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norstadt's avatar

Interesting how language works. The "gold standard" originally applied to money and fell out of favor long ago. Now we have fiat currency that is a lot like the placebo effect.

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Bryan's avatar

The Relative Risk Reduction (aka VE) trick was used to good effect during COVID. Everyone touted 95%, and of course no one quoted the Absolute Risk Reduction, which from memory was .84%. (And even that figure looks entirely bogus now, and is quite likely to be negative).

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Chris's avatar

Prof Norman Fenton showed how the ridiculous insertion of 14 or 21 day waiting period before being considered vaxxed gave a complete illusion of efficacy.

Yet another fraudulent stunt from Pharma....

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John Toomey's avatar

A Brilliant piece Maryanne. I was asked recently by a young relative, "If the pharmaceutical industry does not fund drug research, who will?" I responded that the PBS in Australia spent $1.2 billion on statin drugs in the 23-24 financial year. That means there is a potential billion dollar per year research war chest for Universities. That could work.

Keep up the great work.

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Maryanne Demasi, PhD's avatar

That’s an excellent response.

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CMaryG's avatar

I saw that Pfizer had $5billion income from Australia in the pandemic. Pfizer and Merck both international companies with Australian ABNs allowing them to make political donations received over a billion in the first year of antiviral drugs on provisional approval by Skerritt BOSS of TGA. It can be calculated from PBS script data.

Why can’t regulators engage in the tests not accept manufacturers own trials

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JB watching TV's avatar

No scrap it and start again ! There might be new chiefs at the top, but their effect will be limited. The infestation of corruption is too deep. Need a root and branch clean out. The Apple tree is rotten, the fruit will be poison. Pull it out and plant another.

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Vivien C Buckley's avatar

Thank you Maryanne great article. What I consider false advertising is the words FDA approved in the ads which gives the product a shining star. This is so misleading. I too believed it. Many people are given a false sense of security. As far as anti depressants, I’ve read some horror stories from people who have used them and the withdrawal is horrendous. They have also led people to bi polar disease. But, we do know pharma does what it wants as they own the regulatory process and much more.

I feel a little optimism with the new team, Makary, Bhattacharya and RFK but understand the monumental task of bringing about positive change. The money involved, and with money comes influence. I’m trying not to be too optimistic as I’ve been down this road a number of times with my vaccine injury. I will call it hopeful.

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Maryanne Demasi, PhD's avatar

Clinical trials are focused on efficacy since they are often too small and too short in duration to pick up on serious adverse events (especially rare ones). But yes, I am optimistic that Makary et al will make some positive strides.

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CMaryG's avatar

The mystery example is how fast track worked for Paxlovid to FDA EUA then despite fail of EPIC-SR first reported Dec 2021 then confirmed fail with stopping the recruitment in June 2022, Pfizer commenced ILLEGAL TV advertising with CDC Commissioner promotion in Feb 2023 whilst still EUA and in May 2023 on the basis of RWE (real world evidence) which lacked rigour FULL approval was granted by FDA to begin delusionary advertising that allowed pharmacy sales of a cure for COVID in first 5 days. Not informed consent as the only real trial was in unvaccinated over 65 yr re hospitalisation and death.

But Pfizer paid fees for approval and went into $22B profit in 2022/3

As sales to gullible costing $1500US per course fall back the next Pfizer antiviral protease inhibitor covid drug PF-07817883 Ibuzatrelvir got fast track FDA listing august 2024 and will no doubt in phase 3 trials from dec 2024 be rewarded with EUA in 2025 and vast profits- in the meantime simple antiviral nasal sprays are getting “Letters of Warning” to stop sales which show better efficacy and fewer medicine restrictions to the extent that many smaller pharma dare not market in the US with good trial tests v placebo in viral load reduction.

In Australia TGA follows FDA lead within weeks and no independent requirements - see TGA boss Skerritt exemptions from Poison standard and Australian Register of Therapeutic Goods ARTG normal regulations

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Chris's avatar

I work in the Petfood area, and honestly the reqquirements to back up claims are far better than the complete sham under the FDA.

My doctor wised me up on this some years ago. He used to read the papers himself and refused to prescribe unsupported treatments. He told me how he exposed this with his colleagues but nearly all still kept prescribing useless treatments....the whole system is rotten...

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Henri's avatar

Have started with a new doctor as my previous is about to retire at 72 years old. It's in a brand new surgery that opened last month (yes, they are still opening, much to my surprise). Nice young, early 30s chap, 6 months out of supervision and very energetic and efficient.

As I had a triple bypass 2 years ago - I'm now 69, have changed my lifestyle (used to follow the food pyramid, am now keto). He was alarmed that I wasn't on a statin and didn't like my LDL levels. I explained i will take a mini aspirin but not a statin (was on them for 5 years before bypass). He was shocked and 3 times used the term "gold standard" several times in describing best available medical care based on research and trials.

We had an 'interesting' discussion around publications and how they are gamed, the TGA and the FDA etc, etc - I think he needed blood pressure tablets at the end of it.

He had no idea of any of this and even less interest which in reality has not surprised me. He is starting out, is co-partner in a new medical practice and simply does not want to rock the boat.

My other doc may continue on for another year or two at best, he constantly hums and ahhs about it. He is old school and keeps up with research and discussions/dissensions while advocating for lifestyle changes with minimal drug intervention. He will and has prescribed drugs in the past, but not via a knee-jerk, propaganda based position.

I will keep this new guy as getting onto a doctor's books is very hard where I live but I think I'm in for an interesting ride.

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Maryanne Demasi, PhD's avatar

Really interesting story… Next visit, you might wish to refer him to my Substack.

On second thoughts… perhaps don’t—his head might explode! 🤯

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Julian Gillespie's avatar

excellent article

Thank You Dr Demasi

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Maryanne Demasi, PhD's avatar

Thanks Julian 🙏

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Marilyn Schroeder's avatar

Perhaps Sarah Ferguson from the ABC’s 7:30 might have done well to have read this before her interview with American Pharma representative last night.

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Maryanne Demasi, PhD's avatar

Think I’ve given up on the ABC 😞

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Henri's avatar

The horse has long bolted on that one - too many agendas in there nowadays.

ABC = Absolutely Been Compromised.

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JB watching TV's avatar

Oh Yeah, great acronym!

Occasionally I still tune into the ABC, (as I have paid my 8 cents) just to see how they're getting on with things. No surprises really. Same "soft targets", same inane and useless gabblefest, same sanctimony and self righteous school marm scolding to which nobody pays any real attention. Devoid of REAL WORLD facts, bereft of REAL WORLD analysis, sans REAL WORLD reasoning.

Just a bloated bubble of blandness. Pandering to those who pull their puppet strings !

It's THEIR ABC, but funded via taxpayer money. I shakes my head 😔

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Maryanne Demasi, PhD's avatar

“Bloated bubble of blandness” 🤣

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CMaryG's avatar

Member of TNI

Trusted News Initiative - vet information re what is published worldwide

This is why MaryAnne’s articles questioning regulators would not be published by ABC

The Trusted News Initiative (TNI) is a global partnership of major news organizations and technology companies aimed at combating what “they” describe as harmful disinformation. It was established to promote a unified approach to identifying and limiting the spread of false information, particularly during critical events like elections and public health crises. The initiative focuses on fostering trust in mainstream media and countering narratives that diverge from their designated "trusted" sources.

The TNI was set up by the British Broadcasting Corporation (BBC) in July 2019. The BBC took the lead in convening a coalition that includes prominent media outlets and Big Tech firms. Jessica Cecil, a key figure in the media industry with expertise in disinformation, is credited with founding the initiative during her tenure at the BBC. The effort began with a Trusted News Summit in the summer of 2019, bringing together senior figures from global news and tech sectors to agree on collaborative actions.

Known partners in the TNI include a range of influential organizations: media outlets such as the Associated Press (AP), Agence France-Presse (AFP), Reuters, The Washington Post, Financial Times, BBC, CBC/Radio-Canada, European Broadcasting Union (EBU), The Hindu, The Nation Media Group, Australian Broadcasting Corporation (ABC), Special Broadcasting Service (SBS) Australia, NHK Japan, and others; and technology companies like Google/YouTube, Meta (Facebook/Instagram), Microsoft, and Twitter (prior to its shift under new ownership). These entities work together under the TNI framework, often sharing resources and alerts to manage information flow.

The fields of controlled information primarily revolve around topics deemed to pose significant risks if misrepresented. These include election integrity, where TNI focuses on flagging disinformation that could disrupt democratic processes, and public health, notably during the COVID-19 pandemic when the initiative shifted to combat "harmful vaccine disinformation" and narratives questioning official accounts, such as the origins of the virus. Other areas include climate change, where TNI partners align to promote a consistent narrative and suppress dissenting views labeled as misinformation. The initiative employs mechanisms like rapid alert systems, fact-checking collaborations, and content moderation on digital platforms to shape public discourse in these domains.

Critics, including independent journalists and figures like Robert F. Kennedy Jr., who filed an antitrust lawsuit against TNI members in 2023, argue that this control extends to censoring legitimate alternative perspectives, potentially stifling free speech and competition in the news market. The lawsuit highlights specific instances, such as the suppression of reporting on the Hunter Biden laptop story and early COVID-19 lab leak theories, which were later deemed plausible. Despite its stated goal of protecting democracy and public safety, the TNI’s centralized approach to defining truth remains a point of contention.

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Jillian Stirling's avatar

We can only hope. Then we need to stay healthy.

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CMaryG's avatar

Breaking news where let’s hope FDA examine the role of COMPARATIVE vaxes

Scripps Institute has conducted important trials invitro and invivo animals re antiviral nasal spray VIRALEZE™ - let’s hope this breakthrough research is fast tracked. The PF-07817883 Ibuzatrelvir Pfizer fast track occurred in August 2024 when Pfizer’s novel antiviral protease inhibitor was only through phase one

https://x.com/bigbaddenis/status/1904712852453417372?s=46&t=yzt5Md7IJdL43uvNcxI5OA

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Aviva W.'s avatar

“If Makary is serious about reform, he must push Congress for sweeping legislative changes to dismantle the pharmaceutical industry’s stranglehold on drug regulation.”

The same Congress that’s been bought and paid for by the pharmaceutical industry, and who scuttled Dr. Weldon’s nomination for CDC head?

The call for better drug labeling is interesting, but how many people will take the time to try to read and understand? How many people bother to read nutrition labels? It’s probably the prescribing physicians who need to be better educated on what they’re prescribing… and sadly they’re paid off by pharma, too.

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