Once again, the spectre of cancer is haunting Lantus. A new, 1,340-patient study published in Diabetes Care linked higher doses of the Sanofi-Aventis diabetes remedy to a higher cancer risk, Bloomberg reports. The data comes some 12 months after a researcher highlighted the potential of cancer risk with Lantus use.
With that earlier research--published in Diabetologica--Sanofi quickly issued a rebuttal, pointing out that it relied on database analysis rather than on original clinical data. FDA combed through the data and decided that it didn't prove a cancer link. European regulators also backed Lantus, calling the Diabetologica research flawed and "inconclusive." Soon after, Sanofi announced that it would mount its own research to determine whether insulin use in general--and Lantus in particular--might increase the risk of cancer.
This latest study reads like same song, second verse. Sanofi's CMO Jean-Pierre Lehner told Bloomberg that the research is "unclear" and "methodologically challenged." The new study is small, too. The researchers themselves said that the study data points up the need for more data. "We should all be aware that the epidemiological approach cannot provide definitive conclusions," they wrote.
Analysts pooh-poohed the study. Philippe Lanone of Natixis told Reuters that observational studies like this one don't count for much, science-wise. Jeffries' Jeffrey Holford said, "I don't think it is going to influence prescribing behavior." And Nick Turner of Mirabaud Securities told Bloomberg, "There's no difference in what this study is showing and what was published last year. Clearly the risk is relatively light. If anything, this study shows that the risk could be mitigated with dosage, which is a positive."