Day: November 25, 2022

• Will Harris is a regenerative farming pioneer who runs White Oak Pastures in Bluffton, Georgia

• He produces high-quality grass fed products, including beef and other animal products, and is an inspirational example of how to convert from conventional to regenerative agriculture and thrive financially

• Regenerative agriculture, Harris says, “is a kinder, gentler agriculture … we call it biomimicry, the emulation of nature”

• While it’s an imperfect emulation, it helps to restore the natural cycles that have been broken by industrial farming

• Every agricultural county in the U.S. could replicate what Harris is doing to create sustainably grown food and improved communities

• Toward that end, he and his team created the Center for Agricultural Resilience to educate thought leaders on the benefits of building animal, plant and human ecosystems that can nourish communities instead of destroy them

Will Harris is a regenerative farming pioneer who runs White Oak Pastures in Bluffton, Georgia. He produces high-quality grass fed products, including beef and other animal products, and is an inspirational example of how to convert from conventional to regenerative agriculture and thrive financially.

Prior to the mid-‘90s, Harris ran his farm the way his father and most every other farmer in the country had — “as a very linear, monocultural cattle operation,” he said during an episode of “The Joe Rogan Experience,” “The factory farm model.”1

He now practices what he describes as regenerative agriculture, warning that it’s only a matter of time before Big Ag corrupts this term “and takes it away from us.” Regenerative agriculture, Harris says, “is a kinder, gentler agriculture … we call it biomimicry, the emulation of nature.”2

While it’s an imperfect emulation, it helps to restore the natural cycles that have been broken by industrial farming. As noted on the White Oak Pastures webpage, “Regenerative agriculture is a system of farming principles and practices that seeks to rehabilitate and enhance the entire ecosystem of the farm by placing a heavy focus on soil health with attention also paid to water management, fertilizer use, and more.”3

There are major differences in cows raised on grass versus grains. Those fed grass would have a life expectancy of about 20 years, but Harris states that feedlot cows are so unhealthy at slaughter, he doubts they’d live much more than about three years. “You’re eating an unnaturally obese creature that would never occur in nature and is slowly dying of the same diseases of a sedentary lifestyle, the obesity that’ll eventually kill most of us.”4

When Harris was in his 40s, he became increasingly aware of the pitfalls of the industrialized model of farming. “Animal welfare was the canary in the coal mine,” he told Rogan.5 He previously believed that “good animal welfare” included keeping the animal well fed and watered, in a comfortable temperature range, and not intentionally inflicting pain and suffering. It’s the definition of animal welfare that many still use today.

Harris realized, however, that true animal welfare involves giving the animal an environment where it can express instinctive behavior. “Chickens are meant to scratch and peck. Hogs are meant to root and wallow. Cows are meant to … graze. But in the CAFO confined model, those instinctive behaviors are not an option for them.”6

He changed his cattle operations after this realization. He also quit feeding the cattle chicken litter, which is chicken feces — a widely used, cheap protein source in feedlots. “Most of my transition from what I did 25 years ago to what I do today involved just giving up products and techniques,” Harris said,7 adding that it’s the misapplication of technology that makes agriculture so destructive today. “Reductive science, technology, does not lend itself to living systems.”

In terms of the land, agriculture is misusing cultivation, chemical fertilizers and chemical pesticides, which lead to unintended and unseen changes. When chemical fertilizers are applied, they lead to noticeable changes in growth, but what you don’t see, Harris explained, “is that fertilizer oxidized the carbon, the organic matter, in the ground. It killed the microbes in the soil. It had other negative chemical impacts, but you couldn’t see them.”8

When chemical fertilizers were first widely used, their long-term destruction to the environment were largely unknown. It’s only recently that the importance of soil biology is being recognized.

Before switching to regenerative farming, Harris spent 20 years operating the farm industrially, including using antibiotics and hormone implants to make cows grow faster. But the technologies that industrial agriculture relies on to “improve” food production are destructive.

“Pesticides, chemical fertilizers, GMOs, subtherapeutic antibiotics and hormone implants … These technologies result in horrible, unintended consequences that adversely affect our land, water, climate, and livestock,” Harris wrote on his blog.9

Further, they’ve allowed agriculture to become scalable to the point that a limited number of multinational corporations control most of the food supply. A centralized food system benefits no one but those who control it, and puts consumers at risk. Harris explained:10

“The centralization of food production impoverishes our rural communities as it creates an oligopoly. This centralization of food production is also bad for consumers. This system lacks resilience.

When mega-production facilities that are focused on efficiency break down, consumers’ access to food can become limited, which causes panic. This state of panic allows multinational companies to increase their profits exponentially. When the driving goal of our food production system is efficiency, as opposed to resiliency, consumers suffer.”

Meanwhile, Harris says, the way food and fiber are industrially produced causes farming to be “wastefully abundant and seemingly cheap.”11 Rogan asked Harris if there’s a way to produce the massive amounts of corn, soy and cotton currently produced regeneratively. Harris responded, “I think it’s the wrong question … it’s a matter of living off of what we can produce. How many T-shirts [from cotton] do you have to have?”12

Harris’ farming methods now represent the opposite of the industrialized approach, demonstrating how you can convert conventionally farmed land into a healthy, thriving farm based on regenerative methods. At White Oak Pastures, they’ve:13

• De-commoditized — Instead of relying on commodities, they produce five types of pastured red meats, five types of pastured poultry, pastured eggs and organic vegetables.

• De-industrialized — Instead of operating as a monoculture that grows one destructive crop, like GE soy, they’ve created a living ecosystem that includes 10 species of humanely treated animals that live in a symbiotic relationship. All of their land is managed using holistic principles.

• De-centralized — They were able to break away from the centralized food processing system, building their own abattoirs (slaughterhouses) to retain control of the quality of their products.

The industrialization of agriculture destroyed the land, while “centralizing agriculture impoverished rural America,” Harris said.14 “It caused it to be financially irrelevant. It just wasn’t needed anymore.”

But farming the way Harris does enriches the land and provides jobs for those in the community. “I’ve got 180 employees. My payroll is $100,000 every Friday in one of the poorest counties in America, and the town has gone from being a ghost town to a becoming a destination.”15 Every agricultural county in the U.S. could replicate what Harris is doing to create sustainably grown food and improved communities.

Toward that end, he and his team created the Center for Agricultural Resilience to educate thought leaders on the benefits of building animal, plant and human ecosystems that can nourish communities instead of destroy them.16

Harris tells Rogan that he has the utmost respect for vegans and vegetarians who choose not to eat meat because they oppose eating animals. But he’ll give you an ear full if you tell him you won’t eat meat because it’s destroying the planet. When farming is done regeneratively, it will help to restore the land and even improve the damage done by industrial methods. And animals are an integral, and necessary, part of the restorative process.

“We are sequestering 3.5 pounds of carbon dioxide equivalent for every pound of grass fed beef we sell. Ironically, the same environmental engineers did an analysis on Impossible Burgers,” Harris said. “They’re emitting 3.5 pounds of carbon dioxide equivalent.”17

In fact, Impossible Foods, maker of fake meat, plant-based “burgers,” claimed they have a better carbon footprint than live animal farms and hired Quantis, a group of scientists and strategists, to prove their point. According to the executive summary, their product reduced environmental impact between 87% and 96% in the categories studied, including land occupation and water consumption.18

This, however, compares fake meat to meat from concentrated animal feeding operations (CAFOs), which are notoriously destructive to the environment and nothing like Harris’ farm. Harris commissioned the same analysis by Quantis and published a 33-page study showing comparisons of White Oaks Pastures emissions against conventional beef production.19

While the manufactured fake meat reduced its carbon footprint up to 96% in some categories, White Oaks had a net total emission in the negative numbers as compared to CAFO produced meat.

Further, grass fed beef from White Oak Pastures had a carbon footprint that was 111% lower than a typical U.S. CAFO and its regenerative system effectively captured soil carbon, which offset the majority of emissions related to beef production.20

“The WOP [White Oak Pastures] system effectively captures soil carbon, offsetting a majority of the emissions related to beef production,” the report stated. “In the best case, the WOP beef production may have a net positive effect on climate. The results show great potential.”21

So in addition to a focus on animal welfare, Harris’ regenerative farming methods go beyond sustainable farming to land regeneration. “We believe farming must not only be sustainable, it has to be regenerative to rebuild our soil,” White Oak Pastures’ website reads.22 At White Oak Pastures:23

• Holistic planned grazing methods naturally sequester carbon, control erosion and increase organic matter in soil

• A life cycle assessment found that their farm is storing more carbon in the soil than their grass fed cows emit during their lifetime

• Former commodity crop land is acquired and regenerated into perennial pasture every year

• They’ve partnered with a nearby 2,400-acre solar farm to provide planned livestock grazing and regenerative land management

The majority of meat products sold in the U.S. come from CAFOs, not grass fed farms. To protect the environment and your health, as well as support animal welfare, seek out foods from small farmers using regenerative agriculture practices.

One useful option is to look for the American Grassfed Association (AGA) logo on meat and dairy, which ensures the animals were born and raised on American family farms, fed only grass and forage from weaning until harvest, and raised on pasture without confinement to feedlots.24

You can also get to know a local farmer using regenerative methods near you. Regenerative International, incorporated in 2014, built a global network of regenerative farmers and ranchers, with some 400 affiliates in 60 countries. You can find a map of these regenerative farms on RegenerationInternational.org to secure a source of sustainable food near you.

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Disclaimer: The entire contents of this website are based upon the opinions of Dr. Mercola, unless otherwise noted. Individual articles are based upon the opinions of the respective author, who retains copyright as marked.

The information on this website is not intended to replace a one-on-one relationship with a qualified health care professional and is not intended as medical advice. It is intended as a sharing of knowledge and information from the research and experience of Dr. Mercola and his community. Dr. Mercola encourages you to make your own health care decisions based upon your research and in partnership with a qualified health care professional. The subscription fee being requested is for access to the articles and information posted on this site, and is not being paid for any individual medical advice.

If you are pregnant, nursing, taking medication, or have a medical condition, consult your health care professional before using products based on this content.

• According to the 2022 Greenpeace report on the state of plastic in the U.S., recycling is impractical, expensive and toxic, and the majority of plastic in the recycle bins is going to landfills

• The amount of plastic recycled dropped to a new low of between 5% and 6%, and this number is likely lower based on lost plastic collected under the pretense of recycling, according to data from Bennington College

• Recycling companies are greenwashing consumers, promising to recycle plastics because it’s politically correct. Greenpeace lists five major reasons why recycling fails, including problems with collection, sorting, toxicity risk for workers and economics

• The oil and gas industry understood in the 1970s that recycling was not economical but continues to claim 100% can be recycled by 2040. Our addiction to plastic is fueling exposure to dangerous endocrine-disrupting chemicals

• Data show microplastics are found in human blood, placental tissue and feces. Plastic pollution in the water, food supply and farmland is a fundamental demonstration that plastic recycling has failed

Recycling is impractical and, according to Greenpeace, most plastics in the recycle bin are going to landfills.1 The report pulled data from Bennington College’s Beyond Plastics report2 released May 2022. Researchers from the college revealed that the amount of plastic recycled had dropped to a new low of between 5% and 6% — and that number was likely lower based on lost plastic collected under the pretense of recycling.

They expect this percentage to drop even further as the amount of plastic in production continues to rise. The full picture of plastic recycling has not ever lived up to the promises made by the plastic industry, and likely never will, according to the Beyond Plastics report.

For example, not one type of food service plastics has ever been recyclable according to the legal definition from the FTC Green Guide, despite food companies claiming it is, such as the Starbucks polypropylene strawless cup lids.3

Greenpeace describes the FTC Green Guide requirements in the 2020 report,4 writing that claims plastics can be recycled must be made on the existence of established programs for collection, separation and recovery. Yet, there are no established programs to separate and recover these plastic lids, so the advertising claim violates the FTC requirement.

According to NPR,5 the 2022 Greenpeace report found that not even soda bottles — the most prolific item found in recycling bins — meet the threshold set by The Ellen MacArthur Foundation New Plastic Economy Initiative for being called recyclable.

The Initiative sets a threshold of a 30% recycling rate to reach that standard. Lisa Ramsden, senior plastic manager for Greenpeace USA spoke with an NPR reporter, saying:6

“More plastic is being produced, and an even smaller percentage of it is being recycled. The crisis just gets worse and worse, and without drastic change will continue to worsen as the industry plans to triple plastic production by 2050.”

According to NPR, waste management companies say collecting and sorting plastic is expensive. Added to this, there are thousands of different types of plastics that cannot be melted and recycled together. Greenpeace scientists have also discovered that reusing plastic increases its toxicity to the environment and humans.

On the other hand, producing new plastic is cheaper. When one Oregon sanitation company told customers they could only take soda bottles and jugs in their recycling program, consumers became upset. General manager Trent Carter told NPR he wanted to be transparent with their consumers.

“Politically it’s easier to just say ‘Gosh, we’re going to take everything, and we think we can get it recycled,’ and then look the other way. That’s greenwashing at its best,” he said. The Greenpeace 2022 state of plastic recycling report lists five major reasons why plastic recycling fails.7

1. Collection — Over 33 million people in the U.S. use and dispose of single-use plastics each year. According to Greenpeace, even the recycling industry admits that collection from consumers is a problem.

   Greenpeace also notes that volunteer cleanups, often supported by the plastic industry, is more proof that collecting trillions of pieces of plastic waste is nearly impossible. One nonprofit organization, Keep America Beautiful, is funded by Dow and McDonald’s, and is famous for volunteer-led cleanups to collect plastic pollution.

   Yet, the continued need for these cleanups demonstrates that recycling programs cannot keep plastic out of the environment.

2. Mixed plastic — Even if plastic could be collected effectively, Greenpeace says it is likely a waste of money. This is because mixed plastic waste cannot be recycled concurrently and sorting trillions of pieces to be reprocessed is “functionally impossible” since different plastics have different characteristics, melting points, colorants and chemical additives.

3. Reprocessing creates pollution — During recycling, microplastics are generated and discharged into the environment. Recycling is also toxic to workers in recycling plants.

   In 2021, Canada’s National Observer reported that when plastic products are broken down or incinerated, toxins are released into the environment, including endocrine disruptors and cancer-causing chemicals. These contaminate the people in the recycling plant and the environment.

4. Toxicity risk — The chemical additives make recycled plastic a high toxicity risk when they are recycled into food-grade packaging. This means plastics in current use for food service cannot be recycled back into food service packaging. Instead, it can only safely be downcycled into a lower-value product or sent to a landfill.

5. Economics — Greenpeace notes that collecting, sorting, transporting, and safely reprocessing plastic waste is exorbitantly expensive. With a hike in diesel fuel, one Midwest recycler reported that transporting the plastic waste to Canada was “two to three times more expensive than it was six months ago.”8

Publicly, the oil and gas industry lobbyists have claimed that 100% of plastic can be recycled by 2040. Yet, they are unable to explain how they will reach that recycling rate. Additionally, an NPR investigative report,9 the gas and oil industry understood as early as the 1970s that recycling plastic was not an economical option.

NPR also reports that oil and plastic industry lobbyists have resisted legislation where consumers are paid to bring their plastic bottles in for recycling, so they are sorted at the source and thus lowering the cost. The reduction in the demand for oil during the COVID-19 pandemic,10 in addition to the push to promote electric vehicles, has meant that the oil industry may never fully return to prepandemic levels.

Although plastics use a relatively small number of petrochemicals for production, experts believe that it may be the largest source of new demand for oil. If this fails, then 2019 was likely the peak of fossil fuel demand. While the world drowns in plastic and microplastic, a Carbon Tracker report11 released in September 2020 argues that plastic is increasingly being scrutinized and regulated and as the public turns against its use, growth in the industry could fall to zero.12

Although a reduction in plastic industry growth to zero would be a boon for human health and the protection of the environment, it’s hard to imagine that the strength of the oil and plastic lobby will not find a loophole through which they can continue to produce environmental toxins that damage wildlife and human health.

According to Environmental Health News,13 “Two-thirds of all plastic ever produced remains in the environment,” which helps explain why tap water, bottled water,14 sea salt15 and a variety of seafood16 all come with a “side order” of microplastic.

And in fact, as you survey your own home, grocery store shelves, and big box stores, it’s apparent that our society has an addiction to plastic. BPA and phthalates are endocrine-disrupting chemicals found in plastics, which are particularly concerning for young children and pregnant women since they interfere with normal physiology and maturation, even in minute amounts.

It’s estimated that it can take a plastic bottle 450 years to break down in a marine environment17 and even then, it never fully goes away. It just breaks down into microplastics that persist indefinitely. These tiny pieces migrate up the food chain as they are consumed by fish and other wildlife.

It is extraordinarily challenging to avoid plastic as exposure routes include air,18 dust,19 water, food, food packaging, bottles and any number of household items. Even cashier receipts contain BPA20 that enters your bloodstream through your skin.

Another indication that recycling programs for plastic products have not been successful is the data21 released by researchers in the Netherlands that showed microplastic particles in 77% of the blood samples taken from 22 healthy human volunteers. This was the first time that microplastics had been detected in human blood, according to an ecotoxicologist at Vrije Universiteit Amsterdam in The Netherlands.22

The researchers described particles that were small enough to be absorbed across cell membranes. The mean concentration in the blood was 1.6 µg/ml, “showing a first measurement of the mass concentration of the polymeric component of plastic in human blood.”23

During testing, the researchers use steel syringe needles and glass tubes so that plastic would not be introduced into the samples. Some samples contained up to three different types of plastic. Past studies have also found microsized plastic particles in human feces, human placental tissue and a disturbing amount of plastic in baby poop.24

The vast number of products encased in plastic, in combination with data showing microplastics in human blood, placental tissue and infant feces, demonstrates the considerable failure of the plastic recycling program. Global plastic production doubled from 2000 to 2019, reaching 460 million tons, according to the Organisation for Economic Co-operation and Development.25

It’s also necessary to consider thin plastic fibers released from clothing during washing and microbeads found in facial scrubs and toothpaste that travel through the wastewater treatment plants and clog the waterways.

One 2015 study26 estimated there could be as much as 236,000 tons of microbeads filling the oceans. According to another study,27 the average person swallows an estimated 68,415 plastic fibers each year just from the dust landing on their plates during meals. Plastic pollution is also accumulating on farmland. The annual release of plastics28 to land is estimated to be four to 23 times greater than that released to oceans.

According to the researchers, this is “an alarmingly high input,” exceeding the total accumulated burden of 93,000 to 236,000 tons of microplastics present in ocean surface water around the globe.29

Recycling is nearly impossible, and production has not slowed. However, as you take steps to reduce your exposure to plastic, you are also voting with your pocketbook by lowering demand. Consider using reusable bags at the grocery store, bringing your own leftover containers to restaurants, avoiding disposable utensils, storing food in glass containers at home, and opting for nondisposable razors and cloth diapers.

Subscribe to Mercola Newsletter

Disclaimer: The entire contents of this website are based upon the opinions of Dr. Mercola, unless otherwise noted. Individual articles are based upon the opinions of the respective author, who retains copyright as marked.

The information on this website is not intended to replace a one-on-one relationship with a qualified health care professional and is not intended as medical advice. It is intended as a sharing of knowledge and information from the research and experience of Dr. Mercola and his community. Dr. Mercola encourages you to make your own health care decisions based upon your research and in partnership with a qualified health care professional. The subscription fee being requested is for access to the articles and information posted on this site, and is not being paid for any individual medical advice.

If you are pregnant, nursing, taking medication, or have a medical condition, consult your health care professional before using products based on this content.

• While the U.S. Food and Drug Administration itself does not accept corporate money, it does receive money funneled via a nonprofit foundation, which receives money from other nonprofits funded by private interests

• The Reagan-Udall Foundation is a nonprofit foundation created by Congress in 2007 to support scientific research that is of interest to the FDA. It accepts grants from government, individual donors and other nonprofits — even when those nonprofits are created and funded by industry

• The Reagan-Udall Foundation has received large donations from the Bill & Melinda Gates Foundation

• Ellen Sigal, who currently chairs the Reagan-Udall Foundation’s board of directors, is also vice president of the Cancer Moonshot program, funded by the Gates Foundation, and she’s on the board of the Parker Institute, which is partnered with Inovio, a Gates-funded company that is currently working on a COVID-19 vaccine

• According to the rules, no more than four of the 14-member board of the Reagan-Udall Foundation are supposed to be representatives of FDA-regulated industries, yet in 2017, nine of the then 13-member board had financial ties to industry at the time of their appointment

If you’re like most people, you probably assume that the U.S. Food and Drug Administration is funded by the U.S. government and therefore isn’t catering to private industries.

The agency itself certainly tries to present itself as independent from the industries it regulates but, in reality, legal loopholes have led to the FDA receiving money from, and being captured and corrupted by, private interests.

While the FDA itself does not accept corporate money, it does receive money funneled via a nonprofit foundation, which in turn receives money from other nonprofits funded by private interests. It’s really all a façade because the end result is the same. Those donating the money ultimately end up with the ability to pull strings, when needed.

As explained by NPR1 back in 2012, the Reagan-Udall Foundation is a nonprofit foundation created by Congress in 2007 to support scientific research that is of interest to the FDA. According to NPR:2

“The idea was that this foundation could do things the FDA can’t. It would raise money from private sources, fund research in areas where the FDA lacks expertise, and organize collaborations involving industry, patient groups and academia.”

As explained in a 2008 article3 in the Journal of the National Cancer Institute, the creation of the Reagan-Udall Foundation was part of a larger plan to establish a private-public partnership to facilitate the Critical Path Initiative.

The Critical Path Initiative was part of the FDA’s attempts to streamline and modernize the drug approval process by having companies pay user fees. Part of the Reagan-Udall Foundation’s responsibilities was to set goals and priorities for the Critical Path Initiative, and then award grants to meet those goals.

However, critics voiced concern, saying the Reagan-Udall Foundation might allow the food and medical industries “to sway FDA decisions,” since it could raise money from private, including industry, sources. To quell some of these fears, the Reagan-Udall Foundation said it would only accept grants from government, individual donors and other nonprofits, not industry.

After a few years of scraping by on small, private donations, the foundation received a $150,000 grant from the PhRMA Foundation, another nonprofit foundation funded by drug companies. Being a nonprofit, the PhRMA Foundation fit the description of an acceptable funding source, but just how independent can it actually be when it’s founded and funded by drug companies?

As noted by consumer advocate Sidney Wolfe with Public Citizen, while the PhRMA Foundation is technically a nonprofit, “one can hardly expect that they’re going to do things that are not in the interests of their funders.”4

Indeed, and this influence is in addition to the influence food, drug and medical device companies already have, by way of user fees. Again, the Prescription Drug User Fee Act established an accelerated application process for new drugs. The sped-up process is funded through industry-paid fees.

This fee, however, works more like a payoff or soft bribe. When a company pays the FDA for an accelerated review, the agency no longer has an incentive to find fault with the product or demand more extensive testing.

Not surprisingly, the Reagan-Udall Foundation has received large donations from the Bill & Melinda Gates Foundation, which we now know rarely does anything that doesn’t benefit Gates’ personal bottom line and overall agenda.

As detailed in “Bill Gates — Most Dangerous Philanthropist in Modern History?” Gates has used his philanthropy to shape public policy in ways that benefit his own agenda.

A March 17, 2020, article5 in The Nation titled, “Bill Gates’ Charity Paradox,” even points out that the Gates Foundation has given $2 billion in tax-deductible charitable donations to private companies, including GlaxoSmithKline, Unilever, IBM, Vodafone, the Mastercard affiliate MasterCard Labs for Financial Inclusion,6 7 Scholastic Inc. and NBC Universal Media.8 9

Many of these so-called donations end up benefiting the Gates Foundation, as it also invests in the very same companies and industries that it donates money to. This circular economy is why Gates just keeps getting richer, the more money he gives away.

Part of this wealth growth also appears to be due to the tax breaks given for charitable donations. In short, it’s a perfect money-shuffling scheme that limits taxes while maximizing income generation.

If donating to for-profit companies sounds oddly illegal to you, you’d be right. Gates is a tax evader for doing so — he’s simply getting away with it. The nonprofit foundation is a disguise to avoid taxes while funding the research arms of for-profit organizations that his foundation is invested in, which is illegal.

The image below shows donations received by the Reagan-Udall Foundation in 2013. Topping the list is the Gates Foundation, whose contributions for the year amounted to $977,165, followed by a string of drug companies.

In addition to all of this financial clout, food, drug and medical device makers also have the ability to exert influence over the FDA via the members10 of the Foundation board, and this was a concern right from the get-go.

As reported in the 2008 Journal of the National Cancer Institute article,11 members of the then-newly created Reagan-Udall Foundation executive board had troubling ties to industry — and to the Gates Foundation, which years later (see above) ended up being a top financial donor. The article, written by Joel B. Finkelstein, reads, in part:12

“The Food and Drug Administration’s most recent steps toward modernizing the drug approval process have renewed some old questions about the FDA’s relationship with the industries it regulates.

Several public advocacy groups affiliated with physicians and researchers have voiced their concern over the appointment of certain members to a newly formed agency board. The groups have warned that some members may have conflicts of interest due to past or current roles as board members of pharmaceutical and biotechnology firms …

The [Reagan-Udall] foundation’s board of directors, appointed by the FDA commissioner, will be largely responsible for establishing by-laws, selecting an executive director to oversee day-to-day operations, and reporting to Congress on foundation activities and operations.

The federal statute stipulates that of the 14 members named to the board, four members should come from industry, three from academia, two from consumer or patient advocacy organizations, and one from the health provider community. The remaining four spots are open to anyone with relevant expertise.

The FDA has already chosen the members and is organizing the Reagan–Udall Foundation. However, some advocacy groups are concerned that several nonindustry members have strong ties to pharmaceutical and biotechnology companies, including one who is currently under investigation by the Senate Finance Committee.

Tadataka ‘Tachi’ Yamada, M.D., currently heads the Bill and Melinda Gates Foundation’s global health program but until 2006 worked as head of research for the pharmaceutical company GlaxoSmithKline.

Senate investigators have uncovered evidence suggesting that, during his tenure with the company, he may have been involved in an effort to intimidate a scientist who was raising questions about the heart risks associated with the company’s blockbuster diabetes drug rosiglitazone maleate (Avandia).”

While the Reagan-Udall Foundation is the nonprofit arm of the FDA, the agency does not have the authority to set conflict-of-interest policies for the foundation.13 This, of course, leaves the door wide open for conflicts of interest and allows the Foundation to become a hidden back door of sorts, for corporate influence.

A more recent article,14 published in 2017 in The BMJ, points out that when the Reagan-Udall Foundation is using “big data” assess drug risks and device complications, they’re using “levels of evidence recommended by industry.” The potential for manipulation should be obvious. The article, written by BMJ associate editor Jeanne Lenzer, reads, in part:15

“Big data can be used cautiously to examine real world outcomes and to improve surveillance of drug safety … However, big data are a noisy mess, and analyses by entities with profit motives may identify spurious associations that support fast track approvals and indication creep (broadening the indications for drugs and devices).

The Reagan-Udall Foundation curates real world evidence or ‘big data’ derived from routinely collected health data from insurance claims, electronic health records, voluntary registries, and social media.

The U.S. drug and device regulator, the Food and Drug Administration, says that such data can speed up research, ‘saving time and money’ for ‘therapeutic development, outcomes research [and] safety surveillance.’

In January [2013], Robert Califf, then FDA commissioner, announced the launch of Innovation in Medical Evidence Development and Surveillance (IMEDS), a foundation project that he said would collect and analyze big data to identify ‘important safety issues.’

However, critics of the move say that big data are poor for identifying adverse events … Financial conflicts of interest, they worry, could influence the way big data are used, including exploitation of the weaknesses inherent in observational data to win FDA approval for new uses of drugs and devices and to exonerate drugs of previously detected harms. There is evidence and precedent to support both concerns.”

Lenzer also points out that the Foundation’s board of directors still has financial ties to the drug and device makers that the FDA is supposed to regulate. She notes that while no more than four of the 14-member board should be representatives of FDA regulated industries, in 2017, nine of the then 13-member board had financial ties to industry at the time of their appointment.

To give just one example of how conflicts of interest can have real-world implications, take the case of Ellen V. Sigal, Ph.D.16 Sigal chairs the Reagan-Udall Foundation’s board of directors.17

She’s also vice president of the Cancer Moonshot program, and it too is funded by the Gates Foundation. Sigal’s colleague at the Cancer Moonshot Program, Dr. Doug Lowy, is a co-inventor of the HPV vaccine Gardasil, and Sigal’s son, David Sigal, is married to New York State Sen. Brad Hoylman, who sponsored a bill to make Gardasil mandatory for all school children in New York.

Hoylman also supported a bill that would allow children as young as 9 to receive the HPV vaccine at school without the knowledge or consent of their parents. Gates, of course, is also a supporter of HPV vaccination and funds HPV vaccine research.

Lastly, Sigal is on the board of the Parker Institute, which is partnered with a company called Inovio. Inovio, which is funded by the Gates Foundation, is working on a COVID-19 vaccine. When you start tracing relationships, it’s amazing how often you find the Gates Foundation involved in matters relating to forced vaccinations and the destruction of legal protections.

Sad to say, it’s hard to find a government agency that hasn’t been captured by private interests. I’ve written several articles detailing the corruption at the CDC, for example, including “CDC Petitioned to Stop Lying About Pharma Funds,” “How Conflicts of Interest Have Corrupted the CDC” and “Public Health Agency Sued for Coke Collusion.”

The same can be said about the World Health Organization which, of course, is also funded by the Gates Foundation. In fact, when the U.S. withdrew its funding, Gates stepped in and became the largest funder — larger even than entire nations.

Without doubt, the FDA can be added to the list of agencies that largely serves corporate masters, hidden as they may be behind nonprofit façades. A recent investigative report18 by Science Magazine highlights the agency’s failures when it comes to overseeing clinical research, which is one of its many duties.

“FDA documents obtained via Freedom of Information Act requests reveal it rarely sanctions or penalizes researchers or research companies even when grave problems — including fraud — are found.”

Inspectors conduct routine visits to research trial sites and review trial records to make sure research parameters and safety protocols are followed. They also respond to complaints by whistleblowers.

However, FDA documents obtained via Freedom of Information Act (FOIA) requests reveal it rarely sanctions or penalizes researchers or research companies even when grave problems — including fraud — are found. What’s more, there’s a marked trend toward less and less adequate oversight.

Case in point: Aspen Clinical Research, run by Dr. Michael Harris, has on numerous occasions over the past decade been cited for “egregious errors” in its clinical trials, yet the FDA never followed through on its threats to fine, prosecute or disqualify Harris from conducting clinical research in the U.S. According to the report, written by Charles Piller:19

“FDA found there were serious lapses in obtaining informed consent from trial volunteers, unqualified staff made medical assessments, and Harris failed to properly report abnormal lab test results. He also did not disclose that trial participants were taking opioid, antidepressant, or antipsychotic drugs — which could have skewed results or posed safety concerns.

The agency said Aspen’s records were disorganized, contradictory, and sometimes backdated in a way that ‘begs the question of the authenticity and veracity of data collected.’ Those ‘serious, ongoing deviations’ might constitute ‘fraud, scientific misconduct,’ and ‘significant human subject protection violations,’ according to FDA documents …

Repeat problems and a raft of new ones emerged during inspections in 2014, 2015, and 2019. Each time, in responses to FDA, Harris admitted some transgressions, strenuously disputed others, and promised to improve.

Through all that, FDA never formally sanctioned Harris or pursued other penalties. The agency never made public the alleged offenses or told trial participants they might have been put at risk. Nor did it tell companies sponsoring some of the trials that their data might have been compromised …

Meanwhile, pharmaceutical and medical device companies continued to contract with Aspen. Since 2011, they have paid the firm millions of dollars for work on at least 65 trials, and Aspen is now recruiting people for nine new trials on Alzheimer’s disease, autism, depression, and other serious disorders.”

According to Piller, this isn’t a rare case. After reviewing some 1,600 FDA inspection and enforcement documents, Piller’s conclusion is that the “FDA’s enforcement of clinical research regulations is often light-handed, slow-moving, and secretive.”

“Clear corrections of inspector-reported dangerous or unlawful clinical trial practices were the exception, even amid signs that trial participants were harmed and that data underpinning evidence-based medicine were corrupted,” Piller writes.

“On the rare occasions when FDA formally warned researchers of findings that they had broken the law, the agency often neglected to ensure that fixes occurred … Moreover, the agency frequently closed cases on the basis of unverified claims by those accused.”

I recommend reading Piller’s report in its entirety. It’s a sobering read that raises all sorts of questions about drug safety.

If a drug trial is riddled with errors, omissions and outright fraud and falsification of documents and data — examples of which are given in Piller’s report — and this research is then used to gain FDA approval, the chances of that drug being harmful can be considerable. Clearly, oversight without follow-up and follow-through when problems are found is about as useful as no oversight at all.

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