“The reason why off-label promotion is illegal is that you can greatly magnify the number of people who will be harmed.” — Sydney Wolfe, head of Public Citizen, a health-research group

By Kelly Patricia O’Meara
June 15, 2015

The pharmaceutical industry wants federal legislation to relax Food and Drug Administration (FDA) restrictions on the marketing of drugs. On the surface, the legislation called the “21^st Century Cures Act,” supported by the American Psychiatric Association (APA), is intended to ease healthcare regulations, but if the pharmaceutical industry is successful, psychiatric drugs like antipsychotics, antidepressants and stimulants, carrying serious and even life-threatening side effects, will be marketed “off-label” (for unapproved uses) with impunity.

“Off label” refers to a physician prescribing a drug for a condition it has not been tested to treat and given FDA approval. It is illegal for pharmaceutical companies to market/promote drugs “off label.” In the last few years, psychopharmaceutical companies have agreed to pay more than $8 billion in criminal and civil settlements to the U.S. Department of Justice for such fraudulent and “off-label” marketing practices.

In fact, in November of 2013, Johnson & Johnson paid $1.6 billion to resolve civil and criminal claims relating to the “off-label” marketing of its antipsychotics, Risperdal and Invega. Among other things, federal prosecutors charged that Risperdal was improperly marketed for use in children, and accused the company of concealing the risk of Risperdal gynecomastia (female breast growth in boys).

Psychiatric drugs like antipsychotics, antidepressants and stimulants, carrying serious and even life-threatening side effects

Even marketed and prescribed “on label” (for approved use) psychotropic drugs can cause diabetes, stroke, heart irregularities, irreversible nervous-system damage, birth defects, violent behavior and suicide.

Pharmaceutical companies are spuriously claiming that restrictions on their marketing violate First Amendment Rights. But restricting “off-label” use of drugs is serious and necessary and, more importantly, put in place to provide some level of consumer protection. Allowing “off-label” marketing means not only expanding the drug promotion for uses for other disorders for which the drug has not been approved, but also the promotion of higher doses for which the drug has not been deemed safe.

Not surprising, the APA, which endorses “off-label” prescribing, was quick to support the introduction of the legislation last year, clamoring for more psychiatric drug research while, at the same time, admitting “no cures have been identified yet,” in the treatment of any of the more than 370 “mental disorders” in its diagnostic manual used for insurance billings.

The problem with psychiatry’s support of “off” and “on-label” drug use is that beyond having no cures, there also is no medical or scientific test to confirm the existence of any mental disorder. Ultimately, allowing “off-label” drug use will provide greater freedom to market and increase sales of the drugs.

This is a deadly serious issue. Even the Psychiatric Times reported that 96% of “off-label” psychiatric drug use is determined to have little or no sound scientific evidence for the condition for which the drug was prescribed. Sydney Wolfe, head of the Washington-based Public Citizen health-research group explained, “the reason why off-label promotion is illegal is that you can greatly magnify the number of people who will be harmed.”

Approximately 50-75% of pediatric drugs prescribed to children are “off-label”

Children are a tragic example. Approximately 50-75% of pediatric drugs prescribed to children are “off-label,” and a study that tracked outpatient antidepressant prescriptions for 6-18-year olds in the U.S. found that 91% were “off-label.”

Worse still, University of Maryland professor of pharmacy and psychiatry Julie Zito found that psychotropic drugs often were prescribed off-label to control children’s behavior, reporting that almost 50% of the antipsychotics used under California’s MEDI-CAL health system, were off-label and about a third were for behavior problems such as normal teenage angst: “conduct disorder” or “oppositional defiant disorder.”

Then there is the psychiatric drug abuse of the elderly. The Office of the Inspector General analyzed the use of atypical (new) antipsychotic drugs in nursing facilities and found that 83% of the prescriptions of antipsychotic drugs were prescribed off-label.

There is no doubt that any change to existing FDA marketing regulations will exacerbate the psychiatric prescription drug epidemic now consuming the nation.

Retiring FDA Commissioner, Dr. Margaret Hamburg, in her final address, summed up the problem with the pharmaceutical industry’s latest antics when she noted, “innovation doesn’t matter if the product doesn’t work… It is foolish—in fact dangerous—to believe that reducing regulatory standards will make new treatment interventions appear if the science is not there.”

Excellent point by the out-going Commissioner. Where is the science to support the existence of even one “mental disorder?” Where is the science to support that even one psychiatric drug actually “treats” a known brain abnormality, let alone people’s very real problems in life? Allowing the psychiatric-pharmaceutical industry to further bastardize the scientific process by reducing the slim FDA protections already in place would be nothing short of criminal and, certainly, cannot be called consumer protection.

CCHR is a non-profit, public benefit organization.

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Kelly Patricia O’Meara is an award-winning former investigative reporter for the Washington Times’ Insight Magazine, penning dozens of articles exposing the fraud of psychiatric diagnosis and the dangers of the psychiatric drugs—including her ground-breaking 1999 cover story, “Guns & Doses,” exposing the link between psychiatric drugs and acts of senseless violence. She is also the author of the highly acclaimed book, Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills that Kill. Prior to working as an investigative journalist, O’Meara spent sixteen years on Capitol Hill as a congressional staffer to four Members of Congress. She holds a B.S. in Political Science from the University of Maryland.