Who funds the FDA?
Citizens' Hearing, monkeycarditis, California censorship, gas prices, and FDA lobbying
Welcome back, everyone, to Rounding the News! This is your weekly news roundup brought to you by Rounding the Earth, hosted by me, Liam Sturgess. Let’s jump right in.
Health: Monkeypox, Mutation and Myocarditis
Law: California Ministry of Truth goes live
Economy: Gas price hits a record high in Vancouver
Geopolitics: Russia officially absorbs contested regions
Environment: Let’s fight climate change with climate change!
Culture: Meet the foundations running the FDA
Health
Citizens’ Hearing Round Table with Eric Payne and Chris Milburn
On Wednesday this week, I had the pleasure of helping out behind the scenes during the first round table discussion hosted by A Citizens’ Hearing, the community inquiry initiative led by Sonya Anderson of the Canadian Covid Care Alliance.1 It was a wonderful and wide-ranging discussion with Drs. Chris Milburn and Eric Payne, both of whom spoke out early on against the actions taken by their provincial governments and suffered very familiar consequences for their dissidence.
What I didn’t realize until Wednesday is that both doctors are still practicing. Dr. Milburn is now seeing patients in a small town called Sydney, while Dr. Payne was rehired by his original place of work in Alberta. This is fantastic news, and as Dr. Payne points out during the livestream, it’s also a sign that the system is acknowledging that these brave doctors were right all along.
Watch the video on Rumble by clicking this friendly button:
Monkeypox, Mutation and Myocarditis
Add yet another “suspected” cause behind the recent spike in heart problems: monkeypox. As per the case study published by the Centers for Disease Control and Prevention:2
We report 2 immunocompetent and otherwise healthy adults in the United States who had monkeypox and required hospitalization for viral myocarditis. Both patients were unvaccinated against orthopoxviruses. They had shortness of breath or chest pain and elevated cardiac biomarkers. No immediate complications were observed. They were discharged home after symptoms resolved.
My challenge to you, the audience, is this: after reading the paper in full, what is your best estimation of the situation? In your (likely) non-medical opinion, does the evidence in the details provided show likely correlation between the diagnoses of myocarditis and monkeypox in these two patients? And finally, what other virus is mentioned as a comorbidity/coinfection that seems to counteract the notion that these patients were “immunocompetent”?
Keep in mind that monkeypox is not behaving the way it is allegedly supposed to based on historical examples. Given that, it’s important to remember the role of polymerase chain reaction (PCR) in the “diagnosis” of monkeypox. Why do I emphasize this?
Because there’s this:3
Your second assignment is to read this article in its entirety, and identify an alternative explanation as to why the samples amplified by PCR may not match the genetic sequences “scientists” expect to find.
Law
Ministry of Truth goes live in California
California Governor Gavin Newsom has signed into law Bill AB 2098, allowing the state to revoke the medical licenses of doctors who say things the government doesn’t like. This is a dangerous precedent, as explained by Dr. Meryl Nass:4
California is a lost cause. And the people know it. Between April 2020 and July 2021, California lost nearly 1% of its population. This is the first time in recorded history that California has seen a drop in population.
California’s legislators will vote for anything, when instructed to do so. I can only recommend that its honest doctors relocate, along with so many others who are leaving the golden state for greener pastures.
What about the rest of the country? This is a shot across the bow.
Elected officials are important, and so are clean elections. If we let this continue, soon there will be nowhere to go. Good people need to run for office. Good people need to get to know their candidates.
The misinformation/disinformation meme has worked for the bad guys so far. We need to challenge it wherever we find it. We need to talk about how it has been used as a major strategy to silence the opposition.
Censorship may in fact be the biggest threat to our democracy. …
For patients who want the right to obtain honest information from their physicians and want to have choices regarding their medical treatment, now is the time to speak up. The screws are tightening. This could be your last chance.
Economy
Gas price hits yet another record high in Vancouver
I know what you’re thinking - Putin’s at it again! Now that all four disputed regions in Eastern Ukraine have voted to join Russia, that absolute dictator has flexed his magical economic powers to hit the citizens of the West right in the pocketbook. How else could we explain the record-breaking jump in gas prices in Vancouver? From CTV News Vancouver:5
Another day, another North American gas price record set in Metro Vancouver.
As experts predicted Thursday – when gas prices in the Lower Mainland and Greater Victoria soared to 239.9 cents per litre – the price went up again on Friday.
Some stations in Vancouver were advertising a litre of regular for 241.9 cents on Friday, the second consecutive day that the region has set an all-time record.
The latest surge in the cost of gas has been blamed on local factors in the Pacific Northwest – specifically maintenance on a major refinery and pipeline. Prices elsewhere in Canada have not been spiking.
“It is driven only by local factors here on the West Coast and generally in North America. It has nothing to do with international oil markets this time,” said Werner Antweiler, an economics professor at UBC's Sauder School of Business, on Thursday.
…Oh. My bad. I guess this is what they meant when they coined that phrase about making assumptions.
First, let’s put that price in perspective for our American audience. The price, in Canadian Dollars, is $2.419 per litre. There are 3.785 litres in a gallon, so I would pay $9.156 CAD per gallon. Google tells me that the CAD is worth $0.7229 USD as of Saturday October 1st, making the price $6.62 USD per gallon.6
Prices vary across the United States. The Economic Times published a list on September 29 that broke down the cheapest options in various locations:7
New York, New York: At Bolla Market, the gas will cost $3.33 per gallon.
[Los Angeles], California: At Arco, you can get a gallon of gas for $5.79.
Chicago, Illinois: At Costco, a gallon of gas will cost $4.30.
Houston, Texas: At Circle K, you can get gas at $2.89 per gallon.
Phoenix, Arizona: At Sams Club, a gallon of gas costs $4.19.
San Diego, California: At Shell, a gallon of gas will cost $5.49.
Dallas, Texas: At 7-Eleven, you can get gas at $3.01 per gallon.
San Jose, California: At Arco, a gallon of gas will require you to pay $5.79.
Regarding overall average gas prices, the state of California is the most expensive, with a gallon of gas costing $6.18. Meanwhile, Mississippi is the state that offers the lowest overall gas prices, with a gallon costing only $3.06.
Geopolitics
Russia annexes four contested regions of Ukraine
This past week, Russian President Vladimir Putin officially signed into law the recognition of the four formerly contested eastern regions of Ukraine as part of Russia. CBC News doesn’t like this very much - frankly, the world “sham” has appeared across every news story I can find, referring to the referendums held in each region to vote on whether or not to join Russia. Of course, that can be explained by the fact that The Associated Press is authoring the vast majority of these pieces, as the dominant newswire services in North America. Read below for their take:8
Environment
Let’s use solar geoengineering to fight climate change
An alternative headline could be “it’s time to fight human-caused climate change with more human-caused climate change!”
In an opinion piece published by the Antonio Express News, Hamid Beladi and Amitrajeet A. Batabya wrote:9
Scientists, economists and policymakers throughout the world now agree that climate change is the most serious environmental problem confronting humankind today. Although the long-term changes in temperatures and weather patterns that we are talking about are caused, at least to some extent, by natural forces, there is consensus today that at least since the 1800s, human activities have been the primary factor in making climate change the salient problem that it is today. …
To address this problem, economists and policymakers have generally advocated the use of price (tax) and quantity control (carbon credits) instruments. Efforts have largely been concentrated on creating the right incentives to get people and firms to diminish their use of fossil fuels and move toward renewable energy sources. …
Occasionally, politicians have advocated the use of bans. California Gov. Gavin Newsom recently stated that by 2035, his state would ban the sales of new gasoline-powered cars and light trucks. The hope here is that such an act will provide a forceful nudge to state residents to drive more electric vehicles that typically have no tailpipe emissions. …
It's time to think of new solutions to fight climate change. This means thinking seriously about solar geoengineering or climate engineering. This kind of engineering encompasses two kinds of technologies: carbon dioxide removal and, most intriguingly, sunlight reflection methods. …
The relevant technology involves injecting sulfate aerosols into the stratosphere so that more sunlight bounces off the Earth’s atmosphere instead of being absorbed by the earth with its “blanket covering.” The basic point is that sunlight reflection methods, including stratospheric aerosol injection, can compensate for the negative effects of climate change by cooling planet Earth.
I don’t know about you, but this sounds to me like the definition of “human-made climate change.” How much more intrusive can you get than to literally pollute the air to block out the sun?
I’m not someone who engages the “chemtrail” subject much at all, though you can imagine how dissidents on various topics wind up being relegated to the same circles at a certain point. Frankly, I’m starting to identify some gaps in logic in the official rebuttal that have caught my attention - and the entire premise is clearly going more mainstream anyway.
In 2016, the Smithsonian Magazine proudly boasted that “Science” had officially debunked chemtrails.10 Of course, they made sure to equate people asking about weird streaks in the sky to people who think lizards rule the world. Stay classy, Smithsonian.
But wait, what’s this? Only two years later, CBS News comes out with this:11
You know those conspiracy theorists over at CBS. Always spinnin’ yarns.
But of course, these are real scientists. They brought a diagram!
And so on, and so forth. I don’t know what’s actually going on with the skies. I can only focus on so many things at once! All I know is this: I smell nonsense somewhere. How about you?
I can’t speak for the veracity of this website, but I’ve previously turned to GeoEngineering Watch when I’ve chosen to dip my toes into this area. Let me know what you think.
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Culture
Understanding the capture of the FDA
While the Culture section of Rounding the News has thus far been reserved for discussion of “pop culture”, I wanted to borrow this space to instead introduce you to some friends. You may not have met them yet, and it’s important you become familiar with them sooner rather than later.
The Revolving Door
At this point, it’s no secret that the U.S. Food and Drug Administration is a captured agency.
Its revolving door sees FDA commissioners go on to work in high-level positions for the pharmaceutical companies they only just regulated, a systemic issue that also exists in plain sight in banking and environmental protection. For example, former Commissioner Scott Gottlieb joined Pfizer’s Board of Directors within only three months of leaving the agency in 2019.12 Former Principal Deputy Commissioner Amy Abernethy was hired as President at Verily Life Sciences, Google’s clinical research company, in June 2021.13 And only six months after granting Emergency Use Authorization to Moderna's mRNA-1273 COVID-19 genetic vaccine, former Commissioner Stephen Hahn became Chief Medical Officer at Flagship Pioneering - the venture capital firm that launched Moderna.14
Despite this open and normalized corruption, there are additional layers to the capture of the FDA that require a bit more digging to unearth - and some nuance to understand.
How is the FDA funded?
The FDA is an agency of the U.S. Government, positioned within the Department of Health and Human Services (HHS).15 As such, it is funded by the American taxpayer. Budget proposals are drawn up by the President of the United States and approved by Congress.1617
However, that's only one part of the story. In fact, only about half of the agency’s budget comes from the federal government. The other half comes from a funding mechanism that many members of the general public are only beginning to understand for the first time: user fees. User fees are payments made to the FDA by the companies submitting their products for review and approval by the agency - in essence, a “pay-to-play” fee. In other words, the FDA is funded in large part by the industries it is mandated to regulate.
The FDA’s budget for 2020 was $5.9 billion USD. Of this, 45% came from user fees.18 In 2021, the budget increased to $6.1 billion, 46% of which was paid by industry - that came to $2.8 billion last year.19
While the FDA’s mandate covers food, tobacco and medicine, over 55% of its budget is dedicated to pharmaceutical and biotechnological activities. Obviously, this represents a substantial sum of money that would cause serious problems should it no longer be available to the agency. The entire foundation of the FDA’s operations rests on the sustained and growing stream of funding from Big Pharma.
However, user fees are not the only way the FDA is influenced politically and financially by the pharmaceutical industry. There are a number of non-profit organizations whose primary focus is “improving” the FDA (through money or suggestion), while also lobbying the United States government to further increase the agency’s budget each year. Let’s meet just two of them.
Reagan-Udall Foundation for the FDA
The Reagan-Udall Foundation for the Food and Drug Administration, sometimes referred to as the FDA Foundation, was established by the US Congress in 2007. Officially, it operates as a government agency independent of the FDA. However, its mandate is “to help support and promote FDA's regulatory science priorities.”20
This is a public-private partnership that allows the FDA to operate in conjunction with industry while – at least on paper – avoiding conflicts of interest. In reality, the FDA and its foundation functionally operate as two branches of the same organization; the regulatory arm, and the research arm.
Funding
The FDA Foundation’s annual budget and funding has nearly doubled over the COVID-19 period. In 2019, the foundation’s reported revenue was $2,779,470.21 This jumped to $4,919,584 in 2020,22 and to $5,503,248 in 2021.23 The FDA itself accounts for $1,250,000 in funding each year, with the rest of the money coming from grants, donations, research contracts, fundraising events and investment income. As of 2021, 77.3% of the foundation’s funding came from industry and private philanthropic interests.
Among these financial supporters are organizations directly invested in the COVID-19 pandemic. The pharmaceutical companies behind the first round of genetic COVID-19 vaccines all contribute, including Pfizer, AstraZeneca, Janssen (along with parent company Johnson & Johnson), and the above-mentioned Flagship Pioneering (the venture capital firm that launched Moderna.)24
Other companies currently developing their own COVID-19 vaccine products are also funders, including Bayer, Novartis, Sanofi and Takeda. Further funders include companies developing and distributing various high-dollar patented treatments for COVID-19 such as AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Genentech, Gilead Sciences, and Merck.
Even more pharmaceutical funding comes from industry associations including the Biotechnology Innovation Organization (BIO), Consumer Healthcare Products Association (CHPA) and Pharmaceutical Research and Manufacturers of America (PhRMA). In addition to the already-listed pharmaceutical companies, the membership of these various industry organizations also include Moderna itself, along with Novavax, Medicago, Emergent BioSolutions and National Resilience.252627
Finally, the Bill & Melinda Gates Foundation and the Rockefeller Foundation are both substantial donors. Both of these foundations have developed substantial portfolios of pharmaceutical investments both in the private and public sector, and stand to profit heavily from the FDA’s favourable recommendations towards pharmaceutical products.
COVID-19 Vaccine Confidence Project
Because the FDA can’t openly promote COVID-19 vaccines due to their supposedly limited regulatory role, it outsourced this task to the FDA Foundation. This was done through a mixture of institutional capture and behavioural psychology.
Another federal agency, the National Science Foundation, funded an initiative at the Johns Hopkins Center for Health Security called the Working Group on Readying Populations for COVID-19 Vaccine.28 The group proposed a “social and behavioral research agenda to facilitate COVID-19 vaccine uptake,”29 leading the FDA to tap the FDA Foundation to run a $209,094 “COVID-19 vaccine confidence project” in the fall of 2020.30
This represents a significant investment of resources and attention from the federal government to maximizing uptake of the shots before any were authorized for use. Instead of objectively evaluating the safety and efficacy of the COVID-19 genetic vaccines and conducting a cost-benefit analysis, the FDA directly funded and engaged in pre-marketing campaigns using behavioural psychology while receiving significant funding from the pharmaceutical companies that developed the products.
COVID-19 Evidence Accelerator
This next bit will go nicely with Mathew Crawford’s The Chloroquine Wars on the Rounding the Earth Substack!
The FDA Foundation also spent $1,219,555 in 2020 and 2021 on an initiative called the COVID-19 Evidence Accelerator in collaboration with a lobbying organization called Friends of Cancer Research.
One outcome of this initiative was a study that undermined the use of hydroxychloroquine and azithromycin by only offering the drugs to hospitalized patients, contrary to the well-established protocols using the pair of drugs for outpatient treatment in the early phase of illness.31 This is yet another conflict of interest; in order to legally award an Emergency Use Authorization (EUA) to the COVID-19 vaccine candidates, there must not exist any other viable treatment for COVID-19. That means it was favourable for the FDA’s pharmaceutical funders for the FDA not to acknowledge the safety and efficacy of drugs like HCQ and azithromycin for use in treating COVID-19, compromising the integrity of the regulatory process.
Seems legit, right?
Alliance for a Stronger FDA
In addition to direct financial contributions, the FDA’s funding is bolstered by a lobbying group called the Alliance for a Stronger FDA.
Unlike the Reagan-Udall Foundation, the Alliance is not a government body and overtly represents the voice of the pharmaceutical industry. Its primary activities involve lobbying the U.S. Congress to increase the annual budget for the FDA, providing more funding for the agency and its partners to conduct research and development projects favourable to industry. The Alliance spent $855,000 on its lobbying activities between 2019-2021.32
Membership
As an industry association, the membership of the Alliance for a Stronger FDA is made up of pharmaceutical companies and other industry coalitions.33 Pfizer and Johnson & Johnson are both members, as are AbbVie, Amgen, Eli Lilly, Merck, and Sanofi – all of whom have direct interest in COVID-19 vaccine products and therapeutics under consideration by the FDA, as previously detailed. AstraZeneca was a founding member of the Alliance.34
Non-profit organizations and industry associations who are members include the Advanced Medical Technology Association (AdvaMed), Alliance for Aging Research, Alliance for Patient Access, Alliance for Regenerative Medicine, Biotechnology Innovation Organization, Consumer Healthcare Products Association, International Society for Stem Cell Research, Personalized Medicine Coalition, Pharma and Biopharma Outsourcing Association, and Research!America. Sifting through this web of non-profits, you find the same pharmaceutical companies that fund the FDA Foundation. Oxford BioMedica - AstraZeneca’s partner in developing their adenoviral vector COVID-19 genetic vaccine - can now also be added to the list through its membership in the Alliance for Regenerative Medicine.35
And there you have it: you know a little bit more about the FDA. Tell your friends, because I guarantee most of them still think the agency is at least somewhat “independent” - it’s not.
Thank you for tuning in again this week, and I look forward to bringing you even more educational and interesting content over the next week. Stay tuned for a special episode with Mathew Crawford tonight. I have been Liam Sturgess, and you can find me at www.LiamSturgess.com, or @TheLiamSturgess on Twitter.
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Rodriguez-Nava, G., Kadlecik, P., Filardo, T. D., Ain, D. L., Cooper, J. D., McCormick, D. W., Webber, B. J., O’Laughlin, K., Petersen, B. W., Narasimhan, S., & Sahni, H. K. (2022). Early Release - Myocarditis Attributable to Monkeypox Virus Infection in 2 Patients, United States, 2022. Emerging Infectious Diseases, 28(12). https://doi.org/10.3201/eid2812.221276
Kozlov, M. (2022). The monkeypox virus is mutating. Are scientists worried? Nature. https://doi.org/10.1038/d41586-022-03171-z
Nass, M. (2022, October 3). Want Informed Consent? Speak Out Against California’s New “Misinformation” Law. Children’s Health Defense. https://childrenshealthdefense.org/defender/informed-consent-covid-misinformation-law-california/
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The Associated Press. (2022, October 6). Russia officially annexes 4 disputed Ukraine regions, leaves door open for more. CBC News. https://www.cbc.ca/news/world/russia-law-annex-ukraine-regions-war-1.6606535
Beladi, H., & Batabyal, A. (2022, October 4). Commentary: Use solar geoengineering to fight climate change. San Antonio Express-News. https://archive.ph/niCJ8
Daley, J. (2016, August 22). Science Officially Debunks Chemtrails, But the Conspiracy Will Likely Live On. Smithsonian Magazine. https://www.smithsonianmag.com/smart-news/science-officially-debunks-chemtrails-conspiracy-live-180960139/
Berardelli, J. (2018, November 23). Controversial spraying method aims to curb global warming. CBS News. https://www.cbsnews.com/news/geoengineering-treatment-stratospheric-aerosol-injection-climate-change-study-today-2018-11-23/
Carome, M. (2019, October). Outrage of the Month: Revolving Door to FDA Commissioner’s Office Sows Distrust in Agency. Public Citizen. https://www.citizen.org/article/outrage-of-the-month-revolving-door-to-fda-commissioners-office-sows-distrust-in-agency/
Suchan, R. (2021, June 3). Verily Appoints Health Data Expert and Former FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD as President of Verily’s Clinical Research Platforms. Verily Life Sciences. https://verily.com/press/verily-appoints-health-data-expert-and-former-fda-principal-deputy-commissioner-amy-abernethy-md-phd-as-president-of-verily-s-clinical-research-platforms/
LaHucik, K. (2021, June 14). He authorized Moderna’s vaccine 6 months ago. Now, ex-FDA chief Hahn joins biotech’s backer. Fierce Biotech. https://www.fiercebiotech.com/biotech/six-months-after-granting-moderna-covid-19-eua-ex-fda-commish-joins-biotech-s-founding
Food & Drug Administration. (2016, March 18). U.S. Department of Health and Human Services. https://archive.ph/DWNhF
Jewett, C. (2022, March 28). The F.D.A.’s budget proposal aims to prepare for another pandemic. The New York Times. https://www.nytimes.com/2022/03/28/us/politics/the-fdas-budget-proposal-aims-to-prepare-for-another-pandemic.html
FDA Funding Hangs in the Balance as Congress Struggles with FY 2023 Budget, User Fee Reauthorization. (2022, August 30). Coalition for Healthcare Communication. http://cohealthcom.org/2022/08/30/fda-funding-hangs-in-the-balance-as-congress-struggles-with-fy-2023-budget-user-fee-reauthorization/
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Annual Report 2019. (2019). Reagan-Udall Foundation for the FDA. https://web.archive.org/web/20220712071448/https://reaganudall.org/sites/default/files/2022-02/Reagan-Udall_Annual%20Report%2020219_final_corrected.pdf
Annual Report 2020. (2020). Reagan-Udall Foundation for the FDA. https://web.archive.org/web/20220712065838/https://reaganudall.org/sites/default/files/2021-07/7-1-21_Reagan-Udall_AR.pdf
Sigal, E. V., Winckler, S. C., & Califf, R. M. (2021). 2021 Annual Report. Reagan-Udall Foundation. https://web.archive.org/web/20220712045554/https://reaganudall.org/about-us/annual-reports/2021-annual-report
Moderna. Flagship Pioneering. Retrieved October 5, 2022, from https://archive.ph/HNhye
BIO Member Directory. Biotechnology Innovation Organization. Retrieved April 4, 2022, from https://www.bio.org/bio-member-directory
About. PhRMA. Retrieved April 5, 2022, from https://www.phrma.org/about
Member Companies. Consumer Healthcare Products Association. Retrieved October 5, 2022, from https://web.archive.org/web/20221005193943/https://my.chpa.org/Directories/Member-Companies
Working Group on Readying Populations for COVID-19 Vaccine. Johns Hopkins Center for Health Security. Retrieved October 5, 2022, from https://archive.ph/7WZq3
Brunson, E. K., & Schoch-Spana, M. (2020). A social and behavioral research agenda to facilitate COVID-19 vaccine uptake in the United States. Health Security, 18(4). https://doi.org/10.1089/hs.2020.0106
Bhat, A., Browning-McNee, L. A., Ghauri, K., & Winckler, S. (2021). COVID-19 vaccine confidence project. Journal of the American Pharmacists Association. https://doi.org/10.1016/j.japh.2021.06.006
Stewart, M., Rodriguez-Watson, C., Albayrak, A., Asubonteng, J., Belli, A., Brown, T., Cho, K., Das, R., Eldridge, E., Gatto, N., Gelman, A., Gerlovin, H., Goldberg, S. L., Hansen, E., Hirsch, J., Ho, Y.-L., Ip, A., Izano, M., Jones, J., & Justice, A. C. (2021). COVID-19 Evidence Accelerator: A parallel analysis to describe the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19 patients. PLOS ONE, 16(3), e0248128. https://doi.org/10.1371/journal.pone.0248128
Alliance for a Stronger FDA Lobbying Profile. (2022, July 22). OpenSecrets. https://www.opensecrets.org/federal-lobbying/clients/summary?cycle=2021&id=D000046669
List of Members. (2022, March 4). Alliance for a Stronger FDA. https://archive.ph/Veeqd
AstraZeneca Calls for FDA Funding Increase. (2010, September 20). Pharmaceutical Technology. https://web.archive.org/web/20220817001606/https://www.pharmaceutical-technology.com/uncategorized/news96475-html/
Members & Profiles. Alliance for Regenerative Medicine. Retrieved October 5, 2022, from https://archive.ph/afY9M
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