Cerebral will stop writing prescriptions for Adderall, Ritalin and other controlled substances to new ADHD patients as concerns grow about telehealth companies' prescribing practices.
The well-funded online mental health startup has faced increased scrutiny from the media and former employees about its prescribing practices. Complaints have surfaced that the company has been too quick to prescribe powerful stimulant drugs.
The problems at Cerebral intensified Wednesday as Insider reported that the Drug Enforcement Agency (DEA) is investigating the company. U.S. DEA agents interviewed former Cerebral employees about issues with clinician licensing and about allegations that some patients had set up multiple accounts to obtain more drugs, Insider reported, citing sources.
In response to a request for comment, a Cerebral spokesperson issued the following statement: "We have no further comment on the article or the reporting at this time. Cerebral is and remains dedicated to increasing access to high-quality mental healthcare and providing the best mental health care to our patients."
Earlier this week, online pharmacy Truepill, which is reportedly Cerebral's preferred pharmacy, said it was temporarily halting prescriptions for Adderall and other controlled substances used to treat attention-deficit/hyperactivity disorder (ADHD).
"Truepill has an extremely high standard of clinical protocols and practices in place to ensure the safety of our patients. Out of an abundance of caution, Truepill is temporarily pausing all fulfillment of schedule 2 substances while we evaluate appropriate next steps," the company said in a statement to Fierce Healthcare.
Truepill is a California-based mail-order pharmacy startup that offers pharmacy fulfillment, telehealth and at-home testing services for consumers. It was valued at $1.6 billion in a funding round last fall.
Schedule II substances account for less than 1% of Truepill’s total prescription volume, the company said.
The government classifies Schedule II substances as drugs “with a high potential for abuse, with use potentially leading to severe psychological or physical dependence.” Other Schedule II substances include OxyContin and Vicodin.
Increased scrutiny of online prescribers
Online pharmacies and mental health providers surged in popularity during the pandemic as demand for services grew.
Cerebral launched in January 2020 and grew rapidly, propelled by increased demand for behavioral health care services during the pandemic. The San Francisco-based company banked $300 million in a series C round in December, boosting its valuation to $4.8 billion.
The changes to Cerebral's prescribing practices for ADHD medications take effect May 9. Over the course of the next several months, existing patients will continue receiving their clinically appropriate, prescribed medications, the company said in a statement. Cerebral will be adding additional tools for clinicians to further safeguard prescribing practices.
"Cerebral will work to create a smooth transition for its care professionals and impacted patients. Additionally, we will continue to internally look at our own practices, and identify how we can ensure we are safely deploying all of our offerings," executives said in a press release.
Kyle Robertson, CEO and founder of Cerebral, said in a Wednesday statement that clinical quality and safety are “at the forefront” for the company, but it decided to pull back on stimulant prescriptions "based on recent feedback from stakeholders."
"[I]t is clear that this has become a distraction from our focus to democratize access to mental health care services, provide treatment for more patients and add service lines for new conditions,” Robertson said in a statement.
The Wall Street Journal reported in March that some clinicians working at startups like Cerebral and Done Health felt pressured to prescribe stimulants like Adderall to patients even though, in their view, the company’s 30-minute patient evaluations weren’t long enough to properly diagnose ADHD.
Some of the nation’s largest pharmacies have blocked or delayed prescriptions written by clinicians at telehealth startups that sprang up to treat ADHD, the WSJ reported.
Matthew Truebe, the former vice president of product and engineering at Cerebral, claims in a labor lawsuit that the company fired him after he complained it was too quick to prescribe powerful stimulant drugs.
The lawsuit, filed in California state court, alleges that Cerebral planned to increase customer retention by prescribing stimulants to 100% of its ADHD patients. Truebe alleges that the company "egregiously put profits and growth before patient safety," including overprescribing medications for ADHD, according to the complaint.
Truebe also claims Cerebral leadership ignored serious concerns that he raised. For instance, he told higher-ups that he had found more than 2,000 duplicate shipping addresses in the patient database, suggesting customers were setting up multiple accounts to obtain additional medication.
In response, Robertson wrote in a statement posted on Cerebral's website: "Cerebral is not incentivized or focused on treating a specific condition. Cerebral does not provide its clinicians with a target for prescriptions. Cerebral does not reprimand a clinician for not writing prescriptions as long as they are practicing in a clinically safe way as guided by evidence-based clinical guidelines with clear, appropriate documentation."
As the company faces pushback, Cerebral said it has added more safeguards to its clinical safety protocols. For instance, it has multiple protocols in place to prevent and reduce any potential misuse, such as enabling clinicians to order a urine screen at any point if they suspect possible drug misuse. The company said it also monitors and tracks clinician reassignment requests from patients.
Cerebral uses both automated and manual tools, such as ID verification and cross-checking shipping addresses, to ensure that patients are appropriately accessing its services, executives said.
The company also said it has taken steps to beef up its executive leadership—including promoting Chief Medical Officer David Mou, M.D., to the role of president and hiring a new head of compliance—to "further ensure clinical quality, patient safety and compliance are at the forefront of its business."