This Drug Forever Changed the Conversation About Men’s Health
A Brief History of Viagra from 1989 to 2020
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For men of a certain age, it’s hard to imagine a world without erectile dysfunction medicines like Viagra, Cialis and Levitra. These little blue and orange pills have been prescribed to tens of millions of men around the world seeking a solution to a condition that will affect at least 50 percent of the male population after the age of 40. But there was indeed a time not so long ago before the name Viagra became synonymous with male enhancement and cheeky television commercials. And were it not for an accidental discovery, men in 2020 might not have ever stumbled upon what would prove to be a veritable game-changer in erectile dysfunction treatment.
Serendipity: A Happy Accident
Thirty-one years ago, in 1989, British scientists from the multi-billion dollar pharmaceutical giant Pfizer were working on a compound they believed showed promise in treating high blood pressure and chest pain. Four years later, the team had no positive results to share with their corporate overlords, and the drug seemed doomed to fail. After David Brown — one of the Pfizer chemists working on the project — was given an ultimatum to produce something of value by the fall of 1993 or risk having his funding cut, the outlook was downright grim. That was, until some unexpected results from a study of Welsh miners changed the course of history.
As Brown recounts in an interview he and other colleagues close to the project did for Bloomberg, no more than a few days after he had been given the ultimatum to put up or shut up, the team was in front of the Welsh miners who were part of a study to test the effectiveness of sildenafil citrate on blood pressure and chest pain. Near the end of this particular session with the miners, the Pfizer team asked the same question they ask all study participants: Is there anything else you noticed you want to report? One of the men put up his hand and confirmed that he noticed he had been having more erections during the night than normal. Other men from the study admitted experiencing the same thing. This put Brown’s team on the path that would lead to the little blue pill.
Viagra Comes to America
In May of 1998, the New England Journal of Medicine published the results of the all-important phase III trial of sildenafil citrate (which Pfizer had patented in the U.S. two years prior). The study concluded that Viagra was an “effective, well-tolerated treatment for men with erectile dysfunction”. Given that men’s options for treating ED at the time included direct injections into the penis, inserting small tablets into the urethra, or surgical implants, the arrival of an oral tablet delivery system was welcome news. Around the time the results of the Phase III trials were published, sildenafil (now officially known as Viagra) was approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as the first oral treatment for men with ED.
Viagra quickly began drawing the attention from medical professionals, media outlets, and just about everyone else in the world. More than 40,000 prescriptions were written in the United States in the weeks post-FDA approval. It made the cover of TIME magazine in May, and later that year, Pfizer announced it had hired former presidential candidate Bob Dole as a spokesperson. The following year, an episode of HBO’s Sex and the City portrayed an older gentleman who takes little blue pills for a boost in the bedroom. By the new millennium, Viagra was commonplace in pop-culture as it was in pharmacies and doctors offices.
Cialis, Levitra Join the Party
Five years after Viagra left its indelible mark on the world of men’s health, drug makers Bayer and Lilly USA were granted approval for vardenafil (aka Levitra) and tadalafil (aka Cialis). Men now had a variety of options for ED medicines from which to choose. Though all have a similar mechanism of action (smoothing muscles that line blood vessels causing them to relax and allow for more blood flow to the penis), and cause similar side effects, men could switch to Cialis or Levitra if Viagra wasn’t working for them. Cialis and Levitra would eventually develop innovative ways to distinguish itself from the godfather of erectile dysfunction medicine.
In 2007, the EMA and FDA approved lower doses (2.5mg and 5mg) of Cialis for daily-use in the treatment of erectile dysfunction. While Viagra and Levitra — as well as higher doses of Cialis — are meant to be taken no more than once per 24 hours, and recommended to be taken a couple time a week, this new daily-dose provided a solution for men who didn’t want to worry about taking Viagra or Levitra an hour or two before sex. Three years later, Levitra developed the first dissolvable PDE5 inhibitor (the class of drugs to which it and its two close relatives belong).
Patents Expire, Generic Options Become Available
Starting in 2013 in the UK, patents for Viagra, Cialis and Levitra began to expire, allowing for generic and often cheaper alternatives. Now, instead of reaching for the brand name, men could get their hands on sildenafil, tadalafil and vardenafil in no-name form. Thanks to these generic varieties, and competition from other PDE5 inhibitors, worldwide revenue for Viagra has steadily declined over the past seven years from a high of $2.05 billion in 2012 to $497 million in 2019. Despite this, Viagra/sildenafil still holds about 65 percent of the US market, followed by Cialis/tadalafil and Levitra/vardenafil.
A True Game Changer for Men
Viagra was the first PDE5 inhibitor to come and to conquer. As of 2016, more than 5.4 billion Viagra tablets had been dispensed worldwide, with prescriptions written for more than 64 million men around the world. Pfizer’s profits have certainly taken a hit due to competition from Cialis and Levitra, as well as generic sildenafil. But Viagra’s impact on men’s sexual health far surpasses the billions of dollars it has generated. Marketing efforts around PDE5 inhibitors have helped to remove some of the taboo associated with men seeking treatment for erectile dysfunction. It even brought the term “erectile dysfunction” into the mainstream, replacing “impotence”, a term with far more negative connotations. Thanks to advancements in our understanding of sexual health and technology, men can now see a doctor online and, if appropriate, be prescribed and have Viagra delivered to their door in discreet and private packaging.
Viagra may have been the butt of jokes and topic of the occasional Saturday Night Live skit, but its impact on normalizing discussions of men’s sexual health has been a true game changer.
It’s hard to imagine a world without Viagra, but since 1998, men haven’t had to.
