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Clearing liver of retinoids - and what other toxins

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Silent Victims: The Deadly Cost of Off-Label Prescribing

How profit and negligence put children and the elderly at risk

 
 
 
 
 
 
 
 
 
 
 

You probably have 15,000 elderly patients, people in nursing homes, dying each year from the off label use of antipsychotic medications for an indications that …the FDA knows the drug doesn't work.

— Dr. David Graham, a senior FDA official and whistleblower

This is death by psychiatry.

— Dr. Fred Baughman, Child neurologist

 

Are We Really Protected? The Dark Side of Off-Label Prescribing

 

We often think the FDA and other regulatory bodies are safeguarding us from the inappropriate use of medications. But is this really the case?

Let’s take just one case among millions—Rebecca Riley.

In 2006, 4-year-old Rebecca was found dead on the floor of her home in Massachusetts. Her death was not the result of a tragic accident, a rare disease, or a sudden illness. It was caused by the “combined effects” of multiple powerful prescription drugs—Seroquel, Clonidine, and Depakote—none of which were approved for use in children her age. According to the medical examiner, her lungs and heart showed signs of damage from the prolonged abuse of these medications.

“From age 2 on, Rebecca remained on this daily drug off-label concoction until she was found dead on the floor in her parents’ home on December 13, 2006. The autopsy report stated that she died of the ‘combined effects’ of the drugs and that her lungs and heart were damaged by ‘prolonged abuse of these prescription drugs, rather than one incident.’”[1]

Here’s the disturbing reality: Rebecca was only two-and-a-half years old when she was diagnosed with bipolar disorder and attention-deficit disorder, and prescribed these drugs on a daily basis. This diagnosis alone raises serious questions. How can a toddler—a child still learning to speak, reason, and self-regulate—be reliably diagnosed with a severe adult mood disorder? And why would she be given a cocktail of sedating, untested medications, typically used in adults, when her brain and body were still developing?

The Medical and Regulatory System Failed Her

 

The FDA did not approve any of these medications for pediatric use in children as young as Rebecca. Nor were they ever approved for use in combination—not even for adults. Yet doctors prescribed them anyway, in what is known as off-label use: when a drug is used for a condition, age group, or dosage that the FDA has not reviewed or sanctioned.

While off-label prescribing is technically legal, it can be dangerous—especially in children. And in this case, it was deadly.

Despite this, no major reforms followed Rebecca’s death. No system-wide bans on off-label use in children. No limits placed on marketing drugs for unapproved uses. In fact, the pharmaceutical industry has repeatedly paid massive fines for illegal marketing—Eli Lilly, the maker of Zyprexa (a drug similar to Seroquel), paid $1.4 billion in 2009 for promoting off-label uses of its antipsychotic. But the drug remains on the market. The practices continue.

A Culture of Chemical Restraint

 

What happened to Rebecca wasn’t an isolated tragedy—it reflects a larger, disturbing pattern in modern medicine: the use of powerful psychotropic drugs as tools of behavior control. Often, children who are restless, defiant, or difficult to manage are labeled with psychiatric disorders and medicated—frequently with drugs that have never been tested in children.

This is not therapeutic care. It’s chemical restraint masquerading as treatment.

Behind these decisions are not only misguided clinical judgments, but also perverse incentives: drug manufacturers profit immensely from broadening their markets, especially when doctors use drugs for unapproved conditions. And when regulators like the FDA allow this to continue with minimal oversight, it sends a chilling message: profit matters more than pediatric safety.

Who Speaks for the Children?

 

Rebecca Riley could not speak for herself. But her story should shake the foundations of public trust in the medical system. It should ignite outrage and demand change.

How many other children are out there, suffering in silence under the weight of unnecessary, untested, and dangerous medications? How many parents are unaware that the drugs prescribed to their child are being used off-label—without clear evidence of benefit, and with known risks of harm?

The truth is, the system is not protecting us. It is protecting its own interests. And until we acknowledge that—until we demand stricter regulation, genuine transparency, and a return to ethical, evidence-based care—the most vulnerable among us will continue to pay the price.

The $1.4 Billion Slap on the Wrist

 

The antipsychotic Zyprexa was initially approved for certain psychotic disorders. However, federal prosecutors alleged—and the company later admitted—that Eli Lilly illegally marketed Zyprexa for a range of unapproved conditions, such as agitation, aggression, dementia (including Alzheimer's disease), depression, and sleep disorders. Eli Lilly trained its sales force to disregard the law and directed its sales personnel to promote Zyprexa for off-label uses.

“From Sept. 1999 through at least Nov. 2003, Eli Lilly promoted Zyprexa for the treatment of agitation, aggression, hostility, dementia, Alzheimer’s dementia, depression, and generalized sleep disorder. The information alleges that Eli Lilly’s management created marketing materials promoting Zyprexa for off-label uses, trained its sales force to disregard the law and directed its sales personnel to promote Zyprexa for off-label uses.”[2]

“The case involves off-label marketing of Eli Lilly’s drug Zyprexa for uses other than what the Food and Drug Administration approved. The company is charged with one count of distributing misbranded drugs with inadequate directions for use. Eli Lilly admits that between Sept. 1999 and March 31, 2001, the company promoted Zyprexa in elderly populations as treatment for dementia, including Alzheimer’s dementia.”[3]

Eli Lilly paid a criminal fine of $515 million, the largest ever imposed on a U.S. corporation in a healthcare case, and forfeited assets of $100 million. Eli Lilly will also pay up to $800 million in a civil settlement with the federal government and the states. Civil settlement: Up to $800 million, resolving False Claims Act allegations involving federal healthcare programs like Medicaid, TRICARE, VA, and others.

“The plea agreement provides that Eli Lilly will pay a criminal fine of $515 million and forfeit assets of $100 million. The civil settlement agreement provides that Eli Lilly will pay up to an additional $800 million to the federal government and the states to resolve civil allegations originally brought in four separate lawsuits under the qui tam provisions of the federal False Claims Act.”[4]

The combined $1.415 billion total made it one of the largest pharmaceutical settlements ever, ranking among the highest in the history of False Claims Act cases.

Zyprexa and the Cost of Concealed Risk

 

Zyprexa is still FDA-approved for conditions such as schizophrenia and bipolar I disorder, with both oral and injectable formulations in clinical use. However, it carries a black-box warning due to the increased risk of death in elderly patients with dementia-related psychosis. It is not approved for dementia or Alzheimer’s treatment.

Significant weight gainhyperglycemia, and elevated risk of diabetes—studies show patients may continue gaining weight for up to two years after starting olanzapine.[5]

Internal documents—revealed through lawsuits—alleged efforts to minimize or conceal its severe metabolic risks from healthcare providers and patients.

“In turning the document over to the press, Mr. Gottstein’s goal was also to alert the public about Lilly's illegal off-label marketing schemes aimed at getting doctors to prescribe Zyprexa, a drug FDA approved only for adult patients with schizophrenia or bipolar disorder, to patients of all ages for uses that were not approved as safe and effective.”

“Although a doctor may prescribe a drug for an unapproved use, it is illegal for Lilly to promote Zyprexa for an off-label useThe illegal marketing in this case includes influencing doctors to prescribe the drug to millions of consumers for conditions not listed on the label, prescribing Zyprexa in combination with other drugs or for a longer duration than recommended, and prescribing a drug for children that was only approved for adults.”

“Lilly did not revise the labeling on Zyprexa to include a warning about high blood sugar and diabetes until the fall of 2003, and then it was only because the FDA said do it. With the health risks of Zyprexa concealed for all that time, doctors were led to believe Lilly sales representatives who said they could safely prescribe Zyprexa and Lilly gained millions of new customers.”[6]

Deadly Consequences

 

Many trust the FDA to protect the public from unsafe medications and inappropriate prescribing. But what if that trust is misplaced? According to Dr. David Graham, a senior FDA official and whistleblower, tens of thousands of vulnerable people—particularly the elderly—are dying each year from the very drugs the agency knows are dangerous and ineffective when used off-label.

“In nursing homes they sedate elderly patients with dementia and other types of thought disorders. It's known that these drugs don't work in these settings and you say that it's off label use and they should do what they want. But the fact is … that it increases mortality, perhaps by a 100 percent, doubles mortality. So I did a back of the envelope calculation of this and you probably have 15,000 elderly patients, people in nursing homes, dying each year from the off label use of antipsychotic medications for an indications that …the FDA knows the drug doesn't work. This problem has been known to the FDA for years and years. What has FDA been doing with this? All these clinical trials that we really learn about in New York Times, the weight gain from Zyprexa, the diabetes. Diabetes is a life- threatening disease….Don't kid yourself it's responsible for more lost years of life than many, many disorders.”[7]

When Childhood Becomes a Disorder

 

Child neurologist Dr. Fred Baughman, author of The ADHD Fraud: How Psychiatry Makes Patients of Normal Children, warns that America is facing a silent epidemic of overmedication. According to his estimates, 1 in 5 school-aged children—10 million out of 50 million—are now on one or more psychiatric drugs, often prescribed for behavioral diagnoses like ADHD, anxiety, or depression. He does not mince words in his assessment:

“Overall, child neurologist, Dr Fred Baughman, author of ‘The ADHD Fraud: How Psychiatry Makes Patients of Normal Children,’ reports that 10 million of the 50 million school children in the nation are on one or more psychiatric drugs and states: ‘This is death by psychiatry.’”[8]

Dr. Baughman argues that many of these children are not suffering from organic brain disorders but are instead normal kids pathologized by a system too quick to medicate and too slow to investigate root causes like trauma, poor nutrition, or educational pressures. He contends that psychiatric diagnoses have become a pipeline to pharmaceutical intervention, often without adequate evidence of long-term safety—especially in developing brains.

The consequences, he says, are grave: a generation of children increasingly dependent on drugs that can cause lasting neurological, metabolic, and emotional harm, with risks including suicidal ideation, stunted development, and, in some cases, death.

Profit Over Patients

 

Rebecca Riley’s short life is a tragic indictment of a system that prioritizes profit over safety, expediency over evidence, and compliance over care. Her death, like the thousands of others silently occurring each year, demands more than sympathy. It demands reform.

We must confront the dangerous normalization of off-label prescribing. We must demand accountability from pharmaceutical giants and regulatory agencies alike. And most importantly, we must speak for those who cannot speak for themselves—the children and the elderly, who remain the silent victims of a system built to serve commerce, not care.

Worse still, these preventable deaths are invisible in official records: they are not tracked by the CDC, seldom investigated, and rarely reported by the media. There’s no nightly death count or breaking news alerts. Imagine if the CDC tracked medical errors with the same urgency it tracked COVID deaths, or if major news outlets ran constant counters for lives lost due to dangerous prescribing practices—wouldn’t the system be forced to change?

Instead, the medication roulette continues for millions—fueled by aggressive marketing, silent regulators, and complicit institutions—while the casualties are quietly buried and the profits continue to soar. The suffering and deaths stay silent and hidden.

 

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[1] Evelyn Pringle, “Activists take on Eli Lilly over off-label sale of Zyprexa,” February 26, 2007

[2] Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations of Off-label Promotion of Zyprexa, U.S. Department of Justice, January 15, 2009, https://psychrights.org/Articles/090115DoJMediaReleaseReLillySettlement.pdf

[3] United States v. Eli Lilly and Company, Cr. No. 09-020, U.S. Department of Justice Civil Division, March 26, 2009, https://www.justice.gov/civil/cpb/case/us-v-eli-lilly-and-company-zyprexa

[4] Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations of Off-label Promotion of Zyprexa, U.S. Department of Justice, January 15, 2009, https://psychrights.org/Articles/090115DoJMediaReleaseReLillySettlement.pdf

[5] Stephen McGuir, “Lilly adds weight gain, blood sugar warnings to Zyprexa labeling,” October 9, 2007, https://www.mmm-online.com/home/channel/lilly-adds-weight-gain-blood-sugar-warnings-to-zyprexa-labeling

[6] Evelyn Pringle, “Activists take on Eli Lilly over off-label sale of Zyprexa,” February 26, 2007

[7] Vera Sharav, Activists Take on Eli Lilly Over Off-Label Marketing & Harm Caused by Zyprexa, Alliance for Human Research Protection, February 25, 2007, https://ahrp.org/activists-take-on-eli-lilly-over-off-label-marketing-harm-caused-by-zyprexa

[8] Evelyn Pringle, “Activists take on Eli Lilly over off-label sale of Zyprexa,” February 26, 2007

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