depression
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In what could be the first step in the development of a significant new line of business for the telemedicine prescription provider Ro, the company is finally announcing the general commercial availability of weight loss product, Plenity.
Developed by Gelesis, a biotech company that makes treatments for gastro-intestinal disorders, Plenity is a weight loss treatment that uses citric acid and cellulose to create a non-toxic paste that makes people feel more full after they ingest it. Taken before meals, the pill becomes a substance that expands to take up about 25% of the stomach, so people eat less.
The product has been approved by the U.S. Food and Drug Administration and is available for a much broader segment of the population than other weight loss products. While most prescription medicines are intended for people who are obese, the Gelesis product is made for people who are overweight, too.
“That’s adults who have a BMI from 25 up to 40. That’s 150 million Americans,” according to Gelesis chief commercial and operating officer, David Pass.
Plenity received FDA approval last April, and Gelesis started working with Ro soon after, according to Pass. The idea was to craft a strategy that could get the treatment, which is classified as a medical device and not a drug, in the hands of as many patients as quickly as possible.
For Ro, the agreement with Gelesis is a sign of potential things to come. The company is the exclusive online provider of the Plenity treatment and Ro founder Zachariah Reitano said that there’s an incredible potential to engage in more of these types of deals.
“We would love to be able to partner with pharmaceutical companies to decrease the cost of distribution,” said Reitano. “We were excited to build an exciting treatment solution for weight management. Our high-level mission is to be the patient’s first call.”
With the Gelesis partnership Ro can add another highly desirable treatment to its roster of therapies — and one that can be a contributing factor to increasing the severity of other conditions that the company already provides treatment for, Reitano said.
“There are a few conditions that we currently treat that are exacerbated by a patient being overweight or obese. People who struggle with weight management will also experience ED. Obesity can lead to heart failure, stroke, coronary heart disease, hypertension, depression,” Reitano said. “The breadth of the label is interesting. Only FDA approved with a BMI from 25 to 40. FDA approved treatment have been between 30 and 40. [It] makes the treatment more accessible to a wider variety of people.”
As the only online provider of the treatment, Ro has developed an onboarding process to ensure that the Plenity therapy isn’t abused by people who suffer from eating disorders.
“During our onboarding we not only ask questions to patients about their weight management. There’s a consecutive set of images that need to be uploaded and taken with the provider. That’s something we’ve taken a lot of time and energy to make sure about,” said Reitano.
Like the other treatments Ro offers, Plenity is a cash-pay prescription, because the weight loss treatments aren’t typically covered by insurance, he said.
The benefit of working with an online pharmacy like Ro to provide distribution for a new therapy was obvious to both startups.
“We turned this market on its head by putting the consumer at the heart of everything we do,” said Pass. The treatment costs $98 per month, compared to other therapies or branded medications that could be as much $300 and $350 per month, according to Pass.
One reason that Gelesis is able to reduce the price of the drug is that it won’t have to hire a massive sales force to pitch it. The company has Ro for that.
“Normally you have a pharmaceutical company that would have to hire a sales force and go door to door and it increases the cost of a new drug. [Ro] can make a new, innovative treatment, like Plenity, available nationwide,” Reitano said.
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Telehealth, or remote, tech-enabled healthcare, has existed for years in primary medical care through companies like Teladoc (NYSE: TDOC), Doctors on Demand and MDLIVE.
In recent years, the application of telehealth had rapidly expanded to address specific chronic and behavioral health issues like mental health, weight loss and nutrition, addiction, diabetes and hypertension, etc. These are real and oftentimes very severe issues faced by people all over the world, yet until now have seen little to no use of technology in providing care.
We believe behavioral health is particularly suited to benefit from the digitization trends COVID-19 has accelerated. Previously, we’ve written about the pandemic’s impact on online learning and education, both for K-12 students and adult learners. But behavioral health is another area impacted by the fundamental change in consumers’ behavior today. Below are four reasons we think the time is now for behavioral health startups — followed by five key factors we think characterize successful companies in this area.
Traditional behavioral healthcare is cost-prohibitive for most people. In-person therapy costs $100+ per session in the U.S., and many mental health and substance-use providers don’t accept insurance because they don’t get paid enough by insurers.
By contrast, telehealth reduces overhead costs and scales more effectively. Leveraging technology, providers can treat more patients in less time with almost zero marginal costs. Mobile-based communications enable asynchronous care that further helps providers scale. Access to digital content gives patients on-going support without the need for a human on the other side. This is particularly useful in treating behavioral health issues where ongoing support and motivation may be necessary.
Globally, we face an extreme shortage of behavioral health providers. For example, the United States has fewer than 30,000 licensed psychiatrists (translating to <1 for every 10,000 people). Outside of big cities, the problem gets worse: ~50-60% of nonmetro counties have no psychologists or psychiatrists at all.
Even when providers are available, wait times for appointments are notoriously long. This is a huge issue when behavioral health conditions often require timely intervention.
We are seeing new platforms build large networks of certified coaches, licensed psychologists and psychiatrists, and other providers, aggregating supply in what has historically been a scarce and a highly fragmented provider population.
We believe the stigma associated with mental illness and other behavioral health conditions is dissipating. More and more public figures are speaking out about their struggle with anxiety, depression, addiction and other behavioral health issues. Our zeitgeist is shifting fast, and there’s an all-time high in people seeking help as the Google Trends data below demonstrates.
Image Credits: Google
Note: The anomalous dip in March/April ’20 was driven by mandatory shelter-in-place due to COVID-19.
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Four years ago, Adnan Asar, the founder of the new addiction prevention service Lucid Lane, was enjoying a successful career working as the founding chief technology officer at Livongo Health. It was the serial senior tech executive’s most recent job after a long stint at Shutterfly and he was shepherding the company through the development of its suite of hardware and software for the management of chronic conditions.
But when Asar’s wife was diagnosed with non-Hodgkin’s Lymphoma, he stepped away from the technology world to be with his family while she underwent treatment.
He did not know at the time that the decision would set him on the path to founding Lucid Lane. The company’s mission is to help give patients who have been prescribed medications to address pain and anxiety ways to wean themselves off those drugs and avoid addiction — and its purpose is born from the struggle Asar witnessed as his wife wrestled with how to stop taking the medication she was prescribed during her illness.
Asar’s wife isn’t alone. In 2018, there were roughly 168.2 million prescriptions for opioids written in the United States, according to data from the Centers for Disease Control and Prevention. Lucid Lane estimates that 50 million people are prescribed opioids and another 13 million are prescribed benzodiazepines each year either after surgery or in conjunction with cancer treatments — all without a plan for how to manage or taper the use of these highly addictive medications.
For Asar’s wife, it was the benzodiazepine prescribed as part of her cancer treatment that became an issue. “She was hit by very severe withdrawal symptoms and we didn’t know what was going on,” Asar said. When they consulted her physician he gave the couple two options — quitting cold turkey or remaining on the medication.
“My wife decided to go cold turkey,” Asar said. “It was really debilitating for the whole family.”
It took nine months of therapy and regular consultations with psychiatrists to help with tailoring medication dosages and tapering to get her off of the medication, said Asar. And that experience led to the launch of Lucid Lane.
“Our goal is to prevent and control medication and substance dependence,” Asar said.
The company’s telehealth solution is built on a proprietary treatment protocol meant to provide continuous daily support and interventions, along with proactive monitoring of a personalized treatment plan — all on an ongoing basis, said Asar.
And the COVID-19 pandemic is only accelerating the need for telehealth services. “COVID-19 has made telehealth a mandatory service instead of a discretionary service,” said Asar. “There’s a surge in anxiety, depression, substance use and medication use. We’re seeing a surge of patients who are reaching out to us.”
Asar sees Lucid Lane’s competitors as companies like Lyra Health and Ginger, or point solutions building digital diagnostics to detect anxiety and depression. But unlike some companies that are launching to treat addiction or addictive behaviors, Asar sees his startup as preventing dependency and addiction.
“A lot of people are sliding into these addictions through something that happens at the doctor’s office,” said Asar. ” Our solution does not prescribe any of these medications.”
The company is working on clinical studies that are set to start at the Palo Alto VA hospital, and has raised $4 million in seed funding from investors including Battery Ventures and AME Cloud Ventures, the investment firm founded by Jerry Yang.
“We see great potential for Lucid Lane, as it has developed a scalable solution to one of the biggest problems facing society today,” said Battery general partner Dharmesh Thakker, in a statement. “Telehealth solutions have emerged as highly capable of addressing complex problems, and Lucid Lane has embraced remote care from its beginning. Its design enables care anytime, anywhere for patients in their moment of need. This can make a tremendous difference in the battle between recovery and relapse. We believe that it will help millions of people lead better lives.”
Joining Asar in the development of the company and its healthcare protocols are a seasoned team of health professionals, including Dr. Ahmed Zaafran, a board certified anesthesiologist at Santa Clara Valley Medical Center and assistant professor of anesthesiology (affiliated) at Stanford University School of Medicine; and advisors like Dr. Vanila Singh, who was also previously chairperson of the HHS Task Force in conjunction with the DOD and the VA to address the opioid drug crisis; Dr. Carin Hagberg, the chair of anesthesiology, perioperative and pain medicine of MD Anderson Cancer Center; and Sherif Zaafran, the president of the Texas Medical Board and chair of multiple national committees on pain management, including the subcommittee Taskforce on Pain Management Services for HHS, as well as the department’s Pain Clinical Pathways Committee.
“Lucid Lane provides a patient-centered solution that allows for the best clinical outcomes for patients after surgery and those bravely finishing chemotherapy,” said Dr. Singh, in a statement. “For the many patients who require short-term opioids and benzodiazepine medications, Lucid Lane’s treatment can limit the risk of prolonged dependence of these medications while also ensuring effective pain control with a resulting improved quality of life and functioning.”
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The idea that social media can be harmful to our mental and emotional well-being is not a new one, but little has been done by researchers to directly measure the effect; surveys and correlative studies are at best suggestive. A new experimental study out of Penn State, however, directly links more social media use to worse emotional states, and less use to better.
To be clear on the terminology here, a simple survey might ask people to self-report that using Instagram makes them feel bad. A correlative study would, for example, find that people who report more social media use are more likely to also experience depression. An experimental study compares the results from an experimental group with their behavior systematically modified, and a control group that’s allowed to do whatever they want.
This study, led by Melissa Hunt at Penn State’s psychology department, is the latter — which despite intense interest in this field and phenomenon is quite rare. The researchers only identified two other experimental studies, both of which only addressed Facebook use.
One hundred and forty-three students from the school were monitored for three weeks after being assigned to either limit their social media use to about 10 minutes per app (Facebook, Snapchat and Instagram) per day or continue using it as they normally would. They were monitored for a baseline before the experimental period and assessed weekly on a variety of standard tests for depression, social support and so on. Social media usage was monitored via the iOS battery use screen, which shows app use.
The results are clear. As the paper, published in the latest Journal of Social and Clinical Psychology, puts it:
The limited use group showed significant reductions in loneliness and depression over three weeks compared to the control group. Both groups showed significant decreases in anxiety and fear of missing out over baseline, suggesting a benefit of increased self-monitoring.
Our findings strongly suggest that limiting social media use to approximately 30 minutes per day may lead to significant improvement in well-being.
It’s not the final word in this, however. Some scores did not see improvement, such as self-esteem and social support. And later follow-ups to see if feelings reverted or habit changes were less than temporary were limited because most of the subjects couldn’t be compelled to return. (Psychology, often summarized as “the study of undergraduates,” relies on student volunteers who have no reason to take part except for course credit, and once that’s given, they’re out.)
That said, it’s a straightforward causal link between limiting social media use and improving some aspects of emotional and social health. The exact nature of the link, however, is something at which Hunt could only speculate:
Some of the existing literature on social media suggests there’s an enormous amount of social comparison that happens. When you look at other people’s lives, particularly on Instagram, it’s easy to conclude that everyone else’s life is cooler or better than yours.
When you’re not busy getting sucked into clickbait social media, you’re actually spending more time on things that are more likely to make you feel better about your life.
The researchers acknowledge the limited nature of their study and suggest numerous directions for colleagues in the field to take it from here. A more diverse population, for instance, or including more social media platforms. Longer experimental times and comprehensive follow-ups well after the experiment would help, as well.
The 30-minute limit was chosen as a conveniently measurable one, but the team does not intend to say that it is by any means the “correct” amount. Perhaps half or twice as much time would yield similar or even better results, they suggest: “It may be that there is an optimal level of use (similar to a dose response curve) that could be determined.”
Until then, we can use common sense, Hunt suggested: “In general, I would say, put your phone down and be with the people in your life.”
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