Thousands of women could be at risk from 'silent Thalidomide'

A drug intended to prevent miscarriage is blamed for causing cancer in the daughters – and possibly even granddaughters – of women who took it decades ago. By Sarah Morrison and Jaymi McCann

Michelle Cowen and Dominique Albert have both been exposed to DSE (Justin Sutcillfe/Jay Williams)

Tens of thousands of British families are to be asked if they are victims of a drug given to pregnant women which can cause fatal illness in the second, and possibly even third, generations. Some women given the drug in this country have already obtained compensation in America.

Diethylstilboestrol (DES), a drug given to women for 30 years up to 1973, has been found to cause a rare form of vaginal and cervical cancer in some of the daughters of the women who took it, as well as fertility problems. Compensation of an estimated $1.5bn has been paid out in the US. There is even a suspicion that DES – known as the "silent Thalidomide" – can affect the grandchildren of those who took it.

Legal action against the 14 different drug companies that sold and promoted DES from the early 1940s to 1970s is being brought by at least 80 women in the US, who all believe that the synthetic form of oestrogen, given to their mothers in an effort to reduce miscarriages, caused them to develop breast cancer years later. Their lawyer, Aaron Levine, will travel to the UK in two weeks' time to co-ordinate a hunt for the "DES daughters" in this country who have been unable to get compensation in British courts.

The saga surrounding DES, developed in England in 1938, began when it was prescribed to millions of women in the US, Australia and Europe, despite the fact that research published in the American Journal of Obstetrics & Gynecology in 1953 revealed that women receiving it suffered a higher rate of miscarriage. In 1971, the US Food and Drug Administration told doctors to stop prescribing DES when it was discovered that one in 1,000 daughters of women who had taken it developed a rare form of vaginal and cervical cancer, known as clear cell adenocarcinoma (CCAC).

Mr Levine, a Washington DC lawyer who is representing all 80 women in the US, told The Independent on Sunday that the prescription of the controversial drug was "quackery". "It never worked. It was like leeches or bleeding or copper rings," he said. "It didn't do anything positive for anyone, and didn't help anyone's pregnancy. What is striking is that it was banned in 1971 here [in the US], but that it continued to be sold years later in the UK."

The Royal College of Obstetrics and Gynaecology estimates that 7,500 women in the UK were given the drug and 3,500 exposed girls were born between 1940 and 1971, but this is believed by many to be a gross underestimate. Other reports estimate that up to 300,000 people in Britain were exposed, but no source can confirm this figure. Some children will be unaware if their mother took DES during her pregnancy, especially as some of those who took it have since died.

The "children" that do know, most aged between 35 and 65, are not only concerned about their own health, but also that of their children. Research into the effects of DES exposure on the third generation is in early stages, but studies done on rodents suggest the drug can cause DNA changes in women that can be passed from generation to generation. It was not until 1973 that UK doctors were advised against prescribing the drug.

Janet Hall, 61, from Bournemouth, did not find out she had been exposed to DES until her mother died at 32 from lung cancer. At 20, Ms Hall had to undergo surgery to remove a large part of her cervix, she believes as a result of DES exposure. After one miscarriage she had two daughters, but says both are now showing similar symptoms. Her youngest, Hannah, 26, has pre-cancerous cells in her cervix, but she says the NHS refused to let her undergo a check until last year. "I feel guilty for my girls even though I didn't know [about DES] when they were born," Mrs Hall said. "It messes with your mind; it makes you ask why you had to have children."

Dr Julie Palmer, professor of epidemiology at Boston University's school of public health, who is leading a study on the effects of DES exposure in second and third generations, said she does not think we have uncovered all the side effects of this drug. "Women who took it were given very big doses. They often took one pill every day, all the way through their pregnancy – sometimes a week before their due date," she said.

All DES daughters carry a lifelong risk of CCAC and are 40 times more likely to develop it than unexposed women. Most cases have occurred in women in their late teens and early twenties, and it is estimated that at least 25 per cent of those diagnosed died from the illness. But this is only one of a rapidly increasing list of side effects. According to a recent study, led by Dr Robert Hoover at America's National Cancer Institute, breast cancer risk is nearly doubled in DES daughters over the age of 40, with women recording a one-in-25 chance of developing the disease by 55.

Arline MacCormack, 50, from Massachusetts, first heard about DES from her mother when she was 17. She believes that DES prescribed to her mother before she was born caused her to develop breast cancer when she was 44. "The characteristics of my cancer were for women over 60 typically. It wasn't the type of cancer a 44-year-old woman gets," she said. Her case is scheduled for mediation.

Several studies have found increased risks of premature birth, miscarriage and ectopic pregnancy associated with drug exposure, while "DES sons" run a higher risk of genital problems, such as undescended testicles, cysts on the back of the testes and lowered sperm count. The UK brand Apstil is still authorised in the UK, but only for the treatment of prostate cancer and metastatic breast cancer in post-menopausal women.

The first recorded "DES daughter" in Britain, Heather Justice, 59, from Jarrow, was 25 when she found out she had vaginal cancer and would have to undergo a hysterectomy and partial vaginectomy. Although she found records showing her mother had been given DES in the 1950s, she was unable to bring a case to court because she could not identify which manufacturer had produced the drug. After years of fighting the legal system, she says she feels disillusioned.

"One of the problems is that unlike Thalidomide, where you see the problem the minute the baby was born, women who took DES had healthy babies," she says. "Problems were hidden until the teens and twenties, by which point we were forgotten about. When I asked my mum what she had taken, she didn't even remember the name of the stuff. It is a complete and utter minefield."

While an estimated 2,000 cases have been bought against drug companies in America, with Mr Levine securing more than $100m in out-of-court settlements, there are no records of compensation being won in UK courts. Sallie Booth, a solicitor at Irwin Mitchell who spent years looking into DES exposure cases in this country, said: "It is fraught with difficulty in this jurisdiction. People can't remember which brand they took 40-odd years ago and there were over 200 named DES drugs in circulation."

But not all want compensation. For Mrs Hall and many other DES daughters, it has always been about raising awareness for those who were exposed and providing proper testing to reduce chances of getting cancer. They also want the Government to fund scientific studies for the third generation. MP David Blunkett, who bought up the issue when he was shadow Health Secretary 19 years ago, said he "deeply regret[s]" that in the "intervening time those concerned still feel that their concerns have not been addressed or redress provided".

Andy SlaughterMP said that the UK has a "way of burying our mistakes". He added: "People caricature those in the compensation culture as 'ambulance chasers,' but then we have a case like this, where it really is impossible for people to get redress for what is really a horrific injury they have suffered." He added that it might be possible for those affected to sue the NHS directly.

A Department of Health spokesperson said the issue was "complex" and the department has "every sympathy" for those who believe they had been affected. But she added: "With regard to compensation for people who believe they have been adversely affected by this drug, this is a matter for the manufacturer(s) and/or the UK licensees of the drug."

The latest American case is thought to be the first major lawsuit alleging a link between DES and breast cancer in DES daughters over 40. Last week, Judge Marianne Bowler denied a motion by the drug companies to block the first 53 women, exposed to DES more than 40 years ago, from proceeding with their case. Mr Levine said he was confident that if he could find British lawyers willing to take on the case, they would have a good case against companies in the UK.

His American lawsuit alleges that the 14 American drug manufacturers suppressed certain information about DES from doctors and FDA reports that questioned the safety of the drug. The IoS contacted lawyers and representatives from all 14 companies, but they all either refused to comment or denied any causal link between DES and breast cancer. "We believe these claims are without merit and are prepared to defend against them vigorously," said an Eli Lilly spokesperson.

Julie Oliver-Zhang, an attorney working with Mr Levine on the case, said it was just her and him against 25 lawyers on behalf of the drug companies. "It is a David vs Goliath battle in the most basic sense," she said.

Case study: Michelle Cowen, 60, West London

Michelle Cowen found out she had been exposed to DES after suffering a miscarriage and an ectopic pregnancy. Mrs Cowen and her husband have never been able to have children as a result of her misshapen fallopian tubes and uterus. She had an oesophagectomy after a tumour was found in her stomach, which she believes could have been caused by exposure. She said what we know about DES is just the "tip of the iceberg".

"My husband and I tried to have children ever since we got married in 1972; it was a hopeless task. Finding out we couldn't was quite a terrible experience. [DES daughters] want an acknowledgement that something terrible has gone wrong so that drug companies are better regulated. If what I've got now is down to DES, then there will be other people like me.

"I have two friends who both told me they took DES and now their daughters have symptoms, but they haven't told them because they are frightened. These children are in their forties. I know a woman whose mother saw the same gynaecologist as mine. She was exposed, but wasn't told. That is just three people I know. Look at what the Dutch have done: they gave out compensation and set up clinics. It is unbelievable that we are not talking about that in this country."

Case study: Dominique Albert, 40, Bristol

Dominique Albert lives with her husband Dom and her three daughters, aged between three and eight, in Bristol. She discovered that she was exposed to DES when she was 13 years old and found out she had a T-shaped uterus when she miscarried 11 years ago. After being refused surgery by the NHS, she returned to France for surgery.

"It is really tiring to have to educate GPs when they should be the ones telling you they will take care of you. When you have to convince them, it makes you feel paranoid. There needs to be more awareness. It has been a battle for me; DES daughters are at risk of [breast] cancer over 40, yet my GP said I can't have regular breast examinations because I am not 50. It means I'll have to pay for it.

"There are definitely women who don't know their mum even took the drug. That's the main issue in the UK, because they may be infertile or have breast cancer without knowing it is because of DES. My mum really blamed herself, but it will be worse for me. My mum didn't know what it could do when she took it, but when I had my children, I knew there were some concerns for the third generation. I'm sure many women will make that decision. If my daughters get ill, I'll definitely feel guilty, but I don't want to be a victim of it. It can't rule my life."