...but you don't know how many men had injections. And the injections are the ones that are at the highest risk of having heart attacks and strokes. For example, when we give an injection, we get a super normal testosterone bump. And those are the men that I worry about in my practice. And I constantly get red blood cell counts, hematocrits, because that's where you see an increase in red cell count and a higher chance of having heart attacks and strokes. I'm very worried about those people." This article is definitely worth sharing. From WAMU's Diane Rehm Show.....
Listen to the show here http://thedianerehmshow.org/audio-player?nid=18847
MS. DIANE REHM
10:06:53
Thanks
for joining us. I'm Diane Rehm. Recent studies show a higher risk of
heart attack and stroke in older men who use prescription testosterone.
Last week, the FDA said it's reassessing the safety of the hormone.
Joining me in the studio to talk about risks and benefits of using
testosterone, Dr. Adriane Fugh-Berman of Georgetown University Medical
Center.
MS. DIANE REHM
10:07:24
Joining
us from an NPR studio in New York, Dr. Harry Fisch of New York Hospital
and Cornell University, and Roni Caryn Rabin, a journalist who covers
medicine and health. I'm sure many of you will have your own thoughts,
your questions. Join us on 800-433-8850. Send us your email to
drshow@wamu.org. Follow us on Facebook or send us a tweet. And thank
you all for being with us.
DR. ADRIANE FUGH-BERMAN
10:08:00
Delighted to be here.
REHM
10:08:02
And, Roni Rabin, if I could start with you, tell us about these most recent studies regarding prescribing testosterone.
MS. RONI CARYN RABIN
10:08:16
The
study that came out last week that got everyone's attention said that
heart attacks doubled in men who were 65 and over within 90 days of
getting their first prescription of testosterone and nearly tripled in
younger men who had had a history of heart disease also within that
90-day period. And it wasn't the first study. There have been other
studies, observational studies, randomized controlled trials that were
analyzed that have sent this signal as well. So this alarmed a lot of
people.
REHM
10:08:44
I would wonder why there are so many more people taking testosterone. What does the research tell us, Roni?
RABIN
10:08:59
Well,
it's become a huge business. This has become a $2 billion business in
the United States over the last decade or so. There's been an enormous
amount of money pumped into advertising, not just advertising specific
drugs, but these campaigns to raise awareness about a disease or a
condition. And at this point, nearly one in 25 men in their 60s is
taking testosterone. Use has nearly quadrupled among men 40 and over.
REHM
10:09:32
And,
Dr. Fugh-Berman, the question becomes what is the difference between
the so-called Low T that we hear so much about on television and low
testosterone?
FUGH-BERMAN
10:09:53
Well,
Diane, the term low T was actually invented by pharmaceutical companies
in order to broaden the market that was eligible to receive
testosterone. So the condition is called Low T to consumers. Usually,
with physicians, they call it late onset hypogonadism, but it's really
different than true hypogonadism where somebody might have a pituitary
tumor or was born without testes or with un-descended testicles, for
example.
FUGH-BERMAN
10:10:27
So
there are instances in which somebody should have testosterone therapy.
But normally, aging men should not be taking testosterone therapy.
Not only are there the risks that Roni has discussed, but there's also
no evidence of benefits, really. So it's really being over-promoted
among normal men. The imputed benefits are not real, and the risks are
very real.
REHM
10:11:05
Now,
turning to you, Dr. Fisch. I understand that Low T is talked about in
terms of feelings of fatigue, loss of sexual drive, depressed moods. In
a situation like that, how are you prescribing testosterone?
DR. HARRY FISCH
10:11:33
Well,
there's a couple of things I would -- Dr. Fugh-Berman was saying there
are no studies that show a benefit. There are studies that show
benefits of men who actually have low testosterone. And I agree with
Dr. Fugh-Berman about, you know, people who have very low levels of
testosterone, such as pituitary tumors or testicular problems, can
benefit dramatically from medications.
DR. HARRY FISCH
10:11:54
And
there's no question about those people. The question occurs as men get
older and if they have hypogonadism. Clearly, men who are getting
older and are fatigued and have other issues, such as you just
mentioned, may not need any medication. They may need other more
natural approaches to treatment. But if they do have low testosterone,
that's an indication, that's a red flag that something more serious is
going on and needs to be addressed.
REHM
10:12:21
How rare, Dr. Fisch, are those individuals with a truly medical problem?
FISCH
10:12:31
Well,
there are quite a bit of people that have true medical problems that
manifest with a low testosterone. For example, there was studies that
show about 40 to 50 percent of diabetic men have low testosterone.
Obesity is associated with low testosterone, as is chronic fatigue.
Now, that doesn't mean -- I want to make a point here. That doesn't
mean because they have diabetes, low testosterone, just treat the low
testosterone, not the diabetes.
FISCH
10:12:55
We
always tell people, you know, to change their lifestyles, diet,
exercise, of course, in addition to sleeping more. For example, the
number one cause of fatigue in young men and older men, ready for this,
is lack of sleep. So the first thing we tell people is to sleep.
Testosterone is made when men sleep. So in this country where we're
sleeping five to six hours a night when we should be sleeping eight to
10 hours a night makes a big difference.
FISCH
10:13:20
So
simple information like that, as well as dietary changes. But,
unfortunately, a lot of men may not be able to make those changes and in
many times, we do provide medication to help them along.
REHM
10:13:33
Dr. Fisch, going back to my original question, I'm wondering how frequently you prescribe testosterone.
FISCH
10:13:43
Well,
my practice is one where I do prescribe medications to increase a
body's production of testosterone, and it -- is it rare? Well, it is
not rare. As I said, 50 percent, about half of men who have diabetes
have low testosterone. So but the importance is when you say prescribe
testosterone, in my practice -- and I'm supposed to be the guru of
testosterone therapy. That's what I'm known for in some respects.
FISCH
10:14:10
And
most of the patients that I treat I don't treat with testosterone and
that's a very important distinction. Just like Dr. Fugh-Berman said,
you know, some people who have very low testosterone and are clear
indications for sure those people need testosterone shots or gels, but
for the vast majority of the so-called late onset hypogonadism, I treat
with lifestyle changes, basic information on diet, but also with a drug
called clomiphene citrate. And probably 70 percent of my patients are
on a medication that's a generic medication that allows the body to
produce its own testosterone.
REHM
10:14:47
All
right. Dr. Fisch, I want to ask Roni Rabin specifically about Viagra
and Cialis. Were they somehow exonerated in these studies of
testosterone?
RABIN
10:15:08
Well,
the PLOS-1 study did compare the testosterone effects with Viagra
effects, I mean, not directly. It was in a randomized clinical trial,
and it did try to tease out whether this effect of the cardiovascular
problems was due to a suddenly ramped up sex life perhaps, as opposed to
the actual drug. And they did find that this was an effect of the
testosterone, not the Viagra.
REHM
10:15:36
All right. And to you, Dr. Fugh-Berman, what about AndroGel?
FUGH-BERMAN
10:15:43
Well,
I need to say that determining what low testosterone is, that's not
actually established in medicine. That in studies that have looked at
low testosterone, they've picked all kinds of different levels.
Testosterone levels vary by lab. There's wide ranges of normal
testosterone levels in every age group so while a group of 80 year olds
will have lower testosterone that a group of 20 year olds, in every age
group, there will be a very wide range. There's no connection between
testosterone levels and symptoms, and all of these symptoms are quite
nonspecific, of course, things like...
REHM
10:16:20
Such as?
FUGH-BERMAN
10:16:21
Such
as fatigue or diminished sports performance or diminished body hair.
Some of the Low T tests asks, are you sad and/or grumpy? Everybody in
my office failed the Low T quiz, including the 25-year-old women. But
-- and that quiz was actually invented by a physician who was being paid
by pharmaceutical companies and apparently wrote the quiz on toilet
paper.
REHM
10:16:53
But what about the question of erectile dysfunction?
FUGH-BERMAN
10:16:58
Oh,
yeah, great question. So testosterone doesn't actually work for
erectile dysfunction. So while there is evidence that testosterone
increases libido, it does not increase sexual function, which just seems
like a more frustrating situation to me.
REHM
10:17:13
What does it do?
FUGH-BERMAN
10:17:15
Well,
in very high doses, it has an effect on muscle. AndroGel and these
other popular gels that are being used in people who aren't
bodybuilders, it may not even do that. That's a little unclear, but in a
study several years ago where testosterone gel was given to men over 65
because it was hoped that they could carry packages up steps faster and
just walk around more easily, that study was actually stopped early
because of increased cardiovascular events.
FUGH-BERMAN
10:17:49
So
it was stopped because the treatment was dangerous. As Roni has
pointed out, there have been a number of studies now showing an
increased risk of cardiovascular events with testosterone and those
aren't the only risks. It also increases the risk of prostate
enlargement, congestive heart failure, male breast cancer, possibly
prostate cancer, and pulmonary embolism or blood clots.
REHM
10:18:15
So
there are lots of issues associated with testosterone, the first being
the question of how to determine low testosterone. Short break here and
when we come back, we'll take your calls, your email. Stay with us.
REHM
10:20:00
And
welcome back as we talk about benefits and risks of testosterone use
which prescription testosterone has gone up dramatically in the last ten
years or so between 2001 and 2011. Hormone use by men over 40 nearly
quadrupled. Here's an email. "My husband," she says, "of 20 years was
removed from a restaurant after jumping up, drawing back his fist and
shouting that he was going to hit me. He had been taking testosterone
for a few months and had just had his dose increased. He had never done
anything like this before."
REHM
10:20:58
She
goes on to say, "I believe this therapy is dangerous. Our doctor
admitted it can cause aggression, as did the domestic abuse hotline I
called. What does the research say?" Dr. Fisch, can you talk about
that?
FISCH
10:21:19
Well,
let's be honest, Diane. That's one case. I mean, I've treated
thousands of men with this, and I have never seen that. The issue is --
that we brought up before -- how do you diagnose the low testosterone
hypogonadism? And should men be treated who have normal testosterone
levels? That's really the bottom line, because you don't know if that
man that you were just describing was over treated, and it's very
important.
FISCH
10:21:42
And
what Dr. Fugh-Berman said was absolutely correct. You know, there is
no defining testosterone level by which we can say that somebody is
hypogonadal. And there is no symptom per say that we could say, ah,
that person has low testosterone. Hypogonadism is a clinical situation
that requires both a low testosterone level and clinically relevant
symptoms together, not one or the other.
FISCH
10:22:05
So
people should not be screened for just testosterone levels because the
truth is, it brings up issues that they're not aware of and they may be
over treated in those patients. And what I mean by that is, in the
article in the Plus One study that we're talking about today where
there's an increase incidence of heart attacks and strokes, the bottom
line of that study was that during that study they didn't even know
which men -- or what the testosterone levels were in the men that were
treated at the VA hospital.
FISCH
10:22:34
And
we know that men are being treated who have normal testosterone levels.
Studies have come out that showed well over one-third of men who are
receiving therapy -- testosterone therapy have normal testosterone
levels. So back to your statement, if you're going to take a person who
has normal testosterone levels and you're going to increase their
testosterone levels above normal, well, you know, those have risks
associated such as heart attack, stroke, aggression.
FISCH
10:22:59
But
if we're trying as doctors -- and I -- as I said, I treat thousands of
men. This is my specialty -- we want to maintain the testosterone
levels in the normal range only. And when we do that...
REHM
10:23:09
All right. Dr. Fisch, I want to be clear about one thing. Are you paid by the company that produces AndroGel?
FISCH
10:23:21
I
am not paid by any company at this point. In the past, I was paid by
AbbVie to actually bring product awareness -- disease awareness, I
should say. But I've never ever talked about a specific drug per se.
REHM
10:23:34
Are you on the website that is associated with...
FISCH
10:23:37
Yes, I am.
REHM
10:23:40
...AndroGel or any of the other drugs?
FISCH
10:23:43
I
am on the AbbVie -- or it's called AbbVie website and is at lowT.com
website where I discuss the disease itself, but not which drugs to take.
And as I said...
REHM
10:23:53
All right. All right. And to you, Dr. Fugh-Berman.
FUGH-BERMAN
10:24:00
Well, we don't really know what normal testosterone levels are.
REHM
10:24:04
How is that? How come?
FUGH-BERMAN
10:24:06
Well,
for one thing, well they vary widely in individual men but they also
vary by the hour. They vary by the day. They're generally highest in
the morning. They can actually increase with job status. They can
increase with exercise. They can increase with whether your sports team
won or lost that day. So there are many factors that increase or
decrease testosterone levels. Caretaking apparently decreases
testosterone levels.
FUGH-BERMAN
10:24:34
But,
you know, to return to your reader's comment, testosterone can increase
aggression, and not just in people but also in pets. Since these gels
are sometimes rubbed on the chest or other places where someone might
come into contact with a child or a pet, this is actually caused...
REHM
10:24:54
Well, that's a warning, isn't it?
FUGH-BERMAN
10:24:56
Yeah, it...
REHM
10:24:56
I
mean, isn't there a warning on the ad that says, make sure that you as a
woman, if you're pregnant, you do not touch that site?
FUGH-BERMAN
10:25:09
Right.
Or -- and children as well. If a man is hugging his child, there
might be gel that gets on the child. And even pets who've been handled
by men who've been using testosterone sometimes become more aggressive.
REHM
10:25:24
Now
here's another email from James in Orange, Va. who's 60 years old. He
says, "I watched one of those ads last night on TV. The side effects
were laughable, swelling, bleeding, headaches. Don't let women and
children touch that spot where testosterone was applied. I cannot,"
says James, "imagine that, given proper notification of the potential
side effects, any sane person would choose to take this drug. What
could be the benefits?" Roni, let me ask you that. Did researchers
find benefits?
RABIN
10:26:16
There's
actually a big NIH trial going on right now at University of
Pennsylvania to look at the benefits. And that's one of the questions
in IOM report, an Institute of Medicine report about a decade ago said
was still actually a question, what are the benefits? But, Dr. Fisch,
do you want to add to that?
FISCH
10:26:35
Oh,
I'd love to add to that. You know, my patients who have low
testosterone, primary testicular failure that cannot make testosterone,
this is a life-saving medication for them. And, I mean, that because
literally these people who have no -- are unable to make their own
testosterone benefit dramatically: their increased energy level, muscle
mass, less of a chance to get diabetes, more exercise tolerance.
FISCH
10:27:02
And,
you know, I've been -- my patients have been written up in magazines
about this. So while you're presenting patients that have dramatic side
effects, I could present tons of patients, and I mean tons -- tons was
by weight -- maybe thousands of patients that actually have benefitted
by the testosterone levels.
REHM
10:27:16
All right. Dr. Fugh...
FUGH-BERMAN
10:27:17
But,
Dr. Fisch, you also mentioned that people who don't have low
testosterone who are given exogenous testosterone as a drug, what
happens to them?
FISCH
10:27:26
Well,
first of all, I consider that malpractice. If some doctor is treating
patients who have normal testosterone levels and not -- or not even
checking their testosterone levels, well that is not the approach that I
take. It's not the approach that the Endocrine Society recommends or
anybody recommends...
REHM
10:27:42
All right. Dr. Fugh-Berman.
FISCH
10:27:43
...because that's just treating them and getting complications.
FUGH-BERMAN
10:27:46
Yeah,
a couple of things that need to be said. One is that testosterone may
improve mood, which of course will make people feel better about a lot
of things. And there's a very strong placebo effect. Things like
libido and fatigue and mood are very amenable to the placebo effect.
And this is a very dangerous placebo. But the other thing about health
benefits, I'd really disagree with you there, Harry. In fact, we know
from studies of eunuchs who have had their testicles removed that they
actually live longer than people with normal testicles.
FISCH
10:28:25
Well,
I don't treat eunuchs but I can tell you that patients that I see that
develop testicular failure are in a terrible situation in terms of
depression, low muscle mass. As I said, a lot of them are overweight.
I've had tremendous success in men. We talk about, you know, mood, sex
drive and everything.
FISCH
10:28:41
But
it turns out that, in order to lose weight, I see tremendous weight
loss and consistent weight loss in men who have normal testosterone
levels. And in the general medical community, we know that anybody can
lose weight, but it's maintaining the weight loss over time. We don't
want those yo-yo diets. We want to build muscle mass and maintain
people's ability to maintain that weight loss. And I've had -- I treat
patients like this. And I've had tremendous success with it.
REHM
10:29:04
All right. Are there any -- are there side effects, Dr. Fisch, that you can talk about?
FISCH
10:29:11
Yes.
Yes. There's very important side effects, and some of the studies
including the Plus One study and the past studies are very important to
discuss. Every testosterone therapy is not the same. Everyone is
different. For example, the gels are different than injections. And in
this study that just came out, we don't know how many men were on
injection therapy as opposed to just gel therapy. Now why is that
important?
FUGH-BERMAN
10:29:35
The most common treatment was gel in the (unintelligible)...
FISCH
10:29:38
I didn't see that in the -- yeah, but I...
FUGH-BERMAN
10:29:40
It states in the paper.
FISCH
10:29:42
...but
you don't know how many men had injections. And the injections are the
ones that are at the highest risk of having heart attacks and strokes.
For example, when we give an injection, we get a super normal
testosterone bump. And those are the men that I worry about in my
practice. And I constantly get red blood cell counts, hematocrits,
because that's where you see an increase in red cell count and a higher
chance of having heart attacks and strokes. I'm very worried about
those people.
REHM
10:30:05
All right. I want to open the phones now, 800-433-8850. Let's go first to Dan in Asheville, N.C. Hi, you're on the air.
DAN
10:30:22
Hi, Diane.
REHM
10:30:23
Hi there.
DAN
10:30:25
I
have a brother who has -- OK, he's 35 years old, and he's been taking
testosterone for the past two years. And it just seems like -- I'd like
the panelists to discuss maybe the personality changes that a person
goes through. Because he just keeps -- he's having problems with his
family. He's having problems with his coworkers.
DAN CALLER)
10:30:49
And
it just seems like the doctor who's prescribing it, the testosterone,
just keeps upping and upping his dosage as he goes along. He started
off with the cream, and now he's gone to shots. And it just seems like
all the problems that he's has in the past two years with taking the
testosterone has correlated it with when he started.
REHM
10:31:11
Dan, do you have any idea why he went to the doctor in the first place? Why this was prescribed at all?
DAN
10:31:23
From
what I understand, Diane, he was just like your panelists were
discussing before. He was just chronically fatigued. He was, you know,
he was just kind of "depressed" a little bit.
REHM
10:31:34
That's interesting. All right. Dr. Fugh-Berman.
FUGH-BERMAN
10:31:37
Testosterone
is not an appropriate treatment for depression or fatigues. We have
better, safer treatments for that. And there's actually no evidence
that testosterone actually helps either of these things. So that's a
really concerning story. It'd be great if you could convince him to go
off and maybe change doctors.
REHM
10:31:56
What would...
DAN
10:31:56
I
mean, the thing is, when we try to talk to him about it, he's almost as
if he's become addicted to the testosterone. He doesn't want to talk
about it. He doesn't -- he thinks the testosterone has helped him.
And, you know, it feels like he's on steroids almost.
FUGH-BERMAN
10:32:13
He
-- well, he is on steroids. Testosterone is a steroid. And it would
be maybe -- maybe pointing out some of the risks like a heart attack
might be useful for him. But that's a very concerning story. And
unfortunately there is all of this promotion that is going on in
medicine, the physicians as well, to convince them that it's OK to give
testosterone to men who don't need it. And there may be other
undiagnosed medical problems like depression that really -- they're
important. They need to be treated, but they do not need to be treated
with testosterone.
REHM
10:32:50
Roni, can you tell us about the studies of the older men and the kinds of symptoms they presented with?
RABIN
10:33:04
Well,
there was a randomized control study quite a while back that was
stopped by safety monitors. It was a small study. It was one of those
with a control group that received a placebo. They -- and these were
older frail men, frail elderly men. And they were giving them
testosterone. And so that they -- the ones receiving the testosterone
really did gain strength in their chests and their legs. They were able
to walk upstairs faster. They were able to carry things. But they did
start having heart attacks at high rates.
REHM
10:33:34
Wow.
RABIN
10:33:35
And
the safety monitor saw this and put an end to the trial. That was
quite some time ago. There were questions about how old and frail these
men were, and whether the doses they received were correct. But that
was done probably, you know, quite -- several years ago.
REHM
10:33:54
All right. And you're listening to "The Diane Rehm Show." Let's go to Gary in Arlington, Va. You're on the air.
GARY
10:34:05
Yes. Thanks so much for taking my call.
REHM
10:34:07
Sure.
GARY
10:34:08
I
am 63 years old and I've been on testosterone gels for four years.
When I was 59 I was just feeling old and cranky and there was no joy in
life. And I mentioned this to my doctor, you know, during my routine
physical. And he took, you know, of course, the blood work, and, sure
enough, I was very, very low in my testosterone count. And, you know, I
just feel like a new person within two or three weeks of starting it.
REHM
10:34:40
Mm
hmm. Now what about that Dr. Fugh-Berman? Can a doctor simply measure
that testosterone level through the blood and assume that that's the
problem?
FUGH-BERMAN
10:34:57
Not
really. Not only do the levels vary by what lab you send it to, but it
also varies by the hour and varies by the day. And we don't really
know what a normal range is.
REHM
10:35:09
OK.
But Gary is 63. He says he's felling lots better. Dr. Fisch, I would
assume that you would attribute that to the testosterone.
FISCH
10:35:24
Of
course. A lot of my patients are like that. And again, I treat these
patients. And what I want to make a point about what Dr. Fugh-Berman
said, if we have consistently abnormally low testosterone based on what
the FDA has allowed under 300 anagrams per deciliter, now that is not
the best level for sure, but it is what we have for now. In association
with symptoms, treatment of those patients reveal what Gary just said,
and that is tremendous increase in strength and libido sometimes and
ability to lose weight.
FISCH
10:35:56
But
the thing that I find most fascinating is cognitive function changes.
I've had people that tell me -- geez I had one patient said to me, you
know, when he came after I started treatment he said, you know Dr.
Fisch, now I can read again. I said, what? I didn't even know -- what
do you mean now you can read again? He said, I didn't have the
concentration ability to read again. So now he's able to read. He's
able to concentrate.
FISCH
10:36:15
And
when it comes to depression, let me make a point that the symptoms of
depression and low testosterone overlap. They're very, very similar.
And we now know that men who are depressed tend to have low testosterone
levels. So the future...
REHM
10:36:26
Roni, I wonder if you found that in any of the studies that you went back to look at.
RABIN
10:36:36
Well,
I'm -- there are a couple things I just want to say. First of all, the
caller -- it was a little bit déjà vu. You know, in medicine you're
always trying to balance the benefits and the risks. And this idea that
you take something that makes you feel great, we heard that for years
about hormone replacement therapy for women during menopause. For
years, we thought that was terrific.
RABIN
10:36:59
It
would prevent heart disease in women. It would keep them healthier for
longer and keep them vital and having great sex lives and their skin
and everything. It was supposed to be the magic pill. It turned out
not to be the case. We actually found out once we did randomized
controlled trials that there were a lot of risks to that. And I think
we need to be careful.
REHM
10:37:18
All
right. We've got to take a short break here. Roni Caryn Rabin is a
medical reporter for the New York Times. When we come back, more of
your questions, comments. Stay with us.
REHM
10:39:58
And
in this hour we're talking about testosterone, the prescribed
medication given to men, and indeed some women are using it. We invited
the makers of several of the top-selling testosterone drugs to be on
the program. Most were not able to get back to us before the program
began. But Eli Lilly, maker of Axiron, sent a statement. It reads in
part, "Axiron is a prescription medication approved by the FDA for men
with certain conditions associated with a deficiency or absence of
testosterone.
REHM
10:40:49
"Lilly
does not condone the use of our medication for off-label purposes.
Patient safety is Lilly's top priority. They actively monitor all
adverse events, including cardiovascular events reported in clinical
studies and clinical use. Lilly continues to review available safety
information, including cardiovascular safety information to determine if
updates to the Axiron label are needed." Dr. Fugh-Berman, would you be
in favor of a big or larger warning label on drugs containing
testosterone?
FUGH-BERMAN
10:41:45
Well,
there's certainly does need to be a change in the warning label. And
in fact, the FDA has announced that it is going to look into these
adverse events that have been really cropping up in a lot of studies
lately. And by the way, the FDA does not make a mention of what
testosterone level in the blood should be treated.
REHM
10:42:05
So give me a range in numerical terms of what one might see as a range of testosterone levels.
FUGH-BERMAN
10:42:19
So
it could be anywhere from zero in somebody who doesn't have testicles,
up to over 1000. And various people have said low testosterone is under
150 or 200 or 250 or 300. It's not well established what low
testosterone is.
REHM
10:42:37
Dr. Fisch, how do you determine what low testosterone is?
FISCH
10:42:44
I follow the Endocrine Society guidelines.
REHM
10:42:46
What are those?
FISCH
10:42:47
And
those are the guidelines that say if a testosterone is below 300, with
symptoms -- I want to make an important point. It is not the level
that's important. It's the level and the clinical symptoms combined.
We are not sure…
REHM
10:43:01
But the clinical symptoms, Dr. Fisch…
FISCH
10:43:04
Yes.
REHM
10:43:04
…I gather you would agree, are fairly vague.
FISCH
10:43:09
They
are vague, but the number one, number two symptoms are fatigue and low
libido. And those are things that we see marked increases in with the
treatment -- with people who have low testosterone. That's what I see
in my clinical practice. So the bottom line is there are guidelines by
the Endocrine Society. And in terms of warning labels, yes, the FDA --
you always have to take a look at what happens in the clinical
situation, what happens in the population. But important to remember,
promotion to men who do not have low testosterone is wrong.
REHM
10:43:40
All right.
FISCH
10:43:40
It is only for men that have low testosterone and symptom for a condition called hypogonadism.
REHM
10:43:45
OK. But…
RABIN
10:43:47
I think…
REHM
10:43:48
Go ahead, Roni.
RABIN
10:43:49
I'm
just wondering, though. Men's testosterone levels do seem to decline
with age in a normal age-related decline. And the question is how do
these guidelines fit into that? And should they be adjusted if this is a
normal age-related decline?
REHM
10:44:04
Dr. Fugh-Berman?
FUGH-BERMAN
10:44:06
Right.
And that's really unclear what are "normal" levels for different ages.
So that's really an important question, but also the Endocrine Society
takes quite a lot of money from drug companies. And you actually get
different answers when you look at who's getting paid.
FUGH-BERMAN
10:44:27
So,
for example, there was a meta-analysis of adverse events in
testosterone trials and when they divided out the trials into which ones
had been funded by pharmaceutical companies that made testosterone and
which ones had not, they found that the industry-funded trials found no
increased cardiovascular risks, but that the non-industry-funded trials
did find an increase in cardiovascular risk. So it's always important
to follow the money.
REHM
10:44:52
Did you see that -- hold on, Dr. Fisch. Did you see that, too, Roni, in terms of the kinds of studies being done?
RABIN
10:45:06
Well,
the meta-analysis that Adriane talked about, definitely was able to
separate it out and saw that the trials that were funded by industry did
not see as big an increase as the ones that were independent. And I
think we do see this fairly consistently. Even in talking to -- when I
do my interviews, I'm always very careful to ask if people have industry
ties. And the tone changes dramatically, and it's often consistent
with that.
REHM
10:45:36
All right. I want to take another call. This from Louisville, Texas. Hi, Brett. You're on the air.
BRETT
10:45:44
Hi,
Diane. My question is -- if you guys could talk about how doctors are
actually compensated. My sister-in-law is actually a drug rep. And she
says that oftentimes doctors get direct payments for prescribing
certain drugs. And they also may get Super Bowl tickets or sports
tickets. And if you guys could talk about how that may be influencing
some doctors to make some of those decisions, I would appreciate it.
REHM
10:46:07
All right. Roni, I wonder if you've seen any of that.
RABIN
10:46:13
Well,
I don't know about direct payments. I wouldn't know how that would
happen. There's definitely been a big gift and dinner and lunch
industry. And there have been efforts to crack down on that and have
more transparent reporting. I think actually one of the most dangerous
things is that so much information is coming directly from drug
companies to physicians, and there isn't always moderation of that. So
there's a lot of education that drug companies are doing of physicians.
REHM
10:46:45
All right.
RABIN
10:46:45
And that education may not be as complete or comprehensive or somewhat biased.
REHM
10:46:49
Dr. Fisch, do you want to comment on the question?
FISCH
10:46:53
Of
course, I'd like to comment on the question, Diane. It turns out that
giving money or Super Bowl tickets to doctors is illegal. You can't do
that. In fact, they don't even give pens out anymore. What they do do
is they do sponsor doctors to educate other doctors. And that's where
they have the dinner programs and things like that. And I'm all in
favor of that. But I could tell you that I know for a fact it is
illegal to really compensate doctors for writing prescriptions.
REHM
10:47:19
Dr. Fugh-Berman?
FUGH-BERMAN
10:47:21
It's
illegal to pay someone to write prescriptions, but it's not illegal to
give gifts at all. And there's many ways in which pharmaceutical
companies affect physicians. So not only do drug reps target physicians
who control market share or might be writing a lot of branded
prescriptions, but also pay physicians to be speakers, they pay them to
be consultants, they pay to essentially do fake clinical trials where
they're being paid to enroll patients in clinical trials that don't
really exist. So there's different ways of paying somebody without it
being a direct payment for a prescription.
REHM
10:48:02
Roni,
I'm wondering to what extent the studies looked at the number of
advertisements on television, correlating them with the increase in use
of these prescription drugs.
RABIN
10:48:23
I
am not aware of studies that looked at that correlation. Dr.
Fugh-Berman may know more about that. There certainly has been an
enormous amount of money poured into advertising, about $100 million has
been spent on advertising specific brands of drugs. And then there's
additional money that's spent on raising awareness of the condition and
the disease that's not even tracked the same way. And there's a
correlation between that increase and the increase in sales and increase
in prescriptions.
FUGH-BERMAN
10:48:57
Yes,
absolutely. And, of course, drug companies don't spend money on things
that don't work. And direct-to-consumer advertising is important.
Those ads are very creative. But in the industry they actually have --
industry says that it's more important to get to the doctors because
they're the ones who really have the prescription pad.
FUGH-BERMAN
10:49:16
And
certainly it increases the acceptability of therapies to have
direct-to-consumer advertising. But as Roni mentioned, medical
education or continuing medical education -- a lot of that is funded by
pharmaceutical companies. And it always has subtle messages in it that
do not necessarily even mention brand names.
FUGH-BERMAN
10:49:38
It's
all about what Dr. Fisch called disease awareness, convincing
physicians that a particular disease state, as industry calls it, is
underdiagnosed, it's affecting a lot more people than we think, that
it's having a dramatic effect on people's lives. That's the job of
these physicians who are key opinion leaders. It's their job to tell
other physicians that a particular disease is underdiagnosed and needs
to be treated more often. Low T is a perfect example of that.
REHM
10:50:08
Dr. Fisch, do you want to comment?
FISCH
10:50:10
Of course. Hypogandism is a disease. It's something that has been underdiagnosed in the past.
REHM
10:50:16
But how rare is that, Dr. Fisch?
FISCH
10:50:20
Well,
it's not rare in my practice since that's all I do as a fertility
doctor. I could tell you that many people who have hypogonadism have
low sperm counts and are infertile. Men who have hypogonadism tend to
have low libido, sexual dysfunction problems, in addition to a myriad of
other problems associated with it. It is real. I'm the only person on
this panel that actually treats patients.
FISCH
10:50:40
And
as a professor at an Ivy League university, I'm telling you that this
is an actual disease and not to make fun of a disease because you're not
aware of all of the symptoms or all the problems associated with it. I
want to make a point about the studies that say there is a problem. In
the Plus One study, I want to make a point that patients treated at the
VA center did not have testosterone levels.
FISCH
10:51:01
We
don't know if they were men who had normal testosterone levels or below
testosterone levels. And only men who were hypogonadal with low
testosterone levels should be treated. There are risks associated with
these medications for people who should not be treated, who have normal
levels and whose levels go into super normal, extra, above normal
levels, and that's where you see the problems.
REHM
10:51:21
All right.
FISCH
10:51:22
So
a doctor has to be educated and has to know how to treat patients. And
patients need to be aware of all the risks and benefits associated with
these medications.
REHM
10:51:27
All right. Let me take another call. Dana, in Ft. Worth, Texas, you're on the air.
DANA
10:51:34
Hi. Good morning.
REHM
10:51:36
Hi.
DANA
10:51:38
My
sister is 46 and perimenopausal. And she went to a homeopathic doctor,
if you will, and was prescribed testosterone injections that she does
twice a month. And I'm wondering if any of these studies or side
effects are relevant to women?
REHM
10:51:57
Dr. Fugh-Berman?
FUGH-BERMAN
10:51:58
Well,
there are these anti-aging clinics that unfortunately will mix together
different hormones often in compounded preparations. They might mix
estrogen and testosterone and other kinds of things together. So, yeah,
this is both in conventional medicine and also in alternative medicine.
But there's no such thing as a harmless hormone. Hormones affect the
whole body. We know about the problems with menopausal hormone therapy.
We're going to see an epidemic of adverse effects from testosterone.
FUGH-BERMAN
10:52:30
In
women, the FDA has actually turned down several -- well, they turned
down testosterone treatment for libido in women because it didn't work
very well and they were concerned about safety. Women with higher
testosterone levels, naturally-occurring testosterone levels, for
example, have higher breast cancer rates. And there was just a
testosterone gel study in women that was stopped also for lack of
efficacy.
REHM
10:52:55
And you're listening to "The Diane Rehm Show." Let's go to Jim in Tallahassee, Fla. You're on the air.
JIM
10:53:06
Hi, Diane.
REHM
10:53:07
Hi.
JIM
10:53:08
You
deserve a medal. I recall a parallel discussion on your show about
women and calcium levels. And it seems as if the pharmaceutical
companies were creating these classes of patients who were not quite ill
or diseased, but feel that they need to be treated. My calcium's low.
I should be taking some sort of supplement. And I'm wondering that
this low T thing doesn't strike very similar chords of trying to get
people who may not have disease wanting to treat their fatigue or their,
you know…
REHM
10:53:54
All right. Thanks for your call. Dr. Fugh-Berman?
FUGH-BERMAN
10:53:57
Sure.
It's a really great point because there is a lot more well people than
there are sick people. So well people are a much larger market. And
if pharmaceutical companies can convince people who are perfectly
healthy that they need a drug, they can sell a lot more of that drug.
REHM
10:54:14
All right. To David, in Lillian, Ala. You're on the air.
DAVID
10:54:21
Good morning.
REHM
10:54:21
Hi.
DAVID
10:54:22
I've
been through the ringer on this. I'm 60 years old in two days, and in
1995, exactly to the day of my birthday, I went for an operation. I
tore a solar plex muscle in the Marine Corps, and I put up with it since
'74 until '95. The guy did the surgery. It went horribly wrong. They
left a twist tie on the vas deferens. The gonad swelled up to giant,
and it stayed like that for 20 months. Hard as stone and months later, I
went and saw a urologist. She put me on testosterone.
DAVID
10:54:53
She
said, there's nothing we can do now. They should have opened you up
and took the twist tie off of there. She goes, why was it on there in
the first place? I didn't know. I've got a picture of it. And there
was nothing I could do about it. But I've been taking the testosterone
cypionate, and I got down to a half cc every 10 days.
DAVID
10:55:09
And
I've been doing this for all these years. I can't find out what
exactly it's made out of. Synthetics, they told me -- was best I could
come up with for an answer. Does it cause tumors on organs? I've heard
of heart disease three times greater. I was a distance runner. I've
gone up and down with the mood swings and all the weight.
REHM
10:55:27
All
right. David, it sounds as though you've got multiple problems going
on. And I do hope you'll continue to check in with your own doctor.
What would you say to him, Dr. Fisch?
FISCH
10:55:45
Well,
it sounds like David had a testicular problem and probably had low
testosterone -- although I am not his doctor. But if you're losing a
testicle, remember, that's the organ that makes testosterone. So you
very likely had hypogonadism. And the medication for him may have
helped some of his symptoms. But of course once you're on this
medication you need to have follow-up with, again, testosterone levels
and red blood cell counts and estrogen levels to see if they're
increased in any way because those -- if it's increased you need other
treatment to avoid those increases.
REHM
10:56:16
All right.
FISCH
10:56:16
And, as said, the injections are the ones that cause more problems than if it's in the normal range.
REHM
10:56:20
All right. And finally, Dr. Fugh-Berman, do you believe that this is a drug looking for a disease?
FUGH-BERMAN
10:56:34
Yes,
absolutely. It used to be before we had these gels that were
injections. And there certainly were companies trying to sell the
concept of male menopause or andropause to men, but it's hard to get
them to take injections. So since they've been available in gels it's
really increased the market and increased the opportunities for creating
a disease state in men.
REHM
10:56:55
So you believe there have got to be lots more studies?
FUGH-BERMAN
10:57:01
No. I actually think we have enough studies to say healthy men shouldn't use this.
REHM
10:57:04
All right.
FISCH
10:57:04
That's true.
REHM
10:57:06
Dr.
Adriane Fugh-Berman of Georgetown University, Dr. Harry Fisch -- he's
professor of urology and reproductive medicine at New York Hospital and
Cornell University -- and Roni Caryn Rabin, medical reporter in the New
York Times, thank you all so much.
FUGH-BERMAN
10:57:30
Thank you.
FISCH
10:57:31
Thank you.
RABIN
10:57:31
Thank you.
REHM
10:57:31
And thanks for listening. I'm Diane Rehm.
Transcripts of WAMU programs
are available for personal use. Transcripts are provided "As Is"
without warranties of any kind, either express or implied. WAMU does
not warrant that the transcript is error-free. For all WAMU programs,
the broadcast audio should be considered the authoritative version.
Transcripts are owned by WAMU 88.5 FM American University Radio and are
protected by laws in both the United States and international law. You
may not sell or modify transcripts or reproduce, display, distribute, or
otherwise use the transcript, in whole or in part, in any way for any
public or commercial purpose without the express written permission of
WAMU. All requests for uses beyond personal and noncommercial use
should be referred to (202) 885-1200.
No comments:
Post a Comment