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.
To join in with the discussion please make a donation to The Daily Sceptic.
Profanity and abuse will be removed and may lead to a permanent ban.
Well seeing as the MHRA get 86% of their funding from the pharma industry good luck with that. We’ve seen exactly how *seriously* they’ve taken their role as regulator these last few years ( see table in article ).
Then there’s the small problem of the ‘revolving door’ between industry and regulators;
”Beyond the FDA, Ian Hudson, chief executive of the UK’s MHRA between 2013 and 2019, now serves on the board of biotech company Sensyne Health and is a senior adviser for the Bill and Melinda Gates Foundation. Before joining the MHRA, Hudson held various senior roles at pharmaceutical giant SmithKline Beecham.”
https://www.bmj.com/content/377/bmj.o1538
You’d have to be several sandwiches short of a picnic if you volunteer to participate in a pharmaceutical trial.
But then the Global Authorities knew that, which is why they effectively mandated or coerced millions to participate in the last one.
I used to work for a small pharmaceutical company and took part in several Phase 1 trials. I bought a (cheapo) motorbike with the
paymentscompensation.These trials were all of the form: Blood test. Take these pills. Don’t drink alcohol. Collect your urine for a week. Blood test.
To be fair I probably saved a load of money with the ‘don’t drink alcohol’ bit…
Never did me any harm. Baaaaah!
Thanks for this; very interesting. It’s the kind of content that makes the DS so important.
My default assumption behind any government or Big Pharma or related activity is that it’s not safe for me.
Hearing Dame June Raine talk unashamedly about tearing up the rule book didn’t sit well with me either.
Medics Day 2022- Somerville College Oxford: Speeches from Dr June Raine and Dame Kate Bingham
https://www.youtube.com/watch?v=xUQfzTqPUm4 35’37”
The MHRA is lost, to regulatory capture. Indeed, June Raine stated so in a speech I think last year, noting that they were now “enablers” rather than checkers.
I made an FoI request to MHRA way back, asking whether they considered the jabs to be experimental, and if they were gene therapy.
No to both questions was the answer.
I then quoted to them FDA documents which stated clearly that they ARE experimental and ARE gene therapy (confirmed by Moderna in their documentation). I noted that either they or the FDA must be lying, and asked which of them it was.
No reply.
The MHRA just another institution meant to protect us which will now do anything but.
Interesting piece from Peter Doshi .…..which I think underlines the points made..
As the people who are targeted into taking the ‘drugs’ are so out of touch and uninformed of the reality….it means Pharma companies and associated bodies can literally get away with murder…
“We tried to improve COVID vaccine labeling — the FDA said ‘no thanks’“
Health care providers rely on product labeling for accurate, unbiased and up-to-date information on medical products. But current Food and Drug Administration (FDA)-approved labels for the Pfizer and Moderna COVID-19 vaccines are obsolete, misleading and out of touch with regulators elsewhere. Whatever one thought of the initial shots, people are now getting boosted indefinitely with little reliable information about scientific developments.
https://thehill.com/opinion/healthcare/4037145-we-tried-to-improve-covid-vaccine-labeling-the-fda-said-no-thanks/
“So what are the odds it has a process for investigating adverse events arising in clinical trials?”
As part of my job I have run randomised controlled trials and the procedure for reporting adverse events is entirely different to the post-marketing yellow card system.
It is incredibly stringent….if any trial participant is hospitalised or dies during the trial period then the entire trial gets suspended until an investigation is done and the steering committee is satisfied that it was nothing to do with the treatment being tested.
This is why the covid jab trials made no sense to me. Because the procedures that are laid down are robust, but they were clearly not being followed. Which I guess is the problem.
As they made use of “Emergency Use Authorisation”, it leads to the question as to whether the “trials” were valid at all, once the emergency is over. If you applied the method used for other products, based on the recorded results available, would they result in a valid outcome? And would it be scrapped, or only allowed in certain circumstances?
If you haven’t figured it out yet, the “trials” were a charade, as evidenced by Brook Jackson.
If you look at the actual contracts (available by FOIA) you will see that the “Covid-19 vaccines”, were ordered by the US DoD as a “large scale manufacturing demonstration”
These contracts specify the vaccines as “demonstrations” and “prototypes” only.
In other words, the US Government and DOD specifically ordered a fake theatrical performance from the pharmaceutical manufacturers. Just to make extra certain that the pharmaceutical companies were free to conduct the fakery, the contracts include the removal of all liability for the manufacturers and any contractors along the supply and distribution chain under the 2005 PREP Act and related federal legislation.
How odd – I can’t seem to edit it to non-bold.
Maddie de Garay was dropped from the Pf trial for becoming extremely ill, left to pay her own medical bills, then gaslit and told it’s in her head. There are others I believe.
It seems that the protocol is now seen as optional, or just too expensive to pay attention to.
Pharmacovigilance isn’t vigilant. I worked within the MHRA on their case management system (we dubbed it case manglement due to poor data integrity). The organisation is an absolute shower and their tech is woeful.
Then I also remember listening to the whole of WHO’s (2019?) symposium on PV where they basically admitted the situation worldwide was utterly pants and there really wasn’t a capability worth speaking about.
I worked with the FDA in the USA in the noughties on a medical device. Their timeline for approval was a minimum of 10 years following safety and efficacy clinical trials. This is why I have never and will never take this experimental jab.
Standing ovation at Wimbledon’s Centre Court for Dame Sarah Gilbert who designed the Oxford COVID vaccine.
Iremember how embarrassed she looked. Quite right too. Probably made a Dame
Excellent analysis. Thank you.
How can human drug trial be considered to be safe when no drug is 100% safe? What puzzles me is why anybody volunteers for a trial. Are they paid? In the case of Covid, where the vaccine was quickly approved as safe and effective, the control group could not take the vaccination otherwise long term effects could not be evaluated. It is even more concerning when it comes to drug safety for specific groups. What would convince pregnant women to take part especially after thalidomide?