Under Scrutiny, Some Telehealth Firms Are Rethinking ADHD Drugs

The largest online mental health startup has tightened its prescription practices after criticism by medical professionals that its aggressive social-media marketing and workplace culture made some addictive medications too easy to get. And there are signs that scrutiny of mental telehealth is only intensifying.

On Wednesday, SoftBank-financed Cerebral announced it would stop writing new prescriptions for drugs that treat attention deficit/hyperactivity disorder, such as Adderall and Ritalin. That announcement came after a recently departed executive alleged in a lawsuit that Cerebral’s chief medical officer had told employees the company’s goal was to prescribe stimulants to 100% of its ADHD patients as part of a plan to increase customer retention. The company has denied that contention.

Its rivals face challenges as well. At one, a former nurse practitioner recalls diagnosing a patient with obsessive-compulsive disorder and then being quizzed by her supervisor immediately afterward: Why hadn’t she also prescribed ADHD medication? That company, known as Ahead, announced last month that it would be closing.

A third startup, known as Done, has also stirred concern among clinicians by using a 2020 training manual that told them to consider prescribing addictive amphetamines even to patients who didn’t fit the official criteria for an ADHD diagnosis.

Online mental-health firms have been allowed to prescribe controlled medications, including those for ADHD, for a little over two years, thanks to a regulatory rollback that was meant to improve patients’ access to care during pandemic lockdowns. That rule change also spurred competition among the web-based platforms and a rush of advertising that promised quick diagnoses. Among the changes Cerebral announced this week was a plan to submit all social-media advertisements to an internal clinical review committee.

Agents from the Drug Enforcement Administration have spoken with at least two Cerebral employees about its handling of controlled substances, according to two people familiar with the conversations. A Cerebral spokesperson said that the company was “unaware” of any such conversations and said it has not been contacted by the DEA. A spokesperson for the agency said it “cannot confirm or comment on ongoing investigations.”

Since the new breed of companies began writing online prescriptions, national amphetamine sales have boomed, according to nationwide data from the DEA. In 2021, the amount of prescription amphetamines, such as Adderall, that were sold in the U.S. jumped by 1.37 million grams, or 1 ½ tons, over 2020, the DEA data show. It was the biggest annual gain since 2016. More than 41 million prescriptions for amphetamines were filled last year — an almost 16% increase over 2019, before the Covid-19 pandemic began, according to IQVIA, a clinical research and technology company.

The causes of that surge vary, but it’s being fed in part by online providers, which allow customer complaints — including that prescribers have been too stingy with drugs — to drive business decisions, former employees say. Nearly two-dozen current and former clinicians at the companies described a race to the bottom, in which executives pressured them to prescribe ADHD medicine in order to preserve or increase their firms’ market share.

Executives and spokespeople for the companies defend their approach to telemedicine at a time when the Covid-19 pandemic has stirred concern about mental health even as it limited opportunities for face-to-face treatment. And they reject any suggestion that they’ve put profits ahead of patient care.

“Our team is not incentivized to diagnose and treat any specific condition,” said Don Campbell, a spokesman for Cerebral, which has been valued at $4.8 billion. “Our singular goal is to help patients who are struggling with mental illness get access to clinicians who can carefully assess and provide a professional expert opinion on the best course of treatment.”

The firms say they’re broadening access to much-needed care through impactful advertising and patient-centered approaches — and they win plaudits from many customers who say their lives have improved. Yet some experts say their subscription-based business model — pay a monthly price for diagnosis, prescription and follow-up appointments — can imperil patient health.

“The direct-to-consumer model, supported by the pharmaceutical industry, is an inappropriate, potentially dangerous model,” says Omar Atiq, president-elect of the American College of Physicians, who co-authored a 2021 research paper that examined the role of profit in the U.S. healthcare system. “With the new technologies we have available, many vulnerable people, mostly young, could self-diagnose illnesses that they would not be qualified to diagnose.”

A more troubling concern stems from the ADHD medications that have been a focal point of much of the companies’ advertising. The drugs can be abused — the DEA puts them in the same risk category as cocaine and fentanyl — and are popular with recreational drug users and people looking to improve their focus. Bloomberg News interviewed 23 current and former clinicians for the online companies who said they fear the industry is fueling an inappropriate boom in ADHD-related prescriptions.

‘Don’t Miss Out’

“Don’t miss out on your discounted ADHD diagnosis,” says an ad for Done, which was founded in December 2019 by former Facebook product designer Ruthia He and backed by investors including former San Francisco 49ers quarterback Joe Montana. The company now offers ADHD treatment in 25 states and the District of Columbia. A training manual provided to Done employees in 2020 suggested that clinicians consider prescribing ADHD medications even to patients who didn’t fully fit the diagnosis. “Still might be worth doing a medication trial,” the document stated.

To Hilary Ortega, who joined Done in August 2020 and was later promoted to lead nurse practitioner, the suggestion represented a red flag. She left the company four months later, saying she was alarmed by its practices, which she said included firing any provider who accumulated three negative customer reviews.

In an email to Done executives that Ortega wrote after she left, she said that patients came to the company seeking ADHD drugs, so Done’s complaint policy created an “incentive to prescribe stimulants.” The system placed “patient wants above providers’ clinical decision-making,” her email said.

In emailed statements, He and David Brody, the president of Done’s clinical professional corporation, said the company doesn’t have a three-strike rule for customer complaints about providers. Asked whether the company had such a rule previously, He responded that the company’s review processes are confidential.

Two former Done executives say the company’s focus on growth sometimes collided with quality-of-care concerns. “Ruthia was very sensitive to bad reviews,” said Leslie Tsang, who was hired as a Done adviser in May 2020 and participated in management meetings. He left in January 2021. “It was a challenge to maintain clinical standards while balancing the demands of growth,” he said.

Jayaram Brindala, who joined Done as its chief medical officer in October 2020, said he “made efforts to improve quality of care and patient safety” — including what he described as hiring qualified providers, encouraging evidence-based diagnoses and treatments and adhering to legal, regulatory and compliance requirements. He hasn’t been involved in the company’s operations since June 2021.

Asked whether Brindala’s recommendations were accepted, Done’s He said in an email: “Dr. Brindala generated risk mitigation reports on his own accord without prompting, instruction, or expectation from Done. These reports were not part of his scope of work, nor were they found to be relevant to our business.”

One particular case led to deep concern within the Done organization. In October 2020, the company prescribed amphetamines to a 29-year-old California man who had battled substance abuse for more than a decade, three people familiar with the matter said. Less than two months later, he died by overdose; the medical examiner’s report cited acute opiate and cocaine intoxication as the cause of death. A toxicology report showed amphetamines were among several chemicals in the man’s system at the time of his death.

Done executives conducted an internal review of the case, two people said. State-managed prescription logs showed that the man had been prescribed buprenorphine-naloxone, used to treat narcotic dependence, by an unaffiliated clinician before he got an amphetamine prescription from Done. One person familiar with the case said issuing multiple controlled substances to a patient with documented addiction issues was a cause for concern.

Alta DeRoo, chief medical officer of the Hazelden Betty Ford Foundation, noted that people can become dependent on Adderall and misuse it. “When we have patients who have both substance use disorder and ADHD, it’s important to coordinate our care with the provider who is prescribing the patient’s ADHD medication,” she said in an email. DeRoo did not review the patient’s medical records and spoke only of best practices in the industry. The best course for any given patient might include urine drug screening and reviewing prescription monitoring databases, she said.

At the time of the patient’s death, according to two people familiar with the matter, Done didn’t use urine tests, a common screening tool at brick-and-mortar clinics.

Done’s Brody said the company couldn’t discuss or confirm any patient information due to patient privacy laws. “Overall, any doctor and any organization can suffer overdose deaths of patients who have severe substance use conditions,” he said. “One tragic incident does not demonstrate anything about the doctor or organization as a whole, it is what we call anecdotal or circumstantial evidence.”

In an interview, Ortega, the former nurse practitioner, said Done’s approach made it difficult to provide high-quality care. “They designed it in a way so you really couldn’t evaluate patients in an appropriate way and you’re pressured to prescribe to everyone,” she said. Done typically sets patients initial appointments at 30 minutes — too short, Ortega and others say, for a proper ADHD assessment.

Done’s He defended the company’s quality of care in her emailed remarks. “With guidance from the most advanced clinical leadership and board-certified psychiatrists from day one, we have created a platform that provides a patient-first healthcare experience and the highest quality of ADHD care for our patients,” He said.

Short-Lived Approach

While 30-minute online diagnoses prevail at some startups, at least one mental health company followed a different – albeit shortlived – model.

San Francisco-based Ahead, which opened in 2019, employed salaried workers on its medical staff, while more recent entrants in the market have paid clinicians by the appointment. And the company set initial appointments at 60 minutes and follow-up appointments at 30 minutes – twice the length of its competitors.

The model hasn’t worked. On April 14, Ahead employees were told that it will be closing.

Long before that decision, though, clinicians who worked for Ahead described some of the same concerns their colleagues at other companies have laid out. One nurse practitioner, who asked to remain anonymous to avoid alienating her former employee, recalled her Ahead supervisor asking her why she hadn’t prescribed ADHD medication to a patient she diagnosed with OCD and depression.

While some patients truly needed ADHD treatment, the nurse practitioner said, many were “tech bros wanting to work 80 to 100 hours a week” and seeking stimulants to keep them going. A spokesperson for Ahead didn’t respond to questions about those concerns.

One of Ahead’s most important investors is Truepill, an online pharmacy that has also provided fulfillment services to the firm’s competitors by shipping medications to customers. Truepill, which led a funding round for Ahead in July 2020 and shared executives with the telehealth firm, announced Ahead’s closure last month.

“As our business grows, we have shifted our focus to exclusively support our suite of B2B solutions,” Truepill’s chief executive officer, Sid Viswanathan, said in an emailed statement at the time. On May 2, Truepill made another major announcement: it would stop filling scripts for amphetamines for its business clients, too. A spokeswoman said the company was doing so out of “an abundance of caution” and that schedule 2 controlled substances, including amphetamines, make up less than 1% of the company’s total volume.

Truepill’s customers include Cerebral, which told staffers last month that it had rolled out Cerebral RX, an in-house pharmacy in more than 20 states. The new pharmacy will not fill prescriptions for controlled substances, said Campbell, the company’s spokesman. He said Cerebral is working with pharmacies across the country to ensure clients receive their medications.

New Safeguards

In a Bloomberg Businessweek story published in March, former nurses and other Cerebral employees described several factors, including suggestive advertising and abbreviated appointments, that they said created undue pressure to prescribe amphetamines. Afterward, David Mou, the company’s chief medical officer, told clinicians in an email that Cerebral would implement additional surveys and screenings to help evaluate patients who “self-report” ADHD — steps that Campbell said have been taken. As part of the changes it announced on Wednesday, Cerebral said Mou had been promoted to president of the company.

In a lawsuit filed April 27, Matthew Truebe, a former vice president for the company, said Mou had told employees his goal was to prescribe stimulants to 100% of Cerebral’s ADHD patients. The suit also says Truebe was told by the CEO, Kyle Robertson, to devote zero percent of his resources to compliance issues and to focus instead on client “activation and retention.” Truebe raised concerns about more than 2,000 duplicate shipping addresses in Cerebral’s patient database, including one potential case of prescription fraud, only to be told by Robertson that the issue was his “lowest priority,” the complaint says.

In a statement, Cerebral said Truebe’s allegations were not true, adding: “We plan to vigorously defend ourselves against these false and unfounded allegations.”

Meanwhile, Cerebral is bringing on additional administrative workers to relay messages between patients and clinicians — a key role in its business model. Going forward, the company plans to employ as many as 70% of its coordinators in the Philippines, according to four people familiar with the matter. New workers might be paid less than half the hourly wage of their U.S.-based counterparts, two of the people said.

Cerebral has assured current employees that it plans no layoffs. “The hiring of these new coordinators is designed to supplement our existing staff, not replace them,” Campbell said. “Ultimately, the decision to grow our team of coordinators was made in order to meet the increasing demand for our services and expand our customer service coverage to 24 hours a day.”

Some Cerebral employees say they fear that the change will introduce culture and language barriers into sensitive conversations about mental health. In one case that unfolded earlier this year, a Cerebral nurse declined to provide more ADHD medication to a patient, citing concerns about the patient’s behavior and prescription history, according to internal company messages seen by Bloomberg. The nurse’s decision was relayed to the patient by a U.S.-based coordinator. However, the patient found an alternative within Cerebral, simply by emailing the company; a Philippines-based coordinator directed the patient to a new prescribing nurse.

Asked about the exchange, Campbell said that while Cerebral “requires the current clinician to provide approval for the reassignment of care,” it will flag such reassignments “to all care providers moving forward.”