Vraylar to the Vrescue

We are now seeing TV ads for Vraylar (generic cariprazine) for “manic or mixed episodes of bipolar I disorder.” An atypical antipsychotic, it alters levels of dopamine and serotonin in the brain. Vraylar was first approved by the FDA to treat schizophrenia in 2015. It can be compared to the antipsychotic risperidone, which is now available as a generic and thus not as expensive as the newer drug Vraylar. They say cariprazine is “less risky” than risperidone, but we think it was approved because it is more expensive.

Hungarian drugmaker Gedeon Richter, the developer of the drug, licensed it to the Dublin pharmaceutical company Allergan and receives royalties on its sales. It cost about $400 million to develop, and its projected income at the time was $300 million per year. Allergan’s Vraylar revenue for 2017 was $287.8 million. A month’s supply for one person costs approximately $1,050 (depending on dosage.)

The exact way Vraylar is supposed to work is totally unknown. It is another example of the debunked medical model of psychiatry which fraudulently supposes that messing with the levels of neurotransmitters in the brain can help. The prevailing psychiatric theory is that mental disorders result from a chemical imbalance in the brain; however, there is no biological or other evidence to prove this.

Basically, psychiatrists gave it in clinical trials to a bunch of people with mental disturbances and performed extensive statistical analyses to “prove” that symptoms of mental distress were less severe while taking the drug than while taking a placebo; while at the same time recording, but discounting, all the adverse reactions.

The most common side effects during clinical tests were uncontrolled movements of the face and body (tardive dyskinesia), muscle stiffness, indigestion, vomiting, sleepiness, and restlessness (akathisia). Other possible side effects are stroke, neuroleptic malignant syndrome, falls, seizures, agitation, anxiety — basically most of the adverse reactions we’ve come to associate with similar psychotropic drugs. This particular formulation stays in the body for weeks even after you stop taking it, so that side effects may occur long after you start or stop taking it.

During clinical trials, 12% of the patients who received Vraylar for a diagnosis of bipolar I discontinued treatment due to an adverse reaction. They say that the drug is not habit-forming, but it has withdrawal symptoms. The trials did not run long enough to actually test for physical addiction, although withdrawal symptoms were reported in newborns whose mothers were exposed to it during the third trimester of pregnancy. Also, the drug carries a black box warning that elderly patients with dementia-related psychosis are at an increased risk of death, just like any other atypical antipsychotic.

“Bipolar I disorder” used to be called “manic-depressive”. All it means is that a person roller-coasters — sometimes being up and other times being down. Bipolar disorder is characterized by unusual shifts in a person’s mood, energy and ability to function. Its symptoms are severe mood swings from one extreme of overly high or irritable (mania) to sad and hopeless (depression), then back again. In the 1800s, bipolar was known as manic depression, a term invented by German psychiatrist Emil Kraepelin. In 1953, another German psychiatrist, Karl Kleist coined the term “bipolar.” There is no objective clinical medical test for the condition.

Psychiatric treatment for schizophrenia and bipolar is complicated by high rates of relapse, indicating that the treatments do not really work. The failures to adequately treat bipolar apparently caused the psychiatric industry to split up the diagnosis into bipolar I and bipolar II, where bipolar II means that the individual has not experienced a full manic episode, just an elevated state of irritable mood that is less severe than a full manic episode. It’s splitting a hair that is completely irrelevant to anything except which drug to prescribe.

An estrogen imbalance, hypoglycemia (abnormal decrease in blood sugar), allergies, caffeine sensitivity, thyroid problems, vitamin B deficiencies, stress, and excessive copper in the body can all cause the symptoms fraudulently labeled asĀ  “bipolar disorder.”

“Schizophrenia,” “bipolar,” and all other psychiatric labels have only one purpose: to make psychiatry millions in insurance reimbursement, government funds and profits from drug sales. If you are told that a psychiatric condition is due to a brain-biochemical imbalance, ask to see the test results.

The global bipolar drug market is growing, possibly due to increasing stress in life. For information about how stress can cause someone to roller-coaster, see our blog here. Click here for more information about bipolar, and here for more information about schizophrenia.

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