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Take Your Medicine: This $1.5 Billion Health Startup’s Smart Pills Keep Patients From Forgetting

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Are patients taking their medications correctly, and are the medicines working? A handful of digital health startups tries to make it easier to tell — say, by embedding a tracking system into pills they swallow.

Only 25% to 50% of patients worldwide take medications correctly, and in the U.S., roughly 125,000 people die annually from not correctly taking their prescriptions, according to a 2018 study led by Leah Zullig, a health services researcher at the Duke University School of Medicine.

Failure to take prescribed medicines also increases costs to the healthcare system, by about $300 billion annually, Zullig estimates. Jonathan Watanabe, an associate professor of clinical pharmacy at UC San Diego’s Skaggs School of Pharmacy & Pharmaceutical Sciences, says that number would likely be even higher if you included what it costs hospitals to treat symptoms that arise from improper medicine intake (for example, patients with high blood pressure who have strokes as a result of not taking their medicines)—more than $500 billion annually, or 16% of U.S. healthcare costs, he estimates.

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For the most part, the responsibility has been in the hands of the patient. Think pill boxes marked with the days of the week, or their high-tech versions—apps, like Medisafe and CareClinic, that help users self-report their own intake and schedules. These reminder devices don’t go far enough, say some doctors, because they fail to address a very human fault that patients report as their primary reason for not taking their medication: forgetfulness.  

We Are Our Own Prince Charming

“We need to take responsibility for our own health and care, but when it comes to drug-taking and medication use, that may not be sufficient,” says Dr. Niteesh K. Chouhdry, a professor of medicine at Harvard Medical School and executive director of the Center for Healthcare Delivery Sciences at Brigham & Women’s Hospital in Boston. “We need to leverage these devices in a way that closes the loop—doctors to pharmacists to patients back to pharmacists.”

Proteus Digital Health, a Redwood City, California-based tech health startup, hopes to create that loop. Founded in 2004 by Andrew Thompson and Dr. George Savage, the company makes a 1 millimeter sensor—“the size of a poppy seed or grain of sand,” says Thompson—that is embedded in medications, which are then swallowed.

The sensor, made of “elements found in a typical diet,” including magnesium and copper, says Thompson, will turn on when it contacts a patient’s stomach acid. It then sends a signal a the palm-size patch that patients wear on their skin. The patch, which also tracks physiological signs like steps, rest and heart rate, then sends information to a smartphone app for patients and the desktop browser portal that doctors use.

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The idea for the system, called Proteus Discover, came to Thompson during an American Heart Association conference in 2003. Thompson, who had previously started two medical device companies with Savage, including the publicly traded FemRx, which was acquired by Johnson & Johnson for $22 million in 1998, noticed that none of the companies presenting at the conference were doing anything with digital technologies.

“Silicon and software was innovating every other industry at the time except for pharma,” Thompson says. So he brought his idea for a medicine that communicates with a computer to Savage.

“George looks at me and says, ‘That is the stupidest idea you’ve had in your entire life.’ And then we began to argue,” Thompson says.

In 2017, the FDA approved an antipsychotic drug with Proteus technology, the agency’s first-ever approval for a medicine with digital ingestion tracking system. Abilify MyCite, the drug made with Tokyo-based Otsuka Pharmaceutical, treats schizophrenia, bipolar disorder, depression and Tourette syndrome.

The company has raised $420 million in venture capital funding from investors including Novartis Venture Fund and Kaiser Permanente Ventures at a $1.5 billion valuation. Otsuka, which has a special focus on mental health drugs, announced in October 2018 an $88 million investment in Proteus to continue developing other medications that use the tech-health venture’s ingestible sensors. More than 1,000 patients have used the pill-tracking system, amounting to 195,000 pill ingestions, says the company.

EtectRx, Keratin Biosciences

Other companies have sprung up in the drug delivery space, including etectRx, a Newberry, Florida, health-tech startup with a similar digital health system model. Instead of working with a pharmaceutical company to embed its sensors in a pill, etectRx creates an empty gelatin capsule with an embedded wireless sensor. Its capsule has not received FDA clearance yet, but it can be used in clinical studies that have been approved by the agency’s Institutional Review Board, a committee that reviews and monitors scientific research.

Keratin Biosciences (formerly Microchips Biotech and KeraNetics before the two merged in July 2018) wants to improve medication intake by getting rid of human error altogether. Instead of a pill, this Lexington, Massachusetts, company makes a microchip with hundreds of sealed compartments, each of which can store up to 1 milligram of a drug.

The chip, which originated in a lab at the Massachusetts Institute of Technology, can be activated by a wireless signal that triggers the compartments to release the drug, based on a preprogrammed dosing schedule.

Digital health startups must figure out how to get the new drug delivery methods they are delivering to patients and consumers in a scalable way, which will require collaboration and a commitment from Big Pharma. “The core thing we want the pharmaceutical industry to understand is that we want to integrate silicon software into the definition of their products in order to make information and data a part of what they do,” Thompson says.

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Then there is the matter of consumer hesitance about swallowing hardware that records private activity. While these inventions are meant to help patients, the monitoring aspect has raised privacy concerns from consumer advocates who worry that the information will eventually be shared not just with doctors but with insurers who want to raise premiums or even employers who want to know what drugs a job candidate is taking.

“Security of the data is very important, but in medicine, privacy can be lethal,” Thompson argues. He says that the main issue is not so much privacy but whether companies make it clear to patients where their data is going. “People are happy to share information and data if they know and understand exactly what it is being used for.”

Proteus can claim its smart pills are effective, but it’s still early for most startups that aim to improve the way patients take their medicine.

“This is a tough problem to fix,” says Choudhry from Harvard. “It’s all about forgetfulness, and that is a complex and, frankly, normal behavior.”

-Angel Au-Yeung; Forbes Staff

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Tasty Vegan Options: Consumed By Healthy Eating

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The restaurant market still hungers for healthy options. This entrepreneur is feeding that need, serving earth-conscious customers and gym junkies.  

Her desperation for a healthy meal fueled the fire for business.

Leigh Klapthor, 31, couldn’t find enough eateries that sold healthy food that was not bland, so decided to start her own.

“It is no fun to go out with friends and you are always the girl with the green salad,” she says.

“I wanted to find a way where being healthy is not such a chore and I also wanted for it to be affordable.”

Klapthor, who dropped out of a course in marketing communications at the University of Johannesburg, ditched a job in corporate marketing to pursue her passion for food.

A patron at Sprout Café. Picture: Gypseenia Lion

In 2017, she started Sprout Café at the Stoneridge Centre in Edenvale in Johannesburg with a loan she received from her husband’s business and money that was given to them as a wedding gift.

“Everybody underestimates what everything will end up costing [when starting a new business]. In my mind, I thought R150,000 ($10,588) would work. I thought I would get my shop fitting and everything done and in the first month we would be able to pay salaries with the money we make,” says Klapthor.

But she soon realized the unforeseen challenges faced by many entrepreneurs. She had to eventually pump in a capital of R350,000 ($24,706) to start the venture.

“So I had a couple of life lessons at the beginning. I had to end up using our savings but I didn’t mind having to do that because I trusted and believed in the vision.” 

But though she did, the banks did not because they often declined all her loan applications.

 “I think there are so many young black and enthusiastic individuals that have brilliant ideas and vision but the investment capital is not there. Though I do not have the capital as well to assist them, I would say keep going because the vision is greater,” Klapthor says.

Sprout Café offers health food, light meals, vegan food, and vegetarian and ketogenic diet food.

With her corporate marketing skills, she advertised her food on social media and gained a lot of traction.

“I want to create food on Instagram and people are like, ‘oh my God, I want to eat that’ and when they come into the store, it is the same deliverable they receive,” she says.

Sprout Café turns over R3 million ($211,677) annually and has 10 employees. 

After only two years of business, she has recently opened a second branch in the heart of the busy Moove Motion Fitness Club in Sunninghill in Johannesburg.

“There are people that are on specific diets and there is no one that is giving these people food. There is no one that is saying, vegan people want to be healthy too. They are making a conscious decision to preserve the environment and preserve their health and they are making these decisions but there is no one that is there to accommodate them.”

Klapthor says that the world is moving towards a plant-based lifestyle and she believes that many have recently caught on to that idea recently. 

Trend translator Bronwyn Williams of Flux Trends,  reiterates Klapthor’s views on how the world is adopting healthier habits. She believes that Generation Z is choosing good, clean fun the most.

“Yes, South Africa is not exempt from the global movement towards more locally-sourced and earth-friendly products and packaging,” Williams says.

However, Williams believes that because 64.2% of the South African population still lives in poverty, clean and organic food still remains costly for the majority of people.

“That said, unfortunately, earth-friendly consumer options remain a luxury that only the upper middle class can really afford to support and enjoy… certified organic, eco-friendly products tend to cost far more—up to 40% more than ‘regular’ packaged produce, it would be disingenuous to say that what the market wants is locally-sourced, earth-first produce when the majority of South Africans are struggling just to put any food on the table,” Williams says.

‘Every day, you should be able to eat a Sprout meal without having to feel any kind of guilt and shame,’ Leigh Klapthor says. Picture: Gypseenia Lion

Though Klapthor knows more people are opening healthy-eating establishments because they see that it is a trend, she believes that they need to be in touch with the reality of an ordinary person’s life and consider the cost implications.

“You can’t charge someone R150 ($10.59) for a Beyond Meat burger and expect her to come back tomorrow for the same burger. People are tight with their money and they work hard for it, they do not want to let go, for instance, of R500 ($35.29) in three days,” Klapthor says.

“We want to provide a healthy lifestyle, something that is consistent and that people can live through, and not just a treat-themselves-to at the end of the month. Every day, you should be able to eat a Sprout meal without having to feel any kind of guilt and shame.”

Obviously, it is a concept that has worked and keeps her business healthy as well.

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Young women in Soweto, South Africa, say healthy living is hard. Here’s why

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Data from South Africa has shown that over two thirds of young women are overweight and obese. This predisposes them to non-communicable diseases such as diabetes and hypertension. Most women are not exercising enough, and consumption of processed and calorie-dense foods and high amounts of sugar is common.

It was this knowledge that sparked the establishment of the Health Life Trajectories Initiative. It’s being run in South Africa, India, China and Canada and aims to provide interventions that can help young women stay healthy before, during and after pregnancy.

In South Africa, this randomised controlled trial will provide one-on-one support as well as peer group sessions to over 6000 young women. The idea is provide them with information, and to help them set and maintain goals for healthier lifestyles.

Researchers from the Medical Research Council and Wits University’s Developmental Pathways for Health Research Unit are running the South African arm of the study. We wanted to start by better understanding our target population – that is, young women aged between 18 and 24 living in Soweto.

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Soweto is a large, densely populated urban township which comprises one third of Johannesburg’s population. Soweto is becoming rapidly urbanised, but the majority of people are still very poor and struggle to provide food for their families.

We conducted a series of focus group discussions and in depth interviews to unravel health behaviours, barriers and facilitators to wellbeing and health with young women from Soweto who had not yet had a child. We also asked them about what sorts of interventions they’d prefer to support and guide them.

The women offered important insights that showed it’s not enough to simply promote healthy eating and exercise without considering the very real environmental and structural constraints present in South Africa.

Barriers to healthy choices

The 29 participants spoke about many different facets of health. These included happiness and mental wellbeing, faith, social support, body image, and lifestyle behaviours.

They identified many barriers to healthy eating, among them the cost of and access to healthy food options. Some women also said they had little access to exercise facilities such as gyms and were afraid to exercise on the streets because they feared being assaulted or harassed. One woman said:

No, I don’t feel safe because we have drug addicts, traffic, women trafficking: it’s not safe for us to walk in the streets.

The women we interviewed painted a picture of an environment in which healthy behaviours are difficult to implement or sustain. One said:

Small businesses that are opening up in my community and they all sell fries, literally they just all sell fries…

Women told us that cheap and unhealthy fast foods are on every street corner: “bunny chow” – hollowed out bread stuffed with curry – vetkoek (a fried dough bread stuffed with different fillings) and fried chips are affordable and available within a few steps of most houses. As a result, women did not want to go out of their way to purchase healthier, more expensive foods.

Our interviewees also didn’t feel able to demand that healthier food be bought for their homes, because many were not contributing financially and were therefore not in a position to control food purchases. Women reported being financially dependant on relatives and male partners.

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Exercise

They also said that opportunities for physical activity were neither provided nor prioritised for women in Soweto. Some women said that a lack of facilities made it difficult for them to participate in any exercise, as they did not have access to gyms or fields to exercise.

Other women told us that there were gyms, sports grounds, parks, and even free aerobics classes at community halls in their area. However these facilities often get vandalised quickly, and can no longer be used. More importantly, they didn’t feel safe enough to exercise on the streets, perhaps by jogging or running. They also felt unsafe walking around in leggings or tights. Women were fearful of human trafficking, sexual assault, and violence – very real issues in this community.

Crucially, our research found that young women did not see obesity as a sufficient reason to change their behaviour. But they said they would be motivated to exercise and eat better if they were diagnosed with a non-communicable disease like diabetes.

This suggests that obesity has become normalised in South Africa – and this needs to be addressed.

Policy interventions

These findings are now being worked into our interventions, and we are cognisant of the contextual realities that may affect young women’s ability to change their lifestyles. We hope that this research, along with whatever findings emerge from our interventions, will inform policy makers and motivate them to implement necessary changes in this community.

Women in Soweto and in South Africa in general need support to live healthier lifestyles. This support needs to come from policy makers. If South Africa does not step up and support young women by providing them with access to safe spaces and affordable healthier foods, and by controlling the oversupply of unhealthy options, the country may not be able to curb its ever increasing rise in obesity and related non-communicable diseases.

-Alessandra Prioreschi: Associate Director and Researcher at the Developmental Pathways for Health Research Unit (DPHRU), University of the Witwatersrand

The Conversation

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Measles: Should Vaccinations Be Compulsory?

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Following a measles outbreak in Rockland County in New York State, authorities there have declared a state of emergency, with unvaccinated children barred from public spaces, raising important questions about the responsibilities of the state and of individuals when it comes to public health.

Measles virus is spread by people coughing and spluttering on each other. The vaccine, which is highly effective, has been given with mumps and rubella vaccines since the 1970s as part of the MMR injection. The global incidence of measles fell markedly once the vaccine became widely available. But measles control was set back considerably by the work of Andrew Wakefield, which attempted to link the MMR vaccine to autism.

There is no such link, and Wakefield was later struck off by the General Medical Council for his fraudulent work. But damage was done and has proved hard to reverse.

In 2017, the global number of measles cases spiked alarmingly because of gaps in vaccination coverage in some areas, and there were more than 80,000 cases in Europe in 2018.

Anti-vaxxer threat

The World Health Organisation has declared the anti-vaccine movement one of the top ten global health threats for 2019, and the UK government is considering new legislation forcing social media companies to remove content with false information about vaccines. The recent move by the US authorities barring unvaccinated children from public spaces is a different legal approach. They admit it will be hard to police, but say the new law is an important sign that they are taking the outbreak seriously.

Most children suffering from measles simply feel miserable, with fever, swollen glands, running eyes and nose and an itchy rash. The unlucky ones develop breathing difficulty or brain swelling (encephalitis), and one to two per thousand will die from the disease. This was the fate of Roald Dahl’s seven-year-old daughter, Olivia, who died of measles encephalitisin the 1960s before a vaccine existed.

When measles vaccine became available, Dahl was horrified that some parents did not inoculate their children, campaigning in the 1980s and appealing to them directly through an open letter. He recognised parents were worried about the very rare risk of side effects from the jab (about one in a million), but explained that children were more likely to choke to death on a bar of chocolate than from the measles vaccine.

Dahl railed against the British authorities for not doing more to get children vaccinated and delighted in the American approach at the time: vaccination was not obligatory, but by law you had to send your child to school and they would not be allowed in unless they had been vaccinated. Indeed, one of the other new measures introduced by the New York authorities this week is to once again ban unvaccinated children from schools.

Precedents

With measles rising across America and Europe, should governments go further and make vaccination compulsory? Most would argue that this is a terrible infringement of human rights, but there are precedents. For example, proof of vaccination against yellow fever virus is required for many travellers arriving from countries in Africa and Latin America because of fears of the spread of this terrifying disease. No-one seems to object to that.

Also, on the rare occasions, when parents refuse life-saving medicine for a sick child, perhaps for religious reasons, then the courts overrule these objections through child protection laws. But what about a law mandating that vaccines should be given to protect a child?

Vaccines are seen differently because the child is not actually ill and there are occasional serious side effects. Interestingly, in America, states have the authority to require children to be vaccinated, but they tend not to enforce these laws where there are religious or “philosophical” objections.

There are curious parallels with the introduction of compulsory seat belts in cars in much of the world. In rare circumstances, a seat belt might actually cause harm by rupturing the spleen or damaging the spine. But the benefits massively outweigh the risks and there are not many campaigners who refuse to buckle up.

I have some sympathy for those anxious about vaccinations. They are bombarded daily by contradictory arguments. Unfortunately, some evidence suggests that the more the authorities try to convince people of the benefits of vaccination, the more suspicious they may become.

I remember taking one of my daughters for the MMR injection aged 12 months. As I held her tight, and the needle approached, I couldn’t help but run through the numbers in my head again, needing to convince myself that I was doing the right thing. And there is something unnatural about inflicting pain on your child through the means of a sharp jab, even if you know it is for their benefit. But if there were any lingering doubts, I just had to think of the many patients with vaccine-preventable diseases who I have looked after as part of my overseas research programme.

Working in Vietnam in the 1990s, I cared not only for measles patients but also for children with diphtheria, tetanus and polio – diseases largely confined to the history books in Western medicine. I remember showing around the hospital an English couple newly arrived in Saigon with their young family. “We don’t believe in vaccination for our kids,” they told me. “We believe in a holistic approach. It is important to let them develop their own natural immunity.” By the end of the morning, terrified by what they had seen, they had booked their children into the local clinic for their innoculations.

In Asia, where we have been rolling out programmes to vaccinate against the mosquito-borne Japanese encephalitis virus, a lethal cause of brain swelling, families queue patiently for hours in the tropical sun to get their children inoculated. For them the attitudes of the Western anti-vaccinators are perplexing. It is only in the West, where we rarely see these diseases, that parents have the luxury of whimsical pontification on the extremely small risks of vaccination; faced with the horrors of the diseases they prevent, most people would soon change their minds.

Tom Solomon; Director of the National Institute for Health Research (NIHR) Health Protection Research Unit in Emerging and Zoonotic Infections, and Professor of Neurology, Institute of Infection and Global Health, University of Liverpool

-The Conversation

The Conversation

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