Memorandum

In Major Win, Virta Health Names Dr. Robert Ratner Chief Medical Officer – April 22, 2020

Highly-respected diabetes KOL Dr. Ratner was formerly Chief Scientific and Medical Officer of ADA; 40+ years of experience in diabetes

Virta Health just announced the hiring of Dr. Robert Ratner, a long-time leader in diabetes, as its new Chief Medical Officer. The move brings additional credibility to Virta and its low-carb, remote monitoring-based interventions for type 2 “reversal.” The Virta Health Clinic opened in 2014, the year Virta was founded by Sami Inkinen. Dr. Ratner has been on the Virta Scientific Advisory Board since 2017 and has been a longtime advisor to Inkinen, but he is best known for his work as the chief scientific and medical officer for the American Diabetes Association (2012-2107). Dr. Ratner is also a Professor of Medicine at Georgetown University Medical School. With this move, we expect Virta will see even faster adoption of its model by employers nationally, and it should cement Virta’s leadership in “continuous remote care.”

The hiring of Dr. Ratner comes just a few months after Virta closed a $93 million Series C funding round that also brought on a number of prominent advisors, including Dr. Marty Abrahamson (Associate Professor of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center), Dr. Francine Kaufman (Distinguished Professor Emerita of Pediatrics at USC, The Center for Endocrinology, Diabetes & Metabolism, Children's Hospital Los Angeles, CMO, Senseonics), and Dr. Alan Moses (former Chief Medical Officer, Joslin Clinic, Global Chief Medical Officer at Novo Nordisk).

Dr. Ratner accomplishments and contributions are considerable. While CSMO at ADA, he strengthened partnerships with the JDRF, EASD, AACE, and the Endocrine Society, serving as a Principal Investigator for the Diabetes Prevention Program (DPP) and advocating for Medicare coverage. To support young investigators and next-generation breakthroughs, he established the Pathway to Stop Diabetes research awards in 2013. Beyond research, Dr. Ratner also helped expand the educational scope of the ADA, with outreach initiatives to Spain, India, Brazil, the United Arab Emirates, Indonesia, and Vietnam. He further collaborated with the AACE and Endocrine Society to prepare a petition to the FDA calling for a prediabetes indication for metformin.

We were thrilled to speak with Dr. Ratner about his new role at Virta.

Interview with Dr. Ratner

Kelly Close: Thank you so much for speaking with us. What made Virta a place where you want to serve as CMO – this is a very big deal that you are coming out of retirement.

Dr. Robert Ratner: As you know I’ve had a front row seat to Virta’s progress over the last several years as an advisor. When I first discovered Virta several years ago, it was actually the uniqueness of the healthcare delivery system that piqued my interest. Very quickly, though, I recognized that Virta possessed something not altogether common in digital health, which is a commitment to using data and evidence to back their approach. This puts their outcomes, which are truly groundbreaking for patients, in a whole new light.

In this way, my move to join Virta is a natural one. I have dedicated the better part of 40 years to advancing the treatment and care of type 2 diabetes and obesity, always using the latest, most reliable and effective data we have available to make decisions.

Put simply, data is the most important thing to me. Without it there is no direction, no way to grow and improve outcomes. So, Virta’s outcomes in diabetes, combined with its data-driven approach, really created a perfect situation.

But let me return to the care delivery system for a moment, because this cannot be overlooked. Take everything you know about traditional diabetes care—that it is episodic, that it is based on pharmacological intervention for glycemic control—and ask does it have to be this way.

That is what Virta has done, and the answer is no, it does not. What we’re seeing by providing proactive care, based on inbound data from patients, we can make lifestyle interventions both very effective and sustainable in the long-term. This model can render medications unnecessary for many people, and that is game-changing for population health when scaled. Having seen this model, it is clear that it is the future of chronic disease care, well beyond diabetes.

What Makes Virta Different?

Albert Cai: What helps Virta stand out from a growing group of other virtual clinics? What did you notice initially about Virta that made it stand out, in addition to the fact that every patient sees an MD in each visit?

Dr. Ratner: I mentioned this previously, but again it starts with the commitment to being evidence-based. This has not been the norm in digital health, where unfortunately I’ve seen a lot of companies selling different versions of snake oil.

Virta has had a commitment to science and evidence from the start. They did it right with their founding team, mixing Sami’s background in technology with the scientific, medical, and research expertise of Drs. Phinney and Volek. I have great respect for this founding team, and back to your first question, it is also a large reason that I joined.

The fact that Virta has been a virtual medical provider as its primary model since 2014 is, of course, a major differentiator. Before telemedicine regulations were changed in response to COVID-19, acquiring licenses in every state in the nation was extremely hard to do. And to replicate what Virta has done in care delivery even in today’s environment would be very difficult.

And then of course there are the outcomes, which is a common theme in my answer to these questions. The glycemic control that Virta delivers through its personalized nutritional intervention is really unmatched, and compares even with bariatric surgery. The data support this, but it is cemented when you read the patient testimonials, which are genuinely inspiring.

Dr. Ratner Translates Insights from DPP (Diabetes Prevention Program) and Delves into Priorities

Kelly: How do your experiences working on DPP translate to your new position at Virta? That was nearly 20 years ago now and that journal article has over 10,000 citations now!

Dr. Ratner: DPP (note, see NEJM, 2002 – Dr. Ratner was a Primary Investigator in DPP) taught me to collaborate with very smart people in developing testable hypotheses for the prevention of diabetes. Looking at the development, implementation, analysis of outcomes, and cost effectiveness of our interventions provides me with a basis for doing the same with the enormous Virta database of patients. The ADA provided me with criteria for the establishment of medical standards of care and mechanisms for the dissemination of such. The ADA also taught me the value of cross-professional collaboration and the importance of a team approach to the care of people with diabetes. Ultimately, however, the person with diabetes is the real primary provider in the care of their diabetes.

Ursula Biba: Dr. Ratner, what will you prioritize in your new role? What do you see as the biggest challenges in the next year for Virta? In the next two to three years?

Dr. Ratner: To start, my goal will be to accelerate the adoption of Virta’s core type 2 diabetes treatment. In doing so, though, you can expect that I will do much of what I have always done, which is follow the data, and use my expertise as a scientist and clinician to explain how that data translates into fundamentally better outcomes for patients and payers. This will involve examining the clinical impact of Virta’s care delivery system (called continuous remote care), and examining the strengths, pitfalls and opportunities to improve both the recommendations and delivery of our care.

I’ll also be working with our senior leaders on establishing direction in research. You can expect that Virta’s commitment to science and evidence will remain unchanged. Virta’s care delivery model can be applied to other chronic conditions, and I am excited to explore these areas via clinical trials and research collaborations.

As for challenges, Virta provides a new model of care, with outcomes that in many ways seem too good to be true. This type of disruption, no matter how powerful the intervention may appear, takes time to garner the adoption that Virta hopes for, which is tens of millions of patients. Our biggest challenges are simply around scale at this point. The need is there more than ever, and we feel a strong pull in the market. Now it is a matter of scaling this without compromising the effectiveness and sustainability.

Looking ahead of Virta and the Field – Dr. Ratner’s Crystal Ball

Anirudh Gururaj: Dr. Ratner, similar to our last question, where do you see the biggest wins coming from in the next year for Virta? In the next two to three years?

Dr. Ratner: On the delivery side, I think we will learn so much more about the role of continuous remote care in helping people achieve sustained remission of chronic conditions. The outcomes will be there, but we should see even deeper improvements in care delivery that focus on behavioral health, even further optimization via technology, and scale.

On the commercial front, health plan adoption has already been strong, and I see this only continuing. What is interesting is that COVID-19 is only going to accelerate adoption for treatments that provide sustained glycemic control and resolution of chronic conditions, and the reality is that there are very few of these solutions out there. Treating type 2 diabetes was critically important before COVID-19, and it’s almost impossible to imagine that it has now become even more important, but that is the case. We are going to do everything we can to help people be healthy in this new environment.

Albert: In turn, if you could change one thing in the healthcare system right now to make virtual clinics more accessible, what would it be?

Dr. Ratner: There are two fundamental changes in health care delivery that I feel are critical. First, we must take health care to where the person with diabetes lives. It is naive to believe that four 15-minute office visits per year is adequate for most people. There is a reason why A1c levels are unchanged despite the introduction of three new therapeutic classes for diabetes. Continuous remote care is also the only solution to a growing population of people with diabetes and a static or shrinking supply of diabetes care givers. Second, we need to move away from the fee-for-service reimbursement model toward a pay-for-performance model. I hope and expect Virta to be at the forefront of both of these efforts to improve outcomes for people with diabetes.

Barriers to Scaling Virta

Albert: We would love to dig a little deeper into the different elements of Virta’s model. To start, what’s the biggest barrier to Virta scaling? Technology? Convincing payers?

Dr. Ratner: The question was what really are the limiting factors in moving further forward? It’s education. It’s exposure. It's knowledge, and that's really the case with diabetes management, regardless. Keep in mind that we've had very little shift in the glycemic blood pressure and lipid management of people with diabetes over the last decade. When you look at population health, we haven't moved up that much, which is problematic. We need to reach patients and people with diabetes. We need to let them know what their options are and be able to provide those options. Historically, those options meant asking whether or not to go to a general internist. Do I go to an endocrinologist? Do I go to a diabetes specific endocrinologist? Do I seek services of diabetes educators? We’ve seen a lot of movement there but have always been stuck with two factors. The first is the patient has to go to the provider. That's a pain in the neck. And it's particularly problematic once you get out of big cities that have medical schools because there are not a lot of highly qualified diabetes specialists in this country. There are only about 4,000 endocrinologists, and at least half to two-thirds of them have no desire to see anybody with diabetes. They want to take care of thyroid disease, bone disease, pituitary disease, and I understand that. The waiting list to get a patient to see a diabetes expert in most big cities is six to nine months. That's problematic. We don't have enough diabetes educators, and they all tend to be centered around metropolitan areas. We've got a lot of people who don't live in metropolitan areas that have diabetes. So, continuous remote care, which is the hallmark of the Virta Health delivery system, goes to where the person with diabetes is. That's absolutely critical compared to waiting for that 15-minute visit four times a year. We now have data coming to us that allows us to get back in touch with them with a whole variety of mechanisms. We can say good job and encourage them. We can say, here's what's going on with your glucose. Here's what you need to do to change. It's an ongoing process, which is why we can affect change so much more quickly. The second factor is how we pay for healthcare. With very few exceptions, we're still in a fee-for-service environment. The more you utilize healthcare, the more you spend. And frequently, that really leads to perverse incentives that you do things because you can, not because that's what you ought to be doing. And instead, if you look at healthcare as a pay-for-performance, then you're paying for results. So, Virta has set itself up exclusively as a pay-for-performance process. So those are the two major advantages. Those are the two things. These are massive sociologic barriers for us, and I view those as the biggest challenges moving forward.

Albert: On that note, as we understand it, Virta places virtually all of its fees at risk. So, to us, that's a sign of confidence that your intervention works. Some may ask if in 20 years, the Virta model is going to work for every person with diabetes. Will there be people who might just be more suited towards the traditional model of care?

Dr. Ratner: Can you give me any example in medicine where one approach works for everybody? Statins are wonderful drugs. They prevent cardiovascular events, and 20 percent of people can't take them. Nothing works for everybody, and I would be naive to suggest that the Virta approach will be effective in 100 percent of people. The available data on nutritional intervention is really very, very simple. If you follow it, it works. If you don't follow it, it doesn't work. You look at the diabetes prevention program. Massive NIH collaborative trials that have all the money in the world to support nutritional intervention. And what did you see? You saw 7 percent weight loss in the first six months, sustained for another six months. And then over time, weight goes up. And DPP at 15 years, the metformin group had lost more weight than the lifestyle group had. If you can't sustain it, it doesn't work. The issue is, can you identify a dietary lifestyle intervention that (A) is effective, (B) is safe, (C) is durable and (D) is acceptable which people will follow. I don't pretend that everybody can follow the basic nutritional recommendations that Virta provides. For those though who can, it works. Have any of you ever been on a diet? If you talk to people who’ve been on diets, they will tell you it's really easy to lose weight, but then you get it all back. Most people start on anywhere from 10 to 20 diets. Weight goes down and then the weight comes right back up. Part of that is the ability to stick with it. Some people can do it, some people can't. What you see with the Virta intervention is that we have a nutritional program that results in very, very rapid falls in glucose, particularly postprandial. This accompanies very rapid decreases in the complexity and the cost of pharmacologic therapy within a week. You also see a very significant change in weight very, very quickly. These become the reinforcing characteristics to stick with something because you actually see a benefit.

When you look at our six-month, one year, and two-year data, what you see is an amazingly high retention rate as compared to Jenny Craig, Weight Watchers, and any of the research studies with weight loss drugs. The typical drop-out rate in an FDA regulatory trial of a weight loss drug is 50 percent. We have one-year retention rates of >80%. Part of that is the rapidity with which people see benefit. That becomes self-reinforcing, which they maintain. It’s a combination, both of the specific nutritional prescription with the constant feedback and reinforcement with the coaches that results in our outcomes.

Types of Providers Suited Towards Virta’s Model of Care

Albert:  What types of coaches or physicians are better suited for delivering care in a model like Virta’s? Are there certain characteristics that you would be looking out for if I put you in charge of hiring all other providers?

Dr. Ratner: That’s a great question, and I don’t know the answer.  The issue is how do we make our healthcare delivery and interventions better.  Part of the reason that I was brought in was to ask those questions, to set up the specific research question, to say, all right, let's talk only about the healthcare delivery system.

How can we predict which person with diabetes is going to respond to a totally technological approach versus that individual who requires a very high touch approach? I'm sure you guys have heard the concept of high-tech versus high-touch medicine. What's the interface there? We do both. One of the questions that I'm beginning to ask, and I do not have the answer yet, is if can we identify individuals who do best with a particular mix of high-tech and high-touch. Can we then test that hypothesis? By doing so, we then identify the kinds of providers that we need, some who are pure high tech, others who are predominantly high touch.

We have a group of providers right now that include board-certified, endocrinologists, board-certified internists, nurse practitioners. A mix, because that's what you need to take care of a mix of people with diabetes. Among our coaches, we have a predominance of RDs, but we also have social workers. We also have exercise physiologists. It becomes a mix. Each individual has different needs and requirements to succeed. We're trying to figure out if we can predict those. Can we make the assignments appropriately? That's the long-term goal. We’re a long way from that, but I don't know of anybody else who's even approaching the question.

Ani: If you look at the state of medical education right now, how well is it preparing current students?

Dr. Ratner: I have had very little input into medical school education for a very, very long time. I’m distressed by some of the things that I've seen. I'm optimistic about some of the other things that I’ve seen. Physical diagnosis is frequently not taught in medical schools anymore. That means you don't look at the patient, you don’t examine the patient, you don't listen to the patient. William Osler, a long, long, long, long time ago said, listen to your patient. They'll tell you what the diagnosis is. We don't do that anymore. We are disease oriented. We are clearly laboratory oriented.

Nobody listens to a heart anymore. What they do is they order an echocardiogram. Nobody listens to a chest anymore. They order a chest X-ray or a CT scan. I think that's problematic because the patient will tell you what's wrong. No laboratory study will tell you why a person is not doing well: I am an incredibly strong believer in data. I started using blood glucose monitoring in 1980. I started using CGM with Dexcom 3 studies probably 15 years ago. I believe in that data. If you show me a CGM readout, even if the new ones that are infinitely better than where we were, I can tell you what the Time in Range is for the individual. I can tell you the time in hypoglycemia, and I can tell the time in hyperglycemia. Unless I talk to the patient though, I can't tell you why, and I can't tell you how to resolve it. This is the high-touch, high-tech debate again, that we're really getting to. Only the person with diabetes can tell you why they're getting the findings that they're getting.

The other issue that I have problems with in medical education is the continued emphasis on acute disease management. Right now, I have no argument with COVID-19. No disagreement there. On the other hand, if you went back to November of 2019, the primary cause of death around the world was non-communicable diseases. That's not the case anymore, but that's how quickly it changes. The healthcare system and the medical education system has always emphasized acute disease. We know how to do stents and angioplasties for an acute embolus. We know how to do anticoagulant therapy for TIAs and acute stroke. We clearly have to take care of trauma, and when something like COVID-19 comes up, we need to deal with acute infections. All you have to do though is look at the areas that medical school graduates are going into today.  This primarily includes hospitalists. They don’t even get to know their patients because they’re treating a disease for a fixed period of time, and then they're gone. The next day, you get a new set of patients. They're going into emergency care, where, again, there's no continuity. They're going into ICU medicine where they have no history of what went on before, and they're not going to follow the patient once they leave the ICU.

Chronic disease has always been the stepchild, and the reasons for it are fairly clear. It's a lot more work. There is no short-term outcome that you can claim credit for. I can't go into diabetes clinic and leave saying, I saved three people today. Right? Surgeons do that all the time.

Chronic disease management is a new paradigm that we need to come to grips with, because once this pandemic is over with, it's going to be chronic disease once again that will be the leading cause of morbidity and mortality.

The Role of CGM at Virta and Beyond

Albert: Taking it back to Virta, what is the role for CGM there? More broadly, what is the role for CGM in some of the populations that currently don't have access?

Dr. Ratner: We are actually introducing CGM into Virta for a whole variety of reasons. Number one, it's a superb educational tool to be able to show if you have a therapeutic carbohydrate restriction on board, what happens to your postprandial glucose levels. Right? It becomes another educational tool and reinforcement. CGM can tell me whether or not -- even though they have an A1c of less than 6.5%, are they 100 percent time in range. In fact, we can take that time in range and make it normal and define all glucose levels in the normal range. We can say the A1c is in the sub-diabetic range. I'd like to prove that all glucose levels are in the non-diabetic range. I see a very important role of CGM in early care. The other question though is, what role does it play in general health care delivery for people with diabetes? That's highly problematic, and it's problematic in the standpoint of cost, availability, expertise. 

Let me give you some historical background when some key elements were initially introduced. You had to change the sensor every three to five days. They were expensive. They didn't give you readouts that were particularly useful. There were spaghetti plots of days, and people were going nuts because of the alarms. There were couples that were getting divorced because the spouse couldn’t tolerate all the alarms going off all night long. You had people who were throwing the devices in the toilet because they were so frustrated with all of the alarms and the fact that they couldn't do anything. Technology is only useful if they can affect change for the better and not simply to provide information. If that information doesn't go anywhere, it’s frustrating. Right? For the person who interprets CGM this week and sees I'm 10 percent time in range, 80 percent high, and 10 percent low, they get frustrated, particularly if next week it's exactly the same thing. How many healthcare providers know how to interpret CGMs and make the appropriate changes? How many of those have taught their patients to make the appropriate changes? It's a diminishing funnel. CGM, I think, right now is where fingertip blood glucose was in about 1990. These same arguments were being said about SMBG. Patients didn't want to stick their finger. It was inconvenient. It was expensive. What do we do with the information? Half the doctors never even looked at the glucose logs. Why am I wasting my time? CGM gives you a thousand-fold more information, which until recently was much harder to interpret. It's getting a lot easier and deserves an enormous amount of credit. Doctors though still don't know what to do with the information. Patients frequently don't know what to do with the information. I think that in five years, every single type 1 ought to be on a CGM if they're not on a closed loop system or a hybrid system.

For type 2, it's a little bit different. I think that in type 2, diagnostic CGM is critically important. If you've got an individual who's on metformin only and always had a hemoglobin A1c of 6.5%-6.7%, you don't need to do CGM. However, when that individual suddenly comes in and their hemoglobin A1c is 8%, you want to know what's going on. To do a 10-day or a two-week diagnostic CGM tells the physician what's going on. What can we do about it? If it's all postprandial highs at dinner, then that’s fine. You start working on what are they eating for dinner or if it’s their bedtime snacks and candy during the night. Otherwise, what you begin to do is you begin to say, all right, what's the appropriate intervention? Do we go from metformin only to SGLT2 or a DPP 4 or a GLP 1? Does this person need basal insulin? You can make the decision a whole lot quicker. I think intermittent professional CGM within 10 years is going to be an integral part of the management of people with type 2 diabetes.

Emily Fitts (The diaTribe Foundation): It's exciting to hear about Virta moving forward, even more so using CGM, including a focus on Time in Range, as you note. Can you say anything more about that?

Dr. Ratner: What has made Virta successful is this concept of bringing hemoglobin A1C down by greater than one percentage point absolute or within the normal range. Do people like that? Yes. It’s part of the payment plan that we have for pay for performance (ed. note – see “Virta now places 100% of fees at risk, tied to initial engagement milestone and one-year A1c reduction; strong payer move for the diabetes reversal clinic – November 15, 2018”). The bigger part is the impact on pharmaceutical costs when we de-escalate therapy. If, in fact, you go on the therapeutic carbohydrate restricted diet, the very first thing that occurs is you don't need as much or any prandial insulin. You don't need sulfonylureas, you don’t need DPP4s. As you continue, basal insulin can frequently be discontinued. Now the controversial aspect relates to GLP1 and SGLT2s, and I don't want to get into those because they have non-glycemic indications, and we don't mess with non-glycemic indications in terms of removal (ed. note – Dr. Ratner is referencing cardioprotection and renal protection associated with some GLP-1 and SGLT-2 inhibitors). If they don't have non-glycemic indications, we can get people off of those drugs too. The pharmaceutical cost to the plan or to the payer goes down. Think about the cost of insulin these days, especially if you go from 300 units a day to zero. That means you're saving the cost of a vial every day-and-a-half. If a vial is now $450, do the math. We’re not there yet, and I want to be open about that. Do I want us to get there? Yes, it’s a goal.

Kelly: We love the idea of patients being able to go off sulfonylureas, in particular – not having to gain weight from diabetes medicine, and not having to endure hypoglcyemia, that not only helps time in range, but it really helps engagement by patients. So does getting to take a medicine that can reduce or prevent cardiac and renal risk. What an opportunity for all of them to get to go to the Virta Health Clinic and have a doctor direct all this. There are so many ways in which the Virta Health Clinic has real potential to improve public health for individuals and on a population level – all the more so with you as a new leader at Virta, Dr. Ratner, joining so many other senior leaders there. Congratulations again to you and to the company for such an exciting new chapter!

Albert: Yes, thank you so much Dr. Ratner from our entire team. Thank you so much for spending this time with us.

 

--by Ani Gururaj, Albert Cai, and Kelly Close