Blunders never cease

In meeting minutes of the Australian Drug Reactions Advisory Committee and the Australian Drug Evaluation Committee acquired by DES Action Australia-NSW, the slowness to act on the DES exposure problem and the reluctance to alert the public are obvious. News of the cancer link to DES was received on 15^th October 1971. It was not until 9^th September 1972 that a warning was placed in the Medical Journal of Australia. In the late 1970s the Drug Evaluation Committee considered that there would be practical problems and panic and alarm created if a statement were to be released to the lay press. It was considered more appropriate to heighten awareness of the medical profession, so they can be more alert if young women present with vaginal bleeding.

Comment:

We know that the DES associated cancer type is aggressive and can be symptomless. We know that waiting for DES daughters to present themselves with vaginal bleeding may be too late. We now find, nearly four decades later, that the great majority of DES exposed enquirers to DES Action Australia-NSW have never been identified as DES exposed by the medical profession. Today there is every possibility there are thousands of Australians oblivious to the fact of having been DES exposed, suffering without knowing why and without knowing their vital preventive health care.

Government activities in DES exposure management have usually taken the form of blunders:

• A 1997 commissioned report by NSW Cancer Council Cancer Control Information Centre to review world data stated: There do not appear to be any reports in scientific literature of cases of CCAC associated with DES exposure in utero in Australia. This report, even in the early stages of the evolution of this problem, would suggest that the Australian experience is closer to 1 case than 24 cases.

In conclusion this report stated that investigations to increase the accuracy of data would not likely alter the advice that there is little justification for specific action aimed at reducing the cancer risk associated with past use of DES in pregnancy.

Comment:

Prior to 1997 there had been several cases of DES associated cancer reported by media. In 1997 the Drug Reactions Advisory Committee held data of 4 cases; the International DES Registry (Chicago USA) held data of 7 Australian cases; and the Institute of Health and Welfare held general population data of 88 cases of the cancer type associated with DES, of which 25 cases were aged less than 50 years. To claim that there is no justification for activities to reduce DES associated cancer is also to claim that Australians have no rights in knowing the possibility of having been DES exposed. In startling contrast, in 2001 the US Centers for Disease Control launched a multi-million dollar DES education campaign for the US public and health care providers [ www.cdc.gov/des].

• In 1998 the Cancer Council NSW made the decision to cease distribution of brochures and posters about DES to centres targeting women throughout NSW.

Comment:

This decision followed a statement by the then Federal Health Minister, Dr Michael Wooldridge, that the health benefits of setting up a National Register for those affected by DES would be doubtful and may unduly alarm women who may not have taken DES. The Council then considered the brochures to be "too scary" and stated difficulty in dealing with women who couldn't remember if DES was taken. Since 1995 DES Action Australia-NSW has assisted hundreds of enquirers, including those unable to remember if DES was taken. As part of the comprehensive 2001 DES Education Campaign in US, an interactive self-assessment guide was designed to assist people in assessing whether or not they have been DES exposed. [www.cdc.gov/des/consumers/guide/index.html]

• In June 2004 the Therapeutic Goods Administration issued a bulletin item and media release stating that the cancer risk had passed for DES daughters and that they only needed to follow the current national cervical and breast screening recommendations.

Comment:

We know that there is no known upper age for the development of DES associated cancer and that DES daughters require life-long specific screening. The life-long risk had been highlighted in the article "DES daughters: there is no safe period for clear cell adenocarcinoma", Royal Australian & New Zealand College of Obstetricians & Gynaecologists O&G Magazine Vol 5 No 2 Winter 2003.
[www.ranzcog.edu.au/publications/o-g_pdfs/OG-2000-2003/OG-Contents-May-2003.pdf]

In similar vein as the Therapeutic Goods Administration, the UK Royal College of Obstetricians and Gynaecologists recently published in RCOG news [2009 Vol 16 Issue 2] that DES daughters without detected abnormalities in an initial colposcopic examination only require routine cervical screening.

• In 2003 the draft version of Screening to Prevent Cervical Cancer: Guidelines for the Management of Asymptomatic Women with Screen Detected Abnormalities stated that the decision to screen DES daughters will be determined by the level of anxiety the woman usually tolerates about herself, and no firm recommendation can be made.

Comment:

Besides considering this statement to be open for ridicule by the health profession, we consider it potentially dangerous for the following reasons:

• Guidelines should be based on medical best practice, not on the patient’s level of anxiety.
• Medical doctors are not expert in determining the level of anxiety in a patient, nor do they have a way to screen/measure anxiety.
• The patient may be anxious for other reasons.
• The statement unethically suggests that medical doctors make a decision for which they are not qualified and one which could deny the patient screening that could be life-saving.

All too consistent to be coincidental, these management blunders point dangerously towards damage control in favour of pharmaceutical companies. In spite of all available research evidence and recommendations for specific health care, these management activities show great urge to maintain unawareness of DES and to mainstream the DES exposed population to general population health protocols. Already without outward physical signs of exposure, if mainstreamed, DES exposed people will be become even more “invisible” in the health system, whilst having their health seriously jeopardised.

For our DES Action group, it is important to always keep our ear to the ground, not only for new research developments about DES, but also for any new government activities concerning DES exposure. All of the above matters regarding management have been or are currently being addressed by DES Action Australia-NSW. The continued financial support by members to help us continue our work in ensuring our just and rightful health care is always appreciated.

INSIDE OUR DRUG WATCHDOG

Since 1971 DES exposed Australians have borne the brunt of the negative consequences of failures to report the side effect cancer due to DES. Without having these failures to report cases, it would enable a more accurate estimation of the magnitude of the Australian DES problem and hence, greater validity and recognition to the DES issue.

From 1983 to 2001 the number of DES associated cancer cases held in data by our drug watchdog, the Therapeutic Goods Administration (TGA) strangely remained static at 4 cases, whilst the figures elsewhere in the world were on a slow rise. Media reports during this period consistently cited 10 cases, sourced from the Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

The TGA’s Drug Safety and Evaluation Branch explanation for the static figure of 4 cases (letter 29/3/01) to DES Action Australia-NSW was that “1983 was the end of the period” for identifying cases. It was explained that specialist centres within Australia were maintaining registers and that these centres chose not to report to the Adverse Drug Reactions Advisory Committee (ADRAC). Adverse Drug Reaction Unit correspondence (31/5/01) explains the ADRAC received a phone call by an un-named doctor stating specialist clinics had been set up and that reporting to the ADRAC was not seen as necessary.

In fact, there were NO such specialist centres within Australia maintaining registers. The number of women diagnosed from 1983-2001 who would otherwise have been reported, remains a mystery.

Minutes of the Australian Drug Evaluation Committee acquired by DES Action Australia-NSW reveal the following:

• One doctor on the committee had two patients with DES associated cancer, neither of which were reported and one of whom died.

• The Congenital Abnormality Sub Committee believed there were 4 or 5 cases of the cancer type associated with DES in children in Sydney that had not been reported nor investigated. In later meeting this figure is said to be at least 5 children.

[Note: Prior to the DES problem this cancer type only occurred in older women.]

• The Department of Obstetrics & Gynaecology, University NSW was said to have record of 5 cases of DES associated cancer that had not been reported.

The TGA has only ever conducted one cross-check of its data (2004) with those Australian cases listed on International DES Cancer Registry held in Chicago, USA

[ http://obgyn.bsd.uchicago.edu/registry.html ].

TGA refusal to conduct further checks was on grounds that it is not their administrative role to act as a registry.

On another matter, the ADRAC was unable to afford an explanation to DES Action Australia-NSW for their 10 year delay in entering the data of a 4 year old girl diagnosed in 1972.

The following is an excerpt in correspondence from Senator the Hon Jan McLucas 16/2/09:

“The TGA published the information in April 2008 to assist in informing women who have been exposed to DES about the need to undergo regular screening for cervical and breast cancer. The TGA advised the Department that DES is not a therapeutic good currently on the Australian Register of Therapeutic Goods and is not currently available via any avenue of supply in Australia. As such, it is not the role of the TGA to provide information about DES or to promote public health messages to DES exposed women.”

In spite of continuing to receive reports of DES associated cancer since the withdrawal of DES from the Australian Register of Therapeutic Goods (ARTG), the TGA now has no role in issuing warnings about DES, but it appears it can decide to do so “to be helpful”. This has enormous ramifications for all victims of dangerous drugs that have been withdrawn from market and which, as a consequence are removed from the ARTG, since it may preclude affected individuals from further information that may be potentially life-saving. Adding insult to injury, the Department of Health and Ageing may then choose not to properly support these individuals with information. Lack of support by the Department of Health and Ageing in appropriately informing people about DES has been our experience.

Finding Out About DES By Chance?

Since 2004 DES Action Australia-NSW has organised DES Awareness Weeks June 1-7 on the NSW Health Calendar. These events have only been possible with the practical and financial assistance of members and associates. With numerous media articles about DES published nationally, the response from many DES exposed people who chance upon these articles has been absolute anger and distress. This has been as a consequence of NOT having been directly informed of the dangers of DES previously via government public health programs. For these individuals their health, and indeed, possibly their lives have unnecessarily been jeopardised through not knowing their special cancer preventive health care.

For many people, finding out about DES is like finding the last piece of a puzzle in their health problems. This is especially so, when they are the only sibling in their family exposed to DES and are alone experiencing many of tell-tale signs of DES exposure, eg, recurrent miscarriages, ectopic pregnancies.

One woman reported to us having been diagnosed with the DES associated cancer type at a young age in the 1980s and had NEVER been asked by any health care provider about the possibility of her exposure. Stories along these lines are never ending to us year after year.

Finding out about DES by chance is NOT good enough! Many voices need to be heard in the face of government opinion that “DES information could create unnecessary anxieties for women who may not know if they have been DES exposed.”

You can help change this horrendous situation for DES exposed Australians by writing to:

The Hon Nicola Roxon MP, Minister for Health and Ageing, MG 50, Parliament House, Canberra ACT 2600 Email: nicola.roxon.mp@aph.gov.au

and

The Hon Peter Dutton MP, Shadow Minister for Health and Ageing, House of Representatives, Parliament House, Canberra ACT 2600 Email: peter.dutton.MP@aph.gov.au

Let these politicians know that people need to be directly informed about DES in public health programs and certainly let them know your circumstance if you only found out about DES by chance.

Bell's Book

DES Daughters, Embodied Knowledge, and the Transformation of Women's Health Politics in the Late Twentieth Century

ISBN: 9781592139194

In DES Daughters, Susan Bell recounts the experiences of this generation of “victims.” In moving, heartfelt narratives, she presents the voices of those women who developed cancer, those who were cancer-free but have concerns about becoming pregnant, and those who suffered other medical and/or reproductive difficulties.

Bell examines the hierarchy of knowledge and power of scientists, doctors, and daughters, tracing the emergence of a feminist health movement. The “embodied knowledge” of these DES daughters prompted them to become advocates and form a social movement that challenged reproductive medical knowledge specifically, but also the politics of women’s health in general. Bell’s important book chronicles the history and future of these grassroots activists born out of illness, suffering, and uncertainty.