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Brownstone Institute

The FDA’s Ties to the Gates Foundation

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From the Brownstone Institute

BY Maryanne DemasiMARYANNE DEMASI 

In 2017, the US Food and Drug Administration (FDA) entered into a memorandum of understanding (MOU) with the Bill & Melinda Gates Foundation.

Under the MOU, the two entities agreed to share information to “facilitate the development of innovative products, including medical countermeasures,” such as diagnostics, vaccines, and therapeutics to combat disease transmission during a pandemic.

The FDA has MOUs with many academic and non-profit organizations, but few have as much to gain as Bill Gates, who has invested billions into pandemic countermeasures.

Experts are concerned the Gates Foundation could have undue influence over the FDA’s regulatory decisions of these countermeasures.

David Gortler, an ex-senior adviser to the FDA commissioner between 2019 and 2021, says he is “suspicious” of the MOU.

“If the Gates Foundation establishes an MOU with a regulator on a product they want to develop, it seems like it would be a conflict of interest.  What if every other drug company did the exact same thing as the Gates Foundation?” he says.

Gortler, now a fellow at the Ethics and Public Policy Center in Washington, DC, explained that normally, meetings between developers and regulators are supposed to be an official part of the public record and subject to Freedom of Information Act requests.

“However, an MOU such as this can circumvent the usual requirements for the transparency of official communications,” says Gortler. “This way their communications can be kept secret.”

David Bell, a former medical officer for the World Health Organization (WHO) who now works as a public health physician and biotech consultant, agrees that the MOU has potential to corrupt the regulatory process.

“The narrative is that philanthropic foundations can only be good, because they’re making vaccines and saving thousands of lives, so we need to cut the red tape and help the FDA get stuff done quickly otherwise children will die,” says Bell. “But in reality, it has potential to corrupt the whole system.”

Bell adds, “Speaking generally, close relationships between regulators and developers raise inevitable risks that shortcuts and favours will breakdown the rigorousness of the product review, putting the public at risk.”

Revolving door

The FDA has been roundly criticised for its “revolving door.” Ten of the past 11 FDA commissioners left the agency and secured roles with pharmaceutical companies they once regulated.

Similarly, the Gates Foundation hired high-ranking members of the FDA, who bring with them intimate knowledge of the regulatory process.

For example, Murray Lumpkin had a 24-year career at the FDA, serving as senior advisor to the FDA commissioner and representative for global issues. Now, he is deputy director of regulatory affairs at the Gates Foundation, and signatory on the MOU.

And Margaret Hamburg, who served as FDA commissioner between 2009 and 2015, is now on the Scientific Advisory Board of the Gates Foundation.

Murray Lumpkin, deputy director regulatory affairs, Gates Foundation; Margaret Hamburg, scientific advisory board, Gates Foundation

Bell has no doubt that these appointments were strategic to “game the system” saying, “If I worked at the Gates Foundation, I would certainly hire somebody like Murray Lumpkin.”

The only way to fix the revolving door problem Bell says, is to have a ‘non-compete clause’ in their contracts.

“It might be that FDA employees cannot work for the people they’ve regulated for at least 10 years. There are places that have those rules – private companies have agreements that you can’t work for a rival,” said Bell.

The FDA dismissed questions about the potential for conflicts of interest, or the lack of transparency over its communications with the Gates Foundation. In a statement, the FDA said:

FDA regulatory decision making is science-based. Former FDA officials do not impact regulatory decisions. FDA only collaborates with the Bill and Melinda Gates Foundation under the MOU as described.

Gates has billions at stake

Gates boasted about receiving a 20-to-1 return on his $10 billion investment into the “financing and delivery” of medicines and vaccines.

“It’s the best investment I’ve ever made,” he wrote in the Wall Street Journal. “Decades ago, these investments weren’t sure bets, but today, they almost always pay off in a big way.”

In Sept 2019, just prior to the pandemic, SEC filings showed the foundation purchased over 1 million shares in BioNTech (Pfizer’s partner) for $18.10/share. By Nov 2021, the foundation dumped most of the stock for an average of $300/share.

Investigative journalist Jordan Schachtel reported the foundation pocketed approximately $260 million in profit – more than 15 times its original investment – most of it untaxed because it was invested through the foundation.

In his recent book, How to Prevent the Next Pandemic, Gates warns that future pandemics are the biggest threat to humankind and that survival depends on global pandemic preparedness strategies, firmly positioning himself at the center of shaping the agenda.

In October 2019, the Gates Foundation and the World Economic Forum hosted Event 201, which gathered government agencies, social media companies, and national security organizations to war game a “fictional” global pandemic.

Oct 2019, Gates and WEF fund Event 201 to simulate a global pandemic response

The key recommendations from the event were that such a crisis would require the deployment of new vaccines, surveillance, and control of information and human behaviours, by orchestrating the cooperation and coordination of key industries, national governments, and international institutions.

Several weeks later when the covid-19 pandemic emerged, many aspects of this ‘hypothetical scenario’ became a chilling reality.

The Gates Foundation, which holds shares in a range of drug companies including Merck, Pfizer, and Johnson & Johnson, is now credited with wielding significant influence over the direction of the global response to the pandemic, saying its goal is to “vaccinate the entire world” with a covid-19 vaccine.

Global dominance

The Gates Foundation has poured millions into funding NGOs, media, and international agencies, earning Gates significant political clout.

Financial contributions to the media have garnered Gates favourable news coverage, boasting on the foundation’s website it committed almost $3.5 million to the Guardian in 2020 – 2023.

The UK medicines regulator – the MHRA – disclosed it took approximately $3 million in funding from the Gates Foundation in 2022, which would span across several financial years.

Presidential candidate Robert F Kennedy, Jr labelled Gates “the most powerful man in public health” because he managed to steer the WHO’s pandemic strategy to focus primarily on vaccination.

Kennedy said in an interview that the WHO “begs and rolls over” for Gates’ funding, which now makes up over 88 percent of the total amount of the WHO’s donations by philanthropic foundations.

“I think [Gates] believes that he is somehow ordained divinely to bring salvation to the world through technology,” said Kennedy. “He believes the only path to good health is inside a syringe.”

The Gates Foundation’s CEO Mark Suzman responded to concerns that the foundation has “disproportionate sway in setting national and global agendas, without any formal accountability to voters or international bodies.”

“It’s true that between our dollars, voice, and convening power, we have access and influence that many others do not,” admitted Suzman in his 2023 annual letter .

“But make no mistake – where there’s a solution that can improve livelihoods and save lives, we’ll advocate persistently for it. We won’t stop using our influence, along with our monetary commitments, to find solutions,” he wrote.

Republished from the author’s Substack

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  • Maryanne Demasi

    Maryanne Demasi, 2023 Brownstone Fellow, is an investigative medical reporter with a PhD in rheumatology, who writes for online media and top tiered medical journals. For over a decade, she produced TV documentaries for the Australian Broadcasting Corporation (ABC) and has worked as a speechwriter and political advisor for the South Australian Science Minister.

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Brownstone Institute

Medical Elites’ Disgrace Over Ivermectin

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From the Brownstone Institute

BY David GortlerDAVID GORTLER 

In the wake of the FDA settling a lawsuit brought against it for wantonly and aggressively smearing ivermectin, the agency has deleted its postings. That’s good, but we shouldn’t forget how egregiously it mischaracterized the drug, ignored copious evidence in its favor, and portrayed its proponents as dangerous crackpots.

About 30 months ago, America’s FDA was publishing articles with headlines like this: “Should I take ivermectin to treat COVID?” Answer: No. The agency also told Americans not to use ivermectin to prevent Covid. Then, in what became known as its infamous “horse tweet,” the FDA even patronizingly told Americans: “Seriously, y’all. stop it.

Prescribers who advocated for alternate treatments like ivermectin or hydroxychloroquine were mocked online by America’s “trusted journalists” as being part of a “right-wing conspiracy” and labeled “hucksters.” Those who didn’t demure to the Covid mRNA or other Big Pharma treatment narratives were banned, fired, and spoken harshly about around the world and into the reaches of the stratosphere in what seemed like coordinated messaging.

Many clinicians lost their jobs – at best. At worst, their reputations, practices, finances, and careers were shattered. If that was not bad enough, after losing their jobs, state medical and pharmacy boards initiated legal proceedings against their licensure, singling out their “off-label” Covid treatments, despite other off-label treatments being a near-ubiquitous component of pharmacy and medical practice.

A screenshot of a social media post Description automatically generated

Within days of FDA’s initial postings above, the American Pharmacist’s Association (APhA) the American Society of Health System Pharmacists (ASHP), and the American Medical Association (AMA) all collaborated to release a joint press release condemning doctors who prescribed ivermectin to treat Covid, but it appears that these organizations, instead of actually performing independent analysis of primary literature data, blindly regurgitated FDA, CDC, and NIH plus other government and Big Pharma talking points “strongly opposing” ivermectin use.

For generations and especially during the Covid pandemic, professionals depended on these “elite” medical groups. Some of them have existed for around 170 years and have around $150 million to $1.2 billion in assets, so they clearly had the history, personnel, and wherewithal to objectively examine published data. Even beyond that, the AMA has several floors in a skyscraper in Chicago and the APhA’s Constitution Avenue’s “landmark headquarters” is so luxuriant that it is advertised and utilized as a wedding venue.

Of course, that extravagance was paid for by millions of pharmacists, physicians, and benefactors who expected these organizations to act as a checksum and ensure excellent clinical practice standards. These medical organizations have a duty to honor their histories, responsibilities, and ethical duties to better the human condition through verified scientific evidence. Instead, they appeared to outrageously abandon their obligations from their lofty positions of respect, comfort, money, and power.

APhA, ASHP, and AMA Clinical Declarations Now Indefensible:

On March 22, the FDA rightly acquiesced and agreed to remove their anti-ivermectin postings due to 1) a lawsuit filed against them and 2) the impossible task of having to defend themselves with an overwhelming amount of data disagreeing with not only dispensing medical recommendations, but the published data backing their Covid-19 use (e.g., see below).

With that gone, the APhA, ASHP, and AMA assertions suddenly have no leg upon which to stand.

Several non-FDA links within their press releases have (unsurprisingly) also quietly vanished with no explanation. NIH references are slated to be shut down, on top of multiple FDA and CDC links already no longer working.

Ivermectin Mechanism of Action, History and Evidence:

The broad antiviral mechanism of action of ivermectin is complicated and may partially involve blocking the uptake of viral proteins, but the bottom line is that it has been shown to yield positive results in a variety of published results for Covid-19. Had APhA, ASHP, and AMA pharmacists and physicians independently examined the data, (as I, just one drug-safety analyst without fancy headquarters, have done) rather than simply parroting now-deleted narratives of others, they would have learned that ivermectin works as an antiviral.

It has an extensively proven track record of being not just safe – but astonishingly safe for a variety of viral diseases. This is not breaking or fringe science; it has been known for years. Ivermectin is such a safe and effective drug that back in 2015 it was the first drug for infectious disease associated with a Nobel Prize in 60 years.

While I have stacks of electronic files and printed materials, dog-eared and food/drink-stained, there is a most elegantly presented meta-analysis website designed by some brainy and web-savvy scientists detailing over 100 studies from over 1,000 different scientists, involving over 140,000 patients in 29 countries describing the benefit and safety of ivermectin for Covid-19 treatment. It actually appears to be more extensive than Cochrane’s outdated review of ivermectin which only examined 14 trials – and excluded seven of them from consideration.

A close-up of a blue sign Description automatically generated

According to these data, consisting of smaller international publications that include real-world findings and small observational studies, ivermectin shows a statistically significant lower Covid-19 risk as detailed in the image above.

The less-positive findings associated with late treatment/viral clearance/hospitalization data cohort were associated with delayed administration. That is because any late-state use of antiviral pharmacology tends to be ineffective after hundreds of millions of viral replications have taken place – whether it’s cold sores, influenza, AIDS, or Covid-19.

ASHP, APhA, and AMA Press Releases Contradict Available Data and Clinical Practice Standards:

When the FDA scolded Americans not to use ivermectin for Covid-19, on April 25, 2021, there were 43 different published manuscripts showing its potential benefit. Around three months later, on August 21, the FDA released its infamous horse/cow tweet which implied that ivermectin was only for animals, not humans. This “doubling down” occurred as an additional 20 studies had subsequently been written detailing additional benefits for Covid-19. See the timeline below:

In the picture shown above, the BLUE circles shown are studies which detail positive ivermectin study findings and the RED circles are negative. Negative data exists, but the positive ivermectin findings outnumber them both in study quantity and study size (illustrated by the circle sizes), according to meta analysis data published at: c19ivm.org

Multiple APhA/ASHP/AMA statements ignored published scientific and clinical evidence. Specifically, statements declaring the: “Use of ivermectin for the prevention and treatment of COVID-19 has been demonstrated to be harmful to patients” (bold emphasis theirs) are objectively inaccurate. I do not know on what basis those statements were made. The recommendation to healthcare professionals to …counsel patients against use of ivermectin as a treatment for COVID-19, including emphasizing the potentially toxic effects of this drug” represents a departure from pharmacist and physician practice standards.

The absurdity of the latter statement is quite outrageous. Pharmacists and physicians know that all drugs have “…potentially toxic effects” so if they applied the standard of “emphasizing potentially toxic effects” while discussing every prescribed medication, few if any patients would ever take any of their medications. The APhA/ASHP/AMA discriminatory hostility towards ivermectin was not only clinically unjustified and irresponsible; it was – as far as I know – without precedent.

These anti-ivermectin talking points also benefited new Big Pharma product advancement including the rebounding, overpriced taxpayer-funded boondoggle of Paxlovid and Remdesivir, such a “safe and effective” drug that hospitals had to be heavily incentivized (i.e., bribed) to entice nurses, physicians, and hospital administrators to promote its use with a staggering 20% “bonus” on the entire hospital bill paid by our federal government. Remdesivir quickly earned the sardonic nickname of “run-death-is-near” by American Frontline Nurses and others, due to serious questions about its clinical benefit.

Why were federal agencies’ and professional organizations’ talking points against ivermectin not backed by independent, original APhA/ASHP/AMA data examinations? That question needs to be thoroughly probed with regard to potential regulatory capture within these groups.

Both then and now, those FDA webpages, postings, and tweets were not just biased. They were irresponsible in their denigrating ivermectin as an off-label treatment, which is why they are now gone.

The question is, who was worse? The FDA for overstepping its congressional authority in not just making medical recommendations, but making recommendations ignoring data, or the servile “independent” elite professional organizations exuberantly echoing a narrative?

Prescient or not, here is an excerpt of the expert panel congressional testimony to the Covid Select House Oversight Committee, explaining the FDA’s disparaging ivermectin versus promoting mRNA injections using an automobile analogy, delivered just one day prior to the FDA’s yielding to physicians’ lawsuit to remove its postings denigrating ivermectin:

Heritage Foundation on X: ““To the countries, physicians, & pharmacists who prescribed ivermectin or hydroxychloroquine, I would like to tell you right now, you were right.” Dr. Gortler obliterated the “science” Americans were expected to believe about COVID treatments and the COVID vaccine in Congress… https://t.co/UJInVqdSdb” / X (twitter.com)

Despite FDA Settlement and Data Abundance, the Press is Still Anti-Ivermectin

Even after the FDA’s about-face, on March 26, 2024, a Los Angeles Times journalist published a column calling the removal of FDA tweets “groundless” unilaterally declaring ivermectin is still “conclusively shown to be useless against COVID-19,” comparing ivermectin to “snake oil,” and describing those who advocate for it as “purveyors of useless but lucrative nostrums” …whatever that means. (Regarding the ‘lucrative’ claim, it is worth noting that since ivermectin is generic and inexpensively available, it is not ‘lucrative’ to anyone.) It also referenced ivermectin lacking “scientific validation,” even though the above-cited data abundantly indicates otherwise.

Regarding the FDA’s choice to settle its lawsuit disparaging ivermectin, the FDA’s Center for Drug Evaluation and Research leadership isn’t “shooting itself in the foot” as the Times says. It seems that the FDA is indirectly attempting to prevent further embarrassment likely because it now realizes that its ivermectin assertions were wrong and outdated with every passing day. But where does that leave the APhA, ASHP, or AMA who heavily relied on these now deleted FDA links in their press releases?

The APhA, ASHP, AMA Response to the FDA’s Removal of Postings Used in Press Releases? An Embarrassing Silence:

Over a month later, and as of this publication date, none of these organizations have a single thing to say about their previous press releases quoting the now-removed FDA articles and tweets. In fact, here is an indication of their concerns: one week after the FDA acquiesced to remove its postings in ivermectin, APhA’s newly elected speaker chair and pharmacist Mary Klein is “happy danc[ing]” and giving her official acceptance speech wearing Mickey Mouse ears. ASHP’s (A/K/A “#MedicationExperts”) still shows its official page with clinicians wearing ineffective, unnecessary surgical masks despite the pandemic having ended well over a year ago and Cochrane reviews indicating that this sort of masking is almost certainly ineffective. AMA officials are making multiple posts on transgender issues and declaring climate change a public health crisis, – all while fully ignoring its impactful, incorrect, inappropriate statements on ivermectin.

Take a look:

The APhA, ASHP, and AMA have remained conspicuously silent on this topic while focusing their newsfeeds on everything but. To this day, their press releases remain online, with multiple dead links to government agencies. In blindly backing incorrect narratives pointing to removed web pages, they are now all alone in their ivermectin declarations.

Bottom line: ivermectin was and is safe, and more than likely effective for Covid when timed and dosed correctly, and under medical supervision, despite what was declared by organizations and federal officials. In fact, ivermectin’s general antiviral activity might even be helpful for bird flu (avian influenza) in animals and humans, in lieu of another novel adverse-event-ridden “warp speed” mRNA “vaccine” with an endless boondoggle of boosters.

The past and current record on ivermectin needs to be set straight. We know there is an important (but untransparent) list of who is responsible for misrepresenting published data, but will anyone be held accountable?

DISCLAIMER:  Do NOT discontinue or initiate taking ANY drug without first discussing it with a pharmacist or physician you know and trust. 

Author

  • David Gortler

    Dr. David Gortler, a 2023 Brownstone Fellow, is a pharmacologist, pharmacist, research scientist and a former member of the FDA Senior Executive Leadership Team who served as senior advisor to the FDA Commissioner on matters of: FDA regulatory affairs, drug safety and FDA science policy. He is a former Yale University and Georgetown University didactic professor of pharmacology and biotechnology, with over a decade of academic pedagogy and bench research, as part of his nearly two decades of experience in drug development. He also serves as a scholar at the Ethics and Public Policy Center

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Brownstone Institute

The Predictable Wastes of Covid Relief

Published on

From the Brownstone Institute

BY Daniel NuccioDANIEL NUCCIO  

As documented in a 2023 report from the Electronic Privacy Information Center, more than seventy local governments used ARPA funds to expand surveillance programs in their communities

If you ever had the vague sense that Covid relief funding worked in a manner akin to US aid packages in failed Middle Eastern dictatorships, your instincts weren’t wrong.

First off, there were cases of just outright fraud nearing the $200 billion mark with drug gangs and racketeers collecting Covid unemployment benefits from the US government, with some recipient fraudsters not even having the common decency of being honest American fraudsters.

Even worse, though, were some legitimate uses of Covid funds that actually counted as legitimate despite being laughably frivolous or clearly unrelated to nominal goals connected to public health or helping communities deal with the economic impact of the virus – or, more accurately, the lockdowns.

One of the most should-be-satirical-but-actually-real examples of a legitimate use of Covid cash was a researcher at North Dakota State University being awarded $300,000 by the National Science Foundation through a grant funded at least in part through the American Rescue Plan Act of 2021 to aid her in her 2023 efforts to reimagine grading in the name of equity. (If none of that makes sense, please don’t hurt yourself with mental pirouettes.)

Other more mundane projects pertained to prisons and law enforcement using Covid relief money for purposes that extended well-beyond simply paying salaries or keeping the lights on. In 2022 The Appeal and The Marshall Project  reported on how large sums of Covid money went to prison construction and expansion projects and to outfit police departments with new weaponry, vehicles, and canines. Regardless of how you feel about law enforcement or our prison system, these probably did little to stop the spread of Covid or keep out-of-work bartenders afloat while public health bureaucrats consulted horoscopes or goat entrails or their equally useful models to divine the proper time to let businesses reopen safely at half-capacity to diners willing to wear a mask between bites but too afraid to leave their homes.

Yet, of course, that didn’t stop people from trying to make the case that these expenditures absolutely were essential to slowing the spread. Often coming off like precocious children explaining to their parents how a new puppy would help teach them responsibility or an overpriced pair of sneakers would facilitate their social-emotional development by ensuring the cool kids would like them, local sheriffs and city managers were reported as claiming prison expansions could help prisoners social distance from each other, new tasers would help officers social distance from suspects, and new vehicles would allow officers to take their cars home with them rather than share one with another officer who might end up contaminating it with their Covid cooties.

But even worse than the funds that were outright plundered or just snatched up as part of a cash grab were those that were used on projects that helped further erode the freedoms of American citizens.

As documented in a 2023 report from the Electronic Privacy Information Center, more than seventy local governments used ARPA funds to expand surveillance programs in their communities, purchasing or licensing gunshot detection systems, automatic license plate readers, drones, social media monitoring tools, and equipment to hack smartphones and other connected devices.

Sometimes EPIC reported that this was done with little, if any, public debate over the civil liberties and privacy concerns inherent to these tools. In one case from a town in Ohio, approval for ARPA-funded ALPRs – cameras that can create a searchable, time-stamped history for the movements of passing vehicles – came after only a 12-minute presentation by their police chief.

Similarly, schools also likely used money from ARPA, as well as the 2020 Coronavirus Aid, Relief, and Economic Security Act, for their own surveillance purposes, although documentation of how schools used their Covid money is said to be somewhat spotty at best.

Vice News in 2021 reported how Ed Tech and surveillance vendors such as Motorola SolutionsVerkada, and  SchoolPass marketed their products as tools to help reduce the spread of Covid and allow schools to reopen safely.

Some attempts such as Vice’s description of SchoolPass presenting ALPRs as a means to assist with social distancing come off like police departments explaining the social distancing benefits of tasers.

Others, however, such as Motorola plying schools with lists of behavioral analysis programs that “monitor social distancing violations” and room occupancy while “automat[ing] the detection of students who are not wearing face masks,” seem to offer a glimpse of the dystopian future into which we are heading – as do the other surveillance tools bought with Covid cash.

Maybe at some point Disease X, about which our ruling class has been warning us, will hit and the additional drones, ALPRs, and social media monitoring tools bought by the law enforcement agencies reported on by EPIC will be used to monitor adults for social distancing violations and automatically detect who isn’t wearing a mask. Maybe those tools will just be used to keep a digital notebook of the daily activities of everyone while police reassure us that they promise only to look at it when they really really need to.

In either case, though, if you currently have the vague sense that post-Covid America is a little more like a Chinese surveillance state than in the Before Times, your instincts are dead-on.

Author

  • Daniel Nuccio

    Daniel Nuccio holds master’s degrees in both psychology and biology. Currently, he is pursuing a PhD in biology at Northern Illinois University studying host-microbe relationships. He is also a regular contributor to The College Fix where he writes about COVID, mental health, and other topics.

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