California Group Claims Pharmacia Illegally Promoted Pain Treatment Bextra for Off-Label Uses
The 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).
In other legal news, the California 3rd Appellate District Court last week upheld a lower court ruling that Proposition 215 does not give medical marijuana growers immunity from prosecution if the growers do not have a doctor's recommendation or are not primary care givers for patients who use the marijuana, the AP/San Diego Union-Tribune reports (AP/San Diego Union-Tribune, 12/26/02). Under Proposition 215, a ballot measure approved by California voters in 1996, patients with chronic illnesses such as cancer and AIDS can use medical marijuana to treat pain with a recommendation from a physician (California Healthline, 11/20). The case stems from the 1997 arrest of Robert Galambos for cultivation and possession of medical marijuana that he intended to sell. Galambos had argued that he was using the marijuana to treat ailments resulting from a car accident and that he should be immune to prosecution because he intended to sell the drug to a medical marijuana club. He also said that Proposition 215 does not indicate what constitutes illegal conduct. However, the appeals court agreed with the lower court that Galambos does not qualify as a primary care giver and thus cannot receive immunity. The appeals court also ruled that Proposition 215 is not vague about what constitutes legal and illegal cultivation and possession of marijuana (AP/San Diego Union-Tribune, 12/26/02).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.