Are Pfizer set to win big again with Viagra?

This week’s news that over-the-counter sales of Pfizer’s Viagra Connect will be permitted in the UK in April next year is a landmark moment. With a recent investigation revealing that Viagra accounts for 90% of all counterfeit medication sales, the move aims to clamp down on the rise of online counterfeit pharmaceutical sales. It’s interesting to consider the history of Pfizer’s Viagra, the events that have led to this regulatory change and who will be the winners.

Pfizer’s launch of Viagra

Since Pfizer’s 1998 launch of Viagra for the treatment of erectile dysfunction, this lifestyle medication has been transformative for the pharmaceutical industry. Originally synthesised in an attempt to develop a treatment for hypertension, it was discovered during clinical trials that Viagra could induce erections. Pfizer took advantage of this chance discovery by repurposing the pharmaceutical for the treatment of erectile dysfunction and was granted a patent for Viagra in 1996.

However, Pfizer’s decision to take Viagra to market as a treatment for erectile dysfunction was not without risk. At that time, erectile dysfunction was a highly stigmatised condition still being popularly referred to as impotence. The market opportunity for Viagra did not appear to be huge, with it being estimated that 1% of men were receiving treatment for this condition, in contrast with recent data that shows over 25% of men under 40 and over 50% of men over 40 experience erectile dysfunction.

To profitably bring Viagra to market Pfizer therefore faced challenges. It needed to educate General Physicians about its revolutionary new treatment for erectile dysfunction. Viagra provided consumers with a simple oral medication, offering a much better treatment than the complicated and awkward medical devices which had been used treat erectile dysfunction up to that point. More importantly, Pfizer needed to empower potential consumers to consult with their doctors to seek treatment for their condition.

De-stigmatizing erectile dysfunction

The political climate and medical culture of the 1990s provided Pfizer with a platform to attempt to de-stigmatise erectile dysfunction. Throughout the decade, patients were becoming increasingly involved in the medical decision-making process and the FDA was relaxing direct-to-consumer (DTC) advertising regulation. Pfizer took advantage of this as it set out to create a market for Viagra. By using mainstream publications such as Time magazine, sponsoring Nascar and using well-regarded spokespeople such as former presidential candidate Bob Dole, Pfizer was able to appeal to its target audience to “get educated about ED”.  Pfizer also educated both medical professionals and the population by sponsoring doctors to conduct talks about its new medication.

Media hype quickly followed Pfizer’s DTC launch of Viagra, and the way in which popular culture latched on to erectile dysfunction as a talking point, was central in breaking down the stigma attached to the condition. In the US, comedy was particularly integral to this, as comedians were quick to exploit the idea that a “small blue pill could lead to big erection”. Through this combination of DTC advertising and free publicity, Pfizer achieved a quadrupling of the US market for erectile dysfunction treatments in its first eight months of sales and an 84% increase in Viagra usage from 1998 to 2002. Through the medicalisation of a “non-health” problem, Viagra arguably became the first lifestyle medication helping to develop a lifestyle pharmaceutical industry that is now worth more than $29bn worldwide. By 2002 Pfizer had achieved a 216% increase in Viagra usage among males aged 45-66, and more importantly it had captured the attention of the younger audience with a 312% increase in Viagra usage among males aged 18-45.

The competition want a piece of the action

Viagra was just the first of a range of oral pharmaceutical treatments for erectile dysfunction. After a 5-year monopoly, competitors to Viagra were launched. Bayer released Levitra and Eli Lilly released Cialis, medications which share the same mechanism of action as Viagra. Pfizer’s competitors also invested heavily in DTC advertising, with Bayer’s Levitra sponsoring the US National Football League and Eli Lilly focusing on promoting the longer-acting nature of Cialis. By 2008, Pfizer’s market share for erectile dysfunction medication had fallen to 52%. Moreover, after Patent expiry in 2013, generics manufacturers were able to launch Viagra in markets including the UK and Canada – although a method of use patent protects Viagra from generic competition in the US until 2020.

Regulated pharmaceutical companies were not the only ones trying to profit from the lucrative market in treating erectile dysfunction. The earliest competitive threat to Viagra came from unregulated suppliers of counterfeit medicines. Producers of counterfeit Viagra exploited its brand image as “the blue pill” to offer unregulated, cheap pharmaceutical products that looked like Viagra . The growth in the usage of the internet helped to facilitate consumer access to counterfeit medication and by 2004 there were tens of thousands of men buying pills for erectile dysfunction online without a prescription.

Despite big-pharma’s best efforts to break down the social barriers of seeking treatment for erectile dysfunction, the popularity of buying these pills online can be explained in part by the stigmatisation that some men still feel surrounding this condition. There have been long-standing efforts from many – including Pfizer, the MHRA and the WHO – to clamp down on Viagra replicators and recall counterfeit products. In 2015, approximately £11m worth of counterfeit Viagra was seized in raids across the UK. However, despite continued efforts to tackle the issue, the market in online counterfeit Viagra is still growing.

The winners in the launch of over-the-counter Viagra

The latest move to offer Viagra over-the-counter to men over 18 without the need for a prescription seems a long-overdue response to address the demand of consumers who want easy and quick access to this medication. Hopefully this regulatory change will provide an increasing awareness of the dangers of purchasing counterfeit Viagra online and help to tackle the counterfeiting problem. From April 2018, men suffering from erectile dysfunction will be able to access a safe source of Viagra in a timely and convenient manner, without the need to see a doctor.

In dispensing Viagra over-the-counter, pharmacists will be given a more active role in the dispensing process. Prior to purchasing Viagra, customers will be required to answer a series of questions on their symptoms, general health and other medications so that the pharmacist can confirm that the medication safe for them to use. This process forms part of a growing trend that is seeing pharmacists take on increasing responsibilities in the medical treatment process.

The biggest winner from all of this is likely to be Pfizer. Pfizer’s Viagra Connect is the first medicine for the treatment of erectile dysfunction to be reclassified from prescription only to pharmacy status in the UK. The opportunity for increased sales and the large media publicity generated from this move means that Pfizer appears to have found a new way to profit from the pharmaceutical treatment of erectile dysfunction before the competition can get a piece of the action. Unlike in the US, the UK does not permit DTC advertising of prescription medicines, so the reclassification of Viagra to pharmacy status also presents Pfizer with a new advertising opportunity and thus potential for gains in market share. With the expiry of its US patent for Viagra in 2020, Pfizer is likely to also be looking to replicate this regulatory change in the lucrative American market over the coming years.

 

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