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AndroGel – Risky Business

April 17, 2012
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Two years ago The New England Journal of Medicine, likely the most prestigious journal in all of medicine, published a study, Testosterone in Older Men or TOM trial, that showed the dangerous effects of testosterone in men over the age of 65 years of age. The results, so dramatic, with cardiovascular event rates TEN times more likely in patients who received testosterone gel instead of placebo, caused the doctors that monitored the study, for fear of harming more patients, to halt the trial.

Being the lead author of a paper that is published in the NEJM, especially the lead article, is quite a feather in one’s cap , especially a study like this, which clearly showed, in this group of men, that testosterone replacement was harmful. But rather than promote these findings and start a campaign to discourage some men from using this drug, the first author of the trial, a Shehzad Basaria appears to be trying to convince us that it was all a mistake.
Shortly after the study was published Dr. Basaria was interviewed by Theheart.org, an internet news site that caters to cardiologists, and it appears to me that he wanted to dissuade us from accepting his own results showing that this drug was dangerous. In that interview he is quoted saying, “chance may have played a role in the outcomes observed and that the diversity of the adverse cardiac events that were seen in the prematurely terminated trial makes them less easily explained by a single mechanistic explanation.”

Dr. Basaria wants us to believe that the results in his own study could be “easily” wrong. But why? The author’s own statistical analysis, published in this paper, suggests that there is at least 97% likelihood that these results did not occur by chance and that these men were likely harmed by taking testosterone. It seems almost insane to believe that the author of such an important study, which suggests that a drug could harm millions, would attempt to convince us that he goofed. Bewildering, until Dr. Basaria admitted that he has a significant financial relationship with Solvay Pharmaceuticals (now owned by Abbott Pharmaceuticals) who just happen to be the makers of AndroGel – the most widely prescribed testosterone replacement.

Instead of issuing warnings about the risk of AndroGel, Abbott has pumped up their advertising and many doctors have downplayed the results of the TOM trial. Dr. Snyder, of the University of Pennsylvania, was interviewed by the NY Times in 2010 and called the results of the TOM trial “an aberration.” I found his remarks a bit worrisome since Dr. Snyder and the university are likely to make millions from an NIH sponsored study that will look at the effects of testosterone on men. Do you think the patients who sign up for the study will be told about the TOM study as part of their consent?

Rather than sound an alarm, many influential physicians, who I suspect have money to make, or lose, based on the use of AndroGel, seem to have come up with excuses for the trial results: The patients were old and ill; perhaps the exercise regimen given to the patients caused heart attacks; or perhaps the results occurred by chance.

While I agree that most men who take testosterone looking for the fountain of youth are a bit younger and healthier, I also know that toxins tend to kill the weakest first. Didn’t miners put canaries in their mines so that when they saw the canary die they knew they had better get out before the toxic gasses killed them? Does it not follow then that this toxin, just like the toxins in a superfund site, will just kill the weakest faster?

I’ve watched Big Pharma and Big Doctors manipulate the system for years, resulting in countless deaths, or perhaps homocides, while they pocketed millions and went on to another project. I am concerned that we may have a huge epidemic of heart disease and death on our hands because of the foolish use of testosterone gels. And, perhaps unfortunately, there is a good reason why many men do take AndroGel; it makes you stronger and it can make you a better performer in the gym and in bed. The drug does work! It literally can “Pump you Up”….. until your heart bursts.

While I warn about the potential dangers of applying this gel on your body, AndroGel, and similar ointments, have a danger that even the FDA and Abbott labs admits too — it can result in a burst of the male hormone in anyone who comes into contact with it; your infant girl perhaps.

Below is a warning contained in the Prescribing Information (also known as the PI) that Abbott Labs encloses with every purchase of AndroGel:

This is reviewed by and approved by the FDA.
Potential for Secondary Exposure to Testosterone and Steps to Prevent Secondary Exposure
Secondary exposure to testosterone in children and women can occur with the use of testosterone gel in men. Cases of secondary exposure to testosterone have been reported in children with signs and symptoms including enlargement of the penis or clitoris, premature development of pubic hair, increased erections, and aggressive behavior.
• Physicians should advise patients of the reported signs and symptoms of secondary exposure which may include the following:
• In children; unexpected sexual development including inappropriate enlargement of the penis or clitoris, premature development of pubic hair, increased erections, and aggressive behavior
• In women; changes in hair distribution, increase in acne, or other signs of testosterone effects
• The possibility of secondary exposure to testosterone gel should be brought to the attention of a healthcare provider
• Testosterone gel should be promptly discontinued until the cause of virilization is identified
Strict adherence to the following precautions is advised to minimize the potential for secondary exposure to testosterone from testosterone gel in men [see FDA-Approved Medication Guide]:
• Children and women should avoid contact with unwashed or unclothed application site(s) of men using testosterone gel
• To minimize the potential for transfer to others, patients using AndroGel should apply the product as directed and strictly adhere to the following:
• Wash hands with soap and water after application
• Cover the application site(s) with clothing after the gel has dried
• Wash the application site(s) thoroughly with soap and water prior to any situation where skin-to-skin contact of the application site with another person is anticipated
• In the event that unwashed or unclothed skin to which testosterone gel has been applied comes in contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible.

To MINIMIZE the potential transfer to others, patients using AndroGel should wash hands in soap and water after applications.

Are you frightened about who you may come into contact with after reading this? You should be!

In my fifty years of observation, I have seen too many men leave bathrooms without stopping at the sink, and I can only assume many men are not much better at home after they smear the AndroGel on their body.

Imagine letting a male friend, or even your husband, who happens to be using AndroGel, hold your newborn child. If he is not assiduous in his hygiene skills they could give them a huge boost of testosterone! Your daughter especially could be damaged for life! And what about others, your child’s teacher, the neighbor, the girls coach or even the hairstylist, who, if they have any amount of AndroGel still on their hand could pass this along to your child? I believe there are hundreds of thousands of men walking about with this stuff still on their hands and they are inoculating many of us with it.

My guess is that if we called in a hundred patients who admittedly use AndroGel, and test their hands for testosterone, we would find too many with it all over their hands, rendering them capable of transferring it to anyone they come into contact with. And I bet that there are little girls, living with a dad who uses this, that are being exposed to testosterone every day. I have discussed the possibility of doing this simple study with some in the media. So far, no one seems interested.

 

Dr. Evan S. Levine is a cardiologist in New York and a Clinical Assistant Professor of Medicine at Montefiore Medical Center – Albert Einstein College of Medicine. He is also the author of the book “What Your Doctor Won’t (or can’t) Tell You”. He lives in Connecticut with his wife and children.

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10 Responses to AndroGel – Risky Business

  1. Sam Smith on June 18, 2014 at 9:21 pm

    these gels are evil. i am a man. i was infertile for a couple of years because i used opiate painkillers after 3 surgeries on my body and i have coeliac disease which causes infertility. i didn’t know i had coeliac disease at the time. i thought i had hormonal problems. when i was on holiday, i bought testosterone creams, and also a dht cream called andractim.

    i heard about the risk of exposure, so i always washed my hands. as dickish as it may seem, men wearing this gel and putting others at risk, think about it for a second…is it actually their fault. if taking an antidepressant could be transferred to the system of another person by kissing them, would that be the person’s fault. the point i am making is that men didnt make the testosterone creams. the companies did. we could just as easily be sitting here talking about how the companies made a cream that is 100 percent absorbed and non transferrable from skin. but we are not. it is the fault of the companies, 100 per cent.

    if you asked any man whether they intentionally transferred this cream, unless they were a psychopath, the answer would be no.

    it puts men in a disgusting moral position, and it is completely the companies’ fault.

    i used these creams at uni and there was a girl in the room next to me. she is gorgeous. i was wearing these creams for about a month. her face has changed. i have looked at pictures of her before and after and her forehead has grown, her face has widened, her skin is thicker and her facial bones have hardened.

    how am i supposed to live with this. i have ruined someone elses life. she will never know and she probably doesnt even know its happened but she will never live the potential moments she would have lived if this hadnt happened.

    i am utterly devastated. it is not my fault for transferring this, i washed my hands and wore clothes on top of it, what more can i do. i think its utterly disgusting and outrageous that companies put creams out there that are fucking dangerous and harmful to others, and this is somehow accepted as normal.

    why are these creams even on the market, surely they would have been withdrawn as soon as a study came out indicating transference.

    its like saying you can have guns around kids as long as you are careful. like they’re fucking saying about washing your hands. it’s bullshit. this whole situation beggars belief.

    i have to live for the rest of my life with the knowledge that i have ruined someone elses life, and she doesnt even know about it. how the fuck am i supposed to tell that to her.

    if something is dangerous, then putting it in the hands of irresponsible idiots is going to cause damage.

  2. Paul Molinaro, M.D., J.D. on April 29, 2014 at 3:24 pm

    It’s about time this cure found a disease!

    According to its manufacturer, AbbVie, “AndroGel® (testosterone gel) 1% and 1.62% are controlled substances, available by prescription, used to treat adult males who have low or no testosterone.” The AndroGel website offers the following ten question yes-no quiz to see whether a man “should talk to” his “doctor about Low Testosterone:”

    1. Do you have a decrease in libido (sex drive)?
    2. Do you have a lack of energy?
    3. Do you have a decrease in strength and/or endurance?
    4. Have you lost height?
    5. Have you noticed a decrease in your enjoyment of life?
    6. Are you sad and/or grumpy?
    7. Are your erections less strong?
    8. Have you noticed a recent deterioration in your ability to play sports?
    9. Are you falling asleep after dinner?
    10. Has there been a recent deterioration in your work performance?

    The ten questions might just as well ask, “Are you getting old?” or “Are you naturally aging?” Snake oil salesmen have been selling fountain of youth elixirs since people starting getting old. Fortunately, most snake oils are only harmful to the purchaser’s wallet as many of the alleged aging cures are harmless. However, once in a while a potion does contain harmful ingredients or actual medicinal compounds which have major physiological effects. AndroGel seems to be promoted as the cure for a newly discovered disease called, “Low T.” However, its safety is in question.

    On January 31, 2014, the United States Food and Drug Administration (FDA) issued a Safety Announcement regarding testosterone products. This communication stated, “At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals. Health care professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment. The prescribing information in the drug labels of FDA-approved testosterone products should be followed.” While the beginning of this Safety Announcement might not seem alarming, the FDA further states, “None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition. FDA-approved testosterone formulations include the topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection.”

    What is “an associated medical condition?” The manufacturers of some testosterone products would have one believe that Low T (the condition of having low testosterone levels) is an associated medical condition to the condition of having low testosterone. If you think this is strange logic, you would be correct. There are some who feel that the manufacturers of some testosterone products, realizing that they had a profitable “cure” for a disease that did not exist, simply invented a disease with ten associated symptoms (see quiz above). Recent studies have shown that certain groups of men taking testosterone will have increased risks of stroke and heart attack. Lawsuits are now being filed against the manufacturers of some testosterone products and for failing to warn consumers about the deadly harm that testosterone can cause. Without getting technical, testosterone has been shown to increase the red blood count (thickening of the blood) which can cause clotting issues leading to stroke and heart attack.

    If your physician has prescribed testosterone for you, you should immediately discuss whether you truly need it and whether there are safer alternative drugs. After weighing the risks and benefits, you and your physician can determine what drug, if any, is best for you.

    If you or a loved one, have taken AndroGel, and have suffered a stroke, you should immediately consult with his physician and then consult with an attorney who is experienced in handling such a matter.

    - Paul

    Paul J. Molinaro, M.D., J.D.
    Attorney at Law, Physician

    • heartdude on May 11, 2014 at 9:08 am

      why has it taken too many years for FDA to wake up? I have cared for men with serious coronary disease who saw some idiot MD and were given T replacement I would be happy to help any attorney with a reasonable case against physicians who looked to make big cash and without regard ti their patient’s health.

      • Paul Molinaro on May 11, 2014 at 3:03 pm

        The FDA is asleep… what’s going on is far more sinister… Big Pharm makes big bucks (billions) and pushes prescriptions through by having people on the FDA panels who are former Big Pharm executives… even when the FDA’s own panel says no to a drug, it can get approved… look at Zohydro… the new narcotic that will likely be one of the hottest selling and most abused prescriptions out there. It’s not just unethical or incompetent physicians… the problem of dangerous drugs on the market is much bigger than that… holding all involved responsible is necessary.

        - Paul
        Paul J. Molinaro, M.D., J.D.
        Attorney at Law, Physician

      • heartdude on June 18, 2014 at 3:12 pm

        I’ve b een writing about this for years! Too many physicians, some of the lowest quality, looking to get rich selling this crap to foolish patients.

  3. Mitch Miller on March 13, 2014 at 12:47 am

    I’d take your test. I wash my hands four times after putting it on. But I don’t like the gel, and I do believe it’s very dangerous if used improperly. They are basically allowing irresponsible people to put others bodies at risk.

  4. diane on July 6, 2012 at 9:01 am

    This gel is undoubtedly dangerous to women who are exposed to it. My dad has been using androgel for years to replace the testosterone that his body doesn’t make. I moved closer to my dad 3-4 years ago, and I started staying at his house a few times a week, as did my twin sister. Around three years ago, my sister’s cycle stopped. A year and a half later, mine stopped as well. I believe hers stopped first because she visited him more often. Our faces became more manly, almost round, and less defined. We went to countless doctors, all who couldn’t figure out why we didn’t have a cycle. I really started to believe I was infertile, until now. I’m currently at a friend’s house and watching my face shrink down to the way it used to be. My cycle has also returned, which is a relief because its been over a year since I have had a period. My sister has also left the area for periods of 9-10 days, and she has also observed that her cycle returns after being away from my father’s house as well.

    There is nothing about cycles or changes in facial size on the bottle’s warning label but I believe testosterone directly affects both. My testosterone levels were checked, and while the test indicated they were within range, my testosterone levels were on the upper end of the range. I should also mention that the test had been done after I had taken glucophage in attempt to return my cycle. Glucophage has been suggested to lower testosterone, so I cannot say that my levels were in range before I had taken it. Furthermore, it should be noted that I have no cysts on my ovaries so I do not believe I have PCOS. Also, I am not insulin resistant. My cycle did not return while I was solely on glucophage, but only when I remained completely unexposed to testosterone for over a week. I believe the main thing that one should take from this comment, is that when I am away from the testosterone, my cycle returns. I wish they would do more studies on how this gel affects the families of men who use it. Why should men with wives or children be allowed to use this topical form? It’s selfish and dangerous.

  5. heartdude on April 23, 2012 at 5:35 pm

    Today, a very smart nurse, who read my post, suggested that coloring the AndroGel might encourage patients to wash the stuff off from their hands. I suspect if they colored the Gel red , and caused the patients hands to turn this color, it would be an incentive for them to wash it off.

    • Kelly-Ann on April 6, 2014 at 4:40 pm

      I agree. It should be colored!! My brother, when he uses his AndroGel, says he washes his hands “ALL” the time, yet I have witnessed him “NOT” washing his hands. this causes me great concern. I try to use my sweater sleeves to touch things afterwards, as, if I wash things down he laughs at me or gets mad.

  6. Bill Weaton on April 21, 2012 at 12:31 pm

    Sometimes it seems like our healthcare system exists for the benefit of those making the most money from it. I am never surprised (in the U.S.) when profits trump all other considerations. Whether or not AndroGel is worth the benefits is one issue, but the danger of contaminating women and children seems so poorly dealt by simple guidelines included with the product that it seems criminally negligent. How can the FDA allow this without demanding much more from patients? Wouldn’t a mandatory lecture, tutorial, or something that underscores the potential harmful effects to anyone other than an adult male coming into contact with this be called for?

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