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  The Pill, politics and litigation
By Ellie Lee

Professor Carl Djerassi, inventor of the contraceptive Pill, told Ellie Lee about its controversial history

Next year, the Pill, which first became available to British women in 1961 will be 40. During those forty years, the Pill has become the most researched drug on earth, and has been proven to be medically safe. The risk of blood clots resulting from Pill use - an ongoing fear - has been measured at 15-25 per 100 000 (compared with 60 per 100 000 for having a baby). The risk of death from clots for Pill users is less that one per 100 000. And a recently published study, which followed up 46 000 women over 25 years, found that found mortality rates in Pill users and non users were little different 10 years after Pill use has ceased.

The Pill is safe to use, and its benefits in terms of fertility control are clear. With typical use it has been estimated that 15 couples in one hundred will get pregnant where condoms are used, compared with two or three per hundred for the Pill. The Pill has made a big difference to women's lives, by giving them greater control over when they become pregnant. Yet despite all this, the Pill remains dogged by the suspicion that has surrounded it since it first came on the market. It is hard to think of a medicine which has generated more unwarranted debate about the health risks it allegedly carries. Why has the Pill been dogged by such bad press? And what consequences has it had?

Djerassi was responsible for the first synthesis of the hormones used in the Pill, at a laboratory in Mexico in 1951. He describes the social and political climate at the time as one 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'. This description seems barely recognisable today. Such as positive attitude to new research has been replaced by fear of new developments. The search for new approaches to contraception has almost collapsed: as Djerassi pointed out, 'in the 1960s, thirteen major pharmaceutical companies - nine of them American - were still active in research and development of new contraceptive techniques. By the early 1980s, only four large companies, one of them American, had any research and development committment to this field. In 1988, a survey of research priorities of the international pharmaceutical industry showed the search for a new contraceptive method was not even among their top 35 priorities'. Why the change in approach?

Djreassi suggests that associations between the Pill and health problems from blood clots to cancer has had profound effects on the funding of contraceptive research. This association has generated an extensive amount of litigation in the US: ' In 1982, the congressional Office of Technology Assessment reported that during the preceding decade, liability costs in the oral contraceptive field had been higher than any other drug category.' Cases were brought against pharmaceutical companies, claiming a link between Pill use and ill health. The result was that investment in this area came to an end. For companies manufacturing the Pill, the costs of litigation simply outweighed profits that could be made from its sale.

Why did so much litigation take place? This cannot be explained on the grounds that the Pill constituted the most risky of all of the different drugs on the market. Djerassi suggests that while 'indisputably a small number of women have been harmed by the Pill', the overall incidence of side effects caused by Pill use was in fact low. However, the perception of risk was great, and generated a great deal of litigation.

Djerassi sees the 1960s as the key decade when the problem of the health risks came to dominate attitudes towards the Pill. In fact, Djerassi contends that the 1960s turned out to be 'the worst of all times' to bring new drug onto the market. This time was characterised by a 'changed climate' where optimism about new drugs had evaporated. A key factor which brought about this shift was the Thalidomide tragedy. The drug Thalidomide was given to pregnant women to alleviate sickness, but its side effect was the birth of children with severe limb deformities. The thalidomide tragedy meant that the issue of a new drug's deleterious side effects 'came to preoccupy the American public', and led to a new demand for safety.

While of course there is nothing problematic about wanting a drug to be properly tested, and safe, safety cannot be guaranteed. It is simply impossible to guarantee absolutely that no side effects will result from a new drug. Djerassi suggests that however the meaning of safety was not clarified in the 1960s, generating a continued 'pervasive misunderstanding about the real meaning of safety in medicine'. A desire for a water-tight guarantee that no side effects at all will occur, means a climate of 'risk aversion' came to prevail in attitudes towards new medicines.

Such risk aversion has led, since the 1960s, 'to a marked slowing in the rate and number of new pharmaceuticals, especially contraceptives'. Djerassi suggests that risk aversion impacted on attitudes to contraceptives more than anything else. Since the Pill is taken by healthy people, society less tolerant of potential risk, however small, than it is where the drug is taken by an individual suffering from disease. As a result, people are more prepared to sue where any health problems emerge, which appear to be connected to contraceptive use. How to respond to such 'risk aversion' remains for Djerassi the 'unsolved dilemma' faced by both manufacturers and regulatory agencies responsible for the registering of drugs for sale or prescription, especially contraceptives. The difficulty they face is to respond to 'the public's demand to have all possible untoward effects anticipated and documented, and yet to do so with a minimum of clinical experimentation'.

A further aspect of the 1960s which encouraged a litigious approach was Djerassi suggests, the emergence of three social movements, 'the women's movements, environmental protectionism, and consumer advocacy'. Djerassi argues that all three were for different reasons, 'intrinsically suspicious of technology and even science', and therefore were outraged by the fact that the Pill was still for sale, when it did carry with it any risk side effects. 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 those in these movements may look back on their influence with some regret: their litigious approach has 'ultimately only penalized the very constituency that most stood to benefit most from continued research', women of reproductive age.

Another factor was a specific event, the 'Nelson hearings' of 1970, which Djerassi describes as the 'pivotal event to push contraceptive research permanently into the minor leagues'. The hearings, held before a subcommittee of the US Senate, were, according to Djerassi, set up in response to concerns being raised about the Pill's safety. While the hearings did illuminate 'many little-understood aspects of Pill use and distribution', there were also surrounded by hysteria, as 'witness after witness was produced to illuminate the potential dangers of the Pill'. While the witness stand was open to any representative from any pharmaceutical company, not one testified, reflecting 'the industry's paranoid perception of hearings'. For Djerassi, this refusal to comment was a 'tactical mistake', leading to a bitter, unrebutted condemnation of the pharmaceutical industry during the hearings. Further bad press for the Pill resulted, and further law suits.

The end result of this combination of factors 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 has 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 the 1970s, 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'. As a policy statement from one of the few remaining Pill manufacturers Schering Healthcare put it in 1991, 'Research and development will only continue as long as shareholders permit it; this requires them to see an adequate return on their investment which requires adequate profit.'

The legacy of the events of the 1960s and 1970s is most strikingly the turning of the pharmaceutical's industry's back on contraceptive research. What is striking when one considers that the Pill first became available four decades ago is that it still remains the most recent real 'breakthrough' in contraceptive technology. Other areas of medicine have witnessed dramatic new developments. Yet in contraception the new developments that have taken place - such as Intrauterine Devices (IUDs) which release hormones, lower dose Pills, contraceptive implants and injections - are all variations on a theme, rather than substantially different products from the Pill. Given the continuing litigation around the Pill - last year it was reported that a 137 women are to bring a joint action against Pill manufacturers and litigation has also been responsible for the withdrawal last year of the contraceptive Norplant from the British market - it seems unlikely that this will change any time soon.

It is a terrible pity that such an important area of technology has become such a low priority. As an article in Science pointed out, science has the potential to 'conquer a whole new frontier' and generate a substantially different contraceptive options to those currently available. But so far, that potential has been wasted.

A further indication of the problems generated by 'risk averison' and the Pill is the reluctance to make the most of what we've got. One measure that could make all the difference for women would be the licensing of over-the-counter sale of the Pill. At the moment, the Pill is only available on prescription. But why? In the year 2000, it seems ludicrous that the Pill is not available for sale over the counter in chemists, like aspirin. Djerassi agrees: 'I would be in favour of the Pill being available without prescription. There is no medical reason why not. For healthy young women, oral contraceptives are of such low risk now I would make the case that they should be available over the counter.'

One lesson we can learn from Professor's Djerassi's account of the story of the Pill is that we need a balanced approach to risk. If society carries on demanding that no risk is ever acceptable when new products are being developed, it will be cutting off its nose to spite its face.

Carl Djerassi's autobiography The Pill, Pygmy Chimps and Degas' Horse is published by Basic Books.

His website can be found at http://www.djerassi.com
 
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