How responsible and valuable is the EWG report about Primodos side-effects ?

Sky’s Jason Farrell special report: Primodos revisited – the Government study

Two weeks ago, an Expert Working Group (EWG) of the UK’s Commission on Human Medicines (CHM) has published their report on the use of hormone pregnancy tests (HPTs) and adverse effects relating to pregnancy including possible birth defects.

A lecturer in medical sciences says its not possible for a Government-commissioned study to conclude that Primodos pregnancy drug was safe.

Commission on Human Medicines

  • Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests, gov.uk.
  • Referral letter for genetic testing, gov.uk.
  • Press coverage, news.google.

More About Primodos

MPs Challenge the EWG Report Findings in ref to Primodos and Hormone Pregnancy Tests

MPs attack “whitewash” report on hormone pregnancy test drugs

MP Justin Madders has written – twice – to the government, asking why the Primodos expert working group changed the conclusion of its controversial report.

A large number of MPs have challenged the findings of the EWG report, a government-led review which suggested the Primodos pregnancy test drug was not responsible for causing deformities to children.

I know the Minister very well. He is a passionate and caring Minister, but I am afraid that I disagree with many of the things he said this morning. The families do—I think, rightly—feel that the report is a whitewash. Material has been removed from the draft, and the group looked into matters that were not within its remit. The question of a causal link was not in its remit. The question was whether there was link with a drug that was often given to our constituents with no prescription: a drawer would be opened, and it would be handed out to them so that they could find out whether they were pregnant. An open inquiry was needed, but I am afraid that the families, and many Members who are present today, will not feel that that was what happened. Will the Minister please meet the families again, with members of the all-party group, and try to understand why they are so upset? Will the Minister please also watch last night’s report on Sky News, which exposes much of what has being going on over many Parliaments? No matter who was in government, Governments have ignored these people, and we cannot continue to do so.

Mike Penning,
Conservative, Hemel Hempstead

On Friday, two constituents came to my surgery to speak to me about exactly this. The mother had taken one of these pills and her daughter was born with deformities. This is not the Minister’s report—he is just giving his explanation and doing his job—but may I suggest that we have a proper Back-Bench debate in which we can exercise all these issues? With great respect to the working group, and having had some experience as a former public health Minister and knowing about contaminated blood, I am afraid to say that I smell something like a very large rat in all of this. I think that there have been cover-ups.

Anna Soubry,
Conservative, Broxtowe

My hon. Friend is clearly struggling to defend this position. I urge him to look at the scope of this review and all the evidence that was presented to it, as all the evidence that was available should be looked at and looked at again. Without that, many people across this country will not be satisfied that justice has been done.

Bob Blackman,
Conservative, Harrow East

It is my understanding that in the research on fish, the researcher was reluctant to submit the findings because they had not been peer-reviewed. Is the Minister confident that all the animal studies that were considered in this review were properly and adequately peer-reviewed? We now know there are many studies included that were not peer reviewed.

Liz McInnes,
Shadow Minister (Foreign and Commonwealth Affairs)

 

Like Anna Soubry, I am reminded of the contaminated blood inquiry, which is ongoing. In 1975, the regulator knew that there was a potential 5:1 risk of the drug causing deformity. They told the manufacturers but not the patients, and papers were deliberately destroyed by the chief scientist. It is deeply worrying to the families that there is not an open and transparent investigation into this matter. Does the Minister know whether the Berlin archive papers were examined as part of this inquiry, because they demonstrate the cover-up that has happened over many years?

Madeleine Moon,
Chair, Defence Sub-Committee

I come to this having had no constituency involvement in this issue at all, but I have been listening to the exchanges this morning and it is quite clear that the level of concern on both sides of the House is sufficient for the Government to call a debate on the matter in Government time, so that all these issues can be properly explored.

Philip Hollobone,
Conservative, Kettering

Is the Minister aware of the study in 1979 from Primodos that concluded that the visceral malformations should be considered to be drug-related? The manufacturer seems to have made a link that does not appear to have been dealt with in the report. Does he acknowledge that serious concern is being expressed on both sides of the House about the transparency of this report and that it behoves us all to try to make it transparent and understandable and, above all, to get to the correct answer?

Martin Whitfield,
Labour, East Lothian

The report must be judged against the background of the fact that the thalidomide scandal involved only 20 birth defects in America and 2,000 in this country, that we are still misinforming and under-informing mothers and potential mothers about the valproate scandal and that GlaxoSmithKline was fined $3 billion for distorting the results of its research. The Minister must tell us how many members of the expert group are present or past employees of the pharmaceutical industry.

Paul Flynn,
Labour, Newport West

I have a constituent who has been affected by this issue, and they want justice. Based on what I have heard today, justice has fallen short in this case. In any normal circumstances, justice must not only be done, but it must be seen to be done. If the criteria have not been applied correctly, we would in normal circumstances have a review to get the correct decision in the end. Will the Minister look at the matter and get it reviewed?

Rehman Chishti,
Conservative, Gillingham and Rainham

Is the Minister aware that in all the years that I have been here, I have never heard of such a decision, particularly one made by this party, presented by a Minister of Health who is constantly telling us all about the Stafford inquiry and how important the last Stafford inquiry was? It is time that he considered the possibility of having this thing reviewed, bearing in mind that we are dealing with drug firms that have millions and millions of pounds. He should start all over again from the beginning. It will otherwise be a bad day for the Government if he is allowed to say what he has without listening to the people from both sides of the House who have rubbished the report.

Dennis Skinner,
Labour, Bolsover

As has been said, this is absolutely not a party matter. Colleagues have expressed their interest in a debate on this matter, and I can simply say from the Chair that, one way or the other, through one vehicle or another, this matter will be debated if Members want it to be debated.

John Bercow,
Speaker of the House of Commons, Chair, Speaker’s Committee on the Electoral Commission, Chair, Speaker’s Committee for the Independent Parliamentary Standards Authority, Chair, Commons Reference Group on Representation and Inclusion Committee

House of Commons

Urgent Question: Hormone pregnancy tests,
Thursday 16 November 2017, check from 10:40 to 11:11 here.

UK Commission on Human Medicines

  • Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests, gov.uk.
  • Referral letter for genetic testing, gov.uk.
  • Press coverage, news.google.

More About Primodos

Causal Association Between Primodos and Birth Defects : the EWG report

Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests

An Expert Working Group (EWG) of the UK’s Commission on Human Medicines (CHM) has published their report on the use of hormone pregnancy tests (HPTs) and adverse effects relating to pregnancy including possible birth defects.

Sky’s Jason Farrell confirms alleged victims of pregnancy test Primodos slam EWG report which found the drug was not responsible for serious birth defects. Campaigners say that the hormone pregnancy test review was a complete whitewash.

Commission on Human Medicines

  • Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests, gov.uk.
  • Referral letter for genetic testing, gov.uk.
  • Press coverage, news.google.

More About Primodos

Primodos EWG Report : Jason Farrell Reveals

Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests

An Expert Working Group (EWG) of the UK’s Commission on Human Medicines (CHM) has published their report on the use of hormone pregnancy tests (HPTs) and adverse effects relating to pregnancy including possible birth defects.

Sky’s Jason Farrell shares some thoughts.

Commission on Human Medicines

  • Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests, gov.uk.
  • Referral letter for genetic testing, gov.uk.
  • Press coverage, news.google.

More About Primodos

We should recognise the impact Primodos has had on women who took it, said Theresa May

MP Mims Davies asked PM about Primodos scandal in PMQs

Mims Davies, MP for the Eastleigh Constituency, questioned the Prime Minister about Primodos : “Should there be a public enquiry?

Sky News’ hour-long documentary Primodos: The Secret Drug Scandal – presented by senior political correspondent Jason Farrell, who investigating it for six years – revealed how documents were destroyed and information withheld about a drug that may have deformed and killed babies in the womb.

More Information

More evidence about Duogynon dramatic side effects

A Scottish biologist examines the damaging effects of the Duogynon pregnancy drug

They were born with an open back, with heart defects and brain damage, shortened or missing limbs, deformed intestines, bladders or genitals. The cause for the malformations, among which hundreds of Germans and Britons born between the beginning of the 1950s and the middle of the 1970s, still today as adults, is given to a former drug of the Berlin pharmacy company Schering.

Mothers had received a drug from their doctors at the beginning of their pregnancy to determine if they really expected a child : named Duogynon in Germany, Primodos in the UK. Their content, a combination based on the female sex hormones gestagen and estrogen, was the same ; it could be swallowed or injected and was able to cause a menstrual bleeding.

If menstruation did not take place despite the hormone shock, the woman was considered pregnant. Urine test strips had not yet prevailed.

For the first time, the serious suspicions that are on the preparations of the past could be systematically examined by independent experts and at the present state of science. Neil Vargesson, professor of biology at the Scottish University of Aberdeen, researched on embryonic malformations for many years. He has worked with a team of his faculty to reproduce the Duogynon, Primodos, active ingredient and has already been tested in the laboratory for zebrafish embryos for its fruit-damaging effects.

“We were able to demonstrate that Primodos actually damages fish embryos, depending on both the stage of embryonic development and its dosage.”

Vargesson told the taz.

The Missing Proof

So far there have been indications, but no evidence for a causal link between the intake of Duogynon and the malformations. On the one reason being that clinical studies from the 1950s – when Schering brought the drug on the market – were not carried out in a way from which evidence could be derived. Another reason being that Duogynon has not been produced anymore for almost 40 years. Schering was taken over by Bayer AG in 2006, and they categorically excludes Duogynonas the cause of embryonic malformations“.

“The exact mechanism of action of Primodos / Duogynon on zebrafish is not yet known, but there are indications that the developmental stage of the blood vessels and the nerves play a key role in the nature and extent of embryonic damage”

said Vargesson.

“We could see enlarged hearts, open backs, damaged blood cells and damage to the nervous system. It is not just premature, but dubious, from these first results, to draw conclusions about possible damage to human embryos, I estimate that we will have to research at least three to five years in the lab and in very different animals”

said the scientist.

“Zebrafish, whose embryonic development is similar to those of higher vertebrate animals, and which develop completely and very quickly outside the mother’s body, are an important model organism for biologists. However, further experiments on rodents, fish and also sheep are essential in order to make assured statements. Research on pregnant women is prohibited for ethical reasons”

Vargesson said.

“You have to emphasize again and again that there is no such a thing as a natural malformation rate. Three per cent of all newborns are born with malformations, without apparent causes.”

added Vargesson.

New Hopes

The research approach of Neil Vargesson brings nevertheless new, great hope for the alleged Duogynon victims who have so far vainly struggled in the United Kingdom and in Germany as self-help groups for the recognition of their suffering by governments and parliaments and for a compensation fund based on the model of the foundation for contergan victims. Whether and how fast reliable results will be available, however, is also a matter of financing. The British parliament, which has been examining medical and scientific findings on Duogynon for one and a half years, has recently invited the Scottish biologists to a meeting. There were no concrete financial commitments so far.

“It’s also unusual to want to research a drug that is not there. My attention for Duogynon, came about by chance, almost as a by-product of my actual research interest.”

admited Vargesson.

Contergan was recommended to pregnant women in the 1960s against morning sickness and triggered one of the biggest drug scandal of the past century. The question of how the drug, can be used without harming unborns in the mother’s womb has been the focus for many years. Contergan is still of great therapeutic interest and use, said Vargesson, for the treatment of leprosy as well as certain types of cancer of the plasmatic cells.

Contergan Open Questions

​​Despite years of intensive research, it is still unclear as what exact building blocks of Contergan drug cause the malformations.

Vargesson does research on this, since he wants to know which molecules he has to forego completely, which he could change as well as which he should exchange, in order to make the medium safe and yet medically usable. Vargesson has recently patented several promising varieties of a slightly modified conteric.

Vargesson is optimistic:

“When I heard that another drug might also cause malformations in unborn babies, I had to look at the matter more closely.
Certain substances that were present in Duogynon are still found today in modified form in antibabies. There should be an interest in exploring possible undesirable side effects.
Whether it goes, and how, will depend above all on financial decisions.”

  • Original press release : FEHLBILDUNGEN DURCH DUOGYNON, on taz, 2.6.2017.
  • Translation via Google.
  • Image credit taz.

Questioning the Safety of the Hormonal Pregnancy Test Drugs

1978 London Programme

Greg Dyke and his team, at London Weekend TV, highlight and interview parents and children on the dangers which Primodos was causing to the unborn foetus.

Part 1
Part 2
Part 3

More Information

Primodos Investigation : Jason Farrell Reveals

Jason Farrell has been investigating Primodos for six years – he talked about his experience

March 2017 : MPs have welcomed a Sky investigation, which revealed how hormone pregnancy tests may have caused malformations and even deaths.

Around 1.5 million women in Britain in the 1960s and 70s took Primodos in the early stages of pregnancy. Some say their pregnancies resulted in miscarriage or birth defects.

Sky News’ hour-long documentary Primodos: The Secret Drug Scandal is presented by senior political correspondent Jason Farrell, who has been investigating it for six years.

Sky News revealed how documents were destroyed and information withheld about a drug that may have deformed and killed babies in the womb.

More Information

Calls for Public Inquiry over Primodos Pregnancy Test Drug

Sky News investigation exposed Primodos pregnancy drug cover-up

March 2017 : MPs have welcomed a Sky investigation, which revealed how hormone pregnancy tests may have caused malformations and even deaths.

Around 1.5 million women in Britain in the 1960s and 1970s took Primodos in the early stages of pregnancy. Some say their pregnancies resulted in miscarriage or birth defects.

Sky News’ hour-long documentary Primodos: The Secret Drug Scandal is presented by senior political correspondent Jason Farrell, who has been investigating it for six years.

Sky News revealed how documents were destroyed and information withheld about a drug that may have deformed and killed babies in the womb.

More Information

Primodos and Birth Defects : What was the Risk?

Sky News investigation exposes Primodos pregnancy drug cover-up

Around 1.5 million women in Britain in the 1960s and 1970s took Primodos in the early stages of pregnancy. Some say their pregnancies resulted in miscarriage or birth defects.

Sky News’ hour-long documentary Primodos: The Secret Drug Scandal is presented by senior political correspondent Jason Farrell, who has been investigating it for six years.

Sky News revealed how documents were destroyed and information withheld about a drug that may have deformed and killed babies in the womb.

More Information