Analee Gale

About Analee Gale

Analee Gale is the Food & Health Editor of TBS. Previous to that, she was a freelance writer and editor who has spent so many decades writing about being food and fitness that she sometimes forgets to actually be fit (though she never ever forgets to eat food - hangry is a thing, you know!). Analee made a tree-change from the northern beaches of Sydney, so she now taps out tales from her base in a tiny coastal town in East Gippsland, Victoria.

Taking a long hard look at Viagra, twenty years on

Viagra has been standing strong for twenty years. To, celebrate we’re taking in the full expanse of its size, and impact it has had on us. 

 

 

March 27th marked the twentieth anniversary of when a globally-applauded little blue pill was approved by the US Food and Drug Administration (FDA), for use as a prescription drug to aid erectile dysfunction (ED).

Interestingly, Viagra was actually an accidental discovery when researchers realised the effect it was having on patients. Originally, the drug’s active ingredient, sildenafil, was developed to treat cardiovascular problems by dilating blood vessels in the heart in order to block a protein called PDE-5.

The initial clinical trials were so dismal that the project was almost abandoned by Pfizer, until it was realised that blood vessels were indeed dilating – but not in the heart! A few storeys below, the vessels in the penis were actually dilating, resulting in subjects experiencing involuntary erections. Now at this particular point in time, ED wasn’t even a medically recognised condition. Regardless, Viagra was born.

Now typically, the turnaround time for a drug to be officially deemed effective and safe by the FDA in the US, is about a decade. But maybe those responsible were all middle-aged men with erectile dysfunction, because Pfizer managed to successfully complete all the necessary clinical trials in a mere two years.

These little blue pills looked set to become one of the fastest drugs to clock up $1 billion in annual sales, after 40,000 prescriptions were written in its first few weeks of being released to the market.

In 2003, some five years after Viagra received its regulatory approval, two new ED drugs called Cialis and Levitra were approved, offering patients a “same but different” option to alleviate their “lows”.

Around the same time, US regulators relaxed the rules around direct-to-consumer drug advertising, which kickstarted a decade of bombardment for ED commercials on mainstream television (Viagra’s, Cialis’ and Levitra’s, respectively).

Of course, with the overwhelming uptake of this bonafide-boner-bringer, those (often accused of being greedy, but why?) pharma companies, tried (but failed) to find and market a female equivalent of Viagra.

In 2015, the FDA approved a drug designed to increase the female libido, called Addyi, but a mere 4,000 scripts were written in the six months that followed. The lack of desire for this drug was largely due to its effects being only “moderate” for some women, and its cost was prohibitive at around $40 per pill, with users required to take a pill every single day. What’s more, the potential side effects were extensive, and its interferences with other drugs, alcohol and supplements was significant. So essentially, a woman would need to abstain from drinking booze or consuming any other medicinal or health supplements to minimise her risk of side effects, which included extreme fatigue, light-headedness, nausea, low blood pressure and even loss of consciousness.

Of course, some 20 years after Viagra’s debut, it’s no longer the dominant player on the market. In fact, Viagra’s annual sales peaked in 2012 at $2.05 billion, and in 2017 it reported an annual revenue of $1.2 billion, while for 2018 it is predicted that Viagra’s revenue will not surpass $359 million.

But don’t be misled. These comparatively flaccid revenue figures do not signal a decline in the popularity of ED drugs. On the contrary, prescriptions for ED drugs remain on the rise, however Viagra now shares the market with generic ED drugs, as well as an influx of counterfeit versions. In fact, an estimated 37% of all seized counterfeit drugs are touted as cures for ED. In 2015, in the UK, some $15.6 million worth of unlicensed ED pills were seized. On the other side of the globe, in China, more than 5,300 bottles of liquor containing Viagra’s active ingredient sildenafil, were seized. And in that same year, Singapore’s Health Sciences Authority (HSA) discovered an “organic” orange juice that was marketed as being “suitable for the entire family”, actually contained the active ingredient of Cialis. Closer to home shores, these days you can even skip the GP entirely and buy your ED pills via an online app!

Despite its price rising from around $15 in 1998, to $65 per pill some 20 years later, according to Pfizer there remain around 62 million men all over the world who continue to stand at attention, thanks to the wondrous effects of that little blue pill.

In a roundabout way, Viagra can help save lives; and I don’t just mean that metaphorically. It turns out that in many cases ED can be a warning sign for heart disease/cardiac arrest. This is because while there are numerous causes for ED, the majority are associated with a struggling blood circulation, so if it’s not making its way easily to or through the penis, then it’s possible that it’s not flowing smoothly in other places within the body too; in fact, ED commonly occurs around 18 months prior to a cardiac incident. For this reason, the Mayo Clinic suggests that those who elicit no obvious causes for their ED, be screened for underlying heart problems.

 

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