Sanofi-Aventis – Another Ambush
Yesterday shares of Sanofi-Aventis (NYSE:SNY) fell over 8% on the Paris Exchange on reports that a major peer-reviewed publication will publish a study that links Lantus to cancer. Diabetic Investor can confirm that these reports are correct and a study will be published in Diabetes. Diabetic Investor does not know when the study will be published be we can confirm its existence.
Before everyone jumps into the deep end of the pool it’s important to note that this is the same publication that published a study that attempted to link Januvia to pancreatitis. As Diabetic Investor reported this study was really nothing more than “informed” speculation and not conclusive proof of any link between Januvia and pancreatitis.
Given that Lantus sales reached nearly $3.5 billion last year it’s no surprise that the company is standing behind the drug. Unfortunately for the company they are about to be caught in a meat grinder as this premature release of the study’s existence puts them on the defensive. If this sounds familiar, it should, as this is exactly what happened to GlaxoSmithKline (NYSE:GSK) when the results of the Nissen meta- analysis was leaked to the media prior to its publication. As we all know this meta-analysis is largely responsible for sales of Avandia falling into a sinkhole.
Just as Avandia was used in millions of patients with diabetes so is Lantus. Just as Avandia was on the market for nearly seven years before the meta-analysis was published the same is true for Lantus. The difference here is at least with the meta-analysis we did not have to wait to see the results. Without access to the study or any of its data Sanofi must deal with rumor and speculation. For this reason Diabetic Investor urges the publisher of Diabetes to immediately release the study and allow the vetting process to begin.
Just as the main stream media quickly picked up on the Avandia controversy it won’t be long before we see headlines with the words insulin and cancer in the same sentence. This is exactly what happened to Amylin (NASDAQ:AMLN) when the FDA ambushed the company issuing a letter that appeared to link Byetta and pancreatitis. Although there was no direct link that proved the cases of pancreatitis where actually caused by Byetta, this didn’t matter to the main stream media who rarely bother to investigate matters before publishing.
Making matters even worse is there are nearly 5 million insulin using patients in the United States many of whom use Lantus. As Diabetic Investor has reported before Lantus was only able to become the world’s number one selling insulin by successfully penetrating the type 2 market. Dosed just once a day many physicians prescribed Lantus as a supplement to the patients existing regimen of oral medications. Lantus is also the most popular insulin for patients following multiple daily injection therapy. These patients use Lantus as their base insulin while using a short-acting insulin with meals and snacks.
As sure as night follows day it physicians will soon be inundated with phone calls from their insulin using patients, even those not on Lantus, asking them if they should stop taking insulin as they fear they might develop cancer. This would be a catastrophe as for a majority of these patients insulin is critical if they are to keep their diabetes under control.
While there has been speculation between insulin usage and an increased risk of cancer prior to this yet to be published study that’s all it’s been, speculation. Even when the study is finally published and made public, one has to wonder if the damage already done can be repaired. Although insulin therapy does carry some drawbacks, these drawbacks are manageable if the patient is properly trained. The fact is insulin therapy has been around for years and is one of the most effective therapy options available.
This is why it’s imperative that the publishers of Diabetes immediately release the study and allow its conclusions to be debated in the diabetes community. We have no idea if this just another Byetta/pancreatitis scenario where the link between the use of a drug and adverse event really isn’t there or if this is a situation where there is something to be truly concerned about. Given how long Lantus has been on the market and the millions of patients using the drug Diabetic Investor will need very strong evidence to be convinced that a real issue exists.
Let’s hope that before this story turns into another lynching as it did when the Avandia controversy came to light that cooler heads prevail. Diabetic Investor isn’t overly optimistic this will occur. When it comes to the mainstream media and their zest for attention grabbing headlines rarely do facts actually matter.
Diabetic Investor is deeply concerned that Lantus and all insulin products will be convicted before all the facts are in. This rush to judgment has become all too common and has serious consequences to the millions of patients with diabetes. Let’s hope that we have learned from past mistakes and as Arthur Sulzberger stated; “A man’s judgment cannot be better than the information on which he has based it.” In the absence of information all we have is rumor and speculation.