Contents of Document 1: (1) (2) (3) (4) Hidden Plight letter, 1981 DES & the Meat Industry, 1981 Screening for DES Daughters, 1983 DES Brand Names, 1983 (1) Hidden Plight of the Victims of DES Letter to the Editor The Age, 7 January 1981 It is fitting that in time for the International Year of the Disabled Persons the State Government should recognise the "invisible" disabilities created by exposure to diethylstilboestrol (DES). (The Age, 9/12) It is now nine years since the US Government recognised the effects of this medically prescribed drug on the developing foetus. DES was prescribed for three decades from the 1940s in the mistaken belief that it prevented miscarriage. It has now been linked with a rare form of vaginal cancer in daughters, and other "invisible" disabilities such as infertility and deformities of the upper genital tract. [As reported by The Age, 9/12/1980] the State Government has resolved to establish a DES register and clinic for DES daughters, in order to treat and monitor the after-effects of DES exposure. However, there are no matching provisions for DES sons, now shown to be equally susceptible to genital tract abnormalities, infertility and other problems. Although a similar rare, symptomless and virulent cancer has not been found in DES sons, their future is unknown and new effects could emerge as they become older. DES Action is a "consumer" group which supports the provisions made by the Health Commission so far. We liken our plight to that of Thalidomide sons and daughters, except that our symptoms are hidden and less tangible. They do not "inform" people, even DES victims themselves, of a terrible mistake which we hope will never be repeated with any drug. Felicity Browning, member of DES Action. DES Action Australia Inc 1 Doc.1 (2) DES & the Meat Industry Includes: Serpent Beneath the (Eli) Lilly The DE$ Dollar - part 1 The DE$ Dollar - part 2 From DESPATCH - #5 October 1981 The Serpent Beneath the (Eli) Lilly By Felicity Browning If it's been hard to find out about the ways DES affects our bodies, it's even harder to discover how the almighty Dollar has ordained it. Very little is known about the Eli Lilly Company, a major US manufacturer of DES. However, it is interesting to trace the involvement of Eli Lilly with the development and use of DES for agricultural purposes. We find that: - The original research through which DES was introduced as a feed additive was conducted at Iowa State University, which had a licensing agreement with Eli Lilly and received a royalty from its sales. The research has since been discredited as of dubious quality; and as being, in effect, subsidisation by the US taxpayer of $58 million worth of sales for Eli Lilly. - In 1970 Eli Lilly put pressure on the US Food & Drug Administration (FDA) to double permitted dosage levels of DES per day per animal. The FDA willingly cooperated. Their monitoring of DES levels in slaughtered stock was ineffective and conducted on only a small number of carcasses anyway. - Throughout the 1970s Eli Lilly assisted universities and research stations conducting studies on DES with partial grants, by supplying DES and monitoring its chemical stability, and by providing its own research staff. The objectivity of such research, which was geared towards economic efficiency rather than the quality of meat produced, is surely questionable. - More recently, Eli Lilly has links with the National Cancer Institute (NCI) and the American Cancer Society, through membership on both of its consultant, Frank J. Dixon. Both positions pose a major conflict of interest by Dixon. He is a member of the NCI Advisory Board, which determines NCI funding policy - and Eli Lilly receives research funding. As a member of the National Board of Directors of the American Cancer Society he contributes to its emphasis on diagnosis and treatment, rather than prevention, of cancer. Sources: Samuel Epstein: The Politics of Cancer Journal of Animal Science (US). From DESPATCH - #5 October 1981 The DE$ Dollar, part 1 - Early Days of the DES-Burger By Felicity Browning When DES was first synthesised in 1938, it was found to be cancer-causing in animals... Yet DES has gone on to be manufactured, marketed and distributed for over 40 years and used for a wide range of purposes. Why on Earth? A look at the way DES was used in the meat industry gives an idea of the multi-million dollar business us DES daughters, sons and mothers have inadvertently been the victims of. It is linked to our immediate concerns by a common theme of cancer risk, and more directly by the appreciable increase in natural hormone levels the consumption of DESmeat may cause - an added risk factor to those already exposed to DES. DES Action Australia Inc 2 Doc.1 The use of DES as a stock feed additive in the production of poultry, pigs and cattle has been found to stimulate weight gain in animals faster and on less feed. This means less capital outlay, higher turnover of stock, and increased profits to the cattle and feedlot industry. The enhanced efficiency of meat production takes place at the expense of the quality of the product. DES acts mainly to increase conversion of feed to fat rather than protein, and it increases the amount of water in muscle tissue. The history of the agricultural use of DES in the US is a story of collusion between government and big business in imposing an unnecessary, indeed harmful, commodity on an unwitting population, for the sake of private profits. The main actors in this story are: - the US Department of Agriculture (USDA) and the Food and Drug Administration (FDA); - the pharmaceutical companies, of which Eli Lilly is a leading DES manufacturer; and - the meat-producing industry, which as we know is no "small farmer" affair but consists of large feedlot firms and multi-national "agribusiness" companies. In 1947 the USDA approved the fattening and caponising of chickens by the implanting of 15 mg DES pellets under the skin of their necks. Despite subsequently being sued by mink ranchers, whose animals had become sterile after eating DES chicken scraps, the USDA still allowed its use in chickens. In 1954, the USDA extended the use of DES to cattle. Each animal could be fed 5-10 mg daily, provided DES intake was withdrawn 48 hours prior to slaughter to prevent residues remaining in the meat. In 1958, the Delaney Amendment of the US Food, Drug & Cosmetic Act was introduced. This amendment flatly prohibited food additives (including those in animal feed) which were found to be carcinogenic in either humans or animals. The FDA, which throughout had denied that DES was a carcinogen, successfully argued for the continuation of its use, on the technicality that the amendment could not be applied to substances already in use. However, when in 1959 residues of DES were found in chicken carcasses, its use was banned in poultry. The USDA promptly bought and removed from the market about $10 million worth of treated poultry. Alarmed by this ban the industry lobby introduced another amendment to the Federal Food, Drug & Cosmetic Act. This specifically exempted DES and other carcinogenic feed additives from the Delaney amendment, provided residues were monitored and not present in the meat at time of slaughter. Clearly the implication was that any DES subsequently found in meat would be due to bad feeding practice, not any inherent properties of DES. And the US Congress was virtually handing all responsibility for control of the use of DES over to the discretion of the FDA and USDA, making action at the legislative level less likely. In fact, the USDA and FDA rarely checked on DES residues in meat, sampling only a small number of carcasses with ineffective methods. They kept all records confidential. In 1970, by which time 75% of all beef produced in the US - 30 million head per year - were fed DES, the FDA doubled permitted dosage levels to 20 mg per day / per animal. With the 1971 discovery of vaginal cancer in DES daughters, the activities of the USDA and FDA in regulating the use of DES came under a new scrutiny and attack. To be continued... From DESPATCH - #8 June 1982 The DE$ Dollar, part 2 - US Ban & Use in Australia By Felicity Browning US Ban - At Last! In part 1 we saw the apparent complicity of the US government Food & Drug Administration (FDA) with big business in tolerating and even increasing the use of DES in livestock animals and feed. Despite attempts to ban DES through legislation, the FDA doubled permitted levels of DES in meat, at the request of Eli Lilly, in 1970. Sporadic and DES Action Australia Inc 3 Doc.1 ineffective testing of DES residues in meat took place and the results were not made public. When, in 1971, vaginal cancer was discovered in DES daughters, the activities of the FDA and the US Department of Agriculture (USDA) came under a new scrutiny and attack. Agency record were examined and revealed that DES residues had been found in beef liver since 1966! The levels of DES found would, in a single serving of liver, make an appreciable addition to natural hormone levels in the consumer. More tests were then done, and substantial DES residues were found in the livers of sheep and cattle. These findings caused a furore, and criticism of the agricultural use of DES mounted. Over twenty other countries had by this stage banned DES, and most European countries would not buy US meat because of its DES content. In an attempt to placate the critics, the USDA extended the 48 hour period of withdrawal (of DES prior to slaughter) to 7 days. This arbitrary measure was based on one experiment with one cow! It was also assumed that cattle producers would comply "on their honour" when, in fact, usual practice is to slaughter and sell when the market prices are highest. At this stage evidence from independent enquires persuaded the FDA to ban the use of DES in meat production. However the pressure from the industry lobby must have been enormous. The drug manufacturers were losing millions in profits, and cattle producers had to substitute other, far more expensive, carcinogenic "plumping" oestrogens. It took a joint lobby of the meat and drug industries only nine months to win an appeal to have DES returned to the market place. The FDA then launched new proceedings to ban DES, with proper hearings from all parties concerned, which previously had not taken place. As a result, in June 1979, DES was finally banned as a growth-promoter in cattle and sheep. In essence, the FDA Commissioner responsible for the hearing concluded that: it could not be shown that there was a level below which DES did not cause cancer i.e. any level is potentially hazardous; and residues of DES do occur in food from animals treated with it and there is no reliable way to detect whether these levels are carcinogenic or not. What about Australia? We have learnt (at least by August 1980) Eli Lilly had set up an Australian subsidiary called Elanco, based in West Ryde, NSW. This is not surprising as huge profit-making corporations are constantly searching for new market outlets, and the US ban in 1979 would have intensified this effort. This practice of off-loading unsaleable stock in countries elsewhere is called "dumping " in marketing jargon. We know that at the 13th Biennial Conference of the Australian Society of Animal Production, a symposium was held on "Controlled-Release Subcutaneous Implants" i.e. injections of slow-release pellets containing minerals, growth hormones, etc. into the loose tissue of animals bred for meat. Sure enough a certain A.C. Schlink, representative of Elanco products, was a speaker at the symposium describing Eli Lilly's latest products. The record of proceedings suggests that, to date, carcinogenic oestrogens such as Zeranol and Oestradiol-17B have been used by Australian farmers. One speaker (a farmer) expressed hope that a new Eli Lilly product would be available soon. This new implant is tactfully named "Compudose", and is later described as releasing both "a drug which stimulates secretion of growth-promoting hormones and a hormone itself." Sources: Samuel Epstein: The Politics of Cancer Australian Society of Animal Production: Animal Production in Australia, Vol. 13, 1980. DES Action Australia Inc 4 Doc.1 (3) Recommended Screening for DES Daughters Extract from pamphlet You may be a DES Daughter Produced by DES Action Australia, 1983 The DES Examination If you believe your mother may have been prescribed DES or a related drug, go to a doctor or clinic with experience in DES screening. The time to go is: - when you commence to menstruate or when you are 14 year old (whichever is earlier) or - immediately, if you have any unusual vaginal discharge or irregular bleeding. At the clinic or doctor's rooms ask specifically if the doctor is screening other DES daughters and if he/she is familiar with the procedures described below. DES related changes might not show up in the routine pelvic examination and Pap smear given by most doctors. The examination consists of: - Careful visual inspection of the vagina and cervix for physical differences - Gentle palpation of the walls of the vagina for any lumps or areas of roughness - Smears taken from the cervix and the vagina. The routine Pap smear involves taking a smear of the cells on the cervix. In the DES examination additional smears are taken from the vaginal walls. - Iodine staining of the vagina and cervix. When the diluted iodine solution is applied, normal tissue stains brown while glandular tissue (adenosis) does not stain. Depending on the results of these procedures, further tests may be carried out. These include: - Looking at the tissue of the vagina and cervix with a magnifying instrument called a colposcope. This shows up any abnormal-looking tissue and its exact location. Where possible, it is suggested that your initial examination includes colposcopy. - Taking a tiny sample of tissue from the vagina by biopsy. This involves only slight discomfort though some bleeding may occur. The tissue sample is sent to a laboratory and examined under microscope. You will need to have repeated DES screening examinations at regular intervals for the rest of your life. Some or all of the procedures done at the first examination will be repeated. Usually the doctor will draw any changes seen on your medical record, and discuss with you the changes as they occur over time. It is important that you feel comfortable about the health care you are getting. The screening should also include a breast examination. In addition, DES daughters are encouraged to carry out monthly breast self-examination. DES Daughters and The Pill If you are a DES daughter, you should also know that taking any additional oestrogen may be harmful. Oestrogen in contained in the oral contraceptive pill and the "morning-after" pill. Many DES daughters prefer to steer clear of additional hormones! DES Action Australia Inc 5 Doc.1 (4) Australian DES Brand Names Extract from pamphlet You may be a DES Daughter Produced by DES Action Australia, 1983 Names under which DES and related drugs have been sold: Ambigen Amenorone Amenorone Forte Antiferont Barboestrol Clinestrol Climatost Cyrogene A Cyrogene B Dienobarb Dienoestrol Diesavite Dihydrostilboestrol Diescron Duogynon injections Duogynon oral Enavid Estigyn Estigyn Elixir Estinyl Ethidol Eticyclin Euvalerol M Ferandren Hexoestrol Hextrol Honvan Lut-Ovocyclin Menoclimax Menoform Injections Menotone Menstrogen Injetions Menstogen Tablets Menstrone Mepilin Mepilin Elixir Mixogen Neo-Oestranol Neo-Oestrogenine O.C.P. Oestroform Oestroform Aqueous Oestrogenine Oestrogenine Compound Oramen Orasecron Ovestin Ovocyclin DES Action Australia Inc 6 Doc.1 Pabestrol Pabestrol D Pausandryl Premarin Premarin with Meprobamate Premarin with Methyltestosterone Primodian Primodian Depot Primogyn C Primogyn Depot Stilboestrol Stilboestrol Diphosphate Stilboestrol Diproprionate Synthovo Tace Theelin Thyboestrol Vallestril Viraxasterol This list is not exhaustive, as there is no complete listing [i.e. a list which contains all the generic and proprietary names] available for the period in question. DES Action Australia Inc 7 Doc.1