Adverse drug reactions (ADRs) are a major cause of hospital admissions, with 6.5% due to that cause. Analysis of inpatient stays also shows that 15% of patients experienced one or more ADRs – half of them were definitely or possibly avoidable.
In 1964, the Yellow Card Scheme (YCS) was created to act as an early warning system for unexpected adverse drug reactions (ADRs).
The YCS reporting site allows the submission of reports of suspected adverse reactions to the Medicines and Healthcare Regulatory Agency (MHRA). The MHRA says the system ensures the safe and effective use of medicines, vaccines and medical devices. But does it ensure such safety?
To inform our answer, we searched for publications since 2010 (see here).
The reporting of suspected ADRs by the public is a valuable source of information about the possible harms of pharmaceuticals.
A 2011 health technology review of patient reporting showed that in a two-year (October 2005 to September 2007) period, 5,180 patients and 20,949 healthcare professionals (HCPs) submitted Yellow Card reports.
A questionnaire survey was undertaken among those who did a report, leading to 1,362 evaluable responses. Nearly half learnt about Yellow Card reporting from a pharmacy (49%), followed by their GP (16%).
Most respondents (81%) said the report had been their idea. Forty-three (3.2%) were discouraged by someone from making a report, most by their GP. Fifty-six (4.1%) stated an HCP refused to make a report on their behalf.
Patient reporting of serious ADRs was comparable with healthcare professionals, with a high proportion of patient reports (58%) containing at least one reaction term classified as ‘serious’.
Patients were also more likely to document the impact of ADRs on their lives (47% of patients vs 12% of HCP reports).
A comparison of the ‘patient-only’ with ‘HCP-only’ reports showed that only one in 10 of the YCS reports overlapped. Safety signals generated by patients-only data showed that two-thirds were not in the HCP-only dataset.
One third of respondents expected feedback from the MHRA, and two thirds said they would have liked it. Furthermore, 149 patients wanted to know whether any investigation or action would occur due to their report.
Respondents expected an acknowledgement of their report and information about the reaction, including the frequency of similar reports received, how common the effect was, or whether it was a well-known problem.
Problems with the system
Problems within the system include the inability to distinguish between suspected drug reactions and the underlying condition, impeding the ability to determine signals of harm.
To try and overcome this problem, investigators analyse the proportional reporting ratio (PRR): the spontaneous reporting rate of a particular drug divided by the corresponding proportion for all or several other drugs in the database. This shows whether a given adverse event is reported disproportionately for certain drugs.
The reporting of adverse events can also be assigned causation based on set criteria.
Underreporting
The ability to detect signals and assign causation is hindered by the substantial problems with underreporting of adverse drug reactions. In the U.K., patients have been involved in safety reporting since 2005; however, only one in 12 patients is aware of the possibility of reporting.
A 2006 systematic review of 27 studies reported that underreporting of adverse events was, on average, 94%. It could be as high as 98%, meaning only two in every 100 adverse drug reactions are reported to the MHRA.
This finding is backed by a recent analysis of anticoagulants that compared Yellow Card reports to hospital reports of gastrointestinal bleeds over five years. The North-West of England Hospital Trust recorded 12,013 bleed-related emergency admissions. Of these, 1,058 were taking DOAC anticoagulants. However, only six DOAC Yellow Card reports (0.56% of the possible) were made by the Trust during the period.
In 2018, the MHRA reported that it was “estimated that only 10% of serious reactions and between 2% and 4% of non-serious reactions are reported.”
The Independent Medicines and Medical Device Safety Review (IMMDS; also known as the Cumberlege report) reported gross underreporting with the current system.
The IMMDS recommended that “the spontaneous reporting platform for medicines and devices, the Yellow Card system, needs reform” and that “the MHRA should be required to invite representatives of those who report adverse events (both patients and healthcare professionals) to be involved in evaluating and making decisions on specific safety concerns”.
The IMMDS review showed that patients had been let down and that the reporting problems for devices were, if anything, much worse than for drugs.
The review called for significant reforms at the MHRA due to its mishandling of safety concerns linked to pelvic mesh.
In Europe, EudraVigilance provides online access to suspected side-effect reports. In the U.K., the responsibility falls to the MHRA. The MHRA publishes this information for suspected harms in interactive Drug Analysis Profiles (iDAPs).
They display an overview of all U.K. spontaneous suspected ADRs reported through the Yellow Card Scheme.
However, the system could be more user-friendly and easier to search. For example, medicines are listed alphabetically by the name of the active ingredient, not by the brand name. Clearly, the system for accessing patient information leaflets needs to be better thought through.
As an example, a search for aspirin leads to 7,638 results. Once a disclaimer has been agreed to and ticked, the end user is provided with a bewildering array of choices with documents that are poorly constructed and often impenetrable.
In July 2023 Carl warned MPs that the Yellow Card system should come with a warning:
Professor Carl Heneghan described how under-reporting of adverse drug reactions to the Yellow Card system could be as high as 98%, meaning the ability to detect signals and assign causation is substantially hindered.
The question is whether a system devised 60 years ago is fit for purpose. In the next post in this series, we’ll scrutinise this question further in terms of Covid vaccine data reporting.
Prof. Carl Heneghan is the Oxford Professor of Evidence Based Medicine and Dr. Tom Jefferson is an epidemiologist based in Rome who works with Professor Heneghan on the Cochrane Collaboration. This article was first published on their Substack, Trust The Evidence, which you can subscribe to here.
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Read it and weep, or at least feel your blood boil! Two doctors attended the recent World Vaccine Congress in the U.S and report back their experiences. Fascinating, unbelievable and very reminiscent of a cult, I’d say. For instance, the chap from vaccine research at Mayo Clinic who got vax injured after his second clot shot but went on to have a third anyway now has debilitating tinnitus but sings the praises of the death jabs whilst hating anti-vaxxers who he blames for vax hesitancy. I think the LNPs have clearly migrated across his blood brain barrier!
”In February 2022, Poland reported suffering from significant tinnitus after receiving the second dose of “an mRNA vaccine.” At the time, Poland described his symptoms as “extraordinarily bothersome.” Nevertheless, he chose to receive a third dose (monovalent booster).
Poland’s commentary on the COVID-19 mRNA vaccines was extremely positive. He said the rapid deployment of the new therapy saved millions of lives and would have saved millions more if it weren’t for the disturbing trend of growing vaccine hesitancy.
I assumed that his vaccine-induced tinnitus had resolved over the last year. It was only at the end of the conference, several days later, when he told me personally that his symptoms were still debilitating, making his unmitigated support of these products even more astonishing.
Poland set the tone for the four-day conference in the first 10 minutes. In his mind, the COVID-19 pandemic was halted through the hard work of our regulatory agencies and the remarkable products borne of the mRNA platform.
The only failure came in the form of “inexplicable” vaccine hesitancy, a phenomenon driven by anti-vax pseudoscientists who are profiting from spreading baseless, fear-driven propaganda.
Combatting vaccine hesitancy is as big a challenge as protecting the world from the next deadly pathogen. Indeed, a significant portion of the events focused on strategies to dismantle the troubling “anti-vaxxers.”
Marks supported Poland’s position that the vaccine-hesitant are irrational, “It’s crazy that they don’t get how great vaccines are,” he said. “I am past trying to argue with people who think that vaccines are not safe.”
https://childrenshealthdefense.org/defender/world-vaccine-congress/
Thanks for this link Mogs, an interesting read but also frightening. Thousands of people involved in this medico / pharma industry and they effectively know less about the “vaccine” shyte than me.
It’s also frightening that they seem to be putting a hell of a lot of emphasis and effort into tackling so-called ”vaccine hesitancy”. So they’re basically drilling down into the minutia of how they can best manipulate people who are exercising their fundamental human rights to bodily autonomy in declining a jab they feel they don’t need, by using a full-on assault of the tried and tested PsyOp. How effed up and unethical can you get?? Although, as we already know, medical ethics were well and truly left back in 2019, never to be seen again. Now anything goes, as long as it means a needle in as many arms as possible, by hook or by crook. And if you’ve read that you’ll know where I’m coming from when I say it’s like a cult mentality. Despite getting vax injured themselves…the sick, bent, psychopathic b’stards!
Completely agree. Dr Mike Yeadon’s latest take pulls no punches. I thought I had posted it yesterday but I am blowed if I can find it.
Fortunately, what this report does confirm is that many of these people are away with the faeries. We ‘anti-vaxxers’ will definitely NOT change our position. It doesn’t matter what psyop they think they can deploy it won’t work.
You’re right hux. They’re fully paid up members of Kool-Aid and the Gang! Delusional psychos..
No mention that Arab Countries have no black people running around from when they took slaves because they castrated them all. WHY? Slavery nonsense is all part of the War on the West and Whiteness. If your not white you can get away with anything.
There has been economic exploitation since civilisation began (as attested by the bevelled-rim bowls of 4th-millennium Uruk, for example). If we think that we have so little sin of our own to repent of that the main occupation of the righteous life should be to point the finger at the sins of others, committed in the past and tainting the present, why not focus on the industrial revolution? Conditions in the factories and mines were often appalling, child labour was common, and while wealthy capitalists profited most, there is a sense in which as heirs of the industrial revolution we all profit from their misery. Our civilisation is about to fall, and one of the things God has against her is its consumerism, the consumption of every sort of luxury produced at the expense of human souls (Rev 18:13). The exploitation of poor countries by rich countries, and of poor people by rich people, still goes on, and as beneficiaries we are all guilty of it.
But self-righteousness isn’t the height of moral superiority, it’s the height of moral self-delusion. It stinks as nothing else does, and when it gets hold of an entire society, the disease is terminal.
The UK and the USA are now unintentionally reaping themselves what they sowed when they went overboard continously guilt-tripping post WW2 Germans.
Part of me therefore thinks that it serves them right, but for that reason and not for the ones the zealots are giving.
The bigger part though thinks that such cr*p should be fought and stopped now, worldwide.
The UK and the USA are now unintentionally reaping themselves what they sowed when they went overboard continously guilt-tripping post WW2 Germans.
Well, not really. After the second world war, the anti-German war propaganda mostly kept running in order to ensure that Germany would really remain subdued this time. This means a couple of generations of people grew with the constant calls to fight largely imaginary fascists each and everywhere. This went to the point where fascist became pretty much synonymous with political opponent (eg, both the US left and the US right happily accuse each other of being fascists or Nazis). And that’s all which is happening in the wokiverse now: As always, the mission is Fight the fascists! and the proven methods for that are being employed.
Someone really needs to take back education from ‘brutally’ irrational apparatchiks like Daniel Kebede. According to Unherd, this guy is associated with the SWP (Socialist Workers Party) and he seems to believe that getting elected as NEU leader means he now has a mandate to (finally) achieve the communist revolution, reorganising society, where we are […] free from oppression, in his own words. The work of teachers is about teaching. It’s not supposed to be a convenient platform for extremist crackpots to preach to an impressionable audience. Someone who believes otherwise has no place in this job.
If a bellend like Kebede can become a teacher there is a massive fault in the recruitment and training process
Look at this stupid bint’s tweet from today. I swear she’s got a crush on Handcockwomble! Great to see the comments underneath. People see right through this disingenuous, arrogant shill:
https://twitter.com/IsabelOakeshott/status/1645775138237952000?cxt=HHwWgMC97Zfx-9YtAAAA
Apparently two years supplies of Midazolam were ordered and used in those early months of 2020. Oakshott is playing a stupid game.
Also taking into account her previous writings on him she seems suspiciously incapable of placing blame squarely at Hancockup’s door, in fact she’s barely critical of him at all. Always defending him. Very strange.
“Always defending him. Very strange.”
I agree Mogs, very strange. At the time these diaries began to be serialised I was decidedly ambivalent on Ms Oakshott and her stance but initially gave her a slight benefit of doubt. My current stance is that her position does not make sense. She is hiding something.
Nothing about Midazolam in the Lockdown Files?
Err, perhaps that’s because the Lockdown Files are a “limited hangout”.
These people destroying our heritage are the enemy.
Why are people so reluctant to grasp that pretty much all government policies since 97 ( it was happening before then, but at a very much slower pace) are about the utter destruction of the indigenous people of these islands, our culture, our achievements and our landscapes?
Is there a single significant policy that doesn’t have one or more of these effects?
100% in agreement.
They can’t “Build Back Better” until they have destroyed what we already have.
There’s no need to destroy these people, they’re perfectly accomplishing that themselves by not reproducing enough to keep their numbers at least stable (same phenomenon in all more-or-less Americanized societies where sex life has taken over the place formerly occupied by something like God, king and country). The Marxists (Kebede is one) are sensing another opportunity to take everything over here because a new ‘class’ of oppressed people fell from the sky by the grace of … well … Richard Dawson perhaps? Members of the established ruling class believe everyting’s fine provided they remain in control (Does anyone care about the skin colour, heritage or religion of a delivery serf on a zero hours contract?). Both will eventually find themselves surplus to requirements, as transmissionofflame (probably misspelled) so nicely put this, because our new compatriots will eventually bring all of their culture with them. This process won’t stop unless the Europeans stop their mad dash for ethnic suicide.
And this article from today’s TCW slots right in: George Soros.
https://www.conservativewoman.co.uk/the-indoctrinators-part-1-george-soros/
“With OSF (the Open Society Foundation) the vehicle for his messiah complex, he is relentless in pursuing his agenda. Climate change, ‘refugees’, transgenderism and any woke dogma which undermines traditional liberal democracies are supported by him. Enlightenment values and rationality are scorned in favour of anti-science, magical thinking. The young are targeted, destroying their futures to ‘save the planet’, and mutilating themselves for the pernicious transgender trend.”
Yes, well, maybe in the hallowed halls of academe, but I’m with Chesterton. We will just need more rope.
‘We hear men speaking for us of new laws strong and sweet,
Yet is there no man speaketh as we speak in the street.
It may be we shall rise the last as Frenchmen rose the first,
Our wrath come after Russia’s wrath and our wrath be the worst.
It may be we are meant to mark with our riot and our rest
God’s scorn for all men governing. It may be beer is best.
But we are the people of England; and we have not spoken yet.
Smile at us, pay us, pass us. But do not quite forget’.
I haven’t surrendered.
Keep fighting.
Keep attacking.
A curious thing.
I have read Will Jones’s excellent piece quoting Professor Robert Tombs’s important historical analysis. I note it was posted nearly 21 hours ago, but only just showed up on my screen, despite emails and visiting website.
I have also read all the comments, including that from the ever reliable Mogwai, 19 hours ago. Hard to disagree with him or most of the other 22 comments.
BUT
Am I really the only DS reader who finds it remarkable, that amongst the archipelago of Oxbridge islets, long overrun by the fake scientists, the virtue signalling self haters, the uber-wokesters, the BLM and Wahabi and Trans sycophants, we have the undaunted Professor Tombs with his entirely genuine brickbats piled ready to defend truth against the next wave of attack battalions, whether from the CCP or the Students’ Union. (I know. Pretty much the same thing.)
I for one, salute the intelligence and bravery of Professor Tombs and wish him the very best of luck. He’ll certainly need it.
A problem is that much of the time only the ‘woke progressive’ side of the story is mentionned in most of the media.
People do not hear about the other side.
I take the anti-British propaganda as a compliment: someone obviously fears Britain and the British Commonwealth greatly to put so much effort into discrediting it. The amount of times I have seen people earnestly popping-up on the Internet to share their stories, without presenting actual evidence, about how the British Empire is secretly still intact with the British monarch tyrannically ruling the whole world and how the City of London is not actually a square mile of land where many financial firms are based, but a secret cult controlling everything, is incredible. They even went so far as to slander Cecil Rhodes, whom most people had probably never heard of, as a racist and call for the removal of hist statue. Even seeming hero’s of the anti-lockdown movement, Reiner Fuellmich, David Martin and Robert Malone have engaged in anti-British propaganda rather than looking towards the more obvious suspects of malevolent global power in today’s world. Perhaps the real villains fear the notion, embodied by the British Commonwealth, that people of diverse cultures, backgrounds, beliefs and nationalities can actually get along with one another peacefully and have as their figurehead a person who does not actually have much in the way of former power over them. So such a thing is the stuff of nightmares to wannabe tyrants.