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| Dr. Enrique Jacome |
We shudder every time the endless TV commercials appear for synthetic pills, gels, injections creams and other topical testosterone treatments in unspecified doses. But on September 18, the runaway testosterone train came to a sudden halt as FDA medical advisers concluded that new safety measures were in order. Check out the news reports on this that we have posted below for your convenience.
The advisory panel posed concerns that over 25 percent of the men currently taking these products have been administered testosterone without proper lab work to warrant any treatment. These men also lack individual dosing or post-treatment follow-up to monitor their symptoms and health, often resulting in heart attacks.
As a result, the FDA has imposed new regulations to manage the use of these generic synthetic testosterone drugs. The FDA advisory came exactly one month to the day after Time magazine featured its “Mano-pause” cover story about the booming synthetic Low T business.
Another report on Fierce Biotech, a daily online monitor for the drug industry, explains the story behind the facts, with last-ditch scrambles by drug manufacturers to salvage their Low T wares in the face of new FDA regulations.
According to Dr. Gino Tutera — the founder of SottoPelle Therapy, a system of individually tailored bio-identical hormone pellets — good medicine is about safeguarding human health instead of imposing such serious health risks to millions of people.
“Everyone doesn’t wear the same shoes size,” Dr. Tutera explains. “Back in the early 90′s, I realized that there is no one-size-fits-all hormone for everyone. Each patient is uniquely different and must be treated as an individual.”
The science of pellet hormone therapy is based on precise doses of bio-identical hormones instead of synthetic ones. But what exactly does this mean and how do pellets work?
A bio-identical hormone is one whose molecular structure contains the exact biochemical structure as the human hormone itself. And think of the pellet, about the size of a grain of rice, inserted under the skin as a reservoir that sits in your body awaiting the signal to release the necessary amount of hormone.
The pellet’s release of hormone is controlled by the heart rate. Therefore, as long as the patient’s heart is beating, the secretion of hormone is continuous and will vary according to the patient’s needs. The body therefore controls the release of continuous hormone, naturally increasing or decreasing the amount of hormone released according to the body’s needs.
In addition to right kind of natural hormone, safe and effective hormone therapy requires the following criteria:
Proper testing with thorough analysis and diagnosis
Customized doses based on each individual’s patient’s needs
The hormone needs to be replaced in the exact ratio in which the body produces it to create the maximum physiologic protection
The delivery system must replicates the secretion pattern of the organ being replicated, i.e., the ovary or testicle
Pellet hormone replacement is one of the most researched forms of hormone delivery, starting in the 1930′s in Austria and continued after that by Dr. R Greenblatt from the University of Georgia Medical College. The clinics he established have been using pellets continuously ever since.
Dr. Tutera subsequently developed the system of customizing doses for each individual patient to create a safe, effective pellet method that has restored good health and happiness to so many patients.
http://www.nytimes.com/2014/09/18/health/testosterone-drugs-fda.html?_r=0
http://blogs.wsj.com/pharmalot/2014/09/18/fda-panel-says-testosterone-drugs-need-more-study-and-reduced-use/
www.sottopelletherapy.com/doctors/enrique-jacome-md
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