Glaxo Wellcome ‘Spun’ Lamivudine Drug Trial Results, Researchers Allege
The Washington Post reports that Glaxo Wellcome, now GlaxoSmithKline, attempted to "suppress concerns" that lamivudine, a treatment for HIV known as Epivir, caused patients in clinical trials testing the drug for the treatment of hepatitis B to develop drug-resistant "mutant viruses." While the FDA approved lamivudine for hepatitis B in 1998 based on the results of clinical studies conducted in Asia, Europe and the United States, Hong Kong researcher Nancy Leung said that Glaxo "spun" the results of her tests to ensure a favorable result. Leung, who was initially "pleased" with the drug, said she immediately notified Glaxo of the virus mutation problem when it was discovered in her trial, but Glaxo failed to "adequately acknowledge" problems with the drug, as the company was attempting to "promote more and longer use" of lamivudine. For example, Glaxo removed mention of a patient that had died during Leung's study in a memorandum for an FDA inspector, even though the death had already been reported to the agency. In addition, Leung said that Glaxo wrote study abstracts under her name without consulting her, and failed to address a number of questions she had concerning a report on her research prepared for the FDA. Leung said, "They always want to look on the bright side." She added, "We are too much controlled by [Glaxo]. I feel like I've been constantly, positively spun." The Post reports that other researchers involved with lamivudine tests "described varying degrees of company influence," including writing abstracts and reports for researchers.
Glaxo Defends Research
While noting there may have been a "breakdown in the process" regarding Leung's work in order to complete reports for NIH, Glaxo spokesperson Nancy Jo Pekarek said that the company has reported all study results, including Leung's, to the FDA. Fraser Gray, head of Glaxo's lamivudine development team, said he was not aware of "any unhappiness among Asian researchers over the company's interpretation of their data." Regarding the practice of writing reports for researchers, Gray said, "Some people work better doing a draft of their own, and some prefer that we do it." Pekarek said the company discloses all "potential problems" with drugs in all "scientific and marketing material" (Nelson, Washington Post, 3/18).