Trials like Step-HFpEF were indeed naked marketing exercises, and did not move the needle at all for me.
But much harder to ignore SELECT. I will say I’m less impressed with a BMI of 27 (the inclusion criteria), but when you get to a BMI of 33 (average among actual participants in the study), I feel that constitutes a more intractable health problem that may justify medical intervention, especially in a secondary prevention cohort.
I still use euphemisms like “take this pill, and take it out for a walk daily”. But I have to acknowledge that significant overweight becomes a vicious cycle that precludes pts from being able to do adequate exercise. And so you have to break that vicious cycle somehow. And this drug may be one way.
I must say I do share the email author’s cynicism in many ways. I am dismayed that the major societies (and their guideline writers) have become nothing more than cheerleaders for pharma. I’m not sure how to put that genie back in the bottle.
My version of medical conservatism is to apply the data on patients that look like those who were (or could have been) enrolled in a study. I’ll use a drug on someone who looks like someone who could be a study subject. But I refuse to extrapolate to the kitchen sink (like latter day guideline writers seem so keen to do) in the name or service of knowledge translation.
However, I would stop short of alleging fraud, as the email author seems to be doing. I can believe it happens from time to time; but I don’t think it’s anywhere near as ubiquitous as to require essentially rejecting any and all study data.
I never have and never would recommend drugs for weight loss. Absent any hormonal abnormalities, the physiology of weight gain and loss is pretty simple. Take in more calories than your body expends and you will gain weight. Burn more calories than you ingest and you will lose. People may have different levels of basal metabolism that may make this more difficult for some. I found that those most successful in losing weight were those that followed a low carbohydrate diet---probably because the relatively high fat and protein content seems to enable most people to cut the calories with less hunger pangs and cravings. There are dozens of variations in this diet with different names (and best selling books) every few months or so. But they are all fundamentally the same. Of course this sort of diet is anathema to those who preach the low fat, low cholesterol diet and causes great angst for those who wish to simultaneously advocate these contradictory positions on diet.
I would be interested in hearing your argument for cardiologists medically managing obesity with ABOM certified physicians becoming more abundant.. Perhaps we need a cardiometabolic/obesity subspecialty or CAQ?
If there is even a scintilla of reason to believe that pancreatic cancer can be caused by such drugs that is reason enough to never take them. I just lost my wife to pancreatic cancer and it is not a death I would wish on my worst enemy. It is a death sentence with excruciating pain.
Its all about personal choices and lifestyle. By and large, (no pun intended), you are what you eat! That said, if weight loss is the target, the focus must be on food quality not quantity. The prime evil here is the dishonesty of the food manufacturing industry (which equals the evil of big pharma!) and the misleading advertising that government agencies are unable or unwilling to bring to account.
I am just a regular person, not a medical professional. Look at the history of weight loss. Weight loss is littered with failed treatments. If you go back and look this weight problem really took off with the first t.v. dinner, weight watchers and the metrical for lunch bunch. The coke advertisers were telling us that pop made us lose weight. Go look at photos of people from the civil war era. They were not having weight problems. Then go read their old cookbooks. There was barely any sugar in the food, and they were cooking plain food. It's going to be hard, but the truth is there is no fix without going back and fixing the trajectory of how we got here, and that's going to be very difficult.
What, if anything, do you prescribe for weight loss? Do you ever prescribe Wegovy or the Lilly competitor? Do you ever prescribe Ozempic off-label for weight loss? Are these drugs all that much different in risk (for lack of enough safety studies) than those you prescribe for other conditions?
If the pharmaceutical armamentarium were a warehouse, there'd be a back door where a constant stream of approved drugs eventually get quietly tossed onto the trash heap of failure.
Absent long-term experience, it is impossible to know the fulll benefit/harm, and thus impossible to make an informed prescription. This ethical position must be held against a massive current swept along by big pharma, their paid researchers, the media, demanding patients and a large subset of credulous physicians.
Having been in practice when phen-fen was a fad akin to the current one for GLP-1 agonists, it is best to maintain the conservative way and refrain from prescribing weight loss meds.
thank you for this. I have been long NVO and LLY for quite some time now., and am now ready sell at any point if such rumors turn out to have substance.
If I were a physician I would not prescribe these drugs. They are not safety tested enough and there are a lot of really terrible effects and they seem to be “take for life” drugs, because quitting involves a lot of drama and bad side effects including gaining all the weight lost and then some. They are a disaster and the company is doing what all Big Pharma does — promote promote promote, then eventually 10 years later, pay multi billion dollar settlements but they then they are on to the next drug disaster and have pocketed hundreds of billions.
I so resonate with this! Since I am in primary care and also getting up there in age, I have seen so many things come and go in medicine. I too was taught the conservative prescribing habits of this colleague and now see the wisdom behind this way of practicing medicine, ( think about NSAIDS— I was a medical student when the came out…). Why are we always in such a hurry? First do no harm should still remain our guiding principle.
Trials like Step-HFpEF were indeed naked marketing exercises, and did not move the needle at all for me.
But much harder to ignore SELECT. I will say I’m less impressed with a BMI of 27 (the inclusion criteria), but when you get to a BMI of 33 (average among actual participants in the study), I feel that constitutes a more intractable health problem that may justify medical intervention, especially in a secondary prevention cohort.
I still use euphemisms like “take this pill, and take it out for a walk daily”. But I have to acknowledge that significant overweight becomes a vicious cycle that precludes pts from being able to do adequate exercise. And so you have to break that vicious cycle somehow. And this drug may be one way.
I must say I do share the email author’s cynicism in many ways. I am dismayed that the major societies (and their guideline writers) have become nothing more than cheerleaders for pharma. I’m not sure how to put that genie back in the bottle.
My version of medical conservatism is to apply the data on patients that look like those who were (or could have been) enrolled in a study. I’ll use a drug on someone who looks like someone who could be a study subject. But I refuse to extrapolate to the kitchen sink (like latter day guideline writers seem so keen to do) in the name or service of knowledge translation.
However, I would stop short of alleging fraud, as the email author seems to be doing. I can believe it happens from time to time; but I don’t think it’s anywhere near as ubiquitous as to require essentially rejecting any and all study data.
I never have and never would recommend drugs for weight loss. Absent any hormonal abnormalities, the physiology of weight gain and loss is pretty simple. Take in more calories than your body expends and you will gain weight. Burn more calories than you ingest and you will lose. People may have different levels of basal metabolism that may make this more difficult for some. I found that those most successful in losing weight were those that followed a low carbohydrate diet---probably because the relatively high fat and protein content seems to enable most people to cut the calories with less hunger pangs and cravings. There are dozens of variations in this diet with different names (and best selling books) every few months or so. But they are all fundamentally the same. Of course this sort of diet is anathema to those who preach the low fat, low cholesterol diet and causes great angst for those who wish to simultaneously advocate these contradictory positions on diet.
I would be interested in hearing your argument for cardiologists medically managing obesity with ABOM certified physicians becoming more abundant.. Perhaps we need a cardiometabolic/obesity subspecialty or CAQ?
If there is even a scintilla of reason to believe that pancreatic cancer can be caused by such drugs that is reason enough to never take them. I just lost my wife to pancreatic cancer and it is not a death I would wish on my worst enemy. It is a death sentence with excruciating pain.
Its all about personal choices and lifestyle. By and large, (no pun intended), you are what you eat! That said, if weight loss is the target, the focus must be on food quality not quantity. The prime evil here is the dishonesty of the food manufacturing industry (which equals the evil of big pharma!) and the misleading advertising that government agencies are unable or unwilling to bring to account.
I am just a regular person, not a medical professional. Look at the history of weight loss. Weight loss is littered with failed treatments. If you go back and look this weight problem really took off with the first t.v. dinner, weight watchers and the metrical for lunch bunch. The coke advertisers were telling us that pop made us lose weight. Go look at photos of people from the civil war era. They were not having weight problems. Then go read their old cookbooks. There was barely any sugar in the food, and they were cooking plain food. It's going to be hard, but the truth is there is no fix without going back and fixing the trajectory of how we got here, and that's going to be very difficult.
Dr. Mandrola,
What, if anything, do you prescribe for weight loss? Do you ever prescribe Wegovy or the Lilly competitor? Do you ever prescribe Ozempic off-label for weight loss? Are these drugs all that much different in risk (for lack of enough safety studies) than those you prescribe for other conditions?
Three cheers for skepticism!
If the pharmaceutical armamentarium were a warehouse, there'd be a back door where a constant stream of approved drugs eventually get quietly tossed onto the trash heap of failure.
Absent long-term experience, it is impossible to know the fulll benefit/harm, and thus impossible to make an informed prescription. This ethical position must be held against a massive current swept along by big pharma, their paid researchers, the media, demanding patients and a large subset of credulous physicians.
Having been in practice when phen-fen was a fad akin to the current one for GLP-1 agonists, it is best to maintain the conservative way and refrain from prescribing weight loss meds.
thank you for this. I have been long NVO and LLY for quite some time now., and am now ready sell at any point if such rumors turn out to have substance.
thank you for sharing 💕🙏
Exenatide came out in 2005. I don’t see this class as that “new.”
If I were a physician I would not prescribe these drugs. They are not safety tested enough and there are a lot of really terrible effects and they seem to be “take for life” drugs, because quitting involves a lot of drama and bad side effects including gaining all the weight lost and then some. They are a disaster and the company is doing what all Big Pharma does — promote promote promote, then eventually 10 years later, pay multi billion dollar settlements but they then they are on to the next drug disaster and have pocketed hundreds of billions.
I so resonate with this! Since I am in primary care and also getting up there in age, I have seen so many things come and go in medicine. I too was taught the conservative prescribing habits of this colleague and now see the wisdom behind this way of practicing medicine, ( think about NSAIDS— I was a medical student when the came out…). Why are we always in such a hurry? First do no harm should still remain our guiding principle.