Dr. Sarrel discusses the testosterone available to women and how they can find the right product.
Well, first let’s take a look at the issue of what testosterones are available. We thought by now we would have testosterone available in a skin patch that would meet the needs of post-menopausal women and probably even of younger women, and such a patch was developed, tested, and the data was presented to the FDA a few years ago.
There were no adverse effects in the study, no detrimental findings, and in fact that very interesting study of the American-made testosterone patch was unique in that more women had been studied in that one study than in the 50 years before.
There were more women in that very carefully designed study, but the FDA advisors did not recommend approval of the patch because they said, “You didn’t show if it was safe for the heart, and we are also worried that the testosterone might stimulate breast cancer cells to grow.”
You have to know that this is all in the context of a world, our world in the United States where we are still living under the effects of what’s called the Women’s Health Initiative Study, a major study of hormone actions in post-menopausal women which did get stopped because the hormones being used, not androgens, but the hormones being used showed an increase in breast cancer risk and an increase in stroke and heart attack and blood clots, many detrimental effects.
So the FDA is exquisitely sensitive about something else being made available and then finding out years later that there would be a problem. Interestingly, the rest of the world is not living under the same impact as we are, and in the rest of the world, there has been an acceptance of the testosterone patch data. So for example, you can go anywhere in Europe in the EEC and have the testosterone patch prescribed for you.
You can go to Australia and have it prescribed. Isn’t it ironic that here it is made in the United States and had an excellent safety profile, but American women don’t have it available. That’s true for many of the products I am going to mention, for example.
And there’s another issue. There’s an issue of sexism here. So let’s look at that for a moment. I was starting to mention a substance called AndroGel. So that’s a gel that’s rubbed on the skin that contains the testosterone. It’s widely available in Europe. It’s actually been available since the 1970s, 30 years experience with it, made for women.
In this country, it’s available for men, just as the testosterone patch is available for men. It’s been approved by the FDA. Men are using it every day, men who don’t have enough testosterone, and it’s been deemed safe for them but not for the women. It’s somewhat ludicrous since the dose for men is ten times the dose that would be prescribed for women. I think it is an example of sexism.
What else is available? So we don’t have the patch for American women. We don’t have the AndroGel for American women. We have implants of testosterone. An implant is a little pellet that’s introduced under the skin. It can be introduced into the buttocks. It can be introduced into the abdominal wall, and usually it’s given in combination with estrogen.
Very few American physicians use it. Very few have been trained how to use it. My own experience with the implants was that in fact the problem with implants wasn’t so much with the androgen part of the story. Those levels seem to be fine. The problem was that the women absorbed too much estrogen from the implants, but it is still widely used in Europe, especially in the UK in England, Scotland and Wales, but not very much used in this country. But still it’s a product out there, and if a woman is carefully monitored for adverse effects to be sure that she is not experiencing any adverse effects, it’s an option.
There are other preparations. There is a combination of estrogen with not testosterone but a testosterone-like hormone called methyltestosterone, which actually was invented in the 1930s. The first papers on estrogen with methyltestosterone given to women appear in the 1940s, and there were hundreds of women studied in that period of time showing it was quite safe and quite effective.
And that was marketed for many, many years in this country, a product called Estratest. Estratest in 1982 was put into a category with a couple of hundred other drugs on the American market as a product which the FDA deemed could be sold in this country but was not fully approved. So all of those products were never fully approved, and that only came to light after the big study, the Women’s Health Initiative that there were other hormone products out there American women could use and get, which actually hadn’t been approved by the FDA.
The choice we are talking about right now is oral androgen products, and the one that has been available for the longest period of time with the longest safety profile record is this combination of an estrogen with methyltestosterone. Unfortunately, it hadn’t been approved by the FDA, and when that came to light the company that made it was asked to conduct studies to show its long-term safety.
The studies that were requested were essentially impossible to do. One, because of the expense, and two, because after the Women’s Health Initiative, with all those negative effects of taking hormones was announced, it’s become impossible to recruit women for studies.
So we are seeing in the year 2009 that the company that had been making this for 60 years or more has stopped making it, has quit the women’s health field altogether, given up on women’s health, and what’s stepped in have been generic replicas of the estrogen plus methyltestosterone.
My problem with the generics has been, and this is a very big issue in this issue of what’s available to women, some appear to be reliable and some appear to be totally unreliable, and in some instances they simply don’t deliver what’s advertised. And not delivering what is advertised can translate into either too little or too much, and so I’ll give you an example because I reported a patient recently to the FDA who was taking a generic where she was feeling wonderful.
She said, “Gee, this is even better than the original Estratest.” And I said, “Well, let me test your blood level and see what’s happening.” And her total testosterone should have been around 40 or 30, but it was 1300.
And so I said to her, “I am glad you are feeling great, but you can’t take this because this is, we have no idea what the long-term effects are of levels that are 30 times the normal female level.” And so that’s the problem, and it’s a problem with the other major preparation, oral, that’s available which is called DHEA. Remember we mentioned it earlier, dehydroepiandrosterone, and that’s another of the natural androgens. You can get it in a health food store.
There are a 150+ DHEAs being marketed right now, and in a very important study of the different products that are out there, this issue of unreliability became the dominant finding, namely that there were some that had nothing in it; there were some that had ten times the normal dose; there were some that could be fine for one batch and then the next batch was totally unreliable.
And none of these are, not just that it’s an FDA being approved, but once a drug is FDA approved, it’s also subjected to surveillance. It’s like giving the money to the banks. Now once the banks have their money from the government, the government watches over it to protect us, the consumer. Well, the same thing is true with the FDA.
If you have a product that is approved by the FDA, that means their inspectors regularly go to the factory where it’s made and pull product off the assembly line and test it for consistency, reliability, rule out impurities. All of these things are done to safeguard the consumer, in this case the American woman.
Well, we have a very practical problem, and that is that products that could have been FDA approved haven’t been. So we have a whole group of other androgens like testosterone that are being made up in creams. Two percent testosterone cream is readily available from a pharmacist who can make up a batch for you or sell it to you in a jar, and our experience has been sometimes it’s great, and sometimes it’s worthless, and sometimes it’s excessive.
So the take-away message is going to be, there are newer and better products coming down the pike. For example, only last month the meeting of the North American Menopause Society had a new product presented which is an ovule, so something that could be inserted in the vagina, of DHEA in a sulphated form. So if you are allergic to sulphur you can’t use it, but otherwise it could be used, and the data looked very good and hopefully the FDA will approve it.
On the other hand, they may not. They may say, “You are going to have to show us it doesn’t have detrimental effects in the breasts.” Remember, that the DHEA is also going to get metabolized into other hormones. So it’s not going to just stay DHEA.
There are, there’s at least one major study in this country right now, and it involves over three thousand women. We can’t say much about it because it’s a study in progress, but the protocol was approved by the FDA. It does involve using an androgen, and we are all hoping that, it may take another five or seven years to complete, but then it will have enough women for enough time to show it’s safe for the breast and safe for the heart and the circulation.
But we are still years away from an FDA approved androgen that would be readily available. So the bottom line becomes your doctor may well prescribe something for you, but you must pay attention to what happens in the follow-up care to initiating. You have to know what to expect when you start taking, whether it’s a cream or perhaps a gel or even an injection.
I forgot to mention that there are injections of androgens. You need to know what to expect if you start, and you need to know what measures should be done over time to be sure it’s working and that it is safe for you.
About Dr. Sarrel, M.D.:
Philip M. Sarrel, M.D., completed his medical education at New York University School of Medicine, his internship at the Mount Sinai Hospital, and his residency at Yale New Haven Hospital. In addition to his many years on the faculty of the Departments of Obstetrics and Gynecology and Psychiatry at Yale University School of Medicine, Dr. Sarrel has also been a Faculty Scholar in the department of psychiatry at Oxford University, Visiting Senior Lecturer at King’s College Hospital Medical School at the University of London, Visiting Professor in Cardiac Medicine at the National Heart and Lung Institute in London, and Visiting Professor in the Department of Medicine at Columbia University College of Physicians and Surgeons in New York. He is currently Emeritus Professor of obstetrics, gynecology, and psychiatry at Yale University.