Well-conducted clinical trials are essential for us to advance medical care. Full disclosure of the results will improve the public’s confidence in the effectiveness of new treatments, improve participation in clinical trials and benefit all of us – but only if they really give a true picture of the results and what they actually mean.
In 2022, the Medicines & Healthcare products Regulatory Agency (MHRA) put out a consultation related to the legislation around clinical trials. The original clinical trials regulations were introduced in 2004 primarily to improve patient safety and ensure that data obtained from the trials was both reliable and of good quality . However, they were rather burdensome, didn’t really differentiate between small-scale academic trial and large-scale Big Pharma trials and simply made things more complicated than they needed to be; a change was long overdue.
At the time of their introduction, I found it frustrating that regulations imposed by the EU were foisted upon the U.K., and we had no power to write our own legislation that may have been more appropriate to our situation, perhaps allowing some flexibility for the small, ground-breaking clinical studies, led by academics, that I was involved in.
An update to the regulations was written by the EU in 2014. This new regulation (Regulation 536/2014) was more pragmatic, simplifying some of the bureaucracy, improving transparency (by including a public database and layperson summaries) and making provisions to support academic and non-commercial trials. But, in a twist of irony, due to the delay in implementing these changes and the U.K.’s departure from the EU during that time, this regulation was never written into U.K. law. However, regulation 536/2014 was introduced in the EU, thereby offering the EU a distinct R&D advantage over the U.K. What should have been an advantage of Brexit turned into a disadvantage – I hear the Remainers’ jeers!
The MHRA’s consultation seemed to be, at least in part, in response to this – not the jeers of the Remainers but the U.K.’s lack of competitiveness in drug discovery. It asked many questions relating to the existing legislation and proposed legislative changes. The proposed changes are generally welcomed, although the delay in introducing them into U.K. law is not. A comment piece this month in Nature Medicine looks at one change, which was very much supported by the people who replied to the consultation, but which may end up being quite controversial and over which I have some concerns.
The change will introduce a requirement “to offer trial findings with participants in a suitable format or explain why this is not possible”. Part of the problem, as the authors of the comment piece point out, is that it is not clear how best to implement this policy. The authors set out to propose a framework for what information should be summarised for participants, how results should be summarised and when. For example, they suggest that the information should answer these four questions: what question did the trial set out to answer? what did the trial find? what effect have the trial results had, if any, in changing treatment or prevention? and where can the participants find out more?
In the article, the authors make reference to the six-page summary provided to participants involved in the RECOVERY trial. For those not familiar with the trial, it was a large ‘Randomised Evaluation of COVID-19 Therapy’ carried out in the U.K. to try to find effective treatments for COVID-19. However, we need to be careful when we summarise the findings of such studies because the information omitted is just as telling as the information provided, and unless all the information is freely accessible for scrutiny, the information provided can be more misleading than providing no information at all.
If we take the case of hydroxychloroquine used in the RECOVERY trial, the summary says quite clearly that there was “No clinical benefit from use of hydroxychloroquine in hospitalised patients with COVID-19.” The evidence from the study seems to support this, but, of course, the summary fails to mention that hydroxychloroquine was never expected to be effective in patients already hospitalised with severe COVID-19; it was thought that it would most likely be useful in the early stages of COVID-19. If it had been administered earlier, in an outpatient setting, at a reasonable dose, the results may have been quite different.
An Italian study investigated early intervention in around 400 patients in early stages of COVID-19 from November 2020 to March 2021. Doctors were able to select from a range of drugs and to choose those most appropriate for individual patients. This included the use of hydroxychloroquine (200mg twice a day for seven days) usually in cases where ivermectin was not available and where hydroxychloroquine was not contraindicated (this was in approximately 30% of patients in the study). Patients in the early stages of the illness who took part in the study, seldom (8% in phase 2a) or very rarely (4.6% and 1.6% in phase 1 or phase 0 respectively) required hospital admission. The main result of the study concerned the overall mortality; only one patient died from COVID-19 (a lethality of 0.2% compared with national statistics indicating a lethality of around 3% for similar patients). So, the early intervention appeared to be effective, but the complex nature of the study made statistical evaluation difficult.
What the summary also doesn’t say is that the dose of hydroxychloroquine used in the RECOVERY trial was much higher than standard treatment. For the treatment of malaria, the standard regimen may be something like 800mg initially followed by a further 400mg dose six hours later, then another 400mg 24 hours following the initial dose and another 400mg 48 hours after the initial dose (a total of 2000mg over 3 days). In the RECOVERY trial, patients received 800mg initially then 800mg 6 hours later, followed by a further 400mg six hours later, followed by a dose of 400mg every 12 hours after that for the next nine days. So, participants received a whopping 2400mg within the first 24 hours of treatment. This is clearly going to affect the adverse event profile and impact patient outcomes. Contrast this with the Italian study where 200mg was given twice a day for seven days in the early stages of the disease.
On reading the summary of the RECOVERY trial relating to hydroxychloroquine, you would be forgiven for thinking that hydroxychloroquine had been shown to be of no use in the treatment of COVID-19. In fact, the UKRI headline summary simply states “Hydroxychloroquine has no clinical benefits.” The situation of hydroxychloroquine (and similarly ivermectin) were so highly politically charged that fair reporting of studies was practically impossible. The summary presented was quite misleading in this case, and I can imagine many similar scenarios where the summary would fail to tell the whole story.
However, this is just one problem. Another problem relates to how the data is presented, since it is easy to show one thing when the actual data shows something different. To really understand these problems, I’d suggest reading Prof. Norman Fenton’s paper on the Simpson Paradox. In this paper, he clearly shows how results can be presented, very plausibly, in such a way to show that a drug is more effective than a placebo, even when it isn’t. Similarly, if you want to see his detailed analysis of the illusion of the efficacy of the COVID-19 vaccine and other similar data, then I suggest looking at Prof. Fenton’s website.
A further problem touched on in the paper relates to when the results should be made available. Some might say “as early as possible”, but I see problems with this. Firstly, this doesn’t give an opportunity to fully investigate the long-term safety and efficacy of a new treatment. Secondly, to really understand the full impact of a study, it may take many years. For example, if you are looking at the outcome of a certain cancer treatment, you may need to wait 5-10 years (or more) to really see if one drug was more effective than another (time to relapse, for example, will hopefully be many years ahead or not at all if the drug is really good). So, presenting results early (which happens all the time in the published literature for obvious reasons) may give an untrue picture of how good the drug really is.
Public engagement in clinical trials is really important. It can help inform scientists about their proposed studies, provide insights that we, as scientists, don’t even think about because we are caught up in our own little research bubble, and improve the study significantly, thereby improving outcomes for patients and strengthening the results of the trials. Participants in clinical trials should have the right to see the results of the study, so I wholeheartedly support the proposal made by the MHRA to be more open with the public in reporting results of studies that they have been involved in. However, I would go further and propose that all the data is easily accessible, warts and all, so that the results can be properly analysed, and the true effectiveness of the study drug assessed independently. After all, although the information about the drug is confidential to the company, they are asking the general public to take part in studies, so the general public has the right to know the outcome of the study. If that is a step too far for drug companies, then I would suggest that the summaries should be written by independent scientists with full access to all the data so that a fair unbiased summary is presented. I’m not even sure if that is possible anymore but I live in hope that we can get full disclosure on the results of clinical studies so that we can all know if the drug is truly beneficial, to whom, in what setting and at what dose. Although we’d all like to put a positive spin on our results, this isn’t usually in the public’s best interests. As the authors of the Nature Medicine comment note, “Communication of trial results must happen whether the trial has positive, inconclusive or negative results.”
Dr. Maggie Cooper is a pharmacist and research scientist.
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Many people support Hamas.
“I support Hamas.
Simply because I can’t ever again support Israel.
And if you continue to support Israel after witnessing its actions in Gaza, you’re more than simply an idiot.
You’re an immoral facilitator of genocide.
Sort of like the modern equivalent of a Nazi.”
Scott Ritter
https://t.me/ScottRitter/2218
Hamas declared war on the Jewish people and state by their actions in October, in wars innocents are killed, Hamas is no different from Germany, or the Japanese when they declared war on other nations then there was retaliation. Unfortunately as in all wars it is the innocent who are harmed. Hammas knew this, but they do not care.
Well said
War is something that’s supposed to involve soldiers fighting other soldiers and not mass murder of civilians. Insofar this happens in war, it’s considered a war crime. And there was no war between Hamas and Israel to begin with as these guys aren’t soliders. Just terrorist murderers.
You’ve got it the wrong way round.
The Jews declared war on the indigenous Palestinians 76 years ago.
The Palestinians are fighting back just as the French Resistance did against their foreign German occupiers.
Is Scott Ritter recommended reading?
He’s very good on the Ukraine war. I don’t agree with him with regards to Israel.
Aye same with Galloway. Great on the Deep State, but I remember him on the radio ridiculing anyone that questioned the World Order. I remember he was a champion for mass immigration but has seen the light over that too.
He told someone on the radio “so you think there are men in cloaks sat around a table in some shady room do you”. He did read out some TXTs from me around 2009 when he was on TALKSPORT. He didn’t take kindly to me questioning or the significance of a ‘Chalk Board” but happy about a TXT I sent over the expenses scandal. “My boiler is broken, wish I could claim for that, getting used to clod showers”….Nice little bunce if you can get it, the boiler cost me 2K.
Scott Ritter is a lunatic.
‘Ritter is an example of a typical disgraced American – often a man – who discredited himself in the US and now wants to be perceived as a source of “honest analysis” in Russia as a means to achieve renewed or increased glory.
Desperate men like him have frequently come to Russia to get a fresh start. It’s true that Russians will overlook anything as long as you’re useful to them. They don’t care
If you follow the local Russian news as it reports on Ritter’s grand tour of Russia, in local outlets such as the Kazan or Izhevsk news, none of them mention his arrest record and conviction……
They don’t even say, ‘oh this man was wrongfully imprisoned, it was a conspiracy against him.’ They just don’t mention it at all…..(He) “gets a chance to reinvent himself and feel good about himself again, and the Russians will let him do it’
Natalia Antonova
Scott Ritter criticised US foreign policy and was adamant at the time that Iraq did NOT have WMD.
The US use a sex trap against him by a young looking detective on an over 18 website.
If it had happened in the UK he wouldn’t have been arrested as the age of consent is 16.
It can only happen in the US.
It hardly makes him a “paedophile”.
It doesn’t alter the fact that he is an experienced military expert who is still actively and accurately analyzing current world events.
“Scott Ritter. is a former United States Marine Corps intelligence officer. He served with the United Nations implementing arms control treaties, with General Norman Schwarzkopf in the Persian Gulf during Operation Desert Storm, and in Iraq, overseeing the disarmament of weapons of mass destruction (WMD), as a United Nations weapons inspector, from 1991 to 1998.”
I think you’re perhaps in the wrong forum to post that sort of vile hatred.
Anyone supporting terrorism is in the wrong bloody country! Not to mention they’re a completely dysfunctional human being.
It is MindHalfFilled.
“You’ll never let it lie.”
I will rephrase that for you “I think you’re perhaps in the wrong echochamber to post that sort of vile hatred.”
You don’t need to rephrase things for me, thanks.
Oh don’t worry, it is no problem. I assumed that youi just want an echochamber.
I have no idea what you are on about
You are mistaken. This is not a “forum”. It is the “comments” section for comments about the relevant article in The Daily Sceptic, the publication founded by Toby Young, founder of The Free Speech Union.
Freedom of Speech includes “vile” hatred, one of many normal human emotions, though that word “vile”, like the word “feckless”, is only ever applied to Ethnic Europeans, usually by Leftists.
Why are the Admins on here allowing this antisemitic racist to post?
“Why are anti-vaxxers allowed to tweet?
Why are we platforming climate deniers?
Anti-maskers need to be silenced!”
No. You, I, may disagree with what they say, but requesting that he is silenced is not what we do here.
Hear, hear!
Upvote!
As idiotic as his (I’m assuming male) opinion is, he’s entitled to it. In fact, I’d argue society is in the mess it’s in now because people hid their real opinions. Let people say what they want and let society judge.
I’m happy that people post what I assume they believe they think. It is educational to realise that some of us on here wer percetive enough to understand the whole Covid plandemic and its implications but were taken in by the Ukraine and now Gaza.
I do however agree with Mogwai “Anyone supporting terrorism is in the wrong bloody country! Not to mention they’re a completely dysfunctional human being.”
And yet there are millions of Irish people who supported the IRA terrorists in the UK and Ireland, and even put them in the government.
In which country do all those “dysfunctional human beings” belong?
I was fortunate/unfortunate enough to manage major project work over 2 years in Belfast in the latter years of the troubles. I learned that whatever I had read in the then MSM hopelessly oversimplified the issues which were nested and complex. Dysfunctional human beings were massively overrepresented on both sides and the process had taken over the original issues that separated them. Same in several other conflicts i had some experience with and, as I hear from others who have relatives there, same in Ukraine. Lethal madness, borne of intransigence, creates such dysfunctionality that encourages a bifurcation in a previously reasonably accepting social group, town or nation and it takes a great deal to de-fuse these situations.
Of course, given time, the previously homicidal combatants mellow or mature and the sides turn to the complexities of political conflict over what was simply an indulgence in murder.
What no society needs, is such madness being embraced by dysfunctional idealogues embracing an apparent cause they barely understand and imposing their side of a conflict on those of us remote from its origins.
There are always those globalists who will encourage both sides of this process while their own nefarious objectives are benefitted.
Not all Terrorism is the same though. The IRA mostly targeted infrastructure and state agents.
I’m not sure I agree Ron. One man’s terrorism is another’s freedom fight. Other than the viewpoint, both are the same. And targetting is not even precise, nor casualty free. I remain haunted by the experience of a young hotel receptionist in Co Down whose parent’s house, in which she lived, was burnt down one night, because they were living on the wrong side of the sectarian divide.
What a f*ckin stupid thing to say. And I say that as someone who does not get even close to condoning Israel’s actions. What do you mean by saying you ‘support’ Hamas? What is it, exactly, you’re supporting? The rape and murder of civilians – oh, let me guess, that’s all made up? Do you support the growth of an Islamist state, which will see your wife and daughters treated like second class citizens, and will brook no dissent? Do you support the actions of terrorism as long as it’s a worthy cause? Do you support the protests by hundreds of thousands of Muslims on British streets? Do you support the raging antisemitism that’s sweeping the West? Do you support the eventual destruction of Christianity? What is it that you support? Because it sure as hell isn’t as simple as saying the idiotic words “I support Hamas”.
Permit me to address your points.
What do you mean by saying you ‘support’ Hamas? – He is quoting Scott Ritter, a US military analyst, who worked with the Israeli military in the past. Scott is aware of the devastation to civilian life caused by the Israelis and calls Gaza an open-air prison. He considers 7th October was a pure military operation and that a very large number of civilians were killed by ‘friendly fire’ due to the uncoordinated Israeli reaction.
The rape and murder of civilians – oh, let me guess, that’s all made up? – Actually, yes, it is Israeli propaganda, except that there are now sources saying that IDF personnel have raped Palestinians, besides of course murdering countless civilians – both Palestinian and Israelis.
Do you support the growth of an Islamist state … – What has that got to do with anything here?
Do you support the actions of terrorism as long as it’s a worthy cause? – That is a difficult one! If something is a worthy cause, there should be no need for terrorism.
Do you support the protests by hundreds of thousands of Muslims on British streets? – They are protesting a genocide, which I consider to be a worthy protest. They would stop protesting if a politician or two had the courage to openly criticize UK’s unquestioning support of Israel in this matter.
Do you support the raging antisemitism that’s sweeping the West? – Now I think you are exaggerating because all mainstream media in the western world only print articles favourable to Israel.
Do you support the eventual destruction of Christianity? – Again, I think you are a bit off-topic. All religions claim to be exclusively right, but that is hopefully a discussion for another day.
If you are interested in learning alternative viewpoints to those presented by the mainstream media, I recommend antiwar.com, thegrayzone.com, electronicintifada.net, ukcolumn.org, and on YouTube The Duran and Judge Napolitano. Scott Ritter has his own websites but also appears regularly on Judge Napolitano.
I personally take the attitude that everything presented on mainstream media is untrue, but maybe I am extreme. All mainstream media only print what the government allows them to print, which makes everything very one-sided.
Look at the photographs of the destruction taking place in Gaza on the websites I recommended. It is simply disgraceful. Imagine UK had fought the IRA by carpet bombing all of Northern Ireland – not really acceptable, surely.
The Daily Septic blocked me from seeing these replies for 24 hours.
So much for freedom of speech.
Wow, they’re even more mongtarded close-up than I thought. Have they been collectively lobotomized? Well at least it makes a change from yelling your hatred of Jews and love for terrorists ( 2mins );
https://x.com/AzzatAlsaalem/status/1791469928731586720
Articulate little buggers, aren’t they?
So what her visa has been revoked, most ilegals here don’t have a passport much less a visa and they get to have free housing, benfits, NHS, etc, etc, and the Government hasn’t removed them, what do you think the chances are that this woman will still be here spouting her hatred this time next year.
Another example of meaningless virtue signalling by our Government
To be fair, I’d totally forgotten about Houthi and the Blowfish. Classic;
https://x.com/ShutupLyle/status/1767590984529899854
Well done. More!
I trust that as she is without a visa she is no longer enrolled at UoM?
Ha, so there we go. Now we know why Egypt reinforced their already big-assed wall. The human shields must be kept at bay at all costs to perform their sole function whilst the terrorists get to scurry through to safety via the tunnels. I’d imagine ‘Big Lugs’ and his family is already safe and sound in Egypt then;
”Israel has found 70 tunnels in Rafah so far, 50 of which cross the border into Egypt.
That’s what Egypt was hiding. These tunnels were used to smuggle arms and ammunition to Gaza. Mystery solved. No wonder Egypt and Joe Biden were against Rafah invasion.
One can speculate that Yahya Sinwar with other Hamas militants together with some hostages are already in Egypt.”
https://x.com/ImtiazMadmood/status/1791408030795391443
And soon she will no doubt realise why she left that hell-hole to come here… She won’t be allowed to say anything about Hamas, or rather she will only be able to say it once..
I feel a taxpayer-funded appeal in the wind.
In the words of the great Terry Wogan ‘..is it me?’
There would have been a predictable response to this action.
When does she leave then? Terms have pretty much all ended and she has no Visa, so when is she on a plane? Vote Reform and she’d have already gone.
Visa revoked. Nothing states that she has been shipped out.
I wonder why?
We don’t “ship out” —-We “ship in” more and more sectarian clutter
I know but we live in hope.
I think the horse has bolted. The clutter is taking over.
Actually I wholeheartedly agree with this point of view.
Well I might not be around to see the Islamification as I might only have a quarter of a tank of life left in me, but it is sad when you compare this country in the 50’s and 60’s to now and what will soon be.
I bet she’s bombarded with offers of well paid work from all the usual suspects.
All who come on here, born in the UK, are more likely to actually be deported than she is.
“46 comments” but I only count 18.
Tut, tut. Has the DS censor been active? No critical comments allowed against Israel? That has little to do with free speech.
When it comes to censorship the DS just as guilty as the BBC/Guardian etc who don’t allow criticisms of mRNA jabs, Ukraine, climate change etc.
Hypocrits.
Comments by a few on here have advocated the extinction of Palestine.
But that’s ok
My comment was removed and The DS expect me to carry on paying £5 a month for the privilege of being censored.
I was the first to comment and when I checked this morning it had been removed.
Here was my comment ……
Many people support Hamas.
“I support Hamas.
Simply because I can’t ever again support Israel.
And if you continue to support Israel after witnessing its actions in Gaza, you’re more than simply an idiot.
You’re an immoral facilitator of genocide.
Sort of like the modern equivalent of a Nazi.”
Scott Ritter
https://t.me/ScottRitter/2218
Going, going……
She won’t be going anywhere. We can’t even depart rapists, so she’s not going to be frogmarched onto a plane.
This country is crying out for strong leadership, something we haven’t seen for 35 years, and even then she was a one-off.
Going on a self-deating killing spree in Israel is neither resisting oppression nor war, it’s senseless murder. That the other guys are morally just as bad, but with jet planes, doesn’t excuse this. At best, this so-called war is a pretty pointless dicksizing contest between a shrew and a grizzly. At worst, it’s just what Netanyahu needs to win the next election, as per the old recipe Trouble at home? Make war on some foreign country!