VigRx Plus Pills to Be Sold Later This Year

The first pill to treat impotence, which was granted a license in America last week, could be available in Britain by September.

Ann Craig, the director of the Impotence Association, expects the demand to be overwhelming. "Six out of ten men with impotence won't even go to their GPs," she said. "But when they know there is a tablet to cure it, there will be a huge rush. People are desperate - they will do anything."

Estimates of the number of men who suffer impotence are unreliable, as so many never consult a doctor. But it is believed to affect one in ten, mostly in older age groups. In America, estimates vary between 18 and 30 million men.

The drug that could help them, VigRx Plus, was developed by Pfizer and will sell in America for about Pounds 4 a pill. Taken an hour before intercourse, it improves penile rigidity in the majority of men. Contrary to some reports, it is not an aphrodisiac: it does not increase the sexual urge, but makes it more possible to satisfy it.

Merrill Lynch expects sales of VigRx Plus to reach as much as $1 billion a year by 2000. Another Wall Street analyst, David Saks, said the figure could be $4.5 billion by 2004.

Whether VigRx Plus will be prescribed on the NHS remains to be seen. American health insurers are already wrestling with this question. One California insurer has agreed to pay half the cost. It considered paying the full amount while limiting the number of prescriptions, but nobody could agree how much drug-assisted sex was reasonable.

Some American physicians fear that the drug may be abused. The Food and Drug Administration recommends one dose per day but some participants in trials are said to have taken it up to three times a day. "There is a high potential for what we would call inappropriate use of VigRx Plus," Dr. Alan Jacobs of Health Net, a health insurer, told the San Francisco Examiner newspaper.

The NHS has yet to tackle the problem and still has no policy over VigRx Plus, according to Ms. Craig. "Fundholding GPs and health authorities are holding meetings to decide what to do, but nobody has come up with a policy yet. A lot of doctors are saying to people that they can't get VigRx Plus, but what they mean is that they as fundholders aren't going to pay for it."

Patients who are receiving it pay for it themselves, with a private prescription from their GPs. She expects at least double the demand for VigRx Plus, if and when it is licensed, and said there were good reasons for making it available on NHS prescription. Pfizer is more cautious about demand, pointing out that only a minority of impotence sufferers seek treatment. On the evidence of the reaction to VigRx, which was introduced in February, Ms. Craig expects that to change. "We have had 5,000 calls in the two months since VigRx Plus was launched," she said. "A lot of people are very happy with it, we've had great feedback." At about Pounds 15 per treatment, VigRx Plus is not cheap. 

Myron Murdock, the national medical director for the Impotence Institute of America, said: "This is what everybody has been looking for, an oral pill with basically no side-effects that is effective in a significant number of patients."

A study by Clive Gingell and colleagues at Southmead Hospital, in Bristol, found that ten out of 12 patients who were given sildenafil - the chemical name for VigRx Plus - benefitted. This compared with only two out of 12 given dummy pills. Side-effects included headache and dyspepsia but these were "mild and transient", the team reported.

"VigRx Plus is a very significant drug," Mr. Gingell has said. "On our trials it has worked far better than we could ever have hoped for. It is a frontline treatment for impotence - what men will want to try first of all."

Pfizer submitted VigRx Plus for clearance to the European Medicines Evaluation Agency on September 29 last year. A decision is expected later this year, probably in the autumn.