FDA finally warns about Low-T treatments

I often warn you about the dangers of low-testosterone–or Low-T–drugs. And in September, I updated you about the FDA’s nearly unanimous vote to require warning labels on all testosterone-replacement products. The Drug Safety and Risk Management Advisory Committee actually voted nearly unanimously—20 to 1—in favor of requiring label warnings. They also voted to require more safety studies.

What we really need are more studies not just on the drugs’ safety–but also on their efficacy. Or lack thereof.

You see, not only are Low-T drugs NOT safe. They don’t have clear benefits for the vast majority of men who take them.

Yet mainstream doctors have been prescribing Low-T drugs for years. Originally, doctors only prescribed these products to men who were born without normal testicular function. Or to men whose testicular function was damaged by exposure to heavy metals or cancer chemotherapy.

Once the FDA approved these Low-T treatments for the relatively small group of men who really needed them, big pharma couldn’t leave well enough alone. They saw an opportunity to vastly expand their market. And now, thanks to big pharma’s direct-to-consumer “Low-T” propaganda blitz, it seems they have every Tom, Dick, and Harry clamoring for one of these potentially dangerous drugs.

Thankfully, the FDA is finally questioning the widespread use of these treatments for healthy men–whose only problem is that their testosterone levels are naturally declining with age. It’s also questioning their use in men who report subjective symptoms of “Low-T,” but who–in reality–have normal testosterone. And, the FDA is finally noticing that many doctors don’t even bother to test testosterone levels before prescribing the drugs in the first place!

Data shows only about half of the men who take testosterone treatments have actually been diagnosed with low testicular function. And a quarter of the men never even have their testicular function tested to determine whether such treatments are “necessary.” Finally, four-fifths of men who are on the therapy never have their testicular function re-tested to see if there is any improvement.

A few years back, I helped put a halt to this nonsensical, unethical practice in New Jersey.

Turns out, doctors were prescribing these unneeded Low-T treatments to young, healthy police and fire fighters in droves. And the state was stuck paying the bill.

So the State Attorney General asked me to serve on a panel to revise the state’s prescribing guidelines with the state medical board. As a result, we put a stop to this Low-T drug abuse long before the FDA’s measly warning about it.

As a matter of fact, I just heard from the New Jersey State Attorney’s Office last week. My colleague there said the work of our panel actually helped lead the way for federal efforts. (With that in mind, maybe we should do away with all the federal bureaucracy and let the states take care of their needs directly–as anticipated by the 10th Amendment.)

Now the FDA panel says it’s unclear whether Low-T treatments can benefit men who have no apparent cause for declining testosterone levels other than older age. Of course, most men who receive Low-T treatments are 40 to 64 years old. These are not elderly men…but middle-aged men. And of course, there are even more questions about whether there is any need or benefit for such drugs in this age group.

As you know, there are also serious concerns about the safety of these drugs.

A 2010 study signaled the possibility of increased cardiovascular disease risk with these drugs. And more recently published studies raise the same problems.

This finding should not come as a surprise. Testosterone raises heart disease risk. In fact, men have higher rates of heart disease compared to pre-menopausal women at the same ages because they have more testosterone.

And after menopause, women lose the protection of estrogen and are exposed to more of their own, normal levels of endogenous testosterone. So their risk of heart disease rises to that of men at the same ages.

Plus, testosterone has long been associated with promoting certain types of prostate cancer. That’s why some men with prostate cancer have had their testes removed.  That’s a pretty extreme procedure for lowering testosterone, don’t you think? So maybe normally declining testosterone with age is nature’s way of providing some protection to your heart and prostate.

Bottom line?

The risks of testosterone drugs are real. And the benefits are elusive. Too many doctors who prescribe them don’t employ any kind of ethical or science-based medical practice. Plus, as I mentioned above, big pharma relies on “direct-to-consumer” marketing. And if we don’t do something fast, big pharma will find a way to offer them as OTC drugs and eliminate medical oversight altogether.

An FDA reviewer did note that direct-to-consumer ads for Low-T products that boast benefits–such as improved quality of life and sexual performance–have already prompted warning letters from the agency.

So hopefully, we may see less of those annoying Low-T ads on TV. But the damage has been done already. And now, no one can forget those relentless ads. Like the ridiculous couple sitting in side-by-side outdoor bathtubs (say, what?), looking out toward a distant sunset. I imagine them drowning each other in those tubs.

Of course, new research shows men can experience renewed vitality, physical performance, and healthy aging with a “dynamic duo” of two safe and natural products–dandelion and rooibos (red bush). I have studied this duo for many years. And you can learn more about it in the March 2014 issue of my Insiders’ Cures newsletter.