Below are some of our videos explaining the potential dangers of Testosterone, and especially the connection to heart attacks and strokes. To learn more about the types of injuries that have been linked to this medication, and the legal claims that have been filed, click Testosterone.
Testosterone Craze Is Killing People
Mike Papantonio: Every time that drug companies release a new drug, they pray that it reaches what the industry calls “blockbuster” status. This typically means that the drug will bring in more than a billion dollars a year in total sales. Sometimes this status comes relatively easy, like when a new diabetes medication or arthritis drug comes out. Diseases like those have millions of potential customers, so it’s pretty easy for drug companies to sell a few billion dollars worth of their medications after a year or two. But other drugs and treatments have smaller markets, so drug companies have to resort to deceptive marketing practices in order to help their products hit that “blockbuster drug” status. And that’s exactly what happened with testosterone treatments in the United States.
AndroGel is approved to treat a specific condition called hypogonadism, but the population suffering from that condition was small, and the company knew that they would never hit “blockbuster” status if they only sold their product to men who had that condition. So AbbVie decided to promote their treatment to a much broader population of men by running TV and print ads telling men that they needed to have their testosterone levels checked by a doctors, and they needed to be high. They told men that if they were feeling tired, stressed, or generally less active or lethargic than they felt when they were younger, that it was because their bodies were not producing enough testosterone. They turned all of the natural things that happen to our bodies as we age into symptoms of a new disease that they called “Low T” disease.
As a result of that marketing, AndroGel sales soared, and about 5 million people in the last year alone were buying into the low testosterone hype. The testosterone drug passed the blockbuster mark in 2012 and 2013 before falling more recently after the lawsuits emerged and the FDA placed new safety warnings on the med.
AndroGel profited $675 million last year. Studies and clinical trials have linked Androgel and other testosterone treatments to heart attacks, blood clot injuries, stroke and an increased risk for prostate cancer, among other health reactions. But those negative side effects didn’t matter to the drug companies that were pushing these treatments. The only thing they cared about was whether or not their new product was going to pull in billions of dollars for their companies, and that’s exactly what happened.
Joining me now to talk about this case is Brandon Bogle. Brandon, you were involved in the first case, what? $150 million?
Brandon Bogle: Correct.
Mike Papantonio: Second case, $140 million?
Brandon Bogle: Right.
Mike Papantonio: Both of those cases, you were one of the trial lawyers involved in that case, which leads me to the question, those are startling kinds of numbers. The jury had to be furious about it. Tell us about the cases. How did the jury get to those numbers? What were they the most angry about?
Brandon Bogle: I think the most compelling facts of the case were these were both middle-aged men who had a condition that the drug company created, called “Low T.” They did not have hypergonadism, which is what these drugs, Androgel and other testosterone therapies, were approved to treat. Importantly, when you have Low T, you're in a group of people that the drug companies just, quite frankly, never studied. They never knew whether the drug was safe or effective in this population of men. It turns out, it was neither safe nor effective.
Mike Papantonio: Interestingly enough, they knew they couldn't sell enough of this drug to the normal population. This wasn't even a necessary drug. This is a drug that nobody needed, except maybe a tiny, tiny part of the population. They can't sell enough, so they invent this disease called “Low T” and then they go tell doctors, ‘Gee whiz, you need to start prescribing this if people have Low T.’ Was this company aware of just dangerous this product was?
Brandon Bogle: There were very aware. They very aware of two things, very aware, number one, that the drug was never approved to treat Low T or the symptoms of aging, which is basically what it is. As you get old, your testosterone naturally declines. When you put on a few pounds, your testosterone naturally declines. This drug was never approved to treat those sorts of issues. Importantly as well, they also knew their drug posed serious risks of heart attack, stroke and blood clots, and they did nothing to warn the public or to study those risks.
Mike Papantonio: Many people have died because of this, and you're handling a good many of the cases throughout the country. Has anybody gone to jail for this? This is not just fraud, this is, really, if you analyze it, it's almost an extension of a manslaughter analysis. You know what the problem is, the documents, was it clear to them? Did the documents show how clear this was.
Brandon Bogle: The documents are very clear, and it's very clear these acts were intentional, to your point. These are intentional acts. These aren't mistakes made by the company. This is, over a period of 15, 20 years, a series of continual intentional acts that have harmed people and killed people. To your point, unfortunately, no one has gone to jail for this.
Mike Papantonio: Are you letting the Department of Justice know about this as it goes on? Are you at least giving these documents, are you letting them know, exactly what these thugs did?
Brandon Bogle: Yes, in both cases so far, AbbVie has been found guilty of fraud and every time a company is found guilty of fraud, that goes directly to the Department of Justice for review. This is in front of the Department of Justice as we speak.
Mike Papantonio: Any lawyer that's there with Department of Justice is looking at the same facts that a jury came back with two times and punished this company by taking their money away, is that right?
Brandon Bogle: That's right.
Mike Papantonio: If you were to say, in trying this case, I know there are always documents that stick out and you say, ‘Wow, I can't believe they wrote that.’ What do you think is the most important documents in this case? Why is the jury getting so angry about their conduct?
Brandon Bogle: The most important documents are those, a series of them, that show the internal scientists at the company raising concerns about the risks of heart attack and stroke and blood clots with this drug, and the decisions made internally within the company to do nothing about that knowledge.
Mike Papantonio: In writing, you have scientists saying, A, we know that this can kill people. Basically, that's the conclusion.
Brandon Bogle: That's right.
Mike Papantonio: And then management gets ahold of that. Do they let people know that? Do they put a warning on the product that they're selling? What did they do with that information? The people that are making the big money, top management, what do they do with that information?
Brandon Bogle: They hid it. They hid it. They hid it and, instead, decided to go out and ramp up their marketing campaign to drive more people to take the drug, to put more people at risk for these injuries. They did the opposite of what a good company should do.
Mike Papantonio: They're out there telling doctors that, ‘Gee, you have a patient that is lethargic, they're stressed, they don't have their energy level, they maybe have ED, they've got all these issues,’ and they're saying, ‘We've got the magic bullet. Here it is, testosterone.’ What is the truth of about that, to begin with? That's a lie in and of itself, isn't it?
Brandon Bogle: It is an absolute lie. It's absolutely false. These are all just natural occurrences of aging. Your testosterone naturally declining with age is actually a good thing. It protects you from injury. It's not a bad thing. Yes, they flat out went out and told doctors they should be prescribing a drug that the company knew these men did not need.
Mike Papantonio: When we talk about people dying, explain some of the ways that people died.
Brandon Bogle: There are situations where people have had massive heart attacks that caused death, have very severe strokes which cause death, and even instances where you have a pulmonary embolism, a blood clot that goes to your lungs that causes death frequently. We've seen cases all along those lines, where men are dying, unfortunately, from a drug they never needed.
Mike Papantonio: Again, it comes as the age-old story, FDA is useless. FDA is a dysfunctional, almost useless department. You can almost do away with the FDA and when we'd have the same rules and regulations, we'd have the same problems out there, anyway, wouldn't we? What is your take on what the FDA did here?
Brandon Bogle: The FDA was asleep at the wheel, unfortunately. The FDA was very slow to react to what the company was doing from a marketing perspective, and very slow to react to the emerging science showing that this drug caused heart attacks and strokes. It took them until 2015 to take action, which is 15 years after this drug was first put on the market.
Mike Papantonio: The drug is out there 15 years, people are reporting that men are dying from this drug, heart attacks, strokes, you name it, people are dying. The documents are in the file of the company that say, ‘Yeah, we know people are going to die,’ and management is covering that up, because they're making billions of dollars. At the end of all this, when you presented this to the jury, what was your message? I can't imagine that the jury is sitting there not wanting to get up and strangle the people on the other side. What was your thought?
Brandon Bogle: Our message was very clear. Our message was, nobody can change this but you. The FDA has not acted to change it. You know the company is not going to change it. It's incumbent on you to tell them what they did is wrong and to send a message to make them change their behavior.
Mike Papantonio: Brandon, I always talk about this, I'm always interested in what corporate media does with a story like this. I do recall this story coming, emerging, years ago, the first edge of the story emerging years ago. In your take, how did corporate media do telling this story?
Brandon Bogle: They told a very incomplete story, a very incomplete and misleading story about what was going on here. I think that that's why us getting in front of juries in courtrooms and be able to tell the complete story is so important.
Mike Papantonio: You've got these advertisers, AbbVie, obviously advertising the heck out of this product. This is a gel that men rub on their body and there's no real delivery system other than the gel. It's not like it's controlled delivery. It can all move into the system at one time. Sometimes they use the same spot to put the gel on, it collects. Isn't this, anybody with a brain can look at this and say this a time bomb, right?
Brandon Bogle: Yeah, it was pretty apparent that this was going to be a problem. Again, the company knew that. That was not hidden to the company.
Mike Papantonio: When are you in trial again? When are you going to hit them again?
Brandon Bogle: We're going back in January for another round at them so, I'm looking forward to that opportunity.
Mike Papantonio: I'm proud you're my partner, by the way, I’ve got to disclose that.
Testosterone Makers Dupe Men Into Buying Deadly Treatment
Mike Papantonio: Let’s start with what the company knew about testosterone therapy first. The company was well aware of the fact that clinical trials of testosterone treatments in older men had to be stopped early because of the spectacular risk of heart attacks and strokes on those people being tested. Testing told the company that the product was so dangerous that clinical studies had to stop. Fast forward five years and the FDA decided that even they couldn’t ignore the dangers of the testosterone treatments like AndroGel anymore. They demanded the company include extraordinary warnings on their product about heart attacks and strokes from using those products even as directed. So far, this is your typical big pharma story. A drug maker sees bad results but they keep the product on the market anyway and they keep it all quiet.
Here’s where things get really disgusting. You see, testosterone treatments were originally designed only to help aging men who were suffering from dangerously low levels of testosterone. That’s only a tiny market for a drug company wanting to make billions, so they launched a slick advertising campaign to convince men of all ages that any problem they could be having in life, whether it was loss of libido, weight gain or fatigue or muscle loss, all these things could be fixed with their snake oil. Their big scam ad campaign worked. The company soon saw their yearly sales top $1 billion, but for big pharma, that still isn’t good enough. According to a lawsuit filed against AbbVie by the Federal Trade Commission the company began bribing competitors to keep their product off the market. This is what the FTC has called pay to delay scams. That lawsuit is still pending today.
AbbVie could face as many as 6,000 lawsuits from men who were duped and injured by the company’s dangerous product. I’m joined now by Robert Price to tell us the AndroGel story. Robert, thanks for joining me. The AndroGel testosterone story has so many different levels to it. Let’s start with the basics, Robert, of what this case is about. What do we know about the dangers of testosterone treatments?
Robert Price: Mike, thanks for having me on the show. The basics we know is that testosterone is a therapy used to treat men with testosterone and hormonal disorders. Basically, if your body has too much testosterone in it you’re at a dangerously high increased risk of heart attacks and strokes and cardiac events. That’s why we’re here today. We have been engaged in a years long battle with pharmaceutical companies such as AbbVie for improperly marketing and distributing dangerous testosterone therapy to men who essentially didn’t need it. That’s why we’re here today, Mike.
Mike Papantonio: Robert, is there any question that the company was aware of the dangers? That they had all the material they needed that showed that it caused strokes and heart disease, I mean, heart attacks, really. Is there any question about that?
Robert Price: Absolutely not. There’s so many different signs, so many things that are wrong here. First of all, you have companies like AbbVie with this AndroGel system. This quick delivery, this rapid high-dose delivery system where they’re rubbing it on their arms or their shoulder or their armpits. It’s going directly into the system. These companies, especially companies like AbbVie knew about it. They had early signs. They had clinical trials that had to be stopped due to safety concerns.
This is something that the companies knew, they knew it early on, and as we see all so often, they’re able to get this by the FDA by using limited studies. Studies that are not wide enough, they don’t apply to enough people such that we know what’s going to happen when it’s in the general population. Then you got the usual story with the FDA, which these drug companies are in such a power position, they have so much money, they have so many resources, and the FDA is the opposite. The FDA has thousands of drugs, thousands of cases, thousands of files, and they’re able to prepackage, they’re able to cherry pick and pick and choose what they want to present to the FDA. The FDA …
Mike Papantonio: Okay, well let me ask you this. Let’s talk about the marketing schemes AbbVie devised for this product. Originally the product was only meant to be used for aging men who had dangerously low levels of testosterone. There’s no question about that. It was very clear. The company soon realized that they could peddle this product to men as, really, a fountain of youth. Buy AndroGel, put it on your body, and everything’s going to do better for you in your life. That was the way they sold this product. It was a campaign that made them more than $1 billion a year doing that. Talk about the way that they approached this. Is it typical that we see in pharmaceutical company, the way that they go about promoting a product?
Robert Price: Absolutely, sure. You hit the nail on the head. So many of men that had this therapy and have been injured by this therapy don’t need it in the first place. As you mentioned, this testosterone therapy, this is something that had been out for decades, but until these pharmaceutical companies like AbbVie started this new system, started this new marketing stuff, it was just for people with a condition called hypogonadism, or dangerously low levels of testosterone. What pharmaceutical companies are able to get away with doing, and we see it here and it blew up, is this what they call disease state promotion.
The FDA will let a drug company get away with doing this disease state thing. “Hey doctors, we’re not exactly directly marketing, but you need to know about something called low T.” They blast the airwaves, they send their detailers into these clinics and they say, “Hey, are you 40 years old? Are you tired? Do you not feel like you used to?” Basically any men over 35 years old are going to say, “Yeah, I’m tired. I don’t feel like I used to. I don’t feel like a young kid again.” Anybody statistically, when you hit your mid-30s, most people are going to see a general, normal decline in testosterone. These are the people that are having this testosterone therapy prescribed to them that don’t need it. They’re going to these clinics and they’re hearing this message.
Mike Papantonio: Robert, it sounds to me like what they were actually doing is inventing diseases. In other words, if you’re tired it’s a disease. If your libido is low, it’s a disease. We see the pharmaceutical companies nowadays, because the markup is so high. You see markups of 2,000%, 3,000% on one pill. They understand if they can get that pill into the market, all of a sudden they invent a disease, the pill’s in the market, and they are on easy street by way of creating these cash cow products. In this case we saw another thing. We learned that the Federal Trade Commission was concerned that what AbbVie was doing was they were keeping competitors out of the market by buying them off. Tell us about that lawsuit that the Federal Trade Commission has gone forward with. It’s pending right now.
Robert Price: Yeah, it’s just true greed in its making. Essentially what AbbVie did is, in America you have a limited amount of time to have this cash flow. You’ve got, generally it’s 10 years, your patent, you’ve got exclusive rights on a certain formula of something. This is when the drug company makes their money. If they can get a few more years on their patent, that’s billions and billions of dollars to them. What they did is they basically invented a lawsuit. They sued a couple of generic drug companies under false pretenses. They said, “Hey, you know what? You’re infringing,” it was a patent infringement, “you’re infringing on our molecule. You’re infringing on this delivery system.” Completely baseless, no grounds for it.
What that does, here’s the kicker. When that happens they get an instant, it’s a 30 months, over two year stay. They cannot go in and actually sell generic testosterone. They can’t take AbbVie’s product and go market it. They’re in jail. Not in jail, but they’re stayed. The can’t do it anymore. What AbbVie does is they make a false lawsuit and they say, “Okay guys, you generic drug companies, we’re going to hit you. If you want to make the big bucks, we’ll let you out of this. You got to pay us a certain amount of money,” it’s called pay to play. Hit them with a fake lawsuit, make them pay to get out of it, so they can do to do what they should have been able to do in the first place, which is to be able to do a generic buy and sell on this testosterone therapy. The FTC saw it and said, “This is bogus, this is absolutely untrue.”
Mike Papantonio: Yeah Robert, one thing we see happening, these drug companies make so much money that what we’re seeing, and I think we’re seeing it here, too. If they make $1 billion a year for three or four years, and they understand they’re going to make billions of dollars, and they understand at the end of it, yes, they’re going to kill some people. Some 49 year olds are going to have heart attacks, they’re going to have strokes, but they then calculate how many are going to die and then how much can we pay for those deaths. Then they take that number and they compare it against the billions that they make, and if it only costs them $1 billion, but they’ve made $10 billion, they think that’s a pretty good idea. How often have you seen that in your practice, and is that the way this is looking in this case?
Robert Price: Absolutely. I mean, I say this, it’s tragic, but it’s what I do. It’s what a lot of pharmaceutical lawyers do. It’s like you said, it’s arithmetic. They get that 10 years or whatever it is for that patent, they go and sell it. They figure if they can make $10 billion and sure, they’re going to hurt some people, sure they’re going to get sued, but if they can resolve the litigation for $1 billion or $2 billion, that’s $8 billion profit in their mind. That’s when you see a story like this. You don’t actually get the data, you don’t actually get the studies. The proverbial mess doesn’t hit the fan until eight years into it, billions of dollars into it.
Papantonio: The Low T Cash Bonanza
Mike: The drug industry is trying to convince aging men that all of their health problems are due to low testosterone. The truth is, there are virtually no conclusive studies to show that testosterone therapies are effective. There is plenty of evidence to show us that they're incredibly dangerous if not done properly.
Joining me now to talk about that is Tom Schneider, author of the book Physician's Apology. Dr. Schneider, it appears to be a feeding frenzy out with everybody selling this concept of low T. I think that the bothersome thing about it is, you can benefit from an increased testosterone, if there's a plan. Unfortunately, these companies that are selling this, it's almost like snake oil charlatanism. What's your take on it?
Tom: No, you're absolutely right, Mike. It is charlatanism. The problem is it's charlatanism not selling snake oil but, really, dynamite. It's like snake venom because it really can hurt. The beauty of it is, testosterone, you and I both know, it's a hormone. We make it in our body. As we age, we make less and less and less. I'm a diabetic, my pancreas doesn't make insulin, so I take insulin every day. That's a hormone. Great stuff, keeps me going, I like it. Keeps me alive. If I take twice my dose, I'm going to die. Insulin will kill me.
Mike: Isn't the problem, and I've read your book on this, I think I understand it. Your book is pretty clear, your book is that testosterone ... there are some benefits, but the industry invented this disease called low T. Everything is called low T and they made testosterone deodorant, testosterone gel, testosterone nasal spray. Tell me the problems with that. What happens when a guy ... They even have off the shelf, hell, you can buy it at GNC.
Tom: Yes you can.
Mike: What are the problems with that, if it's not done properly?
Tom: These are the biggies. The fact of the matter is, everything you've said is correct. Testosterone, we do make it, it is natural. It does decrease, particularly as we age. Let me throw in a plug here, Mike, first. It actually depletes faster in women. In my practice, the majority of patients who are really low T were women.
Men have glommed onto this, they have for years. Weightlifters, power wrestlers, they've all used testosterone and growth hormone because it works, it's the real McCoy. The problem is, it needs to be dosed just like aspirin. I could take one aspirin and it helps my blood, it does all sorts of things. I take a bottle of it, I'm going to die. The studies that were done recently that have caused this furor were inadequate studies, as are, by the way, 87% of the ones that are put out. That's another story. They are flawed and they are flawed because the patients were given high, high doses of testosterone. Example-
Mike: What kind of levels, give me an example.
Mike: Give me an example.
Tom: Okay, a healthy male who has low testosterone or fading testosterone and symptomatic, meaning having symptoms from it, would be on about 40 milligrams a week, maybe 50. That's a normal dose for a healthy male, you and me, but with lowering testosterone. These patients were given 100 milligrams a week? No. 100 milligrams a day. A day!
Mike: Isn't part of the problem the delivery system with the, let's say AndroGel. Let's talk about the junk that's out there. You've got creams, you got nasal sprays, you got deodorants. Isn't the delivery system itself part of the problem because the cumulative nature of the delivery system? In other words, if a man wakes up and he's putting on testosterone deodorant every day, doesn't it simply build up in the system and the levels can get extraordinary? Isn't that part of the problem?
Tom: That is totally part of the problem. One other aspect, when it's given over the skin, topically, it absorbs underneath and there is an enzyme underneath, a particular enzyme. It's called aromatase. If you use it dermally, or on your skin, the aromatase takes testosterone and turns it into estrogen. We're all familiar with the problems of estrogen. Increased weight, increased risk of cancer, and the list goes on and on and on.That's what's happening. Men who are taking underarm deodorant testosterone, or any other type topically, are saying, "I do feel a little better, but my tummy is getting bigger." Or, "I'm gaining more weight." Yeah, because you're converting to estrogen and your doctor or these companies really don't know that, if you take testosterone, it has to be given precisely and you have to have safe precautions. The biggie, follow up.
I could put you on 40 milligrams of testosterone but I want to know, 8-12 months later, where's your blood count? Blood count goes up, well that's a good thing, doctor. No. Blood count goes up too much, we have strokes, we have heart attacks, cardiovascular disease. It really does have to be followed so closely, Mike.
Mike: Isn't the bad part of this the estrogen?
Mike: The estrogen is what's created by the testosterone. Unless you control the estrogen ... That's what brings the heart attack to the male, that's what brings the increased risk of stroke to the male. If you look at the packaging on these products, there's no mention of that.
Mike: There's no mention that it ought to be monitored. There's no mention that there's a level you should not exceed. There's no mention that you need to block the estrogen build up or the stuff can kill you. The FDA, again, has allowed it to happen without any kind of oversight. It's just like there was a low T bandwagon and the FDA is driving the wagon, the way this story appears when I read what you've written about it.
Tom: Absolutely. You and I both know that the driving force for all of this is money, money, money. This is an amazing product in terms of marketability. It runs rampant. I don't know of any product, really, that's taken off quite this much other than statins.
Mike: How is it marketed? Is it marketed you don't have sex drive, you're tired, you're fatigued, you're getting fat. Is all of this marketing that the average male looks at and he says, "Hell, I want to find something to fix me."?
Tom: Exactly. Therein lies the problem again. Remembering two points, the Schneider rules, one, last year, we killed 120,000 Americans by giving them medications that they shouldn't have been given. They died. More than twice the number we lost in Vietnam. That's what we lost last year because of medications. These are serious, serious medications.
The other big point is, a medicine like this that's this potent, it has to be monitored. Absolutely has to be.
Mike: Why is there such a difference in what camps of doctors are finding here? One camp of doctors says "Absolutely, this stuff is going to kill you." The other camp, "It's not clear."
Tom: Okay, this is where I have to give my caveat. I am a doctor, an M.D., not a minor deity, a real doctor. I can confess that we, as physicians, are not taught any of this. We are simply not taught it. It is a very specific type of learning process. In our town right here, I would say 99-100% of the physicians here have no idea that when you give testosterone, A, it needs to be monitored and B, the estrogen effect is humongous. You must block that estrogen effect or you're essentially killing your patients.
Mike: There's the other requirements are exercise and proper dieting when you give it to them. Isn't that part of it, also?
Tom: Yeah, you don't need to go to medical school, I'm always impressed when I come here. That's exactly right. I've been on testosterone for 20 years and people say, "Wow, you're 70 years old, you look great, you feel great." I've had a number of medical problems that I've survived because of testosterone but it is not because of testosterone, it's the symphony. Yes, I take testosterone. By the way, I exercise 7 days a week. By the way, I eat a little bit, often, mostly greens. You're right, it's the symphony approach, including the mind, that really plays into it.
There's no price that you can pay for health. Testosterone is not going to give you that. It's just one aspect. Does it work? The answer is yes.
Mike: Tom Schneider, thank you for joining me, okay?
Tom: I love you, Mike. Be good.