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.
