merck CEO George W. Merck implied a corporate vision of social responsibility for Merck & Co., Inc. (Merck) when he stated in 1950 that medicine was for the people and that loyalty to that concept would lead to greater profits. On the surface, it appears Merck has historically lived its declared mission of putting people first. This is demonstrated by the company forfeiting patent and profits from the antibiotic streptomycin and the drug Mectizan (Lawrence, 2014). Merck was well rewarded for its people first philosophy. Though it was ranked fifth in asset and market value, it ranked first in profits. Additionally the company had a stellar reputation of being perceived as the most ethical and socially responsible of the major drug companies (Lawrence, 2014). Today Merck Pharmaceutical’s mission statement is “to discover, develop and provide innovative products and services that save and improve lives around the world (Merck, 2015).” Reading Merck’s current mission statement lacks both the compassion of placing people first and the implied social responsibility of Mr. Merck’s statement in 1950. To be contextually correct historically in forming a view of Merck and the Vioxx recall issue, I sought to find a corporate mission statement from the period of the recall which was in 2006. According to Culp, David R. and Berry, Isobel (2007) Merck’s mission and values statement stressed that its "business is preserving and improving human life." It continued "[w]e value, above all, the ability to serve everyone who can benefit from the appropriate use of our products and services." In the context of Merck’s 2006 mission statement, Merck did not act in a socially responsible or in an ethical manner in regards to its development, marketing, and recall of Vioxx. The process of gaining FDA approval is murky and highly subjective, entirely dependent on how one views free trade, public health, and government oversight. The smoking gun to suggest Merck was aggressively marketing Vioxx for profit is demonstrated best by the amount of money the company spent in the drugs marketing. According to Lawrence (2014) Merck spent $422 million in 2003 to market Vioxx to doctors and hospitals. In 2004, out of $4 billion spent by the pharmaceutical industry for direct-to-consumer (DTC) advertising of all drugs, Merck alone spent $500 million on Vioxx advertising alone. This advertising was profitable; it resulted in $4.25 of revenue for every advertising dollar spent. Beyond the money being spent to market Vioxx, there are other ethical regards to consider in Merck’s marketing of Vioxx. The first is that Merck had an internal training manual for sales representatives which explained how the representatives were to “dodge” questions physicians may have had concerning any associations Vioxx may have with cardiovascular effects the drug may have on patients (Lawrence, 2014). The other is ethical consideration is the direct-to-consumer marketing. Such marketing creates a demand for a drug while sending a message that drugs are safe and there is not a need for a physician to determine its appropriateness of safety for a specific patient (Lawrence, 2014). As evident above, Merck spent a substantial amount of money to market Vioxx and create a consumer demand. In terms of developing Vioxx, internal Merck emails and documents suggest lead one to believe Vioxx was suspect of cardiovascular involvement from the beginning. In light of such concerns, which were expressed by Merck scientists during the drugs development phase (Lawrence, 2014), Merck should have voluntarily pursued additional or ongoing research if they were following the corporate mission at the time: "business is preserving and improving human life” (Culp, 2007). In fact a post-market study code-named VIGOR highly suggested that patients who took Vioxx had a five-times more likely chance of a cardiovascular event than patients on an alternative medicine (Lawrence, 2014). In a later study of patients in the Kaiser health maintenance organization found that Vioxx patients had three times the rate of heart attacks as patients on a competing drug. Merck’s response was that retrospective studies are inaccurate and do not control potentially significant variables that may contribute to the higher incidences of heart attacks (Lawrence, 2014). It was only when the results of the APPROVe study demonstrated the potential hazards of Vioxx did Merck remove the drug from the market. Merck was overly aggressive in marketing Vioxx to physicians and patients early in its release, despite concerns of cardiovascular involvement. When these suspicions were known in 2000, the year the VIGOR study was completed, Merck not only negotiated with the FDA over the level and wording of a drug warning (Lawrence, 2014), but it escalated its spending in marketing. Perhaps Merck’s concern for improving human life with its products and medications would have been demonstrated if a Black Box warning (FDA, 2012) would have been attached to the drug rather than an FDA negotiated label warning at the time of the drugs release. Concern would have even been demonstrated if done in 2000 when the results of the VIGOR study were known. These actions demonstrate a disregard for patient safety for corporate revenue and profit.
Personally, I feel the current system of monitoring drug safety is adequate. A market system provides a balance of powers where profit and public interest are mostly protected. Having worked as a medical mission volunteer in Vietnam and Peru, I witness first-hand the disadvantages of an overly-regulated healthcare system. In the white paper A Call to Action: Protecting U.S. Citizens from Inappropriate Medication Use, the Institute for Safe Medication Practice states that over half of prescriptions taken are used improperly and that 96% percent of patients do not ask for proper drug use instructions. DTC advertising is a leading form of marketing of drugs by pharmaceutical companies (Lawrence, 2014; ISMP, 2007) and such advertising may lead to inappropriate or excessive medication use. This is a result of the patient perceiving a need for a drug and a physician’s prescribing the drug based on the patient’s demand, even when the drug may not be clinically indicated (ISMP, 2007). ISMP (2007) advocates for pharmacists to be assume the responsibility for medication management by expanding the role of the pharmacist from dispenser of the drugs to managers and providers of patient drug education. It is there stance that streamlined and appropriately focused patient education will help prevent medication misuse, reduce costs, and overall improve the population health. To implement a pharmacist drug education initiative Congress, healthcare policy-makers, employers, insurers, and the public need to ensure that sufficient and adequate funding is in provided for pharmacists to offer medication therapy management and drug reviews to patients and families nation-wide in the United States.

References
Culp, David R. and Berry, Isobel (Summer, 2007). Merck and the Vioxx Debacle: Deadly
Loyalty. Journal of Civil Rights and Economic Development, 22(1), 1-34. Retrieved from http://scholarship.law.stjohns.edu/jcred/vol22/iss1/1.
Food and Drug Administration (FDA). (2012, November). A Guide to Drug Safety Terms at
FDA. Retrieved October 17, 2015, from http://www.fda.gov/downloads/ForConsumers/ ConsumerUpdates/UCM107976.pdf
Institute for Safe Medication Practices (ISMP). (2007). A Call to Action: Protecting U.S.
Citizens from Inappropriate Medication Use. Retrieved October 17, 2015, from https://www.ismp.org/pressroom/viewpoints/CommunityPharmacy.pdf
Lawrence, A.T., Weber, J. (2014). Cases in Business and Society. T. Hauger (Ed.), Business and Society: Stakeholders, Ethics, Public Policy (14th ed., pp. 493-502). New York, United States: McGraw-Hill. (Original work published 2005).
Merck &Co, Inc. (2015). Mission Statement. Retrieved October 17, 2015, from http://www.merck.com/about/home.html