The CEO and Clinical President of ADHD telehealth company Done are facing federal charges for allegedly exploiting 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 medical professionals from Stanford University, Kaiser Permanente, and Facebook.
The 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 cost thereafter.
The membership allows patients to access medical professionals at any time and book follow up consultations at no additional cost. Memberships do not cover the cost of prescribed medications.
Since its inception, Done ADHD has built a patient base of between 30,000–50,000 people. Despite the arrests of senior leadership, the company is still tentatively operating. Whether He and Brody’s arrest will impact the future of the company is unclear.
The Impacts of ADHD
Doctors, psychologists, and psychiatrists from premier medical institutions have voiced concern over what will happen to Done patients.
ADHD still carries stigma and skepticism. Research has shown that ADHD has profound long-term consequences on those affected, particularly if they cannot access 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 fired
- Are 30% more likely to experience chronic employment issues
That those with ADHD are more likely to lose their jobs and struggle with consistent employment is particularly concerning. With medical insurance tied to employment, those without insurance might seek an affordable, accessible service like Done ADHD to obtain treatment and medications. Without it, they may be left out cold.
The Cost of a Diagnosis
Obtaining professional care for psychological, emotional, or behavioral disorders through the American healthcare system, even for those with insurance, can be a long, complicated, and expensive process.
A 2022 study by the Journal of Managed Care and Specialty Pharmacy found that the average out-of-pocket cost for an adult with ADHD and insurance is $3,760.3
Done not only made the service affordable, but streamlined the appointment and diagnosis process without having to navigate the complicated system most insurance companies impose, including referrals, multi-appointment tests and interviews, and in many instances, trying other forms of treatment first, such as anti depressants. All of these steps prolong the issues ADHD patients face, as well as adversely impact 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.
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%. Over the same period, non-stimulant prescriptions for ADHD rose by 32%. As a benchmark, prescriptions for antidepressants rose 10% over the same period.
The pandemic brought changes regarding telehealth regulations, specifically, allowing for controlled substances to be prescribed without in-person doctor visits.
That opened the door for virtual, full-range treatment for ADHD that had previously been barred behind extensive testing, ongoing appointment, specialist referrals, insurance red tape, testing other medications, and other hoops to jump through for a cohort that’s less likely to have access or financial means for these services in the first place.
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.
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 category.
Adderall Shortage
In October 2022, the FDA announced there was a nationwide Adderall shortage. While reports pointed to the uptick in ADHD diagnoses and prescriptions, 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 produced an estimated 17% of the generic Adderall market supply. Then, in late 2023, the DEA shutdown Ascent Pharmaceuticals. Ascent produced an estimated 20% of all generic forms of ADHD medications. Between Teva and Ascent, somewhere between 30–40% of all ADHD medication production has been disrupted.
To make matters worse, FDA and DEA impose production quotas on controlled substances, under which stimulant medications fall.
Quotas were raised by over 25% between 2023 and 2024. The quota is in turn divided and approved among manufacturers. With total prescriptions up by 14% since 2020, the quota adjustment should more than cover the increase in market demand.
However, whether this quota is redistributed to other suppliers when manufactures _ such as Teva and Ascent — are shut down is unclear.
Should production of these medications experience interruptions, companies like Mark Cuban’s Cost Plus pharmacy are available to fill the gap. However, the DEA first needs to approve the reallocation of Teva or Ascent’s quotas.
Finger Pointing
According to the DEA, the storages stems from manufacturers not producing their allowable quota.
However, members of Congress aren’t so sure.
In a May 2024 letter, Congresswoman Lisa McClain (R-Mich.) and James Comer (R-Ky.) opened an investigation into the DEA’s handling of drug quota allocation and handling of drug manufactures’ shutdown on 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.”
Whether the shortages are stemming from the modest increase in prescriptions from the rise of tele-health companies, the shutdown of major manufacturers, or the DEA’s failure to reallocate quotas in the wake of the shutdowns, is unclear.
Everyone is pointing fingers in different directions.
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.
But revenue is not profit. Revenue is total amount of income brought in by the company. It does not deduct operating expenses, including the medical professionals on payroll, taxes, licensing, the engineers maintaining the platform, or the lawyers needed to manage various aspects of federal and state law compliance. The amount Brody and He pocketed from Done’s revenue was likely only a minority 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, in whatever dose — Done’s bottom line remains unchanged.
Evidence of Wrongdoing by Done ADHD Executives
But Ruthia He and David Brody are still in hot water and may have something to hide.
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/ ↩︎ - 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 ↩︎