Michael Ejercito
2024-02-29 02:54:09 UTC
https://www.reddit.com/r/unitedkingdom/comments/1b1r5p5/medicines_regulator_failed_to_flag_covid_vaccine/
Medicines regulator failed to flag Covid vaccine side effects and must
be investigated, say MPs
All-party group believe MHRA were aware of heart and clotting issues in
February 2021 but did not highlight the problems for several months
Sarah Knapton,
SCIENCE EDITOR
27 February 2024 • 6:24pm
Related Topics
Vaccines, Medicines, Pharmaceutical industry, Steve Brine, AstraZeneca
987
All-party parliamentary group on pandemic response and recovery say MHRA
failed to raise the alarm on vaccine side effects
All-party parliamentary group on pandemic response and recovery say MHRA
failed to raise the alarm on vaccine side effects CREDIT: iSTOCKPHOTO
The medical regulator failed to sound the alarm over Covid vaccine side
effects and should be investigated, MPs have said.
The Medicines and Healthcare products Regulatory Agency (MHRA) is
responsible for approving drugs and devices and monitors side effects
caused by treatments.
But the all-party parliamentary group (APPG) on pandemic response and
recovery, an influential group of MPs, has raised “serious patient
safety concerns”. It has claimed that “far from protecting patients” the
regulator operates in a way that “puts them at serious risk”.
Some 25 MPs across four parties have written to the health select
committee asking for an urgent investigation. In reply, Steve Brine, the
health committee chairman, has said an inquiry into patient safety is
“very likely”.
In a letter to Mr Brine, the APPG said that there was reason to believe
that the MHRA had been aware of post-vaccination heart and clotting
issues as early as February 2021, but did not highlight the problems for
several months.
Denmark and several other European countries suspended the AstraZeneca
vaccine over clotting fears in March 2021, but the MHRA only published
safety advice on April 7, by which time 24 million people had been
vaccinated.
The watchdog also saw a “signal” for the heart problems myocarditis and
pericarditis in February 2021, but did not include the conditions in
safety updates until June 2021, MPs said.
“In effect, the MHRA licences medical products as safe knowing it lacks
the processes to properly monitor adverse events,” the APPG wrote.
“In the case of Covid-19 vaccines, given the comparatively novel
technology and record manufacturing speed, could the MHRA have even
properly scrutinised the licensing data or known the short term safety?
“Historically trust and confidence in vaccines and vaccine safety has
been high in the UK, but it seems that the experience of the Covid-19
vaccines has undermined this and by association trust in the regulator
and the pharmaceutical industry.
“Now more than ever a wide-reaching and in-depth review is needed.”
Underestimates complexities
The group also warned that the MHRA Yellow Card reporting system – which
encourages patients and doctors to flag-up medicine side effects –
“grossly” underestimates complexities, and in some instances picks up
just one in 180 cases of harm.
An analysis by Stockport NHS Foundation Trust found that in the North
West of England, 1,058 people had been admitted to hospital with stomach
bleeds caused by anticoagulant medication over five years, yet just six
Yellow Card reports were made during the period.
Side effects from drugs account for one in every 16 hospital admissions
in Britain, and cost the NHS more than £2 billion each year.
But trials are often too small to pick up adverse reactions,
particularly when they are driven by rare genetic mutations, meaning it
is vital to continue monitoring drugs in the community.
The MHRA recently said it would investigate why blood thinners were
causing dangerous side effects in between two and five per cent of patients.
The APPG said it was also concerned that MHRA regulation of medicine was
funded by the pharmaceutical industry and said the body had shifted from
focusing on scrutiny to trying to help drugs get approved.
‘Watchdog to the enabler’
Dame June Raine, the chief executive of the MHRA, who announced she
would be stepping down last week, has previously said the agency was
transitioning from “watchdog to the enabler,” a phrase which MPs said
warranted its own investigation.
Graham Stringer MP, co-chair of the APPG on pandemic response and
recovery, said:
“The MHRA oversees a failing system that is slow to act, causing harm to
patients and beset with conflicts of interest.
“We cannot allow it to continue. That’s why we have written to the
health select committee calling for an urgent investigation into the MHRA.”
The APPG said that concerns raised directly with the MHRA had been met
with “an habitually dismissive and evasive response”.
Dame June said: “We have made significant steps to put patients at the
heart of all our work.
“These include incorporating patient views and lived experience into our
safety reviews; involving patients in the early stages of planning
medicines development and building a new responsive reporting system for
patients to tell us about any adverse incidents. We have also led on
legislative changes to strengthen surveillance for medical devices and
medicines, meaning patient safety is embedded firmly into law.
“Our progress so far in making changes based on meaningful patient
involvement gives us a solid base to build upon as we continue on this
important journey.”
“We are committed to enabling innovation that brings transformative
medical products safely to patients.’’
Medicines regulator failed to flag Covid vaccine side effects and must
be investigated, say MPs
All-party group believe MHRA were aware of heart and clotting issues in
February 2021 but did not highlight the problems for several months
Sarah Knapton,
SCIENCE EDITOR
27 February 2024 • 6:24pm
Related Topics
Vaccines, Medicines, Pharmaceutical industry, Steve Brine, AstraZeneca
987
All-party parliamentary group on pandemic response and recovery say MHRA
failed to raise the alarm on vaccine side effects
All-party parliamentary group on pandemic response and recovery say MHRA
failed to raise the alarm on vaccine side effects CREDIT: iSTOCKPHOTO
The medical regulator failed to sound the alarm over Covid vaccine side
effects and should be investigated, MPs have said.
The Medicines and Healthcare products Regulatory Agency (MHRA) is
responsible for approving drugs and devices and monitors side effects
caused by treatments.
But the all-party parliamentary group (APPG) on pandemic response and
recovery, an influential group of MPs, has raised “serious patient
safety concerns”. It has claimed that “far from protecting patients” the
regulator operates in a way that “puts them at serious risk”.
Some 25 MPs across four parties have written to the health select
committee asking for an urgent investigation. In reply, Steve Brine, the
health committee chairman, has said an inquiry into patient safety is
“very likely”.
In a letter to Mr Brine, the APPG said that there was reason to believe
that the MHRA had been aware of post-vaccination heart and clotting
issues as early as February 2021, but did not highlight the problems for
several months.
Denmark and several other European countries suspended the AstraZeneca
vaccine over clotting fears in March 2021, but the MHRA only published
safety advice on April 7, by which time 24 million people had been
vaccinated.
The watchdog also saw a “signal” for the heart problems myocarditis and
pericarditis in February 2021, but did not include the conditions in
safety updates until June 2021, MPs said.
“In effect, the MHRA licences medical products as safe knowing it lacks
the processes to properly monitor adverse events,” the APPG wrote.
“In the case of Covid-19 vaccines, given the comparatively novel
technology and record manufacturing speed, could the MHRA have even
properly scrutinised the licensing data or known the short term safety?
“Historically trust and confidence in vaccines and vaccine safety has
been high in the UK, but it seems that the experience of the Covid-19
vaccines has undermined this and by association trust in the regulator
and the pharmaceutical industry.
“Now more than ever a wide-reaching and in-depth review is needed.”
Underestimates complexities
The group also warned that the MHRA Yellow Card reporting system – which
encourages patients and doctors to flag-up medicine side effects –
“grossly” underestimates complexities, and in some instances picks up
just one in 180 cases of harm.
An analysis by Stockport NHS Foundation Trust found that in the North
West of England, 1,058 people had been admitted to hospital with stomach
bleeds caused by anticoagulant medication over five years, yet just six
Yellow Card reports were made during the period.
Side effects from drugs account for one in every 16 hospital admissions
in Britain, and cost the NHS more than £2 billion each year.
But trials are often too small to pick up adverse reactions,
particularly when they are driven by rare genetic mutations, meaning it
is vital to continue monitoring drugs in the community.
The MHRA recently said it would investigate why blood thinners were
causing dangerous side effects in between two and five per cent of patients.
The APPG said it was also concerned that MHRA regulation of medicine was
funded by the pharmaceutical industry and said the body had shifted from
focusing on scrutiny to trying to help drugs get approved.
‘Watchdog to the enabler’
Dame June Raine, the chief executive of the MHRA, who announced she
would be stepping down last week, has previously said the agency was
transitioning from “watchdog to the enabler,” a phrase which MPs said
warranted its own investigation.
Graham Stringer MP, co-chair of the APPG on pandemic response and
recovery, said:
“The MHRA oversees a failing system that is slow to act, causing harm to
patients and beset with conflicts of interest.
“We cannot allow it to continue. That’s why we have written to the
health select committee calling for an urgent investigation into the MHRA.”
The APPG said that concerns raised directly with the MHRA had been met
with “an habitually dismissive and evasive response”.
Dame June said: “We have made significant steps to put patients at the
heart of all our work.
“These include incorporating patient views and lived experience into our
safety reviews; involving patients in the early stages of planning
medicines development and building a new responsive reporting system for
patients to tell us about any adverse incidents. We have also led on
legislative changes to strengthen surveillance for medical devices and
medicines, meaning patient safety is embedded firmly into law.
“Our progress so far in making changes based on meaningful patient
involvement gives us a solid base to build upon as we continue on this
important journey.”
“We are committed to enabling innovation that brings transformative
medical products safely to patients.’’