The New Straits Times, January 16, 2000
By Prof Dzulkifli Abdul Razak
THAT Viagra is the best-selling drug in Malaysia after being only registered here since April 1 should come as no surprise. It is the icon drug of 1999, a 'wonder' drug that has long been awaited for sufferers of ED (erectile dysfunction or impotence), said to plague about 1.2 million Malaysian men.
It is doubtful if Viagra would have attracted so much attention if it had been marketed as just another 'heart drug' - it was initially intended for that.
The 'darker' side of the story however is also important. That there have been two deaths, and more than a dozen adverse reactions heve been reported to the Ministry of Health illustrate its importance.
The basic message is that all drugs have their downside. The ministry was commendably swift in reminding consumers to take care when contemplating its use.
This message cannot be over-emphasised, particularly in the absence of balanced and objective reporting on this "wonder" drug.
For example, until recently no publicity was given to the fact that up to June 30, there were 217 deaths worldwide associated with Viagra use. This figure is not truly reflective of the situation. In the US alone, more than 130 deaths were reported eight months after it hit the market. In the UK there were 31 as of September.
Many more countries have now registered Viagra for use, including developing countries. The reporting systems in many tends to be lax and there is an underestimation of deaths. A conservative estimate puts the figure at more than 500 worldwide.
It could be argued that this figure is miniscule compared to an estimated 12 million users and 150 million tablets alsold.
But any drug-related mortality or morbidity is one too many, particularly when it dwelt on the ignorance of the users, as the two Malaysian cases seemed to indicate. There are indications even of abuse, where Viagra is used as recreational drug. One user in an internet discussion group shared his experience on how to get the "best" out of Viagra by SMOKING rather than swallowing it. There are also women who are just as keen to use the drug. Not surprisingly, therefore, some post-marketing information showed there were indeed cases of "drug misadventures" on the part of the users.
While the product is "safe" it is only in the context of proper and rational use. The fact remains that, even for men, Viagra is not a perfect drug. In clinical trials, Viagra improved erections - but not necessarily sex lives - in about 70 per cent of subjects who took it. And it is not without serious side-effects.
To this end, the FDA earlier instructed stronger warnings labels on the product.
In some countries its use is always regulated. Reportedly, in the UK, for patients with psychosexual problems, Viagra is available only from special psychosexual clinics. For patients with defined medical conditions such as diabetes, spinal cord injury, previous pelvic surgery, the prescription is endorsed by the general practitioner to the effect that it is being used for these special indications.
Thus, the popularity of a drug depends on a number of factors - mainly how it is made available and accessible in the market. Unfortunately, there is never a clear picture about this. Many marketing forces are at work, some clandestine in nature. Others defy the imagination.
For example, about six months after its registration here, the organisers of a golf tournament reportedly offered a year's supply of Viagra to the first two male players who scored a hole in one. Only after a flurry of protests was it withdrawn. The reason given is that the manufacturer "do not want it misunderstood that we (the manufacturer) are treating (erectile dysfunction) lightly".
That the "Viagra-prize" could actually surface publicly indicates a gross misunderstanding of the dangers associated with Viagra use. To assume that Viagra is meant for just any winner of a golf competition is preposterous!
Prominent public figures have also been enrolled for endorsement, one such being former US presidential candidate Bob Dole.
Dole, who was involved in the testing of Viagra, was paid to talk about his experience and urged other people with ED to get help.
The use of a high-placed figure is no doubt a calculated sales pitch for the drug not only in the US, but also globally. This approach is effective, especially in sports and fashion, which rely heavily on trends. That the drug too is becoming trendy does suggest a threat to public safety.
When all else fails there is always the legal challenge. In December last year, Viagra made the headlines through "an intense lobbying campaign by companies trying to break Australia's system of low-priced drugs" - the Pharmaceutical Benefits Scheme (PBS).
The PBS is a key pillar of an initiative to provide cheap drugs to Australians. It was attacked for its decision to not subsidise Sildenafil, the generic name for Viagra. The committee in-charge advised against subsidising Viagra, arguing that there was a cheaper alternative, and raising concerns that Viagra could be widely misused.
The scheme also requires higher scrutiny for new drugs before they qualify for subsidies. The industry wants to break down the PBS, which it believes forces them to sell drugs to the Australian Government much more cheaply than in America and Europe.
Meanwhile consumer groups, HIV/AIDS organisations and even the Australian Medical Association have defended the integrity of the PBS - regarded as an exemplary gatekeeper on drug prices in Australia.
This is because it insists drug companies provide data showing their "new" drug does not duplicate cheaper ones on the market. In the absence of data products will not be subsidised.
And without a subsidy it would cost patients more - for Viagra, at least three times more. This is enough to make the industry see red. The manufacturer of Viagra wanted the Australian Federal Court to overturn the decision not to put Viagra on the PBS.
The final recourse, of course, is a political one. Drug companies are often politically well-connected and in some cases contribute to political campaign funds to grease their business ambitions. So there is always the possibly of a "political decree" overruling scientific decisions when nothing else seems to work in favour of the industry.
In summary, "popular" drugs are made, not born. Marketing and promotion are powerful strategies in introducing and sustaining 'new' drugs in the market.
Public health interest is vulnerable unless users themselves are vigilant. Malaysians, in this respect, have a long way to go.
Meanwhile, a man was reported dead in a taxi with half a pill, believed to be Viagra, found in his pocket as documented in a Malay newspaper on the eve of the New Year. How many men have found their way into official statistics is another matter altogether.
