Healthy Skepticism Library item: 5656

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Publication type: report

Devine C
Report by DES Action Australia-NSW to the World Health Organisation
Thornleigh NSW: DES Action Australia-NSW 2006 Jul 22

Notes:

REPORT BY DES ACTION AUSTRALIA-NSW
TO WORLD HEALTH ORGANISATION 22nd July 2006

Background
Diethylstilboestrol (DES) is a synthetic oestrogen that was developed to supplement a woman’s natural oestrogen production. It was first prescribed in 1938 for women experiencing miscarriages or premature deliveries and was originally considered effective and safe. In 1971 physicians were advised to stop prescribing DES to pregnant women because it was linked to a rare vaginal/cervical cancer in female offspring. Since 1971 research has shown:
· Women prescribed DES while pregnant, known as DES mothers, are at a modestly increased risk for breast cancer.
· Women exposed to DES before birth (in the womb), known as DES daughters, are at an increased risk for clear cell adenocarcinoma (CCA) of the vagina and cervix, reproductive tract structural differences, pregnancy complications and infertility. The risk for developing this cancer is approximately 1:1,000 DES daughters. Although DES daughters appear to be at highest risk for clear cell cancer in their teens and early 20s, cases have been reported in the 30-50 age groups. This cancer is aggressive and should be detected early.
· Men exposed to DES before birth (in the womb), known as DES sons, are at risk for non-cancerous epididymal cysts.
There is specific preventive health care for DES exposure. (See www.cdc.gov/des ) The cancer risk to DES daughters has not passed, with cases now occurring in the 40s and 50s age groups. (See http://obgyn.bsd.uchicago.edu/registry.html#accessions) Researchers are still following the health of the DES exposed population to determine whether other health problems occur with age. There may be many people who do not know they were exposed to DES and some women may not remember taking DES. DES information is important because people who were exposed must be vigilant about their own health care – to catch cancers early, demand high risk obstetric care when pregnant and factor in their exposure when making decisions about HRT use. It is as much part of a person’s medical history as a family history toward heart disease or diabetes.

Extent of antenatal DES usage
Never patented, DES was marketed under more than 200 brand names and was prescribed to pregnant women in many countries of the world, including USA (estimated 5-10 million DES exposed*), Canada (estimated 400,000-800,000 DES exposed*), UK (estimated 20,000 DES exposed*), France (estimated 400,000 DES exposed*), Australia (estimated 60,000 DES exposed*), The Netherlands (estimated 440,000 DES exposed*), Czechoslovakia (estimated 126,000 DES exposed*), Ireland, Belgium, Germany, Italy and Spain. Countries of possible usage are Finland, Norway, Portugal and Switzerland. DES was still prescribed to women outside the United States after 1971.

• Figure includes women and offspring.

Current antenatal DES usage
As recently as 1993 there were concerns that DES may still be given to pregnant women in East and Central Europe, Africa, Asia and Latin America.

Government Actions to Alert the Public
Very few governments with populations affected have conducted any vigorous campaigns to inform and educate their respective populations about DES exposure and many do not have systematic cancer registries. Some DES Action consumer support groups have made progress through lobbying and developing partnerships with their respective governments.

The most recent and successful partnership model has been that of the consumer group DES Action USA with the US Centers for Disease Control in 2003, whereby the DES Update campaign was launched. The campaign plan involved the production of the documents Draft Strategic Communication Plan of the DES Update and DES National Educational Campaign: Findings from Formative Research, November 29, 2000. An elaborate and comprehensive manual titled 2003 Centers for Disease Control DES Update: For you, your family and health care provider was distributed to both consumers and health care providers throughout USA. The CDC DES Update campaign was a multi-million dollar project, also involving the establishment of the website www.cdc.gov/des, teleconferences, press releases and television and radio announcements across USA. The campaign included the resource for individuals who are unsure of their exposure status. These individuals could access additional information and resources about DES, including an online version of CDC’s DES Update Self-Assessment Guide to help them assess the likelihood of their exposure to DES.

In the Draft Strategic Communication Plan of the DES Update campaign it is stated:
Our mission is to help DES exposed mothers, daughters and sons have access to the latest information about DES and its effects. We want to increase the number of people who know they were DES exposed, and yet, it is unfair – and unethical – to unduly raise fears and concerns among the general public without accompanying efficacy. For this reason, we must focus our campaign efforts on targeted groups of people – the known-exposed populations, women in times of transition, and health care providers.
Women in times of transition are stated to include those seeking information about breast and cervical cancers.

Australian Background
The Australian Drug Evaluation Committee issued statements in 1972 in the Medical Journal of Australia (Med J. Aust.,Sept 9 1972. 2:622) and in 1975 in the Adverse Drug Reactions Bulletin (No:5, April 1, 1975) drawing the attention of medical professionals to the association of DES and the development of clear cell adenocarcinoma of the vagina in female offspring in adolescence and young adult life. In May 2003 the own journal of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, (O

& G, Vol. 15, No.2, May 2003, DES ‘daughters’ – there is no ‘safe period’ for clear cell adenocarcinoma) published an article informing doctors that there is no safe period for the development of clear cell adenocarcinoma of the vagina/cervix in DES daughters. In June 2004 a one-way cross check was conducted by the Australian government with the International Clear Cell Cancer Registry held in Chicago USA, showing a significant increase in the figure of known Australian cases from 7 to 15 cases. The government has recognised concerns about failure by doctors to report DES associated cancer to the Adverse Drug Reactions Unit. With the known 1:1,000 risk of DES daughters developing the associated cancer, this means there are conservatively at least 15,000 DES daughters, the equivalent number of DES sons and 30,000 DES mothers, thus totaling at least 60,000 Australians affected. There has been no complete reciprocal cross-check of Australian cases that have been reported to the International Registry. So far there is refusal by government to conduct regular reciprocal cross-checks with the International Registry. There are also approximately 129 cases of the cancer type associated with DES in data held by the Australian Institute of Health and Welfare for which DES exposure has not been investigated.

Australian Government Action to Alert the Public
To date there has been no concerted campaign to inform and educate the Australian population about DES. Up until 2004, there had only been small intermittent media coverage (not initiated by Government) informing the Australian public about the cancer risk with DES and the reproductive health effects caused by DES. The Therapeutic Goods Administration’s (TGA) media release about DES in June 2004 (http://www.tga.gov.au/media/2004/040609_des.htm ) was the first media release by the Government to inform the public about DES and its effects and required health care and this received nation-wide coverage. This media release followed a TGA Bulletin item about DES targeting doctors (http://www.tga.gov.au/adr/aadrb/aadr0406.htm#1) and contained information about the recommended health care for DES daughters and their ongoing cancer risks that is unsupported by available medical research evidence. Available medical research indicates that the advice given regarding DES daughters in the media release (the national cervical screening recommendation of Pap smear) does not always detect the aggressive type of cancer caused by DES. It is well-known in DES literature that DES daughters require annual DES examinations to prevent clear cell adenocarcinoma of the vagina/cervix. This media release also indicated that the cancer risk to DES daughters has passed. However, available medical research shows that there is no known upper age limit on the development of DES associated cancer, with cases recently appearing in the 40s and 50s age groups. (See http://obgyn.bsd.uchicago.edu/registry.html#accessions) Information readily available in Australia prior to June 2004 is as follows:
· The Royal Australian and New Zealand College of Obstetricians and Gynaecologists’ own journal O&G Vol 5 No2 May 2003 (www.ranzcog.edu.au/publications/o-g_pdfs/OG-2000-2003/OG-May-2003.pdf )

· The Medical Journal of Australia, October 13, 1984 The DES Story by Professor Malcolm Coppleson, Head, Gynaecological Unit, King George V Memorial Hospital, Sydney.
· The NHMRC guidelines issued in 2005 has a reference dated year 2000 regarding the special care of annual pelvic examination for DES daughters [Hacker NF. Vaginal carcinoma. In:Berek JS, Hacker NF eds. Practical Gynaecologic Oncology. 3rd ed. Philadelphia. Lippincott Williams and Wilkins. 2000. Ch 14. p605].
· The annual DES examination has been described on the NSW Health website www.health.nsw.gov.au/des since May 2003 and the US Centers for Disease Control website www.cdc.gov/des since 2003.
· The American College of Obstetricians and Gynaecologists agreed on 31st July 2003 that annual screenings are vital for DES daughters (see www.acog.org/from_home/publications/press_releases/nr07-31-03-1.cfm)
· The American College of Obstetricians and Gynaecologists agreed on 31st July 2003 that annual screenings are vital for DES daughters (see www.acog.org/from_home/publications/press_releases/nr07-31-03-1.cfm)
· On 18th March 2003 Health Canada released a Health Professional Advisory Advisory on diethylstilboestrol (DES) and the risk of genital and obstetrical complications (http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/2003/des_hpc-cps_e.html) in which the annual pelvic examination is outlined under the heading of Systematic monitoring of women exposed in utero to DES.

In October 2005, the TGA published a Bulletin item targeting doctors with information advising the annual DES examination for DES daughters. (See http://www.tga.gov.au/adr/aadrb/aadr0510.htm#3), but did not issue a media release to alert the population of the change in advice.

Concerns regarding the TGA’s June 2004 media release and the disparity by not issuing a further media release are aggravated by the following factors:
(1) There would be women who do not yet know of their in utero DES exposure and also doctors, who for practical reasons, cannot be expected to identify the DES exposed population.
(2)There would be women who are aware of their DES exposure, but still unaware of their special health needs and so would not place importance on informing their doctors about their DES exposure.

The TGA has stated the June 2004 media release was appropriate because prior to the media release there was no national agreement or any national guidelines for the care of DES daughters. The Minister for Health and Ageing, The Hon Tony Abbott has stated that a further media release to inform the public of the Government’s changed position regarding health advice for DES daughters is not warranted.

In Australia’s National Cervical Screening Program there are Registries held in each State and Territory which provide back-up reminders to women for routine screening and follow-up of abnormal smears. (http://www.cervicalscreen.health.gov.au/papsmear/register.html)
One of the program objectives is to ensure that screening services are available to women with special needs, including Aboriginal and Torres Strait Islander women, women from non-English speaking backgrounds, and women living in rural and remote areas, and that those services are consistent with their respective needs. (http://www.csp.nsw.gov.au/publications/stratapp.html) The National Cervical Screening Program is part of the Australian Population Health Division’s Program with a performance indicator to provide effective screening in accordance with a sound evidence base and with responsiveness to new and emerging trends. (http://www.health.gov.au/internet/wcms/publishing.nsf/Content/0DD30D5FD34AB664CA2570F70080F345/$File/outcome1.pdf)

The organisation DES Action Australia-NSW has requested the Australian Screening Advisory Committee’s consideration of including DES information in Cervical Screening reminder letters and the provision of DES information at breast screening clinics. A comprehensive package of US CDC DES Update information, including its strategic communication plan and formative research findings was forwarded in support of this request. The benefit of the CDC DES Update campaign strategy in targeting women in times of transition was emphasised. The instance was explained where DES daughters, unknowing of the fact of their DES exposure and following the national cervical screening recommendation, would be at risk of clear cell adenocarcinoma of the vagina/cervix not being detected early. The advice from the Australian Chief Medical Officer has been that the needs of DES exposed women are beyond the scope of the National Cervical Screening Program.

It is highly impractical for doctors to be responsible for identifying DES exposed individuals and it is the right of Australian people to know the possibility of having been DES exposed and to know the risks and specific preventive health measures involved. In consideration of the details provided in this report, the resistance by Australian government and medical authorities to make reasonable efforts to inform and educate the Australian population on DES exposure and the associated accurate and of necessity ongoing preventive health measures can not be justified.

As a DES daughter, and having had experienced pregnancy complications as a result of DES, I founded DES Action Australia-NSW in 1995 and have since acted as coordinator, fielding over 1300 enquiries from people wanting information about DES. A core membership of 80 people communicates regularly and wants to know the latest details of ongoing management in relation to DES. From 1995 until the TGA’s media release in June 2004, DES Action Australia-NSW sent frequent correspondence to State and Federal health authorities seeking action in raising public awareness of DES and for a period of time, lobbied the Federal government for the establishment of a DES Registry. In 1999, the then Federal Minister for Health and Ageing, Dr Michael
Wooldridge stated that a campaign to raise public awareness of DES would create community anxiety without any tangible benefit. In 2003 some States placed information about DES on their respective health department websites, but without any public promotion advertising these websites.

In response to the TGA’s June 2004 media release, DES Action Australia-NSW frequently informed State and Federal health authorities and politicians about the already known preventive care for DES daughters, highlighting the disparity where there has been no media release to inform the public about DES following the TGA’s Bulletin item targeting doctors in October 2005 and requested that a further media release be issued. In much correspondence in relation to DES spanning 11 years to the relevant authorities, State and Federal Health Ministers and Departmental Heads have neither been helpful nor sympathetic and even the Prime Minister has forwarded our matters back to the Federal Health Minister. Every reasonable effort has been made and all avenues have been exhausted merely to seek parity with the US health authorities in their enlightened management of their own patient cohort which differs only from that in our own developed western nation in terms of scale and population.

As coordinator of DES Action Australia-NSW I am seeking the World Health Organisation’s action as an intermediary between DES Action and the Australian Department of Health and Ageing. With open public debate there may be policy solutions towards ensuring that Australians are made aware of DES exposure and its associated effects and correct advice, thus improving the health outcomes of those exposed to DES.

Carol Devine
Co-ordinator
DES Action Australia-NSW
14 Edmundson Close
Thornleigh NSW 2120
Australia
Ph:02 98754820
Email: c_devine@bigpond.net.au
DES Action Australia-NSW is a non-government, not-for-profit support group for those affected by DES and is an affiliate of DES Action USA (International nongovernmental organisation)

INFORMATION SOURCES

www.cdc.gov/des

Website of DES Action USA http://www.desaction.org/
www.web.ca/~desact/anglais/anglais.html

UK Royal College of Obstetricians and Gynaecologists RCOG Statement No.2, April 2002.

Australian Adverse Drug Reactions Bulletin Vol. 23, No.3, June 2004

www.des-france.org/presse/presse_dates.asp

www.descentrum.nl

DES: A Drug with Consequences for Current Health Policy (Symposium, September 1990, Dublin Ireland, funded by Europe Against Cancer Programme and the Dutch foundation Fundraising Actions for Public Health).

Effects of diethylstilboestrol (DES) medication during pregnancy: report from a symposium at the 10th International Congress of ISPOG. J Psychosom. Obstet. Gynaecol. 14 (1993) 71-89.

www.health.nsw.gov.au/des

Adverse Drug Reactions Advisory Committee Minutes 1971-2003.

Australian Drug Evaluation Committee Minutes 1967-1981.

CORRESPONDENCE COPIES PROVIDED

Letter from Dr Kerri Mackay, A/g Director, Adverse Drug Reactions Unit, Therapeutic Goods Administration, 1 May 2006

Letter from Perry Sperling, Senior Advisor, Office of the Prime Minister, 24 March 2006

Letter from The Hon Christopher Pyne MP, Parliamentary Secretary to the Minister for Health and Ageing, 9 June 2006

Letter to Professor John Horvath, Chief Medical Officer, Department of Health and Ageing, 13 January 2006

Letter from Professor John Horvath AO, Chief Medical Officer, Department of Health and Ageing, 11 April 2006

Letter from Dr Michael Wooldridge, former Minister for Health and Aged Care, 12 October 1999