Remote robotic-assisted surgery is far from new, with various educational and research institutions developing machines doctors can control from other locations over the years. There hasn't been a lot of movement on that front when it comes to endovascular treatments for stroke patients, which is why a team of MIT engineers has been developing a telerobotic system surgeons can use over the past few years. The team, which has published its paper in Science Robotics, has now presented a robotic arm that doctors can control remotely using a modified joystick to treat stroke patients.
That arm has a magnet attached to its wrist, and surgeons can adjust its orientation to guide a magnetic wire through the patient's arteries and vessels in order to remove blood clots in their brain. Similar to in-person procedures, surgeons will have to rely on live imaging to get to the blood clot, except the machine will allow them to treat patients not physically in the room with them.
There's a critical window of time after a stroke's onset during which endovascular treatment should be administered to save a patient's life or to preserve their brain function. Problem is, the procedure is quite complex and takes years to master. It involves guiding a thin wire through vessels and arteries without damaging any of them, after all. Neurosurgeons trained in the procedure are usually found in major hospitals, and patients in remote locations that have to be transported to these larger centers might miss that critical time window. With this machine, surgeons can be anywhere and still perform the procedure. Another upside? It minimizes the doctos' exposure to radiation from X-ray imaging.
During their tests, the MIT engineers only had to train a group of neurosurgeons for an hour to use the machine. By the end of that hour, the surgeons were able to successfully use the machine to remove the fake blood clots in a transparent model with life-size vessels replicating the complex arteries of the brain.
MIT professor and team member Xuanhe Zhao said:
"We imagine, instead of transporting a patient from a rural area to a large city, they could go to a local hospital where nurses could set up this system. A neurosurgeon at a major medical center could watch live imaging of the patient and use the robot to operate in that golden hour. That’s our future dream."
Yelp today announced it would further expand its health grades information on restaurant listings. While the reviews platform developed its own digital standard for restaurant hygiene (called "Local Inspector Value-entry Specification" or LIVES) alongside the "the technology departments of the cities of San Francisco and New York" in 2013, it's now broadening its partnership with firm Hazel Analytics. Yelp and Hazel teamed up last year, and together the LIVES metric now incorporates "data from health departments across 48 U.S. states" as well as Toronto and Vancouver.
“The expansion of Yelp's health scores program comes at a time when people are returning to indoor dining as COVID-19 restrictions continue to lift, health inspections are restarting from the early pandemic pause, and restaurants are embracing more diner safety measures like contactless payments and virtual menus,” wrote Yelp in a blog post.
There’s a chance you’ve seen health scores on your city’s Yelp restaurant pages already. But in recent years, Yelp became even more proactive in grading restaurants, going so far as to estimate scores in cases where a city might not issue a letter grade or numerical score. Yelp listings for restaurants in Los Angeles and Chicago also include a rundown of health code violations.
Still, some in the restaurant industry have criticized Yelp’s efforts. Cities and states vary widely in their food inspection scoring, with some assigning a letter grade or numerical score, and others opting for a pass/fail system. Restaurants have complained about inaccurate or out-of-date scores on their listings. The Mercury News reported that restaurants in Bay Area counties that use a pass/fail system were taken aback when Yelp’s algorithm generated its own health inspection score for their businesses.
Yelp calculates health inspection scores using three methods: directly using a score provided by a city’s health department, generating a score from raw health data or using an estimated health score generated by Hazel’s algorithm. The third option — which Hazel defaults to in cases where cities don’t publish health inspection scores — leaves a great deal of room for misinterpretation. And as The Mercury News points out, restaurants that, deservedly or not, show low LIVES-generated scores on Yelp might see their business dry up significantly.
Following a large-scale virtual health study, Google has submitted Fitbit's passive heart rate monitoring algorithm for review by the US Food and Drug Administration. Approval would allow Google to market the Fitbit as a medical device in the States.
The study, which went live in May 2020, was open to all US Fitbit users over the age of 22, and it was designed to test how accurately the device could detect atrial fibrillation, or irregular heart rhythm. The system used photoplethysmography to track the blood flow in a user's wrist and determine if there are any concerning irregularities. Google said its algorithm correctly identified undiagnosed AFib 98 percent of the time in this study, and the company presented its results to the American Heart Association at its most recent meeting.
Fitbit's Sense Smartwatch was approved by the FDA in 2020 for its ability to assess AFib using built-in electrocardiogram technology.
In addition to the Fitbit FDA news, Google is rolling out a few other healthcare-related tools. Google Search in the US will soon show available appointment slots with local doctors and clinics when looking for care, with an emphasis on the CVS MinuteClinic.
"While we’re still in the early stages of rolling this feature out, we’re working with partners, including MinuteClinic at CVS and other scheduling solution providers," Google chief health officer Dr. Karen DeSalvo said. "We hope to expand features, functionality and our network of partners so we can make it easier for people to get the care they need."
Google is also rolling out "health source information panels" and "health content shelves" on YouTube videos in Japan, Brazil and India this week, in an effort to highlight credible information from legitimate sources.
Meta is introducing new “parental supervision” features for Instagram and virtual reality. The update will be available first for Instagram, which has faced a wave of scrutiny for its impact on teens and children, with new parental controls coming to Quest headsets over the next few months.
On Instagram, the controls will be part of a new “Family Center,” where parents can set time limits and access information about their teen’s activity on the app. For now, parents will be able to see a list of accounts their teen is following, as well as which accounts follow them. Parents will also be notified if their teen reports another user.
Notably, the update is for now only available in the United States and parents will only be able to access the parental control features if the teens “initiate supervision” within the app themselves. Teens will also need to approve any parental requests for parental supervision. “Over the next few months we’ll add additional features, including letting parents set the hours during which their teen can use Instagram, and the ability for more than one parent to supervise a teen’s account,” Instagram Head Adam Mosseri writes in a blog post.
Instagram
The new features, which were first promised back in December, arrive after Instagram was forced to “pause” work on a dedicated app for kids younger than 13 after a whistleblower disclosed internal research documenting Instagram’s impact on teens’ mental health. The disclosures prompted lawmakers to push Meta to end work on Instagram Kids entirely. So far, Meta executives have declined to do so.
Mosseri said the company also plans to add similar parental control features to its Quest headsets so parents can also set limits on their children’s activities in virtual reality. Those features, which won’t launch for a few more months, will enable parents to restrict VR content rated for ages 13 and up and set other limits on VR purchases. Meta is also working on a “Parent Dashboard” for the Oculus app so parents can keep tabs on what their children are watching and how much time they are spending in VR.
Therapy has an engagement problem. Despite the benefits of treatment plans and at-home exercises, people generally resist anything that feels like work, and this impedes the mental-health recovery process across the board. Clinicians have attempted to bridge this gap with various devices and reward systems, but still, it’s often incredibly difficult to motivate patients to help themselves.
Video games have the opposite problem. Players can spend hours immersed in a single digital experience, seated in one spot and lost in their own world, but they’re often branded as “lazy” for this behavior. Video games are widely viewed as a waste of time, even with growing research demonstrating the psychological benefits of play.
So, why not smash these industries together and see what happens? DeepWell Digital Therapeutics is a new video game publisher and developer from Devolver Digital co-founder Mike Wilson and medical device creator Ryan Douglas, and their goal is to alter the way people think about games and mental health. The DeepWell DTx advisory council includes more than 40 medical researchers, doctors and veteran game developers, including Tom Hall (Doom), Zoe Flower (Hellbent Games), Rami Ismail (Nuclear Throne), Lorne Lanning (Oddworld) and American McGee (American McGee's Alice).
“We fight with engagement all the time,” Douglas said. He worked for years with light therapy and other interventions designed to treat anxiety, depression and stress, but said accessibility and participation were constant battles. “And these [game developers] had cracked that code at a level that they were really hitting hard neurological reward centers in the brain, in a way that the availability to effectively change what people do and think in certain times of mental illness was vastly improved over anything I'd seen before.”
DeepWell DTx isn’t about gamifying therapy tools or building digital experiences based on strict medical templates. Instead, the studio will analyze existing games for potential mental health benefits and, in some cases, work with interested developers to enhance these mechanics. The team will then secure approvals from regulators for these games to treat mental health issues including PTSD, anxiety, depression, OCD and addiction.
This is where Douglas’ expertise comes in. He's the founder and former CEO of medical device company Nextern and he's secured FDA approval for more than 25 medical devices over the past 15 years; he knows how to navigate this regulatory process and he sees games as a natural fit. He and Wilson started working on DeepWell about 18 months ago, in the middle of the COVID-19 pandemic.
“There's a very specific regulatory pathway for this work,” Douglas said. “So, a couple key things — agencies have done a lot of work in the last couple years to figure out how software as a medical device and specifically digital therapeutics are going to work. The FDA has been collaborative in that work. And then in this emergency time, there has been more opportunity to do the work that we need to do to get these in people's hands as quickly as possible. It's arduous but not impossible.”
Additionally, DeepWell DTx will provide a framework for players to recognize these benefits as they play – whether that’s a label on the game’s storefront, a welcome screen or another digital signal – allowing them to adjust their mindset before pressing start.
“We're super excited largely because of some intellectual property Ryan filed long before he met me, a couple years before he met me,” Wilson said. “We believe we've got a system built to enable game developers — eventually other media creators, as well — to work their magic and in a way that is already quite beneficial.”
It takes one whole minute before Wilson drops the phrase “digital psychedelics” into the conversation. This is kind of his thing; he’s an evangelist for psychedelics, with endless stories about Burning Man and the personal, therapeutic benefits he’s reaped from trips. Psychedelic therapy was a starting point for Wilson and Douglas, and they’re looking to mimic the perspective-shifting, calming effects of these substances through accessible digital experiences. They’re focused on alleviating a mental health crisis that was exacerbated by the global quarantine, using tools that people already have and naturally reach for.
“While it might not be as powerful as sitting with a macro dose of mushrooms and a couple of therapists, it might not be one session or two sessions or three, but it is an adjunct therapy that is good for you, that you might be way more likely to engage in and that the whole world has access to, even if they don't have access to health care,” Wilson said. “These will be interventions that are helpful to people that are just paying regular game prices.”
Literally every game is up for review from the DeepWell DTx crew, from platformers and narrative adventures to RPGs and shooters, and interested developers can apply starting today. There’s also an in-house development arm of the DeepWell beast, and its first game is already halfway through development, with a few others in pre-production. The first DeepWell games are due to start rolling out in 2023.
Americans pay two and a half times more for their prescription drugs than residents of any other nation on Earth. Though generic versions of popular compounds accounted for 84 percent of America's annual sales volume in 2021, they only generated 12 percent of the actual dollars spent. The rest of the money pays for branded drugs — Lipitor, Zestril, Accuneb, Vicodin, Prozac — and we have the Reagan Administration in part to thank for that. In the excerpt below from Owning the Sun: A People's History of Monopoly Medicine from Aspirin to COVID-19 Vaccines, a fascinating look at the long, infuriating history of public research being exploited for private profit, author Alexander Zaitchik recounts former President Reagan's court-packing antics from the early 1980s that helped cement lucrative monopolies on name-brand drugs.
When Estes Kefauver died in 1963, he was writing a book about monopoly power called In a Few Hands. Early into Reagan’s first term, the industry must have been tempted to publish a gloating retort titled In a Few Years. Between 1979 and 1981, the drug companies did more than break the stalemate of the 1960s and ’70s — they smashed it wide open. Stevenson-Wydler and Bayh-Dole replaced the Kennedy policy with a functioning framework for the high-speed transfer of public science into private hands. As the full machinery was built out, the industry-funded echo chamber piped a constant flow of memes into the culture: patents alone drive innovation... R&D requires monopoly pricing... progress and American competitiveness depend on it... there is no other way...
In December 1981, the drug companies celebrated another long-sought victory when Congress created a federal court devoted to settling patent disputes. Previously, patent disputes were heard in the districts where they originated. The problem, from industry’s perspective, was the presence of so many staunch New Deal judges in key regions like New York’s Second Circuit. These lifetime judges often understood patent challenges not as threats to property rights, but as opportunities to enforce antitrust law. Local circuit judges appointed by Republicans could also be dangerously old-fashioned in their interpretations of the “novelty” standard. By contrast, the judges on the new patent court, named the Court of Appeals for the Federal Circuit, were appointed by the president. Reagan stuffed its bench with corporate patent lawyers and conservative legal scholars influenced by the Johnny Appleseed of the Law and Economics movement, Robert Bork. Prior to 1982, federal district judges rejected around two-thirds of patent claims; the Court of Appeals has since decided two-thirds of all cases in favor of patent claims. Reagan’s first appointee, Pauline Newman, was the former lead patent counsel for the chemical firm FMC.
The Supreme Court also contributed to the industry’s 1979–1981 run of wins. When Reagan entered office, one of the great scientific-legal unknowns involved the patentability of modified genes. Similar to the uncertainty around the postwar antibiotics market—settled in the industry’s favor by the 1952 Patents Act — the uncertainty threatened the monopoly dreams of the emergent biotechnology sector. The U.S. Patent Office was against patenting modified genes. In 1979, its officers twice rejected an attempt by a General Electric microbiologist to patent a modified bacterium invented to assist in oil spill cleanups. The GE scientist, Ananda Chakrabarty, sued the Patent Office, and in the winter of 1980 Diamond v. Chakrabarty landed before the Supreme Court. In a 5–4 decision written by Warren Burger, the Court overruled the U.S. Patent Office and ruled that modified genes were patentable, as was “anything under the sun that is made by man.” The decision was greeted with audible exhales by the players in the Bayh-Dole alliance. “Chakrabarty was the game changer that provided academic entrepreneurs and venture capitalists the protection they were waiting for,” says economist Öner Tulum. “It paved the way for a more expansive commercialization of science.”
But the industry knew better than to relax. It understood that political victories could be impermanent and fragile, and it had the scar tissue to prove it. Uniquely profitable, uniquely hated, and thus uniquely vulnerable — the companies could not afford to forget that their fantastic postwar wealth and power depended on the maintenance of artificial monopolies resting on dubious if not indefensible ethical and economic arguments that were rejected by every other country on earth. In the United States, home to their biggest profit margins, danger lurked behind every corner in the form of the next crusading senator eager to train years of unwanted attention on these facts. Not even Bayh-Dole, that precious newborn legislation, could be taken for granted. This mode of permanent crisis was validated by the return of a familiar menace in the early 1980s. Of all things, it was the generics industry, an old but weak enemy of the patent-based drug companies, that reappeared and threatened to ruin their celebration of achieving dominance over every corner of medical research and the billions of public dollars flowing through it.
***
As late as the 1930s, there was no “generic” drug industry to speak of. There were only big drug companies and small ones, some with stature, others obscure. They both sold products that were, in the parlance of ethical medicine, “nonproprietary.” To be listed in the United States Pharmacopeia and National Formulary, the official bibles of prescribable medicines, drugs could only carry scientific names; the essential properties of a good scientific name, according to the first edition of the Pharmacopeia, were “expressiveness, brevity, and dissimilarity.” The naming of drugs and medicines formed the other half of the patent taboo: branding a drug evidenced the same knavishness and greed as monopolizing one. The rules of “ethical marketing” did permit products to include an institutional affiliation—Parke-Davis Cannabis Indica Extract, or Squibb Digitalis Tincture—but the names of the medicines themselves (cannabis, digitalis) did not vary. “The generic name emerged as a parallel form of social property belonging to all that resisted commodification and thereby came to occupy a central place in debates about monopoly rights,” writes Joseph Gabriel.
As with patents on scientific medicine, the Germans gave the U.S. drug industry early instruction in the use of trademarks to entrench market control. Hoechst and Bayer broke every rule of so-called ethical marketing, aggressively advertising their breakthrough drugs under trademarks like Aspirin, Heroin, and Novocain. The idea was to twine these names and the things they described in the public mind so tightly, the brand name would secure a de facto monopoly long after the patent expired.
The strategy worked, but the German firms did not reap the benefits. The wartime Office of Alien Property redistributed the German patents and trademarks among domestic firms who produced competing versions of aspirin, creating the first “branded generic.” During the patent taboo’s extended death rattle of the interwar years, more U.S. companies waded into the use of original trademarks to suppress competition. As they experimented with German tactics to avoid “genericide” — the loss of markets after patent expiration — they were enabled by court decisions that transformed trademarks into forms of hard property, similar to the way patents were reconceived in the 1830s.
After World War II, branding and monopoly formed the two-valve heart of a post-ethical growth strategy. The industry’s incredible postwar success — between 1939 and 1959, drug profits soared from $300 million to $2.3 billion — was fueled in large part by expanding the German playbook. While branding monopolies with trade names, the industry initiated campaigns to ruin the reputations of scientifically identical but competing products. The goal was the “scandalization” of generic drugs, writes historian Jeremy Greene. The drug companies “worked methodically to moralize and sensationalize generic dispensing as a dangerous and subversive practice. Dispensing a non-branded product in place of a brand-name product was cast as ‘counterfeiting’; the act of substituting a cheaper version of a drug at the pharmacy was described as ‘beguilement,’ ‘connivance,’ ‘misrepresentation,’ ‘fraudulent,’ ‘unethical’ and ‘immoral.’”
As with patenting, it was the drug companies that dragged organized medicine with them into the post-ethical future. As late as 1955, the AMA’s Council on Pharmacy and Chemistry maintained a ban on advertisements for branded products in its Journal. That changed the year Equanil hit the market, opening the age of branded prescription drugs as a leading source of income for medical journals and associations. “Clinical journals and newer ‘throwaway’ promotional media now teemed with advertisements for Terramycin, Premarin, and Diuril rather than oxytetracycline (Pfizer), conjugated equine estrogens (Wyeth) or chlorothiazide (Merck),” writes Greene. In 1909, only one in ten prescription drugs carried a brand name. By 1969, the ratio had flipped, with only one in ten marketed under its scientific name. In another echo of the patent controversy, the rise of marketing and branded drugs produced division and resistance. By the mid-1950s, an alliance of so-called nomenclature reformers arose to decry trademarks as unscientific handmaidens of monopoly and call for a return to the use of scientific names. These reformers — doctors, pharmacists, labor leaders — made regular appearances before the Kefauver committee beginning in 1959. Their testimony on how the industry used trademarks to suppress competition informed a section in Kefauver’s original bill requiring doctors to use scientific names in all prescriptions. The proposed law reflected the norms that reigned during ethical medicine’s heyday, and would have allowed doctors to recommend firms, but not their branded products. Like most of Kefauver’s core proposals, however, the generic clause was excised. The only trademark-related reform in the final Kefauver-Harris Amendments placed limits on companies’ ability to rebrand and market old medicines as new breakthroughs.
David Bennett, the first human to successfully undergo a heart transplant involving a genetically modified pig heart, has died, according to The New York Times. He was 57. It’s unclear if his body rejected the organ doctors implanted in January. “There was no obvious cause identified at the time of his death,” a spokesperson for the University of Maryland School of Medicine, the hospital that performed the procedure, told the outlet. Physicians plan to carry out a full evaluation before publishing their findings in a peer-reviewed journal.
When Bennett’s transplant was first announced, doctors treated the news with cautious optimism. And for a time, it looked like that feeling was warranted. Not only did Bennett’s body not immediately reject the organ, but he was also able to take part in physical therapy and spend time with his family. And while he was never discharged from the hospital, he did survive two months with the genetically modified organ beating in place of his human heart.
Even if doctors determine the cause of death was organ rejection, that’s no small milestone. Stephanie Fae Beauclair, one of the most famous patients to undergo a xenotransplantation procedure, survived for 21 days before her body rejected her adopted baboon heart. Part of the reason doctors were hopeful the procedure would work is that there’s a dire organ shortage in the US and many others parts of the world. According to the Health Resources and Services Administration, about 17 Americans die every day waiting for an organ transplant.
President Biden's surgeon general Dr. Vivek Murthy has formally called on tech companies to provide information on sources and the scale of COVID-19 misinformation, The Washington Post has reported. "This is about protecting the nation’s health," he told The Post in a written statement. "Technology companies now have the opportunity to be open and transparent with the American people about the misinformation on their platforms."
Murthy's request pertains to social networks, search engines, crowdsourced platforms, e-commerce and instant messaging companies. To start with, he wants data and analysis on typical vaccine misinformation already identified by the Centers for Disease Control and Prevention. That includes falsities like "the ingredients in COVID-19 vaccines are dangerous" and "COVID-19 vaccines contain microchips."
The administration seeks to learn how many users have been exposed to such misinformation, and which demographic groups may have been disproportionally affected. On top of that, it's looking for data about the major sources of COVID-19 falsities, including individuals or businesses that sell unapproved COVID-19 products or services. Tech companies have until May 2 to comply, though they won't be penalized if they don't.
Last summer, Murthy called health misinformation an "urgent threat to public health" that tech platforms needed to address, adding that "health misinformation has already caused significant harm."
The request is part of the White House's COVID National Preparedness Plan announced yesterday, designed to achieve "minimal disruption" by COVID-19. The administration also asked health providers to submit statements on how coronavirus misinformation has hurt patients and communities. "We’re asking anyone with relevant insights — from original research and data sets to personal stories that speak to the role of misinformation in public health — to share them with us."
Apple continues to release findings from its ongoing Women's Health study, and is announcing updated results today ahead of International Women's Day (March 8th). The report, published on Harvard's website, reveals some insights on polycystic ovary syndrome (PCOS) and cardiovascular health, based on data from more than 37,000 participants.
Apple and Harvard found that its participants who had received PCOS diagnoses tended to be diagnosed between ages 14 and 35, with the median age being 22 years old. They were also more likely to report a family history of the syndrome and have unpredictable menstrual cycles after their first periods.
According to the report, more than 70 percent of participants without PCOS diagnoses said their menstrual cycles became regular within four years of their first period, while just 43 percent of those with PCOS experienced the same. In fact, 49 percent of participants with PCOS diagnoses never had regular menstrual cycles or only got regularity after using hormones.
The study also looked at the health conditions related to PCOS. It reported that participants with PCOS diagnoses were four times more likely to have pre-diabetic conditions, three times more likely to have Type 2 diabetes and twice as likely to have high blood pressure and high cholesterol. It also said irregular heartbeats or arrhythmia was more common among participants with PCOS diagnoses than those without.
Apple Women’s Health Study - Harvard T.H. Chan School of Public Health.
Apple did caution that these were preliminary insights. Data was gleaned from medical history surveys completed by more than 37,000 participants enrolled from November 2019 through December 2021. Of those who completed the medical history surveys, about 30,000 also filled out reproductive history surveys and answered questions about their menstrual cycles over time.
According to co-principal investigator Dr. Shruthi Mahalingaiah, "The Apple Women’s Health Study is one of the first studies where we can look at the connection between menstrual health, polycystic ovary syndrome, and heart health at a population level.”
Mahalingaiah also said "Despite the association between PCOS and heart-related conditions, historically, research studies about heart health have not included information about menstrual cycles," adding that the study "is important for having a better understanding of PCOS and its health impacts, including for people with PCOS and those that might have PCOS, but do not know.”
Looking forward, Apple and Harvard want to "create a larger foundational data set on PCOS, with self-tracked variables, and its connection with heart health."
"Our hope is that by expanding the understanding of the public health burden of PCOS, we can create research models that can be applied to further scientific understanding of other health conditions and the burden of other diseases,” Mahalingaiah said.
Tandem Diabetes Care says the Food and Drug Administration (FDA) has cleared its smartphone app to program and cancel insulin doses from the t:slim X2 insulin pump. The company claims it's the first time the FDA has cleared a phone app for such a purpose.
The t:connect mobile app on iOS and Android will enable users to program and cancel bolus insulin doses from the pump, according to Tandem Diabetes Care. When connected to the pump, the app can display information about the last 24 hours of a user's glucose trends, changes in status (including alerts and alarms) and insulin therapy data.
Pumps typically require users to dial in insulin doses manually. Given that they are often able to view glucose readings on their handset, patients will be able to use their phone to determine how much insulin they need and then program their dose.
The FDA clearance could be a step toward a more convenient way for diabetes patients to administer insulin doses. Tandem Diabetes Care plans to offer the feature at no extra cost to new and in-warranty t:slim X2 insulin pump customers via a software update. The plan is to grant access to a limited number of users in the spring ahead of a broader rollout this summer.
