Tens of thousands of people with attention deficit hyperactivity disorder could face disruptions to treatment after a major telehealth company was accused of selling millions of Adderall pills without securely confirming an ADHD diagnosis, federal prosecutors announced Thursday.
Done Global Inc. sold more than 40 million pills of Adderall and other medicine since the start of the COVID-19 pandemic, according to a federal indictment charging the company's founding CEO and clinical president, who were arrested Thursday in California.
The company was struggling to make money until the pandemic hit, court records said. At that point it began taking advantage of the crisis by hastily subscribing patients to monthly auto-refills of medication after brief telehealth calls without conducting a proper assessment for ADHD or allowing follow-up visits, according to court documents.
Prosecutors also allege that executives deleted documents and used encrypted messaging platforms instead of the company email in anticipation of a subpoena after another telehealth company was subpoenaed. Done did not produce documents when a grand jury ultimately issued a subpoena, according to the indictment.
“As alleged, these defendants 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,” said Attorney General Merrick Garland. “Those seeking to profit from addiction by illegally distributing controlled substances over the internet should know that they cannot hide their crimes and that the Justice Department will hold them accountable.”
Done Global did not immediately respond to USA TODAY’s request for comment Thursday. The company's website said it was founded to make mental health care more readily accessible and provide ADHD treatment to people who otherwise wouldn’t be able to due to stigma, cost or availability.
The Centers for Disease Control and Prevention released an advisory soon after the announcement, warning that treatment for 20,000 to 50,000 adults with ADHD across the United States could be disrupted.
Thursday's announcement comes as people with ADHD face a chronic nationwide medicine shortage, facing steep price hikes and sometimes rationing prescriptions. The CDC warned against taking counterfeit pills in its advisory Thursday, noting they can be laced with dangerous substances such as fentanyl, which can be fatal even in miniscule doses.
Feds: Company crammed in appointments
Done CEO Ruthia He was arrested in Los Angeles, and clinical president David Brody was arrested in San Rafael, California. They each face up to 20 years in prison if convicted of conspiracy to distribute and distributing controlled substances.
The company was not making much revenue until the pandemic, which they exploited through their telehealth scheme, prosecutors alleged Thursday. They allegedly held shorter appointments than other medical clinics, purporting to screen out people who likely did not have ADHD.
The executives also mandated initial appointments to stay under 30 minutes, causing workers to write prescriptions that were not for a “legitimate medical purpose," the indictment said.
Done paid a group of doctors and nurse practitioners to diagnose its members with ADHD, the indictment said. They allegedly wrote prescriptions without examining the patients or establishing a relationship, and sometimes only based on a short call, and other times with no video or audio communication at all.
He and Brody also issued an auto-refill policy for medicine and told the group of medical professionals they were not allowed to follow up with patients, court papers said.
Dr. Craig Surman, director of an Adult ADHD clinical and research program at Massachusetts General Hospital and psychiatry professor at Harvard Medical School, told USA TODAY that a full assessment is supposed to take an hour and a half.
“It’s a specialty to understand how to evaluate ADHD,” said Surman, who co-chairs the Professional Advisory Board of nonprofit organization Children and Adults with ADHD. “Many other conditions look like it.”
Risk and benefits of treatment also needs to be monitored and reevaluated over time, he added, raising flags about the no follow-up policy.
The direst consequence, Surman said, would be that limited assessments prevent a company from screening out people for whom the treatments were unhealthy. And he noted that Adderall and other stimulants used to treat ADHD have a high market value, meaning they can be illegally resold.
“There’s a whole ecosystem in which people are misusing these products,” Surman said.
He also noted that people with ADHD seeking treatment already face a lot of stigma, and Done’s case may compound that, further preventing people from seeking treatment.
“It’s very interesting [the government] fired this warning shot across the bow of telehealth," Surman said, noting that companies should not cut corners on evaluation and monitoring treatment.
Done case spotlights questions about in-person vs. online care
The announcement Thursday also shines light on questions about in-person patient care requirements.
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 requires providers to hold at least one in-person medical evaluation before it can dispense medicine virtually. The Drug Enforcement Administration granted a temporary lift during the pandemic so patients could get medicine through solely telehealth evaluation.
"Telehealth policies implemented during the COVID-19 pandemic have allowed for greater access to ADHD treatment, including treatment with prescription stimulants, without the need for an in-person health care visit," the CDC said.
The temporary lift of in-person requirements for prescriptions is currently extended through the end of 2024.
“As more health care needs are met through telemedicine, we will not tolerate fraud schemes that seek to recklessly exploit digital technologies,” Department of Health and Human Services Inspector General Christi A. Grimm said Thursday.
What is ADHD?
Attention deficit hyperactivity disorder affects nearly 10% of children and 4.4% of adults across the U.S., according to the CDC. Stimulants such as Adderall are increasingly used to treat ADHD.
The American Psychiatric Association says people with ADHD may deal with inattention, excess movement and impulsivity. It is considered a chronic and debilitating disorder that can affect people in several aspects of their life, such as professional goals, personal relationships and daily functioning.
Scientists have not determined what causes ADHD, but genetics does appear to be a factor.
Patients and medical workers affected by the alleged scheme can report it to the DEA by calling 646-466-5159.
This article originally appeared on USA TODAY: Struggling telehealth company exploited Adderall sales for profit, prosecutors say
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