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Professor Carl Djerassi, inventor of the contraceptive pill, told Ellie Lee the story of its controversial history

'Oral contraceptives are of such low risk to healthy young women, they should be available over the counter.' Professor Carl Djerassi sees 'no medical reason' why the pill is still only available on prescription. So why do women still have to make that annoying six-monthly trawl to their GP or family-planning clinic?

In 2001, the pill will celebrate its fortieth birthday. Over that time it has become the most researched drug on Earth, and has been proven to be safe. The risk of blood clots resulting from pill use - one of the ongoing fears - has been measured at 15 to 25 per 100 000 (compared with 60 per 100 000 for having a baby). And a recent study of 46 000 women over 25 years convincingly challenged the notion that ill health will result some time in the future in pill users. Mortality rates in pill users and non-users were little different 10 years after pill use ceased. In terms of fertility control, the benefits of the pill are clear - it has been estimated that, with typical use, 15 couples in 100 will get pregnant where condoms are used, compared with two or three per hundred for the pill.

Yet despite the effectiveness of the pill and its proven safety, it remains dogged by a suspicion that has surrounded the drug since it first came on the market. When Djerassi first synthesised the hormones used in the pill, at a laboratory in Mexico in 1951, it was, he says, in a climate where 'pharmaceutical companies, the media, and the public proclaimed and accepted the benefits of the postwar chemotherapeutic revolution with barely a reservation', and when 'the search for new approaches to contraception was a glamorous and exciting field'. But the pill came on the market in the 1960s, 'the worst of all times' to bring a new drug on to the market, according to Djerassi. In the wake of the Thalidomide tragedy, where a drug given to pregnant women to alleviate sickness resulted in the birth of children with severe limb deformities, the issue of the deleterious side effects of any new drug 'came to preoccupy the American public' and led to a new demand for safety.

While it is common sense to want a drug to be properly tested and safe, it is simply impossible to guarantee absolutely that no side effects will result from a new drug. Djerassi suggests that this was not clarified in the 1960s, generating a climate of 'risk aversion' in attitudes towards new medicines - especially contraceptives. Since the pill is taken by healthy people, who are less tolerant of potential side effects than those suffering from disease, Djerassi argues that people are already more predisposed to sue where any health problems emerge which appear to be connected to contraceptive use. Indeed, in 1982 the Congressional Office of Technology Assessment reported that during the preceding decade, liability costs facing contraceptive manufacturers had been higher than in any other drug category.

But Djerassi also points out that the litigious approach of the 1960s was encouraged by three newly emerging social movements, 'the women's movements, environmental protectionism, and consumer advocacy', all three of which were 'intrinsically suspicious of technology and even science'. Fuelled by sensationalist media headlines such as 'Pill kills', representatives of these three movements encouraged litigation as an expression of their hostility to the pharmaceutical industry. While their concern for optimising women's health was legitimate, in retrospect Djerassi suggests that those in these movements may look back on their influence with some regret - their litigious approach has 'ultimately only penalised the very constituency that stood to benefit most from continued research' - women of reproductive age.

The pharmaceutical industry played its own part in contributing to the suspicion surrounding the pill. Djerassi uses the example of the 'Nelson hearings' of 1970: a 'pivotal' event, which pushed contraceptive research 'permanently into the minor leagues'. Held before a subcommittee of the US Senate, the Nelson hearings were set up in response to concerns being raised about the pill's safety. 'Witness after witness was produced to illuminate the potential dangers of the pill', says Djerassi. Not one representative from any pharmaceutical company testified, reflecting 'the industry's paranoid perception of hearings': a 'tactical mistake', according to Djerassi, which led to a bitter, unrebutted condemnation of the pharmaceutical industry during the hearings. Further bad press for the pill resulted, and further lawsuits.

The end result of all this was a startling deterioration in contraceptive research and development. According to Djerassi, by the end of the 1970s the pill, with regard to prospects for spending on research and development, was a 'boat that had set sail'. Djerassi himself, who was in charge of research at Syntex, an American company that until the 1970s had spent a higher proportion of its research and development budget on contraception than any other company, took 'the regrettable though unavoidable step of recommending to the board of directors that Syntex withdraw from this field of research'. Djerassi advised that the company's stockholder's money should be spent on health areas for which there were fewer barriers. Since then the pharmaceutical industry, unwilling to spend the time, energy and resources necessary to refute the pill's critics, has maintained its focus on 'the bottom line'.

It is disturbing that the pill, which first became available four decades ago, remains the most recent real breakthrough in contraceptive technology. Other areas of medicine have witnessed dramatic new developments. Yet those new contraceptive developments that have taken place, such as Intrauterine Devices which release hormones, lower-dose pills, contraceptive implants and injections, are all variations on a theme, rather than substantially different products from the pill. There continues to be litigation around the pill - last year it was reported that 137 women are to bring a joint action against pill manufacturers. Litigation has also been responsible for the withdrawal last year of the contraceptive Norplant from the British market. In this climate, a positive change in pharmaceutical companies' attitudes to contraceptive research is unlikely. It's a good job Djerassi invented the pill when he did.

Ellie Lee is coordinator of the research and education trust Pro-Choice Forum (www.prochoiceforum.org.uk)

Reproduced from LM issue 128, March 2000



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