August 27, 2008
Here We Go Again
“In critically ill adult patients, tight glucosecontrol is not associated with significantly reduced hospitalmortality but is associated with an increased risk of hypoglycemia.” This was the conclusion of a study entitled Benefits and Risks of Tight Glucose Control in Critically Ill Adults published in the recent issue of JAMA. This conclusion is the exact opposite of several other studies which found that tight glucose control improved mortality and reduced costs as patients were released from ICU units earlier.
According to Renda Soylemez Wiener, a critical care doctor and lead author of the study, “Overall, it seems that the time has come to reconsider whether professional societies should continue to recommend tight glucose control as the standard of care in all critically ill adults.”
So once again we have a meta-analysis that contradicts several individual studies that found the exact opposite result.
It remains to be seen what impact this meta-analysis will have on the three companies with FDA approved continuous glucose monitoring systems (CGMS), Medtronic (NYSE:MDT), Abbott (NYSE:ABT) and Dexcom (NASDAQ:DXCM) as well as the many companies who have systems under development specifically for use in hospitals. As with conventional glucose monitoring the problem is not with the data but proper application of the data.
The findings do point to a bigger problem facing physicians who treat patients with diabetes now that the FDA has decided to limit their options for treating patients. Yesterday Amylin (NASDAQ:AMLN) and Lilly (NYSE:LLY) went to great lengths to provide some context to the issue surrounding Byetta. Although Diabetic Investor is not as pessimistic as others on the future prospects for Byetta, there is no question sales of this effective medication will suffer in the near term. As we mentioned yesterday a Black Box warning could kill Byetta in the minds of physicians and patients.
This is not unlike what occurred with the Avandia controversy last summer. Like Amylin and Lilly, GlaxoSmithKline (NYSE:GSK) was ambushed with news of increased cardiovascular risk and Avandia usage. Once again there was a rush to judgment before all the facts were known. Not waiting for all the information to be vetted physicians took their patients off Avandia. Patients also took matters into their own hands many of whom stopped taking any of their meds.
In the end Avandia was given a Black Box warning, even though there were several experts who did not believe the data justified such a warning. It really didn’t matter as Avandia was already dead in the eyes of physicians and patients. Just as many will condemn Byetta based on sensational headlines, Avandia didn’t stand a chance after the news was made public.
So here we are as two popular diabetes drugs, one dead and one on life support, have been branded as killers. This happens just as diabetes is exploding across the globe and is transforming from a healthcare issue to a major economic issue. Not wanting to risk the health of their patients or chances of a lawsuit, physicians once again must look for other options to treat their patients with diabetes.
Here’s the problem with Avandia gone and Byetta on the ropes, physicians have a limited set of options to effectively treat diabetes. The folks at Merck (NYSE:MRK) are surly enjoying this as Januvia could soon be the only branded medication left on the shelf. So far, Januvia has not been hit with any death scares although there has been one label change warning of the risk of a serious form of skin cancer. Many are concerned this is only the tip of iceberg for Januvia and more problems are just around the corner.
Even without any new adverse events Januvia isn’t that effective. Look over the data from Januvia and you’ll find that real control comes when the drugs is used with metformin. Used a monotherapy Januvia results are lackluster at best.
Physicians can use Actos which does not appear to have the cardiovascular issues that Avandia had. However, Actos has its own set of issues weight gain, edema and increased incidences of bone fractures – an adverse event that was not discovered until the drug had been on the market for nearly seven years.
That leaves insulin. While no one will question that insulin therapy is effective it comes with its own set of issues. Hypoglycemia is one; lack of proper patient education is another. If trained professional working in hospitals can’t figure out how to dose insulin properly even with reams of glucose readings think of what this means for the average patient who spends less than 10 minutes with their physician.
The fact of the matter is and there is no getting around this, all medications have adverse events. The key is understanding, the risk reward profile of each medication. It’s equally important that when adverse events are identified they are kept in the proper context. Patients with diabetes are at increased risk of cardiovascular events and pancreatitis just because they have diabetes. It goes without saying that no medication should increase this risk, however if the incidence rate is lower than the general population evidence based medicine should be used to determine what action, if any, should be taken.
Finally, no action should be taken BEFORE the issue is fully investigated. The sad reality is that try as we might patients with diabetes will experience complications even death. Diabetes is a serious disease which is difficult to control. Diabetic Investor fails to see the benefit from rushing to judgment when there are so many factors which influence outcomes and adverse events.
