GAITHERSBURG, Md. — Government experts and a panel of medical advisers repeatedly voiced skepticism on Tuesday about the trustworthiness of GlaxoSmithKline, which makes the controversial diabetes drug Avandia.
The committee is to vote Wednesday to advise the Food and Drug Administration on whether the drug, Avandia, which is widely used despite persistent concerns about its safety, should remain on the market. In recent days, internal company documents have shown that Glaxo hid important safety data from the public. A federal medical officer’s review of a major clinical trial, nicknamed Record, found multiple instances of heart attacks that were not included in the study’s final tally.
And on Tuesday, the company settled a lawsuit with plaintiffs who claimed that Avandia caused heart attacks and strokes, lawyers for the plaintiffs said. J. Paul Sizemore, a California lawyer for 2,132 people who had filed suit over Avandia, said his cases were settled on Friday for “a substantial portion” of the $460 million company lawyers told him was being paid in total. The company had no comment.
Dr. Nancy L. Geller, a committee member who is director of the Office of Biostatistics Research at the National Heart, Lung and Blood Institute, said she was “concerned about data quality over all.” Told that death estimates can usually be trusted in clinical trials, she quickly retorted, “Not if you report the wrong follow-up date and not if you withdraw someone from a trial just before their death.”
The committee is to vote Wednesday to advise the Food and Drug Administration on whether the drug, Avandia, which is widely used despite persistent concerns about its safety, should remain on the market. In recent days, internal company documents have shown that Glaxo hid important safety data from the public. A federal medical officer’s review of a major clinical trial, nicknamed Record, found multiple instances of heart attacks that were not included in the study’s final tally.
And on Tuesday, the company settled a lawsuit with plaintiffs who claimed that Avandia caused heart attacks and strokes, lawyers for the plaintiffs said. J. Paul Sizemore, a California lawyer for 2,132 people who had filed suit over Avandia, said his cases were settled on Friday for “a substantial portion” of the $460 million company lawyers told him was being paid in total. The company had no comment.
Dr. Nancy L. Geller, a committee member who is director of the Office of Biostatistics Research at the National Heart, Lung and Blood Institute, said she was “concerned about data quality over all.” Told that death estimates can usually be trusted in clinical trials, she quickly retorted, “Not if you report the wrong follow-up date and not if you withdraw someone from a trial just before their death.”
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