Posts Tagged “Opioid Epidemic”
When we hear of new artificial intelligence (AI) applications, especially those that seem a bit too “big brother” for the liking of many, this story should better represent the true intent of libertarian paternalism, or the ethical framework designed to provide optimal decision making while still allowing for freedom of choice.
Medasense Biometrics, a company that has developed a patented technology platform to objectively assess the physiological response to pain (nociception), and which could ebb opioid addiction post-surgery.
See featured article on artificial intelligence.
This company has come up with a portable pain sensor that can tell doctors how much pain a patient is feeling and how much pain care they need. Using artificial intelligence algorithms and real-time data, the company’s easy-to-use system is already changing precision medicine, allowing for personalized and optimized pain care to ensure that the patient doesn’t get too many opioids.
“Unlike other aspects of anesthesia, there have not been good monitors of painful stimuli during surgery, and how patients react. It has thus been challenging for anesthesiologists to know how much medication is needed to blunt surgical pain in individual patients. The problem is that too much or too little pain medication (usually narcotics) can be harmful. A monitor that accurately measures how patients react to surgical pain might therefore help guide clinical care,” Dr. Daniel Sessler, the founder and director of the Outcomes Research Consortium (the world’s largest clinical anesthesia research group), tells NoCamels.
Indeed, the average rate of later opioid dependence and addiction among surgical patients hovers at 12 percent, according to a US national pain report.
“We know that the first exposure to opioids for a large number of people addicted to opioids occurs after surgery. Thus it is logical that if we have a technology that allows us to titrate opioids more carefully during surgery, we can potentially decrease the habituation to opioid analgesia that the body develops during and immediately after surgery,” Dr. Frank J. Overdyk, an anesthesiologist in Charleston, South Carolina, tells NoCamels in an email exchange.
In fact, a recent study published in a peer-reviewed American Society of Anesthesiologists journal showed a 30-percent reduction in remifentanil consumption (a potent, short-acting synthetic opioid analgesic drug that is given to patients during surgery to relieve pain and as an adjunct to an anesthetic) in procedures performed with the Israeli company’s platform.
The pain sensor tech has been part of a number of clinical studies across the world including in the US, Europe, Canada, Japan, Israel, and Chile.
“For the first time in the history of surgery and anesthesia will we have the ability to measure painful stimuli during surgery directly. Currently, we have had to use indirect measures of pain such as high heart rate, pupil dilation and sweating as signs of pain. The NOL will allow us to titrate pain medicines more precisely and early studies suggest we will be able to use less opioid pain medicine. For patients, this means fewer side effects such as nausea, vomiting, itching, constipation and inability to void,” says Overdyk.
How smiley-faces warned of the need for new pain assessment
Founder and CEO of Medasense, Galit Zuckerman-Stark grew up in operating rooms, watching her mom, a nurse, care for patients.
According to Wikipedia, drug overdoses have become the leading cause of death of Americans under 50, with two-thirds of those deaths from opioids. In 2016, the crisis decreased
The opioid epidemic or opioid crisis is the rapid increase in the use of prescription and non-prescription opioid drugs in the United States and Canada beginning in the late 1990s and continuing throughout the next two decades. The increase in opioid overdose deaths has been dramatic, and opioids are now responsible for 49,000 of the 72,000 drug overdose deaths overall in the US in 2017. The rate of prolonged opioid use is also increasing globally.
The remainder of this text was originally published by NoCamels.com
According to the FDA, Brainsway is set to develop a device for opioid use disorder therapy. The seven other companies, a majority US-based, will develop systems for pain therapy, medication dispensation, overdose detection, drug screening, and virtual reality (VR) treatments for chronic pain.
Medical devices at any stage of development were eligible for the challenge.
The opioid crisis in the US has garnered international attention for its startling statistics. According to the US National Institute on Drug Abuse, 115 Americans die every day from an opioid overdose.
More than 40 percent of all US opioid overdose deaths in 2016 involved a prescription opioid, according to the Centers for Disease Control and Prevention. Overdose rates from prescription opioids were highest among people aged 25 to 54 years, according to the report. And based on data from Substance Abuse and Mental Health Services Administration’s national survey on drug use and health, 11.1 million people aged 12 and older had misused prescription pain relievers in 2017.
The eight companies selected for the FDA innovation challenge will work closely with the agency to “accelerate the development and expedite marketing application review of innovative products, similar to what occurs under the Breakthrough Devices Program“, which helps expedite “certain medical devices that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases for which no approved or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives.”
The companies will enter a 90-day collaboration to develop mutual understanding of the product profile including the patient and user needs, and the important risks and benefits, and to discuss the potential regulatory pathways going forward.
“While these products will not automatically receive marketing authorization from the FDA, the device developers will receive increased interaction with CDRH experts, guidance for clinical trial development plans, and expedited review,” wrote Drs. Jeffrey Shuren and Jonathan
“We believe the greatest opportunities for medical devices to help prevent opioid use disorder are devices that could help identify people likely to become addicted, devices that manage pain as an alternative to opioids or reduce the need for opioid medications,” they wrote.
The CDRH has cleared, granted, or approved more than 200 devices related to the treatment or management of pain, including 10 with new or novel technologies…which may reduce the need to administer opioid drugs to patients suffering from either acute or chronic pain, they said.
Brainsway was founded by Abraham Zangen, Yiftach Roth, Avner Hagai