In the last decade, noteworthy advancements in medical applications of nanotechnology have become more prevalent. As SingularityHub points out, researchers are developing nanoscale patterns on medical implants that can stimulate bone cell growth and positive gene expression. Others are working to make guided nanoparticles that detect (and even destroy) cancer cells.

Multiple groups, like the Center for Cancer Nanotechnology Excellence at Stanford, are altering various nanoparticles to get behaviors useful to medical professionals. For example, nanoparticles are being created that give off a detectable color signal when a cancer cell is found or that hold onto a cancer cell until it can be studied.

More unique reactions have been developed in the lab. For instance, some nanoparticles absorb light and then produce very low-power acoustic vibrations when a tumor is located or even release heat to kill a cancer cell.

At the University of Chicago, scientists are testing a way to spur checkpoint blockade into more potent action using nanoparticles. Checkpoint blockade therapy works by interfering with cancer’s ability to turn off the body’s immune reaction. When cancer cells first develop, the body is able to recognize them as foreign, triggering T-cells to attack and eliminate them.

As malignant cells multiply and form tumors, they release biochemical signals that suppress the immune system, and the T-cells no longer function properly. Checkpoint blockade therapy obstructs those signals, makes T-cells see the cancer cells as invaders again and allows the immune system to do its job. The problem, says chemistry professor Wenbin Lin, is that if a tumor has been growing for years there are no longer any T-cells inside it to activate. This causes the therapy to fail.

“So, what we’re trying to do is to come up with ways to recruit T-cells to the tumor,” he says, “and if you have a way to make the T-cells recognize cancer cells, the T-cell will be able to kill the cancer cells.”

The treatment Lin and collaborators invented is a drug cocktail contained in nanoparticles. The nanoparticles assemble themselves from zinc and a drug called oxaliplatin, which is widely used against advanced-stage metastatic colon cancer. A photosensitizing agent called pyrolipid forms the outer layer.

When light is shined on the pyrolipid, it generates molecules that can kill cancer. It also activates T-cells that can recognize cancer cells thereby enabling the nanoparticles to pack a triple punch.

Used in concert, the nanoparticles and a checkpoint blockade agent eliminated tumors in a mouse, even when the tumors were widely separated and one tumor had received no treatment. This ability to activate T-cells in one place and have them travel to disease sites in the body could be a powerful tool for treating cancer.

Most patients that struggle in their battle with cancer do so because of metastatic disease, not their primary tumor. When patients have surgery, doctors don’t know if there are other, smaller lesions elsewhere in the body.

“You cannot treat them because you don’t know where to look for them,” Lin says. “If you activate immune cells, they can home in to cancer cells selectively. So, you have a better chance of getting rid of these small metastatic tumors throughout the body.”

Although ongoing research is still needed to ensure the safety and success of nanotechnology medical applications, recent discoveries definitely make you think about what is to come. Treatments, such as those for cancer, could look very different in the near future.

________________________

Ryan Lahti is the managing principal of OrgLeader and author of The Finesse Factor. Stay up to date on Ryan’s STEM organization tweets here: @ryanlahti

(Photo: Nanotechnology Book Cover by jurvetson)

Ribonucleic acid (RNA) code is coming for you, cancer cells. A new Northwestern Medicine study reports that a kill code is embedded in every cell in the body whose function may be to cause the self-destruction of cells that become cancerous. As soon as the cell’s inner bodyguards sense it is mutating into cancer, they punch in the kill code to extinguish the mutating cell.

Scientists at Northwestern University know the code is triggered by chemotherapy, but they’ve learned enough about the code to trigger it without chemo. They believe this finding could lead to new therapies.

“My goal was not to come up with a new artificial toxic substance,” said lead author Marcus Peter, Ph.D., a professor of cancer metabolism at Northwestern’s Feinberg School of Medicine, in a statement. “I wanted to follow nature’s lead. I want to utilize a mechanism that nature developed.”

This builds on Peter’s prior work. In research Peter published last year, he showed that cancer cells treated with toxic RNA molecules don’t become resistant, because genes that the cells need to survive also die.

That mechanism involves six nucleotides in small RNAs. Peter’s team tested 4,096 combinations of nucleotide bases in those RNAs and hit on one that seems to be the most toxic to cancer cells. Separately, they discovered that a gene that promotes the growth of cancer cells gets chopped into pieces that act like cancer-killing microRNAs.

Although much of the excitement in oncology research of late has focused on immunotherapy, there is still significant interest in improving chemotherapy—or replacing it with drugs that confer its benefits without its harmful side effects. Startup Ascentage, for example, recently raised $150 million to advance its pipeline of drugs that work by promoting apoptosis, or programmed cell death, in cancer cells.

Zombie Gene

Killer code is not the only threat to cancer. Three years ago, oncology researchers discovered that elephants have 20 copies of p53, a gene that’s essential to cancer suppression. Humans, by contrast, have just one copy of p53. The researchers, which included a team at the University of Chicago, concluded that elephants are especially resistant to cancer because of p53—but they didn’t know the exact mechanism by which the tumor suppressor gene works.

Now the Chicago team has uncovered a key part of that process: a nonfunctioning, or “zombie” gene. The gene, called LIF6, is activated in elephants by p53, after which it kills cancer precursor cells. They believe that the discovery, which they described in the journal Cell Reports, could boost efforts to develop drugs for people that target p53.

Cells that are unable to repair DNA damage often go on to become cancerous. Elephants are estimated to have 100 times as many of these cancer precursor cells than people do, but less than 5% of captive elephants end up dying from the disease. The scientists discovered that in elephants, LIF6 makes a protein that zooms to the damaged cells’ mitochondria, or energy center, and pokes holes in it, which causes cell death.

“When [LIF6] gets turned on by damaged DNA, it kills that cell, quickly,” said senior author Vincent Lynch, Ph.D., assistant professor of human genetics at the University of Chicago, in a university press release. Lynch believes that the strategy employed by elephant cells to reawaken LIF6 could be translated to human oncology.

Interest in p53 research remains high. Startup PMV Pharma raised $74 million from venture capitalists last year to develop a pipeline of p53-targeted cancer drugs. Its approach is to use small molecules to restore the function of the gene in cancers marked by p53 mutations.

Aileron, which raised $56 million in an IPO last summer, is also targeting p53 with its lead product candidate, ALRN-6924. It’s designed to reactivate p53 tumor suppression by targeting two proteins. The drug is in early-stage clinical trials for advanced solid tumors and blood cancers.

For more information, check out:

Discovery of Cancer “Kill Code” Could Inspire New Treatments

How Elephants Resist Cancer by Reviving a “Zombie” Gene

________________________

Ryan Lahti is the managing principal of OrgLeader and author of The Finesse Factor: How to Build Exceptional Leaders in STEM Organizations being published in early 2019. Stay up to date on Ryan’s STEM organization tweets here: @ryanlahti

(Photo: Gene, Pixabay)

Medical device recalls reached record highs in the first three months of 2018 due to software complications that are likely to continue with the spread of high-tech devices. Device recalls increased 126 percent in the first quarter of 2018. At 343 recalls, it was the highest number in a single quarter since 2005, according to a report by Stericycle’s Recall Index, which tracks recall data across several industries.

Software was the biggest driver of medical device recalls in the first quarter, accounting for 23 percent of all recalls. Software issues have been the leading factor in device recalls each quarter since the beginning of 2016.

Bethany Hills, an attorney at Mintz Levin in New York who chairs the firm’s Food and Drug Administration (FDA) practice, says the rapid increase is not totally unexpected. Medical device software is becoming increasingly complex, with analytics that provide a higher level of clinical decision support.

“The more complex the software, the more likely it is that the developers did not account for all variables in the clinical environment, increasing the risk of bugs and errors,” she explained in a FierceHealthcare interview. “This risk increases further if the device manufacturer outsources software development because integration of outside software and the inability to quickly modify the code can lead to additional errors slipping through the cracks.”

All told, more than 208 million devices were recalled in the beginning of the year, more than the total number of recalled devices in all of 2017. There doesn’t appear to be one singular reason for the startling uptick, making it difficult to pinpoint an underlying trend.

Although it’s possible the first three months of 2018 were an anomaly, software challenges aren’t likely to recede. Device manufacturers are building more innovative devices with software that requires frequent updates and patches.

“[Manufacturers] don’t have this figured out yet and it’s going to continue to be a driver,” Mike Good, vice president of marketing and sales operations at Stericycle, told FierceHealthcare.

Medical Device Cybersecurity

At the same time, medical device cybersecurity has emerged as a growing concern among industry leaders and lawmakers. Legacy devices are especially susceptible to attacks. A recent report from analysts at Symantec indicated a hacker group known as Orangeworm has been launching targeted attacks on the healthcare imaging suites where devices run on outdated operating systems.

Although there have been a limited number of cybersecurity recalls, the most notable was a firmware update for Abbott-manufactured cardiac devices. According to Healthcare IT News, Abbott recently released its second and final round of planned cybersecurity updates to its pacemakers, programmers and remote monitoring systems to fix severe cybersecurity flaws in the devices.

The patch will update the battery performance alert. This allows the device to monitor for abnormal battery behavior and automatically vibrate to tell the patient when something is wrong.

The planned updates began last year, and the latest firmware update was approved by the FDA last month. The update applies to about 350,000 of Abbott’s implantable cardioverter defibrillators and implantable cardiac resynchronization therapy defibrillators.

The devices were originally manufactured by St. Jude Medical, which Abbott acquired last year. At that time, St. Jude was under fire for remaining quiet about defibrillator issues that caused rapid battery depletion. The FDA found St. Jude continued to ship these devices despite knowing about the defect.

The flaws, made public in 2016 by Muddy Waters and security firm MedSec, could allow an unauthorized user to access the defibrillators and modify the programming controls. Since acquiring St. Jude, Abbott has been working to patch those vulnerabilities.

The FDA’s recall notice said the firmware update will reduce the risk of patient harm due to premature battery depletion and potential exploitation of the flaws in the devices. The update will effectively complete the necessary patches to prevent unauthorized access.

Hills expects the medical device recall trend to continue, particularly now that the FDA is accepting devices with artificial intelligence and more complex clinical decision support algorithms. While the trend may continue, the FDA is trying to come up with possible solutions. Food and Drug Administration Commissioner Scott Gottlieb, M.D., has asked Congress for funding to create a cybersecurity “go-team” that would be housed in a new Center of Excellence on Digital Health.

Hills points out that reducing the number of devices recalled from the market requires a joint effort by manufacturers and the FDA to minimize risks prior to approval. Doing so is a delicate balance between constantly testing and validating software and the clinical benefits of using the software.

________________________

Ryan Lahti is the managing principal of OrgLeader and author of The Finesse Factor: How to Build Exceptional Leaders in STEM Organizations being published in early 2019. Stay up to date on Ryan’s STEM organization tweets here: @ryanlahti

(Photo: Medicine Equipment, Pixabay)

GE Healthcare and Roche entered into a strategic partnership to co-develop and co-market digital clinical decision support (CDS) solutions. GE Healthcare is a worldwide leader in medical imaging equipment, while Roche Diagnostics is the global leader in in-vitro diagnostics. The partnership will initially focus on products that accelerate and improve individualized treatment options for cancer and critical care patients.

The two companies aim to develop an industry-first digital platform, using advanced analytics to provide workflow solutions and apps that support clinical decisions. This will allow the seamless integration of in-vivo and in-vitro data, patient records, medical best practice, real time monitoring and the latest research outcomes. Clinicians will then have the comprehensive decision support for providing the right treatment and quality of care for their patients.

For example, oncology care teams with multiple specialists will have a full data dashboard to help them collaborate on treatment decisions for cancer patients at each stage of their disease. In the critical care setting, data from a patient’s hospital monitoring equipment will be integrated with their biomarker, tissue pathology, genomic and sequencing data. Physicians will be able to identify, or even predict severe complications before they strike.

According to FierceBiotech, GE chief innovation officer Nadeem Ishaque cites the bringing together of diagnostic images, pathology and genomic information for a breast cancer patient as an example of the potential of the collaboration. Ishaque stated, “By leveraging this combined data set using machine learning and deep learning, it may be possible in the future to reduce the number of unnecessary biopsies that are performed due to suspicious findings in the mammograms and possibly also reduce mastectomies that are performed to combat ductal carcinoma in situ, a condition that may evolve into invasive breast cancer in some cases.”

The strategic partnership will have to navigate the new FDA guidance on CDS solutions. Some types of CDS will no longer be defined as a medical device and subsequently regulated by the FDA. Software that suggests a provider order liver function tests before starting statin medication is an example. However, the FDA will continue to enforce oversight of software programs intended to analyze medical images, signals from in vitro diagnostic devices or patterns acquired from a processor like an electrocardiogram. These programs use analytical functionalities to make treatment recommendations. Consequently, they remain medical devices under the Cures Act, because inaccurate information provided in the CDS has the potential for significant patient harm.

Many of the ideas driving the GE-Roche collaboration have been discussed for years, but action to date has not resulted in a noticeable reduction in healthcare inefficiencies and medical errors. With medical errors being the third leading cause of death in the U.S., an effective CDS solution by GE and Roche could have a significant impact.

“This is the first time that two major players in healthcare have combined advanced analytics with in-vivo and in-vitro diagnostics to this degree. We believe this alliance will help accelerate the delivery of data-driven precision health for customers, patients and the healthcare industry,” said GE Healthcare CEO Kieran Murphy in a recent press release.

As Murphy suggests, the potential for clinical decision support software success is there. We just need to see empirical evidence to show it.

Related posts:

Human Dx Changes the Process for Medical Diagnoses

Artificial Intelligence and Deep Learning Aid Cancer and Stroke Diagnostics

———–

Ryan Lahti is the founder and managing principal of OrgLeader. Stay up to date on Ryan’s STEM organization tweets here: @ryanlahti

(Photo: General Electric Logo, Flickr)

How is your experience at your doctor’s office likely to change? The Human Diagnosis Project (also referred to as “Human Dx”) could be a big factor. Human Dx is a worldwide effort led by the global medical community to build an online system that maps the best steps to help any patient. By combining collective intelligence with machine learning, Human Dx constructs an online map designed to help physicians diagnose illnesses quicker and connect patients to the appropriate specialists. Ultimately, Human Dx intends to enable more accurate, affordable and accessible care for all.

The project is structured as a partnership between the social, public and private sectors. Its partners include the American Medical Association, the American Board of Internal Medicine, the American Board of Medical Specialties, the Association of American Medical Colleges, the Association of Clinicians for the Underserved, the National Association of Community Health Centers and the Dartmouth Institute for Health Policy and Clinical Practice.

Currently, Human Dx includes more than 6,000 doctors across 70 countries. An alliance with some of the country’s largest medical groups offers more weight to the initiative and provides an influx of new users. The project plans to focus its efforts on making specialty care more accessible for patients at safety net hospitals. These patients often delay care because of the high out-of-pocket costs associated with seeing a medical specialist.

Human Dx’s development was inspired by other scientific projects (e.g., the International Space Station, the Large Hadron Collider at CERN and the Human Genome Project) and open technology efforts (e.g., Wikipedia, Linux and the Internet Protocol Suite). The global medical community submits clinical case contributions to Human Dx similar to the way people around the world contribute encyclopedia articles to Wikipedia or engineers contribute code to open source software projects like Linux. This can be done from any connected device. As medical practitioners, residents and students give and receive input on clinical cases within Human Dx, the open system automatically puts their clinical insights into context.

A recent Wired article provides a good example of how it works from a physician’s perspective. When a primary care doctor gets a patient with a perplexing issue, the doctor describes the patient’s background, medical history and presenting symptoms via Human Dx. The doctor may add an image of an X-ray, a photo of a rash or an audio recording of lung sounds. Human Dx’s natural language processing algorithms will mine each case entry for keywords to funnel it to specialists who can create a list of likely diagnoses and recommend treatment.

Since getting back 10 or 20 different doctors’ viewpoints on a single patient can be cumbersome, Human Dx’s machine learning algorithms comb through the responses to check them against all the project’s previously stored case reports. The network uses them to validate each specialist’s finding, weight each one according to confidence level and combine it with others into a single suggested diagnosis. With every solved case, Human Dx gets a little smarter.

Some physicians are skeptical about the quality of information generated by Human Dx. Because of this skepticism, researchers at Johns Hopkins, Harvard and UCSF have been assessing the platform for accuracy and recently submitted results for peer review.

The next big hurdle for Human Dx is money. The project is currently one of eight organizations in contention for a $100 million John D. and Catherine T. MacArthur Foundation grant. If Human Dx wins, the project will spend the money on a nationwide roll out. Human Dx is not dependent upon the $100 million award, but it would certainly be a nice way to kick-start the process.

If all goes well, it is possible your experience will be different the next time you have a medical issue that stumps your regular physician. Instead of seeing a specialist across town, you will see five or 10 specialists from around the country.

———–

Ryan Lahti is the founder and managing principal of OrgLeader. Stay up to date on Ryan’s STEM organization tweets here: @ryanlahti

(Photo: Doctor with Tablet, Public Domain Pictures)

How close are we to cyborgs being a practical reality? Some say that Dr. Kevin Warwick became the first cyborg back in 1998. While at the University of Reading in the U.K., he decided to implant a radio-frequency identification (RFID) chip in his shoulder. He wanted to see how well sensors within his office building could pick up the chip’s presence and respond by turning lights on or off and giving him access to locked doors. In 2002, Warwick proceeded to up the ante considerably by having a surgeon implant a device called the BrainGate. With its 100 electrodes, it tapped directly into the nerves of his arm, giving him remote control of a robotic hand.

More recently, Neil Harbisson and Moon Ribas have integrated other forms of technology into their bodies. Harbisson, whose U.K. passport shows he’s the first legally recognized cyborg, was born colorblind. He designed an antenna which translates colors into one of 360 musical tones he’s memorized. At first, he connected it to headphones and a laptop. Eventually, he persuaded a surgeon to drill into his skull, implant a chip and fuse the antenna to his occipital bone. Ribas has a Bluetooth implant in her left arm designed to analyze the earth’s seismic movements. The implant vibrates at different intensities based on data from online seismographs. Harbisson and Ribas say the merging of technology with their bodies has created new senses.

Cyborg Nest, a London startup, is manufacturing DIY kits to enhance senses and bring transhumanism to the mainstream. The first kit, the North Sense, is essentially a $425 wearable implant. “It does one simple thing,” says co-founder and Chief Executive Officer Liviu Babitz, who was fitted with one in December. It produces “a short vibration every time you’re facing north.” That doesn’t sound like an advantage worth body modification, but Babitz likens the experience to a second childhood. “I remember my son discovering things as his senses developed and the look in his eyes when it happened,” he says. “I feel the same.”

Stanford genetics department chairman Michael Snyder says these implants aren’t as fringe as they sound. He employs similar medical sensors to detect colds, Lyme disease and diabetes risk. He calls the North Sense “analogous to the radiation monitor that I use.” The World Economic Forum says Cyborg Nest’s type of biohacking could be commonplace by 2020. “If you’re alive today, you’re probably going to end up having at least one electronic attachment,” Babitz says.

It’s not just startups that see a human-technology integration as reality versus science fiction. Google has a vision for cyborg eyes that goes well beyond the idea of smart contact lenses. The Alphabet-owned company filed a patent on the idea of replacing the human eye’s natural lens with an electronic lens implant. Such a cyborg eye implant could replace normal eyesight functions and correct for eyesight problems. The concept’s existence also hints at future possibilities for putting the capabilities of a smart contact lens directly inside the eye.

The Google patent application envisions a laser drilling a hole in the lens capsule that protects the human eye’s natural lens, according to research provided by legal technology firm ClientSide. Ultrasonic vibrations would help shatter the eye’s natural lens so that the fragments could be suctioned out the hole. That would clear the way for the injection of the electronic lens device and a fluid capable of solidifying into silicone hydrogel. This would produce a new electronic lens that can adjust its shape to provide the appropriate focus for normal eyesight — or correct for problems such as nearsighted vision without requiring extra contact lenses or glasses.

A cyborg eye implant like this could change its shape and adjust the wearer’s vision by using technologies such as liquid crystals , micro mirrors and tiny micro-fluidic pumps. It may also include additional lenses to help fix eyesight problems such as myopia (nearsightedness) or astigmatism.

The implant could wirelessly send data to a smartphone, tablet or laptop that has an Internet connection. These devices could pass on the data to an optometrist’s office or a clinic. In response, an optometrist or another medical expert could send signals with commands to change the programming that controls the electronic lens vision. This would equate to a wireless update for corrective lens prescriptions.

Some argue that cyborgs are not just a reality–they are a necessity. At the World Government Summit, Elon Musk warned that humans must become cyborgs if they are to stay relevant in a future dominated by artificial intelligence. Musk argued that as artificial intelligence becomes more sophisticated, it will lead to mass unemployment. He stated, “There will be fewer and fewer jobs that a robot can’t do better.”

If humans want to continue to add value to the economy, they must augment their capabilities through a “merger of biological intelligence and machine intelligence”. If we fail to do this, Musk contends we’ll risk becoming “house cats” to artificial intelligence.

While you may not see the Terminator, the Borg from Star Trek or even the Six Million Dollar Man walking down the street today, you can certainly find real examples of technology integrated with the human body. We may not know enough to tell if this transhumanism could prevent us from becoming house cats. However, evidence does suggest it can provide solutions to address vision problems and other medical issues.

———–

Ryan Lahti is the founder and managing principal of OrgLeader, LLC. Stay up to date on Ryan’s STEM-based organization tweets here: @ryanlahti

(Photo: Cyborg, Pixabay)

What do stem cells, jaw bones, and salamanders have in common? They all have played a part in the recent advancements in regenerative medicine. As the Mayo Clinic points out, regenerative medicine itself isn’t new — forms of regenerative medicine such as the first bone marrow and solid-organ transplants were done decades ago. But advances in developmental and cell biology, immunology, and other fields have unlocked new opportunities to refine existing regenerative therapies and develop novel ones.

Mayo’s Center for Regenerative Medicine explains that regeneration involves delivering specific types of cells or cell products to diseased tissues or organs, where they will ultimately restore tissue and organ function. This can be done through cell-based therapy or by using cell products, such as growth factors. Bone marrow transplants are an example.

Stem cells are a key component of regenerative medicine, as they open the door to new clinical applications. Stem cells have the ability to develop — through a process called differentiation — into many different types of cells, such as skin cells, brain cells, lung cells and so on. Consequently, regenerative medicine holds the promise of definitive, affordable healthcare solutions that heal the body from within. Recent work done at Columbia University and the University of New South Wales (UNSW) in Australia is close to making this promise a reality.

Columbia College of Dental Medicine researchers have identified stem cells that can make new cartilage and repair damaged joints. The cells reside within the temporomandibular joint (TMJ), which articulates the jaw bone to the skull. When the stem cells were manipulated in animals with TMJ degeneration, the cells repaired cartilage in the joint.

“This is very exciting for the field because patients who have problems with their jaws and TMJs are very limited in terms of clinical treatments available,” said Mildred C. Embree, DMD, PhD, assistant professor of dental medicine at Columbia and the lead author of the study. Dr. Embree’s team, the TMJ Biology and Regenerative Medicine Lab, conducted the research with colleagues including Jeremy Mao, DDS, PhD, the Edwin S. Robinson Professor of Dentistry (in Orthopedic Surgery) at Columbia.

In a series of experiments, Dr. Embree and her colleagues isolated fibrocartilage stem cells (FCSCs) from the joint and showed that the cells can form cartilage and bone, both in the laboratory and when implanted into animals. Ultimately, Dr. Embree and her team say, the findings could lead to strategies for repairing fibrocartilage in other joints, including the knees and vertebral discs.

At UNSW in Australia, breakthrough research could make stem cell therapies capable of regenerating any human tissue damaged by injury, disease or aging available within a few years. The repair system, similar to the method used by salamanders to regenerate limbs, could be used to repair everything from spinal discs to bone fractures, and has the potential to transition current treatment approaches to regenerative medicine.

Study lead author, hematologist and UNSW Associate Professor John Pimanda, said the new technique reprograms bone and fat cells into induced multipotent stem cells (iMS). The technique has been successfully demonstrated in mice.

“This technique is ground-breaking because iMS cells regenerate multiple tissue types,” Associate Professor Pimanda said.

Prior to the UNSW research, no adult stem cells have been found that are capable of regenerating multiple tissue types. Typical adult stem cells are problematic, because they are tissue-specific. Embryonic stem cells can generate every type of cell in the human body, but they have challenges in therapeutic applications.

The UNSW study’s first author, Dr. Vashe Chandrakanthan, who developed the technology, said the new technique is an advance on other stem cell therapies being investigated. The reason is these other therapies have a number of deficiencies.

“Embryonic stem cells cannot be used to treat damaged tissues because of their tumor-forming capacity. The other problem when generating stem cells is the requirement to use viruses to transform cells into stem cells, which is clinically unacceptable,” explained Dr. Chandrakanthan.

“We believe we’ve overcome these issues with this new technique. We are currently assessing whether adult human fat cells reprogrammed into iMS cells can safely repair damaged tissue in mice, with human trials expected to begin in late 2017,” Associate Professor Pimanda said.

As the work at Columbia and UNSW show, advancements in stem cell technology can produce bone and cartilage as well as approximate how salamanders repair limbs. This work broadens the potential of regenerative medicine to treat joint and spine problems and accelerate recovery following complex surgeries where bones and joints are involved.

———–

Ryan Lahti is the founder and managing principal of OrgLeader, LLC. Stay up to date on Ryan’s STEM-based organization tweets here: @ryanlahti

(Photo: Stem Cell, Pixabay)

Medical device cybersecurity continues to be a major concern for companies given the impact breaches can have on the health of patients. Johnson & Johnson (J&J) and St. Jude Medical are prime examples. Johnson & Johnson’s Animas unit recently disclosed cybersecurity flaws in its wirelessly controlled insulin pump that hackers could exploit and potentially deliver unauthorized doses of insulin to patients. While such an attack could result in insulin overdose and hypoglycemia, Animas says the risk of attack is low.

The OneTouch Ping Glucose Management System comprises an insulin pump worn by the patient and a remote that uses a radio frequency communication system to wirelessly tell the pump to deliver insulin. Cybersecurity firm Rapid7 first identified the security issues earlier this year and communicated them to Animas in April.

In an interview with FierceMedicalDevices, Jay Radcliffe, a senior security researcher at Rapid7, explained that the major vulnerability is that the device lacks protection against a replay attack. If a person is in range of the device and can pick up its communications, they could “replay” those signals to cause the pump to do things that the user doesn’t command it to do. Such an attack is possible because the transmissions between the remote and pump are not encrypted. They don’t use sequence numbers either, which are unique numbers for each communication that allow the device components to talk to each other, but would ensure a hacker couldn’t carry out a replay attack.

Animas disclosed the security issues in a letter to customers. “We also want to assure you that the probability of unauthorized access to the One Touch Ping System is extremely low,” the company wrote. Animas told Reuters that it considered the device to be “safe and reliable.”

“We urge patients to stay on the product,” said Brian Levy, chief medical officer with J&J’s diabetes unit, as quoted by Reuters. Rapid7’s Radcliffe worked with Animas on the security issues and underscored the importance of understanding risk. He shared in a blog post that “removing an insulin pump from a diabetic over this risk is similar to never taking an airplane because it might crash.”

Besides Johnson & Johnson, St. Jude Medical has been dealing with medical device cybersecurity issues. A report on cybersecurity vulnerabilities in St. Jude Medical’s implantable heart devices was jointly released in August by cybersecurity research firm MedSec Holdings and investment firm Muddy Waters, which primarily focuses on short selling, or betting that the stock prices of companies it picks will decline. The report claimed that pacemakers and implantable defibrillators sold by St. Jude could be hacked in ways that could jeopardize a user’s safety. The implanted devices have wireless radios to connect to a home monitoring station that can then back up data to St. Jude.

In a Fortune article, University of Michigan researchers stated that the report by MedSec and Muddy Waters didn’t prove the flaws existed. “We’re not saying the report is false,” Kevin Fu, associate professor of computer science and engineering and director of the Archimedes Center for Medical Device Security at University of Michigan, said in a statement. “We’re saying it’s inconclusive because the evidence does not support their conclusions. We were able to generate the reported conditions without there being a security issue.”

St. Jude said the MedSec/Muddy Waters report analyzed outdated software and demonstrated a “fundamental lack of understanding of medical device technology.” Security expert Robert Graham also challenged some of the MedSec findings by stating in his blog, “The report is clearly designed to scare other investors to drop St. Jude stock price in the short term so that Muddy Waters can profit. It’s not designed to withstand long term scrutiny. It’s full of misleading details and outright lies.” To be transparent, MedSec and Muddy Waters did disclose that they had a joint financial arrangement to profit from a fall in St. Jude’s stock price.

Whether it is J&J’s Animas unit, St. Jude or another medical device company, cybersecurity remains a high priority. The FDA further underscored the importance with the release of recommendations for managing cybersecurity vulnerabilities for medical devices. The ultimate test is how well medical device companies can protect patient health by preventing cyber breaches or quickly recovering when breaches happen.

———–

Ryan Lahti is the founder and managing principal of OrgLeader, LLC. Stay up to date on Ryan’s STEM-based organization tweets here: @ryanlahti

(Photo: Johnson & Johnson, Flickr)

The United States is currently experiencing an epidemic of opioid abuse. According to the Centers for Disease Control and Prevention, the amount of prescription opioids sold in the U.S. nearly quadrupled since 1999. Opioids include codeine, fentanyl, morphine and forms of oxycodone (e.g., Oxycontin and Percocet) as well as hydrocodone (e.g., Vicodin). They are typically prescribed to treat moderate to severe pain that do not respond well to other pain medications. This large increase in opioid prescriptions might lead you to believe that there has been an increase in the amount of pain experienced by Americans, but this is not the case. Unfortunately, the impact of this abuse can be tragic. More than 165,000 Americans died from overdoses related to prescription opioids from 1999 to 2014.

Given these statistics, you might question what is being done about opioid abuse. The implementation of drug-monitoring programs has provided some positive results. A study by Bao and colleagues at Cornell Medical College found that doctors in states that track painkiller prescriptions were nearly one-third less likely to offer patients dangerously addicting opioids. Twenty-four states have implemented drug-monitoring programs. In these states, the probability of a doctor prescribing a Schedule II opioid dropped from 5.5 percent to 3.7 percent – a more than 30 percent reduction. The results were immediate and held for three years.

Dr. Caleb Alexander, who directs the Johns Hopkins Center for Drug Safety and Effectiveness in Baltimore, believes that many overdoses could have been avoided if doctors had been able to check a prescription drug-monitoring database. A database could show when patients are obtaining opioids under their own name from multiple doctors, which might assist in identifying potential abuse and dependency.

Bao and colleagues feel that drug-monitoring databases may make doctors think twice before prescribing pain medications for a variety of reasons in addition to uncovering “doctor shopping” by patients. Knowing that they’re being watched may serve as a deterrent, and the programs may generally increase awareness of the dangers of prescribing opioids.

According to the Washington Post, health insurance companies also believe monitoring the prescribing of opioids can bring positive results. Using the vast amount of data it collects from insurance claims by pharmacies, Aetna has begun contacting doctors whose prescribing habits are far outside the norm. In a letter it wrote to 931 physicians across the country earlier this month, Aetna stated, “You have been identified as falling within the top 1 percent of opioid prescribers within your specialty.”

Harold Paz, Aetna’s chief medical officer, said his experience has convinced him that the best way to change doctors’ behavior is to provide them with the numbers. “By nature, doctors are data-driven…If you show them how they’re doing, they’ll want to do better,” he said. Paz shared that if the 931 doctors brought their refill rate in line with the average for all physicians who prescribe opioids, 1.4 million fewer pills would be dispensed annually. The physicians receiving the letter had an average refill rate of 4.5 for each prescription written (the overall average was 0.3 refills per prescription).

The opioid abuse epidemic is real. Fortunately, physicians, researchers and insurance companies are recognizing it and taking steps to address the issue. While there is no quick fix, actions taken to date are showing some promising outcomes.

———–

Ryan Lahti is the founder and managing principal of OrgLeader, LLC. Stay up to date on Ryan’s STEM-based organization tweets here: @ryanlahti

(Photo: pop life, Flickr)

Where are artificial intelligence and deep learning going to be applied next? Beth Israel Deaconess Medical Center and Harvard Medical School believe it is breast cancer pathology. According to FierceBiotech, researchers at Beth Israel Deaconess Medical Center and Harvard Medical School have worked together to create an analysis of breast cancer pathology that incorporates artificial intelligence. They found that their system–and the evaluation by pathologists themselves–worked better when used in conjunction than either did alone.

In an evaluation of slides of lymph node cells, the automated diagnostic method was accurate about 92 percent of the time. This was almost as accurate as human pathologists–who are about 96 percent correct. When combined, the results were even better.

“The truly exciting thing was when we combined the pathologist’s analysis with our automated computational diagnostic method, the result improved to 99.5 percent accuracy,” said pathologist Dr. Andrew Beck, director of bioinformatics at the Cancer Research Institute at Beth Israel Deaconess Medical Center and associate professor at Harvard Medical School. “Combining these two methods yielded a major reduction in errors.”

“Our AI method is based on deep learning, a machine-learning algorithm used for a range of applications including speech recognition and image recognition,” said Beck. “This approach teaches machines to interpret the complex patterns and structure observed in real-life data by building multi-layer artificial neural networks, in a process which is thought to show similarities with the learning process that occurs in layers of neurons in the brain’s neocortex.”

Increasingly, the industry expectation is that deep learning can be useful to aid human analysis. This is a first step to pre-analyze and learn from massive quantities of data to offer insights that are subsequently reviewed by people.

Breast cancer is not the only new area where artificial intelligence and deep learning are being applied. MedyMatch Technology Ltd. and Capital Health are focusing on strokes. MedyMatch Technology, the data analytics healthcare company focused on providing physicians with artificial intelligence and real-time decision support tools, recently announced a partnership with Capital Health. This is the first of several partnerships with hospitals in the United States intended to improve stroke patient outcomes. As part of the agreement, Capital Health will provide anonymized data from its two-hospital health system to MedyMatch for use in the development of its first decision support tool directed towards stroke patients.

“MedyMatch is excited to be working with a leading institution like Capital Health which offers advanced radiology services that help support the critical diagnostics needed for its comprehensive stroke center. True innovation in healthcare only comes from the close collaboration between industry and world-class clinicians,” said Gene Saragnese, Chairman and CEO of MedyMatch Technology. “Our partnership with Capital Health brings together breakthrough technology in deep learning and clinical expertise that will accelerate the transformation we all desire in healthcare–better care at lower cost…The data Capital Health will provide will allow us to move closer to providing this decision support tool which can help ensure appropriate diagnosis critical for treatment.”

“MedyMatch is going to make clinical decision support in radiology faster and more accurate,” said Dr. Ajay Choudhri, Director, Vascular and Interventional Radiology and Assistant Director, Radiology, Capital Health, “MedyMatch’s AI capability augments physicians’ reading ability and provides a second set of eyes on the patient’s imaging study. In the area of stroke where time equals brain, it is critical to get a fast, spot on diagnosis.”

Additionally, MedyMatch will leverage medical imaging libraries across multiple imaging modalities including CT, X-ray, MRI, Ultrasound and PET, which will be utilized as part of its research and development efforts to train its next set of applications and deep learning algorithms. “The right data is at the core of application innovation,” said Robert Mehler, co-Founder and Chief Operating Officer.

Artificial intelligence and deep learning have a lot of potential especially with the wealth of data that is now available to researchers and clinicians. Diagnosing strokes and breast cancer is a great starting point to turn this potential into practical value.

———–

Ryan Lahti is the founder and managing principal of OrgLeader, LLC. Stay up to date on Ryan’s STEM-based organization tweets here: @ryanlahti

(Photo: Harvard Medical School, Flickr)