CASE 4.3 A Whistle-Blower's Quandary Explore the Concept on mythinkinglab.com
As a vice-president for Pharmacia (which was acquired by Pfizer in 2003), Dr. Peter Rost was in charge of worldwide marketing for the drug Genotropin,
which is a synthetic human growth hormone that is used to treat a limited range of hormonal deficiencies in children and the elderly42 Beginning in 1997 and continuing to 2003,
Pharmacia aggressively promoted Genotropin for conditions beyond those for which the drug had received approval from the Food and Drug Administration (FDA).
Physicians may legally prescribe an FDA-approved drug for such "offilabel" use, but pharmaceutical companies are strictly prohibited from any promotional activities designed to encourage physicians to prescribe a drug for any but approved uses.
However, Pharmacia attempted to persuade physicians to prescribe Genotropin for short children without any hormonal deficiency as well as for elderly patients as an antiaging therapy.
Among the means used to increase prescriptions were kickbacks to physicians in the form of all expense-paid company-sponsored conferences, paid participation in drug studies,
and lucrative consulting positions These efforts produced results. During the period 1997 to 2003,
approximately 25percent of all prescriptions for children and 60 percent of prescriptions for adults were for off-label use
Dr. Rost became aware of the illegal promotional activities in his role as head of marketing for Genotropin, and he immediately protested to his superiors.
After an investigation by Pharmacia, the off-label promotion activities, including the kickbacks to physicians, were curtailed but not eliminated.
Soon after Pfizer's acquisition of Pharmacia which occurred on April 16, 2003, Dr. Rost presented evidence to his new superiors of the illegal off-label marketing of Genotropin.
Without Dr. Rost's knowledge, Pfizer conducted its own investigation, and exactly one month after the acquisition, on May 16, 2003,
Pfizer voluntarily notified the FDA and the other relevant government agencies of the illegal off-label promotion activities and within a few days provided them with extensive documentation of the kickbacks,
as well as information about the corrective actions that were being taken
Case Study: A Whistle-Blower's Quandary [Chapter 4, Case 4.3, pp. 86-88]
Read the case study as presented, and address the following.
-Summarize the case, and describe the participants.