On Aug. 25, 2017, Elizabeth Newlin, M.D., watched from her office window as rain engulfed the city. She was part of The University of Texas Health Science Center at Houston (UTHealth) ride-out team during Hurricane Harvey, the catastrophic storm that unleashed more than 50 inches of rain over six days, displacing more than 30,000 people and prompting more than 17,000 rescues.
“We knew after a disaster of that magnitude there would be an increase in demand for mental health care. At the same time, we knew that resources were already limited,” said Newlin, who serves as the associate executive director at UTHealth’s Trauma and Resilience Center. “Many people lost their cars, for example. Transportation to get to appointments became more of a challenge. … In the immediate hours and days following the storm, I started thinking, ‘Wow, we’re going to need to really think about how to triage and reach people in innovative ways because the needs are going to be overwhelming.’”
In response to the mental trauma left in Harvey’s wake, Newlin spearheaded an effort to create an app for mobile devices that would provide patients with the same psychiatric support they would receive in the clinic.
UTHealth partnered with Magellan Health to create the On to Better Health app, which officially launched in January 2019. The app, which is available to all UTHealth Trauma and Resilience Center patients free of charge, offers six different programs: MoodCalmer for depression, which helps break the cycle of negative thinking; FearFighter for anxiety, panic and phobias, which helps users confront and change their thoughts; ComfortAble for chronic pain; Restore for insomnia and sleep problems; OCFighter for obsessive compulsive disorder; and Shade for alcohol and substance abuse. Each module contains between 4 and 10 sessions that last from 25 to 50 minutes.
“It’s not unusual for me to recommend an app to one of my patients,” Newlin said. “There’s an app for just about everything now.”
The app has undergone 12 clinical trials and covers the selected conditions because of their prevalence among the adult population, said Summer Danner, program coordinator at UTHealth.
“These conditions are present in over 25 percent of all adults and make up 90 percent of behavioral health complaints,” Danner said.
The app uses cognitive behavioral therapy (CBT), which is considered the gold standard of psychotherapy for treating a wide range of mental health issues. Experts tout it as an extremely effective, evidence-based intervention for psychological disorders without a high price tag or potential side effects from psychotropic drugs (including antidepressants, antipsychotics and mood stabilizers), which work by influencing the neurochemicals that regulate emotions and thought patterns.
“CBT is a type of talk therapy that helps people identify and develop skills that help them change their negative thought patterns and behaviors,” Newlin explained. “By changing their negative or distorted thoughts or behaviors they’ve developed over time as a result of living with pain, for example, they can change their awareness and develop better ways to cope with that pain— even if their actual physical level of pain stays the same. In other words, the focus can shift from ‘I have to get rid of this pain. I have to stop this pain’ to ‘How can I live more effectively and experience my life differently despite this pain?’”
A spoonful of software
UTHealth’s On to Better Health app is just one example of a new, emerging trend in medicine called digital therapeutics.
“[Digital therapeutics] is a digital product delivering an intervention to a patient with a goal of preventing, managing or treating a disease or optimizing medication,” said Megan Coder, executive director of the Digital Therapeutics Alliance, a non-profit trade organization.
Delivering personalized medicine with a few taps and swipes on patients’ smartphones is the next medical frontier.
According to McKinsey & Company, a global management consulting firm, there are two types of digital therapeutics: digital companions, used to augment treatments along with a health care provider; and replacement therapies, which—as the name suggests— potentially replace traditional pharmaceutical drugs.
Much like UTHealth’s On to Better Health app, the U.S. Department of Veterans Affairs (VA) developed several digital companion apps for veterans suffering from post-traumatic stress disorder (PTSD), substance abuse, anger management and concussions, to use in conjunction with a health care professional. The VA’s PE Coach app uses prolonged exposure to teach veterans how to confront PTSD-related memories, fears and situations. Using the app, patients can record their PE therapy sessions, track PTSD symptoms and access homework and exercises to decrease anxiety.
But can software code replace pharmaceuticals?
One digital therapeutic that replaces a drug is Akili Interactive’s video game to treat children with autism spectrum disorder (ASD) and attention deficit-hyperactivity disorder (ADHD). While antipsychotic drugs and stimulants are used to treat ASD and ADHD, respectively, Akili’s video game uses software as a primary treatment. The game targets specific cognitive neural systems in the brain to deliver sensory and motor stimuli. As the child plays the game, the program trains the brain to filter out distractions, focus on multitasking and improve memory.
“We’re always looking for drug alternatives—things that will reduce the risk of adverse effects or longterm effects that medications are having on patients that we still don’t necessarily know a lot about, particularly in the mental health space,” said Lance Black, M.D., associate director of the TMC Innovation Institute. “There are mechanisms of action that we don’t quite understand how these drugs are working, quite frankly, when it comes down to the biochemical processes. We just know that they have positive effects on some patient populations. But it’s always concerning when there are questions around what else the drug is doing—not just immediate adverse effects, but long-term. Is it changing the neurochemistry? Is it causing things that we won’t recognize until five, 10, 15 years later?”
Not to be confused with health and wellness apps
Digital therapeutics shouldn’t be confused with apps like FitBit or Calm, the meditation and relaxation tool. Unlike the 320,000-plus health and wellness apps flooding the marketplace, such as sleep trackers and fitness guides, digital therapeutics sets itself apart by conducting pre-market randomized clinical trials to demonstrate a very real and measurable clinical value.
“Health and wellness products are fantastic,” Coder said. “But if digital therapeutics are assumed to be in that health and wellness space only, they may not be given the recognition they need. … This is not just an app. This is a health care delivery tool that is clinically validated.”
Education is one of the biggest issues facing digital therapeutics.
“Trying to convey to patients, providers and payers and regulatory agencies what these are and what these are not is really important,” Coder said. “It’s going to be a shock for providers and patients when these are prescribed.”
In addition, technology advances faster than regulators can keep up.
“Historically, health care has been slow to implement disruptive technology tools that have transformed other areas of commerce and daily life, such as ride-sharing apps and virtual home assistants,” said Bakul Patel, associate director for digital health at the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health. “These digital health products are creating an opportunity for medicine and health care to reach patients outside the clinic and deliver therapies that can be personalized to the individuals. One factor that can allow this potential to be realized, among many, is the regulation that accompanies medical products.”
In 2013, a group of global medical device regulators formed the Software as a Medical Device Working Group to develop policies and a common framework for this new and nebulous application of existing technology. Chaired by Patel, the group established key definitions, framework for risk, and more.
Since then, the FDA has taken steps to encourage more development and greater innovation in the digital health arena. In 2017, the agency launched the Digital Health Innovation Action Plan to establish policies, add expertise and implement a software precertification pilot to bring clarity and efficiency to the regulation of digital health products.
Investors poured a staggering $12.5 billion into digital health ventures in 2017 and 2018—representing a 230 percent increase in investments compared to 2013 when Software as a Medical Device was formally introduced, according to PricewaterhouseCoopers Health Research Institute’s annual report.
In many ways, this sets up 2019 as a pivotal year for digital therapeutics. While there are already several apps that have been cleared by the FDA—among them, Pear Therapeutics’ opioid use disorder treatment program reSET-O and WellDoc’s mobile diabetes management platform BlueStar—the massive injection of money into digital health has lit a fire under the FDA.
In January 2019, the FDA announced the Digital Health Software Precertification (Pre-Cert) Program test plan, part of the Digital Health Innovation Action Plan, to establish a regulatory framework for evaluating new digital health products.
“Our approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation,” Patel said. “This requires us to take modern, flexible, risk-based approaches to regulation in this area, which we hope will reduce the time and cost of market entry, while assuring appropriate patient safeguards are in place. ”
David versus Goliath
Digital therapeutics tout a variety of benefits. These apps eliminate the physical barriers of accessing health care, minimize the risk of side effects from drugs and can track and generate real-world patient results and data—all while driving down health care costs.
Sleepio, Big Health’s CBT app to treat insomnia, costs about $400 a year, whereas Ambien, a prescription sedative often prescribed for sleeping disorders, costs $73 for six tablets, according to MIT Technology Review. And instead of paying $63 for a 30-tablet Xanax prescription, UTHealth’s On to Better Health app offers anxiety treatment for free. Studies conducted by Magellan Health showed that patients who used the On to Better Health app experienced a 63 percent reduction in symptoms and a 49 percent reduction in direct costs.
Yet digital therapeutics start-ups must be prepared to face off against the pharmaceutical industry in a David-versus-Goliath battle.
“When drug companies start to compete against things like digital therapeutics, watch out because it’s a huge industry,” Black said. “They not only have the money, they have the influence, the power, the downstream assets—everything a company that’s new and up-and-coming will have difficulty struggling against.”
Black, who has shepherded dozens of start-ups through the TMCx accelerator, said digital therapeutics companies need to accept a “cold dose of reality.”
“What I think people oftentimes fail to see, especially in the health care industry, is that even though you’re better, it doesn’t mean you’re going to get the lion’s share of the market,” Black said. “If you discover a medication, for instance, that’s better than the current standard of care, it’s really challenging to be able to get that market share to sustain that company. Digital therapeutics faces that same challenge. They could be better than an antidepressant medication, for instance, but they’re going up against large companies that have an established base and have millions of patients.”
Return The Favor: Glowing green for Veterans https://t.co/w7LwFweRyD via @abc27News
@j_rodricks1 @MJEjags @katyisd We are so grateful for these blood donations. They make a huge difference in our cancer patients’ lives. Thank you.
Thousands of patients in need of heart surgery may soon have a new option. Read more: https://t.co/3p9SO6C3xz. https://t.co/PZ71Ui3vkB
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@MDMagazine Thanks for the shout-out
After a surprise diagnosis at age 36, Paula Carrillo finds success with overcoming stage 2A #colorectalcancer with Dr. Michael Overman: https://t.co/iVnpQGygSR #CancerMoonshot #endcancer
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Two of the graduate education programs at Cizik School of Nursing at UTHealth were ranked among the highest in the nation in the just-released 2020 edition of the Best Graduate Schools guide by U.S. News and World Report.
Veteran reopens family business in Sweetwater https://t.co/no8JZ6xvjW via @MCADnews
Angiogenesis is the process of creating new blood vessels. Learn how angiogenesis inhibitors work in treating cancer: https://t.co/z42nWglE58 #endcancer
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Today’s #VeteranOfTheDay is Army Veteran Aida Nancy Sanchez. Aida served during the Vietnam War from 1952 to 1976.Aida was born in Santurce, Puerto Rico in November 1931. She graduated at the age of 15 and won a scholarship to attend St. Mary of the Woods College in Indiana. She graduated in 1952 with a bachelor’s degree in biology and chemistry. Upon graduation, she applied and was accepted into the army physical therapy school program with an age waiver due to being under 21 at the time. Aida then headed to Fort Sam Houston, Texas to attend and graduate from the program in 1953. This is where she also met then General Dwight Eisenhower. Afterwards, she was assigned to the Brooke Army Medical Centre at Fort Sam Houston then to Fitzsimmons Army General Hospital in Denver, Colorado around 1956. During this assignment, Aida met President Eisenhower when he came to visit his friend whom was her patient. She stated that he remembered her from the physical therapy school and sent a pot of stew he made a day or two after the visit.After she completed her assignment at Fitzsimmons, she was sent to Rodriguez Army Hospital in Puerto Rico until she was discharged from active duty and went into the army reserves for two years. During that time, Aida worked for the Edward Hines Jr. VA Hospital in Hines, Illinois for a year before becoming the Director of the Bureau of Crippled Children within the Department of Health of Puerto Rico. During her time in Puerto Rico, she received a letter from the Department of Defense stating that they needed more physical therapists, so she decided to return to active duty. Her first assignment was the burn unit at Brooke Army Medical Center, then she was sent to Fort Bragg, North Carolina for a year or two. Afterwards, Aida was sent to Fort Myer, Virginia to establish a physical therapy clinic within the Andrew Rader Clinic at the Walter Reed Army Medical Center. Once setting up the unit, Aida was sent to graduate school at the University of North Carolina at Chapel Hill and upon graduation was assigned to Letterman Army Medical Center to oversee the clinical affiliations of five universities located near the hospital.Aida’s next assignment was to become the assistant chief of physical therapy at the Tripler Army Medical Center in Hawaii before she received orders to deploy in support of the Vietnam War in 1970. She was originally sent to the Army hospital in Saigon to replace the physical therapist but was routed to the 95th Evacuation Hospital near Da Nang to establish the first physical therapy clinic within the hospital. During her tour of duty, Aida was extended to deploy to Cambodia and assist then President Lon Nol because she had previously helped him during his stay at the Tripler Army Medical Center. She was constantly flying back and forth between Vietnam and Cambodia to help the president get physically better. She assisted many American and Cambodian soldiers and citizens with their physical therapy needs while deployed. After Aida redeployed, she was sent to Fort Gordon as the chief physical therapist who oversaw the transfer of the physical therapy clinic from older barracks into the newly built Eisenhower Army Medical Center. It took about six years to complete the task and Aida retired as a Lieutenant Colonel shortly after with about 24 years of service.Thank you for your service, Aida!
Join us, @TexasChildrens and @SPARKforAutism at a Community Awareness Research Event for underrepresented communities this Saturday. Register here: https://t.co/uNhKL7aXnM #autism #autismresearch https://t.co/KBpDj7yRQD
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Learn how Dr. Lisa Hollier is helping to shine a spotlight on maternal mortality and working to make childbirth safer for women around the world. #OBGYN
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"With all of this support and love, it’s difficult to not be positive. Of course, some days were harder than others. I still remember how weak I sometimes felt and how uncomfortable it was to wear a pump after chemo," says Paula Carrillo."Still, I won’t complain. Despite the sudden bad news, I got a second chance, thanks to my family, my friends and my team at MD Anderson." #endcancer