Little Pill, Big Pharma
Speaker 1: In the second episode of the three-part series of Hard produced by our WNYC colleagues at Death, Sex & Money, the team dived into the scientific advancements that led up to Viagra's FDA approval in 1998. From an unforgettable conference presentation to an overnight drug study where an unexpected side effect kept popping up. Also, the intentionality around the early marketing of Viagra when former Senate Majority Leader Bob Dole encouraged men to summon the bravery to talk to their doctors and how that message has shifted over the years. Here's DSM host, Anna Sale.
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"?
Dr. Irwin Goldstein: It's like they won the lottery. [chuckles] 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? [chuckles] Am I guilty of something? What did I do wrong?"
Anna Sale: I'm Anna Sale, and this is Hard, a series from Death, Sex & Money about Viagra.
Speaker 4: Men worry about their erections all the time.
Anna Sale: Erectile dysfunction.
Speaker 5: Abstinence does not make the hard grow fonder.
Anna Sale: The ways we do and don't talk about sex, relationships, and our bodies.
Speaker 6: I went to therapy for a year and never really talked about it.
Anna Sale: 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 that risk their lives.
Anna Sale: 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.
Bob Dole: When I was diagnosed with prostate cancer, I was primarily concerned with ridding myself off the cancer, but secondly, I was concerned about possible post-operative side effects like erectile disfunction, ED.
Ann Sale: 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 "impotence and incontinence."
Bob Dole: It's a little embarrassing to talk about ED, but it's so important to millions of men and their partners.
Anna Sale: While there's a little bit of Pfizer branding on the commercial and a nondescript phone number to call for more information at the end, Senator Dole never says anything about Viagra.
Bob Dole: The point I want to make is there are many treatments available for ED, so my advice is get a medical check-up.
Anna Sale: 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?
Speaker 8: I heard that Viagra thing ad?
Speaker 9: Yes.
Speaker 8: You don't want to hear about Bob Dole's cock.
[laughter]
Anna Sale: Ever since its inception, Viagra has been the subject of late-night jokes.
Speaker 10: I tried the Viagra pill, my tongue that hard.
Anna Sale: Many memorable ad campaigns, TV episodes.
Speaker 11: What would happen if I tried one of these?
Anna Sale: 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.
Speaker 12: If you look at the history of Viagra, it could have been lost maybe 10 or 15 times on the way.
Anna Sale: 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 the show to talk about living with ED.
Larry King: People are embarrassed to talk about it, it affects them and their partners, were you embarrassed?
Bob Dole: Yes, I was, still am. It's something you don't sit around talking about in the coffee shop, or particularly in a public television program like- [crosstalk]
Larry King: Why are you here now- [crosstalk]
Anna Sale: There were two doctors also joining senator Dole in this conversation about erectile dysfunction.
Bob Dole: 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?
Larry King: What is Dr. Goldstein, how should you approach it?
Bob Dole: Do you have a back door?
Larry King: Yes. [laughs] Sneak in impotence wing.
Dr. Irwin Goldstein: Yes, this is international impotence education month.
Larry King: It is.
Anna Sale: That's Dr. Irwin Goldstein, a silver-haired yet youthful-looking urologist who had led Pfizer-sponsored clinical trials of Viagra in the US.
Larry King: Would you call it an amazing drug?
Dr. Irwin Goldstein: 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.
[music]
Anna Sale: 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.
Dr. Irwin Goldstein: My children have a saying, [chuckles] 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. I embarrass all my children all the time.
Anna Sale: 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.
Dr. Irwin Goldstein: I became fully fascinated by you can take a flaccid penis, press a button, and bingo, you have actual rigidity. I remember asking, "Well, how the hell does an erection occur in the first place?" He says, "We have absolutely no idea." I said, "Okay, well, that is what I'm doing."
Anna Sale: Just 40 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.
Dr. Irwin Goldstein: Boy oh boy, it was resistant to [unintelligible 00:07:32]. You would have thought most of the physiology of the body would have been understood by then. We had to understand, for example, that a muscle needs to contract to have an erection, you need to relax, all of those questions had never been addressed. 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. The muscles in the penis contract all the time unless you're in the state of erection.
Anna Sale: Hang on, I want to interrupt you because maybe other people are aware of this, people who have penises 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.
Dr. Irwin Goldstein: Most people are not.
Anna Sale: Okay.
Dr. Irwin Goldstein: 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.
Anna Sale: When you want it, yes.
Dr. Irwin Goldstein: The species requires two things, yes, reproduction and survivability. Those are your two quintessential things you need to have a species persist.
Anna Sale: When had you learned that an erection is because of relaxation?
Dr. Irwin Goldstein: [chuckles] You'll laugh at this one. 1983, I'm showing- [crosstalk]
Anna Sale: Dr. Goldstein remembers that year particularly because of one very memorable scientific advancement. 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.
Dr. Irwin Goldstein: We have a dinner meeting. People are in tuxes and suits and evening gowns.
Katie Bishop: Dr. Goldstein was one of the speakers at that fancy dinner meeting. He was slated to talk about his research about how erections work. Of course, because it's 1983, Dr. Goldstein goes to drop off his carousel of slides to the projectionist.
Dr. Irwin Goldstein: As I'm going there, there's a British gentleman in a jogging outfit. I'm in my, of course, suit and tie, as is everybody. He looked odd and he gives in his carousel. I realize he's the first speaker, he's Giles Brindley.
Katie Bishop: Giles Brindley. Now, he's not a urologist, he's actually a physiologist, someone who studies the body and how it works. Dr. Brindley gets up on stage in his tracksuit and delivers his presentation about a muscle relaxant that he had learned caused erections.
Dr. Irwin Goldstein: He shows pictures of different angles of penile erections, so different hardnesses of the penile erection, but they're his photos. He was taking drugs himself. These are unapproved things that he was taking. It was interesting and Vegas amusing at the time. It was fascinating because we all want drugs to help our patients. With 15 minutes to go, he says the words, "Oh, hell," in a British accent and takes his pants down in front of freaking everybody [laughs] and he had this massive erection.
Dr. Giles Brindley: Then I said, "I have given myself an injection shortly before the meeting and I have an erect penis now."
Anna Sale: This is Giles Brindley, whom we called up at home in England. He's now 95 years old. I just feel like we need to pause here, Katie, to talk about how you tracked him down for this podcast interview.
Katie Bishop: It's a long story, but Giles Brindley is not someone easily found on the internet, as I quickly realized. I did find out that he was part of a choir in London. 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.
Anna Sale: Amazing.
Katie Bishop: Okay. Anyway, back to Las Vegas where Dr. Brindley says he never really intended to flash anybody.
Dr. Giles Brindley: I wasn't going to show the erect penis. There was no need, it seemed to me it, but the chairman thought differently, and he said, "Oh, no, show the audience." I did. Are you still there?
Katie Bishop: I am still there. I'm hearing. Yes.
Dr. Giles Brindley: You heard it all.
Katie Bishop: Yes.
Dr. Giles Brindley: Good.
Katie Bishop: Yes. The chairman told you to and you showed this to the audience. What do you remember about that moment? What did the audience do?
Dr. Giles Brindley: I don't know. [unintelligible 00:12:26] much, I think. I told them I had an erection. They [unintelligible 00:12:32] nothing very strange about it.
Anna Sale: Dr. Goldstein remembers it differently.
Dr. Irwin Goldstein: Of course, the audience goes nuts. Lot of buzz, a lot of smiling, a lot of laughing, and nobody knows what the hell's going on. 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.
Katie Bishop: Is it surprising to you that people remember that speech so many years later?
Dr. Giles Brindley: No, of course, it's not surprising. It's a very unusual event that I would expect everybody who saw it to remember it for life.
Katie Bishop: Yes. [laughs] It is a quite unusual speech to give at a medical convention, I would have to say. [laughs]
Anna Sale: 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. I'd also like to add that just last week, we heard that he is still playing the French horn in a London orchestra.
Katie Bishop: 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.
Dr. Giles Brindley: Within a few days, I had men in Boston self-injecting.
Anna Sale: Suddenly, doctors had another way to medically treat erectile dysfunction, injectable drugs. 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.
Dr. David Brown: This was my best chance of gaining a good reputation. If we lost this, then nobody's going to trust my judgment again. Yes, it would've been pretty bad.
Anna Sale: 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 chemist and the cardiovascular department at Pfizer. After several years of research, they decided to launch a trial of a new drug that might help with reducing chest pain. He was really excited about it.
Dr. David Brown: It seemed to me it had lots of possibilities for treating various diseases. That's why I was keen on it anyway. Everything went wrong the first year.
Anna Sale: Dr. Brown says the first thing to go wrong was the preliminary safety test.
Dr. David Brown: They sent the data back saying it's lethal, it's killed all the animals. [laughs]
Anna Sale: Bad news.
Dr. David Brown: A good start. That's the death of a drug, absolutely. We were just skeptical because we had done much testing ourselves.
Anna Sale: Now, we asked another scientist on Dr. Brown's team about this, he doesn't remember that happening. According to Dr. Brown, the lab eventually admitted they'd sent back the wrong results. Either way, the problems did not stop there.
Dr. David Brown: It was proving difficult to show the drug worked. The head of Pfizer Europe, he basically said, "You wasted money for eight years, David. We got to close this in three months if you don't get some good data." It looked as if it was dead.
Anna Sale: What was that like when you heard that from your bosses, like, "We're going to shut this all down"?
Dr. David Brown: Yes, it was pretty hard because most drugs do fail at this stage. The failure rate of new drugs in the clinic is 19 out of 20 fail, 95% fail. The chance of success is actually very low, and we accept that. You only advance your career by being one of those 1 out of 20 that succeeds.
Anna Sale: At the time, was your wife working?
Dr. David Brown: No. Yes, we had three teenage children and a big mortgage.
Anna Sale: 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.
Dr. David Brown: In the 1980s, you remember our coal mines were closing around the world, and the men that volunteered were coal miners that were out of work that just wanted to earn some money. With that study, it was an overnight study, they came in, they were given the drug. Then the next morning, the young lady who's running the study gives them a questionnaire. Then she asks-- There's always an open question in case the questionnaire has missed something, "Anything else you want to report? Did you notice anything else?"
One of the men puts his hand up and says, "I seemed to have a lot of erections all night," and all the other men said, "Yes, so did we." [laughs] Fortunately, she didn't ignore that. She came into my office next day and told me this. I must say, she really blushed this deep red. She was embarrassed. It was one of those things you never forget. Instantly, I went and talked to my two closest colleagues on this. We understood why it was working because there'd been science published in the previous couple of years that helped us understand why they should be giving erections.
Anna Sale: Dr. Brown knew there was a big potential market for this. 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.
Dr. David Brown: He said no. [laughs]
Anna Sale: Oh.
Dr. David Brown: He said no. It was one of those moments in your life where you don't even think. His name was David McGibney and he's a very good man, by the way. 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. [chuckles] He'd said to me right at the beginning of that conversation, "Look, Brown, it was only August and 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 and sat down and he listened. I went through the science and everything else. He did give me the money after an hour. If he had said no, there would've been no Viagra.
Anna Sale: 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. That ended up being the key to its success.
Dr. David Brown: What it does is it amplifies the natural process of dilation of blood vessels in the penis so it becomes erect. It doesn't increase sex drive, it amplifies the sex drive that's there already by acting on the vascular system. It doesn't act in the brain. We took this to Pfizer management and it literally got every bit of resource it needed from that point onwards. Then a remarkable thing happened, they took the product away from me, I wasn't allowed to lead it anymore.
Anna Sale: Oh, interesting. Why was that?
Dr. David Brown: Well, it was actually-- It wasn't explained to me very well, and that was the most shocking thing in my life. I think I was so depressed. After eight years of struggling through this, and suddenly got an absolute big winner, and now you can't lead anymore. Never quite right because once you get to that stage in clinical, it's like a military operation. It has been led by a clinician and the commercial people. It was the right decision, but I just didn't see it coming.
Anna Sale: Did you personally benefit financially?
Dr. David Brown: No, because when you join pharmaceutical companies, employees had to sign away their rights to any compensation because the company had funded the research. Directly, no, I got nothing from it, but it didn't exactly do my career any harm.
Anna Sale: You left the company before Viagra came out to market, right?
Dr. David Brown: Yes. Glaxo approached me just when they bought Wellcome and became Glaxo Wellcome in 1995. Their research had kept traveling down to a country where I was living, and I didn't want to leave, but he doubled my salary, offered me a big red Jaguar, [chuckles] [unintelligible 00:21:22] options, gave me whatever I wanted to go, basically, and so in the end, I did.
Anna Sale: I feel very glad that after helping to invent Viagra, you may not have made any money off of that, but you got a fancy red car. That feels appropriate. [laughs]
Dr. David Brown: That was back then. Now I'm on my fourth Jaguar. I love the cars.
Anna Sale: Coming up, Viagra hits the market, but who it's being marketed to and what it's for starts to shift.
Speaker 19: What did you expect, Bob Dole?
Anna Sale: This is Hard from Death, Sex & Money, I'm Anna Sale. In the weeks following Viagra is FDA approval in the spring of 1998, media outlets from the Washington Post to Wired reported the doctors were writing between 15,000 and 40,000 Viagra prescriptions a day. By July, Pfizer reported that approximately 2.7 million prescriptions had been written, the most ever for any drug and its first quarter. Sales were over $400 million. There was a lot of initial hype around this drug.
Dr. Carol Bennett: It was exciting, I'd have to say, back then to know that you were doing something that was adding to somebody's quality of life.
Anna Sale: 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.
Dr. Carol Bennett: You have a patient comes to see you for, "I need some help with my urination," so you go through everything and you spend 20 minutes with them and then you prescribe the medicine. [unintelligible 00:23:09] with feedback, "In three months, this should work fine for you." 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 would almost like, "Should I, shouldn't I, should I, shouldn't I," you could almost hear it. 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 [unintelligible 00:23:39]
Anna Sale: 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's sponge, a contraceptive.
Dorothy Wetzel: I'd like to describe myself as a below-the-belt marketer. [laughs]
Anna Sale: 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.
Dorothy Wetzel: No one knew what drugs were made by what company, and pharmaceutical companies were under the radar. Viagra was going to be the first drug that was going to put Pfizer on the map because any drug that has to do with sex gets a lot of attention and has a cultural relevance. For example, when birth control pills came out, it wasn't just another drug, it was freedom for women. When Viagra came out, it was permission for men to talk about sex and to talk about issues with sex.
Anna Sale: I just think you had the most interesting position in the moment the Viagra was coming to market. You had to translate the science to a public and a set of cultural expectations about how we talk about sex and erectile dysfunction, and you were talking directly to the people you wanted to buy in.
Dorothy Wetzel: Oh, yes. For example, Viagra is a product that addresses a medical condition, but it has tremendous impact on people's relationships. There was a big tension between is this a product that addresses a medical issue or is this a lifestyle issue?
Anna Sale: That first commercial with Bob Dole definitely kept the focus on Viagra as a solution for a medical problem. Within a few years, Dorothy and her team decided to pivot.
Dorothy Wetzel: When we changed the strategy from being about courage and being about taking care of a problem, I was involved in one strategy that involved reminding men that sometimes they miss the power of their youth when they had more sexual ability. We'd come up with a campaign that was a little edgy. 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 come up behind his head. We knew that was going to be controversial, so we talked to some women's groups, but I personally went to my minister.
Anna Sale: Oh, really?
Dorothy Wetzel: Yes, I showed him the print ad because I wanted to get an idea of was this going to be so offensive to people? The idea was to talk about a relationship between a man and a woman when they're rekindling the joy of their relationship, which includes sex. That's what we were trying to capture and I wanted to make sure that's what was coming through the ad as opposed to this guy's a lech.
Anna Sale: A creep, deviant, somehow.
Dorothy Wetzel: His exact words to me were something like, "As long as the guy's looking at her lovingly and not leeringly, I think this makes sense."
Anna Sale: Your minister said that?
Dorothy Wetzel: Yes, Presbyterians are kind of liberal.
[laughter]
[music]
Anna Sale: Help me understand what was the context for wanting to update the campaign. When you were reframing the strategy, why were you doing that?
Dorothy Wetzel: 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. We wanted to broaden the target audience or broaden the market beyond just those who had identifiable medical conditions, like if you had diabetes, or high blood pressure, or prostate cancer. There are certain conditions where ED happens specifically. Then there's just as you age, some men get ED that's not specifically attached to a serious disease.
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, Viagra as a way to have better sex. There's been an evolution in its messaging over time.
[music]
Anna Sale: Pfizer went on to make billions off of Viagra. Sales peaked 10 years ago when Viagra brought in more than $2 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." In 2007, the AIDS Healthcare Foundation 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-
Speaker 22: I think that if men had more realistic expectations for their penises, we'd have a lot less distress.
Anna Sale: We hear from people for whom Viagra opened up a deeper conversation about their bodies and what it means to have good sex.
Speaker 23: I would sometimes say, "Oh, yes, my dick's got a bit of a personality of its own."
Speaker 24: It is definitely a lot, but they have to learn other ways.
Speaker 25: I have so much sex right now that does not include me having an erect penis, and it's just really fucking fantastic.
Anna Sale: 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. I'm Anna Sale and this is Death, Sex & Money from WNYC.
Brooke Gladstone: Thanks for listening to the podcast extra. You can join us for the big show this Friday where we'll be talking about our much maligned [unintelligible 00:31:01], the Neanderthal, and how these distant ancestors can help us understand what it means to be human. I'm Brooke Gladstone.
[music]
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