The ubiquitous presence of direct-to-consumer (DTC) drug ads on U.S. TV is not the result of any authorizing legislation, but rather a regulatory relaxation allowed by the U.S. Food and Drug Administration (FDA) in 1997, leading to a massive surge in industry spending and market influence.
While DTC advertising may prompt some patients to seek appropriate care for under-diagnosed conditions, evidence derived from clinical trials and public health analyses demonstrates that these ads actively promote inappropriate prescribing for unclear or questionable indications.
Current efforts to regulate this $13.8 billion yearly ad blitz, such as Robert F. Kennedy Jr. and the U.S. Department of Health and Human Services seeking a total ban, and the FDA seeking to reinstate effective restrictions, are ongoing.
Why Regulate Ads in the First Place?
The main impetus for regulation is to prevent fraudulent therapeutic claims.
The fact that this had to be regulated in the first place is a sad commentary on our health system. Initial attempts at regulation were to provide consumers with a “brief summary” of the product label to enforce a “fair balance” of information. This was much too vague to effectively define and enforce. The incredibly long list of potential side effects for many drugs, and the vagueness of what a “fair balance” of information meant, led to the pharmaceutical industry’s dissatisfaction with the status quo and the resultant high cost of advertising.
The Emergence of Broadcast Advertising
In 1997, the FDA issued draft regulatory guidance on broadcast advertising (finalized in 1999) that changed disclosure requirements by redefining “brief summary” and “fair balance.”
By making broadcast promotion more economically viable, there was an immediate explosion of TV advertising, incidentally favoring expensive, newly branded products over older, cheaper generics, leading also to significant national healthcare cost inflation.
The immense financial resources allocated to DTC ads combined with research data showing a poor scientific quality of the ads form the core justification for the current political movement seeking a ban.
A 2024 review found that 62% of DTC video ads were of “poor scientific quality,” 48% were classified as “misleading,” and 34% were considered “potentially harmful”.
The Legal Environment
The Judicial System, particularly the Supreme Court, is heavily involved in this regulatory process, regarding the First Amendment (Freedom of Speech) and the Government’s right of regulation (Laws and Rules). Primary considerations are the government compelling disclosure (like safety warnings), and government restricting speech (like a total ban). This is no small effort, and it remains to be seen how it plays out with the Department of Health and Human Services, the FDA, and the courts; all ultimately to mitigate documented financial and public health harms from both fraudulent drug claims and TV drug advertising.
The Psychiatric Connection and Your Mental Health
Physicians are significantly more likely to diagnose Depression or Adjustment Disorder when the patient requests a drug compared to when no request is made, particularly a brand-specific request; and apparently DTC advertising also stimulates such diagnosis and drug prescriptions more strongly when the patient’s symptoms do not indicate a clear-cut diagnosis, leading to a higher volume of unnecessary drugging.
Which of course is of great economic benefit to the psychopharmaceutical industry.
Knowing that the “campaign to stop the stigma of mental illness” is a pharmaceutical marketing campaign and not a public benefit campaign, one might wonder if DTC drug ads actually increase the public perception of stigma associated with mental trauma, as some research suggests.
The DSM and ICD
Behind all this debate is the very real harm done by The Diagnostic and Statistical Manual of Mental Disorders (current version DSM-5-TR). Unofficially called the psychiatric “billing bible,” this publication from the American Psychiatric Association (and its international equivalent the International Statistical Classification of Diseases and Related Health Problems (ICD) from the World Health Organization), delineate the official diagnoses for which psychiatric drugs can be prescribed, and for which insurance reimbursements can be made.
In fact in Missouri, the DSM is built into state law, as it is defined in Chapter 376 Section 1550 of the Missouri Revised Statutes:
““Mental health condition”, any condition or disorder defined by categories listed in the most recent edition of the Diagnostic and Statistical Manual of Mental Disorders“. Furthermore, insurance carriers in Missouri are required to provide health benefit coverage for these mental health conditions, which generally means a prescription for a psychiatric drug.
Taking the two diagnoses previously mentioned (Depression and Adjustment Disorder), we note that there are 77 diagnostic entries in the DSM using the words “depressed”, “depressive”, “depression”, or “antidpressant”, and 7 entries for various “adjustment disorder” diagnoses.
To ensure a comprehensive ability to diagnose these, there are also the all-encompassing diagnoses of “Unspecified depressive disorder” and “Adjustment disorder, Unspecified”. Together, all these diagnoses mean that pretty much anyone can be diagnosed with one or another disorder and prescribed an antidepressant or other psychiatric drug paid for by insurance.
No small wonder then, that DTC TV advertisements have markedly increased the incidence of these diagnoses and the subsequent increase in psychiatric drug prescriptions.
But wait, that’s not all.
Using the DSM, a psychiatrist need only label the patient with one of these “mental disorders” (regardless of any clinical tests), prescribe a drug and bill the patient’s insurance or Medicaid. The psychiatrist with the DSM in hand can try various labels on the patient as if they were different sizes of apparel until he finds one that either fits the patient’s symptoms or comes close enough to allow him to bill the patient’s insurance.
These mental “disorders” are voted into and out of existence and edited into the DSM based on factors that have nothing to do with medicine, or indeed with any clinical tests.
Did we just say “clinical tests?” For the record, there are NO clinical tests for any of these diagnoses; no blood tests, no x-rays, no MRI’s, etc. The defining factor of such a diagnosis is the psychiatrist’s opinion, which we can say with some certainty is something of which the psychiatrist just disapproves or dislikes.
People can and do experience depression, anxiety and sadness, children do act out or misbehave, and some people can indeed become irrational or psychotic. This does not make them “diseased.” There are non–psychiatric, non–drug solutions for people experiencing mental difficulty, there are non–harmful medical alternatives.
Safe and effective medical treatments for mental difficulties are often kept buried. The fact is, there are many medical conditions that when undetected and untreated can appear as psychiatric “symptoms.” The psychiatric pharmaceutical industry is making a killing — $84 billion per year — based on people being labeled with mental disorders that are not founded on science or medicine, but on marketing campaigns designed to sell drugs such as DTC TV Ads.
What Can Be Done About This
Start by contacting your State Legislators and asking them to remove all references to the DSM from State Law.
Then help us investigate and expose psychiatric violations of human rights by making a tax deductible donation to CCHR St. Louis.