Another Mind Altering Drug Seeks FDA Approval

Globally, the World Health Organization (WHO) estimates that over 800,000 people die to suicide every year. A recent study carried out by the Nordic Cochrane Centre, with 70 trials involving 18,000 people found that antidepressants doubled the risk of suicide and aggressive behavior in people under the age of 18 years. Therefore, researchers are focused on finding an effective drug to treat suicide.

An Israeli-based startup company has been researching a new molecule, D-cycloserine (DCS), as a treatment option for depression and suicide. The company expects a fast track approval for this drug from the U.S. FDA once the clinical trials are completed by the end of 2017.

But what do we know about this molecule, turned drug? In this 2014 study, D-cycloserine for Treating Anxiety Disorders: Making Good Exposures Better and Bad Exposures Worse, gives some warnings about this compound that should be taken into consideration prior to rushing another drug to market that manipulates the brain.

D-cycloserine works by interacting with a brain receptor called glutamatergic N-Methyl-D-Aspartate, known as NMDA for short. This receptor has been shown in animal studies to be involved with extinction learning, the gradual decrease in response to a thing or situation that causes fear or anxiety. For example, extinction learning though blocking the NMDA receptor can eliminate an intense fear of heights or fear of spiders with re-exposure.

Prior to being tested as a psyche drug, DCS was used as an antibiotic for tuberculosis. When used in this capacity, the package insert lists some serious neurological side effects:

The most frequent adverse effects include drowsiness, somnolence, dizziness, headache, lethargy, depression, tremor, dysarthria, hyperreflexia, paresthesia, nervousness, anxiety, vertigo, confusion and disorientation (with loss of memory), paresis, major and minor clonic seizures, seizures, and coma have been reported. Psychosis (possibly with suicidal tendencies), personality changes, hyperirritability, and aggression have also occurred.

Doesn’t it seem strange a drug that caused these side effects is now being promoted as a drug to prevent suicide?

There are other concerns about DCS. Peak blood levels of DCS occur within a narrow window, about four to six hours after ingestion. Most trials report positive results only when the dose is administered 1–2 hours before an “exposure session.” And when taken repeatedly over an extended period of time, the NMDA receptor can become desensitized, altering how the DCS receptor works. Instead of desensitizing or extinguishing a bad memory, DCS can intensify the memory and make the experiences worse. 

In other words, DCS appears to make “good” exposures better and “bad” exposures worse.

How does someone who is suicidally depressed know to take this drug within 1-2 hours of an “adverse exposure”?

What we need is to do is stop pounding infant brain with vaccines and toddler brains of with brain-damaging prescription medications that lead to brain injured adults. We need to stop prescribing long-term amphetamines for children. The most commonly prescribed drugs for ADD/ADHD, Ritalin and Adderal, are classified as Schedule II drugs, meaning they have the same potential for abuse as morphine, opioids and cocaine – and they have the same effects on the brain.

According to a study reported by the American College Of Neuropsychopharmacology, long-term use of Ritalin can lead to serious brain injury. If you have a child or a loved one on Ritalin, you really need to carefully read this package insert. The long-term consequences and side effects of this drug are truly frightening. 

Instead of fast tracking and approving another brain-altering chemical, why not teach people about nutrition. The positive effects on mood and mental clarity after removing fast food, gluten, and dairy from the diet has been well documented. Consuming high doses of B vitamins and adequate doses of Vitamin D can eliminate depression. It has long been known that taking 3ooomg of Omega3 fish oil is more effective for depression than any medications.

The rush to “fast track” approval of drugs is not a good idea. The rush to approve for more mind-changing drugs is a really bad idea.