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Distilbène® is the trade name for a synthetic hormone (also known internationally as DES or diethylstilbestrol) prescribed in France between 1950 and 1977 to pregnant women to prevent miscarriages. In 1977, 6 years after the U.S. Food and Drug Administration (FDA) advised physicians to discontinue prescribing diethylstilbestrol to pregnant women because of its link to a rare vaginal cancer, UCB Pharma (the manufacturer of Distilbène® in France) decided to make public that the use of this drug was contra-indicated in pregnant women. It is estimated that 200,000 French mothers have been prescribed DES and have given birth to 160,000 DES exposed daughters and sons. The number of children whose grandmother were given DES during pregnancy (DES 3rd generation) is yet to be assessed.
Even though many French women have suffered from the devastating side effects of Distilbène®, very few have understandably taken their case to court. DES trials are long, complicated, expensive and painful for the DES victims and their families. Battling in court against giant and powerful pharmaceutical companies is not an easy thing to do when you also have to deal with health issues such as cancer and infertility linked to your DES exposure. According to Mrs. Martine Verdier, French lawyer who specializes in DES court cases, only 150 to 170 lawsuits have been initiated by Distilbène®’s victims over the past fifteen years. Until 2009, many DES daughters who had filed lawsuits against UCB Pharma and Novartis who respectively distributed Distilbène® and Stilbestrol-Borne® in France were unsuccessful because they were unable to produce the documents proving that their mum had been prescribed the toxic and carcinogenic drug diethylstilboestrol.
A few landmarks in the French DES legal battle history
First lawsuits against UCB Pharma from French women with genital cancers whose mothers had been prescribed Distilbène® during pregnancy (14 years after Distilbène® stopped being prescribed in France and 20 years after DES stopped being prescribed in the USA).
May 24th – Victory for two DES daughters. After eleven years of court battle, the Tribunal of Nanterre recognizes UCB Pharma’s responsibility in the cancer developed by two DES victims. They are granted 15,244 euros in damages. UCB Pharma makes an appeal against the court decision.
April 30th: The Court of Appeal of Versailles confirms the responsibility of UCB Pharma in the 2002 above cases.
The number of lawsuits increases. However the court decisions remain inconsistent because of the difficulties for victims to prove the link between their cancer and Distilbène®.
December 17th: The Tribunal of Nanterre condemns UCB Pharma to pay 310,000 Euros in damages to the family of a deceased DES victim before the end of the procedure.
December 21st: A women who has developed cancer is unsuccessful in Marseille. The court says she can not prove that her mother was prescribed Distilbène® so no link can be established. Yet her body affected by this rare vaginal cancer called adenocarcinoma, so typical of DES exposure, is the ultimate proof. She appeals.
March 08th – The Court of Cassation confirms the responsibility of UCB Pharma in the Marseille court case.
March 19th – Three women won their cases against UCB Pharma and Novartis, who had requested the cancellation of the court decision during an appeal in a view to request an expertise, arguing that the victims should have provided the original DES prescriptions.
October 13th – The Court of Nanterre condemns UCB Pharma to pay 344,000 euros to the family of a young woman who died of cancer before the end of her trial.
September 24th – Turning point – The Supreme Court reverses the burden of proof, forcing UCB Pharma and Novartis to prove that their product is not responsible for the health issues of the DES victims who are taking their case to court. It is a massive step forward in the history of French DES legal battles since it allows women not to be dismissed when they can’t show proof that diethylstilbestrol have been prescribed to their mum. The Court however, gives victims who can’t show the original drug prescription the opportunity to pursue either Novartis or UCB Pharma and claim for compensation. The pursued laboratory now has to prove that the victims did not take their drug, but the competitor’s. UCB Pharma distributed Distilbène® which was by far the main drug used in France whilst Novartis distributed Stilbestrol-Borne®. So it is expected that the battle between UCB Pharma and Novartis is going to be fierce. Novartis won’t want to share responsibilities and compensations costs when their drug’s sales represented only 2% of the market share compared to 98% for UCB Pharma.
The same year, the Court also condemns UCB Pharma to pay “compensation provisions” of 70,000 Euros to a young disabled girl of 12 and 60,000 Euros to her parents.
June 09th – First victory for DES third generation – The Versailles Court of Appeal confirms the decision of the Court of Nanterre made in April 2009 and recognizes a link between taking Distilbène® and disability in the third generation, giving the grandson of a woman who was prescribed Distilbène® 1.7 million Euros in damages.
I wish the decision of the Court of Appeal of Versailles will encourage other victims to engage in this legal battle but it takes more than courage to file a lawsuit for such a complex and difficult journey against what seems to be a lost battle. I really admire the victims and their families who took their DES cases to court and thank them, as well as their lawyers, for allowing justice to make progress not only for them but for many other victims who may consider going to court in the future.
Distilbène®: 20 Years of Legal Battle is just a quick overview of the main dates in the history of DES French lawsuits. These lawsuits won’t bring back the DES daughters who died from cancer to the families affected by di-ethyl stilbestrol. They won’t repair the long term damages of this toxic drug but if nothing else they show that DES is not something invented by the media, or something that DES exposed individuals, like myself, should feel guilty about. We are victims and we deserve that justice is made.
I am missing important information and this blog post doesn’t highlight enough the pain and suffering the victims and their families had to go through to seek justice and get compensation. If you are considering filing a DES lawsuit make sure you seek expert advice and professional support from your local DES Action group.
Listen to the short radio interview featuring Carol Devine, founder and coordinator of DES Action Australia (NSW), and Dr Jules Black, Queensland Gyneocologist and sexuality expert, about the silence around the DES issue and the difficulties to push for a much needed Australian DES National Public Education Campaign 10 years after the USA first DES national campaign launched in 2001. In Australia it is estimated that 740,000 people have been exposed to DES diethylstilbestrol, yet no such campaign has been held. These people are not receiving proper medical treatment, or making truly informed decisions about their healthcare, as a result.
“Culture of Silence on sex hormone link to cancer“ – Radio Interview about DES featuring Carol Devine and Dr Jules Black, produced by Annamarie Reyes April 05th, 2011.
Below is a short summary and a few quotes from this interesting radio interview from down under:
DES National Public Education Campaigns or the Wall of Silence
The USA has moved to legislate to make it compulsory that a DES National Public Education Campaign is held for DES affected communities. Dr Black explains that the USA acting first on public campaigns came out of increased pressure amongst affected women in the number of millions. In Australia he says “I found constantly with my patients a wall of silence”.
“Since the Food and Drug Administration approved this drug it was important for them to make sure this drug was ok (…). It wasn’t (…). There was a certain degree of cover up fear at first but then when the story came out and due to pressure by female organisations, support groups and so on, they admitted”, comments Dr Black. The FDA acknowledged the DES tragedy 40 years after they issued a warning about the DES cancer link.
The equivalent support group in Australia pushing for change is DES Action Australia (NSW). Carol Devine, the coordinator, explains the strugle to put the issue on the public agenda since the 1970’s when the issue came to light. The USA could not keep it quiet anymore. Too many people were affected by Diethylstilbestrol exposure. The USA went as far as holding a DES National Public Education Campaign in 2001 which led to legislate that research should happen and DES and potential DES affected people should be informed. “Over there”, comments Carol Devine, “there is a fantastic body of women called DES Action USA. They are all right behind making sure these things happen in the USA”. In Australia, Carol Devine sent all the documentation papers about the USA DES National Public Education Campaign to the Australian Federal Health Minister. A few days later she received the package back in her doorstep saying “We do not require these”. “It has been a total shut down on this issue in Australia and quite frankly this is a national disgrace” comments Carol. Advocates in Australia have no choice but take the matters to the Human Rights Commission.
What’s the situation in France and Europe?
In France and in other parts of Europe, the FDA warning issued in 1971 about the health concerns related to Di-ethyl Stilbestrol didn’t get heard and the drug continued to be prescribed to pregnant women until the late 1970’s early 1980’s. The support group Réseau DES France was established in 1994. Their first DES public education campaign was launched in 1997 with the brochure “DES Distilbène® Exposure, the questions you ask yourself” aimed at raising DES awareness amongst the general public. Since 1994 Réseau DES France has engaged in many areas (information, cooperation, advocacy and lobbying, and DES lawsuits to name just a few). They’ve achieved many results and successes such a the right to longer maternity leave for DES pregnancies.
In the United Kingdom, Ireland and the Netherlands support groups have also been created. DES Action UK launched a petition in 2009 to demand a Public Enquiry aimed at investigating the effects of the drug diethylstilboestrol (DES) on women. They collected 130 signatures. “The government statistics are hopelessly out of date and information is not freely or widely made available by the government” write the petition creators Nick de Bois and Barbara Killick.
I can’t stress enough the importance and crucial need for efficient DES National Public Education Campaigns to ensure all people affected by DES exposure are aware of its side effects for them and their children. Collaboration between DES Action groups is also very important. The silence around the DES issue poses health risks in itself as many people including doctors don’t even know what DES is, what the health risks are, and how to prevent them. With so many people affected by it, and so few aware that they have been exposed, it is the responsibility of our governments to raise public awareness of this global health catastrophe.
I wish DES Action Australia (NSW) the very best of luck with their battle for an Australian DES National Public Education Campaign and hope more DES daughters and sons will make their voice heard. We are not alone in this; Millions of people around the world have been exposed to DES so surely if we shout loud enough we will be heard not only by governments but also by fellow DES victims unaware of their DES exposure and its health risks.
Sources: Réseau DES France, DES Action Australia (NSW), DES Action UK
The DES (Diethylstilbestrol) Drug Disaster, 40 Years Later
Below is a guest post from DES Daughter and WONDER DRUG screenwriter Caitlin McCarthy.
The DES Tragedy Is Far From Over
By Caitlin McCarthy
April 22, 2011 marks the 40th anniversary of the DES cancer link being made at Boston’s Massachusetts General Hospital. DES (diethylstilbestrol), a toxic and carcinogenic synthetic estrogen, is considered the world’s first drug disaster. It was prescribed to millions of pregnant women for decades: from 1938 until 1971 (and in a small number of cases for several years thereafter) in the United States; and until the mid-1980s in parts of Latin America, Europe, Australia, and the Third World. The currently proven effects of exposure include a rare vaginal cancer in DES Daughters; greater risk for breast cancer in DES Mothers; possible risk for testicular cancer in DES Sons; abnormal reproductive organs; infertility; high-risk pregnancies; and an increased risk for breast cancer in DES Daughters after age 40. There are a number of other suspected effects, including auto-immune disorders, but many of these effects are still awaiting further research.
I’m a DES Daughter who was born at the tail end of the tragedy in the U.S. My mother was unknowingly prescribed a prenatal vitamin which contained DES. I didn’t discover my DES exposure until 2005, when a doctor made the connection during a colposcopy. How scary is that?
What’s even scarier is that I’m not alone. Around the world, there are thousands – maybe even millions – of people walking around today, totally unaware that they, too, were exposed to DES. All of these people are not receiving proper medical treatment, or making truly informed decisions about their healthcare, as a result.
In an effort to raise awareness about DES, I wrote a feature film screenplay entitled WONDER DRUG. Set in Boston, Massachusetts, WONDER DRUG interweaves the lives of a Big Pharma executive, feminist doctor, and thirtysomething newlywed across different decades. The script has won awards or received nominations in over 20 international film festival screenplay competitions and labs, including selection as an Alfred P. Sloan Foundation script for the prestigious Hamptons Screenwriters Lab, and a live staged reading of select scenes at the 15th Annual Hamptons International Film Festival, sponsored by the Sloan Foundation and starring Steve Guttenberg (THREE MEN AND A BABY) and Alysia Reiner (SIDEWAYS). Acclaimed independent director Tom Gilroy (SPRING FORWARD) has expressed an interest in directing WONDER DRUG. All we need now is financing. (Producers can contact me via my official website: www.caitlinmccarthy.com.)
I also worked jointly with the offices of US Senators John Kerry (D-MA) and Scott Brown (R-MA) on obtaining an apology from the FDA for the DES drug disaster. That effort was first publicized on acclaimed author Elizabeth Searle’s website, and later picked up by renowned media outlets such as The Huffington Post.. (Thank you, Diana Bianchini, for writing the HuffPo piece!).
The FDA declined to apologize, but did send a three-page letter to Senators Kerry and Brown acknowledging DES as a “tragedy” on February 22, 2011. Upon reading the FDA acknowledgement, I immediately emailed Jeanne Ireland (who signed the FDA’s letter), asking the FDA to remove DES from its webpage touting DES as one of its milestones in “100 Years of Promoting and Protecting Women’s Health.” Jeanne Ireland didn’t respond to me. Instead, she palmed me off on Marsha B. Henderson, Associate Commissioner for Women’s Health (Acting) for the FDA. (Check out the communication between Caitlin and Ms. Henderson by reading the post: The FDA is lying by omission).
To this day, the offensive item about DES remains on the FDA’s website. And to this day, not one drug company has ever apologized or accepted responsibility for the DES tragedy. Nevertheless, they have paid millions in verdicts and out-of-court settlements to DES Daughters and Sons who suffered injuries from their exposure.
I am grateful that the 40th anniversary of the DES cancer link has triggered a flurry of press coverage. The Boston Globe recently ran a feature story about concerns for third generation effects; WCVB-TV Boston’s “Chronicle” newsmagazine aired a DES segment; Reuters published an item about DES Grandsons; New England Journal of Medicine ran an article about living with DES exposure; and Psychology Today features a story about remembering DES’s “tragic chapter in American childbirth.” Even the old “Lou Grant” TV episode about DES is making the rounds on Hulu.
On April 25, 1985, Ronald Reagan was the only US President to proclaim a National DES Awareness Week. No other president has ever done that. Why? DES is far from a dead issue.
I will continue my fight to raise awareness about the DES drug disaster. DES victims are the canaries in the coalmine when it comes to synthetic estrogen. The reproductive abnormalities, cancers, and infertility we deal with daily show what could happen to the human race if we don’t employ the precautionary principle. It suggests we act to protect public health when there is credible evidence of harm, rather than wait for absolute proof. What we do now clearly has an impact on future generations. Please join this fight with me.
ABOUT CAITLIN MCCARTHY:
Caitlin McCarthy received her Master of Fine Arts in Creative Writing from Emerson College, which is ranked by U.S. News & World Report as one of the best graduate programs in the country. An award-winning screenwriter at international film festivals and labs, Caitlin has a screenplay project in development: RESISTANCE with Populus Pictures and director Si Wall (SPEED DATE; THE DINNER PARTY). In addition to screenwriting, Caitlin serves as an English teacher at an inner-city public high school. Prior to education, Caitlin worked in public relations, where she fostered relationships with the press and crafted messages for companies that were delivered worldwide.
Diethylstilbestrol (DES) has affected and continues to affect in many different ways the health and lives of those who have been exposed to this drug more than 30, 40, 50 years ago. Cancer, infertility problems, ectopic pregnancies, premature labour, depression, genital abnormalities are just a few of the many delayed side effects of DES exposure; but what most DES victims share in common is that at some point in their lives they all had to face doctors who completely dismissed their DES concerns, doctors who disregarded their medical conditions as being a consequence of diethylstilbestrol.
Despite overwhelming medical evidence, DES continues to be dismissed by doctors
Over 10 million people have been exposed to diethylstilbestrol worldwide between 1938 and the late 70’s, early 80’s in some countries. After more than 40 years of research, there are confirmed health risks and side effects associated with DES exposure.
An entire generation of women have had great problems with infertility and pregnancy. Women and girls as young as nine years old have died from a rare form of vaginal cancer called adenocarcinoma, others have suffered from irreparable genital malformations. Many DES sons have experienced health problems including undescended testicles, epididymal cysts, and testicular cancer. Yet, many doctors dismiss a history of DES exposure as the cause of their patients’ conditions – even for those who were born in the timeframe the drug was prescribed to their mums before a health warning was issued by the U.S. Food and Drug Administration (FDA) in 1971 and even for those who have evidence that they have been exposed before birth to this carcinogen and teratogen.
When Michael Freilick founder of the National DES Sons Network said to his doctor he was a DES son, his doctor replied: “Forget it. It has nothing to do with your testicular cancer.”
When DES daughter Kathy saw her doctor to share her concerns about DES she was told that because she had been conceived a few years after doctors were supposed to stop prescribing DES, she couldn’t have been exposed. Yet her genital abnormality is only seen in DES daughters.
“I hear the struggles, the anger, the depression, the cries of “why me?” echoing from every part of the blogosphere. And these insensitive docs just blithely dismiss it as not a big problem! (…). And then, there are the stories of multiple miscarriages, stillbirths, and so on. Stuff I don’t even want to imagine, but I know is a daily reality to a lot of DES exposed women” writes Kathy in her blog “Women to women childbirth education”.
I recently gave a DES leaflet to my physician hoping it would make her more aware of DES and breast cancer risks for women of my age. She smiled when she read that DES was causing infertility problems. She commented: “Well surely you’ve not been affected by infertility problems with 3 daughters…”.
The lack of recognition of the risks and health issues associated with DES is very distressing for those who have to put up with the consequences of this drug disaster in their everyday lives. This is not only a burden for DES daughters and sons throughout their lives but it poses a health risk in itself due to the consequences of wrong diagnosis, or lack of preventive care which can sometimes lead to disastrous consequences.
Anne-Françoise Lof in her beautifully written book “Saskia or the mourning of a Distilbène baby” tells the sad story of her baby daughter born too early to survive at 22 weeks pregnancy. Anne-Françoise knew her mum had been prescribed Distilbène® during pregnancy, she warned her doctor. Yet, the high risk of premature labor was dismissed. The story of not only Saskia but many other premature babies shows the tragic consequences of some doctors’ misinformation and dismissive attitude towards diethylstilbestrol.
Before the FDA issued a warning that DES was not safe for mums and their unborn babies, many doctors happily prescribed a drug that had not been properly tested and some even continued to prescribe it long after the warning was issued. Others questionned its efficiency and raised their concerns about the possible side effects. Years later, now that many health problems have ruined and continue to ruin the lives of DES exposed individuals very few aware doctors acknowledge the link between diethylstilbestrol exposure and their patients’ conditions.
Many young doctors don’t even know about DES and its consequences. To them it’s something of the past that their predecessors have prescribed in the belief that it would prevent miscarriage, especially if the women had a previous history of miscarriage, bleeding during pregnancy or diabetes. Most DES daughters and sons know more about diethylstilbestrol than their doctors and end up in an awkward situation where they have to educate their doctors in order to get appropriate treatment and preventive care.
DES Aware Doctors List
Most DES Action Groups have compiled a list of doctors aware of the DES history and its devastating consequences. Back in 2001, when I asked DES Action UK if they could provide me with their doctors list they provided me with a list of only four aware doctors, all London based, yet it is estimated that more than 300,000 people have been exposed to diethylstilboestrol in the UK. In the U.S. the doctors list is a compilation of the names of aware doctors given to DES Action USA by its members who were satisfied with their care. These recommended doctors are not considered DES experts, but rather aware doctors who do not dismiss DES concerns. I have no doubt that if DES Action Groups were naming and shaming the doctors who dismiss the DES concerns of their patients the list would be a lot longer.
My DES pregnancy had an happy ending thanks to a fantastic, sensitive and well informed doctor / professor. Without him I wouldn’t be celebrating mother’s day today. So there are aware doctors out there who know how to help DES victims. If you know a sensitive doctor that you would recommend please contact your local DES Action Group and share his / her contact details. It may help others.
If only doctors could understand, be more informed, aware and sensitive to what diethylstilbestrol has done to people’s lives. Di-ethyl stilbestrol is not something of the past. It hasn’t gone away. Years after exposure, the consequences and health risks for DES daughters, sons and their children are still there. The delayed consequences of the drug are felt and will most likely continue to be felt for many years to come as reveal new research carried out to determine the impact on the third generation. DES daughters and sons want answers and recognition. We need, we demand sensitive, aware doctors who acknowledge the danger and continued risks of DES exposure. Is it too much asking? The FDA waited 40 years to acknowledge the DES tragedy. How much longer doctors will need to stop dismissing their patients’ DES concerns?
Sources: Women to women childbirth education, DES Gone but not Forgotten.
The Food and Drug Administration claims historical step with DES diethylstilbestrol
In 1971, the US Food and Drug Administration (FDA) issued a warning that diethylstilbestrol (DES) was unsafe for pregnant women. Exposed in the womb to DES, the daughters developed a rare form of vaginal cancer and suffered from many more DES side effects. The FDA changed the labelling on this hormone to warn women against taking this drug during pregnancy.
40 years later, on February 22nd 2011, the FDA acknowledged the DES “tragedy”.
Caitlin McCarthy, an award winning screenwriter currently working on the issue of DES, emailed Jeanne Ireland who signed the FDA’s letter of apology, asking the FDA to remove DES from its webpage touting DES as one of its milestones in “100 Years of Promoting and Protecting Women’s Health”:
Here’s what the FDA emailed back:
Dear Ms. McCarthy,
Thank you for your email. Please be assured that we acknowledge the tragedy of DES. However, it marks an important historical step when FDA took action to stop the use of DES in pregnancy, and to limit its use. This was a real benefit to the health of women and their children. You will notice other milestones described on our website that detail FDA’s authority in response to major tragedies such as Elixir Sulfanilamide,Thalidomide, and the Dalcon Shield. We do not consider the highlighting of these milestones as accolades, but rather learning milestones for the medical community, the public and the world. They serve to make FDA even more vigorous and proactive in implementing strategies to identify products that may have hidden cancer causing potential or serious long-term health problems. In light of this historical record our description will remain on the FDA/OWH website.
Marsha B. Henderson
Assoc. Commissioner for Women’s Health (Acting)
US Food and Drug Administration
Below is what Caitlin sent Ms. Henderson, along with the two women she copied on her email to her (Terrie Crescenzi and Deborah Kallgren). Note she also included Jeanne Ireland.
You are clearly hoping that the general public thinks a “contraindication for pregnancy” was a “real benefit to the health of women and their children.” Hardly. BANNING the toxic, carcinogenic DES would have been the “real health benefit.” The FDA is lying by omission.
DES should have been banned. There were some doctors in the US who continued to prescribe it after the FDA’s “important historical step,” up until 1980 in some places. And DES continued to be prescribed until the mid-1980s in parts of Latin America, Europe, Australia, and the Third World.
Some advice: When writing to DES victims moving forward, don’t use phrases like “learning milestone.” That is dismissive of the currently proven effects of exposure which include a rare vaginal cancer in DES Daughters; greater risk for breast cancer in DES Mothers; possible risk for testicular cancer in DES Sons; abnormal reproductive organs; infertility; high-risk pregnancies; and an increased risk for breast cancer in DES Daughters after age 40. There are a number of other suspected effects, including auto-immune disorders, but many of these effects are still awaiting further research.
I’ll be sure to share the FDA’s response with others, seeing how you’re sending this canned response out to others who asked the FDA to remove the offensive DES “milestone.”
Thanks for caring about women’s health (not!).
The Food and Drug Administration email is shocking! I was born in France in 1971 where the DES drug continued to be prescribed until 1977 not only to my Mum but to more than 200,000 women … Where are the health benefits of their “action” for the DES mothers, DES daughters and sons born in France and in many other countries after the warning was issued? DES should have been banned.
A big THANK YOU goes to Caitlin for speaking out on behalf of all the DES victims!