The Lantus Fallout
As Diabetic Investor predicted patients have already begun contacting their physicians with a simple question; Should I continue using Lantus? Unfortunately even after reading through all the studies the physician cannot give a simple answer. About the only fact that can be drawn from all the studies released by Diabetologia is they have created more questions than answers.
Reading through all the data Diabetic Investor does not believe you can draw a straight line from using Lantus and getting cancer. The best you can conclude is Lantus MIGHT cause cancer. While this fact will surly lead to heated debate and even more studies that won’t do much for patients, the physicians who treat them, Sanofi-Aventis (NYSE:SNY) and other insulin companies like Novo Nordisk (NYSE:NVO) and Lilly (NYSE:LLY).
Looking at the data and the debate which has already begun it’s not too early to predict who the winners and losers will be. Before we look at the impact this situation will have on patients and their physicians, Diabetic Investor will examine the business impact.
The biggest loser here will be Sanofi-Aventis as they are caught in the impossible position of disproving a negative. This is the same situation GlaxoSmithKline (NYSE:GSK) found themselves after the premature release of the Nissen meta-analysis and Amylin (NASDAQ:AMLN) found themselves in after the FDA letter on pancreatitis and Byetta usage.
Given the retrospective nature of the studies done, look for Sanofi to follow a tactic used by Amylin as they looked at the larger US databases to prove that there was no link between Byetta usage and pancreatitis. This detailed analysis actually concluded that the incidence rate of pancreatitis and Byetta usage was actually lower than the incidence of pancreatitis and the general diabetes population. While Amylin did a fine job of making this information public the damage was already done and sales of Byetta slowed. The sad fact is the perception created in the market is that Byetta causes pancreatitis.
Lantus will likely experience a similar fate. The immediate impact will come with patients who have yet to start Lantus, new patient starts will come to a halt. Next physicians will likely use this situation to switch poorly controlled patients to another therapy option. Although it’s possible a physician would switch a well-controlled patient to another therapy option, perhaps moving them off Lantus and onto Levemir, the physicians interviewed by Diabetic Investor indicated they would be reluctant to switch well-controlled patients.
A common theme shared by these physicians was they don’t see evidence that convinces them that Lantus actually causes cancer. They did however did acknowledge that this fact might not matter given the litigious nature of their business. Unfortunately as we have seen with the Avandia controversy, lawyers are going to have a field day with this information. We all know what’s coming – the class action lawsuit.
This puts Sanofi in an unwinnable situation as it will take time to dispel the notion that Lantus causes cancer and time is something Sanofi does not have. All the major networks have covered this story as well as major newspapers around the country. No statement, no matter how well written will ease patient concerns especially since many patients associate cancer with death. Although pancreatitis is serious issue, nothing scares patients more than the Big C.
Diabetic Investor believes Novo Nordisk is both a winner and loser. While it’s likely they will use this situation to boost sales of their long-acting insulin Levemir this is a dangerous path. The main reason Lantus was signaled out in these studies is that Lantus has been around since 2000 and is more widely used than Levemir. The fact is Levemir just hasn’t been around long enough. There are some who believe that similar data could appear with Levemir.
Both Novo and Lilly will also have to deal with the overall fear factor as in the eyes of many patients it won’t matter that these studies did not condemn any short-acting insulin; simply put the words insulin and cancer are now linked.
It’s also difficult to gauge whether this situation will help Byetta sales. As already noted while Amylin has largely disproved the notion that Byetta causes pancreatitis the stigma remains. This situation becomes even more problematic as Novo’s GLP-1 Liraglutide has been linked with thyroid cancer.
Think for a moment the decision facing the physician and patient on Lantus. Do they switch to Levemir and risk the possibility that all long-acting insulin’s carry a cancer risk? Do they switch to Byetta which may be linked to pancreatitis? Do they switch to short-acting insulin only which would mean multiple injections each day? It’s unlikely they would add additional oral medications as patients on insulin typically have already failed on orals. Just what is the physician and patient supposed to do as it appears almost every medication, with the exception of metformin, used to treat type 2 diabetes comes with a variety of serious risk factors. This is the most devastating consequence of this controversy.
It’s a well known fact that nearly two-thirds of all patients with diabetes are not under control. It is also well known that when a patient is not under control there serious complications such as cardiovascular and kidney issues. While Diabetic Investor believes these patients could switch to Byetta and achieve solid results, we have already noted that Byetta has also come under scrutiny due to the pancreatitis issue. The fact is Sanofi-Aventis, Amylin, Novo Nordisk and Lilly have a major task ahead as they must make every effort to convince patients and physicians that insulin and/or GLP-1 therapy is safe and effective for patients with type 2 diabetes.
Using the Avandia controversy as a guide Diabetic Investor is not optimistic that Sanofi can dispel the notion that Lantus causes cancer. It will take years for additional studies to be done and as we have seen with Avandia even if those studies show positive results once your drug is publicly tainted it becomes difficult, if not impossible to displace the impression placed in the minds of patients and physicians. In the real world even if the physician believes Lantus is safe the risk of a malpractice lawsuit cannot be underestimated.
Once again it is the patient who will suffer the most. Once again we have a series of studies that create more questions than answers. Once again patients are told they must wait for even more studies to be conducted so they can see if the conclusions drawn from these studies are correct. Once again physicians must deal with real world issues of lawsuits while making therapy decisions. Once again patients are being asked to fight their diabetes with a limited set of weapons. The way things are going it won’t be long before every option used to treat diabetes becomes tainted.
Diabetic Investor is getting just a little tired of researchers using retrospective or meta-analysis. The fact is you can have two researchers look at the same data set and reach two very different conclusions. While this may be great for the researchers as it leads to even more research, it ignores the real world consequences their research has on millions of patients with diabetes. As J. William Fulbright wrote; “Science has radically changed the conditions of human life on earth. It has expanded our knowledge and our power but not our capacity to use them with wisdom.”