"David and Goliath"
Why did we use a Hormone Pregnancy Test? - Our doctors' gave it to us.
What were we thinking? - We didn't think, we trusted.
Who did we trust? - Our own Doctor and The Committee on Safety of Medicines.
Who are they? - The Authority formed after the Thalidomide Disaster to ensure it never happened again.
What happened? - Look
What about the Drug Company responsibility? - The Drug Company took their responsibilities very seriously - The serious responsibility for making huge profits.
Didn't they ensure that the drug was fully tested and safe? - They have no conclusive data on the safety of the drug, in pregnancy.
Did the Committee and the Drug Company know there were serious concerns? - Look
Radio Interview with Marie Lyon in Germany
The below article has been translated from German and includes journalistic interpretation in some areas. Thank you to Mrs. Falla, who funded the translation. Please click on the article to read the full story.
Der Speigel Article 2016 - Translated from German. We owe a huge thank you for the assistance of Robin Hayes, former Secretary of the Association and to his Son in Law, for the translation.
Hundreds of women that have taken the hormone drug Duogynon have given birth to dead or severely disabled children. Internal documents show that the Schering concern knew about possible health dangers.
Birgit had nice hair long and blond, on pictures you can see her laugh. She got married to Heiko her childhood sweetheart and they managed a small shop. From her last cruise holiday she wrote, "the water in the Mediterranean Sea is glorious."
Birgit was the daughter of Gisela Clerc. Her mother has taken the pictures of her from the wall in the living room, "I could not stand to see them anymore" she says.
Birgit died on the 9 of January 2016 after a long battle with death, she was 47 years old and her heart did not managed anymore.
Gisela Clerc aged 74 has not coped with her death very well, she feel partly responsible that her daughter died so young, "I feel so guilty and the feeling does not leave me alone".
48 years prior, it was on a Tuesday, the mother of a 7 year old boy sat at her doctor, her menstruation did not happen and she was unsure, as doctors have told her that due to kink in her uterus she would not be able to have more children. Her Doctor suggested a pregnancy test the drug was Duogynon a hormone drug that was used to bring on the menstruation unless the women was pregnant. Gisela Clerc started to bleed heavily despite being pregnant.
When Brigit was born in January 1969 her parents were shocked, the baby was almost deaf in her left ear, bad eyesight and has crippled fingers on her left hand. But most serious was the Ductus Botalli - a potential life-threatening heart condition that will restrict your normal stamina.
To make sure Birgit could live a good life the family moved from Berlin to Franken, the nursing of the disabled child controlled their life from then on.
In the clinic where her daughter was operated on, Gisela meet other women that also where given Duogynon during their pregnancy. Their children suffered from Hydrocephalus, crippled arm and legs, damaged bladders and penises, hearts and kidneys.
Some of the women started to seek the responsible party for their ordeal. They started to look at way to start court action against Schering AG, a Berlin based pharmaceutical company which has bought Duogynon to the market. Gisela Clerc was now certain that what happened wasn't fate and instead the pregnancy test was responsible for the disabilities of her daughter.
But she decided not to sue, instead she brought up her child. The outrage came later, now she wants that the people guilty are going to take responsibility.
This is why she is now the main person in the drama surrounding Duogynon, a fight between people that see themselves as victims of a pharma concern and a pharma giant. It is a drama that always stood in the shadow of the big Contangan-Scandals, but we are seeing here similar pain and fate.
With support from the Duogynon Interest Society where affected parents and children are organised, Gisela filed a lawsuit at the Berlin Prosecution Service for murder of her daughter. The official lawsuit is aimed at unknown, but means the responsible personal at Schering AG at the time this happened. The opposition is not the Bayer Concern in Leverkusen which has bought Schering 10 years ago.
The new court case is possibly the last chapter in a health scandal which has left hundreds if not thousands of disabled people and parents of dead children. Until now they have had no explanation, no responsibility and no compensation. Until now all that they have seen is playing it down and playing for time, from one side to the other. A show of the power of money and the feeling of being powerless against a multibillion concern.
The history of Duogynon starts in the fifties. Schering sells the hormone drug for the treatment of menstruation problems and as a pregnancy test in form of pills or as an injection. There was already the possibility to do a urine test but it did not give accurate results. So if a woman did not start her menstruation bleeds the result was PREGNANT.
The drug become a hot seller, Schering sold worldwide just in 1968 around 3.8 million packets.
"My marriage did not survive the strain put on by having a disabled child".
Gisela was devastated when her daughter Birgit was born disabled, she never smoked and also did not drink alcohol. Her son was born healthy weighing 9 pounds. Initially she did not think about the 2 tablets of Duogynon given to her by her GP.
Also her Doctors seemed to be clueless on what could have caused the disabilities. Nobody drew a line between Duogynon and the possible dangers. The knowledge about possible dangers for growing foetuses was very limited - at least outside of the Schering AG.
Schering had, at least since the end of the sixties, knowledge that Duogynon possibly was risky medication. Internal documents which, were kept under lock and key, show that Schering certainly knew about possible risks of this drug - but still kept selling it regardless.
Schering brought this drug to market without adequate tests. This was not an uncommon practise in those days as the pharmaceutical market was barely regulated. Companies where allowed to sell even highly effective drugs without proper tests. Under today's rules and regulation Duogynon would not even remotely have a chance to become certified.
Old court files, which Der Spiegel was able to see, show that Schering was warned in the late sixties by various animal tests. They had knowledge of possible side effects of this hormone drug.
Tests were conducted with different dosages, with the result that some dosages resulted in disabilities and the death of foetuses. Other test showed that test animals showed weight loss. In 1971 a scientist recorded that a test dose was "highly embryotoxic is and a cause of early cell death".
But according to the test protocols these findings where put aside, sometimes with the argument that test samples were too small to relate the results to the drug. Further test where prolonged in order to delay further results. Then scientist also argued that the disabilities could have natural causes. Schering tested the drug on Rats and Rabbits, never on humans, for a long time not even of monkeys.
Most of the time the tests were conducted only on "Duogynon Simple" the injecting version. Critics felt that this version was not as dangerous as the "Duogynon Tablets". The aggressive tablets were sold considerably more often. The tablets effects are only recorded in a few tests on animals - with alarming results. One foetus had an oedema in the full body which indicates a serve heart fault, also recorded are deformity of the brain. There is a note in the test report saying "a connection between the abnormalities and the substance application cannot be fully discarded".
Unrest was raised by the end of the sixties at the concerns headquarters in Berlin, as more and more letters from angered parents reached the law department. All of which had children with severe disabilities and where making taking of Duogynon responsible.
Very critical was an initiative from the UK, where the paediatrician Isabel Gal 1967 openly raised the suspicion, that the female sexual steroids in the drug can cause the disabilities of the foetuses. The drug remained on the English market where it was sold by Schering under the name "Primodos".
It still took a few years before Schering added warnings about side effect to their packs not to take Primodos during pregnancy and to use this drug only for problems with menstruation.
In the Schering headquarters some doctors become very concerned, which is shown by an internal protocol notice from 1977. That there is still no evidence to be put forward in order to contradict Isabel Gal's suspicions. To quote these "Should this matter ever be discussed openly, would we as a company receive some compromising questions, why we have not made any afford to proof the safety of our products."
This was the time when the company started a strategy which was aimed to perfect the art of "playing it down". The driving force here was the Schering's internal law department. In 1977 Schering expected a law suit from the UK. At the beginning the law department did not enforce any tactical matters in order to fight this, as there was no knowledge on which court would handle this, so an internal notice from Schering states "we do not want to be forced at an early stage to have the public against us".
Law suits could endanger Schering worldwide business and concerns over the image of the company were growing. The danger of being held liable is always there - was noted by Schering for the Japanese market - and started to look for experts that could clear Schering from guilt if it went to court.
Schering was searching for suitable Professors all over Europe, and produced detailed profiles. In long list records of the first contact the name of the Schering employee that worked on this contact. The verdict on one scientist read, he is friendly toward the industry but does not come cheap!
1977 Schering's layers knew that their central line of defence was not easy to hold. Some experts raised concerns and judged the arguments of Schering's as "not sufficient". It was stated that even industry friendly science have a tendency to show morals. It was suggested that Schering has a serious problem as the results on animal test in the sixties should have been pursuit.
The law department ignored the critical voices, and went to go with optimistic experts and blocked further. It went so far that even their own insurance companies where not informed. The assurance did ask, because of the pending court case in the UK for the full file with all the documents available on this. The law department was ask to check which documents that could be given if forced, bearing in mind that internal documents also contain internal thoughts, which only reflect their point of view.
The in house documents showed that some of the own employees and internal experts where critical about their own Schering science: as they did not conform to the usual scientific standard, also where all the tests conducted were not applicable to humans. Schering still did not follow proper procedure "by taking the suspicious product of the market".
1976 - 25 years after introducing Duogynon to the market - Schering also first started test on Rhesus Monkeys. But more for selfish reasons: "such test would help when defence is needed in a court case" one internal note reads. In Germany the questionable drug was renamed from Duogynon to Cumorit.
Finally Schering found an English expert - at a symposium in Bermuda . This man produced a 2 page expert report in which he gave precise instructions.
"It would have been necessary to take the drug off the market - they did not do this"
In the public Schering still showed self-confidence. A company spokesman said in November 1978, it is the "solid" and most severe analysed and factual based conviction, that there is no causal relation between the disabilities and Duogynon.
1981 Schering stops the distribution of Duogynon in Germany without giving a reason.
In this year the second act of the Duogynon drama begins. Mothers that have given birth to disabled children went public. The Stern magazine showed large format pictures of children with crippled arms and legs. On picture shows a boy with Lederhosen: "Andre is 2 and a half years old and has severe disabilities on his bladder and penis".
Minutes for internal meeting in the higher ranks of Schering show how nervous they became. Prosecutors started in 1978 to interview Schering employees. An internal taskforce became the order to collect all files concerned and to check that they are worded in a way that could not be held against the company in any case of an expected court case.
In a board meeting Schering managers announced that they have signed an adviser contract with the lawyer who has been working for the Pharmacompany Chemie Gruenthal "to ensure his experience he has made in the Contangan case"
The drug Contangan which was recommended as a remedy for pregnant women caused birth defects in around 5000 children. It resulted in a court case, but after 250 days in court the damaged parties cut a deal with Gruenthal. They dropped the case and Gruenthal paid 100 million D-Mark to the Contangan fund.
Gisela Clerc learned about the criminal charge filed by the "Interest group Duogynon damaged against Schering" in the TV news in summer 1978. The spoke about "negligent bodily injury" Gisela was electrified, but she had not the strength to join. "My marriage has not survived the drain on bringing up a disabled child" she says, "during the day I have looked after my children and during night I have worked in order to maintain ourselves". In a readers letter to the Stern magazine she talk about her daughter Birgit who by then has been subjected to two complicated heart surgeries.
The Berlin prosecution office confiscated files at Schering, but then stopped the case against the responsible party rather quick with the reason, that it cannot be proven beyond doubt that the disabilities been caused by Duogynon, and embryos are not Humans in the letter of the law.
In a dossier over 182 pages the lawyer of the "Interest group Duogynon damaged against Schering" complains about serious faults in this case from the side of the prosecution - one of which was that he was not given access to important files concerning this case, but his criticism was not considered.
Schering documents are now proving that Schering has influential allies on the government side, and also had an informant in the Ministry for Health (BGA).
The Professor was employee of the Ministry of Health (BGA), but was also in close contact to Schering. Through him Schering was informed in advance about internal predictions, conclusion of internal discussions and possible steps to be taken by the Ministry. Through him Schering also placed documents into the Ministry in order to ease the relations between the Ministry and Schering in order to get a milder sentence.
According to a notice made about a conversation, the Ministry of Health person called himself an "Advocate for Schering", in another notice he states "his aim is to stop a decision made to withdraw Duogynon from the market".
Representatives from the Ministry and Schering had a number of informal discussions in order to decide, how to precisely doctors should be informed over the usage of the drug, or how the patient information packed inside the pack should be worded. Schering seemed to have such a good relation with the Ministry that letters in which they pay their respects and gratitude, are exchanged and talk about "that the common problems and interest where discussed in an atmosphere of trust and understanding shown by both sides".
In practise nothing was done by the Ministry to take Duogynon off the market. In interviews given by the head of the Ministry he was proud to say, that his department with oversight and responsibility have fought off calls for Duogynon to be withdrawn from the market.
With the withdrawal of the investigation in Berlin Schering was relieved of their biggest problem, the frustrated parents went back to their everyday lives. Also the court cases pending in UK did not go anywhere fast. One of the biggest German pharmaceutical scandals would have gone for forgotten if it had not been for Andre Sommer - A sporty man from the Allgaeu (Bavaria), who's picture, dressed in a Lederhose was published in the Stern magazine 35 years prior.
Sommer was born with his bladder placed outside his body, and he fought through life despite his disability, a massive burden to carry as he said. Due to his disability he had up to now suffered 14 operations, he has never had a normal childhood. His mother who was an early fighter in the Duogynon movement also suffered 15 years prior a heart infarct and is since then in a waking coma.
When Sommer started his job as a teacher in Pfronten (Bavaria), he felt secure enough to tackle the question that has been bothering him for a long time. How could such a disaster happen, and why have this never been fully investigated? He started internet site Duogynonopfer.de.
In summer 2010 the Spiegel magazine started to publish his story. That's how the 3rd act of the drama started. More the assumed 400 sufferers got in touch with Sommer, this time not the parents instead the damaged children, which were demanding answers. First Sommer started to catalogue of the damages suffered. 141 sufferers reported deformed limbs, 66 sufferers report deformed organs and 26 suffered brain damage.
Gisela Clerc also contacted Sommer. Her daughter was by now grown up but health wise she did regardless of all the operations suffered with a weak heart.
Sommer involved Joerg Heynemann a medical layer based in Berlin, who already had had fought a few big players in the pharmaceutical industry. He is also a pharmacist, "first of all I was very sceptical, but then I discovered the amazing parallels to the Contangan case" Heynemann says, "with the only difference that Bayer and Schering are taking advantage of their power even more than Gruenthal back then".
Heynemann filed a law suit against Bayer AG. But very quickly it becomes obvious that Bayer had no intention to hand over either the old files or that the wanted to go into battle with the Duogynon victims.
Heynemann talked to scientists who had been involved in Duogynon research. He also met a few times with a man who introduced himself as an ex-employee of Schering France. This man claimed that at the beginning of the nineteen eighties he handed five figure sums of money to well-known scientists. For this they vouched for the harmlessness of Duogynon. Heynemann stated this to the court in 2012 and ask for this man to be heard as a witness.
Bayer did not comment on this allegation. The company just repeated what they always have said, that there is no connection between Duogynon and the deformities and that this has been proven by numerous studies. The Bayer layers also stated that the case has now lapsed as time has gone by. The Berlin county court filed in favour of Schering on the argument that the case was lapsed. But the judge gave some advice to the layers of both parties, that he thought a large company such as Bayer should be interested in a solution and a dialog should be started.
Gisela Clerc was present at the court hearing. She gets angry when she listens to Bayer lawyers as well as the Bayer board at shareholder meeting, "Everything bounces off them like water of a ducks back", she says.
In 2013 she wrote to the German Chancellor Angela Merkel to ask her if she could make an effort to start a "round table" discussion, but the government saw no need to interfere.
The civil servants involved also advise that due to experts report triggered by the Ministry for Pharmaceuticals and Medical Equipment, the experts involved can neither confirm nor dismiss any connection between the deformities and Duogynon. That the Professor who led the project on behalf of the Ministry also worked for Bayer on the side, remains suspicious.
The story about Duogynon would probably end here, if Layer Heynemann and Sommer during her investigation for the lawsuit had not made a surprising discovery. In the county archives of Berlin they find the case files for the 1980 stopped court case, a total of 7000 pages. With them also the supporting files of the case, documents from Schering, which were not disclosed to the victims lawyers at the time. Now Bayer tried, unsuccessfully, to keep these files under wraps.
Whilst Heynemann managed to fight for the full hand over of these files in Berlin, the daughter of Gisela Clerc fights for her life. In the passing years Birgit has weakened considerably, her heart struggles to supply her body with blood and the heart valves are very damaged. A further operation on her aorta at the University Clinic in Essen is needed, Birgit is connected to heart-lung machine, she dies after 4 days after the operation.
Whilst Sommer and a team of helpers works through the old Schering files, he finds reports on the old animals tests, and the advice from the Schering scientists that, in case of lawsuits, to always doubt any connection between the drug and the problem.
At the beginning of June, Heynemann together with the law expert Detlev Stoffels, brings charges in the name of Gisela Clerc at the Berlin Prosecution Service for murder of her daughter Birgit - a criminal offence that never lapses, in the eyes of the law.
The files show, confirmed by the two lawyers, that leading Schering employees themselves did not dismiss causality between the taking of Duogynon and the deformities. Later, when it was feasible to see the risk, including cases of death, the medication should have been withdrawn from the market. By not doing so have at the least, responsibility for the consequential deaths of the children. The Berlin Prosecution Service is now investigating under case number 234 UJs 2041/16.
Until this day Bayer denies any responsibility. The company "still excludes Duogynon as the causing factor for the embryonal deformation". "Extensive studies have been conducted in the by prominent scientist and experts in the seventies and eighties which have been evaluated for possible causes without showing any evidence of a causality connection", as stated by a Bayer spokesperson.
The pharmaceutical people have not spoken to Gisela Clerc or anybody else concerned.
I attended a meeting with the MHRA on 18th August 2015 in London, to discuss our understanding of the mechanism involved in the Inquiry. The meeting was arranged to ensure full discussion about the the process of the Inquiry, including the agreed Terms of Reference. This issue is yet to be resolved.
A huge thank you to all the members who responded to the request to contact their MP's, to ask them to attend the Chamber of the House of Commons on Wednesday, to support Ms. Yasmin Qureshi MP, Chair of the APPG and Mr. Jacob Rees-Mogg MP, Vice Chair. Although the urgent Question regarding the Inquiry could not be taken on Wednesday, it was asked by Mr. Jeff Smith MP, on 17th Sept'. The link on the BBC website isA huge thank you to Mr. Smith.
It has become apparent that the disputed effects of HPT's have been a source of concern throughout the world for quite some time, especially Germany and other countries in the European Union. With this in mind, I have written to a representative number of MEP's, who cover the areas of our membership, in Scotland, Ireland and Wales. I have had some positive response and will continue to follow this up.
I have also written to nine members of the House of Lords, who have particular interest in Health, or could be influential in other areas. I will keep members updated on the response to this request.
The Association is extremely lucky in the assistance we have had from 2 friends in Germany, who have given their time to search for vital studies needed for the Inquiry. The people involved do not wish to be named, but I would like to thank them for their invaluable help. We had a very difficult and all consuming period of searching and reviewing these studies for the deadline implemented by the MHRA. The last studies were forwarded at 2 minutes past midnight on the last day of the deadline. I would also like to thank Daniela, who helped with translating some of the documents.
We are currently waiting for studies and information from the U.S.A. which we have requested. I have asked that these be included in the Inquiry, as the time taken to supply theses studies is out of our control, which would mean receipt of the documents is after the deadline.
The first meeting of the Expert Working Group (EWG) is on 14th October and I will be attending as an Observer, plus attending all subsequent meetings. The discussions at the EWG meetings will be strictly confidential and will remain so, until the final Report is produced at the end of the Inquiry. Consequently there will be no updates on the progress of the Group or the content of the documents assessed. However, I will keep members updated on the dates of the EWG meetings.
Thank you to so many of our members who have given their unfailing support. I really cannot thank you enough for your kind words and positive response to the many requests for your help.
A great deal of time was spent in Westminster during the last 18 months, lobbying MPs to join the All Party Parliamentary Group, set up to support the Association in our call for an Inquiry. Although time consuming and tiring, it was to prove a great success, as we gained the commitment of 45 MPs, who agreed to join the Group. This was made possible by Ms. Yasmin Qureshi MP who was instrumental in setting up the APPG and Mr. Nick De Bois MP, who agreed to the position of Vice Chair. We also thank Ms. Sadia Ali, Personal Assistant to Ms. Qureshi MP, who has worked tirelessly to support us, since reviewing our focus in November, 2012
It was a great blow to the campaign that Mr. De Bois did not retain his seat in the election and he will be missed for both his contribution and for his dedication to his constituents and the Association.
At a debate in the House of Commons, on 23rd October, 2014, Mr. George Freeman, Minister for Life Sciences, agreed to a full Medical Inquiry into the effects of Hormone Pregnancy Tests. The debate was fascinating to observe and can be viewed on Hansard,Ms. Yasmin Qureshi MP, and Mr. Nick De Bois MP, were magnificent in their supporting speeches. All MPs who contributed at the debate were both compassionate and articulate in sharing the stories of their constituents and I believe it was the support of all the MPs, which helped secure the agreement of Mr. Freeman to an Inquiry.
Our AGM was held in Birmingham on 14th March 2015 and was attended by 91 members. A separate meeting held on 11th April, near Gatwick Airport was attended by 24 members, who were unable to attend the AGM in Birmingham. On 22nd April 2015, a meeting was held in St. Andrews House, for our Scottish members. The meetings were arranged to ensure that I could share with as many members as possible, the sensitive and highly confidential information relating to our progress.
The Association has now reached 180 registered members, which is a huge increase from our membership of 67 members, in November, 2012. Thank you to everyone who has contacted the media and helped to raise awareness of the campaign.
The meeting Mike and I attended in St. Andrews House, Edinburgh on 22nd April, was followed by a meeting in Holyrood with Ms. Shona Robison, Minister for Health, Scotland and Ms. Kathryn Fergusson, Head of Medicines Branch. Ms. Robison has offered vital support to the Scottish members and the Association, by writing to Mr. Freeman on several occasions, to highlight her concerns about the effect of HPT's and also confirms her commitment to monitor the progress of the Inquiry. Ms. Fergusson has also vigorously supported our campaign, plus kindly provided refreshments and premises for the initial members meeting.
I contacted Ms. Lisa Lunt, Solicitor, Gregory Abrams Davidson LLP, late last year, to ask if she would be interested in representing members of the Association, in a legal challenge. Lisa arranged to meet with me the following day and spent 5 hours discussing the evidence we had and the feasibility of representing our members. I was very impressed by the commitment displayed by Lisa and her Associate Sarah and agreed that all documents could be photocopied for their files. Lisa also attended the AGM in March and gave a welcome presentation on the legal aspects relating to litigation. A pack containing information and an application form was available to all members who attended. We have finally completed the task, of sending the information packs by email and post, to all non attending members. I emailed Lisa early this year, with contact details for Dr. Gal's daughter, who had the many files Dr. Gal had accumulated over the years. I believe the files have now been received by Lisa. I also agreed to sign a release to enable Lisa access to the files from Peter Todd, our former Solicitor. I will update the website when I have more news on Lisa's progress.
Please contact Lisa if you wish to have legal representation. Lisa's email details are:
Contactto ensure your details are added to our members list. Members of the Association will have access to confidential information, which will not be made available to non members, although they may still be represented by Gregory Abrams Davidson.
Chris Gooch and Michael Lyon have completed the mammoth task of compiling all the information detailing the anomalies and medical histories of our members. This has been extremely time consuming and we owe a huge thank you to both Mike and Christine for their hard work in completing the detailed information. The spreadsheet containing the names and anomalies suffered by the members who returned the completed enquiry form, will be forwarded to the MHRA, prior to the Inquiry.
It is essential that members who wish their details to be included in the spreadsheet, contact us without delay, on the contact numbers displayed on the website.
Due to the general election, the APPG had to be dissolved and re-formed when the new Parliament was resumed. The last few weeks have been focussed on writing individual letters to MPs, whose constituents are members of the Association, asking them to join the new APPG. A total of 100 letters have been posted and by the end of this week, the full list should be completed.
Ms. Yasmin Qureshi MP, will continue to Chair the APPG and Mr. Jacob Rees-Mogg MP, has kindly agreed to the position of Vice Chair.
At a meeting with Robin Hayes, Secretary of the original Association, I was allowed access to the many documents and correspondence, initiated by Robin during his years as Secretary. The documents and correspondence highlighted the enormous amount of work and initiatives, undertaken by Robin, during that time. Robin was a great driving force and travelled extensively to promote the concerns about HPTs and continues to be a supportive member today.
Mrs. Valerie Williams was Chair of the original Association. Mr.Karl Murphy held the position of Chair from 2009 until November, 2012. Both Mrs. Williams and Mr. Murphy have worked to highlight the dangers of HPT's and we acknowledge their contribution.
Mrs. Williams and Mr. Murphy are no longer members of the Association and their views do not represent either the Association or it's members. We wish Mrs. Williams and Mr. Murphy well in their endeavours, but our campaign does not reflect their aims or direction.