FDA ties with Gates Foundation

FDA ties with Gates Foundation

A collaboration between US drug regulator and the Gates Foundation has raised concerns about undue influence over the regulation of pandemic countermeasures.

MARYANNE DEMASI, PHD

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 organisations, 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 Organisation (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.

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 centre 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 organisations to war game a “fictional” global pandemic.

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 co-operation and co-ordination 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% 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 Kenney. “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.

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(TLB) published this article by Maryanne Demasi, Reports with our appreciation for this perspective

Maryanne Demasi Reports is a reader-supported publication. To support her work, please consider becoming a free or paid subscriber.

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Header featured image (edited) credit: FDA/Gates picture/org. Maryanne Demasi Reports article

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