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Caution: FDA Warnings Can Be Hazardous to Your Health!

April 7, 2015
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FDA1 Raymond Ishman, MD

Director of Medical Quality Assurance,
Cenegenics Elite Health
President, Cenegenics Philadelphia


In their own words, the “FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs…”

We put our trust in the FDA to assure the safety of new medications and devices, and to protect us from harm. However, some of their warnings seem to go against their own mission statement. We are frequently given conflicting messages and warnings that are simply not supported by the medical literature. At times, these warnings and even new drug approvals are tainted by personal agendas and conflicts of interest.

Take for example, the FDA’s March 3rd, 2015 statement regarding testosterone products where they warn of “a possible increased cardiovascular risk associated with testosterone use.” This was based on 2 flawed studies that have been refuted by many medical experts worldwide including The Mayo Clinic. (see FDA Statement on Testosterone Contradicts Medical Experts)

What is most disturbing about the new warning is that on July 16th of 2014, the FDA used the very same 2 studies mentioned above to deny a Citizens Petition for additional warnings on testosterone products, citing multiple study flaws that made the results invalid. In that document, the FDA went on to state “Randomized controlled studies have shown that testosterone supplementation generally improves biomarkers of cardiovascular health.” Did the FDA think no one would notice? Well, we did!

In the March 2015 statement, the FDA advisory panel recommended a change in the labeling for testosterone-replacement products, with the aim of curbing their use for “age-related” low testosterone. This means that to discourage what they consider to be inappropriate testosterone prescribing, the FDA issued warnings using information they previously stated was invalid. These unsubstantiated warnings deprive appropriate patients of valuable therapy by needlessly scaring them, along with their doctors. Is this the right way to achieve their aim, scare tactics?

So is “age related” low testosterone something we shouldn’t be concerned about? On the contrary, numerous studies have documented that the age related loss of various hormones, including testosterone, plays a causative role in the development of heart disease, diabetes, Alzheimer’s disease and osteoporosis to name a few.

Billions of dollars are spent every year treating these age related diseases, along with researching new modalities to treat them. Yet hormone replacement is vilified in spite of convincing medical evidence that it could help prevent a significant portion of these diseases.

There is something very wrong with this picture!

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Posted in Blog, Medical News by rishman