The UK has become the first country in the world to approve the Pfizer/BioNTech jab

[Old Greg]

It won't be just a month next time

It's been arranged...

What does his respite care team say about that?

[AtW]

What does his respite care team say about that?

His designated care nurse Ms Annie Wilkes is on a knife edge waiting, ready to hammer when the time comes

HTH

[AtW]

You caught up. True to form.

This is the Official thread, best to keep all relevant stuff here

Pfizer is reported to have specifically excluded people with severe allergic reactions from trial - this must have been written down in trial plan, so WTF regulator ignored that? I guess they had to speed read it to get Boris a “win”

[clearedforlanding]

This is the Official thread, best to keep all relevant stuff here

Pfizer is reported to have specifically excluded people with severe allergic reactions from trial - this must have been written down in trial plan, so WTF regulator ignored that? I guess they had to speed read it to get Boris a “win”

P-value hacking in Pharma is a big rabbit hole. Get this:

Only positive trials have to be reported the regulators. Pharma buries negative trials as commercially confidential IP and as such they don't have to be reported. The FDA & Pharma in the US is a have a revolving door. The UK is complex to say the least.

Winner of the BMJ book of the year and something I recommend to everyone is:

Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare: Amazon.co.uk: Gotzsche, Peter: 9781846198847: Books


A book who's opening sentence is "PRESCRIPTION DRUGS ARE THE THIRD LEADING CAUSE OF DEATH AFTER HEART DISEASE AND CANCER" and then goes on to prove it amongst many other things makes for a fascinating read. It really is a good book. The fact that the author is the co-founder of the Cochrane Foundation & the preface is by the editor of the Lancet lend some credence.

[AtW]

Only positive trials have to be reported the regulators. Pharma buries negative trials as commercially confidential IP and as such they don't have to be reported. The FDA & Pharma in the US is a have a revolving door. The UK is complex to say the least.

They can't hide negative stuff that is recorded to have happened in the same trial they use to apply for authorisation.

It is obviously in the interest of pharma to exclude suspect vulnerable groups from trial - ie children, pregnant women and in this case people who had adverse allergic reactions, make sense really, I am 100% certain that was documented in the trial for them to cover their fat pharma arses.

[clearedforlanding]

They can't hide negative stuff that is recorded to have happened in the same trial they use to apply for authorisation.

It is obviously in the interest of pharma to exclude suspect vulnerable groups from trial - ie children, pregnant women and in this case people who had adverse allergic reactions, make sense really, I am 100% certain that was documented in the trial for them to cover their fat pharma arses.

Sure they can. They can & do run the same trial with a slight modification to exclude the adverse condition & report that.

All they have to do is write in the PI sheet that there may be a risk to patients with a history of adverse reactions & the liability is shifted to the prescribing doctor.

I am not stating that with a vaccine with so many eyes on it they have done this, but you can only scrutinise what is transparent and this really is SOP for Pharma

[AtW]

Sure they can. They can & do run the same trial with a slight modification & report that.

All they have to do is write in the PI sheet that there may be a risk to patients with a history of adverse reactions & the liability is shifted to the prescribing doctor.

Yes, as separate trial but in this case they simply did not have time to have multiple trials one after another, it’s probably as honest as it gets

[clearedforlanding]

Yes, as separate trial but in this case they simply did not have time to have multiple trials one after another, it’s probably as honest as it gets

Again, I am not stating that with a vaccine with so many eyes on it they have done this, but you can only scrutinise what is transparent and this really is SOP for Pharma. Totally agree with the time factor.

[AtW]

Again, I am not stating that with a vaccine with so many eyes on it they have done this, but you can only scrutinise what is transparent and this really is SOP for Pharma. Totally agree with the time factor.

Prizer/Moderna mRNA vaccines will become the most tested vaccines in human history...

[clearedforlanding]

Prizer/Moderna mRNA vaccines will become the most tested vaccines in human history...

Indeed. Nice of Canada to show solidarity with us.

Nice people those Canadians.