FDA Turns a Blind Eye

The US Food & Drug Administration acknowledged the DES tragedy on February 22, 2011. However, it seems only part of the tragedy has been acknowledged.
This is evidence by http://www.fda.gov/ForConsumers/ByAudience/ForWomen/ucm118458.htm where DES is touted as a milestone in the FDA's "100 Years of Protecting and Promoting Women's Health". On this website, the FDA further extolls its action in changing the labeling on this hormone to warn women against taking this drug during pregnancy. The FDA has turned a blind eye to the continued usage of DES in pregnancy beyond 1971 -which could have been stopped had DES been banned.

DES Action Australia-NSW made a request to the FDA for the removal of the 1971 entry re DES on this website and received the following:

....."Please be assured that we acknowledge the tragedy of DES. However, it marks an important historical step when the 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.".....

In response, DES Action Australia-NSW has written:
"Thank you for your email below explaining the FDA's rationale for the inclusion of DES on the website (http://www.fda.gov/ForConsumers/ByAudience/ForWomen/ucm118458.htm), titled "100 Years of Protecting and Promoting Women's Health".

I wish to inform you that the FDA is seriously mistaken with this rationale due to the following:
As the FDA did not ban DES, the usage of DES during pregnancy did NOT stop, and therefore there could only be very limited benefit to the health of women and their children. Our organisation is aware that DES usage in pregnancy continued in many countries after 1971 and this a stated fact at http://www.cdc.gov/des/hcp/pharmacology/index.html
We know its usage peaked in France in 1976 and our organisation has received reports of DES usage in Australia in the mid 1980s. We have also received reports of its continued usage in India (1975), Germany (1973), Poland (1991), Pakistan (late 1990s, and Bangladesh (late 1990s). A 1992 Symposium held in Sweden raised concerns that DES might still be given to pregnant women in many parts of the world, including East and Central Europe, Africa, Asia and Latin America and there were requested measures for a ban. Unfortunately this did not eventuate and concerns are still held for ongoing usage. Consequently, this listing of DES by the FDA bears no resemblance whatsoever to a "learning milestone", but is instead, deceptive and gravely misleading by its omission of information about its continued usage in pregnancy for the medical community. In addition to the issue of continued usage, there is the known fact of the tardiness by the FDA in issuing warnings about the danger of DES and the numerous missed opportunities to review its safety.

As the public becomes increasingly aware of the above situation, the FDA is open for ridicule with the inclusion of DES on this webpage - now more than ever, in the 40th Anniversary of the cancer link to DES. In view of the above information, it would be more fitting for the listing of DES on an FDA website titled "40 Plus Years of Abysmal Failure in Women's Health".

Aside from the factual flaws in the FDA's rationale in this matter, there is the matter of this DES item causing offense to the DES community. Regardless of whether the FDA considers this listing to be "a learning milestone"for the medical community, for those exposed to DES, this listing under the title which strongly touts "protecting and promoting women's health", is in extremely bad taste and is dismissive of the catastrophic health effects of DES on the 5-10 million DES exposed people in USA and millions of DES exposed worldwide, including in Australia.

In view of the above, we ask again for the removal of the 1971 entry re DES at http;//www.fda.gov/ForConsumers/ByAudience/ForWomen/ucm118458.htm as it does not represent protection and promotion of women's health in any respect and is offensive to the DES exposed population."

The part of the DES tragedy involving the continued usage of DES in pregnancy beyond 1971 is outrageous and shocking. DES Action Australia-NSW has even received a report where a DES daughter in Sydney, 1977, was keenly offered DES for her threatened miscarriage by a General Practitioner. Luckily for this DES daughter, she had previously chanced upon information about the danger of DES and refused the doctor's treatment.

The recent acknowledgment of the DES tragedy by the FDA is clearly not enough. Efforts should continue towards an official apology by the FDA, which details the FULL extent of the DES tragedy.