UK took 20 years to withdraw drug after harms were first made known
Most people are aware of Thalidomide, many are aware of Valproate, but there are several other drugs that have caused birth defects in children that are less well known including Debendox, Carbimazole and Primodos.
Primodos families achieved a main house parliamentary debate on 7th September led by Yasmin Qureshi. Whilst the House was not well attended, every single MP in the Chamber was on the side of the families and little effort was made to defend Government and regulator action.
Yasmin Quereshi explained:
“Children were born with serious deformities due to the hormone pregnancy test drug Primodos, which was taken by expectant mothers between 1953 and 1975”
“The UK regulator first received a warning about the drug in 1958. A definitive study was published in 1967, which linked birth defects to the synthetic hormones in Primodos. Baroness Cumberlege concluded that Primodos should have been removed from the market in 1967. The UK regulator failed in its duty of care to women: Primodos was eventually withdrawn in 1978, 20 years after the first warning.”
Finland, Sweden, Holland and Norway banned the use of hormone pregnancy tests at least 7 years earlier by 1971. MPs passionately recounted many stories of harm caused to their constituents, including Allan Dorans who explained the impact on Nan’s daughter Michelle in 1975, 4-5 years after it was withdrawn in other countries.
Why is the UK always so late to act on medicine harm?
You may say “that was 50 years ago”, things have changed, but MHRA’s lack of action on AstraZeneca covid vaccines resulted in patient deaths as recently as 2021. If anything, the MHRA’s recent transformation from “From watchdog to regulator” (as proclaimed by June Raine) is making things worse. As was pointed out several times during the debate, Primodos was 40 times the strength of the contraceptive pill, this is a risk a lay person can understand, why didn’t the regulator?
Sir Jacob Rees-Mogg stated “The drug was used in South Korea and Germany as an abortifacient. It was used to procure abortions.” Why would MHRA allow a drug that is used overseas for abortions, as a pregnancy test? It would be reasonable to assume there could be a risk of miscarriage. Why did MHRA reject Professor Carl Heneghan’s (director of the Centre for Evidence-Based Medicine at Oxford University) report showing “a clear association” between Primodos and several forms of malformation? Why hasn’t MHRA taken the actions recommended by the Cumberlege report? The yellowcard system is clearly not fit for purpose and is resulting in unnecessary harm to patients.
The Perseus Group believes that a large part of the problem is that medicine safety doesn’t follow the best practice safety management practices of other safety critical sectors like aviation or nuclear. For example, MHRA does not set safety thresholds for the number of deaths/injuries which is allowed before a medicine is suspended. Previous Inquiries, such as the Cumberlege Inquiry, do little or nothing to improve the fundamentals of MHRA’s safety management because there is no input from those involved in managing safety in other safety critical sectors.
The Government committed to take action on Primodos after the Cumberlege report (if fact Primodos was a key driver resulting in the commissioning of the report), but they have limited that action to pelvic mesh and Valproate. The Patient Safety Commissioner role was created to close the gap but again her scope has been limited to mesh and Valproate. Primodos families have been fighting for decades for redress but the system is against them, they have been failed by the Government, the legal system and the regulator.
There are dozens of medicine and medical device victim groups (antidepressants, morning sickness medicines, vaccines etc) fighting their own battles for justice, what is the underlying theme?
A regulator failing to do their duty to keep people safe, influenced by pharmaceutical companies and defended by the Government.
Esther McVey stated “Sadly, Primodos is not an isolated case, and we have seen many examples over the years of our regulatory bodies failing to keep patients safe from new medicines and medical devices. In 2013, the Medicines and Healthcare products Regulatory Agency listed 27 medicines that had been withdrawn on safety grounds. The average time they were on the market was 11 years. I wonder how many times we will allow history to repeat itself. There have been reports and reviews calling for reform, and back in 2004 the Health Committee undertook an inquiry into the influence of the pharmaceutical industry. It noted, of drug companies, the ‘closeness that has developed between regulators and companies’”
Of MRHA’s 16 board members, 6 have Declarations of Interest relating to healthcare companies including pharmaceutical giants such as Sanofi, AstraZeneca and Pfizer. Pharmaceutical companies have been given immunity for several medicines by the Government, incentivizing them to support the pharmaceutical companies position rather than the victims. Pharmaceutical companies already have deep pockets, why are the Government willing to support them rather than those harmed?
Sitting from the outside, I see many victim groups fighting their individual battles in silos. Imagine their power if they all came together as a single voice demanding reform of MHRA? 22 MPs spoke in the Primodos debate, every single one of them wanting justice for the victims. The Parliamentary Under-Secretary of State for Health and Social Care Maria Caulfield has agreed to meet with families and review the findings of the Cumberlege report, so this looks like a small step forwards for this group or at least a little more hope.
Do we now have the critical mass to demand reform of MHRA? If everyone came together, could we get a regulator that prioritises patient safety over pharmaceutical company profits?
Will the media start joining the dots?
October 6, 2023
Posted by aletho |
Science and Pseudo-Science, Timeless or most popular | MHRA, UK |
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Drug regulators and public health agencies have saturated the airways with claims that serious harms following covid vaccination are “rare.”
But there has been very little scrutiny of that claim by the media, and I could not find an instance where international agencies actually quantified what they meant by the term “rare” or provided a scientific source.
The best evidence so far, has been a study published in one of vaccinology’s most prestigious journals, where independent researchers reanalysed the original trial data for the mRNA vaccines.
The authors, Fraiman et al, found that serious adverse events (SAEs) – i.e. adverse events that require hospitalisation – were elevated in the vaccine arm by an alarming rate – 1 additional SAE for every 556 people vaccinated with Pfizer’s mRNA vaccine.
According to a scale used by drug regulators, SAEs occurring at a rate of 1 in 556 is categorised as “uncommon,” but far more common than what the public has been told.
Therefore, I asked eight drug regulators and public health agencies to answer a simple question: what is the official calculated rate of SAEs believed to be caused by Pfizer’s mRNA vaccine, and what is the evidence?
The agencies were FDA, TGA, MHRA, HC, PEI, CDC, ECDC and EMA.
The outcome was startling.
Not a single agency could cite the SAE rate of Pfizer’s vaccine. Most directed me to pharmacovigilance data, which they all emphasised does not establish causation.
The Australian TGA, for example, referred me to the spontaneous reporting system but warned, “it is not possible to meaningfully use these data to calculate the true incidence of adverse events due to the limitations of spontaneous reporting systems.”
Both the German regulator (PEI) and European CDC referred me to the European Medicines Agency which, according to its own report, saw no increase at all in SAEs. “SAEs occurred at a low frequency in both vaccinated and the placebo group at 0.6%.”
The UK regulator MHRA went so far as to state it “does not make estimations of a serious adverse event (SAE) rate, or a rate for adverse reactions considered to be causally related for any medicinal product.”
The US FDA, on the other hand, did conceded that SAEs after mRNA vaccination have “indeed been higher than that of influenza vaccines,” but suggested it was justified because “the severity and impact of covid-19 on public health have been significantly higher than those of seasonal influenza.”
Despite analysing at the same dataset as Fraiman, the FDA said it “disagrees with the conclusions” of the Fraiman analysis. The agency did not give specifics on the areas of disagreement, nor did it provide its own rate of SAEs.
In response to the criticism, Joe Fraiman, emergency doctor and lead author on the reanalysis said, “To be honest, I’m not that surprised that agencies have not determined the rate of SAEs. Once these agencies approve a drug there’s no incentive for them to monitor harms.”
Fraiman said it’s hypocritical for health agencies to tell people that serious harms of the covid vaccines are rare, when they have not even determined the SAE rate themselves.
“It’s very dangerous not to be honest with the public,” said Fraiman, who recently called for the mRNA vaccines to be suspended.
“These noble lies may get people vaccinated in the short term but you’re creating decades or generations of distrust when it’s revealed that they have been misleading the public,” added Fraiman.
Dick Bijl, a physician and epidemiologist based in the Netherlands, agreed. “It goes to show how corrupted these agencies are. There is no transparency, especially since regulators are largely funded by the drug industry.”
Bijl said it’s vital to know the rate of SAEs for the vaccines. “You must be able to do a harm:benefit analysis, to allow people to give fully informed consent, especially in young people at low risk of serious covid or those who have natural immunity.”
Bijl said the mainstream media has allowed these agencies to make false claims about the safety of vaccines without interrogating the facts.
“The rise of alternative media is strongly related to the lies being told by the legacy media, which just repeats government narratives and industry marketing. In the Netherlands, there is a lot of discussion about the distrust in public messaging,” said Bijl.
June 28, 2023
Posted by aletho |
Deception, Mainstream Media, Warmongering, Science and Pseudo-Science | CDC, COVID-19 Vaccine, EMA, FDA, MHRA |
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COVID-19 vaccines must be suspended owing to the level of reported injuries and deaths across all age groups and a full inquiry launched into the MHRA, the regulator which approved them, a group of experts has said.
In a groundbreaking new report sent to every member of Parliament, the Perseus group – a team of experts from the fields of medicine, pharmaceutical regulation and safety management – has set out in detail the numerous concerns raised by experts globally about the vaccines and the specific concerns about the U.K.’s Medicines and Healthcare products Regulatory Authority (MHRA) responsible for giving them the green light.
“MHRA announced that it has morphed from ‘watchdog’ to ‘enabler’. Would anyone be concerned if that was said by the Office for Nuclear Regulation, the Civil Aviation Authority or the Defence Safety Regulator,” Perseus group spokesman Nick Hunt said.
The evident lack of interest in post-rollout issues with the COVID-19 vaccines was highlighted as particularly shocking.
Before the rollout in December 2020 the MHRA promised a rigorous “four-strand proactive vigilance” of Covid vaccine safety. But freedom of information requests have revealed that very little of this work is being done. The single report supplied from the “Targeted Active Monitoring” strand was 15 months old, from August 2021, the report says.
The group slams the MHRA for failing to act on problems with the AstraZeneca vaccine for months after many other national regulators suspended and withdrew it for certain age groups. The MHRA also continued to ignore “ever increasing evidence of Covid vaccine risks, notably blood clotting, heart inflammation, neurological conditions, immune downgrading and menstrual disorders”, the report states.
The secrecy around Covid vaccines in particular is blasted, with key documents on risks versus benefits that are routinely published for other medicines being absent for Covid vaccines. “This compromised informed consent,” notes the group.
Other problems include that the MHRA authorised the mRNA products as vaccines, which have lower regulatory requirements, rather than properly classifying them as novel genetic products, and that it failed to identify and address problems with manufacturing and quality control, leading to batch quality problems.
More general criticisms of the agency include that it assesses the safety of a medicine relative to its benefit rather than in absolute terms, which the report likens to the Nuclear Regulator saying, “Our nuclear power station is safe because it has fewer contaminated water leaks than other stations.”
The regulator also nowhere defines the tolerable rate of fatal and serious side-effects of new medicines, which the report blames for its slowness to act when problems emerge.
Freedom of information requests also reveal, alarmingly, that the MHRA has no process for investigating Yellow Card reports of adverse events potentially linked to the COVID-19 vaccines or other medicines. This, the report highlights, is just one facet of a broader lack of the kind of robust safety management systems and processes that are standard in other safety critical sectors such as aviation, defence, nuclear, oil and gas and rail. Similarly, freedom of information requests reveal that there has never been a safety audit of MHRA.
The reports findings are damning and expose a regulator not fit for purpose and clearly failing in its basic aim of keeping the public safe from harmful medical products.
Concerns about the MHRA are nothing new. The 2020 Cumberlege report listed basic safety and governance issues that the Commons Health Select Committee in December 2022 noted with concern were slow in being addressed. But the new Perseus group report lays out in devastating detail for the first time how the MHRA’s longstanding failings have directly impacted on the disastrous rollout of the Covid vaccines.
The Perseus group suggests that anyone who shares its concerns could write to his or her MP to ask if they have read the report and what they intend to do. Other suggested actions include signing the petition to “Launch a Public Inquiry into the approval process for COVID-19 vaccines” and signing the open letter to the Health Secretary organised by the Together Declaration.
April 19, 2023
Posted by aletho |
Deception, Timeless or most popular, War Crimes | COVID-19 Vaccine, MHRA, UK |
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Gillian Dymond is determined to find out what the Medicines and Healthcare products Regulatory Agency (MHRA) is doing to investigate the enormous number of adverse reactions to the Covid vaccines that have been reported under the Yellow Card scheme and what risk/benefit analysis was carried out to justify rolling out the experimental gene therapy to under-18s.
We published her letters to MHRA chief executive officer Dame June Raine, first sent in November last year, here and here.
At the end of April, after an unsatisfactory response from the MHRA’s Chief Safety Officer Dr Alison Cave, Gillian returned to the fray, to ask Dame June for a copy of the risk assessment carried out by the MHRA before it decided to approve experimental Covid medications for use on children. After 20 working days, having still received no reply, she emailed her the following:
Dear Dame June,
Open letter: Your failure to produce a risk assessment justifying the approval of injections against SARS-CoV-2 for people under 18 years of age
On April 28 I wrote to you requesting a copy of the risk assessment which I assumed you must certainly have carried out prior to approving the incompletely tested medications against SARS-CoV-2 for children as young as five years of age.
I asked you to send this information within 20 working days. That period has now elapsed without a response to my request or an acknowledgement of my email.
It seems that you are either unable or unwilling to provide me with a copy of the document requested.
We parents and grandparents must therefore conclude that:
1. You have approved an experimental treatment for our young families without carrying out and recording a thorough risk/benefit analysis for the age group in question; or
2. You did carry out such an analysis, but are reluctant to make it public because its conclusions do not support approval of the medications in question.
Where you have remained silent, however, others have stepped in to fill the gap. Doctors for Covid Ethics have now produced a risk/benefit analysis for the Pfizer and Moderna vaccines, in relation to children and adolescents: exactly the kind of analysis that we had every right to expect from your own organisation.
This analysis concludes that the medications under investigation are neither necessary, nor effective, nor safe for prescription to the age group in question. It also ‘addresses the risk of genotoxicity of the mRNA vaccines, which according to recent experimental evidence of their integration into host cell genomes must be considered urgent’.
I note from your public meeting in February this year that the MHRA, in its headlong rush to become a ‘world-class regulatory agency’, is planning to build on the ‘success’ of the Covid injection roll-out by fast-tracking a succession of ‘100-day vaccines’ tweaked into being on computers, shortening the time necessary for approval by using the public as ‘real-time’ guinea pigs. Any checks on medium to long-term safety, it seems, are to be thrown to the winds.
The steadily accumulating numbers of serious adverse reactions to the present experimental treatments argue against these foolhardy proposals.
As the numbers of deaths and injuries following injection grow, it is becoming clear that the genuine successes against Covid have come not from pharmaceutical innovations or top-down diktats by centralised bureaucracies kow-towing to the World Health Organisation, but from the cross-border co-operation of dedicated doctors all over the world who have faced censorship, smears, and even loss of their livelihoods, as they relied on tried and trusted medicines and years of solid experience to devise the early-treatment protocols which have saved so many lives and which, but for the intervention of those charged with assuring our safety, might have saved so many more.
The facts could not be clearer. In future, the MHRA should respect the precautionary principle. Meanwhile, you should lose no time in withdrawing approval for the injection of our children with unnecessary, ineffective and unsafe experimental substances whose long-term effects on young people with their lives before them will for many years remain unknown.
Yours sincerely, etc
Gillian Dymond
June 1, 2022
Posted by aletho |
Deception, Science and Pseudo-Science, Timeless or most popular, War Crimes | COVID-19 Vaccine, MHRA, UK |
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