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Information
Resource Library
Contraception |
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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Such as positive attitude to new research has been replaced
by fear of new developments.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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