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Steve: So we’ve covered that, let me ask you another question, when it comes to the SGLT-2s. I know I have a friend who’s a type 1, Andres, I know you have met him, and he started taking Empagliflozin, and he lowered his insulin, just like you said, he lowered his insulin requirements dramatically, which helped him to get better control of his diabetes and lower A1C. So in that situation, you just said, they have to be very careful in lowering your insulin, you know, using that to lower your insulin, because you can put yourself in DKA possibly. So what are your thoughts about type 1 and SGLT2s? It’s off label obviously.
Dr. Vinik: It’s off label right now. At this meeting there are two posters on doing just that. One of them from our good friend up at Niagara Falls, he likes to do these short quick studies, like this he’s combined the two. And you can do it, I mean it works; it works in type 1. And if you want use a combination of Dulaglutide or a little Dulaglutide and Empa or its equivalent of it, that works too. So you have a nice place to be, but when you start doing things like that, you’ve got to know the full ramification of what you are doing, like you’re talking about Andrew, you’ve got to know that if your insulin requirements has dropped say 50%, and it can, I mean it can plummet, it’s dropped 50% you mustn’t think ok well that’s fine I can drop it another 5% and another 10%, you know, and I’ll get away with it. No you won’t. You won’t get away with it. And that is what people have got to learn. Now they’re going to learn that. From this experience, they’re going to learn, I mustn’t fool with that, it’s not a safe place to be. Alright? But it’s a new paradigm because all these years we’ve been teaching people too much insulin is bad for you. It increases your edema, your swelling, the congestive heart failure, it increases your blood pressure, all the things about insulin, so we think it’s so fantastic. Look we can get your insulin up, all these things will get better, but what they forget about is there is a down side. And the down side is ketoacidosis. So you don’t want to do that. You don’t want to be in that place.
Steve: That really comes from, doctors are going to use this drug, we don’t want make it happen like it did with Resulin, where the doctors weren’t performing the right diagnostic test before they put a patient on it, so the FDA just pulled it off the market. It had some great benefits, and we saw that in the UKPDS study. So this could actually fall into that same class, but we have enough experience now where we can forewarn the doctors, when you use this drug, A, B, C, and D, you know you should be aware of these things, you should tell your patient to drink more fluids, and that’s the fear is that really getting done, or does the doctor write a prescription or electronically send it to the pharmacy and say just pick up your prescription at the pharmacy.
Dr. Vinik: You’re getting into another area of where we are and what is happening. Today the practice goes like this. You decide you are going to use one of the new drugs. You ask the patient who her insurer is and she will give you the insurer and then you find out what the insurer will pay for and what they will approve. And you have to do all that instead of just writing out a prescription and then you finally learn that that insurer will not allow you to use this combination of drugs, so then you are forced into the combination that the insurer will allow and you know what that insurer is also going to do? That insurer is going to hike the price of this. I mean even insulin. In a decade, the cost of insulin has gone up 300%, you know, so you see what’s happening and these guys they don’t want you to use the new drugs and if they do, they want to capitalize on it, so they are going to sock it to you and then they are going to cut their deals. And you know that, they are going to go to the company that will give them the biggest rebate, and got that nice fancy rebate. That’s the drug, and we have the same with pumps now. Exactly the same issue. Cut the deal with one company and when you’ve cut it, all the other pumps’ gone.
Steve: So, if we take the profit out of medical care, quote “socialized medicine,” if we take the profit out of it, do you think we would have better medicine?
Dr. Vinik: Not necessarily, I think we’ve got to look for who’s skimming the system and at what levels. Unfortunately this last year I’ve served on its committee and everyone is skimming. The manufacturer, of you know, I’ve got two other people who I’ve trained at this meeting over here who I questioned at an interview about what they were doing and why they weren’t doing it at the manufactory level. They don’t talk to me anymore. They say that’s not us, that’s somebody else down the line and then you go and say where am I seeing every bit of the skimming and it’s a multitude of levels. I mean, so you end up not being able to point a finger and then the person who is hurt is the patient. And the person who can’t practice the way he or she likes to is the physician over there. And these guys are singing all the way home and putting the money in the bank.
Steve: So what do you recommend? How are we going to take care of this?
Dr. Vinik: I think our problem is, as physicians, is we’re a very weak organization. I’ve never seen the AMA do anything that helped physicians and unfortunately I’ve never seen American college do anything that helped physicians. AACE is a small group, you say “Hey look at this big meeting it’s the biggest we’ve ever had” It’s true, but we’re a small group. And the individual physicians, I just had the whole thing, I mean I wrote the position statement, challenging Novitas. I wrote the position statement now challenging Anthem Group, Anthem Blue Cross, to say you can’t not pay for these things anymore. If you don’t pay for them, people won’t have those things and they are going to die. We need to recognize… They said no that’s you. You’re just a specialist in this small area, but we’ve got to worry about the rest. We’ve got to worry about the rest. So you worry about the rest, but you don’t have the power to do it. So what’s got to happen is AACE has got to talk to endo and endo’s got to talk to ADA, and ADA has go to talk to Canadian… and the European society. And they’ve got to say, “Look guys we’ve got a problem and if we don’t do anything about this, we go to hell. I mean that’s what’s going to happen. What’s happening already? You asked me about ketoacidosis, the euglycemic ketoacidosis. You know what the biggest new cause of ketoacidosis is? People are not getting their scripts filled. They’re not getting enough insulin to use. They are running out of their insulin and the pharmacies are saying sorry. Your doctor didn’t give you enough.
Steve: Have you seen an increase in regular and NPH insulin because of that?
Dr. Vinik: Yes, I’ve seen an increase in that and I’ve also seen the following. I’ve seen my kids, I’ve got a lot of young people I take care of. I see them cutting their doses and they say we’ve got to spread it out. You know why. Because if I write up a script, like, this is how much you must take in the morning… and in the evening, … and this is your carbohydrate pressure and et cetera and I write that all out for them, and then the pharmacy asks one question. How many CCs must I give them? Nice. And how do we contest that? The nurse in charge and the administrator in charge of our clinic calls me up and says, you realize you made a bad mistake. You didn’t put the volume on the thing. I said you don’t even begin to comprehend what that means. They said oh yes we do, that’s the rule now.
Steve: I just attended a meeting where they invited some doctors and the FDA and the drug companies for ISMP, the Institute for Safe Medicine Practices, and we got about 40 people in the room to discuss how we can prevent insulin errors because insulin is the number 1 drug that causes the most errors and it has been for the last 20 years. So we know that this drug is causing the most errors why don’t we address it? So they had a lot of great ideas, they’ll be coming out with a white paper shortly to…
Dr. Vinik: I’d love to see that.
Steve: So, there’s two new drugs that’ll be big at ADA, excuse me, two companies with combinations, with the GLP-1 and insulin combined together. What is your experience or what do you think about that?
Dr. Vinik: I love the idea. Whatever you say, I love the idea. Am I doing it? Yes, am I doing it off-label? Like in type 1s? Yes. Why am I doing it? Because the idea is good and it works. And we really change things for people. We make it so much easier for them. People are bouncing around like crazy. Everything just evens out. It’s a really nice place to be. So yes, there are a couple of avant-garde people. One endo who you know over there, I’m sure he was at the meeting. The moment these came on board that’s the first thing he did. He put an incretin together with a… you put a GLP-1 agonist together with it, then he switched around depending on which company was giving him the most money to do the research, and he did that. He did the study too. Small groups of people, always are small groups of people, but it works. So I think this is the future for us. Is to be smart about the combinations that we use. And use drugs with different mechanisms. And use drugs that actually do not promote hypoglycemia. The beauty of these drugs is they only promote hypoglycemia when you add them to insulin or to a sensitizer.
Steve: But this is they’re adding GLP-1 to insulins.
Dr. Vinik: Right, but it allows them to use less insulin. Less… so you’re reducing the trend towards hypoglycemia by doing that. Like if I give you GLP-1 it will simulate the insulin only in the presence of elevated glucose. It will not simulate it when the glucose level returns to the threshold. That’s the beauty of that.
Steve: So you would look at a patient who belongs on insulin and you would consider this combination because you’re going to have to use less insulin.
Dr. Vinik: Less insulin, and less bad decision-making. You know you just put your finger on saying that look at the situation we’re in. The situation we’re in, insulin is a killer and you know you can’t live without it and you can’t live with it. So we know that. OK. But the decision-making on dosing is not an easy one. And you think that everybody has got a university degree and they’re cognitively totally intact, and they are fully aware of this complexity of decision-making and that’s not true. That’s not true. It’s too much. We make huge demands on people to make complex decisions. You know I loved the, he didn’t, O. Host, didn’t pitch up for his paper but he sent the text and the slides and then he showed all these people, 7 or 8 examples of the complexity of decision-making, and I guarantee 95% of people in that audience who are endocrinologists didn’t understand a thing he was saying because they were such complex decisions and then we give it to our patients who sort of barely matriculated and we say to them do you see this nice algorithm we got for you, we’re going to download all this for you and when you see this spike you mustn’t do this, when you see that spike you must do this over here and if you see too many spikes, then you must back off… That’s what I… I think it’s really very pertinent that we need ways of delivering these things that don’t require brain power. Look what happens to older people. When older people start making mistakes, and they have, it’s because they’re getting cognitive impairment. And what’s one of the biggest drivers of cognitive impairment? Hypoglycemic episodes. And now we give them cognitive impairment and then say look you need to start making the right decisions. They can’t make those decisions. They’re crazy. And we did it.
Steve: So the A1C is an average blood sugar but it doesn’t give us the fluctuations. So obviously we need to look at more information rather than just the average blood sugar. And there are tests to do that. Do you use that in your practice?
Dr. Vinik: Only for one very important reason. That you get neuropathic pain with fluctuations in the glucose. So if I can even out glucose, the neuropathic pain improves or disappears. And it’s one… I bet you, you have not heard that before. A lot of people they think…
Steve: I’ve read it, ok, because that’s where I got the philosophy that a 7.4 for one person is…and a 7.4 for another person, they could be completely different as far as what that means and that’s due to fluctuations.
Dr. Vinik: That’s exactly right. So I’m very attuned into… cut the fluctuations and people will get a lot better.
Steve: So my last question.
Dr. Vinik: That was your last question. Two questions ago.
Steve: What should we look for at ADA? You know, they prevent you from talking about all this stuff prior to them bringing it out in the news. What is the exciting thing, if there is anything with this year at ADA? I know you’re not going to be there but I know you are up on the research.
Dr. Vinik: I think the exciting thing is that we’re going to hear, first of all, get closer to… It’s really closer to a closed-loop system for taking care of people. That’s going to be announced at the ADA this year. And I’m excited about that because it’s exactly what we are talking about. Is that you’re not going to have to make those decisions. They’re going to be made for you. OK? And that’s going to be announced at the ADA.