(Also at LifeIssues.net: http://www.lifeissues.net/news.php?newsID=00037984&topic=)
Mail Online (UK)
February 12, 2014
Have 800 women been killed
by the Pill? The alarming dangers of taking so-called third generation
contraceptives
- Nancy Berry died after taking
Femodene
- Trudi Banning suffered a blood clot
when she was 22
- She had also been taking
Femodene
- She survived but is now
infertile
- Warns other women to be aware of the
risks
- Campaigners calling on some Pills to be
banned
By Lois Rogers
Life destroyed: Trudi Banning survived a blood clot but
now can't have children
When Trudi
Banning collapsed, apparently lifeless, on the floor of the army supplies
warehouse where she worked, everyone was mystified as to what could have struck
down such a seemingly healthy young woman.
The 22-year-old
super-fit young soldier was rushed to hospital, where it quickly became clear
that much of her digestive system was riddled with
gangrene.
Two enormous
blood clots had blocked the entire area, starving it of oxygen, which had caused
large sections to die and rot. She was so ill that medics at the military
hospital in Swindon, Wiltshire, doubted she would
live.
Then there was another shock. Doctors revealed to Trudi's
distraught family that the likely cause
of her blood clots was the contraceptive pill Femodene, which she had been
taking for the past four years.
She was placed in
a medically induced coma and for the next six months remained unconscious,
wavering between life and death.
Eighteen years
later, Trudi, who is now 40 and living in Warwickshire with her fiancé, has been left
infertile, her ovaries ruined by complications from the
gangrene.
She also suffers
from memory problems and has been left with a permanent blood-clotting
disorder that needs constant treatment with
medication.
'I'd always
imagined myself with three children, but it's never to be and that has destroyed
me,' says Trudi, who had to give up
her army career and now works as a security
guard.
'If I'd stayed in the Army I would have progressed through the ranks and
got a pension. I lost all of that, too.
'My boyfriend has given me huge strength. He's 59 and
understands how I feel about what has been taken away from me. My skin is paper-thin because of scarring;
I've had so many operations I've lost count. Even if I could get pregnant,
I've been told it [the skin] would just
break open. I don't think about having children
anymore.'
Trudi is just one of potentially thousands of women who have had
their lives ruined by so-called third generation contraceptive pills - including
up to 800 who may have lost their
lives.
Developed in the 1980s, these were supposed to offer an alternative to women
who complained of spots, mood swings or weight gain from the older, original
Pill formulations.
Produced by drug
companies Schering, Organon and Wyeth under the brand names of Femodene, Marvelon, Mercilon, Minulet and
Triminulet, they contain synthetically produced
formulations of the hormones progestogen and oestrogen, which prevent
ovulation by mimicking a state of pregnancy.
Unbeknown to
Trudi, many experts have long
suspected a link between these pills and potentially fatal blood
clots.
Last year an inquiry was launched by the European
Medicines Agency, which regulates drug use in Britain and Europe, into another third generation pill,
Dianette.
Prescribed as an
anti-acne treatment but also used as a contraceptive by 62,000 women in the UK,
it has been linked to 31 deaths in this
country since its launch in
1983.
It was suspended
from sale in France last year pending investigations into seven deaths
there, and there were calls to extend the ban to the UK - but regulators decided the benefits of the drug
in treating acne outweighed the risks, and it is still on the
market.
Victim: Nancy Berry died
after taking Femodene
A bitter irony for Trudi is that she was an 18-year-old virgin
when, she says, she was instructed as a young cadet to see an army GP to be
put on Femodene.
'I was very naive,' she says. 'I was the eldest of four
children and my father and grandfather had been in the
Services.
'The Army
didn't want girls getting pregnant, and although I wasn't having sex with
anyone then anyway, I didn't question their
authority.'
The Army,
however, last week denied it had a
policy of issuing contraception to female recruits. Trudi took the Pill for
the next four years with no problems. She did have boyfriends, but not at the
time when she was struck by the terrifying blood
clots.
In 2002, Trudi
and 122 other victims and relatives of those who had died tried to sue the three
drug manufacturers for damages.
The case
collapsed in July that year when the High Court ruled that there was no
evidence to suggest the pills were
more dangerous than other contraceptive pills.
Last month, however, their case was revived when a European review
suggested that the pills might be more dangerous after
all.
The risk of these
third generation pills causing potentially fatal blood clots has been put as
high as 1.2 per 1,000 users - more than
double the one-in-2,000 risk for the formulations of pills found in studies
to be the safest.
It prompted the
UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) to write to the nation’s 60,000 GPs warning
them to be alert to the risk of life-threatening clots in patients using
Femodene, Marvilon or Mercilon.
The letter does
not reveal that 78 deaths have been reported since the drugs came on the
market in the 1980s - and the real
figure could be nearer 800 because the MHRA says only 10 per cent of cases of
drug-related deaths are ever passed on to them.
Now Trudi is
campaigning to get other members of the original group to rejoin the fight,
this time against drug companies Bayer
and MSD, which have taken over manufacture of the pills from Schering and
Organon.
She hopes the new action will include the family of Beverley Marsh, who died from a blood clot
in 1995, aged 20, and Sue Haskins, a newlywed 26-year-old who was left paralysed
and unable to communicate by locked-in
syndrome.
'I would love to have one chance at last to stand up in
court and tell the world what happened to me and probably to thousands of women
like me,' she says.
Martyn Day,
one of Britain’s most successful lawyers, led their 2002 claim. He argued that
it was already known that the third
generation products carried increased risk compared with other Pills, and there
should have been a warning to prescribers and
users.
Mr Day admits he was distraught at the court’s decision:
'This recent warning to doctors is
evidence suggesting we were right all along.
'Sadly the judge
never got to grips with the science and came to the wrong conclusion. A lot
of young women were very badly affected. The question would be, how many more of them are out
there?'
Trudi has already contacted Yvonne Berry, a 65-year-old swimming
instructor from Bexley, Kent, who lost her only daughter Nancy in 1995 when she
was just 16. She had been on Femodene for a month, with her mother's
blessing, in the hope it would help with her painful
periods.
Within 24 hours
of developing breathing difficulties - a symptom initially dismissed by
hospital doctors as a panic attack - the vibrant teenager, who had been planning
to train as a hairdresser, was
dead.
'After complaining she couldn't breathe, she started
coughing up blood,' Yvonne remembers. 'The doctors didn't know what to do. They
said it was pneumonia, even though she had been perfectly healthy until then. A
young woman doctor was trying to suck fluid out of her
lungs.
'Nancy's last words, before she went into a coma, were:
"I'm sorry".'
Yvonne, her husband Colin and their son Paul, 18 at the
time of Nancy's death, sat helplessly at her bedside in intensive care as she died of a heart
attack.
Bayer, which makes Dianette and Femodene, say: 'The
benefits of combined hormonal contraceptives outweigh the
risks'
'For the first five or six months I was literally mad
with grief,' says Yvonne. 'We all were. When we got to the inquest, the drug company Schering was there with their QC. They
did most of the talking.'
The result was an open verdict on Nancy's death: the drug was
not held to blame.
After publicity about other Pill victims, however, the
Berrys joined the ill-fated group legal action.
'There were quite a few families with daughters who had
died,' Yvonne says. 'When the legal case was closed, I said to my family that it
would come up again because other girls would die. Now, it gives me no pleasure
to say that I've been proved right.'
Yvonne now has three grandchildren - two boys aged five
and two, and a four-year-old girl named Nancy.
'We talk about my Nancy all the time. They know she died
young but they don't know how.'
Charlotte Porter,
from Maidstone in Kent, was 16 when she died in 2010. The school cheerleader had
developed acne at 15 and was prescribed Dianette for eight
months.
It seemed to clear Charlotte's spots and so boosted her
confidence, but in March 2010 she developed a strange swelling in her
leg.
'It was mottled and looked bruised, but nothing was done
and she was sent home by the GP,'
says Charlotte's mother Beverley, 50, who lives with her husband Trevor, 65, a
retired financial adviser.
Two weeks later,
in excruciating pain from her leg, Charlotte was taken by her mother to
Maidstone Hospital. Blood was taken for testing - but as Charlotte joked
with schoolfriends who had gone to hospital with her, she suddenly stopped breathing and was
pronounced dead before the blood test results were even
returned.
Despite the
evidence of a blood clot, an inquest concluded that her death was due to natural
causes.
'I feel we're trying to fight the world,' Beverley says.
'We never got any sense out of the doctors. We have written to David Cameron and
got nowhere. People say time heals, but it doesn't. It gets
worse.'
The family has
launched an online petition calling for Dianette to be banned. Under new
government rules, if they can get
100,000 people to sign, Parliament will have to debate their
proposal.
Helen Schofield,
33, a shop assistant from Whitefield, Manchester, had been taking Dianette for
two weeks when she collapsed and died in the street in front of her shocked
family in 2008, minutes after signing the contract to buy her first
home.
'If I had known more I might have saved her,' her mother
Kay says today. 'Although I blame the
drug, I also blame the doctors. We had no idea of the
risks.'
The inquest
into Helen's death heard that doctors
had not warned her about the risk of Dianette, and she died after a blood clot
developed in her leg and travelled to her lung, causing a fatal
blockage.
Coroner
Carolyn Singleton recorded a verdict of
death by misadventure.
'I find this incredibly frustrating,' says Professor Frits Rosendaal, a world expert
on blood-clotting disorders from the University of Leiden in Holland. He is in no doubt that third generation
pills should not be offered to women.
'They are
still being used because of hard-sell marketing by drug companies and the
ignorance of doctors,' he says. 'They offer no additional benefits
whatsoever. Women have no idea of the
risk and there are equally effective treatments for
acne.'
Other
contraception specialists, though, question the reliability of the data
suggesting the pills are more dangerous.
'A lot of us think it is not clear cut,' said Diana Mansour of the
UK Faculty of Reproductive and Sexual Healthcare. 'But doctors should
assess women's individual risk factors when selecting a suitable version of the
Pill for them.'
The American-owned manufacturer MSD, which
makes Marvelon and Mercilon, says blood clots are a known risk but stresses
that the risk of blood clots in
pregnancy is many times higher. 'Some combined hormonal contraceptives suit
some women better than others,' a company spokesman
says.
Bayer, which
makes Dianette and Femodene, says: 'The benefits of combined hormonal
contraceptives outweigh the risks.
The well-known risk of venous thromboembolism [blood clots] is
small.'
But the spokesman
adds that it is doctors' responsibility to make sure women understand the
risks.
Despite the
acknowledged deaths, Dr Sarah Branch, of the MHRA's Vigilance and Risk
Management of Medicines Division, says
all contraceptive pills are safe and highly effective: 'The benefits associated
with their use far outweigh their risks.
'These have been recently reviewed at a European level
and no important new evidence has
emerged - the review simply confirmed what we already know, that the risk
associated with all combined hormonal contraceptives is
small.'
Nevertheless, Trudi is determined to reopen the fight: 'It's not just about the money. There may
be thousands of other young girls who have suffered. I don't want any more
of them to have to go through what I did.
'None of us ever had the chance to stand up in court and tell everyone what happened to us. That's what I would love to do.'