Data published in the journal Diabetologia suggest that there may be a possible link between the use of sanofi-aventis’ Lantus (insulin glargine) and an increased risk of cancer, according to The European Association for the Study of Diabetes. The association made an “urgent call for more research” into the potential link, while sanofi-aventis stated that the findings “clearly show that no definitive conclusions can be drawn regarding a possible causal relationship between Lantus and the occurrence of malignancies.”
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The EASD stated that findings from a German study of insulin-treated patients in an insurance database “identified a statistically significant link” between patients who had used the insulin analogue product and those who had been diagnosed with cancer. In a Swedish study, researchers found that compared with patients on other insulin products, patients who received sanofi-aventis’ drug alone had double the risk of breast cancer, while results from a study in Scotland demonstrated a non-significant increased risk for breast cancers. Data from a study in the UK showed no link between cancer and Lantus.
The president of the EASD, Ulf Smith, and Diabetologia editor, Edwin Gale, commented that they thought “people are entitled to know that use of Lantus insulin might be associated with a greater risk, but this must also be balanced against the possibility that we might be causing unnecessary alarm by raising these concerns.” The EASD added that “a large combined analysis of the best available databases worldwide is the best way forward, and EASD and sanofi-aventis are pledged to carry this investigation forward until we have either confirmed these preliminary observations or, more hopefully, finally put them to rest.”
According to analyst Tim Anderson of Sanford C. Bernstein & Co., the possibility of Lantus being a cancer-causing compound has been around for nearly a decade, noting that FDA review documents dating back to 2000 mentioned findings of malignancies in animals. Jack Scannell, also from Sanford C. Bernstein, remarked that “clearly this issue was scrutinised around the time of Lantus getting approved…it’s perfectly plausible as an effect but I’d be surprised if the effect was that big.” If there is a risk, it may apply to other long-acting insulins, he noted.
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Sanofi-aventis noted Friday that it had “just been made aware of data associated with a retrospective follow-up of four patient registries” appearing in Diabetologia. Chief Medical Officer Jean-Pierre Lehner added: “We consider that the results of these patient registries are not conclusive.”
Sales of Lantus were 2.5 billion euros ($3.5 billion) in 2008.
Source: FirstWord
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