Psychiatric Inpatients Have Elevated Risks for Adverse Reactions

[Reference: “Multiple adverse outcomes following first discharge from inpatient psychiatric care: a national cohort study”, The Lancet Psychiatry, June 03, 2019]

People discharged from inpatient psychiatric care are at higher risk than the rest of the population for a range of serious fatal and non-fatal adverse outcomes.

These individuals are also more likely to perpetrate violent crimes, including homicide. Suicide risk is known to be especially raised soon after discharge.

Results were summarized from 62,922 Danish people who had been discharged from inpatient psychiatric services and 1,573,050 who had never been a psychiatric inpatient, examining these adverse outcomes over ten years post-discharge: mortality, suicide, accidental death, homicide victimization, homicide perpetration, non-fatal self-harm, violent criminality, and hospitalization following violence.

The risk of at least one of these adverse outcomes was highest in people using psychoactive drugs.

Although no detailed clinical information was available regarding what psychiatric treatments were given, it can be assumed that psychiatric (psychoactive) drugs were a major part of most treatments, since worldwide statistics show that a rapidly increasing percentage of every age group, from children to the elderly, rely heavily and routinely on psychiatric drugs in their daily lives. Worldwide sales of antidepressants, for example, were more than $14 billion in 2017, and expected to surpass $15 billion by 2023.

These statistics give one more result in a long line of significant research that concludes:

  • psychiatry cannot cure any so-called mental illness
  • psychiatric treatments cause violence and suicide
  • psychiatric treatments actually harm rather than help vulnerable people
  • psychiatry is junk science
  • psychiatric drugs can only chemically mask problems and symptoms; they cannot and never will be able to solve problems

People in desperate circumstances must be provided proper and effective medical care. Medical, not psychiatric, attention, good nutrition, a healthy, safe environment and activity that promotes confidence will do far more than the brutality of psychiatry’s treatments.

While life is full of problems, and sometimes those problems can be overwhelming, it is important for you to know that psychiatry, its diagnoses and its drugs are the wrong way to go.

The Psychiatric Opioid Connection

Current media abounds about the opioid addiction and overdose crisis, and often points to the Sackler brothers of Purdue Pharma as major enablers of this horrific epidemic.

Rarely, however, does the media point out that Arthur, Mortimer and Raymond Sackler, pushing OxyContin for profit, were each practicing psychiatrists.

Psychiatrists have a history of pushing addictive drugs as “treatments.” LSD, heroin, psilocybin, mescaline, peyote, cannabis, ecstacy, and other hallucinogens have all been pushed by various psychiatrists as treatments for mental symptoms. Today, drug regulatory agencies all over the world approve clinical trials for the use of hallucinogenic drugs to handle anything from anxiety to alcoholism, despite the drugs being known to cause psychosis.

Now that psychiatrists have been exposed as perpetrators of drug addiction, we find that the opioid crisis has been claimed by the psychiatric industry as a behavioral health problem, because psychiatry claims that addiction is now a mental illness. Unfortunately there is no science to support this.

The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and the International Statistical Classification of Diseases and Related Health Problems (ICD-10) euphemistically call addiction a “use disorder.” To cement its control of addiction “treatments”, the DSM lists hundreds of “use disorders” for a wide range of substances (alcohol, amphetamines, caffeine, cannabis, cocaine, inhalants, opioids, hallucinogens, phencyclidines, sedatives, hypnotics, anxiolytics, stimulants, tobacco, and other, unknown, or unspecified substances or stimulants.) Not to mention other types of impulsive or compulsive behaviors such as anorexia, gambling, gaming, pyromania, kleptomania and promiscuity.

Then, to confuse the situation even more, psychiatrists recommend treating drug addictions with more addictive drugs; this is called “medication-assisted treatment,” an increasingly influential and controversial paradigm in the world of medicine that, among other things, considers addiction a chronic “brain disease” treated by more drugs, rather than a condition that can be treated by addressing the social and spiritual aspects underlying addiction.

The late Professor Thomas Szasz said, “If we recognize that ‘mental illness’ is a metaphor for disapproved thoughts, feelings, and behaviors, we are compelled to recognize as well that the primary function of Psychiatry is to control thought, mood, and behavior.” Coercive psychiatry is not about curing mental disorders; it’s about controlling behavior and “we know best what’s good for you.”

By the way, you can also become addicted to common psychiatric drugs such as antidepressants, psychostimulants, anti-anxiety drugs, and barbiturates. Addictive drugs should never be discontinued abruptly, since the withdrawal side effects can be severe. For more information about how to safely withdraw from these harmful and addictive drugs, download and read the booklet Coming Off Psych Drugs Harm Reduction Guide.

Psychiatrists Anxious to Treat All Child-bearing Women for Post-Partum Depression

The FDA approved the first drug treatment for post-partum depression (PPD) on March 19, 2019. Psychiatrists call this “peripartum depression”, which means depressive symptoms during pregnancy or after childbirth. While there is no  actual diagnostic test for this, the current revision of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) labels this with various alternative wordings of “depressive disorder” or “bipolar disorder” or “anxiety disorder” or “stress disorder,” sometimes with the specifier “with peripartum onset“, depending on the circumstances.

The diagnosis is totally subjective, and is a justification for making money for prescribing an antidepressant. Psychiatrists do not typically perform any clinical tests to find out if there is a real medical reason for the symptoms, such as thyroid problems or vitamin deficiencies. Research suggests that rapid changes in hormones and thyroid levels during and after delivery have a strong effect on moods, yet this is mostly ignored by the psychiatric industry since it is easier and more profitable to prescribe a psychotropic drug.

The drug is Zulresso (generic brexanolone), an intravenous infusion administered continuously over 60 hours (2.5 days) and requiring constant monitoring. There is a risk of serious harm due to a sudden loss of consciousness during the treatment, the appearance of suicidal thoughts and behaviors, or hypoxia (loss of oxygen in the blood). The drug passes into breast milk, but there is no data on the safety of brexanolone while breastfeeding. The cost has currently been set at $34,000 per course of treatment.

Sage Therapeutics says that this neurosteroid, a derivative of allopregnanolone, affects GABAA (Type-A gamma-Aminobutyric acid) neurotransmitter receptors in the brain, although the actual mechanism of action of this drug with respect to PPD (or any other condition) is unknown.

Many people think that post-partum depression is a mental illness. However, this is very misleading for a mother who has experienced the trauma of just giving birth. To have them think the emotional roller coaster they may be experiencing is the result of a “chemical imbalance in the brain,” requiring mind-altering medication, is false and potentially very harmful.

This does not mean that serious emotional difficulties do not exist. But it does mean that psychiatrists and psychologists have used such difficulties to their advantage, promoting powerful drugs as a “solution” for vulnerable individuals. This has been for the sake of profit, often at the expense of people’s lives.

Quite apart from such drugs causing harm, they are also unnecessary. Any competent medical doctor who takes the time to conduct a thorough physical examination of someone exhibiting signs of what psychiatrists say are “mental disorders,” including post-partum depression, can find undiagnosed, untreated physical conditions.

Instead, psychiatrists prefer to tell young mothers that their condition is an “illness,” requiring “medication,” potentially endangering the life of the mother and her child.

Women may experience drastic drops in hormone levels after the birth of a child that can deliver a major shock to the woman’s body. Nutritional and mineral depletion or deficiencies as well as a lack of sleep while caring for a baby can also cause the symptoms psychiatrists say are a “mental disorder.” It can be treated nutritionally.

For more information, download and read the CCHR bookletThe Drugging of ‘Post Partum Depression’ – Clearing up Misconceptions About ‘Chemical Imbalances,’ Antidepressant Drugs and Non-Drug Solutions“.

NARPA Annual Rights Conference

ANNUAL RIGHTS CONFERENCE

September 18 – 21, 2019

Holiday Inn Hartford Downtown Area — East Hartford, CT

Visit http://www.narpa.org for registration form and updates.

 NARPA’s mission is to support people with psychiatric diagnoses to exercise their legal and human rights, with the goals of abolishing forced treatment and ensuring autonomy, dignity and choice.

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Attend the conference to promote social justice for people who experience the world in ways the psychiatric industry fraudulently calls “mental illness.”

Mental Health in St. Louis

A new report (“St. Louis Regional Mental Health Data Report“, May, 2019) outlines mental health trends in the St. Louis, Missouri region.

The St. Louis County Department of Public Health and the City of St. Louis Department of Health prepared the report for System of Care St. Louis Region.

One significant finding is that “…intentional self-harm (i.e., suicide) was the sixth leading cause of death for children under 18 years of age and the third leading cause of death for ages 18 to 24 years in St. Louis County, and it is the tenth leading cause of death for all age groups in both the United States and the state of Missouri.”

Unfortunately, the report fails to notice that there is overwhelming evidence that psychiatric drugs cause suicide and violence.

While there is never one simple explanation for what drives a human being to commit such unspeakable acts of violence, all too often one common denominator has surfaced in hundreds of cases—-prescribed psychiatric drugs which are documented to cause mania, psychosis, violence, suicide and in some cases, homicidal ideation. To date, there has been no federal investigation of the link between psychiatric drugs and acts of suicide and violence.

Mental disorder is not a predictor of aggressive behavior, but rather the adverse effects of the drugs prescribed to treat it. Drug proponents argue that there are many shootings and acts of violence that have not been correlated to psychiatric (psychotropic) drugs, but that is exactly the point. It has neither been confirmed nor refuted, as law enforcement is not required to investigate or report on prescribed drugs linked to suicide and violence, and media rarely pose the question.

Those with a vested, financial interest will continue to champion the use of such drugs, as the psychiatric-pharmaceutical drug industry rakes in an average of $35 billion a year in sales in the U.S. alone. It is that vested financial interest which may be preventing a thorough investigation of the link between prescription psychoactive drugs and increased suicide and violence, especially considering that there have been calls for such investigations since the Columbine High School massacre in 1999.

The theory that a person is violent because he “stopped taking his medication” is misleading and omits the fact that it is more likely to be the withdrawal from a drug of dependence that is experienced—-not the return of the person’s “untreated mental illness.” Numerous studies and expert opinions support this. Psychotropic drug withdrawal destroys mental faculties and creates impulsivity.

It is long past time that government agencies answered that call with an investigation. Legislative hearings should be held to fully investigate the correlation between psychiatric treatment and violence and suicide. None can argue against the fact that disclosure of the facts would serve the public interest.

Click here for more information about the link between suicide, violence, and psychiatric drugs.

You’re Not Paranoid, It’s Really Happening

Abilify Mycite® (aripiprazole tablets with sensor, from Otsuka Pharmaceutical) is a prescription drug of an aripiprazole tablet (an atypical antipsychotic) with a metallic Ingestible Event Marker (IEM) sensor inside it, used in adults for diagnoses of schizophrenia, bipolar I disorder, and major depressive disorder. A month’s supply of it costs around $1,650. The actual mechanism of action of aripiprazole is unknown, although it messes with the levels of dopamine and serotonin in the brain, which is playing Russian Roulette with your mind.

The sensor is intended to track, with a smartphone app, if the drug has been taken. The ability of this drug to improve patient compliance or modify dosage has not been established. The only thing the FDA approved was functions related to tracking drug ingestion. The use of this drug to track drug ingestion in real-time or during an emergency is not recommended because detection may be delayed or not occur.

The drug sends information to a patch worn on the patient’s arm, which is then logged on a mobile app, which then sends the data to their doctor. Some experts warn that the idea of swallowing a tracking chip may be too much for paranoid patients to handle.

Said one expert, “I am concerned about the formation of new pharmaceutical persons who are digitally enhanced to be compliant with the profit motives of corporations and the directives of health providers and drug companies. … The fact that the drug is Abilify, which is prescribed to people who experience serious mental distress, should raise many ethical red flags. These concerns are especially relevant because the patent for the original Abilify drug expired in 2016… My concern is that … the company will be motivated to profit from the technology as much as possible, regardless of whether the drug actually improves health.”

The idea for this gross invasion of privacy comes about because refusing to take prescribed drugs is a particular psychiatric concern, and is even enshrined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) as “Nonadherence to medical treatment.”

Abilify MyCite is still not widely used in the US, possibly because of skepticism from patients, prescribing doctors and insurance providers, although Otsuka has collaborated with Magellan Health to roll the drug out to the US, and UnitedHealthcare has developed complex rules for insurance authorization.

This drug has potentially severe side effects including stroke; akathisia; neuroleptic malignant syndrome; tardive dyskinesia; unusual urges such as compulsive gambling, sex, eating, or shopping; seizures; suicidal thoughts or behaviors. Side effects may be considerably more severe with known CYP2D6 poor metabolizers (a Cytochrome P450 enzyme.)

This drug also has a Boxed Warning about an increased risk of suicidal thinking and behavior in children, adolescents and young adults.

Recognize that the real problem is that psychiatrists fraudulently diagnose life’s problems as an “illness”, and stigmatize unwanted behavior as “diseases.” Psychiatry’s stigmatizing labels, programs and treatments are harmful junk science; their diagnoses of “mental disorders” are a hoax — unscientific, fraudulent and harmful.

If you are taking this drug, do not stop suddenly. You could suffer serious withdrawal symptoms. You should seek the advice and help of a competent medical doctor or practitioner before trying to come off any psychiatric drug.

FDA Reclassification of Electroconvulsive Therapy Devices

A new rule by the Food and Drug Administration (FDA) went into effect on 12/26/2018 that reclassifies certain uses of ECT machines from Class III (high risk) to Class II (moderate risk).

Although the FDA solicited comments regarding the use of ECT, many of which described the harm done by ECT and were against the reclassification of ECT devices, the FDA does not consider such comments to be valid scientific evidence, and basically ignored them.
Contrary to the psychiatric community’s position, the FDA is supposed to recognize “reports of significant human experience with a marketed device” as a form of valid scientific evidence.

The new rule is somewhat complicated, and has some “ifs, ands and buts” that require some explanation. Here is the actual rule:

The FDA reclassifies the electroconvulsive therapy (ECT) device from Class III to Class II for use in treating catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition; and requires the filing of a premarket approval (PMA) application or a notice of completion of a product development protocol (PDP) for all other uses of ECT.

Practically speaking, Class III means that a device presents a high risk of illness or injury to the patient and requires a premarket approval or product development protocol. A PMA is documentation which demonstrates the safety and effectiveness of the device before it can be sold and used. A PDP is documentation which demonstrates the clinical evaluation of a device and the development of necessary information for marketing approval; it may not involve actual clinical testing.

Practically speaking, Class II means that a device presents a moderate risk of illness or injury to the patient, and may require special labeling. Powered wheelchairs, x-ray machines and condoms fall under this category. Special labeling for ECT machines includes warnings that “ECT device use may be associated with: Disorientation, confusion, and memory problems” and “When used as intended this device provides short-term relief of symptoms. The long-term safety and effectiveness of ECT treatment has not been demonstrated.”

While the FDA acknowledges that the individuals for whom ECT therapy may be prescribed are at significant risk for complications, they are effectively ignoring these complications at the urging of the psychiatric industry, and doing so with a lot of psychobabble and pseudoscience, and the expectation that putting warning labels on the devices is protection enough.

Here are some facts which the FDA does not want you to know

In the forty years that the ECT device manufacturers have had the device on the market they have never conducted a clinical trial to support its safety and efficacy from which they have profited.

The procedure administers up to 460 volts of electricity through the brain causing a grand mal seizure.

Adverse effects from ECT include: irregular heartbeat; heart attack; stroke; cognition and memory impairment [sometimes permanent]; dental or oral trauma and physical trauma; manic symptoms; prolonged seizures; worsening of psychiatric symptoms and death.

Based on a 0.3% death rate found with ECT administered in Texas, an estimated 300 people receiving ECT may die each year in the U.S. and 3,000 worldwide.

Claims that ECT is safe and effective are not supported by clinical science and its use remains a theoretical practice with no conclusive mechanism determined to prove how ECT works. We have repeatedly suggested that psychiatrists stick their finger into an electric wall socket to see how well that works. So far, we have no takers.

ECT is not a cure. There is a high failure (relapse) rate within six months of receiving ECT, requiring more electroshock that creates more damage. Called “continuation” and “maintenance ECT,” antidepressants and/or other psychotropic drugs continue to be administered — the very drugs said to have failed, “requiring” ECT. A person might as well smack their thumb with a hammer, since this will take their mind off their mental troubles with less permanent damage than smacking their brain with electricity. (We’re not actually recommending this! Please do not try this at home!)

We do, however, recommend that a person consult a competent, non-psychiatric medical doctor for a thorough physical examination to determine whether an underlying, undiagnosed and untreated physical problem is causing the mental condition.

Pregnant women are electroshocked as late as their third trimester, despite adverse events that include miscarriage, premature labor, stillbirth, fetal heart problems and malformations.

In some countries children aged six and younger (U.S., Australia, and Canada) are electroshocked, damaging their developing brain and body. Psychiatrists are continually pushing the boundaries on whom they can shock. One of the current efforts is called external Trigeminal Nerve Stimulation (eTNS), where an electric current is sent into the brains of children as young as 7 years old.

A 2017 published review of more than 90 ECT studies since 2009 showed they remain “methodologically flawed” and “Given the well-documented high risk of persistent memory dysfunction, the cost-benefit analysis for ECT remains so poor that its use cannot be scientifically, or ethically, justified.”

In 2005 and again in 2015, the World Health Organization (WHO) warned against electroshocking children, and reported: “In addition to inappropriate use of medication, children with psychosocial disabilities in institutions around the world are subjected to other severe forms of inappropriate treatment such as electroconvulsive therapy (ECT, also known as electric shock therapy). WHO has stated that there are no indications for the use of ECT on minors, and hence this should be prohibited. The United Nations Special Rapporteur on torture and other cruel, inhuman or degrading treatment or punishment has remarked that ECT without anaesthesia, muscle relaxant or oxygenation amounts to torture. However, monitoring efforts worldwide continue to uncover instances of ECT being administered to children and adolescents.”

The FDA and state and federal legislators must put patient protection above the financial interests of companies that have failed to conduct clinical trials and provide a PMA for 40 years.

Write your state and federal legislators and tell them to ban ECT. For more information go to http://www.cchrstl.org/ect.shtml.

Set It and Forget It Birth Control

We’ve recently been seeing frequent TV ads for Kyleena and Mirena, intrauterine devices (IUDs) that slowly release a progestin hormone called levonorgestrel into the uterus to prevent pregnancy, sometimes referred to as “Set it and forget it birth control.”

Interestingly enough, the manufacturer of levonorgestrel tablet contraceptives (Plan B) says “This medication is an emergency contraceptive and should not be used as a regular form of birth control.”

Possible adverse side effects from these IUD devices include ovarian cysts, abdominal/pelvic pain, headache or migraine, acne, breast tenderness or pain, heavier bleeding, depression, changes in hair growth, and hair loss.

The potential for depression as a side effect caught our attention.

Then the May 2019 Scientific American was published with several articles about birth control, indicating that the occurrence of bad side effects from IUDs are much higher than one might suspect.

One article brought it even closer to our home, saying that “Much of the recent enthusiasm over IUDs can be traced back to a single study called the Contraceptive CHOICE research project [2007-2011]. Funded in part by a then anonymous donor now known to be the Susan Thompson Buffett Foundation and facilitated by Washington University in St. Louis, the project had the explicit goal of increasing the use of LARC [Long-Acting Reversible Contraception] among women at high risk of unintended pregnancy.”

Obviously we are not advocating for or against anything related to birth control; our sole interest is in how the psychiatric industry may be involved. And with depression as a side effect of these devices, we have a clue.

We’ve all heard the term Premenstrual Syndrome (PMS), which includes symptoms such as mood swings, irritability and depression. Current thinking is that over 90% of women get some PMS adverse side effects.

Naturally, if psychiatrists can prescribe a drug for it, they will include it in the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) so that insurance will pay for diagnosing it and prescribing a drug.

So what does the DSM have to say about it? Here are some possible related diagnoses:

— Premenstrual dysphoric disorder [dysphoric means “a state of unease or dissatisfaction”]
— Problems related to unwanted pregnancy
— Depressive disorder due to another medical condition
— Unspecified depressive disorder
plus another 75 disorders related to depression of one kind or another.

All of these fraudulent diagnoses can be used to prescribe an antidepressant or some other harmful and addictive psychiatric drug, none of which actually address the root cause of the condition.

Need we actually say that premenstrual dysphoric disorder, or PMS, is not a “mental illness” requiring an antidepressant? Need we actually say that a depressive side effect of an IUD is not a “mental illness” requiring an antidepressant?

Well, we’ve said it anyway. Protect yourself from psychiatric fraud and abuse by insisting on Full Informed Consent with your doctor.

Shock and Awe – the Latest Psychiatric Abuse of Children

Shock and Awe is a tactic based on the use of overwhelming power and spectacular displays of force to paralyze an enemy.

Now the psychiatric industry is introducing electrical “stimulation” of children’s brains as a socially acceptable gradient to just plain shocking them into good behavior.

The U.S. Food and Drug Administration (FDA) approved on April 19, 2019 a medical device for so-called attention deficit hyperactivity disorder (ADHD). The prescription-only device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System from NeuroSigma, is for patients ages 7 to 12 years old who are not currently taking prescription ADHD drugs. It was originally developed at the University of California, Los Angeles, to reduce epileptic seizures. Research continues on using eTNS for epilepsy, depression, migraine, PTSD, and ADHD.

This device delivers an electric current to the brain (through the V1 branch of the 5th cranial nerve) with an electrode taped to the forehead. It costs about $900 to start, with additional costs for more of the electrode patches which are only used once each. It is not currently reimbursed by insurance.

While the exact mechanism of how eTNS is supposed to work is not known, one physical effect is apparently to increase blood flow in certain areas of the brain and decrease it in others. They recommend using it daily for up to four weeks before any significant changes are observed; we could not find any information about long-term effects or whether any changes are observed after treatment is stopped. It was clinically tested in 2017 in the U.S. for this FDA approval, paid for by a grant from the U.S. National Institute of Mental Health, on 62 children for four weeks. The most common side effects observed were drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue.

Results were recorded during clinical testing by asking the child to answer questions on the ADHD Rating Scale (ADHD-RS) such as whether they have difficulty paying attention or regularly interrupt others. Ratings of ADHD symptoms on various rating scales are entirely subjective, as are the diagnostic criteria for ADHD.

A prior feasibility study in 2015 was performed with 24 children for 8 weeks, using the ADHD-IV Rating Scale. It did not establish the durability of treatment effects following discontinuation of treatment, either.

To be blunt, ADHD is a fraudulent “disease.” In 1987, ADHD was literally voted into existence by a show of hands of American Psychiatric Association members and included in the Diagnostic and Statistical Manual of Mental Disorders (DSM-V). Within a year, 500,000 children in America alone were diagnosed with this, and to expand the client base it has also been associated with Asperger syndrome and Autism spectrum disorder.

ADHD actually represents the spontaneous behaviors of normal children. When these behaviors become age-inappropriate, excessive or disruptive, the potential causes are limitless, including: boredom, poor teaching, inconsistent discipline at home, reading difficulty, tiredness, street drugs, nutritional deficiency, toxic overload, bullying, abuse, stress, and many kinds of underlying physical illness.

By making an ADHD diagnosis, we ignore and stop looking for what is really going on with the child. These children need the adults in their lives to give them additional attention and to find and treat the actual causes, rather than shock their brains to see if that “works.”

There are no workable ADHD drugs, either for children or for adults. This new “treatment” is supposed to be appealing because it does not use drugs, but guess what? They don’t know how it is supposed to work, either; and they haven’t tested it long enough to know the consequences of running an electric current into a child’s brain.

Aw shucks, no one denies that children can have difficult problems in their lives. Mental health care is therefore both valid and necessary. However, the emphasis must be on workable mental healing methods that improve and strengthen them by restoring personal strength, ability, competence, confidence, stability, responsibility and spiritual well-being. Psychiatric treatments are not workable; they are designed, with shock and awe, to overwhelm.

Chanting the Chantix Mantra

Recently there has been a gross increase in the TV ad campaign for Chantix, promoting this deadly drug for smoking cessation.

We’ve written about Chantix before, but we thought a repeat was in order due to this massive ad campaign.

In 2008 the Federal Aviation Administration banned Chantix for pilots and air traffic controllers, and reissued that decision in 2013.

The U.S. Food and Drug Administration (FDA) slapped a “Black Box” warning on Chantix (varenicline tartrate, made by Pfizer) in 2009 after receiving thousands of reports linking the drug to mental health issues, including suicidal thoughts, hostility and agitation.

In 2015, the FDA expanded the warning to note that the drug had also been linked to reduced alcohol tolerance leading to seizures.

However, in 2016 the FDA removed the Black Box warning, after heavy lobbying from Pfizer claiming that additional data showed that the benefits of Chantix outweighed its adverse side effects (oh, and since its sales had significantly dropped.)

But the adverse side effects did not go away; only the Black Box warning went away. One study found that Chantix had more cases of suicidal thoughts, self-harm, and homicidal thoughts than any other drug, by a more than three-fold margin. Pfizer’s prescribing information still warns about new or worsening mental health problems such as changes in behavior or thinking, aggression, hostility, agitation, depressed mood, or suicidal thoughts or actions while taking or after stopping Chantix.

We suspect that the recent spate of TV ads is related to the removal of the Black Box warning and the prior drop in sales. Also, the price of Chantix more than doubled between 2013 and 2018. In 2013, Pfizer paid out $273 million to settle a majority of the 2,700 state and federal lawsuits that had been filed over adverse side effects. Now the company is trying to grow the market with clinical studies for smokers age 12 to 19.

What is Chantix?

Chantix is a psychiatric drug — a benzodiazepine-based anti-anxiety drug, also called a minor tranquilizer or sedative hypnotic. Daily use of therapeutic doses of benzodiazepines are associated with physical dependence, and addiction can occur after 14 days of regular use. Typical consequences of withdrawal are anxiety, depression, sweating, cramps, nausea, psychotic reactions and seizures. There is also a “rebound effect” where the individual experiences even worse symptoms than they started with as a result of chemical dependency.

The exact mechanism of action of benzodiazepines is not known, but they affect neurotransmitters in the brain and suppress the activity of nerves, under the unproven theory that excessive activity of nerves may be the cause of anxiety. Chantix was developed to specifically affect nicotinic receptors in the brain, under the theory that this would reduce nicotine craving and block the rewarding effects of smoking. Messing with neurotransmitters in the brain is playing Russian Roulette with your mind.

Benzodiazepines are metabolized by cytochrome P450 enzymes, so a genetic lack of these enzymes can cause a buildup of harmful toxins and increase the severity of adverse side effects.

Psychiatric “best practices” consider that smoking is an addiction and recommend that psychiatrists assess tobacco use at every patient visit, since tobacco addiction is covered in the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) as a “mental illness” under eight separate items, and disorders related to inhalant use have 33 entries. Smoking is not a mental illness and addiction cannot be fixed with psychiatric drugs.

The psychiatric industry considers that smoking cessation therapies are their territory, however this drug masks the real cause of problems in life and debilitates the individual, thus denying one the opportunity for real recovery and hope for the future. Treating substance abuse with drugs is a major policy blunder; contact your state and federal representatives and let them know you disapprove of this trend.

Recognize that the real problem is that psychiatrists fraudulently diagnose life’s problems as an “illness”, and stigmatize unwanted behavior like smoking as a “disease.” Psychiatry’s stigmatizing labels, programs and treatments are harmful junk science; their diagnoses of “mental disorders” are a hoax — unscientific, fraudulent and harmful. All psychiatric treatments, not just psychiatric drugs, are dangerous.