The FDA is Lying by Omission

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.

US Food and Drug Administration image
US Food and Drug Administration, caring about women’s health (not!)

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.

Sincerely,

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!

My DES Daughter Journey – Doctors

You’ve been exposed to DES in-utero, so what?

When I miscarried in 2001, I rushed to my general practioner (GP) to tell him that I had been exposed to diethylstilbestrol before birth in my mum’s womb. She had been prescribed the Distilbène® throughout her pregnancy. My GP knew very little about prenatal DES exposure and its side effects. I contacted DES Action UK who kindly sent him their leaflets and newsletter. They also provided him with the details of four UK consultants (yes, only four!) who have taken a close interest in DES drugs.

Below are a few quotes from letters of doctors and consultants I saw after I had a hysterosalpingogram in France in 2001.

January 2002:
Dr B., my GP, in a letter to Dr W. says: “This French lady has been informed by her French gynaecologist that her uterine cavity is too small and irregular. Also, her fallopian tubes did not show on a hysterosalpingograph (…) she was told she requires a hysteroscopy and laparoscopy.

February 2002:
Reply from Dr W.’s Appointments Office: “Mr W. has a waiting list of approximately 20 weeks whilst we are making every effort to shorten his list we are not at this time able to allocate you a firm appointment date”.

Response dated February 2002 from Dr M. to a letter I sent him to ask for his advice in January of the same year: “I read with interest your letter and the details of your investigations in France. This certainly raises the possibility that you have an abnormally shaped womb. Such abnormalities do occur sporadically but there is an increased risk in someone who has been exposed to DES (…) This condition is in no way dangerous to your health. (…) It is possible that this abnormality contributed to your recent miscarriage but it is equally possible that the problem was related to some developmental disturbance in the pregnancy itself which is a far more common cause of miscarriage. (…) Before advising any treatment for this suspected abnormality I think we would need much more concrete evidence that it is contributing to miscarriage”.

Dr M. continues: “There are two ways to approach this, either we could be pragmatic and advise you to try for another pregnancy (…) alternatively, if you have further miscarriage we could investigate further (…) You are right that it is highly unlikely that you will receive treatment on the NHS for many months”.

March 2002:
So I applied to the Department of Health for an E112 for investigations to be carried out in France. My application was denied: “With regret, I am unable to approve your application. Approval for an E112 is normally given only in situations where, for clinical reasons, the local health service provider is unable to provide the patient care required (…) I was unable to established that although DES may perhaps be more commonly investigated in France, it is entirely appropriate for the procedures and care required for your case to be provided by our local health services”.

So basically, I had to wait for an appointment with Dr W., try for another baby and see what happens!!!! You’ve been exposed to DES, so what? Doctors needed more evidence that it was contributing to miscarriage. How could I try again for a baby with such a worrying result from the hysterosalpingogram? I arranged for a hysteroscopy and laparoscopy to be carried out later (September 2002) in France.

July 2002:
Dr W.’s Appointments Office: “Further to our phone conversation today, I am writing to confirm the private appointment for you to see Mr W. on Thursday 4th July at the Bristol Nuffield Hospital. The cost of your appointment will be £160”.

I was pleased to see you for your consultation at the Bristol Nuffield Hospital last week (…) I would suggest you telephone the fertility clinic at Southmead in the near future to arrange a follow up appointment with me after you will have had your laparoscopy and hysteroscopy operation with Professor Frydman.” comments Mr W.

In a letter Dr W. wrote to my GP: “Mrs A. was understandably concerned about the result of her hysterosalpingogram (HSG) and the suggestion that she might have bilateral tubal blockage. She was also concerned about the possible risks of a further miscarriage as a result of her DES exposure in-utero (…) I am not convinced that the HSG show a true tubal occlusion (…) The cavity of the uterus appears normal, apart from being rather excessively distented in the later stages of her HSG examination (…) Although there is no doubt that in-utero exposure to DES increases risk of miscarriage and the risk of premature delivery, the vast majority of women in this situation do have successful pregnancies. The risks are higher if there is any structural abnormality of the shape of the uterine cavity and this does not seem to be the case from Mrs A.’s hysterosalpingogram”.

September 2002:
A hysteroscopy and laparoscopy performed by Pr. Frydman in France confirmed a uterine malformation, a T-shape uterus with a septate which was removed by surgery during the examination.

October 2002:
Dr W. comments: “I understand that her laparoscopy showed a normal pelvis with patent fallopian tubes. Her hysteroscopy demonstrated a 3cm-long septum which has been partially resected with a Versapoint”.

I returned to France to see Dr T. for a follow-up appointment. She confirmed: “The hysteroscopy and laparoscopy show a typical DES uterus. However the uterine cavity is acceptable thanks to the fact that the septum has been resected.

Dr T. explained that even though the uterine cavity was large enough to envisage a pregnancy there was a high risk of premature labour.

September 2003:
2 years after I miscarried, I gave birth to a beautiful baby girl, thanks to Pr. Frydman.

My DES Daughter Journey – Introduction

My DES journey started with a miscarriage. When I started bleeding after 11 weeks of pregnancy,  I vaguely remembered what my mum told me when I was a teenage girl about the DES drug she had been prescribed when she was pregnant which may prevent me from having normal pregnancies or even worst from knowing the joy of being a mum. When I miscarried,  this information kept somewhere in the back of my mind came back at once.

Being diagnosed DES daughter meant I would most likely never be able to experience the joys of pregnancy and motherhood. I may never give a daughter or son to my husband; grandchildren to my parents and in-laws. Additionally, I may be under higher risks of developing other health problems such as cancer. I was promised to live the rest of my live with fear, stress, anxiety and guilt to name just a few of the many emotions that went trough my mind the day I was first called .

Making UK doctors and consultants accept to further investigate the reason why I miscarried considering my DES exposure was a lost battle. I was told that it was highly unlikely that I would be able to receive treatment on the NHS (National Health Service) for many months; I should be pragmatic and try for another baby. Since I knew I had been DES exposed, I couldn’t possibly take the risk and put myself through this pain again.

So I returned to France to have first a hysterosalpingography (an infertility test that shows whether both fallopian tubes are open and whether the shape of the uterine cavity is normal) and then an hysteroscopy and laparoscopy (procedure that allows a surgeon to examine the fallopian tubes, ovaries and womb to diagnose and treat a condition). I was very lucky to have both examinations performed by eminent specialists aware of the consequences of DES exposure. The results confirmed a septate and T-shape uterus – uterine malformation typical of daughters whom mothers had been prescribed diethylstilbestrol during their pregnancy.

My womb was like two tiny rooms with a wall in between. No baby would have enough room to grow if the septum was not removed to make a proper home for him to develop and spend 9 months of his life. Professor René Frydman who performed the operation removed the septum and changed my uterus to a room big enough for a baby to develop even though there would still be a high risk of complications and miscarriage due to its shape and other DES related injuries.

Pr. Frydman, obstetrician-gyneacologist and head of the “Male-Couple-Embryo-Children Hospital“, gave birth in 1982 in Clamart to the first French test-tube baby, Amandine, less than four years after the birth of the world’s first baby conceived by IVF, Louise Brown in July 25, 1978 in Great Britain.

When I returned to the UK with the green light to try again for a baby, the battle intensified with health care providers to make them accept to monitor my DES pregnancy and treat me like any DES daughter should be treated.

So I desperately turned to DES Action UK and Réseau DES France for help and support. This is when my DES journey as a DES daughter really started, even though my mum had warned me when I was just a teenage girl about this wonder drug and its consequences. All her fears and what I thought was just paranoia from a loving and caring DES mother were justified. There was no more doubt. I was, I am a DES daughter.

The journey started with a miscarriage and an operation. Now my DES journey is taking a new start with my Journal of a DES Daughter Blog and Diethylstilbestrol facebook page. In between, many tears, fears, many hopes, successes, and three beautiful daughters… The journey continues as concerns for my daughters (DES third generation) arise…