Schizo Christmas Present from the FDA

The US Food and Drug Administration (FDA) finally approved the new antipsychotic drug lumateperone (Caplyta, from Intra-Cellular Therapies, Inc) on December 23, 2019 for treatment of schizophrenia in adults, in spite of previously canceling its review because of mixed results in testing, which were blamed on positive responses to placebos.

As with other antipsychotics, lumateperone includes a boxed warning that elderly patients with dementia-related psychosis are at an increased risk for death.

Also as with other antipsychotics, the mechanism of action is unknown — they’re just guessing about how it is supposed to “work.” It plays Russian Roulette with serotonindopamine and glutamate (another neurotransmitter) in the brain.

It has all the usual possible side effects – neuroleptic malignant syndrome, tardive dyskinesia, hyperglycemia, diabetes, weight gain, sedation, increased risk of falls, seizures, infertility, etc.  Newborns exposed to antipsychotic drugs during the third trimester of pregnancy may suffer withdrawal symptoms.

Since cytochrome P450 enzymes such as CYP3A4 are involved in its metabolism in the liver, a person’s genetic abnormality with these can lead to the drug or its metabolites reaching a toxic level in hours or days, correlating with the onset of severe side effects. One is also ill-advised to drink grapefruit juice with this drug because it strongly inhibits the CYP3A4 enzyme, again increasing the risk of serious adverse reactions.

Of course, psychiatrists attribute any attempts at suicide to the underlying diagnosis and not to the drugs.

Speaking of the Underlying Diagnosis

Today, psychiatry clings tenaciously to antipsychotics as the treatment for “schizophrenia,” despite their proven risks and studies which show that when patients stop taking these drugs, they improve.

The late Professor Thomas Szasz stated that “schizophrenia is defined so vaguely that, in actuality, it is a term often applied to almost any kind of behavior of which the speaker disapproves.”

These are normal people with medical, disciplinary, educational, ethical or spiritual problems that can and must be resolved without recourse to drugs. Deceiving and drugging is not the practice of medicine. It is criminal.

Any medical doctor who takes the time to conduct a thorough physical examination of a child or adult exhibiting signs of what a psychiatrist calls Schizophrenia can find undiagnosed, untreated physical conditions. Any person labeled with so-called Schizophrenia needs to receive a thorough physical examination by a competent medical—not psychiatric—doctor to first determine what underlying physical condition is causing the manifestation.

Any person falsely diagnosed as mentally disordered which results in treatment that harms them should file a complaint with the police and professional licensing bodies and have this investigated. They should seek legal advice about filing a civil suit against any offending psychiatrist and his or her hospital, associations and teaching institutions seeking compensation.

No one denies that people can have difficult problems in their lives, that at times they can be mentally unstable, subject to unreasonable depression, anxiety or panic. Mental health care is therefore both valid and necessary. However, the emphasis must be on workable mental healing methods that improve and strengthen individuals and thereby society by restoring people to personal strength, ability, competence, confidence, stability, responsibility and spiritual well–being. Psychiatric drugs and psychiatric treatments are not workable.

For more information, click here to download and read the full CCHR report “Schizophrenia—Psychiatry’s For Profit ‘Disease’“.
Calvin and Hobbes

More About Serotonin

We often remark on serotonin when discussing psychiatric drugs, so we thought we’d describe it in more depth.

The word comes from the combination of sero- (serum) + tonic (from Greek tonos string or stretching) + -in (from Latin -ina a term used to form words). It was first named in 1948, although its effects had likely been observed since 1868.

Serotonin is a neurotransmitter hormone synthesized in the adrenal glands and elsewhere in the body from the essential amino acid tryptophan (chemical formula C10H12N2O, also called 5-hydroxytryptamine), found in the brain, blood, and mostly the digestive tract, which allows nerve cells throughout the body to communicate and interact with each other.

Some of its effects include:
— helping smooth muscles to contract, such as the abdominal muscles that aid digestion,
— helping to regulate expansion and contraction of blood vessels,
— assisting the clotting of blood to close a wound,
— helping to regulate mood, aggression, appetite, and sleep.

It helps to create a sense of well-being or comfort in the body, which is the starting point for the theory of using it as an antidepressant.

Since serotonin impacts every part of your body, messing with it can cause unwanted and dangerous side effects. Obviously, the body must closely regulate and balance the level of serotonin, since both a deficiency or an excess can be harmful.

It is mainly metabolized in the liver and the resulting products are excreted by the kidneys.

It is also found in animals, insects, fungi and plants.

Extremely high levels of serotonin can cause a condition known as serotonin syndrome, with toxic and potentially fatal effects. It can be caused by an overdose of drugs or interactions between drugs which increase the concentration of serotonin in the central nervous system, the most common of which are the selective serotonin reuptake inhibitors (SSRIs), whose purpose is to raise the level of serotonin in the brain.

A toxic level of serotonin can occur by taking two or more of these types of drugs, even if each is only a normal therapeutic dose. Many drugs, both legal and illegal, influence the level of serotonin in the brain — including some antidepressants, appetite suppressants, analgesics (pain drugs), sedatives, antipsychotics, anti-anxiety drugs, antimigraine drugs, antiemetics (for relief of nausea and vomiting), antiepileptics, cannabis (marijuana), LSD, MDMA (Ecstasy), psilocybin (the active ingredient in magic mushrooms), and cannabidiol (CBD).

There aren’t any tests that can diagnose serotonin syndrome. Instead, one has to observe the extent and severity of the various adverse reactions. Some side effects of serotonin syndrome can be altered mental status, muscle twitching, confusion, high blood pressure, fever, restlessness, sweating, tremors, shivering, or death.

Some people have a genetic defect with cytochrome P450 enzymes which influences serotonin metabolism. Some research also suggests that the interactions of psychotropic drugs with cytochrome P450 in the brain may also influence serotonin metabolism. Basically, these interactions can be extremely complex, and the results are unpredictable — meaning that wild variations in serotonin concentration, both lower and higher than optimum, may occur, with the attendant adverse reactions.

The proponents of all these drugs basically ignore the fact that they mess with serotonin when making claims for safety and usefulness. Messing with neurotransmitters in the brain without totally understanding how they work is serious business. Researchers know that 60 to 70 percent of patients diagnosed with depression continue to feel depressed even while taking such drugs. There is still a lot unknown about such interactions and long term safety, so caution is definitely advised.

An article in the October, 2018 print issue of Scientific American (“Postpartum Relief” on page 22) makes an interesting point, saying, “Many women who suffer from postpartum depression receive standard antidepressants, including selective serotonin reuptake inhibitors such as Prozac. It is unclear how well these drugs work, however, because the neurotransmitter serotonin may play only a secondary role in the condition or may not be involved at all.” (Emphasis ours.)

Researchers still only conjecture about any relationship between depression and serotonin, and they are coming to understand that the results do not support the hype.

Psychiatrists have known since the beginning of psychopharmacology that their drugs do not cure any disease. Further, there is no credible evidence that depression is genetic or linked to serotonin transport; these are just public relations theories to support the marketing and sale of drugs. The manufacturers of every such drug state in the fine print that they don’t really understand how it works. Psychiatric drugs are fraudulently marketed as safe and effective for the sole purpose of earning billions for the psycho-pharmaceutical industry.

These drugs mask the real cause of problems in life and debilitate the individual, so denying him or her the opportunity for real recovery and hope for the future. This is the real reason why psychiatry is a violation of human rights. Psychiatric treatment is not just a failure — it is routinely destructive to the individual and one’s mental health.

Cannabidiol (CBD) – Can We Be Sure It’s Safe?

Every time we say “CBD” out loud we think Bidi Bidi and picture Buck Rogers’ Twiki the Robot.

But really, what is CBD, and is it harmful or helpful?

Derived from Cannabis (marijuana), CBD is one of many cannabinoids which are chemical compounds capable of binding to specific biological receptors in the brain or other sites in the body.

The theory is that when CBD binds to these brain receptors it seems to suppress or limit the immune system’s inflammatory signals.

Another cannabinoid, THC (tetrahydrocannabinol, also called “The High Causer”), is the principal psychoactive component of marijuana, and when it binds to receptors in the brain it gets you high. We also know that THC damages the immune system, yet proponents of cannabis call it a “medicinal herb.” Click here for more information about the harmful effects of this “herb.”

CBD and THC are structural isomers, which means they share the same chemical composition but their atomic arrangements differ.

The claim is that CBD, unlike THC, is not hallucinogenic. Much of the research information so far available about CBD comes from animal studies.

Although it is a cannabinoid, CBD apparently does not directly interact with the principal receptors in the brain to which THC binds, and binds to many other non-cannabinoid receptors in the brain.

Basically, the research to date is unclear on exactly how CBD works, except that we know it affects the brain. We’d call these observations mostly anecdotal — that is, people have reported on their observations and feelings, but the double-blind human clinical trials are sparse.

Animal studies have demonstrated that CBD directly activates multiple serotonin receptors in the brain, and we know that in humans at least, psychiatric drugs which mess with serotonin levels in the brain are addictive and have some disastrous side effects. The manufacturers of every psychiatric drug so far which messes with serotonin in the brain say they don’t really know how it works.

CBD, LSD, mescaline, and other hallucinogenic drugs bind to the same serotonin receptors in the brain, so calling CBD totally non-intoxicating is a bit of a stretch. We think the insistence on calling CBD “non-intoxicating” or “non-hallucinogenic” is Public Relations for “Bidi bidi, gee, we can make a bundle with this.” While the anecdotal evidence claims no hallucinogenic effect for CBD, the fact that it affects serotonin in the brain makes it less attractive as a healthy alternative. Its long-term effects are simply unknown.

Some proponents promote taking THC and CBD together. We think this is a short path to becoming a bidi bidi robot.

At higher dosages, CBD will deactivate cytochrome P450 enzymes, making it harder to metabolize certain drugs and toxins, particularly psychiatric drugs.

What about CBD oil or cream (hemp extract) applied to the skin? Is there a difference between CBD derived from hemp and CBD derived from marijuana?

CBD is legally available in the United States, but it must be derived from imported high-CBD, low-THC hemp. CBD itself is not listed under the Controlled Substances Act, so it’s legal in all 50 states provided it’s not extracted from marijuana.

A huge amount of fiber hemp is required to extract a small amount of CBD, so researchers are focused on breeding plants with more CBD and less THC just for this purpose. It is important to note that all cannabidiol products are not approved by the FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease.

CBD and THC both interact with the body through a vital nerve signaling system which regulates a wide array of functions, some of which include: pain, appetite, mood, memory, immune response, and sleep. There are still very little long-term safety data available. The proponents of CBD, whether for internal or external use, ignore the fact that it messes with serotonin when making claims for its safety and usefulness, so caution is advised. There is a lot of money riding on making these substances legal and ubiquitous; any bad effects are not going to be advertised or promoted.

At present, we’d prefer not to experiment with substances that tweak the brain in ways that are not fully understood, lest we become like bidi bidi Twiki. As always, your fully informed consent for any treatment is of paramount importance.