ADVANTAGE: Science First, Marketing Second

IN RESPONSE:

The evidence that Merck pursued a seeding trial to support sales of Vioxx is clear and is derived from their own internal documents.

Dr. Edelman states that ADVANTAGE was developed by a group that was separate from Merck's marketing department. David Anstice, the former president of Merck's USHH organization, which had overarching responsibility for the study, affirmed in court, under oath, that ADVANTAGE was initiated and conducted by physicians in marketing (1).

ADVANTAGE is not a case, as suggested by Dr. Edelman, in which marketing is leveraging a study that originates within a company's research division. It is a study that was developed by marketing to boost sales. In the published Merck memo about the Merck Marketing Annual Awards, the objectives of ADVANTAGE were “to provide product trial among a key physician group to accelerate uptake of Vioxx as the second entrant in a highly competitive new class and gather data important to this customer group. The trial was designed and executed in the spirit of Merck marketing principles … ” (2).

Dr. Edelman claims that the purpose of ADVANTAGE was to answer unaddressed scientific questions. The stated objective was “to assess the tolerability of rofecoxib compared with naproxen for treatment of osteoarthritis” even as the drug had already been compared with other nonsteroidal anti-inflammatory drugs. The claim of the scientific value of the study is countered by the assessment of Dr. Edward Scolnick, former president of Merck's Research division, who called the study “intellectually redundant” (3).

Dr. Edelman states that Merck's business interests were understood by physician-investigators, participants, and institutional review boards. Although these groups would know that Merck is a for-profit company, we doubt that they understood the extent to which marketing played a role in the design and execution of the study. Moreover, the physician-investigators probably did not know that they were participants in a study of the effect of ADVANTAGE on their own prescribing habits.

Dr. Edelman states that ADVANTAGE does not meet the definition of a seeding trial. We believe otherwise and find it very consistent with the definition by Kessler and colleagues (4). The study has many of the key attributes of a seeding trial. It included a scientific objective of limited value, the recruitment of investigators because they are frequent prescribers, and the sponsorship of the studies by the company's sales and marketing division rather than its research department.

Finally, as a clarification, the date of the Marketing memo represented in Figure 1 was 4 January 1999, and a revision in December 1999 is noted in the bottom right corner, indicating that the original memo was created before the start of ADVANTAGE (2).