The CEO and Clinical President of ADHD telehealth company Done are facing federal charges for allegedly taking advantage of pandemic-related regulation changes involving the prescription of controlled substances via telehealth.
According to a Department of Justice press release, Done CEO Ruthia He and Clinical President David Brody “exploited the COVID-19 pandemic to develop and carry out a $100 million scheme to defraud taxpayers and provide easy access to Adderall and other stimulants for no legitimate medical purpose.”
He and Brody are in federal custody awaiting trial.
About Done ADHD
Done ADHD was founded in 2019 by Johns Hopkins and Stanford-educated psychiatrist Dr. David Brody, and former Facebook product designer Ruthia He.
The user friendly platform offers low-cost virtual consultations with psychiatric nurse practitioners, psychiatrists, and doctors for an initial consultation fee of $199 and a $79 monthly subscription thereafter.
Done’s platform is simple to use, bypassing passwords in favor of 2-factor authentication for account access. The UX is built with users in mind. Done also sends frequent appointment reminders via text and email, a useful feature for patients who are more likely to forget appointments.
The membership provides patients with unlimited access to medical professionals and the ability to book follow-up consultations at no extra charge. However, membership fees do not include the cost of prescribed medications.
Since its launch, Done ADHD has grown its patient base to an estimated 30,000–50,000 people.
Despite the recent arrests of senior leadership, the company continues to operate, though the impact of He and Brody’s arrests on its future remains uncertain.
The Impacts of ADHD
Doctors, psychologists, and psychiatrists from leading medical institutions have expressed concern about the future care of Done ADHD patients.
ADHD continues to face stigma and skepticism, yet research shows it has significant long-term effects, especially when individuals lack access to proper care.
Studies have suggested that people with ADHD:
- Have a shorter life expectancy by 9–13 years 1
- Are 36% more likely to be in a car accident 2
- Are 60% more likely to get fired3
- Are 30% more likely to experience chronic employment issues
People with ADHD face higher risks of job loss and inconsistent employment, which raises concerns considering medical insurance is often tied to work. Without insurance, many turn to affordable, accessible services like Done ADHD for treatment and medication.
Without these options, they may be left without support, and outcomes may worsen.
The Cost of a Diagnosis
Accessing professional care for psychological, emotional, or behavioral disorders in the U.S. healthcare system, even with insurance, is often lengthy, complex, and costly.
A 2022 study by the Journal of Managed Care and Specialty Pharmacy found that adults with ADHD, even with insurance, face an average out-of-pocket annual cost of $3,760.4
Done simplified access to ADHD care by making services affordable and streamlining the diagnosis and appointment process, with or without insurance. Patients bypass the typical hurdles of insurance companies, such as referrals, multiple tests, interviews, and trying other treatments like antidepressants first.
These steps delay treatment for ADHD patients, worsening the challenges they face in both their personal and professional lives.
Between the membership fee and medications, the out-of-pocket expenses for Done patients ranged from $1,350–$2,250 a year. Done ADHD did ultimately cut costs by $1500 per year for ADHD patients to get medications.
Moreover, untreated ADHD inherently makes it more difficult for patients to maintain the numerous appointments required to manage the condition. Done reduced the friction required to gain access to professionals and get medication refills.
In other words, Done may have helped patients who never had access to the resources they need available at a more affordable price and through a more streamlined process.
One Done Patient’s Story
We spoke with a patient from Done about their experience navigating the American medical system prior to working with Done.
“I personally tried to get care for my poor working memory through Kaiser,” one Done patient, who wished to remain anonymous, says. “I also forget small tasks and say things I don’t realize upset people. I interrupt and change topics quickly, and while sometimes I can see I’m doing it, it’s like I only realize it after it’s already happened.”
“When I went to Kaiser, and explained very specifically that I had a hard time remembering things and was inattentive, they first made me take anti-anxiety medications for nearly three months. I didn’t think that was the issue, but I was willing to give it a shot. But that honestly made my absentmindedness worse. I followed up with doctor, who agreed that Buspar was not the right treatment for me. Still, they insisted I first try an antidepressant regimen before they’d consider ADHD testing and treatment options, like I had asked. I tried telling them — I am not depressed.”
“I am actually a pretty happy-go-lucky person. But they insisted we try this, despite the whole Buspar fiasco. I was already struggling at work with a series of careless mistakes upsetting my boss, who had put me on a performance improvement plan after I sent an important document to the wrong person on accident. I started the anti-depressants. A month later, I was fired.”
“I really don’t know why they made me go through four months of everything-but ADHD hoops. But by the time I got through the prescribed antidepressants, I no longer had insurance. That’s when I started doing my own research and found Done.”
Benchmarking Against Telehealth Growth
A 2024 study published in JAMA Psychiatry found that between 2018–2022, prescriptions for stimulant medication for ADHD increased by 14%.
In a 2023 joint letter by the FDA and DEA to the public, the regulation agencies note:
“Data show that, from 2012 to 2021, overall dispensing of stimulants (including amphetamine products and other stimulants) increased by 45.5 percent in the United States.”
Using the FDA and DEA’s own data, the supposed “spike” in stimulant prescriptions due to “pill mills” like Done ADHD are essentially non-existent. Written prescriptions were already growing at a rate of between 3-5% a year on average, even for the 8-year period leading up to the regulatory changes that allowed companies like Done and Celebral to exist.
In other words – there really wasn’t a statistically meaningful change in prescriptions written after companies like Done and Cerebral entered the market.
Over the same period, non-stimulant prescriptions for ADHD rose by 32%. As a benchmark, prescriptions for antidepressants rose 10% over the same period.
This difference, however, may be explainable by statistics that show those with ADHD are less likely to maintain steady employment and may be overrepresented in the uninsured, unemployed category.
The pandemic brought changes regarding telehealth regulations, specifically, allowing for controlled substances (stimulant medications) to be prescribed without in-person doctor visits.
This paved the way for comprehensive virtual ADHD treatment, which was previously hindered by extensive testing, multiple appointments, specialist referrals, insurance complications, and medication trials—barriers that often limit access for those lacking resources and in some cases, the wherewithal to complete the byzantine process.
By comparison, the rise of online therapy platforms such as BetterHelp and TalkSpace led to a 32.6% growth rate in overall adults seeking mental health services between 2019–2023. Increases in ADHD diagnoses are comparable to those of other types of health services after adoption of telehealth models.
Who’s to Blame for the Adderall Shortage?
In October 2022, the FDA announced a nationwide Adderall shortage. While reports pointed to the uptick in ADHD diagnoses and prescriptions — despite the fact that they were growing by less than 4% a year — another key factor was at play.
Just two months earlier, pharmaceutical drug manufacturer Teva, one of the largest producers of ADHD medications, closed an Irvine, California-based manufacturing site. As part of the site closure, Teva laid off 305 employees.
The closure followed an FDA inspection that found mold and bacteria in vials used to mix medications for a range of conditions, including cancer.
Teva accounted for approximately 17% of the generic Adderall market, while Ascent Pharmaceuticals, which produced about 20% of all generic ADHD medications, was shut down by the DEA in late 2023. This disruption affects 30-40% of total ADHD medication production.
To make matters worse, FDA and DEA impose production quotas on controlled substances, under which stimulant medications fall.
Quotas for Adderall production increased by over 25% from 2023 to 2024, with approvals divided among pharmaceutical manufacturers. Given that total Adderall prescriptions have risen by 14% since 2020, this quota adjustment should adequately meet the modest demand increase.
However, when manufacturers with approved quotas, such as Teva and Ascent, are shut down, it’s unclear if their quota allocations are redistributed to other pharmaceutical companies. If not, the 30–40% production gap persists, meaning the 25% quota increase fails to address the shortfall. This appears to be the central issue—and the question that remains unanswered.
“Based on DEA’s internal analysis of inventory, manufacturing, and sales data submitted by manufacturers of amphetamine products, manufacturers only sold approximately 70 percent of their allotted quota for the year, and there were approximately 1 billion more doses that they could have produced but did not make or ship. Data for 2023 so far show a similar trend,” the 2023 joint DEA-FDA letter reads.
However, a 30% gap in Adderall production fits like a puzzle piece to the allocations for the now-shutdown pharmaceutical producers Teva and Ascent, fully explaining the shortage.
The critical question is: Were Teva and Ascent’s Adderall manufacturing quotas transferred to other manufactures when they were shut down?
Should production of these medications experience interruptions, companies like Mark Cuban’s Cost Plus pharmacy are available to fill the gap, and there would be no Adderall shortage.
However, the DEA would first needs to approve the transfer of Teva or Ascent’s quotas to producers like Cost Plus Pharmacy before that happens.
Finger Pointing
According to the DEA, the storages stems from manufacturers not producing their allowable quota.
However, members of Congress aren’t so sure, also questioning the DEA’s quota distribution.
In a May 2024 letter, Congresswoman Lisa McClain (R-Mich.) and James Comer (R-Ky.) launched an investigation into the DEA’s management of drug quota allocation and the impact of drug manufacturers’ shutdowns on the total market supply.
“In a letter to Drug Enforcement Administration (DEA) Administrator Anne Milgram, the lawmakers request documents and communications related to DEA’s impact on and response to the prolonged shortages of Schedule II drugs, including Adderall,” they write. “Despite increased demand and fewer manufacturers, DEA has not provided manufacturers an increased APQ. As a result, shortages of these drugs have remained for more than a year and a half.”
Who’s Money Is It Anyways?
The DEA charges that Done ADHD brought in $100 million in revenue between 2020–2023. That averages out to approximately $30–$40 million annually.
However, revenue does not equate to profit. Revenue refers to the total income generated by the company without deducting operating expenses, such as salaries for medical professionals, taxes, licensing fees, platform maintenance costs, and legal expenses related to federal and state compliance. The amount Brody and He personally pocketed from Done’s revenue was likely only a small percentage of the total revenue.
A 2023 study estimated that ADHD-related services, such as testing, therapy appointments, and medication, generate approximately $8.3 billion in revenue annually in the U.S. alone. Thus, Done ADHD’s slice of the U.S. market amounted to less than 0.5%.
Importantly, Done ADHD did not directly sell nor profit from the purchase of the medications themselves. Whether a patient is prescribed a stimulant medication or a non stimulant medication, regardless of dose — Done’s bottom line remains unchanged. In other words, Done had no financial incentive to prescribe patients stimulants over non stimulants or lower doses versus higher doses.
Evidence of Wrongdoing by Done ADHD Executives
But Ruthia He and David Brody are still in hot water, facing prison time if convicted.
The lawsuit alleges that “R. He, Brody, and others sought to conceal and disguise the conspiracy, and obstruct justice, by corruptly altering, destroying, and concealing records and documents; refraining from using company email and messaging platforms; and using encrypted messaging platforms, personal email accounts, and personal devices to communicate about company business, all with the intent to impair the communications and documents for use in the government and Grand Jury’s investigation; and caused Done not to produce records in response to a Grand Jury subpoena.”
If true, He and Brody face criminal culpability for obstruction of justice, at the bare minimum.
In response to the arrest, Done ADHD issued a statement on its website.
“Done Global disagrees with the criminal charges filed last week against its founder, Ruthia He, and Dr. David Brody, which are based on events that principally occurred between February 2020 and January 2023. Both are presumed innocent,” it reads.
“During these current proceedings, Done continues normal operations and is doing everything we can to ensure stable care for our patients. We deeply value the trust of our clinicians and patients.”
The Waiting Game
Shortly after the arrests, the CDC issued an emergency health advisory to the public and medical officials.
“Patients whose care or access to prescription stimulant medications is disrupted, and who seek medication outside of the regulated healthcare system, might significantly increase their risk of overdose due to the prevalence of counterfeit pills in the illegal drug market that could contain unexpected substances, including fentanyl,” the CDC warned.
The CDC is especially concerned with patients turning to illegal sources if they are unable to obtain treatment through services like Done ADHD. Off-market sources have a higher likelihood of containing dangerous, potentially fatal additives, such as fentanyl.
Though ADHD medications are stimulants, not opioids, the prevalence of fentanyl in off-market illegal drugs is cause for concern. The CDC advises patients with interrupted care to “carry naloxone, a life-saving opioid overdose reversal drug.”
The CDC also advises clinicians to “avoid stigmatizing patients affected by a disruption in care” and to “communicate to patients that 7 out of every 10 pills seized by DEA from the illegal drug market contain a lethal dose of fentanyl.”
The case against Done ADHD is pending as He and Brody await trial.
References
- ADHD Likely Reduces Estimated Life Expectancy by Young Adulthood. Russell A. Barkley, Ph.D., 2018.
https://www.russellbarkley.org/factsheets/ADHD_Likely%20_Reduces_Estimated_Life_Expectancy_Barkley.pdf ↩︎ - Motor Vehicle Crash Risk Among Adolescents and Young Adults With Attention-Deficit/Hyperactivity Disorder, Allison E. Curry, Ph.D., 2017
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5710634/ ↩︎ - Impairment in Occupational Functioning and Adult ADHD: The Predictive Utility of Executive Function (EF) Ratings Versus EF Test. Russell A. Barkley, Kevin R. Murphy. 2010. ↩︎
- Economic burden of attention-deficit/hyperactivity disorder among adults in the United States: a societal perspective. 2022. Jeff Schein, DrPH, MPH.
https://www.jmcp.org/doi/full/10.18553/jmcp.2021.21290 ↩︎
