Sanofi-Aventis is pulling out the big guns in defense of Lantus. The drugmaker announced that a board of 14 experts have picked apart the recent studies that suggested a link between the diabetes drug and cancer. In a news release, Sanofi also pointed out that drug regulators and scientific associations had already raised questions about the studies, "cautioning against over-interpretation of and over-reaction to these data."
"Regarding the merits of the published data, we agreed that all four published manuscripts have significant methodological limitations and shortcomings", an endocrinologist at Oregon Health Sciences University said in a statement, adding that the studies "do not justify new clinical recommendations to patients."
What does the data justify? A meta-analysis of "available randomized clinical trial data," which should be publshed ASAP, the experts' report recommends. And a close critique of the four cancer-risk studies that kicked off the furor "should be urgently prepared and submitted ... [to] a top-tier medical journal." That critique should set some standards for evidence of cancer risk, the experts said. Presumably to head off future furor.
Four studies were recently published in Diabetologica, and that data suggested Lantus patients had a higher risk of cancer than patients who took other diabetes meds. Sanofi's stock went into a tailspin, and its execs went into crisis-management mode. Pharma analysts worried that the data didn't have to be high-quality to affect sales, and cut their forecasts. And still those analysts are skeptical. "What the market is really waiting for is not statements from experts on data we've already seen but new information, new studies and new data," one told Reuters. But for that we'll all have to wait.
- read Sanofi's release
- check out the report from Sanofi's external experts (pdf)
- see the Reuters story