EXPOSED:
THE BOGUS WORK OF PROF BRIGGS Page 2
The hopes of
many researchers for further reducing the risk of
vascular disease were raised with the discovery by
the West German pharmaceutical giant Schering AG of a
new way of preparing pills, delivering three varying
doses of hormones over the menstrual cycle.
Although other
products make competing claims, these pills, known as
“triphasics”, and containing the synthetic
progestogen levenorgestrel, have been extensively
promoted by drug companies as an even safer form of
contraceptive pill, in an attempt to bring
increasingly sceptical women to use oral
contraception.
“Trinodial
- the lowest ever monthly hormone dose to provide
reliable contraceptive protection,” declares a
typical advertisement in the medical press. That one
was placed by the American drug company Wyeth, which
makes the Schering product under license. It goes on
to offer: “Minimal breakthrough bleeding, while
minimal interference with metabolism points to
increased safety.”
But these new
products raise questions of their own. Besides the
absolute levels of oestrogen and progestogen, the
proportions in which they are combined and the manner
by which they are artificially synthesised are also
of key concern. And in this area of science, there
was no more important researcher than Professor
Michael Briggs.
“First it
was the GPs who moved over to the triphasics, and
eventually we in the family planning clinics began to
be impressed,” says Dr Fleur Fisher, of the
National Association of Family Planning Doctors, and
a community physician in the north of England.
“We looked at Briggs’s studies when we made
that decision.”
MONEY is
usually the first big problem for any scientific
inquiry, but Briggs easily overcame that hurdle. In
the 1960s, he had been UK research director for
Schering Pharmaceuticals in Sussex, and was able to
raise research grants from Schering AG, its West
Berlin-based parent. The Schering group has
subsidiaries in 19 countries and an annual turnover
of more than £1.6 billion.
Schering
AG’s contraceptive pill formulations are also
sold under a licensing agreement by the
Pennsylvania-based Wyeth, a subsidiary of American
Home products, the world’s biggest producer of
sex hormones, holding nearly a quarter of the
international market. Wyeth, too, contributed heavily
when Briggs passed round the hat.
With the money
sorted out, Briggs pressed on with the work. Among
his most important papers from Deakin University were
Recent Biological Studies in Relation to Low Dose
Hormonal Contraceptives, published in 1979;
progestogens and Mammary Tumours in the Beagle Bitch,
published in 1980; and Comparative Metabolic Effects
of Oral Contraceptives Containing levonorgestrel or
Desogestrel, published in 1983.
Of particular
interest is a series of investigations reporting the
effects on blood metabolism in a large sample of
women using the pill over six, 12 and 18 months. This
series culminated in his very widely quoted paper,
Implications and Assessment of Metabolic Effects of
Oral Contraceptives, published in 1981, and still the
biggest such study in the literature.
BUT much of
the research work as described and presented by
Briggs never took place. He did not do tests on which
the papers appeared to present results, some of his
reported tests were impossible to conduct, and , in
one paper he wrote up a study of dogs that he had not
done.
In a four-hour
interview in Spain, Briggs admitted to The Sunday
Times that he had collected from other people
unpublished, small-scale findings and generalised
them into apparently big and convincing trials. He
refused, however, to reveal from where he got this
data. “If I tell you who organised the studies
you will know who is involved,” he said. “I
still know a lot of them personally and I’m not
prepared to drop people in it.”
Although
Briggs believed his deceptions would not be exposed,
he underestimated the errors that he built into the
work. First, he failed to allow the right length of
time for the recruitment of subjects for the studies.
Pill researchers have always had trouble persuading
suitable women to take part, yet Briggs found it
strikingly straightforward.
In a key
series of papers, he presented findings on more than
80 women who were under 30 years old, within 10% of
ideal body weight, who did not smoke and were taking
no medicines, who had never used the pill and who
were prepared to fast overnight before attending, for
18 months, monthly hospital interviews and blood
tests. The timing of his papers also suggests that
virtually none of the women dropped out.
Second, the
investigations Briggs was conducting were of great
breadth and sophistication. His ostensible task - to
find out just what was happening in the blood of
women who took the pill demanded tests for up to 16
different possible changes in proteins. Doctors
believe some of these changes are strongly implicated
in raising the risk of heart disease and stroke.
