The Government recently put its weight behind increasing the number of clinical trials in the U.K., increasing the number of people enrolled in them and speeding up the MHRA’s licensing based on the trials data. (Here’s the Government’s announcement and the O’Shaughnessy Report on which it is based.)
I’ve been critical of MHRA since I uncovered failures in its licensing and monitoring of medicines which I wrote about here. Those articles led to me being a co-author of the Perseus Report, which was sent to all MPs and Peers in April. So, knowing that MHRA also regulates clinical trials, I decided to take a closer look.
First, let me say that of course I realise that clinical trials are, in principle, a good thing. Otherwise, new medicines wouldn’t get to market. I’m just concerned, as with the Covid vaccines, about the safety of clinical trials and the principle of fully informed consent.
Before I even got to researching the MHRA’s role in regulating clinical trials, I found a few wider issues that you should consider very seriously should you ever be tempted to enrol – the sorts of things they don’t tell you about in the ‘Informed Consent’ document for trial participants.
The first thing you need to know is that a lot of the motivation for this is money – big money. And I don’t mean that some commercial trials pay you to participate. I mean that you participating in a trial saves the Government money and increases the profits of pharmaceutical companies. Let me explain.
Here are a few quotes from the O’Shaughnessy Report which underpinned the Government’s initiative:
- “The U.K. life sciences sector had £94.2 billion in turnover in 2021.”
- “Commercial research… generated £1.8 billion to the U.K. economy in 2018/19.”
- “The NHS received about £355 million in 2018/19 from life science companies and saved about £29 million from pharmaceutical cost-saving, where a trial drug replaced the standard of care treatment.”
- “The NHS receives about £9,000 for each participant recruited onto a clinical trial and saves about £6,000 per participant due to treatment costs being covered by the commercial sponsor.”
- “If the patients enrolled in commercial trials had remained at the same level as in 2017/18 (rather than reducing), the NHS would have generated an estimated £570 million in income, and £360 million in savings.”
The next thing to know is that the pharmaceutical companies’ business model has been in trouble for the last 20-plus years. Their business model revolves around identifying promising new molecules, testing them in small, medium and then large clinical trials to gather safety and efficacy data, putting those data to the regulators and, hopefully, bringing new drugs to market. It requires very big investment over a long timeframe. Getting a new product to market takes on average 13 years with a low probability of success. One assessment by Bain & Co was that in 1995-2000, the ‘failure rate’ averaged eight to one. In 2000-2002, it had increased to 13 to one. Their Internal Rate of Return has been steadily decreasing for years with a steep decline between 2010-2014. You can read more yourself about all this here, here and here.
Big Pharma has made significant efforts behind the scenes to get Governments in the U.K., Europe and the US to help them to protect and improve their profits. For example, in the U.K., a Ministerial/Pharmaceutical Industry Strategy Group (MISG) was established in 2010. The minutes make interesting reading. For example, in the November 2014 meeting, Patrick Vallance (working for GlaxoSmithKline at the time) said: “In the future, medicines will come to market quicker with less data with more research being conducted in the post-license phase.” Feeling worried?
As an aside, I think that MISG must have been renamed the ‘U.K. Life Sciences Council’. See here and here. Also, Twitter reveals that Rishi Sunak is personally involved. But that’s another story for another day.
Anyway, back to clinical trials. I’ve already described the financial benefits to Big Pharma and the Government of you enrolling in a clinical trial.
It has, of course, also to be said that participating in a clinical trial can benefit you medically if you suffer from the disease or condition under trial – but only if you don’t receive the placebo or partial dosage and the trial medicine actually works. You might even get paid to participate. And even if you don’t have the relevant disease, the trial medicine can also benefit the wider public if the trial is successful and the medicine gets to market. However, as noted above, about 90% of trial drugs fail to meet safety or efficacy criteria.
So much for benefits. What about risks?
First, the MHRA, which licenses clinical trials in the U.K., has a poor track-record and is under-staffed, not just in quantity, but in terms of suitably qualified and experienced staff. The Government is obviously worried about this too because it says it has given MHRA extra funding. However, this is classic smoke and mirrors – it’s just reversing the funding cuts the Government imposed on MHRA in 2020.
Next risk? There is an increasing trend of less face-to-face clinical contact during drug trials. Doesn’t sound to me like that will improve the safety of trials participants!
Then there are the MHRA’s failings in regulation highlighted in the Perseus Report. For example:
- No independent safety audits of MHRA
- No separation between regulation (rule making and enforcement) and safety management
- No individual responsibility – it’s all done by groups of assessors
- No system for senior management governance of safety
- Significant conflicts of interest
- Lack of transparency
These apply to MHRA’s regulation of clinical trials just as much as they do to its Licensing and Pharmacovigilance of public use of medicines.
What about speeding up MHRA’s approvals of clinical trials? Just to point out that Dame June Raine has publicly declared MHRA’s purpose has changed from Watchdog to Enabler. Say no more.
Next, there’s a risk relating to investigation of safety incidents arising in clinical trials. It’s vitally important to accurately describe every single adverse event which arises in a clinical trial as unrelated, possibly related or most likely related to the drug under trial. This process directly drives calculations of safety risk and efficacy. When I worked in the Ministry of Defence, we caught out some defence contractors trying to ‘disguise’ problems in trials by dubious sentencing of incidents as being unrelated to the weapon under trial. Many pharmaceutical companies also have form in this regard and we saw it most recently with the Pfizer and Moderna Covid vaccine trials which were re-analysed here. MHRA therefore needs a robust process for rigorous checking of Pharma’s sentencing of all suspected adverse events during a clinical trial. Feeling confident? I’m not. MHRA admitted that it doesn’t have a process for investigating Yellow Card reports of adverse events potentially linked to medicines in public use. So what are the odds it has a process for investigating adverse events arising in clinical trials? Let alone a robust one. I will be submitting an FOI request to MHRA to check this out.
Finally, if, God forbid, a clinical trial does injure or kill people, guess who will investigate? The MHRA! As it did with the infamous Northwick Park tragedy in 2006 from which it absolved itself from any blame.
So if you want to enrol in a clinical trial, you go right ahead.
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. drugs regulator the MHRA.
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Not really a surprise, they didn’t spend all that money for nothing. However I resigned myself to them being used at some point a while ago and I know which side I am on. And I am fully prepared for the consequences.
It never ceases to amaze me how few people seem to understand the idea of the thin end of the wedge and how much impact it has on their lives.
With you 100%.
IT IS a dangerous mistake for leaders to make laws on the basis of received wisdom.Tin Men, try to find your hearts
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The EU has been planning for vaccine passports since 2016, with a delivery date of 2022.
The British Establishment was obviously fully on board with this programme since it pre-dates Brexit. We are still significantly aligned to the EU so it’s hardly surprising to find that the British Government will be complying with the EU’s policy.
They will have to create an alternative to an APP, since not everyone owns a smart phone and the very people who need to access the NHS most frequently are the ones least likely to be computer-literate and own one.
They are champing at the bit, especially those who would profit from it all. With any luck, a large majority would declare themselves exempt, or take their trade elsewhere.
Vaccine / health passports – who really benefits?
https://www.dr-rath-foundation.org/2021/04/european-plans-for-vaccine-passports-were-in-place-20-months-prior-to-the-pandemic-coincidence/
They are carrying on with their plans, regardless…
People should start joining the dots, the majority leading the push for this agenda have talked openly about population reduction and are eugenicists.
The UK has pioneered the state spying on its citizens for decades. This comes as no surprise, I binned my smartphone in 2020. Haven’t looked back. There’s a company in the USA that specialises in scarves, clothing and masks that disrupt cameras. They’ll soon become a fashion accessory! Plus the old ‘chav’ uniform of hoodie and baseball cap will return.
Assuming the RPTB have yet to completely nobble the ONS etc. (see Professor Norman Fenton re this) it will be interesting to see precisely how the new “bi-variant booster vaccine” is rolled out and more importantly, the percentage of takers.
Make no mistake, the only reasons vax passports aren’t yet mandatory is, thankfully the resistance of the 19 million plus refuseniks and the simple fact that the jabs are, on any cost/benefit analysis, dangerous.
How dangerous remains to be fully seen.
I’ve never had the jab: the NHS gave up contacting me eventually. My parents had the originals and one booster and have said they won’t have any more. We’ve know of a couple of people in our wider circle of friends of family and friends of friends who have either died (one of a heart attack age 38 and another in her 50s died in agony from blood clots all over her body within days of the jab, both previously healthy) or been permanently injured by the drugs (an 18-year-old trainee nurse was severely injured by the first jab and can’t have any more ever, meaning she can no longer work in the profession.) Allegedly they’re going to come after the unjabbed in a campaign starting later this month. We’ll have to see whether it’s been postponed in the last few months…
‘If a citizen only has NATURAL immunity or negative test results, they will only be eligible for a ‘limited venues’ (voluntary) pass.’
This says it all: natural immunity is more effective and longer lasting than waning vaccinated immunity. It is all about controlling the masses and ensuring Big Pharma makes plenty of money in the process.
The purpose of continuing with the injections, which are no longer needed and even if they did work, is not protection from illness but promotion of death.
We have to stop blathering on about a cold virus which has been and gone and accept that government focus now is on killing people.
The covid virus has morphed into a deadly injection virus. That is what we need protection from.
Moderna are rolling out a six in one injection, completely untested, and why, because it will make it nearly impossible to blame the forthcoming deaths on the injections – too many variables.
Morning all…
An update from Professor Norman Fenton on the supposed ‘updates’ on the Government website in regard to vaccination of pregnant women….
https://www.normanfenton.com/post/uk-government-sneakily-updates-web-page-with-vaccine-report-yet-again
Apologies…wrong thread…! Sausage fingers!
I remember there was a job advert for a deputy lead director – covid pass – pulled in June 2022 after questions raised in parliament about it. Savage Jabber was allegedly unaware of it.
https://web.archive.org/web/20220608081858/https://www.civilservicejobs.service.gov.uk/csr/jobs.cgi?jcode=1791653
Yes, they have been carrying on regardless, determined to have a ‘covid pass’ in place by hook or by crook.
It’s just a social credits app by the back door.
“remember there was a job advert for a deputy lead director – covid pass – pulled in June 2022”
ellie, the post was subsequently filled.
I didn’t know – I didn’t follow it up, to be honest. I’m not at all surprised, they are grand masters in the dirty tricks brigade. Accomplished liars.
Dido Harding who is tasked with this, is a member of the Bilderberg Group. The list of members makes for some illuminating reading & helps one to connect a few more dots…
https://expose-news.com/2022/09/04/bilderbergers-whove-played-a-role-in-covid-event/
BB – what a bloody eye-opener.
It most certainly is.
Power, once acquired, WILL be used and will never voluntarily be given up.
The vaccine passport is the control mechanism, the civil service in most countries positively salivate at the prospect of locking ppl they disapprove of out from society.
Let’s be clear – £37,000,000,000+ wasn’t spent on phone calls, min wages and dodgy tests. But it did buy a world-class surveillance system. The Stasi-esque NHSX is sheltering – unaccountable and out of sight – in the bosom of the sacred NHS.
Its purpose is the deployment of personal digital biometric IDs.
For your own safety, of course.
In the same week that the weather turns colder the health-harms of fuel poverty will be linked into the repurposed NHS app. The NHS app will be a pathway to the issuing of ‘energy vouchers’ to those on welfare and pensions. These vouchers will be redeemable against fuel bills, including your care home, your family or neighbour – to keep us all safe (i.e.warm).
And where have we heard that before?
Non-welfare people will be able buy these vouchers a heavy discount – as long as they get that digital NHSX ID and submit to its controls on how you then ‘spend’ your voucher on energy ONLY.
And following this ‘brilliantly effective and successful Govt vouchering scheme’ expect similar schemes for food and fossil fuels.
In this way – linking the distribution and spending of personal vouchers – the money we call CASH will be replaced by a programmable digital currency.
The people will willingly sacrifice the freedom of cash and choice to just keep warm ands fed in mild, abundant Britain. The new fudalism.
Beware vouchers!
Beware personal digital IDs.
“Let’s be clear – £37,000,000,000+ wasn’t spent on phone calls, min wages and dodgy tests.”
Well I had worked that out early doors. And I remain convinced that a large portion of the money was spent on road / traffic measures which will allow for vehicle tracking. Some of the money has been used on ‘track and trace’ but not in the ways we have been led to believe.
But people on pensions are the people least likely to have a smart phone. My mother, my elderly neighbours….none of them have internet or phones.
If they do this, there will be chaos. It’s too mad, surely, even for our government? we don’t even have mobile phone coverage in our village so goodness knows how they think it would work.
The vast majority of people without smart phones will be older people who are unlikely to be a threat to TPTB so they will be ignored – literally. If they fall ill, tough. If they die they help towards government targets.
To be blunt – the unconnected will be disconnected and permanently.
My feeling is that it’s the infrastructure (and the funding to implement it) that was desired, and that this relates to the imminent introduction of CBDCs. Once the system is in place, and the public is primed to accept conditional entry to venues and constant surveillance it will be much easier to install this new type of economy.
However the ‘Covid-19’ enterprise fraud cover story was so unbelievably weak and stupid that the wheels fell off, and it began to look absurd. They’ll be some scratching of heads about how to proceed now. They had one chance to gain the initiative, and ended up looking ridiculous and back at the drawing board. My guess is they’ll go for ‘cyber attack’ next.
Yes of course they kept the vaccine pass. I must have been fooling myself big time. For a brief moment in the summer it seemed like all their plans were going to be ripped to shreds, stuffed down the pants of Javid, Johnson, Patel et al and set on fire but unfortunately that never happened. So despite all thousands of reams of evidence, all the weight of knowledge and understanding about the true dangers or, rather, non-dangers of Covid and the very real dangers of the vaccine itself over two and a bit long exhausting years, despite all the science that actually shows a completely different picture, all the eminent scientists and doctors speaking out, all the evidence of vaccine harms, nothing has persuaded them that anything is amiss with the vaccines. No doubt at all. The good ship Lollipop – or Vaxalot – sails on, on calm steady seas with nary a hint of a breeze to ruffle the waters of absolute certainty. Meanwhile all the shock troops, the Covid Marshalls in Waiting, the mask manufacturers, BIg Pharma, all the cohorts of believers and cheerleaders will fall into lockstep again come the next vari-airy-ant this autumn or winter. Well, carry on if you must, but I’ve got a train to catch – it’s called the Reality Express and it’s not stopping at any stations on your line…
medical apartheid dompas
Bureaucratic opportunism. That’s what it looks like in the DHSC paper published above. In various departments, fashions come and go. E.g. a few years ago, there was a push to develop car engines that would churn out less than 100g/km of carbon dioxide, which resulted in zero road tax. I bought one of those in 2013 – I still had to “pay” tax every year, except that it was zero; I’m not joking!
Farage hit the nail on the head. All governments are into short termism(vote winning). No long term strategic planning, hence the energy crisis. So I wouldn’t worry.. Everytime the public push back, the government about- face.
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I think there can be no doubt that covid passes will return this winter. When they do, the propaganda will be ‘anyone can get it, even if you’ve had it before, and anyone can spread it, even if not unwell’. People in general will support the covid pass’s return.
The facts, meanwhile, will remain (1) that at most 20% of the population has been susceptible to any variant, (2) no one has been at mortal risk from covid unless age-frail or already seriously ill, and (3) no evidence or rationale whatever exists for saying covid can be transmitted by people not coughing, sneezing and running a temperature.
Now its been fully established that the vaccines do not prevent spread of Covid, Why is our government wasting money on this?