(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
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.'