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Trials and errors; Viagra might go the way of other drugs when hype dies down.

Its properties are already legendary. Not only has Viagra revived the sex lives of impotent pensioners but, if the hype is to be believed, it has also captured the imagination of couples looking for a better time in bed.

The drug, which received European approval for sale yesterday, has also gone a long way to raising the share price of its manufacturing company, Pfizer.

But could the Viagra bubble, inflated by its intensive marketing and publicity, burst?

Sales in America, where the drug has been marketed for five months, are down by a quarter, and questions over its potency and nasty side-effects are flooding in.

So, too, are reports of deaths possibly associated with the small blue pill. The American Food and Drug Administration had been notified of 123 deaths associated with Viagra last month, although Pfizer and the FDA insist that trials have proven that it is totally safe.

The question is, how reliable are the research figures? And if Viagra fails to measure up to all the hype, it will not be the first so-called wonder drug to flop.

Many scientific breakthroughs, hailed as miracle cures, have fallen by the wayside, the victims of a combination of flawed research and exaggerated claims

In the early 1990s, when Viagra was a mere twinkle in Pfizer's eye, leading medical journals were full of reports for new treatments for heart attacks. Two drugs in particular, cardiologists claimed, could save the lives of thousands.

One which emerged in 1992, called anistreplast, could double the survival rate of a heart attack victim, it was claimed in the British Medical Journal.

Then, another miracle cure emerged - magnesium injections, which were also claimed to halve death rates.

Despite increasing sales of these clinically proven treatments however, death rates stubbornly refused to shift. A study published last year in the same journal found that death rates among cardiac patients in the early 1990s were no different from those in the 1980s, before "clinically proven" treatments were on the market.

The amazing life-saving properties of magnesium injections had disappeared. The view now is that the effectiveness of anistreplase is half that of what was originally claimed.

A similar picture emerges when you look at the claims surrounding aspirin in the mid-80s.

The drug was said to prevent pre-eclampsia, a potentially fatal condition that affects pregnant women, claims that were backed up by a number of scientific studies.

But in 1994, a large study failed to confirm what the small studies had claimed, and, like the miracle heart drugs before it, the wonder properties of aspirin vanished.

Other drugs have been pulled off the market, following initial claims.

In February, the antihistamine, Seldane, was withdrawn by Hoechst Marion Roussell.

And in June, following death reports, Janssen Pharmaceutical alerted doctors about risks with Propulside, for heartburn.

A spokeswomen for Pfizer said that each of the deaths associated with Viagra had been closely reviewed and were not found to have been caused by the drug.

She said: "Around 4000 men, generally in the 50-70 age group, have been on Viagra, and in that age group there are a great many underlying factors which would cause death. The FDA have said that it is a safe and effective drug when taken as prescribed."

It may be that the deaths are more to do with 70-year-olds with newly- found sexual potency overdoing things a little.

Even so, doubts are growing over the inflated claims surrounding the drug. For instance, Pfizer claims that 74 per cent of men on 50mg Viagra (and 24 per cent of men on the placebo) say that they experience an "improvement in erection."

An "improvement in erection" on men who are impotent is not exactly an objective measure of how successful sex is as a result.

A 75 per cent success rate, in most people's eyes, is probably worth the pounds 6 per tablet.

However, the success of the first trial could be interpreted quite differently. In accordance with the FDA rules, which is that "successful sex," be the measure of the drug's viability, the success figure is closer to 50 per cent. Furthermore, the psychological effect on men of taking a pill to cure their impotence is relatively high.

The two trials used to determine the drug's effectiveness used a very small sample - just 861 men.

And on the basis of that small number, an estimated 25,000 Viagra prescriptions per day are now being written in the US, with hundreds more being sold on the Internet, on the black market and even in some clubs and bars.

During the first trial, almost a quarter of men who received a placebo drug - one with no active ingredient whatsoever - also reported successful attempts at sex. On the second trial, 13 per cent of volunteers who received the placebo reported success.

In the New England Journal of Medicine figures suggested that between a quarter and a half of Viagra's benefits may have psychological roots.

Among the volunteers, 532 men, taking the drug for 24 weeks in fixed doses of 25mg, 50mg or 100mg, only 51 per cent of intercourse attempts were a success. In the second trial, of 329 men, less than half of the attempts at sex were reported as successful.

Significance testing, the basis for determining for all drugs whether the results with clinical trials represent a significant breakthrough or not, has been questioned. One scientist, Professor James Berger, of Purdue University, published papers criticising, "the astonishing tendency" of the standard significant tests to mislead.

He warned: "Significant evidence can actually arise when the data provide very little or no evidence in favour of an effect."

According to Robert Matthews, a visiting fellow at Aston University, Birmingham: "If scientists abandon significance tests, many of their claims would be seen as meaningless aberrations on which taxpayers' money should not have been spent."

Pfizer, however, stand firmly behind their wonder drug.

Dr Gill Samuels, director of science policy at Pfizer Central Research, and a member of the original research team, insisted: "The trials were subject to rigorous analysis, both by the FDA and by the European Medical Evaluation Agency and I am confident that the product is safe and effective."
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Title Annotation:Features
Author:McVEIGH, KAREN
Publication:Daily Record (Glasgow, Scotland)
Date:Sep 16, 1998
Words:1031
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