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- THE
PILL: PROFESSOR'S SAFETY
- TESTS
WERE FAKED
The
Sunday Times (London) September 28 1986
By
Brian Deer, Social Affairs Correspondent
RESEARCH into the long-term side effects of a new
generation of contraceptive pills was fabricated by a
British scientist. His deceptions put a question mark
over safety checks on pills being taken by up to 2m
women in Britain and 10m worldwide.
An
investigation by The Sunday Times into the research
of Professor Michael Briggs, one of the most
influential international experts on contraceptives
and an adviser to the World Health Organisation, has
revealed scientific fraud on a large scale.
Briggs's
bogus research purported to assess possible risks of
heart and arterial disease in women after prolonged
use of the pill. His area of work was on changes in
fats in the blood, or "lipids", which are
thought to be as serious a threat as cancer to women
taking the pill.
His
research culminated in the biggest survey of these
risks yet published and was extensively relied on in
drug company advertising to promote the pill's safety
claims. The companies which make the pills involved,
Schering AG of West Germany and Wyeth of the United
States, financed much of his work through grants.
A
number of products, including Logynon and Trinordial
in Britain and TriLevlen and Triphasil in the United
States, were granted government licenses on the basis
of submissions including work by Briggs over more
than a decade.
After
an investigation in Australia, Europe and the United
States, Briggs was tracked down by The Sunday Times
in Spain where he now lives with his wife, a
British-registered family planning doctor. She is a
joint author of some of his scientific papers.
In a
four-hour interview at his new home in Marbella on
the Costa Del Sol, Briggs, aged 51, admitted serious
deceptions in his research, among them that he had:
*
Pretended to have organised studies of the effects of
oral contraceptives which he had not done. He said
the studies had been organised by someone else, but
declined to name this person.
*
Produced a study on animals which he had never done.
This study, on beagle bitches, later helped persuade
the British government that arrangements which
previously delayed the granting of licenses were no
longer necessary.
*
Included in scientific papers complex biochemical
test results, the origins of which he couldn't name.
One paper, he said, he was unaware even of the
country in which the analyses were purported to have
been done.
"It
is a sad story," said professor Max Elstein, who
sits on the drug safety committee of the health
department's Committee on the Safety of Medicines.
"The whole scientific community was bamboozled
over this."
Schering
and Wyeth paid for Briggs to present his work at
special international symposia and then financed its
publication in one-off books. Through publication in
these books and in journals, Briggs's bogus findings
have become part of medical literature. They are now
found in the work of nearly all major contraceptive
researchers.
"This
is a very serious matter," said Dr James
Rossiter, chairman of the ethics committee at Deakin
University, Australia, where Briggs's bogus work was
written. "This material was published and
circulated by drug companies to doctors who don't
have time to read the references."
Schering
and Wyeth have denied knowledge of the frauds and
said last week that they had no responsibility to
ensure that research they supported was fair. Wyeth,
which has continued to advertise Briggs's data,
despite knowing that it was in question, said doctors
would not allow such promotions to affect their
prescribing.
But
both drug companies said they would no longer be
using the research. "We are not going to cover
up for, or try to defend, Michael Briggs if he is
wrong," said Glen Branham, vice-president of
Wyeth International in Pennsylvania. "I would
like not to believe it, but I have to believe there
is some fire with the smoke."
Briggs
produced most of his bogus research while holding the
post of professor of human biology and head of the
sciences school at Deakin. However, the studies he
described were based on research equipment that was
not available at the university, on drugs that were
illegal in Australia, and on groups of women patients
assembled at a speed and ease other researchers found
impossible to emulate.
A
year ago, an international meeting of contraceptive
research specialists in Berlin held an emergency
discussion about Briggs after growing incredulity at
the speed with which he produced highly complex data
on trials on women. His work has also been considered
at the World Health Organisation.
Many
experts privately believe all of Briggs's research is
now in doubt, but have focused on a series of papers
he produced while at Deakin. An analysis of these
papers reveals extraordinary flaws.
At a
meeting in Chicago last week, senior staff of the two
drug companies urged The Sunday Times to stress that
the public was protected through research by other
scientists - whose findings resembled those of
Briggs.
The
companies have known for a year that Briggs's
research was in dispute and the UK Committee on the
Safety of Medicines said that it would be a breach of
regulations if it were not told of doubts over data.
The US Food and Drug Administration said it would
launch an investigation into the continued use of
Briggs's work in promotions to doctors.
If
the research had been done in the United States, the
FDA said it would have been subject to stringent
checks, but these powers did not extend abroad.
"This could be a very important story,"
said Dr Solomon Sobel, head of its hormone division
in Washington. "You should pursue it."
Two
years later...
- RESEARCH
REVEALS BIRTH PILL
- RISK
FOR 2M BRITISH WOMEN
The
Sunday Times (London) September 18 1988
By
Brian Deer, Social Affairs Correspondent
FAMILY doctors are to be urged to switch more
than 2m British women from their current brands of
contraceptive pills, after a scientific investigation
which suggests that the most popular pills available
carry the greatest health risks.
The
pills, which all contain the synthetic hormone
levonorgestrel, include leading brands Microgynon,
Eugynon, Ovran, Ovranette, Trinordial and Logynon,
which currently dominate the British oral
contraceptive market. Worldwide, more than 15m women
are believed to be taking this type of pill.
Doubts
about the levonorgestrel pills have circulated among
scientists and doctors for the last two years, after
The Sunday Times revealed that important research
publications, purporting to show the relative safety
of the products, was fabricated.
Now,
the gap left in the medical literature by the
exposure of the fraud is to be filled by research
which shows the pills to be more likely to cause
heart disease and other cardiovascular problems than
other brands available.
The
new research was carried out in Britain on behalf of
the American government's National Institutes of
Health, and is the largest investigation of its type
ever undertaken independently of drug firms.
The
£500,000 research project was led by Professor
Victor Wynn, whose team at the Cavendish clinic in
north London studied more than 1,400 healthy women
taking nine different formulations of pill.
Wynn
has been a leading authority on contraceptive safety
for more than 20 years. His team measured complex
changes in the blood, which are now regarded as key
indicators of whether a person is likely to develop
cardiovascular diseases. Across a range of
measurements, they found that women taking
levonorgestrel pills were in significantly greater
danger.
The
implications for women now taking the pill are likely
to be far-reaching. Professor Wynn is currently
recovering from illness, but his staff said that
family doctors should be alerted to the increased
risks which they believe are posed by the
levonorgestrel pills.
"These
are significant effects that we have found. Here we
have the basis for a major shift in
prescribing," said Dr Ian Godsland, a senior
biochemist in Wynn's team and co-author of the
research.
More
women are taking levonorgestrel pills than any other
type of oral contraceptive, after a marketing
campaign in the medical profession by their
multinational manufacturers. The firms involved are
Schering AG of West Berlin and the Philadelphia-based
company, Wyeth.
In
recent years, the two companies have particularly
encouraged doctors to prescribe their so-called
"triphasic" levonorgestrel pills, which
deliver a smaller quantity of the synthetic hormone.
These "low-dose" pills also fared badly in
the research.
It
was also the triphasics that became the centre of an
investigation by The Sunday Times. This revealed that
Professor Michael Briggs, a British scientist and a
former senior staff member of Schering, faked a
series of papers which appeared to refute links
between the pills and heart disease.
His
work, carried out at Deakin University in Australia,
was financed by Schering, which also paid for the
results to be published and distributed to doctors
worldwide. The company denied knowledge of the
deceptions and, after our inquiries, deleted Briggs's
work from its literature.
Schering
said this weekend that it did not contest Wynn's
findings at present, and that it is not currently
promoting levonorgestrel pills. The company said that
it is now recommending to doctors that they consider
Femodene, a new oral contraceptive containing a
different hormone.
Dr
Peter Longthorne, medical director of Schering's UK
subsidiary, said: "We do not know what the
implications of this study are in a clinical setting.
It is an interesting finding and I do not think we
can draw a definitive conclusion at this stage."
Wynn's
method was to examine more than 30 aspects of blood
metabolism in more than 1,400 women. They were a
random sample, with an average age of 28. The most
worrying sign he detected was a decline in an element
in blood known as HDL2, which is believed to protect
women against heart disease.
The
pill which fared best in the investigation was
Marvelon, which contains a hormone called
desogestrel, rather than the suspect levonorgestrel.
Very closely behind this were pills containing small
amounts of norithisterone, such as Brevinor, Minovlar
and Loestrin.
General
practitioners and doctors in family planning clinics
may wish to switch women to these pills, but this
will not be easy. Levonorgestrel-containing
contraceptives are popular because they are good at
preventing "breakthrough bleeding" and
because the hormonal changes can in many cases
promote a sense of well-being and improved libido.
Dr
John Guillebaud, medical director of the Margaret
Pyke centre for family planning in London, said that
he wanted further research on the alternatives to
levonorgestrel before he would advise women to
change. "It is not that these pills have
suddenly become dangerous, but that from the
laboratory studies it appears that the others are
better," he said.
Focus - Exposed: the
bogus work of Prof Briggs
Selling the pill like
soap
Copyright,
Times Newspapers Ltd. All rights reserved. No portion
of this article on Professor Michael Briggs and a
pharmaceutical fraud may be copied, retransmitted,
reposted, duplicated or otherwise used without the
express written approval of the copyright owner.
Responses, information and other feedback are
appreciated - via Brian Deer's homepage.
