Dawn of a new era for Viagra drug

Erectile dysfunction drug Viagra, which is manufactured by Pfizer. Picture: PA
Erectile dysfunction drug Viagra, which is manufactured by Pfizer. Picture: PA
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What are the implications for public health and private happiness as Pfizer’s patent on Viagra runs out, asks Dani Garavelli

NOT since Valium – aka 
Mother’s Little Helper – helped housewives of the 1960s cope with the drudgery of everyday life has a prescription drug become so embedded in the cultural landscape.

From the moment it was launched amid a blaze of publicity in 1998, Viagra has been a household name. Ask any man or woman in the street to list 
five medicines and Viagra will be in there, and not just because they’ve been inundated with spam mail asking if they want something to enhance their sexual prowess.

Featured on breakfast television shows and endorsed by celebrities, the diamond-shaped little blue pill proved a salvation for men whose sex lives were flagging. More than that, it transformed impotence from a social taboo into an accepted medical condition. In the space of a few years the word itself – so redolent of inadequacy – was jettisoned in favour of “erectile dysfunction”, a cause which became so fashionable that fundraising marathon runners were proud to have it emblazoned on their T-shirts.

The only problem for those in need of Viagra has been the price; even bought over the counter in supermarkets, the drug, manufactured by Pfizer, can cost between £6 and £10 a pill. Government guidelines mean only men who are suffering from specified conditions – such as diabetes and multiple sclerosis – or who have been judged by a specialist clinic to be suffering “severe distress” 
as a result of erectile dysfunction – are allowed it on the NHS. This means a significant proportion of those who receive Viagra get it on private prescription, 
either from their own GP or a registered online pharmacy. Since 2010, it has been possible to buy it over the counter from certain chemists and supermarkets, including some branches of Boots, Lloyds and Tesco, once a series of health checks have been carried out by trained pharmacists. Many men go down this route to avoid having to raise the subject with their GP.

There is also, of course, a flourishing illicit trade, with as much as 80 per cent of the drug sold online thought to be fake and potentially dangerous, particularly since many of those who buy 
online are using Viagra to offset the 
effects of other drugs. Taking Viagra with amyl nitrite (poppers), for example, is potentially fatal.

This week, however, Pfizer’s patent runs out in the UK, meaning rival manufacturers will be able to sell the drug under its generic name – sildenafil 
citrate – for the first time. The impact is likely to be huge, not only for Pfizer, which made £1.35 billion from its sixth-biggest seller last year alone, but for the NHS – which spent £40.3 million on the drug in 2012 – and consumers, who will soon be able to buy it at a fraction of its current cost.

Already Pfizer has taken steps to shore up its losses: last month it announced it would be selling the drug online direct to customers in the United States, where its patent doesn’t run out until 2020. It has also started manufacturing different versions of the drug, such as a chewable pill which is already available in Mexico.

It is believed that when the patent 
expires, generic versions of sildenafil 
citrate could be sold for as little as 85p a pill. South of the Border this news has been greeted with a degree of caution. According to David Ralph, urologist at University College London Hospitals and trustee of the Sexual Advice Association, it may lead even more consumers to bypass their GPs, as the cost of buying it privately will be less than the cost of an NHS prescription.

“More people are likely to buy it 
over the counter, so although patients may have easier access to medication, because they are not seeing their GP it might not be appropriate,” he says. “If they have a sexual problem and they see their GP, they will ask is it just erectile dysfunction? If it is, fine, give them some pills – but there may be other things 
going on. Sometimes taking a Viagra tablet is not the answer, there may be psychological or physical problems a doctor would be able to assess.”

North of the Border, however, where NHS prescriptions are free, there is hope that the manufacture of cheaper generic versions could lead to a reassessment 
of the national guidelines. “I’ve never liked the restrictions that have been put on the use of this drug. If a man has 
impotence, what does it matter what’s causing it – it’s a medical problem,” says Dr Andrew Buist, a GP in Blairgowrie and the deputy chairman of the BMA Scotland’s GP committee. “Hopefully such a reduction in price would allow the government to relax them.”

Viagra may have established itself as an essential ingredient in many couples’ sex lives, but it came into existence largely by accident. Developed as a 
treatment for hypertension and angina in Pfizer’s research facility in Kent, the fact it improved the size and duration of men’s erections only emerged after some of those it was trialled on were reluctant to come off it.

Further research revealed that sildenafil citrate inhibits the phosphodiesterase type 5 enzyme which breaks down a chemical messenger cyclic GMP, 
causing an erection to subside. Left to its own devices, cyclic GMP causes the blood vessels in the penis to widen by relaxing a thin layer of muscle found in the blood-vessel walls. This allows more blood to enter, which ultimately results in the penis becoming rigid.

The discovery was a watershed moment; nearly 5 per cent of men aged over 40 and 15-20 per cent of men aged 65 and over suffer from erectile dysfunction on a long-term basis, while many more experience the problem for a short 
period due to exhaustion, stress or other problems. Viagra provided a much more acceptable solution to sufferers who had previously relied on unwieldy aids such as penile injections or vacuum pumps.

That a drug aimed at boosting men’s erections should cause excitement in the medical world was inevitable. What was surprising was that Pfizer managed 
to market Viagra in such a way that it became not only socially acceptable but hugely desirable.

Enlisting the help of the rich and famous, including US Republican senator Bob Dole, who told how it helped revive his sex life after prostate cancer, and Pelé, who insisted he didn’t really need it, but would recommend it for anyone who did, the company created a global appetite for the drug not only amongst older men who suffered erectile dysfunction as a result of other medical conditions, but amongst young men who simply liked the idea of being more virile.

Later, as Pfizer realised Viagra was 
being used as a recreational drug, 
especially on the gay scene, it honed some of its advertising to cater for that market, creating adverts which featured racing car drivers saying “Gentlemen, start your engines” and men with the blue V sign coming out of the top of their heads like devil horns and the 
slogan “Get back to mischief”.

Viagra’s impact was immediate, and within a decade it was being prescribed to more than 30 million men in 120 countries. Though its monopoly of the market was challenged in 2007 when rival drugs Cialis and Levitra were launched and some reports suggested it could cause blurred vision, Viagra remains popular today, with the number of British men being prescribed the drug rising to a record high of 2.3 million last year.

Indeed, it could be argued Pfizer’s marketing campaign was almost too successful, not only because, as sociologist Meika Loe argued in her book The Rise Of Viagra: How The Little Blue Pill Changed Sex In America, it contributed to the ongoing “blurring of disease and discontent” but because it created unrealistic expectations amongst consumers about how readily available it would be and caused the British government to take fright.

This – according to Buist – is one 
explanation why in 1998 the then UK health secretary Frank Dobson issued guidelines limiting the prescription of Viagra on the NHS to those with a 
handful of specified conditions, guidelines more or less reiterated by the 
Scottish Government after devolution in 1999. Dobson said that setting more money aside for Viagra would take it from “paying doctors and nurses, dealing with cancer and people who have accidents”.

So bitterly did the BMA oppose 
these restrictions on Viagra that, for 
the first time in its history, it criticised the decision, branding it “cruel and 
unethical”.

It is understood some GPs get round the restrictions by referring patients who do not fit into any of the appropriate categories to specialist clinics where they know experts will rule they are 
suffering “extreme distress”, but Buist said a relaxation of the rules would make life easier for patients already 
embarrassed by their plight.

Asked last week if the Scottish Government would consider re-examining the guidelines in the light of the reduction in price, a spokesman said no, 
adding: “Viagra is only prescribed on the NHS if there is a clinical need for it – this is not solely a cost-based decision.”

But as Buist points out, erectile dysfunction affects sufferers’ self-esteem, leads to mood disorders and breaks up marriages. “Erectile dysfunction is not just a social inconvenience, it’s a genuine medical problem,” he says. “Treatments for it are just as justifiable as dozens 
of other things you could mention. If 
the cost comes down it would be an 
opportunity for the government to say these restrictions GPs are working to are too tight.”

For Pfizer, the expiry of the patent 
is likely to have profound financial 
repercussions. UK managing director Jonathan Emms has been bullish, claiming Viagra would continue to sell 
because most people asked for the medicine by name. But when the company lost the patent for its highly profitable drug Lipitor, used to tackle high cholesterol in 2011, sales plummeted from $9.6bn to $3.65bn.

In New Zealand, where its Viagra patent expired last year, Pfizer brought out Agriva, a drug which contains many of the same ingredients, at a much lower price in an attempt to retain its market share and is rumoured to be planning something similar in the UK.

For the Scottish consumer and the NHS, though, the approaching free-for-all is a win-win situation. Not only 
will the cost of the drug itself decrease, making it more affordable, but the fall is likely to drive down the cost of its rivals, Cialis and Levitra, whose patents do not run out until 2017 and 2018 respectively.

In addition, it seems reasonable to 
assume it will reduce the demand for 
illicit supplies, which have been found to contain rat poison and paracetemol. “It should completely torpedo the black market. If you can buy it for a pound 
or two a pill, why would you go to 
some dodgy internet site?” said Wallace Dinsmore, a specialist in sexual health at the Royal Victoria Hospital in London.

When Viagra reached its 15th birthday earlier this year, some experts suggested demand for the drug had already peaked; a growing realisation that erectile dysfunction drugs are not infallible combined with the economic crisis meant its popularity would soon start to wilt, they said. But the news that sildenafil citrate will soon cost less than a litre of milk will be welcomed by all those whose love lives it has revived. It seems destined to ensure the little blue pill will rise again. «

Twitter: @DaniGaravelli1