Your Prescription Is Ready for Download
A close up of a doctor pointing at a smart phone, heralding the new era of prescription digital therapeutics.
You may be familiar with Moore's Law, the prediction made by Intel co-founder Gordon Moore that computer chips would get faster and cheaper with each passing year. That's been borne out by the explosive growth of the tech industry, but you may not know that there is an inverse Moore's Law for drug development.
What if there were a way to apply the fast-moving, low-cost techniques of software development to drug discovery?
Eroom's Law—yes that's "Moore" spelled backward—is the observation that drug discovery has become slower and more expensive over time, despite technological improvements. And just like Moore's Law, it's been borne out by experience—from the 1950s to today, the number of drugs that can be developed per billion dollars in spending has steadily decreased, contributing to the continued growth of health care costs.
But what if there were a way to apply the fast-moving, low-cost techniques of software development to drug discovery? That's what a group of startups in the new field of digital therapeutics are promising. They develop apps that are used—either on their own or in conjunction with conventional drugs—to treat chronic disorders like addiction, diabetes and mental health that have so far resisted a pharmaceutical approach. Unlike the thousands of wellness and health apps that can be downloaded to your phone, digital therapeutics are developed and are meant to be used like drugs, complete with clinical trials, FDA approval and doctor prescriptions.
The field is hot—in 2017 global investment in digital therapeutics jumped to $11.5 billion, a fivefold increase from 2012, and major pharma companies like Novartis are developing their own digital products or partnering with startups. One such startup is the bicoastal Pear Therapeutics. Last month, Pear's reSET-O product became the first digital therapeutic to be approved for use by the millions of Americans who struggle with opioid use disorder, and the company has other products addressing addiction and mental illness in the pipeline.
I spoke with Dr. Corey McCann, Pear's CEO, about the company's efforts to meld software and medicine, designing clinical trials for an entirely new kind of treatment, and the future of digital therapeutics.
The interview has been edited and condensed for clarity and length.
"We're looking at conditions that currently can't be cured with drugs."
BRYAN WALSH: What makes a digital therapeutic different than a wellness app?
COREY MCCANN: What we do is develop therapeutics that are designed to be used under the auspices of a physician, just as a drug developed under good manufacturing would be. We do clinical studies for both safety and efficacy, and then they go through the development process you'd expect for a drug. We look at the commercial side, at the role of doctors. Everything we do is what would be done with a traditional medical product. It's a piece of software developed like a drug.
WALSH: What kind of conditions are you first aiming to treat with digital therapeutics?
MCCANN: We're looking at conditions that currently can't be cured with drugs. A good example is our reSET product, which is designed to treat addiction to alcohol, cannabis, stimulants, cocaine. There really aren't pharmaceutical products that are approved to treat people addicted to these substances. What we're doing is functional therapy, the standard of care for addiction treatment, but delivered via software. But we can also work with medication—our reSET-O product is a great example. It's for patients struggling with opioid addiction, and it's delivered in concert with the drug buprenorphine.
WALSH: Walk me through what the patient experience would be like for someone on a digital therapeutic like reSET.
MCCANN: Imagine you're a patient who has been diagnosed with cocaine addiction by a doctor. You would then receive a prescription for reSET during the same office visit. Instead of a pharmacy, the script is sent to the reSET Connect Patient Service Center, where you are onboarded and given an access code that is used to unlock the product after downloading it onto your device. The product has 60 different modules—each one requiring about a 10 to 15-minute interaction—all derived from a form of cognitive behavioral therapy called community reinforcement approach. The treatment takes place over 90 days.
"The patients receiving the digital therapeutic were more than twice as likely to remain abstinent as those receiving standard care."
Patients report their substance abuse, cravings and triggers, and they are also tested on core proficiencies through the therapy. Physicians have access to all of their data, which helps facilitate their one-on-one meetings. We know from regular urine tests how effective the treatment is.
WALSH: What kind of data did you find when you did clinical studies on reSET?
MCCANN: We had 399 patients in 10 centers taking part in a randomized clinical trial run by the National Institute on Drug Abuse. Every patient enrolled in the study had an active substance abuse disorder. The study was randomized so that patients either received the best current standard of care, which is three hours a week of face-to-face therapy, or they received the digital therapeutic. The primary endpoint was abstinence in weeks 9 to 12—if the patient had a single dirty urine screen in the last month, they counted as a failure.
In the end, the patients receiving the digital therapeutic were more than twice as likely to remain abstinent as those receiving standard care—40 percent versus 17 percent. Those receiving reSET were also much more likely to remain in treatment through the entire trial.
WALSH: Why start by focusing your first digital therapeutics on addiction?
MCCANN: We have tried to build a company that is poised to make a difference in medicine. If you look at addiction, there is little to nothing in the drug pipeline to address this. More than 30 million people in the U.S. suffer from addiction disorders, and not only is efficacy a concern, but so is access. Many patients aren't able to receive anything like the kind of face-to-face therapy our control group received. So we think digital therapeutics can make a difference there as well.
WALSH: reSET was the first digital therapeutic approved by the FDA to treat a specific disorder. What has the approval process been like?
MCCANN: It's been a learning process for all involved, including the FDA. Our philosophy is to work within the clinical trials structure, which has specific disease targets and endpoints, and develop quality software, and bring those two strands together to generate digital therapeutics. We now have two products that have been FDA-approved, and four more in development. The FDA is appropriately cautious about all of this, balancing the tradeoff between patient risk and medical value. As we see it, our company is half tech and half biotech, and we follow regulatory trials that are as rigorous as they would be with any drug company.
"This is a new space, but when you look back in 10 years there will be an entire industry of prescription digital therapeutics."
WALSH: How do you balance those two halves, the tech side and the biology side? Tech companies are known for iterating rapidly and cheaply, while pharma companies develop drugs slowly and expensively.
MCCANN: This is a new space, but when you look back in 10 years there will be an entire industry of prescription digital therapeutics. Right now for us we're combining the rigor of the pharmaceutical model with the speed and agility of a tech company. Our product takes longer to develop than an unverified health app, but less time and with less clinical risk than a new molecular entity. This is still a work in progress and not a day goes by where we don't notice the difference between those disciplines.
WALSH: Who's going to pay for these treatments? Insurers are traditionally slow to accept new innovations in the therapeutic space.
MCCANN: This is just like any drug launch. We need to show medical quality and value, and we need to get clinician demand. We want to focus on demonstrating as many scripts as we can in 2019. And we know we'll need to be persistent—we live in a world where payers will say no to anything three times before they say yes. Demonstrating value is how you get there.
WALSH: Is part of that value the possibility that digital therapeutics could be much cheaper than paying someone for multiple face-to-face therapy sessions?
MCCANN: I believe the cost model is very compelling here, especially when you can treat diseases that were not treatable before. That is something that creates medical value. Then you have the data aspect, which makes our product fundamentally different from a drug. We know everything about every patient that uses our product. We know engagement, we can push patient self-reports to clinicians. We can measure efficiency out in the real world, not just in a measured clinical trial. That is the holy grail in the pharma world—to understand compliance in practice.
WALSH: What's the future of digital therapeutics?
MCCANN: In 10 years, what we think of as digital medicine will just be medicine. This is something that will absolutely become standard of care. We are working on education to help partners and payers figure out where go from here, and to incorporate digital therapeutics into standard care. It will start in 2019 and 2020 with addiction medicine, and then in three to five years you'll see treatments designed to address disorders of the brain. And then past the decade horizon you'll see plenty of products that aim at every facet of medicine.
The Friday Five: Artificial DNA Could Give Cancer the Hook
In this week's Friday Five, artificial DNA could give cancer the hook. Plus, research suggests that this daily practice can improve relationships, social media could be good for finding factual information, injecting a gel may speed up recovery from injuries, and a blood pressure medicine is promising for a long healthy life.
The Friday Five covers five stories in research that you may have missed this week. There are plenty of controversies and troubling ethical issues in science – and we get into many of them in our online magazine – but this news roundup focuses on scientific creativity and progress to give you a therapeutic dose of inspiration headed into the weekend.
Listen on Apple | Listen on Spotify | Listen on Stitcher | Listen on Amazon | Listen on Google
Here are the promising studies covered in this week's Friday Five:
- Artificial DNA gives cancer the hook
- This daily practice could improve relationships
- Can social media handle the truth?
- Injecting a gel could speed up recovery
- A blood pressure medicine for a long healthy life
9 Tips for Online Mental Health Therapy
Research shows that, for most patients, online therapy offers the same benefits as in-person therapy, yet many people still resist it. A behavioral scientist explains how you can use it to improve mental health.
Telehealth offers a vast improvement in access and convenience to all sorts of medical services, and online therapy for mental health is one of the most promising case studies for telehealth. With many online therapy options available, you can choose whatever works best for you. Yet many people are hesitant about using online therapy. Even if they do give it a try, they often don’t know how to make the most effective use of this treatment modality.
Why do so many feel uncertain about online therapy? A major reason stems from its novelty. Humans are creatures of habit, prone to falling for what behavioral scientists like myself call the status quo bias, a predisposition to stick to traditional practices and behaviors. Many people reject innovative solutions even when they would be helpful. Thus, while teletherapy was available long before the pandemic, and might have fit the needs of many potential clients, relatively few took advantage of this option.
Even when we do try new methodologies, we often don’t do so effectively, because we cling to the same approaches that worked in previous situations. Scientists call this behavior functional fixedness. It’s kind of like the saying about the hammer-nail syndrome: “when you have a hammer, everything looks like a nail.”
These two mental blindspots, the status quo bias and functional fixedness, impact decision making in many areas of life. Fortunately, recent research has shown effective and pragmatic strategies to defeat these dangerous errors in judgment. The nine tips below will help you make the best decisions to get effective online therapy, based on the latest research.
Trust the science of online therapy
Extensive research shows that, for most patients, online therapy offers the same benefits as in-person therapy.
For instance, a 2014 study in the Journal of Affective Disorders reported that online treatment proved just as effective as face-to-face treatment for depression. A 2018 study, published in Journal of Psychological Disorders, found that online cognitive behavioral therapy, or CBT, was just as effective as face-to-face treatment for major depression, panic disorder, social anxiety disorder, and generalized anxiety disorder. And a 2014 study in Behaviour Research and Therapy discovered that online CBT proved effective in treating anxiety disorders, and helped lower costs of treatment.
During the forced teletherapy of COVID, therapists worried that those with serious mental health conditions would be less likely to convert to teletherapy. Yet research published in Counselling Psychology Quarterly has helped to alleviate that concern. It found that those with schizophrenia, bipolar disorder, severe depression, PTSD, and even suicidality converted to teletherapy at about the same rate as those with less severe mental health challenges.
Yet teletherapy may not be for everyone. For example, adolescents had the most varied response to teletherapy, according to a 2020 study in Family Process. Some adapted quickly and easily, while others found it awkward and anxiety-inducing. On the whole, children with trauma respond worse to online therapy, per a 2020 study in Child Abuse & Neglect. The treatment of mental health issues can sometimes require in-person interactions, such as the use of eye movement desensitization and reprocessing to treat post-traumatic stress disorder. And according to a 2020 study from the Journal of Humanistic Psychology, online therapy may not be as effective for those suffering from loneliness.
Leverage the strengths of online therapy
Online therapy is much more accessible than in-person therapy for those with a decent internet connection, webcam, mic, and digital skills. You don’t have to commute to your therapist’s office, wasting money and time. You can take much less medical leave from work, saving you money and hassle with your boss. If you live in a sparsely populated area, online therapy could allow you to access many specialized kinds of therapy that isn’t accessible locally.
Online options are much quicker compared to the long waiting lines for in-person therapy. You also have much more convenient scheduling options. And you won’t have to worry about running into someone you know in the waiting room. Online therapy is easier to conceal from others and reduces stigma. Many patients may feel more comfortable and open to sharing in the privacy and comfort of their own home.
You can use a variety of communication tools suited to your needs at any given time. Video can be used to start a relationship with a therapist and have more intense and nuanced discussions, but can be draining, especially for those with social anxiety. Voice-only may work well for less intense discussions. Email offers a useful option for long-form, well-thought-out messages. Texting is useful for quick, real-time questions, answers, and reinforcement.
Plus, online therapy is often cheaper than in-person therapy. In the midst of COVID, many insurance providers have decided to cover online therapy.
Address the weaknesses
One weakness is the requirement for appropriate technology and skills to engage in online therapy. Another is the difficulty of forming a close therapeutic relationship with your therapist. You won’t be able to communicate non-verbals as fully and the therapist will not be able to read you as well, requiring you to be more deliberate in how you express yourself.
Another important issue is that online therapy is subject to less government oversight compared to the in-person approach, which is regulated in each state, providing a baseline of quality control. As a result, you have to do more research on the providers that offer online therapy to make sure they’re reputable, use only licensed therapists, and have a clear and transparent pay structure.
Be intentional about advocating for yourself
Figure out what kind of goals you want to achieve. Consider how, within the context of your goals, you can leverage the benefits of online therapy while addressing the weaknesses. Write down and commit to achieving your goals. Remember, you need to be your own advocate, especially in the less regulated space of online therapy, so focus on being proactive in achieving your goals.
Develop your Hero’s Journey
Because online therapy can occur at various times of day through videos calls, emails and text, it might feel more open-ended and less organized, which can have advantages and disadvantages. One way you can give it more structure is to ground these interactions in the story of your self-improvement. Our minds perceive the world through narratives. Create a story of how you’ll get from where you are to where you want to go, meaning your goals.
A good template to use is the Hero’s Journey. Start the narrative with where you are, and what caused you to seek therapy. Write about the obstacles you will need to overcome, and the kind of help from a therapist that you’ll need in the process. Then, describe the final end state: how will you be better off after this journey, including what you will have learned.
Especially in online therapy, you need to be on top of things. Too many people let the therapist manage the treatment plan. As you pursue your hero’s journey, another way to organize for success is to take notes on your progress, and reevaluate how you’re doing every month with your therapist.
Identify your ideal mentor
Since it’s more difficult to be confident about the quality of service providers in an online setting, you should identify in advance the traits of your desired therapist. Every Hero’s Journey involves a mentor figure who guides the protagonist through this journey. So who’s your ideal mentor? Write out their top 10 characteristics, from most to least important.
For example, you might want someone who is:
- Empathetic
- Caring
- Good listener
- Logical
- Direct
- Questioning
- Non-judgmental
- Organized
- Curious
- Flexible
That’s my list. Depending on what challenge you’re facing and your personality and preferences, you should make your own. Then, when you are matched with a therapist, evaluate how well they fit your ideal list.
Fail fast
When you first match with a therapist, try to fail fast. That means, instead of focusing on getting treatment, focus on figuring out if the therapist is a good match based on the traits you identified above. That will enable you to move on quickly if they’re not, and it’s very much worth it to figure that out early.
Tell them your goals, your story, and your vision of your ideal mentor. Ask them whether they think they are a match, and what kind of a treatment plan they would suggest based on the information you provided. And observe them yourself in your initial interactions, focusing on whether they’re a good match. Often, you’ll find that your initial vision of your ideal mentor is incomplete, and you’ll learn through doing therapy what kind of a therapist is the best fit for you.
Choose a small but meaningful subgoal to work on first
This small subgoal should be sufficient to be meaningful and impactful for improving your mental health, but not a big stretch for you to achieve. This subgoal should be a tool for you to use to evaluate whether the therapist is indeed a good fit for you. It will also help you evaluate whether the treatment plan makes sense, or whether it needs to be revised.
Know when to wrap things up
As you approach the end of your planned work and you see you’re reaching your goals, talk to the therapist about how to wrap up rather than letting things drag on for too long. You don’t want to become dependent on therapy: it’s meant to be a temporary intervention. Some less scrupulous therapists will insist that therapy should never end and we should all stay in therapy forever, and you want to avoid falling for this line. When you reach your goals, end your therapy, unless you discover a serious new reason to continue it. Still, it may be wise to set up occasional check-ins once every three to six months to make sure you’re staying on the right track.