I was struck by Professor Carl Heneghan’s comments to a House of Commons All Party Parliamentary Group reported last week. Like me, he is scathing about Medicines and Healthcare products Regulatory Agency’s (MHRA) safety management. In relation to MHRA’s strategies and proposals to improve medicine safety he said that “fine words butter no parsnips”. How true. I want to go a step further and explain why I think medicine safety will actually get worse, not better, unless MHRA learns from other safety critical sectors.
Unlike other safety-critical sectors, medicine safety is managed in relative terms, not absolute. Take aviation for example. Aircraft are designed to meet absolute safety targets such as the number of fatal incidents per million flying hours. In contrast, MHRA do not set safety targets for licensed medicines like ‘no more than x deaths or y serious adverse events’. Instead, MHRA licenses a medicine if the clinical trials data indicate that ‘the benefits outweigh the risks’. That’s a charter for collateral damage to start with.
It gets worse. In 2014, Patrick Vallance (then working for GlaxoSmithKline) told Health Ministers that “In the future, medicines will come to market quicker with less data, with more research being conducted in the post-license phase.” Imagine Airbus or Boeing telling the Transport Secretary that they intend to ignore absolute design safety targets, do less testing on new aircraft and then find the missed safety problems once they’re in service. Or nuclear power plants. Or oil/gas rigs. It would be ridiculous, but bizarrely, it’s okay for medicines.
On to the post-license phase. Other safety-critical sectors define absolute tolerable levels of in-service safety incidents and investigate them all. Not MHRA. They don’t define a tolerable level of harm, and they don’t investigate even just the fatal/serious Yellow Card reports and those involving children or pregnancy. It’s excuse is pathetic – it doesn’t have the resources (see slide 23 here). Instead, MHRA does statistical analysis of Yellow Card reports to compare the likelihood of different types of adverse events between different medicines. That’s a relative assessment of safety. And bear in mind that the vast majority of adverse events go unreported. So it’s a poor relative assessment at that. Nor does MHRA assess causation of Yellow Cards – to what extent was the reported fatal/serious adverse event caused by the medicine: definitely, probably, possibly, unlikely or not related. There are, of course, other aspects to MHRA’s pharmacovigilance but June Raine has confirmed that statistical analysis of Yellow Card reports remains “the most significant method” of its safety management (see slide 19 here).
To make matters even worse, MHRA knows that its statistical analysis misses safety signals:
a) In 2013, MHRA listed 27 medicines withdrawn on safety grounds since 1995. The average time on the market was 11 years. That’s how long it took MHRA to wake up to missed safety signals. Earlier this year, I asked MHRA to update the list to 2023 but they said it would cost too much to find the data.
b) In 2020, the Cumberlege Inquiry reported on two drugs and one medical device where MHRA missed safety signals for years. Sadly, the report’s recommendations tinkered around the edges. Indeed, the main one was the establishment of a Patient Safety Commissioner to “listen to patients” – a safety net, but it’s too late at that point anyway. There was nothing to improve the fundamentals of safety management because, as Appendix Five of the report confirms, the Inquiry had no input from those involved in managing safety in other safety critical sectors. That’s a failure soon to be repeated by the Covid Inquiry – Baroness Hallett is planning to appoint an independent vaccine safety expert but not any wider safety management experts. The Perseus Group offered to help but has so far been declined. The only glimmer of hope is that the Patient Safety Commissioner confirmed to me recently that she is “engaging beyond the healthcare sector to learn from other high-safety industries”.
c) For the Covid ‘vaccines’, MHRA admitted that it missed safety signals until mid-2022 when it changed its methods of statistical analysis. Ironically, one of those changes was to assess Covid vaccine safety against other drugs not other vaccines. But that works both ways – the safety of other drugs is now being compared against the Covid vaccines! Hands up if you think that’s a good idea.
d) MHRA’s statistical analysis uses signal detection thresholds. Setting low thresholds generates lots of potential safety signals which they don’t have the resources to investigate. Setting higher thresholds leaves more potential safety signals undetected.
The corollary to all of this is that those missed safety signals from all drugs down the years remain in the Yellow Card database and are incrementally baked into the baseline of MHRA’s relative statistical analysis of comparative drug safety. Day after day, the baseline of acceptability goes up and newer drugs can have more adverse events and still be considered acceptably safe because the older ones have safety issues undetected by MHRA’s statistical analysis.
It’s surely time for radical reform. We won’t though. We didn’t in 2004 when the House of Commons Health Select Committee published its report on the ‘Influence of the Pharmaceutical Industry’. We didn’t in 2009 with serious problems with Pandemrix, the Swine Flu vaccine. We didn’t after the Cumberlege Report in 2020. And we haven’t now despite the tsunami of evidence of harms from the Covid vaccines. The pharmaceutical industry is now too lucrative and too many doctors, the public and politicians are now addicted to ‘a pill for every ill’ that it now seems unstoppable. Depressing, isn’t it?
What’s the next ‘scandal’ going to be (apart from the Covid vaccines)? God knows. Perhaps it’ll be ‘SSRI antidepressants’. Serious concerns have been swirling around those for over a decade – which is, coincidentally, the average time it takes MHRA to wake up! Google ‘SSRI PSSD’ and judge for yourself.
Whatever it is, you just know there will be yet another medicine scandal along soon.
The fact is that there needs to be root and branch reform of MHRA and how it manages medicine safety. Sadly, that doesn’t seem likely – for example, the Government is already lining up to allow MHRA to rubber stamp anything licensed by the FDA or EMA. You have been warned.
Until Nick retired a few years ago, he was a Senior Civil Servant in the Ministry of Defence responsible for the safety and effectiveness of ammunition used by the Armed Forces. He is co-author of the Perseus Group report on U.K. medicines regulator the MHRA.
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These nonladies and ungentleman have learnt the lessons of the pandemic well: Someone who’s in control of the megaphones can tell an unlimited amount of plain lies unchallenged. There was no summer in 2021, it just kept raining until autumn. Then, preciously few warm and somewhat dry weeks followed before it started getting cold again. With the exception of April, winter 2021/ 2022 basically lasted until the first week of July. There was plenty of rain and more often than not, it was so uncomfortably cold that I had to turn the heating on. I’ve never done that in June before. Come July, sort-of sommer came. Often overcast and rather cool but with longer pauses between the downpours. In the middle of this exactly three warm (not hot) days occurred. This doesn’t make an extreme heatwave and BBC employees who keep claiming the contrary and who know very well that they’re lying shouldn’t wonder why annoyed people keep calling them out on that.
Was it at least a safe and effective heatwave?
We’ve had some average July days this year, two really hot days thanks to a particular weather system, that was followed by a week of below average temperature and above average rainfall. Now it’s back to July norms. Overall I’d guess this July’s average temperature was middle to slightly low compared to the multi-year average.
There’s a technically interesting article in the Udraigna on this:
https://www.theguardian.com/environment/2022/aug/01/uk-farmers-count-cost-as-heatwave-kills-fruit-and-vegetable-crops
The first interesting thing to note here is that the top heading and the sub heading already differ in meaning, the top heading claiming a catastrophe (of sorts) occurred while the sub heading states that a catastrophe might occur if more extreme heat caused by clima crisis materializes. Chances are that the point of the sub headline is mostly to put extreme heat and clima crisis in one sentence, thereby implying a factually wrong cause-and-effect relation.
Half of the article is composed of quotes from a guy running a green wholesale business for fruit and vegetables in London. This is basically just a lot of handwaiving as no London business man has any first-hand experience of growing stuff in the fields somewhere out of London. The most amusing one is his assertion that he had faced a day long shortage of berries because they had all been cooked out in the open. As the cooking temperature of water is 100C and not 40C (at Heathrow), this certainly didn’t happen. As the next sentence reveals, this was really because fewer berries were picked for a couple of days, followed by the assertion that there could be real trouble of more hot spells occurred.
It then switches to farmers being concerned about the possible effects of the recent dry spell, implying that a few weeks without rain (we haven’t seen yet) would be somehow uncommon and dangerous during the summer months. Farmers – obviously – doesn’t refer to farmers but to another pencil pusher, namely, the deputy secretary of the union of farmers. Again, nothing has happened so far, but if different stuff would happen in future, there could well be difficulties in future.
— I really wish I was better at describing this, IMHO, the article is a textbook example of lying by implication while accurately reporting that nothing happened —
I was reading today that British winegrowers don’t want any rain because they are going to have the best wine year ever if the dry weather continues. My own observations show bumper crops of fruit coming on the trees and the wheat still standing, waiting to be harvested, has ripened perfectly (as opposed to some recent years where it has gone black on the stalk due to the wet). Even some blackberries are ready to pick.
According to the Met office, the definition of a heatwave is FIVE consecutive days of very high temperatures…not the one and a half we had the other week – Monday was Costa del Sol hot, Tuesday started that way, but by the afternoon it was raining. Call that a heatwave? No, Met office, you can’t because it b****y wasn’t you dorks.
The climate changer dream summer was 2018 which it was really unpleasantly hot and dry for an unusually long time. Since then, they’ve been trying to rerun this based on media fantasies every summer (with the exception of 2020 and 2021, when these clowns of doom were too occupied with COVID to care for the weather). 2018 was also the last year when we had normal weather forecasts in summer instead of climate catastrophe nudging by swapping the informational map showing a green outline of the country with cloud, sun and rain symbols to indicate local weather conditions to one using a gradient of light red to dark red calibrated such that the highest temperatures expected on a certain day get the darkest red, regardless of what these temperatures actually are. Any other information which used to be on this map has been silently dropped.
I’d really like to ask this BBC meteorlogist of 25 years why the BBC has chosen to remove the cloudy/ rainy/ sunny/ windy symbols from the overview map in favour of focussing exclusively on temperatures indicated in colours commonly associated with mortal danger from fire. There’s certainly no science which has determined that clouds, rain and wind don’t occur over England anymore. Hence, the BBC is selectively withholding important meteorological information about the actual weather in England in its visualizations of the weather forecast. What’s the rationale behind this?
Great points but this stopped being about observable reality, demonstrable fact and science long ago.
Crybullies, as they are known, have been a long established tactic of the left. It’s pretty easy to do:
Step 1, stoke up anger with a series of unprovoked inflammatory and/or abusive social media posts.
Step 2, cry victim when you get the inevitable backlash. If you are an A-lister this involves a sympathetic appearance on the BBC or in The Guardian.
The best way to deal with a crybully is to give them something to cry about, lol.
For most climate alarmists it’s a fashionable bourgeoise religion and one that ties in nicely with their pathological snobbery and their desire to tell the ghastly stinky little people how to live their lives. But for the BBC – the Grand Muftis of the sect – it’s more serious. They have most of their pensions invested in carbon trading and so-called renewables. The pyramid is collapsing and the only way they think they can shore up its foundations is by calling in ever more frequent truck loads of tax payer funded junk science bullshit, otherwise it’s goodbye gold plated pensions.
Driest July since 1935 according to met office as reported by the BBC
https://www.bbc.co.uk/news/science-environment-62382703
Not sure how wet July 1976 was or July 2003.
This is the same bullshit as with the global temperatures: They’re averaging different rainfall measurements to arrive at a fictional England-wide level of rain. Mathematically, averages are subject to distortions by outliers and regardless of that, averaging measurements of different quantities still makes no sense.
A sensible way to present this information would be something like the “We’re on fire!” temperature map, just using a neutral colour (eg, light grey to dark gray) which would show how much rain was measured where. One could also create a so-called histogram by adding measurements rounded to mm of the same value together and present the outcome as 2D-plot. One could get then an idea of weather trends by calculating the average number of entries in each category for a number of years.
This isn’t exactly rocket science, more basic working with numerical data. When the Met Office doesn’t do this, either the people working there are very unqualified or a serious presentation of rainfall data would not suit itself to the intended kind of headlines.
I came across a speech made by Hitler in Munich in 1937. He emphasises community, much like Twitter, Facebook and the New World Order gangs.
“…And that brings us to the problem of freedom! Freedom, yes! Insofar as the interest of the national community gives the individual freedom, it is given! Where the freedom affects or even impairs the interest of the national community, the freedom of the individual ceases! Then the freedom of the national community takes the place of the freedom of the individual.”
If you’re stupid enough to watch the BBC you get what you deserve. They’re a propagandist organisation; they pump out propaganda.
Turn it off.
On a positive note. Greta Thumberg has just won (for the 3rd consecutive year) the award for “International Truant of the Year”
The 4-year contract for broadband services costing £70 billion sounds like a modest Government programme to manipulate our lifestyles.
The £70bn contract went to a small company called Place Group Ltd, which in its last published accounts had 2 employees.
Correct. More about this surprising contract award here:
https://www.cornwalllive.com/news/cornwall-news/small-company-cornwall-awarded-giant-7407664
Most people promoting net zero and a climate change “emergency” are not scientistists and Marr is a typical example. I listem to the view of those scientists who have studied climate and what has efffected it over billions of years rather than people whose opinion is based on what happened in the last few weeks. Most real climate scientists tell us that CO2 generated by humankind has a very minor impact on climate compared to a whole list of other factors that mankind can neither impact or control. There is no current climate emergency apart from that generated by politicians and companies that benefit from the idea of it.
The climate crisis scam that is reaching a scope of almost 1 trillion per year worldwide. This is all funded by tax money from rich Western Countries treasuries using Non Profits NGOs, fake charities, billionaire class trust funds & charities, University grants & government funded agencies. Tens of thousands are making a living & rely on peddling this religion for their livelihood. Climate change only occurs in rich western countries for a reason. This climate crisis will not end until rich Western Countries stop allowing abuse of their tax systems.