[music] KATH i, welcome to episode 52 of the BioBalance Healthcast. I’m Dr. Kathy Maupin. BRET nd I’m Brett Newcomb. Today we are continuing our conversation about the FDA. Kathy and I are writing a book about testosterone for women in terms of hormone replacement for women. And as we have been writing this book we’ve been getting a lot of questions from a lot of people about is that legal? Is that something you can really do? What are the ramifications of that? Is this something slightly insidious? And so we did a podcast on the FDA and the regulation and the approval process. Today we are continuing that conversation as we talk about off-label use of medicines, because that’s the area where testosterone for women comes into play. The FDA does approve testosterone usage for men with a specific diagnosis. But doctors can choose legally, appropriately, ethically, to use that medicine for women. And today we’re going to talk about the process where by that occurs. We’re going to start our conversation about a couple of other relatively famous and commonly known off-label uses of different drugs before we talk about testosterone. KATH ost of the women in the audience will remember a drug called Tributaline. Now Tributaline is approved for asthma, that’s it. Or it was approved for asthma. BRET DA approved, going through the whole regulatory process that we explained before for the treatment of asthma. KATH nd that was the diagnosis it was approved for. However back in the 70’s when I was finishing up med school we used it and it was a new drug then and we used it off-label and we used it to stop labor. And it stopped labor very well. BRET o someone that wasn’t really ready to deliver but for some reason went into the labor process and you wanted to stop that process to buy you time. KATH reterm labor, to save the baby. BRET o that was the drug that you used, even though it was an asthma drug. And did you know in med school that it was an asthma drug or did they just say this is what we use in this case. KATH ell we knew it was an asthma drug but we also thought it was a preterm labor halting drug to stop preterm labor. So we had no idea that it wasn’t approved for preterm labor. It’s one of those things that we were trained with this. Here, use this it’s better than IV alcohol and it was. IV alcohol was what we used before which was horrible for babies and Tributiline had fewer side effects and was more effective. So we used it all the way through my residency into private practice. And then they came out with another drug that’s very similar to Tributiline which is FDA approved for labor. So everybody, most people stopped using Tributiline. But, Tributiline is a generic so it’s cheap. So it was just as effective as the new drug but the new drug had all the FDA approval for labor and it was expensive. BRET o some smart pharmaceutical company went back through the administrative process to get a slightly modified version approved for use in labor. KATH hange a couple side chains and you’ve got a similar drug. And it does the same thing. BRET hen you say side drugs you mean amino acids, protein? KATH ea, carbons, hydrogens, you just kind of change a few things on the molecule and it does the same thing as Tributiline but it looks different so we can name it something different. BRET nd then we can patent that and get a 5 or 7 year window to recoup and then go back to the generic we were using anyways. KATH ight, but interestingly enough this is one of those things that we talk about testosterone all the time and we use testosterone like we use Trubulitine. It is an old drug. It’s been used since the 1930’s. It’s a drug that’s really similar, exactly similar in the bioidentical case as our own testosterone. So we’ve been using this for all these years. BRET hen you say exactly similar you’re talking about the side chains, the carbons, all the organic chemistry components are exactly the same. KATH ioidentical testosterone. Exactly the same, that’s what makes it bioidentical. BRET o there is bioidentical testosterone and then there’s non-bioidentical testosterone? KATH nd then they’re synthetic testosterone. Like methyl-testosterone which has a little extra side chain on the side of it. There are different types of testosterone. And those are approved for use in men, not women. They’re approved for hypogonadism which is what they call low testosterone or a lack of production of testosterone as we age. So for men, they’re approved for that. BRET always get hyper and hypo confused. KATH ea well not on that one. Hyper is too much, hypo is too little. So hypogondaism means you’re not making enough testosterone. So they’ve approved that for men, they’ve approved testosterone use even in the bioidentical form for men, which is interesting because it kind of was grandfathered in. It’s been around forever. And it’s more of a generic drug. But they’ve said you know testosterone pellets are okay for men. Unfortunately they have not approved testosterone pellets or any form of testosterone for women. And women have more testosterone, prior to andropause or their 40’s, they have more testosterone then they do estrogen. And we need it as well. BRET hat’s innately, naturally, biologically, they produce testosterone. And then when they’re in their 40’s and they start to go through what you’re calling andropause in men and something new in this book for women. KATH ight, testosterone deprivation syndrome. BRET ight and part of the book is to argue the case for having a label for this condition which occurs in women naturally as part of the aging process, but has not yet been defined by the medical establishment as a definite set of syndromes or diagnosis for women, and because that has not been done, testosterone for women. KATH nd that’s true. We don’t have a drug for it. If you don’t have a name of syndrome or a name of a disease they can’t possibly approve a drug for a particular condition because that condition hasn’t been named. So they’ve named it in men but not in women. BRET ort of the corollary to Murphy’s Law. If it ain’t broke, don’t fix it. KATH ot exactly, except that it is broken. BRET xcept that it is broken, yes, exactly. So now it’s a matter of coming up with a label that people agree upon as a set of symptoms and coming up with a treatment for that, which you have done in your practice. So that brings us back to the whole conversation about the regulation of testosterone by the FDA. It is a legal drug it is a regulated drug, it is approved for use in men. But physicians can choose to use it in treating women if they’re willing to do that. KATH nd many of us are across the United States but it’s very quiet. And it’s very quiet partially because there’s no money to really test it because it’s individual physicians. The pharmaceutical companies really aren’t all that crazy about doing anything with it because they’re not going to make money, they can’t patent it. BRET o that testing process through the FDA is generally funded by large pharmaceutical companies or major universities because they have the financial backing. Rarely does it start with a hand full of doctors getting together and saying let’s combine our patient base and accumulate the statistical data and make an application for this. KATH n general doctors don’t have that kind of financial backing. Neither do pharmacists. Compounding pharmacists are the pharmacists who make bioidentical testosterone; they make it in their pharmacies. There are not enough of them to fund it. BRET et’s talk about that for a minute too. KATH kay BRET ecause I know we’ve covered it in a couple other podcasts but I think it’s relevant to come back and review the terminology. A compounding pharmacist or a compounding pharmacy is kind of like the old fashion idea of the pharmacy with the mortar and pestal and the guys in the back that are putting these ingredients together. KATH t’s really much more sophisticated than that. BRET would hope that it would be. KATH hey have air filters and it looks like a high tech sterile lab. BRET t’s a high tech lab. KATH nd they are very careful about exactly what the dosage is because they have to be just as careful as a drug company making pills on a machine. They have to be just as accurate, there can’t be a variance in the amount of milligrams, it has to have the exact substance, I mean that’s a process of regulation. BRET o it’s not like buying an e-mail drug from china. KATH ight that would be bad or eastern Europe. The reason testosterone has such a bad rap is that is because it has been used improperly. And not necessarily by doctors giving a prescription to people in this country, like athletes which gives them an uneven advantage. But most of the time it is [weight] lifters and people like that getting their steroids or testosterone type drugs from eastern Europe and you’re not even sure what’s really in them. I don’t know how they get it. I interviewed a couple of guys at several gyms and they get it on the internet they didn’t tell me exactly where. And they inject themselves with this stuff and I have no idea what’s really in it. And neither do they. And they have tons of side effects it’s not pure testosterone. But worse yet, it’s such a high dose they use too much, don’t have a doctor managing it. They use such a high does that they shut down their adrenal glands. And they shut down their testicles. So that when they come to me, or they used to come to me for infertility they didn’t make sperm anymore, they were infertile. Tthat’s a1 real problem. Especially in younger men who don’t need testosterone who use it to buff1 up. It’s not true testosterone, it’s a testosterone kind of drug.1 BRET o you’re not making yourself more of man, you’re making yourself more1 of a eunuch? KATH ventually. You’re making yourself1 feel like superman but it makes you feel good to use those drugs. That’s why those drugs1 are controlled pretty carefully but the internet we haven’t come to that yet. But we don’t1 use those drugs in the United States. BRET ut that’s part of why the questions1 that we’ve been getting arise, which is people know that there’s a market out there1 for those drugs that people use them individually without going through medical supervision1 for gain mostly in athletics to get an unfair advantage to buff up or bulk up or something1 like that and so the common wisdom is that that stuff is out there and there’s something1 wrong with it. KATH hat’s right. Everybody thinks1 that it’s a bad thing and that it’s illegal. It’s certainly not illegal. It’s like1 any other drug. It is actually managed by a doctor.1 BRET et’s be clear. When you’re talking about it not being illegal, you’re1 talking about for what you’re using it for and where you’re getting it. That is all1 legal and regulated. KATH nd the type of testosterone. It’s1 pure testosterone and not some kind of byproduct. BRET o the production systems are standardized.1 They’re monitored. They’re regulated. They’re legal. Their usage is legal.1 KATH nd a doctor is prescribing it. BRET o this isn’t the same thing.1 And that’s part of what we’re trying to prove.1 KATH e’re also not using it in young men. We only use it in people who have lost1 the ability to produce testosterone. And when we do that in older men, older women it brings1 back a lot of our health. We don’t need all of those other drugs we’ve been taking1 for cholesterol and sometimes high blood pressure, diabetes. Many of those drugs fall by the1 way side. And for women all of the drugs for bone thickness go away because testosterone1 is a great bone builder. BRET o that whole osteoporosis issue.1 KATH ight there’s like 5 drugs for that now and that is something that competes1 with testosterone because really after 2 years your bone density comes back and so it’s1 one of those things with testosterone. BRET es with the treatment of testosterone1 in women the bone density for them returns. So now is there that same 10 year window for1 starting it after menopause? KATH o matter when you start it if you1 take calcium and vitamin D, you’re going to start growing bone. But if you think about1 it we start losing bone when our testosterone drops. And then when our estrogen drops we1 lose even more. So you’re going to start at a much lower level of bone to try to recover1 from. So you can’t recover really in 2 years that way but you’ll recover at least better1 bone. You’ll make better bone if you take testosterone.1 BRET nd that’s a conversation for another day. To stay on target and on focus1 for what we’re discussing today. We’re talking about the legal, regulated, consistent,1 medically supervised use of testosterone for women which is a legitimate thing, especially1 the use of bioidentical pellets which are manufactured by a compounding pharmacy that1 is also consistent dosage regulated and legal. KATH y the FDA. And they come in and1 inspect them just like they do any other pharmaceutical companies. But these are still, there are1 not enough compounding pharmacies to get together and try to fund a study that’s going to1 prove this. And then when they did anybody can make it of course. So once it’s proven,1 we’ve already proven it in many studies, but once it’s proven for the FDA then anyone1 can make it or formulate it so they would lose their investment because there’s no1 patent. BRET o you go back to the economic mechanics1 of the system and the fact that there’s not a large body of capital out there to come1 into the production of bioidentical testosterone for women.1 KATH ut I want to make perfectly clear that doctors are here to prescribe for problems1 and illnesses and even things that go along with aging to replace hormones. We have the1 knowledge to do it. We have usually 8 years of training and we have pharmacology behind1 us. We understand how these work and how a safe way of giving them helps a patient but1 doesn’t hurt them. So it’s very important that a drug be given by a physician. So that1 what is the limiting factor in making a drug a productive drug or a safe drug versus a1 drug that can be abused, because almost any drug can be abused.1 BRET nd you know what most physicians are really ethical, really highly trained,1 really legitimate. There are some that float around the edges for whatever reasons, and1 those you have to be careful about. But this is an ethical, legal, standardized use of1 a legitimate drug for a legitimate purpose under the supervision of a licensed physician.1 So that’s what you need to know when you go to consider this treatment and when you1 go to talk to your own physician about obtaining this treatment. So when the book comes out1 and you get a chance to look at it, that’s what we’re going to be emphasizing. This1 is for consumer education, for you to become knowledgeable about your own body and its1 treatment so that you can talk to your physician about it if your physician is not current1 on the data. KATH hat’s right, I just want to add1 there’s other forms of testosterone that can be written that they’re pure testosterone1 but it can be given though the skin, or it can be given sublingually, vaginally, there1 are lots of different ways to take testosterone, it’s not just pellets.1 BRET t’s different delivery mechanisms but we’re still talking about the same drug1 and the legitimate use and the consistent methodological production of those drugs.1 KATH o if you’d like to know more about bioidentical hormones please go to our1 website at BioBalanceHealth.com or you can call my office at 314-993-0963.1 BRET r you can reach us through my blog at brettnewcomb.com.1 [music]1 Copyright ? 2011 BioBalance Health | St. Louis, MO 63141 • 314.993.09631 Produced by Davis Interactive.