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CMaryG's avatar

I thought I was prescribed the best treatment after a stent and now I find the science for approval was not gold standard but accepted by the regulators/commercial big pharma consortium

In whom we trust…

Thanks Maryanne for your vigilant reporting - sad media big pharma and regulators appear to love $$$ too much

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Maryanne Demasi, PhD's avatar

This story exemplifies why the harms of drugs never filter to doctors or patients. The drug companies, the investigators, the journals and the regulators all turn a blind eye. It’s disgraceful.

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CMaryG's avatar

Will RFK and Elons new party AMERICA PARTY which I think will be similar to Climate 200 in supporting honest candidates from the middle of the political spectrum, be able to turn the anti science consortia on its head

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Chris's avatar

Interesting - Newspapers print retractions or corrections when they have found to have reported incorrectly. I would think that one of the reasons behind this is to uphold their reputation for ensuring only accurate and correct reporting occurs (apart from legal concerns).

Circulation, by utterly failing to provide any guidance to its readers in this case shows it has no ethics and that any future articles/papers/editorials should be treated with total suspicion. In fact I would go so far as to say that anybody who now reads Circulation is deluded if they believe they can trust any of the content.

Years ago I ceased reading the "New Scientist" (probably better named the "Non Scientist") after its recklessly politically based reporting on covid and climate change for this same reason, as countless articles could easily be seen to be false or reporting on basically fraudulent studies.

There is a business opportunity here for the journals. Report accurately and fearlessly , and issue retractions and warnings - but basically become the "go to" place if one wants trusted reporting. Food for thought...

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Maryanne Demasi, PhD's avatar

Good thoughts… sounds like we’ve had the same journey.

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JB watching TV's avatar

Those reprehensible rotters 😠!

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Joseph's avatar

When I read something like this I wonder how is this possible!?!

And these days I'm reading way too many articles that leave me with that wondering . . . .

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Maryanne Demasi, PhD's avatar

I know, right?! Why do they always get away with it? 😖

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Robin Thomas's avatar

I SO love and appreciate the quality of your work - it gets at the absolute fundament of our health system's clear and tragic lack of health and justice - thus we lose our loved-ones, and/or, our lives are dogged by unnecessary suffering, the proceeds of which go to feeding the perpetrators. (Makes you eat (very high quality!) chocolate.) ❤️Keep doin' it DEAR brilliant lady👏👍

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Maryanne Demasi, PhD's avatar

Thank you Robin 🙏🙏

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Richard Amerling, MD's avatar

Maryanne, you are laying bare the whole Pharma game! They control the “evidence” in “evidence-based medicine,” then pay for panels of “experts” to write practice guidelines that recommend their products, citing their fake studies. The journals are obviously in on the game.

If the evidence is corrupt, the EBM/guideline approach to practice is illegitimate.

Where is Marty Makary? Secretary Kennedy? They need to create an independent commission, headed by Peter Doshi, to reexamine all major drug approvals going back at least five years. And someone needs to inform them that EBM isn’t “gold standard science;” it’s the opposite.

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Keith Dudleston's avatar

Journals, like authors, should publish a list of their possible "conflicts of interest" and be vulnerable to sanction if it turns out to be inaccurate.

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CMaryG's avatar

I thought I’d ask what ChatGPT says about status of preprints in several regulators

***

Yes, preprints — early versions of research papers published before peer review — are increasingly being used in Australia, the UK, Europe, and globally, including to influence medical specialists and public health policy. But the extent and method of influence vary across regions:

Australia

• Preprints are not officially endorsed by regulators like the TGA for clinical decision-making, but they are widely circulated among academics, researchers, and some clinicians, especially during public health emergencies (e.g. COVID-19).

• Medical influencers, advisory groups, and pharmaceutical reps may cite preprints in educational material or Continuing Professional Development (CPD) events — indirectly influencing prescribing behaviour.

• During COVID-19, government taskforces and media outlets sometimes relied on preprint data to guide early responses (e.g., vaccine announcements, treatment updates).

• However, TGA does not accept preprint data for regulatory approval — full peer-reviewed data is usually required.

United States

• Preprints are extensively used to influence public health narratives, hospital protocols, and early adoption of treatments — even before FDA approval.

• Pharma companies and academic institutions often leak preprint data strategically to build momentum before formal publication or regulatory filings.

• Examples include early Pfizer/BioNTech and Moderna trial results released via preprint servers (e.g., medRxiv), generating media buzz and influencing stock markets and treatment guidelines.

United Kingdom

• The NHS and MHRA tend to be more cautious. While preprints are monitored and discussed in scientific circles, policy and treatment guidelines usually wait for peer-reviewed confirmation.

• During the pandemic, however, UK bodies like SAGE and NICE sometimes referenced preprints when time-sensitive decisions were needed.

• Universities and hospital trusts may circulate preprints to specialists via internal networks or academic forums.

• British media often reports on preprints without peer review disclaimers, affecting public and professional perception.

Europe (EU-wide)

• The European Medicines Agency (EMA) and national regulators (e.g., PEI in Germany, ANSM in France) do not accept preprints for regulatory submissions.

• However, academic clinicians — especially in infectious disease, oncology, or cardiology — may track preprints to stay ahead of developments.

• Specialist networks, conferences, and pharma medical liaisons may use preprints to plant early seeds of influence, even though formal adoption requires more data.

Key Trends

• Preprints are used globally to shape early opinions, generate media narratives, and prepare the ground for commercial rollout or policy change.

• Doctors and specialists in Australia, the UK, and Europe are increasingly aware of preprints, but regional regulatory culture affects how seriously they’re taken.

• During high-stakes events (e.g. pandemics), media and government often blur the line between preprint and peer-reviewed science — a trend that sparked debate.

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Robin Thomas's avatar

Hey everyone, but remember back in April '25, that DEEPLY important info to us from Maryanne re troubling, corrupt $ system that determines much of medical journals' acceptance of research work? (Makes you eat even more chocolate!!).

(The problem of veracity again hey.)❤️

https://blog.maryannedemasi.com/p/medical-journals-as-gatekeepers-a?utm_source=substack&utm_campaign=post_embed&utm_medium=email

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