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Tech startups are stepping up to meet the needs of 60 million people worldwide who use opioids, representing about 1 percent of the world’s adult population. In the United States, deaths involving synthetic opioids have risen 1,040 percent from 2013 to 2019. The COVID-19 pandemic and continued prevalence of fentanyl have since worsened the toll, with an estimated 81,083 fatal overdoses in 2023 alone.

Innovations include biometric monitoring systems that help doctors determine proper medication dosages, nerve stimulators that relieve withdrawal symptoms, wearable and ingestible systems that watch for signs of an overdose, and autonomous drug delivery systems that could prevent overdose deaths.

Helping Patients Get the Dosage They Need

For decades, opioid blockers and other medications that suppress cravings have been the primary treatment tool for opioid addiction. However, despite its clinical dominance, this approach remains underutilized. In the United States, only about 22 percent of the 2.5 million adults with opioid use disorder receive medication-assisted therapy such as methadone, Suboxone, and similar drugs.

Determining patients’ ideal dosage during the early stages of treatment is crucial for keeping them in recovery programs. The shift from heroin to potent synthetic opioids, like fentanyl, has complicated this process, as the typical recommended medication doses can be too low for those with a high fentanyl tolerance.

A North Carolina-based startup is developing a predictive algorithm to help clinicians tailor these protocols and track real-time progress with biometric data. OpiAID, which is currently working with 1,000 patients across three clinical sites, recently launched a research pilot with virtual treatment provider Bicycle Health. Patients taking Suboxone will wear a Samsung Galaxy Watch6 to measure their heart rate, body movements, and skin temperature. OpiAID CEO David Reeser says clinicians can derive unique stress indications from this data, particularly during withdrawal. (He declined to share specifics on how the algorithm works.)

“Identifying stress biometrically plays a role in how resilient someone will be,” Reeser adds. “For instance, poor heart rate variability during sleep could indicate that a patient may be more susceptible that day. In the presence of measurable amounts of withdrawal, the potential for relapse on illicit medications may be more likely.”

Nerve Stimulators Provide Opioid Withdrawal Relief

While OpiAID’s software solution relies on monitoring patients, electrical nerve stimulation devices take direct action. These behind-the-ear wearables distribute electrodes at nerve endings around the ear and send electrical pulses to block pain signals and relieve withdrawal symptoms like anxiety and nausea.

The U.S. Food and Drug Administration (FDA) has cleared several nerve stimulator devices, such as DyAnsys’ Drug Relief, which periodically administers low-level electrical pulses to the ear’s cranial nerves. Others include Spark Biomedical’s Sparrow system and NET Recovery’s NETNeuro device.

Masimo’s behind-the-ear Bridge device costs US $595 for treatment providers.Masimo

Similarly, Masimo’s Bridge relieves withdrawal symptoms by stimulating the brain and spinal cord via electrodes. The device is intended to help patients initiating, transitioning into, or tapering off medication-assisted treatment. In a clinical trial, Bridge reduced symptom severity by 85 percent in the first hour and 97 percent by the fifth day. A Masimo spokesperson said the company’s typical customers are treatment providers and correctional facilities, though it’s also seeing interest from emergency room physicians.

Devices Monitor Blood Oxygen to Prevent Overdose Deaths

In 2023, the FDA cleared Masimo’s Opioid Halo device to monitor blood oxygen levels and alert emergency contacts if it detects opioid-induced respiratory depression, the leading cause of overdose deaths. The product includes a pulse oximeter cable and disposable sensors connected to a mobile app.

Opioid Halo utilizes Masimo’s signal extraction technology, first developed in the 1990s, which improves upon conventional oxygen monitoring techniques by filtering out artifacts caused by blood movement. Masimo employs four signal-processing engines to distinguish the true signal from noise that can lead to false alarms; for example, they distinguish between arterial blood and low-oxygen venous blood.

Masimo’s Opioid Halo system is available over-the-counter without a prescription. Masimo

Opioid Halo is available over-the-counter for US $250. A spokesperson says sales have continued to show promise as more healthcare providers recommend it to high-risk patients.

An Ingestible Sensor to Watch Over Patients

Last year, in a first-in-human clinical study, doctors used an ingestible sensor to monitor vital signs from patients’ stomachs. Researchers analyzed the breathing patterns and heart rates of 10 sleep study patients at West Virginia University. Some participants had episodes of central sleep apnea, which can be a proxy for opioid-induced respiratory depression. The capsule transmitted this data wirelessly to external equipment linked to the cloud.

Celero’s Rescue-Rx capsule would reside in a user’s stomach for one week.Benjamin Pless/Celero Systems

“To our knowledge, this is the first time anyone has demonstrated the ability to accurately monitor human cardiac and respiratory signals from an ingestible device,” says Benjamin Pless, one of the study’s co-authors. “This was done using very low-power circuitry including a radio, microprocessor, and accelerometer along with software for distinguishing various physiological signals.”

Pless and colleagues from MIT and Harvard Medical School started Celero Systems to commercialize a modified version of that capsule, one that will also release an opioid antagonist after detecting respiratory depression. Pless, Celero’s CEO, says the team has successfully demonstrated the delivery of nalmefene, an opioid antagonist similar to Narcan, to rapidly reverse overdoses.

Celero’s next step is integrating the vitals-monitoring feature for human trials. The company’s final device, Rescue-Rx, is intended to stay in the stomach for one week before passing naturally. Pless says Rescue-Rx’s ingestible format will make the therapy cheaper and more accessible than wearable autoinjectors or implants.

Celero’s capsule can detect vital signs from within the stomach. www.youtube.com

Autonomous Delivery of Overdose Medication

Rescue-Rx isn’t the only autonomous drug-delivery project under development. A recent IEEE Transactions on Biomedical Circuits and Systems paper introduced a wrist-worn near-infrared spectroscopy sensor to detect low blood oxygen levels related to an overdose.

Purdue University biomedical engineering professor Hugh Lee and graduate student Juan Mesa, who both co-authored the study, say that while additional human experiments are necessary, the findings represent a valuable tool in counteracting the epidemic. “Our wearable device consistently detected low-oxygenation events, triggered alarms, and activated the circuitry designed to release the antidote through the implantable capsule,” they wrote in an email.

Lee and Purdue colleagues founded Rescue Biomedical to commercialize the A2D2 system, which includes a wristband and an implanted naloxone capsule that releases the drug if oxygen levels drop below 90 percent. Next, the team will evaluate the closed-loop system in mice.

This story was updated on 27 August 2024 to correct the name of Masimo’s Opioid Halo device.

In the spirit of the Halloween season, IEEE Spectrum presents a pair of stories that—although grounded in scientific truth rather than the macabre—were no less harrowing for those who lived them. In today’s installment, Robert Langer had to push back against his field’s conventional wisdom to pioneer a drug-delivery mechanism vital to modern medicine.

Nicknamed the Edison of Medicine, Robert Langer is one of the world’s most-cited researchers, with over 1,600 published papers, 1,400 patents, and a top-dog role as one of MIT’s nine prestigious Institute Professors. Langer pioneered the now-ubiquitous drug delivery systems used in modern cancer treatments and vaccines, indirectly saving countless lives throughout his 50-year career.

But, much like Edison and other inventors, Langer’s big ideas were initially met with skepticism from the scientific establishment.

He came up in the 1970s as a chemical engineering postdoc working in the lab of Dr. Judah Folkman, a pediatric surgeon at the Boston Children’s Hospital. Langer was tasked with solving what many believed was an impossible problem—isolating angiogenesis inhibitors to halt cancer growth. Folkman’s vision of stopping tumors from forming their own self-sustaining blood vessels was compelling enough, but few believed it possible.

Langer encountered both practical and social challenges before his first breakthrough. One day, a lab technician accidentally spilled six months’ worth of samples onto the floor, forcing him to repeat the painstaking process of dialyzing extracts. Those months of additional work steered Langer’s development of novel microspheres that could deliver large molecules of medicine directly to tumors.

In the 1970s, Langer developed these tiny microspheres to release large molecules through solid materials, a groundbreaking proof-of-concept for drug delivery.Robert Langer

Langer then submitted the discovery to prestigious journals and was invited to speak at a conference in Michigan in 1976. He practiced the 20-minute presentation for weeks, hoping for positive feedback from respected materials scientists. But when he stepped off the podium, a group approached him and said bluntly, “We don’t believe anything you just said.” They insisted that macromolecules were simply too large to pass through solid materials, and his choice of organic solvents would destroy many inputs. Conventional wisdom said so.

Nature published Langer’s paper three months later, demonstrating for the first time that non-inflammatory polymers could enable the sustained release of proteins and other macromolecules. The same year, Science published his isolation mechanism to restrict tumor growth.

Langer and Folkman’s research paved the way for modern drug delivery.MIT and Boston Children’s Hospital

Even with impressive publications, Langer still struggled to secure funding for his work in controlling macromolecule delivery, isolating the first angiogenesis inhibitors, and testing their behavior. His first two grant proposals were rejected on the same day, a devastating blow for a young academic. The reviewers doubted his experience as “just an engineer” who knew nothing about cancer or biology. One colleague tried to cheer him up, saying, “It’s probably good those grants were rejected early in your career. Since you’re not supporting any graduate students, you don’t have to let anyone go.” Langer thought the colleague was probably right, but the rejections still stung.

His patent applications, filed alongside Folkman at the Boston Children’s Hospital, were rejected five years in a row. After all, it’s difficult to prove you’ve got something good if you’re the only one doing it. Langer remembers feeling disappointed but not crushed entirely. Eventually, other scientists cited his findings and expanded upon them, giving Langer and Folkman the validation needed for intellectual property development. As of this writing, the pair’s two studies from 1976 have been cited nearly 2,000 times.

As the head of MIT’s Langer Lab, he often shares these same stories of rejection with early-career students and researchers. He leads a team of over 100 undergrads, grad students, postdoctoral fellows, and visiting scientists, all finding new ways to deliver genetically engineered proteins, DNA, and RNA, among other research areas. Langer’s reputation is further bolstered by the many successful companies he co-founded or advised, like mRNA leader Moderna, which rose to prominence after developing its widely used COVID-19 vaccine.

Langer sometimes thinks back to those early days—the shattered samples, the cold rejections, and the criticism from senior scientists. He maintains that “Conventional wisdom isn’t always correct, and it’s important to never give up—(almost) regardless of what others say.”

When it comes to the effects that the upcoming Trump presidency will have on healthcare, attendees’ attitudes ranged from cautiously optimistic to fairly anxious. Some of the issues they highlighted included mental health parity, telehealth prescribing flexibilities, and the role of Robert F. Kennedy Jr.

The post How Did Attendees at a Behavioral Health Conference React to Trump’s Victory? appeared first on MedCity News.

CDMO Avid Bioservices is being acquired by the private equity firms GHO Capital Partners and Ampersand Capital Partners. Avid specializes in manufacturing biologic products for companies at all stages of development.

The post Private Equity Is Picking Up Biologics CDMO Avid Bioservices in $1.1B Acquisition appeared first on MedCity News.

Value-based care contracting is especially difficult for behavioral health providers, Taft Parsons III, chief psychiatric officer at CVS Health/Aetna, pointed out during a conference this week.

The post CVS Health Exec: Payers Need to Stop Making Behavioral Health Providers Jump Through Hoops In Order to Participate in Value-Based Care appeared first on MedCity News.

While startups in highly regulated industries like healthcare and finance are almost certain to face heightened scrutiny, there are controllable factors that can offset these challenges.

The post The Startup Economy is Turbulent. Here’s How Founders Can Recognize and Avoid Common Pitfalls appeared first on MedCity News.

Two executives at behavioral health care companies discussed why it’s important for provider organizations to partner with the 988 Suicide & Crisis Lifeline during a panel at the Behavioral Health Tech conference.

The post There’s an Opportunity for More Providers to Partner with the 988 Lifeline, Execs Say appeared first on MedCity News.

Whitney Haggerson — vice president of health equity and Medicaid at Providence — discussed the significance of her role, as well as how her health system is working to give all employees, regardless of title, the skills needed to help reduce health inequities.

The post Inside Providence’s Health Equity & Medicaid Strategy appeared first on MedCity News.

The Pew Charitable Trusts joined dozens of research, health care, and nonprofit stakeholders in urging President-elect Joe Biden to prioritize and strengthen the national response to antibiotic resistance.

In 2018, opioid overdoses in the United States caused one death every 11 minutes, resulting in nearly 47,000 fatalities. The most effective treatments for opioid use disorder (OUD) are three medications approved by the Food and Drug Administration (FDA): methadone, buprenorphine, and naltrexone.

Few correctional facilities in the United States have treatment programs for individuals with opioid use disorder (OUD), despite clear evidence that certain medications reduce the risk of overdose and death. Even in facilities where treatment is available, the COVID-19 pandemic has complicated efforts to provide such care.

Breaking COVID-19’s chain of transmission requires effective physical distancing, contact tracing and rapid analyses of demographic data to reveal illness clusters and populations at high risk, such as people older than 65, Latinos and Blacks.

Between 1999 and 2014, opioid use disorder (OUD) among pregnant women more than quadrupled, risking the health of the women—before and after giving birth—and their infants. As states grapple with COVID-19’s exacerbation of the opioid crisis, several are taking innovative steps to address the needs of high-risk groups, including low-income, postpartum patients with OUD.

As the coronavirus pandemic grips the world, the opioid epidemic continues to affect millions of Americans. Several states are developing innovative ways to tackle this public health issue. In this episode, we speak with Beth Connolly, who leads Pew’s research on substance use disorders, and Louisiana Representative Paula Davis, who helped ensure effective treatment in her state.

2020 was a difficult year for dental providers as the COVID-19 pandemic swept across the country. When stay-at-home orders went into effect in the spring, dental offices closed their doors to all but emergency patients.

The United States is grappling with two severe health crises: the COVID-19 pandemic and an opioid epidemic that appears to be worsening as more people deal with stress and isolation as they face increased barriers to medical care. Preliminary numbers for 2020 show that overdose deaths were outpacing the record-setting number of more than 71,000 fatalities in 2019.

Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented product is not a “commercial sale” of the invention that triggers the on-sale bar of 35 U.S.C. § 102(b) (pre-AIA).[1]  The en banc opinion...… Continue Reading

We’ve all seen Medicare Advantage (MA) plans become a significant player in the healthcare industry. Yet, with the […]

This paper begins with a look at both optimization modeling and discrete-event simulation modeling, and explores how they can most effectively work together to create additional analytic value. It then considers two examples of a combined optimization and simulation approach and discusses the resulting benefits.

HONG KONG — China's National Health Commission (NHC) published its first set of guidelines to standardise the diagnosis and treatment of obesity, with more than half of China's adults already overweight and obese, and the rate expected to keep rising.  The guidelines, made public on October 17, come as China experiences an upward morbidity trend of its overweight and obese population. The rate of overweight or obese people could reach 65.3 per cent by 2030, the NHC said.   "Obesity has become a major public health issue in China, ranking as the sixth leading risk factor for death and disability in the country," the guidelines said. China is facing a twin challenge that feeds its weight problem: In a modernising economy underpinned by technological innovation, more jobs have become static or desk-bound, while a prolonged slowdown in growth is forcing people to adopt cheaper, unhealthy diets.

David Duchovny and Gillian Anderson didn't speak to each other for "weeks at a time" when they worked on The X Files. The 64-year-old actor and Gillian, 56, enjoyed huge success with the iconic sci-fi series — but the duo actually had a turbulent relationship for many years. David said on the Fail Better podcast: "There was a long time, working on the show, where we were just not even dealing with one another off-camera. And there was a lot of tension. Which didn't matter, apparently, for the work cause we're both f****** crazy, I guess. We could just go out there and do what we needed to do." Gillian was amazed that they achieved so much success while their off-screen relationship was so tense.

WASHINGTON — Donald Trump is expected to take a slew of executive actions on his first day as president to ramp up immigration enforcement and roll back signature Biden legal entry programs, a sweeping effort that will be led by incoming "border czar" Tom Homan and other Republican immigration hardliners, three sources familiar with the matter told Reuters. The executive actions would give federal immigration officers more latitude to arrest people with no criminal records, surge troops to the US-Mexico border and restart construction of the border wall, the sources said. Homan, who served as acting director of US Immigration and Customs Enforcement from 2017-2018 under Trump, will bring a deep understanding of the US immigration system after a four-decade career that took him from a frontline Border Patrol agent to head of the agency that arrests and deports immigrants in the US illegally.

Feb 10, 2024

Assaf Zoran argues that it is crucial to hold Iran accountable and convey the cost associated with arming, training, financing, and promoting violence through proxies.

Nov 2, 2022

U.S. power extends beyond the military and economic spheres to include policing. The United States has used its global policing power to capture terrorists, warlords, and drug kingpins. But extradition is not simply a bureaucratic tool. States’ geopolitical interests shape their willingness to cooperate with others in extraditing fugitives. 

Pakistan's National Security Adviser to the Prime Minister, Mahmud Ali Durrani, on the 2008 bombing of the Indian Embassy in Kabul

U.S. feared another LeT attack in India in mid-2009, and sought Pakistan's help to ‘disrupt and prevent' it

This cable contains information which we hope will be useful to you in engaging host governments, media, and the public after the President's address.

Zardari made repeated pleas for drones to be "put in Pakistan's hands" so that Pakistan would own the issue and drone attacks (including collateral damage) would not provoke anti-americanism.

President Musharraf also asked the U.S. to put more pressure on India to negotiate over Kashmir, concluding that the time is ripe for resolution of the issue.

Menon emphasized that India had been tough on Pakistan with regard to accountability, but restrained in its rhetoric and actions.

Spoke of DMK leader's attempted ‘blackmail' on Sri Lanka, warned that the Congress ‘will carry this grudge and retaliate at the right time'

S.M. Zafar, Khan's prominent and highly respected lawyer, had pledged to the government that the meeting with the press would be Khan's "first and last" such encounter.

Chinese officials had approached the Indian government for more information but had since been reportedly told by the Indian government that the information presented was sufficient to justify the listing.

Deputy Director Shen acknowledged the message but offered no further comment.

As leaders mull over who will head the party next, the Congress Working Committee announced that elections will be held on October 17.

NOTA continues to be salient in Naxalite areas, but its share has fallen in recent elections

The Pakistani Taliban on Monday claimed responsibility for the January 30 mosque attack in Peshawar which left 100 people dead and over 220 injured

Jun 10, 2022

This book is intended to advance the next phase of the U.S.-Colombia relationship. In a rapidly changing world, the following chapters present a roadmap for a new type of engagement that challenges our ambitions and extends the ties that bind our countries. 

Nov 18, 2022

Former Colombian President Iván Duque discussed Latin America’s resurgent left wing and advocated for environmental action at the Harvard Kennedy School on Thursday afternoon.

Feb 20, 2023

U.S. President Joe Biden spent five hours in the Ukrainian capital on Monday, meeting President Volodymyr Zelensky and even taking a stroll through the streets of Kyiv – despite the sound of air sirens – to visit The Wall of Remembrance, which displays portraits of the approximately 4,500 Ukrainian soldiers who have died since Russia annexed Crimea in 2014.

The trip was kept under a media blackout until a few hours after Biden’s arrival, with the president’s official schedule only saying he would fly in the evening to Warsaw for a planned visit. The New York Times reported, quoting an anonymous official source, that Biden arrived in Kyiv early this morning after making the same 10-hour long journey from Poland that every world leader visiting Ukraine since the start of the war has.

Apr 10, 2023

The following is an event write-up about the recent Future of Diplomacy Project (FDP) seminar on “The Geopolitics of Latin America amid the War in Ukraine and China-U.S. Tensions” moderated by Negah Angha, Fellow at the Institute of Politics, on March 29, 2023.

Jun 1, 2024

How can scholars write effective policy recommendations? Despite the potential importance of academic work to the policy debate, many scholars receive little training on why and how to make policy recommendations. To remedy this problem, here are steps to guide scholars as they begin developing policy recommendations for their articles. 

Jun 4, 2021

The last time Joe Biden met Vladimir Putin, the two did not exactly hit it off. During the March 2011 meeting the-then vice president of the United States urged the then-prime minister of Russia not to return to the Kremlin, and then claimed to have reached unflattering conclusions about his Russian counterpart’s soul after the meeting was over. Putin too seems to have no love lost for Biden, even if he has been less blunt in showing it.

Dec 1, 2021

One of the few things America’s Joe Biden and Russia’s Vladimir Putin had agreed upon prior to their first summit almost half a year ago was that they would not hold a joint press conference after their June 16 huddle at an 18th century villa in Geneva. The two presidents’ decision to talk to press separately came as no surprise, given how many major issues they publicly disagreed on at the time.

Nov 6, 2023

The Harvard Project on Climate Agreements collaborated with the Salata Institute on Climate and Sustainability at Harvard University to provide financial and logistical support for students to attend the Twenty-Eighth Conference of the Parties (COP-28) to the United Nations Framework Convention on Climate Change (UNFCCC). COP-28 will be held in Dubai, Nov. 30 – Dec. 12, 2023.

Dec 13, 2023

The Harvard Project on Climate Agreements (HPCA) assembled a panel of leading academics and government officials to discuss strategies for achieving significant methane emissions reductions at relatively low costs at an official COP 28 Side Event last Wednesday (Dec. 6). The event, titled “Reducing Global Methane Emissions: Imperatives, Opportunities, and Challenges,” was moderated by HPCA Director Robert Stavins.