Posts Tagged ‘FDA’

Stress Reduction Shot or Pacifier for the Sleepless, Angry Public?

Wednesday, August 4th, 2010

 

Vaccine: Choice or Mandate for the Future?

Governments worldwide are anxiously awaiting further tests on a new vaccine announced yesterday by Rachel Quigley in her Mail Online article from the UK. Dr. Robert Sapolsky, a professor at Stanford University, is “on the path to a genetically engineered formula that would remove the need for relaxation therapies or prescription drugs.” His studies on glucocorticoids, the hormones chiefly responsible for our fear responses, have led him to the vaccine which works on rats. He admits that human trials are years away. Will the strong-armed governments of the world, seeking to calm the sleepless and sometimes angry public masses controlled by them, allow the tests on humans to wait that long?

Glucocorticoids are essential for life. They are present in the cells of almost all vertebrates. Cortisol is the most important human glucocorticoid. It “regulates or supports a variety of important cardiovascular, metabolic, immunologic, and homeostatic functions.” Cortisol, along with adrenalin, works to assist the brain in remembering stressful and dangerous situations. Those memories stimulate the fear and flight responses to dangerous situations that may confront us in the future. It is vital to the survival of the species.

Dr. Sapolsky thinks that the human species produces too many glucocorticoids and that man cannot turn them off after stressful situations. He claims, according to Quigley’s article, the hormone “becomes toxic both biologically, by destroying brain cells and weakening the immune system, and socially, when people continue to snap at their friends or family hours after the original cause of tension has vanished.”

The “Sapolsky shot” utilizes a herpes virus carrying genetically engineered “neuroprotective “genes to “neutralize the rogue hormones.” The shot supposedly short circuits the brain’s natural response to stress. Claims are that “It would leave you fresher and ready to deal with another threat, so you can maintain your drive, but with more focused calm.”

How will the short-circuited brain remember the stressful situation? Will a future similar threat be ignored by the chemically altered passive brain? Research in this important area must be done before human trials are initiated.

The FDA, with its quick approvals of fluoride additions to water supplies, aspartame and acesulfame potassium addition to foods, drinks, and medicines, despite studies proving their harmful effects, does not inspire confidence. Headlines across the internet already shout the “brain-eating” and “lobotomizing” effects of the “Sapolsky shot” as well as the conspiratorial applications of this vaccine as a secret additive to government required vaccinations worldwide.

Billions of dollars are being donated by the wealthy “elite” of the world in efforts to control population growth through vaccinations. Some nations refuse the donated vaccinations because of an increase in sterility among their female populations following their widespread use. It isn’t much of a stretch to suspect the ever-reaching arms of big governments everywhere to promote the “Sapolsky shot.” They are no doubt dreaming about the future populations of calm and sleepy subjects, no longer stress-filled, sleepless, and angry about the loss of their freedoms. FDA approvals for human testing will be quickly forthcoming.  The “Sapolsky shot” is coming to a clinic near you. It will be provided free of charge by your friendly government sponsor. There are no harmful side effects according to the Center for Disease Control, the FDA, and the Administration. The supply will be “unlimited” according to Health and Human Services Secretary, Kathleen Sebelius.

The stress-filled, sleep deprived masses are already lining up for their calm inducing injections. Yoga and meditation will become a relic of the past as our minds and bodies slumber into a passive stupor of paralytic responses. As our self-preserving survival responses to stress are neutralized the pandemic of sleep deprivation will probably disappear. At risk will be our doubting responses to the threats of government theft of our liberties.

Copyright 2010. All rights reserved to Ronald Czarnecki.

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Insomnia Cure Bred from Mother Nature and Israel

Tuesday, July 20th, 2010

Insomnia

Circadin® “not only improves the onset of sleep, but also improves the quality of sleep” says Nava Zisapel, company founder and Chief Scientific Officer of Neurim Pharmaceuticals. Dr. Zisapel, a Professor of Neurobiology at Tel Aviv University, reports that people who take the drug “have better daytime functioning and an improved quality of life.” The drug stimulates the body’s natural melatonin production. Her prolonged release formula of a mere 2mg dosage mimics the pineal gland’s production of the sleep inducing hormone. Melatonin production normally begins at dark, peaks at around 2am, and then gradually disappears at daylight. Dr. Zisapel began her work in 1992 and she received approval to market it in 2007. The European Medicines Agency (EMEA) at that time approved it for the short term (3 week) treatment of primary insomnia in patients over 55 years of age. The drug, unlike traditional sedatives, does not impair cognitive functions the following day, nor does it impair psychomotor skills. There are no abuse or dependency risks. Insomniacs, numbering nearly a third of the world’s population, will be cheered by the European Commission’s July, 2010 approval to expand the treatment duration from 3 weeks to 13 weeks. Circadin® is the first insomnia treatment approved for the extended length of time. It is currently marketed in Australia, Thailand, and Israel. US, Asian, and Latin American markets are in the registration process.

Insomnia, defined as the “difficulty to initiate or to maintain sleep,” affects almost all adults at one time or another. Transient (symptoms less than a week) insomnia and short term insomnia (one to three weeks) can occur as a result of jet lag, indigestion, shift work schedule changes, noisy sleep environments, stress, and recent medical situations. Long term (more than 3 weeks) or chronic insomnia is usually caused by psychological or medical conditions such as depression, pain, heart disease, acid reflux, asthma, sleep apnea, Parkinson’s disease, Alzheimer’s, brain tumors and strokes. Delayed or untreated insomnia costs America $42 billion dollars a year in healthcare costs. The seriously sleep deprived insomniacs have been limited to prescription sleep aids with their risks of dependency and abuse, or to over the counter antihistamines with their residual drowsiness hazards. The FDA has consistently discouraged natural supplements since they have no jurisdiction over them. They have issued warnings against the use of the natural alternatives of valerian, melatonin, and kava.

Circadin® is now in use in over 33 countries. It is naturally preferable to prescription sleep aids and their over the counter competitors.  It’s time for the FDA to approve it for the sleepless and tired insomniacs of the USA. Everyone deserves a good night’s rest!

Copyright 2010. All rights reserved to Ronald Czarnecki.

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