FDA finally warns about Low-T drugs

For more than a decade, big pharma has relentlessly marketed prescription testosterone drugs for the quasi-fictitious condition of low testosterone — or “Low-T.”

As I often report, Low-T drugs are not safe. Furthermore, they’re not even necessary.

In fact, a man’s testosterone level normally declines as he gets older. And this normal decline probably protects him from conditions such as cancer, heart disease, and other conditions that increase with age.

Indeed, high testosterone levels cause cardiovascular diseases and increase the risk of prostate cancer. So, artificially increasing testosterone levels in aging men is an absolute recipe for disaster.

In October, the FDA finally issued a new warning and new labeling requirements for “Low-T” drug treatments.

But I have to wonder, is it too little, too late?

States took action first…

The FDA is a federal agency that approves and regulates drugs and medical devices. But states regulate the actual practice of medicine in their states, including how doctors prescribe drugs approved by the FDA. In fact, the states tried to limit the prescription of these drugs long ago…

First, some states specified that male hormonal treatments should only be administered by physicians who specialize in internal medicine and/or endocrinology.

Second, they said physicians should only prescribe the drugs following appropriate testing and diagnosis for low testosterone.

Third, physicians should only prescribe testosterone therapy, if, following the testing, the men are found to lack or have low testosterone in conjunction with a real medical condition, such as genetic failure of the testicles to produce testosterone.

Despite guidelines, some doctors still dole out testosterone willy-nilly

In many places around the country, these important regulations were never heeded. Doctors of all backgrounds set up “testosterone mills,” handing out testosterone pills to anyone who wanted them. Even orthopedic surgeons and “sports medicine” doctors jumped in to prescribe these drugs willy-nilly. (I don’t put this particular medical sub-specialty of glorified carpenters at the top of the list when it comes to keeping up with, or understanding, biomedical science or human nutritional and hormonal metabolism.)

In New Jersey, Gov. Chris Christie recognized the disaster brewing in his state. The practice of prescribing Low-T drugs to men was completely out of control and against all medical standards. Doctors there inappropriately prescribed Low-T drugs to young, healthy government employees in New Jersey. Then, they charged the bill to their government-paid health insurance plans, wasting millions of state dollars each year, not to mention the long-term health risks.

Gov. Christie asked me to serve on a panel of the state medical board to review and revise medical practice guidelines for prescribing these and other hormonal treatments. The State Attorney General also prosecuted physicians who were abusing prescriptions. As a forensic pathologist and toxicologist, I was asked to serve as an expert witness.

In my investigations in New Jersey, I found many of the men who were tested showed normal testosterone levels, but were given the drugs anyway. And many of the men who had Low-T who were given the drug inappropriately would have been better off without it. Worst of all — research by Public Citizen found that almost 25 percent of men prescribed testosterone never even took a blood test to show they had Low-T.

A lot of talk, little action

This new action against Low-T drugs isn’t the FDA’s first effort. Last year, the agency told big pharma to clarify that their Low-T products are approved only for men with specific medical conditions — and that they may increase the risk of heart attacks and strokes.

So why is big pharma still allowed to run that ridiculous commercial with the couple staring into the sunset in twin outdoor bathtubs? (Say what?)

Clearly, the message isn’t reaching those who need to hear it.

The new FDA warning alerts prescribers to the abuse potential of testosterone and the serious adverse outcomes, especially those related to heart and mental health.

Reported adverse outcomes include heart attack, heart failure, stroke, depression, hostility, aggression, personality changes, liver toxicity, and male infertility. High doses can also lead to withdrawal symptoms of depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia.

Long-term abuse of testosterone acts on key brain chemical pathways — including dopamine and serotonin pathways. No wonder there is often a significant effect on behavior and mood with testosterone.

Low-T treatments won’t solve your aging problem. In fact, quite the opposite. They might ensure you die young.

The FDA is finally getting the picture — all of which could have been, and was, predicted long ago.

In the meantime, big pharma had many years to make big bucks on their useless, dangerous drugs protected under government patent. So all remained well in the government-industrial-medical complex. You need to make sure you stay well.

Source:

  1. “FDA approves new changes to testosterone labeling regarding the risks associated with abuse and dependence of testosterone and other anabolic androgenic steroids (AAS),” FDA (fda.gov) 10/25/2016

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