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The risks of digital health companies to psychiatric patients

Arthur Lazarus, MD, MBA
Physician
June 26, 2024
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In early 2022, during the coronavirus pandemic, I considered practicing psychiatry via telehealth. I looked into two telemental-health companies in particular—Cerebral and Done Global, Inc. (hereafter “Done”)—and turned them both down. I did not believe their ethics measured up. In the case of Done, I asked to be withdrawn from consideration as medical director because I believed the company lacked adequate infrastructure and was exclusively focused on treating patients with ADHD.

Sure enough, on June 13, 2024, executives from Done were arrested and charged with fraud. Federal authorities alleged that the founder and clinical president (a psychiatrist) orchestrated a scheme to profit from Adderall prescriptions. DEA administrator Anne Milgram wrote, “The defendants allegedly preyed on Americans and put profits over patients by exploiting telemedicine rules that facilitated access to medications during the unprecedented COVID-19 public health emergency; instead of properly addressing medical needs, the defendants allegedly made millions of dollars by pushing addictive medications.”

The Department of Justice said the indictment is the first criminal drug distribution prosecution against a telehealth company dealing in controlled substances. Done said in a statement that it “disagrees” with the charges and that both executives were “presumed innocent.” Well before the indictment, Forbes Health commented, “It’s worth noting that pharmacies across the country have started blocking or delaying prescriptions from telehealth companies (including Done) over concerns that doctors are over-prescribing ADHD medications such as Adderall.”

The allegations against Done – accusing the company of arranging the prescription of over 40 million pills of Adderall and other stimulants, resulting in more than $100 million in revenue – are deeply troubling. They highlight the severe ethical and legal breaches that can occur when corporate greed potentially jeopardizes patient health and safety. The charges underscore a critical message: corporate executives prioritizing profit over patient well-being, even through technological innovations, will face accountability. Moreover, anyone believed to be exploiting patients will be prosecuted to the fullest extent of the law: Done’s executives each face up to 20 years in prison if convicted.

What makes this situation particularly unsettling is that it compounds the vulnerability of psychiatric patients. In essence, telehealth adds another layer of defenselessness to an already vulnerable and stigmatized population. Psychiatric patients often require comprehensive, in-person evaluations and ongoing monitoring that can be challenging to replicate through virtual platforms. The absence of physical presence can make it difficult for health care providers to fully assess the nuances of a patient’s mental state, potentially leading to misdiagnoses or inappropriate treatment plans.

Additionally, the reliance on digital communication tools can exacerbate feelings of isolation or anxiety in some psychiatric patients, who may struggle with the lack of personal interaction. The convenience of telehealth also raises the risk of over-prescription or inappropriate prescription of controlled substances, as it can be easier for unscrupulous providers to bypass rigorous checks and balances that are typically in place in traditional health care settings. This can lead to increased instances of medication misuse or abuse, further endangering these patients.

Ironically, the digital divide can cause unintended roadblocks to treatment. While it is clear that for those in remote or underserved areas, telehealth has been a game-changer, providing much-needed access to health care services that might otherwise be unavailable, many individuals in remote or underserved areas may lack reliable internet access or the necessary technology to engage in telehealth services effectively. This can lead to disparities in the quality of care received and may prevent some patients from accessing the help they need altogether.

Some psychiatric patients may harbor suspicions about digital health companies and feel exploited by them. A February 2, 2023 letter to Cerebral from U.S. Senators Amy Klobuchar and Susan Collins stated, “Although your website claims that information entered on these intake forms is confidential and secure, this information is reportedly sent to advertising platforms, along with the information needed to identify users. This data is extremely personal, and it can be used to target advertisements for services that may be unnecessary or potentially harmful physically, psychologically, or emotionally.”

Informed consent is equally critical as data privacy. Some companies may not provide clear information about data usage, storage, and sharing practices. This lack of transparency can result in patients inadvertently consenting to terms that do not protect their interests, leading to further exploitation.

Misleading marketing practices are also problematic. Companies might overpromise the effectiveness of treatments or technologies without sufficient scientific backing, causing patients to spend money on services that do not deliver the expected benefits. Additionally, high costs and hidden fees can burden patients financially, especially those already under financial strain. Some companies may not disclose affiliations with pharmaceutical companies or other commercial interests that influence their overall business practices.

Some digital health companies may not meet professional standards in terms of quality of care. Patients might encounter poorly trained providers, inadequate follow-up, or a lack of personalized care, which can lead to ineffective treatment and worsening mental health issues. Moreover, these platforms may not offer the full range of necessary services, such as crisis intervention or integrated care with other providers, limiting comprehensive treatment options.

For example, Done focuses on patients with a diagnosis of ADHD, which affects about 3 percent of adults, compared with major depression, which has 12-month and lifetime prevalences of 10.4 percent and 20.6 percent, respectively. Furthermore, by targeting ADHD, about 75 percent of the overall psychiatric population – those with depression, anxiety, schizophrenia, substance use, and other disorders, are excluded from treatment.

Algorithmic bias and inequality also pose risks to psychiatric patients. Algorithms used by digital health platforms might not adequately account for cultural, racial, or socioeconomic differences, leading to unequal treatment and outcomes. Patients might become overly reliant on digital platforms, potentially neglecting other important aspects of their treatment, such as in-person therapy or community support.

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To mitigate these risks, it is crucial to implement stringent regulatory measures, including thorough verification of patient identity and medical history, regular audits of telehealth practices, and enhanced training for providers on the unique challenges of delivering psychiatric care remotely. Ensuring equitable access to technology and support for those who may have difficulty using digital platforms is also essential. By addressing these vulnerabilities, we can optimize the benefits of telehealth while safeguarding the well-being of psychiatric patients.

The implications of Done’s alleged criminal activities extend far beyond the immediate legal consequences for the involved parties. Done’s CEO says that she “cannot stop being creative.” She might have overreached in this instance.

Arthur Lazarus is a former Doximity Fellow, a member of the editorial board of the American Association for Physician Leadership, and an adjunct professor of psychiatry at the Lewis Katz School of Medicine at Temple University in Philadelphia, PA. He is the author of several books on narrative medicine, including Medicine on Fire: A Narrative Travelogue and Narrative Medicine: Harnessing the Power of Storytelling through Essays.

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  • Most Popular

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The risks of digital health companies to psychiatric patients
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