health

mdma—aka-ecstasy—submitted-to-fda-as-part-of-ptsd-therapy

MDMA—aka ecstasy—submitted to FDA as part of PTSD therapy

fda, health, maps, mdma, psychedelics, PTSD, Science, therapy / /

Groovy —

If FDA approved, it would require the DEA to reclassify MDMA.

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Girl with an ecstasy tablet on her tongue.

Enlarge / Girl with an ecstasy tablet on her tongue.

A corporation dedicated to studying the benefits of psychedelic drugs filed an application with the Food and Drug Administration this week for approval to use MDMA—aka ecstasy or molly—in combination with talk therapy to treat post-traumatic stress disorder.

If approved, it would be the first-of-its-kind combination treatment—a psychedelic-assisted therapy. An approval would also require the Drug Enforcement Administration to reclassify MDMA, which is currently in the DEA’s most restricted category, Schedule I, which is defined as drugs “with no currently accepted medical use and a high potential for abuse.” The category also includes LSD, heroin, and marijuana.

The public benefit corporation (PBC) that filed the FDA application was created by MAPS, The Multidisciplinary Association for Psychedelic Studies, which has been supporting this type of work since 1986. The application is based on positive data from two randomized, double-blind, placebo-controlled Phase III studies, which were funded and organized by MAPS and MAPS PBC.

The first study, published in Nature Medicine in 2021, involved a total of 90 participants with moderate PTSD. It found that MDMA-assisted talk therapy (aka psychotherapy) significantly improved Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) scores compared with participants who were given talk therapy with a placebo. In the second study, published in September in Nature Medicine, the finding held up among 104 participants with moderate or severe PTSD (73 percent had severe PTSD).

In both trials, participants took 80 to 180 mg doses of MDMA or a placebo at the start of three eight-hour sessions, which were spaced around a month apart. Between those experimental treatment sessions, participants also had three 90-minute sessions for participants to process the experimental experience.

MDMA—3,4-methylenedioxymethamphetamine—affects neurotransmitters in the brain, increasing the activity of serotonin, dopamine, and norepinephrine, to be specific. This leads people who take the drug to experience euphoria, hallucinations, sharpened sensory perception, and sociability, but it can also induce confusion, depression, and paranoia. Its use in psychotherapy has been explored for decades.

In a statement this week, MAPS PBC CEO Amy Emerson celebrated the FDA submission. “The filing of our [new drug application] is the culmination of more than 30 years of clinical research, advocacy, collaboration, and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades,” she said.

MAPS founder and President Rick Doblin also celebrated the submission this week, saying in a statement: “When I started MAPS in 1986, the FDA was still blocking all research with psychedelics. … By breaking that barrier, we have opened doors for others to conduct their own promising research into psychedelic-assisted therapies with psilocybin, ayahuasca, ketamine, and more. The novel approaches undertaken in psychedelic-assisted therapy research have led to fundamental shifts in our understanding of how these devastating mental health conditions can be treated.”

So far, the MDMA-assisted therapy has drawn criticism for its expected inaccessibility. The treatment outlined in the two MDMA trials involves lengthy—and likely pricey—therapy sessions with highly trained therapists. The Washington Post published an estimated price of between $13,000 to $15,000 per treatment round, and it’s unclear for now whether it would be covered by health insurance if approved by the FDA. “Most people in the world won’t be able to afford these clinics,” Allen Frances, a Duke University professor emeritus of psychiatry, told the Post.

Now that the NDA is submitted, the FDA has 60 days to determine whether it will be accepted for review and whether it will be a priority or standard review (six months or ten months, respectively), MAPS PBS noted. MAPS is seeking a priority review. In 2017, the FDA granted MDMA “Breakthrough Therapy,” designed to help hasten the development and review of drugs for serious conditions when evidence indicates they may substantially improve upon current therapies.

The only psychedelic with FDA approval to date is esketamine, a variation of ketamine, which was approved in 2019 to treat treatment-resistant depression.

MDMA—aka ecstasy—submitted to FDA as part of PTSD therapy Read More »

humana-also-using-ai-tool-with-90%-error-rate-to-deny-care,-lawsuit-claims

Humana also using AI tool with 90% error rate to deny care, lawsuit claims

AI, claim denial, coverage, health, humana, insurance, insurance coverage, medicare, medicare advantage, nH Predict, nursing home, post-acute care, Science, unitedhealth / /

AI denials —

The AI model, nH Predict, is the focus of another lawsuit against UnitedHealth.

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Signage is displayed outside the Humana Inc. office building in Louisville, Kentucky, US, in 2016.

Enlarge / Signage is displayed outside the Humana Inc. office building in Louisville, Kentucky, US, in 2016.

Humana, one the nation’s largest health insurance providers, is allegedly using an artificial intelligence model with a 90 percent error rate to override doctors’ medical judgment and wrongfully deny care to elderly people on the company’s Medicare Advantage plans.

According to a lawsuit filed Tuesday, Humana’s use of the AI model constitutes a “fraudulent scheme” that leaves elderly beneficiaries with either overwhelming medical debt or without needed care that is covered by their plans. Meanwhile, the insurance behemoth reaps a “financial windfall.”

The lawsuit, filed in the US District Court in western Kentucky, is led by two people who had a Humana Medicare Advantage Plan policy and said they were wrongfully denied needed and covered care, harming their health and finances. The suit seeks class-action status for an unknown number of other beneficiaries nationwide who may be in similar situations. Humana provides Medicare Advantage plans for 5.1 million people in the US.

It is the second lawsuit aimed at an insurer’s use of the AI tool nH Predict, which was developed by NaviHealth to forecast how long patients will need care after a medical injury, illness, or event. In November, the estates of two deceased individuals brought a suit against UnitedHealth—the largest health insurance company in the US—for also allegedly using nH Predict to wrongfully deny care.

Humana did not respond to Ars’ request for comment for this story. United Health previously said that “the lawsuit has no merit, and we will defend ourselves vigorously.”

AI model

In both cases, the plaintiffs claim that the insurers use the flawed model to pinpoint the exact date to blindly and illegally cut off payments for post-acute care that is covered under Medicare plans—such as stays in skilled nursing facilities and inpatient rehabilitation centers. The AI-powered model comes up with those dates by comparing a patient’s diagnosis, age, living situation, and physical function to similar patients in a database of 6 million patients. In turn, the model spits out a prediction for the patient’s medical needs, length of stay, and discharge date.

But, the plaintiffs argue that the model fails to account for the entirety of each patient’s circumstances, their doctors’ recommendations, and the patient’s actual conditions. And they claim the predictions are draconian and inflexible. For example, under Medicare Advantage plans, patients who have a three-day hospital stay are typically entitled to up to 100 days of covered care in a nursing home. But with nH Predict in use, patients rarely stay in a nursing home for more than 14 days before claim denials begin.

Though few people appeal coverage denials generally, of those who have appealed the AI-based denials, over 90 percent have gotten the denial reversed, the lawsuits say.

Still, the insurers continue to use the model and NaviHealth employees are instructed to hew closely to the AI-based predictions, keeping lengths of post-acute care to within 1 percent of the days estimated by nH Predict. NaviHealth employees who fail to do so face discipline and firing. ” Humana banks on the patients’ impaired conditions, lack of knowledge, and lack of resources to appeal the wrongful AI-powered decisions,” the lawsuit filed Tuesday claims.

Plaintiff’s cases

One of the plaintiffs in Tuesday’s suit is JoAnne Barrows of Minnesota. On November 23, 2021, Barrows, then 86, was admitted to a hospital after falling at home and fracturing her leg. Doctors put her leg in a cast and issued an order not to put any weight on it for six weeks. On November 26, she was moved to a rehabilitation center for her six-week recovery. But, after just two weeks, Humana’s coverage denials began. Barrows and her family appealed the denials, but Humana denied the appeals, declaring that Barrows was fit to return to her home despite being bedridden and using a catheter.

Her family had no choice but to pay out-of-pocket. They tried moving her to a less expensive facility, but she received substandard care there, and her health declined further. Due to the poor quality of care, the family decided to move her home on December 22, even though she was still unable to use her injured leg, go the bathroom on her own, and still had a catheter.

The other plaintiff is Susan Hagood of North Carolina. On September 10, 2022, Hagood was admitted to a hospital with a urinary tract infection, sepsis, and a spinal infection. She stayed in the hospital until October 26, when she was transferred to a skilled nursing facility. Upon her transfer, she had eleven discharging diagnoses, including sepsis, acute kidney failure, kidney stones, nausea and vomiting, a urinary tract infection, swelling in her spine, and a spinal abscess. In the nursing facility, she was in extreme pain and on the maximum allowable dose of the painkiller oxycodone. She also developed pneumonia.

On November 28, she returned to the hospital for an appointment, at which point her blood pressure spiked, and she was sent to the emergency room. There, doctors found that her condition had considerably worsened.

Meanwhile, a day earlier, on November 27, Humana determined that it would deny coverage of part of her stay at the skilled nursing facility, refusing to pay from November 14 to November 28. Humana said Hagood no longer needed the level of care the facility provided and that she should be discharged home. The family paid $24,000 out-of-pocket for her care, and to date, Hagood remains in a skilled nursing facility.

Overall, the patients claim that Humana and UnitedHealth are aware that nH Predict is “highly inaccurate” but use it anyway to avoid paying for covered care and make more profit. The denials are “systematic, illegal, malicious, and oppressive.”

The lawsuit against Humana alleges breach of contract, unfair dealing, unjust enrichment, and bad faith insurance violations in many states. It seeks damages for financial losses and emotional distress, disgorgement and/or restitution, and to have Humana barred from using the AI-based model to deny claims.

Humana also using AI tool with 90% error rate to deny care, lawsuit claims Read More »

every-homeopathic-eye-drop-should-be-pulled-off-the-market,-fda-says

Every homeopathic eye drop should be pulled off the market, FDA says

eye drops, fda, health, homeopathic, infection, Science, Vision / /

don’t risk it —

Eye drops are uniquely risky because the eye is an immune-privileged site.

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Young man applying eye drops.

This year has been marked by many terrifying things, but perhaps the most surprising of the 2023 horrors was … eye drops.

The seemingly innocuous teeny squeeze bottle made for alarming headlines numerous times during our current revolution around the sun, with lengthy lists of recalls, startling factory inspections, and ghastly reports of people developing near-untreatable bacterial infections, losing their eyes and vision, and dying.

Recapping this unexpected threat to health, the Food and Drug Administration on Tuesday released an advisory titled “What You Should Know about Eye Drops” in hopes of keeping the dangers of this year from leaking into the next. Among the notable points from the regulator was this stark pronouncement: No one should ever use any homeopathic ophthalmic products, and every single such product should be pulled off the market.

The point is unexpected, given that none of the high-profile infections and recalls this year involved homeopathic products. But, it should be welcomed by any advocates of evidence-based medicine.

Homeopathy is an 18th century pseudoscience that produces bogus remedies that work no better than a placebo and, if prepared improperly, can be toxic, even deadly. The practice relies on two false principles: the  “law of similars,” aka “like cures like,” meaning a substance that causes a specific symptom in a healthy person can treat conditions and diseases that involve that same symptom, and the “law of infinitesimals,” which states that diluting the substance renders it more potent. As such, homeopathic products begin with toxic substances that are then extremely diluted—often into oblivion—in a ritualistic procedure. Some homeopaths hold that water molecules can have “memory.”

Clear risks

In the US, these products are marketed as legitimate treatments and sold alongside evidence-based treatments (though consumer advocates are trying to change that). The reason this is allowed for now is because of a regulatory quirk: Based on the 1938 Food, Drug, and Cosmetic Act, homeopathic products are generally considered exempt from pre-market FDA safety and efficacy reviews as long as the active ingredient in the product is included in the Homeopathic Pharmacopoeia, a list of substances approved by homeopaths.

In recent years, the FDA and the Federal Trade Commission have cracked down on homeopathic products, though. And it seems from today’s advisory that the FDA is not holding back on homeopathic products for the eyes. The regulator notes that any products meant for the eye “pose a heightened risk of harm” because the eyes are an immune-privileged site in the body. That is, innate immune responses are restrained in the eye to prevent damaging inflammation, which could threaten vision. “Any drug used in the eyes must be sterile to reduce the risk of infection,” the FDA said.

But whether or not homeopathic eye drops are labeled as sterile doesn’t seem to matter to the FDA. The regulator cautions: “Do not use ophthalmic products that: Are labeled as homeopathic, as these products should not be marketed.” Their lack of pre-market safety and efficacy reviews appears to be enough to warrant avoidance.

The FDA also cautions consumers not to use any over-the-counter eye drop product that claims to treat glaucoma, cataracts, retinopathy, or macular degeneration because there are simply no actual over-the-actual treatments for these conditions. If a non-prescription product claims this, you can assume it’s bogus and avoid it. Consumers should also avoid anything that includes Methylsulfonylmethane (MSM), which is illegally sold in the US, and anything with silver sulfate or argentum because these can permanently change the white color of your eyes.

Every homeopathic eye drop should be pulled off the market, FDA says Read More »

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CVS, Rite Aid, Walgreens hand out medical records to cops without warrants

Amazon, cops, cvs, health, health privacy, HHS, HIPAA, law enforcement, Medical records, pharmacy, Policy, prescription drugs, rite aid, Science, Walgreens, warrant / /

prescription for privacy —

Lawmakers want HHS to revise health privacy law to require warrants.

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CVS, Rite Aid, Walgreens hand out medical records to cops without warrants

All of the big pharmacy chains in the US hand over sensitive medical records to law enforcement without a warrant—and some will do so without even running the requests by a legal professional, according to a congressional investigation.

The revelation raises grave medical privacy concerns, particularly in a post-Dobbs era in which many states are working to criminalize reproductive health care. Even if people in states with restrictive laws cross state lines for care, pharmacists in massive chains, such as CVS, can access records across borders.

Lawmakers noted the pharmacies’ policies for releasing medical records in a letter dated Tuesday to the Department of Health and Human Services (HHS) Secretary Xavier Becerra. The letter—signed by Sen. Ron Wyden (D-Ore.), Rep. Pramila Jayapal (D-Wash.), and Rep. Sara Jacobs (D-Calif.)—said their investigation pulled information from briefings with eight big prescription drug suppliers.

They include the seven largest pharmacy chains in the country: CVS Health, Walgreens Boots Alliance, Cigna, Optum Rx, Walmart Stores, Inc., The Kroger Company, and Rite Aid Corporation. The lawmakers also spoke with Amazon Pharmacy.

All eight of the pharmacies said they do not require law enforcement to have a warrant prior to sharing private and sensitive medical records, which can include the prescription drugs a person used or uses and their medical conditions. Instead, all the pharmacies hand over such information with nothing more than a subpoena, which can be issued by government agencies and does not require review or approval by a judge.

Three pharmacies—CVS Health, The Kroger Company, and Rite Aid Corporation—told lawmakers they didn’t even require their pharmacy staff to consult legal professionals before responding to law enforcement requests at pharmacy counters. According to the lawmakers, CVS, Kroger, and Rite Aid said that “their pharmacy staff face extreme pressure to immediately respond to law enforcement demands and, as such, the companies instruct their staff to process those requests in store.”

The rest of the pharmacies—Amazon, Cigna, Optum Rx, Walmart, and Walgreens Boots Alliance—at least require that law enforcement requests be reviewed by legal professionals before pharmacists respond. But, only Amazon said it had a policy of notifying customers of law enforcement demands for pharmacy records unless there were legal prohibitions to doing so, such as a gag order.

HIPAA and transparency

The lawmakers note that the pharmacies aren’t violating regulations under the Health Insurance Portability and Accountability Act (HIPAA). The pharmacies pointed to language in HIPAA regulations that allow health care providers, including pharmacists, to provide medical records if required by law, with subpoenas being a sufficient legal process for such a request. However, the lawmakers note that the HHS has discretion in determining the legal standard here—that is, it has the power to strengthen the regulation to require a warrant, which the lawmakers say it should do.

“We urge HHS to consider further strengthening its HIPAA regulations to more closely align them with Americans’ reasonable expectations of privacy and Constitutional principles,” the three lawmakers wrote.

They also pushed for pharmacies to do better, encouraging them to follow the lead of tech companies. “Pharmacies can and should insist on a warrant, and invite law enforcement agencies that insist on demanding patient medical records with solely a subpoena to go to court to enforce that demand. The requirement for a warrant is exactly the approach taken by tech companies to protect customer privacy.” The trio noted that Google, Microsoft, and Yahoo have since 2010 required law enforcement to have a warrant to obtain customers’ emails.

Also noting tech companies’ lead, the lawmakers encouraged pharmacies to publish annual transparency reports. In the course of the investigation, only CVS Health said it planned to do so.

“Americans deserve to have their private medical information protected at the pharmacy counter and a full picture of pharmacies’ privacy practices, so they can make informed choices about where to get their prescriptions filled,” the lawmakers wrote.

For now, HIPAA regulations grant patients the right to know who is accessing their health records. But, to do so, patients have to specifically request that information—and almost no one does that. “Last year, CVS Health, the largest pharmacy in the nation by total prescription revenue, only received a single-digit number of such consumer requests,” the lawmakers noted.

“The average American is likely unaware that this is even a problem,” the lawmakers said.

CVS, Rite Aid, Walgreens hand out medical records to cops without warrants Read More »

ai-companion-robot-helps-some-seniors-fight-loneliness,-but-others-hate-it

AI companion robot helps some seniors fight loneliness, but others hate it

Aging, AI, companion robot, depression, ElliQ, health, loneliness, new york, Science / /

AI buddy —

There’s limited evidence for health benefits so far; early work suggests no one-size-fits-all.

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ElliQ, an AI companion robot from Intuition Robotics.

Enlarge / ElliQ, an AI companion robot from Intuition Robotics.

Some seniors in New York are successfully combating their loneliness with an AI-powered companion robot named ElliQ—while others called the “proactive” device a nag and joked about taking an ax to it.

The home assistant robot, made by Israel-based Intuition Robotics, is offered to New York seniors through a special program through the state’s Office for the Aging (NYSOFA). Over the past year, NYSOFA has partnered with Intuition Robotics to bring ElliQ to over 800 seniors struggling with loneliness. In a report last week, officials said they had given out hundreds and had only 150 available devices.

ElliQ includes a tablet and a two-piece lamp-like robot with a head that lights up and rotates to face a speaker. Marketed as powered by “Cognitive AI technology,” it proactively engages in conversations with users, giving them reminders and prompts, such as asking them how they’re doing, telling them it’s time to check their blood pressure or take their medicine, and asking if they want to have a video call with family. Speaking with a female voice, the robot is designed to hold human-like conversations, engage in small talk, express empathy, and share humor. It can provide learning and wellness programs, such as audiobooks and relaxation exercises.

Interest in using social robots, such as ElliQ, for elder care has been growing for years, but the field still lacks solid evidence that the devices can significantly improve health, well-being, and depression. Systemic reviews in 2018 found the technology had potential, but studies lacked statistical significance and rigorous design.

The program in New York adds to the buzz but doesn’t offer the high-quality study design that could yield definitive answers. In August, the state released a report on an unspecified number of ElliQ users, which indicated that the device was helpful. Specifically, 59 percent of users reported the device was “very helpful” at reducing loneliness, while 37 percent reported it was “helpful” and only 4 percent reported it as “unhelpful.” Engagement with the device declined over time, with users initially interacting with ElliQ an average of 62 times a day in the first 15 days of use, which fell to 21 times a day between 60 and 90 days and 33 times a day after 180.

Mixed feelings

“We had high hopes for the efficacy of ElliQ, but the results that we’re seeing are truly exceeding our expectations,” Greg Olsen, director of the New York State Office for the Aging, said in a statement at the time of the report’s release. “The data speaks for itself, and the stories that we’re hearing from case managers and clients around the state have been nothing short of unbelievable.”

But other recent data on the potential for companion robots to reduce loneliness has indicated that there’s no one-size-fits-all approach. There are a lot of factors that can influence how individuals perceive such a device. A 2021 qualitative study evaluated the responses from 16 seniors who were asked for feedback on three types of robot companions, including ElliQ. The results were mixed for the proactive robot. While some felt the occasional chattiness of ElliQ would be comforting during an otherwise solitary day, others felt it was intrusive and “nagging.” Some felt the device’s tone was “rude.”

“I don’t know whether that would drive me mental if it kept interrupting me and telling me what to do … I might want to get an ax and cut it up,” one study participant said.

How welcoming a person might be to an assertive AI-assistant like ElliQ may link with a person’s general preferences regarding human company, the authors suggested. Those who value their space and autonomy may be less open to such as device compared with more gregarious seniors.

While some participants said ElliQ’s reminders could be useful, others expressed a deep concern that an overreliance on technology for everyday tasks—like paying bills, taking medications, or turning lights off—could hasten the decline of cognitive and physical abilities. Study participants also raised concerns regarding the inauthenticity of a relationship with a nonhuman, a loss of dignity, and a lack of control. Some disliked that ElliQ couldn’t be fully controlled by the user and was so assertive, which some perceived as pushy. Some worried about feeling embarrassed about being seen interacting with a robot companion. A 2022 study also explored the issue of stigma, with participants expressing that the use of such devices could reinforce stereotypes of aging, including isolation and dependency.

While researchers continue to explore the potential use and design of AI-powered companion robots, anecdotes from New York’s program suggest the tools are clearly helpful for some. One New Yorker named Priscilla told CBS News she found ElliQ helpful.

“She keeps me company. I get depressed real easy. She’s always there. I don’t care what time of day, if I just need somebody to talk to me,” Priscilla said. “I think I said that’s the biggest thing, to hear another voice when you’re lonely.”

AI companion robot helps some seniors fight loneliness, but others hate it Read More »

fda-approves-first-crispr-therapy—here’s-how-it-works-against-sickle-cell

FDA approves first CRISPR therapy—here’s how it works against sickle cell

health, hemoglobin, Science, sickle cell anemia, sickle cell disease / /

historic —

The landmark treatment turns on another blood protein that prevents sickling.

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This digitally colorized scanning electron micrograph (SEM) revealed some of the comparative ultrastructural morphology between normal red blood cells (RBCs), and a sickle cell RBC (left) found in a blood specimen of an 18-year-old female patient with sickle cell anemia.

Enlarge / This digitally colorized scanning electron micrograph (SEM) revealed some of the comparative ultrastructural morphology between normal red blood cells (RBCs), and a sickle cell RBC (left) found in a blood specimen of an 18-year-old female patient with sickle cell anemia.

The Food and Drug Administration on Friday approved two gene therapies to treat sickle cell disease, one of the which is the first CRISPR/Cas9-based treatment to win regulatory approval in the US.

The announcement is a landmark in the treatment of sickle cell disease, a devastating condition in which red blood cells deform into a sickle shape and clog up blood vessels. Sickle cell disease affects around 100,000 people in the US, most commonly African Americans. It leads to anemia, vaso-occlusive events and crises (painful episodes in which small blockages starve tissue of oxygen), strokes, progressive and irreversible organ damage, decreased quality of life, and early death.

Until today, treatments have been limited. A bone marrow transplant from a genetically matched sibling can cure the condition more than 90 percent of the time, but only around 20 percent of people with the disease have such a genetically matched sibling donor. There are also multiple drugs available and supportive care, but these mainly reduce the severity of the disease. The new gene therapy treatments, on the other hand, have shown to be highly effective at preventing vaso-occlusive events and crises.

“Sickle cell disease is a rare, debilitating and life-threatening blood disorder with significant unmet need, and we are excited to advance the field, especially for individuals whose lives have been severely disrupted by the disease, by approving two cell-based gene therapies today,” said Nicole Verdun, director of the Office of Therapeutic Products within the FDA’s Center for Biologics Evaluation and Research, said in the FDA’s announcement.

To understand how the gene therapies work, it’s useful to understand what causes sickle cell disease. The central problem is with adult hemoglobin, the iron-containing protein in red blood cells that transports oxygen from the lungs to the rest of the body. In patients with sickle cell disease, there’s a single, small mutation in the gene that encodes hemoglobin. The mutation is a switch of a single nucleotide, or base, (often represented by letters A, C, T, and G). The switch of an A to a T in the genetic code for hemoglobin results in a hemoglobin protein with a valine instead of a glutamic acid at the sixth amino acid position. This transforms normal adult hemoglobin (HbA) to sickle hemoglobin (HbS). In red blood cells, when HbS loses the oxygen it was carrying, it polymerizes with itself, forming strand-like structures that deform the cell.

Effective edits

The CRISPR/Cas9 therapy approved today, called Casgevy, prevents this deformation by essentially turning on the production of another type of hemoglobin encoded in our genetic blueprints—fetal hemoglobin (HbF). HbF is optimized for pregnancy, transferring oxygen from maternal blood to fetal tissue, and the gene that encodes it is shut off shortly after birth as the body transitions to HbA. About six months after birth, HbF usually makes up just 1 percent to 2 percent of hemoglobin in the body.

But, HbF can effectively treat sickle cell disease—the hemoglobin transports oxygen just fine in adults, and it doesn’t polymerize. Moreover, when it’s mixed with HbS, it gets in the way of the mutated protein polymerizing with itself, preventing it from forming structures that deform red blood cells.

Casgevy turns on HbF with the CRISPR/Cas9 system, a gene-editing system initially swiped from bacteria that snips DNA using an enzyme (a nuclease) called Cas9. Cas9 can be targeted to specific stretches of DNA using a short RNA guide sequence. In Casgevy, the CRISPR/Cas9 system is targeted to snip a gene encoding a protein called BCL11A, which controls other genes, aka a transcription factor. The BCL11A transcription factor is the protein responsible for shutting off the gene for HbF shortly after birth as the body transitions to the adult version. With the CRISPR/Cas9 snip, BCL11A is shut off, and HbF production can resume.

For patients being treated, this process involves first harvesting their bone marrow stem cells, which then get CRISPR-ed in a specialized lab. Meanwhile, the patients receive chemotherapy to kill bone marrow cells to make way for the gene-edited cells that are then put back in. Of 31 patients treated with Cagevy and followed for at least 24 months, 29 (93.5 percent) went at least 12 consecutive months without a vaso-occlusive crisis.

The other gene therapy approved by the FDA today is Lyfgenia, which used a Lentiviral vector to insert genes into the human genome. In this case, the system delivers the genetic code for a modified type of hemoglobin that is designed to be anti-sickling, called HbAT87Q. Among 32 patients treated with Lyfgenia, 28 (88 percent) were free of vaso-occlusive events for between six to 18 months after treatment.

Both gene therapies are approved for patients ages 12 years and up.

FDA approves first CRISPR therapy—here’s how it works against sickle cell Read More »

get-your-groove-on-with-these-10-fun-online-dance-classes

Get Your Groove On With These 10 Fun Online Dance Classes

Exercise, fitness, health, Highlights, Wellness / /

internal/modules/cjs/loader.js: 905 throw err; ^ Error: Cannot find module ‘puppeteer’ Require stack: – /home/760439.cloudwaysapps.com/jxzdkzvxkw/public_html/wp-content/plugins/rss-feed-post-generator-echo/res/puppeteer/puppeteer.js at Function.Module._resolveFilename (internal/modules/cjs/loader.js: 902: 15) at Function.Module._load (internal/modules/cjs/loader.js: 746: 27) at Module.require (internal/modules/cjs/loader.js: 974: 19) at require (internal/modules/cjs/helpers.js: 101: 18) at Object. (/home/760439.cloudwaysapps.com/jxzdkzvxkw/public_html/wp-content/plugins/rss-feed-post-generator-echo/res/puppeteer/puppeteer.js:2: 19) at Module._compile (internal/modules/cjs/loader.js: 1085: 14) at Object.Module._extensions..js (internal/modules/cjs/loader.js: 1114: 10) at Module.load (internal/modules/cjs/loader.js: 950: 32) at Function.Module._load (internal/modules/cjs/loader.js: 790: 12) at Function.executeUserEntryPoint [as runMain] (internal/modules/run_main.js: 75: 12) code: ‘MODULE_NOT_FOUND’, requireStack: [ ‘/home/760439.cloudwaysapps.com/jxzdkzvxkw/public_html/wp-content/plugins/rss-feed-post-generator-echo/res/puppeteer/puppeteer.js’ ]

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12 Exercises You Can Perform at Your Standing Desk

Exercise, fitness, health, Highlights, Wellness / /

internal/modules/cjs/loader.js: 905 throw err; ^ Error: Cannot find module ‘puppeteer’ Require stack: – /home/760439.cloudwaysapps.com/jxzdkzvxkw/public_html/wp-content/plugins/rss-feed-post-generator-echo/res/puppeteer/puppeteer.js at Function.Module._resolveFilename (internal/modules/cjs/loader.js: 902: 15) at Function.Module._load (internal/modules/cjs/loader.js: 746: 27) at Module.require (internal/modules/cjs/loader.js: 974: 19) at require (internal/modules/cjs/helpers.js: 101: 18) at Object. (/home/760439.cloudwaysapps.com/jxzdkzvxkw/public_html/wp-content/plugins/rss-feed-post-generator-echo/res/puppeteer/puppeteer.js:2: 19) at Module._compile (internal/modules/cjs/loader.js: 1085: 14) at Object.Module._extensions..js (internal/modules/cjs/loader.js: 1114: 10) at Module.load (internal/modules/cjs/loader.js: 950: 32) at Function.Module._load (internal/modules/cjs/loader.js: 790: 12) at Function.executeUserEntryPoint [as runMain] (internal/modules/run_main.js: 75: 12) code: ‘MODULE_NOT_FOUND’, requireStack: [ ‘/home/760439.cloudwaysapps.com/jxzdkzvxkw/public_html/wp-content/plugins/rss-feed-post-generator-echo/res/puppeteer/puppeteer.js’ ]

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How Active Games Can Make You Healthy

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Video games have been blamed for sedentary lifestyles and social problems since early arcade games hit the streets in the 1970s. Throughout my career, from post-doctoral research to the company boardroom, I have made it my mission to change that perception and truly bring physical activity into the gaming industry.

The recipe is simple: By fully utilizing the capabilities of mixed reality technologies, we can make active, social, and fun gaming experiences that reward exercise. Combining the benefits of an active lifestyle with everything we love about video games, we can finally bury all the negative stereotypes for good.

The Pandemic Glued Us to the Couch

The COVID-19 pandemic was a tough time for many. A study by WHO found that the global prevalence of anxiety and depression increased by 25%. Especially young people found themselves cut off from their social networks. At the same time, interest in gaming skyrocketed.

When we were stuck in our houses, playing video games became one of few ways to spend time with friends and family. Studies undertaken after the pandemic show that people who played augmented reality games like Pokémon Go or Harry Potter: Wizards Unite were less likely to develop anxiety and depression. Another study showed that young people who played online games coped better with anxiety, depression, and stress related to lockdown measures.

Many of our gaming habits have stuck with us after restrictions were lifted. In the US, 56% of male and 47% of female respondents to a recent survey said they play video games as often as they did during the pandemic. Safe to say, gaming is here to stay.

Active Games Make People Active

While games are more popular than ever, we are facing another problem: Sitting down is the new pandemic. As much as 80% of the global underage population does not get enough weekly exercise. The average American sits more than 6.5 hours daily, and it’s even worse in the UK at over 9 hours. Yet we have to acknowledge that going for a run or to the gym is not for everyone. To include more people, we have to rethink what exercise could be.

Gamified exercise is the key. Active games have been around for a long time and are growing in popularity. The first dancing game with a floor pad launched in 1987, and by the late 90s, they were a feature at every arcade. All major consoles have featured active games since Playstation 2’s EyeToy. Yet, these games all share the same issue: they are primarily for one or two players, and the experience relies heavily on factors like additional controllers, having a good TV, or enough space in the living room.

Pokémon Go took on this challenge and made active gaming accessible. Players have to move around to progress and so they had no other choice than to take the dog for a walk or go to the park. Data from 2017 showed the number of active players that walked more than 10,000 steps per day had increased from 15% to 28% since the game launched. Using AR technology and mobile phones, inserting the game directly into the player’s surroundings made the gaming experience feel real.

So how do we build on the success of Pokémon Go? For me, the digitalization of theme parks, arcades, and activity centers, provides a fantastic opportunity to introduce MR active games to larger groups. Using immersive technology, we can create fun and challenging group gaming experiences that could never fit in our living rooms.

Active Games Are Social Arenas

Video games are social, and creating social games is also what MR systems do best. New, immersive, digital attractions are a great social way to inspire competition and get people moving. Friends can work out together, and you are free to move around in the game arena. Competing against real people in a mixed reality space where they can see, hear, touch, and talk to each other while playing takes the gaming experience to the next level.

As a social arena, gearless MR games have an advantage over their equipment-based VR cousins. By removing the need for mobile phones or headwear, we can create games that let you stay connected with your fellow players in the real world. The game truly becomes a challenge you face together. The sense of jeopardy is real, as are the interactions you have with other players.

MR technology also lets us create new, gamified activities for traditional sports venues such as gyms or climbing centers. By boosting the spread of MR gaming experiences, we can introduce healthy activity to more people and promote healthy living. I can think of no better use of technology.

Guest Post

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Vitruvian’s Trainer+ Is the Next-Generation Home Gym

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March 3, 2022• by

Thousands experienced the newest technological advance in fitness, the Vitruvian Trainer+, which debuted at CES 2022 last week. Recently featured on FORBES.COM and named one of the best fitness workout equipment for your compact, space-saving home gym, The Trainer+ is the most powerful adaptive fitness device coming to the market, with cutting-edge algorithmic technology for the most intelligent workout.

The Trainer+ is a highly portable, luxurious, and sleek carbon fiber platform that employs algorithms, a dynamic tension system, and has the power to release up to a whopping 440lb, smashing its competition in weight training capabilities. Featuring intelligent software that motivates, responds, and adapts to you, you have a whole gym at your fingertips. When paired with the Vitruvian App, the compact Trainer+ knows how much weight you can safely and effectively move at any given time. The app offers coached sessions with leading trainers, customizable workout plans, performance data insights, over 200+ exercises available, technique tutorials, and the ability to compete with friends.  

The innovative platform was developed more than a decade ago by Jon Gregory, a former high-frequency trader with a degree in applied physics after he began looking for an alternative to pumping metal weights in between trades at his desk. He decided to combine his two passions and create algorithms that revolutionize how we work out.  How does the Trainer+ work? Essentially, the adaptive weight acts as a spotter, learning the user’s ability to lift, adjusting to their strengths and weaknesses over 50 times per second.

Once the Trainer+ builds a data-driven picture of your training level, it can modify the workouts accordingly to extract the best out of your efforts and increase your strength rather than maintain it. What sets the Trainer+ apart is its ability to simultaneously offer concentric and eccentric resistance workouts.

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Last modified: March 2, 2022

About the Author:

Tom is the Editorial Director at TheCESBible.com

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Caregiver Smart Solutions wins AARP’s best Eureka Park startup to help those 50+ to Age in Place with technologies focused on making homes smarter, safer, accessible, and fun!

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January 15, 2022• by

Caregiver Smart Solutions is The Best Way to Monitor Loved Ones As they Age In Place. By using AI for Aging in Place, we provide a proactive solution that enables your loved ones to retain their independence, dignity, and live on their own as long as possible while reducing your stress through Peace of Mind.

This was confirmed at CES 2022. It all started by winning the CTA Foundation Eureka Park Accessibility Contest. Then we won the International Business Times for Best of CES 2022. Then finally Caregiver Smart Solutions wins AARP’s best Eureka Park startup to help those 50+ to Age in Place with technologies focused on making homes smarter, safer, accessible, and fun!

We are helping our loved ones be able to live their “Golden Years” at home. At the same time, our system allows us – their adult children – to truly answer the critical question. – “How are they doing?” The insight we provide is stress-reducing, life-changing, and gives us so much incredible information!

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Last modified: January 12, 2022

About the Author:

Tom is the Editorial Director at TheCESBible.com

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YogiFi for HER Well-organized Yoga Mat

ces2022, fitness, health, Health Tech, Highlights, yoga, yogifi / /

October 28, 2021• by

What is she keeping right here?

Put up-pandemic lifestyles has accelerated the “hybrid fitness” model—an diagram to exercise that meets the fresh demands of a fresh each day life blurring the traces between dwelling and work. Fitness giants, cherish Orange Thought and Soul Cycle, luxuriate in created merchandise to meet this hybrid model, similar to keeping digital offerings or the Soul Cycle At-Home Bike, but I desired to introduce you to a fresh player in the industry with a recurring secure on hybrid fitness.

YogiFi is the first tidy yoga mat in the marketplace, geared up with a built-in modern sensor layer to note and supply recommendations to lend a hand factual develop in true-time. The YogiFi mat’s AI affords the in-studio feel to raise at-dwelling yoga note AND instructors are ready to sync their mats with their students to note their growth and continue their industrial, without reference to the device.

Why is she so pleased?

Because she has learned her final wellness partner and also, we requested her smartly!

Product Highlights:

— AI-Powered Yoga Mat (Bluetooth + WiFi Enabled)

— Precise-Time Feedback from Digital Coach

— Customized Exercise Plans

— Tune Flexibility, Energy, Steadiness & Yoga abilities

— Digital Ambiance to carry nature shut to dwelling

How did it initiate?

Founded in 2016 and launched in 2020, Founder Murali Somisetty used to be impressed to impact YogiFi after yoga had cured his chronic debilitating support danger. After practicing as an licensed yoga trainer, he realized individuals were inconsistent in attending courses, due to busy work schedules, family commitments, etc. So, he idea, “what if a yoga mat might well well well additionally talk over with you and e book you step-by-step cherish a yoga trainer? What if we might well well well additionally program the mat to learn different postures the utilization of AI?” Thus, the birth of YogiFi.

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Final modified: October 28, 2021

In regards to the Creator:

Eric is the Editor-In-Chief at TheCESBible.com

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