One of the most effective treatments I offer in my practice is bioidentical hormone replacement – for both men and women.
It’s remarkable to see how these treatments rejuvenate my patients’ brains, muscles, bones, and sex lives – and they start noticing the difference quickly.
And there is practically no hormone out there that produces better or faster results than testosterone.
I ask my male patients to remember what it was like when they were in their late teens and early 20s, and they always get a big smile on their faces. Their hormones were raging, they felt like Superman, and they never worried about getting sick.
It’s not a stretch to think that their health was so amazing because of their high testosterone levels… and as their testosterone levels dipped, their health started to dwindle as well.
There’s lots of scientific data that supports this link between testosterone levels and good health. And keeping a male’s testosterone level in the normal-to optimal range is the goal of almost all integrative doctors.
But unfortunately, this therapy took a ‘hit’ in the beginning of 2014 when the US Food and Drug Administration (FDA) placed an official warning on it.
So I’d like to take this opportunity to explain what happened… why the FDA responded as they did… and how they got it wrong.
No matter what you may have read or heard elsewhere, testosterone is safe and effective. And the latest research – a study you can trust, from a reliable source with real results – confirms it.
But first: a little background.
Two bad apples spoiled the bunch
In 2013 and 2014, testosterone replacement was at an all-time high. The pharmaceutical industry had poured a decent chunk of money in to advertising and educating the public about ‘Low T’.
But testosterone therapy hit a big roadblock when two different published studies implicated testosterone therapy in an increased risk of heart attacks and strokes.
The FDA subsequently issued a black box warning1 – and, within weeks, lawyers started to circle like bloodthirsty sharks, striking fear into patients, their spouses, and their children. The calls started to pour in to my office. Worried patients wanted to know if they should stop their testosterone therapy.
This was shocking information to me, because at that point I’d already treated many men with testosterone without ever seeing anything to make me cautious about giving it to them.
But, trying to be a responsible doctor, I delved into the two nefarious studies – and what I found was shocking. I instantly noted that there were gaping holes and problems with both studies – especially the most damning one, published in the heralded JAMA magazine.
I was outraged at the poor science being used in these studies – and, fortunately, I wasn’t the only one.
In response to the shoddy studies, an organisation called The Androgen Study Group (ASG) immediately formed to make sure that the public and the medical community could be properly educated… with real facts… that would be accurately reported.
ASG organised 25 major medical societies3 as well as over 160 distinguished medical experts from around the world to petition the FDA to reconsider issuing a black box warning on testosterone therapy.4 While the FDA didn’t accept the petition, they did eventually soften their stance on testosterone replacement.
The medical experts of the ASG were so passionate and confident in the mistakes that had been made that they did something else, too – something that had never been done before. They petitioned JAMA to remove the study and print a full retraction from their prestigious and influential magazine, stating that ‘the quality and magnitude of these errors indicate gross data mismanagement and contamination, to a degree that the reported results are no longer reliable.
JAMA was forced to issue two retractions to the erroneous and misleading study to boot.
Of course, by then, the damage had already been done.
The Androgen Study Group Chairman Dr. Abraham Morgentaler perhaps put it best when he was quoted as saying, ‘JAMA has violated the public trust… and JAMA’s continued support of this discredited study, defying the worldwide community of experts, represents medical literature malpractice.
Bad science can spread like a virus
But something good did come out of this debacle. The outrage caused hundreds of doctors to do what I did, and dig down into the studies. Like me, they found some serious flaws.
The craziest mistake was that the researchers behind the study published in JAMA mistakenly included WOMEN in their data! They didn’t even realize it until the ASG brought it to their attention.
And then, shockingly, the authors of the JAMA study didn’t disclose their egregious errors for two whole months – just enough time for the press to take this bombshell study and run with it, plastering their pages with headlines that testosterone therapy was harmful.
The cat was let out of the bag. Now, the only reason that this study was picked apart was because it was about a therapy that people are passionate about: hormones. Most people and doctors are not passionate about their diabetes or hypertension drugs!
So, if the researchers made such embarrassing errors – and JAMA editors missed them – that begs the question: What other studies have been loaded with errors and falsehoods?
And how have these flaws shaped the way that we practice medicine, because of a resulting firestorm of negative press?
I wonder what other beneficial therapies have been wounded by the same calamity – and which dangerous therapies have managed to squeak by unnoticed.
A study that was designed to fail (but didn’t)
But now, there’s a new study that’s good enough to start to shift the public perception of this amazing therapy that’s been dragged through the mud.
Earlier this year, a new US study out of the Intermountain Medical Center Heart Institute in Utah directly addressed and REFUTED the FDA warning, showing that testosterone therapy is not only safe in elderly men… but actually protects their hearts!
Of course, this data about testosterone prolonging the lives of men with heart problems isn’t really revolutionary – there have already been studies that have shown that testosterone replacement can add years to your life.
But the great part of this study is that these researchers didn’t take the easy way out and rig the system to make sure that the results ended up in their favour. Instead, they had the guts to up the stakes and enroll patients who had the highest risk of having a stroke or a heart attack.
The study followed 750 men between 58 and 78 years old – all with severe coronary artery disease – for three years. They gave some of the patients very high-dose testosterone therapy via injection, but the study showed no increased risk in cardiovascular events (stroke, heart attack, or death).
Not only that, but it actually showed a reduced risk. The researchers compared their results to an aged-matched group of cohorts and found that the patients who didn’t receive testosterone had a whopping 80 per cent greater risk of stroke, heart attack, or death.
What a difference from thinking that testosterone is the cause of heart disease!
The unrefuted research speaks for itself
One of the silver linings from the attacks on testosterone is that they prompted the Androgen
Study Group to amass ALL of the data about testosterone therapy over the last 70 years, which you can read all about on their website www.androgenstudygroup.org. And one of the major takeaways is that this new study is just the tip of the iceberg of amazingly positive studies supporting the benefits of testosterone therapy.
Even more studies show that raising your low T levels can reduce your cardiovascular risk factors such as obesity, fat mass, waist circumference, blood pressure, and glycemic control.
Based on the literature, however, there is a clear, absolute risk of having a LOW level of testosterone. The data shows that low testosterone levels are associated with atherosclerosis, osteoporosis, cardiovascular risk factors, and even early death.
Between the abundance of studies that have shown a positive outcome… as well as the scarcity of data that show that this therapy is dangerous… I really wonder how in the world the FDA issued a black box warning on this therapy in the first place.
Are you ready to get back in the saddle?
Gentlemen, there are some ‘side effects’ of testosterone therapy that you’ll want to watch out for… and warn your wives of: better sex drive, energy, memory, and stronger erections. Taking testosterone can help you feel younger, stronger, and more vital – both in and out of the bedroom.
If your current doctor doesn’t want to go down this path with you, please find an integrated doctor to work with who will.
Dr. Glenn S. Rothfeld
Nutrition & Healing
Vol. 10, Issue 6 • June 2016