Day: May 23, 2023

• According to a recent “cradle-to-gate life cycle” analysis, the lab-grown meat industry produces four to 25 times more CO₂ than traditional animal husbandry

• Cultured meats are ultraprocessed and therefore likely to cause health problems similar to those caused by other ultraprocessed products, such as obesity, cardiovascular diseases, Type-2 diabetes, metabolic syndrome, irritable bowel syndrome, cancer, mental health problems and increased all-cause mortality

• The starting ingredients in the new fermented synthetic biology products are cheap sugars derived from genetically engineered (GE) corn and soy. GE crops are grown in environmentally destructive monocultures that use loads of herbicides, pesticides and synthetic fertilizers. As a result, they’re loaded with chemical residues

• Once the target organisms in the ferment have consumed the nutrients they need, what’s left over is hazardous biowaste that must be deactivated and safely disposed of. The waste cannot be sent to a landfill or used for any other purpose

• Lab-grown meats are not about your health or the environment’s; they’re a tool to phase out farmers and ranchers and replace them with an ultraprocessed product controlled by patents

Lab-grown, or cultured, meat is being promoted as the wave of the future — the “green, sustainable” way to eat. No animal suffering, no greenhouse gas emissions, just meat-like protein that will taste like the burgers and steaks you’re used to. Too bad it’s all a lie.

Beneath the greenwashed façade, the promises of lab-grown meat fall flat. Lab-grown meats are not about your health or the environment’s; they’re a tool to phase out farmers and ranchers and replace them with an ultraprocessed product controlled by patents.

Importantly, even if cultured meats aren’t toxic per se, they’re ultraprocessed products

and therefore likely to cause health problems similar to those caused by other ultraprocessed foods, such as obesity,

cardiovascular diseases, Type-2 diabetes, metabolic syndrome, irritable bowel syndrome, cancer,

mental health problems

and increased all-cause mortality.

On top of that, they’re more harmful for the environment than conventional ranching. Since synthetic biology relies on genetically engineered (GE) monoculture, it creates the very things they claim to counteract, namely environmental degradation that promotes climate change.

In the video above, Alan Lewis, vice president of government affairs for Natural Grocers, reviews what goes into the making of synthetic biology. Synthetic biology goes by many names, including “gene edited fermentation” and “precision fermentation products.”

While that sounds fairly innocuous, synthetic biology manufacturers rarely ever discuss what goes into the feed they use to grow the target organism, or what happens to the waste at the end of the fermentation process. That’s understandable, as both raise a number of serious questions.

As explained by Lewis, the starting ingredients in fermented synthetic biology products are cheap sugars derived from genetically engineered corn and soy. All GE crops are grown in environmentally destructive monocultures with taxpayer subsidies, and use loads of herbicides such as glyphosate, pesticides like neonicotinoids, and synthetic fertilizers.

As a result, they’re loaded with chemical residues. In addition to a base of sugars, hundreds of other ingredients may be added to the ferment in order to produce the desired end product, such as a certain protein, color, flavor or scent.

As explained by Lewis, the most-often used microorganism in the fermentation process is E. coli. The E. coli is gene-edited to produce the desired compound through its digestive process.

The microorganism must also be antibiotic-resistant, since it needs to survive the antibiotics used to kill off other undesirable organisms in the vat. As a result, antibiotic-resistant organisms also become integrated into the final product, and the types of foodborne illness that might be caused by gene-edited antibiotic-resistant E. coli and its metabolites are anyone’s guess. Nobody knows what such illness might look like.

Aside from the desired target metabolite, these gene-edited organisms may also be spitting out any number of non-target metabolites with unknown environmental consequences and health effects.

As explained by Lewis, the various “feed” ingredients are placed in a fermentation bioreactor set at 87 to 90 degrees Fahrenheit for anywhere from 24 to hundreds of hours to grow the target microorganism. The target organisms in the ferment consume the nutrients they need, and what’s left over after those organisms are extracted is hazardous biowaste.

While traditional fermentation processes, such as the making of beer, produce waste products that are edible by animals, compostable and pose no biohazard, the biowaste from these synthetic biology ferments must first be deactivated, and then must be securely disposed of. It cannot go into a landfill. Making food that produces hazardous biowaste is hardly a sustainable model.

Lab-grown meats are also an environmental disaster in the making. Their impact is far more akin to that of the pharmaceutical industry than the food industry.

“According to a recent ‘cradle-to-gate life cycle’ analysis, the lab-grown meat industry actually produces anywhere from four to 25 times more CO₂ than traditional animal husbandry.”

Indeed, precision fermentation — i.e., the process of engineering a gene sequence for a specific protein into a bacterium or yeast strain, and then growing it in fermenters to produce the required protein — has been used for decades in the production of drugs and vaccines.

According to a recent “cradle-to-gate life cycle” analysis,

the lab-grown meat industry produces anywhere from four to 25 times more CO₂ than traditional animal husbandry.

As noted by the authors, investors have poured billions of dollars into animal cell-based meat (ACBM) sector based on the theory that cultured meat is more environmentally friendly than beef. But according to these researchers, that hype is based on flawed analyses of carbon emissions.

The primary sources of CO₂ emissions are the purification processes, which require fossil fuels. The bacteria used to produce the “meat” releases endotoxins, and these must be eliminated from the growth medium or else the cells won’t reproduce properly. As noted by the authors:

“Animal cell culture is traditionally done with growth medium components which have been refined to remove/reduce endotoxin. The use of these refinement methods contributes significantly to the economic and environmental costs associated with pharmaceutical products since they are both energy and resource intensive.”

Based on this assessment, each kilo of cultured meat produces anywhere from 542 pounds (246 kilos) to 3,325 pounds (1,508 kg) of carbon dioxide emissions, making the climate impact of cultured meat four to 25 times greater than that of conventional beef.

The authors also point out that several estimates of ACBM climate impacts are dependent on novel technologies that either do not exist yet or are unlikely to work.

For example, some have proposed growing cyanobacteria hydrolysate in open concrete ponds to then be “harvested, sterilized, hydrolyzed and used as an animal cell growth medium.” The problem is that this technology is not currently used, “nor is it one that is currently near feasibility,” the authors note.

In short, the claims propping up the cultured meat industry are a sham, as the idea that cultured meat is a greener option is based on nonexistent technologies rather than the technologies that are in use.

Other studies have also been critical. For example, a 2019 article in the journal Frontiers in Sustainable Food Systems found that were the world to make the transition to cultured meat, its impact on global warming might initially appear to be beneficial. However, over time, cultured meat production would result in greater warming. As explained in the abstract:

“Improved greenhouse gas (GHG) emission efficiency of production has been proposed as one of the biggest potential advantages of cultured meat over conventional livestock production systems … In this study, we present a more rigorous comparison of the potential climate impacts of cultured meat and cattle production than has previously been made.

Warming impacts are evaluated using a simple climate model that simulates the different behaviors of carbon dioxide (CO₂), methane (CH₄), and nitrous oxide (N₂O), rather than relying on carbon dioxide equivalent (CO₂e) metrics.

We compare the temperature impact of beef cattle and cultured meat production at all times to 1,000 years in the future, using four synthetic meat GHG footprints currently available in the literature and three different beef production systems studied in an earlier climate modeling paper.

Cattle systems are associated with the production of all three GHGs above, including significant emissions of CH₄, while cultured meat emissions are almost entirely CO₂ from energy generation.

Under continuous high global consumption, cultured meat results in less warming than cattle initially, but this gap narrows in the long term and in some cases cattle production causes far less warming, as CH₄ emissions do not accumulate, unlike CO₂.

We then model a decline in meat consumption to more sustainable levels following high consumption, and show that although cattle systems generally result in greater peak warming than cultured meat, the warming effect declines and stabilizes under the new emission rates of cattle systems, while the CO₂ based warming from cultured meat persists and accumulates even under reduced consumption, again overtaking cattle production in some scenarios.

We conclude that cultured meat is not prima facie climatically superior to cattle; its relative impact instead depends on the availability of decarbonized energy generation and the specific production systems that are realized.”

Another paper,

published in the April 2023 issue of Animal Frontiers, concluded there are several implications of cell-based meat that need to be considered, but aren’t. In the video above, the corresponding author, Paul Wood, also reviews these issues, which include:

• Significant technical, ethical, regulatory and commercial challenges

• Widespread adoption is likely to “exacerbate global inequity between affluent and poor individuals and between high- and low-income countries”

• Cell-based products are not identical to the foods they’re intended to replace in terms of sensory and textural properties, nor are they nutritionally equivalent

• Societal roles associated with animal production will be lost, “including ecosystem services, co-product benefits and contributions to livelihoods and cultural meaning”

• Detailed production procedures are unavailable, which makes it “impossible to corroborate the many claims related to their product characteristics and sustainability.” According to the authors, “most of the claims related to the production of ‘CBM’ [cell-based meat] in view of sustainability improvements (e.g., energy or water use) seem not scientifically substantiated or remain at best speculative, especially for its environmental footprint”

• Cell-based meat companies claim the cost of synthetic meat will be significantly reduced, as per Moore’s law. However, cell-based meat systems “have natural limits and feedback mechanisms that negate this law”

As noted in this paper:

“There has been significant investment in the precision fermentation space and many predictions that this technology is going to disrupt the traditional meat and dairy industries; however, there are many technical, regulatory, and consumer challenges that need to be addressed.

The major technical challenge will be the cost of goods, with precision fermentation being significantly more expensive. For milk proteins, a range of yeast strains can produce recombinant proteins at a rate of 10–30 g/l, but these proteins then need to be separated from the yeast cells and cell debris using a variety of downstream processing techniques that can account for up to 60% of the cost of manufacture.

Precision fermentation technology will also be critical for the ‘CBM’ sector to produce the various growth factors and perhaps other compounds required to culture mammalian cells. To scale-up precision fermentation, companies use fermenters at >100,000-l capacity, which will require complex engineering and energy intensive processors.”

There are also unanswered questions about the potential carcinogenicity of cell-based meats. Most cultured or cell-based meats are created by growing animal cells in a solution of fetal bovine serum (FBS).

Aside from the fact that this “green” alternative requires the slaughter of pregnant cows in order to drain the unborn fetus of its blood, to get the cell cultures to grow fast enough, several companies are using immortalized cells. As reported by The Fern,

“Immortalized cells are a staple of medical research, but they are, technically speaking, precancerous and can be, in some cases, fully cancerous.”

The reason precancerous and cancerous immortalized cells are used is because normally-behaving cells cannot divide forever. Most cells will only multiply a few dozen times before they become senescent (old) and die.

This won’t work when your intention is to grow thousands of pounds of tissue from a small number of cells, hence they use immortalized cells that continue to divide indefinitely. Immortalized cells are by definition cancerous (or at bare minimum precancerous) as there’s no off switch for their replication.

MIT biologist Robert Weinberg, Ph.D., believes humans won’t get cancer from these cells because they’re not human cells and therefore cannot replicate inside your body.

However, there’s no long-term research to back this claim.

The fact that “cow tumors sometimes wind up in store-bought ground chuck”

and doesn’t cause a problem does not mean that a piece of meat consisting of nothing but cancerous and precancerous cells won’t have unpredictable effects.

To circumvent this PR nightmare, some cell-based meat companies are using embryonic stem cells rather than immortalized cells. Others are using cells from living animals.

Both of these strategies, however, destroy the argument that cultured meat is animal-free.

The video above features a presentation I made at The Attack on Food Symposium, hosted by Dr. Meryl Nass and presented by Children’s Health Defense TV, March 4, 2023. In it, I describe how food and agriculture are under attack, and how the fake food agenda threatens human health and the environment alike.

In attempting to create cultured meat on the scale that would be necessary to feed the world, logistical problems are numerous and, possibly, insurmountable. There are waste products — catabolites — to deal with, as even cultured cells excrete waste that is toxic.

The environmental benefits are also on shaky ground when you factor in GE soy production and the use of conventional energy sources. When that is factored in, analyses predict cultured meat will be worse for the environment than conventionally produced chicken, pork

and beef.

At the end of the day, it’s important to realize that the synthetic meat market is based on a slew of false premises and assumptions, and that the real agenda has nothing to do with saving the planet or improving human health. It’s to eliminate traditional farming and make populations dependent on mass-produced, patented, ultraprocessed foods.

There are also open questions about whether lab-grown meat may be weaponized in some way. GOOD Meat, which recently gained FDA approval for its cultured chicken, is using a Chinese firm called JOINN Biologics for its production and quality control — a company linked to China’s biowarfare program.

JOINN Biologics is also involved in some sort of animal-breeding operation. In 2022, they purchased 1,400 acres of land in Morriston, Florida, with the intention to build a primate facility. As reported by The National Pulse:

“A number of key personnel who work for JOINN Biologics and its parent company studied or worked at the Academy of Military Medical Sciences in Beijing. In 2021, the Academy was added to the U.S. trade blacklist for supplying biotechnology to the Chinese military.

The founder of JOINN and chair of its board of directors is Yuxia Feng, a military physician and a graduate of the Academy. Her co-founder and vice chair of the board of directors, Conglin Zuo, worked at the Academy, in its Institute of Biotechnology.

Other key personnel such as Hemei Wang and Shusheng Feng were also employed by the Academy, in the Institute of Pharmacology and Toxicology. Feng has worked on research with a number of scientists in the People’s Liberation Army who are considered key players in China’s biological weapons research …

JOINN’s involvement in the testing and production of America’s first commercially available lab-grown meat raises questions about the safety certification process for the product and about Chinese influence over critical aspects of America’s infrastructure, including its food supply.”

What are we to make of this? I don’t know, but the idea of relegating production and quality control, of all things, to a company tied to the Chinese biowarfare program seems rather reckless, and certainly doesn’t instill confidence. Without doubt, however, food could be used as a distribution route for a bioweapon, and I’ll just leave it at that for now.

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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.

By: Tessa Lena

• A “remarkable” video of Robert F. Kennedy Jr. talking with MSNBC in 2005 shows Joe Scarborough agreeing with him on vaccines

• In 2003, The Sydney Morning Herald issued a condemnation of business using fear of contagion to sell “farce masks”

• In 2003, Fauci said that that Americans would not accept country-wise vaccinations; in March 2020, he compared COVID to bad flu

• Cultural change, dramatic when straight in our faces, takes a long time to build up, and refusing to accept abuse here and now goes a long way

The slippery slope toward the elimination of free expression and critical thinking rights has long turned into a roller coaster ride. In that light, it’s interesting to look back and see how the “update in the cultural norms” has been ushered in.

Joomi Kim recently unearthed and wrote about a “remarkable video of Kennedy talking with MSNBC’s Joe Scarborough in 2005.” Today, Robert F. Kennedy Jr. is portrayed by the mainstream media as a “dangerous antivaxxer” and a “conspiracy theorist” for bringing up safety issues with “holy” vaccines.

But less than twenty years ago, when people on mainstream TV were allowed to talk like normal human beings — as opposed to obedient clockwork parrots, blindly touting the party line — they were far less afraid to agree with Kennedy on his views. Oh, now much difference can a couple of decades and a series of successful fear-mongering campaigns make!

Here is a telling excerpt from the interview:

SCARBOROUGH:

Let’s talk about Thimerosal … There are a lot of people, a lot of Americans very concerned about the impact of this drug, which is found in vaccines, and how it causes autism. Talk about that.

KENNEDY:

That’s right. Thimerosal is a preservative that was put in vaccines back in the 1930s. Almost immediately after it was put in, autism cases began to appear. Autism had never been known before. It was unknown to science. Then the vaccines were increased in 1989 by the CDC and by a couple of other government agencies.

SCARBOROUGH:

OK, let me stop you there. That’s an important date. And I will tell you why. My son, born in 1991, has a slight form of autism called Asperger’s. When I was practicing law and also when I was in Congress, parents would constantly come to me and they would bring me videotapes of their children, and they were all around the age of my son or younger. So, something happened in 1989.

Remarkably, Scarborough plays along with Kennedy in considering the possibility that the increase of vaccinations in 1989 had something to do with the rise in autism.

KENNEDY:

Exactly. What happened was the vaccine schedule was increased. We went up from receiving about 10 vaccines in our generation to these kids receive 24 vaccines. And they all had this Thimerosal in them, this mercury. And nobody bothered to do an analysis of what the cumulative impact of all that mercury was doing to kids.

As it turns out, we are injecting our children with 400 times the amount of mercury that FDA or EPA considers safe. A child on his first day that he is born is injected with a Hepatitis B shot. Under EPA guidelines, he would have to be 275 pounds to safely absorb that shot.

SCARBOROUGH:

And yet, we are just constantly pumping our kids with these vaccines. Where is the federal government in all of this?

KENNEDY:

What happened was that, in 1988, one in every 2,500 American children had autism. Today, one in every 166 children has autism. And, plus, one in six have other kinds of learning disorders, other kinds of neurological disorders, speech delay, language disorders, ADD, hyperactivity, that all seem to be connected, that are all connected, the science shows are all connected to autism — to Thimerosal.

SCARBOROUGH:

… You can’t prove it, but, intuitively, you look at the spike. You look at what happened with Thimerosal. There’s no doubt in my mind — maybe it’s two years from now. Maybe it’s five years from now. Maybe it’s 10 years from now. We are going to find out Thimerosal causes, in my opinion, autism [emphasis by Joomi].

Kennedy then goes on to mention that there are “hundreds and hundreds of studies that connect Thimerosal to these disastrous neurological disorders,” but the studies that federal bureaucrats use to defend Thimerosal, are weak.

KENNEDY:

Then I went and I talked to the federal bureaucrats who are defending Thimerosal. And I said, what are you relying on? And I looked at the science they are relying on. And I can tell you, Joe, it is so weak. And you and I have seen, in the legal practice, junk science. And we know what these phony scientists are who create this stuff.

SCARBOROUGH:

It happened in big tobacco.

KENNEDY:

Right. Tobacco.

SCARBOROUGH:

It happens in big oil. It’s happening in global warming. And now it’s happening in a way that is impacting our kids’ lives.

Scarborough even said to Kennedy: “Let’s get you running for a public office. I will defend your honor whenever any Republican says anything nasty.” The full interview transcript can be found here.

By the way, here is an official wishy washy and roundabout statement about Thimerosal on the CDC website [emphasis mine]. Looks like straightforward talk doesn’t come easy to the CDC:

“Thimerosal is a mercury-based preservative that has been used for decades in the United States in multi-dose vials (vials containing more than one dose) of medicines and vaccines. There is no evidence of harm caused by the low doses of thimerosal in vaccines, except for minor reactions like redness and swelling at the injection site.

However, in July 1999, the Public Health Service agencies, the American Academy of Pediatrics, and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines as a precautionary measure.”

Meanwhile, the mouthpieces for Big Pharma have seemingly forgotten to recall the study showing that Thimerosal is “linked to immune system dysfunction”: “The study provides the first evidence that dendritic cells show unprecedented sensitivity to thimerosal, resulting in fundamental changes in the immune system’s ability to respond to external factors.”

As noted by Joomi, in 2021, Joe Scarborough, the very Joe Scarborough who had been sympathetic to Kennedy’s views in 2005, expressed support for vaccine mandates — and this year, he called anti-vaxxers “freaks”:

“Let me say something about anti-vaxxers. I felt really sorry for anti-vaxxers and their children when they were left-wing freaks. And I feel really sorry for anti-vaxxers and their children now that they’re right-wing freaks … This misinformation keeps getting spewed out there, and unfortunately the weakest, and perhaps the least educated, are the ones that fall prey to these stupid lies.” (True? No.)

Here is a stunning blast from the past. In 2003, The Sydney Morning Herald published a sweet (and truthful!) article titled, “Farce mask: it’s safe for only 20 minutes”:

“Retailers who cash in on community fears about SARS by exaggerating the health benefits of surgical masks could face fines of up to $110,000.

NSW Fair Trading Minister Reba Meagher yesterday warned that distributors and traders could be prosecuted if it was suggested the masks offered unrealistic levels of protection from the disease.

“I’m sure everyone would agree that it is un-Australian to profiteer from people’s fears and anxieties,” Ms Meagher said.”

Remember December 2020? The time when mandating adult vaccines was still a conspiracy theory? Erase that. Don’t believe the evidence of your own eyes. Speaking of evidence of your own eyes, Biden did say that he would NOT introduce mandates:

A year later, he announced vaccine mandates:

Is there accountability? Asking for a friend.

Meanwhile, in March 2020, The New England Journal of Medicine published Fauci’s article, titled, “Covid-19 — Navigating the Uncharted.” Guess what Fauci compared COVID to?

“If one assumes that the number of asymptomatic or minimally symptomatic cases is several times as high as the number of reported cases, the case fatality rate may be considerably less than 1%.

This suggests that the overall clinical consequences of Covid-19 may ultimately be more akin to those of a severe seasonal influenza (which has a case fatality rate of approximately 0.1%) or a pandemic influenza (similar to those in 1957 and 1968) rather than a disease similar to SARS or MERS, which have had case fatality rates of 9 to 10% and 36%, respectively”

And if we go far enough, here is what Fauci in 2003: “The country wouldn’t have accepted being vaccinated [for smallpox], and we knew it.”

If we see today’s America through the eyes of somebody who fell asleep in 1999 and just woke up, that person would think that he’s been drugged. Between the censorship, the attack on liberty, the attempt to withdraw the medical freedom, and the push for isolation camps, it doesn’t feel real. And yet …

People usually ignore philosophers at their peril, resorting to crisis management when the crisis is impossible to ignore. However the signs of decay and self-betrayal are usually on display for a long time, available for observation to anyone with a pair of eyes.

It is little by little — personal choice by personal choice — that the big monster is born. And yes, the conception of the monster is more often than not brought upon by the people with some power and not so good intentions. But the nourishment of the developing monster is impossible without the participation by the regular people: the people who are broken, fearful, dependent on external validation, emotionally wobbly, and not quite connected to their souls.

For example, if the entire citizenry produced a giant outcry at the mention of vaccine mandates, there would be no vaccine mandates regardless of how much the people with not so go intentions wanted to usher them in.

But they worked the citizens meticulously, using every possible trick: from fear to resentment of happiness to pseudoscientific talk.

For example, before any COVID, they had introduced and popularized the antiscientific concept that in order for an “effective” vaccine to work, everyone has to get the “effective” vaccine. Even without going into the bigger picture of vaccine development, this concept is absurd on its face. I was kind of extremely suspicious of that move a few years ago when they started ramping up the fear in the context of measles and the flu. I thought, something’s up! Well …

But again, individual views may vary, and when someone is convinced by the propaganda to make personal choices against their interests, they remain in the category of the abused. However, when they become so disconnected and terrified that they feel like their world will come apart if they don’t force their view on others, they receive the “abuser” badge as well. And the monster gets bigger. And so it goes.

This applies to any views, by the way. I have never encountered a person who is healed and whole on the inside, who has any inclination to proselytize on people against their will. And the irony is that the more broken the person is (assuming sincerity), the more self-righteous that person feels! Never fails.

There is no easy formula for starving out the ugly monster but there is definitely a way out. I believe that a big part of the deal is refusing to be afraid, refusing to freak out, and remembering our beautiful spiritual worth. Once we get the part of our souls that knows no fear, we become a force for good. We can be warriors, we should be warriors — but we are more effective warriors without fear. Letting go of fear and remembering the love go hand in hand.

In my own life, I have found that it is far more productive to be focusing on my job in this life than to obsess with other people’s “wrong” beliefs, even if I find their beliefs bizarre. I have found that doing my job with love contributes to the process of starving out the monster. And that’s all I can do. And the rest is in the hands of the universe (God, the higher powers, however you pray). One the monster will disappear. If we have faith and patience and do our jobs right, it will disappear.

To find more of Tessa Lena’s work, be sure to check out her bio, Tessa Fights Robots.

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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.

By: The Vaccine Reaction

• In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA) to accelerate FDA licensing approvals of new drugs and vaccines. More than half of the FDA’s budget is now funded by the pharmaceutical industry through PDUFA fees

• The Food and Drug Administration Amendments Act of 2007 allows companies developing treatment for neglected or rare pediatric diseases to pay the FDA for a priority review voucher (PRV) to fast-track approval of the drug or vaccine

• The PRV has proved to be a windfall for companies producing vaccines. A PRV typically secures fast-track approval in six rather than 10 months

• Under the law, drug companies developing treatments for neglected and rare pediatric diseases can sell their PRVs to other companies, including vaccine manufacturers, for millions of dollars to fast-track licensure of completely different, profitable drugs and vaccines, including the HPV vaccine

• The federal government helps the drug industry to market more vaccines. A grant to Emory University for $767,107 for fiscal year 2017 targets pregnant women and their children for vaccination using sophisticated sales and marketing techniques

Editor’s Note: This article is a reprint. It was originally published September 28, 2018.

When it comes to cozy business relationships between government and industry, there is nothing like the lucrative one that Congress has encouraged federal health agencies to create with the drug and vaccine industry. One hand washes the other.

Have you ever wondered how some new drugs and vaccines vault to the front of the line of the FDA’s licensing process using fast-track approvals? One way is through a federal law, the Food and Drug Administration Amendments Act passed by Congress in 2007, which allows a company developing a treatment for a neglected or rare pediatric disease to pay the FDA for a priority review voucher (PRV).

Although FDA approval is not guaranteed, most of the time a PRV secures fast-track approval in six rather than 10 months.

According to the FDA, to earn a priority review designation, a pharmaceutical product must pose “significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications.”

The company seeking approval must also provide “evidence of safety and effectiveness in a new subpopulation.”

The PRV was created and included in the 2007 law to provide an incentive to companies developing nonprofitable drugs for rare pediatric diseases, but has proved to be a windfall for companies producing vaccines.

Under the law, drug companies developing treatments for neglected and rare pediatric diseases may sell the PRVs they have purchased from the FDA to other companies, including vaccine manufacturers, for millions of dollars to fast-track the licensure of completely different, profitable drugs and vaccines.

When sold, the PRVs designed to help small companies fund their development of nonprofitable disease treatments can give extreme advantages to multinational corporations developing and selling other high-priced drugs and vaccines.

“If you develop a new drug for malaria, your profitable cholesterol-lowering drug could go on the market a year earlier,” said Bill Gates at the World Economic Forum in Davos in 2008.

Describing the 2007 law creating PRVs, Gates pointed out that, “This priority review could be worth hundreds of millions of dollars.”

The Bill and Melinda Gates Foundation has invested hundreds of millions of dollars in the vaccine industry.

Early PRV approval from the FDA gives drug companies several months of additional sales because the first licensed drug or vaccine in a category to reach the market often becomes the front-runner, leaving competitors in the dust.

For example, Regeneron and Sanofi bought a PRV in the hopes that its cholesterol drug Praluent would beat Amgen’s Repatha to market.

Gilead paid $125 million for a PRV and AbbVie paid $350 million, in addition to the $2.7 million paid to the FDA for the shortened review.

As Gates pointed out, companies that purchase PRVs stand to make millions on pharmaceutical products that the FDA fast-tracks to market. PRVs, then, appear to be primarily making money for drug companies rather than truly helping patients suffering with rare and neglected diseases.

The FDA is charged with the legal duty to regulate the food and pharmaceutical industries to ensure that prescription drugs, vaccines and other biological products, medical devices and certain types of foods are safe, labeled properly and effective before being released for use by the public.

Reportedly, FDA officials objected to the priority review program, which was included in the 2007 law passed by Congress without soliciting input from FDA staff.

According to an unnamed FDA source, “FDA does not get a true seat at the table” during the legislative process so “well-meaning academics, advocates and legislators ‘sold’ FDA to the highest bidder in setting up this program.”

Critics of the PRV program point out that it does not really encourage drug development for rare diseases. Since medical reviewers in FDA cannot be easily moved from one review division to another in order to handle PRVs, it creates added workload strain to an overtaxed regulatory agency that is understaffed.

The program also makes it easier for pharmaceutical products, for which there are existing treatments, such as for diabetes or cholesterol, to move to the front of the approval line at the expense of other, more important ones for which there are no treatments.

For example, Janssen used a PRV to accelerate the approval of Tremfya (guselkumab) to treat plaque psoriasis, a lucrative drug category competing with the best-selling psoriasis drug, Humira.

Drug giants Gilead Sciences and Jazz Pharmaceuticals have also bought PRVs.

Of course, not all of the accelerated FDA reviews that big drug companies are enjoying involve priority review vouchers created under the 2007 law. In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA) to accelerate FDA licensing approvals of new drugs and vaccines.

It was the first law to allow pharmaceutical companies to pay the FDA to let them bypass normal licensing procedures so they could fast-track new products to market. The act was reauthorized by Congress as PDUFA VI in the Food and Drug Administration Reauthorization Act of 2017 (PL 115-52).

More than half of the FDA’s budget is now funded by the pharmaceutical industry through PDUFA fees.

This raises serious questions about the integrity of the FDA licensing process when Congress has allowed drug companies to, in effect, bribe the FDA to lower licensing standards in order to grease the skids for certain drugs and vaccines to be fast-tracked to licensure.

Recently, the FDA granted priority review to Merck’s new Supplemental Biologics License Application (sBLA) for Gardasil 9 vaccine under PDUFA.

In a June 13, 2018, press release, Merck stated that the FDA has set a PDUFA, or target action, date of October 6, 2018, for a decision about whether Merck will be granted “an expanded age indication for Gardasil 9 for use in women and men ages 27 to 45 to prevent certain cancers and diseases caused by the nine human papillomavirus (HPV) types covered by the vaccine.”

Dr. Alain Luxembourg, a Merck official, said:

“Women and men ages 27 to 45 continue to be at risk for acquiring HPV, which can lead to cervical cancer and certain other HPV-related cancers and diseases. We look forward to working with the FDA on the review of this application for GARDASIL 9, which, if approved, would enable more people to have access to the vaccine.”

Serious reactions to Gardasil (and Cervarix, another HPV vaccine), including autoimmunity, brain dysfunction and infertility, have been reported in the U.S. and countries around the world and are documented in the medical literature.

As of July 2018, there have been more than 57,000 HPV vaccine adverse events reported to the federal Vaccine Adverse Event Reporting System (VAERS) since 2006, including more than 15,000 emergency room visits, 5,600 hospitalizations and 358 deaths.

Reported reactions include syncope (sudden loss of consciousness), Guillain-Barre Syndrome (GBS), seizures, acute disseminated encephalomyelitis (ADEM), rheumatoid arthritis, lupus, thyroid disorders, deep vein thrombosis and blood clots, pancreatitis, postural orthostatic tachycardia syndrome (POTS), disabling fatigue, muscle and joint pain, memory loss and speech problems.

In June 2006, the National Vaccine Information Center (NVIC) publicly criticized the FDA for fast-tracking Gardasil to licensure before it had been fully evaluated for serious side effects and recommended for all 11- to 12-year-old girls by the Centers for Disease Control (CDC).

Merck’s prelicensure clinical trials used an aluminum-containing “placebo,” even though aluminum is an ingredient in Gardasil and can cause inflammation and nerve cell death.

The next year, Congress passed the PRV legislation reinforcing and expanding the fast-track licensing process.

Merck is now the sole source manufacturer of HPV vaccine in the U.S.,

although the well-known reactivity of HPV vaccine, together with its questionable effectiveness, has resulted in low vaccine uptake because of a reluctance by parents to give the vaccine to their children.

There have been Gardasil vaccine injury lawsuits in Japan and France.

In 2016, judges in India’s Supreme Court demanded answers after children died during a trial of Gardasil and Cervarix vaccines.

In July 2018, the British Medical Journal published an indictment of a May 2018 Cochrane Collaboration clinical trial review of HPV vaccines that came to the conclusion that HPV vaccines “do not increase the risk of serious adverse events, miscarriage or pregnancy termination.”

A trio of well-credentialed epidemiologists wrote the BMJ critique, detailing how the Cochrane group in charge of the review cherry picked 26 randomized clinical trials — all funded by vaccine manufacturers — to include in the review.

Charging that the Cochrane review could not be considered “trusted evidence” because it was influenced by reporting bias and biased trial designs, they pointed out that Cochrane used the biased review to publicly pronounce that HPV vaccine “causes no serious side effects,” even though the published review incompletely assessed serious and systemic HPV vaccine adverse events and failed to assess vaccine-related safety signals.

The muddy record of HPV vaccine safety and parental resistance is clear and federal health officials are planning to use taxpayer money to launch a stepped-up nationwide HPV vaccine promotion campaign in the U.S.

At the same time, Merck is still determined to get its money’s worth by selling Gardasil in other countries, like Australia and China.

The recent request to FDA to fast-track an expanded use license for Gardasil is not Merck’s first attempt to enlarge the patient pool and market for its lucrative HPV vaccine. After a priority review in 2008, the FDA rejected the company’s application for Gardasil approval in females aged 27 to 45 years. But Merck is nothing if not persistent.

A dose of Gardasil costs between $168 and $205 in the U.S.

Like many drugs that enrich the drug industry due to high prices, much of Gardasil’s development was funded by the U.S. government and taxpayers, and the vaccine continues to receive taxpayer funding.

In 2013, the NIH gave half a million dollars to the University of Texas SW Medical Center Dallas to try to “identify an optimal and feasible self-persuasion intervention strategy to promote adolescent HPV vaccination in safety-net clinics” also known as “sell more vaccines.”

Nor was that the only marketing grant.

The University of Texas El Paso received $422,716 from the NIH to do similar free marketing and “pilot test a future intervention to promote adoption of the HPV vaccine in the Latino community” while “considering cultural factors.”

In fiscal years 2013/2014, Yale University received $390,389 from the NIH to “identify and describe barriers to HPV vaccination completion among lower income racial and ethnic minorities” and “generate ideas for future interventions that will be culturally relevant and have the greatest potential for impact.”

In 2017 and 2018, NIH (National Cancer Institute) awarded Vanderbilt University Medical Center $1,173,628 to fund a study project entitled “Increasing HPV Vaccine Uptake in Community-Based Pediatric Practices” for the purpose of identifying “the optimal approach to implementing an evidence-based intervention for the uptake and completion of HPV vaccine among adolescents receiving care in the community, guided by implementation science theory.”

In plain language, it means that the NIH grant is being given to a Vanderbilt researcher to develop strategies to sell more Gardasil vaccine. The problem, according to the grant is, “despite clear and indisputable value in cancer prevention, uptake and completion of the HPV vaccine series has lagged far behind the goal of 80%.”

The federal government helping the drug industry to market more vaccines is not limited to Gardasil and HPV vaccines. Another grant, this one to Emory University for $767,107 for fiscal year 2017, targets pregnant women and their children for vaccination using sophisticated sales and marketing techniques.

The Emory grant reads, “Overall, the proportion of children not receiving all recommended vaccines or whose parents are consistently limiting visit-level vaccine administration is increasing … Additionally, despite evidence showing the effect of vaccinating pregnant women in reducing disease among infants too young to be fully vaccinated, maternal immunization rates remain low.”

Grantees at Emory will explore how to sell more vaccines by using “vaccine champions, expanded reminder-recall systems,” “standardized talking points” and “interactive tablet computer (iPad) education application for pregnant women to view while waiting for care.”

Vaccine hesitancy and refusal are being addressed with a five-year NIH grant for $1.7 million to Georgetown University researchers working with researchers from University of Georgia, Pennsylvania State and Emory University “to identify areas of the country where vaccine refusal is on the rise.”

A Georgetown University press release announcing the NIH grant in November 2017 stated, “With anti-vaccine activists growing in number and influence in recent years, public health professionals have become increasingly interested in identifying where and why people refuse vaccines and how this behavior drives the spread of vaccine-preventable disease.”

Although the CDC tracks rates of vaccine refusal at the state level, the grant will be used to utilize datasets that can track vaccine refusal at the ZIP code level.

Georgetown’s lead researcher on the grant commented, “While there is previous work on what motivates individuals to engage in vaccine hesitancy, we don’t know much about the populations that tend to have higher rates of this behavior. But public health policy is made at the population level. And our work will help us understand how to design and target effective population-level policies.”

Finally, at least one NIH grant suggests that the federal agency is going to take a look at vaccine safety knowledge gaps associated with the childhood vaccine schedule, which vaccine safety advocates have spoken about for years.

Those big gaps in vaccine safety research were highlighted by the Institute of Medicine in a 2013 report, “Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence and Future Studies.”

Acknowledging that “a few of the existing studies show that there are cases in which the risk of adverse events depends on the vaccine schedule used,” NIH has awarded a grant of $392,999 to Harvard Pilgrim Health Care Inc. to evaluate the safety of the federally recommended childhood vaccine schedule and alternative schedules.

Researchers will evaluate “the timing of individual vaccines; the timing between doses of the same vaccine; the interaction effect between vaccines and concurrent health conditions or pharmaceutical medications; the interaction effects of different vaccines given on the same day; the ordering of different vaccines; and the effect of cumulative summary metrics such as the total number of vaccines or the total amount of some vaccine ingredient.”

The NIH-funded project will also cover “study designs for the comparative evaluation of the CDC recommended schedule, popular alternative schedules and completely unvaccinated children. Methods will be developed for both adverse events with an early onset, which are the easiest to study, and for adverse events with a late onset, including serious chronic conditions.”

So, while giving the green light to speedy vaccine approvals and aggressively marketing vaccines that yield big profits for drug companies, public health officials know there are outstanding questions about just how safe government recommended vaccines really are for infants and children being required by law to use them.

It will be interesting to see if the design of the NIH-funded study designed and conducted by Harvard Pilgrim Health Care Inc., a corporate partner with CDC, will truly qualify as good science the public can trust, or if it will turn out to be just another transparent sales pitch that wastes the taxpayers’ money.

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