As a reminder, in the month of June, a study by the European Association for the Study of Diabetes observed that Lantus (generic name insulin glargine) increases the risk of cancer in diabetics taking the drug. The study, carried out on 127,000 patients in four European countries found that out of every 100 patients using Lantus for about 1 1/2 years, one additional person developed cancer.

But the FDA was not convinced with the study as patients were not studied long enough to substantiate the risk. Accordingly, it planned to review the safety data of Lantus including the new study. The FDA has declared that it will continue its discussions with the company to decide the requirement of any additional safety and effectiveness trial. Sanofi, on its part decided to extend any kind of help to the FDA to resolve this issue. The recommendation of the experts all the more emphasizes FDA’s viewpoint that no definite conclusion can be drawn from the studies.

Lantus is an important product for Sanofi, its third-best-selling drug and a key growth driver as its other key drugs, blood thinners Plavix and Lovenox are likely to face possible generic competition. Lantus recorded revenue of $3.5 billion in 2008, an increase of 28% over last year.

Earlier this month, Sanofi announced the result of a 5 year study (on 1024 patients) of Lantus versus NPH insulin on progression of retinopathy (a major cause of blindness among diabetic patients) in patients with type 2 diabetes. According to the study, overall survival along with the effect of retinopathy was similar in both the groups.

Adverse publicity for Lantus could turn away patients to other drugs such as Novo Nordisk’s (NVO) long-acting insulin Levemir, Amylin’s (AMLN) Byetta and Merck’s (MRK) Januvia and Janumet hitting its topline.  We have a Hold recommendation on Sanofi.

- Western public opinion fell with disconcerting facility for the thesis advanced -- from the very first day -- by the Kremlin's propaganda machine. We know now that the Russian army had been hard at work on its war preparations since before Aug. 8. We know that it massed at the "border" between Georgia and Ossetia a considerable military and paramilitary logistical presence. We know the Russians had methodically repaired the railroad tracks that the troop-transport trains were to take, and we know that at least 150 tanks went through the Roky tunnel separating the two Ossetias the morning of Aug. 8. In other words, no one can ignore the fact that President Saakhashvili only decided to act when he no longer had a choice, and war had already come. In spite of this accumulation of facts that should have been blindingly obvious to all scrupulous, good-faith observers, many in the media rushed as one man toward the thesis of the Georgians as instigators, as irresponsible provocateurs of the war. We must re-examine all of this. We must analyze in greater depth the mechanisms of a blindness that may, if we are not careful, perpetuate the Western "decline in courage" denounced in his time by Alexander Solzhenitsyn, but which we thought belonged to the past. Reason, if not honor, demands that we go to the rescue of Europe in Tbilisi.