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UK regulators find Pfizer CEO guilty of misleading public

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From the Brownstone Institute

BY Molly KingsleyMOLLY KINGSLEY

This is the inside story of how UsForThem, a UK children’s welfare campaigning group, held Pfizer to account for misleading parents about Covid vaccine safety.

On 2 December 2021, the UK’s national public broadcaster, the BBC, published on its website, its popular news app, and in a flagship news program, a video interview and an accompanying article under the headline Pfizer boss: Annual Covid jabs for years to come.’

The interview by the BBC’s medical editor, Fergus Walsh, conducted as a friendly fireside chat, gave Dr Albert Bourla, the Chairman and CEO of Pfizer, a free pass promotional opportunity that money cannot buy — as the UK’s public service broadcaster, the BBC is usually prohibited from carrying commercial advertising or product placement.

Perhaps unsurprisingly, Pfizer made the most of that astonishing opportunity to promote the uptake of its vaccine product. As the BBC’s strapline suggests, the key message relayed by Dr Bourla, responding to an obediently leading question from Mr Walsh, was that many more vaccine shots would need to be bought and jabbed to maintain high levels of protection in the UK. He was speaking shortly before the UK Government bought another 54 million doses of Pfizer vaccines.

Misleading statements about safety

Among his explicit and implicit encouragements for the UK to order more of his company’s shots, Dr Bourla commented emphatically about the merits of vaccinating children under 12 years of age, saying “[So] there is no doubt in my mind that the benefits, completely are in favour of doing it [vaccinating 5 to 11 year-olds in the UK and Europe]”. 

No mention of risks or potential adverse events, nor indeed the weighing of any factors other than apparent benefits: Dr Bourla was straightforwardly convinced that the UK and Europe should be immunising millions of children.

In fact, it later emerged that the BBC’s article had misquoted Dr Bourla, who in the full video interview recording had ventured the benefits to be “completely completely” in favour of vaccinating young children.

Despite the strength of Dr Bourla’s unconditional and superlative pitch for vaccinating under-12s, the UK regulatory authorities would not authorise the vaccine for use with those children until the very end of 2021; and indeed this came just a few months after the JCVI — the expert body which advises the UK Government on whether and when to deploy vaccines — had already declined to advise the Government to roll out a mass vaccination programme for healthy 12 to 15 year-olds on the basis that “the margin of benefit, based primarily on a health perspective, is considered too small to support advice on a universal programme of vaccination of otherwise healthy 12 to 15-year old children…”.

In response, soon after the interview aired, UsForThem submitted a complaint to the UK’s Prescription Medicines Code of Practice Authority (PMCPA) — the regulator responsible for policing promotions of prescription medicines in the UK. The complaint cited the overtly promotional nature of the BBC’s reports and challenged the compliance of Dr Bourla’s comments about children with the apparently strict rules governing the promotion of medicines in the UK.

A year-long, painful process

More than a year later, following a lengthy assessment process and an equally lengthy appeal by Pfizer of the PMCPA’s initial damning findings, the complaint and all of the PMCPA’s findings have been made public in a case report published on the regulator’s website.**

Though some aspects of that complaint ultimately were not upheld on appeal, importantly an industry-appointed appeal board affirmed the PMCPA’s original findings that Dr Bourla’s comments on using the Covid vaccine for 5 to 11 year-olds were promotional, and were both misleading and incapable of substantiation in relation to the safety of vaccinating that age group.

Even after UsForThem involved a number of prominent UK parliamentarians, including Sir Graham Brady MP, to help accelerate the complaint, the process was dragged on — or perhaps ‘out’ — while the rollout of Pfizer’s vaccine to UK under-12s proceeded, and the BBC’s interview and article stayed online. Even now the interview remains available on the BBC’s website, despite the PMCPA in effect having characterised it as ‘misinformation’ as far as vaccinating children is concerned.

When news of the appeal outcome was first revealed in November 2022 by a reporter at The Daily Telegraph newspaper, Pfizer issued a comment to the effect that it takes compliance seriously and was pleased that the “most serious” of the PMCPA’s initial findings — that Pfizer had failed to maintain high standards and had brought discredit upon and lowered confidence in the pharmaceutical industry — had been overturned on appeal.

It must be an insular and self-regarding world that Pfizer inhabits, that discrediting the pharmaceutical industry is considered a more serious matter than making misleading and unsubstantiated claims about the safety of their products for use with children. This surely speaks volumes about the mindset and priorities of the senior executives at companies such as Pfizer.

And if misleading parents about the safety of a vaccine product for use with children does not discredit or reduce confidence in the pharmaceutical industry, it is hard to imagine what standard can have been applied by the appeal board which overturned that initial finding.

Perhaps this reflects the industry’s assessment of its own current reputation: that misinformation promulgated by one of its most senior executives is not discrediting. According to the case report, the appeal board had regard to the “unique circumstances” of the pandemic: so perhaps the view was that Pfizer can’t always be expected to observe the rules when it gets busy.

Multiple breaches. No meaningful penalty

Indeed, a brief look at the PMCPA’s complaints log confirms that Pfizer has been found to have broken the UK medicines advertising rules in relation to its Covid vaccine a further four times since 2020. Astonishingly, though, for their breaches in this most recent case, and in each of the other cases decided against it, neither Pfizer nor Dr Bourla will suffer any meaningful penalty (the PMCPA will have levied a small administrative charge to cover the cost of administering each complaint). So in practice neither has any incentive to regret the breach, or to avoid repeating it if it remains commercially expedient to do so.

And this is perhaps the crux of the issue: the PMCPA, the key UK regulator in this area, operates as a division of the Association of the British Pharmaceutical Industry, the UK industry’s trade body. It is therefore a regulator funded by, and which exists only by the will of, the companies whose behaviour it is charged with overseeing.

Despite Pharma being one of the most lucrative and well-funded sectors of the business world, the largely self-regulatory system on which the industry has now for decades had the privilege to rely has been under-resourced and has become slow, meek and powerless.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA), a governmental agency, in principle has jurisdiction to hold the BBC accountable for what seems likely to have been mirroring breaches of the medicines advertising rules when it broadcast and promoted Dr Bourla’s comments, but no action has yet been taken.

This case, and the apparent impunity that companies such as Pfizer appear to enjoy, serve as evidence that the system of oversight for Pharma in the UK is hopelessly outdated and that the regulatory authorities are risibly ill-equipped to keep powerful, hugely well-resourced corporate groups in check. The regulatory system for Big Pharma is not fit for purpose; so it is time for a rethink.

Children deserve better, and we should all demand it.

** Endnote: an undisclosed briefing document

As part of its defence of UsForThem’s complaint, Pfizer relied on the content of an internal briefing document that had been prepared for the CEO by Pfizer’s UK compliance team before the BBC interview took place. Pfizer initially asked for that document to be withheld from UsForThem on the grounds that it was confidential. When UsForThem later demanded sight of the document (on the basis that it was not possible to respond fully to Pfizer’s appeal without it), UsForThem was offered a partially redacted version, and only then under terms of a perpetual and blanket confidentiality undertaking.

Without knowing the content of that document, or the scope of the redactions, UsForThem was unwilling to give an unconditional perpetual blanket confidentiality undertaking, but reluctantly agreed that it would accept the redacted document and keep it confidential subject to one limited exception: if UsForThem reasonably believed the redacted document revealed evidence of serious negligence or wrongdoing by Pfizer or any other person, including evidence of reckless or wilful damage to the public health of children, UsForThem would be permitted to share the document, on a confidential basis, with members of the UK Parliament.

This limited exception to confidentiality was not accepted. Consequently UsForThem never saw the briefing document, and instead drew the inference that it contained content which Pfizer regarded as compromising and which it therefore did not wish to risk ever becoming public.

Author

  • Molly Kingsley

    Molly Kingsley is a co-founder at UsForThem, the parent campaign group formed in May 2020 to advocate against school closures. They have since been joined by tens of thousands of parents, grandparents and professionals across the UK and beyond, advocating for children to be prioritized in the pandemic response and beyond.

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Brownstone Institute

Deborah Birx Gets Her Close-Up

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From the Brownstone Institute

BY Bill RiceBILL RICE 

According to Birx, she intentionally buried the more draconian elements of the lockdowns in text at the end of long documents, theorizing (correctly apparently) that most reporters or readers would just “skim” the document and would not focus on how extreme and unprecedented these mandates actually were.

Most Americans will remember Dr. Deborah Birx as the “scarf lady” who served on the White House’s Covid Response Team beginning in February 2020.

According to a recently-released (but little-seen) 24-minute mini-documentary, it was Birx – even more so than Anthony Fauci – who was responsible for government “guidelines,” almost all of which proved to be unnecessary and disastrous for the country.

According to the documentary, the guidelines ran counter to President Trump’s initial comments on Covid, but ultimately “toppled the White House (and Trump) without a shot being fired.”

The mini-documentary (“It Wasn’t Fauci: How the Deep State Really Played Trump”) was produced by Good Kid Productions. Not surprisingly, the scathing 24-minute video has received relatively few views on YouTube (only 46,500 since it was published 40 days ago on Feb. 26).

I learned of the documentary from a colleague at Brownstone Institute, who added his opinion that “Birx (is) far more culpable than Fauci in the Covid disaster…Well worth the time to see the damage an utter non-scientist, CIA-connected, bureaucrat can do to make sure things are maximally bad.”

I agree; the significant role played by Birx in the catastrophic national response to Covid has not received nearly enough attention.

Brought in from out of Nowhere…

From the video presentation, viewers learn that Birx was added to the White House’s Coronavirus Task Force as its coordinator in latter February 2020.

Birx worked closely with Task Force chairman Vice President Mike Pence, a man one suspects will not be treated well by future historians.

According to the documentary, “career bureaucrats” like Birx somehow seized control of the executive branch of government and were able to issue orders to mayors and governors which effectively “shut down the country.”

These bureaucrats were often incompetent in their prior jobs as was Birx, who’d previously served as a scientist (ha!) in the Army before leading the government’s effort to “fight AIDS in Africa” (via the PEPFAR Program).

When Birx was installed as coordinator of Covid Response she simply rehashed her own playbook for fighting AIDS in Africa, say the filmmakers.

The three tenets of this response were:

  1. “Treat every case of this virus as a killer.”
  2. “Focus on children,” who, the public was told, were being infected and hospitalized in large numbers and were a main conduit for spreading the virus.
  3. “Get to zero cases as soon as possible.” (The “Zero Covid” goal).

The documentary primarily uses quotes from Scott Atlas, the White House Task Force’s one skeptic, to show that all three tenets were false.

Argued Atlas: Covid was not a killer – or a genuine mortality risk – to “99.95 percent” of the population. Children had virtually zero risk of death or hospitalization from Covid. And there was no way to get to “zero cases.”

Atlas Didn’t Shrug, but was Ignored…

Furthermore, the documentary convincingly illustrates how the views of Atlas were ignored and how, at some point, his ability to speak to the press was curtailed or eliminated.

For example, when Atlas organized a meeting for President Trump with Covid-response skeptics (including the authors of the Great Barrington Declaration) this meeting was schedule to last only five minutes.

The documentary also presents a report from the inspector general of the Department of State that was highly critical of Birx’s management style with the African “AIDS relief” program she headed.

Among other claims, the report said she was “dictatorial” in her dealings with subordinates and often “issued threats” to those who disagreed with her approach.

Shockingly, this highly-critical report was published just a month before she was appointed medical coordinator of the Coronavirus Task Force.

A particularly distressing sound bite from Birx lets viewers hear her opinion on how controversial “guidance” might be implemented with little pushback.

According to Birx, she intentionally buried the more draconian elements of the lockdowns in text at the end of long documents, theorizing (correctly apparently) that most reporters or readers would just “skim” the document and would not focus on how extreme and unprecedented these mandates actually were.

The documentary points out that Birx’s prescriptions and those of President Trump were often in complete conflict.

Birx, according to the documentary, once pointed this out to Vice President Pence, who told her to keep doing what she believed.

Indeed, the Vice President gave Birx full use of Air Force 2 so she could more easily travel across the country, spreading her lockdown message to governors, mayors, and other influencers.

Several Covid skeptic writers, including Jeffrey Tucker of Brownstone Institute, have noted that President Trump himself went from an opponent of draconian lockdowns to an avid supporter of these responses in a period of just one or two days (the pivotal change happened on or around March 10th, 2020, according to Tucker).

Whoever or whatever caused this change in position, it does not seem to be a coincidence that this about-face happened shortly after Birx – a former military officer – was named to an important position on the Task Force.

(Personally, I don’t give Anthony Fauci a pass as I’ve always figured he’s a “dark master” at manipulating members of the science/medical/government complex to achieve his own desired results.)

This documentary highlights the crucial role played by Deborah Birx and, more generally, how unknown bureaucrats can make decisions that turn the world upside-down.

That is, most Americans probably think presidents are in charge, but, often, they’re really not. These real rulers of society, one suspects, would include members of the so-called Deep State, who have no doubt installed sycophants like Fauci and Birx in positions of power.

I definitely recommend this 24-minute video.

A Sample of Reader Comments…

I also enjoyed the Reader Comments that followed this video. The first comment is from my Brownstone colleague who brought this documentary to my attention:

“… As I said, things can change over the period of 20 years but in the case of Birx/Fauci, I do not believe so. I have never seen people entrenched in the bureaucracy change.”

Other comments from the people who have viewed the mini-documentary on YouTube:

“Pence needs to be held accountable.”

“What does Debbie’s bank account look like?”

“(The) final assessment of President Trump at the 23:30 mark is, while painful, accurate. He got rolled.”

“This is very hard to find on YouTube. You can literally search the title and it doesn’t come up.”

“Excellent summary, hope this goes viral. Lots of lessons to learn for future generations.”

“Eye opening. Great reporting.”

Post from One Month Ago…

“37 likes after 3 years of the most controversial and divisive action in recent history. How can this be?”

“Oh never mind. YouTube hid it from the public for years.”

“Probably hasn’t been taken down yet for that reason, relatively low views.”

“Thanks for this! Sounds like everyone below President Trump was on a power trip and I didn’t think it was possible to despise Pence more than I already do.”

“…the backing of CDC, legacy media, WHO and government schools, business folding in fear are ALL responsible. Accountability for every person and agency is paramount!”

“Should be noted that her work on AIDS in Africa was just as useless and damaging.”

“First, any mature, adult woman who speaks with that much vocal fry should be immediately suspect. And the glee with which she recounts her role at undermining POTUS is remarkable and repulsive. This woman should NEVER be allowed to operate the levers of power again.”

Republished from the author’s Substack

Author

  • Bill Rice

    Bill Rice, Jr. is a freelance journalist in Troy, Alabama.

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Brownstone Institute

Justices’ Grave Error in Murthy v. Missouri

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From the Brownstone Institute

BY Aaron KheriatyAARON KHERIATY 

Along with my co-plaintiffs, I was at the Supreme Court last week for oral arguments in our Murthy v. Missouri case, in which we are challenging the federal government’s alleged censorship on social media. The Supreme Court will likely rule in June whether to uphold, modify, or strike down the Fifth Circuit Court of Appeals’ injunction against five federal agencies, in what, the district court judge wrote, “arguably involves the most massive attack against free speech in United States’ history.”

At the hearing, Justice Samuel Alito pointed out that emails between the White House and Facebook “showed constant pestering of Facebook.” He went on to comment, “I cannot imagine federal officials taking this approach to the print media…It’s treating these platforms like subordinates.” He then asked the government’s attorney, “Would you treat the New York Times or the Wall Street Journal this way? Do you think the print media considers themselves ‘partners’ with government? I can’t imagine the federal government doing that to them.”

The government’s attorney had to admit, “The anger is unusual” — referring to White House official Rob Flaherty literally cursing at a Facebook executive and berating him for not taking action quickly enough to comply with the government’s censorship demands.

Justice Brett Kavanaugh followed up, asking, “On the anger point, do you think federal government officials regularly call up journalists and berate them?” It’s worth recalling that Kavanaugh worked as a White House attorney before he was appointed to the court, as did Justices John Roberts and Elena Kagan. No doubt there were times they dialed a journalist or editor to try to convince them to change a story, clarify a factual assertion, or even hold or quash the publication of a piece. Kavanaugh admitted, “It’s not unusual for the government to claim national security or wartime necessity to suppress a story.”

Perhaps colorful language is sometimes used in these conversations, as Kavanaugh himself hinted. Kagan concurred: “Like Justice Kavanaugh, I have had some experience encouraging the press to suppress its own speech…This happens literally thousands of times a day in the federal government.” With a wink to the other former executive branch attorneys on the bench, Roberts quipped, “I have no experience coercing anyone,” which generated a rare chuckle from the bench and audience.

This analogy to government interactions with print media, however, does not hold in the case of the government’s relationship with social mediaThere are several crucial differences that profoundly change the power dynamic of those interactions in ways directly relevant to our case. These differences facilitate, in Alito’s words, the government treating the platforms like subordinates in ways that would be impossible with print media.

Behind the Scenes

First, when a government official contacts a newspaper, he is talking directly to the journalist or editor — the person whose speech he is trying to alter or curtail. The writer or editor has the freedom to say, “I see your point, so I’ll hold my story for one week to allow the CIA time to get their spies out of Afghanistan.” But the speaker also has the freedom to say, “Nice try, but I’m not persuaded I got the facts wrong on this, so I’m running the story.” The publisher here has the power, and there is little the government can do to threaten that power.

By contrast, with requests or demands for social media censorship, the government was never talking with the person whose speech was censored, but with a third party operating entirely behind the scenes. As my co-plaintiff, the eminent epidemiologist Dr. Martin Kulldorff, quipped, “I would have been happy to get a call from a government official and hear about why I should take down a post or change my views on the scientific evidence.”

Power Dynamic

Additionally, there is little the government can do to destroy the business model and cripple the New York Times or Wall Street Journal, and the journalists and editors know this. If the government pushes too hard, it will also be front page news the next day: “Government Trying to Bully The Post to Censor Our Breaking Story,” with the lede, “Naturally, we told them to go pound sand.”

But the power dynamic is entirely different with Facebook, Google, and X (formerly Twitter): The government does have a sword of Damocles to hang over the head of noncompliant social media companies if they refuse to censor — in fact, several swords, including the threat to remove Section 230 liability protections, which Facebook founder Mark Zuckerberg has accurately called an “existential threat” to their business, or threats to break up their monopolies. As the record in our lawsuit shows, the government explicitly made just such threats, even publicly on several occasions, in direct connection to their censorship demands.

Furthermore, unlike the major tech companies, newspapers or magazines do not have massive government contracts that might disappear if they refuse to comply. When the FBI or Department of Homeland Security calls Facebook or X with censorship demands, the corporate executives know that a weaponized agency has the power to launch frivolous but onerous investigations at any time. It thus becomes virtually impossible for social media companies to tell the government to take a hike — indeed, they may have a fiduciary duty to shareholders not to incur serious risks by resisting government pressure.

The text of the First Amendment doesn’t say the government shall not “prevent” or “forbid” free speech; it says the government shall not “abridge” free speech — i.e., shall not do anything to lesson a citizen’s ability to speak or diminish one’s potential reach. A sensible and clear injunction would simply state, “Government shall not request that social media companies remove or suppress legal speech.”

But if the justices want to distinguish between persuasion and coercion in the injunction, they need to appreciate that social media companies operate in a very different relationship with government than traditional print media. These asymmetrical power dynamics create a relationship ripe for unconstitutional government coercion.

Republished from The Federalist

Author

  • Aaron Kheriaty

    Aaron Kheriaty, Senior Brownstone Institute Counselor, is a Scholar at the Ethics and Public Policy Center, DC. He is a former Professor of Psychiatry at the University of California at Irvine School of Medicine, where he was the director of Medical Ethics.

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