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Government

Washington Passes Law Requiring Consent Before Companies Collect Health Data (theverge.com) 13

Yesterday, Washington Governor Jay Inslee signed the My Health, My Data bill into law, requiring companies to receive a user's explicit consent before they can collect, share, or sell their health data. When the law comes into effect in March 2024, users will have the right to withdraw consent at any time and have their data deleted. The Verge reports: The law should help shield users' health data from the companies and organizations not included under the HIPAA Privacy Rule, which prevents certain medical providers from disclosing "individually identifiable" health information without consent. The HIPAA Privacy Rule doesn't cover many of the health apps and sites that collect medical data, allowing them to freely collect and sell this information to advertisers.

Under Washington's new law, which comes into effect in March 2024, medical apps and sites must ask a user for permission to collect their health data in a nondeceptive manner that "openly communicates a consumer's freely given, informed, opt-in, voluntary, specific, and unambiguous written consent." The site and apps must also disclose what kind of data they plan to collect and if they plan to sell it. Additionally, the bill will block medical providers from using geofencing to collect location information about the patients that visit the facility.

Biotech

The First IVF Babies Conceived By a Robot Have Been Born (technologyreview.com) 55

An anonymous reader quotes a report from MIT Technology Review: Last spring, engineers in Barcelona packed up the sperm-injecting robot they'd designed and sent it by DHL to New York City. They followed it to a clinic there, called New Hope Fertility Center, where they put the instrument back together, assembling a microscope, a mechanized needle, a tiny petri dish, and a laptop. Then one of the engineers, with no real experience in fertility medicine, used a Sony PlayStation 5 controller to position a robotic needle. Eyeing a human egg through a camera, it then moved forward on its own, penetrating the egg and dropping off a single sperm cell. Altogether, the robot was used to fertilize more than a dozen eggs. The result of the procedures, say the researchers, were healthy embryos—and now two baby girls, who they claim are the first people born after fertilization by a "robot."

The startup company that developed the robot, Overture Life, says its device is an initial step toward automating in vitro fertilization, or IVF, and potentially making the procedure less expensive and far more common than it is today. Right now, IVF labs are multimillion-dollar affairs staffed by trained embryologists who earn upwards of $125,000 a year to delicately handle sperm and eggs using ultra-thin hollow needles under a microscope. But some startups say the entire process could be carried out automatically, or nearly so. Overture, for instance, has filed a patent application describing a "biochip" for an IVF lab in miniature, complete with hidden reservoirs containing growth fluids, and tiny channels for sperm to wiggle through.

"Think of a box where sperm and eggs go in, and an embryo comes out five days later," says Santiago Munne, the prize-winning geneticist who is chief innovation officer at the Spanish company. He believes that if IVF could be carried out inside a desktop instrument, patients might never need to visit a specialized clinic, where a single attempt at getting pregnant can cost $20,000 in the US. Instead, he says, a patient's eggs might be fed directly into an automated fertility system at a gynecologist's office. "It has to be cheaper. And if any doctor could do it, it would be," says Munne.

AI

Supreme Court Rejects Computer Scientist's Lawsuit Over AI-Generated Inventions (reuters.com) 69

The U.S. Supreme Court on Monday declined to hear a challenge by computer scientist Stephen Thaler to the U.S. Patent and Trademark Office's refusal to issue patents for inventions his AI system created. From a report: The justices turned away Thaler's appeal of a lower court's ruling that patents can be issued only to human inventors and that his AI system could not be considered the legal creator of two inventions that he has said it generated. Thaler founded Imagination Engines Inc, an advanced artificial neural network technology company based in Saint Charles, Missouri. According to Thaler, his DABUS system, short for Device for the Autonomous Bootstrapping of Unified Sentience, created unique prototypes for a beverage holder and emergency light beacon entirely on its own.

The U.S. Patent and Trademark Office and a federal judge in Virginia rejected his patent applications for the inventions on the grounds that DABUS is not a person. The patent-focused U.S. Court of Appeals for the Federal Circuit upheld those decisions last year and said U.S. patent law unambiguously requires inventors to be human beings. Thaler told the Supreme Court that AI is being used to innovate in fields ranging from medicine to energy, and that rejecting AI-generated patents "curtails our patent system's ability - and thwarts Congress's intent - to optimally stimulate innovation and technological progress."

Censorship

How China Censored Research About Covid-19 (seattletimes.com) 229

Long-time Slashdot reader schwit1 spotted this story in today's New York Times. (Also re-published in the Seattle Times.) In early 2020 a team of U.S. and Chinese scientists "released critical data" on the speedy spread and lethality of the coronavirus, remembers Times, "cited in health warnings around the world... Within days, though, the researchers quietly withdrew the paper, which was replaced online by a message telling scientists not to cite it...

"What is now clear is that the study was not removed because of faulty research. Instead, it was withdrawn at the direction of Chinese health officials amid a crackdown on science."

It's not the only retraction. The Times also points out a paper published on March 9 of 2020 relying on patient samples from mid-December of 2019, which "added to evidence that the virus was spreading widely before the Chinese government took action." Two months later the journal that published an update that "said that the Wuhan samples were not collected in December after all, but weeks later, in January... After Jesse Bloom of the Fred Hutchinson Cancer Center in Seattle tweeted about the discrepancy, the journal's editors posted a third version of the paper, adding yet another timeline. This revision says the samples were collected between Dec. 30 and Jan. 1." Beijing's stranglehold on information goes far deeper than even many pandemic researchers are aware of. Its censorship campaign has targeted international journals and scientific databases, shaking the foundations of shared scientific knowledge, a New York Times investigation found. Under pressure from their government, Chinese scientists have withheld data, withdrawn genetic sequences from public databases and altered crucial details in journal submissions. Western journal editors enabled those efforts by agreeing to those edits or withdrawing papers for murky reasons, a review by The Times of over a dozen retracted papers found.

This scientific censorship has not universally succeeded: The original version of the February 2020 paper, for example, can still be found online with some digging. But the campaign starved doctors and policymakers of critical information about the virus at the moment the world needed it most. It bred mistrust of science in Europe and the United States, as health officials cited papers from China that were then retracted. The crackdown continues to breed misinformation today and has hindered efforts to determine the origins of the virus.

The article notes an international team's discovery last month of genetic sequence data collected in January of 2020 at Wuhan market, "withheld from foreign experts for three years — a delay that global health officials called 'inexcusable.'" The sequences showed that raccoon dogs, a fox-like animal, had deposited genetic signatures in the same place that genetic material from the virus was left, a finding consistent with a scenario in which the virus spread to people from illegally traded market animals... Soon after the group alerted Chinese researchers to their findings, the genetic sequences temporarily disappeared from a global database. "It's just pathetic that we're in this stage where we're having cloak-and-dagger conversations about deleted data," said Edward Holmes, a University of Sydney biologist who was part of the group that analyzed the sequences containing raccoon dog DNA.
The Times cites retracted coronavirus papers flagged by Retraction Watch, which tracks withdrawn research. Amid tighting government censorship in 2020, Chinese researchers began asking journals to retract their work, the Times reports, and "a review of more than a dozen retracted papers from China shows a pattern of revising or suppressing research on early cases, conditions for medical workers and how widely the virus had spread — topics that could make the government look bad." Journals are typically slow to retract papers, even when they are shown to be fraudulent or unethical. But in China, the calculus is different, said Ivan Oransky, a founder of Retraction Watch. Journals that want to sell subscriptions in China or publish Chinese research often bend to the government's demands. "Scientific publishers have really gone out of their way to placate the censorship requests," he said...

The journal retractions continued, and for unusual reasons. One group of authors noted that "our data is not perfect enough." Another warned that its paper "cannot be used as the basis for the origin and evolution of SARS-CoV-2." A third said its findings were "incomplete and not ready for publication." Several scientists promised in retraction notices to update their findings but never did.

Medicine

Researchers Discover Our 'Motor Cortex' Actually Links to Other Parts of the Brain (npr.org) 19

While medical textbooks teach that our movements are controlled solely by the brain's motor cortex — that may be wrong, reports NPR, with another area keeping track of the entire body.

"Scientists at Washington University School of Medicine in St. Louis have found that previously overlooked areas of the brain's motor cortex appear to link control of specific muscles with information about the entire body and brain." As a result, the act of, say, reaching for a cup of coffee can directly influence blood pressure and heart rate. And the movement is seamlessly integrated into brain systems involved in planning, goals and emotion. Textbooks, though, still portray a motor cortex in which "the region that controls your finger is not going to be connected to a region [that asks], 'what am I going to do today?' " says Dr. Nico Dosenbach, an author of the study and an associate professor of neurology and radiology.

But the MRI data leaves little doubt that "there is this interconnected system," says Evan Gordon, an assistant professor of radiology and the study's first author. "It always was there, but we had not perceived it because of our training, because of the things we learned in the first neuroscience class that we ever took...." There's two interleaved systems," Dosenbach says. So right below an area controlling the fingers, for example, the team would find an area involved in "whole body integrative action...."

The new view of primary motor cortex may help explain how the brain solves a difficult problem, says Peter Strick, chair of neurobiology at the University of Pittsburgh. "Even simple movements require nuanced control of all organ systems," he says. "You have to control heart rate. You have to control blood pressure. You have to control so called fight and flight responses...." A system that weaves together movement and mental states also could explain why our posture changes with our mood, or why exercise tends to make us feel better.

"How you move can have an impact on how you feel. And how you feel is going to have an impact on how you move," Strick says. "You know, my mother would tell me, 'stand up straight, you'll feel better.' And maybe that's true."

Thanks to Slashdot reader Tony Isaac for sharing the article.
Science

Scientists Identify Mind-Body Nexus In Human Brain (reuters.com) 77

An anonymous reader quotes a report from Reuters: Researchers said on Wednesday they have discovered that parts of the brain region called the motor cortex that govern body movement are connected with a network involved in thinking, planning, mental arousal, pain, and control of internal organs, as well as functions such as blood pressure and heart rate. They identified a previously unknown system within the motor cortex manifested in multiple nodes that are located in between areas of the brain already known to be responsible for movement of specific body parts -- hands, feet and face -- and are engaged when many different body movements are performed together.

The researchers called this system the somato-cognitive action network, or SCAN, and documented its connections to brain regions known to help set goals and plan actions. This network also was found to correspond with brain regions that, as shown in studies involving monkeys, are connected to internal organs including the stomach and adrenal glands, allowing these organs to change activity levels in anticipation of performing a certain action. That may explain physical responses like sweating or increased heart rate caused by merely pondering a difficult future task, they said.
"Basically, we now have shown that the human motor system is not unitary. Instead, we believe there are two separate systems that control movement," said radiology professor Evan Gordon of the Washington University School of Medicine in St. Louis, lead author of the study.

"One is for isolated movement of your hands, feet and face. This system is important, for example, for writing or speaking -movements that need to involve only the one body part. A second system, the SCAN, is more important for integrated, whole body movements, and is more connected to high-level planning regions of your brain," Gordon said.

"Modern neuroscience does not include any kind of mind-body dualism. It's not compatible with being a serious neuroscientist nowadays. I'm not a philosopher, but one succinct statement I like is saying, 'The mind is what the brain does.' The sum of the bio-computational functions of the brain makes up 'the mind,'" said study senior author Nico Dosenbach, a neurology professor at Washington University School of Medicine. "Since this system, the SCAN, seems to integrate abstract plans-thoughts-motivations with actual movements and physiology, it provides additional neuroanatomical explanation for why 'the body' and 'the mind' aren't separate or separable."

The findings have been published in the journal Nature.
Medicine

Study Reveals Cancer's 'Infinite' Ability To Evolve (bbc.com) 45

An unprecedented analysis of how cancers grow has revealed an "almost infinite" ability of tumors to evolve and survive, say scientists. The BBC reports: The results of tracking lung cancers for nine years left the research team "surprised" and "in awe" at the formidable force they were up against. They have concluded we need more focus on prevention, with a "universal" cure unlikely any time soon. The study -- entitled TracerX -- provides the most in-depth analysis of how cancers evolve and what causes them to spread. More than 400 people -- treated at 13 hospitals in the UK -- had biopsies taken from different parts of their lung cancer as the disease progressed.

The evolutionary analysis has been published across seven separate studies in the journals Nature and Nature Medicine. The research showed:

- Highly aggressive cells in the initial tumor are the ones that ultimately end up spreading around the body
- Tumors showing higher levels of genetic "chaos" were more likely to relapse after surgery to other parts of the body
- Analyzing blood for fragments of tumor DNA meant signs of it returning could be spotted up to 200 days before appearing on a CT scan
- The cellular machinery that reads the instructions in our DNA can become corrupted in cancerous cells making them more aggressive.
"I don't think we're going to be able to come up with universal cures," said Prof Charles Swanton, from the Francis Crick Institute and University College London. "If we want to make the biggest impact we need to focus on prevention, early detection and early detection of relapse."

Last week, Dr Paul Burton, the chief medical officer of pharmaceutical company Moderna, said he believes the firm will be able to offer vaccines for cancer, cardiovascular and autoimmune diseases, and other conditions by 2030. The new analysis reported on by the BBC casts doubt on that timeline.

"I don't want to sound too depressing about this, but I think -- given the almost infinite possibilities in which a tumor can evolve, and the very large number of cells in a late-stage tumor, which could be several hundred billion cells -- then achieving cures in all patients with late-stage disease is a formidable task," said Swanton.
Medicine

Cancer and Heart Disease Vaccines 'Ready By End of the Decade' 154

An anonymous reader quotes a report from the Guardian: Millions of lives could be saved by a groundbreaking set of new vaccines for a range of conditions including cancer, experts have said. A leading pharmaceutical firm said it is confident that jabs for cancer, cardiovascular and autoimmune diseases, and other conditions will be ready by 2030. Studies into these vaccinations are also showing "tremendous promise", with some researchers saying 15 years' worth of progress has been "unspooled" in 12 to 18 months thanks to the success of the Covid jab.

Dr Paul Burton, the chief medical officer of pharmaceutical company Moderna, said he believes the firm will be able to offer such treatments for "all sorts of disease areas" in as little as five years. The firm, which created a leading coronavirus vaccine, is developing cancer vaccines that target different tumor types. Burton said: "We will have that vaccine and it will be highly effective, and it will save many hundreds of thousands, if not millions of lives. I think we will be able to offer personalized cancer vaccines against multiple different tumor types to people around the world."

He also said that multiple respiratory infections could be covered by a single injection -- allowing vulnerable people to be protected against Covid, flu and respiratory syncytial virus (RSV) -- while mRNA therapies could be available for rare diseases for which there are currently no drugs. Therapies based on mRNA work by teaching cells how to make a protein that triggers the body's immune response against disease. Burton said :"I think we will have mRNA-based therapies for rare diseases that were previously undruggable, and I think that 10 years from now, we will be approaching a world where you truly can identify the genetic cause of a disease and, with relative simplicity, go and edit that out and repair it using mRNA-based technology." But scientists warn that the accelerated progress, which has surged "by an order of magnitude" in the past three years, will be wasted if a high level of investment is not maintained.
Medicine

Xanax and Adderall Access Is Being Blocked by Secret Drug Limits 242

Patients diagnosed with conditions like anxiety and sleep disorders have become caught in the crosshairs of America's opioid crisis, as secret policies mandated by a national opioid settlement have turned filling legitimate prescriptions into a major headache. Bloomberg reports: In July, limits went into effect that flag and sometimes block pharmacies' orders of controlled substances such as Adderall and Xanax when they exceed a certain threshold. The requirement stems from a 2021 settlement with the US's three largest drug distributors -- AmerisourceBergen Corp., Cardinal Health Inc. and McKesson Corp. But pharmacists said it curtails their ability to fill prescriptions for many different types of controlled substances -- not just opioids. Independent pharmacists said the rules force them come up with creative workarounds. Sometimes, they must send patients on frustrating journeys to find pharmacies that haven't yet exceeded their caps in order to buy prescribed medicines. It's unclear how the thresholds are impacting major chain pharmacies.

The Drug Enforcement Administration regulates the manufacturing, distribution and sale of controlled substances, which can be dangerous when used improperly. Drugmakers and wholesalers were always supposed to keep an eye out for suspicious purchases and have long had systems to catch, report and halt these orders. The prescription opioid crisis, enabled by irresponsible drug company marketing and prescribing, led to a slew of lawsuits and tighter regulations on many parts of the health system, including monitoring of suspicious orders. One major settlement required the three largest distributors to set thresholds on orders of controlled substances starting last July.

The "suspicious order" terminology is a bit of a misnomer, pharmacists said. The orders themselves aren't suspicious, it's just that the pharmacy has exceeded its limit for a specific drug over a certain time period. Any order that puts the pharmacy over its limit can be stopped. As a result, patients with legitimate prescriptions get caught up in the dragnet. Adding to the confusion, the limits themselves are secret. Drug wholesalers are barred by the settlement agreement from telling pharmacists what the thresholds are, how they're determined or when the pharmacy is getting close to hitting them. The exact limit for each pharmacy is kept secret in order to prevent pharmacists from gaming the system, according to Krista Tongring, leader of the DEA compliance practice at Guidepost Solutions and a former agency attorney. The purpose, she said, is to keep pharmacies from manipulating "their ordering patterns so as to get around the thresholds."
According to a Cardinal Health document, limits are "calculated on a daily, monthly, and quarterly basis," reports Bloomberg. "But without more detailed information, it's impossible for pharmacists to predict when they are going to have to turn patients away."

"Pharmacies can request increases to their thresholds, but those take time to adjudicate, leaving patients scrambling to find their daily medicines elsewhere in the meantime."
Medicine

Sugar-Powered Implant Successfully Manages Type 1 Diabetes 50

Researchers have developed a novel fuel cell implant for type 1 diabetes that can successfully produce and release insulin when triggered. New Atlas reports: The fuel cell itself, which resembles a teabag that's slightly larger than a fingernail, is covered in a nonwoven fabric and coated with alginate, an algae-derived product used widely in biomedicine because of its high degree of biocompatibility. When implanted under the skin, the cell's alginate soaks up body fluid, allowing glucose to permeate the surface and flow into the power center. Inside the cell, the team developed a copper-based nanoparticle anode that splits glucose into gluconic acid and a proton to generate an electric current. "Many people, especially in the Western industrialized nations, consume more carbohydrates than they need in everyday life," [Martin Fussenegger from the Department of Biosystems Science and Engineering at ETH Zurich] said. "This gave us the idea of using this excess metabolic energy to produce electricity to power biomedical devices.

The fuel cell was then coupled with an insulin capsule featuring the team's beta cells, which could be triggered to secrete insulin via electric current from the implant. Overall, the two components provide a self-regulating circuit. When the fuel cell powered by glucose senses excess blood sugar, it powers up. This then stimulates the beta cells to produce and secrete insulin. As blood sugar levels dip, it trips a threshold sensor in the fuel cell, so it powers down, in turn stopping the insulin production and release. This self-sustained circuit could also produce enough power to communicate with a device such as a smartphone, which allows for monitoring and adjusting, and even has potential for remote access for medical intervention.
The study was published in the journal Advanced Materials.
IBM

IBM Installs World's First Quantum Computer for Accelerating Healthcare Research (insidehpc.com) 44

It's one of America's best hospitals — a nonprofit "academic medical center" called the Cleveland Clinic. And this week it installed an IBM-managed quantum computer to accelerate healthcare research (according to an announcement from IBM). IBM is calling it "the first quantum computer in the world to be uniquely dedicated to healthcare research."

The clinic's CEO said the technology "holds tremendous promise in revolutionizing healthcare and expediting progress toward new cares, cures and solutions for patients." IBM's CEO added that "By combining the power of quantum computing, artificial intelligence and other next-generation technologies with Cleveland Clinic's world-renowned leadership in healthcare and life sciences, we hope to ignite a new era of accelerated discovery."

em>Inside HPC points out that "IBM Quantum System One" is part of a larger biomedical research program applying high-performance computing, AI, and quantum computing, with IBM and the Cleveland Clinic "collaborating closely on a robust portfolio of projects with these advanced technologies to generate and analyze massive amounts of data to enhance research." The Cleveland Clinic-IBM Discovery Accelerator has generated multiple projects that leverage the latest in quantum computing, AI and hybrid cloud to help expedite discoveries in biomedical research. These include:

- Development of quantum computing pipelines to screen and optimize drugs targeted to specific proteins;

- Improvement of a quantum-enhanced prediction model for cardiovascular risk following non-cardiac surgery;

- Application of artificial intelligence to search genome sequencing findings and large drug-target databases to find effective, existing drugs that could help patients with Alzheimer's and other diseases.


The Discovery Accelerator also serves as the technology foundation for Cleveland Clinic's Global Center for Pathogen & Human Health Research, part of the Cleveland Innovation District. The center, supported by a $500 million investment from the State of Ohio, Jobs Ohio and Cleveland Clinic, brings together a team focused on studying, preparing and protecting against emerging pathogens and virus-related diseases. Through the Discovery Accelerator, researchers are leveraging advanced computational technology to expedite critical research into treatments and vaccines.

Medicine

Psychedelic Brew Ayahuasca's Profound Impact Revealed In Brain Scans 119

An anonymous reader quotes a report from The Guardian: The brew is so potent that practitioners report not only powerful hallucinations, but near-death experiences, contact with higher-dimensional beings, and life-transforming voyages through alternative realities. Often before throwing up, or having trouble at the other end. Now, scientists have gleaned deep insights of their own by monitoring the brain on DMT, or dimethyltryptamine, the psychedelic compound found in Psychotria viridis, the flowering shrub that is mashed up and boiled in the Amazonian drink, ayahuasca. The recordings reveal a profound impact across the brain, particularly in areas that are highly evolved in humans and instrumental in planning, language, memory, complex decision-making and imagination. The regions from which we conjure reality become hyperconnected, with communication more chaotic, fluid and flexible.

"At the dose we use, it is incredibly potent," said Robin Carhart-Harris, a professor of neurology and psychiatry at the University of California, San Francisco. "People describe leaving this world and breaking through into another that is incredibly immersive and richly complex, sometimes being populated by other beings that they feel might hold special power over them, like gods." He added: "What we have seen is that DMT breaks down the basic networks of the brain, causing them to become less distinct from each other. We also see the major rhythms of the brain -- that serve a largely inhibitory, constraining function -- break down, and in concert, brain activity becomes more entropic or information-rich."

For the latest study, Chris Timmermann, head of the DMT research group at Imperial College London, recruited 20 healthy volunteers who received a 20mg injection of DMT and a placebo on separate visits to the lab. All were screened to ensure they were physically and mentally suitable for the study. Using electroencephalography (EEG) and functional magnetic resonance imaging (fMRI), the scientists recorded the participants' brain activity before, during and after the drug took hold. The volunteers gave updates throughout on how intense the experience felt. None vomited as the emetic is another ingredient in ayahuasca. The results, published in the journal Proceedings of the National Academy of Sciences, provide the most advanced picture yet of the human brain on psychedelics. The recordings show how the brain's normal hierarchical organization breaks down, electrical activity becomes anarchic, and connectivity between regions soars, particularly those handling "higher level" functions such as imagination, which evolved most recently in humans. "The stronger the intensity of the experience, the more hyperconnected were those brain areas," said Timmermann.
"We suspect that while the newer, more evolved aspects of the brain dysregulate under DMT, older systems in the brain may be disinhibited," said Carhart-Harris. "A similar kind of thing happens in dreaming. This is just the beginning in cracking the question of how DMT works to alter consciousness so dramatically."
Science

Caffeine May Reduce Body Fat and Risk of Type 2 Diabetes, Study Suggests (theguardian.com) 62

Having high levels of caffeine in your blood may lower the amount of body fat you carry and reduce the risk of type 2 diabetes, research suggests. From a report: The findings could lead to calorie-free caffeinated drinks being used to reduce obesity and type 2 diabetes, though further research is required, the researchers wrote in the BMJ Medicine journal. Dr Katarina Kos, a senior lecturer in diabetes and obesity at the University of Exeter, said the research showed potential health benefits for people with high levels of caffeine their blood, but added: "It does not study or recommend drinking more coffee, which was not the purpose of this research."

She said any caffeinated drinks containing sugar and fat would offset the positive effects. The researchers said their work built on previously published research, which suggested that drinking three to five daily cups of coffee, containing an average 70-150mg of caffeine, was associated with a lower risk of type 2 diabetes and cardiovascular disease. As those were observational studies, they made it difficult to pinpoint whether the effects were because of caffeine or other compounds, the researchers said. This latest study used a technique known as Mendelian randomisation, which establishes cause and effect through genetic evidence. The team found two common gene variants associated with the speed of caffeine metabolism, and used these to work out genetically predicted blood caffeine levels and whether this was associated with lower BMI and body fat.

Medicine

How Medicare Advantage Plans Use Algorithms To Cut Off Care For Seniors In Need (statnews.com) 92

An anonymous reader quotes a report from STAT News: Health insurance companies have rejected medical claims for as long as they've been around. But a STAT investigation found artificial intelligence is now driving their denials to new heights in Medicare Advantage, the taxpayer-funded alternative to traditional Medicare that covers more than 31 million people. Behind the scenes, insurers are using unregulated predictive algorithms, under the guise of scientific rigor, to pinpoint the precise moment when they can plausibly cut off payment for an older patient's treatment. The denials that follow are setting off heated disputes between doctors and insurers, often delaying treatment of seriously ill patients who are neither aware of the algorithms, nor able to question their calculations. Older people who spent their lives paying into Medicare, and are now facing amputation, fast-spreading cancers, and other devastating diagnoses, are left to either pay for their care themselves or get by without it. If they disagree, they can file an appeal, and spend months trying to recover their costs, even if they don't recover from their illnesses.

The algorithms sit at the beginning of the process, promising to deliver personalized care and better outcomes. But patient advocates said in many cases they do the exact opposite -- spitting out recommendations that fail to adjust for a patient's individual circumstances and conflict with basic rules on what Medicare plans must cover. "While the firms say [the algorithm] is suggestive, it ends up being a hard-and-fast rule that the plan or the care management firms really try to follow," said David Lipschutz, associate director of the Center for Medicare Advocacy, a nonprofit group that has reviewed such denials for more than two years in its work with Medicare patients. "There's no deviation from it, no accounting for changes in condition, no accounting for situations in which a person could use more care."

STAT's investigation revealed these tools are becoming increasingly influential in decisions about patient care and coverage. The investigation is based on a review of hundreds of pages of federal records, court filings, and confidential corporate documents, as well as interviews with physicians, insurance executives, policy experts, lawyers, patient advocates, and family members of Medicare Advantage beneficiaries. It found that, for all of AI's power to crunch data, insurers with huge financial interests are leveraging it to help make life-altering decisions with little independent oversight. AI models used by physicians to detect diseases such as cancer, or suggest the most effective treatment, are evaluated by the Food and Drug Administration. But tools used by insurers in deciding whether those treatments should be paid for are not subjected to the same scrutiny, even though they also influence the care of the nation's sickest patients.

Medicine

People Were Unwittingly Implanted With Fake Devices In Medical Scam, FBI Alleges (vice.com) 55

Chronic pain patients were implanted with "dummy" pieces of plastic and told it would ease their pain, according to an indictment charging the former CEO of the firm that made the fake devices with fraud. Motherboard reports: Laura Perryman, the former CEO of Stimwave LLC, was arrested in Florida on Thursday. According to an FBI press release, Perryman was indicted "in connection with a scheme to create and sell a non-functioning dummy medical device for implantation into patients suffering from chronic pain, resulting in millions of dollars in losses to federal healthcare programs." According to the indictment, patients underwent unnecessary implanting procedures as a result of the fraud. Perryman was charged with one count of conspiracy to commit wire fraud and health care fraud, and one count of healthcare fraud. Stimwave received FDA approval in 2014, according to Engadget, and was positioned as an alternative to opioids for pain relief.

The Stimwave "Pink Stylet" system consisted of an implantable electrode array for stimulating the target nerve, a battery worn externally that powered it, and a separate, 9-inch long implantable receiver. When doctors told Stimwave that the long receiver was difficult to place in some patients, Perryman allegedly created the "White Stylet," a receiver that doctors could cut to be smaller and easier to implant -- but was actually just a piece of plastic that did nothing. "To perpetuate the lie that the White Stylet was functional, Perryman oversaw training that suggested to doctors that the White Stylet was a 'receiver,' when, in fact, it was made entirely of plastic, contained no copper, and therefore had no conductivity," the FBI stated. "In addition, Perryman directed other Stimwave employees to vouch for the efficacy of the White Stylet, when she knew that the White Stylet was actually non-functional." Stimwave charged doctors and medical providers approximately $16,000 for the device, which medical insurance providers, including Medicare, would reimburse the doctors' offices for.

Medicine

Artificial Sweetener Erythritol Linked To Heart Attack and Stroke, Study Finds 221

An anonymous reader quotes a report from CBS News: Erythritol, a zero-calorie sugar substitute used to sweeten low-cal, low-carb and "keto" products, is linked to higher risk of heart attack, stroke and death, according to a new study. Researchers at the Cleveland Clinic studied over 4,000 people in the U.S. and Europe and found those with higher blood erythritol levels were at elevated risk of experiencing these major adverse cardiac events. The research, published Monday in the journal Nature Medicine, also found erythritol made blood platelets easier to form a clot.

"Our study shows that when participants consumed an artificially sweetened beverage with an amount of erythritol found in many processed foods, markedly elevated levels in the blood are observed for days -- levels well above those observed to enhance clotting risks," said Dr. Stanley Hazen, senior author of the study and chairman for the department of cardiovascular and metabolic sciences at Cleveland Clinic, in a press release.

While the study doesn't definitively show causation, CBS News medical contributor Dr. David Agus says there's "certainly enough data to make you very worried." "Most artificial sweeteners bind to your sweet receptors but aren't absorbed. Erythritol is absorbed and has significant effects, as we see in the study," Agus explains. Sweeteners like erythritol have "rapidly increased in popularity in recent years," Hazen noted, and the researchers say more in-depth study is needed to understand their long-term health effects. "Cardiovascular disease builds over time, and heart disease is the leading cause of death globally. We need to make sure the foods we eat aren't hidden contributors," he said.
"In the study, researchers looked at the levels of erythritol in the blood of around 4,000 people from the United States and Europe and found that those with the highest blood concentration of the sugar substitute were more likely to have a stroke or heart attack," adds the New York Times in their reporting. "The participants, who mostly were over the age of 60, either already had or were at high risk for cardiovascular diseases because of conditions like diabetes and hypertension."

"The researchers also found that when they fed mice erythritol, that promoted blood clot formation. Erythritol appeared to induce clotting in human blood and plasma as well. Among eight people who consumed erythritol at levels typical in a pint of keto ice cream or a can of an artificially sweetened beverage, the sugar alcohol lingered in their blood for longer than two days."

Dr. Hazen said: "Every way we looked at it, it kept showing the same signal."
Medicine

5th Person Confirmed To Be Cured of HIV 72

Researchers are announcing that a 53-year-old man in Germany has been cured of HIV. From a report: Referred to as "the Dusseldorf patient" to protect his privacy, researchers said he is the fifth confirmed case of an HIV cure. Although the details of his successful treatment were first announced at a conference in 2019, researchers could not confirm he had been officially cured at that time. Today, researchers announced the Dusseldorf patient still has no detectable virus in his body, even after stopping his HIV medication four years ago. "It's really cure, and not just, you know, long term remission," said Dr. Bjorn-Erik Ole Jensen, who presented details of the case in a new publication in "Nature Medicine."

"This obviously positive symbol makes hope, but there's a lot of work to do," Jensen said. For most people, HIV is a lifelong infection, and the virus is never fully eradicated. Thanks to modern medication, people with HIV can live long and healthy lives. The Dusseldorf patient joins a small group of people who have been cured under extreme circumstances after a stem cell transplant, typically only performed in cancer patients who don't have any other options. A stem cell transplant is a high-risk procedure that effectively replaces a person's immune system. The primary goal is to cure someone's cancer, but the procedure has also led to an HIV cure in a handful of cases.
Earth

Where More People Will Die -- and Live -- Because of Climate Change (washingtonpost.com) 131

An anonymous reader shares this thought-provoking article by a graphics reporter at The Washington Post who was part of its Pulitzer Prize-winning Explanatory Reporting team: The scientific paper published in the June 2021 issue of the journal Nature Climate Change was alarming. Between 1991 and 2018, the peer-reviewed study reported, more than one-third of deaths from heat exposure were linked to global warming. Hundreds of news outlets covered the findings. The message was clear: climate change is here, and it's already killing people. But that wasn't all that was happening. A month later, the same research group, which is based out of the London School of Hygiene and Tropical Medicine but includes scientists from dozens of countries, released another peer-reviewed study that told a fuller, more complex story about the link between climate change, temperature and human mortality. The two papers' authors were mostly the same, and they used similar data and statistical methods.

Published in Lancet Planetary Health, the second paper reported that between 2000 and 2019, annual deaths from heat exposure increased. But deaths from cold exposure, which were far more common, fell by an even larger amount. All told, during those two decades the world warmed by about 0.9 degrees Fahrenheit, and some 650,000 fewer people died from temperature exposure....

But whose lives? Projections indicate milder temperatures may indeed spare people in the globe's wealthy north, where it's already colder and people can buy protection against the weather. Yet heat will punish people in warmer, less wealthy parts of the world, where each extra degree of temperature can kill and air conditioning will often remain a fantasy....

What about the long term? A groundbreaking peer-reviewed study, published in November in Harvard's Quarterly Journal of Economics, gives us a glimpse. In the study, a team of researchers projected how mortality from temperature would change in the future. The worldwide temperature-linked mortality rate is projected to stay about the same, but you can see enormous geographic variation: colder, wealthier countries do well, while hotter, poorer countries suffer.

Science

Higher Risks of Stroke and Heart Disease Linked to Added Sugars (cnn.com) 77

A new study on added sugars (also known as "free sugars") concluded they're bad for your health, reports NBC News.

"The research, published in the journal BMC Medicine, found that diets higher in free sugars — a category that includes sugar added to processed foods and sodas, as well as that found in fruit juice and syrups — raise one's risk of heart disease and stroke." The study relied on data about the eating habits of more than 110,000 people ages 37 to 73 in the United Kingdom, whose health outcomes were then tracked over about nine years. The results suggested that each 5% increase in the share of a person's total energy intake that comes from free sugars was associated with a 6% higher risk of heart disease and a 10% higher risk of stroke.

An author of the study, Cody Watling, a doctoral student at the University of Oxford, said the most common forms of sugar the study participants ate were "preserves and confectionary," with the latter category including cookies, sugary pastries and scones. Fruit juice, sugar-sweetened beverages and desserts were also common, he added.... The people found to have the highest risk of heart disease or stroke consumed about 95 grams of free sugar per day, or 18% of their daily energy intake, Watling said. By comparison, U.S. guidelines suggest that added sugars should make up no more than 10% of one's daily calories.

"Avoiding sugar-sweetened beverages is probably the single most important thing we can be doing," said Walter Willett, a professor of epidemiology and nutrition at Harvard University who was not involved in the study. Willett added that although there are some health benefits to drinking a small glass of orange juice occasionally, its sugar content means "a glass of fruit juice is the same thing as Coke...."

The Oxford researchers found a positive relationship when it comes to fiber, unlike sugar intake: Consuming 5 grams of fiber a day was associated with a 4% lower risk of heart disease, the study suggested, although that did not hold true when researchers controlled for participants' body-mass indexes.... Watling said, the study demonstrates that the types of carbs people choose to eat may matter more than the total amount. "What's really important for overall general health and well-being is that we're consuming carbohydrates that are rich in whole grains," he said, while "minimizing the consumption of sugar-sweetened beverages, as well any kind of confectionary products that have added sugars."

It's a point underscored by CNN: After over nine years of follow-up, the researchers found total carbohydrate intake wasn't associated with cardiovascular disease. But when they analyzed how outcomes differed depending on the types and sources of carbohydrates eaten, they found higher free sugar intake was associated with a higher risk for cardiovascular disease and greater waist circumference. The more free sugars some participants consumed, the greater their risk of cardiovascular disease, heart disease and stroke was....

"This study provides much needed nuance to public health discussions about the health effects of dietary carbohydrates," said Dr. Maya Adam, director of Health Media Innovation and clinical assistant professor of pediatrics at Stanford University School of Medicine, via email. Adam wasn't involved in the study. "The main takeaways are that all carbs are not created equal...."

CNN adds that the mechanism seems to be that sugar intake "can promote inflammation," according to an assistant cardiology professor at Columbia's medical center. "This can cause stress on the heart and blood vessels, which can lead to increased blood pressure..."
AI

Musk Warns AI 'One of the Biggest Risks' To Civilization (cnbc.com) 158

ChatGPT shows that artificial intelligence has gotten incredibly advanced -- and that it is something we should all be worried about, according to Elon Musk. From a report: "One of the biggest risks to the future of civilization is AI," Musk told attendees at the World Government Summit in Dubai, United Arab Emirates, shortly after mentioning the development of ChatGPT. "It's both positive or negative and has great, great promise, great capability," Musk said. But, he stressed that "with that comes great danger."

ChatGPT "has illustrated to people just how advanced AI has become," according to Musk. "The AI has been advanced for a while. It just didn't have a user interface that was accessible to most people." He added: "I think we need to regulate AI safety, frankly. It is, I think, actually a bigger risk to society than cars or planes or medicine." Regulation "may slow down AI a little bit, but I think that that might also be a good thing," Musk added.

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