Australian DES Time Line

WHAT HAPPENED IN AUSTRALIA?
1964 - In the wake of the Thalidomide tragedy, the Adverse Drug Reactions unit and Australian Drug Evaluation Committee are established. The Medical Journal of Australia states Australian doctors are aware that care should be taken in prescribing drugs for women.

1971 - Oct 15, information from US arrived in Australia about cancer link to DES (clear cell adenocarcinoma vagina/cervix).

1972 - Sept 9, Therapeutic Goods Administration's (TGA) warning about DES appears in Medical Journal of Australia.

1973 - A national register of DES cancer cases is recommended by TGA committee, but did not eventuate.

1975 - Further warning appears in Adverse Drug Reactions Bulletin (TGA).

Late 1970s - Failure by doctor to report DES cancer in two girls is revealed. At least five children at one children's hospital with likely DES exposure are not investigated. TGA made decision to keep medical profession informed, rather than release statement to lay press. Media release is thought to risk practical problems and public alarm.

1976-1979 A few articles about DES appear in lay press.

1981 - Australia's only DES Clinic established in Melbourne. Its promotion is not mandated. The clinic's listing of patients is purported to be a State Register. Article in Medical Journal of Australia states: A major problem in this country is that there is no recall system which could identify those pregnant women given DES. This Journal alerts doctors of increased risk of unfavourable outcome of pregnancy in DES daughters.

1983 - Reporting of DES cancer cases to TGA is stymied for almost two decades and remains static with only 4 cases. TGA was informed by a doctor that gathering reports by TGA is unnecessary and so TGA complies with this information. Australian media cites 10 cases, sourced from RANZCOG.

1984 - Research shows increased risk of breast cancer in DES mothers.

1995 - DES Action Australia-NSW established and re-named DES Action NSW in 2013.

1997 - Government commissioned report states probably only 1 case of DES cancer in Australia and provides little justification to keep the DES community informed. Available data (AIHW and State Cancer Registries) in 1997 indicates between 25 and 88 cases.

1998 - At request of DES Action Australia-NSW with a government grant, Cancer Council NSW distributes DES information targeting NSW women. Minister for Health & Aged Care states:...a general publicity campaign for DES exposed people to identify themselves would create anxiety without tangible benefit. Cancer Council NSW ceases DES information distribution as the information is "too scary" for women.

2001 - The Strategic Communication Plan for the US Centers for Disease Control's DES National Education Campaign as a model for Australia is ignored by the Minister for Health & Aged Care.

2004 - TGA issues a Bulletin item giving interim advice (until government completion of a review re DES exposure recommendations) that DES daughters follow the same cervical cancer screening as for the unexposed population. This "interim advice" is inadequate for the early detection of DES associated clear cell adenocarcinoma vagina/cervix. A media release was also issued generating publicity with inaccurate information that DES cancer risk had passed. RANZCOG spokeswoman, Dr Margaret Davy states in interview (The World Today-ABC Radio, 28/6/04 12:34) that in Australia, less than 1,000 women all up would have been exposed to DES as miscarriage treatment. She adds that given there are 10-15 cases of clear cell adenocarcinoma of the vagina reported in Australia, DES was not a big problem.  Government correspondence to the DES Action group states promotion of DES information may create community anxiety and refuses to directly inform the public about DES in health promotion programs.

2005 - TGA's Bulletin (which targets medical professionals) reports on screening guidelines for DES daughters. There is no media release issued in relation to this Bulletin item.

2006 - Research shows DES daughters over age 40 have increased risk for developing breast cancer.

2008 - Legal assistance sought by DES Action Australia-NSW, following four years unsuccessful lobbying to have TGA's 2004 media release misinformation addressed. TGA then issues a Safety Alert and media release with the correct information, including 2006 research finding regarding increased breast cancer risk in DES daughters and their need for annual mammography. No media interest transpired. Australian woman wins a legal battle with DES manufacturers in USA.

2010 - By acquiring data of instances of clear cell adenocarcinoma of vagina/cervix from the TGA, Australian Institute of Health & Welfare, and former State Cancer Registries, DES Action Australia-NSW estimated up to year 2010 there are 168,000-740,000 DES mothers, daughters and sons in Australia. Based on average projected cases this figure could rise by 20,000 per year.

2011 - Matter of Government failure to properly inform Australians about DES is relayed to Australian Human Rights Commissioner by DES Action Australia-NSW. The Commission acknowledges the importance of ensuring DES exposed people have full information, but does not have the resources to advocate in the DES matters raised. This year marks 40th Anniversary of the DES cancer link. The US FDA declined to issue an apology for DES, but acknowledged DES exposure as a "tragedy". Yet still, DES information remains buried in Australian Government websites. The majority of the estimated 740,000 DES exposed Australians remain unaware of the danger of DES and the special vital preventive health care they need.

2013 - The Australian Senate responded to questions about the DES exposure issue. Australian Senate However, these questions were not painstakingly answered.

Please view the DES Action USA Key Events at http://www.desaction.org/timeline.htm

DES and Mental Health

There is relatively little research about the effects of DES exposure on mental health. A list of Psychology References can be found at www.cdc.gov/des/hcp/bibliography/bibli_psych.html
DES Action Australia-NSW has received phone calls from DES exposed people experiencing mental health issues, as well as relationship difficulties with family members/partners in regards to DES exposure.

This week we have news of a French study showing DES exposure in utero linked with mental health issues. The study's survey showed significant occurrence of psychiatric disorders in DES exposed offspring in comparison with non-DES exposed siblings.* Some of these disorders included depression, anorexia and schizophrenia. The incidence of attempted suicide and suicide showed another startling result. The researcher involved, Marie-Odile Gobillard-Soyer, will be working further on this study result in collaboration with AFFSSAPS (the equivalent of the Therapeutic Goods Administration in Australia). More information (in English), along with a French TV news clip about this, can be found at http://diethylstilbestrol.co.uk/des-psychological-side-effects-news/

* Further information from the researcher has clarified that the surveyed group of DES exposed offspring also included those exposed in utero to other synthetic hormones, ie, ethinyl oestradiol (oestrogen), synthetic progesterone (often administered in addition to DES). DES represented a third of all in utero hormonal exposures in the surveyed group.

To help with psychological counselling needs, DES Action Australia-NSW has the listed resources of:

Relationships Australia (a national counselling service)
www.relationships.com.au
Phone 1300 364 277 (for details of nearest service)

and

Mothersafe Counselling Service (NSW)
(for exposures during pregnancy)
Phone 0293826539
Toll free 1800 647848

DES and ETHICS

Over many years the Australian Government has been resistive to the public promotion of information about DES exposure, due to concerns that this information might raise anxiety in the community.

Below is a Memo from USA National Institute of Health Association of Bioethics 16/7/85 in response to Creutzfeldt-Jakob Disease (CJD). If you alter the second word to "politicians", then this Memo brilliantly applies to the current political attitudes faced by DES exposed Australians. Read it here:

If physicians in positions of responsibility have knowledge about potentially harmful consequences and do not disclose them, they could be blameworthy in an ethical sense. If one reason that the risk is remote and the chances of unduly alarming the informees is great, therefore, justification exists for withholding that information......then the rejoinder would be, "who are you to decide what will or will not upset me?" The burden of proof in these cases is always on those who argue for non-disclosure, and if you look at the evidence, people normally want to be told of these things. I should say, people in our culture want to be told.

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.

DES Message Spreads

Whenever networking or making representations at various public events about breast cancer, the organisation DES Action Australia-NSW encounters many DES exposed women previously diagnosed with breast cancer. These women report not being previously aware of the link between DES and breast cancer. DES Action Australia-NSW has been able to provide these women information resources covering all aspects of DES exposure health effects.

As a result of liaising with Breast Cancer Network Australia (BCNA), there is pleasing news that the Network now has an item about DES exposure on its website at http://www.bcna.org.au/about-breast-cancer/diethylstilbestrol-and-breast-cancer

Please note: The Australian Government does not officially make any provision for DES mothers and DES daughters over age 40 to receive their recommended annual mammograms at BreastScreen clinics. However, it is possible for DES mothers and DES daughters over age 40 to acquire free annual mammograms at BreastScreen clinics, by writing to their own local Breastscreen Director. (See blog item 17/1/09)