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Subscribe to RSS"Are you falling asleep after dinner?"
"Do you have a decrease in libido?"
"Have you noticed a recent deterioration in your ability to play sports?"
"It could be Low-T."
Welcome to the latest big marketing push by the nation's drug companies. In this case, it's a web page for Abbott Laboratories' Androgel, a billion-dollar selling testosterone gel used by millions of American men struggling with the symptoms of growing older that are associated with low testosterone, such as poor sex drive, weight gain and fatigue.
Androgel is one of a growing number of prescription gels, patches and injections aimed at boosting the male hormone that begins to decline after about age 40. Drugmakers and some doctors claim testosterone therapy can reverse some of the signs of aging — even though the safety and effectiveness of such treatments is unclear.
"The problem is that we don't have any evidence that prescribing testosterone to older men with relatively low testosterone levels does any good," says Dr. Sergei Romashkan, who oversees clinical trials for the National Institute on Aging, a part of the National Institutes of Health conglomerate of research centers.
Low testosterone is the latest example of a once-natural part of getting old that has become a target for medical treatment. Bladder problems, brittle bones and hot flashes have followed a similar path: from inconvenient facts of life, to ailments that can be treated with drugs. The rise of such therapies is being fueled by both demographics and industry marketing.
Baby boomers are living longer and looking for ways to deal with the infirmities of old age: Life expectancy in the U.S. today is 78 years, up from 69 years a half-century ago. And companies have stepped up their marketing to the older crowd: Spending on print and television ads promoting testosterone by firms like Abbott and Eli Lilly has risen more than 170 percent in the last three years to more than $14 million in 2011, according to advertising tracker Kantar Media.
Doctors say that's led to an increase in men seeking treatment for low testosterone. Prescriptions for the hormone have increased nearly 90 percent over the last five years, according to IMS Health. Last year, global sales reached $1.9 billion.
"People are living longer and want to be more active," says Dr. Spyros Mezitis, a hormone specialist at Lenox Hill Hospital in New York. "They no longer consider that because they're older they shouldn't have sexual intercourse."
Former marathon runner Damon Lease, 50, had been complaining of low energy and depression, for which his doctor prescribed a combination of four psychiatric drugs. But since he started taking twice-a-week testosterone injections in May, he says he's been able to stop taking two of the medications and hopes to eliminate them completely. He says he has more energy, improved mood and concentration.
"I spent 27 years running long distances, I like biking, I like hiking, and I guess every guy wants to have an active sex life ... I want to keep doing those things as long as I can," says Lease, who works as a software company executive. "I feel 20 years younger."
Mass-market hormone
Despite its rising popularity, testosterone therapy is not completely new. Testosterone injections were long used for men with hypogonadism, a disorder defined by low testosterone caused by injury or infection to the reproductive or hormonal organs.
But the latest marketing push by drugmakers is for easy-to-use gels and patches that are aimed at a much broader population of otherwise healthy older men with low testosterone, or androgen deficiency. The condition is associated with a broad range of unpleasant symptoms ranging from insomnia to depression to erectile dysfunction. Drug companies peg this group at about 15 million American men, though federal scientists do not use such estimates.
Watson Pharmaceuticals now markets its Androderm patch, which slowly releases testosterone into the bloodstream. Abbott has its gel that can be applied to the shoulders and arms. And Eli Lilly's Axiron is an underarm gel that rolls on like deodorant. Androderm, launched last year, had $87 million in sales, and Axiron, which was launched in 2010, had sales of $48 million last year.
"All of a sudden you've got these big players with a lot of money using consumer directed marketing to change the landscape," said Dr. Natan Bar-Chama, a male reproductive specialist at Mount Sinai Hospital in New York. "They see the potential, they see the market growth annually and it's very impressive."
But government researchers worry that medical treatments have gotten ahead of the science.
Male testosterone is mainly produced in the testes and affects muscle mass, sperm production and various sexual characteristics. The hormone can easily be checked with a blood test, but doctors can't agree on what constitutes a low reading in older men. Typical testosterone levels for younger men range between 300 and 1,000 nanograms per deciliter, but once levels begin dropping there is little consensus on what makes a "normal number."
Some doctors believe testosterone levels below 300 lead to sexual dysfunction in older men, but the rule does not cover all cases. A 2010 study by researchers at the University of Manchester and other European institutions found that 25 percent of men with testosterone levels above that threshold had the same sexual problems used to diagnose low testosterone. Adding to the ambiguity is that testosterone levels change by the hour, so a man who takes a blood test for testosterone in the morning may get a completely different reading when tested in the afternoon.
Safety concerns
Adding to the confusion over what defines "low testosterone," there's not much understanding of whether testosterone replacement therapy actually improves men's symptoms. Evidence of the benefits of testosterone is mixed, and the potential health risks are serious. The largest study conducted to date, a 2008 trial involving 230 patients in the Netherlands, found no improvement in muscle strength, cognitive thinking, bone density or overall quality of life among men taking testosterone. Muscle mass increased 1.2 percent, but not enough to improve physical mobility.
The National Institute on Aging is currently conducting an 800-man trial to definitively answer whether testosterone therapy improves walking ability, sexual function, energy, memory and blood cell count in men 65 years and older. But those results aren't expected until 2014.
In addition to concerns about testosterone's effectiveness, the long-term side effects of the hormone are not entirely understood because most trials to date have only followed patients for a few months. But the most serious risks include heart problems and prostate cancer. In fact, all testosterone drugs carry a warning that the hormone should not be given to men who have a personal or family history of prostate cancer.
In 2010, researchers at Boston University's school of medicine halted a large study of testosterone in senior men because patients taking the hormone were five times more likely to suffer a serious heart event, including congestive heart failure, than those taking placebo. A review of 19 testosterone trials in 2006 found that prostate cancer was significantly higher among men taking testosterone.
Also in 2006, the Endocrine Society published the first physician guidelines for prescribing testosterone for men with androgen deficiency. All six of the co-authors had received consulting fees or research funding from drugmakers that market testosterone. Despite those ties, the authors took a cautious tone, stressing the difficulty of accurately diagnosing low testosterone and acknowledging that they were unable to reach an agreement about when doctors should begin therapy. They also recommend doctors have an "explicit discussion of the uncertainty about the risks and benefits of testosterone therapy."
History has shown that hormone replacement therapy can be dangerous. That hit home for women in 2002 when a landmark study shook up the conventional wisdom about the benefits of estrogen replacement therapy for menopause, the period when women stop producing eggs and the hormone estrogen. The federal study found that women taking hormone pills were more likely to suffer heart attacks, breast cancer and strokes. Doctors now generally recommend hormones only to relieve severe menopause symptoms — in the lowest possible dose and for the shortest possible time.
In the case of testosterone, Abbott Laboratories says Androgel and other drugs like it are an important treatment option for men with low levels of the hormone. But the company acknowledges that more study is needed.
"Abbott believes that the long-term effects of testosterone replacement therapy should be studied, which is why we continually fund and support additional clinical trials, such as the National Institute of Aging's testosterone trial," the company says.
Doctors who prescribe testosterone say more men should be talking to their doctors about the hormone. "If an older man feels excessively tired or his erectile dysfunction has worsened he should be asking 'Is there something wrong with my testosterone?'" says Mezitis of Lenox Hill Hospital. "The awareness should be much broader than it is at this point."
Even critics of the testosterone craze acknowledge that the interest in anti-aging products may be inevitable as life expectancy increases. But they say doctors can do more to help seniors by focusing on lifestyle adjustments that keep them connected to their friends and family, rather than prescribing drugs.
"We really 'medicalize' seniors so much that they think the secret always has to be scientific," says Dr. Nortin Hadler of the University of North Carolina at Chapel Hill, who has written four books on excessive medical care. "We need another perspective to understand the secrets to healthy aging, which by and large are not pills."
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Just what the world needs: MORE testosterone. From a daily reading of the news, it appears that there's already an over abundance.
This article is more about how seniors should simply accept the consequences of aging rather than what it should be about and that is celebrating the fact that senior men who still feel like they did when they were in their 20s 30s 40s mentally want the same when it comes to their sexual ability. And theres absolutely nothing wrong with wanting that if your heart can handle it...LOL
When I was 50 I talked with my doc about some changes in mood and behavior that concerned me. My sex interest was still lively and functioning well enough.
He suggested trying Androgel, explaining that it was something I could rub on daily. Noting my up-perking look, he went on to explain that the application site was my shoulder.
The stuff was very expensive and not covered by my drug insurance, but I decided to try it for a month anyway, and dutifully slathered my shoulder every day.
There was no noticeable change until the third week. I was still watching TV then. I used to laugh at a friend who teared up at Hallmark commercials. One night, watching something inane that had a very shallow emotional appeal--I started to cry--loud sobs and weeps and salty tears. I put that episode down to an overindulgence in vodka. But ti happened a couple of times again.
I mentioned it to another doc, a neurologist. He explained that the androgen is supposed to aid production of testosterone, but sometimes it switches on estrogen instead. I decided to call an immediate end to that approach to combating aging.
Subsequently, I found that it was much easier to express myself emotionally in some situations where I'd been non-responsive, so some good came from the experiment. But I see that these things need to be approached with caution.
So now I take daily capsules of Maca root and imagine they make me feel better. If they don't in fact, no harm done.
An overabundance of testosterone is what the problem is in the Middle East. What we need is an aerosol testosterone blocker, not more testosterone.
Weird - Researchers of a Netherlands trial found little gain in a statistically insignificant sample number of men - But men who take the drug recreationally (A typical TRT dose of Testosterone is 200mg a week, for recreational use the number USUALLY 400-600mg) universally report better moods, drives, energy, and can easily put on 20 pounds in two to three months.
Even disregarding that, the placebo is usually more than enough.
Also: Androgel is terrible for absorption. Injections, though less fun, are a VASTLY more effective way of administration.
But hey, don't trust me - Go educate yourself on PubMed.
Testosterone prescriptions to patient with deficiency has been one of the most rewarding and side effect free medications I prescribe to men. There are major physical, mental and physiologic changes with low testosterone and aging. It is absolutely reasonable for us to pursue safe ways to decrease the inevitable negative symptoms of aging to try to have a better quality of life. This article is behind, we have been using testosterone in medicine for several decades now, longer than most of the Rxs I give to patients.
I medicate myself with Test injections a couple of times a year. Most of the claims in this article are nonsense. Test rocks. It will raise your blood pressure and cholesterol temporarily, but that hasn't been a problem for me.
As a 45 year old dealing with this, I am irritated with everything about this. It is undoubtedly a 'FAD" treatment, but for me at least, it is out of necessity. It is not about NORMAL aging process, not is it about simple fatigue or weight gain. It is fully miserable, and an issue between me and my doctor. I honestly thought i would not make it another 5 years. Now I do not see those limitations. My doctor is very cautious and careful, and I have paid for many tests before we started. It has been worth it.
My health care costs have actually gone down. Additionally my sick leave has been eliminated. I am not trying to become a body builder - the stigma is strong, but it does not hold.
My concern is that the 'FAD' nature of the treatment will interfere with the proper treatment for those of us who do greatly benefit from it. To compound the concern are the countless 'pundit nation' that feels they need to be involved with my treatment. Fads come and go. So do proper treatments when too many people get involved.
I won't be around long enough for the long-term studies to be completed, but I'd tend to side with Dr. Harris on the theory that lowering testosterone levels with age is one of Nature's way of helping to combat the increased risk of prostate cancer. If you have a lower than normal level of T, then I can see taking a supplement. But if your level is normal, or near so, then adding more T plainly makes your level abnormal. If you're tired, or experiencing the consequences of natural aging, try changing your diet and exercising more before you go on the latest (heavily promoted) fad.
Everyone looks for the easy way out.
This article and a large number of the comments concern me in several ways.
I am a generally healthy 45 year old. 12 months ago, I did not think I would last another 5 years. My muscles and joints were failing as well as my eyesight. NOT normal aging. The one thing many of the pendents do not understand is that everyone ages differently. I have watched other men in my family incur the pain and degradation due to this disorder. For some of us, it is not about sex drive, or fatigue or weight gain. It is about living a decent life.
For those that are 'concerned' that it may form an addiction - I am not a body builder. I never will be. I have however been addicted to testosterone for 35 years or so. I am not sorry about it nor am I embarrassed. That in fact is normal. Those commenting that it is an issue are flapping their jaws, brain disengaged, without any clue what they are talking about or concern for those they are speaking.
There is no doubt that it is a 'FAD' treatment for many. The real issue is, that the cookie cutter approach for health that is emerging is dangerous and completely unreasonable. My doctor is incredibly careful and cautious, and I have spent a great deal of money to make sure this is the correct course of action. At this point, the more people who are involved, the less likely I am to get proper treatment.
Since starting the treatments, my eyesight has stabilized a bit, I am more active because I suffer from less pain. My healthcare costs have DECREASED. I have not had a sick day since I started, and although I feel like a 45 year old, my quality of life is improving. Most of the people posting here treat it as some sort of spectator sport - where they can show how smart they are. Please understand two things: 1) Unless you have been there, you do not know. 2) There are real people on the other end of your comments - karma has a funny way of cathing up with you in this life.
I'm only 39 years old and I had wondered for years if my testosterone levels were low. I started seeing all the comercials about Low T and the benefits of Hormone replacement therapy. I have experienced weight gain even though I eat less now than ever and low energy levels and reduced sex drive.
I went to the doctor a couple months ago and was scheduled to have a blood test to see why my blood pressure was high and asked the doctor if he could test my Testosterone levels too. He said he would do so and call me if anything was out of sorts.
The next day a nurse called and said that they are prescribing androgel 1.62 because my T level was 98. I've been taking androgel since mid july and I have noticed some improvements. For one the chest pains I was experiencing daily have completely disappeared. I have more energy and my sex drive is significantly better. I haven't noticed any weight loss yet but otherwise I feel great now.
Everyone's looking for a magic pill. Try eating healthy, keeping the extra weight off and and exercising. They work wonders. I'm 56, had a prostatectomey 6 months ago and am back to a normal (welll, almost normal) sex drive and life. I run and weight train, not obsessively but enough to keep all cylanders popping. Oh, and glass of wine or two doesn't hurt either. I feel like I'm in the best years of my life.
I have been on testosterone replacement therapy now for three years and can tell you it has helped my energy level tremendously. I know there are doubters out there, but all I know is that it has helped me remain active and excercising which has kept me healthy. As a middle-class male approaching 50, I need every edge I can get to stay ahead of all the natural, economic and societal forces working against me. I see from some of the posts that people have different expectations of what they want to experience as they grow older. That is fine. I just don't understand why some people assume that my desire to maintain a healthy hormone level equates to some negative agenda on my part. After all, I have the same rights about my body and what to do with it that a woman does.
Testosterone therapy for individuals with very low levels is not all about sex. Low T can cause bone loss, depression, and several other conditions. Men with normal levels of testosterone for their age group rarely have bone loss and are healthier and live longer.
If it also helps a low libido, that's a plus, but not everyone going through andropause experiences it exactly the same way (which is also true in menopause), and hormones out of balance affect many things beyond the sex organs.
You are spot on Mike,
I have never noticed the loss of libido - there is a lot more going on there anyway. I can attest to a very large range of other symptoms that have nearly been eradicated. Sleep loss, muscle and joint pain, bone loss, my eyesight has nearly stabilized, infections and vein issues. These are all being lessed with careful and monitored therapy.
I have been using hormone T cream and for about a year and feel much better, more confidence, more muscle tone, endurance and no longer fatigued in the day!
I love it!
No Joke......Eat tons of fruit and Veg and workout = Ton of energy and Increases libido alot. Over 40 years old.
Being overweight causes low testosterone. Fat cells release estrones that mimic estrogen. Being overweight results form overeating. Overeating causes a lot of issues.
People with these problems should join Overeaters Anonymous.
we medicalize almost all segements of our society...It's huge business and drug Companies make the prblem and the meds....AMAZING....And we want to tech are kids about drugs..we are....everyday....Wake UP
Hell who needs clinical trials? Abbott is making billions and they're a big contributor to the re-elect Odumbo campaign so OF COURSE the FDA is gonna say yes... Wherever there's corruption you'll always find that Democrat with his hand out! (Kinda like a black-Muslim Anti-Batman)
Men have as much reason to be suspicious of government medical institutions under Health and Human Services, as they do the pharmaceutical industry. When the article states that more research needs to be done in this area, it could just as well be said about any men's health topic, except heart disease. There are multiple men's health issues where solutions are urgently needed and have been for some time - like prostate cancer screening, contraceptives development, excessive cancer incidence, and overall poor access to health care - these get diminished attention from Health and Human Services. So why men would be attracted to solutions from the pharmaceutical industry is perfectly understandable because no other aspect of medicine is paying them much attention. Men have ample reasons to think Health and Human Services ignores them, leaving them to suffer unnecessarily. Look at the poor coverage they are getting from the healthcare act; look at the fact no Office of Men's Health exists in HSS; go to CDC Sortable Stats and look up male sorted statistics. These all reveal a general pattern of neglect. That men would look for solutions elsewhere is perfectly reasonable.
Despite the understandable naysayers, all I know is that Androgel is keeping me alive. The consequences of prolonged testosterone deficiency are not good and include premature death. I have experienced no discernible side effects after more than five months of use. I was feeling lethargic and became narcoleptic at times. My testosterone as determined via blood draw was 215, far below the normal average 545 for a 49 year old male. I had testicular cancer in 1995, and I lost one of my testicles. I was fine until 18 months ago when I could no longer sustain an erection so I was given Viagra then Cialis. Then a few months later I started becoming scatter-brained and tired as well as getting hot flashes. After some months of this I felt unable to function at which point I made a trip to the urologist who treated my cancer and determined the low-T. There is nothing "lifestyle" or recreational about my use of the product. After four months of it, I felt more like myself and had taken up going to a fitness club 3x per week as well. The two of them have helped restore my health, but even with working out I would not be able to function without Androgel. I no loner need to use erectile dysfunction meds either!
Yes, drug companies market their products. In my personal case, I feel it may have saved my life. It is a doctor's decision whether to prescribe, so ultimately he or she must be the gatekeeper for the use of any drug. Also, the use of this stuff is so heavily restricted per FDA rules that it seems doubtful to me that anyone would use this for unintended purposes or if not needed, especially given the possible side effects. I can only speak for myself when I say I thank God that somebody invented the drug I am taking because otherwise I might not be here to type this right now or I would be very, very ill.
Looks like I'm one of the long timers on testosterone here. In 2000 I made it into a REAL pain clinic after decades of untreated pain and other problems. They ran a lot of tests. They started me on testosterone. What a day and night difference! I had reduction of pain, increase of energy, improvment of mood, return of erections and all that good stuff. Now 12 years later, with suitable vitamins doing much better but still on the testosterone. I swtiched to injections at $25/month for my partner to inject instead of $7/day for a gel. And the injections work better for me. The gels were never enough and way too expensive. After 12 years on testosterone, and with the right vitamins and exercise, I have lost 85 pounds of water, 40 pounds of fat and gained 50 pounds of muscles, back to normal. No more congestive heart failure.
Interesting perspective Freddd. I do think that many doctors fail to recognize the importance of a proper balance of natural hormones. This is particularly true as we age. Way too many of them seem to want to tell us to just get used to it because you are getting old. Others warn about all manner of scary side effects. My answer to that is what the heck is the value of a useless life if you are suffering and miserable? I would rather take my chances with what ever side effects and make the most of what remains of my miserable existence. Yes the sex part is important but as you point out the physical well being and the self esteem are well worth any possible risks. Say what you will about American medicine but sometimes you get better service in foreign countries where the customer is always right and the doctors don't try and tell you how you should feel about some treatment or another.