Hypogonadism on short statured boys after infusion of human Pituitary Gonadotrophins (hPG) causing castration (hyperstimulation) on boys. The Unapproved Recipients of pituitary hormones, leaving them at risk of CJD.Enduced Cryptorchidism with hPH as in animal studies. The Luitenizing Hormone Program (I.V.F.) 1972-1976 in Melbourne

Two thousand one hundred Australians were treated with human pituitary hormones under the Australian Human Pituitary Hormone Program (AHPHP) which ran in Australia from 1967 until 1985. No-one from CSL - whose actions in harvesting the pituitary glands under completely uncontrolled conditions must border on criminal negligence - has ever been held to account. Nor have any members of HPAC, who sought kudos and career advancement ahead of prudent medical practice and patient safety. Overall, 1 in about 300 people treated with hGH got CJD. All CJD patients received some hGH before 1977. Of those treated before 1977, 1 in 104 got CJD. In 1977, the NHPP changed the way it made hGH. Scientists added a new purification step that greatly reduced and may have removed the risk of CJD. So far, no patient who started hGH after 1977 has become ill with CJD. Since CJD takes so long to develop, we still don't know for sure that those who started treatment after 1977 are safe. The longest reported time from the start of hGH treatment to first signs of CJD is 33 years in U.S. patients. In Canada it is 38 years after diagnostic infusion of hGH to measure Growth Hormone

The Senate Inquiry was never told of the 466 subjects, ranging in age from 2 to 101 years, were studied to examine blood levels of the pituitary gonadotrophins. Radioimmunoassay of hPG imported from USA and England as FSH/hPG and LH. It was tested on 466 males administered at Prince Henry's Hospital. (Ref to[71] Submission No.85, CSL Attachment, p.5 DHFS). Medical files released under FOI confirm hPG administered causing castration to boys. References to hGH batches used during the excercise tests

Recommendation 15: That once it is established that a person did receive hPG or hGH from the AHPHP, the recipient's status should be of no difference to that of approved recipients. In the event of a dispute between the Department and a person who claims to have received human pituitary derived hormone, the matter should be referred to an independent arbitrator for resolution.

Side Effects & Warnings, icluding a follow up study overseas of hGH recipiants. Numerous recipiants have died from Adrenal Crisis. We believe that the report completed by Professor Allars, her executive summaries and Dr Lawrence's speech to the House prove beyond any question that there had been significant breaches of the law as it applies to a wide variety of areas. These include the manufacture of the hormone, including the collection of glands, distribution of the hormone by various agencies, including HPAC, CSL and others as detailed in the Allars report, and non-disclosure of possible side effects.

7.166 Evidence received from the Department added to the Committee's concerns about unapproved applicants. It was stated by Mr Hughes of DHFS that there were 500 to 600 unapproved recipients.[162] When the Committee requested clarification of this information, DHFS only provided the number of unapproved recipients on its database. It did not clarify the figure of 500 to 600 as requested nor did it provide any information as to how it came to this figure or the groups it covered. The Committee considers that the answer provided was unacceptable and a further example of the Department's lack of effort in relation to unapproved recipients. 4.1 This term of reference primarily refers to the documents generated by and relating to the Allars Inquiry, which have been at the centre of contention between the Commonwealth and the recipients' legal advisers. An additional grouping of documents has been identified generally as other Departmental and CSL files and records, relevant to matters in issue in the legal proceedings. Within these two groups of documents are records and information held by the Department, and as well by doctors, hospitals and others which may be regarded as relevant to issues concerning individual recipients and their treatment, to which individual recipients have been seeking access. To obtain your Medical Records in regards to HPAC. Pituitary Gonadotrophins (hPG)in the form of FSH and LH were imported from bothe England and USA for

PRIVATE MEMBERS’ BUSINESS Hormone Treatments Speech FRAN BAILEY (McEwen) (8.01 p.m.)—I rise to speak to the motion listed in my name. On 1 November 1971, the Melbourne Herald ran a story that reported on scientific work being conducted at Prince Henry Hospital that was a breakthrough in the treatment of abnormal growth in children. A means of measuring children’s growth hormone produced in their pituitary glands enabled doctors to ascertain the height stature of children. The treatment developed to correct predicted stature abnormalities was to administer a human growth hormone known as HGH that was extracted and collected from cadavers. This program was known as the Australian Human Pituitary Hormones Program, known as AHPHP. The human growth hormone administered to these children was in fact the same hormone, human pituitary gonadotropin, known as HPG, that was administered to over 1,500 women and an estimated 60 men for infertility. Thanks to the member for Higgins, the tragic issue of the connection between HPG and the fatal disease of Creutzfeldt-Jakob disease has been recognised as a public health issue. As well as being treated with HPG, unknown numbers of prepubertal and adolescent boys with a prediction of short stature were treated with synthetic androgens or steroids to accelerate their growth after being primed with HPG. This caused hypogonadism, including prostate disease, in unknown numbers of boys. This meant that these boys developed a permanent defective reproductive system resulting from a lack of function of the testes often accompanied by lack of sexual development and premature menopause. Those treated with HPG fell into two categories: those who were treated as ‘approved’ patients as part of an official program, and unrecorded numbers who were treated in the same way, using the same HPG, by medical practitioners who did not officially record details of patients they treated. These are referred to as ‘unapproved’. The Allars inquiry established by this House to investigate the operation of the Australian Human Pituitary Hormones Program, conducted by Associate Professor of Law, Margaret Allars, is to be commended for its investigative work in relation to establishing the link between HPG and Creutzfeldt-Jakob disease and its recommendations to assist recipients, including compensation. However, as the Allars inquiry states, the departmental database records 188 unapproved recipients, but only 28 per cent of those were able to be traced. The reality is that there is a high probability that there are many hundreds more than the recorded 188 unapproved recipients. As was stated in evidence in the Allars inquiry: Some doctors have come clean and told the department, others haven’t. This is why there are bound to be a lot of unofficial people out there that doctors have treated like this. I am raising this issue tonight because Mr Michael O’Meara, a constituent of mine, came to me seeking assistance in relation to hPG treatment he received as a boy. His treatment was unapproved, and as a result it has taken many years to access any information about this treatment. His search for information was reiterated by Professor Allars when she stated in her submission: ‘When recipients were asked at interview what they wanted from the government, the vast majority said they wanted factual information.’ They, like my constituent, need that vital information in order to understand why today, some 30 years after the initial treatment, they experience debilitating side effects that cause hardship in daily living and real anxiety about future prognosis. Those concerns go to the heart of this motion and underpin the reason I have brought these issues to the attention of the House. We need to recognise that the many hundreds of unapproved male recipients like my constituent received the same treatment as those who were approved in receiving hBG treatment, that they suffer the same, if not worse, risks and side effects because they have been denied access to medical records and because they have been part of this hidden or non-existent list of unapproved recipients. They have never been included in any considerations, whether they be in counselling, appropriate treatment or financial compensation. Further, in spite of the Allars inquiry making a recommendation on further actions which government might take to identify people in Australia who received the pituitary derived hormones and to provide counselling and support to them, this has not happened. I want to emphasise further that, following the Allars inquiry, the Senate community affairs committee reported on the CJD settlement offer that resulted from Allars. While the compensation is to be commended, neither the Allars inquiry nor the Senate committee acknowledged the other side effects of hPG treatment, which have resulted in castration, delayed puberty, induced puberty due to high doses of testosterone or hypogonadism. The government accepted the Senate recommendation stating: That once it is established that a person did receive hPG or hGH from the AHPHP, the recipient’s status should be of no difference to that of approved recipients. I strongly commend that Senate committee for making that recommendation to government and government for accepting it. But the point is that, in accepting this recommendation in relation to a link to CJD with hPG recipients, this acceptance should also be extended to other life-debilitating and life-threatening side effects of hPG treatment. Let me give the House an actual example that my constituent has given me permission to speak of. My constituent was treated with hPG as a boy of 10 years of age. This resulted initially in a spontaneous onset of full-blown puberty. As treatment doses and frequency were varied, he was effectively castrated, with his testes so damaged that puberty was then delayed to such an extent that he was treated with anabolic steroids to induce puberty. This experimental nature of hPG treatment was exposed by Dr Wes Whitten, reproductive physiologist and former assistant director of the then National Biological Standards Laboratory. When giving evidence to the Allars inquiry, he said, It was a shocking product, I can’t believe this had ever been marketed. As a result of hPG treatment my constituent, as an adult, some 30 years later suffers from hypogonadism and requires three operations per year to keep him alive and reduce these extremely debilitating side effects. Every four months he has to undergo testosterone implants because, without these, his hormone level replicates that of a man over the age of 100. Mr O’Meara is just one of many hundreds treated with hPG who officially do not exist on any health department list and who suffer in silence. I commend Mr O’Meara for his courage in being prepared to come forward and to provide me with very personal details in order to highlight the plight of so many others like him who justly, I believe, must be included in any government response to the ongoing needs of those whether approved or unapproved for treatment. In the same way that approved recipients who were treated with hPG became victims of CJD and were recognised as being in need of counselling and compensation in some instances, so too do all the unapproved recipients need recognition of the treatment they received. This means that the spirit of Allars and the Senate committee must not just be adhered to; they must be implemented. There is simply no discrimination in the suffering experienced by both the men and women who were subjected to this treatment, and certainly no discrimination and suffering between those men and women who were approved under specific programs or those who were not approved. All who received hPG treatment and have suffered as a result of that treatment need to be recognised and supported. I commend this motion to the House and I thank my colleagues who have agreed to speak to this motion.

In Australia, from the early 1970's, prepubertal and adolescent boys with a prediction of 'short stature' (recruitment article, Melbourne Herald, November 1971) were treated with pituitary hormones (human pituitary gonadotrophin, hPG) a fertility drug of protein, taken from cadavers, infused into short statured boys, causing hyperstimulation to the testes, and then treated with synthetic androgens to treat the damage. One cannot under estimate the effects of exposure to other persons brain protein being infused. The oxandrolone was used in the belief to accelerate linear height, but oxandrolone (testosterone) is used for hypogonadism (damaged testes) Synthetic steroids acts as a hormone blocker. Oxandrolone is no longer used as a growth promotant, due to side effects. The hidden agenda, and the short statured boys werent advised was the secret development of the male birth control pill in collaboration with the World Health Organization (WHO) (refer to website) Three decades on, the male pill has still not arrived. The most recent breakthrough came earlier this month (October 2003), with the announcement by Australian scientists of a treatment involving an implant under the skin — meaning men could not forget to take it — of hormones that switch off sperm production. It’s said to be 100 per cent effective and free from unpleasant side effects. Oxandrolone (an anabolic steroid) was used after the radioimmunoassay, in vivo study, of FSH/LH causing the hyperstimulation of the gonads, resulting in one form of cryptorchidism (ectopic testes). FSH levels rose 9 fold after hyperstimuation (precosious puberty - neuroendocrine with hPG and doubling testosterone levels). Hyperstimulation causing castration! Bilateral orchidopexy was required to relocate the hyperstimulated testes back into the scotum 6 weeks after exposure, invivo of hPG. The infusion of hPG hyperstimulated the testes as indicated with an elevated FSH level and testosterone increase from 122 to 250 ng. 7.56 The measure of potency was particularly important for hPG recipients where there was a risk of multiple pregnancies or hyperstimulation of the ovaries, a potentially fatal condition, if dosage was incorrect. CSL stated in its submission to the Committee that every single batch of pituitary product was assayed for potency. It also developed additional assays requested by HPAC, for example the luteinizing hormone assay, introduced in 1972.[71]. Never disclosed to the Inquiry was the hyperstimulation effect on the boys at Prince Henry's, and the short term and long term effects upon the testes. Cryptorchidism (ectopic testes) was certainly a side effect to the experiement, an experiment never disclosed to the boys. Hyperpigmentation, Melanoma, Basal Cell Carcinoma, nocturnal enuresis, prostate disease, gynecomastia, IBS, fluid retention, inreased bladder muscle markings, knock knee, vestibular dysfunction, Myoclonic jerks, muscle spazms, Low FSH and Testosterone, Skeletal dysplasia, Liver disease, osteoporosis and growth stunting to name a few side effects, notwithstanding puberty was never completed. Attempting suicide through self harm as a withdrawal effect, and enduring nervous breakdowns were apart of the experience of endocrine disruption with hormones and sex steroids. 9.108 (Allars pg. 620) In 1985 a nurse of some of the treating medical practitioners at Prince Henrys, forwarded to the Deptartment of Health a list of hPG recipients in response to the third Department letter. One of the treating medical practitioners did not recall this request of the Department in 1985. It is also important to acknowledge the participation of numerous patients in the studies described. Without their help, clinical research would not be possible and quite often their misfortune prompted a new study or helped to elucidate a novel concept The Pituitary and Testes - Clinical and Experimental Studies 1983 Concerns are raised upon page 460 of The Allars Report where The Subcommittee approved themselves to Hyperstimulate with hPG. Disclosure and side effects of the potential deaths and castration wasnt concented to by the subjects, nor their Parents. A fertility treatment used in 10 year old boys that had devistating effects. The boys were left with hypogonadrophic hypogonadism, they didn't complete Tanner Stage V Puberty, and have been refused treatment for the last 25 years. The LH stimulated androgen secretion in males to from .2 to 1.8 (the adult range in a 10 year old). Oxandrolone kicked the testosterone levels to Tanner Stage 111 (14-18 year old) as a 12 year old, with FSH after hPG exposure into the adult range (PP). Tanner Stage V was never achieved. Precosious Puberty as a 10 year old with an adult range (libido) was most concerning. Premature aging, 30 years on is a major consequence of the refusal of treatment for the condition. It becomes a major concern when the hPG administration has been associated with deaths of CJD - the human equivilant of BSE/Mad Cow Disease, with an incubation period of upto 38 years after the Stimulation Test for GH deficiency. ....................................................................................................... The problem with many of the compounds that have been used over the years was side effects. Although it is quite simple to make a man infertile, it has to be achieved with an acceptable level of side effects. It is known that 2 out of 3 males with childhood cryptorchidism will be infertile. The fertility rate of enduced ectopic testes with hPG exposure is unknown. Various compounds have had different side effects, including acne, weight gain, increased appetite, mood changes, lethargy and longterm impotence. Some of the side effects experienced are similar to those reported by women on the Pill. Unlike womens estrogen to be replaced every month, male testosterone levels drop off over the years. Many of the chemicals that have been tried do work, but they also have side effects, Robaire says. You can easily block the production of the male hormone, and then you obviously have a contraceptive, but that is equivalent to a castration, and that is not good. http://www.theage.com.au/articles/2003/10/26/1067103267041.html?from=storyrhs&oneclick=true ........................................................................................................ Using Batch 25 FSH (combined with LH), and a further release of Batch 25 on 21st April 1972, The in vivo study wasn't ratified by the FSH Subcommittee until September 1972; 5 months after it was used as an unapproved fertility agent causing hyperstimulation. Batch 25 was stated by Turner on 23/12/71 to be dispensed but not tested, yet HPAC released a further batch of the same batch in April 1972, and ratified it shortly afterwards. 2.70 In evidence Professor Whitworth stated: The Human Pituitary Advisory Committee instituted a requirement that any specialist seeking to be approved by them to treat patients with hPG must have access to a laboratory to carry out the assays required. A computerised recording system was developed in the [Health] department which doctors were required to provide information to on the outcome of treatment. Certainly, hyperstimulation remains a side effect of gonadotropin treatment to this present day. Prior to 1979, (1972-1976), FSH was a combination of FSH and LH. with the importation of FSH and LH from overseas pituitary glands, a gift from the National Pituitary Agency (Bethesda, Maryland)and Dr Anne Stockell Hartree (University of Cambridge, England), used on males, including prepubertal at Prince Henry's Hospital. No thorough multidisciplinary, long-term follow-up has ever been done with regard to this treatment, the NHMRC Recinded the follow up application. Many of the Australian Men now report a range of medical problems which they fear may be the result of their treatment with androgens, after hyperstimulation of LH. There is however evidence about their concerns since the fact that Oxandrolone treatment was discontinued in 1990 and other Growth promotors such as Human Growth Hormone (hGH) has now ceased being manufactured from Pituiarty Glands in 1985. Hudson of Melbourne University, leading a United Nations' task force hoped to give the world a male birth control pill. The funding was granted by the NHMRC, and 30 years on their has been no gain in achieving the Pill, not help for those subjected to this experiment. The boys at PHH were treated with oxandrolone (an anabolic steroid) that encouraged growth but prematurely closed the growth plates. Other concerns surround the estrogenic effects with the conversion of testosterone into estrogen, leaving the boys with gynecomastia and prostate disease (BPH) as a teenager. We hope this group will be able to support you and help with the side effects of this hormone program. The program that was an in-patient (in vivo) experiment, without consent or approval. One recipient told the committee All who conspired to force this terrible legacy on hPG and hGH [human growth hormone] recipients are now being protected by a government and its officers who would rather see innocent recipients denied justice than admit to the ineptitude and negligence of those involved in producing these treatments and administering this program.

While there is evidence that HGH builds muscle mass and reduces fat in non-deficient adults, it can have side effects including edema, insulin resistance and joint pain. People who take it do so at their own risk and peril, says Pinchas Cohen, chief of pediatric endocrinology at the University of California, Los Angeles (UCLA).

Eugenics Howard Florey Laboratories of Experimental Physiology devoted especially to the study of integrative physiology by long term experiments and these gentlemen and all other donors including the Commonwealth of Australia, the Reserve Bank of Australia and the Rockefeller Foundation made their gifts for that purpose and on these terms the Laboratories were commissioned in 1963:

After 10 years of asking questions of his treatment to his Endocrinologist and The Dept. of Health, and being told he wasnt at risk, FOI documents reveals batch numbers documented on records