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!