This is a warning about two linked posts – with two more next week.
The Eclipse of Health Care features on dhblog.wpengine.com. It has a partner There was a Young Woman who Swallowed a Lie on RxISK.org
These were combined in one document – Mandating Unproven Technologies, which along with a set of appendices was sent to Dr Chaand Nagpaul, the Chair of the British Medical Association 10 days ago. The BMA support vaccination but are against mandates for healthcare staff.
This document along with cover letter and appendices was sent to the Ministers of Health in England – Sajid Javid, Wales – Eluned Morgan, and Northern Ireland – Robin Swann, along with June Raine of the British drugs regulator MHRA and the Chair and CEO of the National Institute of Health and Care Excellence.
There is absolutely nothing new in the first half of the document for those to whom it was sent as all have had comparable letters and documents from me before. None have denied any of the points being made. The common response is to reach for the lifebelt I throw them – that its not their job to police the medical literature.
Eric Rubin of the New England Journal of Misinformation told us last week that its not his job either.
Given that the drug and vaccine related medical literature is mostly written by pharma, they are not likely to police it.
Which is why this letter went to BMA, in the first instance – that and the fact that doctors are likely to be out of a job if they let this situation persist.
As regards the second half of the letter There was a Young Woman who Swallowed a Lie, there should be nothing new in this for any of them – if there is, it means they are not doing the job most people think they are doing or should be doing.
Twenty years ago, I wrote to the British regulator and offered to come along and air my concerns about SSRI antidepressants as the things I was saying, which are much the same as I am saying here, are not things I should be saying if they are not true. The visit was to offer MHRA a chance to point out anything wrong in what I was saying. They didn’t quibble with anything.
Twenty years later we have an SSRI public health crisis.
Twenty years from now what will we have with vaccines?
Swedish Lectures
On September 9, I gave some talks to a group of Family Doctors in Sweden, at the invitation of André Marx. This was just as vaccine mandates had appeared as a threat on the Canadian horizon.
The lectures cover all the ground in The Eclipse of Health Care and more.
People are the Data in Clinical Trials
They Used to Call it Medicine.
I thought about finishing up on a tricky note – every thing you have heard in these lectures about drugs applies to vaccines also. But my sense was that whatever hope I have to reach some of these doctors will vanish if I take that extra step.
The note on which the lectures do end is in my opinion by far the best possible note.
Things have changed – there is not option now but to extend the argument. The scenarios outlined in Shipwreck – El Naufragio as mentioned in Chronicle of a Tyranny Foretold have been dramatically realised with extraordinary rapidity.
The destabilizing force of The Crowd that has been an element of politics since the French Revolution which is typically viewed as irrational seems a factor now – with at least one crowd being comprised of university academics, and other members of what a group that likes to think of itself as a liberal or meritocratic elite but which does not seem immune to acting in a primitive fashion.
Correspondence to: H Naci h.naci@lse.ac.uk
MHRA’s new delivery plan strikes the wrong note
On 4 July 2021, the Medicines and Healthcare Products Regulatory Agency (MHRA) published its delivery plan for 2021-2023: Putting Patients First: a New Era for our Agency.1 In this plan, the MHRA promises to make drug regulation in the UK more patient centred, while being “an agile and supportive regulator” to accommodate the interests of the United Kingdom’s life sciences industry.
The MHRA’s latest commitment to put patients first follows last year’s landmark report by the Conservative peer Julia Cumberlege.2 The Independent Medicines and Medical Devices Safety Review (2020) chronicled the failure of regulators, alongside those of clinicians and other healthcare professionals, to tackle decades of patient reports of harm from medical treatments.3 The Cumberlege report characterised a healthcare system that is unfit for protecting patients and preventing harm, recommending that the MHRA engage more with patients and their outcomes.
Going forward, the MHRA plans to include patients on all decision making committees.4 It will also support the development of patient reported outcome measures to make their use more widespread in clinical trials……
the rest is behind a pay wall – which most ‘patients’ are exluded from unless they pay – how ridiculous
With thanks to David here is the whole mess of a proposition
On 4 July 2021, the Medicines and Healthcare
Products Regulatory Agency (MHRA) published its
delivery plan for 2021-2023: Putting Patients First: a
New Era for our Agency.
In this plan, the MHRA
promises to make drug regulation in the UK more
patient centred, while being “an agile and supportive
regulator” to accommodate the interests of the United
Kingdom’s life sciences industry.
The MHRA’s latest commitment to put patients first
follows last year’s landmark report by the
Conservative peer Julia Cumberlege.2 The
Independent Medicines and Medical Devices Safety
Review (2020) chronicled the failure of regulators,
alongside those of clinicians and other healthcare
professionals, to tackle decades of patient reports of
harm from medical treatments. The Cumberlege
report characterised a healthcare system that is unfit
for protecting patients and preventing harm,
recommending that the MHRA engage more with
patients and their outcomes.
Going forward, the MHRA plans to include patients
on all decision making committees.
It will also support the development of patient reported outcome
measures to make their use more widespread in
clinical trials. The recent Patient Involvement
Strategy further outlines how the MHRA will deliver
on its vision to become a “patient focused regulator.”
Including patients in regulatory decision making is
a welcome development—and long overdue. But one
lesson of the Cumberlege report is that regulatory
agencies have a poor track record in prioritising
patients, especially when patient interests are at odds
with those of other stakeholders, including drug
companies. So it is concerning that the MHRA fails
to recognise the potential for conflict between its role
as a public health agency and its promise to “reduce
regulatory burden” to support “today’s brilliant life
sciences industry” and “boost growth.”
Fast track pathways
Of additional concern is a growing body of research
showing that initiatives similar to those proposed by
the MHRA frequently fail to put patients first. One
example is expedited regulatory pathways. Despite
substantial evidence questioning the effectiveness
of these pathways,
the MHRA is launching a new one
—the Innovative Licensing and Access
Pathway—designed to accelerate the development
and approval of new drugs.
Expedited regulatory pathways are not new. They are
modelled on initiatives first developed by the US Food
and Drug Administration and continue a dominant
trend in the European Union and UK medicines
policy. Some programmes expedite regulatory
review, while others reduce clinical trial
requirements, thereby shortening the duration of
clinical development.
The Innovative Licensing and Access Pathway is just
the latest example in a spate of government initiatives
designed to make the UK a more attractive destination
for drug companies following its departure from the
European regulatory system. The Accelerated Access
Collaborative was launched in 2018 to establish a
faster route to market for “transformative” medicines,
devices, diagnostics, and digital health
technologies. In 2019, NHS England set up a
Commercial Medicines Unit to develop tailor made
confidential agreements with industry to support
rapid uptake of new medicines in the NHS. With the
launch of the new pathway, the MHRA now intends
to “ensure that the UK becomes an even greater place
to develop, manufacture, and supply products.”
Such pathways predictably deliver for drug
companies by faciliating frequent interactions with
regulators and securing early market access for
medical products. But they may not ultimately benefit
patients. Patients expect that medicines will improve
either the quality or quantity of their lives, or
both. Yet a growing proportion of drugs in
expedited pathways are approved without robust
studies and are supported by surrogate endpoints
rather than patient relevant outcomes. Greater
uncertainty may be an acceptable trade-off for some
patients if fast-tracked drugs ultimately offer
important therapeutic benefits. But research shows
this is rarely the case. More than two thirds of
expedited drugs do not perform better than existing
alternatives. Some are later found to be ineffective
Expedited pathways may also lead to major safety
concerns. Previous studies from the United States,
which has a long history of expedited drug approvals,
show an association between products approved
through expedited pathways and increased risk of
postmarketing safety events similar to those identified
by the Independent Medicines and Medical Devices
Safety Review. The MHRA will need to take into
account this evidence if it continues to pursue policies
that prioritise ever faster drug development and
regulatory review.
As last year’s Independent Medicines and Medical
Devices Safety Review concluded, the MHRA should
take steps “to ensure that the patient perspective and
the public interest always takes precedence over the
interests of the industry.”
In addition to including
patients in decision making committees, regulators
should more meaningfully engage patients and the
public in setting the strategic direction of the agency.
Consequential decisions like launching a new
expedited pathway, for example, should take into
account patient and public preferences for timely generation of
good quality evidence on new drugs.
In its latest attempt to strike a balance between health and industrial
policy objectives, the MHRA’s delivery plan fails to put patients
first. To realise its goal of improving the patient centredness of
medicines regulation, the MHRA must be guided by the current best
evidence on the benefits and harms of expedited regulatory
pathways.
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Register to watch the Commission on Human Medicines (CHM) consideration of the isotretinoin review
Inbox
MHRA webmaster@subscriptions.mhra.gov.uk via service.govdelivery.com
1:54 PM (1 hour ago)
to me
Isotretinoin review to the CHM
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Medicines and Healthcare products Regulatory Agency bulletin
Dear Colleague,
As you may remember the Isotretinoin Expert Working Group (IEWG) has been reviewing the risk of psychiatric and sexual side effects with isotretinoin. This information is now going to be presented to the Commission on Human Medicines (CHM), where the next step of the isotretinoin review will be considered.
Patients and other stakeholders have been involved throughout the isotretinoin review and we want to continue to involve patients and stakeholders in the next steps.
Although the content and proceeding of CHM meetings are strictly confidential, we are offering patients and other stakeholders who have contributed or have an interest in the review an opportunity to watch CHM’s consideration of the information associated with the review.
The CHM meeting will be held in two sessions, the first session will consider the information reviewed by the IEWG and the second session will consider the IEWG’s recommendations and the regulatory action needed. Patients and other stakeholders are invited to watch the first session.
Please note that this CHM meeting is dedicated to the isotretinoin review, it is not a public meeting and only those who have registered will be able to attend.
Date: Friday, 17 December 2021
Time: 14:00-15:30
Register now to confirm your place
The deadline for registering to watch the CHM meeting is Monday, 13 December 2021 at 17.00 (GMT).
Finally, please note that the CHM members must be independent, and we ask that individuals or campaign groups do not directly contact them regarding this review.
We hope you will continue to be involved with this review and you’re able to join the CHM meeting, so please remember to register.
If you have any further questions, please email us at MHRACustomerServices@mhra.gov.uk.
Kind regards,
Patient, Public and Stakeholder Engagement Team
The Medicines and Healthcare products Regulatory Agency