Microdosing Benefits Might Be Largely Placebo, Experimental Study Suggests

Psilocybin mushrooms in a grow room at the Procare farm in Hazerswoude, central Netherlands.

Psilocybin mushrooms in a grow room at the Procare farm in Hazerswoude, central Netherlands.
Photo: Peter Dejong (AP)

The sometimes hyped benefits of microdosing—regularly using small amounts of psychedelic drugs like lysergic acid diethylamide (LSD)—might be overstated, new research this week suggests. The study found that people who microdosed did experience psychological benefits, including greater sense of well-being, but that these benefits weren’t substantially different from how others felt when they took a placebo instead. The experimental study’s findings indicate that at least some of the positives of microdosing can be attributed to the placebo effect, but the study does have its own caveats.

Psychedelic drug treatment has emerged as a promising approach to improving people’s mental health in recent years. Some studies have suggested that drugs like LSD and psilocybin—the main ingredient in magic mushrooms—can help treat anxiety and depression, particularly when combined with therapy. Other research has found evidence of positive changes in the brain cells of animals or people when exposed to psychedelics, further bolstering the case for a real biological benefit. One method of using these drugs is microdosing, which is when people take much smaller doses than used recreationally, on a regular schedule.

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Much of the evidence for the benefits of microdosing has been based on real world observations or anecdotal experiences, though, which comes with its limitations. Some people’s self-reported symptoms while taking a drug will improve, for instance, even if the drug hasn’t treated the underlying condition causing those symptoms. One clear way to overcome the limitations of anecdotal evidence is through a placebo-controlled study, but these studies are generally expensive and take a lot of time and resources to pull off. That’s especially true for microdosing studies, since these drugs are still illegal in many countries and scientists have to jump through hurdles to use them for research.

The authors behind this new study, published in eLife Tuesday, decided to take a unique approach to carrying out their placebo-controlled study. They enlisted the aid of people already microdosing regularly, then helped them essentially conduct the experiment on their own.

These citizen-scientists were given instructions on how to make the experiment placebo-controlled, so that they wouldn’t know whether they were taking a placebo or the real drug (mostly LSD, but some also took psilocybin). This included putting the drug, which was in powder form, inside opaque gel capsules, then putting these capsules and placebo capsules inside envelopes that contained a week’s supply of four doses. Some envelopes would contain nothing but placebo, others contained a mix of both placebo and the drug.

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All of the envelopes had a QR code attached that would allow the researchers to know the contents of each envelope and the specific order of pills taken that week, but not the volunteers. Some of the subjects of the study were randomly assigned to microdose two of the four weeks and received placebo during the other two weeks, and some were receiving the placebo the entire time. During the study, all the volunteers regularly filled out surveys about their ongoing psychological state.

All in all, 191 people completed the experiment, making this the largest placebo-controlled study of its kind, according to the authors. Microdosing volunteers reported psychological improvements from their baseline, including reduced anxiety and greater sense of well-being, but so did people taking placebo, and overall, there weren’t any significant differences between all three groups.

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“The findings suggest that anecdotal benefits of microdosing can be explained by the placebo effect,” the authors wrote.

There are some important caveats to these findings. For one, the study did find a small but statistically significant difference on certain outcomes when comparing the placebo group to the microdose group; these included improvements in mood, energy, and creativity. But the researchers argue there’s a mundane explanation for that as well. About 72% of the time, better than chance, the volunteers were able to accurately guess whether they were taking a placebo or drug. So it’s possible their expectations of feeling better rose when they correctly suspected they had taken the drug as opposed to placebo, meaning that their blinding wasn’t entirely foolproof.

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The study also couldn’t control variables like the purity or actual dosage of the microdosing, since it relied on the typical drugs that the volunteers were using already (on average, users reported taking 13 milligrams of LSD per dose, but the authors couldn’t test how much of the active ingredient people were taking). And though they did try to make sure people stuck to the instructions they were given, the very nature of the study meant they had less control over whether everything was followed correctly. As for the ethics of this research, the authors said they only reached out to self-identified microdosers and that they didn’t collect any other identifiable personal information from them besides their email (the study was cleared by an outside committee).

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It’s also worth highlighting that psychedelic drugs are being studied and taken for mental health in different ways, and microdosing is only one approach. Some researchers have argued that it’s the intensive experience of taking psychedelics (either in relatively high microdoses or macrodoses), along with guided therapy, that really provides the clearest benefits to people, for instance. In 2019, the drug ketamine was adapted into a FDA-approved treatment for depression. This is taken in smaller doses than when taken recreationally and under medical supervision, but it may also be a higher dosage than what people would take on their own while microdosing.

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Importantly, the authors also note that the volunteers of the study were generally healthy, with only 7% having a current mental health diagnosis. So they don’t discount the possibility that microdosing could still be useful for people experiencing mental illness.

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Of course, no single study should be seen as the final word on any topic, especially when it’s relying on an experimental approach. Still, the authors hope that their unique study design can be used in the future for other tricky areas of research where it’s hard to include a placebo control. One immediate benefit could be cost, since this study only required around 1% of the funding typically used to run a clinical trial. Other possible applications for this approach include studying CBD, nootropics, and nutrition, they wrote.

Smoke 100 Cigarettes Right Now If You Want a Vaccine in North Carolina (Kidding, Please Don’t)

Illustration for article titled Smoke 100 Cigarettes Right Now If You Want a Vaccine in North Carolina (Kidding, Please Don't)

Photo: Joe Raedle (Getty Images)

Have you smoked 100 cigarettes in your life? Can you take up, and kick, a pack-a-day habit in the next two weeks? Are you capable of looking a health professional square in the eye and lying? I do not condone these things, but if any of the above applies to you, and you are a North Carolina resident, you may be eligible to get your covid-19 vaccine by the end of the month.

Today, North Carolina Gov. Roy Cooper announced that on March 24, the state will start opening vaccine eligibility to Group 4, a large swath that includes people living in group settings, additional frontline workers, and people ages 16-64 with medical conditions that put them at higher risk—among them, asthma, cancer, and “smoking,” which is defined as having smoked 100 cigarettes in the course of a lifetime. Five packs throughout a whole lifetime.

The North Carolina Department of Health and Human Services designated Group 4 medical conditions that put people at higher risk for severe covid-19 illness, as advised by the CDC:

  • Asthma (moderate to severe)
  • Cancer
  • Cerebrovascular disease or history of stroke 
  • Chronic kidney disease 
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Cystic fibrosis
  • Dementia or other neurologic condition 
  • Diabetes type 1 or 2 
  • Down Syndrome 
  • A heart condition such as heart failure, coronary artery disease, cardiomyopathy
  • Hypertension or high blood pressure 
  • Immunocompromised state (weakened immune system) from: immune deficiencies, HIV, taking chronic steroids or other immune weakening medicines, history of solid organ blood or bone marrow transplant
  • Liver disease, including hepatitis 
  • Pulmonary fibrosis
  • Overweight or obesity  
  • Pregnancy 
  • Sickle cell disease (not including sickle cell trait) or thalassemia 
  • Smoking (current or former, defined as having smoked at least 100 cigarettes in their lifetime)

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Social smoking and cheat cigs included.

The governor’s office was not immediately available to comment on whether doctors will use the honor system or whether vaping counts, but does it matter? This might compel some people to, say, revisit the CDC’s finding that smoking is the leading cause of preventable deaths worldwide and to Google permanent lung damage (it is not good). And then maybe check some state health resources.

Starting tomorrow, the state will begin expanding eligibility for Group 3, who, through no fault of their own, are frontline essential workers. These include people who work in child care centers, grocery stores, manufacturing, food production, transportation, health care, public safety, and government services.

You (me, ahhhckkk-heeehh-ahem) might feel a little less terrible with President Biden’s announcement today that the U.S. may have enough supply available to vaccinate every adult American by May, moving up the timeline from July. So maybe just hold off on those Marlboros.

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Merck Will Help Johnson & Johnson Make Its New Covid-19 Vaccine With Biden Push

Illustration for article titled Merck Will Help Johnson & Johnson Make Its New Covid-19 Vaccine With Biden Push

Photo: Tom Mihalek (Getty Images)

Johnson & Johnson is getting some help to make their newly available covid-19 vaccine. On Tuesday, the White House confirmed that pharmaceutical company Merck has agreed to step in and produce some of J&J’s vaccines, in order to address a potential shortfall in supply. The single dose vaccine was authorized for emergency use by federal regulators over the weekend.

The deal is expected to be announced in detail by President Joe Biden on Tuesday afternoon, the Washington Post first reported. At this point, it’s not known just how much of the supply Merck is expected to pick up, nor the exact financial arrangement of the deal between the companies. Merck plans to use two plants as part of the collaboration, one to make the actual vaccine and the other to package it into vials. The Post reported that Biden will use the Defense Production Act to ensure that Merck can acquire the equipment needed to get its facilities ready to produce the vaccine.

Merck’s entry into vaccine production on behalf of J&J is certainly unusual given the normally competitive nature of the pharmaceutical industry. It’s also notable because Merck had recently abandoned its own development of a covid-19 vaccine candidate, following a lack of promising early trial data. In their announcement of the shutdown, however, the company did state that it would redirect its resources into developing treatments for covid-19.

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J&J’s vaccine was granted an emergency use authorization by the Food and Drug Administration on Saturday, making it the third to receive an EUA, along with vaccines developed by Moderna and Pfizer/BioNTech. On Sunday, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommended the vaccine for people over the age of 18, setting the stage for distribution to start this week.

The company had earlier pledged that it would have nearly 4 million doses available following the EUA, along with 20 million doses total by the end of March. The AP reported that the company told the government it was now facing production problems that would delay this schedule, which led officials to look for and broker a deal with a suitable partner that could help with production. Both Pfizer and Moderna encountered similar issues that lowered their initial promised supply.

With the new deal in place and rosier recent production projections from Pfizer and Moderna (the companies have promised to deliver a combined 220 million doses by the end of March), the White House is expected to announce a significant acceleration in the availability of covid-19 vaccines. According to the AP, President Biden will claim in his speech this afternoon that there will be enough doses available for every willing American by June. And there may yet be two more vaccines—one by Novavax and the other by Oxford University/AstraZeneca—that will receive a EUA and be available for use by this summer.

Some public health experts had already called for more cooperation between pharmaceutical companies to boost the availability of covid-19 vaccines, even prior to this deal. They’ve argued that it’s especially important for addressing the shortage of vaccines worldwide. Though the U.S. has struggled to meet demand, it’s still far better off than many lower-income countries. Experts have warned that it will take until next year at the earliest to vaccinate a significant portion of the world if production continues to be limited and wealthier countries stockpile all the vaccines for themselves.

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The Truth Behind the Kickstarter Gadget That Was Accused of ‘Child Torture’

It all started with some tweets.

“I really don’t want to live here anymore… fully funded child torture device. Will no reporters cover this…” @roryreckons tweeted.

Embedded in the tweet was a link to a Kickstarter page for a wearable device called NOIT. In the main picture, you can see a patch and rectangular device plastered onto the back of a child’s neck.

“Kickstarter thinks a device stuck to a Child’s back/neck that continually emits tones (every 8 seconds) to enforce focus and attention that’s supposed to ‘treat’ ADHD and Autism doesn’t violate it’s own guidelines against claiming to treat or cure conditions,” another user, @NDPoet wrote.

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In the replies, you can see self-identified members of the autism and ADHD community decry Kickstarter, saying they’d reported the page for violating the platform’s rules against projects that claim to diagnose, cure, treat, or prevent an illness or condition. Also included in the replies were screencaps of Kickstarter’s response, which purported that the device did not violate its terms. Some added hashtags saying the product was #inhumane and not at all based on science. Others related that sort of device would make them “insane” or drive them to become “suicidal, homicidal, or both.” Rightfully, some questioned what an auditory device would have to do with dyslexia, a learning disorder that impacts a person’s ability to read, write, spell, and speak.

Child torture is a serious claim and not one that should be taken lightly. Torturing disabled children is a serious allegation. If Kickstarter were truly hosting a device that could harm children, it’d be unconscionable for the company to not take it down. Yet at the same time, there are several gadgets out there that blur the line between wellness tech and medical devices with scientific studies validating their claims. Most famously, the Apple Watch may detect atrial fibrillation, can notify you of abnormal heart rates, has FDA clearance for its ECG features, and has been used in several clinical research studies for heart health, women’s health, and hearing—but it’s not considered a medical device that can diagnose, treat, or prevent a condition.

Looking at the Kickstarter critically, it’s easy to see why the internet reached for its pitchforks. The device itself looks intimidating. Nowhere is there a link to clinical peer-reviewed research. There’s no slick video showing how the product is meant to be used, just one of Beth Shier, the Kickstarter’s creator and director of NOIT International, sitting at her desk quickly demoing the device. In it, she holds the device up and says, “You all know how the NOIT works.” It’s a sentiment repeated further down on the Kickstarter page. The description itself says the device can be “helpful for anyone who wishes to create and maintain orientation” and especially autistic people and those with ADHD, sensory issues, or dyslexia. It also says those who have used the device reported better focus and improved motor skills, language, reading, and concentration without explaining how a noise-emitting gadget can enable that. You can find two testimonials in the updates section, but anecdotal evidence is not ironclad proof. The FAQ is blank.

It’s completely reasonable for the average person to look at all this and think this is, at the very least, a scam that preys on vulnerable parents seeking to help a child with a developmental or learning disability. But a hastily thrown-together Kickstarter page doesn’t tell the whole story about this device, the people who made it, or why it’s causing such a ruckus.

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You can’t tell from the Kickstarter alone whether the NOIT is based on real, viable education methods with ethical protocols. But what if it is? Would that then make this a case of miscommunication and a badly written Kickstarter campaign?

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“The idea here is actually not an entirely new one,” said Dr. Gregory Endelman, the executive director of special services at Orange County School of the Arts & California School of the Arts San Gabriel Valley. Endelman leads the school’s special services department, which helps students with learning disabilities. “It is based in part on this idea, very loosely in this idea of metacognition approach. That’s not new in philosophy or psychology. If you can orientate someone more successfully in their thought process, then you can improve attention and productivity and other types of things.”

Endelman went on to explain that auditory and visual stimuli could potentially help maintain a sense of rhythm. So for children with developmental or learning differences, it may help keep them present and give them something to orient themselves to within their environment. According to Endelman, there are devices that special needs educators might use, such as the Time Timer or interactive metronomes, that can help those with special needs better visualize how much time is left for a certain task. For neurotypical folks, Endelman pointed to seatbelt alarms as something that functions in a similar way to bring your attention back to something that needs addressing.

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However, Endelman noted that it’s hard to make any conclusions based on the NOIT Kickstarter. Usually, these kinds of devices are paired with some sort of “bridge” that helps a child associate external stimuli with a response. There should be people who are formally trained to help a child make those associations, as well as judge whether that specific tool would be useful for a particular individual. There’s no indication of such a bridge or formal training in the Kickstarter, and alone, the NOIT may not be helpful for some of the conditions it claims to be useful for.

“I would be, personally, professionally, cautious of the claim it could somehow improve dyslexia, which is a language processing disorder,” Endelman said. “I don’t see any direct connection to actually improving reading or the processing abilities required to utilize language.”

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But could this device potentially cause harm?

“In and of itself, it doesn’t seem like it’s harmful in an open and obvious way. It’s not like an electric shock or something like that. But what I would say is that potentially with a younger child or a child who is nonverbal, for some people, I’m positive this would be adverse.”

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On a Zoom call, Beth Shier didn’t look like someone who would engage in child torture. She just seemed like a sincere person eager to tell her side of the story. When asked about the NOIT Kickstarter, Shier immediately claimed responsibility.

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The Kickstarter, Shier said, was never meant to be public—at least, not in the way that it currently is. The Kickstarter was meant to be a place for Davis facilitators—people who are trained in the Ron Davis Autism Foundation’s programs—to pool their money together to keep the NOIT alive. As it turns out, each NOIT device thus far has been made by hand by Ron Davis, the organization’s elderly founder who also is autistic. This particular campaign was a means to get this device mass-produced.

“Kickstarter was a way to put all the money in one place in a transparent and international way, and then the public got interested in it,” Shier explained. “So it’s definitely been our fault that we have not provided the answers to these questions upfront, because we didn’t foresee the need for the answers.”

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According to Shier, the NOIT’s singular purpose is to “help create an orientated state” that allows a person to correctly perceive their environment. While the Kickstarter mentions that it may help people with autism, ADHD, or dyslexia, Shier said it’s actually meant for anyone with trouble focusing. That includes neurotypical people as well.

In response to some of the concerns raised online, Shier said that the device is easily removable and related a story of seeing a child reaching back and flinging one across the room when it became itchy. As for the sound itself, Shier said there are seven different noise levels and that users with the cognitive ability to do so are taught how to turn the device’s noise levels down or off without having to remove it.

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However, Shier also readily admitted there isn’t really much science behind the NOIT either. A field trial was done in 2011 and 2012, but there have only been 250 NOIT users over the past 11 years. None of those users, Shier said, has reported harmful effects. Shier also said the device had received FCC certification that the device doesn’t cause harm.

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“We don’t have any actual science. That’s one of the goals for the Kickstarter, is to give us enough units and we can get this and give 100 to a recognized research facility at a university and say, ‘Here, can you quantify what we’ve been seeing?’” Ideally, Shier says such research would also be able to identify who NOIT would be ill-suited for.

All this sounds well-intentioned, but as Endelman pointed out, what may work for some people will not for others. This is true in medicine, skincare, meditation, or basically anything that involves individual human bodies and minds. Also, 250 users is an extremely small sample size, especially when you consider that the CDC says 1 in 54 children have been identified with autism spectrum disorder, and 6.1 million children have been diagnosed with ADHD as of 2016. While anecdotally, Shier said there had been only two instances of users deciding they didn’t want to use the NOIT, that’s not definitive proof that NOIT is harmless.

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Visceral online reactions like this don’t come out of nowhere. Several people reported the device to Kickstarter and several thousand more have since signed a petition to get NOIT taken off Kickstarter. Clearly, NOIT has struck a nerve.

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That nerve appears to be the conflict between those who think autism is something that can be cured and autism self-advocates who believe the focus should be on supporting autistic people to lead fulfilling lives on their terms. At the crux of this are therapies that aim to make them behave in a way that is supposedly socially acceptable.

Applied Behavioral Analysis (ABA) therapy, according to the Autistic Self Advocacy Network (ASAN), is the most common of these types of therapies. The organization says that ABA therapies use “rewards and punishments to train autistic people to act non-autistic” and may cause actual harm in that pursuit. Given how NOIT is described in its Kickstarter, it’s not a stretch to interpret the noise it emits as a form of negative feedback, a “punishment,” to get the desired outcome. It doesn’t help that a YouTube video of the NOIT specifically states it can be used to reduce the characteristics of non-verbal autism and replace it with “socially acceptable behavior.”

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Shier said that the YouTube video used poor wording and that NOIT is not an ABA therapy device, as it doesn’t target behavioral changes. “The NOIT is simply worn to help the person feel calm and centered. There are no target behaviors, and there are no expectations of changes in behavior,” Shier explained. “If changes do occur, it’s because the user no longer feels threatened, anxious, or overwhelmed by a stimulus or situation. There are no rewards or removal of rewards for any behaviors.”

Shier also contended that no one at NOIT is seeking to make children conform to a certain type of behavior and in a video update posted to Kickstarter said that the group doesn’t believe anyone they work with needs to be treated or cured.

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“The NOIT is not a form of ABA therapy,” agreed Shannon Des Roches Rosa, senior editor of Thinking Person’s Guide to Autism, a site that provides news and resources from autistic people, professionals, and parents. “But like ABA it is a normalization tool that aims to ‘fix’ autistic kids instead of accommodating them, or learning how they learn best. While the NOIT may not change kids’ behaviors, it is doing so through cattle prod-like conditioning, not actually helping them in any way.”

Des Roches Rosa also said that although NOIT isn’t an ABA device, that doesn’t mean the potential for harm isn’t there.

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“Autistic people report depression, anxiety, and PTSD from being subjected to normalization therapies like the NOIT as children, so yes, there is a real risk of harm from this device. The better way to help students with developmental and learning disabilities is to understand how they experience the world, and how they learn, and build from there.”

Another factor muddying the waters is that many autistic children experience sensory sensitivities. Things that may not bother a non-autistic person might be torturous for an autistic person, including things like buzzing fluorescent lights or constrictive clothing.

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“My own autistic son would likely throw a NOIT device across a room if anyone tried to use it on him,” Des Roches Rosa said.

At the same time, not every autistic child or person with learning disabilities may find the NOIT irritating. It’s possible that some might actually like the device, as Shier claimed.

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What it all boils down to is consent. What if a special needs child, particularly a nonverbal special needs child, can’t consent to a device like NOIT and therefore experiences a negative reaction to it? That’s an ethical quagmire.

“I don’t have a problem with NOIT being used by anyone who can consent to it,” said Des Roches Rosa. “But as it is in part aimed towards children who have not yet had success with communication methods, how is consent supposed to be possible? How can we have faith that NOIT facilitators will respect the ways in which autistic children indicate ‘no’ when so much autism therapy is based on getting kids to comply by any means necessary?”

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For what it’s worth, Shier said NOIT instructions state that “if someone other than the actual user is putting the device on, it must be offered and that users must be respected when they tire of it.”

Ideally, she said, a person would use it when they feel it may help, such as in tests or situations they find difficult, with the understanding that it can be removed at any time. However, even with such protocols in place, there stands a chance a child may not be able to properly express consent or that a well-meaning caregiver might misinterpret consent where there is none.

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Again, a major problem is that none of this context is easily available online. And even if it were, without independent research and collaborative input from autism advocacy groups, it’s unclear if any of this will allay concerns raised by NOITs critics.


So what, if any, is Kickstarter’s responsibility in all this?

A Kickstarter spokesperson told Gizmodo that the NOIT page did in fact go through a manual review before being approved.

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“As written, the project has not violated our rules and we’ve reassessed the project against our rules since receiving reports, as the project is presented as an assistive tool rather than a cure, treatment, or diagnostic tool, or preventative measure. Kickstarter prohibits items that claim to diagnose, cure, treat, or prevent an illness or condition. Health devices that could be subject to FDA regulation are also not allowed.”

NOIT’s critics may be displeased with Kickstarter’s response, but the reality is Kickstarter has the final say in what does or doesn’t violate its rules. It is true that the page does not overtly claim to treat, diagnose, or cure autism, ADHD, or dyslexia. Its description says the device is “helpful for anyone who wishes to create and maintain orientation, otherwise known as being focused or concentrating.” As mentioned earlier, it’s technically presented as a device that could be used by anyone, not solely people with those conditions. Intentionally or not, it skirts the same line that herbal supplements, essential oils, and jade vaginal eggs peddled by Gwyneth Paltrow do. None of these things may necessarily cause harm on their own, but if misused or marketed improperly, they definitely could.

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Right now health tech is like the Wild West. You can find anything from metabolism breathalyzers that say they can help you potentially lose weight to allergy sensors that promise to tell you whether a restaurant’s food may trigger a reaction. There’s even a controversial FDA-cleared basal body thermometer and app that claims to prevent pregnancy. Some wearables issue broad claims to improve your mental wellness, decrease stress, and increase your ability to focus with a combo of biometric analysis and guided meditation. Most health and wellness tech doesn’t have clinical research to back these assertions and relies on internal white papers to give credibility to well-intentioned-but-not-scientifically-bulletproof gadgets.

In many instances, these gadgets fly under the radar because if they don’t work, they don’t harm anything other than your pride or wallet. But when you have a device like NOIT that may negatively impact a vulnerable population, they should be evaluated thoughtfully by medical experts and health institutions—not corporate entities like Kickstarter. For many, the obvious choice would be the FDA. However, the FDA’s guidelines don’t reflect our new technological reality and if a device maker says it’s not meant to cure, treat, or diagnose—it doesn’t require FDA’s go-ahead. Often, if something goes wrong, the only recourse is a lawsuit.

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It’s a frustrating scenario that creates murky gray areas where real people may get hurt—whether or not harm was intended. And until legislative bodies figure out a way to clearly outline how health and wearable tech should be regulated, marketed, and sold, the onus is on the consumer to make smart, ethical choices for themselves. Unfortunately, in the case of the NOIT, it comes down to which side you believe more: the device makers who say they’re just trying to do good or the critics who say NOIT relies on outdated research at the expense of the people it’s intended to help.

“Ethical autism approaches should have autistic buy-in, from a reputable source like The Autistic Self Advocacy Network, or the Participatory Autism Research Collective,” said Des Roches Rosa. “It’s not enough, as with the NOIT, to have one autistic person’s testimonial—that’s tokenism, at best. There is a huge problem with quackery in the autism ‘treatment’ community, so parents need to be extraordinarily vigilant about protecting their kids from questionable and even harmful approaches.”

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“One of the things that’s important to recognize is that we do understand their concerns and we assume that they are genuinely good people,” Shier said of NOIT’s critics. “I’m glad that they spoke up.”

Until companies, lawmakers, consumer advocates, and health institutions come together to create a framework that protects the vulnerable groups, cases like this will only become more frequent, not less. NOIT happens to be an instance that when the online brouhaha happened, there were no reported cases of serious harm. There’s still an opportunity for NOIT’s makers to work together with autism advocacy groups, and if need be, adapt the device or how it’s used to better serve the community. Next time, we might not be so lucky.

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Covid-19 Survivors Have a Low Risk of Reinfection, Study Suggests

Illustration for article titled Covid-19 Survivors Have a Low Risk of Reinfection, Study Suggests

Photo: Simon Dawson (Getty Images)

New government-funded research this week should offer some comfort to people who have survived covid-19. It suggests they have a low risk of reinfection from the coronavirus, at least around three months later.

Researchers at the National Cancer Institute teamed up with commercial testing labs and two healthcare data collection companies for this study, published Wednesday in JAMA Internal Medicine.

They analyzed de-identified data from more than 3 million Americans who had gotten a commercial antibody test for SARS-CoV-2, the coronavirus that causes covid-19, sometime between January to August 2020. Antibody tests, while not perfect, indicate whether someone has had a prior recent infection. These people were divided into those who had antibodies and those who didn’t, based on testing. Then the researchers looked at how many people in both groups later got a PCR test for covid-19, which is meant to diagnose an active infection.

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About 10% of people in each group went on to get a PCR test. More people with antibodies tested positive for the virus within the first 30 days after their antibody test than those without antibodies. But that’s not surprising, since detectable traces of the virus can remain in the body for months, even after symptoms have passed and the person is no longer infectious. So it’s likely these positive PCR results were usually picking up the first infection. When the researchers looked specifically at the positive test rate after the first month and especially more than 90 days later—enough time for a positive PCR test to likely indicate a true reinfection—the results were encouragingly different.

After three months or longer, only 0.3% of people with an earlier positive antibody test tested positive for the coronavirus again, compared to 3% of those with a negative antibody test. In other words, having a past infection was linked to a much lower risk of infection three or more months later.

“People who have recovered from covid-19 should be reassured that being antibody-positive is associated with some protection against a new infection,” study author Douglas Lowy, the principal deputy director of the NCI, said in an email.

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The findings do come with their limitations, though. For one, they can’t tell us exactly how much protection a past infection will provide against reinfection, or how long it’s expected to last (though other research has suggested that it may be years). Another factor this study can’t account for is the recent emergence of coronavirus variants. Some—like the one first identified in South Africa last year—are thought to raise the risk of reinfection, since they may be able to partly evade the immune response created by an earlier infection or vaccination.

Still, there’s no research showing that any currently spreading variants can completely evade someone’s natural or vaccine-provided immunity. Our immune system has plenty of weapons against a familiar germ, and it’s likely that most reinfections will turn out to be milder than the first time.

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Even before these new variants were around, though, there had been documented cases of reinfection, including cases where symptoms were worse the second go-around. And the new study’s findings still suggest that reinfection does happen, if rarely. So no one should assume they’re impervious to covid-19 just because they survived an earlier infection with no problem. Ultimately, the best way to keep everyone safe from covid-19 is to vaccinate as many people as possible, including those who have already had the viral illness, according to Lowy. It’s a remedy that involves a lot less risk than getting a natural infection.

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“People who have recovered from covid-19 should still plan to be vaccinated when they have the opportunity,” he said.

The NCI plans to continue funding research that will track the prevalence of reinfection in the general public, along with studies that will look at how our immune response to the virus may change over time and against new variants.

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The Flu Season That Wasn’t

Illustration for article titled The Flu Season That Wasn’t

Photo: David Zalubowski (AP)

This winter has been a complete nightmare for Americans, thanks to the raging covid-19 pandemic. But new data from the Centers for Disease Control and Prevention continues to show one bright spot: The flu has been suppressed to some of the lowest levels on record. It’s likely that the interventions meant to slow the spread of covid-19, like avoiding gatherings and mask-wearing, have helped stop the less-contagious flu in its tracks, and more people than usual got the flu vaccine.

All 50 states are experiencing minimal activity right now, in what might be normally be the tail end of the peak period for flu, and the overall flu season has been peaceful from start to end. According to the CDC, the country’s cumulative hospitalization rate from flu is lower than it’s been during a flu season dating back to 2005, when the country began routinely collecting this kind of data. And perhaps most importantly, only a single pediatric flu death has been reported this winter. Contrast that with the brutal, record-setting 2017-2018 flu season, when over 60,000 Americans, including 186 children, died from the viral illness.

Illustration for article titled The Flu Season That Wasn’t

Graphic: CDC

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The numbers, while great news, are a bit unexpected. Last fall, many scientists were genuinely worried about the possibility of a “twindemic” of flu and covid-19. Covid-19 has certainly held up its end of the bargain, with more deaths and hospitalizations this winter than any other point of the pandemic. Yet there had been evidence in other countries that experienced the flu earlier in the year this season would be mild, for very understandable reasons.

Though both the flu and covid-19 are caused by viruses that spread through the respiratory system via infectious aerosols and droplets, for instance, the coronavirus is more contagious than the garden-variety influenza virus. So interventions that lower a person’s chance of spreading covid-19, like frequent hand washing, mask-wearing, or just keeping a distance, are likely even more effective for the flu. This could be especially important when it comes to schools, since children are often drivers of flu outbreaks in normal times. Vaccination, too, is probably playing a role. Early data has suggested that vaccine uptake is higher than in recent years, and higher rates have been credited for other countries’ success in keeping flu levels low.

Flu isn’t the only disease that’s been suppressed thanks to pandemic-related measures. Last summer, an expected surge in children who develop a polio-like paralysis never came to pass, since infection rates of the common cold virus that can cause it declined around the same time. Other common diseases, like norovirus, have also taken a dip in the past year.

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Of course, trying to stay safe during the pandemic hasn’t come without its social and mental costs. And the lull in these seasonal diseases could mean that we’ll see spikes of these illnesses once people go back to their normal routines. But there’s a lesson for future flu seasons: Maybe we can’t ever eradicate flu, but a little more hand-washing, vaccinating, and staying home when sick—or wearing a mask when you’re sick and must go out—should undoubtedly make it less of a seasonal threat.

Pandemic-Related Unemployment Linked to 30,000 Excess Deaths in U.S., Study Finds

Illustration for article titled Pandemic-Related Unemployment Linked to 30,000 Excess Deaths in U.S., Study Finds

Photo: Eric Baradat (Getty Images)

A new study out Thursday is one of the first to try measuring deaths during the pandemic that were caused not by the virus itself but by the economic devastation it sparked. The study estimates that the spike in unemployment seen last spring helped cause an additional 30,000 deaths among working-age adults in the U.S. over the past year.

Researchers at the University of California San Francisco (UCSF) looked at various sources of data to come up with their numbers, including government-collected unemployment and mortality data reported in 2020. Last year saw the highest reported monthly unemployment rate—14.7% in April 2020—seen since the Great Depression. Then they mapped that data to past estimates of how much a sudden rise in unemployment can contribute to excess deaths that wouldn’t have happened otherwise.

By their calculations, the springtime decline in jobs linked to the pandemic will lead to an excess death toll of 30,231 Americans between the ages of 25 and 64 from April 2020 to March 2021.

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The team’s findings, published in the American Journal of Public Health, do carry some uncertainty. Using different assumptions about the risk of increased deaths from unemployment, or relying on different measures of unemployment (some measures include people able to work but not currently seeking a job as unemployed, for instance, while others don’t) changed their math. So in different scenarios, unemployment-related deaths connected to the pandemic ranged as low as 8,315 to high as 201,968.

Because the study’s findings are only based on modeling the expected death toll, it can’t show us exactly what may have caused these deaths. But it is known that job loss contributes to poorer physical and mental health, often because people also end up losing their health insurance. The role of one presumptive factor—suicide—is less clear. Some early evidence has suggested that suicides aren’t likely to have gone up significantly in the U.S. last year. Yet other data has shown that other health problems possibly related to unemployment spikes, like drug overdoses, did become more prevalent.

What is clear is that the impact of these excess deaths, much like those directly attributed to the viral disease, wasn’t shared equally across different racial and socioeconomic groups of Americans. According to the study, somewhere around 72% of these excess deaths involved Americans without a college degree, despite this group only representing 37% of working age Americans overall. Black Americans, men, and people over the age of 45 were also disproportionately more likely to die in their analysis.

It’s difficult to separate out the indirect effects of a natural disaster, especially one that’s gone on as long as the covid-19 pandemic has. Some people have argued that aggressive measures to contain the pandemic, which have at times included the shutting down of businesses like bars and restaurants, have been counterproductive, in part because of the fallout of potential lost jobs. Yet some countries, including New Zealand, were able to entirely stop the pandemic’s spread within their borders through these measures, allowing them to bounce back strong from their recessions.

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In any case, the U.S. hasn’t done a good job at either stopping the pandemic, with nearly half a million deaths directly attributed to covid-19, or at keeping financially struggling Americans on solid footing. It’s likely that some of these deaths could have been prevented with simply better policy—a lesson that the authors hope we can learn in the second year of covid-19.

“A number of different programs and policies could help prevent unemployment-related deaths and their disproportionate impacts on vulnerable communities,” lead author Ellicott Matthay, a postdoctoral researcher with the Center for Health and Community at UCSF, told Gizmodo in an email. “Some of the most prominent include: (1) more generous and extended unemployment benefits with broader eligibility criteria, (2) programs to promote quick re-employment after job loss, and (3) expanded access to health insurance and mental health/substance use services, particularly for those who have been hardest hit.”

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This article has been updated with comments from the study’s lead author.

Survivors of Severe Covid-19 Should Get Their Eyes Checked, Study Suggests

Illustration for article titled Survivors of Severe Covid-19 Should Get Their Eyes Checked, Study Suggests

Photo: William Thomas Cain (Getty Images)

Doctors are warning that covid-19 may be capable of causing lingering eye problems. A new study suggests that some people who survive a severe infection can develop growths in the back of their eyes that could lead to vision loss. It is not yet clear how covid-19 might cause these growths, or if people with milder covid-19 are also at risk of this complication.

Researchers at the French Society of Neuroradiology looked at medical records from certain patients with severe covid-19. These patients had all gotten a brain MRI at some point during their illness, which allowed the researchers to look for potential abnormalities in and around the eye.

In total, they looked at data from 129 patients across 16 hospitals who were infected during the first wave of the pandemic in France, between March and May 2020. Nine of these patients (7%) had evidence of nodules around the back of the eyeball, with most having growths on both eyes. Eight patients had also been in the intensive care unit.

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There have been occasional reports of people with covid-19 with abnormal test results or health issues related to the eye, such as conjunctivitis (pink eye). But the authors say theirs is the first study to try estimating how commonly this might be happening through MRI data. The findings should be enough to convince doctors to look for potential eye problems in patients with severe illness, they add, especially since they could be hard to spot at first.

“Severe eye problems might largely go unnoticed as these patients are often treated in intensive care units for much more severe, life-threatening conditions,” they wrote in their paper, published Tuesday in the journal Radiology. “Our data support the need for a screening and follow-up of these patients to provide appropriate treatment and improve the management of potentially severe ophthalmological manifestations.”

The results do have their limitations. They can’t conclusively show that having covid-19 led to these eye growths, nor can they explain how it might have happened if the disease was responsible. One theory voiced by the authors is that the infection reached the eyes and directly damaged the retina. Another is that inflammation indirectly caused by infection is the main culprit. It’s even possible that the practice of laying patients on their stomachs (the prone position)—a common intervention that’s been shown to help patients breathe more easily—could have contributed to faulty drainage of veins connected to the eye. Pre-existing circulation problems, common in patients with diabetes, might also be a factor.

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The researchers are already working on future studies to better understand these potential complications. This includes proactively studying severe covid-19 patients from more recent waves of the pandemic, which would confirm whether these growths and other eye problems are really the result of the illness and not an earlier, hidden issue. Survivors with these growths are also being tracked to see if they’re at increased risk for long-term vision problems. And the researchers are pursuing a similar study, focusing on patients with mild to moderate covid-19.

“We have launched a prospective study with dedicated high-resolution MR images for exploring the eye and orbit in patients with light to moderate COVID,” said lead author Augustin Lecler, a radiologist and associate professor at the University of Paris, in a statement released by the Radiological Society of North America, which publishes Radiology. “Therefore, we will be able to know whether our findings were specific to severe COVID patients or not.”

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Ebola Has Returned to Africa and Officials Are Racing to Contain It

The gates of the Matanda Hospital in Butembo, found in the North Kivu province of the DRC. The hospital is where the first case of a new Ebola outbreak in the country died earlier this month.

The gates of the Matanda Hospital in Butembo, found in the North Kivu province of the DRC. The hospital is where the first case of a new Ebola outbreak in the country died earlier this month.
Photo: Al-hadji Kudra Maliro (AP)

The deadly viral disease Ebola has once again surfaced in Africa, and health officials are rushing out vaccines and other measures to stop its spread. As of Tuesday, there have been at least 11 cases and seven deaths in two countries, including Guinea, which had a massive outbreak in 2013 that ultimately left 11,000 dead. Several other African countries are now on high alert.

In Guinea, at least seven cases have been reported since early February, with three victims having died so far. It’s the first outbreak in the region since the 2013-2016 epidemic that swept across West Africa and even briefly made its way to countries outside of Africa, including the U.S. It was the largest and deadliest outbreak of Ebola in recorded history, with almost 30,000 cases and 11,000 deaths reported.

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Elsewhere, the Democratic Republic of Congo—located in Central Africa—has reported four cases during the same time period, with two deaths so far. The DRC has faced the bulk of Ebola outbreaks since the virus was first discovered in 1976, including an outbreak that ran from 2018 to 2020 and left over 2,000 dead (the second-largest death toll ever). It is not yet known whether the outbreaks in Guinea and the DRC are connected. But according to Reuters, DRC officials have confirmed through genetic analysis that their current cluster can be traced back to the earlier outbreak in 2018. Genetic analysis of the virus found in Guinea is still underway and should provide answers soon.

On Monday, Guinea officially declared an Ebola epidemic, while the DRC had done so on February 7. The World Health Organization has also now alerted six countries bordering Guinea to be on the lookout for cases, including Liberia and Sierra Leone. Those three countries were the hardest hit during the 2013-2016 epidemic.

Much has changed since then—namely, the development of a highly effective vaccine by the company Merck as well as antiviral drugs (Merck’s vaccine was briefly deployed at the tail end of the 2014 outbreak but didn’t see wide use until 2018). But Africa, like many parts of the world, is still grappling with the covid-19 pandemic. The WHO said Tuesday that stockpiled supplies of vaccines and drugs are being sent over to Guinea and nearby countries. The United Nations also announced today that it will allocate $15 million in emergency relief funds to aid the response in both countries.

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Ebola is a zoonotic disease, meaning the virus is natively found in wildlife (likely bats) and then spills over to people. If the DRC cluster is connected to an earlier outbreak, though, that may indicate it was somehow started through a human survivor. In people, it’s spread through close contact with an infected person’s bodily fluids, which can include sex. Some people are known to carry the virus months after surviving their ordeal, usually in parts of the body less monitored by the immune system, like the eyes and sperm. At this point, it is not known how either outbreak began.

Symptoms of Ebola include fever, headache, and muscle pain that can quickly progress to severe and fatal internal bleeding. The mortality rate of Ebola can range from 25% to 90%, though it usually hovers around 50%.

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CDC Releases New Advice and Data on Double-Masking

Illustration for article titled CDC Releases New Advice and Data on Double-Masking

Photo: Sean Gallup (Getty Images)

The U.S. Centers for Disease Control and Prevention has released new guidance about the best ways to use masks to help prevent transmission of covid-19. One key recommendation highlights the added benefits of using a more snugly fitting mask or pairing a cloth mask with a surgical mask. Experimental data collected by the agency suggests that either option should greatly reduce the risk of transmission between people.

Rochelle Walensky, the newly appointed CDC director, discussed the new recommendations during a White House coronavirus briefing on Wednesday. Walensky first reiterated the current consensus that properly worn masks can help limit the spread of the coronavirus. Some masks are better at protecting the wearer from infection (N95 and KN95 masks in particular), but they all limit the outward transmission of potentially infectious droplets and aerosols to others. New research from the CDC, however, looked at the relative effectiveness of different methods using cloth and surgical masks and how it could be improved.

In the study, even cloth masks were more effective than no masks at limiting the spread of aerosol and droplet particles the size of those emitted by people with covid-19. But surgical masks that were more snugly fit or that had a cloth mask worn on top of them were the most effective at protecting the user and others. In an experiment that simulated being exposed to an infectious person breathing nearby, having both parties wear better-fitted or double-layered masks reduced the level of exposure by more than 95 percent, Walensky said, compared to no mask at all.

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“I want to be clear that these new scientific data released today do not change the specific recommendations about who should wear a mask or when they should wear one, but they do provide new information on why wearing a well-fitting mask is so important to protect you and others,” she added.

The CDC has now updated its website on improving the effectiveness of masks based on this new data. To make surgical masks better-fitting, for instance, the CDC recommends first knotting the strands of the ear loops and tucking in the outer layer of the mask fabric (there’s a helpful guide and visual provided by the CDC if that description isn’t clear enough). There are also other products, such as mask fitters and braces or masks with nose bridges, that will make a mask tighter. However it’s done, you can tell a mask is snug enough if you can feel warm air come through the front of the mask and the mask moves with every breath you take.

As for double-masking, the CDC recommends either wearing a cloth mask with multiple layers or wearing a cloth mask over a surgical mask. However, it doesn’t recommend wearing two surgical masks at once, or combining an KN95 mask with any other mask (to be fair, these masks are already very good at protection when worn correctly).

In addition to wearing masks in public, people should obviously still practice physical distancing whenever possible, avoid crowded indoor spaces, and wash their hands regularly.

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