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Thursday, August 31, 2023

Why iCoreConnect Stock Is Skyrocketing

 Shares of iCoreConnect (ICCT 31.84%) are skyrocketing 39.8% higher as of 11:07 a.m. ET. The huge gain came after the healthcare technology company announced late Tuesday evening that trading of its shares would resume at the market open on Wednesday.

Trading of iCoreConnect's shares was halted on Tuesday. This halt occurred after the discovery that some shares didn't convert correctly following the company's merger on Aug. 25, 2023, with FG Merger, a special purpose acquisition company (SPAC). 

iCoreConnect stock had vaulted more than 250% higher on Tuesday when trading was suspended. Today's move picks up on that impressive momentum.

Investors are obviously super excited about iCoreConnect's prospects. The stock has risen more than 40x since the combination with FG Merger. However, "irrational exuberance," the phrase used years ago by former Federal Reserve Chair Alan Greenspan, comes to mind.

iCoreConnect projects revenue of $17 million in fiscal year 2023. Its current market cap is more than 14 times that level. Even if we use the projected annualized recurring revenue of $29 million that the company hopes to hit by the end of this year, the stock trades at a steep price-to-sales multiple. 

iCoreConnect continues to pick up partnerships with state and regional healthcare associations that use its cloud-based workflow platform. The $18.8 million in proceeds generated by its merger should help the company fund efforts to drive future growth. 

However, iCoreConnect's subscriber count rose by only 14% between announcing the combination with FG Merger on Jan. 6, 2023, and the completion of the merger on Aug. 25, 2023. The company will need much higher growth to justify its lofty valuation. 

https://www.fool.com/investing/2023/08/30/why-icoreconnect-stock-is-skyrocketing-today/

Longeveron Awaits Alzheimer's Disease Trial Data

Longeveron Inc. (LGVN), a clinical stage biotechnology company, will be participating at the 149th annual conference of the National Investment Banking Association, to be held in Fort Lauderdale, FL, September 6-7, 2023.

The company will discuss about its pipeline progress and investment strategies at the conference.

Longeveron's lead drug candidate LOMECEL-B is in Phase 2a study in Alzheimer's disease, dubbed CLEAR MIND, with topline results expected by October 2023.

A Phase 2 study of LOMECEL-B in hypoplastic left heart syndrome, dubbed ELPIS II, is ongoing, with enrollment expected to be completed by mid-2024.

A Phase 2 study of Lomecel-B in patients with aging-related frailty has been initiated and enrolment is underway in Japan.

https://www.rttnews.com/3387335/longeveron-awaits-alzheimer-s-disease-trial-data.aspx

Zevra to Acquire Acer, Expanding its Rare Disease Portfolio and Adding Commercial Product

Proposed acquisition of Acer for $15M in Zevra stock plus Contingent Value Rights (CVRs) and Zevra’s purchase of Acer’s secured debt in capital efficient structure

Zevra to assume commercialization efforts of OLPRUVA™, recently approved for the treatment of urea cycle disorders (UCDs)

FDA-approved commercial asset expected to increase and diversify Zevra’s revenues

OLPRUVA™ commercial operations provide Zevra scale and cost synergies to complement the potential launch of arimoclomol

Adds EDSIVO™, a Phase 3 program for vascular Ehlers-Danlos Syndrome (vEDS), to Zevra’s rare disease clinical pipeline

Zevra to discuss details during conference call today, at 8:30 a.m. ET

Zevra will host a conference call and live audio webcast with a slide presentation today, August 31, 2023, at 8:30 a.m. ET, to discuss details of the acquisition agreement with Acer.

The audio webcast with a slide presentation will be accessible via the Investor Relations section of the Company’s website, http://investors.zevra.com/. An archive of the webcast and presentation will be available for 90 days beginning at approximately 9:30 a.m. ET, on August 31, 2023.

Additionally, interested participants and investors may access the conference call by dialing either:

  • (800) 245-3047 (U.S.)

  • +1 (203) 518-9765 (International)

  • Conference ID: ZevraUpdate

Mesoblast's CEO takes 30% pay cut to fund 3rd shot at cell therapy approval

 Mesoblast’s CEO will “lead by example” and take a 30% pay cut as the biotech continues to reel from another FDA rejection of its off-the-shelf cell therapy.

The Australian company had “anticipated that remestemcel-L would have been approved by the FDA for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD),” CEO Silviu Itescu said in a second-quarter earnings release yesterday.

Mesoblast had asked the FDA back in February to reconsider approval of remestemcel-L for children with SR-aGVHD. The reworked application contained what the company described as “substantial new information,” including efficacy and biomarker data, some of which were compared to a database of patients with aGVHD that the Mount Sinai medical system maintains.

But the biotech revealed earlier in August that it had received another complete response from the regulator, requiring yet more data. Despite previously pushing back againt the FDA’s request to conduct a fresh trial, the company seems to have now accepted the inevitable.

“Following the complete response, a Type A meeting with FDA has been scheduled for mid-September and we will discuss the potential paths to approval via additional potency assay data or new clinical data in adults,” Itescu said in yesterday's release.

In the meantime, the company has “implemented a significant cost containment strategy and enacted substantial payroll reduction to protect our cash reserves and ensure that we are fiscally prudent,” the CEO added. “Leading by example, I have deferred my entire short term incentives (STI) and reduced my annual salary by 30%, and the same initiatives have been agreed to by our CMO Dr Eric Rose.”

In place of their STIs, Itescu and Rose will receive long-term noncash incentives (LTIs) “to further align with shareholders,” the company explained, adding that all Mesoblast employees would see their STIs deferred. The rest of the biotech’s management have the option of receiving LTIs “in lieu of a 30% reduction in salary.”

Itescu said he was “pleased” that Mesoblast’s nonexecutive directors have agreed to “defer all cash compensation.” They have also signed up to receiving 50% of their fees in LTIs, subject to shareholder approval.

In total, the company is aiming for a 40% annualized reduction in payroll by February 2024 when taking account of base salaries, STI payments and contractor fees. The release makes no mention of any layoffs, and Fierce Biotech has contacted the company to confirm this is the case.

The savings are expected to cover a new trial to try to finally get remestemcel-L over the line. Mesoblast said it’s in discussions with the Blood and Marrow Clinical Trials Network to “conduct a targeted, controlled study in adults with high mortality risk.”

The company was sitting on $71.3 million in cash and equivalents as of the end of June, according to the release.

https://www.fiercebiotech.com/biotech/mesoblasts-ceo-takes-30-pay-cut-fund-third-shot-cell-therapy-approval

Wednesday, August 30, 2023

Regulators Legitimize Decentralized Trials with New Draft Guidances

 Early adopters of new technologies often cite regulatory uncertainty as a hurdle. In the biopharma space, one area where this has been a recurring theme is in clinical trials. In fact, a 2021 survey from the Clinical Trials Transformation Initiative, where I was once executive director, showed that regulatory uncertainty and lack of regional harmonization were the top roadblocks to the adoption of decentralized clinical trial (DCT) technologies.

I have been working in clinical trials for decades, starting out in academia before transitioning to industry, including in my current role as chief scientific officer at Medable, Inc. As both a researcher and a trials technology designer, I’ve seen firsthand that lack of regulatory harmonization between different regions makes it difficult to change the clinical research model for the betterment of all. We can—and must—do better.

Better Guidance Should Expedite Drug Development

Drug development is much too slow. The FDA approves an average of only 50 novel drugs per year; in 2022, that number was just 37. At this pace, we will not have treatments for the majority of the more than 10,000 human diseases within any of our lifetimes.

Delays in clinical trials center around patient enrollment, complex protocols and a system that allows only a fraction of the population to participate. Responsible and thoughtful technology deployment should help accelerate clinical trial timelines and improve participant diversity.

During the COVID-19 pandemic, the increased adoption of decentralized methodologies was guided by temporary guidances put out by many regulators, including the FDA  and EMA. Since then, these agencies and others have released documents clarifying their expectations for the responsible adoption of trials with decentralized elements. These guidances reinforce that regulations apply to clinical trials using decentralized elements in the same way they do for site-based trials: participants’ safety needs to be maintained and trials should generate reliable data.

However, the sheer number of different documents (see list) means that guidelines do not always align or harmonize globally. We know that sponsors run trials in many regulatory jurisdictions requiring compliance with the whole quilt of applicable regulations and laws. These regulations can be related to DCTs generally or be more specific to particular elements, such as a consent guidance about types of technology applications. Managing it all can become very complex.

Make Your Voices Heard

Regulatory agencies often offer a feedback period during which every stakeholder has an opportunity to comment on and offer suggestions on draft guidances. For the FDA’s E6(R3) Guideline for Good Clinical Practice, that time is now—but the window is closing, with a deadline of September 5. As of August 30, 2023, it had only garnered 13 comments. However, on the recently closed docket for the FDA DCT draft guidance, there were a total of 82 comments, most of which were submitted in the last two weeks before the end of the comment period, so there is still time. In fact, our team at Medable is adding comments to the ICH E6(R3) draft guidance now.

This guidance, which addresses certain decentralized elements under the umbrella of Good Clinical Practice (GCP), uses a principle-based approach that is explicitly meant to be flexible and applicable to a broad range of clinical trials in addition to remaining relevant as technological and methodological advances occur. It too outlines regulators’ expectations on how DCT elements should be deployed and was prepared under the auspices of the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use.

I applaud the ICH for its thoughtful update to GCP and for highlighting the value of aligning and cross-referencing with other ICH guidelines. The ICH recognizes the value of modern approaches to clinical research, including the use of technology to improve efficiency, patient focus and data quality. Regulators are taking significant steps toward creating a flexible, forward-looking framework to allow for adaptation as science and technology advances.

Another action we can all take is to collect prospective data on how various decentralized elements are impacting clinical trials. Are participants more diverse? Are enrollment timelines decreased? Is trial data of the quality we need? Early research by researchers at Tufts Center for the Study of Drug Development—based in part on clinical trials enabled by Medable’s clinical trials platform—shows that, on average, DCTs can greatly accelerate Phase II and Phase III trials, equating to up to $39 million increased return on investment. Having this knowledge in the public domain would increase confidence and establish a trusted and verified model.

Clinical trials with decentralized elements are here to stay. In fact, eventually we are not going to make this distinction—all trials will have some elements of decentralization. Thus, we need to collaborate and reach consensus on regulatory guidelines that align worldwide. Every stakeholder must be an active part of the solution. The time is now: Be a part of the revolution; let your voices be heard. Together, we can ensure scalable, responsible DCT adoption industrywide.

Pamela Tenaerts, MD, is Medable’s Chief Scientific Officer. She previously served as executive director of the Clinical Trials Transformation Initiative and has held various other research positions.

https://www.biospace.com/article/opinion-regulators-legitimize-decentralized-trials-with-new-draft-guidances/

We, The Targeted: How Government Weaponizes Surveillance To Silence Its Critics

 by John and Nisha Whitehead via The Rutherford Institute,

“Once a government is committed to the principle of silencing the voice of opposition, it has only one way to go, and that is down the path of increasingly repressive measures, until it becomes a source of terror to all its citizens and creates a country where everyone lives in fear.”

- President Harry S. Truman

Ever since Martin Luther King Jr. delivered his groundbreaking “I Have a Dream” speech during the March on Washington for Jobs and Freedom on Aug. 28, 1963, the Deep State has been hard at work turning King’s dream into a living nightmare.

The end result of the government’s efforts over the past 60 years is a country where nothing ever really changes, and everyone lives in fear.

Race wars are still being stoked by both the Right and the Left; the military-industrial complex is still waging profit-driven wars at taxpayer expense; the oligarchy is still calling the shots in the seats of government power; and the government is still weaponizing surveillance in order to muzzle anti-government sentiment, harass activists, and terrorize Americans into compliance.

This last point is particularly disturbing.

Starting in the 1950s, the government relied on COINTELPRO, its domestic intelligence program, to neutralize domestic political dissidentsThose targeted by the FBI under COINTELPRO for its intimidation, surveillance and smear campaigns included: Martin Luther King Jr., Malcom X, the Black Panther Party, John Lennon, Billie Holiday, Emma Goldman, Aretha Franklin, Charlie Chaplin, Ernest Hemingway, Felix Frankfurter, and hundreds more.

In more recent decades, the powers-that-be have expanded their reach to target anyone who opposes the police state, regardless of their political leanings.

Advances in technology have enabled the government to deploy a veritable arsenal of surveillance weapons in order to “expose, disrupt, misdirect, discredit, or otherwise neutralize” perceived threats to the government’s power.

Surveillance cameras mounted on utility poles, traffic lights, businesses, and homes. License plate readers. Ring doorbells. GPS devices. Dash cameras. Drones. Store security cameras. Geofencing and geotracking. FitBits. Alexa. Internet-connected devices. Geofencing dragnets. Fusion centers. Smart devices. Behavioral threat assessments. Terror watch lists. Facial recognition. Snitch tip lines. Biometric scanners. Pre-crime. DNA databases. Data mining. Precognitive technology. Contact tracing apps.

What these add up to is a world in which, on any given day, the average person is now monitored, surveilled, spied on and tracked in more than 20 different ways by both government and corporate eyes and ears.

Consider just a small sampling of the ways in which the government is weaponizing its 360 degree surveillance technologies to flag you as a threat to national security, whether or not you’ve done anything wrong.

Flagging you as a danger based on your feelings. Customs and Border Protection is reportedly using an artificial intelligence surveillance program that can detect “sentiment and emotion” in social media posts in order to identify travelers who may be “a threat to public safety, national security, or lawful trade and travel.”

Flagging you as a danger based on your phone and movements. Cell phones have become de facto snitches, offering up a steady stream of digital location data on users’ movements and travels. For instance, the FBI was able to use geofence data to identify more than 5,000 mobile devices (and their owners) in a 4-acre area around the Capitol on January 6. This latest surveillance tactic could land you in jail for being in the “wrong place and time.” Police are also using cell-site simulators to carry out mass surveillance of protests without the need for a warrant. Moreover, federal agents can now employ a number of hacking methods in order to gain access to your computer activities and “see” whatever you’re seeing on your monitor. Malicious hacking software can also be used to remotely activate cameras and microphones, offering another means of glimpsing into the personal business of a target.

Flagging you as a danger based on your DNA. DNA technology in the hands of government officials completes our transition to a Surveillance State. If you have the misfortune to leave your DNA traces anywhere a crime has been committed, you’ve already got a file somewhere in some state or federal database—albeit it may be a file without a name. By accessing your DNA, the government will soon know everything else about you that they don’t already know: your family chart, your ancestry, what you look like, your health history, your inclination to follow orders or chart your own course, etc. After all, a DNA print reveals everything about “who we are, where we come from, and who we will be.” It can also be used to predict the physical appearance of potential suspects. It’s only a matter of time before the police state’s pursuit of criminals expands into genetic profiling and a preemptive hunt for criminals of the future.

Flagging you as a danger based on your face. Facial recognition software aims to create a society in which every individual who steps out into public is tracked and recorded as they go about their daily business. Coupled with surveillance cameras that blanket the country, facial recognition technology allows the government and its corporate partners to identify and track someone’s movements in real-time. One particularly controversial software program created by Clearview AI has been used by police, the FBI and the Department of Homeland Security to collect photos on social media sites for inclusion in a massive facial recognition database. Similarly, biometric software, which relies on one’s unique identifiers (fingerprints, irises, voice prints), is becoming the standard for navigating security lines, as well as bypassing digital locks and gaining access to phones, computers, office buildings, etc. In fact, greater numbers of travelers are opting into programs that rely on their biometrics in order to avoid long waits at airport security. Scientists are also developing lasers that can identify and surveil individuals based on their heartbeats, scent and microbiome.

Flagging you as a danger based on your behavior. Rapid advances in behavioral surveillance are not only making it possible for individuals to be monitored and tracked based on their patterns of movement or behavior, including gait recognition (the way one walks), but have given rise to whole industries that revolve around predicting one’s behavior based on data and surveillance patterns and are also shaping the behaviors of whole populations. One smart “anti-riot” surveillance system purports to predict mass riots and unauthorized public events by using artificial intelligence to analyze social media, news sources, surveillance video feeds and public transportation data.

Flagging you as a danger based on your spending and consumer activities. With every smartphone we buy, every GPS device we install, every Twitter, Facebook, and Google account we open, every frequent buyer card we use for purchases—whether at the grocer’s, the yogurt shop, the airlines or the department store—and every credit and debit card we use to pay for our transactions, we’re helping Corporate America build a dossier for its government counterparts on who we know, what we think, how we spend our money, and how we spend our time. Consumer surveillance, by which your activities and data in the physical and online realms are tracked and shared with advertisers, has become a $300 billion industry that routinely harvests your data for profit. Corporations such as Target have not only been tracking and assessing the behavior of their customers, particularly their purchasing patterns, for years, but the retailer has also funded major surveillance in cities across the country and developed behavioral surveillance algorithms that can determine whether someone’s mannerisms might fit the profile of a thief.

Flagging you as a danger based on your public activities. Private corporations in conjunction with police agencies throughout the country have created a web of surveillance that encompasses all major cities in order to monitor large groups of people seamlessly, as in the case of protests and rallies. They are also engaging in extensive online surveillance, looking for any hints of “large public events, social unrest, gang communications, and criminally predicated individuals.” Defense contractors have been at the forefront of this lucrative market. Fusion centers, $330 million-a-year, information-sharing hubs for federal, state and law enforcement agencies, monitor and report such “suspicious” behavior as people buying pallets of bottled water, photographing government buildings, and applying for a pilot’s license as “suspicious activity.”

Flagging you as a danger based on your social media activities. Every move you make, especially on social media, is monitored, mined for data, crunched, and tabulated in order to form a picture of who you are, what makes you tick, and how best to control you when and if it becomes necessary to bring you in line. As The Intercept reported, the FBI, CIA, NSA and other government agencies are increasingly investing in and relying on corporate surveillance technologies that can mine constitutionally protected speech on social media platforms such as Facebook, Twitter and Instagram in order to identify potential extremists and predict who might engage in future acts of anti-government behavior. This obsession with social media as a form of surveillance will have some frightening consequences in coming years. As Helen A.S. Popkin, writing for NBC News, observed, “We may very well face a future where algorithms bust people en masse for referencing illegal ‘Game of Thrones’ downloads… the new software has the potential to roll, Terminator-style, targeting every social media user with a shameful confession or questionable sense of humor.”

Flagging you as a danger based on your social network. Not content to merely spy on individuals through their online activity, government agencies are now using surveillance technology to track one’s social network, the people you might connect with by phone, text message, email or through social message, in order to ferret out possible criminals. An FBI document obtained by Rolling Stone speaks to the ease with which agents are able to access address book data from Facebook’s WhatsApp and Apple’s iMessage services from the accounts of targeted individuals and individuals not under investigation who might have a targeted individual within their network. What this creates is a “guilt by association” society in which we are all as guilty as the most culpable person in our address book.

Flagging you as a danger based on your car. License plate readers are mass surveillance tools that can photograph over 1,800 license tag numbers per minute, take a picture of every passing license tag number and store the tag number and the date, time, and location of the picture in a searchable database, then share the data with law enforcement, fusion centers and private companies to track the movements of persons in their cars. With tens of thousands of these license plate readers now in operation throughout the country, affixed to overpasses, cop cars and throughout business sectors and residential neighborhoods, it allows police to track vehicles and run the plates through law enforcement databases for abducted children, stolen cars, missing people and wanted fugitives. Of course, the technology is not infallible: there have been numerous incidents in which police have mistakenly relied on license plate data to capture out suspects only to end up detaining innocent people at gunpoint.

Flagging you as a danger based on your political views. The Church Committee, the Senate task force charged with investigating COINTELPRO abuses in 1975, concluded that the government had carried out “secret surveillance of citizens on the basis of their political beliefs, even when those beliefs posed no threat of violence or illegal acts on behalf of a hostile foreign power.” The report continued: “Groups and individuals have been harassed and disrupted because of their political views and their lifestyles… Intelligence agencies have served the political and personal objectives of presidents and other high officials.” Nothing has changed since then.

Flagging you as a danger based on your correspondence. Just about every branch of the government—from the Postal Service to the Treasury Department and every agency in between—now has its own surveillance sector, authorized to spy on the American people. For instance, the U.S. Postal Service, which has been photographing the exterior of every piece of paper mail for the past 20 years, is also spying on Americans’ texts, emails and social media posts. Headed up by the Postal Service’s law enforcement division, the Internet Covert Operations Program (iCOP) is reportedly using facial recognition technology, combined with fake online identities, to ferret out potential troublemakers with “inflammatory” posts. The agency claims the online surveillance, which falls outside its conventional job scope of processing and delivering paper mail, is necessary to help postal workers avoid “potentially volatile situations.”

Now the government wants us to believe that we have nothing to fear from these mass spying programs as long as we’ve done nothing wrong.

Don’t believe it.

As Matthew Feeney warns in the New York Times, “In the past, Communists, civil rights leaders, feminists, Quakers, folk singers, war protesters and others have been on the receiving end of law enforcement surveillance. No one knows who the next target will be.

The government’s definition of a “bad” guy is extraordinarily broad, and it results in the warrantless surveillance of innocent, law-abiding Americans on a staggering scale.

Moreover, there is a repressive, suppressive effect to surveillance that not only acts as a potentially small deterrent on crime but serves to monitor and chill lawful First Amendment activity, and that is the whole point.

Weaponized surveillance is re-engineering a society structured around the aesthetic of fear.

As I make clear in my book Battlefield America: The War on the American People and in its fictional counterpart The Erik Blair Diariesthe police state wants us silent, servile and compliant.

They definitely do not want us to engage in First Amendment activities that challenge the government’s power, reveal the government’s corruption, expose the government’s lies, and encourage the citizenry to push back against the government’s many injustices.

And they certainly do not want us to remember that we have rights, let alone attempting to exercise those rights peaceably and lawfully, whether it’s protesting police brutality and racism, challenging COVID-19 mandates, questioning election outcomes, or listening to alternate viewpoints—even conspiratorial ones—in order to form our own opinions about the true nature of government. 

https://www.zerohedge.com/political/we-targeted-how-government-weaponizes-surveillance-silence-its-critics

What the Back-to-School Adderall Shortage Really Tells Us

 It’s back-to-school season and that’s prompting concerns about further shortages of medications to treat attention deficit hyperactivity disorder (ADHD). 

Last fall, the US Food and Drug Administration (FDA) declared a nationwide shortage of Adderall, a popular ADHD drug. That shortage is expected to worsen. According to CNBC: “Many children and young adults with ADHD often take the summer off medication and primarily rely on it during the school year. That could lead to even more demand in the months ahead that may not be met. Historically, prescriptions for ADHD medications increase as the school semester starts around the U.S.”

The CDC estimates that over 6 million children have been diagnosed with ADHD, and 60 percent of them are medicated for it. If many children don’t need their ADHD medication during summertime and then resume the use of these powerful psychotropic drugs at the start of the school year, that should send alarm bells ringing. Schooling is the problem.

Indeed, as Boston College psychology professor Dr. Peter Gray asserts: “What does it mean to have ADHD? Basically, it means failure to adapt to the conditions of standard schooling.” 

In his research of children diagnosed with ADHD who left a conventional classroom for homeschooling and related unconventional learning environments, Gray found that their ADHD characteristics and behaviors ceased to be problematic and that most children no longer needed to be medicated. This was particularly true if these children learned in more self-directed educational environments that intentionally avoided the trappings of traditional schooling. 

This topic is so important that I strongly recommend you listen to my podcast conversation today with Dal “Doc” Richardson, who founded BreakOut School in Utah County, Utah specifically for children with ADHD and related diagnoses. Richardson holds a doctorate in pharmacy and worked as a community pharmacist for 20 years before deciding to become an education entrepreneur. He was concerned about children—and especially boys—with ADHD being unable to flourish in a conventional classroom.

“The families that come to BreakOut School, many of them are just at their wits’ end,” said Richardson. “They find that this system has been trying to jam the square peg into that round hole and all they see are splinters occurring.”

Richardson founded BreakOut School in 2019 as an outdoor-based microschool, similar to a “forest school” model, that provides ample opportunities for unfettered movement and play, along with core academics. He has seen extraordinary results in his students—both academically and emotionally.

From an economic perspective, we should be concerned about the shortage of Adderall, which is likely due, at least in part, to various quotas imposed on manufacturers by the US Drug Enforcement Administration (DEA) that regulates narcotics and controlled substances like Adderall. These shortages would likely not exist in a free market devoid of government meddling.

From an educational perspective, we should be even more concerned about the shortage of Adderall this back-to-school season. This signals that Adderall is being used to equip children to “adapt to the conditions of standard schooling” without questioning whether or not that’s a desirable goal. As Richardson told me, these drugs do work. Kids will conform and perform. But at what cost? What are we taking away from them when we force them to comply with the standard schooling mold?

I always trust parents first, and back them in their decisions regarding what is right for their children. But I hope that more parents who may have children with ADHD characteristics consider that standard schooling may be the real problem.

Fortunately, there are now so many more schooling alternatives for these parents to explore, including BreakOut School, which is a recognized, low-cost private school in Utah that participates in several Utah school choice programs, including the new Utah Fits All Scholarship. This recently-passed universal education savings account (ESA) program provides each K-12 child in Utah with access to about $8,000 per year to use toward approved educational expenses, including microschools like BreakOut School whose tuition hovers right around that ESA amount. Today, more children have access to standard schooling substitutes than ever before.

Several years ago, I wrote about how Thomas Edison would have been given Adderall today. When he was eight years old, his teacher called him “addled” and by all accounts he was unable to adapt to the conditions of standard schooling. His mother found the “addled” label to be unacceptable. She removed young Thomas from school after only a few weeks and homeschooled him from then on using a largely self-directed approach. “She understood me; she let me follow my bent,” Edison recalled.[1]

Years later, as Edison was securing his place as one of America’s greatest inventors with more than 1,000 US patents—including for the phonograph, the motion picture camera, and the incandescent light bulb—a chemist working in his massive New Jersey laboratory said: “Had Edison been formally schooled, he might not have had the audacity to create such impossible things...”[2]

Today, as millions of children return to school—and some return to potent medications— it’s worth asking: Is standard schooling really worth it? Or, is there something better that will allow each child to follow his or her own bent and create those impossible things?

[1] Josephson, Matthew. Edison: A Biography. New York: John Wiley & Sons, Inc., 1992, p. 22.

[2] ibid, p. 412.

Kerry McDonald is a Senior Education Fellow at FEE and host of the weekly LiberatED podcast. She is also the author of Unschooled: Raising Curious, Well-Educated Children Outside the Conventional Classroom (Chicago Review Press, 2019), an adjunct scholar at the Cato Institute, education policy fellow at State Policy Network, and a regular Forbes contributor. Kerry has a B.A. in economics from Bowdoin College and an M.Ed. in education policy from Harvard University. She lives in Cambridge, Massachusetts with her husband and four children

https://fee.org/articles/what-the-back-to-school-adderall-shortage-really-tells-us/