Opinion ID: 2968817
Heading Depth: 3
Heading Rank: 4

Heading: dose-dumping study

Text: The next issue about which Parks says she complained concerned a “dose-dumping” study conducted by Alpharma. In July 2005, the FDA asked a competitor pharmaceutical company to withdraw the pain medication Palladone from the market because a study had shown risks of dose-dumping, which is the premature and exaggerated release of the pain-killing component in a drug caused by alcohol use. J.A. 57, 202-04. The FDA then requested that Alpharma also conduct a dose-dumping study of its own with regard to Kadian. See id. at 57, 1616-18. The study was completed after Parks’s July 2006 termination, and the final results indicated that Kadian was not susceptible to dosedumping risks. See id. at 1618. In February 2006, however, Parks learned third-hand from a competitor’s sales representative that a clinical trial showed risks of dose-dumping in Kadian. Parks relayed the information to Hill, Slesinski, and Alpharma marketing director Eric Vandal. They told her that those rumors were false. See J.A. 772-73, 1547-50, 1955. Also in February 2006, Parks was told by an Alpharma sales representative that the clinical trials were showing a risk of dose-dumping. J.A. 1955-56. Parks says that she relayed this information to Dr. Sun. She claims that he told her to “stop asking questions” and “mind your own business.” 11 Id. at 774. Dr. Sun has no recollection of this conversation. See id. at 1201-02, 1218-19. Parks also says that she expressed concerns to Ron Warner, Alpharma’s Vice-President, that Alpharma was marketing the drug as having no risk when co-ingested with alcohol, when the dose-dumping study was not yet complete. See id. at 1956-57.