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.

How many psychiatrists does it take to change a light bulb?

The old joke, “How many psychiatrists does it take to change a light bulb?”, brings us to the present observations. [Answer: Just one, but the light has to really want to change.]

It is currently common for the main-stream news media to carry stories about well-known people who are being castigated for something inappropriate they may have said or tweeted many years ago. Often these famous people are apologizing for some past insensitivity. The conflict the media enjoys promoting appears to be between those who say people cannot change, and those who say people can change.

We wondered where or how this conflict may have originated, since there is a very long history behind this conflict. We’re sure we could write a whole book about this, so we’re just going to touch on a few interesting aspects.

We think there is no hope for humanity and society unless one can change for the better, and many methods have been developed to address such changes. But when a person says they have changed for the better, and they no longer endorse some prior unfavorable position or opinion, there can be an enormous backflash of mistrust from those who cry foul about such a change.

There must be some basic lack of confidence or doubt in one’s ability to change for the better. We think this stems from psychobabble originating from psychiatry and psychology.

As an example, there is a persistent theme in psychology and psychiatry that there is no evidence that intelligence can increase after cognitive training, education, or any other treatment.

“Scholarly” articles abound about intelligence and IQ (Intelligence Quotient), but the reality is quite simple. Intelligence, which is often confused with IQ, is actually the ability to recognize differences, similarities and identities. IQ is a relative measure of so-called “mental age” compared to others, and has been abused and exploited ever since the term was coined in 1912. Today there are many different IQ tests, since there are so many theories and disagreements about exactly what intelligence is.

One crackpot theory comes from Lecture 36 of the Teaching Company course, Understanding the Brain, from neuroscientist and Vanderbilt University School of Medicine professor Jeanette Norden, Ph.D., who says “Short of having massive brain damage, what we call IQ doesn’t change.” This is the misanthropic psychiatric point of view which makes the ridiculous claim that no change is possible.

In fact, one third of electroconvulsive therapy (ECT) patients indeed experience such massive brain damage, and many suffer a steep drop in IQ. Before-and-after IQ testing of persons given ECT typically show a loss of 20 to 40 points.

Unfortunately, IQ has been used by psychiatrists and psychologists as justification to suppress and harm entire populations. For example, eugenicist Paul Popenoe and psychologist Lewis Terman used biased IQ tests to belittle non-white races.

Psychiatrists developed the racial purity ideology used by Hitler which lead to the Nazi euthanasia program and, later, ethnic cleansing in the Balkans. No wonder there is such an aversion to the true data about intelligence, IQ, and one’s ability to change — these have been used by psychiatry and psychology to commit eugenics atrocities.

The psychiatric industry also has a history of deliberately reducing their patients’ intelligence, evidenced by this 1942 quote from psychiatrist Abraham Myerson: “The reduction of intelligence is an important factor in the curative process. … The fact is that some of the very best cures that one gets are in those individuals whom one reduces almost to amentia [feeble-mindedness].”

Psychiatry has enshrined the difficulties of change in the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), with seven disorders under the category of Adjustment Disorder, which are a group of behavioral, emotional and/or physical symptoms that can occur after going through a stressful life event, indicating one is having a hard time coping with change. By emphasizing change as a disorder, they have given change a bad name.

So when someone apologizes for having said something stupid in the past, and says they now see the error of their ways, why not give them a break and take it on face value? Let’s acknowledge that people can indeed change for the better, in spite of the claims of psychiatry and psychology that “they know best!”

Committee on Quackery Hides Psychotropic Drug Proliferation

The 1963-1974 American Medical Association Committee on Quackery set out to discredit chiropractors, with the AMA urging its members to lend “their full support to the continuing vigorous attack on medical quackery and to the education program on the cult of chiropractic.”

The AMA recommended that Congress exclude payment for chiropractic services from federally supported health programs. On August 25, 1987, Federal Judge Susan Getzendanner, in U.S. District Court, found the AMA had engaged in an illegal boycott against chiropractors and an injunction against such activity was entered and affirmed by the U.S. Court of Appeals for the 7th Circuit on February 7, 1990.

Chiropractors, of course, do not prescribe drugs.

It is not surprising that the AMA — also top heavy with psychiatrists as members — feared chiropractors. By the mid 1970s, 48% of American adults had taken a prescribed psychotropic drug. In 1977 alone, there were 85 million prescriptions for tranquilizers and 5 billion doses of pills, with an estimated 50 deaths related to Valium use alone. In 1970, 150,000 children were prescribed Ritalin, a figure that nearly doubled over the next two years to 250,000.

Cocaine-like stimulants such as Ritalin, now known to cause strokes, heart attacks, psychosis and death, were being handed out like candy for a completely fictitious “mental disorder.” Since then chiropractors and doctors practicing complementary medicine have continued to speak out against psychiatric drug practices.

In 2000, the Drug Enforcement Administration (DEA) revealed the results of studies on both animals and humans who were given cocaine and Ritalin. The test subjects could not tell the difference. The DEA concluded that, “They produce effects that are nearly identical.”

Overdoses from methylphenidate, the primary ingredient in Ritalin, doubled between 2004 and 2005.

By 2006, nearly 7 million Americans abused prescription drugs, including Ritalin — more that the number who abused cocaine, heroin, hallucinogens, Ecstasy and inhalants, combined. In the US, the number of stimulant prescriptions soared from around 5 million in 1991 to nearly 35 million in 2007.

There are thousands of physicians, acupuncturists, holistic psychiatrists, nutritional psychologists, nutritionists, chiropractors, herbalists, and other healers who do not rely upon psychiatric drugs.  Instead we are bombarded with ads that continually shove their message that psychiatric drugs are the solution to all our problems.

In the US today, more than 8 million children have been put on mind-altering psychiatric drugs. Psychiatric drugs can only chemically mask problems and symptoms; they cannot and never will be able to solve problems. The true resolution of many mental difficulties begins, not with a checklist of symptoms, but with ensuring that a competent, non-psychiatric physician completes a thorough physical examination.

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.

For more information go to www.CCHRSTL.org.

Psychiatric Hospitals With Safety Violations Still Get Accreditation

The Wall Street Journal reported December 26, 2018 that 141 psychiatric hospitals across the U.S. remained fully accredited despite serious safety violations between 2014 and 2015, including the death, abuse or sexual assault of patients.

A lot of money is at stake: Medicare payments to inpatient psychiatric facilities reached $4.5 billion in 2017, growing an average of 1% each year since 2006.

Evidence repeatedly shows that patients are at risk in for-profit psychiatric facilities that lack effective oversight.

The largest U.S. psychiatric hospital chain, owned by Universal Health Services (UHS) has approximately 200 behavioral facilities in the U.S. alone. As of September 2018, UHS had set aside $90 million in reserves to potentially settle a Federal Department of Justice (DOJ) investigation into its billing practices involving 30 behavioral facilities and UHS headquarters. UHS continues to come under scrutiny for patient abuse, yet is allowed to purchase or build more psychiatric hospitals.

Another major behavioral hospital chain is owned by Acadia Healthcare, which has 586 mental health and substance abuse facilities nationwide. Both these chains capture billions of dollars in Medicaid and Medicare funding in an overall $220 billion-a-year U.S. behavioral health industry.

The potential for fraud in these two chains alone could be upwards of $230 million to $460 million. Over the past decade, UHS has already accounted for about $37 million in False Claims Act settlements and fines.

Psychiatric Times estimates that between 10 and 20 percent of state mental health funds are lost to fraud, waste, and excess profits to for-profit managed care companies—representing $5 billion-$10 billion.

The National Health Care Anti-Fraud Association (NHCAA) says that individual victims of health care fraud are sadly easy to find. These are people who are exploited and subjected to unnecessary or unsafe medical procedures, or whose medical records are compromised or whose legitimate insurance information is used to submit falsified claims.

Many health care fraud investigators believe mental health caregivers, such as psychiatrists and psychologists, have the worst fraud record of all medical disciplines.

What is needed is legislation that provides not only more effective oversight but also stronger accountability measures: criminal and civil penalties, removal from Medicare and Medicaid programs and their funding, and hospital closure where systemic abuse is found.

Click here for more information about massive psychiatric fraud.

Involuntary Commitment Under Another Name

The Acting Cook County Illinois Public Guardian filed a class-action lawsuit (Golbert et al v. Walker et al) December 13, 2018 on behalf of hundreds of children and teenagers in state care who have been held in psychiatric hospitals after they had been cleared by doctors for release, calling the practice inhumane and unconstitutional.

The lawsuit follows a ProPublica Illinois investigation that found nearly 30 percent of children in DCFS care who were sent to psychiatric hospitals between 2015 and 2017 were held there after doctors had cleared them for discharge.

It may not legally be Involuntary Commitment, but it has the same harmful physical and emotional effects. Some children were sexually exploited.

Every 1¼ minutes, someone in the U.S. becomes the next victim of involuntary incarceration in a psychiatric hospital. And there’s nothing they can do about it.

With health care eating up vast amounts of our national budget, the first spending cut to make is the cost of “treating” people who prefer not to be mentally treated or whose treatment is no longer necessary. Involuntary incarceration hikes federal, state, county, city and private health care costs under the strange circumstance of a patient–recipient who is not allowed to leave when treatment is over. ProPublica Illinois found that DCFS spent nearly $7 million on medically unnecessary hospitalizations between 2015 and 2017.

Read more about this here.

The Psychiatric Scientific Double Standard

When it comes to psychiatric scientific research, there is a double standard that favors what makes money and disavows what does not make money. When we say “double standard” we mean some rule or principle which is unfairly applied in different ways to different groups or situations, or that favors one group or situation over another. The actual principle in question here is called “evidence-based science.”

Many scientists, particularly those in the psychiatric-pharmaceutical industry, mouth that they favor “evidence-based science” when in fact they favor what can make the most money regardless of the evidence.

A recent Scientific American editorial (“The WHO Takes a Reckless Step“, April, 2019) denigrates Traditional Chinese Medicine because it is purportedly not “evidence-based.”

Yet Scientific American promotes psychiatry and psychiatric drugs, when it knows that every psychiatric drug on the market has somewhere in its fine print a statement to the effect that “we don’t know how it works,” while the FDA approves these drugs based on so-called “evidence.”

Here are some representative quotes:

  • The fine print for Rexulti (brexpiprazole, an antipsychotic) says, “the exact way REXULTI works is unknown”.
  • The fine print for Latuda (lurasidone, an antipsychotic) says, “It’s not known exactly how LATUDA works, and the precise way antipsychotics work is also unknown”.
  • The fine print for Xanax (alprazolam, a benzodiazepine anti-anxiety drug) says, “Their exact mechanism of action is unknown”.

So much for evidence-based practice! The actual evidence is, they don’t have a clue how these drugs are supposed to work — it’s all conjecture!

As we continue to examine the actual evidence, we come up against the adverse reactions, or side effects, of these drugs. This is hard evidence, not conjecture.

What is a Side Effect?

Side effects (also called “adverse reactions”) are the body’s natural response to having a chemical disrupt its normal functioning.

One could also say that there are no drug side effects, these adverse reactions are actually the drug’s real effects; some of these effects just happen to be unwanted.

The FDA takes the adverse side effect of suicide seriously by placing a Black Box Warning on certain psychiatric drugs. For example, the FDA says that “Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD [Major Depressive Disorder] and other psychiatric disorders.”

What about those who say psychotropic drugs really did make them feel better? Psychotropic drugs may relieve the pressure that an underlying physical problem could be causing but they do not treat, correct or cure any physical disease or condition. This relief may have the person thinking he is better but the relief is not evidence that a psychiatric disorder exists. Ask an illicit drug user whether he feels better when snorting cocaine or smoking dope and he’ll believe that he is, even while the drugs are actually damaging him. Some drugs that are prescribed to treat depression can have a “damping down” effect. They suppress the physical feelings associated with “depression” but they are not alleviating the condition or targeting what is causing it.

Once the drug has worn off, the original problem remains. As a solution or cure to life’s problems, psychotropic drugs do not work.

For the first time the side effects of psychiatric drugs that have been reported to the U.S. Food and Drug Administration (FDA) by doctors, pharmacists, other health care providers and consumers have been decrypted from the FDA’s MedWatch reporting system and been made available to the public in an easy to search psychiatric drug side effects database and search engine. This database is provided as a free public service by the mental health watchdog, Citizens Commission on Human Rights International (CCHR).

Hear This — Zone Out on Zonisamide

The March 15-21, 2019 issue of the St. Louis Business Journal noted a $10.5 million Army grant to the Washington University in St. Louis Medical School to study the epilepsy drug Zonisamide to see if it could prevent hearing loss from loud noises. This seemed like such an imaginative stretch that we decided to look into it in more detail.

The justification given is that Zonisamide is conjectured to protect hearing loss when given ahead of exposure to loud noises. We wondered how this came about. We also note that other epilepsy drugs are psych-related, so we wondered if there was a psych drug connection here as well.

In a rat study, researchers proposed using a substance that blocks calcium channels to see if it could prevent hearing loss against loud noises. Zonisamide also blocks calcium channels. Gee, maybe Zonisamide can prevent hearing loss.

Zonisamide is the generic name used in the United States for a seizure drug whose common brand name is Zonegran. It was first used in Japan in the early 1970’s to treat so-called psychiatric disorders, and has been used off-label by psychiatrists in the U.S. as a mood stabilizer. The FDA approved it for seizures in 2000, although it is totally unknown as to how it works to prevent seizures. The FDA notes that taking this drug may increase the risk of depression, psychosis and suicidal thoughts or actions.

Using Zonisamide during pregnancy may present a significant risk to the fetus due to the possibility of birth defects.

Zonisamide was first studied in Japan in the 1970’s during exploratory research on drugs for psychiatric disorders. The drug alters the concentration of dopamine in the brain, but is apparently dosage dependent — that is, different dosages can increase or decrease dopamine concentrations, leading to unpredictable results.

Zonisamide is metabolized in the liver by Cytochrome P450 enzymes, so its side effects can be magnified in those persons with a genetic lack of these enzymes.

Typically we see that the psychiatric research community makes a guess about re-purposing some old drug so it can be re-used for a new patient population, guesses how it might work in the rat brain, then guesses how it might work in the human brain, each time asking for more funding to make further guesses, eventually leading to the FDA approving a new use for an old drug even though they still don’t know how it “works.”

While medicine has advanced on a scientific path to major discoveries and cures, psychiatry has never evolved scientifically and is no closer to understanding or curing mental problems, thus must continually seek to find new uses for old treatments.

While medicine has nurtured an enviable record of achievements and general popular acceptance, the public still links psychiatry to snake pits, straitjackets, and “One Flew Over the Cuckoo’s Nest.” Psychiatry continues to foster that valid impression with its development of such brutal treatments as ECT, psychosurgery, the chemical straitjacket caused by antipsychotic drugs, and its long record of treatment failures including Zonisamide as a mood stabilizer.

In over 40 years, “biological psychiatry” has yet to validate a single psychiatric condition/diagnosis as an abnormality/disease, or as anything neurological, biological, chemically imbalanced or genetic.

The drugs prescribed for psychiatric conditions, such as using Zonisamide as a mood stabilizer, only exacerbate the conditions they are supposed to treat. And when these drugs are used for other non-psychiatric conditions, they continue having the same adverse reactions, such as depression and suicide when Zonisamide is used for epilepsy. It will have the same adverse reactions if it is ever used for hearing loss. And they will still not know how it “works.”

We suggest that funding only be provided for workable medical treatments that dramatically improve and cure health and mental health problems. For more information, download and read the CCHR booklet “Psychiatric Hoax – The Subversion of Medicine – Report and recommendations on psychiatry’s destructive impact on health care.