Healthy Skepticism Library item: 997

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

California Group Claims Pharmacia Illegally Promoted Pain Treatment Bextra for Off-Label Uses
The California Healthline 2003 Jan 3

Full text:

Congress of California Seniors filed a suit in California Superior Court in Los Angeles in December, alleging that Pharmacia illegally promoted the pain medication Bextra for a use not approved by the FDA, the AP/Los Angeles Times reports. According to federal regulations, companies cannot “actively suggest” that doctors prescribe drugs for off-label purposes but can share with doctors research and journal articles that discuss unapproved uses, the AP/Times reports. The suit alleges that Pharmacia hired Scirex, a clinical testing firm partly owned by advertising conglomerate Omnicom Group, to study Bextra’s use in treating acute pain caused by impacted molars, even though the FDA had declined the company’s request to promote the drug for acute pain (AP/Los Angles Times, 12/26/02). The FDA approved Bextra for chronic pain treatment late last year, but not for acute pain. The Congress of California Seniors contends that because the results of the study were “widely read” in the Journal of the American Dental Association, a “significant portion” of Bextra sales were created by off-label uses, the Newark Star-Ledger reports. The suit states that the study’s purpose was to create “propaganda” and that independent doctors who reviewed the study doubted its findings. Ahaviah Glaser of Prescription Access Litigation, of which the Congress of California Seniors is part, said, “The FDA regulations exist to protect consumers, and Pharmacia’s efforts to circumvent those regulations without regard for anything but its own bottom line must stop” (Silverman, Newark Star-Ledger, 12/25/02). Pharmacia spokesperson Paul Fitzhenry said the company has not seen the lawsuit and did not comment, the AP/Times reports (AP/Los Angles Times, 12/26/02).