Judge-led inquiry into pregnancy drug Primodos not “off the table”, the Government confirmed
There have been growing calls for a public inquiry into the “Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests” scandal, after MPs debated the Primodos drug’s legacy.
Severals MPs have joined the Primodos campaigners to say that the Expert Working Group review was a complete whitewash.
House of Commons and House of Lords Debates
House of Commons’ talks ref “Hormone pregnancy tests“, 14 December 2017 – 15:20:54parliamentlive.tv.
House of Commons’ talks ref “Hormone pregnancy tests“, 16 November 2017 – 10:40:26parliamentlive.tv.
House of Lords’ talks ref “Hormone pregnancy tests“, 16 November 2017 – 17:53:45parliamentlive.tv.
House of Commons’ talks ref “Hormone pregnancy tests“, 13 October 2016 – 15:05:52parliamentlive.tv.
House of Lords’ talks ref “Hormone pregnancy tests“, 21 January 2016 – 11:06:20parliamentlive.tv.
Marie Lyon, Chair of the Association for Children Damaged by Hormone Pregnancy Tests, speaks live to Jason Farrell, Senior Political Correspondent for Sky News, about the growing anger among MPs over last month’s Government-commissioned report on the pregnancy drug Primodos.
Severals MPs have joined the Primodos campaigners to say that the Expert Working Group review was a complete whitewash.
To download the Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests : gov.uk.
House of Commons and House of Lords Debates
House of Commons’ talks ref “Hormone pregnancy tests“, 14 December 2017 – 15:20:54parliamentlive.tv.
House of Commons’ talks ref “Hormone pregnancy tests“, 16 November 2017 – 10:40:26parliamentlive.tv.
House of Lords’ talks ref “Hormone pregnancy tests“, 16 November 2017 – 17:53:45parliamentlive.tv.
House of Commons’ talks ref “Hormone pregnancy tests“, 13 October 2016 – 15:05:52parliamentlive.tv.
House of Lords’ talks ref “Hormone pregnancy tests“, 21 January 2016 – 11:06:20parliamentlive.tv.
Nick Dobrik thinks the committee had no right to reach the conclusion they did
Thalidomide campaigner Nick Dobrik is very angry about his name used to give credibility to the EWG report after its publication. He told Sky’s Jason Farrell he doesn’t agree with the conclusion the committee reached.
Govt apologises to Nick Dobrik – who feels his name was used incorrectly to endorse Primodos inquiry.
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.
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.
I did not receive satisfactory answers from the Department for Health on Primodos, so I've written another letter to the Minister. pic.twitter.com/Ya9nvvEVHP
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
.@justinmadders demands the Government explains what further steps it will take to ensure families who have suffered feel justice in the #primodos scandal is finally delivered pic.twitter.com/3Tet4xGRHJ
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
Today I raised in the urgent question @HouseofCommons my very great lack of confidence in regard to #Primodos & the recent report. I pay tribute to campaigners @hormonepregtest
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)
It’s so worrying that there wasn't an open & transparent investigation into children damaged by hormone pregnancy tests. The Minister said he would write to me about whether the Berlin Archive papers were examined in the inquiry. Watch my question here: https://t.co/GXjxyx4vdLpic.twitter.com/7QhQtlrJk9
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
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.
James Moore interviews Professor Peter Gøtzsche, Nordic Cochrane Centre Director, 2017
James Moore was keen to talk to Prof. Peter Gøtzsche about his background in research, his views on antidepressant prescribing and how pharmaceutical manufacturers have influenced mental healthcare.
Overview
Professor Gøtzsche’s background in clinical trials within the Pharmaceutical industry.
How the pharmaceutical manufacturers were manipulating clinical trial data for their own gain.
How drug manufacturers have denied for more than 20 years that benzodiazepines and antidepressant drugs cause dependance.
How the UK drug regulator (MHRA) also denied this in 2003 at the same time that the World Heath Organisation reported that 3 antidepressants were in the top 30 list of drugs that create dependance.
That surveys of patients show that between 50% and 66% of those taking antidepressants experience dependance.
The similarities between the pharmaceutical industry and the tobacco industry.
That stopping an antidepressant suddenly can be very dangerous.
How prescription drugs have become the third leading cause of death behind heart disease and cancer.
How pharmaceutical manufacturers have used their power and influence to the detriment of patient safety.
That the best science shows that there is no doubt that psychiatric drugs have killed millions of people over the years.
How psychotherapy is shown to reduce the risk of suicide but instead we prescribe pills that increase the suicide risk for all ages of patients.
That the chemical imbalance lie is still being propagated amongst psychiatrists even thought here is no scientific evidence whatsoever so support it.
How psychiatric drugs should be used for acute/emergency situations only.
That the medication centred approach of psychiatry does more harm than good.
How patients should avoid psychiatric drugs unless they are used for a very short time or that the patient really feels that they need them.
That when you look at the randomised controlled trials, there is a large risk of bias in these trials and that antidepressant efficacy has been overstated.
That the Cochrane Collaboration undertook the most rigorous meta analysis ever undertaken of 131 trials involving 27,422 patients taking SSRI’s, this analysis showed that antidepressants do not have any meaningful effects and their harms outweigh any benefits there might be.
Sources
Mad in America: science, psychiatry and social justice, itunes/podcast, 2017.
Pregnant women still unaware of epilepsy drug risks
Was there a deliberate decision not to publish Valproate’s risks ?
The public hearing was part of a review of the safety of using valproate-containing medicines in women and girls who are pregnant or of childbearing age by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). There is a risk of malformations and neurodevelopmental problems in babies who are exposed to valproate in the womb, and the review follows concerns that European Union (EU)-wide risk minimisation measures currently in place do not seem to be sufficiently effective.
Warnings to young women who might become pregnant that the epilepsy drug sodium valproate could cause birth defects and developmental problems in their babies could have been made public more than 40 years ago, according to campaigners.
Being better informed about the risks of taking valproate medicines during pregnancy
Valproate is a treatment for epilepsy and bipolar disorder and is prescribed to thousands of women. Since its introduction in 1974, the product information for doctors has included a warning about the possible risk of birth defects. As the risks to unborn children have been increasingly understood, the warnings have been strengthened.
The risk of developmental disorders is up to 4 in 10 and the risk of birth defects is approximately 1 in 10. The risk for autism, ASD and ADHD is higher for children exposed in-utero.
MHRA has worked with industry, healthcare professionals and patient groups on a toolkit to ensure female patients are better informed about the risks of taking valproate medicines during pregnancy.
In women who take valproate while pregnant, around 1 in 10 babies will have a birth defect.
Birth defects seen when mothers take valproate during pregnancy include:
spina bifida (where the bones of the spine do not develop properly)
facial and skull malformations (including cleft lip and palate, where the upper lip or facial bones are split)
malformations of the limbs, heart, kidney, urinary tract and sexual organs.
In women who take valproate while pregnant, about 3–4 children in every 10 may have developmental problems. The long-term effects are not known.
The effects on development can include:
being late in learning to walk and talk
lower intelligence than other children of the same age poor speech and language skills
memory problems.
Children exposed to valproate in the womb are more likely to have autism or autistic spectrum disorders (ASD). There is also some evidence children may be more likely to be at risk of developing symptoms of attention deficit hyperactivity disorder (ADHD).
MHRA February 2016 advice
Valproate should not be used in female children, in female adolescents, in women of childbearing potential and in pregnant women unless other treatments are ineffective or not tolerated. Women of childbearing potential must use effective contraception during treatment.
No-one should stop taking valproate without discussing it first with their doctor and the benefits of valproate treatment must be carefully balanced against the risks.
If valproate is the only option, women of childbearing age should be given effective contraception. Women taking valproate must have regular reviews of their treatment.
