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 to govt 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

Subsys, Fentanyl Spray Nationwide Bribery Scam : Opioid Manufacturer Insys Therapeutics ex-CEO Arrested

Dangerously Addictive Painkiller Prescribed for Patients Who Shouldn’t Have Received It

Opioid crisis in the USA : D. Trump declares a state of emergency health for this scourge that causes 100 deaths / days, while the ex-CEO of Insys Therapeutics, producing Subsys, Fentanyl Spray, is arrested for corruption.

“the company looked to bribe doctors into prescribing Subsys, a fentanyl spray, outside the usual course of their professional practice”

“the company started misleading insurers and agents into authorizing payment for the Fentanyl Spray”

Press Releases

  • Drug company’s billionaire ex-CEO arrested in nationwide bribery scam, abcnews, Oct 26, 2017.
  • Insys Founder Arrested Over Subsys Fentanyl Spray Marketing, Resigns from Company Board, rxinjuryhelp, October 30, 2017.
  • Dangerously Addictive Painkiller Prescribed for Patients Who Shouldn’t Have Received It, Says Whistleblower, nbcnews, JUN 5 2017.

Why prescription drugs are now the third leading cause of death and the pharmaceutical manufacturers dominance of mental healthcare

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

Long-term use of ADHD drugs impair fertility in mammals

Impaired reproduction after exposure to ADHD drugs : Nordic Cochrane Centre systematic review of animal studies

Researchers from the Nordic Cochrane Centre have reviewed animal studies for effects of long-term use of drugs against Attention Deficit Hyperactivity Disorder (ADHD). The findings show that long-term use may impair the reproductive system, with some studies showing delayed sexual maturation. There were a total of 17 studies available, published between 1975 and 2016, where 13 were rat trials.

2017 Study Abstract

BACKGROUND
Few studies have reported on long-term harms caused by ADHD drugs but they are known to impair growth.

OBJECTIVE
To assess whether ADHD drugs impair reproduction in mammals.

METHODS
Systematic review of reproduction in studies of animals treated with ADHD drugs.

DATA SOURCES
PubMed, Biosis and EMBASE.

RESULTS
We included 17 studies. The studies were generally of poor quality or poorly reported. Two studies reported the use of one of three advised randomisation methods. Fifteen studies used placebo which suggested blinding. On clonidine, the ability to produce offspring was reduced for male rats, which approached two females each. In one study, 10 treated rats produced no offspring while all four controls did. In another study, 10 treated rats impregnated nine females while 10 controls impregnated 16. On methylphenidate, vaginal opening was delayed in two studies (in one, the mean difference was 4.0 days, 95% CI 2.5 to 5.6, and number of estrous cycles was halved; in the other, the minimum delay was 6 days), while in two other studies no difference occurred. Generally, the impairments improved after a drug-free period and were less pronounced when treatment started later in life.

CONCLUSION
ADHD drugs impair the reproduction in animals.

Sources, More Information

  • Impaired reproduction after exposure to ADHD drugs: Systematic review of animal studies, IOS Press, International Journal of Risk & Safety in Medicine, vol. 29, no. 1-2, pp. 107-124, DOI: 10.3233/JRS-170743, 2 September 2017.
  • New systematic review links long-term use of ADHD drugs to impaired fertility in mammals, Cochrane Nordic, Oct 11 2017.
  • Featured image The Cochrane Collaboration on Facebook.

Breast Cancer Prevention – How to Reduce Your Risk

Breast Cancer UK works to reduce breast cancer rates by tackling the environmental and chemical causes of the disease

Our lifestyles and our environment are potential contributors to disease. Diet, lack of exercise and exposure to environmental pollutants, including endocrine (hormone) disrupting chemicals (EDCs) present in many everyday products, may increase the risk of hormone related diseases such as breast cancer.

Sources

Endocrine Disruptors

More Information

Overuse of medical care : a well-recognized problem

2017 Update on Medical Overuse : A Systematic Review

2017 Study Abstract

Objective
To identify and highlight original research articles published in 2016 that are most relevant to understanding medical overuse or strategies to reduce it.

Evidence Review
A structured review of English-language articles on PubMed published in 2016 coupled with examination of tables of contents of high-impact journals to identify articles related to medical overuse in adults. These articles were appraised for their importance to medicine.

Findings
This study considered 2252 articles, 1224 of which addressed medical overuse. Of these, 122 were deemed most relevant based on originality, methodologic quality, and number of patients potentially affected. The 10 most influential articles were selected by author consensus. Select findings from the studies include the lack of benefit of transesophageal echocardiography in the workup of cryptogenic stroke, increasing use of computed tomography in the emergency department from 2.2% to 9.4% from 2001 to 2010, and carotid ultrasonography and revascularization being performed for uncertain or inappropriate indications with 95% frequency. Likewise, services for which harms are likely to outweigh benefits include treatment for early-stage prostate cancer, which provides no mortality benefit but increases absolute risk of erectile dysfunction by 10% to 30%, oxygen for patients with moderate chronic obstructive pulmonary disease, surgery for meniscal tear with mechanical symptoms, and nutritional interventions for inpatients with malnutrition. This review highlights 2 methods for reducing overuse: clinician audit and feedback with peer comparison for antibiotic use (reduction in inappropriate antibiotic use from 20% to 4%) and a practical and sensible shared decision-making tool for low-risk chest pain (reduction in emergency department workup from 52% to 37%).

Conclusions and Relevance
The body of empirical work continues to expand related to medical services that are provided for inappropriate or uncertain indications. Engaging patients in conversations aimed at shared decision making and giving practitioners feedback about their performance relative to peers appear to be useful in reducing overuse.

Diethylstilbestrol crystalline powder

CAS No.: 56-53-1 via Hangzhou Royall Import & Export Co., Ltd, China

DES was/is still sold under many names including Distilbène®, Stilbetin®, Stilboestrol-Borne®, Benzestrol®, Chlorotrianisene®, Estrobene® and Estrosyn® to name just a few.

Many different companies manufactured and marketed this drug under more than 200 different brand names.

This Diethylstilbestrol CAS No.: 56-53-1 is sold by Hangzhou Royall Import & Export Co., Ltd, China.

DES Drugs Pictures
DES DiEthylStilbestrol Resources

Diethylstilbestrol dimethyl ether

DES dimethyl ether via Shenzhen Cisco reaches biological technology LLC, China

DES was/is still sold under many names including Distilbène®, Stilbetin®, Stilboestrol-Borne®, Benzestrol®, Chlorotrianisene®, Estrobene® and Estrosyn® to name just a few.

Many different companies manufactured and marketed this drug under more than 200 different brand names.

These Diethylstilbestrol dimethyl ether bottles are sold by Shenzhen Cisco reaches biological technology LLC, China.

DES Drugs Pictures
DES DiEthylStilbestrol Resources