Pharma Influences Diagnoses and Treatments in “Bible” of Psychiatric Disorders

A new study published in the British Medical Journal (BMJ) found that 55 of the 92 American doctors who determine what diagnoses and treatments are included in the American Psychiatric Association’s (APA) most recent edition of their Diagnostic and Statistical Manual (DSM) collectively received more than $14 million in previously undisclosed industry funding.¹

The APA’s manual is often referred to as the “bible” of psychiatric disorders because of its enormous influence on clinical practice, affecting such disparate domains as jurisprudence and insurance claims. The APA also produces and disseminates clinical-practice guidelines directly tied to DSM diagnoses.² The DSM’s fifth edition, the DSM-V, was published in May 2013; a text revision was published in March 2022 as the DSM-5-TR.

Study participants included physicians based in the United States who served as members of either a panel or task force on the DSM-5-TR with information recorded in the Centers for Medicare and Medicaid Service’s Open Payments database during 2016 to 2019. This period includes the year that development of the DSM-5-TR began and the three years preceding, a time consistent with previous research on conflicts of interest and consistent with the APA’s disclosure requirements. Open Payments is a publicly accessible database of payments that drug and medical device companies make to physicians.

Panel members of the DSM who received the most remuneration from drug companies were those working in diagnostic areas where drug interventions are often the standard treatment, such as depressive disorders, neurocognitive disorders, and drug induced movement disorders.³

Research Funding Accounts for Most Payments

The most common types of payments to DSM reviewers were for food and beverages, followed by travel and consulting. More than one third received compensation for services other than consulting, including serving as faculty or as a speaker at a venue other than continuing education.⁴ This category captures what the pharmaceutical industry refers to as ”key opinion leaders”—physicians who influence their peers’ medical practice, including but not limited to prescribing behavior. Being on a speaker‘s bureau or being a key opinion leader is widely recognized as an egregious financial conflict of interest because the role of the key opinion leader is essentially a marketing one; the talks given are usually presented at educational events sponsored by industry.⁵

Industry payments ranged from $13.80 to $2.7 million per individual, with over 70 percent across all years going to research funding or research payments. Research funding was excluded from the APA’s disclosure policy for DSM-5, and evidence is lacking to suggest that simply because money comes in the form of a research grant it does not create an obligation to reciprocate or invoke an implicit bias. Empirical research shows that even small gifts can have a substantial impact on behavior.⁶

Transparency is Not the Answer

After the 1994 release of DSM-4, the APA instituted a policy requiring expert advisors to disclose drug industry ties. But the move toward transparency did little to cut down on conflicts of interest, with nearly 70 percent of DSM-5 task force members reporting financial relationships with pharmaceutical companies—up from 57 percent for DSM-4.⁷

“Organizations like the APA have embraced transparency too quickly as the solution,” said Lisa Cosgrove, PhD, clinical psychologist and professor of clinical psychology at the University of Massachusetts-Boston and lead author of the study. “Our data show that transparency has not changed the dynamic.”⁸

A long-term critic of conflicts of interest and industry influence on the DSM, Dr. Cosgrove explained:

Transparency alone won’t prevent academics or researchers from having financial relationships with industry, and more robust measures are needed to protect the integrity of the DSM’s revision process.⁹

A key step to creating trustworthy clinical guidelines is ensuring that they are developed by experts who are free of industry ties, as organizations such as the Institute of Medicine recommended over a decade ago. In the case of the DSM, this recommendation is also important because panel members are able to eliminate disorders—not just add new ones—and thus could play a vital role in tackling overdiagnosis and overtreatment.¹⁰

Expanded Diagnostic Criteria May Lead to Overdiagnosis and Overtreatment

The problem of overdiagnosis is not limited to the inclusion of new disorders in the DSM. Even seemingly small changes to the manual (for instance, adding symptomatology to previously included disorders) can have a substantial impact on increasing the number of people who would receive a diagnosis and increasing the number of people prescribed drugs.

For example, many researchers and clinicians, including the former chair of the DSM-4, pointed out that the seemingly small changes to the criteria for attention deficit/hyperactivity disorder (ADHD) in the 2013 edition of the DSM-5 would likely result in a considerable increase in the diagnosis of ADHD and an increase in the prescriptions of stimulants.

Limitation of Study

The present study only used information provided by Open Payments, which does not include payments to physicians based outside the U.S. Although mandatory disclosure of payments for U.S. pharmaceutical and medical device companies that make products covered by Medicare and Medicaid is required, until recently the database did not include payments to non-physicians. (Under the 2021 SUPPORT ACT, Open Payments expanded its database to include non-physician prescribers such as nurse practitioners and physician assistants).

Expanded Diagnostic Criteria Benefits Pharmaceutical Industry

The drug industry has a sizable financial stake in the outcome of DSM disorders and treatment methods. Panel members with drug industry ties have introduced new diagnoses or proposed revisions to treatment which have drawn criticism from experts arguing lack of scientific evidence. One example is a notable revision from the DSM-4 to the DSM-5 of a provision known as “bereavement exclusion”—the two month grieving period following the death of a loved one where clinicians formerly were advised to refrain from diagnosing major depression in individuals. The revised bereavement exclusion in DSM-5 advised clinicians to consider medicating family members who have lost a loved one as early as two weeks after death.¹¹

In another example, the DSM-5-TR added a diagnosis of Prolonged Bereavement Disorder for those people whose experienced intense grief beyond one year. In published correspondence in The Lancet in July 2022, authors Joanne Cacciatore and Allen Frances state, “Pathologising [sic] grief is an insult to the dignity of loving relationships—it proclaims grievers as mentally ill and will too often result in the careless prescription of antidepressants or other drugs to treat enduring symptoms, without consideration of the context. The misuse of psychiatric medication for grief will be particularly problematic in primary care, where most antidepressants are prescribed. This pathologising reflects the undue influence that a small group of researchers can exert on the diagnostic system. Experts love their diagnoses and thus perceive benefits, while ignoring risks. Critics have expressed concerns about pernicious conflicts of interest once a proposal becomes a diagnosis.”¹²

Psychoactive Drug Market is Growing

The market size for psychotropic drugs—pharmaceutical medications used to treat bipolar disorder, depression, anxiety, psychosis and attention regulation—was $20.2 billion in 2022, and is expected to reach $37.2 billion by 2032.¹³ In 2019, 15.8 percent of Americans (approximately one in six) over age 18 took medication for a psychiatric disorder.¹⁴

Institute of Medicine Attempts to Curb Industry Influence

Concerns about preventing bias led the Institute of Medicine (IOM) to recommend that only independent experts without commercial ties be involved in clinical guideline decision-making. Questions about the potential for bias when making judgments about the validity of new DSM disorders, and about what interventions should be developed to treat these conditions, are even more important when possible pharmaceutical treatments are under patents that have expired or will soon expire. Without patent protection, companies lose considerable profit to generics, providing a strong incentive to find new indications that will grant extended patent protection to a drug.¹⁵

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