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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“BBC journalist says her family will pay slavery reparations”
But presumably not so generously that they can’t afford their homes and a new BMW..?
Indeed
Trillions have already been transferred to descendents of slaves in the US through welfare, probably here too, and trillions in aid to African countries. How many more trillions will be needed before people realise that it’s not going to work. The only way Africa will become as prosperous as Europe is if Europe impoverishes itself. Ah, hold on….
Three downvotes already – looks like I’ve hit a nerve!
Six now. Loving the quality of these counterarguments.
I have upticked tof simply because you are right.
Thanks! I don’t mind people disagreeing with me – in fact I think a bit more intelligent, constructive and even heated to and fro here would be a good thing – but simply downticking without saying why seems kind of lame to me.
“Proposed ban on importing fur and foie gras will be dropped”
As our personal freedoms are eroded day by day, I applaud the government for ensuring that the few people who can afford to buy foie gras can still do so.
“Ron DeSantis is the future of conservatism”
I’m very much of the mind that DeSantis needs to stay in Florida and build up his power and support rather than going toe to toe with the blob until the tide begins to turn on woke. Where that leaves Trump is another matter. Four more years of the Democrats is unthinkable.
Surely the silent (vast) majority are anti-woke and just waiting for someone to legitimise and enable their expression of that. The trouble in the US is that the Democrats have stitched up the voting apparatus to such an extent that persuading a majority of the people is not enough in itself to win.
“Nicola Sturgeon’s approval rating plunges in wake of trans row”
Inept and corrupt, but as in England, the opposition is even more hopeless than the administration.
“Nicola Sturgeon’s approval rating plunges in wake of trans row”
Couldn’t happen to a nicer chap.
5G: from the makers of Covid and Climate Hoax.
We do not need 5G.
Stand in the Park Make friends & keep sane
Sundays 10.30am to 11.30am
Elms Field
near Everyman Cinema & play area
Wokingham RG40 2FE
Looking at the photos in the Mail’s piece on the Let Women Speak event in Glasgow and the opposition event, it looks as if the age demographic is quite different.
Regarding ChatGPT, no-one should be under any illusions. The teams who design and train all this stuff will doubtless be woke as hell, as will their bosses and their firms, and they will either actively want woke results or they will be paranoid about their AI tool speaking uncomfortable truths. Either way, you can bet money that it will be very hard to find an AI tool that is anything other than woke, left-wing and on-message about all the hot topics. Control of AI will give the left even more power than they already have.
If ChatGPT were a human, one might be very tempted to answer its pontifications by suggesting it broadens its reading. But like politicians, it seems only able to “think” popular consensus, not truth. You won’t find it saying, “I read an article by Philosopher X that really changed the way I see the world.”
It’s an interesting question – on what basis does an AI form an “opinion”. It can either be based on “consensus” or on some motivating criteria designed by those that “train” it. Either way it’s going to end up woke.
Why haven’t we joined the panic about intercontinental magically-steered weather balloons dropping dirty bombs on cows in Montana? Every other news outlet is full of it, and urging war with China on their Chinese-built computers.
Just a quick aside, the UK will ban the sale of new ice cars in 2030.
Being as they cannot control production and sales in other countries what’s stops us importing an ice car? Only a ban from uk roads would stop that and that would be a massive mistake and almost impossible to achieve!
https://www.dailymail.co.uk/news/article-11714955/Proposed-ban-importing-fur-foie-gras-dropped.html
Foi-gras is required as a necessary food supplement for the ‘elites.’
Fur will be used in the manufacture of fake ‘meats.’
https://www.conservativewoman.co.uk/will-this-5g-challenge-fall-on-deaf-ears-too/
Michael Mansfield in court challenging the legitimacy of 5g roll out. This should be an interesting test of our judiciary.
https://www.spiked-online.com/2023/02/05/the-lethal-cost-of-lockdowns/
What about the 2,332 deaths registered on the MHRA Yellow Card system and the many more thousands of deaths reported on VARS System in the USA not to mention those in Europe again tens of thousands of deaths, then there’s Australia,Canada and New Zealand? Funny how they are all in the most “vaccinated” countries in the world. African countries on the other hand…..
Apparently African countries will suffer the initial onslaught of Billy’s “Catastrophic Contagion,” as an initial levelling up exercise.
https://www.conservativewoman.co.uk/its-what-big-brother-watch-doesnt-tell-us-that-counts/
A cracking article from James Delingpole demolishing the “leaks” from 77 Brigade et al. I am sure this will appear in tomorrow’s Round-Up but anyway here it is.
As James says, an article which includes Kneel as a purveyor of disinformation decidedly stinks.
The balloon story in proper perspective:
https://www.conservativewoman.co.uk/spy-balloons-flights-of-fancy/
And here’s Off-G ‘s decidedly blunt take on the matter:
https://off-guardian.org/2023/02/05/offg-on-the-chinese-spy-balloon/
The stupidity of TPTB gets more ridiculous by the day. The Alt Media simply has to –
Pop their balloons.
Oh look. Head of CBDC Job Advert.
Get your applications in, you have only until 7th February.
Some frantic back peddling by a councillor in Southend with regard to ’15-minute cities’.
https://www.southend.gov.uk/news/article/2794/statement-regarding-recent-15-minute-cities-and-oxford-trial-local-media-article
I congratulate the people of Southend. Keep up the pressure.
Here we go. No mention of blockchain technology and programmability. In other words, the totalitarian control of people the technology enables. I’ll keep using cash where I can.
https://www.bbc.co.uk/news/technology-64536593