 The little blue pillMarch 28, 2018 |
Don't forget this anniversary
On this day in 1998, the US Food and Drug Administration approved a chemical compound called sildenafil citrate for use as a prescription drug. It had taken Pfizer, the New York-based pharma giant, just two years to push its little blue pill through the wringer of clinical trials the government requires before it'll call a medication safe and effective. Most drugs take about a decade.
At the time, erectile dysfunction wasn't even a recognized medical condition. And yet, the men bringing this new drug to market believed they were treating one of biggest problems of the modern world.
Thus was born Viagra.
1668: Dutch physician Regnier de Graaf discovers erections were the result of increased blood flow to the penis.
1983: British physiologist Giles Brindley shows the American Urology Academy that it's possible to induce an erection with a shot of vein-dilation medication, using his own penis as Exhibit A. 😳
1989: Chemists in a Pfizer lab in Sandwich, England discover sildenafil citrate, a compound they think might be useful to treat blocked arteries.
1993: David Brown, a chemist on the sildenafil team is told that the clinical trials were a bust, and the company is abandoning the project—until a few months later, when a group of mine workers in the clinical trial report more erections than usual.
1996: Pfizer patents the compound and it gets FDA approval two years later.
2015: Authorities in China bust liquor distillers for adding Viagra to their products. The same year, an "organic" orange juice brand sold online in Singapore was laced with the active ingredient in Cialis.
An uplifting effect on drug prices
Viagra was a rousing success from the moment it came on the market. In the few weeks following FDA approval, some 40,000 prescriptions were written. A year later, Viagra served as a plot point on HBO's Sex and the City on its way to becoming the fastest drug ever to surpass $1 billion in annual sales. Viagra's rapid growth in popularity had a buoying effect on the growth of entire pharmaceutical industry. Of course, that sort of rapid growth couldn't … well … last.
"We were rock stars. Never before, and probably never again, will anybody get a standing ovation in the waiting room."
Thanks to "a very observant nurse"
The researchers who discovered Viagra weren't even looking for it. Sildenafil, the drug's active ingredient, was originally developed to treat cardiovascular problems—specifically to dilate the heart's blood vessels by blocking a particular protein called PDE-5.
In phase-one clinical trials in the UK, all seemed to be going well—except for one weird thing that men enrolled in the study did when nurses went to check on them. "They found a lot of the men were lying on their stomachs," John LaMattina, the head of research and development at Pfizer while this research was ongoing, told the STAT Signal Podcast (listen in around 7:15).
"A very observant nurse reported this, saying the men were embarrassed [because] they were getting erections." The blood vessels were dilating not in the heart, but rather the penis.
The art of the ED ad
Viagra hit the market just a year after US regulators eased up on rules regarding direct-to-consumer drug advertising. Then in 2003, the FDA approved two Viagra competitors, Cialis and Levitra, ushering in a decade of relentless TV ads that promised to improve the sex lives of middle-aged men.
This Cialis commercial is a perfect example of what every ED drug advertisement essentially tries to do: Be sexy without talking about sex. These ads get a lot of play during family-centered programming (like football games)—so they need to be PG. The separate outdoor bathtubs don't really make sense, but at this point they're iconic.
Other ED drug commercials have reached similar levels of cultural saturation. There's no forgetting Pfizer's "Viva Viagra!" campaign of the mid-2000s, while Levitra was introduced to the world in 2003 with a TV spot centering on a legendarily bad metaphor for sex.
But those years may be over. Annual sales of Viagra peaked at $2.05 billion in 2012, with generics entering the market in recent years. In 2020, Pfizer's patent on Viagra is set to expire. Since generic ED drugs have begun to eat into its market share, Pfizer has pulled out of what used to be Viagra's biggest media moments. Viagra was the National Football League's largest pharmaceutical advertiser for years, but it bought no commercial time whatsoever during the 2017-2018 season. Cialis is expected to follow suit, and Levitra stopped advertising during football games in 2011.
"The pose"
Ads for Viagra and its competitors have evolved over the years. In the beginning, the ads centered around the potential Viagra users (including the occasional "We Are the Champions" slo-mo montage). But a new template soon emerged, as The Cut's Gabriella Paiella explained:
The vast majority of Viagra ads feature a polished woman in her 40s with long, straight hair gazing seductively at the camera and saying things like "Hey, you, let's fix your penis" in dulcet tones … You know the pose: Her stomach's on the mattress, she's resting on her elbows, and her feet might be kicked up in the air. It's the "We need to talk about your boner" pose.
So where's the female Viagra?
Sexual dysfunction drugs tend to focus on the penis, which makes up (at most) only half of the horizontal tango. Pharmaceutical companies have tried and failed to find and market a female Viagra equivalent.
Pfizer tried to use Viagra to treat "female sexual arousal disorder" in the early 2000s—one critic called it "a textbook case of disease mongering by the pharmaceutical industry"—but clinical trials were inconclusive and the efforts were scrapped.
In October 2015, Sprout Pharmaceuticals got clearance from the FDA to start selling Addyi, which reportedly increased women's libido. Unfortunately, it was a flop—doctors had written only 4,000 prescriptions for the drug by the following April.
Why? For one thing, Addyi needed to be taken daily, as opposed to when a woman was planning on having sex (like Viagra)—yet each pill cost the same as a dose of Viagra. Additionally, physicians had to be "certified" to prescribe Addyi. (It was just a 10-minute online course, but … doctors.) And finally, Addyi only worked "modestly," even for women who took it daily as recommended.
"The recent history of the study of female sexual dysfunction is a classic example of starting with some preconceived, and non-evidence based diagnostic categorisation for women's sexual dysfunctions, based on the male model, and then requiring further research to be based on that structure," John Bancroft, director of the Kinsey Institute at Indiana University, told the medical journal BMJ. "Increasingly it is becoming evident that women's sexual problems are not usefully conceptualised in that way."
In the late 2000s, filmmaker Liz Canner took a job with a pharmaceutical company called Vivus. Her task: Edit erotic movies for a drug trial to develop what Vivus hoped would be the first "female Viagra." She ended up getting permission from the company to document the process, and the result was the 2009 movie Orgasm Inc., which explores the pharmaceutical industry's motives when it comes to defining and providing treatment for women's health issues.
6: The number of prescriptions you had to fill on your Viagra frequent-user "value card" in order to get a free seventh script in 2004
62 million: Number of men who take the little blue pill globally, according to Pfizer
$15: Cost of an individual Viagra pill in 1998 (adjusted for inflation)
$65: Cost of a single Viagra pill today
$1.2 billion: Viagra revenues in 2017
$359 million: Estimated amount of revenue Viagra will generate in 2018
Could Viagra save your life?
Probably not, but a trip to the doctor for an ED prescription just might. There are a variety of underlying causes of ED and most have to do with the circulatory system. (Some notable exceptions are psychological issues and direct injuries.) If blood isn't flowing well to the penis, chances are it's not flowing well elsewhere in the body, and ED can be an early warning sign for much bigger issues, heart disease in particular. Mayo Clinic recommends that men without any obvious cause for ED should be screened for underlying heart problems, and Dr. Michael P. O'Leary told the Harvard Health blog that erections "serve as a barometer for overall health."
Pfizer explicitly tapped into this dynamic when it began marketing the drug. "We had to give physicians a reason to have a conversation about this," Ken Begasse, formerly of the Viagra ad agency Cline Davis & Mann, told the trade magazine Medical Marketing & Media. "That meant linking [erectile dysfunction] to the things physicians were traditionally concerned about — diabetes and cardiac conditions in particular. In so many words, it was pretty much, 'Hey, doc, you should be asking about erectile dysfunction, because it often happens 18 months before a cardiac event.'"
Quiz Which former US presidential nominee became the spokesperson for Viagra in 1998? |
In yesterday's poll about the "Plywood Palace," 47% of you said LIGO is the breakthrough that blew your mind the most.
Today's email was written by Katherine Ellen Foley and Annaliese Griffin, edited by Elijah Wolfson and Adam Pasick, and produced by Luiz Romero.
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