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Primodos

ANNUAL REPORT OF THE ASSOCIATION FOR CHILDREN DAMAGED BY HORMONE PREGNANCY TESTS FOR THE A.G.M. TO BE HELD IN BIRMINGHAM 2009

Introduction

In the September of 1974, I was prescribed the drug Primodos by my N.H.S. doctor. I was to take one tablet in the evening and another the next morning and was told that if there was no subsequent bleeding I would know that I was definitely pregnant. In fact, there was some bleeding after I took the tablets although my son had already been conceived. Like myself, there were many other women who took the test who did experience a slight bleed at this very crucial time, which was usually between five and ten weeks after conception. This is the time when any human foetus is at its most vulnerable and vital stage of its development. My son Daniel was born in the April of 1975 with several congenital malformations including his heart, but it was only in 1976, when I was again prescribed Primodos – this time for amenorrhoea, that I saw that there was now a warning which accompanied it, a warning which said: ‘Not to be taken during pregnancy as it can cause heart defects to the unborn baby.’ I felt very worried and disturbed by this and it occurred to me that taking the Hormone Pregnancy Test had been the cause of my son’s very poor state of health, and numerous surgical procedures. I began to make enquiries and to campaign for action with the help of Greg Dyke a journalist who introduced me to television, such as The London Programme, and Sue Lawley on Nationwide which was an introduction to alert other families whose mothers taken the hormone pregnancy test, and had given birth to babies with congenital abnormalities, or babies that had died soon after, or whose children had died in early childhood. Other contacts were with my local M.P. Hugh Jenkins who, together with the M.P. Jack Ashley, was most sympathetic and supportive of our cause, and further interviews with journalist in this country and abroad to reach out to many more families of affected children.
I would also like to extend my thanks to Manchester CHC who wrote to all Local Health Councils in England, Wales, and Scotland, and their efforts to mount a national survey of the children who had been affected by HPT.s. The Chairman of Roehampton Community Health Council, Mrs Joan Wheeler-Bennett in 1979 J.P., from the district in which I live and still do, also wrote to all other C.H.C.s.to inform parents of the dangers of the H.P.T. and provided contact details for the Association.

Our Association was formed in 1978 and the media showed a good deal of interest in the stories of our affected children. Many other parents who thought that their child had also been damaged by the effects of this pregnancy test soon wanted to join our campaign for justice. The original aims of our Association were as follows:

· To have these unnecessary drugs removed from the market.
· To advise, support and assist parents of children who may have been affected by the use of the hormone pregnancy test.
· To bring to the attention of the public and the authorities the plight of parents and children so affected.
· To raise money so that families could fight for compensation for these children.

Unfortunately, we were unable to obtain any compensation for the children who suffered from the effects of Primodos or any of the other drugs which were used for the diagnosis of pregnancy although we did achieve our primary aim which was to stop the tests being used. What is perhaps most tragic about this whole situation in retrospect is that not only was the human suffering that was caused manmade and completely unnecessary, but it was eleven years before doctors stopped prescribing the tests after the first scientific evidence was published, clearly indicating that severe harm could be caused by using them. Furthermore, simple and safe alternative methods of establishing pregnancy were available throughout this period.

I would like to take this opportunity to thank several people for their dedication to our cause and their outstanding efforts in support of the Association when it was first formed, because some of them have now passed away or moved on. Isabel Gal as well as Mark Mildred, our solicitor, gave their time and expertise freely and most generously over a period of several years. Greg Dyke for his commitment to highlight through the media of our cause to the general public. Robin Hayes, who was the secretary of the Association also worked tirelessly in taking down details and sending out newsletters, particularly when media publicity was at its height and membership numbers rose so rapidly. I am also very grateful for the persistence and endeavour of our treasurer David Cahill, who kept the finances of the charity in such good order and like so many others, campaigned so hard. Although all of the parents who joined us had added domestic demands in caring for their poorly and/or disabled children, they too managed to find time to raise money when the Association had attained charitable status. Their efforts were vital to the running of the association and we were finally able to pay for the services of our solicitor, Mark Mildred. He had been working full-time in his attempt to find justice for the children, preparing and setting out the legal documentation for the preliminary hearings which had to be heard in court before the final trial could commence.

History

Hormone Pregnancy Tests were introduced in 1953 by the intramuscular route and in 1956 by the ingestion of tablets. During the 1960’s they were increasingly being prescribed by doctors to women who thought that they may be pregnant throughout Great Britain as well as Europe, America and Japan. At this time there were several different drugs which were used for this purpose: Amenorone, Amenorone Forte, Disecron, Menstrogen, Norlestrin, Norlutin A, Norone, Orasecron, Paralut, Pregornot, Primodos and Secrodyl. Of these, the two most frequently prescribed in Britain were Primodos which was manufactured by Schering AG in Germany, and marketed by a subsidiary company in Sussex, and Amenorone Forte - manufactured of synthetic hormones and chemically it was similar to the oral contraceptive pill which women take today, although it contained very much higher concentrations of these hormones. When the drug Primodos was first launched in 1958, its manufacturers said that if a woman was pregnant, in no way would the foetus be affected by this diagnostic procedure. Their promotional literature quoted. “if you don’t bleed, then you are pregnant – if you do then you are not pregnant” But what was equally offensive was when Schering Chemical actually ran an advertisement promoting Primodos which stated, “Toads Unite down with tablets, a hundred per cent unemployment unacceptable”. This referred to the injection of urine in Azenipus Toads. If a women was pregnant the toads would react and would spawn within a few days). By 1975 however, every box carried the warning that it was not to be taken during pregnancy. Each Primodos tablet was equivalent to approximately forty of the contraceptive pills which were stronger then those administered today. The drugs had two principal uses: the Hormone Pregnancy Test H.P.T. and the treatment of Amenorrhoea - the absence of monthly periods.

Even in the 1950’s doubts about administering hormones during pregnancy were expressed by some members of the medical profession. In 1957, for example, J.S. Edwards in the British Journal of Preventive and Social Medicine, said that it was ‘the type of insult which is likely to cause foetal malformation and would often be administered at a stage in pregnancy when it might initiate malformation of the central nervous system’. London Weekend Television transcript.April1978 However, although some of the early studies showed what were later described to show some worrying signs, the results were at that time believed to be inconclusive and the H.P.T. began to be increasingly prescribed by doctors throughout the country. A brief review of the events that took place in the chronological order in which they occurred, follows:

· In 1967, Dr. Isabel Gal, who was working at Queen Mary’s Hospital for Children in Carshalton, Surrey, published the first suggestion that there was a possible link between the use of the H.P.T. and congenital malformation in Nature. Vol.216, p.83. She had noticed that there was a significantly higher incidence of spina bifida among the children of those mothers who had been prescribed a H.P.T. as a diagnostic aid to confirm their pregnancy. Of a survey of one hundred babies with congenital malformation and a control group of an equivalent size, she and her colleagues had found that out of the two hundred mothers, twenty-three had been prescribed the test. Nineteen mothers had given birth to malformed babies and four had had healthy babies. In Dr. Gal’s view, the potential risks of the tests outweighed any possible benefits and she saw their use as being unnecessary. In the same year a new and easy method of confirming pregnancy had become available, measuring the level of hormones already present in the body by a simple urine test.
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· Schering’s research director at the subsidiary company in Sussex, Dr. Michael Briggs was disturbed by Dr. Gal’s findings and he sent the details of sales of Primodos throughout the country together with a detailed breakdown of all birth deformities as well as the sales figures for Amenorone Forte to Dennis Cooke, a Mathematics Lecturer at Sussex University. On November the 2nd, 1967, Cooke reported ‘a strong correlation’ between the incidence of malformations and the sales of the drugs. When Briggs passed this information to his Head Office, Schering AG, however, they said that no such correlation existed in Germany. Briggs showed Cooke their data and he pointed out that in Germany only deaths from abnormalities were recorded and that their statistics could therefore easily be misleading. Sunday Times April 23rd, 1978
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· Throughout what was happening during this period Schering’ Head Office still took a consistent line; it attacked uncomfortable news, and tried to protect Primodos.
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· In 1977 an industrial espionage spy, Ian Withers, wanted to sell some very important letters for £10,000 to my then husband and I through our solicitor Mark Mildred, which he had stolen from Schering Chemical Ltd (the subsidiary company at Burgess Hill). Although we really did welcome these letters, we had to refuse this offer through lack of funds. This did not deter Ian Withers who then began to sell these letters to various newspapers. The Sunday People initially agreed to run the story but then exposed Mr Withers in a front page news story as a predatory opportunist under the headline “A RAT AND HIS PITIFUL PREY” (the story was accompanied by a picture of my son next to the photograph of Ian Withers).
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· The documents were photocopies of letters and medical papers that disclosed dialogue between Schering’s subsidiary company in Burgess Hill and the parent company in Germany. The documents stated that the matter had to be resolved as the adverse publicity was damaging to the company. An extract of one document included the following: Should adverse publicity appear we will be hard pressed to explain why the only investigations made since the matter was first reported were those that related to the statistical aspect of the problem.
In the June of 1968, two medical advisors from Schering Chemical Ltd in Britain wrote to the parent company in Germany saying that the question of the safety of Primodos had to be resolved, and appeared to be suggesting that Primodos should not be used as a pregnancy test. The Sunday Times later obtained a copy of this letter in which the advisors expressed their concern: ‘We must reach a decision regarding our own product Primodos and its possible relationship to foetal abnormalities. As manufacturers it is our moral duty to do all possible to ensure the safety of the preparations which we market. Where suspicion has been aroused by an investigator whose integrity and ability cannot lightly be challenged, the onus of proof must lie with us. It
is for us to establish that the drug is safe to use. The letter went on, ‘Ethically speaking we are not satisfied that sufficient has been done to remove suspicion that has been cast upon Primodos to a sufficient degree, for us to be confident in supporting its continued availability to pregnant women in this country.’ [Sunday Times April 23rd, 1978.

One of the letters from Schering Chemicals in the late sixties to the parent company in Germany recommended that further action needed to be taken. They said this should consist of: (1) setting up studies with animals to see if Primodos caused abnormalities in the foetus. These should be carried out in such a way as to stand up to scrutiny by The Committee of Safety of Drugs; (2) setting up a further study to be carried out in Britain.
However, there were two studies carried out in 1960 showing worrying signs. One was done in Britain; the other was done in Germany on a fairly large group of patients. Both showed that in fact a minority of women with an earlier pregnancy did in fact bleed from the uterus when the hormone test was administered.

Professor Graham Duka, an author on an authoritive book on the side effects of drugs. He lives in Holland and was Vice Chairman of the Dutch Committee for the Evalution of Medicines which vets all drugs in Holland. He stated that in some cases the effort that the pregnancy itself would be completely interrupted then an abortion would follow and that it could cause some defect in the development of the embryo.

Even the concerns expressed in 1967 by Schering’s own subsidiary company, appeared to have little impact on the parent company in Germany. They continued to encourage the sale of this drug with little regard to our unborn babies. They also appeared to be heedless to the two studies carried out in 1960, and still denied there was any connection between the drug and the damage to the unborn foetus until they eventually removed it from the market in January 1978. Their reason was because it was not viable to continue selling Primodos commercially.

However, Schering AG’s Directors appear to have been primarily concerned with commercial gain, wanting to maintain their monopoly over the birth control pill market. Any public discredit would probably have been seen as being detrimental to the future success of the company. Interestingly, the Hormone Pregnancy Test had been ‘a spin off’ from the development of the oral contraceptive pill. It was like taking a vast number of birth control pills all in one go.
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· Evidence continued to accumulate and in the January of 1969 a survey by the Royal College of General Practitioners showed a higher incidence of miscarriages or natural abortions among women who had taken the pregnancy tests. Dr. Dean who led the survey, soon recommended that Primodos be withdrawn from the market because he was so alarmed by the results. The current President of the college, Dr Ekkehard von Kuenssberg, felt able to write to Schering. “I hope you won’t feel worried” by what he called Dean’s personal opinion. Yet in 1978 the survey remained unpublished but admits that further analysis confirms its conclusion that the hormone test do cause abortions.
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In July 1970, Schering decided to stop promoting Primodos as a pregnancy test. However, they did not inform doctors of their decision, and many British G.P.s continued to prescribe it. Finland was the first European country to take action, deciding to completely ban the use of the H.P.T. in 1971.
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· In 1973 it was reported that transposition of the great blood vessels was associated with the maternal use of oestrogen-progestogen preparations during pregnancy. Levy et al. Lancet Vol.1. p.611 In the same year another paper was published, indicating that the vertebral, anal, cardiac, tracheal, oesophageal and limb syndrome of malformations were also associated with the use of such hormonal preparations.Nora and Nora Lancet Vol.1.p.941
· Dr. Gillian Greenberg and Dr. William Inman, who were working on behalf of the Committee on Safety of Medicines reported their initial findings of an inquiry into the safety of the HPT. For the thirty-one mothers who had taken the HPT, eight had given birth to normal babies and twenty-three had given birth to children who had serious congenital malformations. Their results led them to recommend that there was little justification for the continued use of such pregnancy tests when alternative methods were available. British Medical Journal 26th April 1975
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· In June 1975, a warning was finally issued by the Committee on Safety of Medicines about a possible association between the use of the H.P.T. and congenital abnormalities. Some of the drugs used were removed from the market at this time although others continued to be marketed for the treatment of a variety of conditions in women who were not pregnant. There was now to be a clear warning that it was not to be taken during pregnancy.
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· During the 1970’s the call for justice gradually increased throughout this country with many more countries joining in on the campaign - France, Germany, Italy, Sweden, Finland, Norway, Switzerland, and even Japan. Publicity also increased up and down the country in the form of newspaper articles and television interviews. This resulted in many more parents from this country and abroad contacting the association and the media was most effective in helping to advertise the Association and its aims throughout England, Scotland and Wales.
· Holland banned the use of the H.P.T. in 1975 as did the Australian Government, when scientific research which had been conducted there had shown a clear association between the use of the drug and children born with cleft palates and hare lips.Medical Journal of Australia 1975 W.F. Brogen
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· By January 1976, our solicitor Mark Mildred visited a law firm in Jackson Hole, Wyoming in January 1976 called Sterns Mority against Squibb in respect of Gestest, a product very like Primodos sold in the USA. They recommended an expert called Dr Ellenhorn whom he met later in London but we could not afford the case. (This was before the formation of the Association). His visit was as a result of the two million dollar award that was made to a family as a result of the mother taking the hormone pregnancy test with conditions attached that they were not to disclose the out of court settlement..
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In April 1977, the results of a further study of a hundred and four infants who had congenital heart disease and a corresponding control group of the same number of healthy infants were published. The exposure of foetuses to exogenous sex hormones was found to be eight and a half times more common among those babies with malformations than it was among the control group and a H.P.T. was reported as having been the most frequent form of exposure to the hormones. Janerich et al. B.M.J. Vol 1.pp.1058-1060

In the October of 1977, Gillian Greenberg, William Inman et al published results on a thorough study which involved 836 mothers of congenitally malformed babies and an equal number of control mothers from the same doctor’s practices. B.M.J. 2, pp.853-856 They found that there was a clear association between the use of a H.P.T. and the subsequent birth of a malformed baby. During the same year, however, the magazine General Practitioner had revealed that even more H.P.T.s were being prescribed in Britain, and according to independent market research figures, sales of Primodos and other hormone pregnancy drugs in Britain fell by a third following these warnings. Yet some 40,000 women were still prescribed the drugs as a pregnancy test in 1975, even after the first yellow warning, and some 25,000 had been prescribed in 1976, and still in November 1977, after the second yellow warning was issued advising doctors not to prescribe H.P.T.s to pregnant women, 6,000 women in Britain took the drug as a pregnancy test.
The Committee on the Safety of Medicines now informed doctors and chemists ‘that an association between H.P.T. and birth defects had been confirmed.’ C.H.C. News November 1977

As a result of the Associations campaign and the fiasco and the inefficiency of the yellow warnings from the Committee and Safety and Medicines to General Practitioners and Hospitals, was that there was a complete overhaul of this warning system, and a safer alternative was enforced.

· On the 8th of February 1978 the Labour M.P. for Stoke on Trent, Jack Ashley, invited parents of children who were thought to have been damaged by an H.P.T. to a meeting at the House of Commons. He had been influential in helping to gain compensation for those families who had suffered from the effects of the thalidomide drug and had himself become completely deaf when he was 45, due to complications which had arisen during a routine ear operation to correct what had been a mild hearing disability. The drug thalidomide had been launched in Europe in 1958, as a treatment for morning sickness in pregnant women. ‘Tests in animals had failed to find any significant side-effects; indeed, the drug was so non-toxic that researchers were unable to identify a dose which killed the animals. However, thalidomide was withdrawn from the market after it was demonstrated in 1960 that the drug caused birth defects in a proportion of the children of pregnant women who had taken the drug. In Britain, thalidomide was banned in 1961.’ aidsmap.com website/Thalidomide

As a direct consequence of the meeting with Jack Ashley, the Association for Children Damaged by Hormone Pregnancy Tests was formed and he subsequently made many requests for a public inquiry in the House of Commons, but this was repeatedly evaded. Roland Moyle, the Minister of State, Department of Health and Social Security, at the time finally acceded to a request for a meeting with representatives of the Association and this was held on June 6th, 1978. At this meeting Mr. Moyle agreed to reconsider a public inquiry if the Association could produce new evidence.
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· In June 1978, all Community Health Councils C.H.C.s in Engand and Wales as well as all Local Health Councils in Scotland were written to by the Manchester C.H.C. in order to mount a national survey and discover the actual numbers of children who could have been affected by the H.P.T.s. The secretary of the Association’s contact details were included on the forms which were sent out.
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· On the 10th of August, 1978, Mr. Hugh Jenkins received a letter from Erik Deakins on behalf of Roland Moyle and the Department of Health and Social Security saying that he ‘should first like to emphasize that to date the Committee on Safety of Medicines has no definite evidence that hormone pregnancy tests have indeed damaged babies.’ This is an astonishing statement. In addition to some of the scientific research which has been referred to above, the Committee is also reported to have carefully reviewed the following articles in which a positive correlation between the H.P.T. and congenital malformations was found in the results of other independent studies. Hansard 3rd of August, 1978 Janerich et al. ‘Oral contraceptives and congenital limb reduction defects. 1974. Harlap et al. ‘Birth defects and Oestrogens and Progestogens in Pregnancy’ Lancet 1975. L.B. Homes ‘Prospective evaluation of newborns for malformation caused by putative teratogens’ 1975. Nora and Nora ‘A syndrome of multiple congenital abnormalities associated with teratogenic exposure’ 1975. Hellestrom et al. ‘Prenatal sex hormone exposure and congenital limb reduction defects’ 1976. Goujard and Rumeau-Rouquette ‘First trimester exposure to progestogen/oestrogen and congenital malformations’ Lancet 1977. In Hansard, a further note was added stating that ‘a classification of ‘positive’ needs to be interpreted with caution as this does not in itself indicate evidence of a causal relationship between the tests and the abnormalities.’
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· By the October of 1978 the Association had gathered information on over 700 possibly affected children, with additional responses and enquiries from other parents each and every time the topic received publicity. Writs were issued to Schering on behalf of children in an attempt to gain compensation for personal injuries which were alleged to have been caused by the use of Primodos.
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· During the next few months over 200 members of parliament had signed the Early Day motion 422: ‘That this House notes that children have been born with serious deformities due to hormone pregnancy test drugs; that no official warnings were issued about these drugs until eight years after the first reports indicated possible dangers; that some doctors continued to prescribe the drugs for pregnant women after official warnings from the Committee on Safety of Medicines; that the Department of Health and Social Security have continuously rejected requests for an inquiry into these matters; and now calls upon the Secretary of State to set up an independent public inquiry.’ No such inquiry ever took place.

· By 1979, many other European countries had noticed that there was a correlation of the abnormalities mentioned above and the use of the H.P.T. and a similar Association to ours was formed in Germany. However, the Managing Director of Schering continued to deny this and he made a statement on the 19th February which read as follows: ‘At all times Schering has denied that hormonal pregnancy tests like Primodos have caused or were capable of causing injuries or malformations.’ R.D. Rebhuhn

· In the report included in the Community Health Council News of March 1979 it was stated that there was ‘No All Clear for Primodos’ ‘despite a review of the evidence by the Committee on Safety of Medicines C.S.M. which concluded that a causal relationship between the use of the H.P.T. and congenital abnormality had not been established.’ This conclusion had been relayed by Roland Moyle to the House of Commons and was subsequently restated in the medical press. However, the D.H.S.S. on behalf of the C.S.M., assured doctors and chemists in the C.H.C. News that the November 1977 warning still stood. There remained alternative methods for pregnancy testing that were free from such risks available.

· The response to the request for a national survey was sparse and disappointing and in the May of 1979 the chairman of Roehampton Community Health Council, Mrs. Joan Wheeler-Bennett, J.P., from the district in which I still live, also wrote to all other C.H.C.s in England and Wales. She encouraged them to inform parents of the dangers of the H.P.T. and provided contact details for the Association. By that time, two test cases had been filed in the courts against Schering AG and it was thought that parents who had used the tests may be able to obtain some compensation.

· The preparation for the trial was both costly and lengthy and on the 21st of April 1982, when the Association met for the A.G.M. the main topic which was discussed, was the court case against Schering Chemicals. Mark Mildred gave a detailed report of the events of the previous year and reminded the Association that we were being financed by the Law Society out of public funds and that this support could be withdrawn if it was felt that our cause could not be won. At that time, Schering proposed to call three expert witnesses to our one and we were reminded that on the basis of weight of argument alone, Schering must be regarded as favourites to win the case.

· The announcement in 1982 that the trial could not continue was a shattering blow to those who had worked hard to campaign in the interest of the children. We had so much support from many sectors – which included the press, the medical profession as well as two hundred members of parliament who had formally agreed with the motion that a public inquiry should be instigated.

· However, we also felt betrayed because one of our leading medical experts, a Norwegian Scientist who had been in close contact with us, switched allegiance at the last minute and decided to give evidence on behalf of Schering AG as we were preparing to go to court. He had previously disclosed areas in his research that supported our case, and proved how the chemicals present in Primodos could interrupt the growth of the genitalia organs at a most critical stage of foetal development. What was to follow next did not surprise me when another four medical experts suddenly left us to join him. Words cannot fail me of the integrity and trust that we were led to believe by such responsible people who could have helped with their expertise to form a decision that the drug indeed was weighted down with suspicion.

· Also disappointing for the UK campaign was the decision not to broadcast a Thames Television documentary entitled, The Primodos Affair. The Court of Appeal banned the screening of this documentary because of a complaint by Schering’s legal team. The great pity was that this would have been the first network television program which would have brought our plight to the attention to the public in a way that had so far not been possible. We give credit to Thames TV, for their expensive and valiant attempt to make this film which was due to be shown immediately prior to the trial. This film dealt with the development, distribution and discontinuance of the drug.

· In summation, we could prove that Schering’s were negligent but we could not prove causation. The imbalance of Schering’s thirty two expert witnesses to our eventual eight meant the trial could not go ahead, though the judge Mr. Justice Bingham ruled that our children should have the right to return to the courts should new evidence arise in the future which should strengthen our case. In this unlikely event, all of the Association records have been retained by our solicitors in order that members may be re-contacted should a change in situation justify such action.

Questions for our future

It is the view of the Association that the suggestion that people who have taken any prescribed medicine should be asked to demonstrate that there is a causative link between the drug and its effect is unreasonable. We consider this task to be the responsibility of medical scientists and pharmaceutical experts although we understand that it is impossible for all potential and long-term effects to be revealed until a drug has been tried and tested by members of the general public over a period of several years. All drugs are potentially dangerous and we strongly believe that any benefits must be explored alongside potential risks by all pharmaceutical companies before they are sold. In the light of the historic events which have been summarized above, the following statement which is currently being displayed on the Schering Home Page is a complete travesty of the truth of the matter. ‘As a successful pharmaceutical company we are investing in the future of medicine. We develop drugs of high medical value so as to continuously improve the quality of life.’! schering.com website. January 2009

A substance is only a medicine when it acts as a preventive or remedy of illness and if it causes harm, deformity or disease it is effectively a poison. From the scientific research which has been carried out, the Hormone Pregnancy Tests that were prescribed were undoubtedly influential in causing congenital malformations although not necessarily to every foetus or to the same extent in every instance. Does this mean that a causal relationship did not exist? The impairments which have come to be associated with the Test are very wide ranging, from heart defects, hair lips, cleft palates, spina bifida, hydrocephalus, hypospadios, undescended testicles, kidney damage to limb deformities. These are of course all observable physical malformations and it is a possibility that the healthy brain development of some children was also impaired and later identified as some form of learning disability because the first few months of embryonic development are so crucial. Interestingly, a broad spectrum of consequences was also found among those who were affected by the Thalidomide drug. A book written by a leading Paediatric Consultant, Mr. Claus Newman on the Thalidamide subject, previously at Queen Mary’s Hospital, Roehampton, told me that in fact limb abnormalities constituted only a part of the total effect which taking the drug could have on a developing embryo. There is a possibility that the numbers of growing foetuse’s that were affected by the H.P.T. was even greater than those who were affected by Thalidomide. How many miscarriages occurred as a result remains unknown.

Interestingly, the evidence which had rapidly accumulated concerning the connection on between the use of Hormone Pregnancy Tests and congenital abnormalities was so convincing to the American Watchdog, the Food and Drugs Administration, that in January 1975 it warned that sex hormones ‘should not be used in early pregnancy for any purpose. Such use of these hormones may seriously damage the foetus including heart and limb reduction defects.’ Why was it that in Britain, even when the Committee on Safety of Drugs had been succeeded by the Committee on Safety of Medicines which had stronger powers, the authorities were so slow to take action? Why did they deny that there had been any clear outcome of any research including that of their own medical experts? Why were the requests for a public inquiry repeatedly rejected?

Schering was one of the main contenders for the oral contraceptive pill during the late sixties and 1970s. If they had lost their case in court and had to pay compensation to the many children who were damaged by Hormone Pregnancy Tests, they also stood to lose their standing as a reputable manufacture of safely tested drugs as well as any contracts as suppliers of the oral contraceptive pill. Despite warnings in medical literature as early as 1967 in this country and abroad, Schering AG never admitted liability and yet they have the impudence to continue to sell the drug in Nigeria, where it is in fact used ’to effect self-termination of unwanted pregnancy.’ ppf.org website Roussel, the French manufacturer of Amenorone Forte at least had the decency to remove it from the market as a valid test for pregnancy in 1969. Even the concerns expressed in by the Medical advisors of Schering’s own subsidiary company, appeared to have little impact at the head office in Germany. They continued to encourage the sale of this drug with no concern for our unborn babies.
The medical authorities and doctors have, in our view, a very real responsibility to ensure that sufficient efforts have been made and continue to be made so that any prescribed or available drugs are as safe to use as is practically possible. Why was it that the first Yellow Warning - the Medical Profession’s ‘Red Alert’ was sent to all General Practitioners eight years after the first serious doubts were expressed by the doctor and paediatrician, Dr Isobel Gal? Surely, the very utmost of medical care is required to help to ensure that no unnecessary harm is done to a newly conceived embryo. We believe that throughout the stage of pregnancy, most especially the first semester, any potent medication should be avoided unless there are exceptional circumstances and that the Department of Health should do all that they can to protect all persons from needless suffering through the implementation of a thorough, reliable and efficient method of drug screening.

Hormones are the chemical messengers in our bodies, responsible for physical growth, sexual development, metabolic rate and energy levels. They are powerful. ‘It takes only a tiny amount to cause big changes in cells or even your whole body. That is why too much or too little of a certain hormone can be serious.‘ MedlinePlus website Increased amounts of oestrogens in river water have been found to change the sex of fish, for example. It is a well known fact today that if you plan to become pregnant it is advisable to discontinue using the contraceptive pill for several months before trying to conceive so that the natural balance of hormones within your body can be restored. The reason that the contraceptive pill works as a method of birth control is that it makes the body think that the woman has already conceived and although when they were first manufactured they were seven times stronger than those which are taken today, any hormones, even at low concentrations, are extremely potent. Perhaps now is the time that we say enough is enough, and to ask ourselves, ‘Why were so many of us, as women, being slowly poisoned with hormone drugs into a chemically-controlled generation?’ I mention this because as an individual I have always trusted that medical doctors would know what was best for my health. In the 1980’s I saw a Consultant Gynaecologist at my local hospital who advocated that all post-menopausal women should be put on Hormone Replacement Therapy H.R.T. for life and I took his advice. Twenty five years later on, medical research has shown that particularly for women over the age of 50 years, H.R.T. increases the risk of developing breast cancer, strokes as well as heart disease. There is also some evidence to indicate that it can affect a decline in cognitive ability.

Oral contraceptive pills are now freely provided to women within our society without a doctors’ prescription and they are very widely used. Not only may this not be in the best interest for the health of all the women who take them but there is growing scientific evidence to show that the future of the human race may now be in jeopardy. Two Cambridge Scientists, who began their studies in 2001, are continuing to investigate the impact of everyday chemicals in the environment on male reproductive health. They have found that more boys are now born with undescended testicles, which often leads to a higher rate of infertility as well as testicular cancer. The Scientists report that testicular cancer rates have doubled in the past quarter of a century and a potential recent study which was carried out in Scotland found that one in six men now has a low sperm count. There has also been an increase in more serious genital abnormalities. Last year, the European Union were so concerned about the impact of modern chemicals on human health that they decided to have 30,000 chemicals tested at a cost of £7.5 billion. Perhaps the results of this investigation will help to clarify and illuminate any dangers of our current lifestyle. Mr. Imran Mustag, a Consultant Paediatric Urologist at Great Ormond Street Hospital, London is quoted as saying: ‘There just doesn’t seem to be enough public awareness and enough interest in what is a common condition. The general impression of people who do this form of surgery is that the incidence of undescended testicles is increasing. Hypospadia is also on the increase with one boy in every two hundred and sixty, with the opening of the penis in the wrong place, in some cases at the base of the penis, or even underneath the scrotum.’ Steven Swinford and Roger Waite The Sunday Times 20th January 2008

A scientific paper by Shiva Dindyal of Imperial College, London, which reviewed the research on whether there is a hormonal basis for the decrease in sperm count of males throughout Western Industrial society referred to thirty-four studies, many of which suggest that synthetic oestrogens have been highly influential. Over a period of twenty years the average sperm count has halved and this is serious because if this downward trend continues, within one generation, the ‘average’ man will be classified as being infertile, by current standards. Dindyal explains that any manmade chemical can act as a weak oestrogen because they mimic in part, the actions of natural hormones. These synthetic chemicals are present in plastic containers, in pesticides, paints and exhaust fumes. Another source of oestrogens is tap water because although they are excreted in women’s urine, water treatment does not remove them. Several studies indicate that the exposure of the embryo or foetus to a higher level of oestrogen than is normal is the main cause of the decreasing sperm count. The Internet Journal of Urology Vol.2 No.1. 2004
Even more publications have been written of the association of hormone drugs that have been leaking into our rivers and the sea via sewage waste for years. The affect of this hormone to fish that we consume, and of the catastrophic changes to the sex of fish could have an adverse affect to mankind. The discovery of these hermaphrodite fish was kept quiet by the Department of Agriculture for two years. Yet researchers surveying the Great Lakes of Apopka in the late eighties found that members of sixteen bird species, which were fed on fish from the lakes (especially alligators and birds), were known to be contaminated with some sort of oestrogen- like chemicals. These animals were failing to develop to reach adulthood and were sterile. (The Internet Journal of Urology Vol.2 No.1. 2004)

CONCLUSION

I hope that this background information will be useful to all of you and especially to the children of the mothers who were prescribed Hormone Pregnancy Tests, who are now grown men and women. What I would like to convey to you is that the association fought in vain to compensate you for your injuries. Sadly, we lost to a major drug company who showed no compassion, who spent five and a half million pounds on their defence to prevent us winning and were insincere throughout in their claim that their product was safe, which has resulted in a life sentence of suffering to thousands of children worldwide.
Also it must be noted that the Q.C’s decision though complex, in no way eliminates or in any way diminishes the suspicion about Primodos and other HPT drugs.

Finally, to the parents and siblings of the babies and children who never stood a chance, and to the children whose lives were short lived, and whom the memories may still be a significant part of your lives: I can only hope that you have found peace in your hearts as well as adjusted to your tragic loss, supported by the strength that is within you, from the love and comfort of those who are nearest and dearest to you.

Valerie Williams - Chairman
valival@live.com
19 Drew Close
Bridport
Dorset
DT6 3JG
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