17 Comments
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Bryan's avatar

[Unlike the independently monitored US sites, the European trial centres were overseen by AstraZeneca itself.]

always good when you get to mark your own homework !

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Maryanne Demasi, PhD's avatar

Fox in the henhouse 😖

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Paula Chandler's avatar

Monstrous. And dare I say business as usual?

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Maryanne Demasi, PhD's avatar

Sad but true…

By the way, thanks for your support Paula 🙏🙌

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MikeTomAus's avatar

Interesting.

I was prescribed Ticagrelor and had to discontinue because it was too effective at anti-clotting - I had nosebleeds lasting for hours, culminating in an ambulance being called.

This does not necessarily lead to satisfactory overall outcomes!

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Maryanne Demasi, PhD's avatar

Yes, that is what Victor Serebruany is concerned about….

I think it has a black box warning about it.

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JB watching TV's avatar

Shocking 😲 !

Such Cruel Connivance...☹️

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Gareth Thomas's avatar

In my sports and exercise medicine practice, where I never have reason to prescribe antithrombotic agents, I come across plenty of patients taking long term aspirin and to an extent clopidogrel, but cannot recall seeing anyone taking ticagrelor.

I wonder what it's market penetration has been in Australia?

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Maryanne Demasi, PhD's avatar

Not sure of the extent but it’s on the PBS

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CMaryG's avatar
3dEdited

I was told this was a brilliant new drug, BRILINTA, must take for a year after heart attack with 99% blockage and stent insertion. No informed consent in 2014 if they hadn’t met gold standard in trials.

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Maryanne Demasi, PhD's avatar

Given FDA’s own medical reviewer said the drug should not be approved (even though he was overruled), it is concerning.

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Philipp Conradi's avatar

Thank you for again an excellent and important article. You ask if PLATO trial was truly blinded?''

I gather, that PLATO was truly blinded but was easy to unblind at level of study center because of its double blind double dummy study design. I very much appreciate the work of Thomas A. Marciniak, the then senior reviewer at the FDA. His contributions to the FDA report opened my eyes for the pitfalls of blinded study design where the blind easily can be broken. The report is worth reading - I refer to page 121 from 640. Thank you Thomas Marciniak.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022433orig1s000MedR.pdf

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Maryanne Demasi, PhD's avatar

Thank you, Philipp — I agree. Marciniak was a very skilled medical reviewer at the FDA. I interviewed him once for an investigation I was conducting for The BMJ, and his depth of knowledge was truly impressive.

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Guilherme's avatar

Another amazing piece, Demasi! Thanks for bringing light to malfeasance. Justice must prevail.

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Nic Tydens's avatar

Hi Maryanne,

Keep 'em coming!

BTW I saw the interviews of RFK JR on Tucker Carlson and Dr Phil. Unfortunately he does not look or sound so good. The text is excellent though.

Hopefully he can break through the wall of opposition.

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Henry Engelking's avatar

How can you trust that any drug approved is safe and effective?

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Chris's avatar

I would think its high time to legislate that trials of new Pharma products need to be carried out only by independent organisations who have no conflicts of interest.

Also, like you Maryanne, I wonder why this drug is still on the market?

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