Dr. Chad Edwards: This is Dr.Chad Edwards and you’re listening to Podcast No. 52. I’ve a guest today. Are you tired and fatigue? Are you frustrated to the doctors because they just don’t seem to listen? Do you want to fix your pain without surgery? If you answered yes to any of these questions, then we are the clinic for you.
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Automated voice: Welcome to Against the Grain Podcast with Dr. Chad Edwards where he challenges the status quo when it comes to medicine. We get in the hot topics in the medical field with real stories from real patients to help you on your way to a healthy lifestyle. Get ready, because we’re about to go against the grain.
Morris Marshall: Hello, hello. This is the super tall Marshall Morris. Today I am joined with Dr. Chad Edwards who believes that 80% of medical recommendations are crap, technically speaking. He served in the US Army. He is an author of Revolutionize Your Health with Customized Supplements founder of revolutionhealth.org; and, there again, sorry again, Against the Grain Podcast. I messed up the one that we’re actually featuring right now.
Dr. Edwards: But fortunately you’re already here.
Marshal: Yes, so all right. Dr. Edwards, how are you doing?
Dr. Edwards: I’m doing well, excited to be here. This topic right here I’m a little passionate about. I think that might come out.
Marshal: Okay, what is it, what is the hot topic that we got coming in?
Dr. Edwards: You know, it’s a mixed bag because I started off on one path. And as I started going down this path I started seeing all these little trails that developed. It started off as testosterone, and does my insurance cover testosterone. Because there’s a lot of–I get patients that will come in, we put them on testosterone then insurance won’t cover it, and why?
Then somebody else comes and their insurance, their testosterone’s covered. Then they’ll cover this form of testosterone but not that one. They’ll do this but not that. The funny thing is, like with testosterone, they’re commercially available testosterone gel, specifically AndroGel. That’s the one, that’s one of them, test them, and Axiron, and other commercially available testosterone gels and your insurance company will want you to use that one because its quote on formula and it might be cheap from account payer’s perspective.
I don’t want to say it doesn’t work, but it doesn’t work. It does work but it doesn’t get patients to optimal because the stuff is 1.62%, 1.62. I often have to give patients 50. I’m sorry, five, 10, 15 even as much as 30%. And they’re giving 1.62%.
Marshal: So not as much.
Dr. Edwards: Correct, by a lot. By a whole lot. But the issue is the cash price on this stuff is outrageous. It’s like $400 a month, if you’re having to pay cash for it. But your insurance wants you to use that. But they won’t cover the compound that you can get for 50 bucks, why? It is ridiculous. It set me off on this process to look, let’s look at this. I stared looking into some policies on insurance and coverage on different things, and multiple different things started popping up. We’re just going to work through some of these, hopefully listeners will have a better understanding of why some things are cover and some things are not. I’ll just tell you upfront a lot of this stuff doesn’t make any sense Tulsa prolotherapy.
Marshal: Testosterone and the insurance coverage of testosterone, would you say that this affects a lot of people or not very many people?
Dr. Edwards: It does. The problem is this, when you go to your doctor and you get a prescription, one of the first questions is, will my insurance cover this? I have no idea. I had no idea. Even if I’m out of network, I don’t deal with the insurance companies. But if you’re in network, your doctor doesn’t know then either because you’re talking about a pharmacy benefit, not their medical benefit. You don’t know until you go file the prescription, and then you’ll figure, you’ll find out.
Marshal: There’s a lot of different insurance companies and policies, I would imagine.
Dr. Edwards: Even within like Etna or Blue Cross, there’s multiple different plans that will have different benefits, and it covers this but not this on this plan. But this plan doesn’t cover that at all. It just covers great on this–you don’t know. It’s maddening.
Marshal: We’re getting into the specifics of, maybe the hot topic, the Against the Grainness. I think I just coined a new term for the podcast.
Dr. Edwards: Against the grainness?
Marshal: Against the grainness, yes. Of why, maybe the insurance is covering some of these testosterone prescriptions and not others.
Dr. Edwards: I don’t know. We’ll figure out why. But we’ll definitely address why they’re not covering.
Marshal: We’ll put it out there.
Dr. Edwards: Absolutely.
Marshal: Okay, get us into it.
Dr. Edwards: Like I said, this started because I started looking into what’s covered and what’s not. The first thing I wanted to look at, and for our listeners that don’t know, we do testosterone–hormone replacement period, but our new preferred way of providing bioidentical hormones is through pellets Tulsa prolotherapy.
Marshal: What does bioidentical mean?
Dr. Edwards: Bioidentical means that the hormones are the exact same structure as what’s normally produced in your body. The difference is – you can listen to some of our older podcasts in the past about non-bioidentical hormones, synthetic hormones, or naturally derived from a horse. They’re not estradiol, you know 17 hydroxyestradiol. They’re not the same structure as the hormones that your body produces.
With testosterone, you got testosterone which has this four ringed structure, and has a relatively short half-life, less than a day. For example, if you’re getting a testosterone injections, then we have to—if we give you an injection, most of our patients that do testosterone injections are doing one a week, and sometimes two a week, just depends on what the patient can do and compliance, and all that stuff.
But if I were injecting plain old testosterone, just testosterone, it would only stay in their system a day, maybe. Then, you’d feel like stink for six days. So what we inject is called depo-testosterone or testosterone cypionate. The depo basically means it’s like a deposit. We’re giving a depo of testosterone and they changed the chemical structure of it. They add this little tail onto one specific spot. That tail makes it where it hangs out in the tissues and its slowly released over time Tulsa prolotherapy.
But it’s not bioidentical testosterone. Bioidentical testosterone doesn’t last in your system that long you’d have to give yourself an injection every day. With the pellets, as I started looking into this and why won’t insurance cover certain things. One of the things that I came across of course I knew this part, but Testopel is the brand name of testosterone pellet that is FDA approved.
If you go to your urologist or your doctor and they offer pellets, they very well maybe inside a network, inside a big clinic or something like that. They very well may be recommending Testopel. Testopel, actually first FDA approved in 1972. Standards back then were a little bit different. They didn’t have to have the same data, the same criteria, but they were FDA approved back then.
They didn’t start marketing them until 90s or 2000s, I can’t remember exactly when. They’ve been on the market or they’ve been approved and available for a long time but nobody was using them. I started looking into that. Interestingly, some insurance companies, even though the stuff is FDA approved, the pellet itself is approved, insurance may not cover it, even though its FDA approved.
What is this? I had to start digging. The first one that I came across is–first of all, the difference between what we consider normal and what we consider optimal. Because when you look at FDA approval, then you have to consider who is an appropriate candidate for Testopel? So certain things have to be proven.
For example, with Etna, they require that you have to have two consecutive testosterone levels that are low, and they define it as less than 255 on your testosterone level. If you are very severe, in other words, if your testosterone level is less than 150, then you only need the one, the only one sample. You have to have a certain level.
We see this all the time men come in fatigued and their testosterone maybe 400. That’s clearly above what Etna considers too low, but their testosterone level is low and they feel bad. But Etna won’t cover, by this criteria, Etna won’t cover their testosterone, why? Etna itself, by their policy statement which I found online says that they consider testosterone pellets testopel necessary for 104 conditions. I’m not going to go into this, so I’ll just give you the names if they mean something great if not then don’t worry about it. Primary hypogonadism, hypogonadotropic hypogonadism, delayed male puberty, and gender reassignment, so it’s the last one that caught my attention Tulsa prolotherapy.
Gender reassignment basically a woman wanting to become a man, and I’m not going to get into the discussion of is that appropriate or not, it’s not any of my business I don’t care. The issue for me is that it’s a woman wanting to become more like a man, and Edna considers that necessary or they consider it appropriate. You can get testopel and have insurance pay for it, if you’re a woman wanting to become a man.
Now Edna further goes on and says that testosterone pellets are considered experimental and investigational, and what that means is they’re not going to cover it. It’s experimental and investigational for male menopause meaning your testosterone levels are too low. Hypogonadism due to aging meaning that your testosterone is low because you’re — as we age our testosterone tends to decline. Idiopathic hypogonadism meaning we don’t know why your testosterone is low and all other causes, “because their effectiveness has not been established.”
Edna says that if you are a woman and wanting to become more like a man we’ll cover that, if you’re a man wanting to become more like a man we’re not going to cover that.
Marshal: Just because you’re getting older.
Dr. Edwards: Correct. That’s Edna’s position at least according to the paper that I found online. Now the other thing is when — Edna goes on to say that while — and this is talking about estradiol specifically, but while implantable estradiol pellets have been suggested as treatment for symptoms of menopause, there are no FDA approved commercially available formulations of implantable estradiol pellets available in the US. Here they are alluding to FDA approved, and that’s an important piece that we’re going to get into in just a second.
They go on to talk about testosterone, and they say testosterone is FDA approved as replacement therapy only for men who have low testosterone due to disorders of the testicle pituitary gland, or brain that cause hypogonadism. However the FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging.
The benefits and safety of this have not been established. Apparently the benefits and safety of this has been established to if you’re a female wanting to become a male, but it’s not established to if you’re a male wanting to become more like a male. Is it just me or it this sounding like a lot of horse crap?
Marshal: At least.
Dr. Edwards: Okay so we’re going to go on. We talked about these two consecutive levels that Edna requires, and let me back up the testosterone and the estrodial that may have been from a blue cross position statement I don’t remember, I’ll try and get in the show notes. So it gets into this question of you’ve got levels, you’ve got testopel that’s FDA approved, but the interesting thing its only approved for certain conditions, and is only approved for certain doses Tulsa prolotherapy.
Its two to six doses, 150mg to 450mg, if you use seven pellets which would be 525mg it’s no longer FDA approved. It’s not the testopel it’s not necessarily the condition, and it’s not necessarily the dose, it’s the combination of all three. It has to be proven safe and effective for each condition at each dose with each medication. Let’s talk a little bit about FDA approval probably when we come back from the break.
Marshal: Okay, so we’ll take a quick break, FDA approval is going to be hot.
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Marshal: All right we are back and we’re getting into it with testosterone and insurance coverage, it is crazy.
Dr. Edwards: Its crap.
Marshal: Its crap its crazy crap, so we’re getting into it with doctor Dr. Chad Edwards here. Now doctor Edwards before the break we were talking about FDA approval, and how does something become FDA approved and specifically testosterone? Let’s get into a little bit more of these specifics.
Dr. Edwards: Yes, so basically a lot of people and I understand that the FDA has an important role, and the role is to protect the citizens, Americans, from crap stuff out there. Basically what they do is if you have a drug and you want to get it approved for use by the FDA, then you have to have a lot of scientific data. You have to do studies, the FDA does not do studies they evaluate the studies that were done, and if it’s proven safe and beneficial then it will likely pass FDA approval Tulsa prolotherapy.
There’s a few issues with that the first one is that it requires a lot of money to get that done. The studies that are required cost a lot of money. The only people that have the money do that or it’s somebody with something to gain, like a pharmaceutical industry or something that is pharmaceutical company. Someone that can fund all of these studies, so they can get stuff approved. Getting a drug FDA approved and this is directly from the FDA’s website, new drugs and biologics must be proven safe and effective as I mentioned before, to FDA satisfaction before companies can market them.
The FDA does not develop or test products, FDA expert review the results of laboratory, animal, and human clinical testing done by manufacturers. If FDA grants an approval it means, the agency has determined that the benefits of the product outweigh the risks for the intended use. Again going back to testopel and its approved at 150 to 450mg, but its not approved at 525 and its not approved at 75. So it’s a balance of safe and effective for FDA indication.
75mg is I don’t think anybody could argue that’s safe because you can do nothing and that’s safe. You can do 150 and that’s safe, you can do 450 and that’s safe, so 75 is not pushing the limits at all but is not FDA approved. Probably I am guessing because of the balance between the risks and benefits that’s been proven in the studies. There probably wasn’t sufficient evidence of benefit, so then when you talk about risk it could be an infection trying to put the thing in, and all kinds of different potential risks with the procedure itself, although –.
Marshal: Not with the actual drug or not with the actual hormone?
Dr. Edwards: Right, well I suspect that’s correct. Because there is a risk with the procedure so if we’re putting this thing in and they’re not really getting any benefit, then why are we doing it? It’s a balance between risk and benefit. That’s the foundation for how they approve drugs. Then going on with some of these FDA approval and how — all these– again straight from the FDA’s website, you can go on there and look this stuff up. There are some things that are not FDA approved and it does not mean they’re harmful; it does not mean they’re bad, anything to that effect.
In fact its directly from — I’m going to read this directly from the FDA’s website it says, pharmacy compounding is a vital service that helps many people, including those who are allergic to inactive ingredients in FDA approve medications, but consumers need to be aware that compounded drugs are not FDA approved. This means that the FDA has not verified their safety and effectiveness. We can take a drug that’s produced by Joe Blow Pharmaceutical Manufacturer that contains Sildenafil the Viagra, the chemical.
Joe Blow’s Pharmacy pays for all the studies that at this dose with this structure, this I want to say compound but this formulation, here is our data. The FDA reviews it and says okay that’s good to go, but if I take that exact same medication and compound it to the exact same dose in a compounding pharmacy, it’s no longer FDA approved. That’s what that says, so the reason for that is because with compounding I can adjust the dose. I can say, “I don’t want 50 milligrams, I want 25 or 37.5.” I can put exactly in it how much that I need. You’re not going to get FDA approval on that because you have to have the data on every dose. So you would have to have the data on 25 milligrams, and 50, and 32.5, and all of those things, you have to have the data for all of them. According to what I’m seeing from the FDA, there may be some policy at that do wish I’m not aware but that’s what I’m collecting from their website because we’re balancing risk and benefits.
There’s directly from the FDA’s website, they say it is a vital service. Compounding pharmacy or pharmacy compounding is a vital service, says it right there on the FDA’s website, but it’s not FDA approved. So we see good things, we see bad things. The New England Compounding Center, NECC, a couple of years ago, few years ago, they had a lot of fiasco come out of a compounding pharmacy up there that a lot of people got sick about. The guy is sick from using the medications that were compounded in that pharmacy.
A lot of information out there about that, you can go look it up. But those compounds weren’t FDA approved and the FDA’s job is to protect us, that’s why they exist, and people got harmed. So they started cracking down on compounds a little bit and there’s a lot of things that make it a little bit more difficult for compounding, but these things still aren’t FDA approved. Which I understand and I get and that doesn’t bother me at all.
But insurance companies cover testosterone that’s FDA approved, don’t cover testosterone that’s not—and I’m not saying that’s a black and white statement, I’m saying that depends on the insurance plan. But they might cover your testopel pellets for one person but not for the other because your stuff doesn’t meet criteria. It’s not been proven safe and effective but they’ll cover a compound for something else.
Basically you get pharmacy, you get your—your insurance company is covering things that are FDA approved and they cover things that aren’t FDA approved. Then they don’t cover things that are FDA approved and don’t cover things that—you got all of the whole mix. Some things are covered, some things aren’t, FDA approved, not, it doesn’t matter. It seems to be somewhat random to me based on how they feel about the data, and they don’t feel that there’s sufficient benefit for using testosterone to feel better.
Now, I can tell you in my clinic, we do a lot of testosterone where we prescribe testosterone to help our patients. They’ll come in with all symptoms of testosterone deficiency, we’ll check their labs and their low, we’ll give them testosterone and they feel amazing. What other evidence do you need? There’s the question of safety but you could run a study for six months. We’ve got decades of data showing the safety of testosterone. Now, there is some mixed data, there’s some minor studies that I would argue were very flawed, that shows that there’s the potential risk of increased risk of cardiovascular disease.
There is some risk with testosterone but the vast majority, when you discuss it with your patients and let them know, “Here are your risks.” Patients feels so much better on it that it’s worth the risk to them. So my point with this thing is that there is a big double standard with insurance coverage, and the FDA approval, and all of those kinds. I’m not arguing against FDA approval, I’m not arguing against the insurance. Insurance does what they do, it’s a commercial business, they’re trying to make money, I don’t have any issue with that.
What I do have an issue with is, patients need to understand that your insurance plan isn’t going to cover everything you want to do especially in our clinic. There are some things that are beneficial to you that are not FDA approved, there’s some things that are beneficial to you that your insurance isn’t going to cover. So what do you do? You talk with the physician that is well versed in helping you, that understands the risks and benefits, you discuss those risks and benefits, and you choose what you deem to be in your best interest and you may have to pay it out of pocket. But a lot of these stuff is not that expensive. That’s my thought with all that.
Marshal: Would you say, a lot of patients come into the clinic looking for purely FDA approved prescriptions? Or what is the mentality of many of the patients coming into—let me rephrase that. Not necessarily revolution health but like the normal family physician’s clinic?
Dr. Edwards: I think some people come in looking for stuff that—I don’t hear them say, “I only want things that are FDA approved.” I do hear them when you recommend something a little bit different. They may say, “Is this FDA approved?” And I think they think there’s a safety benefit to that. Now, we can expand on this and if you go back and listen to the podcast on Tamiflu, Tamiflu was released without all the data being released. The test were done by GSK or GlaxoSmithKline and Roche, the manufacturers of Tamiflu. The FDA reviewed the available information and they approved Tamiflu, but they didn’t release all the data.
When they released the data sometime later when the British Medical Journal called them out on it, and they finally released all of the data. When the Cochrane Database reviewed the data, we found that the Tamiflu was—you only get better like half a day faster, and you’re spending $150 on the medication that’s been banned in some counties because of potentially severe psychiatric problems. That’s not the FDA’s fault. The FDA review the available data but the company didn’t release all the data. So I would argue that may be a criminal issue. Is that deception? I don’t know. I wasn’t there, I haven’t reviewed everything, it’s not my job to review all that.
But is that deception? Did they intentionally withhold this information? Sure look shady. Is it the FDA’s responsibility to make sure that they release all available data? Going by the letter of the law with the purpose of the FDA, you’d say probably so. But that process, in my opinion, is not 100% trustworthy because they have to make decisions based on the data that’s presented to them.
Marshal: So understand the data and do your own due diligence. They make the data available and if you need help in trying to find out maybe where to go find that data, find the physician or a functional medicine physician that can direct to you to where to maybe look for it. Where would you suggest some of those that are starting?
Dr. Edwards: You can certainly use Google and start looking, or one of the best sources is PubMed. Nhlb.—no, I don’t remember the whole thing. I just Google, PubMed, and it pulls up. And that is a federal database of all of the scientific studies. There is a wealth of information out there, and a lot of it is cross-referenced, and you can find a lot of scientific data up there. A great site.
Marshal: Okay. So in closing. FDA approval does not necessarily mean insurance is going to cover it. Furthermore, the FDA is acknowledging effectiveness of drugs, hormones, a number of different treatment. They are effective but maybe not necessarily FDA approved. So understand, there’s differences between all of those different languages the next time you go in and see your physician.
Dr. Edwards: Yes and basically, we’re on that. Like there are some things specific at compounds that they would say is a vital service and it is of benefit to patients, but not FDA approved.
Marshal: So bottom line, each person is going to be a little bit different. So it would make sense that maybe the drugs that we’re prescribing are a little bit different.
Dr. Edwards: Novel concept.
Marshal: Novel concept. Doctor Edwards, thank you so much.
Dr. Edwards: Thanks man. Have a great day.
Thanks for listening to this week’s podcast with Doctor Dr. Chad Edwards. Tune in next week where we’ll be going against the grain.