Advance/Accord – So what?

Advance/Accord – So what?

Before we get into our daily briefing a quick note. There is so much going on here that Diabetic Investor has decided to issue updates on the most important stories. Also in the interest of time we will likely be issuing multiple updates throughout the conference. After the show is over we’ll issue, what will likely be, a lengthily review of the entire show.

Also before we get into our thoughts on Advance and Accord, it should be noted that the biggest news to come out of the show may not even happen during the show. Diabetic Investor has learned that Bayer is in serious discussions to acquire Abbott’s (NYSE:ABT) diabetes business. Diabetic Investor sees this deal coming together before 2008 comes to end. We also suspect that Bayer will not acquire Abbott’s nutritional business only the devices. This move is further evidence of the changing nature of the blood glucose monitoring (BGM) market where size and scale really do matter.

The only remaining piece to complete the puzzle for Bayer and bring the company all the way back would be an insulin pump component. Just as LifeScan owns Animas and Roche owns Disetronic, Bayer knows having a pump of their own is critical to strip sales. The most logical fit, Insulet (NASDAQ:PODD). Besides a growing market share and revolutionary design, the company already has a relationship with Abbott.

(Although not the subject of this daily briefing it’s worth noting that neither Insulet or Medingo made their scheduled presentations at what was an excellent conference put on by Canaccord Adams. What we can say is prior to the Medingo presentation being rescheduled and eventually cancelled the room was packed to capacity. With Johnson and Johnson (NYSE:JNJ) indicating during their medical device event on Thursday that they, like Medtronic (NYSE:MDT), were pursuing a patch pump everyone is beginning to realize that wireless pumping is the next big thing. This puts Insulet firmly in the catbirds seat and the most coveted medical device company attending the conference.)

Know on to Advance and Accord.

So what have we learned from these two clinical trials? Advance (Action in Diabetes and Vascular Disease) involved 11,1140 patients with type 2 diabetes who were treated and followed up for five years. Accord (Action to Control Cardiovascular Risk in Diabetes) 10,251 patients and followed up for 3.5 years.

Before we discuss the results and more importantly the implications for the market, a quick comment on how the two studies handled themselves. Like children fighting for Mom and Dad’s attention the Accord study lifted their news embargo on Friday at 2pm PST just when the Advance study was being presented at the conference. This childish act did nothing more than confirm what everyone knows but no one talks about, the two studies appear to care more about trumping each other than providing quality information to the patients or the physicians that treat them.

So just what did learn from over 20,000 patients and years of study? That intensive control might help reduce cardiovascular complications but were just not sure. On the other hand, intensive control just might cause a major cardiovascular event and kill the patient.

“The results clearly demonstrate that intensive control of blood glucose, as recommended by most current clinical guidelines, has an important role in the prevention of renal complications of type 2diabetes. The other major finding of the trial was that major macrovascular events- heart attack, stroke and death from cardiovascular disease- were not significantly reduced with intensive glucose control, although there was a trend towards improvements in these outcomes. However, the results suggest that a multifactorial approach addressing all they major risk factors including blood pressure and blood lipids is required to prevent macrovascular disease,” said Anushka Patel, MBBS, SM, PhD, Study Director of Advance trial, and Director, Cardiovascular Division, The George Institute for International Health.

“The major clinical implication is that there is some risk associated with this level of intensification of glycemic control in high risk cardiovascular patients with type 2 diabetes similar to ACCORD patients and that has to be considered by clinicians in the management of the disease, “ said Robert Byington, Phd, head of the Accord coordinating center and Professor of Epidemiology and Prevention, Wake Forest University School of Medicine.

In an editorial published yesterday in the New England Journal of Medicine “Intensive Glycemic Control in the ACCORD and ADVANCE Trials” By Robert G. Dluhy, M.D., and Graham T. McMahon, M.D., M.M.Sc. they state “The most compelling message from both studies is that near-normal glycemic control for a median of 3.5 to 5 years does not reduce cardiovascular events within that time frame.”

In a corresponding perspective also in the Journal Redefining Quality — Implications of Recent Clinical Trials by Harlan M. Krumholz, M.D., and Thomas H. Lee, M.D., “ACCORD, ADVANCE, and other recent studies remind us that practice is complex and that ultimately we need to understand a strategy’s effects on people, not just on surrogate end points.”

After all these years and all this money and all we get is that practicing medicine is complex, give me a break. The messages being sent from these studies are so mudded that Diabetic Investor believes they will actually do more harm than good. And just as the sun rises in the East and sets in the West, some respected researcher will surly utter those immortal words, “Given the complexity of the results, contradictory as they may be, this issue warrants further study.”

No wonder more than two thirds of the diabetes patient population is not achieving control, the physicians who are supposed to treat them have absolutely no idea if what they are doing will actually help the patient lead a better, more productive life. What diabetes needs and does not have is a clear message to the patients and the physicians that treat them. It can’t be intensive control might be good or possibly bad. No intelligent human being believes smoking cigarettes is healthy. The message is loud and clear – smoking causes cancer – if you stop smoking you greatly reduce your chances of developing cancer. Diabetes has no such message.

Patients and now their physicians are being asked to perform a multitude of tasks. Patients must check their glucose levels, get quarterly A1c tests, take their medications, eat right, exercise and see their physician regularly. Physicians are being asked to not only watch glucose levels, but blood pressure, cholesterol, lipids and triglycerides. What these researchers, who must be living in some fantasy land, are asking patients is to live their lives FOR diabetes instead of WITH diabetes. Already studies have shown that patients would rather sacrifice years off their lives rather than deal with the daily grind of living with diabetes. It certainly doesn’t help matters any when what are supposed to be major clinical findings not only contradict each other but take shots at each other belittling each other results.

Some will say that diabetes is too complex a disease to offer a simple message, like smoking causes cancer. They will argue that each patient and their physician should consider a host of factors and design a treatment regimen to fit that individual patient. This sounds great but is hardly realistic with the way healthcare is delivered and paid for in America. The bottom line is patients with diabetes are no different than anyone else, in that, they crave simplicity in an increasingly complex world. It’s about time started listening to the patients and stopped worrying about their professional reputation or whether or not their study was better than another. Patients and the physicians who treatment them are desperate for answers and screaming for help. Unfortunately no one appears to be listening.

David Kliff
Diabetic Investor
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