Hard: Little Pill, Big Pharma

ANNA SALE: What was it like being able to talk with men who had struggled with erectile dysfunction and tried to manage it as a mental health problem that you were able to say to them, actually, there's something going on physiologically that I think we can help you out with?
IRWIN GOLDSTEIN: It's like they won the lottery. I mean, you're not a man and you don't have a penis, but when it doesn't work, you challenge all aspects of your ego, your being, your self worth. You say, what did I do? Am I guilty of something? What did I do wrong?
I’m Anna Sale… and this is Hard.
A series from Death, Sex & Money about Viagra…
DAVID ROWLAND: Men worry about their erections all the time.
erectile dysfunction…
BOB: Abstinence does not make the heart grow fonder.
and the ways we do and don’t talk about sex, relationships and our bodies.
LOUISE: I even went to therapy for a year and never really talked about it.
Viagra was approved by the FDA almost a quarter century ago… in the spring of 1998. It was the first oral pill to treat erectile dysfunction. Sex lives were going to be revolutionized.
And who did Pfizer hire as their spokesperson?
Former Republican senator… Bob Dole.
BOB DOLE: “Courage. Something shared by countless Americans. Those who’ve risked their lives.”
Some of you might remember this commercial well. Others of you might be hearing about this for the first time. But this is how Senator Dole’s Viagra commercial begins. He’s sitting in what looks like a stateroom hallway… wearing a suit with a red tie.
BD: When I was diagnosed with prostate cancer, I was primarily concerned with ridding myself of the cancer. But secondly, I was concerned about possible post-operative side effects like erectile dysfunction, ED.
ED, of course, has a myriad of causes…some physiological, some related to underlying mental health conditions, or both. Senator Dole had talked openly about his prostate cancer when he ran for president in 1996… a Time Magazine article from that year describes him as speaking “knowingly” of the common surgery side effects of quote “impotence and incontinence.”
BD: You know it’s a little embarrassing to talk about ED, but it’s so important to millions of men and their partners.
And while there’s a little bit of Pfizer branding on the commercial… and a non-descript phone number to call for “more information” at the end… Senator Dole never says anything about Viagra.
BD: The point I want to make is there are many treatments available for ED… so my advice is, get a medical checkup.
This is not a sexy commercial. It feels like a PSA… encouraging men to summon the bravery to have hard, embarrassing, vulnerable conversations with their doctors… that also happen to be about sex.
Of course, what happens… when we’re faced with something deeply uncomfortable?
NORM MCDONALD: ...that Viagra thing out? You don’t want to hear about Bob Dole’s cock, you know?
Ever since its inception… Viagra has been the subject of late night jokes…
RODNEY DANGERFIELD: I tried a Viagra pill. My tongue got hard!
many memorable ad campaigns… TV episodes…
SAMANTHA, SEX AND THE CITY: What would happen if I tried one of these?
But hidden behind the Viagra punchlines are deeply personal stories and a pretty interesting history. One that, as we found out, has a lot of twists and turns.
DR. DAVID BROWN: If you look at the history of Viagra, it could have been lost maybe 10 or 15 times on the way.
In this second episode of our three-part series, we're going to talk about how America got to know Viagra—and we’ll talk with some of the people who helped create this little blue pill.
But before we get into it – I just quickly want to go back to Senator Dole, who was in his mid-70s when he made that famous Viagra commercial. He was hired by Pfizer after speaking publicly about taking part in Viagra trials. Larry King even had him on his show to talk about living with ED.
BD: People are embarrassed to talk about it, it affects them and their partners.
LK: Were you embarrassed?
BD: Yeah, I was - still am. I mean, it's something you don't run around, you know, sit around talking about the coffee shop or particularly in a public television program...
There were two doctors also joining Senator Dole in this conversation about erectile dysfunction…
BD: Maybe the two doctors could tell men who may be watching, who are embarrassed about this, how's the best way to approach a doctor?
LK: What is, Dr. Goldstein? How should you approach - ?
BD: Do you have a back door? [Laughs]
LK: Sneak in. "Impotence Wing!"
IG: [Laughs] This is International Impotence Education Month…
That’s Dr. Irwin Goldstein – a silver haired yet youthful looking urologist… who had led Pfizer-sponsored clinical trials of Viagra in the U.S.
LK: Would you call it an amazing drug?
IG: It really is. We've been waiting a long time, the therapists for this field, but in particular, humanity has been waiting for an oral pill.
Today, Dr. Goldstein is in his 70s… and he runs a clinic devoted solely to sexual medicine. I called him up at his home in San Diego.
IG: My children have a saying whenever I'm in company with them, someone looks at their watch and counts how many seconds it is until the word sex is mentioned. Like I embarrass all my children all the time.
Dr. Goldstein has parlayed his expertise in sexual health into lucrative consulting for drug companies. He earned more than half a million dollars from them in the last eight years, according to government records.
He began developing his expertise back in the late 1970s, when his urology mentor became one of the first doctors to perform penile implant surgeries.
IG: I became totally fascinated by, you can take a flaccid penis, press a button and bango, you have axial rigidity. Um, and I remember asking, well, how the hell does an erection occur in the first place? He says, we have absolutely no idea.
AS: Huh.
IG: So I said, okay, well, there is what I'm doing.
So, just forty years ago, doctors still didn't totally understand how erections... or the penis... worked. As we talked about in the last episode: problems with erectile dysfunction then were usually viewed as a psychological issue. If you went to the doctor for help, you'd most likely get referred to a counselor or therapist.
But physicians like Irwin Goldstein started trying to figure out the mechanics of erections—how they happened and why.
IG: Boy oh boy it was resistant to our understanding. You would have thought most of the physiology of the body would have been understood by then. And we had to understand, for example, did the muscle need contract to have an erection? Did it need to relax? All of those questions had never been addressed. And unlike most muscles of the body, which live in the relaxed state, and then when you want to do something, the muscle contracts, the penis is this weird organ where it's always contracted. I mean, the muscles of the penis contract all the time, unless you're in the state of erection.
AS: Hang on, I want to interrupt you because I – maybe other people are aware of this. People who have penises, um, might be more aware of this. I wasn't aware that an erection is actually the state of the muscle being relaxed. That's the opposite of what I would think.
IG: Most people are not. If you think of it like a sponge, because it's basically a sponge, the sponge is being run dry so that it stays out of the way so you can survive. But you do have to have it work so you can reproduce.
AS: When you want it, yeah.
IG: The species requires two things. Reproduction and survivability. Those are your two sort of quintessential things you need to have a species that persist.
AS: When had you learned that an erection is because of relaxation?
IG: So, um, so you will laugh at this one, 1983….
Dr. Goldstein remembers that year particularly because of one very memorable scientific advancement… and to explain, I'm going to bring in our producer Katie Bishop.
KATIE BISHOP: Okay… I want you to close your eyes and come back in time with me. It’s Monday, April 18th, 1983. “Come On Eileen” is at the top of the pop music charts… Flashdance has just opened in movie theaters. And at the Las Vegas Hilton Hotel and Convention Center, the American Urological Association is having its annual conference. Dr. Goldstein is there, along with his wife, Sue.
IG: We have a, uh, a dinner meeting. People wearing tuxes and suits and you know, uh, evening gowns.
Dr. Goldstein was one of the speakers at that fancy dinner meeting. He was slated to talk about his research about how erections work. So of course, because it’s 1983 Dr. Goldstein goes to drop off his carousel of slides to the projectionist…
IG: So as I'm going there, there's a British gentleman in a jogging outfit. I'm in my suit and tie as is everybody. And he looked odd. And he gives in his, uh, carousel, and I realize he's the first speaker, he’s Giles Brindley.
Giles Brindley. Now he's not a urologist – he’s actually a physiologist. Someone who studies the body and how it works. So - Dr. Brindley gets up on stage in his tracksuit and delivers his presentation. About a muscle relaxant that he had learned… caused erections.
IG: And he shows pictures of different angles of penile erection. So different, like, uh, hardnesses of the penile erection, but they're his photos. He was taking drugs himself - these were unapproved things that he was taking. So it was sort of interesting. It's sort of Vegas amusing at the time. But it was fascinating because we all want drugs to help our patients. But, uh, with 15 minutes to go, he says the words, "Oh, hell," in a British sort of accent. And takes his pants down in front of freaking everybody. And he had this massive erection.
GILES BRINDLEY: And then I said, "And I have given myself an injection shortly before the meeting, so that I have an erect penis now."
This is Giles Brindley, whom we called up at home in England. He’s now 95 years old. And I just feel like we need to pause here, Katie, to talk about how you tracked him down for this podcast interview?
KB: Well, it's a long story. But Giles Brindley is not someone easily found on the internet, as I quickly realized. But I did find out that he was part of a choir in London, and so I actually reached out to the choir. They connected me with his neighbor. And his neighbor brought him a cell phone to talk with us on.
Amazing.
KB: Okay, so anyway – back to Las Vegas - where, Dr. Brindley says – he never really intended to flash anybody.
GB: I wasn't going to show the erect penis. There was no need, it seemed to me. But the chairman thought differently. Um, he said, oh no, you must show the audience. So I did. Are you still there?
AS: I am still there. I'm hearing. Yes, yes.
GB: You heard it all, good.
AS: So the chairman told you to, and you, you showed this to the audience. What do you remember about that moment? What did the audience do.
GB: Nothing very much I think. I told them I had an erection, and they thought - well there's the erect penis. Nothing very strange about it.
Dr. Goldstein… remembers it differently.
IG: Of course the audience goes nuts. A lot of buzz, a lot of smiling, a lot of laughing. Nobody knows what the hell is going on. But in one hour in front of hundreds and hundreds of people, he proved that a drug that causes muscle relaxation caused penile erection. Period. End of the conversation. At that point, everybody knew that muscle relaxation is how you got an erection.
AS: Is it, is it surprising to you that people remember that speech so many years later?
GB: No, of course it's not surprising. It's a very unusual event, but I would expect everybody who saw it to remember it for life.
AS: Yeah. It is a quite unusual speech to give at a medical convention. I would have to say. [Laughs]
KB: Dr. Brindley’s role in the Viagra story ends here – but he kept on making really useful discoveries. He studied the mechanisms of bladder control for people with spinal cord injuries, he worked on early bionic eyes, and I’d also like to add that just last week we heard that he’s still playing the French horn in a London orchestra.
Dr. Goldstein told me that after that 1983 conference… he went right back to his practice in Boston and started telling his patients about what he’d seen.
IG: Within a few days I had men in Boston self-injecting.
Suddenly doctors had another way to medically treat erectile dysfunction – injectable drugs. And it also broke open the mystery of how erections work. Which was key for the later development of Viagra.
Coming up… we go back across the ocean to hear more about that development… and how it almost derailed one scientist’s career.
DAVID BROWN: This was my best chance of, um, gaining a good reputation. And, you know, if we lost this, then nobody's going to trust my judgment again. So yeah, it would have been pretty bad.
—
This is Hard, from Death, Sex & Money. I’m Anna Sale.
When chemist David Brown first started working on the drug that would eventually become known as Viagra… it was the mid-80s. And he was leading a team of chemists in the cardiovascular department at Pfizer. After several years of research, they’d decided to launch a trial of a new drug that might help with reducing chest pain. And he was really excited about it.
DB: It seemed to me it had lots of possibilities for treating various diseases. So that's why I was so keen on it. Anyway, so, everything went wrong in the first year.
Dr. Brown says the first thing to go wrong… was the preliminary safety test.
DB: They sent the data back saying it's lethal, it's killed all the animals.
AS: Bad news.
DB: A good start. You know, I mean, that's the death of a drug. Absolutely. But we, we were just so skeptical because we had done so much testing ourselves.
Now, we asked another scientist on Dr. Brown’s team about this… he doesn’t remember that happening. But according to Dr. Brown, the lab eventually admitted they’d sent back the wrong results. Either way… the problems did not stop there.
DB: It was proving difficult to show the drug worked. And the head of Pfizer Europe said to me, you know, he basically said, "You've wasted money for eight years, David. We've got to close this in three months if you don't get some good data." I mean, it looked as if it was dead.
AS: What was that like when you heard that from your bosses? Like, we're going to shut this all down.
DB: Yeah, it was pretty hard because, um, you know, most drugs do fail at this stage. The failure rate of new drugs in the clinic is 19 out of 20 fail, 95% fail. So the chance of success is actually very low and we accept that. But you only advance your career by being one of those, you know, one out of 20 that succeeds.
AS: At the time, was your wife working?
DB: No, no. I mean, yeah, we had three teenage children and a big mortgage.
Dr. Brown needed to show Pfizer that this heart drug could be profitable. And he needed to do it quickly. With time ticking down, he and his team threw a Hail Mary: they set up a study to test bigger doses in healthy volunteers in Wales.
DB: In the 1980s, you remember, a lot of coal mines were closing around the world and the men that volunteered were coal miners that were out of work. They just wanted to earn some money. And so with that study, it was an overnight study. They, they came in. They were given the drug, and the next morning, the young lady who was running the study gives them a questionnaire. And then she asked, you know, there was always an open question, you know, in case the questionnaire has missed something. Um, anything else you want to report? Did you notice anything else? And one of the men puts his hand up and says, well, I seem to have a lot of erections all night! And all the other men said, yeah so did we!
AS: Huh! [Laughs]
DB: Uh, yeah. And fortunately she didn't ignore that. She came into my office next day and told me this, and I must say she really blushed a deep red she was so embarrassed. It was one of those sort of things you never forget. And instantly, you know, I went and talked to my two closest colleagues on this. We understood why it was working because we there've been science published in the previous couple of years that helped us understand why this should be giving erections.
Dr. Brown knew there was a big potential market for this. So he went to the head of clinical research at Pfizer, and asked him for money to study the drug’s effectiveness at treating erectile dysfunction.
DB: He said no.
AS: Oh!
DB: He said no. And it was one of those moments in your life where you don't even think. I just—his name was David McGibney, and he's a very good man by the way. Um, and I literally got up and went and closed his office door and said, "David, I'm not leaving this room until you give me the money." And I could have got fired for that. [Laughs] But you know, he'd said to me, right at the beginning of that conversation, it was only August, "I've already spent all the money for the year. I'm over budget. I'm in trouble. Nobody wants this drug. Why should I give you the money?" Anyway, I closed his door, sat down and he listened. I went through the science and everything else, and he did give me the money after an hour. You know, if he had said no, that there would have been no Viagra.
Dr. Brown’s name is on one of the patents for Viagra…also known as sildenafil. Remember, it started out as a cardiovascular drug. It helps… with blood flow. And that ended up being the key to its success.
DB: What it does is, it amplifies the natural process of dilation of the blood vessels in the, in the penis. It doesn't increase, um, sex drive, it amplifies the sex drive that's there already by acting on the vascular system. It doesn't act in the brain. And then, we took this to Pfizer management and it literally got every bit of resource it needed from that point onwards. Um, and then a remarkable thing happened. They took the project away from me. I wasn't allowed to lead it anymore. [Laughs]
AS: Oh, interesting. Why was that?
DB: Well, it was actually, it wasn't explained to me very well, and that was the most shocking day of my life, I think, I was so depressed. You know, after eight years of struggling through this and suddenly got an absolute big winner and now you can't lead it anymore. And they were quite right, because once you get to that stage in clinical it's like a military operation. It has to be led by a clinician and the commercial people. It was the right decision, but I just didn't see it coming.
AS: Did you personally, uh, benefit financially?
DB: No, because, um, when you join pharmaceutical companies, employees had to sign away their rights, uh, to any compensation, um, because the company had funded the research. So directly, no, I got nothing from it. Um, but you know, it didn't exactly do my career any harm.
AS: And you left the company before Viagra came out to market, right?
DB: Yeah. Glaxo approached me just when they bought Wellcome and became GlaxoWellcome in 1995. And in fact, their research head kept traveling down to Canterbury, where I was living. And I didn't want to leave. But you know, he kind of doubled my salary, offered me a big red Jaguar, gave me share options, gave me whatever I wanted to go, basically. And so in the end I did.
AS: Um, I feel very glad that after, uh, helping to invent Viagra, you may not have made any money off of that, but you got a fancy red car. That feels appropriate.
DB: That was back then. Now I'm on my fourth Jaguar now. I love the cars. [Laughs]
Coming up… Viagra hits the market. But who it’s being marketed to… and what it’s for… starts to shift.
VIAGRA AD: “Who’d you expect? Bob Dole?”
—
This is Hard from Death, Sex & Money. I’m Anna Sale.
In the weeks following Viagra’s FDA approval in the spring of 1998, media outlets from the Washington Post to Wired reported that doctors were writing between 15 and 40 thousand Viagra prescriptions… a day. By July, Pfizer reported that approximately 2.7 million prescriptions had been written… the most ever for any drug in its first quarter. Sales were over 400 million dollars. There was a lot of initial hype around this drug.
CAROL BENNETT: It was exciting. I'd have to say, um, back then to know that you were doing something that was adding to somebody's quality of life.
Dr. Carol Bennett was seeing patients as the chief urologist at the West Los Angeles VA at the time. And she started to notice a familiar pattern happening in her office.
CB: You know, you have a patient who comes to see you for - I need some help with my urination. So you go through everything and you spend 20 minutes, you examine them. You do, you know, you prescribe the medicine. You say, okay Mr. Jones. We'll see you back in three months. This is, should work fine for you. And then he gets to the door every last time. It used to be every last time. The patient would get to the door. Not open the door, but just put his hand on the door handle and say, "Doc, one more thing." And that one more thing was never anything else besides erectile dysfunction. They were almost like, "Should I, shouldn't I, should I, shouldn't, I," you could almost hear it, you know. They'd come to the urologist, they heard the urologist might have something that might help them with their function. And they wanted to make sure that that got discussed.
One way that patients knew about Viagra was because for the first time, Pfizer was telling them about it directly. Something marketing executive Dorothy Wetzel played a big part in. Before Viagra, she worked on bladder medication… fertility products… and the Today Sponge… a contraceptive…
DOROTHY WETZEL: I like to describe myself as a, below the belt marketer. [Laugh]
When Viagra was approved, Dorothy was running the consumer marketing department at Pfizer. The FDA had eased restrictions on pharmaceutical companies advertising prescription drugs directly to consumers a year before, in 1997… and Pfizer knew this was a big opportunity.
DW: No one knew what drugs were made by what company and pharmaceutical companies were kind of under the radar. Um, and so Viagra was going to be the first drug that was going to put Pfizer on the map. Because you know, any drug that has to do with sex gets a lot of, um, attention and has a cultural relevance. For example, you know, when birth control pills came out, it wasn't just another drug, it was freedom for women. And so, you know, when, when Viagra came out, it was permission for men to talk about sex and to talk about issues with sex.
AS: I just think you had the most interesting position in the moment that Viagra was coming to market. Like, you had to translate the science to a public and a set of kind of cultural expectations about how we talk about sex and erectile dysfunction. And you had to, and you were talking directly to the people you wanted to buy in.
DW: Oh yeah. I mean for example, Viagra is a product that addresses a medical condition, but it has tremendous impact on people's relationships. So there was a big tension between, you know, is this a medical, is this a product that addresses a medical issue or is this a lifestyle issue?
That first commercial with Bob Dole… definitely kept the focus on Viagra as a solution for a medical problem. But within a few years… Dorothy and her team decided to pivot.
DW: When we changed the strategy from being about, you know, courage and being about, um, um, taking care of a problem, I was involved in one, uh, strategy that involved, um, reminding men that sometimes they miss the power of their youth when they had more, um, sexual ability. So, we’d come up with a campaign that was a little edgy, um, because it shows people, you know, one showed a man and a woman shopping and all of a sudden he sees a dress and he starts thinking of sex. And then these little devil ears, um, come up behind his, his head and, um, so, what I did was - we knew that was going to be controversial. Um, so we talked to some women's groups, but I personally went to my minister. [Laughs]
AS: Oh really?
DW: Yeah, I showed him, I showed him the print ad because I wanted to get an idea of, was this going to be so offensive to people? I mean, the idea was to talk about a relationship between a man and a woman when they're kind of rekindling the joy of their relationship, which includes sex. And that's what we were trying to capture. And I wanted to make sure that, um, that's what was coming through the ad, um, as opposed to, you know, this guy's a lech.
AS: Uh huh. A creep. Deviant somehow.
DW: His exact words to me were something like, as long as the guy's looking at her lovingly and not leeringly, um, I think this makes sense.
AS: Your minister said that?
DW: Yeah, yeah. Well you know, Presbyterians are kind of, uh, liberal. [Laughs]
AS: And help me understand what was the context for wanting to update the campaign? What, when you were kind of reframing the strategy, why were you doing that?
DW: Uh, we were reframing the strategy to talk about Viagra more in a sexual context, because at that point, there was a lot of different competition and our growth had slowed. And we wanted to broaden the target audience or broaden the market beyond just those who had um, identifiable medical conditions. So like if you had diabetes or high blood pressure or prostate cancer, there are certain conditions where ED happens specifically. And then there's just as you age, um, men, often - some men get ED, that's not specifically attached to a serious disease. So we wanted to expand the market beyond just those people with, a medical condition and Viagra being the solution for a medical condition, to you want better sex? Um, Viagra is a way to have better sex. So there's been an evolution in its messaging over time.
Pfizer went on to make billions off of Viagra. Sales peaked ten years ago, when Viagra brought in more than two billion dollars in 2012 alone.
But that marketing strategy… of expanding who and what Viagra is for… was controversial. The FDA quickly pulled those devil horn ads for making unsubstantiated claims about providing a “return to a previous level of sexual desire and activity.” And in 2007, the AIDS Healthcare Foundation even sued Pfizer… claiming that their ads promoted recreational use of the drug… which they said could lead to an uptick in unsafe sex and HIV infections.
On the next episode in our series…
JENN BOSSIO: I think that if men had more realistic expectations for their penises, we'd have a lot less distress.
We hear from people for whom Viagra opened up a deeper conversation… about their bodies…and what it means to have good sex.
CONNOR CREIGHTON: Like I would sometimes say, oh yeah, my dick's got a bit of a personality of its own
DR. GAIL WYATT: It is definitely a loss, but they have to learn other ways.
CARSON TUELLER: I have so much sex right now that does not include me having an erect penis. Um, and it's just really fucking fantastic.
That’s next time, on Hard.
This series was produced by Katie Bishop. Andrew Dunn composed the music. Alex Barron provided additional editing. The rest of our team includes Afi Yellow-Duke and Emily Botein. Special thanks to Caitlin Pierce. Our intern is Gabriela Santana.
Death, Sex & Money is a listener supported podcast. Make a contribution today at deathsexmoney.org/donate.
Look out for the final episode of Hard next week. Subscribe to death, sex & money so you don't miss it.
I’m Anna Sale… and this is Death, Sex & Money from WNYC.