The great Pill panic - justified or not?

By NAOMI LARKIN

Forty years ago the Pill was hailed as the convenient and safe answer to global contraceptive woes. Today, thousands of women fear that swallowing it will kill them.

Since the 1995 "Pill scare" - which linked third-generation Pills to increased rates of potentially lethal blood clots - thousands of women have obliterated the Pill from their bathroom cupboards.

But a new study in the British Medical Journal claims that these fears are unfounded.

The study, headed by Professor R. Farmer at the postgraduate medical school of the University of Surrey, compared the number of blood clots in women in the three years before and after the 1995 scare in Britain.

It found that although the use of third-generation contraceptives fell over the period, the rate of clots among Pill takers did not.

"The newer types of combined oral contraceptive Pills do not put women at increased risk of clots in the veins, contrary to previous information," the study found.

Data came from 304 general practices throughout Britain.

So how did Pill poppers get to the point of fear in the first place?

Third-generation Pills, such as Femodene, Minulet, Marvelon and Mercilon, differ from older ones in that they contain progestogens called desogestrel or gestodene.

They came on to the market in the 1980s promoted as more easily tolerated by women and causing fewer side-effects such as weight gain and skin problems.

Then, in October 1995, the Committee on Safety of Medicines in the United Kingdom warned that oral contraceptives containing desogestrel or gestodene presented a small increase in the risk of venous thromboembolism (blood clots) compared with older preparations.

The clots occur in the leg veins, causing swelling, tenderness and pain. They can be fatal if pieces of a clot dislodge and travel to the lungs.

The committee's announcement was followed by the publication of four studies, derived mainly from European data, which gave a consistent picture - women using third-generation oral contraceptives were twice as likely to suffer blood clots as those on the second-generation Pills.

Chaos followed, and use of the Pills in Britain dropped from 54 per cent to 14 per cent in women aged 15 to 49.

New Zealand women learned the news - and the fear.

A flood of articles, reviews and symposiums followed. The debate was acrimonious and confused many doctors - and women.

Since 1996, the use of third-generation Pills here has more than halved, and they now account for only 35 to 40 per cent of the market.

Still, New Zealand's use of third-generation contraceptives remains the highest in the world. They are not widely used in Australia or the United States.

The Ministry of Health has remained firm in its stance, formulated in 1996: third-generation Pills will not be taken off the shelves.

The ministry recommends that all doctors discuss the risks and benefits of each Pill and let women make an informed choice.

Ministry Medsafe spokesman Dr Stewart Jessamine: "The Pill is relatively safe and effective, not just for preventing pregnancy but it has other benefits.

"There is insufficient evidence to warrant removing third-generation oral contraceptives from the market."

However, a New Zealand study, released in June, found that 20 women taking oral contraceptives had died of blood clots in the lungs during the past 10 years. Of these, 15 were on third-generation Pills.

The study found that for every 100,000 women taking contraceptive Pills, clots would kill one a year. Given the wide use of oral contraceptives, two deaths a year would be expected in New Zealand.

An Otago University professor of preventive and social medicine, Dr David Skegg, who headed this study, said yesterday that it had to be recognised that his findings were based on actual deaths from blood clots - nearly all confirmed by autopsies.

Professor Farmer's study, however, was based on blood clots per se, as diagnosed by GPs.

Said Professor Skegg: "Clots in the leg are very hard to diagnose ... so people have been critical of studies which rely just on the general practitioner's diagnosis where there is no verification."

The Pill scare could also have skewed the results.

"It may well be that general practitioners' awareness of this condition - and women's likelihood of going to the doctor about it - will have increased greatly with all the publicity. So when you are comparing the incidents before and after October 1995, you've got a real problem as it's likely that more would have been diagnosed in the second period because there has been so much interest and publicity.

"That wouldn't be the case with a study based on fatalities, because death is death."

This was not Professor Farmer's first report based on the same database and several of his earlier reports had drawn the same conclusion, Professor Skegg said.

In addition, a group of Boston-based scientists who had analysed the same database found the same doubling of risk with the third-generation Pills as had several other studies.

"That two groups using the same computerised database, though with overlapping rather than identical data, report opposite conclusions must be of concern to all," Professor Skegg said.

"I think it would be a great pity if people were given the impression that this study is the last word on the matter, because basically it's just yet another analysis of one computer database."

Medical Association chairwoman Dr Pippa MacKay said the findings of Professor Farmer's study were in keeping with results from other international studies.

"How is it that New Zealand still seems to persist in the belief that there is something different? Is it something different about our women or about our studies?"

There had been a lot of "hype" around the third-generation Pills and much of it was unjustified, she said.

"In the past the evidence was not absolutely convincing that third-generation Pills were a greater risk, and this would seem to support it.

"There are many women who want to take third-generation Pills because they suit them better."

The Family Planning Association takes its lead from the Ministry of Health.

Executive director Gill Greer said yesterday that while the "academic debate" raged, women were advised to come in to clinics if they had any concerns around third-generation Pills because "we don't want people acting out of fear."

One of the positive things to have come out of the debate was the recognition of risk factors when prescribing the Pills, she said.

These included a history of blood clots in the family, smoking, excess weight, cancer, recent surgery, being immobilised and bad varicose veins through to women having recently taken a long flight.

"We would obviously look at it case by case. It's absolutely critical that a thorough history is taken from all clients.

"Women need to be really informed as to what is going on out there - aware that there is this research, aware of the Ministry of Health's guidelines.

"Then if they are saying, 'Well look, we've been on this and we know that,' then they just carry on taking third-generation Pill."

But Women's Health Action executive director Sandra Coney believes that, irrespective of Professor Farmer's report, the combined weight of all the studies indicated that the risk was higher with third-generation Pills.

"There has been an acceptance, or an agreement of almost all parties except for the drug companies ... that the risk is higher in these Pills. So the next thing you have to ask then is, 'Do women have to be on them?' The answer to that is no.

"There are perfectly good second-generation Pills which reduce the risk by at least half ... and there are other forms of contraceptives available which don't carry this risk."