Still A Bitter Pill
Sydney Morning Herald
Monday March 13, 1995
AMID the clutter of medical textbooks, rows of shiny instruments and piles of drug packets lie two framed photographs: one of Dr Kevin Hume talking to the Pope, and another of him and Mother Theresa.
In this room, in an old brick building in Randwick, Hume has treated patients for the last 48 years. He is proud that he has not once prescribed the oral contraceptive pill for use as a contraceptive in all those years.
"I don't know whether you take the pill or not," he said during an interview. "But my advice to you is to get off it." He emphasises that this is because of safety concerns - "it sets out deliberately to harm the healthy woman" - rather than his moral and religious beliefs.
Hume is international secretary of the World Organisation of the Ovulation Methods (Billings), or WOOMB, and has taught the Billings natural family planning method in more than 40 countries. He is a Catholic, with seven children, and a member of NSW Right to Life.
He becomes irritated when asked whether these factors have any bearing on a letter which he, with several other Sydney doctors and pharmacists, recently had published in The Australian.
It cited two studies, published in The Lancet last year, linking oral contraceptive use with increased risk of breast and cervical cancer, and said women should be made "fully conscious of the serious risks associated with oral contraceptives".
It accused media reporting of the recent release of new forms of low-dose contraceptives of making "scant mention" of associated risks such as cervical and breast cancer. "While some mild and transient side-effects have been mentioned, major issues pertaining to women's health go unreported," it proclaimed.
Pharmacist John Wilks drafted the letter. At his Seven Hills day and night pharmacy, he plasters warning stickers - "This medication may cause cervical cancer" - across pill packets before dispensing them.
Wilks, who encourages customers to use natural family planning methods, declines to discuss his religious beliefs, emphasising that he is motivated by scientific concerns about the pill's safety.
"I was concerned that what seemed to be an important health issue for women was not receiving any attention," he says. "The problem is that there is not calm rational debate about it."
His is probably one of the few opinions which Professor Ian Fraser, professor of reproductive medicine at Sydney University and author of a new book on the female cycle, The Body of Knowledge, shares with what he terms the "anti-pill lobby".
"The pill is associated with so many emotive issues," he says. "Many groups, sadly, wish to force their views on to others."
Dr Edith Weisberg, medical director of Family Planning NSW, emphasises that she supports the right of groups such as Right to Life to express their views. But she is clearly angered by the letter, saying it selectively quotes from the two studies and that its "scare-mongering" will provoke undue concern.
Fraser says it is unfair of health workers to use their professional status to scare women about the pill: "Their views are not taking into account the whole picture. The modern, low-dose pill is extraordinarily safe - the pill is by far and away the most thoroughly researched drug that has ever been available to the human race."
He says the health benefits of the pill, including roughly halving the risk of ovarian and endometrial cancer, so outweigh any hazards that two US studies have suggested that young women who use the pill extend their lives by an average of 40 to 50 days.
THE Federal Health Department's Adverse Drug Reactions Advisory Committee has received 527 reports of suspected side-effects to oral contraceptives since November 1972, including 13 deaths. The most common problems reported were failure to prevent pregnancy, menstrual irregularities, blood clotting, disturbed liver function and raised blood pressure.
The committee says it is not possible to draw conclusions from this data as it is based on voluntary reporting by doctors and is certain to underestimate the true incidence of adverse reactions. However, the committee says the weight of scientific evidence and the widespread use of the pill strongly support the view that the modern pill is very safe when used as recommended.
Professor Richard Day, a clinical pharmacologist at St Vincent's Hospital, is widely regarded as a leading authority on drug safety. He also ranks the oral contraceptive as one of the safest drugs available. "I don't have any concerns about the safety of the modern contraceptive pill, particularly if it is prescribed by a doctor who evaluates the situation and is aware of risk factors," he says.
But doctors who regularly prescribe the pill report that many women worry about its safety. They say the pill gets a disproportionate share of bad press, that its beneficial effects on health rarely gain a mention in the media.
However, the studies cited by Dr Hume et al show that the question of whether the pill - which the World Health Organisation (WHO) estimates is used by about 60 million women - increases the risk of breast or cervical cancer is yet to be conclusively answered.
This is partly because the pill has been through so many incarnations since it first was used in a clinical trial in Puerto Rico in 1956. Findings from studies of women who began using the high-dose pill 30 years ago may not be relevant for women who now take pills with a hormone content up to one-tenth of the original dose.
In one of the recent studies, US researchers compared 195 women with an uncommon form of cervical cancer with 386 cancer-free women. Those who had used the pill were twice as likely to develop adenocarcinoma of the cervix; the risk was greatest for those who had taken the pill for more than 12 years.
"The findings suggest that the increasing rate of adenocarcinoma of the cervix that has been observed in young women over the past 20 years might be partly explained by use of oral contraceptives," they said.
The other study, in which Dutch researchers compared 918 women with breast cancer with a control group, found those who had used the pill for more than 12 years were 1.3 times more likely to have breast cancer. The researchers concluded that four or more years of pill use, especially if begun before age 20, is associated with an increased risk of breast cancer developing at an early age.
However, Weisberg says the new studies are not cause for alarm: "One of the problems that the media doesn't understand is that when something is published in a medical journal, that is not fact ... until it has been confirmed with a whole lot of studies, you can't say that is a fact."
She says a link between cervical cancer and the pill is not proven as it is difficult to distinguish the effects of the pill from other factors which increase cervical cancer risk, such as certain sexually transmissible diseases and smoking. But even if it did increase the risk, this type of cancer would remain extremely uncommon and theoretically should be preventable through regular pap smears, she says.
Fraser agrees that the relationship, if any, between the pill and cervical cancer remains to be understood: "It's a very difficult and controversial issue that people do not have the final answers to."
"I cannot say that hormones don't have an effect on cervical cancer, but if they do, it is very small," says Fraser.
The latest study on the pill and breast cancer adds to about 50 previous studies which have produced conflicting results in this controversial area.
Weisberg says the message is that the pill does not increase overall risk. But it may increase the risk for a small sub-group - probably women already at increased risk of developing breast cancer before age 35 and who have taken the pill for several years.
To put this risk into perspective, she says one in 500 women can be expected under normal circumstances to develop breast cancer before age 35. The pill may increase the risk to one in 350.
"We think that these women would have got breast cancer anyway but that being on the pill for four to eight years has promoted the cancer to manifest itself earlier," Weisberg says, adding that further research is needed to clarify the issue.
"The benefits of the pill far outweigh the risks but I think each individual woman needs to make up her own mind," she concludes. "It is a very good contraceptive but I would have to say that we don't have an ideal contraceptive."
And that's the way it will stay for some time. Although researchers around the world are developing a host of alternatives to the pill, ranging from male "pills" to hormonal vaginal rings, it is likely to be years before any find their way onto the Australian market.
Even when new choices do become available, as happened recently with the female condom, companies are often reluctant to market them due to our small market, and the fear of litigation.
Meanwhile, groups such as WOOMB will continue to advocate natural family planning, dismissing concerns that it offers no protection against sexually transmissible diseases (STDs). Asked for his views on the use of condoms to prevent STDs, Hume exclaims: "To encourage condom use is irresponsible. Of course they are unreliable. The faith that modern medicine has in condoms is pathetic..."
FROM VOODOO TO SCIENCE
THE HISTORY of oral contraception dates back thousands of years, varying from pellets of mercury fried with oil to potions made from willow tea and the water in blacksmiths' buckets.
"The Chinese, for instance, spent nearly as much time cooking contraceptives as meals, and most of them sound ludicrously like something on a restaurant menu," says Shirley Green's book, The Curious History of Contraception.
"But appetising names like The Four Ingredients Broth were misleading - you had to marinate the ingredients in a child's urine or fry them up with a handful of earth."
The origin of oral contraceptives as we know them dates back to the late 1930s when a scientist called Makepeace discovered that giving the hormone progesterone to rabbits stopped them from ovulating.
A few years later, an American chemist, Russell Marker, learnt how to extract progesterone from a steroid in the Mexican yam. This was vital for research to continue into progesterone as it was a rare, expensive drug in the 1940s. Tons of animal tissue had been needed to produce even tiny amounts.
The finding that plants contained steroids suggests some of the traditional contraceptives found in the folklore of so many civilisations may have had a basis. It also explained the dilemma of Australian farmers who were mystified in the 1940s when lambing percentages fell to as low as 10 per cent: the sheep had been on a "grass roots" version of the pill because of the clover's high hormone content.
The final step in the pill's evolution is widely attributed to a chance dinner meeting between an American biologist, Dr Gregory Pincus, and Margaret Sanger, a pioneer of American birth control. Sanger was depressed about the failure rate of existing contraceptives and Pincus resolved to research the issue.
The story goes that he quickly found the answer: driving home from work next day he wondered whether, if progesterone stopped the release of further eggs in pregnant women, it would also do the same in non-pregnant women.
By 1956, a pill had been developed for trial in Puerto Rico; the first brand, Anovlar, went on sale in Australia in 1961; by 1966, 26 brands were available; and today 69 products are registered in Australia.
Health Department figures suggest pill usage may be increasing. In 1993-94, 3.9 million scripts were dispensed - 10 per cent up on 1989-90.
THE GENERATION GAP
FRANCES Wilde, 60, and her daughter Shivaun, 25, are among the two generations of Australian women who have taken the pill since it was first sold here in 1961.
Frances, a research nurse at the Family Planning Association of NSW, remembers its introduction being greeted with tremendous excitement. She associates it with the heady days of the 1960s, flower power and sexual liberation.
She also remembers the pre-pill days - in the 1950s, friends dropped out of nursing when they fell pregnant; others gave up careers when they married and inevitably fell pregnant soon afterwards. And, as a nurse, she heard of the hospital wards filled with women ill from abortions gone wrong. (Until the 1970s, abortion was one of the major causes of death in pregnant women.)
"I have always thought the pill was the most wonderful thing," says Frances. "Until that time there really wasn't anything reliable. I had no intention of having seven children (like my mother)."
Frances took the pill for two five-year periods with few side-effects. "I was very happy with the pill; I was safe from getting pregnant," she says.
Shivaun is surprised by this perspective; avoiding HIV infection is far more of a priority for her and for many of her friends than avoiding pregnancy. "If you don't have permanent partners, the pill and getting pregnant are the least of your concerns," she says.
THE KNOWN DISADVANTAGES:
* The pill is bad news for smokers. A recent large WHO study showed it increases the risk of heart attack 20 times in women who smoked 15 or more cigarettes a day. It also increases smokers' risk of stroke. But modern, low-dose pills do not increase the risk of heart disease in non-smokers and there is some evidence that they have a beneficial effect on cholesterol.
* It increases the risk of deep vein thrombosis (DVT), particularly in women with a family history of DVT, because of its effect on blood clotting.
* Six out of every 100 women who take the pill for one year will fall pregnant.
* Women with focal migraine should not take the pill because it increases their risk of stroke.
* About 15 per cent of women are sensitive to progesterone and may suffer bloating
* The pill does not prevent spread of STDS
THE KNOWN ADVANTAGES:
* The incidence of endometrial and ovarian cancer is roughly halved in women who have been on the pill for at least five years. Weisberg says this is particularly important for older women, in whom these cancers are more common, and that the protection lasts for 10-15 years after stopping the pill.
* It halves the risk of benign breast lumps, benign ovarian cysts, and pelvic inflammatory disease, says Fraser.
* It can help control eratic bleeding for women approaching menopause
* It allows control of menstrual cycles.
* It reduces period pain and eliminates it for many people, decreases heavy bleeding, and reduces risk of anaemia.
* Weisberg says it may reduce the likelihood of rheumatoid arthritis and thyroid disease, although this is not proven.
* It is a myth that the pill causes infertility; one in four women will fall pregnant in the first month after stopping the pill, Weisberg says.
© 1995 Sydney Morning Herald