Hormone Nazis to men: "No testosterone for YOU!"

By Dr. Ronald Hoffman

Last month, an FDA advisory committee dealt a severe blow to testosterone therapy for men. Voting 20 to 1, they urged tighter labeling on testosterone products and a narrowing of the definition of hypogonadism (testosterone deficiency) to encompass only severe pituitary or testicular abnormalities rather than the natural decline of testosterone that occurs as men age (andropause). They also urged more research into the potential cardiovascular risks of testosterone.

Over two million men across the country are using testosterone drugs. The vast majority tap it for its anti-aging, reinvigorating effects. The new guidelines would leave them high and dry; doctors would be increasingly reluctant to prescribe testosterone, and insurers would invoke the new rules to deny coverage for testosterone meds.

Paradoxically, men all over the country enjoying this fall's bounty of macho sports programming on TV-the start of hockey and basketball season, NFL and college football, and the World Series-can scarcely watch for half an hour before they're exhorted by yet another commercial to check if they have "low T" and, if so, ask their doctors for a testosterone Rx!

So what's a man to do?

First, let's address the claims of testosterone harms. Of primary concern is the potential for testosterone to promote prostate cancer. This is a potential worry. When I treat men for low T, I always demand a PSA. If it's high or even borderline I suggest they see a urologist for a full check-up.

Only after they get a clean bill of health do I prescribe testosterone, and every few months I insist on a repeat PSA to make sure it's not inching upwards. I also like to monitor testosterone levels to confirm my men are not taking unsafe amounts. I only want to replace testosterone to average levels seen in younger men, not supercharge my patients with abnormally high doses with possible side effects.

Interestingly, studies do not show inordinate risk of prostate cancer in well-monitored men receiving testosterone. If cancer is detected, it is likely a pre-existing cancer whose presence might be revealed even sooner because of the attention lavished on the testosterone recipient. Once the testosterone is stopped and treatment undertaken, these men generally do well. It is not the testosterone that caused the cancer, it merely unmasked its presence earlier.

It's also worth noting that the very men who usually get prostate cancer are older, and thus more likely to suffer from low testosterone. If testosterone were to be the culprit in prostate cancer, why is it that younger men who have the highest levels of testosterone almost never get prostate cancer?

When I place men on testosterone, I also boost their intake of anti-prostate cancer nutrients like vitamin D, flax seed lignans, EGCG from green tea, lycopene, and saw palmetto.

After years of prescribing testosterone to scores of men, I can attest to the safety of this approach. And increasingly we are seeing urologists line up in favor of testosterone for debilitating symptoms of hypogonadism even for men who have been successfully treated for prostate cancer, something once thought strictly contraindicated.

What about heart risks? The newly proposed testosterone prescribing guidelines were inspired, in part, by recent studies that suggest that testosterone can increase the risk of heart attacks and strokes.

But these studies have been heavily criticized on the grounds that they were poorly designed. Men already at high risk of heart attacks were placed on non-individualized doses of testosterone that were not even monitored; some men got injections of synthetic testosterone, while others applied creams and gels of natural, bio-identical testosterone like I prescribe.

And recently, my position has been vindicated by the European version of the FDA, the European Medicines Agency (EMA). They recently ruled that testosterone's benefits outweigh its risks. They concluded that there's no consistent evidence that testosterone increases the risk of heart problems in men with hypogonadism.

A similar thing happened with estrogen. Some early studies of synthetic hormones for menopausal women sowed panic after a higher incidence of heart attacks and strokes was detected; only later was it found that giving younger healthier women natural hormone replacement therapy was protective to the heart.

I actually think prescribing testosterone is a great way to avert circulatory disease. Most obese men who suffer from metabolic syndrome or Type 2 diabetes are low in testosterone. They are often depressed, lethargic, and flabby.

It's even been claimed, picturesquely, that the ability to have erections is like a "dipstick" for checking the status of your heart!

Metabolic syndrome and diabetes are key risk factors for heart attack and stroke. Once a man's testosterone is restored, he often gets a new lease on life, and begins to exercise and shed pounds with renewed motivation and vigor.

Testosterone has even been studied as a remedy for claudication (painful walking due to poor circulation to the legs) and heart failure. It promotes arterial circulation and increases the pumping action of weak cardiac muscles.

I never give testosterone alone, unlike hastily put together testosterone "chop shops" that now hand out prescriptions like party favors. I always offer testosterone as part of a comprehensive effort at lifestyle modification, comprising diet, exercise and heart-protective supplements.

That's why I'm dismayed by the new FDA panel's proposed guidelines. Should they be adopted by the FDA, I think they'll deal a major setback to the health and well-being of countless men.

I hope that one of the panel's recommendations will be heeded: we do need more research on the effects of testosterone in men. I think that several proposed large-scale research studies will ultimately vindicate testosterone and the medical establishment will come to recognize it for the safe, invaluable tool it is.

If you're contemplating testosterone, make sure you obtain it from a testosterone-literate health provider, and insist on bio-identical testosterone, not a synthetic version. Get frequent monitoring. And make sure you use testosterone as part of a comprehensive program of lifestyle modification and supplementation.

Meanwhile, I for one will continue to be an advocate for judicious testosterone prescribing on behalf of the scores of men I've treated for whom testosterone has proven a real boon.