In 2062, the world may be a futuristic utopia with elaborate robotic contraptions, holograms, and whimsical inventions, like flying cars that morph into briefcases after sending the kids in glass pods to Little Dipper Elementary. The outer-space home is filled with push-button conveniences including 3D food printing technology along with real-time virtual visits with care providers.
This now not-so-distant future—the premise of the popular American animated sitcom The Jetsons that hit the airwaves in 1962—might be nearer than we think, especially the part regarding healthcare.
The idea of patient-centric, personalized, and at-home medicine is no longer a theory, let alone a wild idea whipped up by the imagination of Hanna-Barbera cartoonists from 60 years ago. It’s precisely the type of healthcare that Jay G. Wohlgemuth, MD. senior vice president, R&D, medical and chief medical officer at Quest Diagnostics, thinks is just at our fingertips. In his eyes, a healthcare system with a seamless, highly engaging, and online medical experience around preventative and chronic care is not out of reach.
Wohlgemuth envisions all the necessary information—questionnaires, blood samples, biometrics (e.g., waist circumference and height)—will enable preventive care recommendations at home. “It’ll be done by artificial intelligence and reviewed by a clinician, who can run through the analysis and check off prescribing cholesterol medication or sending a colorectal screening kit for cancer,” said Wohlgemuth. “You will only have to come in to see a doctor or go to a health care system when there is an issue like getting a knee replacement.”
House calls 2.0
One of the silver linings of COVID is that people looked for ways to interact with health care from the comfort of their own homes. Coming out of the pandemic, people now embrace, appreciate, understand, and trust at-home testing and telemedicine more. Virtual models like Telehealth do not require patients to go to a pharmacist, have a laboratory test, or even visit their physician to relay any of this information.
And beyond COVID, telemedicine has an important role in our healthcare. “Take the example of people in remote areas, like Appalachia and the Gulf States, who live hundreds of miles away from a pharmacy or are homebound but should continue to have access to healthcare and, more so, precision medicine,” said Jeffrey A. Shaman, PhD, MS, the chief science officer at Coriell Life Sciences (CLS). “What’s more, academic health centers are not typically in rural areas, and that’s where some cutting-edge work is being done. To get those living in the Bayou to benefit from the work these good academic institutions are doing, we need to reach out and make at-home healthcare easier and less intimidating.”
The irony of the situation, to Shaman, is that doctors used to go to people’s homes making house calls. “We’re kind of returning to house calls in a way,” said Shaman. “We’re also enabling patients to have the specialist show up and not just the family doctor. Precision medicine is about giving people the power to ask questions and be advocates of their own healthcare in a comfortable environment.”
Shaman points to a study demonstrating that at-home testing and care outcomes result in clinical and economic improvements. Comparing members that opted into the program to those who did not (i.e., identified interventions and controls, respectively), the paper demonstrates an average calculated $218.34 savings per patient per month. Those people with comprehensive medication management who spoke with a pharmacist to create a medication action plan, those participants never had to leave the comfort of their homes for any of this. Moreover, there was a 1.9%, 6.8%, and 14.9% reduction in the outpatient emergency department and inpatient events, respectively, suggesting an increase in the use of sound, scalable health care.
User acceptance has gone up not only from a patient perspective but also gained traction from the physician’s standpoint. With telemedicine and at-home testing, physicians don’t need to feel like they must be geneticists, radiologists, oncologists, cardiologists, etc. when they have a pharmacist and specialist assisting them through this at the center of care. “We find that the physicians have been more willing to integrate and adopt pharmacogenomics into their practice when they have the pharmacist to help because now, they don’t have to be a specialist in every medication,” said Shaman.
On top of that, Shaman would have assumed that the new generation of doctors would be dialed into all this new tech, whilst a lot of the geneticists and older generation of doctors would say that they didn’t need it and already knew everything. To his surprise, Shaman found that it was the other way around. “Some older doctors said that while they always had a hunch, they would much prefer if they could give their patient a test and get an actual scientifically-based result.”
We (almost) have the technology
In addition to patient and provider adoption, there are significant barriers to the widespread adoption of patient-centric, precision medicine. For example, the technology infrastructure needs to be built to have a seamless interaction that interfaces with the complicated existing healthcare IT systems and electronic medical records (EMRs). Wohlgemuth said, “It’s not just that we must develop software that will engage you. We must do it in a way that links into that healthcare system, which is pretty fragmented. The software to engage you around your preventative care and telemedicine, that all exists, but figuring out how to make all the software come together is a whole other challenge.”
Another barrier is that more home-based diagnostics need to be validated. One of the significant breakouts of the COVID pandemic was the conversion of respiratory viral testing to home-based self-collection. Showing off one of Quest’s new self-collection devices for serum plasma or blood, which gets plenty of liquid to enable lots of testing, Wohlgemuth said that the technology exists today but needs to be validated and brought to market for many indications, such as diabetic and transplant monitoring panels, and preventative care. He thinks that 90% or more of lab testing can be done from home, a home-based phlebotomist, a patient service center, or a retail site. “You need the home-based lab to bring it to life at scale. 95% of preventative healthcare can be done at home with telemedicine and electronically prescribing for labs and drugs when those components are in place.”
While there has been so much growth in the genomics space, with more and more human samples being sequenced, accessing genomics data is far from ubiquitous. It is not commonplace for a person to be able to access their genomics data, and have it kept in a useful format for future analysis as our health changes over time. “There’s a development on the horizon now, via a collaboration between Quest and Boston Children’s Hospital, to give you your genomic data on a zip drive or a cloud in a standardized format so that anyone in the future at your behest can analyze your genetic data for you,” said Wohlgemuth. “If you had a whole-exome in a physical format or on the cloud, you could have a clinician look at it any number of years from now.”
Breaking the healthcare mold
While we already have a lot of technology, Wohlgemuth thinks it takes a long time to implement change in the healthcare system. The U.S. healthcare system was built around physicians and hospitals when things couldn’t be done remotely because we didn’t have the technology, resulting in an extensive, concentrated healthcare system localized to hubs. Until the last ten years, the whole model was to bring patients to the healthcare setting for everything, even for a doctor to have a conversation with a patient to communicate that they need to have ‘labs’ done. Physicians and healthcare systems are paid to see people in person and perform procedures.
However, this vision is happening at a glacial pace in the US standard, brick-and-mortar health systems. Wohlgemuth thinks this is partly because the incentives are not aligned. “I’m very optimistic that all the pieces are there, but incentives are still a problem because the current healthcare system is still mostly ‘fee for service,’” said Wohlgemuth. “There’s a real incentive to do things to people and to see people in person with facility charges. Healthcare should be designed around the consumer. We have all these tools, so how can we make it happen?”
But it is not as if these trends toward patient-centric health can’t also benefit insurers and health systems. Wohlgemuth thinks it makes a lot of sense for someone managing spending at a health plan to ensure that if people can get tests done at home or a retail location, it will be much cheaper for the insurers. But there’s still a lot of pushback from the insurer side.
One trend in this space that Wohlgemuth is excited about is employer healthcare. “In an employer-sponsored self-insured health plan, which is where 90 million people get their healthcare right in the US, the incentives are pure because employers run their health plan,” said Wohlgemuth. “At Quest, we have 60,000 members for an average of 10 years, some of them for 40 or 50 years. We are paying for all their healthcare. At the same time, they’re paying for a piece of it. We’re on the hook for their healthcare. So, when you’re in that environment, all the incentives are suddenly aligned: improved patient experience, lower cost of healthcare, and improved outcomes.”
Wohlgemuth thinks that the best way to do that is to deliver directly to the employees in their homes in a virtual primary care experience. “It’s a thing of beauty because we’re doing our employees a great service, and we’re not paying an outrageous amount for it. The reality is a lot of people are not going to have healthcare unless the employer provides it. They’re not going to wander in to see a doctor. So, the employer healthcare arena is where consumer-driven healthcare comes to life.”
The preventative care paradox
Michael E. Chernew, PhD, Professor of Health Care Policy at Harvard Medical School, said that, in a fee-for-service system where people get paid for what they do, there’s a lot of concern that testing and treatments are overdone. “There are sometimes limits on how certain types of services are reimbursed, which might make it challenging in our current fee-for-service system to use those types of care,” said Chernew. “In other words, we will restrict access to a certain number of tests or limit the provider network in ways that may be considered impediments to patient-centered care.”
The economics of preventative care is very case-dependent. For example, Chernew doesn’t think that more testing saves money. “More testing doesn’t save money, even if it’s used for preventative care,” said Chernew. But he doesn’t think that the healthcare system should ignore at-home tests. “Like every other medical service, testing can be underdone and overdone. The more people are tested, typically, the more money gets spent. That doesn’t mean there aren’t examples of testing that couldn’t save money. But as a general premise, if you take a population and dramatically increase the amount of testing, you will increase the spending. You may improve health in ways, but it’s very case dependent.”
Even in the case of preventative testing, Chernew thinks lots of money is wasted. For example, a system of continual testing that is very aggressive will, just by chance, get false positive results that don’t necessarily indicate a health problem. “If I just were to take your blood pressure hourly, I’m going to find some readings that are above normal and may decide that I’m now going to put a patient into a protocol, which could end up being bad for your health and spending,” said Chernew. Getting more information is applicable only if it’s integrated wisely. While there was already plenty of high-tech at-home testing that could be brought into healthcare, the COVID era has triggered a boom in the development of at-home testing. But Chernew cautions that at-home testing must be used practically and not be overdone, saying, “While I’m not opposed to at-home testing, I also don’t believe that everything at home will make things cheaper and more information automatically makes care better.”
Ideally, the financing system would be set up to separate these services’ high- and low-value utilization. Because the world is so complex, the financing system is imperfect. On the one hand, we’re often being too permissive—encouraging a lot of utilization that probably shouldn’t be done but making sure we get all the high-value use. On the other hand, we’re often too restrictive; in other words, our concern about overuse may impede access to high-value things, even if it’s cutting out low-value items. The system’s merits boil down to how well we can develop financing, information, and technology to get that level of clinical nuance where we are promoting the use of high-value tests.
Chernew said whether a test is high- or low-value depends on the context. For example, when testing many low-risk people, there will be many false positives, depending on how low-risk they were. “When many people are tested, there will be many more findings, which might be good, but, on the other hand, it might be harmful,” said Chernew. “So, the testing paradigm needs to be thought through thoroughly. If I took an otherwise healthy person and gave them remote patient monitoring for various conditions, I’m much more likely to mess things up than make things better. But if I took somebody who I knew had a lot of conditions in terms of fluctuation in their blood sugar, remote patient monitoring might help.”
“I think we haven’t yet fully understood the ramifications,”said Chernew. “Even then, most patient monitoring has a lot of potential. But there are a lot of risks and challenges associated with remote patient monitoring.” Chernew said that there’s a lot to be done to understand how to use it and how to use it differently based on different patients. It’s a question of building in the structures to understand the information and how it will be used. “How you build the systems around using that information matters because it’s not evident that the care patterns would be better if everybody were tested way more,” said Chernew.
Shaman pushes back on the idea that too much testing will lead to more unnecessary issues. “I understand that too much data will overwhelm our physicians, but the resolution afforded to us by new assays and new tests has, for the most part, been helpful. If we follow the science and understand the outcomes, we can use that resolution to increase our understanding of where the threshold should be. Without the data, we can’t make those determinations.” Shaman thinks that precision health should use as much information as possible. For example, take pharmacogenomics. Suppose the goal is to improve medication management. In that case, Shaman imagines that the health care system will want to ensure that all the risks associated with a patient’s medication regimen, such as drug-drug interactions, are accounted for. The key, according to Shaman, is that the data needs to provide medically relevant and clinically actionable results.
Dialing in dosages
But now, we are seeing more approaches beyond pharmaco-genomics and individualized treatments tailored to genetics as precision medicine. There are many drugs where physicians will make a diagnosis, write a script, and three months later, they come back and ask a patient how they are feeling. But patients can only really remember the last few days—not the last three months. So, the level of information that the clinician is using to decide is minimal, yet that information could potentially warrant a dose change. If that information can be captured to create an aggregated view of the last few months, clinicians may be able to decide whether a dosage should go up or down.
There’s a huge opportunity space for precision medicine in dosing. “Precision medicine has often been viewed as the domain of high-cost oncological drugs,” said Hakim Yadi PhD, CEO of Closed Loop Medicine—a U.K.-based TechBio healthcare company developing combination products of drug and software, where the software, as a medical device, informs the precision care of that therapeutic and changes the dose of that therapy. “But every drug needs to be given in a precise way. That’s where we are trying to get to, which is a grand vision. We should consider dose optimization of every therapeutic, old and new.”
Yadi believes that the vision for how you do that is through combination therapeutics that link digital health with existing therapeutics. “Every time a patient takes a drug, the dose that will deliver the optimal balance of benefits versus unwanted effects should be prescribed. But it’s not. There’s a lot of ‘one size fits all’ and guesswork. And little follow up of the patient to fine tune.,” said Yadi.
The British company’s approach includes a Software as a Medical Device dosing engine. An important aspect is taking an outcome-focused approach, with dose adjustment based on longitudinal data. That data may be coming from a diagnostic, device, or patient recorded outcome, whatever it is that’s required to give the feedback loop to inform the optimization of that therapy. Closed Loop Medicine has taken a 21st-century medicine approach, incorporating elements of a pharma company along with big tech, to drive efficiencies in healthcare delivery and deliver better outcomes for patients through precision medicine.
Many elements need to come together to deliver this: quality systems, technical, regulatory and commercial. This is all platform, with the therapies and data collected, depending on the indication. Closed Loop Medicine is not changing the ingredients of the standard of care, just optimizing how they are used. “If we take blood pressure management for hypertension, currently this involves a blood pressure cuff reading, although the technology is evolving fast,” said Yadi. “We want to work with the existing standard of care technology, but integrate new tools as they emerge. Another indication that we are looking at will require a blood test and a resulting lab result. The engine is the same, the inputs and outputs are different.”
Personalized printed prescriptions
Today, many patients are coming through the door for things that could have been done remotely in an automated way. In the future, diagnostics and combination medicines will help inform clinical decision-making. Safely automating that decision-making, incorporating appropriate AI approaches, will be the big tech transformation that ultimately happens. Availability of clinicians is arguably now the biggest health challenge and freeing patients from dependency of frequent doctor interaction will improve quality and cost. That is the future to which we are building. Closed Loop Medicine is applying its platform to a whole range of therapeutics. “If you look at the pharmacopeia, there’s only a handful of very well-dosed drugs, such as warfarin and insulin,” said Yadi. “But that trail quickly disappears.”
So, Yadi’s long-term vision is a more tailored opportunity for individual patients. “We are doing our own drug development, working with drug manufacturers to develop our formulation that will lend itself to a more tailored approach,” said Yadi. “Although we’re far away from an Amazon drone-delivered 3D-printed pill, we are mindful of laying the right foundations. I believe we are making significant steps towards that.”
Yadi imagines that today’s children will be telling their parents in twenty years: When you were younger, they used to give you medicine but didn’t know if it was going to work or if the dose was right for you. That’s mad!
Jonathan D. Grinstein’s wonder for the human mind and body led him to an undergraduate education in Neural Science and Philosophy and a doctorate in Biomedical. He has 10 years of experience in experimental and computational research, during which he was a co-author on research articles in journals such as Nature and Cell. Since then, Jonathan hung up his lab coat and has explored positions in science writing and editing. Jonathan’s science writing work has featured in Scientific American, Genetic Engineering and Biotechnology News (GEN), and NEO.LIFE.