Get Ready to Argue About the SELECT Outcomes Study
It’s coming. Sometime before September we will be hearing about the results of the SELECT outcomes study of semaglutide in people with obesity and we may as well start getting ready to argue about it now. Because value is in the eye of the beholder. And this study is all about the long-term health value of treating obesity with an advanced generation of anti-obesity medicines.
Yes, It Will Be a Landmark Study
There will be no room to argue that this study is anything but a landmark study. It is a five-year trial of major adverse cardiovascular events (MACEs) in patients randomized to receive either semaglutide 2.4 mg injections weekly or a placebo. This is a study of 17,605 persons with an average BMI of 33. All of them already had heart disease, but none of them had diabetes. We already know that semaglutide reduces the risk of MACEs in people with diabetes.
In plain English, preventing MACEs is all about preventing deaths, heart attacks, strokes, or heart failure. Three quarters of these patients had already had a heart attack. two thirds of them had prediabetes. So they were well on their way to further heart problems.
Why the Argument?
The argument we expect will not be about the quality of the study or the results. This is top notch research and the first of its kind in this population. But the real argument will be over the implications. Damian Garde, Andrew Joseph, and Elaine Chen explain in a recent article for STAT:
“We already know it’s not a home run.
“Novo Nordisk designed SELECT to include an interim analysis, in which independent data monitors took an early look at the results, with the option of ending the trial if Wegovy was outpacing placebo so dramatically that concluding the study would be pointless. That would have required a roughly 35% relative improvement in MACE, according to an analysis by Evercore ISI. And it didn’t happen, suggesting Wegovy’s actual effects will be more modest.”
A significant but not stunning effect on outcomes will leave people with room to ague about just how important the results of the SELECT outcomes study really are. Motivated reasoning almost guarantees it.
Some are predicting that this study will be yet another game changer for obesity care. If treating obesity with a highly effective obesity drug prevents some of these really bad outcomes, what excuse will health insurance plans have to avoid covering them? This leads to suggestions that semaglutide and related medicines could become the biggest selling class of drugs ever. That’s certainly a reasonable scenario and a likely one.
Lame Arguments
But the health insurance industry has a track record of putting money first and health second all too often. So we have great confidence that they will find ways to quibble with results that are good but not the greatest ever seen. Some public health advocates will continue to insist we wouldn’t need any of this if only we could drive big food into submission and tax the foods they don’t think poor people should be eating. Fat acceptance advocates will continue to insist that this is just another manifestation of fat phobia.
Make no mistake. These are all lame arguments. But that will not stop them from surfacing. Because humans have a capacity to rationalize anything.
Click here for further perspective from STAT, here for more on the study itself, and here for perspective on the interim analysis.
The Argument, photograph by DavidKF1949 of a bronze sculpture by Austin Andrew Wright, licensed under CC BY-SA 3.0
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July x, 2023